TW527195B - Fast-soluble solid pharmaceutical combinations - Google Patents

Abstract

Fast-soluble solid preparations which are quickly disintegrated and solublizied in water-limited adminsteration place such as oral cavity, etc. are provided. One kind of the fast-soluble solid preparation is obtained from subjecting drug, sugar with solubility against 100 g water at room temperature is below 30 g and sugar with solubility against 100 g at room temperature is above 30 g dissolve and mix in the amount of water which can not totally dissolve the sugar with solubility against 100 g water at room temperature is below 30 g, then removing water. Also, other kinds of the fast-soluble solid preparation are obtained from drug. Sugars and polyvinylpyrrolidone dissolving and/or dispersing in the aqueous solution of sugar, then lyophilizing. Since these will be easily take for the patient of swallow-suffered, elder people and children, then improvement of compliance is expected.

Description

527195 Printed by the Consumer Standards Cooperative of the Central Bureau of Standards Department A7 V. Description of the Invention (,) Technical Field The present invention is a fast-dissolving solid preparation, in particular, it is a favorite place for limited use of water in the oral cavity, etc., quickly. Collapse and dissolve fast soluble solid preparation. Background Art In the past, for patients who have difficulty in swallowing medicines, elderly people, or children, the development of a solid preparation that rapidly collapses and dissolves in the oral cavity in the form of an easy-to-take preparation has been developed. For example, in the respective publications of Chikai Kai 53-446 19, Chikai Kai 58-113121, Japanese Patent Laid-Open No. 3-56412, Chikai Kaihei 3-86837, and Tobei Hei 9-502622, it is proposed to use a freeze-dried solid preparation. In addition, in JP-A-Heisei 2-32014 or JP-A-Heisei 5-271054, it is proposed to use a solid preparation of a wet fragrant obtained by press-molding a wet preparation powder under low pressure and drying. Moreover, Yukai Sho 58- 1 94808, Hiroki Hei 6-502 1 94, JP-A 5-310558, JP-A 8-99904, JP-A 8-208520, JP-A 8-208521, JP-A 8-333243 In each of JP-A-9-71523, it is proposed to use a compression-molded solid preparation that dissolves and collapses in the oral cavity. Also, in WO 93/12769, a solid preparation obtained by dispersing a mixed powder of a drug with lactose and / or mannitol in an aqueous solution of agaric, filling it with a template, and then drying it is proposed. However, the previous formulations proposed above have not been described as sufficient in terms of formulation, and they contain various problems. For example, in the manufacturing method of pressure molding, not only the usual compression molding, but also the method of making wet tablets can also increase the hardness, but the paper size obtained through this method applies the Chinese National Standard (CNS) Λ4 Regulations (210X 297 male f) „— ^ — 1 ^ —4 ^ Water ------, order ----- (Read the precautions on the back before filling this page) 527195 A7 Η 7 V. Explanation of the invention (> Loss, or when the solution is dissolved, the internal cavity will change and the cavity will be broken, and the disintegrating agent, soil disintegrate and dissolve, the internal cavity will not be drooling, and the agent must be prepared. Time is easy to change, and it is easy to change, and it is easy to change and change. The physical properties are fixed and used for damage, and also »» The color rate change and the large rate gap of ground security. The empty is the method of making the agent dry. C ο Blow the cold and use it, etc., the agent of the complex to the colony phase is a hard agent 0 0 because of the,, the speed is faster, the constant is not included For the purpose of sexual dissolution, the solution is highly soluble, and the cavity is 0 mouths in the same way as the reason agent pine afl-3ttflo. The operating temperature and wet pipe high heat preservation agent are highly controlled. It is easy to be special in the ordinary place. 〇 The soil with high quality and difficult materials is easy to be brittle and wet. It is absorbing, so it has a low degree. The system changes to the shape of the agent, etc. The instructions on the preparation of the hand with wet sticking are also made by the agent, and the piece of service is only used when the residence is in the field. First read the notes on the back and then fill out this page to fix the cavity in the fast-fixing and fast-solving isokinetic mouth. Use the point to answer the question, you can provide the final solution, and provide the solution. It is shown as a solution to the problem of dissolving and dissolving, and the bad and bad is the legal system A3, and f agent 0. It is printed by the Ministry of Standards Bureau employee consumer cooperatives, and the order for the medicine is changed from the supply to the state. The mega class of Mingfa Ben is a gram of sugar that is dissolved under the degree of ο 3 as the degree of dissolution. Ο 1 Water is dissolved in gold in the lower greenhouse, and the type of sugar is 30 grams per gram. The solution of 30 is the solution of solubility, and the solution of 00 is 10 The water temperature can be obtained from the solid solution under the room and the warm shape. After the water is removed, the amount of water in the water is 0. The polysaccharide and the sugar-like substance are ordered from the supply to the I state. Zhimingfa and this paper are in accordance with Chinese National Standards (CNS) Λ4 gauge (210 × 297 ^^) 527195 A7 B7 V. Description of the invention (4 The solid machine is soluble in sugar. After the order is taken out, the separated powders are dried and thawed for drying and thawing. It is solid in the cold state, and it is made in the form of a solid solution. The three-part machine can be solid or insoluble. In the solution of Rongming and ketone, the solvent can be quickly dissolved. The solid-state isotropic agent dissolves in the dissolving speed machine, or the liquid-three-soluble water is in the state, and the form 1 is the sugar state and the shape of the substance is best used for medicine. It is clear that _ the hair and hair tools are made in shape and form _ dry speed matter into the middle group C state floating _ shape suspension three types of shape are fixed to make the character and dissolve and speed one, the first thing wants some accomplishment This group has to make a clear statement. As a special agent, a special agent made by Huizhang, it is a solid form, and it is used to dissolve dryness. (Read the precautions on the back before filling in this page.

1T The fast-dissolving solid preparation in the first form provided by the present invention, one of the aspects is that the drug has a solubility with 100 g of water at room temperature and a solubility of 30 g or less at room temperature and 100 with water at room temperature. An instant soluble solid preparation obtained by mixing water having a solubility of 30 grams or more and 100 grams of water having a solubility of 30 grams or less in water at room temperature as an incompletely dissolved amount of water and removing water. Specifically, such fast-dissolving solid preparations are prepared by adjusting the drug to 100 g of water with a solubility of 30 g or less in water at room temperature and 100 g of water with a solubility of 30 g or more to water at room temperature. The saccharides having a solubility of 30 g or less in 100 g of water are mixed with water having an incompletely dissolving amount to obtain a milky suspension, and the suspension is then filled into a template for a preparation and then manufactured by removing water. This paper size applies to Chinese National Standard (CNS) A4 regulations (210X297 male f)% Printed by the Consumers 'Cooperative of the Central Standards Bureau of the Ministry of Printing 527195 Printed by the Consumers' Cooperative of the Central Standards Bureau of the Ministry of Printing A7 B7 V. Description of the invention ( 4) Alas, the first fast-dissolving solid preparation provided by the present invention is a combination of saccharides with low solubility in water for drugs, and saccharides with high solubility in water, used as a water strip suspension. After the milky composition, the moisture is removed to make it special. According to the review by the inventors, if the drug is only combined with sugars with low water solubility, the resulting suspension cannot become the desired milky composition, and the drug and sugar are separated from water when filling And cannot be filled evenly. Furthermore, the surface of the solid preparation after drying the composition has unevenness, and it lacks practicality as an actual preparation. B—On the other hand, the composition that combines the drug with only water-soluble sugars is a composition in the form of an aqueous solution, and it cannot be dried into a solid preparation under room temperature air supply and reduced pressure drying. It also takes a lot of time to dry and lacks productivity. Surprisingly, however, it was found that for medicines, a combination of tadpoles with low solubility in water and sugars with high solubility in water was combined to form a milky composition of a water strip suspension, and this composition was used in The solid preparation obtained by ventilating and drying at room temperature or removing moisture under reduced pressure has a hardness that is resistant to practical use, and can quickly collapse and dissolve in the oral cavity and the like without taking it with water. Manufacturing process, and if necessary, the content of the drug can be increased. In the form provided by the present invention, the saccharides having low solubility in water used in the instant solid preparations are saccharides that are soluble in a large amount of water but not in a small amount of water, that is, a solubility of 100 grams of water at room temperature. For sugars below 30 grams. As long as you have such solubility, please read this (please read the notes on the back before filling this page).

I quasi-standard home country I use moderate rule paper

Ns 527195 Printed by A7 Consumers' Cooperative of Central Standards Bureau of the Ministry of Economic Affairs 5. Description of Invention (,) The type of 耱 is not particularly limited. Specific examples include milk 耱, mannitol, etc., which can be used alone or in combination. The above is for use. In addition, for sugars having high solubility in water, at room temperature, and sugars having a solubility of 30 grams or more for 100 grams of water, as long as such sugars have such solubility, the type of the sugar is not particularly limited. Specific examples of such sugars include fructose, glucose, sucrose, xylose, trehalose, xylitol, sorbitol, erythritol, dextrin, and branched starch. These sugars may be used singly or in combination of two or more kinds. It can also be used in powder form, or it can be redissolved in water to form an aqueous solution, and it can also be added to a mixed powder of drugs and sugars with low water solubility. In the present invention, the mixing ratio of the above-mentioned low-water-soluble sugars with high-water-soluble sugars used in combination with drugs is determined by the inventors and others to determine the weight ratio of solids as In the range of 95: 2 ~ 80: 20, it is better to maintain rapid soil collapse and solubility, and it can be dried in a short time during manufacture. Furthermore, in the present invention, the amount of saccharides with low solubility in water and saccharides with high solubility in water used together with drugs in the formulation is based on the properties of the drugs used and the combined Additives vary. However, in order to maintain practical hardness and rapid solubility, in general, the total solid content of the solid preparation is preferably 40% by weight or more, and more preferably 60% by weight or more. On the other hand, although the content of the drug contained in the solid preparation of the present invention is also based on the amount of each dose taken and the physicochemical properties of the drug, it is preferably 60% by weight or less of the total solid content, and even more preferably all The solid paper size is applicable to the Chinese National Standard (CNS) Λ4 specification (210 '乂 297mm 牦) --- · --1 ^ --- clothing ------ order ----- (read first read the back (Notes on this page, please fill in this page) 527195 Printed by the Central Bureau of Standards of the Ministry of Industry and Technology Co., Ltd. A7 1Π 5. Description of invention (k) 40% by weight or less. Furthermore, in the first aspect provided by the present invention, a preferred specific aspect of the instant solid preparation is a drug in which the total solid content is 60% by weight or less, and preferably 40% by weight or less. 100 grams of water with a solubility of less than 30 grams of saccharides and 100 grams of water with a solubility of 30 grams or more at room temperature, with a solid content weight ratio of 98: 2 ~ 80: 20, and using more than 40% by weight of all solid content, It is preferably 60% by weight or more, and is a fast-dissolving solid preparation obtained by mixing water with an incompletely dissolved amount of saccharides having a solubility of 30 g or less to 100 g of water at room temperature and removing water. The size and shape of the instant soluble solid preparation in the first aspect of the present invention are not particularly limited. For example, granules, pills, lozenges, suppositories, etc. can be prepared in the usual preparation form, and among them, it is also preferable to prepare lozenges. The manufacturing method of such an instant solid preparation can be specifically performed as follows. That is, after adding purified water to a mixed powder of a drug, a sugar having low solubility in water, and a sugar having high solubility in water, and adding it to a milky suspension, the suspension is filled into a desired preparation template. For example, in the cavity of the concave template, the solid preparation can be obtained by drying. However, a mixture of a drug and a carbohydrate having high solubility in water can also be dissolved and added in purified water. The drying to remove moisture from the suspension can be carried out by air-drying at normal temperature or by drying under reduced pressure. The instant soluble solid preparation of the present invention having the first form manufactured according to such a manufacturing method does not specifically adopt the processes of pressure molding and freeze drying, etc.-This paper size applies the Chinese National Standard (CNS) Λ4 Regulations ( 210X297 public) (Please read the notes on the back before filling this page)

527195 A7 B7 V. Description of the invention (?) The solid preparation that quickly collapses and dissolves in the oral cavity. On the other hand, one of the aspects of the fast-dissolving solid preparation in the second aspect provided by the present invention is to remove the organic solvent by dissolving and dispersing the drug, sugar and polyethylene-fedrolidone in an organic solvent. The obtained fast-dissolving solid preparation. Specifically, such a fast-dissolving solid preparation is obtained by dissolving and dispersing a drug, a saccharide, and a polyvinylpyrrolidine surface in an organic solvent to obtain a suspension, and then filling the suspension with a template for the preparation, and then removing the organic solvent. Manufacturing. That is, the fast-dissolving solid preparation in the second aspect provided by the present invention has a special feature of using a saccharide and polyvinylpyrrolidone in combination with a drug, and dissolving and dispersing it in an organic solvent, and then removing the organic solvent. In this second aspect, the saccharide used in the instant solid preparation is not particularly limited as long as it is soluble in water. Examples of such saccharides include monosaccharides, disaccharides, oligosaccharides, sugar alcohols, reducing sugars, isomerized sugars, and the like. More specific examples include glucose, fructose, lactose, maltose, M sugar, xylose, trehalose, dextrin, sorbitol, xylitol, and mannose (read the precautions on the back before filling out this page)

， \ = 口 纛 In the case of printing by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs, the quality of hard breeding is better for some applications. The same medicine is divided into two parts, which are sugar-resistant and tangible. Two medicines are used to hold the lettuce and the protected lettuce. According to the whole, C is the alcohol agent. Emulsion milk is made, chemically prepared, and the amount of deformation is changed to 9 alcohols. _ Buds are added with the sexual formula of one wheat seed, and the two-speed medium-speed alcoholic agent is added to dissolve the sugar. Moss may be issued in the same speed, mono-sugar, and co-alcohol, which can be reconciled with the standard of Chinese paper ((milk) / \ 4 size (210 '漦 297 gong)), which is the same as the paper size. 527195 A7 Ministry of Economic Affairs Central Standards Bureau staff consumer cooperatives printed 15 but if the solution is dissolved, the supply is reconstituted into solids under the solid system, the system is made to order, and the solvent is dissolved into 40 parts. , The agent is difficult. Although the solid part of the molding part is solid, the total amount of the soluble alcohol solution in the t part is solidified and the alkylene is dissolved in a solid amount, and the organic solvent is contained in a B agent. The system has the order to be mixed, and full-speed 60 shape and gather. Pycnidol is a good medicine in the form of solids and solids, and the solution is added to the olefin »° Solid dispersion is better than water in the middle class %% mn32 ^ tt State into a full Μmachine. % Polymerization ο Dissolve, dissolve, dissolve, dispose, and reshape with a dose of the speed-speed-2 solution, which can be intermediate, two solid, the 15 liquid system reused the same as the fast dissolving solution What is the best part of the agent? Conformation 60 makes the Republican ketones better. The drug is better than the whole drug% M. It is mixed with the same degree of compatibility and the shape of the alkane is very soluble and the amount of U is 0. Its solid-liquid solid content is lowered to lower weight_water soluble -1, which is a good dipyridine, which has a good combination. It is used in the same way as 60% and speed, and the use of sugar is lower than that of ketones. Ming state ¾ is 'alcohol'. Ethyl pyridine is limited to physical distribution. This is the best amount to issue. The weight is good. B is f. The drug is cost-effective. «1 or take-% of the medicinal data can be in the form of acetic acid and 40, ο alcohol in the noodles, and the amount and dependence of the alcohol. The amount is similar to ignorance and weight, it is better to be on the top -2 dry and dry, although the insurance department% and sugar order are issued, 30 a weight per minute and preferably 1 to dry M40, the whole amount is more, more The weight of this paper is 40%, which is more than 40%. The weight of 4 is the weight of the medium-shaped agent, the amount of ketone is divided, and the five paper sizes apply the Chinese National Standard (CNS) Λ4 specification ( 210X 297 ^ " y (Read the precautions on the back before filling in this page)

Printed by the Consumers' Cooperative of the Central Standards Bureau of Didi Department 527195 A7 Η 7 V. Description of the Invention (9) The size and shape of the instant solid preparation in the second form of the present invention are not particularly limited. For example, granules, nine preparations, lozenges, suppositories, etc. can be prepared in the usual preparation form. Among them, lozenges are also preferable. The manufacturing method of such an instant solid preparation can be specifically performed as follows. That is, add an organic solvent to the mixed powder of drugs, sugars, and polyvinylpyrrolidone to make a dissolved and dispersed suspension, and then fill this suspension into the desired preparation template, for example, in the cavity of the concave template, and obtain it by drying. Purpose solid preparation. It is also possible to dissolve polyvinylpyrrolidone in an organic solvent and add it to a mixed powder of medicine and sugar. The drying can be performed by air drying at normal temperature or by drying under reduced pressure. The instant soluble solid preparation of the present invention having the second form produced according to such a manufacturing method does not specifically adopt processes such as pressure molding and freeze-drying, but obtains a solid preparation that rapidly collapses and dissolves in the oral cavity. One of the aspects of the fast-dissolving solid preparation in the third aspect provided by the present invention is the fast-dissolving solid preparation obtained by dissolving and / or dispersing the drug in an aqueous solution of sugars and freeze-drying. That is, when the present inventors reviewed the above-mentioned first and second forms of the fast-dissolving solid preparations, and added the solid-form preparations that dissolve rapidly in an environment with little water such as in the mouth according to the freeze-drying method, they found that In aqueous solution of various excipients that can dissolve or disperse the drug, it can also be lyophilized in a short period of time. It is specifically formulated using lactose, trehalose, mannitol, sorbitol, erythritol, dextrin, etc.耱 -type aqueous solution is used as an excipient, and in this aqueous solution, the drug is dispersed and / or dissolved and cold -11- This paper size applies to Chinese national standards ([milk] / \ 4 gauge (210/297)) ( (Please read the notes on the back before filling out this page)

, 1T Printed by the Consumer Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs 527195 A7 B7 V. Description of the invention (,.) Freeze-drying is acceptable. Furthermore, it has been found that when the concentration of the aqueous solution of saccharides for dispersing and / or dissolving the drug is in the range of 10 to 30% by weight, the freeze-dried solid preparation can be given a degree of hardness that can withstand practical use, and can be rapidly obtained in the oral cavity. Solubility. Moreover, in the third aspect provided by the present invention, a preferred aspect of the instant soluble solid preparation is one selected from lactose, trehalose, mannitol, sorbitol, erythritol, and dextrin, or In a 10 to 30% by weight aqueous solution of two or more kinds of saccharides, the drug is dissolved and / or dispersed, and the fast-dissolving solid preparation obtained by freeze-drying is particularly preferable. The aqueous solution of the hydrazone type that dissolves and / or disperses the drug is trehalose. And / or a fast-dissolving solid preparation of an aqueous dextrin solution. Specifically, such a fast-dissolving solid preparation is prepared by dissolving and / or dispersing a drug in an aqueous solution of a saccharide to form a suspension composition. Next, the composition is filled with a template for a preparation and freeze-dried. That is, the third fast-dissolving solid preparation provided by the present invention has the characteristics of dissolving and / or dispersing a drug in an aqueous solution of a specific carbohydrate having a predetermined concentration, and freeze-drying it. In this third form, the saccharides used in the instant solid preparation are preferably lactose, trehalose, mannitol, sorbitol, erythritol, and dextrin, and they may be used alone or in combination. The above is for use. Among them, trehalose and / or dextrin are preferred. In the present invention, if trehalose and / or dextrin are used as sugars, for example, a large lozenge shape having a diameter of about 20 niffi can be obtained. The solid preparation of hardness, therefore, it can be seen that it can also cope with a large amount of medicine taken per day. Still, the Institute of the Invention -12- This paper size is applicable to Chinese National Standard (CNS) Λ4 gauge (210X297 male f) (Please read the precautions on the back before filling this page)

527195 A7 V. Description of Invention (υ) The content of the drug contained in the solid preparations varies according to the amount of each drug taken and the physical properties of the drug, and is not particularly limited. In addition, it is learned that the less the content of the hydrazone solution, the lower the hardness of the freeze-dried solid preparation, and the higher the sugar content, the higher the hardness, which takes time for freeze-drying and the dissolution time of the solid preparation. long. Therefore, in the present invention, these sugars are preferably dissolved in water at 10 to 30% by weight, particularly preferably at 15 to 25% by weight. In the third aspect of the present invention, the fast-dissolving solid preparation is preferably added with a dispersant described later when the drug is not completely dissolved or dispersed in an amidine solution. The dispersant is not particularly limited as long as it can disperse the drug until the suspension is freeze-dried after preparing the suspension. Particularly preferred examples of such dispersants include alpha-starch, partially alpha-starch, sodium carboxymethyl starch, methyl cellulose, hydroxypropyl methyl cellulose, hydroxypropyl cellulose, and carboxymethyl cellulose. Sodium, gum arabic powder, gum tragacanth, gum glutinous steel, gum gum, pectin, arabinogalactan, papaya, locust bean gum, guar gum, tamarind polysaccharides, alginic acid, carrageen Gum, Faslerane, xanthan gum, Cadran, casein, amylopectin, polyvinylpyrrolidone, polyvinyl alcohol, which can be one or this paper size applies Chinese National Standard (CNS) Λ4 Regulations (210X 297 public) ( (Please read the notes on the back before filling out this page)

In addition, the preparation agent is small, and the preparation is usually made with a flux of α. The amount of α agent is used to make the weight dry. The CO can be dried and frozen, and the liquid may be frozen. If the liquid is not soluble, the speed may be suspended. Because of the regularity in the middle, the intermediate tense state is 3-. The amount is in the form of short form -1. Adding% in San Wu makes the amount of addition can also provide the weight and kind of agent 1. This form is based on the loose nature of the drug. Printed by the Central Standards Bureau of the Ministry of Economic Affairs and printed by the Consumer Cooperatives of the Ministry of Economic Affairs. Printed by the Central Consumers Bureau of the Ministry of Economics and printed by the Consumer Cooperatives of the Central Standards Bureau. 527195 Α7 Β7 V. Description of the invention (π) Granules, pills, lozenges, suppositories, etc. in the form of rain Among them, it is better to make lozenges. The manufacturing method of such an instant solid preparation can be specifically performed as follows. That is, a dispersant as needed, and other additives such as flavors and sweeteners described later are dissolved and / or dispersed in an aqueous solution of sugars together with the drug to form a suspension composition. Next, this composition is filled to the desired The preparation template, such as the cavity of the concave template, can be freeze-dried to obtain the intended solid preparation. The fast-dissolving solid preparation of the third aspect of the present invention manufactured by such a manufacturing method has a practical hardness, and has a disintegration and solubility in the oral cavity and the like even if it is not taken with water. Quick emblem. There are no particular limitations on the types of drugs used in the instant soluble solid preparations of the first to third aspects provided by the present invention, and various drugs can be blended. Representative examples of such drugs include the following drugs. Eye sedatives, antiepileptics, antipyretics, analgesics, anti-inflammatory drugs, stimulants, awakening drugs, sedatives, neuropsychiatric drugs and other central nervous system drugs; skeletal muscle relaxation drugs. Autonomic nerve drugs, autonomic nerve group medication, plant preparations Peripheral nerve medications; ophthalmic medications, otolaryngology medications, and other sensory organ medications; cardiotonic medications, irregular pulse medications, diuretics, antihypertensive medications, vasoconstrictors, vasoconstrictors, vasodilators, and arteriosclerosis medications. Furthermore, it can be used for respiratory organs such as breath-promoting drugs, antitussive and expectorants, etc. This paper is applicable to Chinese National Standards (CNS) A4 Regulations (210 × 297 公 #) (Read the precautions on the back before filling in this page, -ut 527195 A7 printed by the Consumer Cooperative of the Central Standards Bureau of the Ministry of Lithology 5. Description of the Invention (d) Medicines; Peptic ulcer medicines, stomach digestion medicines, antacids, lowering agents, choleretics, intestinal medicines and other digestive organ medicines ; Hormones, anti-hormones and other hormones; urinary urinary disinfectants, uterine contractions, urogenital drugs. Hemorrhoids, anal drugs, and other urogenital and anal drugs; vitamins, nourishing strong modifiers, blood and Metabolic medicines such as body fluid medicine, liver disease medicine, detoxification medicine, habitual poison medicine, ventilation therapy agent, enzyme preparation, urination medicine medicine, etc .; cell activation medicine, tumor medicine, etc. Antibiotics, chemotherapeutic drugs, antiprotozoal drugs, insect repellent drugs, etc. Anti-pathogenic drugs; biological tampon drugs, non-biological tampons Anesthetics, etc. These drugs can be used alone or in combination of two or more. These drugs can be solid, powder, or liquid. If solid drugs are finely pulverized, etc., and used as powders, they can be used in the oral cavity. It disintegrates internally, feels smooth when dissolved, and has a good feeling of taking. In addition, the medicine used in the present invention can also be microcapsules, cutballs, millicapsules, and milliballs. Two or more drugs are arranged in another layer. The fast-dissolving solid preparations in the first to third forms provided by the present invention can, in any case, not cause its disintegration, solubility and hardness to deteriorate significantly. Within the scope, other compounding ingredients, and natural or synthetic high molecular compounds as dispersants are added. Also, if desired, any one or more sweeteners, sour agents, spices, and colorants can be further compounded. Such natural or Specific examples of synthetic polymer compounds include starches such as potato starch, corn starch, rice starch, wheat starch, α-chemical starch, partially ot-chemical starch, sodium carboxymethyl starch, and hydroxypropyl starch. Their derivatives This paper scales applicable Chinese National Standard (CNS) A4 size (210X297 male #) (Please read the notes and then fill in the back of this page)

Printed by the Consumers' Cooperative of the Central Standards Bureau of Didi Ministry 527195 A7 B7 V. Description of the invention (4) Biological; crystalline cellulose, methyl cellulose, low-substituted hydroxypropyl cellulose, ethyl cellulose, carboxymethyl fiber Cellulose, calcium carboxymethyl cellulose, sodium carboxymethyl cellulose, sodium carboxymethyl cellulose with low degree of substitution, croscarmellose sodium, cellulose acetate, cellulose acetate phthalate, hydroxymethyl methyl Cellulose phthalate, hydroxypropylmethylcellulose acetate succinate, carboxymethylethylcellulose, crystalline cellulose, cellulose such as sodium carboxymethylcellulose, and derivatives thereof. In addition, gum arabic powder, gum tragacanth, gum sycamore, gum, gum, pectin, arabinogalactan, papaya, locust bean gum, guar gum, tamarind polysaccharides, alginic acid, carrageenan Natural polymer compounds such as carrageenan, Faselerane, xanthan gum, Cadran, casein, amylopectin, albumin, etc .; polyvinylpyrrolidone, polyvinyl acetate, polyethylene glycol, polyvinyl alcohol, amino alkyl methyl Acrylic acrylate copolymer E, amine alkyl methacrylate copolymer RS, methacrylic acid copolymer S, carboxyvinyl polymer, polyvinyl acetal diethylamino acetate, dimethylpolysiloxane Synthetic polymer compounds such as alkanes. Specific examples of the sweetener include glycyrrhizin, disodium glycyrrhizinate, trisodium glycyrrhizinate, snake daisy, stevia alfalfa, Levo d i a s i de, saccharin, sodium saccharin, and aspartame. In addition, specific examples of the sour material include citric acid, tartaric acid, and malic acid, and specific examples of the flavor include strawberry, lemon, citrate, orange, mint, and peppermint oil menthol. Specific examples of the coloring material include Examples include caramel, Anato extract, / 3-carotene, and Beet Red. -16- This paper size applies Chinese National Standard (CNS) Λ4 Regulation (210X 297 male f) (Please read the precautions on the back before filling this page)

1T.0 Printed by the Consumer Standards Cooperative of the Central Standards Bureau of Didi Ministry 527195 A 7 B7 V. Description of the Invention () Examples The following examples are given to explain in more detail the first to third forms provided by the present invention. A fast-dissolving solid preparation, but the present invention is not limited by these examples. A: 笛 一 FORM 的 谏 解 # 因 形 馎 面 啻 旃 Example 1 37.5 g of tetrafluorosulfan (Quazepam), 415 g of mannitol, 5 g of aspirin and 2.5 g of menthol are evenly mixed. Next, a solution of 40 g of sucrose mixed with 200 g of purified water was added to the mixed powder to obtain a milky suspension. This suspension was filled with 280 mg each into a concave cavity having a diameter of 9 μm, and dried at 301 C for 24 hours to obtain the instant soluble preparation of the present invention. To make a toilet—2_, mix 37.5 grams of tetraflurane diazepam, 415 grams of mannitol, 5 grams of aspirin, 2.5 grams of 1-menthol and 40 grams of sucrose. Next, a liquid suspension of 200 g of purified water was added to the mixed powder to obtain a milky suspension. This suspension was filled into concave cavities with a diameter of 9am with 280 mg each, and air-dried at 3010 for 24 hours to obtain the instant soluble preparation of the present invention. m.MJSL2u Meclizine Hydrochloride, 2 grams of maleic acid aniline, 20 grams of pyridoxine hydrochloride, 452 grams of mannitol, 400 grams of lactose, 24 grams of aspartame and 1-menthol 12 grams of alcohol are evenly mixed, and mixed in 80 grams of sucrose dissolved in 420 grams of purified water. This paper size applies the Chinese National Standard (CNS) A4 specification (210X297). (Please read the precautions on the back before filling in this. page)

527195 Printed by the Central Bureau of Standards, Ministry of Work, Consumer Cooperatives A7 V. Description of Invention (4) Obtain a milky suspension. This suspension was filled with 365 milligrams of concave cavities with a diameter of llrain, and dried in aeration for 30 hours at 30 ° to obtain the instant soluble preparation of the present invention. Fenshi Example 4 1 g of wet sheep's root extract, 2 g of mountain plant extract, 7.5 g of rosin, 1.5 g of dried extract of Polygonum multiflorum, 4.5 g of dried extract of ginseng, 1 g of dried extract of Rehmannia glutinosa, and dried asparagus Extract, 0.5 g of diphenylthiamine. 0.5 g of pyridosyl sulfate, 123 mg of vitamins, 2.5 g of caffeine, 10 g of crystalline cellulose, 120 g of mannitol, 2 g of trehalose and 1.1 g of sucrose. 60 g of purified water was added to this mixed powder to obtain a milky suspension. This suspension was filled into concave cavities with a diameter of 201,018 with 219.6 mg each, and then air-dried at 301 C for 12 hours, and then dried under reduced pressure for 1 hour to obtain the instant soluble preparation of the present invention. ILIMJl 25g of Pirenzepine Hydrochloride, 160g of mannitol, 20g of lactose, 20g of sucrose, 20g of corn starch, 2g of aspartame, and 1g of 1-menthol are mixed and put into it Mix with 100 g of purified water to obtain a milky suspension. This suspension was filled into concave cavities with a diameter of llmin at 348 mg each, and then air-dried at 301 for 12 hours, and then dried under reduced pressure for 12 hours to obtain the instant soluble preparation of the present invention. Test Example 1 The hardness of each of the preparations manufactured in the above Examples 1 to 5 was measured with a Toyama Industrial Tablet Hardness Tester (TH-303RP type). Also, use-1 8 _ This paper size applies to China National Standard (CNS) A4 specification (210X297). (Please read the precautions on the back before filling this page)

527195 A7 Η 7 V. Description of the invention (π) Refined water is used as the test solution, and its collapse time is measured according to the Japanese Pharmacopoeia 13th Disintegration Test. Then, the dissolution time in the oral cavity was measured. The results are summarized in Table 1. Table 1: Hardness, disintegration time and dissolution time in the mouth Example hardness (Kg) (average of 10 値) Disintegration time (seconds) (average of 6) Dissolution time in the mouth (seconds) (of 3 persons) Average value) Example 1 6.62 66.0 53,3 Example 2 4.83 51.8 46.7 Example 3 3.54 37.3 38.0 Example 4 6.37 79 · 8 58.3 Example 5 8.73 23 · 2 47.3 (Please read the precautions on the back before filling in this (Page), 1T. Printed by the Central Bureau of Standards, Shellfish Consumer Cooperative, as the results in the table show, the solid preparation of the present invention has hardness and can withstand practical use, and the dissolution time in the mouth is about 1 minute. Within this range, it is understood that it is a particularly excellent preparation. Fenshi Example 6 25 grams of Diclophenac Sodium, 170 grams of mannitol, 12 grams of citric acid, 20 grams of corn starch, 2 grams of aspartame and 1 gram of spices, and mixed with sucrose 20 Gram dissolved in refined water Gram paper size Applicable to Chinese National Standards (CNS) Λ4 Regulations (210 ×? 97 公 #) Printed by the Shell Standard Consumer Cooperative of the Central Standards Bureau of the Ministry of Lithuania 527195 A7 B7 V. Solution for Invention (J) Mix in medium to obtain a milky suspension. This suspension was filled with 350 mg each into concave cavities with a diameter of 1 OBiffl and dried in the air at 30 ° C for 8 hours, and then dried under reduced pressure for 10 hours to obtain the instant soluble preparation of the present invention. Mix 20 grams of Piroxicam, 175 grams of mannitol, 12 grams of citric acid, 20 grams of corn starch, 2 grams of aspartame and 1 grams of spices, and dissolve in 20 grams of mochi in purified water 100 g of the solution was put into a mixture to obtain a milky suspension. This suspension was filled with 350 mg each into concave cavities with a diameter of 10 nm, and dried under ventilation at 30 ° C for 8 hours, and then dried under reduced pressure for 10 hours to obtain the instant soluble preparation of the present invention. Fenyu Example 8 25 grams of diphenylthiamine, 196 grams of mannitol, 2 grams of aspartame, and 2 grams of spices were mixed uniformly, and 20 grams of sucrose was dissolved in 120 grams of purified water and mixed to obtain milk. Like a suspension. This suspension was filled into concave cavities with a diameter of 10 inm at 365 mg each, and then dried in the air at 30 ° C for 8 hours and then dried under reduced pressure for 10 hours to obtain the instant soluble preparation of the present invention. The oral dissolution time of each of the preparations produced in Examples 6 to 8 was measured. The results are shown in Table 2. -20- This paper size applies Chinese National Standard (〇 奶) / \ 4 \ (210 乂 297 公 §) (Please read the notes on the back before filling this page)

527195 Α7 Β7 V. Description of the invention (π) Table 2: Intraoral dissolution time Example Intraoral dissolution time (seconds) (average of 3 persons) Example 6 26.3 Example 7 26. 7 Example 8 18.7 Which Clothing-(Please read the precautions on the back before filling this page), 11 As the results in the table show, the dissolution time of the preparation of the present invention in the oral cavity is also within 30 seconds, which can be understood as a special Excellent formulation. Β: Mirror-shaped shape Xixi 耱 Solution 袢 due to shape cutting Example 9: 施. 15 grams of tetrafluorosulfan stabilization, 169,5 grams of sucrose, 50 grams of corn starch, printed by the Consumers' Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs Mix 2 grams of aspirin and 0,5 grams of bubolol. Next, to this mixed powder, a solution of 12.5 g of polyvinylpyrrolidine garden dissolved in 150 g of ethanol was added and mixed to obtain a suspension. This suspension was filled with 400 mg each into concave cavities with a diameter of 9 μm, and dried under ventilation at 30 C, and then dried under reduced pressure for 12 hours to obtain the instant soluble preparation of the present invention. Fen_Example〗 0 ~ 啻 Steal example 1 9 Examples 10 to 19 use the sugars described below instead of the sucrose used in Example 9, and the others are treated in the same way to obtain the instant soluble system of the present invention. Applicable to China National Standard (CNS) Λ4 Regulations (210 x 297 males) 527195 A7 V. Description of Invention (%). Example 1 0 ... Trehalose Example 11 ... Mannitol Example 1 2 ... Erythritol Example 1 3 ... Sorbitol Example 1 4 ... Lactose Example 15 ... Powder reduced malt mash pulp Example 16 ... Mutyl alcohol Example 17 ... Grape mash Example 18 ... Fructose Example 19. Dextrin is the same as Test Example 1 By the method, the hardness of each preparation manufactured in Examples 9 to 19 was measured. The disintegration time and the oral dissolution time were measured. The results are summarized in Table 3. (Please read the notes on the back before filling this page

、 1T Printed by the Central Bureau of Standards, Ministry of Standards and Industry, Cooperating Cooperatives. This paper is printed in accordance with Chinese National Standards (CNS) A4 (210 × 297) # 527195 A7 V. Description of Invention (M) Staff Consumption of Central Standards Bureau, Ministry of Economic Affairs Printed by Cooperatives Table 3: Hardness, soil collapse time, and oral dissolution time Hardness (Kg) Disintegration time (seconds) Oral dissolution time (seconds) Example (average of 10 値) (average of 6 値) ( Average of 3 people) Example 9 1.56 8.0 37.7 Example 10 1.80 6 · 3 37 * 3 Example 11 2.12 6.3 18.3 Example 12 2.53 6,5 15.3 Example 13 2.01 9 · 5 31.0 Example 14 L95 7 · 2 16,3 Example 15 4.43 12.5 26.3 Example 16 2.88 6.5 13.3 Example 17 1.92 10 · 3 17.0 Example 18 3.59 16.3 31.0 Example 19 2.22 15 · 3 41.3 -23- (Please read the note on the back first Please fill in this page for further information), 1T This paper size applies the Chinese National Standard (CNS) Λ4 specification (210 × 297 public records) 527195 A7 V. Description of the invention (") As indicated by the results in the table, the preparation of the present invention is Hardness is also resistant to practical use and dissolves in the mouth Also between about 30 seconds, it is understood that the formulation is particularly excellent. Shi-yu Mix 15 grams of tetrafluorosulfanil, 177 grams of sucrose, 50 grams of corn starch, 2 grams of aspirin, 0.5 grams of menthol and 5 grams of polyvinylpyrrolidine. Next, 150 g of this mixed powder was added and mixed to obtain a suspension. This suspension was filled with 400 mg each into concave cavities with a diameter of 9 μm, and dried under ventilation for 3 hours at 30 υ, and then dried under reduced pressure for 12 hours to obtain the instant soluble preparation of the present invention. Example 2 1 Except that the amount of the curtain sugar of Example 20 was changed to 157 g, and the amount of polyvinylpyrrolidone was changed to 25 g, the same treatment was performed to obtain the instant soluble preparation of the present invention. Example 22 Except that the amount of sucrose in Example 20 was changed to 144.5 g and the amount of polyvinylpyrrolidine was changed to 37.5 g, the instant treatment was obtained in the same manner as in the present invention. After printing by the Central Standards Bureau employee consumer cooperative, the processing volume is the same. The amount of sugar cane is changed to 20 grams. Example 55 is used to change the amount of the _ alkane agent into a more variable sugar cane. 2 Examples In addition to the paper size applicable to Chinese National Standards (CNS) Λ4 Regulations (210 × 297 公 #) Slight ratio ffr 1X of ethylene polymer g 0 For comparison, take ethylene polymer to remove Λ g (please read the note on the back first) (Fill in this page again)

527195 A7 B7 V. Explanation of the invention (W) Other than pyrrolidone, the same treatment was performed to obtain the preparation of Comparative Example 2. Test Example 4 The same treatment as Test Example 1 was used to measure and measure the hardness and boron time of the preparations of the present invention prepared in Examples 20 to 22 and the preparations of Comparative Examples 1 and 2. The results are summarized in Table 4. (Read the precautions on the back before you fill out this page. Printed by the Ministry of Standards and Standards Bureau Consumer Cooperatives. Table 3: Hardness, disintegration time, and oral dissolution time. Hardness of polyvinylpyrrolidone (Kg). Collapse time (seconds) Adding amount of the examples (%) (average of 10) (average of 6) Example 20 2 1,03 6.0 Example 21 10 2.80 55.0 Example 22 15 5.83 58.0 Comparative Example 1 22 8.24 271.8 Comparative Example 2 0 0,30 1.2 As shown in the results of the table, the preparation of Comparative Example 2 without polyvinylpyrrolidine was very brittle. In addition, the preparation of Comparative Example 1 with a large amount of polyvinylpyrrolidine added collapsed. The soil time is longer than 4 minutes. Relatively, the paper size applies the Chinese National Standard (CNS) Λ4 Regulations (210X297 Gong), -5 mouths. Ju. 527195 Printed by the Shell Standard Consumer Cooperative of the Central Standards Bureau of the Ministry of Lithuania A7五 7 V. Description of the invention (), the preparation of the present invention has hardness and can withstand practical use, and the disintegration time is rapid, which can be understood as a particularly excellent preparation. Za. Tetrafluorosulfan 15 g, sucrose 179,5 G, corn starch 50 g, aspirin 2 grams of sweetness, 0.5 grams of 1-menthol and 2.5 grams of polyvinylpyrrolidone are uniformly mixed. Next, a mixed solution of 105 grams and 45 grams of water is added to this mixed powder and mixed to obtain a suspension. This suspension is 400 mg each Fill it into a concave hole with a diameter of 9βιπ, and dry it at 30t! For 3 hours under ventilation and dry under reduced pressure for 12 hours to obtain the instant soluble preparation of the present invention. The hardness of this preparation is 1.85 kg (average of 10), and it disintegrates. The bad time is 8.3 seconds (average of 6), and the dissolution time in the oral cavity is 37.3 seconds (average of 3 people). Example 2 4 30 g of pyridoxine hydrochloride and 151 g of erythritol , 50g of corn starch, 1g of citric acid, 1g of aspartame, and 2g of spices. Secondly, to this mixed powder, add 15g of polyvinylpyrrolidone to a solution dissolved in 110g of ethanol and mix to obtain Suspension: This suspension was filled into concave cavities with a diameter of 100 nm at 360 mg each, and then dried under aeration in 301 and then dried under reduced pressure for 12 hours to obtain the instant soluble preparation of the present invention.

The dissolution time of this preparation in the oral cavity was 19.7 seconds (average of 3 persons). Fen J & jajLL uniformly mixed 30 g of pyridoxine hydrochloride, 151 g of xylitol, 50 g of corn starch, 1 g of citric acid, 1 g of aspartame and 2 g of spices. Secondly, add 15 grams of polyvinylpyrrolidone to this mixed powder and dissolve it in ethanol-26- This paper size applies Chinese National Standard (CNS) Λ4 gauge (210X 297 public space (please read the precautions on the back before filling this page) )

Printed by the Consumers' Cooperative of the Central Standards Bureau of the Drop Department 527195 A7 R7 V. Description of the Invention (<) 100 g of the solution and mixed to obtain a suspension. This suspension was filled with 350 mg each into concave cavities with a diameter of 10 inm, and after being air-dried at 30¾, it was dried under reduced pressure for 15 hours to obtain the instant soluble preparation of the present invention. The dissolution time of this preparation in the oral cavity was 16 seconds (average of 3 persons). C: Made of the three-dimensional form of the dilute bear. I dissolve 50 grams of trehalose in 200 grams of purified water, and add 15 grams of tetrafluorosulfanil, 5 grams of spices, and aspartame 4.5 to this solution. Grams and Scutellaria baicalensis 0.5 grams were mixed uniformly to obtain a suspension. Next, this suspension was filled with 275 mg each into concave cavities with a diameter of 9 minutes, and freeze-dried to obtain the instant soluble preparation of the present invention. Fenshi Example 27 Dissolve 50 g of seaweed tincture in 200 g of purified water, and add 20 g of indomethacin, 2 g of spices, 5 g of aspartame, and 1 g of guar gum to this solution, and mix uniformly. Get the suspension. Next, this suspension was filled into concave cavities with a diameter of 9 ιπιπ with 278 mg each, and freeze-dried to obtain the instant soluble preparation of the present invention. Fenzhi Example 28: Dissolve 50 g of dextrin in 200 g of purified water, and add 15 g of tetrafluorothioazepam, 5 g of spices, 4.5 g of aspartame and 0.5 g of guar gum to this solution and mix uniformly. Get the suspension. Next, this suspension was filled into concave cavities with a diameter of 9 mio at 275 mg each, and freeze-dried to obtain the instant soluble preparation of the present invention. Fen Shi Example 2.i This paper size applies to Chinese National Standard (CNS) Λ4 specification (210X 297 male f) (Please read the precautions on the back before filling this page)

527195 Printed A7 by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs 5. Description of the Invention (4) Dissolve 76 g of dextrin in 292 g of purified water, and add 25 g of sodium amphoteric phenol and 10 citric acid to this solution Grams, 3 grams of spices, 6 grams of aspartame, and 1 gram of guaco gum, and evenly mixed to obtain a suspension. Next, this suspension was filled into concave cavities with a diameter of 10 μm at 410 mg each, and freeze-dried to obtain the instant soluble preparation of the present invention. The hardness of each of the preparations produced in Examples 26 to 29 was measured in the same manner as in Test Example 1. In addition, the disintegration time and the intraoral disintegration time were measured. The results are summarized in Table 5. Table 5: Hardness, soil collapse time and oral dissolution time hardness OCg) Soil collapse time (seconds) Oral dissolution time (seconds) Examples (average of 10) (average of 6) (average of 3 persons) Value) Example 26 1.23 10.17 6.0 Example 27 1.12 7.33 5.3 Example 28 1,43 6.17 4 · 3 Example 29 1,50 4.83 5.3-28-This paper size applies the Chinese National Standard (CNS) Λ4 regulation (210X297 (Enthalpy) (诮 Please read the notes on the back before filling this page)

Printed by the Central Standards Bureau of the Ministry of Economic Affairs, Shellfish Consumer Cooperative, 527195 A7 V. Description of the invention (V) As the results in the table show, the preparation of the present invention has hardness and can withstand practical use, and the soil collapse time is within 10 seconds. In addition, the dissolution time in the oral cavity also shows rapid solubility within about 6 seconds, and it can be understood that it is a particularly excellent preparation. The industrial applicability is as described above. The fast-dissolving solid preparation provided by the present invention is rapidly dissolved in the oral cavity, so it is easy to take for patients, elderly people, and children who have difficulty with pharyngeal pharynx. It can be taken whenever necessary, and it is expected to improve compliance. In addition, it has practical hardness and low hygroscopicity, so it is easy to handle when taking it, and easy to store. It has the advantages of simple and convenient operation, and has great usability in medical treatment. -29-This paper size applies to China National Standard (CNS) Α4 ^ Grid (210 × 297) (It is said that you must read the precautions on the back before filling in this page)

Claims (1)

527195 VI.Scope of patent application No. 87 1 1 6540 "Fast soluble solid pharmaceutical composition" patent case (amended on December 6, 91) Λ scope of patent application: 1. A fast soluble solid pharmaceutical composition, which has a solubility of 100 grams of water at room temperature through the drug Carbohydrates below 30 grams and 100 grams of water with a solubility of 30 grams or more at room temperature, 100 grams of water with a solubility of 30 grams or less at room temperature are incompletely dissolved in water, and then filled Obtained by removing water from the template. 2. The pharmaceutical composition according to item 1 of the scope of the patent application, wherein one or two sugars having a solubility of 100 g of water or less at room temperature of 30 g or less 3. The pharmaceutical composition according to item 1 of the scope of the patent application, wherein the sugar having a solubility of 30 grams or more for 100 grams of water at room temperature is one or two or more kinds selected from glucose, fructose, sucrose, xylose, trehalose, xylose Sugar alcohol, sorbitol, erythritol, dextrin, amylopectin. 4. The pharmaceutical composition according to item 1 of the patent application range, wherein the drug content in the composition is less than 60% by weight of the total solids content, and 100 grams of water has a solubility of 30 degrees or less at room temperature and 100 grams of water has a sugar content of 30 grams or more, and the saccharide content is 40% by weight or more of the total solid content. 5. If the pharmaceutical composition of the first patent application scope, the composition is 527195 Sixth, the drug content in the patent application scope is less than 40% by weight of the total solid content, the solubility of 100 grams of water at room temperature is less than 30 grams The saccharides with a solubility of 100 grams of water at room temperature and 30 grams or more are 60% by weight or more of the total solids content. 6. A fast-dissolving solid pharmaceutical composition, wherein the drug is less than 60% by weight of the total solids content, and is selected from the group consisting of sucrose, trehalose, mannitol, erythritol, sorbitol, lactose, and powder-reducing maltose One or two of the syrup, xylitol, glucose, fructose, and dextrin are based on 40% by weight or more of the total solids content of the V, and the polyethylene ratio is 1 to 20% by weight of the total solids content. 'It is obtained by dissolving and dispersing a drug, a saccharide, and polyvinylpyrrolidone in an organic solvent and filling it with a template', and removing it from an organic solvent. 7. The pharmaceutical composition according to item 6 of the patent application, wherein the drug is less than 40% by weight of the total solids content, the sugar is more than 60% by weight of the total solids content, and the polyvinylpyrrolidone is 2 to 15% by weight of the total solids content %. 8. The pharmaceutical composition according to item 6 of the scope of the patent application, wherein the organic solvent is ethanol or a mixed solution of ethanol and water. 9. A fast-dissolving solid pharmaceutical composition, wherein the concentration of an aqueous solution of saccharides selected from one or two types of trehalose and dextrin is 10 to 30% by weight; It is dissolved and / or dispersed in an aqueous solution, filled with a template, and freeze-dried to obtain 0 527195. ----- --- VI. Patent application scopem. The pharmaceutical composition according to item π of the patent scope, in which sugars The concentration of the aqueous solution is 15 to 25% by weight. U • If you apply for a pharmaceutical composition in the scope of patent application No. 丨, 6 or 9, it is added with natural or synthetic polymers. 12 • If the pharmaceutical composition in the scope of patent application No. 丨, 6 or 9 is applied, it is further compounded with more than one sweetener, sour agent, flavor, and colorant. 13. The pharmaceutical composition according to item 11 of the scope of the patent application, wherein the added natural or synthetic tube molecules are one or two kinds of alpha starch and partially alpha starch selected from dispersants , Residual methyl starch sodium, methyl cellulose, hydroxypropyl methyl cellulose, hydroxypropyl cellulose, sodium carboxymethyl cellulose, arabic rubber powder, tragacanth gum, sycamore resin, plus gum, fruit Gum, arabinogalactan, papaya, locust bean gum, guar gum, tamarind polysaccharides, alginic acid, carrageenan, Faslerane, gum gum, Cadran, casein, amylopectin, polyethylene Pyrrolidone, polyvinyl alcohol.