TW203012B - - Google Patents

Description

203012 A6 B6 V. Description of the invention (1 The present invention is based on the solid brewing pharmaceutical composition and its preparation method. More to be determined, the present invention contains a photosensitive active ingredient that is selectively soluble in water The pharmaceutical composition for fixing hips is also related to the preparation method of such a composition. The preparation of a composition for the use of a lotus containing a photosensitive substance as an active ingredient has serious difficulties and is well known. Under the action, decomposition products are formed. From the point of view of treatment, it may be that the substance loses its effectiveness and is even harmful to the human body. At the same time, the Pharmacopoeia regulations also have increasingly stringent requirements for decomposition products. It cannot be dissolved immediately. The active ingredients of water can only be formulated after overcoming great difficulties, and Yiyi »is also known. On the one hand, the ingredients that are insoluble in water are hardly soluble in the carrier and used to prepare the pharmaceutical composition and Among the additives, on the other hand, the poor water solubility of the molecule is used, and the release of the active ingredient is slight. From the above matter, it can be seen that the photoactive and almost insoluble active ingredient formula is included in the solid _ It is a difficult task for the skilled technicians to use the composition, and at the same time, the demand for the pharmaceutical industry is also urgent. The above question will not happen in the preparation of didipyridine derivatives. On the other hand, the dihydropyridine derivatives are both photosensitive and almost insoluble in water. One of the most important representative of the Japanese compounds is nifedipine (ie: 4- (2'-nitrophenyl)- 2,6-dimethyl-3,5-dimethylaminocarbonyl-1,4-dihydropyridine), which is a widely used calcium antagonist (calc iu · antagonist), in the treatment of acute and chronic local anemia Cardiovascular disease, blood squeegee, brain and peripheral dysfunction are very useful. This paper scale is applicable to the Chinese National Standard (CNS) A 4 specifications (210x297 mm). Please read the notes on the back side. Item-Fill in the page again A6 B6 203012 produced by Beigong Consumer Cooperation of the Central Bureau of Economics and Trade of the Ministry of Economic Affairs V. Description of invention (2 Please read the note on the back * Intention _ item-then fill in this page

The sensitivity of Nifedipine ’s sensitivity to light and its insolubility in water are well known (refer to the description of the British government case No. 1,362,627. Due to the high sensitivity of the molecules of the compound, the decomposition products-especially nitro derivatives and nitroso Derivatives-Very easy to form. The maximum allowable placement of decomposition products is determined by several pharmacopoeia specifications. According to the US Twenty-Second Edition (USP XXII), the maximum allowable amount of nitro compounds must not exceed 2.0X (In terms of amount), and the maximum allowable amount of nitroso compounds should not exceed 0.5Χ (in terms of mass). In addition, due to its poor solubility in water, nifedipine cannot be easily dissolved in the commonly used _industrial In the carrier and auxiliary rib agent of the solid preparation component, the release rate of its active ingredients is very low because it is almost insoluble in water, which hinders proper absorption. The preferred representative of the printing composition containing nifedipine from the consumer cooperative is a soft capsule, but due to the sensitivity of its active ingredients and the trace water solubility Difficulties have arisen. Several methods have been published for the preparation of Di-Yo soft capsules. According to the description of British Patent No. 1,362,627, one or more opacifiers (such as titanium dioxide or calcium sulfonate) and selectivity A synthetic dye (for example, Gelborange, Erythrosin) that absorbs light from a certain wavelength range is mixed into the bladder's perseverance. The use of shading is indispensable, and the use of synthetic dyes is only selective. Colored shading-for example: vaporized yoke pigments-gives the mash capsule shell a pleasing appearance and color. The above-mentioned colored pigments are mixed into the shell of the ® capsule in an amount of 2 to 3% by mass to ensure the supplement of the anti-slip The amount of shading can be reduced by adding a dye to the composition to about 0.5 to 1.5 percent (by mass), but this paper scale is applicable to China National Standard (CNS) A 4 specifications (210X297 Cli) ^ 〇3〇ia A6 _____B6 Five'Instructions for the invention (3) It can not be omitted if it is added. The synthetic dye itself cannot ensure an absolutely reliable anti-fading effect, only when used together with 邃 光 _ Yes, but The method of using the anti-light intrusion on the wall of the capsule is flawed. That is, only the pouches that can be used by Di have anti-color effects. Dao capsules already contain "filling solution containing active ingredients. And this The active ingredients cannot completely prevent the invasion of light during the manufacturing and installation process. Therefore, it is necessary to implement expensive and cumbersome preventive measures that require precise technology and labor discipline to avoid the decomposition caused by light (for example: Working under the irradiated red light, etc.). In the case of filtering the prepared solution, it is important to prevent the filling solution from being attacked by the light effect. In the case of filling the pouch, it must be ensured to prevent Light attack (for example: use of black film, special device for blocking light, light filter, etc.). The lack of S-item that uses the wall of the mash sac to prevent photoinfestation is: mixing subdivided dispersed solid sunscreen into the capsule wall and performing separation operations and separation equipment. The fine powdered sunscreen must be evenly distributed in the sticky material that constitutes the _ capsule wall, which is a long and cumbersome process. During the manufacturing process, the possibility of accidental non-uniformity is unavoidable. • Mash materials may blister when carried and mixed, so the formation of foreign body inclusions occurs. In case of some heterogeneous residues, Non-uniformity, and it remains in the wall of Huan Huan. Printed by the Central Standard of the Ministry of Economic Affairs-f-bureau employee consumer cooperatives (please read the second ii-Ii.Io.-then fill in this trade). The already announced European Patent Application No. 143,857 shows that it contains nifedipine as effective Ingredients in soft sacs. This type of B capsule wall contains glycerol (glycerol), one or more dyes that absorb the desired wavelength range, and a sunscreen agent, and the mixture that constitutes the contents of the sacral capsule contains nifedipine solution dissolved in an organic solvent. The complaint in this case is a false pack ____ The paper size is in accordance with Chinese National Standard (CNS) A 4 specifications (210x297 mm) A6 B6 203012 V. Description of invention (4 The filling contains nifedipine and is soluble in polymer Ether fermentation is dissolved in a solution of tetrahydrofuran fermentation (tetrahydrofuran methyl fermentation) polyvinylpyrrolidine strontium (PVP), and it is completely free of glycerol fermentation, which only exists in the wall of the sac. The method also has the above-mentioned shortcomings, that is, the shading_single kiwi is mixed into the material of the wall of the bladder, so that the decoration of the bladder in the production of Di and Zhuangpu does not prevent the irradiation of light. The difficulty that occurs when mixing the fast light thin into the wall of the bladder is also stubborn. The purpose of the present invention is to create a simple method for preparing a composition for solid hydration, and the medicinal composition contains optional Photosensitive substances that are considered to be insoluble in water are effective ingredients. This method can ensure that it can achieve twice the prevention of light intrusion and eliminate the lack of stickiness of the previously known methods. The purpose of the present invention is to provide an easy-to-implement Method to ensure the prevention of light attack to prepare A solid composition for nifedipine containing photosensitivity and slightly soluble in water as an active ingredient-especially soft sac. The present invention is based on the fact that the plant dye itself can prevent the photosensitive active ingredient from proceeding in the absence of a shading ingredient Cognition of photolysis According to the special joy of the present invention, the present invention provides a method for preparing a solid pharmaceutical composition containing an active ingredient that is photosensitive and selectively hardly soluble in water and a conventional carrier and / or adjuvant This method includes mixing vegetable dyes into the composition. As for vegetable dyes, it is desirable to use pharmacokinetics, caramel, saffron yellow (saffron yellow) or beetroot dye (Rote Beete · Dragocoo). According to the desired form or actual understanding of the method of the present invention, it is best to use the natural dye-pharmaceuticals of green plants. This paper scale is applicable to the Chinese National Standard (CNS) A 4 specifications (210x297 mm). Please read the precautions first. Refill this page Printed by the Employee Consumer Cooperative of the Central Bureau of Standards of the Ministry of Economy < i〇3〇l2

A B 5. Description of the invention (5) Both lipophilic and hydrophilic phytohormones are suitable for carrying out the invention method with the desired results. The lipophilic berberine is derived from organic solvents. The lipophilic phyllocyanin is a dark green honey-like substance. Hydrophilic pheromone is a dye of natural origin. After the central iM atom of the molecule is replaced with a sulfur atom, its water-containing sodium salt can be obtained by reacting with hydrogen hydride. The salt can be prepared in a similar way with hydrogen gas desulfurization. The hydrophilic drug is a kind of fine color powder. The use of vegetable dyes * can be used according to 0.1 to 10 percent of the total mass of the product. According to my experience, the following interesting photosensitive compounds that are almost insoluble in water can be used to prepare the active ingredients of the solid «pharmaceutical composition according to the present invention: Vitamin Sardine, desirably rapeseed 0 (fertility) Ding Er · Dd; Please listen to the face < i matters and fill in% This page is printed by the Ministry of Economic Affairs, Central Bureau of Industry and Fisheries Consumer Cooperatives of Vitamin A; imidazoline (m-dicyanopentapentene) derivatives, it is desirable lethynazol piperazine (p-dicyanohexyl) derivative, desirable JStripolydine hydrazine hydrochloride; ergot pheasant and indole mortar, desirably methyl hydrogen dihydroergotoxine or ergotamine tartrate; butylbenzene derivatives , Desirable is haloperidol · droperidol or benper i do 1; Nitroglycerin; Derivatives of dihydrogen%, Desirable is nifedipine, nirudipine, nitrendipine, nisoldipine, niaodipine, nicarbipine This paper scale is applicable to China National Standard (CNS) A4 (210x297mm) Printed by employees' consumer cooperatives of the Central Bureau of Standards of the Ministry of Economic Affairs 2〇3⑽ V. Description of invention (6) or phenodipine; composed of solid fermented yeast, which means ph enoxynesteron; thyroid hormone carp, desirably levothyroxine (levothyroxine); antimetabolites of folic acid analogs, desirably Bethotrexate; _ antimetabolites of face analogs, desirably azathoprine; nitroso Derivatives of furan, desirably nitrofurantoin; anti-neoplasticity nethy 1 hydrox i nes, desirably procarbaz ine; corticosteroids (corticosteroids), desirably betanethasone; nitroso ferricyanide (ie, nitroprusside Sodium acid, nitroprusside> morphine derivatives, desirably sulphuric acid drink, poppy koji hydrocyanide; catechol (i.e., catechol), desirably dopa (i.e., dihydroxybenzene Propionic acid) or isoprenaline; estrogen, desirably hexyl sterase; sulfapyridazine; eyelid, desirably colchicine Pr 〇fe η derivatives, desirably ket 〇pr 〇fe η; antibiotics, desirably It is a split mackerel anti-Huiso or Bacitracin: Sanchen anti-inhibits W, desirably carba * az: epine; hope siazine (ie, thiodiazepine M), desirably hibernal or trifluorotonazine: nustardnitrogens : Coca_Cyanide; B Amine derivatives, tripelenaiine is desirable: or 8 A6 B6 (please read the precautions on the back before filling in this page). 裟. • Hitting • • Edges • This paper size applies to China National Standards (CNS) A4 specifications (210x297 mm) ^ 03012 Printed by the Consumer Cooperative of the Central Bureau of Standards of the Ministry of Economy V. Description of the invention (7 Aminobitoline derivatives, chloroquine is desirable. According to a particularly desirable embodiment of the present invention, a photosensitive dihydropyridine derivative such as vitamin A or nitroglycerin, which is almost insoluble in water, is used as an active ingredient. According to another particularly favorable example of the present invention, a dihydropyridine derivative whose solubility in water does not exceed 20 g / L at 25 ° C can be used as an active ingredient. Therefore, it is undesirable that nifedipine, niludipine nitrendipine, nisoldipine, niaodipine, nicardipine and felodipUe are all recognized as effective ingredients by Zheng Yin. According to the method of the present invention, the photosensitive and selective selective water-insoluble active ingredients can be desirably formulated into soft waist pouches, tablets, Chiao Jiu Jiu, or hard bladders, especially soft pouches. When preparing a soft lumbar sac, a plant dye, to be treated as a medicine, is mixed into the entropy of the capsule. Therefore, it is not only after being enclosed in the bursa, but also in the manufacture and installation of the package. The package containing the photosensitive active ingredient has already been protected from light. This method can eliminate the costly and cumbersome way of ensuring protection from light when manufacturing articles containing photosensitive active ingredients. The lipophilic chlorophyll is blended into Zhuangpu in an amount of 1 to 10% (in terms of quality), the desired amount is 1 to 5%, and the undesirable amount is 1.5 to 3.5%. The content of "hydrophilic type" in the filling can be between 0.5 and 10 percent by mass, desirably between 1 and 7 percent, and particularly preferably between 1.5 and 5 percent. If nifed ip 丨 ne is used as the active ingredient, the content of the active ingredient in the filling can be between 0% and 0%. Please read the precautions carefully before filling this page. The paper size is applicable to the Chinese national standard ( CNS) A4 specifications (210x29 / mm) 203012 A6 B6 Central Ministry of Economic Affairs Bureau of the Central Bureau of Samples and Consumers' cooperation in printing du. Fifth, the description of invention (8) to 7, between 1 and 5 percent is desirable, Particularly agreeable is between 1.5 and 3 percent. With regard to further other ingredients, the container may also contain a solution suitable for oral use and compatible with the soft wall material. For this purpose, the following solvents can be used. Vegetable oils and aromatic oils (such as sunflower oil, gourd oil, olive oil, lime oil, etc.), non-ionic surfactants (for example: poly (ethylene oxide) -Sorbus Glycolic acid esters of fatty acids, desirably poly (ethylene gas) -sorbitan monooleate), lecithin or polyethylene glycol (eg Carbowax 300). The lumbar pouches can also optionally contain Fang Fan_ (for example, fan material or incense box oil). When using lipophilic medicine chlorophyll, the contents of the capsule can contain poly (ethylene oxide) -sorbic acid fatty acid ester, and poly (ethylene oxide) -sorbic acid. Anhydride-oleate. When the flute uses hydrophilic metabolites, it is best to use polyethylene glycol (eg Carbowax 300) as the solvent. The preparation of the entropy of Miao capsules is carried out by the conventional method of noodle making music. It is desirable to dissolve the active ingredient in a solvent heated to a suitable temperature. The lipophilic phytohormones or hydrophilic phytohormones and other components can be added while the solution is still hot, or after cooling, and if necessary, filtering the solution thus obtained on a screen. Then, the preparation containing the vegetable dye prepared by the above method is injected into the soft waist pouch. The wall of the absurd sac may contain a Mingji matrix plasticizer (for example: glycerin or sorbose) and a preservative (for example: methyl paraben, common name: Nipajin, Hipagin). It is also possible to add a plant dye-desirably phytoxanthin-to the material of the cyst wall. At the time of the combination of Dao species, the content of pharmacokinetics in the wall of the capsule is as follows (please read the "i-Importance" on the back and then fill out this page) CNS) A4 specifications (210x297 mm)

6 6 AB ^ 03012 V. Description of the invention (9) {Please read the back of the page: ¾Isif ifi · Fill in this page) The quality manager counts as 0.1 to 5 percent, and the desired is 0.2 to 3 percent It is 0.3 to 1.5 percent to be unconvinced. The sac wall can also contain a hydrophilic fusarium. The preparation of the wall of the cysts containing vegetable dyes is carried out as follows: a plasticizer (for example: glycerol (glycerol) or sorbose) and other components (for example, polyvinylpyrrolidone or A kind of antiseptic W) dissolved in warm water (70 degrees to 90 degrees Celsius), and then added Ming Ji to this solution. The material thus obtained was continuously and vigorously stirred under vacuum until it formed a translucent spider honey. First dissolve chlorophyll kiwi in a small amount of water, and then mix it with the previously-made and cooled honey-like mandarin orange. The potting of the absurd pouch is carried out by eaves machining using a known method in its own right. The Η, sugar-coated Jiu Jiu and hard B capsules may contain the following customary carriers and / or auxiliary ribs: The Ministry of Economic Affairs Central Standards Bureau staff consumption cooperation du printing dispersions: such as starch, modified starch, cellulose, Jiwei Derivatives, cross-linked polyethylene propylene (PVPP), sodium alginate and zirconium dioxide gas binder; binders such as: Ming Yao, Huang Fan, grape syrup, starch, polyethylene propylene, ore derivation Substances, polyethylene glycol (PEG 1000-5000) and thin prionate; lubricants such as: stearic acid, stearic acid, paraffin, talc, vegetable or animal fats, oils and seeds, silicon alcohol, polyethylene Glycol (eg PEG 1000-5000); Carrier and fillers such as starch, Jiweisu, Polyethylene propylene, Polyethylene propylene, Gelatinized silicon dioxide, Lactose, Stearic acid, stearin Calcium acid; dilute conversion agents such as: lactose, mannose, starch, microcrystalline cellulose; coloring and fragrances and conventional coatings. The above-mentioned medicinal composition of Guhuan may contain 9% by mass _11_ This paper scale is applicable to the 4 specifications (210x297 mm) of China National Standards (CNS) A6 B6 ^ 03013 V. Description of the invention (10) A vegetable dye of 0.1 to 5 is desirably 0.5 to 3 percent, and its coating may contain the same substance as 0.1 to 1 percent by mass and desirably 0.3 to 0.7 percent. The splitting of the tablets, dragee 9 and hard capsule according to the present invention is carried out by a known method enacted by itself. According to another feature of the present invention, there is provided a composition for solid brewing containing a photosensitive active ingredient selectively hardly soluble in water and a conventional carrier_and / or_rib_, wherein the composition Contains vegetable dyes. Desirable forms of the solid pharmaceutical composition according to the present invention, vegetable dyes, and the active ingredients desirably used in the solid pharmaceutical composition according to the present invention and almost insoluble in water have been described above. According to one of the present invention, it is desirable to provide a composition containing nifedipine as an effective ingredient-to be a soft capsule. According to the S-item of the present invention, a soft capsule containing nifedipine as an active ingredient is provided, in which the contents and / or the wall of the sac sac are mixed with plant dyes, preferably metabolites, the suspension of which is based on mass It accounts for 0.1 to 10 percent. According to the photolysis decomposition effect of the active ingredients of the soft absurd pouch according to the present invention, you will explore it in the so-called "sunshine test" after four hours. The results are listed in Table 1. Please read the precautions before you fill in this page. The sample quasi-authorized shellfish consumer cooperation du printing watch uses the sample instance number. The initial "degree (percentage by mass) of the active ingredient of photolysis decomposition% 12" degree (percentage by mass>) of the decomposition product " % This paper scale is applicable to China National Standard (CNS) A 4 specifications (210x297 mm) 203012 Α (ί Π 6

V. Description of the invention (lD 81 -02-06 amended

Nitro-nitroso other loading solution: Example 2 Mash capsule wall: Example 4 98.50 1.00 0.23 0.27 Packing solution: Example 1 Huan capsule wall: Example 5 98.00 0.90 0.24 0.86 Comparative example 1.8 0.4 0.8 (please read the back first Zhi Note Competition Item #Fill in this page) The Ministry of Economic Affairs, Bureau of Standards, EX Industry and Consumer Cooperation Co., Ltd. du printed the knowledge of the formation of the solution, according to the amount. The value of the soft country pharmacopoeia lightening agent should be in accordance with the requirements of the United States Pharmacopoeia 22 (USP XX II). The amount of nitro compounds should not exceed 2.0% in terms of quality eggs, while nitroso The quantity shall not exceed 0.5% in terms of quality. According to the data in Table 1, the decomposed products contained in the soft sacs prepared by the present invention are lower than the allowable degree. Note that even if only the plant-containing dyed capsules are contained in the filling, there is no alfalfa color in the sac wall. The incorporation of spurs can also meet the requirements of the 22nd US vendor. On the other hand, the wall of the lumbar sac does not contain anyone. It was surprisingly found that the method according to the present invention not only can prevent the invasion of light but also plant dyes can also increase the nifedipine 13 private paper "standard use rate. (CNS) T4 specifications (20 x 297 public) A6 B6 3〇i2 Λ, invention description (12) Solubility in certain carriers (for example: in vegetable oil). It is known that nifedipine is almost insoluble in vegetable oil. At the same time, due to the compatibility of vegetable oil and Huancao wall, it is a good carrier, but its use is hindered by the solubility of nifedipine. The following experiments confirmed that under the effect of plant-based dyes, the solubility and release of nifedipine in different vegetable oils can be improved. The release of the drug from the sachet is measured according to the rotating paddle equipment of Meipu _ Code 22nd Vendor • Using distilled water as the dissolution medium, the test time is 15 minutes, the test temperature is * 37 soil 0.5 degrees (50 shovel per minute). The results are listed in Table 2. Table 2 Release of active ingredients (please read the precautions on the back before filling in this page) Calculated percentage, X) Active ingredients extracted from the mash sac within 15 minutes (percentage based on mass suspension, X) (required: 80 X) Gourd oil-82.30 Moist oil 1.5 92.40 Gourd oil 3.0 97.02 Earned oil 1. 90.76 _____._ 14 This paper scale is applicable to the Chinese National Standard (CNS) A 4 specifications (210x297 mm) • Line. 203012 5. Description of the invention (13) Lime oil 1.5 95.37 Lemon oil 3.0 100.14 Olive oil-86.38 Olive oil 1.5 90.50 Olive oil 3.0 96.40 Printed by the Central Purchasing Agency of the Ministry of Economic Affairs and the Cooperative Consumer Printing Co., Ltd. According to the regulations stated in the 22nd Pharmacopoeia of the United States, the release of nifedipine must reach at least 80X. It can be seen from the data listed in Table 2 that the nifedipine released from the samples using vegetable oils as solvents (pascinia oil, birch oil, olive oil) exceeds this value by a large amount. In addition, it is worth noting that in the presence of forbidden chlorophyll, the amount of nifedipine released is significantly greater than that using only the same vehicle without using any vegetable dyes. It is impossible to predict the release of plant-based dyes from drugs, so the results of the previous item are completely surprising. Further details of the present invention can be obtained from the following examples. These examples do not limit the scope of the present invention. Example 1 Equipped with a zipper pack with the following composition: material content, (percentage by mass, X) (please continue with the first step on the back, then fill out this page) • Pack ... line.

Nifedipine 3.0 Poly (vinylidene gas) -Sorbitose IF-oleate 22.85 Smell oil 14.65 __ 15 This paper scale is applicable to China National Standard (CNS) A 4 specifications (210x297 mm) ^ 03012 A6 B6 V. Description of invention (14) Lecithin chlorophyll (lipophilic) 57.00 2.50 Printed by Beigong Consumer Cooperative of Central Bureau of Standards, Ministry of Economic Affairs 100.00 Preparation method: Heat poly (ethylene gas) -sorbic acid monooleate_ to approximately 70 degrees Celsius, then Dissolve nifedipine in it. When the dissolution is complete, add lecithin and lipophilic chlorophyllin to this solution while it is hot, then cool the mixture to room temperature and add citrus oil to it. In case of pain, filter the solution through a plastic screen (aperture: No. 120 mesh). Example 2 Preparation of capsule entropy with the following composition: Ingredient content (percentage by mass, X) Nifedipine 2.80 Poly (ethylene oxide) -sorbitan-oleate 82.50 Gourd oil 11.50 Ye Susu (lipophilic ) 3.20 100.00 Preparation method: Heat poly (ethylene oxide) -sorbican_oleic acid_ to about 70 degrees Celsius, and then dissolve nifedipine in it. When the dissolution is complete, cool the solution to 45 degrees Celsius, and then add the box of reed oil and lipophilic drug chlorophyll. If there is any pain, pass the solution through the plastic filter screen (please read the precautions on the back before filling the page) for the hole T. • Thread. · The paper size is applicable to the Chinese National Standard (CNS) A 4 specifications (210x297 Mm) < i〇3〇l2 A6 B6 V. Description of the invention (15) Diameter: No. 120 mesh). Example 3 The equipment has the following composition of 0 capsules: Ingredients Containing the most (percentage by mass, X)

Nifedipine Carbovax 300 Lemon-like oil Phyllanthin (hydrophilic) 4.00 88.00 3.00 5.00 DuPont Printing by Employee Consumer Cooperation, Central Bureau of Standards, Ministry of Economic Affairs 100.00 Preparation: Heat Carbowax 300 to 60 degrees Celsius, and then dissolve Nifedipine in it. When the dissolution is complete, cool the solution to 25 to 30 degrees tweezers, and add the hydrophilic phytohormones and lemon oil to it. If necessary, filter the solution through a plastic waist screen (aperture: No. 120 mesh). Example 4 Preparation of a wall of absurd bladders with the following composition: Ingredients containing Μ (percentage by mass, X) Mingji 50.00 Glycerin 27.00 ------ This paper scale is applicable to China National Standard (CNS) A 4 specifications (210x297 %) ^ 03012 A6 B6 V. Description of the invention (16) Sorbushase 70¾ 6.00 Steamed water 17.00 100.00 Preparation method: Heat the water to 80 degrees Celsius, then add sorbitan and glycerin. Then add bright sleep to this mixture under vigorous stirring and continue to set under vacuum until the mixture becomes a translucent spider-like substance. This material is mechanically made into a mash in a known way for itself. Example 5 Preparation of mash capsule wall with the following composition: Ingredients containing Dong (percentage by mass, *) [Please read the precautions on the back before filling out this page) • Pack · Gelatin glycerin preservative phytolactin (hydrophilic) ) Distilled water 45.00 36.300.20 0.50 18.00. Line. Central Printing Bureau of Ministry of Economic Affairs, Beigong Consumer Co., Ltd. Duprint 100.00 Preparation method: Heat the water to 80 degrees Celsius, and dissolve the antiseptic _ in it. Glycerin is then added to this solution, and ming yang is added to it with vigorous stirring. Under vacuum, sloppy ore "mix until the mixture becomes translucent ____18_ This paper scale is applicable to China National Standard (CNS) A 4 specifications (210x29 / mm) 203012 A6 ___B6 V. The description of the spider honey (17) Like substance. Dissolve phylloxanthin alone in a small amount of water, and then mix the aqueous solution with the above-mentioned honey-like substance cooled to 60 degrees Celsius. The resulting material is then made mechanically by a known method in its own right as a fallacy. Example 6 Preparation of the wall of the pharyngeal sac with the following components: Content of the component (percentage based on quality, X) (please read the U on the back and fill in page ^ 4) Ming glycerin polyvinylpyrrolidone (Hydrophilic) Steamed preserved water 45.00 37.00 5.001.0012.00 Printed 100.00 by the Beigong Consumer Cooperative of the Central Standards Bureau of the Ministry of Economy. Preparation method, heat the water to 80 degrees Celsius, then dissolve polyvinylpyrrolidone in it, and then add glycerin here Solution. Secondly, under the vigorous agitation of the Yunkuang Mine, add Mingsleep to this mixture. Then mix it with the pumping and emptying until it turns into a translucent spider honey product. Separately dissolve hormonin in a small amount of water, and mix this aqueous solution with the above-mentioned bee-weed that has been cooled to 60 degrees Celsius. Finally, the resulting product is mechanically manufactured into a mash in a known manner that is inherent in itself. The size of this paper applies to China National Standard (CNS) Grade 4 (210x297 mm)

Claims (1)

Zhengzhengzheng 0000 6. Applying for a patent fan garden (please read the notes on the back and then fill in this page) 1.—A kind of light-stabilized solid chrysanthemum composition, which contains a kind of photosensitivity and selection The active ingredient that is practically insoluble in water is the same as the customary truncated and / or ribbed soft mash capsules, wherein the composition is Nifedipine containing active ingredient and containing paracetamol in the container solution. And selectively contain the drug Sisi in the wall of the cyst. 2- A method for preparing a solid pharmaceutical composition according to Item 1 of Difanlan, which includes mixing the suspicion into this composition. 3. For example, if the method of item 2 of Shenli Fanfan is included, it includes: in terms of the mass of the composition, the amount of valerin is 0.1 to 10 percent. 4. For example, the method of item 2 of the _Patent Fanyuan, which includes the use of Nifedipine as an almost insoluble and / or photoactive active ingredient. 5. For example, the method of applying for item 2 of the Lifanpu, which includes the production of soft sacs, boiled H, sugar-coated jiujiu or saccharomyces sac as solid pharmacy composition. 6. For example, the method of claim 5 of the «Letter of Patent Application>, which includes the preparation of a soft pharmaceutical capsule as a solid pharmaceutical composition. 7. The method as described in item 2 of Shenfan Fanyuan, which includes mixing 0.1% to 10% of phytoalexin into capsules and / or sac crab. The Central Standard of the Ministry of Economic Affairs is produced by S-Industry and Consumer Cooperation Co., Ltd. 8. For example, the method of item 6 of the «Park», which will include 1 to 10 percent by mass, desirably 1 to 5 percent, It is unfavorable that 1.5% to 3.5% of the prolactin is mixed into the filling of the soft pouch. 9. For example, the method of item 6 of the application plan, which includes the quality of 0.5 to 10 percent, desirably 1 to 7 percent, and particularly desirably 1.5 to 5 percent Hydrophilic drug suspects are mixed into the soft bursa. -20-This paper scale is applicable to the Chinese National Standard (CNS> A4 specifications (210 X 297 mm) 81.9,10,000 ^ 03012 A7 B7 C7 D7 _ 6. Apply for a patent model group I (please read the note on the back first Take the item and fill in this ranunculus) 10. For example, if you apply for the method of item 6 of the Tuna Circle, it includes the use of medicines with a quality of 1 to 7 percent and desirably 1.5 to 5 percent.的 载 _ 予 _rib_ -Desirably vegetable oil and aromatic oil or non-ionic surface active_ and Fangfan explain- to prepare the filling of soft hull. 11. As in the method of item 7 of Shenfanlifanlan, This includes mixing 0.1 to 5 percent of Yuan Dong, desirably 0.2 to 3 percent, and particularly desirably 0.3 to 1.5 percent, into the wall of the purgular sac. 12. For example, the method of item 2 of Shenfanli Fanyuan includes filling a composition containing the following ingredients into the episac: Hifedipine, 2 to 5 percent by weight, a non-difficult surface active agent, and 0.5% to 10% by mass, desirably 1 to 7%, and particularly desirably 1.5 to 5% phytoalexin, this capsule has a packet Contains melamine base plasticizer-desirably glycerin or sorbic acid yeast, and tincture contains a kind of antiseptic M, ordered-and optionally contains 0.1 to 5, percent by quality, desirable The area is 0.2 to 3 percent, and particularly desirable is 0.3 to 1.5 percent. The central government ’s Ministry of Economic Affairs ’Central Standards Consumer Cooperation Co., Ltd. Du Duan 13. The method of item 12 in the application of the law, including The composition containing the following ingredients is loaded into "mash capsules containing glycerol-containing three enzymes and S selectively containing 0.3 to 1.5% of the analyte by mass as the base of the 0-basic wall: a percentage based on the amount of corn Part 2 to 5 (Nifedipine, — a group of oils composed of free sunflower oil, hawthorn oil, sylvestris oil, and koji oil, a type of poly (ethylene gas) -sorbitan fat-fat brewing-desirably Poly (ethylene gas)-sorbitan-oleic acid_, or poly-glyoxygenase and medicinal chlorophyll -21-81.9.10,000 in terms of mass Λ-81.9.10,000 This paper size is applicable to China Standard (CNS) A 4 specifications (210 X 297 mm)