WO2007003113A1 - Compositions de matieres premieres pour une capsule creuse contenant du polyose d'origine vegetale et procede de preparation d'une telle capsule - Google Patents

Compositions de matieres premieres pour une capsule creuse contenant du polyose d'origine vegetale et procede de preparation d'une telle capsule Download PDF

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Publication number
WO2007003113A1
WO2007003113A1 PCT/CN2006/001480 CN2006001480W WO2007003113A1 WO 2007003113 A1 WO2007003113 A1 WO 2007003113A1 CN 2006001480 W CN2006001480 W CN 2006001480W WO 2007003113 A1 WO2007003113 A1 WO 2007003113A1
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raw material
weight
hollow capsule
material composition
plant polysaccharide
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PCT/CN2006/001480
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English (en)
Chinese (zh)
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Liande Tang
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Liande Tang
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Publication of WO2007003113A1 publication Critical patent/WO2007003113A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816—Wall or shell material

Definitions

  • Plant polysaccharide hollow capsule raw material composition and preparation method of hollow capsule Plant polysaccharide hollow capsule raw material composition and preparation method of hollow capsule
  • the present invention relates to a pharmaceutical preparation, and more particularly to a hollow capsule for filling granular, powdery solid medicines, functional foods, health care products and cosmetics, and a preparation method thereof.
  • Hard hollow capsules have long been used as pharmaceutical carriers.
  • Hard hollow capsules are generally made from gelatin and added with water.
  • the production method is that the gelatin is soaked and expanded with water, stirred and dissolved in the reaction pot, and the temperature of the reaction pot is maintained at 60-75 ° C; after the dissolution, the glue is filtered, the concentration of the glue is adjusted, the storage is kept warm, and the skin is removed. Bubbles, finished on the automatic silicone production line by silicone, drying, cooling, stripping, cutting, nesting, inspection and packaging.
  • gelatin Since the raw material of gelatin is derived from the skin and bone of animals, gelatin is an animal protein colloid and contains a small amount of animal fat. After using some animal skins and bone gelatin to make hollow capsules, people who believe in Islam and Judaism cannot take it. On the other hand, the spread of animal-borne diseases such as mad cow disease and foot-and-mouth disease in Europe has caused safety problems in use.
  • hollow capsules made of gelatin are sensitive to temperature and humidity.
  • the medicine packaged in the hollow capsule made of the product is preferably stored under constant humidity conditions. If the humidity is too high, the capsule will be softened and deformed; if the humidity is too low, the capsule will be brittle.
  • gelatin easily reacts with aldehyde-containing and enamel-containing drugs to produce insoluble substances, which prolongs the disintegration time of the capsules and changes the color of the capsules.
  • capsules made of gelatin have the above-mentioned deficiencies, researchers in this area have focused their attention on the study of preparing hollow capsules from plant polysaccharides.
  • Chinese Patent Application No. 200410012944. 7 (Applicant Date: March 30, 2004, published on January 12, 2005, publication No. CN1561971A) discloses a plant hard hollow capsule which is composed of the following weight percentages. 3% ⁇ 27. 5%, The coagulant is 3. 3, the konjac glucomannan is 31% - 51%, the soy protein isolate is 25. 4% - 47. 8%, the coagulant is 8. 8% - 27. 5%, the coagulant is 3.
  • modified konjac glucomannan is carboxymethyl konjac glucomannan, oxidized glucomannan, maleic anhydride esterified glucomannan, acetic anhydride Esterified glucomannan;
  • coagulant is carrageenan or xanthan gum;
  • coagulant is a salt providing cationic Ca 2+ , strontium such as potassium chloride, potassium citrate, potassium phosphate, calcium chloride.
  • the preparation method comprises the following steps: A) The konjac flour is gelatinized at a temperature of 40-70 ° C, and the konjac flour 10 wt% - 120 wt% modifier is added, and the reaction is 2-4 hours, washed, dried and pulverized to obtain modified konjac glucomannan.
  • soy protein isolate is stirred and dispersed at 30-6 (TC temperature, the solid content of soy protein isolate is 1 8%, heat treated at 80-100 ° C for 25-35 minutes, and the pH value is 9-10.
  • soy protein isolate 65wt%-20 vt% of konjac flour modified product and total dry powder 0. 01% - 10% of cross-linking agent, at 40-7 (TC temperature copolymerization 2 - 5 Hour, wash, dry, pulverize the modified konjac glucomannan-soy protein isolate complex.
  • CMGM-SPI complex sol is added to the solidification system at a temperature of 60-80 Torr, and the mixture is stirred evenly. After defoaming by heat preservation, the liquid is poured into the dip tank, and then the cross-plate is glued, dried, and shelled. After cutting and finishing, the plant hard hollow capsule can be made.
  • the invention does not require constant temperature storage; all of which are plant materials, do not spread foot-and-mouth disease and mad cow disease, are not easily contaminated, meet the requirements of vegetarian cultures, and are suitable for storage and transportation of aldehyde-containing drugs. But there are also deficiencies. Since the addition of potassium salt affects the disintegration time limit, the addition of protein makes the microorganisms easily exceed the standard and is not easy to store.
  • a plant hollow capsule and a production process thereof are disclosed. 5%, 0%, 0%, 0%, 0%, 0%, 0%, 0%, 0%, 0%, 0%, 0%, 0%, 0%, 0%, 0%, 0%, 0%, 0%, 0%, 0%, 0%, 0%, 0%, 0%, 0%, 0%, 0%, 0%, 0%, 0%, 0%, 0%, 0%
  • the balance is water.
  • the vegetable gum is one or two of pectin and carrageenan
  • the reinforcing agent is one or more of chitosan, carboxymethyl starch and hydroxypropyl cellulose.
  • the surfactant is sodium lauryl sulfate and the humectant is glycerin.
  • the preparation process of the hollow capsule is as follows: according to the weight percentage ratio of each component, the vegetable glue is first immersed and swelled in water, and then placed in a reaction pot to be stirred and dissolved, during which a reinforcing agent, a surfactant and a moisturizer are added, and Circulating water of 50 °C - 85 °C is introduced into the reaction pot interlayer, and after being fully dissolved, 100-120 mesh filter glue is used, stored in a heat preservation bucket, and the concentration of the glue is adjusted during use, and the bubbles are removed. Automatic silicone production line through silicone, drying, cooling, stripping, cutting, nesting, inspection, packaging.
  • the plant hollow hard capsule produced by the invention and the production process has good stability, is not deformed under high temperature or high humidity environment, is not brittle, and is convenient for long-term storage.
  • No potassium salt or calcium salt is added in the process, but the ratio of each component is not suitable, and the disintegration time is prolonged, which is difficult to conform to the current.
  • a further Chinese patent document application number is 99116921. 2 (Applicable file is September 28, 1999, published as April 25, 2001, publication number is CN1292261A), and another plant hard capsule and its production process are disclosed.
  • the plant hard gelatin capsule is composed of a hydrophilic gel, a water-soluble cellulose, a coagulant, and water, and their component weight percentage is: hydrophilic gel 0.11% - 11.87%, water-soluble fiber 71. 25% - 94. 8%, help gel 0. 1 0% - 11. 87%, water 5% - 8%.
  • the hydrophilic gel may be a type of carrageenan, and the coagulant is potassium chloride, calcium chloride, calcium phosphate or potassium citrate.
  • the production process is: in a weight percentage of 0.01% - 5% of the hydrophilic gel and 0.01% - 5% of the coagulant into the 60% -89. 98% of the water, stir evenly, Heat to 80 °C or above, until the colloid is dissolved evenly, then 10% - 30% of water-soluble cellulose is poured, dried, plucked, cut and finished.
  • the plant hollow hard capsule prepared by the invention is not deformed after being kept at a high temperature for 10 days, because the raw materials used are mainly low in plant polysaccharide, protein and fat content (0.5% and 0.3%, respectively), and Plant proteins and vegetable fats avoid contamination that may be caused by animal proteins.
  • the shortcomings are that although the amount of K-carrageenan used is relatively low, the potassium salt or calcium salt is added to form a K-carrageenan potassium salt or a calcium salt, so that the disintegration time limit of the capsule becomes long, up to 15- 16. 5mi n does not meet the requirements of the current Chinese Pharmacopoeia standards. The current edition of the Pharmacopoeia of the People's Republic of China requires that the time limit for disintegration in the stomach is within 10 minutes. Summary of the invention
  • the object of the present invention is to develop a plant polysaccharide hollow capsule raw material composition, which uses the raw material composition as a raw material to prepare a hollow capsule, which overcomes the shortage of the capsule prepared by the prior art, at high temperature, high humidity or It does not deform, is not brittle, has good stability in cold environment, and is convenient for long-term storage.
  • the disintegration time limit can meet the current edition of the Pharmacopoeia of the People's Republic of China and/or national standards.
  • Another object of the present invention is to prepare a method for preparing a hollow capsule which is excellent in conformity with the standards of the Pharmacopoeia of the People's Republic of China by using the above-mentioned plant polysaccharide hollow capsule raw material composition as a raw material.
  • plant polysaccharides, cellulose derivatives and/or resins, starches and derivatives thereof, and alcohols are mixed in an appropriate ratio to form a plant polysaccharide hollow capsule raw material composition, by controlling plant polysaccharides.
  • plant polysaccharides By controlling the amount of K-carrageenan and the amount of other ingredients, it can be made into a plant polysaccharide hollow capsule which is easily disintegrated and dissolved.
  • the plant polysaccharide hollow capsule raw material composition of the present invention comprises K-carrageenan 0.5 to 26 parts by weight, cellulose derivative and/or resin 75-98 parts by weight, and alcohol 12-12 parts by weight.
  • the resin is added to the raw material composition to form a raw material composition containing a fiber derivative and a resin, or a raw material composition containing only a resin without a cellulose derivative, in order to change the disintegration performance of the capsule, and to control the drug according to the requirements of the drug.
  • the release rate allows the produced hollow capsule to be insoluble in the stomach and dissolve in the intestine, controlling it to disintegrate in the intestine within 60 minutes, which sometimes prevents some drugs from stimulating the stomach or being decomposed by gastric acid in the stomach. Destruction, after being disintegrated in the intestine, is absorbed by the intestine, increasing the therapeutic effect of the drug on the disease.
  • the amount of the cellulose derivative and/or resin to be added is 75 to 98 parts by weight, preferably 90 to 96 parts by weight.
  • polyvinyl alcohol is added to the raw material composition, and the mixture of the polyvinyl alcohol and the cellulose derivative is 75-98 parts by weight to form K-carrageenan.
  • a mixture of a cellulose derivative and a polyvinyl alcohol of 75 to 98 parts by weight, 1 to 12 parts by weight of an alcohol, starch and a derivative thereof, 0 to 15 parts by weight of a raw material composition 0. 5-26 parts by weight, a mixture of a cellulose derivative and a polyvinyl alcohol of 75 to 98 parts by weight, 1 to 12 parts by weight of an alcohol, starch and a derivative thereof, 0 to 15 parts by weight of a raw material composition,
  • the amount of the fiber derivative and the polyvinyl alcohol to be added is preferably 90 to 96 parts by weight.
  • the cellulose derivative and the polyvinyl alcohol may be in a mixture of any weight ratio, and the weight ratio of the polyvinyl alcohol to the cellulose derivative is preferably 1:1-3, and the degree of polymerization of the polyvinyl alcohol used is 500. — 1700.
  • the cellulose derivative may be one of hypromellose, ethyl cellulose, hydroxypropyl cellulose, carboxymethyl cellulose or two of any weight ratio thereof.
  • the resin is one of polyvinyl alcohol, polyacrylic resin, povidone or any of them in any weight ratio.
  • the polyacrylic resin may be an ethyl acrylate-methyl methacrylate copolymer Eudragit E30D (Acrylic Acid Ethyl Ester-Methacrylic acid Methyl Ester Copolymer), dimethylaminoethyl methacrylate-neutral methacrylate copolymer Eudragit E100, methacrylic acid-methyl acrylate copolymer Eudragit L100-55, neutral acrylate-methyl methacrylate copolymer Eudragit NE30D, triammonium methacrylate-acrylate copolymer Eudragit RL and other polyacrylic resins , there are sales on the market.
  • the polyvinyl alcohols used Polyving Alcohol has a polymerization degree of 500-1700, and the polyvinyl alcohol PVA-0588, polyvinyl alcohol PYA-1788 and the like have a polymerization degree of 500, 1700, respectively.
  • the alcohol to be used is one of ethanol, glycerol and a mixture of ethanol and glycerol in any weight ratio, and the amount is 1-12 parts by weight, preferably 4-12 parts by weight, ethanol and C3
  • the weight ratio of the alcohol is 1: 1-2.5.
  • the starch and its derivative are a mixture of corn soluble starch, potato soluble starch, carboxymethyl starch, sodium carboxymethyl starch, dextrin, a mixture of two or more of any weight ratio, added
  • the amount is from ⁇ 0 to 15 parts by weight, preferably from 2 to 8 parts by weight.
  • the parts by weight may be units of weight such as grams, kilograms, kilograms, tons, and the like.
  • the method for preparing a hollow capsule of the present invention which comprises the plant polysaccharide hollow capsule raw material composition as a raw material, comprises the following steps:
  • the raw materials taken in each component are placed in a reaction vessel, and 4 to 10 times the sum of the weight components of the components other than the alcohol raw materials is added, At a temperature of 65 ° C to 85 ° C, the raw material is dissolved to form a glue, and an alcohol raw material is added during the dissolution of the raw material.
  • the formed glue is kept at a temperature of 30 ° C - 60 ° C for 1 to 24 hours.
  • Hollow capsules such as silicone rubber, dried (ie dry), stripped (ie, shelled), cut, and sleeved synthetic products.
  • stirring the stirring speed does not have much influence on the quality of the product, but the stirring speed is such that the glue does not blister.
  • the raw material used may be a K-carrageenan which is free from potassium salts, and a K-carrageenan which is prepared by the following method.
  • a mixture of carrageenan is used as a raw material, and a mixture of carrageenan and a concentration of 10% to 60% by volume of ethanol is added to a mixture of carrageenan to form a mixture, and the mixture is refluxed at a temperature of 55 ° C to 85 ° C. 5— 2. 5 hours, placed at room temperature, filtered to obtain K-carrageenan.
  • An aqueous solution forms a mixture. 5 ⁇ , Place at room temperature 25 °C, at a temperature of 80 ° C, refluxing at a temperature of 80 ° C, at a temperature of 0 ° C. After filtering with filter paper, it was washed 3 times with a 35% by volume aqueous solution of PH-8. 5 and washed at a temperature of 70 ° C for use in a laboratory thermostat (DPH-240, Beijing). ⁇ Guangming Medical Instrument Factory) was dried to a moisture content of 11% by weight.
  • the type is WP-645 high-efficiency automatic capsule cutting machine (Zhejiang Xinchang County Changjiang Machinery Factory) for cutting.
  • WP-645 high-efficiency automatic capsule cutting machine
  • JN26MAB capsule automatic forming production line Zhejiang Xinchang Chenguang Electromechanical Research Institute. Imported Canadian production capsule production lines are preferred.
  • the capsule prepared by using the plant polysaccharide hollow capsule raw material composition of the invention as a raw material not only has good stability, but also does not deform under high temperature or high humidity environment, and is not brittle in a cold and dry environment, and is convenient for long-term storage. Due to the use of plant polysaccharides as raw materials, it will not spread foot-and-mouth disease and mad cows. Disease, etc., avoids contamination that may be caused by animal peptone. Under normal conditions, the shelf life can be as long as 18 months, the stomach dissolves completely disintegrated within 10 minutes, and the enteric solution completely disintegrates within 60 minutes, in line with the current edition of the Pharmacopoeia of the People's Republic of China. It is also possible to control the release rate of the drug according to the requirements of the drug, and is also suitable for filling the oral solid preparation containing the aldehyde-based drug and the proprietary Chinese medicine.
  • the process of the invention can prepare capsules by using the original equipment, with less investment and simple process. detailed description
  • the plant polysaccharide hollow capsule raw material composition used in this example was 3 kg of K-carrageenan, 85 kg of hydroxypropylmethylcellulose, 4 kg of sodium carboxymethyl starch, and 8 kg of glycerol.
  • the preparation method is as follows:
  • the formed glue is kept at 60 ° C for 20 hours to maintain the glue.
  • the glue is dried, dried, stripped, cut, nested, inspected, printed, packaged, and sterilized.
  • the hollow capsule prepared in this embodiment has complete disintegration within 7 minutes of gastric dissolution, and the shelf life can be up to 18 months under normal conditions.
  • High temperature resistance, high humidity, and cold resistance are in full compliance with the quality standards stipulated in the current edition of the Pharmacopoeia of the People's Republic of China.
  • the process equipment and raw material composition used were basically the same as those in Example 1. The only difference was that there was no sodium carboxymethyl starch in the raw material composition, and the prepared hollow capsule completely disintegrated in the stomach for 10 minutes.
  • the process equipment and raw material composition used are basically the same as in the first embodiment except that the raw material composition is different.
  • the preparation process comprises the following steps: placing strontium-carrageenan, corn soluble starch or potato soluble starch, hypromellose, in a plasticization jar, adding strontium-carrageenan, corn soluble starch or potato soluble starch, hypromellose fiber 8 times the total weight of the water, forming a glue at 65 °C, adding ethanol and glycerol during the dissolution of the raw material, and curing the gel at 30 ° C for 12 hours to make a hollow capsule, completely dissolved in the stomach for 8 minutes. Disintegration.
  • the process equipment and raw material composition used were basically the same as those in Example 1, except that K-carrageenan 2.3 kg, hydroxypropyl cellulose 80 kg, 1 kg dextrin, ethanol and glycerol amount 4 kg , the weight ratio of ethanol to glycerol is 1:2.
  • the preparation method comprises the following steps:: K-carrageenan, hydroxypropylcellulose, dextrin is placed in a chemical gelatin jar, and K-carrageenan, hydroxypropylcellulose, and water of 6 times the total weight of dextrin are added to the water at 85.
  • a glue solution was formed at a temperature of ° C.
  • a mixture of ethanol and propanol was added during the dissolution of the raw material, and the gel was aged at 45 ° C for 8 hours, and the prepared hollow capsule was completely disintegrated in the stomach for 9 minutes.
  • the process equipment and raw material composition used were basically the same as those in Example 1. The only difference was 10 kg of K-carrageenan, 90 kg of hypromellose, 8 kg of sodium carboxymethyl starch, and 11 kg of glycerol.
  • the preparation method comprises the following steps:: K-carrageenan, carboxypropylmethylcellulose, sodium carboxymethyl starch is placed in a plasticization jar, and the total weight of K-carrageenan, carboxypropylmethylcellulose, and sodium carboxymethyl starch is added. 7 times of water, forming a glue at 80 ° C, adding glycerol during the dissolution of the raw material, and curing at 55 ° C for 24 hours, the prepared hollow capsule dissolves in the stomach for 9 minutes and completely disintegrates. .
  • the process equipment and raw material composition used were basically the same as those in Example 5. The only difference was that the hollow capsule made of 90 kg of ethyl cellulose substituted with hypromellose completely disintegrated in the stomach for 9 minutes.
  • the process equipment and raw material composition used were basically the same as those in Example 5. The only difference was that the hollow capsule made of 96 kg of hydroxypropylcellulose was completely dissolved in the stomach for 9. 5 minutes.
  • the process equipment and raw material composition used are basically the same as those in the first embodiment, except that the carrageenan is 2 kg.
  • the K-carrageenan, polyvinyl alcohol PVA- 0588, corn soluble starch was placed in a plastic can, adding K-carrageenan, polyvinyl alcohol PVA- 0588, corn soluble starch total weight of 6.5 times the water
  • the gelatin solution was formed at a temperature of 80 ° C, and ethanol and glycerol were added during the dissolution of the raw material, and the gel was cured at a temperature of 45 ° C for 16 hours. .
  • the process equipment and raw material composition used are basically the same as those in the first embodiment except that the carrageenan is 0.5 kg, polyvinyl alcohol PVA-1788, polymerization degree 1700, 94 kg, corn soluble starch 10 kg, ethanol 8 kg, C. Triol 4 kg.
  • the preparation method comprises the following steps:: K-carrageenan, polyvinyl alcohol PVA-1788, polymerization degree 1700, corn soluble starch are placed in a plasticization jar, and K-carrageenan, polyvinyl alcohol PVA-1788, total weight of corn soluble starch are added. 7. 5 times of water, forming a glue at a temperature of 75 ° C, adding ethanol and glycerol during the dissolution of the raw material, and curing the gel at a temperature of 57 ° C for 10 hours to form a hollow capsule. Completely disintegrated in 6 minutes.
  • the process equipment and the raw material composition used are basically the same as those in the embodiment 8, except that the polyvinyl alcohol PVA-0588 is added, the degree of polymerization is 500 kg, and the PVA-1788 is replaced by the hollow rubber gelatin. Disintegration.
  • the process equipment and raw material composition used were basically the same as those in Example 8, except that the corn soluble starch, sodium carboxymethyl starch 10 kg, and the weight ratio of corn soluble starch to sodium carboxymethyl starch were 1:1.5.
  • the process equipment and raw material composition used were basically the same as those in Example 8, except that the carrageenan 3 kg, the polyvinyl alcohol PVA- 0588, the polymerization degree of 500 and the total amount of carboxymethyl cellulose was 93 kg, polyvinyl alcohol PVA.
  • the weight ratio of -0588 to hypromellose is 1:1, sodium carboxymethyl starch is 9 kg, ethanol is 5 kg, and glycerol is 6 kg.
  • the preparation method comprises the following steps: K-carrageenan, polyvinyl alcohol PVA- 0588 and hypromellose, sodium carboxymethyl starch are placed in a plasticization jar, and K-carrageenan, polyvinyl alcohol PVA- 0588 and hyprothenol are added.
  • the total weight of methyl starch sodium is 7.0 times of water, forming a glue at a temperature of 75 ° C, adding ethanol and glycerol during the dissolution of the raw material, and curing the gel at a temperature of 6 (TC for 8 hours).
  • the capsule dissolves in the stomach for 8.5 minutes and completely disintegrates.
  • the process equipment and raw material composition used were basically the same as those in Example 8, except that K-carrageenan 2.5 kg, polyvinyl alcohol PVA-1788, polymerization degree 1700 and hypromellose total weight of 90 kg, polyethylene
  • the weight ratio of alcohol PVA-1788 to hypromellose was 1:3, sodium carboxymethyl starch 8 kg, and glycerol 6 kg.
  • the preparation method comprises the following steps: K-carrageenan, polyvinyl alcohol P-1788 and hypromellose, sodium carboxymethyl starch are placed in a plasticization jar, and K-carrageenan, polyvinyl alcohol PVA-1788, hyprothenol are added. 6.5 times the total weight of cellulose and sodium carboxymethyl starch, forming a glue at a temperature of 65, adding glycerin during the dissolution of the raw material, and curing at 60 ° C for 10 hours. The hollow capsule dissolves in the stomach for 8.5 minutes and completely disintegrates.
  • the process equipment and raw material composition used were basically the same as those in Example 1, except that K-carrageenan 3.5 kg, hypromellose 32 kg, polyacrylic resin (ethyl acrylate-methyl methacrylate copolymer Eudragit E30D) Or methacrylic acid-methyl acrylate copolymer Eudragit L30D) 53.5 kg, sodium carboxymethyl starch 3 kg, glycerol 8 kg.
  • the preparation method is as follows: K-carrageenan, hypromellose, ethyl acrylate-methyl methacrylate copolymer E30D or methacrylic acid-methyl acrylate copolymer Eudragit L30D, sodium carboxymethyl starch
  • the water is doubled, and a glue is formed at a temperature of 75 ° C.
  • Glycerol is added during the dissolution of the raw material, and the gel is cured at 65 ° C for 5 hours, and the prepared hollow capsule is completely disintegrated after being incinerated for 45 minutes.
  • the process equipment and raw material composition used were basically the same as those in Example 1, except that K-carrageenan 0.5 kg, polyvinyl alcohol PVA-0588, polymerization degree 500, 55 kg, polyacrylic resin Eudragit L100 or Eudragit (100- 55) 20 kg, corn soluble starch 15 kg, glycerol and ethanol total weight 10 kg, ethanol: glycerol weight ratio is 1:1.
  • the preparation method is as follows: K-carrageenan, polyvinyl alcohol PVA- 0588, Eudragit L100 or 0 ⁇ Eudragi t Ll OO- 55, corn soluble starch was placed in a chemical tank, adding K-carrageenan, polyvinyl alcohol PVA- 0588, Eudragi t L100 or Eudragi t Ll OO- 55, corn soluble starch total weight of 7. 0 times The water was formed at a temperature of 80 ° C, and a mixture of ethanol and glycerin was added during the dissolution of the raw material, and the rubber was aged at 80 ° C for 3 hours. The prepared hollow capsules were completely dissolved in the intestines for 30 minutes.
  • the process equipment and raw material composition used were basically the same as those in Example 1. The only difference was 5 kg of K-carrageenan, 50 kg of polyvinyl alcohol PVA-1788, 33 kg of E30D, 6 kg of ethanol, and 6 kg of glycerol.
  • Example 17 The process is exactly the same as in Example 15. Only starch was added, and it was completely disintegrated after 45 minutes of enteric dissolution.
  • the process equipment and raw material composition used were basically the same as those in Example 16, except that K-carrageenan 4 kg, polyvinyl alcohol PVA- 0588, polymerization degree 500, 33 kg, E30D polyacrylic resin 62 kg, ethanol 4 kg, Glycerol 8 kg.
  • the preparation method comprises the following steps:: K-carrageenan, polyvinyl alcohol PVA- 0588, E30D polyacrylic resin are placed in a plastic can, and the total weight of K-carrageenan, polyvinyl alcohol PVA-0588, and E30D polyacrylic resin is 10 times.
  • the water is formed at a temperature of 81 ° C.
  • Ethanol and glycerin are added during the dissolution of the raw material, and the gel is cured at 85 ° C for 2 hours.
  • the prepared hollow capsule is a sustained release capsule.
  • the process equipment and raw material composition used were basically the same as those in Example 1. The only difference was 22 kg of K-carrageenan, 90 kg of hypromellose, 15 kg of sodium carboxymethyl starch, and 12 kg of glycerol.
  • the preparation method comprises the following steps: adding 7 times water of total weight of K-carrageenan, hypromellose, sodium carboxymethyl starch, forming a glue at a temperature of 80 ° C, adding glycerin during the dissolution of the raw material, The gel was cured at a temperature of 55 24 for 24 hours to make a hollow capsule of the plant, and the stomach was dissolved for 10 minutes.
  • the process equipment and raw material composition used were basically the same as those in Example 18 except that K-carrageenan 20 kg and hypromellose 93 kg were used.
  • the process equipment and raw material composition used were basically the same as those in Example 19 except that K-carrageenan was 26 kg.

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Abstract

La présente invention a trait à une capsule creuse destinée à une utilisation médicale et son procédé de préparation. La composition de ses matières premières contient 0,5 - 26 % en poids de carraghénine, 75 à 98 % en poids de dérivés de cellulose et/ou de résines, et 1 à 12 % en poids d'alcools. Le procédé de préparation comprend les étapes suivantes: le placement de toutes les matières premières sauf les alcools dans un récipient auxquelles on ajoute de l'eau, l'ajout des alcools lors du traitement de fusion pour la formation d'une solution de gomme, l'immersion dans la gomme, le refroidissement et le séchage, le démoulage, la découpe et le scellement pour obtenir des capsules creuses. La capsule creuse de la présente invention présente une stabilité, et une durée de préservation, et satisfait les critères de la version la plus récente de la Pharmacopée de la République Populaire de Chine et/ou ceux de normes nationales.
PCT/CN2006/001480 2005-07-01 2006-06-28 Compositions de matieres premieres pour une capsule creuse contenant du polyose d'origine vegetale et procede de preparation d'une telle capsule WO2007003113A1 (fr)

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CN 200510079888 CN1276779C (zh) 2005-07-01 2005-07-01 一种植物多糖空心胶囊原料组合物及空心胶囊的制备方法
CN200510079888.3 2005-07-01

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Cited By (6)

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CN107890113A (zh) * 2017-12-21 2018-04-10 瑞昌市渝瑞实业有限公司 山药硬质胶囊生产系统及生产方法
CN109966501A (zh) * 2019-05-09 2019-07-05 徐燕滨 羧甲基淀粉钠在制备植物多糖硬胶囊中的应用及硬胶囊
US10793687B2 (en) 2012-12-05 2020-10-06 Lotte Fine Chemical Co., Ltd. Hard capsule having improved thickness uniformity
CN113876739A (zh) * 2021-11-15 2022-01-04 新昌中国计量大学企业创新研究院有限公司 一种植物空心胶囊及其制备方法
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CN115282125A (zh) * 2022-06-27 2022-11-04 江苏辰星药业股份有限公司 一种抗菌空心胶囊及其制备方法

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CN104758271A (zh) * 2015-03-16 2015-07-08 中华生物科技有限公司 纤维素胶与红藻卡帕胶复配的植物空心胶囊及制备方法
CN105434394B (zh) * 2015-12-16 2019-01-25 刘松林 一种聚乙烯醇空心胶囊
CN107674354B (zh) * 2017-10-18 2020-11-17 无锡鼎加弘思饮品科技有限公司 可溶解的咖啡胶囊杯体、其制备方法及咖啡胶囊
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CN110075081A (zh) * 2019-06-12 2019-08-02 江苏艾兰得营养品有限公司 一种植物软胶囊及其制备方法与用途
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US11312878B2 (en) 2012-07-23 2022-04-26 Lotte Fine Chemical Co., Ltd. Aqueous composition for preparing hard capsule, preparation method therefor, hard capsule, and method for recycling hard capsule scraps
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CN115282125A (zh) * 2022-06-27 2022-11-04 江苏辰星药业股份有限公司 一种抗菌空心胶囊及其制备方法

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