WO2017107628A1 - Capsule de chtiosnaoligosaccharide et son procédé de préparation - Google Patents

Capsule de chtiosnaoligosaccharide et son procédé de préparation Download PDF

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Publication number
WO2017107628A1
WO2017107628A1 PCT/CN2016/102114 CN2016102114W WO2017107628A1 WO 2017107628 A1 WO2017107628 A1 WO 2017107628A1 CN 2016102114 W CN2016102114 W CN 2016102114W WO 2017107628 A1 WO2017107628 A1 WO 2017107628A1
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WO
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Prior art keywords
chitosan oligosaccharide
capsule
parts
thickener
plasticizer
Prior art date
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PCT/CN2016/102114
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English (en)
Chinese (zh)
Inventor
苏政权
郭姣
黄兰兰
Original Assignee
广东药科大学
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Filing date
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Application filed by 广东药科大学 filed Critical 广东药科大学
Publication of WO2017107628A1 publication Critical patent/WO2017107628A1/fr

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Classifications

    • 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
    • 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
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/716—Glucans
    • A61K31/722—Chitin, chitosan
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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

  • the invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a chitosan oligosaccharide capsule and a preparation method thereof.
  • Chitosan naoligosaccharide is a homopolymer or heteropolymer of glucosamine and N-acetylglucosamine linked by ⁇ -1,4 glycosidic bonds.
  • COS is the only abundant organic polysaccharide in natural sugar. In addition to its chitosan-like properties, it also has the advantages of low viscosity, good water solubility, small molecular weight, easy absorption and degradability, and its biological activity and function. The properties are superior to chitosan.
  • a large number of studies have shown that COS has the functions of regulating blood sugar, blood sugar, anti-oxidation, anti-infection, enhancing immunity and anti-tumor. It is an ideal bioactive substance with broad medical application prospects.
  • Chinese patent CN103316031B discloses a slimming and lipid-lowering application of chitosan oligosaccharide, which has a remarkable application effect in controlling body weight, reducing body fat ratio and lowering serum total cholesterol and low density lipoprotein cholesterol content, indicating shell Oligosaccharides have significant weight loss and lipid-lowering effects, and also have the function of relieving fatty liver and reducing blood lipids in serum.
  • chitosan oligosaccharides have the characteristics of low molecular weight, easy moisture absorption, and easy oxidation, their application in the field of health care products or medicines is greatly limited. At present, the application of chitosan oligosaccharides is mainly focused on crops.
  • Chinese patent CN102613197B discloses the use of chitosan oligosaccharide for preventing premature aging, which can effectively prevent premature aging of crops and ensure stable yield and income of agriculture.
  • Chinese patent CN101818181B discloses a method for enzymatically preparing agricultural chitosan oligosaccharide and a crop nutrient preparation containing chitooligosaccharide, which can not only provide nutrition for crops, stimulate crop growth, but also inhibit the reproduction of harmful bacteria and improve the crop itself. Disease resistance.
  • the object of the present invention is to provide a chitosan oligosaccharide capsule and a preparation method thereof to solve the above defects.
  • the present invention provides a chitosan oligosaccharide capsule comprising a content and a capsule comprising the following components and their weight percentages: chitosan oligosaccharide 80-100%, microcrystalline cellulose 0-6%, bonding Agent 0-5%, calcium stearate 0-3%, ethanol 0-4% and micronized silica gel 0-2%;
  • the capsule comprises the following components and parts by weight: 4-10 parts of hydroxypropyl starch, 2-6 parts of xanthan gum, 4-8 parts of thickener, 3-6 parts of plasticizer and 10 parts of water. 20 copies.
  • the content includes the following components and their weight percentages: chitosan oligosaccharide 80-92%, microcrystalline cellulose 2-6%, binder 2-5%, calcium stearate 1-3%, ethanol 2-4% and micronized silica gel 1-2%.
  • the contents include the following components and their weight percentages: chitosan oligosaccharide 85.5%, microcrystalline cellulose 4%, binder 4%, calcium stearate 2%, ethanol 3%, and micronized silica gel 1.5% .
  • the binder is a povidone solution having a concentration of 5%
  • the ethanol is anhydrous ethanol.
  • the capsule comprises the following components and parts by weight: 8 parts of hydroxypropyl starch, 4 parts of xanthan gum, 5 parts of thickener, 4 parts of plasticizer and 16 parts of water.
  • the thickener is composed of guar gum and propylene glycol alginate in a weight ratio of 1-2:3-4, preferably, the thickener is composed of guar gum and propylene glycol alginate by weight. It is composed of 1.2:3.5.
  • the plasticizer is composed of glycerin and triethyl citrate in a weight ratio of 2-4:1-3, preferably, the plasticizer is 3.5:2 by weight of glycerin and triethyl citrate. composition.
  • the content of the capsule provided by the invention adopts a povidone solution having a concentration of 5% as a binder, which can improve the uniformity of the particles without occurrence of the phenomenon that the particles cannot be granulated, the particles are loose or agglomerated.
  • the use of anhydrous ethanol as a wetting agent can prevent the appearance of mushy or lumps of chitosan oligosaccharides.
  • the composition of the capsule contents provided by the invention is reasonable, and the prepared contents are dry, moderately tight, and the moisture content is qualified, which complies with the relevant provisions of the Chinese Pharmacopoeia on the contents of the capsules.
  • the hydroxypropyl starch in the capsule provided by the invention has the formula C 3 H 8 O 2 ⁇ x, the CAS number is 9049-76-7, and has the advantages of high stability, good expandability and good film forming property, yellow
  • the original rubber has the advantages of high viscosity, good thermal stability and acid-base stability, and is an ideal bio-adhesive.
  • the combination of hydroxypropyl starch and xanthan gum can improve the gelation and gel temperature of hydroxypropyl starch, which is beneficial to the film formation of hydroxypropyl starch.
  • the guar gum in the capsule provided by the present invention is a nonionic galactomannan which has good water solubility and exhibits a high viscosity at a low mass fraction.
  • the propylene glycol alginate is a deep-processed alginic acid extracted from natural seaweed, which does not gel in an acidic solution, and is an environmentally-friendly thickener.
  • the combination of guar gum and propylene glycol alginate in a certain proportion can greatly enhance the thickening effect of propylene glycol alginate.
  • Glycerin has the characteristics of low viscosity, easy dispersion and good compatibility, while triethyl citrate has the advantages of strong solubility and good mold resistance. Glycerin and triethyl citrate are used in combination in a certain ratio to have a remarkable plasticizing effect.
  • the capsules provided by the invention have reasonable distribution, and the prepared capsules have no odor, the appearance is neat, no sticking, deformation, leakage or capsule rupture, and the sealing property is good, the oxidation resistance is high, and the improvement is greatly improved.
  • the stability of the capsule is beneficial to the preservation of the capsule.
  • the present invention also provides a method for preparing a chitosan oligosaccharide capsule, comprising the following steps:
  • S1 grinds chitosan oligosaccharide, microcrystalline cellulose, calcium stearate and micro-powder silica gel into a fine powder, and mixes with a binder and ethanol to pass through a sieve of 18-25 mesh to obtain a fine powder;
  • the fine powder obtained in the step S1 is subjected to wet granulation, the wet granulation temperature is 22-28 ° C, the humidity is 35-45%, and the granulation is dried to less than 10% moisture to obtain a content;
  • S3 grinds the hydroxypropyl starch into a fine powder, adds xanthan gum, thickener, plasticizer and water to mix evenly, and dries at a temperature of 55-60 ° C for 4-5 h, then at a temperature of 50 ° C Carrying out silicone, drying, demoulding, cutting, nesting, and obtaining a capsule;
  • step S4 the content obtained in step S2 is filled into the capsule obtained in step S3, and the capsule is sealed.
  • the chitosan oligosaccharide capsule provided by the present invention has the following advantages:
  • the chitosan oligosaccharide capsule provided by the invention has no odor, has a neat appearance, is smooth, and has high solubility, and is beneficial to the effect of medicine, and is an ideal chitosan oligosaccharide capsule;
  • the chitosan oligosaccharide capsule provided by the invention has good sealing property and high oxidation resistance, and can effectively solve the problem that the chitosan oligosaccharide is easy to oxidize and absorb moisture, and is beneficial to the long-term preservation of chitooligosaccharide.
  • Example 1 A chitosan oligosaccharide capsule
  • the content is 100% chitosan oligosaccharide
  • the capsule comprises the following components and parts by weight: hydroxypropyl starch 8 parts, xanthan gum 4 parts, thickener 5 parts, plasticizer 4 parts and water 16 parts; the thickener is made of melon
  • the guar gum and the propylene glycol alginate were composed at a weight ratio of 1.2:3.5, and the plasticizer was composed of glycerin and triethyl citrate in a weight ratio of 3.5:2.
  • S1 grinds the chitosan oligosaccharide into a fine powder and passes through a 20 mesh sieve to obtain a fine powder;
  • the fine powder obtained in the step S1 is subjected to wet granulation, the wet granulation temperature is 25 ° C, the humidity is 40%, and the granulation is dried to less than 10% moisture to obtain a content;
  • S3 grinds the hydroxypropyl starch into a fine powder, adds xanthan gum, a thickener, a plasticizer and water to mix uniformly, and dries at a temperature of 60 ° C for 4 h, and then writes the tannin at a temperature of 50 ° C. Drying, demoulding, cutting, nesting, obtaining a capsule;
  • step S4 the content obtained in step S2 is filled into the capsule obtained in step S3, and the capsule is sealed.
  • Example 2 A chitosan oligosaccharide capsule
  • the contents include the following components and their weight percentages: chitosan oligosaccharide 92%, microcrystalline cellulose 2%, 5% povidone solution 2%, calcium stearate 1%, absolute ethanol 2%, and fine powder Silicone 1%;
  • the capsule comprises the following components and parts by weight: 4 parts of hydroxypropyl starch, 2 parts of xanthan gum, 4 parts of thickener, 3 parts of plasticizer and 10 parts of water; the thickener is made of melon
  • the guar gum and the propylene glycol alginate were composed at a weight ratio of 1:4, and the plasticizer was composed of glycerin and triethyl citrate in a weight ratio of 2:3.
  • S1 grinds chitosan oligosaccharide, microcrystalline cellulose, calcium stearate and micro-powder silica gel into fine powder, and mixes with 5% povidone solution and absolute ethanol, and passes through a 20 mesh sieve to obtain a fine powder;
  • the fine powder obtained in the step S1 is subjected to wet granulation, the wet granulation temperature is 25 ° C, the humidity is 40%, and the granulation is dried to less than 10% moisture to obtain a content;
  • S3 grinds the hydroxypropyl starch into a fine powder, adds xanthan gum, a thickener, a plasticizer and water to mix uniformly, and dries at a temperature of 60 ° C for 4 h, and then writes the tannin at a temperature of 50 ° C. Drying, demoulding, cutting, nesting, obtaining a capsule;
  • step S4 the content obtained in step S2 is filled into the capsule obtained in step S3, and the capsule is sealed.
  • Example 3 a chitosan oligosaccharide capsule
  • the contents include the following components and their weight percentages: chitosan oligosaccharide 85.5%, microcrystalline cellulose 4%, 5% povidone solution 4%, calcium stearate 2%, anhydrous ethanol 3%, and fine powder Silicone 1.5%;
  • the capsule comprises the following components and parts by weight: hydroxypropyl starch 8 parts, xanthan gum 4 parts, thickener 5 parts, plasticizer 4 parts and water 16 parts; the thickener is made of melon
  • the guar gum and the propylene glycol alginate were composed at a weight ratio of 1.2:3.5, and the plasticizer was composed of glycerin and triethyl citrate in a weight ratio of 3.5:2.
  • the preparation method was similar to that of Example 2.
  • Example 4 a chitosan oligosaccharide capsule
  • the contents include the following components and their weight percentages: chitosan oligosaccharide 80%, microcrystalline cellulose 6%, 5% povidone solution 5%, calcium stearate 3%, absolute ethanol 4%, and fine powder Silicone 2%;
  • the capsule comprises the following components and parts by weight: 10 parts of hydroxypropyl starch, 6 parts of xanthan gum, 8 parts of thickener, 6 parts of plasticizer and 20 parts of water; the thickener is made of melon
  • the guar gum and the propylene glycol alginate were composed at a weight ratio of 2:3, and the plasticizer was composed of glycerin and triethyl citrate in a weight ratio of 4:1.
  • the preparation method was similar to that of Example 2.
  • the thickener is composed of guar gum and propylene glycol alginate at a weight ratio of 3:2, and the remaining components are as in Example 3.
  • the preparation method was similar to that of Example 2.
  • the plasticizer is composed of glycerin and triethyl citrate in a weight ratio of 1:4, and the remaining components are as in Example 3.
  • the preparation method was similar to that of Example 2.
  • Test materials Shell oligosaccharide capsules prepared in Example 1, Example 2, Example 3, Example 4, Comparative Example 1 and Comparative Example 2.
  • the contents of the shell oligosaccharide capsules prepared in Examples 1-4 of the present invention are dry, moderately tight, and the moisture content is less than 9.0%, and the capsule has no peculiar smell, and the appearance is neat, without sticking, deformation, and seepage.
  • Leakage or capsule rupture, its loading difference and solubility are in line with the relevant provisions of the Chinese Pharmacopoeia, while the capsules prepared in Comparative Example 1 and Comparative Example 2 have irregularities in appearance, such as sticking, deformation, leakage or rupture of the shell.
  • the dissolution rate is less than 90% at 45 min, which does not comply with the relevant regulations of the Chinese Pharmacopoeia, indicating that the capsule formulation provided by the invention is reasonable, can greatly improve the product quality, and promote the promotion and application of the chitosan oligosaccharide capsule.
  • Test materials Shell oligosaccharide capsules prepared in Example 1, Example 2, Example 3, Example 4, Comparative Example 1 and Comparative Example 2.
  • the chitosan oligosaccharide capsules prepared in Examples 1-4 of the present invention are placed under the conditions of temperature of 40 ° C ⁇ 2 ° C and relative humidity of 75% ⁇ 5% for 6 months, and the indexes thereof are all in accordance with The quality requirements of the Chinese Pharmacopoeia for the capsules, while the stability of the chitosan oligosaccharide capsules prepared in Comparative Example 1 and Comparative Example 2 were inferior to those of the chitosan oligosaccharide capsules prepared in Examples 1-4, indicating the shell oligomer provided by the present invention.
  • the formula of the sugar capsule is reasonable, and the stability of the chitosan oligosaccharide capsule is greatly improved.
  • Test Example 3 Long-term test of chitosan oligosaccharide capsules
  • Test materials Shell oligosaccharide capsules prepared in Example 1, Example 2, Example 3 and Example 4.
  • Example 1 The chitosan oligosaccharide capsules prepared in Example 1, Example 2, Example 3 and Example 4 were subjected to long-term tests with reference to the test method of "Chinese Pharmacopoeia 2010 Edition Part II Appendix XIX C".

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

L'invention a trait au domaine technique de préparations médicinales à partir d'herbes utilisées en médecine traditionnelle chinoise et concerne plus particulièrement une capsule de chtiosnaoligosaccharide (COS) et son procédé de préparation. La capsule de chtiosnaoligosaccharide comprend un contenu et une enveloppe de capsule, le contenu étant essentiellement composé de COS, de cellulose microcristalline, d'un adhésif, de calcium stéarate, d'éthanol et de gel de silice en poudre superfine. Le chtiosnaoligosaccharide est essentiellement composé d'amidon d'hydroxypropyle, de gomme xanthane, d'épaississant, de plastifiant et d'eau. La capsule de COS ne présente pas de goût particulier, elle est d'apparence agréable et régulière, la tolérance en poids et la solubilité de la capsule de COS satisfait aux normes de la pharmacopée chinoise. Par ailleurs, la capsule de COS présente une bonne étanchéité et une bonne résistance à l'oxydation, et est en mesure de palier efficacement au problème lié au risque du chtiosnaoligosaccharide de s'oxyder et d'absorber l'humidité trop facilement, ce qui améliore la durée de conservation.
PCT/CN2016/102114 2015-12-24 2016-10-14 Capsule de chtiosnaoligosaccharide et son procédé de préparation WO2017107628A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201510988017.7A CN105380924B (zh) 2015-12-24 2015-12-24 一种壳寡糖胶囊剂及其制备方法
CN2015109880177 2015-12-24

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022194351A1 (fr) 2021-03-16 2022-09-22 Symrise Ag Capsules de substances actives
WO2023184828A1 (fr) * 2022-03-30 2023-10-05 扬州日兴生物科技股份有限公司 Nanomicrosphère pour améliorer la biodisponibilité orale d'oligosaccharide de chitosane, et son procédé de préparation

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CN105380924B (zh) * 2015-12-24 2018-01-16 广东药科大学 一种壳寡糖胶囊剂及其制备方法
CN108186701A (zh) * 2018-02-08 2018-06-22 沈勇子 一种壳寡糖胶囊及其制备方法
CN108553426B (zh) * 2018-06-01 2020-04-03 广东药科大学 一种壳聚糖滴丸及其制备方法
CN108578374B (zh) * 2018-06-01 2020-04-03 广东药科大学 一种壳寡糖颗粒剂及其制备方法
CN109316460B (zh) * 2018-09-26 2021-11-26 青岛大学 一种多糖类聚电解质中空胶囊的制备方法及得到的中空胶囊
CN114376982B (zh) * 2022-01-18 2023-06-30 广东药科大学 一种壳寡糖肠溶胶囊及其制备方法和应用

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CN104586877A (zh) * 2015-02-10 2015-05-06 河北工业大学 含壳寡糖的药物组合物及其应用
CN105380924A (zh) * 2015-12-24 2016-03-09 广东药学院 一种壳寡糖胶囊剂及其制备方法

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CN101744164A (zh) * 2009-12-29 2010-06-23 江西省三抗保健品有限公司 壳寡糖胶囊
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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022194351A1 (fr) 2021-03-16 2022-09-22 Symrise Ag Capsules de substances actives
WO2023184828A1 (fr) * 2022-03-30 2023-10-05 扬州日兴生物科技股份有限公司 Nanomicrosphère pour améliorer la biodisponibilité orale d'oligosaccharide de chitosane, et son procédé de préparation

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