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Enteric capsule shell and preparation method thereof

A technology of enteric-coated capsules and solutions, which is applied in the field of enteric-coated capsule shells and its preparation, can solve the problems of capsule solubility reduction, impact on biocompatibility, impact on gelatin capsule production, etc., and achieve easy purification, low price, and easy raw materials The effect

Inactive Publication Date: 2017-02-01
NANTONG TEXTILE & SILK IND TECH RES INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, gelatin is easy to degrade. For enteric-coated capsules, a chemical cross-linking reaction is required to reduce the solubility of the capsule and delay the disintegration of gelatin capsules in gastric juice. The residue of chemical cross-linking agents may affect its biocompatibility
[0005] Due to some religious beliefs and problems such as mad cow disease, many countries and regions prohibit the use of mammals to make gelatin, which also affects the production of gelatin capsules.

Method used

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  • Enteric capsule shell and preparation method thereof

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preparation example Construction

[0023] A method for preparing an enteric-coated capsule shell, comprising the following steps: Step 1: preparing a sericin solution; Step 2: preparing a silk fibroin solution; Step 3: preparing an aqueous solution of formamide, proline and ethylene glycol; Step 4 : Prepare mixed solution; Step 5: Prepare finished product;

[0024] in:

[0025] Step 1: Using silkworm cocoon shells or silkworm raw silk as raw materials, add deionized water to boil the cocoons in a boiling water bath, centrifuge and take the supernatant to obtain a sericin solution, measure its mass percentage concentration, and refrigerate in the refrigerator for later use;

[0026] Step 2: Use silkworm cocoon shells or silkworm raw silk as raw materials, degumming to remove sericin, drying, dissolving with lithium bromide, dialyzing in deionized water for 2 to 5 days at 4°C to obtain a silk fibroin solution, and measuring its mass percentage Concentration, refrigerated in the refrigerator for later use;

[00...

Embodiment 1

[0034] Step 1, boil the cleaned silkworm cocoons and deionized water in a ratio of 1:10 in a high temperature and high pressure sterilizing pot for 20 minutes, filter the cocoon shells to obtain a sericin solution;

[0035] Step 2, degumming silkworm cocoons with sodium bicarbonate-sodium carbonate buffered aqueous solution, washing and drying the silkworm cocoons to obtain degummed silk. According to the degummed silk: lithium bromide solution (9.3mol / L) = 1:20 to dissolve the degummed silk, the mixed solution is dialyzed with deionized water at 4°C for 3~4 days to obtain the silk fibroin solution;

[0036] Step 3: Take formamide, ethylene glycol and proline, configure it into an aqueous solution containing formamide, proline and ethylene glycol, and set aside;

[0037] Step 4: Mix silk fibroin, sericin, formamide, ethylene glycol, and proline into the mold at a mass ratio of 45:45:8:1:1;

[0038] Step 5: Put the mixed solution in an oven at 75°C for 1 hour, and then place i...

Embodiment 2

[0041] Step 1, cooking the cleaned silkworm cocoons and deionized water at a ratio of 1:20 in a high temperature and high pressure sterilizing pot for 1 hour, filtering the cocoon shells to obtain a sericin solution;

[0042]Step 2, degumming silkworm cocoons with sodium bicarbonate-sodium carbonate buffered aqueous solution, washing and drying the silkworm cocoons to obtain degummed silk. According to the degummed silk: lithium bromide solution (9.3mol / L) = 1:10 to dissolve the degummed silk, the mixed solution is dialyzed with deionized water at 4°C for 3~4 days to obtain the silk fibroin solution;

[0043] Step 3: Take formamide, ethylene glycol and proline, configure it into an aqueous solution containing formamide, proline and ethylene glycol, and set aside;

[0044] Step 4: Mix silk fibroin, sericin, formamide, ethylene glycol, and proline into the mold according to the mass ratio of 77:13:7:2:1;

[0045] Step 5: Put the mixed solution in an oven at 75°C for 2 hours, an...

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Abstract

The invention relates to an enteric capsule shell. The enteric capsule shell is prepared from, by mass, 1%-45% of sericin protein, 35%-70% of silk fibroin, 1%-15% of formamide, 2%-30% of ethylene glycol and 2%-25% of proline; natural silk protein good in biocompatibility serves as a raw material, small molecules are added to improve the crystallization property of the material, the natural silk protein can be used for replacing gelatin to serve as the capsule shell material, and the problems caused by capsule shells prepared from the gelatin are solved. It is proved through cell proliferation assays that the obtained capsule shell material can support good growth of cells and is good in cell compatibility and harmless to human body. The silk protein is low in price, capable of obtaining the raw materials easily and easy to purify, cannot carry pathogens common to mammals and is suitable for pharmaceutical materials.

Description

technical field [0001] The invention relates to the field of pharmaceutical excipients, in particular to an enteric-coated capsule shell and a preparation method thereof. Background technique [0002] As a drug coating material, capsules can not only cover up the smell of drugs, but also improve the stability of drugs and have a certain degree of protection for drugs, especially enteric-coated capsules, which can improve the bioavailability of drugs and prevent gastric juice from affecting drugs. damage, which makes it the main dosage form of oral medicaments. [0003] The material widely used in the production of hollow hard capsules is gelatin. Gelatin is obtained by boiling the bones and skins of cattle, sheep, pigs, etc. As the main raw material of capsules, gelatin has many unique properties, such as gelling, film-forming, emulsifying, and cohesive properties of gelatin. These properties are the advantages of gelatin as a capsule material. However, the gelatin capsu...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K47/42A61K47/18A61K47/10A61K47/22
CPCA61K9/4825A61K9/4816
Inventor 卢神州吴峰陈大旗付华卢欣暘
Owner NANTONG TEXTILE & SILK IND TECH RES INST
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