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Gelatin hollow capsule with anti-crosslinking effect and preparation method thereof

A hollow capsule and cross-linking technology, which is applied in the direction of medical preparations with non-active ingredients, medical preparations containing active ingredients, capsule delivery, etc., can solve the problems that gelatin empty capsules are prone to cross-linking reactions, etc., and achieve obvious resistance Effect of cross-linking, reduction of risk of non-equivalence, effect of reducing degree of cross-linking

Active Publication Date: 2020-10-30
青岛益青生物科技股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In order to solve the problem that the above-mentioned gelatin hollow capsules are prone to cross-linking reactions, the invention provides a gelatin hollow capsule with anti-crosslinking effect and a preparation method thereof. The gelatin hollow capsules prepared by the present invention have obvious cross-linking resistance, By adjusting the raw material index and excipient composition of gelatin hollow capsules, the capsules that are prone to cross-linking reactions can avoid cross-linking reactions and affect the dissolution rate of the preparation during the accelerated stability test, and at the same time reduce the biological risk of cross-linking capsules. The risk of non-equivalence of efficacy experiments

Method used

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  • Gelatin hollow capsule with anti-crosslinking effect and preparation method thereof
  • Gelatin hollow capsule with anti-crosslinking effect and preparation method thereof
  • Gelatin hollow capsule with anti-crosslinking effect and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Add 1,000 parts of 1,000 parts of purified water to a sol tank heated to 73°C, stir to dissolve, and pump at -0.05 MPa. After vacuuming for 15 minutes, use a 350-mesh filter to filter the glue into the glue barrel, add an appropriate amount of food coloring and titanium dioxide, and adjust the viscosity to the process requirements with purified water, and let it stand for heat preservation to remove air bubbles; the glue is stable for 5 hours after removing air bubbles and then used in the automatic capsule production line Production, after the mold is glued, it is automatically pushed into the drying kiln for drying, and the capsules that have passed the drying weight loss are demoulded, cut and fitted. The unqualified capsules are picked out by the automatic capsule sorting machine and then packaged, inspected, and put into storage.

Embodiment 2

[0026] Add 1000 parts of 220 B Loomg gelatin, 7 parts of polyethylene glycol 6000, 10 parts of ammonium bicarbonate, 4 parts of DLTP and 4 parts of BHT into 3500 parts of purified water, which has been heated to 80 ℃, and stir to dissolve. After vacuuming at -0.05MPa for 15 minutes, use a 350-mesh filter to filter the glue into the glue barrel, add an appropriate amount of food coloring and titanium dioxide, and adjust the viscosity to the process requirements with purified water, and let it stand for heat preservation to remove air bubbles; the glue is stable for 7 hours after removing air bubbles and then used Fully automatic capsule production line, after the mold is glued, it is automatically pushed into the drying kiln for drying, and the capsules that pass the drying weight loss are demoulded, cut and fitted. storage.

Embodiment 3

[0028] Add 1000 parts of gelatin, 4 parts of polyethylene glycol 4000, 2 parts of glycerin, 10 parts of sodium hydroxide and 10 parts of TDPA into 3500 parts of purified water heated to 83 ° C in a sol tank, stir to dissolve, After vacuuming at -0.05MPa for 17 minutes, use a 350-mesh filter to filter the glue into the glue barrel, add an appropriate amount of food coloring and titanium dioxide, and adjust the viscosity to the process requirements with purified water, and let it stand for heat preservation to remove air bubbles; the glue is stable for 6 hours after removing air bubbles and then used Fully automatic capsule production line, after the mold is glued, it is automatically pushed into the drying kiln for drying, and the capsules that pass the drying weight loss are demoulded, cut and fitted. storage.

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Abstract

The invention provides a gelatin hollow capsule with an anti-crosslinking effect and a preparation method thereof. The gelatin hollow capsule comprises the following components in parts by weight: 1000 parts of gelatin, 2-10 parts of a plasticizer, 2-15 parts of an antioxidant, 2-10 parts of a pH regulator, 0-30 parts of a coloring agent and 2800-4000 parts of purified water, wherein the concentration of a gelatin solution is 25%-35%. The invention further provides a preparation method of the gelatin hollow capsule with the anti-crosslinking effect. The gelatin hollow capsule prepared by the method has an obvious anti-crosslinking effect; by adjusting the raw material indexes and the auxiliary material composition of the gelatin hollow capsule, the capsule prone to cross-linking reaction can be prevented from generating cross-linking reaction to influence the dissolution rate of the preparation in the accelerated stability experiment process, and meanwhile, the risk that the bioequivalence experiment of the capsule prone to cross-linking is not equivalent can be reduced.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical excipients, in particular to a gelatin hollow capsule with anti-crosslinking effect and a preparation method thereof. Background technique [0002] As the most popular dosage form for consumers, capsules are widely used in the development of pharmaceutical preparations, among which gelatin hollow capsules account for the highest proportion. Capsules effectively cover the taste and smell of the contents, and are easy to swallow, but the cross-linking reaction that gelatin hollow capsules are prone to produce is one of the important factors affecting the dissolution test of capsules in vitro. The dissolution rate is an important quality control of solid oral preparations. index. [0003] The raw and auxiliary materials, fillers and storage conditions of gelatin capsules are the main factors causing the crosslinking reaction. The crosslinking phenomenon of gelatin capsules refers to the pheno...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K47/42A61K47/02A61K47/04A61K47/10A61K47/20A61K47/18A61K31/7048
CPCA61K9/4825A61K9/4816A61K47/02A61K47/10A61K47/20A61K47/183A61K31/7048
Inventor 崔荣强刘杰李同杰
Owner 青岛益青生物科技股份有限公司
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