A kind of gelatin hollow capsule with anti-crosslinking effect and preparation method thereof

A technology of hollow capsules and cross-linking, which is applied in the direction of non-active ingredient medical preparations, 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: 2022-06-07
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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  • A kind of gelatin hollow capsule with anti-crosslinking effect and preparation method thereof
  • A kind of gelatin hollow capsule with anti-crosslinking effect and preparation method thereof
  • A kind of gelatin hollow capsule with anti-crosslinking effect and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] 1000 parts with flat freeze strength 210 B Loomg gelatin, 5 parts polyethylene glycol 4000, 10 parts ammonium bicarbonate and 5 parts BHA added to 3000 parts of purified water has been heated to 73 °C in the sol tank, stirred to dissolve, -0.05MPa vacuum for 15min after 15 minutes with 350 mesh filter filter glue to the rubber barrel, add the appropriate amount of food coloring and titanium dioxide, purified water to adjust the viscosity to the process requirements, stand insulation to remove bubbles; The glue solution is stable for 5 hours after removing the bubbles for the production of automatic capsule production line, the mold is automatically pushed into the drying kiln after gluing, the capsules with drying weightless qualified are demoulded, cut and fitted, and the capsules are packaged, inspected and stored after the automatic capsule sorting machine proposes unqualified products.

Embodiment 2

[0026]1000 parts with flat freeze strength 220 B Loomg gelatin, 7 parts polyethylene glycol 6000, 10 parts ammonium bicarbonate, 4 parts DLTP and 4 parts BHT added 3500 parts of purified water has been heated to 80 °C in the sol tank, stirred to dissolve, -0.05MPa vacuumed for 15 minutes after 15 minutes with 350 mesh filter to filter the glue liquid to the rubber barrel, add an appropriate amount of food coloring and titanium dioxide, purify the water to adjust the viscosity to the process requirements, stand insulation to remove the bubbles; The glue is stable for 7 hours after removing the bubbles for the production of the automatic capsule production line, the mold is automatically pushed into the drying kiln after the glue is dried, the drying weightless qualified capsules are demoulded, cut and fitted, and the capsules are packaged, inspected and stored after the unqualified products are proposed by the automatic capsule sorting machine.

Embodiment 3

[0028] 1000 parts with flat freeze strength strength 230 B Loomg gelatin, 4 parts polyethylene glycol 4000, 2 parts glycerin, 10 parts sodium hydroxide and 10 parts TDPA added 3500 parts of purified water has been heated to 83 °C in the sol tank, stirred to dissolve, -0.05MPa vacuum for 17 minutes after 17 minutes with 350 mesh filter filter glue liquid to the rubber barrel, add the appropriate amount of food coloring and titanium dioxide, purified water to adjust the viscosity to the process requirements, stand insulation to remove bubbles; The glue is stable for 6 hours after removing the bubbles for the production of the fully automatic capsule production line, the mold is automatically pushed into the drying kiln after the glue is dried, the drying weightless qualified capsules are demoulded, cut and fitted, and the capsules are packaged, inspected and stored after the automatic capsule sorting machine is put forward by the automatic capsule sorting machine.

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Abstract

The invention provides a gelatin hollow capsule with anti-crosslinking effect and a preparation method thereof. The composition ratio of the gelatin hollow capsule is as follows: 1000 parts of gelatin, 2-10 parts of plasticizer, 2-15 parts of antioxidant, 2-15 parts of 10 parts of pH regulator, 0-30 parts of colorant, 2800-4000 parts of purified water, the concentration of the gelatin glue is 25%-35%. The preparation method of the above-mentioned gelatin hollow capsule with anti-crosslinking effect is also provided. The gelatin hollow capsule prepared by the present invention has obvious anti-crosslinking effect, by adjusting the raw material index and auxiliary material composition of the gelatin hollow capsule, the capsule that is prone to crosslinking reaction can avoid crosslinking reaction in the accelerated stability test process. Affect the dissolution rate of the preparation, and at the same time reduce the risk of non-equivalence in the bioequivalence experiment of the easily cross-linked capsules.

Description

Technical field [0001] The present invention belongs to the field of pharmaceutical excipient technology, in particular to a gelatin hollow capsule having an anti-crosslinking effect and a method of preparation thereof. Background [0002] As the most popular dosage form for consumers, capsules have been widely used in the development of pharmaceutical preparations, with gelatin hollow capsules accounting for the highest proportion. The capsule effectively masks the taste and odor of the contents and is easy to swallow, but the crosslinking reaction of gelatin hollow capsules is one of the important factors affecting the detection of in vitro dissolution of capsules, and the dissolution degree is an important indicator of the quality control of solid oral preparations. [0003] Gelatin capsule raw materials, fillers and storage conditions are the main factors causing crosslinking reaction, gelatin capsule crosslinking phenomenon refers to the preparation in the unenzing dissoluti...

Claims

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Application Information

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Patent Type & Authority Patents(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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