Enteric soluble hollow capsule and preparation method thereof

A hollow capsule, enteric-coated technology, applied in the directions of capsule delivery, pharmaceutical formulations, and non-active ingredients medical preparations, etc., can solve problems such as complex production processes, and achieve the effects of good safety, protection stability, and uniform color and luster.

Active Publication Date: 2017-07-07
青岛蓝谷药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It can be seen that the enteric-coated vegetable cellulose hard hollow capsule disclosed in CN104288120A and its preparation method use the organic solvent ethanol as the coating solvent, and it needs to be dried twice to prepare the enteric-coated hollow capsule, and the production process is more complicated.

Method used

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  • Enteric soluble hollow capsule and preparation method thereof
  • Enteric soluble hollow capsule and preparation method thereof
  • Enteric soluble hollow capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] The enteric hollow capsule of Example 1 includes a capsule body, the outer surface of the capsule body is covered with an enteric coating layer, the capsule body is composed of hypromellose, gel and water, and the enteric coating layer is composed of a low acyl knot Composed of cold glue, curing agent and water, wherein the gelling agent is κ-carrageenan, and the curing agent is calcium chloride. The empty capsule of Example 1 is composed of 74% hypromellose, 5% kappa-carrageenan, 12.5% ​​low-acyl gellan gum, 0.08% calcium chloride, and the balance is water. The preparation method of this enteric-coated hollow capsule is as follows:

[0030] (1) Preparation of capsule body glue A: Mix 14.5 parts of hypromellose and 0.9 parts of κ-carrageenan evenly to obtain mixed raw materials; disperse the above mixed raw materials with 100 parts of deionized water, and heat Dissolve at the temperature of the sol for 1.0h; when the sol is finished, keep it warm for 1h at a temperatur...

Embodiment 2

[0035] The enteric hollow capsule of Example 2 includes a capsule body, the outer surface of the capsule body is covered with an enteric coating layer, the capsule body is composed of hypromellose, gel and water, and the enteric coating layer is composed of low acyl knot Composed of cold glue, curing agent and water, wherein the gelling agent is κ-carrageenan, and the curing agent is calcium lactate. The empty capsule of Example 2 is composed of 75.2% hypromellose, 4.5% kappa-carrageenan, 11.6% low-acyl gellan gum, 0.1% calcium lactate, and water as the balance. The preparation method of this enteric-coated hollow capsule is as follows:

[0036](1) Preparation of capsule body glue A: Mix 15.5 parts of hypromellose and 0.9 part of κ-carrageenan evenly to obtain the mixed raw material; disperse the above mixed raw material with 100 parts of deionized water, and heat Dissolve at the temperature of the sol for 1.0h; when the sol is finished, keep it warm for 1h at a temperature o...

Embodiment 3

[0041] The enteric hollow capsule of embodiment 3 comprises a capsule body, the outer surface of the capsule body is covered with an enteric coating layer, the capsule body is composed of hypromellose, gel and water, and the enteric coating layer is composed of a low acyl knot It consists of cold gum, curing agent and water, wherein the gelling agent is mixed with κ-carrageenan and low acyl gellan gum at a weight ratio of 2:1, and the curing agent is calcium acetate. The hollow capsule of Example 3 is composed of 76% hypromellose, 3.25% kappa-carrageenan, 12.2% low-acyl gellan gum, 0.1% calcium acetate, and water as the balance. The preparation method of this enteric-coated hollow capsule is as follows:

[0042] (1) Preparation of capsule body glue A: Mix 16.5 parts of hypromellose with 0.6 parts of κ-carrageenan and 0.3 parts of low-acyl gellan gum to obtain mixed raw materials; use 100 parts of deionized Disperse the above mixed raw materials with water, and dissolve at a s...

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Abstract

The invention discloses an enteric soluble hollow capsule and a preparation method thereof. The outer surface of a capsule body of the hollow capsule is covered with an enteric coating; the capsule body consists of hydroxypropyl methylcellulose, gel and water; the enteric coating consists of low-acyl gellan gum, a curing agent and water; the hollow capsules comprise the following components in percentage by weight: 70-80% of hydroxypropyl methylcellulose, 2-5% of gel, 10.5-14% of low-acyl gellan gum, 0.05-2% of a curing agent and the balance of water. The enteric soluble hollow capsule has the characteristics of being stably maintained and not disintegrated within 2 hours or even longer in simulated gastric fluid, and disintegrated within 1 hour in simulated intestinal fluid, and provisions of Chinese Pharmacopoeia on enteric soluble hollow capsules can be met; the enteric soluble hollow capsule is prepared by using a process of two times of gum dipping, one time of calcification and 1 time of drying molding, the preparation method is simple and easy to operate, and particularly no organic solvent or preservative is used in the preparation process, so that the enteric soluble hollow capsule is safe and reliable and environment-friendly, and current hollow capsule development tendency is met.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical excipients, and in particular relates to an enteric-coated hollow capsule and a preparation method thereof. Background technique [0002] Hollow capsules are mainly divided into gastric-soluble capsules and enteric-coated capsules. Enteric-coated capsules can be located in the small intestine or large intestine of the human body and release drugs, which have the characteristics of protecting drugs from damage by gastric enzymes or gastric acid, and avoiding strong stimulation of drugs on gastric mucosa. At present, enteric-coated empty capsules on the market mainly include gelatin empty capsules and hypromellose empty capsules. [0003] Gelatin empty capsules are usually made by formaldehyde cross-linking reaction or the surface is coated with enteric coating materials. Hypromellose empty capsules are also coated with a layer of enteric coating outside the capsule shell. The mainstream pro...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K47/38A61K47/36
Inventor 钱国英刘利萍程丹欧阳伟虹孙武千
Owner 青岛蓝谷药业有限公司
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