Non-gelatine enteric hard capsule shell material and method for producing the same

A hard capsule shell, non-gelatin technology, applied in the field of materials, can solve problems such as the spread of mad cow disease, brittle aldehyde drugs, and unsatisfactory transparency

Inactive Publication Date: 2009-05-20
上海慧源植物胶囊股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Although gelatin has good properties in the preparation of hard capsules, gelatin as a heterologous protein may be antigenic
For example, imported bovine-derived gelatin materials may contain prions, and soft capsules made from them may cause the spread of mad cow disease
And gelatin enteric-coated hard capsules have other defects, such as its tolerance to temperature and humidity is relatively strict, so its application is limited; and gelatin enteric-coated hard capsules can only swell in cold water and cannot be dissolved; The hard capsule shell is easy to deform when exposed to high humidity and heat, and it is easy to become brittle under low temperature and low water content conditions and cannot be filled with aldehyde drugs; in addition, its transparency is not satisfactory

Method used

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Examples

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preparation example Construction

[0143] The preparation method of the non-gelatin enteric hard capsule shell of the present invention can be carried out on the existing equipment for preparing the gelatin hard capsule shell. Under the condition that no additional equipment is required, the required non-gelatin enteric-coated hard capsule shell can be produced by adjusting the parameters such as drying temperature, humidity, coating film thickness, operating speed, and mold size according to the formula.

[0144] Compared with the prior art, the main advantages of the present invention are:

[0145] (1) The colloid material used in the preparation of the enteric-coated capsule shell is mainly hydrophilic non-gelatin colloid, and does not contain animal protein and fat, thereby avoiding possible pollution caused by animal protein.

[0146] (2) Optionally add plasticizers listed in the present invention.

[0147] (3) The hydrophilic non-gelatin gel is easy to dissolve, which can save the necessary water absorpt...

Embodiment 1

[0158] Non-gelatin enteric hard capsule shell material 1

[0159] formula Dosage Acetylated gellan gum 1.25 grams hypromellose 25 grams Hypromellose Phthalate 30 grams calcium chloride 1 g ammonia 25ml (25g) Deionized water 192.8 grams

[0160] The production method is as follows: take 1.25 grams of acetylated gellan gum, 30 grams of hypromellose phthalate, 25 ml of ammonia water, and 1 gram of calcium chloride, pour them into 192.8 grams of deionized water, and heat to 100°C. Dissolve evenly, then add 25 grams of hypromellose and stir evenly, after heat preservation and defoaming, use a dip in glue to obtain a hard capsule shell, dry at 40 ° C, the water content of the capsule shell is 2 grams (3%), The prepared non-gelatin enteric-coated hard capsule shell is transparent, elastic and has good taste.

[0161] Measured according to the disintegration standard of enteric-coated hard capsules of Chinese Pharmacopoeia 2005...

Embodiment 2

[0163] Non-gelatin enteric hard capsule shell material 2

[0164] formula Dosage iota carrageenan 4 grams Hydroxypropyl starch 16 grams 1,2,4-Benzenetricarboxylic acid acetic acid

Cellulose 30 grams calcium chloride 2 grams Deionized water 138 grams Sodium carbonate 10gram

[0165] The production method is as follows: take 4 grams of iota-type carrageenan, 16 grams of hydroxypropyl starch, 2 grams of calcium chloride, 30 grams of 1,2,4-benzenetricarboxylic acid cellulose acetate, 10 grams of sodium carbonate and pour 138 grams of deionized water, heated to 100°C. Dissolve evenly, after heat preservation and defoaming, dip the glue once to obtain the enteric-coated hard capsule shell, dry at 40°C, the water content of the capsule shell is 4.8 grams (8%), and the non-gelatin enteric-coated hard capsule shell is translucent , elastic, good taste.

[0166] Measured according to the disintegration standard of enteric-coate...

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Abstract

The invention provides a composition used for preparing a non-gelatin enteric hard capsule shell material. The composition contains non-gelatin hydrophilic jellies, an enteric type material, a pH conditioning agent, water and optional coagulant aid, plasticizer and adhesive, and does not contain any organic solvent basically. The invention also discloses a method for producing the enteric hard capsule shell material. The composition does not contain the organic solvent basically, and the enteric hard capsule shell has the advantages of good mouthfeel, high clarity, fast capsule cracking and reduced requirement on storage condition of the capsule.

Description

technical field [0001] The invention relates to the field of materials, in particular to the components and production method of non-gelatin enteric hard capsule shells. Background technique [0002] At present, enteric-coated materials need to be used in the preparation of the capsule shell of enteric-coated hard capsules. Examples of enteric materials are shellac, polyvinyl acetate phthalate, acrylic resins, cellulose derivatives (examples of said cellulose derivatives are: cellulose acetate phthalate, 1,2 , cellulose acetate 4-benzenetricarboxylate, hydroxypropylmethylcellulose phthalate, hydroxypropylmethylcellulose 1,2,4-benzenetricarboxylate, cellulose acetate succinate and hydroxypropyl acetate succinate base methyl cellulose), etc. [0003] The above-mentioned enteric-coated hard capsules using enteric-coated materials all require a large amount of organic solvents, so fires and explosions are likely to occur. In addition, the speed of its rupture and complete dis...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K47/18A61K47/32A61K47/36A61K47/38
Inventor 吴国庆张士楚
Owner 上海慧源植物胶囊股份有限公司
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