Composition for preparing empty capsules with modified starch matrixes and empty capsules

A modified starch and hollow capsule technology, applied in the field of medicine, can solve the problems of unqualified capsule shape, low filling pass rate, long disintegration time, etc., and achieve the effects of improving filling pass rate, maintaining flexibility and strength, and prolonging shelf life.

Active Publication Date: 2016-10-12
INST OF CHEM CHINESE ACAD OF SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Chinese patent CN104055748A discloses a composition for preparing hard capsules containing a modified starch matrix, which mainly includes 55-95wt% of modified starch and 5-45wt% of gelling agent as the matrix, the denatured Starch is a modified starch containing 1-2.5wt% of acetyl groups and 0-6.5wt% of hydroxypropoxyl groups. Although the hollow capsules prepared by the present invention can meet the pharmacopoeia standards, there are problems in the actual application process of pharmaceutical factories. Low rate, long disintegration time, short shelf life, unqualified capsule shape, etc.

Method used

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  • Composition for preparing empty capsules with modified starch matrixes and empty capsules
  • Composition for preparing empty capsules with modified starch matrixes and empty capsules
  • Composition for preparing empty capsules with modified starch matrixes and empty capsules

Examples

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Effect test

Embodiment 1

[0030]From 95wt% modified corn starch (calculated on anhydrous basis, containing 2.2wt% acetyl group and 6wt% hydroxyoxy group and crosslinked modified starch by sodium trimetaphosphate, the crosslinking chemical bond is 2000 anhydroglucose units) , 3wt% sorbitol, 1wt% gellan gum, and 1wt% hypromellose were used to prepare the composition of the hollow capsule of the modified starch matrix.

[0031] Mix the above prepared hollow capsule composition for the modified starch matrix with water 6.5 times the weight of the composition and heat to gelatinize and gelatinize. The heating temperature is 70° C. and the heating time is 30 minutes. The hollow capsules were obtained by the conventional preparation process, and the disintegration time limit, friability and filling rate of the prepared hollow capsules were measured respectively, as shown in Table 1.

Embodiment 2

[0033] By 80wt% modified tapioca starch (calculated on anhydrous matter, containing 2.5wt% acetyl group and 6.5wt% hydroxyloxy group and crosslinked modified starch through sodium phosphate trichloride, the crosslinking chemical bond is 1000 anhydroglucose unit), 10wt% xylitol, 5wt% pectin, and 5wt% glycerin are used to prepare the composition of the hollow capsule of the modified starch matrix.

[0034] Mix the above-mentioned composition for preparing hollow capsules of modified starch matrix with water 3 times the weight of the composition and heat to gelatinize and gelatinize. The heating temperature is 95° C. and the heating time is 150 minutes. The hollow capsules were obtained by the conventional preparation process, and the disintegration time limit, friability and filling rate of the prepared hollow capsules were measured respectively, as shown in Table 1.

Embodiment 3

[0036] By 85wt% modified tapioca starch (calculated on anhydrous basis, containing 1wt% acetyl group and 2wt% hydroxyloxy group and crosslinked modified starch through sodium trimetaphosphate, the crosslinking chemical bond is 350 anhydroglucose units), 8wt% of mannitol, 4wt% of carrageenan, and 3wt% of chitosan are used to prepare the composition of the hollow capsule of the modified starch matrix.

[0037] Mix the above-mentioned composition for preparing hollow capsules of modified starch matrix with water 4 times the weight of the composition and heat to gelatinize and gelatinize. The heating temperature is 80° C. and the heating time is 100 minutes. The hollow capsules were obtained by the conventional preparation process, and the disintegration time limit, friability and filling rate of the prepared hollow capsules were measured respectively, as shown in Table 1.

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Abstract

The invention discloses a composition for preparing empty capsules with modified starch matrixes. The composition comprises 80-95 wt% of modified starch, 3-15 wt% of fluidizers, 1-9 wt% of gelatinizers and 1-15 wt% of hygroscopic reinforcing agents. The modified starch comprises 0-2.5 wt% of acetyl and 0.5-6.5 wt% of hydroxypropoxy which are subjected to cross linking by sodium trimetaphosphate or phosphorus oxychloride. With the fluidizers, defects of thin shoulders, cone vertex and riffled ends of the capsules are avoided, swelling of the cross-linked starch is suppressed, consistency of gelatinous solution is reduced, and fluidity is improved. Therefore, the empty capsules with modified starch matrixes, having high flexibility, high fillibility, long preservation period and short disintegration time, can be prepared from the composition.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a composition for preparing hollow capsules of a modified starch matrix and the hollow capsules. Background technique [0002] The use of animal-derived gelatin to make hollow capsules has a history of at least nearly 200 years. Since gelatin can mask the bad taste, smell or irritation to the stomach of many medicines, gelatin capsules are quickly promoted and used in the production of various solid preparations. Over the past 100 years, various capsules made of gelatin have been sold well in the international pharmaceutical market for a long time. At the end of the last century, the outbreak of mad cow disease finally dragged gelatin capsules into an unprecedented crisis of confidence. In April 2012, the "poisonous capsule" incident that broke out in my country undoubtedly aggravated the distrust of the Chinese people towards gelatin capsules. In addition, gelat...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K47/36
CPCA61K9/4816A61K47/36
Inventor 闫丰文袁国卿
Owner INST OF CHEM CHINESE ACAD OF SCI
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