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A kind of soft capsule composition containing dutasteride and its preparation method

A technique for dutasteride and soft capsules, which is applied in the field of soft capsule compositions containing dutasteride and its preparation, which can solve the problems of low dissolution rate, prolonged disintegration time limit, and non-compliance with quality requirements, and achieve stability Good results

Active Publication Date: 2021-09-03
南京恒生制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

During the placement of the long-term stability samples, it was found that the disintegration time limit was gradually extended, and after 3 years, the rubber aging phenomenon was serious, the disintegration time limit was significantly prolonged, and the dissolution rate was lower than 80%, which did not meet the quality requirements

Method used

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  • A kind of soft capsule composition containing dutasteride and its preparation method
  • A kind of soft capsule composition containing dutasteride and its preparation method
  • A kind of soft capsule composition containing dutasteride and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] The preparation method of dutasteride soft capsule specifically comprises the following steps:

[0015] (1) Preparation of the content solution: Weigh the prescribed amount of dutasteride and 2,6-di-tert-butyl-p-cresol into the solvent mono / bis-caprylyl and capric glyceride, heat and stir to dissolve, and obtain The content solution is ready for use;

[0016] (2) Preparation of rubber: Mix glycerin with an equal amount of water, add sorbitol, glycine and citric acid and stir to dissolve, then add titanium dioxide and yellow iron oxide, and grind it repeatedly (generally need to grind 3 times) until titanium dioxide Disperse evenly with yellow iron oxide; pour the above solution into a sol tank, heat to 40-50°C, then add gelatin, fill with N 2 And keep it warm for 2-4 hours, vacuumize and degas, and use it for later use after degassing;

[0017] (3) Pressing and setting: set the relevant parameters of the soft capsule machine, press the rubber and content solution with...

Embodiment 2

[0027]

[0028]

[0029] The study found that when sorbitol, glycine and citric acid were added to the capsule shell at the same time, when the amount of sorbitol was 3-7% of that of gelatin, the rubber stability of dutasteride soft capsules could be significantly increased.

Embodiment 3

[0031]

[0032] The study found that when sorbitol, glycine and citric acid were added to the capsule shell at the same time, when the amount of glycine was 1.5-3.5% of that of gelatin, the stability of the dutasteride soft capsule rubber could be significantly increased.

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Abstract

The invention discloses a dutasteride soft capsule composition and a preparation method thereof. The soft capsule composition comprises contents and a capsule shell, and the contents include dutasteride, 2,6-di-tert-butyl p-cresol and a pharmaceutically acceptable filler; the capsule shell contains gelatin, glycerin, and water, and is characterized in that the capsule shell also includes sorbitol, glycine, and citric acid, and the sol temperature of the capsule shell is 40-50°C , and charge N2. The preparation method of the soft capsule includes the preparation of the content solution, the preparation of the rubber skin, compression molding and pill making. The prepared soft capsule composition is stable in the process of long-term sample retention, avoids the aging of the rubber skin, has no obvious prolongation of the disintegration time limit, and has a dissolution rate higher than 90%, which has the characteristics of good stability.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a soft capsule composition containing dutasteride and a preparation method thereof. Background technique [0002] Dihydrotestosterone (DHT) acts as an androgen in the initial development and subsequent enlargement of the prostate gland. Testosterone is converted to DHT by 5α-reductase (5AR), and 5AR has two isoenzymes, type I and type II. The type II isozyme is mainly distributed in male reproductive tissues, while the type I isozyme also plays a role in the conversion of testosterone in the skin and liver. Dutasteride inhibits the conversion of testosterone to DHT. Both dutasteride and similar drug finasteride belong to 5AR inhibitors, but the selectivity and strength of action on the enzyme are different. Dutasteride is a dual inhibitor of both type I and type II 5ARs, whereas finasteride is a type II 5AR inhibitor. Dutasteride selectively and competitively inh...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/48A61K47/10A61K47/18A61K47/12A61K31/58A61P13/08
Inventor 王芳韦超杨炫刘勇
Owner 南京恒生制药有限公司
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