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Dutasteride-containing soft capsule

A technology for dutasteride and soft capsules, which is applied in the field of soft capsules containing dutasteride, and can solve the problems that diluents are difficult to obtain prescription stability and safety.

Active Publication Date: 2014-01-01
SICHUAN GOWELL PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] In order to overcome problems such as diluents being difficult to obtain in the prior art, and prescription stability and safety, the present invention provides the following technical solutions:

Method used

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  • Dutasteride-containing soft capsule
  • Dutasteride-containing soft capsule
  • Dutasteride-containing soft capsule

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0061] Content Content (per capsule) Percent content (g / g)

[0062] Dutasteride 0.6mg 0.076%

[0063] Corn Oil 750mg 94.86%

[0064] Span 80 40mg 5.059%

[0065] Take dutasteride, diluent, and surfactant according to the prescription, first dissolve and mix a small amount of diluent, surfactant, and dutasteride, then add the remaining diluent in equal increments, mix well, To obtain the content, put the content and the glue solution containing gelatin, water and glycerin into a soft capsule pill press machine respectively, press the soft capsule, shape it, dry it, wash the pill with absolute ethanol, and finally dry it to obtain dutasteride. Amine Soft Capsules. In 2.0% SDS 0.1mol / L hydrochloric acid solution, the dissolution rate was 86.9% in 20 minutes.

Embodiment 2

[0067] Content Content (per capsule) Percent content (g / g)

[0068] Dutasteride 0.336mg 0.042%

[0069] Medium Chain Triglycerides 787.68mg 98.46%

[0070] Span 80 11.984mg 1.498%

[0071] Take dutasteride, diluent, and surfactant according to the prescription, first dissolve and mix a small amount of diluent, surfactant, and dutasteride, then add the remaining diluent in equal increments, mix well, To obtain the content, put the content and the glue solution containing gelatin, water and glycerin into a soft capsule pill press machine respectively, press the soft capsule, shape it, dry it, wash the pill with absolute ethanol, and finally dry it to obtain dutasteride. Amine Soft Capsules. In 2.0% SDS 0.1mol / L hydrochloric acid solution, the dissolution rate was 87.7% in 20 minutes.

Embodiment 3

[0073] Content Content (per capsule) Percent content (g / g)

[0074] Dutasteride 0.5mg 0.071%

[0075] Peanut Oil 650mg 92.79%

[0076] Span 80 50mg 7.138%

[0077] Take dutasteride, diluent, and surfactant according to the prescription, first dissolve and mix a small amount of diluent, surfactant, and dutasteride, then add the remaining diluent in equal increments, mix well, To obtain the content, put the content and the glue solution containing gelatin, water and glycerin into a soft capsule pill press machine respectively, press the soft capsule, shape it, dry it, wash the pill with absolute ethanol, and finally dry it to obtain dutasteride. Amine Soft Capsules. In 2.0% SDS 0.1mol / L hydrochloric acid solution, the dissolution rate was 88.4% in 20 minutes.

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Abstract

The invention relates to a soft capsule with contents containing dutasteride, a diluent and a surfactant, wherein the diluent is selected from one of a group consisting of soybean oil, peanut oil, corn oil and a medium-chain triglyceride, and the surfactant is selected from one or two of a group consisting of span 80 and span 85. Preferably, the weight percentage content of dutasteride accounts for 0.042%-0.143% of that of the contents, the weight percentage content of the diluent accounts for 79.87%-98.46% of that of the contents, and the weight percentage content of the surfactant accounts for 1.498%-19.99% of that of the contents. The dutasteride-containing soft capsule prepared by the prescription provided by the invention has wide raw material sources, strong stability, good safety, high dissolution rate and good bioavailability.

Description

technical field [0001] The invention relates to a pharmaceutical preparation, in particular to a soft capsule containing dutasteride. Background technique [0002] Dutasteride (DUTASTERIDE, 17β-N-(2,5-bis(trifluoromethyl))phenylcarbamoyl-4-aza-5α-androst-1-en-3-one) is a A new dual inhibitor of 5α reductase, which can inhibit both 5α reductase 1 and 5α reductase 2, is mainly used for the treatment of benign prostatic hyperplasia in men. A large number of clinical trials have shown that dutasteride can significantly reduce the level of dihydrotestosterone in human blood and prostate in the long-term compared with finasteride, and can continuously and effectively reduce the volume of the prostate. Its structural formula is as follows: [0003] [0004] The original manufacturer of dutasteride is GlaxoSmithKline (GLAXOSMITHKLINE). In November 2002, dutasteride was launched in the United States and Europe under the trade name of AVODART (Shi Niao Tong). On April 11, 2011...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/58A61K47/44A61K47/22A61P13/08
Inventor 贾朝宇郭礼新
Owner SICHUAN GOWELL PHARMA
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