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Preparation method of proscar tablet, and prepared proscar tablet

A technology of finasteride and androsteride tablets, which is applied in the directions of non-active ingredient medical preparations, medical preparations containing active ingredients, pharmaceutical formulas, etc. Effect

Inactive Publication Date: 2019-06-18
湖北舒邦药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This patent also has the problem of organic solvents used in the preparation process and production safety control

Method used

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  • Preparation method of proscar tablet, and prepared proscar tablet
  • Preparation method of proscar tablet, and prepared proscar tablet
  • Preparation method of proscar tablet, and prepared proscar tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] 5mg finasteride tablets

[0043] (1) Plain tablets

[0044]

[0045] (2) Coating

[0046] Stomach Dissolved Opadry: 8%

[0047] Purified water: 92%

[0048] Preparation process: After mixing the finasteride raw material and lactose, pregelatinized starch, microcrystalline cellulose, sodium starch glycolate, stir for 4 minutes to make the mixture uniform, add sodium lauryl sulfate aqueous solution for stirring, shearing and granulation 1min, 24 mesh sieve wet granules, after drying at 60-65°C until the moisture content is less than 4.0%, 24 mesh sieve, mixed with magnesium stearate, and compressed according to the theoretical tablet weight. If the uniformity and friability of the plain tablets are tested, they can be coated.

Embodiment 2

[0050] 5mg finasteride tablets

[0051] (1) Plain tablets

[0052]

[0053] (2) Coating

[0054] Stomach dissolving Opadry: 10%

[0055] Purified water: 90%

[0056] Preparation process: After mixing the raw material of finasteride with lactose, pregelatinized starch, microcrystalline cellulose and sodium starch glycolate, stir for 5 minutes to make the mixture uniform, add sodium lauryl sulfate aqueous solution for stirring, shearing and granulation 1min, 24 mesh sieve wet granules, dried at 60-65°C until the moisture content is less than 4.0%, 24 mesh sieve, mixed with lubricant, and compressed according to theoretical tablet weight. If the uniformity and friability of the plain tablets are tested, they can be coated.

Embodiment 3

[0058] 5mg finasteride tablets

[0059] (1) Plain tablets

[0060]

[0061]

[0062] (2) Coating

[0063] Stomach Dissolved Opadry: 8%

[0064] Purified water: 92%

[0065] Preparation process: After mixing finasteride raw material with lactose, pregelatinized starch, microcrystalline cellulose, sodium starch glycolate, stir for 5 minutes to make the mixture uniform, add sodium lauryl sulfate aqueous solution for stirring, shearing and granulation 1min, 24 mesh sieve wet granules, dried at 60-65°C until the moisture content is less than 4.0%, 24 mesh sieve, mixed with lubricant, and compressed according to theoretical tablet weight. If the uniformity and friability of the plain tablets are tested, they can be coated.

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PUM

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Abstract

The invention relates to a proscar tablet and a preparation method thereof. The proscar tablet is prepared from main drug components and various ingredient components which are subjected to processesof wet granulation, drying, granulating, total mixing, tabletting and coating. The proscar tablet does not adopt an organic solvent in the whole production process, safety in the drug production process and stability of the product quality are improved, the dissolution condition of a prepared sample is consistent with that of a reference preparation, namely a Hangzhou Merck product Proscar, quickrelease can be achieved, the operation process is simple, the proscar tablet is stable, and wide application prospects are achieved.

Description

Technical field [0001] This application belongs to the technical field of pharmaceutical preparations. More specifically, this application relates to a preparation method of finasteride tablets and the prepared finasteride tablets. Background technique [0002] Finasteride tablets were launched in the United States by MERCK RESEARCH LABORATORIES DIV MERCK CO INC in 1992 under the trade name Proscar, with a specification of 5 mg (RLD); the same company launched in the United States in 1995 under the trade name PROPECIA. The specification is 1mg (RLD). Among Japanese prescription drugs, Wanyou Pharmaceutical's product name is PROPECIA, and its specifications are 1mg and 0.2mg tablets. They were approved for marketing in 2005, but they have not been listed in the Japanese Orange Book. Due to a long time to market and a long history, finasteride tablets and many generic drugs are on the market in other countries in the world. The market specifications are mainly 1mg and 5mg. [0003]...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K31/58A61K47/26A61K47/36A61K47/38A61P13/08
Inventor 黄晶龚明峰李守明马泽秀肖科军
Owner 湖北舒邦药业有限公司
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