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Finasteride purification method

A technology of finasteride and purification method, applied in the field of purification of finasteride, can solve the problems of difficulty in achieving higher purity and low purification yield of finasteride, and achieve the effect of high purification yield

Inactive Publication Date: 2012-07-25
蒋勇
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  • Summary
  • Abstract
  • Description
  • Claims
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Problems solved by technology

At present, relevant finasteride patents and documents such as US4760071, US20060046994, US5547957, US5981543, EP0599376, US2886184, US567043, CN1718586, J Med Chem 1984, 27, 1690-1701, reported purification methods such as methanol dissolution-water Finasteride obtained by washing out, ethyl acetate recrystallization, ethyl acetate-isopropyl acetate recrystallization and other methods generally has a low purification yield, and the purity is difficult to meet the higher requirements of the European Pharmacopoeia

Method used

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Embodiment Construction

[0011] 1 Purification of Finasteride

[0012] Dissolve 10 g of finasteride crude product (HPLC=98.0%, total impurity 2.0%, maximum single impurity 0.6%) in 50 ml of 1:1 methanol-formic acid solution, then add 1 g of activated carbon and stir for 3 h, filter, and the filtrate Rinse with 500ml of water to precipitate a large amount of white solid, collect the precipitate by suction filtration, and dry under reduced pressure to obtain 9.7g of finasteride product, with a recovery rate of 97%, HPLC > 99.7%, total impurities < 0.3%, single impurities < 0.1 %, mp = 255.5-257°C.

[0013] 2 Methanol dissolution-water washing method for purifying finasteride

[0014] 10g of crude finasteride (HPLC=98.0%, total impurity 2.0%, maximum single impurity 0.6%) was stirred and dissolved in 50ml of methanol, filtered, and the filtrate was rinsed with 500ml of water, a large amount of white solid was precipitated, and the precipitate was collected by suction filtration , dried under reduced pr...

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Abstract

The invention discloses a finasteride purification method which comprises the following steps of: dissolving crude finasteride into a methanol-formic acid solution; adding active carbon and stirring for 2-3 hours; filtering and flushing the filtrate with water to obtain a white precipitate; and collecting the white material and drying under reduced pressure to obtain a high-purity finasteride product. Compared with the prior art, the method has the advantages of being simple, quick and efficient and being low in cost.

Description

technical field [0001] The invention relates to a method for purifying chemical drugs, in particular to a method for purifying finasteride. Background technique [0002] Finasteride, English name: Finasteride, chemical name: N-tert-butyl-3-carbonyl-4-aza-5α-androst-1-ene-17β-amide. Finasteride is a 4-azasteroid that is a specific inhibitor of type II 5a-reductase, an intracellular enzyme involved in the metabolism of testosterone to the stronger dihydrotestosterone. Benign prostatic hyperplasia, or enlarged prostate, depends on the conversion of testosterone to dihydrotestosterone in the prostate. This drug can effectively reduce the blood and dihydrotestosterone in the prostate, reduce the weight of the prostate, increase the urinary flow rate, significantly improve the urinary tract obstruction and complications, and significantly reduce the symptoms of the prostate. It is suitable for the treatment of existing Symptoms of benign prostatic hyperplasia (BPH). At present,...

Claims

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Application Information

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IPC IPC(8): C07J73/00
Inventor 蒋勇
Owner 蒋勇
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