Refining method for lurasidone

A lurasidone and refined technology, applied in the field of medicinal chemistry, can solve the problems of high impurity content, complicated operation process, low product purity, etc., and achieve the effects of high purity, simple operation, and reduced impurity content.

Inactive Publication Date: 2018-03-06
TIANJIN HANKANG PHARMA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The preparation method of lurasidone is disclosed in the prior art, such as CN103450172A, CN102936243, etc. However, the above-mentioned method still has problems such as very complicated operation process, low product purity, and high impurity content, so there is an urgent need for a good refined method lurasidone

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] (1) Put 5.0 g of crude lurasidone into a one-mouth bottle, add 80 ml of pure ethanol aqueous solution (ethanol: pure water = 1:3), and stir to dissolve at 45°C;

[0016] (2) Then add 600ml ether solution, and stir and crystallize at 20°C for 2 hours;

[0017] (3) The precipitated lurasidone crystals were collected by filtration, washed with 100 ml of the above diethyl ether solution and dried in an oven at 30° C. to obtain 4.5 g of lurasidone crystals with a yield of 90% and a purity (HPLC) of 99.2%. .

Embodiment 2

[0019] (1) Put 5.0 g of crude lurasidone into a one-mouth bottle, add 100 ml of pure ethanol aqueous solution (ethanol: pure water = 1:4), and stir to dissolve at 40°C;

[0020] (2) Then add 550ml ether solution, and stir and crystallize at 25°C for 4 hours;

[0021] (3) The precipitated lurasidone crystals were collected by filtration, washed with 100 ml of the above diethyl ether solution and dried in an oven at 30° C. to obtain 4.6 g of lurasidone crystals with a yield of 92% and a purity (HPLC) of 99.4%. .

Embodiment 3

[0023] (1) Put 5.0 g of lurasidone crude product into a one-mouth bottle, add 120 ml of pure ethanol aqueous solution (ethanol: pure water = 1:3), and stir to dissolve at 35°C;

[0024] (2) Then add 500ml isopropyl ether, stir and crystallize at 30°C for 5 hours;

[0025] (3) The precipitated lurasidone crystals were collected by filtration, washed with 100 ml of the above isopropyl ether solution and dried in an oven at 30° C. to obtain 4.55 g of lurasidone crystals with a yield of 91%, purity (HPLC) 99.2%.

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PUM

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Abstract

The invention belongs to the field of medicinal chemistry, and relates to a refined method for lurasidone. The crude lurasidone is stirred and dissolved with pure ethanol aqueous solution, and then ether solution is added, stirred and crystallized; collected by filtration, washed, and vacuum-dried to obtain The yield of pure lurasidone crystals is more than 90%, the purity (HPLC) reaches 99.4%, and the impurities are reduced to about 0.1%.

Description

technical field [0001] The invention belongs to the field of medicinal chemistry, and in particular relates to a refined method for lurasidone. Background technique [0002] Lurasidone hydrochloride (lurasidone HCI) belongs to the class of atypical antipsychotic drugs. It is an antipsychotic drug with dual effects developed by Japan's Sumitomo Pharmaceutical Co. Drugs, which have high affinity to 5-HT2A receptors and dopamine D2 receptors, have significant curative effects on both positive and negative symptoms of mental patients. On October 28, 2010, the U.S. FDA approved the listing for the treatment of patients with schizophrenia. Its trade name is Latuda, and the recommended dosage is 1 tablet per day, which is used for the first-line treatment of patients with schizophrenia. [0003] The preparation method of lurasidone is disclosed in the prior art, such as CN103450172A, CN102936243, etc. However, the above-mentioned method still has problems such as very complicated ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D417/12
CPCC07D417/12
Inventor 严洁王志凤
Owner TIANJIN HANKANG PHARMA BIOTECH
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