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Production technique for synthesizing Manidipine Hydrochloride through separation with non-column chromatography

A technology of hydrochloric acid and dipine base, applied in the fields of drug combination, cardiovascular system diseases, organic chemistry, etc., can solve the problems of endangering the physical and mental health of operators, difficult to remove impurities, etc., to reduce production costs, improve product quality and yield, The effect of reducing environmental pollution

Active Publication Date: 2012-04-18
XUCHANG HENGSHENG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Aiming at the defects that chloroform is used as a solvent in the existing impurity removal method before manidipine hydrochloride is formed into a salt, which endangers the physical and mental health of operators and is not easy to remove impurities, the present invention discloses a new impurity removal method. Removing the impurities in the crude product of manidipine alkali not only has a good effect of removing impurities, does not endanger the physical and mental health of the operators, does not pollute the environment, but also improves the purity and yield of the finished product of manidipine hydrochloride

Method used

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  • Production technique for synthesizing Manidipine Hydrochloride through separation with non-column chromatography
  • Production technique for synthesizing Manidipine Hydrochloride through separation with non-column chromatography
  • Production technique for synthesizing Manidipine Hydrochloride through separation with non-column chromatography

Examples

Experimental program
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Effect test

Embodiment 1

[0018] Take 10 kg of manidipine base crude product and 70 kg of ethyl acetate, stir to dissolve the manidipine base crude product, wash with water three times to remove impurities with 25 kg of water at a temperature of 60° C. Nidipine

Embodiment 2

[0020] Take 10kg of crude manidipine base and 80kg of ethyl acetate, stir to dissolve the crude manidipine base, wash with 50 kg of water at 50°C for four times to remove impurities, dry after removing impurities, and feed HCL gas to make hydrochloric acid manidipine

[0021] With the method of the present invention for impurity removal, the purity of manidipine hydrochloride can be improved to 92.2% from 75.8% of the traditional method for impurity removal and purification; pollution of the environment.

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Abstract

The invention discloses a new method for removing impurities from Manidipine coarse alkali product. The adopted technical proposal includes the steps of: taking Manidipine coarse alkali product, adding ethyl acetate for dissolution, adding warm water for rinsing, drying, salifying and obtaining Manidipine Hydrochloride. The technique can be used as a substitute for silica gel column chromatographyto remove impurities, is more applicable to industrial production, and not only has good impurity removal effect, no harm to the physical and psychological health of operating staffs and no pollutionto the environment, but also can improve the purity and yield of the finished products of Manidipine Hydrochloride.

Description

technical field [0001] The invention discloses a method for synthesizing manidipine hydrochloride without removing impurities through silica gel column chromatography, which is suitable for industrial production. The invention belongs to the technical field of chemical product production, and is particularly related to a method for removing impurities of manidipine hydrochloride raw materials before salt formation. Background technique [0002] Manidipine hydrochloride is a raw material for antihypertensive drugs. In 1992, it was first developed and marketed by Takeda, Japan, and has been listed in South Korea, Italy, the United Kingdom and other countries for its good blood pressure lowering effect. At present, there is no listing and sales of this product in China. The inventor is the first unit in China to successfully develop and complete the clinical research and production of Class 3.1 new drugs approved by the State Food and Drug Administration. [0003] The foreign...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07D211/90A61P9/12
Inventor 朱军朝吴胜蚩晓娜
Owner XUCHANG HENGSHENG PHARMA
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