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Method for preparing meclofenoxate hydrochloride sterile bulk drug

The technology of meclofenxe hydrochloride and raw material medicine is applied in the field of preparation of aseptic raw material medicine of central stimulant meclofen axetil hydrochloride, and can solve the problems of easy hydrolysis of the raw material of meclofen axetil hydrochloride of filter, easy blockage of pipelines and the like, Achieve the effect of low cost, stable process and low moisture content of finished products

Inactive Publication Date: 2010-06-23
YAOPHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The technical problem to be solved in the present invention is to provide a kind of preparation method of meclofenoxate hydrochloride aseptic bulk drug, this preparation method recrystallizes meclofenoxate hydrochloride in isopropanol, by increasing the consumption of isopropanol, Filtrate first, then concentrate, effectively solving the problems of crystallization and clogging of pipes and filters, and the problem of easy hydrolysis of meclofenoxate hydrochloride raw materials

Method used

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  • Method for preparing meclofenoxate hydrochloride sterile bulk drug

Examples

Experimental program
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Effect test

Embodiment 1

[0017] In the reflux reaction device, add accurately weighed 1 kg of non-sterile meclofenoxate hydrochloride and 15 L of isopropanol, stir, heat and reflux until completely dissolved, add 50 g of medicinal activated carbon, decolorize under reflux for 15 minutes, and pass through 0.45 μm Coarse filtration with a microporous membrane, and sterile filtration with a 0.25 μm microporous membrane; the resulting filtrate was concentrated under reduced pressure at 50°C to a volume of about 4L, then stood for crystallization, filtered, and dried under reduced pressure at 50°C to obtain 938.9g of the product , the moisture content is 0.25%, and the yield is 93.9%.

Embodiment 2

[0019] In the reflux reaction device, add accurately weighed 1kg of non-sterile meclofenoxate hydrochloride and 12L of isopropanol, stir, heat and reflux until completely dissolved, add 25g of medicinal activated carbon, decolorize under reflux for 30 minutes, and pass through 0.45μm Coarse filtration with a microporous membrane, and sterile filtration with a 0.25 μm microporous membrane; the resulting filtrate was concentrated under reduced pressure at 50°C to a volume of about 3L, then stood for crystallization, filtered, and dried under reduced pressure at 50°C to obtain 922.6g of the product , the moisture is 0.19%, and the yield is 92.3%.

Embodiment 3

[0021] In the reflux reaction device, add accurately weighed 1kg of non-sterile meclofenoxate hydrochloride and 10L of isopropanol, stir, heat and reflux until completely dissolved, add 100g of medicinal activated carbon, decolorize under reflux for 25 minutes, and pass through 0.45μm Coarse filtration with a microporous membrane, and sterile filtration with a 0.25 μm microporous membrane; the resulting filtrate was concentrated under reduced pressure at 50°C to a volume of about 4L, then stood for crystallization, filtered, and dried under reduced pressure at 50°C to obtain 917.1g of the product , the moisture is 0.33%, and the yield is 91.2%.

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Abstract

The invention relates to a method for preparing a meclofenoxate hydrochloride sterile bulk drug, which is characterized in that a meclofenoxate hydrochloride sterile finished product is obtained by the following steps: dissolving meclofenoxate hydrochloride in isopropanol in a certain mixture ratio, then decoloring and carrying out aseptic filtration and decompression concentration, and then devitrifying, filtering and drying. The product prepared by the method has more stable quality and simple process, thereby being suitable for industrial big production.

Description

technical field [0001] The invention relates to a method for preparing a central stimulant drug meclofenoxate hydrochloride aseptic bulk drug. Background technique [0002] Meclofenoxate hydrochloride (Meclofenoxate), chemical name 2-(dimethylamino) ethyl p-chlorophenoxy acetate hydrochloride, was artificially synthesized by Professor Thuillier of the French National Center for Scientific Research in 1957. The product obtained by the esterification of phenoxyacetic acid (p-chlorphenoxyacetic acis) and dimethylaminoethanol (dimethylaminoethanol). Clinically, meclofenoxate hydrochloride is a central nervous system stimulant drug that has been used for many years. It is mainly used for the treatment of traumatic brain injury coma, neonatal hypoxia, and alcoholism, and can be used to control the symptoms caused by deep sleep and low awakening alert point. Enuresis in children, etc. [0003] Regarding the synthetic preparation method of meclofenoxate hydrochloride, the Japanese...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07C219/06C07C213/10A61K31/221A61P25/26
Inventor 杨海川王信见
Owner YAOPHARMA CO LTD
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