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Moxifloxacin hydrochloride purification method

A technology of moxifloxacin hydrochloride and purification method, which is applied in the direction of organic chemistry, can solve the problems of cumbersome operation and low yield, and achieve the effect of simple operation, high purity and easy industrial production

Inactive Publication Date: 2017-03-08
苏州正济药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0006] Patent CN102285986 discloses a method for purifying moxifloxacin hydrochloride with DMF and ethanol. The purity is as high as 99.9%. Yield is only about 40%

Method used

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  • Moxifloxacin hydrochloride purification method

Examples

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Effect test

Embodiment 1

[0026] Configure 1% dilute hydrochloric acid, add 100g of crude moxifloxacin hydrochloride to 500mL methanol and 1% dilute hydrochloric acid solution (volume ratio of methanol to dilute hydrochloric acid is 3:1), heat up to 65-69°C, after clarification Add 3% activated carbon, keep warm at 65-69°C for 1 hour, filter while hot, heat the filtrate to 65-69°C, keep warm for half an hour, cool down naturally, drop to room temperature, cool to 8-12°C with ice water, keep warm for 1 hour , filtered with suction, washed with a small amount of anhydrous methanol, and dried under vacuum at 50-55°C to obtain 72g of bright yellow powder with a yield of 72% and a purity of 99.9%.

Embodiment 2

[0028] Configure 1% dilute hydrochloric acid, add 100g of crude moxifloxacin hydrochloride to 500mL methanol and 1% dilute hydrochloric acid solution (volume ratio of methanol to dilute hydrochloric acid is 4:1), heat up to 65-69°C, after clarification Add 3% activated carbon, keep warm at 65-69°C for 1 hour, filter while hot, heat the filtrate to 65-69°C, keep warm for half an hour, cool down naturally, drop to room temperature, cool to 8-12°C with ice water, keep warm for 1 hour , filtered with suction, washed with a small amount of anhydrous methanol, and dried under vacuum at 50-55°C to obtain 75g of bright yellow powder with a yield of 75% and a purity of 99.9%.

Embodiment 3

[0030] Configure 2% dilute hydrochloric acid, add 100g of crude moxifloxacin hydrochloride to 500mL methanol and 1% dilute hydrochloric acid solution (volume ratio of methanol to dilute hydrochloric acid is 3:1), heat up to 65-69°C, after clarification Add 3% activated carbon, keep warm at 65-69°C for 1 hour, filter while hot, heat the filtrate to 65-69°C, keep warm for half an hour, cool down naturally, drop to room temperature, cool to 8-12°C with ice water, keep warm for 1 hour , filtered with suction, washed with a small amount of anhydrous methanol, and dried under vacuum at 50-55°C to obtain 71g of bright yellow powder with a yield of 71% and a purity of 99.9%.

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Abstract

The invention relates to a moxifloxacin hydrochloride purification method, which specifically comprises: adding an alcohol and dilute hydrochloric acid mixing solution to moxifloxacin hydrochloride, heating, dissolving, decolorizing, carrying out hot filtration, cooling, crystallizing, carrying out suction filtration, carrying out alcohol washing, and drying to obtain the product, wherein the volume of the added alcohol and dilute hydrochloric acid mixing solution is 3-8 times the weight of the moxifloxacin hydrochloride, and a volume ratio of the alcohol to the dilute hydrochloric acid is 2:1-5:1. According to the present invention, the operation of the method is simple, the characteristics that the solubility of the moxifloxacin hydrochloride in the alcohol solvent is poor and the solubility of the moxifloxacin hydrochloride in the dilute hydrochloric acid is good are utilized, the purity of the purified product is high, the single impurity is less than 0.1%, the total impurity is less than 0.2%, and the method is suitable for industrial production.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a method for purifying moxifloxacin hydrochloride. Background technique [0002] Moxifloxacin hydrochloride, English name: Moxifloxacin Hydrochloride, chemical name: 1-cyclopropyl-7-{S,S-2,8-diazo-bicyclo[4.3.0]non-8-yl}-6- Fluoro-8-methoxy-1,4-dihydro-4-oxo-3-quinoline carboxylic acid hydrochloride, the chemical structure is as follows: [0003] [0004] Moxifloxacin hydrochloride was successfully developed by Bayer AG of Germany, and was first launched in Germany in September 1999. In December of the same year, moxifloxacin was approved by the FDA for listing in the United States. Moxifloxacin hydrochloride is a DNA topoisomerase inhibitor, which is mainly used for the treatment of respiratory tract infections. It has the advantages of high antibacterial activity, wide antibacterial spectrum, high human absorption rate, low cytotoxicity and less damage to liver and kidney....

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D471/04
CPCC07D471/04
Inventor 戴光渊姚青薛程良
Owner 苏州正济药业有限公司
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