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A method for purifying rifampicin

A technology for rifampicin and compounds, applied in the field of purifying rifampicin, can solve problems such as difficulty in obtaining products, and achieve good removal effect and high yield

Active Publication Date: 2022-04-05
CHENGDU JINHUA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It is difficult for researchers to obtain products that do not contain more than 0.1% simple impurities according to the disclosed method

Method used

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  • A method for purifying rifampicin
  • A method for purifying rifampicin
  • A method for purifying rifampicin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Add 100g of rifampicin to be purified to 1000mL of water, add 50mL of hydrochloric acid (35%-37%, g:mL), heat to 50°C for 12h, cool to 25°C, extract with 1000mL of ethyl acetate, and wash the organic layer with water , washed with saturated aqueous sodium bicarbonate solution, washed with aqueous sodium chloride solution, the organic layer was separated, dried over anhydrous sodium sulfate, and concentrated under reduced pressure to obtain 81.93 g of compound II (3-formyl rifamycin SV). Yield 92.9%.

Embodiment 2

[0045] Add 100g of rifampicin to be purified to 1200mL of water, add 50mL of hydrochloric acid (35%-37%, g:mL), heat to 55°C for 8h, cool to 10°C, extract with 1000mL of ethyl acetate, and wash the organic layer with saturated After washing with aqueous sodium bicarbonate solution, the organic layer was separated, dried over anhydrous sodium sulfate, and concentrated under reduced pressure to obtain 83.78 g of compound II (3-formylrifamycin SV). Yield 95.0%.

[0046] Preparation of α-hydroxysulfonate sodium rifamycin

Embodiment 3

[0048] Dissolve 80g of compound II in 400mL of ethyl acetate, add dropwise 400mL of aqueous solution containing 17.2g of sodium bisulfite at 20°C, and stir for 2h. The aqueous layer was separated, and the aqueous layer was washed with ethyl acetate; the aqueous layer was separated to obtain an aqueous solution of compound III (α-hydroxysulfonate sodium rifamycin).

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Abstract

The invention discloses a method for purifying rifampicin. Firstly, the rifampicin to be purified is hydrolyzed into 3-formyl rifamycin SV, and then forms the α-hydroxyl sulfonate of rifamycin with bisulfite. Sodium acid structure, remove impurities, and then adjust base to convert to 3-formyl rifamycin SV, condense with 1-amino-4-methylpiperazine to obtain crude rifampicin, and then refine to obtain pure rifampicin. The unknown individual impurities of the rifampicin product obtained by the method are all less than 0.1%.

Description

technical field [0001] The invention belongs to the field of medicine manufacture and relates to a method for purifying rifampicin. Background technique [0002] Rifampicin, CAS No.: 13292-46-1, with the structural formula shown in Formula I below, is a broad-spectrum antibiotic drug of the rifamycin family. Bacteria, viruses, etc. are also curative. It is red or dark red crystalline powder, insoluble in water. [0003] [0004] Rifampicin was first synthesized in an Italian laboratory in 1959. In 1968, it was first marketed by Sanofi in Italy under the trade name RIFADIN, and its listed dosage forms include capsules, tablets and syrups. [0005] Although generic drugs of rifampicin have been on the market in China for many years, because the previous relevant regulations did not require the comparison of generic drugs with original drugs, the quality and efficacy of generic drugs vary. With the changes in drug-related laws and regulations, it will be an inevitable tr...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07D498/08
CPCC07D498/08C07B2200/07
Inventor 严冬江敏郭敏王庆周红云张凡黄辉孙海丽李林符畔
Owner CHENGDU JINHUA PHARMA