Method for producing rifampicin raw material medicines with densities of less than or equal to 0.3g/ml and more than or equal to 0.8g/ml

A production method and rifampicin technology are applied in the production field of recrystallization in the production of rifampicin raw materials, which can solve the problems of no guidance scheme and low impurities, and achieve good fluidity, increase drug content, and obvious crystallinity. Effect

Active Publication Date: 2011-06-01
HEBEI XINGANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This technology does not give a specific guidance on how to purposefully and effectively produce rifampicin APIs with density specifications of ≤0.3g / ml and ≥0.8g / ml, and make the crystals of the APIs uniform and orderly with low impurities

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0011] Embodiment 1: the production method (synthetic method) of rifampicin crude drug ≤0.3g / ml and ≥0.8g / ml density specification, take rifamycin S-Na salt as starting material, through acidification, cyclization, Condensation, crude crystallization, centrifugation to obtain crude rifampicin, and the crude product is recrystallized to obtain rifampicin bulk drug product. The recrystallization process includes the steps of obtaining rifampicin bulk drug products with a density of ≤0.3g / ml and the steps of obtaining rifampicin bulk drug products with a density of ≥0.8g / ml. specifically is:

[0012] A, recrystallization process obtains the steps (sequentially) of ≤ 0.3g / ml density rifampicin crude drug product: 1. rifampicin crude product is dissolved with n-butanol under stirring, (stirrer) stirring speed is 70 revs / min, the temperature during the dissolution process is maintained at 75°C±1°C, the temperature at the end of the dissolution is 75°C (74°C to 80°C can be selected...

Embodiment 2

[0014] Embodiment 2: the production method (synthetic method) of rifampicin crude drug ≤ 0.3g / ml and ≥ 0.8g / ml density specification, take rifamycin S-Na salt as starting material, through acidification, cyclization, Condensation, crude crystallization, centrifugation to obtain crude rifampicin, and the crude product is recrystallized to obtain rifampicin bulk drug product. The recrystallization process includes the steps of obtaining rifampicin bulk drug products with a density of ≤0.3g / ml and the steps of obtaining rifampicin bulk drug products with a density of ≥0.8g / ml. specifically is:

[0015] A, recrystallization process obtains the step (sequentially) of ≤0.3g / ml density rifampicin crude drug product: 1. rifampicin crude product is dissolved with n-butanol under stirring, (stirrer) stirring speed is 60 revs / min (or 80 revolutions / min), the temperature of the dissolution process is kept between 78°C and 80°C, the temperature of the dissolution is not lower than 78°C (...

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Abstract

The invention relates to a method for producing rifampicin raw material medicines with densities of less than or equal to 0.3g/ml and more than or equal to 0.8g/ml. The recrystallization process for obtaining the rifampicin raw material medicine product with the density of less than or equal to 0.3g/ml comprises the following steps of: dissolving a rifampicin crude product in n-butyl alcohol with stirring, keeping the temperature, and dissolving completely; controlling the concentration of solution; forming a large number of crystal nuclei, adjusting stirring speed, and circularly reducing the temperature; and separating to obtain a wet product by using a centrifugal machine, and performing vacuum drying. The recrystallization process for obtaining the rifampicin raw material medicine product with the density of more than or equal to 0.8g/ml comprises the following steps of: dissolving a rifampicin crude product in acetone with stirring, keeping the temperature, and dissolving completely; controlling the concentration of solution; and putting a previously cleaned and dried stainless steel cylinder into the solution, circularly reducing the temperature, taking the stainless steel cylinder out for later use, putting into a centrifugal machine with continuous stirring, separating to obtain a wet product and performing vacuum drying. By the method, the rifampicin raw material medicines with the densities can be purposefully and effectively produced; and raw material medicine crystals are uniform and ordered, and have high liquidity, low impurity content and high content.

Description

technical field [0001] The invention relates to a production method of rifampicin bulk drug, in particular to a production method of recrystallization in the production of rifampicin bulk drug. Background technique [0002] Rifampicin is a semi-synthetic antibiotic raw material medicine, which is used for the treatment of Mycobacterium tuberculosis, Bacillus leprae, Staphylococcus aureus infection, and also for the treatment of anaerobic infection. The synthesis method takes rifamycin S-Na salt as the starting material, and is composed of steps such as acidification, cyclization, condensation, crude crystallization, recrystallization, and vacuum drying. The existing production method of rifampicin crude drug is mainly obtained by dissolving rifampicin crude product with organic solvent n-butanol or acetone, cooling down to crystallize, centrifuging and drying. Due to the control of crystallization conditions and the crystallization process, the density of the rifampicin bul...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D498/08
Inventor 刘伟刘胜昔
Owner HEBEI XINGANG PHARMA
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