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
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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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