【摘要】 在异丁基哌嗪力复霉素质量考察研究工作中,发现一种质量稳定、生物活力高的含水晶形产品,定为A型。本文报告A晶的粉末X-射线衍射光谱、红外光谱、热分析谱以及各种条件下的热、湿稳定性研究结果。结合三年的自然室温下长期留样考察以及对已贮存两年半以上样品的生物利用度测定报告,充分证实A晶产品具有特别好的质量稳定性和很好的生物利用度。更多还原

【Abstract】 Many of the rifamycin antibiotics show polymorphism. 3-(4-isobuty1-1-piperazinyl)-rifamycin(I) also exists in several different crystal forms. During the investigation of its product quality, a stable and good bioa-vailability crystalline product, known as A-form was found.It is a water-solvated crystalline. In the present study, X-ray powder diffraction, IR spectra, thermogravimetric and differential thermal analyses were usedto characterize the A-form crystal. The-stability of A-form crystal under various humidity conditions and temperatures was examined. The products after storing for 3 years at ambient temperature or under various humidity conditions are stable, while the content of(I)only decrease for ca. 5%.In. addition, after storing for 2.5 years, A-form of (I) was found to be in a good bio-available state.更多还原