药用复合辅料甘露醇-交联聚维酮的制备及质量评价

发布时间：2019-05-22 17:13

【摘要】：目的:制备新型的功能性复合辅料甘露醇-交联聚维酮(Man-Cro),并对其进行质量评价。方法:通过处方组成与制备工艺的考察,对该辅料进行了质量标准研究与休止角、卡尔指数等辅助性功能研究,并进行压片试验比较。结果:以共同结晶法为工艺,确定其处方组成为甘露醇-交联聚维酮为80:20,平均粒径为251μm,休止角小于40°,卡尔指数在22%~25%之间,该复合辅料具有良好的膨胀度、流动性、可压性以及崩解性,同时符合中国药典对甘露醇及交联聚维酮的质量要求,适用于口崩片的制备。结论:功能性复合辅料Man-Cro制备工艺简单可行,性能优良,可应用于直压性口崩片的制备,质量可控。
[Abstract]:Objective: to prepare a new functional compound excipients mannitol crosslinked povidone (Man-Cro) and evaluate its quality. Methods: through the investigation of prescription composition and preparation technology, the quality standard, rest angle, Karl index and other auxiliary functions of the auxiliary material were studied, and the tablet pressing test was compared. Results: the prescription composition of mannitol-crosslinked povidone was 80 鈮，

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