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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。
Objective: To prepare a new functional composite adjuvant Man-Cro and evaluate its quality. Methods: Through the investigation of prescription composition and preparation process, the auxiliary materials were studied on the quality standard and the rest function such as angle of repose, Karl index and other auxiliary functions, and the comparison of the tabletting test. Results: By the common crystallization method, the prescription was determined to be 80:20 mannitol - Crospovidone, the average particle size was 251μm, the angle of repose was less than 40 °, and the Karl index was between 22% and 25% The composite excipient has good expansibility, fluidity, compressibility and disintegration, and also meets the quality requirements of Chinese Pharmacopoeia for mannitol and cross-linked povidone, and is suitable for the preparation of orally disintegrating tablets. Conclusion: Man-Cro preparation process of functional composite excipient is simple and feasible and has good performance. It can be used in the preparation of pressure-orally disintegrating tablets with quality controllable.