药用复合辅料甘露醇-交联聚维酮的制备及质量评价

Preparation and quality evaluation of mannitol-crospovidone co-processed excipient

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 co-processed excipient of mannitol and crospovidone （ Man-Cro ） and to evaluate its quality performance. Method： The formulation and the processing steps of the exeipient were investigated. The quality specification and functionality such as the angle of repose and Cart index of the excipient characteristics were determined. The co-processed excipient was further tested in comparison with direct tablet compression. Results： The functional co-processed excipient was prepared by coerystallization with the ratio of mannitol-crospovidone at 80：20. The mean particle diameter was 251 μm, the angle of repose was smaller than 40° and the Carr index was between 22%-25%. The resulted co-processed excipient showed fairly good expansion degree, mobility, compressibility and disintegration. The quality was also in consistence with the standards of both mannitol and crospovidone indicated in the Chinese pharmacopoeia. The co-processed excipient can be used for the preparation of orally disintegrating tablets. Conclusions： The preparation procedure of the functional co-processed excipient was simple and feasible. The performance and quality of the excipient was stable and controllable. The excipient can be applied to prepare for the preparation of orally disintegrating tablets by direct compression.