摘要
目的研究国内外不同厂家交联聚维酮(PVPP)在直压工艺中的应用性能,为仿制药一致性评价或新药研发中辅料的选择提供参考。方法选取进口和国产PVPP,对其物理化学性质、粉体学性质和制剂功能性质进行对比研究。结果不同厂家PVPP物理化学性质基本一致,但过氧化物指标略有差异;粉体学性质、制剂功能性质存在差异,尤其是流动性、溶胀性能差异明显,进而导致制备的片剂崩解溶出性能存在差异。结论完善和提高PVPP产品生产工艺是促使其应用性能一致的根本途径。
Objective To observe the application performance of crospovidone(PVPP)by different manufacturers both domestic and overseas in the process of direct compression,and to provide reference for the selection of excipients in consistency evaluation of generic drugs or in new drug research and development.Methods Physicochemical properties,powder properties and pharmaceutical functional properties of chosen imported and domestic PVPP were compared.Results Their physicochemical properties were basically the same,but the difference was found in powder properties and pharmaceutical functional properties,especially the differences of flowability and swelling properties were obvious,which led to the differences of disintegration and dissolution performances of the prepared tablets.Conclusion The improvement in the manufacture process of PVPP is key to the consistency of its application performance.
作者
王晓燕
刘韵
潘卫三
WANG Xiao-yan;LIU Yun;PAN Wei-san(Shenyang Pharmaceutical University,Shenyang 110016;Shenyang Harmony Health Medical Laboratory&Key Laboratory of Shenyang Medical Mass Spectrometry Technology,Shenyang 110016)
出处
《中南药学》
CAS
2019年第4期536-541,共6页
Central South Pharmacy
关键词
交联聚维酮
直压工艺
粉体学性质
制剂功能
cospovidone
direct compression
powder property
pharmaceutical function
