复方盐酸小檗碱分散片的制备及其溶出度考察

Preparation and the dissolution research of the dispersible tablet of Berberine hydrochloride and paeonol

目的 制备复方盐酸小檗碱分散片 ,并与市售片剂的溶出度进行比较。方法 以微晶纤维素为填充剂 ,交联聚乙烯吡咯烷酮为崩解剂 ,湿法制粒制备分散片。制定质量标准和溶出度测定方法 ,并进行质量评价和溶出度比较。结果 符合中国药典中有关分散片的要求 ,其体外溶出释药明显优于普通片。结论 所制分散片处方合理 ,崩解快、溶出快而完全。

OBJECTIVE To prepare the dispersible tablet of Berberine hydrochloride and paeonol,and the dissolution rate was compared with the other two commericial tablets.METHODS The tablet was prepared by compressing moist granulation,taking the microcrystalling cellulose(MCC) as the bulking agent,and the polyvinylpolypyrrolidone(PVPP) as the disintegrant.Also the estimation of its quality and comparison on dissolution were carried out.RESULTS The quality of dispersible tablet of berberine hydrochloride and paeonol reached to the standard of ChP(2000 edition).The dissolubility of the dispersible tablet was better than that of common tablets in vitro.CONCLUSION The dispersible tablet was stable.Compared with common tablets,the dispersible tablet dissolved faster and more complete.