阿奇霉素片剂的溶出度比较

目的　比较阿奇霉素片剂溶出度。方法　用高效液相色谱法测定片剂含量 ,并按中国药典 (2 0 0 0年版 )规定的方法测定溶出度。结果　阿奇霉素普通片和分散片在 12 0min时的累积溶出量均 >75 % ,符合药典规定。两两比较显示 ,普通片中 4厂与 2厂的t63 .2 无显著性差异 (P >0 .0 5 ) ,其余各厂普通片的t50 、t63 .2 都存在显著性差异 (P<0 .0 1)。分散片中C厂与F厂的t50 无显著性差异 (P >0 .0 5 ) ,F厂与E厂、C厂、A厂 ,E厂与C厂、A厂 ,C厂与A厂的t63 .2 无显著性差异 (P >0 .0 5 ) ,其余各厂产品的t50 、t63 .2 都存在显著性差异 (P <0 .0 1)。结论　阿奇霉素普通片溶出度差异相对分散片大。

Comparison of Dissolubilities of Azithromycin Tablets from Eleven Producers

Objective To compare the dissolution of azithromycin tablets from eleven manufacturers.Methods High-performance liquid chromatography was used to determine azithromycin produced by eleven pharmaceutical factories according to the method described in Chinese Pharmacopeia (Edition 2000).Results The accumulative dissolving quantity of azithromycin tablets was no less than 75% at 120 min, it was conformed to the criteria set by ChP(2000).In general tablets the comparison of Weibull parameters T_ 50,T_d showed significant differences among the producer 1,3,5(P< 0.01).There were no differences between producer 2 and producer 4(P>0.05).In the dispersible tablets T_ 50 showed no difference between producer C and producer F(P>0.05),T_d showed no significant difference among A,C,E,F(P> 0.05).Conclusion The dissolubility of general tablets has significant difference from the dispersible tablets.As a whole,the dissolubilities of Azithromycin tablets from 11 producers are conformed to the criteria set by ChP(2000).