罗红霉素体外溶出度考察

目的]为评价药品内在质量、控制药品的均匀性,为评价药品质量提供方法与参数。方法]硫酸显色法,根据1995年版药典第一法研究了四厂家罗红霉素片剂的体外溶出度对比实验,实验数据用威布尔分布处理。结果]统计学结果表明四厂家的样品的溶出速率有显著性差异（p＜0．01）,同一厂家同一批号的药片溶出度亦有明显差异。结论]不同厂家生产的同类产品质量明显不一致性。

Comprarison of the Dissolution Rate of Roxithromycin Tablets(Capsules)

In order to evaluate the intrinsic quality of Roxithromycin tablets or capsules, keep itS homogeneity and provide methods and parameters for the quality control, controlled experiments were conducted to comare the dissolution rate of Roxithromycin tablets and capsules produced in 4 different pharmaceutical factories based on the assay method from "Pharmacopcia of People's Republic of China". The data were processed via Wei Bull Distrbution. The result showed the significant difference(p<0.01) of dissolution speed in the Samples from the 4 factories and also showed that the quality of Roxithromycin tablets and capsules in the 4 factories did not share the same standard.