摘要
目的 :为评价罗红霉素内在质量、控制药品的均匀性 ,评价该制剂质量提供方法与参数。方法 :对四厂家罗红霉素片剂的体外溶出度进行对比实验 ,实验数据用威布尔分布处理。结果 :统计学结果表明四厂家样品的溶出速率有显著性差异 (P<0 .0 1)。结论
Objective:In order to examine the intrinsic quality and homogeneity of roxithromycin tablets(capsules)and to provide methods and parameters for evaluating quality of products.Methods:Controlled experiments in vitro were designed and performed to determine the dissolutions of roxithromycin tablets(capsules) from four pharmacentical manufacturers,and data were analyzed with Weibull distribution.Results:Statistic analysis showed that the differences between dissolutions of tablets(capsules) from the four producers were significant( P <0.01).Conclusion:Dissolutions of tablets(capsules) produced by different factories could be greatly different.
出处
《华夏医学》
2000年第4期449-451,共3页
Acta Medicinae Sinica
