摘要
目的:对2个厂家的拉米夫定片进行质量比较研究,探讨其质量差异的原因,对其质量进行评价。方法:采用光纤药物溶出/释放度原位过程监测仪测定拉米夫定片溶出曲线,用高效液相色谱法测定拉米夫定片含量、有关物质,分析试验结果。结果:两家产品溶出行为有显著差异,有关物质量也有明显区别。结论:原料药质量和产品处方工艺不同是导致不同厂家生产拉米夫定片剂质量差异的关键因素。
Objective： To investigate the quality of differences lamivudine tablets and explore the reason of their differences for quality evaluation.Method： The dissolution procession of lamivudine tablets was determinated simultaneously with fiber-optic medicine dissolution/release rate process monitoring system.Stress studies were employed to obtain the degradation information of lamivudine tablets.Result： There were significant differences in dissolution procession as well as impurities between two lamivudine tablets.Conclusion： The bulk drug quality and production technology may lead to quality differences of lamivudine tablets.
出处
《药学与临床研究》
2011年第3期220-223,共4页
Pharmaceutical and Clinical Research
关键词
拉米夫定
溶出度
有关物质
比较研究
质量评价
Lamivudine
Dissolution
Impurities
Comparative study
Quality evaluation
