摘要
目的 建立银黄片溶出度测定方法 ,评价和提高产品质量 ,并对二家药厂的银黄片进行体外溶出度考察。方法 以 0 .1mol/L盐酸为溶出介质 ,采用转蓝法 ,10 0 r· m in- 1 ,以紫外分光光度法测定累积溶出百分率 ,提取威布尔溶出参数并进行统计学处理。结果 统计结果显示 ,二个厂家的银黄片溶出参数 T50 、Td、m均存在显著性差异 (P<0 .0 1) ,溶出速度明显不同。结论 认为有必要将溶出度测定纳入其质量标准中 。
Objective To establish the method of dissolution determination for evaluating and improving the quality of Yinhuang Tablets. Yihuang Tablets from two enterprises were investigated.Methods To 0.1 mol/L hydrochloric acid as dissolvent and rotating-basket method at 100 r·min^(-1),the cumulative dissolution percentage was determined by UV spectrophotometry.The dissolution parameters was obtained by Weibull distribution model and dealed with one-way ANONA.Results The significant differences in dissolution parameters (T_(50),T_d,m)(P<0.01) of the two samples Yihuang Tablets were discovered by statistical analysis.Conclusion It will be necessary to bring the dissolution determination method into the quality control standard for improving the quality and preparation technology of Yinhuang Tablets.
出处
《现代中药研究与实践》
CAS
2004年第5期48-50,共3页
Research and Practice on Chinese Medicines
