【摘要】 目的:研究精密度、准确度和范围的具体考察方法、限度设定和数据要求。方法:采用RP-HPLC法,以黄芩单味药材和复方制剂一清颗粒为例,对黄芩苷含量进行测定,在方法学验证过程中,重复性和回收率试验分别设计不同范围和不同考察方法。结果:黄芩药材中黄芩苷含量测定,在不同范围内,方法重复性RSD在1.5%～3.7%之间;平均回收率在91.6%～96.3%之间,RSD在2.7%～4.2%之间。一清颗粒中黄芩苷含量测定,不同范围内,方法重复性RSD在1.3%～4.2%之间;平均回收率在100.5%～103.1%之间,RSD在1.5%～3.3%之间。结论:根据黄芩单味药材和复方制剂一清颗粒的测定结果,参考中国药典2005年版(一部)项下规定含量限度,确定重复性RSD应不大于5.0%;平均回收率在90.0%～110.0%之间,RSD应不大于5.0%,本研究结果将为中国药典2010年版(一部)附录ⅩⅧA修订提供数据支持。更多还原

【Abstract】 Objective:To study the specific investigation method,limit and data requirements of precision,accuracy and range.Methods:For the RP-HPLC determination of baicalin in Scutellaria baicalensis Georgi and Yiqing granules,in different range,different methods were used to evaluate the repeatability and accuracy.Results:For Scutellaria baicalensis Georgi,RSDs of the repeatability were 1.5%-3.7% in different range.The average recoveries were 91.6%-96.3%,with RSDs of 2.7%-4.2%.For Yiqing granules,RSDs of the repeatability were 1.3%-4.2%.The average recoveries were 100.5%-103.1%,with RSDs of 1.5%-3.3%.Conclusion:According to the results of Scutellaria baicalensis Georgi and Yiqing granules,it is showed that in ten times range,RSD of the repeatability should be no more than 5.0%.The average recoveries should be 90.0%-110.0%,with RSD no more than 5.0%.We provide data support for the revision of ChP.appendix ⅩⅧ A(2010 Edition).更多还原