缩泉丸质量标准研究

Studies on the Quality Standard of Suoquan Pills

目的:建立缩泉丸的质量标准体系。方法:采用TLC法对方中乌药、益智仁、山药进行定性鉴别,并采用HPLC法对制剂中乌药所含乌药醚内酯进行含量测定。结果:薄层色谱中,供试品溶液色谱在与对照药材相应位置上出现相同颜色的斑点,阴性对照无干扰;高效液相色谱中,乌药醚内酯在2.8～28μg·mL-1范围内呈良好线性关系(r=0.9999),平均加样回收率为97.08%,RSD%为1.50%(n=6)。结论:所建立的方法可准确进行定性、定量测定,可用于该制剂的质量控制。

Objective：To establish the quality standard of Suoquan pills.Methods：Radix Linderae,Rhizoma Dioscoreae,Semen Coiciswere identified by TLC;The content of linderane in Suoquan pills was determinated by HPLC.Results：Spots obtained from the test solutions had the same color in medicalmaterial in the same location,and the bland solution had no interference.The linear range of linderane was from 2.8 to 28 μg·mL^-1 （r=0.9999）,the average recoverywas97.08%,with RSD of 1.50%（n=6）.Conclusion：The method is simple, feasible, and reproducible,which could be applied to the quality control of Suoquan pills.