益智合剂质量标准研究

Studies on the quality standards of Yizhi mixture

目的建立益智合剂的质量控制方法。方法用薄层色谱法对益智合剂中的远志、黄柏、甘草进行定性鉴别;用HPLC-MS法对益智合剂中痕量的芍药苷进行定量分析。结果表明本品定性鉴别色谱特征明显,易于区别;本品中芍药苷含量测定线性范围为0．25～10mg·L^(-1),平均加样回收率为99．06%,RSD为4．91%(n=5)。结论建立了该制剂的质量标准,其鉴别与含量测定方法简单、可靠、实用。

OBJECTIVE Establish a method for the quality control of Yizhi mixtrue. METHODS Radix Polygalae,Phellodendron, Licorice, were identified by TLC. A method of HPLC-MS to determine paeoniflorin of Yizhi mixture was developed. RESULTS The studies on the quality control showed that the characteristics for identification by TLC were distinct. The quantification method had the linear range of 0.25 - 10mg · L^-1 ,The average recovery was 99.06% and its RSD was 4.91%. CONCLUSION The quality standard of the mixture was provided. The methods for identification and quantification were simple, reproducible and realizable.