地黄除痹乳膏的质量标准研究

Study on the quality standard of Dihuang Chubi Cream

目的建立地黄除痹乳膏的质量标准。方法用薄层色谱法(thin layer chromatography,TLC)鉴别地黄除痹乳膏中地黄、当归、三七;用双波长高效液相色谱法(high performance liquid chromatography,HPLC)测定梓醇、地黄苷D、阿魏酸、三七皂苷R_(1)、人参皂苷Rg_(1)、人参皂苷Rb_(1)的含量。结果TLC特征斑点清晰,且阴性样品无干扰。梓醇、地黄苷D、阿魏酸、三七皂苷R_(1)、人参皂苷Rg_(1)、人参皂苷Rb_(1)质量浓度分别在9.82~157.12、11.88~190.08、2.68~42.88、10.64~170.24、24.24~387.84、20.88~334.08μg·mL-1范围内与其峰面积线性关系良好(r≥0.9993);平均回收率分别为96.89%、100.60%、104.32%、98.62%、101.76%、95.87%,RSD均小于1.5%。结论建立的鉴别及含量测定方法准确、可靠,可用于地黄除痹乳膏的质量评价。

Objective To establish the quality standard of Dihuang Chubi Cream.Methods Rehmanniae radix,Angelica sinensis and Panax notoginseng in Dihuang Chubi Cream were identified by thin layer chromatography(TLC).Dual wavelength high performance liquid chromatography(HPLC)was used to determine the contents of catalpol,rehmangoside D,ferulic acid,notoginsenoside R_(1),ginsenoside Rg_(1)and ginsenoside Rb_(1).Results The TLC spots were clear and the negative samples showed no interference.The mass concentrations of catalpol,rehmannin D,ferulic acid,notoginsenoside R_(1),ginsenoside Rg_(1),and ginsenoside Rb_(1)showed good linear relationship with their peaks in the ranges of 9.82-157.12,11.88-190.08,2.68-42.88,10.64-170.24,24.24-387.84,and 20.88-334.08μg·mL^(-1)(r≥0.9993)respectively.The average recoveries were 96.89%,100.60%,104.32%,98.62%,101.76%,and 95.87%,respectively,and the RSDs were all lower than 1.5%.Conclusion The established identification and content determination method is accurate and reliable,and can be used for the quality evaluation of Dihuang Chubi Cream.