冠心丹参滴丸质量标准的研究

Study on quality standard for Guanxindanshen Dropping Pill

目的建立并提升冠心丹参滴丸质量标准。方法采用TLC对冠心丹参滴丸中的丹参、降香油、三七进行定性鉴别,HPLC测定冠心丹参滴丸中三七皂苷R1、人参皂苷Rg1及人参皂苷Rb1的含量。结果鉴别方法专属性强,定量方法简便、准确,三七皂苷R1、人参皂苷Rg1及人参皂苷Rb1分别在0.0655~1.092μg、0.1980~3.2997μg及0.1802~3.0032μg范围内与峰面积呈良好的线性关系,平均回收率在96.1%~102.1%范围内,RSD均小于3.0%。结论该方法简便、准确、重复性好,可作为冠心丹参滴丸的质量标准。

OBJECTIVE To eastablish and improve the quality standard of Guanxindanshen dropping Pill. METHODS TLC was used to identify Radix et Rhizoma, Dalbergia odorifera T. Chen oil and Notoginseng Ra- dix et Rhizoma,and HPLC was applied for the determination of saponins R1 ,ginsenosides Rg1 and ginsenosides Rb1 in Guanxindanshen dropping pill. RESULT The TLC identification was highly specific. The method of content deter- mination was simple and accurate. The good linearity with peak areas was achieved in the range of 0. 0655-1. 092μg for saponins R1 ,0. 1980 -3. 2997μg for ginsenosides Rg1 ,0. 1802 -3. 0032μg for ginsenosides Rb1,The average re- coveries （ n = 6 ） were 96. 1% - 102. 1% with RSD less than 3.0%. CONCLUSION The method is simple, accu- rate and reproducible, can be used for quality control of Guanxindanshen dropping pill.