安心康滴丸质量标准研究

Quality standard for Anxinkang Dripping Pills

目的:制定安心康滴丸(苦参、黄芪等)质量标准。方法:用TLC法进行定性鉴别,以RP-HPLC测定苦参碱和氧化苦参碱含量。采用C18柱,流动相为乙腈-甲醇-磷酸混合液(3∶7∶90),检测波长为210 nm。结果:TLC可以很好地鉴别滴丸中的主要成分,苦参碱的线性范围在0.05-0.50μg,平均回收率为97.3%,氧化苦参碱的线性范围为0.1-1.0μg,平均回收率为97.6%。结论:定性、定量方法简便、可靠、准确,可用于安心康滴丸的质量控制。

AIM： To estabolish the method for quality control of Anxinkang Dripping Pills （Radix Sophorae Flavescentis, Radix Astragali, etc. ） METHODS ： Using TLC to identify the dripping pills, matrine and oxymatrine in dripping pills were determined by RP-HPLC. Using C18 column, the mobile phase was made from the acetone methanol-H3PO4（3： 7： 90） , the detection wavelength was at 210 nm. RESULTS： The herbs could be identified by TLC. For matrine, the linear range was from 0.05 -0.50 μg, and the average recovery was 97.3% , and for oxymatrine, the linear range was from 0.1 - 1.0 μg, and the average recovery was 97.6%. CONCLUSION ： The method is simple, reliable, accurate and can be applied to the quality control of the Anxinkang Dri-pping Pills.