一测多评法测定心脑健胶囊(片)中6种儿茶素

Determination of six catechins in Xinnaojian Capsules(Tablets) by QAMS

目的建立一测多评法测定心脑健胶囊(片)(茶叶提取物)中6种儿茶素的含有量。方法该药物50%甲醇提取液的分析采用Shimadzu Wonda Cract ODS-2色谱柱(4.6 mm×250 mm,5μm);流动相0.5%乙酸(A)-乙腈(B),梯度洗脱;体积流量1.0 mL/min;检测波长280 nm;柱温35℃。以表没食子儿茶素没食子酸酯为内标,计算表没食子儿茶素、儿茶素、表儿茶素、没食子儿茶素没食子酸酯、表儿茶素没食子酸酯的相对校正因子,测定其含有量。结果 6种成分在各自范围内线性关系良好(r≥0.999 8),加样回收率96.00%~98.47%,RSD 2.09%~2.91%,一测多评法所得结果接近于外标法。结论该方法简便可靠,可用于心脑健胶囊(片)的质量控制。

AIM To establish a quantitative analysis of multi-components by single marker（QAMS） method for the content determination of six catechins in Xinnaojian Capsules（Tablets）（tea extract）.METHODS The analysis of 50% methanol extract of this drug was performed on a 35 ℃ thermostatic Shimadzu Wonda Cract ODS-2 column（4.6 mm×250 mm,5 μm）,with the mobile phase comprising of 0.5% acetic acid（A）-acetonitrile（B） flowing at 1.0 mL/min in a gradient elution manner,and the detection wavelength was set at 280 nm.With epigallocatechin gallate as an internal standard,the relative correction factors of epigallocatechin,catechin,epicatechin,gallocatechin gallate and epicatechin gallate were calculated,from which the content determination was made.RESULTS Six constituents showed good linear relationships within their own ranges（r ≥ 0.999 8）,whose average recoveries were 96.00%-98.47% with the RSDs of 2.09%-2.91%.The results obtained by QAMS method approximated those obtained by external standard method.CONCLUSION This simple and reliable method can be used for the quality control of Xinnaojian Capsules（Tablets）.