一测多评法测定不同企业心脑健制剂中9个成分的含量

Determination of content of nine components in Xinnaojian preparations from different manufacturers by QAMS

基于超高效液相色谱技术,建立心脑健制剂超高效液相指纹图谱。采用一测多评法(QAMS)以表儿茶素没食子酸酯为内标参照物,同时对不同企业心脑健制剂中的没食子酸、表没食子儿茶素、儿茶素、咖啡因、表儿茶素、表没食子儿茶素没食子酸酯、没食子儿茶素没食子酸酯、表儿茶素没食子酸酯、儿茶素没食子酸酯等9个成分进行含量测定。通过比较一测多评法与外标法含量测定结果的差异性,验证所建立方法的可行性和准确性。结果9个成分在一定范围的浓度内呈良好的线性关系,平均加样回收率为87.57%~107.4%(RSD 1.5%~2.9%),除表没食子儿茶素外,其余成分的相对校正因子在不同实验条件下重现性良好,表没食子儿茶素的相对校正因子在同一仪器同样波长下也可满足条件。28批样品中9个成分含量结果外标法和一测多评法之间无显著性差异。最后对含量测定结果进行分析,发现不同企业的样品含量存在差异,但是同一企业不同批次的样品含量没有明显差异。综上,所建立的超高效液相指纹图谱结合一测多评法准确且可行,可用于心脑健制剂中9个成分的快速质量分析。

This study established the ultra-performance liquid chromatography(UPLC) fingerprint of Xinnaojian preparations. With epicatechin gallate as the internal reference substance, a quantitative analysis of multi-components by single marker(QAMS) method for determining the content of nine components(gallic acid, epigallocatechin, catechin, caffeine, epicatechin, epigallocatechin gallate, gallocatechin gallate, epicatechin gallate, and catechin gallate) in Xinnaojian preparations was established. The content determined by the external standard method(ESM) and QAMS method was compared to evaluate the feasibility and accuracy of QAMS method. The results showed that the standard curves of nine components had good linear relationship within the test concentration ranges. The average recoveries were 87.57%-107.4%, and the RSD was 1.5%-2.9%. Except epigallocatechin, the other components showed good repeatability under different experimental conditions. Epigallocatechin could meet the requirements in the same instrument and at the same wavelength. The results generally showed no significant difference between QAMS and ESM. The content of 9 components varied between the samples from different manufacturers, while it showed no significant difference between the samples from the same manufacturer. In summary, the UPLC fingerprint combined with QAMS method is feasible and accurate for determining the content of the nine components, which can be used for rapid quality evaluation of Xinnaojian preparations.