小儿咳喘灵颗粒中金银花及麻黄的质量控制研究

Study on the Quality Control of Lonicerae Japonicae Flos and Ephedrae Herba in Xiaoer Kechuanling Granules

目的:建立小儿咳喘灵颗粒中金银花及麻黄的质量控制方法。方法:采用高效液相色谱的方法测定小儿咳喘灵颗粒中金银花及麻黄的主要成分。绿原酸、木犀草苷、3,5-二-O-咖啡酰奎宁酸、4,5-二-O-咖啡酰奎宁酸含量以乙腈-0.1%磷酸溶液为流动相,梯度洗脱,检测波长210 nm,柱温30℃;盐酸麻黄碱、盐酸伪麻黄碱含量以乙腈-0.1%磷酸溶液(5∶95)为流动相,检测波长为207 nm,柱温30℃。结果:HPLC法测定绿原酸、木犀草苷、3,5-二-O-咖啡酰奎宁酸、4,5-二-O-咖啡酰奎宁酸、盐酸麻黄碱、盐酸伪麻黄碱的线性关系良好;平均回收率分别为89.9%、97.7%、96.7%、98.2%、101.3%及97.8%。结论:本方法专属性强,稳定性好,重复性好,能够有效评价和控制小儿咳喘灵颗粒中金银花和麻黄的质量。

Objective:To establish the quality control methods of Lonicerae Japonicae Flos and Ephedrae Herba in Xiaoer Kechuanling Granules.Methods:HPLC were used to determine the main components in Lonicerae Japonicae Flos and Ephedrae Herba.Chlorogenic Acid,Luteolin-7-O-glucoside,3,5-ODicaffeoylquinic Acid and 4,5-Dicaffeoylquinic Acid were determined with a gradient mobile phase of acetonitrile-0.1%phosphoric acid aqueous solution system,the detection wavelength was 210 nm,and the column temperature was 30℃.Ephedrine Hydrochloride and Pseudoephedrine Hydrochloride were determined with acetonitrile-0.1%phosphoric acid(5∶95),the detection wavelength was 207 nm and the column temperature was 30℃.Results:For HPLC determination of Chlorogenic Acid,Luteolin-7-O-glucoside,3,5-O-Dicaffeoylquinic Acid,4,5-Dicaffeoylquinic Acid,Ephedrine Hydrochloride and Pseudoephedrine Hydrochloride,the linear relationships were good.The average recovery was 89.9%,97.7%,96.7%,98.2%,101.3% and 97.8%.Conclusion:This method methods are highly specific,stable and reproducible,which can be used for the quality evaluation and control of Lonicerae Japonicae Flos and Ephedrae Herba in Xiaoer Kechuanling Granules.