复方桔梗麻黄碱糖浆(Ⅱ)的质量标准研究

Quality standard for Compound Balloonflower and Ephedrine Syrup(Ⅱ)

目的建立复方桔梗麻黄碱糖浆(Ⅱ)的质量标准。方法采用薄层色谱法进行定性鉴别,以反相高效液相色谱法测定盐酸麻黄碱的含量。采用C18柱,流动相为乙腈-0.1%磷酸溶液(含0.1%三乙胺)(5∶95),检测波长为210nm。结果薄层色谱分离度较好,盐酸麻黄碱的线性范围为40.94～1 637.6 ng(r=0.999 9,n=5),平均回收率为100.8%(RSD=1.1%,n=9)。结论该法简便、准确、专属性强,可有效地控制复方桔梗麻黄碱糖浆(Ⅱ)的质量。

Objective To establish a method for the quality control of Compound Balloonflower and Ephedrine Syrup（ Ⅱ ）. Methods TLC was used to qualitatively identify and RP - HPLC was used to determine ephedrine hydrochloride in the Compound Balloonflower and Ephedrine Syrup. C18 column was adopted, the mobile phase was acetonitrile -0.1% phosphoric acid （ containing 0.1% triethylamine） （ 5 ： 95 ） , and the detection wavelength was 210 nm. Results The herbs could be identified by TLC. The linear range of ephedrine hydrochloride was from 40.94 N 1 637.6 ng（ r = 0. 999 9, n = 5 ） and the average recovery was 100.8% （RSD = 1.1%, n = 9）. Conclusion The method was simple, accurate and specific, and it can be applied to the quality control of the Compound Balloonflower and Ephedrine Syrup.