止嗽定喘丸(浓缩丸)质量标准研究

Study on Improving Quality Standard for ZhiSouDingChuan Pills

目的：制定提高止嗽定喘丸（浓缩丸）质量标准的方法。方法：用RP-HPLC法对制剂中的盐酸麻黄碱进行含量测定，TLC法对止嗽定喘丸（浓缩丸）中苦杏仁进行定性鉴别，化学反应鉴别石膏。色谱柱：Allsphere ODS（4.6mm×250mm，2.5μm）；流动相：乙腈：水（1mL·L^-1磷酸和1mL·L^-1三乙胺）（3/97）；检测波长：207nm。结果：盐酸麻黄碱对照品在0.2246～1.1240/.范围内线性关系良好，平均回收率为98.03％，处方中的药材苦杏仁能得到很好的专属性定性鉴别。结论：处方中苦杏仁的TLC定性鉴别专属性好，君药麻黄中盐酸麻黄碱含量测定方法准确、操作简单、专属性和重现性良好，可以有效用于止嗽定喘丸（浓缩丸）的质量控制。

Objective： To establish the method for improving quality standard of Zhisoudingchuan Pills. Methods： Ephedrine Hydrochloride in pills was determined by RP-HPLC,TLC was used to identify Bitter Apricot Seed, chemical reaction is used to identify gypsum; o The samples were separated by Allsphere ODS-2.5μm（4.6×250 mm） with the mobile phase consisting of acetonitrile-water（0. 1% phosphoric acid and 0. 1% triethylamine）（3：97）;The detection wavelength was at 207 nm. Results： For Ephedrine Hydrochloride,linear range was 0. 2246～1. 1240μg,and the average recovery was 98. 03%. Bitter Apricot Seed in Zhisoudingchuan Pills could be identified by TLC,The reaction to identify gypsum is evident. Conclusion： The method to determine content of Ephedrine is precise and the operation of extraction is simple,The specificity of this method is reliable,The specificity to identify Bitter Apricot Seed using TLC is good, The reaction to identify gypsum is acurate, simple, specialized, reproducible and suitable for quality control of Zhisoudingchuan Pills.