薄层扫描法测定麻黄及其制剂中盐酸麻黄碱的含量

Determination of ephedrine hydrochloride in Herba Ephedrae and its preparation by TLC-scanning

目的 :制定麻黄及其制剂止嗽立效片 (麻黄 ,罂粟 ,苦杏仁 ,甘草 ,石膏 ,葶苈子 ,莱菔子等 )和止嗽立效胶囊中麻黄碱的质量控制方法。方法 :采用薄层扫描法测定麻黄及其制剂止嗽立效片和止嗽立效胶囊中麻黄碱的含量。以氯仿 醋酸乙酯 甲醇 水 (1 3∶40∶2 2∶1 0 ) 1 0°C以下放置 1 2h的下层溶液为展开剂 ,反射单波长锯齿扫描。结果 :通过方法学考察 ,盐酸麻黄碱的点样量在 0 .2 91 1 2～ 1 .4556μg范围内呈良好的线性关系。麻黄药材的平均回收率 98.74% (n =5) ,止嗽立效片的为 99.45 % (n =5) ,止嗽立效胶囊的为 99.1 4 % (n =5)。结论 :方法简便、准确、重现性好、精密度高。可用于控制麻黄药材及其制剂的质量。

Objective: To establish the quality control method for ephedrine in Herba Ephedrae and its preparation Zhisoulixiao Tablets (Herba Ephedrae, Pericarpium Papaveris, Semen Armeniacae Amrum, Radix Glycyrrhizae, Gypsum Fibrosum, Semen Lepidii, Semen Raphani, etc.) and Zhisoulixiao Capsules. Methods:Ephedrine hydrochloride contents in Herba Ephedrae and its preparation Zhisoulixiao Tablets and Zhisoulixiao Capsules were determined by TLC scanning with a mixture of chloroform ethyl acetate methanol water(13∶40∶22∶10)as a developer and single wavelength reflection sawtooth scanning. Results: The methodological study showed that a good linear correlation in the range from 0.29112μg to 1.4556μg of the ephedrine hydrochloride applied. The average recovery of ephedrine hydrochloride in Herba Ephedrae, Zhisoulixiao Tablets and Zhisoulixiao Capsules was 78.74%( n=5 ),99.46%( n=5) and 99.14%( n=5) ,respectively. Conclusion: The method established is simple,accurate with good reproducible and high precision.The method can be used for the quality control of Herba Ephedrae and its preparation