麻杏止咳胶囊质量标准的研究

Study on Quality Standard for Maxing Zhike Capsules

目的:制定麻杏止咳胶囊的简便快捷的质量标准。方法:对制剂中的麻黄与甘草在同一块薄层板上进行了鉴别,采用高效液相法测定了麻杏止咳胶囊中麻黄碱和伪麻黄碱的含量。结果:通过方法学考察,盐酸麻黄碱的进样量在0.03968～0.8928μg范围内,呈良好的线性关系。盐酸麻黄碱的平均回收率为99.22%(n=9),RSD为1.18%。结论:方法简便、准确、重现性好、精密度高。可用于快速、准确地控制中药制剂质量。

Objective： To establish a quality standards for Maxing Zhike Capsules. Methods： Thin layer chromatography was used for identification of Herba Ephedrae and Radix et Rhizoma Glycyrrhizae at the same time. The content of ephedrine and D-pseudo-ephedrine in preperation was determined by HPLC. Results：The methodological study showed that a good linear correlation existed in the range of 0. 03968-0. 8928μg of ephedrine hydrouhloride. The average recovery of ephedrine hydrochloride was 99.22%（n=9） and RSD was 1. 18% Conclusion： This method is simple,accurate and with good reproducibility and high precision. The method can be used for quality control rapidly and accurately for TCM preparations.