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目的为哮喘宁片建立一个科学、全面的质量控制标准。方法利用薄层色谱法对哮喘宁片中的麻黄、五味子、远志进行定性鉴别,采用高效液相色谱法测定制剂中麻黄的有效成分盐酸麻黄碱。结果麻黄、五味子和远志可在不同的薄层色谱条件下分别检出;利用高效液相色谱法测定制剂中麻黄的有效成分盐酸麻黄碱。盐酸麻黄碱的线性范围为4.7~75.5μg/ml,平均回收率为100.05%,RSD为2.21%(n=6)。结论建立的定性和定量方法均具有专属性好、准确可靠和简便的特点,能有效的对哮喘宁片进行质量控制。
Objective To establish a scientific and comprehensive quality control standard for Asthma Tablets. Methods The ephedra, schisandra and Polygala in Asthma Tablets were qualitatively identified by thin-layer chromatography. Ephedrine hydrochloride, the active ingredient of ephedra, was determined by high performance liquid chromatography. Results Ephedra, Schisandra and Polygala could be detected under different TLC conditions. Ephedrine hydrochloride, the effective ingredient of Ephedra, was determined by high performance liquid chromatography. The linear range of ephedrine hydrochloride was 4.7-75.5 μg/ml, the average recovery was 100.05%, and the RSD was 2.21% (n=6). Conclusion The established qualitative and quantitative methods have the characteristics of good specificity, accuracy, reliability and simplicity, which can effectively control the quality of Asthma Tablets.