前列通片质量标准的研究

A Study on the Quanlity Standard of Qianlietong Tablets

目的提高中药复方制剂前列通片的质量标准。方法对琥珀进行了显微鉴别,采用薄层色谱法对制剂中的八角茴香油、肉桂油、盐酸小檗碱等进行定性鉴别,用高效液相色谱法蒸发光检测器对制剂中的黄芪甲苷进行了定量分析。结果在薄层色谱中能检出八角茴香油、肉桂油、盐酸小檗碱,黄芪甲苷含量测定线性范围0.0294~0.2058 mg/ml,回归方程Y=1.6285X＋6.8399,r=0.9996,限度含黄芪甲苷不得少于0.1 mg/片。结论建立的方法可对本制剂进行准确、快速的定性定量分析。

Objective To improve a quality control standard of Qianlietong Tablets.Methods The technique of thin layer chromatography was used to identify anise oil,cassia bark oil,berberine hydrochloride.High performance liquid chromatography-ELSD was applied to determine the content of Astragaloside in Qianlietong Tablets.Results The anise oil,cassia bark oil,berberine hydrochloride could be determined by thin layer chromatography.The linear ranger of astragaloside was 0.0294～0.2058 mg/ml.The regression equation was Y=1.6285X＋6.8399,r=0.9996.The content of astragaloside in Qianlietong Tablets was not less than 0.1mg per tablet.Conclusion This method is simple,sensitive,accurate and with good reproducibility.It can be used as a quality control standard of the drug.