【摘要】 目的建立花芪灵丹丸的质量控制标准。方法采用显微鉴别法鉴别花芪灵丹丸中茯苓、牡丹皮、肉桂;采用薄层色谱法鉴别花芪灵丹丸中黄芪、红花、延胡索;采用高效液相色谱法定量检测花芪灵丹丸中丹参酮ⅡA的含量,建立质量控制标准。结果显微鉴别和薄层色谱鉴别效果好,专属性强;含量测定丹参酮ⅡA在0.01592μg~0.796μg范围内,进样量与峰面积积分值呈良好的线性关系,平均加样回收率为101.5%(RSD值3.8%)。结论花芪灵丹丸的质控方法操作简便、结果准确、重现性好,而且能够对花芪灵丹丸进行定性和定量质控,符合中药制剂的质控要求,可用于花芪灵丹丸质量的控制。更多还原

【Abstract】 Objective To establish a quality control standard of Huaqi Lingdan pill. Methods The microscopic identification method was adopted to identify Huaqi Lingdan pill in poria cocos,cortex moutan and cinnamon. TLC method was used to identify the Huaqi Lingdan pill in astragalus root,safflower and yanhusuo. The high performance liquid chromatography( HPLC) method was applied to detect the content of Huaqi Lingdan pill in tanshinone Ⅱ A. The quality control standard was set up. Results The microscopical identification and TLC identification effect were good,and had strong specificity. Content determination of tanshinone Ⅱ A in 0. 01592 μg-0. 796μg. The sample quantity and the peak area of integral value had good linear relationship,and the average sample recovery rate was 101. 5%( RSD 3. 8%)values. Conclusion The quality control method of Huaqi Lingdan pill is simple,accurate and reproducible,and can carry out qualitative and quantitative quality control of the Huaqi Lingdan pill,to meet the requirements of quality control of traditional Chinese medicine preparation,and can be used to control the quality of Huaqi Lingdan pill.更多还原