花芪灵丹丸质控标准研究

摘要

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 ⅡA.The quality control standard was set up .Results The microscopical identification and TLC identification effect were good , and had strong specificity .Content determination of tanshinoneⅡA 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 .%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。