藏药八味秦皮丸的质量标准研究

Quality Standard Study on zang Medicine Baweiqinpi Pill

目的:建立藏药八味秦皮丸的定性定量质量标准,为其质量控制提供有力技术依据。方法:采用显微鉴别方法对制剂中的秦皮、针铁矿、寒水石、朱砂进行鉴别,采用薄层色谱法(TLC)对制剂中的秦皮甲素、秦皮乙素、7-羟基香豆素进行定性鉴别,采用滴定法对制剂中朱砂含量进行测定,采用高效液相色谱法(HPLC)对制剂中秦皮乙素含量进行测定。结果:各药材显微鉴别特征明显,薄层色谱鉴别方法专属性强,斑点清晰,分离效果好,且阴性对照无干扰;滴定法含量测定结果显示,重复性好,准确度高;HPLC含量测定结果显示,秦皮乙素在0~0.04 mg/mL范围内与峰面积呈现良好线性关系(r^(2)=0.9991),平均加标回收率为96.8%。结论:此方法简便、准确度高、重现性好,可作为八味秦皮丸的质量控制方法。

Objective To establish the qualitative and quantitative detection methods for tibetan medicine baweiqinpi Pill, and to provide a powerful technical basis for its quality control.Methods The microscopic identification method was used to identify qingpi, ferrithori, calcspar and cinnabar seed in the preparation. Thin layer chromatoqingpigraphy(TLC) was used for qualitative identification of aesculin, aesculetina and 7-Hydroxycoumarin seed in preparation.The content of cinnabar was determined by titration, and the content of aesculetina was determined by high performance liquid chromatography(HPLC).Results The microscopic identification features of the said four medicinal material were obvious. The TLC qualitative identification methods were established with strong specificity, the TLC spots were clear, separating degree was perfect and negative control had not any interference. The result of cinnabar content determination by titration was repeatable and accurate.According to the analysis of HPLC,aesculetina had a good linear relationship on the range of 0~0.04 mg/mL(r^(2)=0.9991) and the average recovery was 96.8%.Conclusion These methods are simple, accurate and repeatable, and can be used as the method for the quality control of Bawei Qinpi Pill.