健脑合剂的质量控制方法研究

目的 建立健脑合剂中君药首乌藤的鉴别及大黄素含量测定方法. 方法 采用薄层色谱(TLC)法对合剂中首乌藤进行定性鉴别;采用高效液相色谱(HPLC)法进行含量测定. 结果薄层色谱能明显检出首乌藤的特征有效成分大黄素;HPLC法中,大黄素在0.053 7～215.000 0 μg.mL^-1范围内呈良好线性关系(R2≥0.999 7);日内、日间精密度良好,RSD≤1.53%(n＝6);各组分低、中、高浓度的平均加样回收率均在98.83%～99.53%之间,RSD≤1.33%(n＝6). 结论 该方法简便、快速、灵敏、准确、重复性好,可以作为健脑合剂的质量控制方法.

Study on the Quality Control of Jiannao Mixture

Objective To establish a method for identification of Caulis Polygoni Multiflori in Jiannao mixture and determination of emodin.Methods Emodin,as an effective constituent of Caulis Polygoni Multiflori in preparation,was identified by thin-layer chromatography(TLC),and the content was determined by high performance liquid chromatography(HPLC).Results The characteristics of the active ingredient of Caulis Polygoni Multiflori could be identified by TLC.The linear range of emodin was within 0.053 7-215.000 0 μg·mL-1(R2≥0.999 7).The RSD of intra-day and inter-day precisions were not more than 1.53%(n=6).The average recovery rates of the investigated compound at low,medium and high concentration levels were in the range of 98.83%-99.53% for all with RSD no more than 1.33%(n=6).Conclusion The developed method is simple,rapid,sensitive and accurate with good repeatability.It can be used for quality control of Jiannao mixture.