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目的:本研究为活血益肾颗粒提供简单准确的质量鉴定方法提供科学依据。并为进一步开发新药打下基础。方法:采用薄层色谱法进行定性鉴别;用高效液相色谱法,以川芎当中阿魏酸含量为指标,进行含量测定。结果:川芎、当归采用薄层色谱法作为定性鉴别标准;高效液相色谱法测定川芎中阿魏酸的含量并制定含量限度,规定本品含川芎以阿魏酸计,每克不得少于0.345mg。结论:质量标准重复性高、准确性高,可作为该制剂的质量控制方法。
OBJECTIVE: This study provides a scientific basis for the simple and accurate quality identification of Huoxue Yishen granule. And laid the foundation for the further development of new drugs. Methods: TLC was used for qualitative identification. The contents of ferulic acid in Chuanxiong rhizome were determined by high performance liquid chromatography (HPLC). Results: Chuanxiong, Angelica TLC as a qualitative identification standard; HPLC determination of Chuanxiong ferulic acid content and the development of content limits, the provisions of Chuanxiong containing ferulic acid, per gram of not less than 0.345 mg. Conclusion: The quality standard has high repeatability and high accuracy, which can be used as the quality control method of the preparation.