补肾活血颗粒的制备及质量标准研究

Study on preparation and quality standard of Bushen Huoxue granule

研究补肾活血颗粒的制备工艺并建立相应的质量控制标准.通过正交试验设计优化提取工艺;采用薄层色谱法对制剂中黄连、淫羊藿定性鉴别;并用高效液相法测定黄芪甲苷的含量.最佳提取工艺为加水量12倍,提取3次,提取1 h;薄层色谱法可鉴别出黄连、淫羊藿;黄芪甲苷进样量在11. 259 5～22. 519 0μg之间峰面积对数与黄芪甲苷量对数具有良好的线性关系(R^2=0. 999),平均回收率为96. 59%.补肾活血颗粒的制备工艺可行,质控检测专属性强、精密度好、重现性高,可作为该制剂的质量控制标准.

To study the preparation process of Bushen Huoxue granule and establish qualitycontrol standard. The optimum extraction process was optimized by orthogonal experiment.The optimal identification of Huanglian and Epimedium in the prescription was detemfined bythin layer chromatography. HPLC - ELSD was used to detemfine the content of astragalosidein Astragalus membranaceus. The best water extraction process was added 12 times water,extracting for 3 times, 1 h, TLC clearly showed characteristic spots, The linear relationshipbetween astragaloside Ⅳ was 11.26 - 22.52 μg （ R2 = 0. 999） , the average recovery was96.59%. Bushen Huoxue granule preparation process was reasonable, quality control wasgood precision and high reproducibility, which can be used as a quality standard.