强脊炎丸质量标准研究

Study on Quality Criteria of Qiangjiyan Pill

目的:建立强脊炎丸的质量标准。方法:采用薄层色谱法对强脊炎丸中的淫羊藿、何首乌、党参、当归、川芎、白芍等六味主要中药进行了鉴别,以高效液相色谱法对其主药淫羊藿中的淫羊藿苷进行含量测定。结果:定性鉴别分离度好,专属性强;淫羊藿苷的含量测定线性范围为0.0944～0.9440μg(r=0.9998),平均回收率为100.28%,RSD=1.92%。结论:所建立之方法可靠、准确、专属性强,可有效控制强脊炎丸的质量。

Objective:To establish the quality criteria for Qiangjiyan Pill.Methods:Thin - layer chromatography(TLC) was employed to make qualitative determination of herba Epimedii,Polygoni multfloria,Codonopsis,Angelicae sinensis,Chuanxiong and Paeoniae alba.While high performance liquid chromatography(HPLC) was applied for the determination of Icarline in Epimedii in Qiangjiyan Pill.Results:The characteristic identification by TLC was distict and highly specific.The quantitative evaluation of Icarline had the linear range of 0.0944～0.9440μg(r = 0.9998 ),The average recovery was 100.28%,RSD was1.92%.Conclusion:The method is reliable,accuate and specific,It can be used for quality control of Qiangjiyan Pill.