复方血三七颗粒的质量标准研究

Quality standards for compound Xuesanqi granules

目的:建立复方血三七颗粒的质量控制方法。方法:采用薄层色谱法对复方血三七颗粒中当归、大血藤、葛根进行定性鉴别;按照《中国药典》2010年版附录规范对复方血三七颗粒的水分、溶化性进行检查;HPLC法测定复方血三七颗粒中槲皮素,比色法测定总黄酮。结果:薄层色谱法鉴别出当归、大血藤、葛根,斑点清晰,专属性好;颗粒的水分平均值为8.24%,RSD值为1.75%,溶化性良好;槲皮素在20~80μg/ml与峰面积呈良好的线性关系,r=0.9999,平均加样回收率为99.17%,RSD值为1.98%;总黄酮在0.01~0.1 mg/ml呈良好的线性关系,r=0.9996。结论:本方法可有效地控制复方血三七颗粒的质量。

Objective:To establish a quality control method for compound Xuesanqi granules.Methods:Thin-layer chromatography(TLC)was used for qualitative identification of Angelica sinensis,Sargentodoxa cuneata,and Radix Puerariae in compound Xuesanqi granules.The standard in the appendix of Chinese Pharmacopoeia(version 2010)was used to examine the water content and dissolubility of compound Xuesanqi granules.High-performance liquid chromatography was used to measure quercetin in compound Xuesanqi granules,and colorimetry was used to measure total flavonoids.Results:Angelica sinensis,Sargentodoxa cuneata,and Radix Puerariae were identified by TLC,with clear spots and good specificity.The mean water content of granules was 8.24%(relative standard deviation[RSD]=1.75%),and the granules had good dissolubility.Quercetin showed a good linear relationship with peak area within the range of 20~80μg/ml(r=0.9999),with an average recovery rate of 99.17%(RSD=1.98%).Total flavonoids showed a good linear relationship within the range of 0.01~0.1 mg/ml(r=0.9996).Conclusion:This method can effectively control the quality of compound Xuesanqi granules.