黄连降脂合剂的质量标准研究

Study on the Quality Standard of Huanglian Jiangzhi Mixture

目的建立黄连降脂合剂的质量标准。方法采用薄层色谱(TLC)法对黄连降脂合剂中黄连、三七进行定性鉴别;采用高效液相色谱(HPLC)法测定黄连降脂合剂中葛根素。色谱条件:色谱柱为C 18分析柱(250 mm×4.6 mm,5μm),流动相为甲醇-水(25:75),检测波长为250 nm,流速为1.0 mL·min^-1,柱温为30℃,进样量为10μL。结果在薄层色谱中能检出盐酸小檗碱和三七,葛根素在27.15~135.75μg·mL-1范围内线性关系良好,加样回收率为97.00%(RSD为1.62%),3批次样品平均含量为7.01 mg·mL-1。结论所建立的方法稳定可靠,可有效控制该合剂的质量。

Objective To establish the quality standard of Huanglian Jiangzhi mixture.Methods Rhizoma coptidis and Panax notoginseng in Huanglian Jiangzhi mixture were identified by thin layer chromatography(TLC)methods.The content of Puerarin was determined by high performance liquid chromatography(HPLC).Chromatographic column for the analysis was C 18 column(25 mm×4.6 mm,5μm),mobile phase was methanol-water(25:75),the detection wavelength was 250 nm,and the flow rate was 1.0 mL·min^-1 with column temperature of 30℃,the injection volume was 10μL.Results Berberine hydrochloride and Panax notoginseng could be detected by TLC.The detection of Puerarin had a good linear relationship within the range of 27.15-135.75μg·mL-1,and the recovery rate was 97.00%(RSD was 1.62%).The average content of three batches of samples was 7.01 mg·mL-1.Conclusion The established method is repeatable and reliable,and can be effectively used for the quality control of Huanglian Jiangzhi mixture.