参葛降脂浓缩丸质量标准研究

Study on Quality Standard of Shenge Jiangzhi Concentrated Pill

目的：建立参葛降脂浓缩丸的质量标准。方法：采用TLC法对处方中人参、三七、葛根进行了定性鉴别研究；采用HPLC法测定葛根素的含量，选用Dikma ODS C18（4.6mm×250mm，5μm）色谱柱，甲醇-水（25：75）为流动相，检测波长250nm，柱温30℃，流速1.0mL·min-1。结果：TLC法可鉴别出人参、三七、葛根的特征斑点，且专属性强，分离度好；葛根素在1.25～8.75μg范围内呈良好的线性关系（r=0.9998），平均回收率为100.05%，RSD=1.83%。结论：该方法简便可行，可用于参葛降脂浓缩丸的质量控制。

Objective:To establish the quality Standard for Shenge Jiangzhi concentrated pill. Methods:Applying TLC Ginseng Radix et Rhizoma, Notoginseng Radix et Rhizoma and Puerariae lobatae Radix was quantitative identified.To establish a determination method of puerarin by HPLC, the Dikma ODS C18 column(4. 6mm×250mm, 5μm) was used, mobile phase:methanol-water(25:75), detection wavelength:250nm, flow rate was 1. 0 ml·min-1. Results:The spots on TLC plates were clear with highly specific identifica-tion and good resolution. Puerarin showed a good linear relationship at the range of 1.25~8.75μg, with a correlative coefficient 0.9998. The average recovery was 100.05%and RSD was 1. 83%. Conclusion:The method is simple with reliable results and can be used for the quality control of the Shenge Jiangzhi concentrated pill.