五参二连颗粒的质量标准

Study on Quality Standard of Wushen Erlian Granules

目的:建立五参二连颗粒的质量标准。方法:采用TCL法鉴别处方中的丹参、黄连;采用HPLC法测定陈皮中橙皮苷的含量,ZOBRAX SB C_(18)色谱柱(150 mm×4.6 mm,5μm),甲醇-0.5%冰醋酸(38:62),流速1.0 ml·min^(-1),柱温32℃,检测波长283 nm。结果:TLC法鉴别色谱特征斑点明显,橙皮苷在4.144～62.160μg·ml^(-1)范围内线性关系良好(r=0.9999),平均回收率为99.96%,RSD=0.48%(n=6)。结论:所建立的TLC和HPLC方法操作简便快捷,准确可靠,重复性好,可用于该制剂的质量控制。

Objective： To establish a quality standard for Wushen Erlian granules. Method： Radix Salviae mihiorrhizae and Rhizoma coptidis were identified by TLC method, and hesperidin was determined by HPLC. Agilent C18 column （ 150 mm×4. 6 mm ,5 μm） was used with methanols0. 5% glacial acetic acid （38： 62） as the mobile phase. The detection wavelength was at 283nm. Result： The developed TLC spots were quite clear. The calibration curve showed good linearity （r = 0. 999 9 ） within the range of 4. 144-62. 160μg · ml-1,and the average recovery was 99.96% with RSD of 0. 48%. Conclusion： The established method is simple,accurate and repeatable, and can be applied in the quality control of Wushen Erlian granules.