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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 the quality standard of Wuxian Erlian granules. Methods: Salvia miltiorrhiza and coptis chinensis were identified by TCL method. The content of hesperidin was determined by HPLC on ZOBRAX SB C 18 column (150 mm × 4.6 mm, 5 μm), methanol - 0.5% glacial acetic acid 38:62). The flow rate was 1.0 ml · min ~ (-1) and the column temperature was 32 ℃. The detection wavelength was 283 nm. Results: The chromatographic features of TLC were obvious. Hesperidin showed good linearity (r = 0.9999) in the range of 4.144 ~ 62.160μg · ml ~ (-1) with an average recovery of 99.96% and RSD = 0.48% 6). Conclusion: The established TLC and HPLC methods are simple, rapid, accurate, reliable and repeatable and can be used for the quality control of this preparation.