高效液相色谱法检测中药制剂中非法添加的肾上腺皮质激素

Determination of adrenal cortical hormone illegally added into traditional Chinese medicine preparations by HPLC

目的建立检测中药制剂中非法掺入肾上腺皮质激素的高效液相色谱法,并对11批市售药品进行检测。方法采用C8色谱柱(4.6 mm×250 mm,5μm),以乙腈-水(35∶65)为流动相,流速1.0 mL/min,检测波长:246 nm,柱温:45℃。结果市售药品中,3批样品检测出非法掺有醋酸泼尼松,其重量百分含量分别为0.274 8%、0.267 2%、0.012 1%。结论该方法操作简便,选择性强,灵敏度高,结果准确可靠,可以有效检测出中药制剂中非法添加的肾上腺皮质激素。

Objective To develop an HPLC method for determination of adrenal cortical hormone illegally added into traditional Chinese medicine preparations,and test 11 formulations.Methods C8 column（4.6 mm×250 mm,5 μm）with mobile phase of acetonitrile-water（35∶ 65）was used,the flow rate was 1.0 mL/min,detective wavelength was 246 mm,column temperature was 45 ℃.Results Prednisone acetate was found in 3 formulations,and the percentages of contents were 0.274 8%,0.267 2%,0.012 1% respectively.Conclusion The method is simple,selective,sensitive,reliable and accurate,and it can be used to detect adrenal cortical hormone illegally added into the traditional Chinese medicine preparations.