【摘要】 目的建立复方鼻炎膏的质量标准。方法对穿心莲内酯、盐酸麻黄碱进行薄层色谱鉴别;采用三氯甲烷溶解后酸性溶液萃取的方法除去了软膏基质,采用以下色谱条件对盐酸麻黄碱进行含量测定:色谱柱为Waters Nova-pakC18(150mm×3.9mm,4μm),流动相为乙腈-0.1%磷酸溶液(4∶96),进样量为10μl,流速为1.0ml.min-1,柱温为30℃,检测波长为207nm。理论板数按盐酸麻黄碱峰计算应不低于2000。结果薄层鉴别的专属性较好,阴性无干扰;盐酸麻黄碱测定方法的线性范围为0.07376～0.36880μg,r=0.9999,平均回收率为98.31%,RSD=1.16%(n=5)。结论本法简便、准确、灵敏度高、重现性好,可用于该制剂的质量控制。更多还原

【Abstract】 OBJECTIVE To establish a method for quality control of Fufangbiyan Ointment.METHODS Andrographolide and Ephedrine hydrochloride were identified by TLC;the ointment matrix could be excepted after the sample chloroform solution extracted by the acid solution.The contents of Ephedrine hydrochloride was determined by RP-HPLC.Chromatographic column:Waters Nova-pak C18(150mm×3.9mm,4μm),mobile phase :acetonitrile-0.1% phosphoric acid solution (4∶96),injection volume:10μl,flow rate:1.0ml·min-1,column temperature:30℃,detection wavelength:207nm.The number of theory plates was not less than 2000 determined by the peaks of Ephedrine hydrochloride.RESULTS The specificity of TLC was good,and had no interference by the negative reference substance;the calibration curve of Puerarin was linear in the concentration range of 0.07376～0.36880μg,r=0.9999.The average recovery and RSD of Ephedrine hydrochloride was 98.31%and 1.16%(n=5),respectively.CONCLUSION The method was convenient,accurate,sensitive,reproducible and suitable for the quality control of Fufangbiyan Ointment.更多还原