宣肺止嗽合剂中4种生物碱的含量测定方法研究

Determination of Four Alkaloids in Xuanfei Zhisuo Mixture

目的:建立同时测定宣肺止嗽合剂中4种生物碱含量的高效液相色谱分析方法。方法:色谱柱为安捷伦SB-C 18(250 mm×4.6 mm,5μm);流动相:乙睛-0.1%磷酸溶液(3∶97);检测波长:210 nm;流速:1.0 mL·min^(-1);柱温:30℃;进样量:10μL。结果:吗啡、磷酸可待因、蒂巴因、盐酸罂粟碱4种生物碱成分在各自的质量浓度范围内线性关系良好,相关系数r 2≥0.9960,平均回收率分别为97.8%、96.9%、97.4%、97.5%,对应的RSD分别为1.2%、1.2%、1.6%、1.4%(n=9)。10批宣肺止嗽合剂样品中吗啡的含量为0.078~0.160 mg·mL^(-1)、磷酸可待因的含量为0.008~0.025 mg·mL^(-1)、蒂巴因的含量为0.0002~0.0013 mg·mL^(-1)、盐酸罂粟碱的含量为0.010~0.025 mg·mL^(-1)。结论:该方法操作简便,结果准确,可用于宣肺止嗽合剂的质量控制,为其质量标准的提升提供参考依据。

Objective To establish a HPLC method for simultaneous determination of four alkaloids in Xuanfei Zhisuo mixture.Methods Chromatographic column:Agilent SB-C 18(250 mm×4.6 mm,5μm);mobile phase:ethylene-0.1%phosphoric acid solution(3∶97),detection wavelength:210 nm;Flow rate:1.0 mL·min^(-1);column temperature:30℃;injection volume:10μL.Results The linearity of morphine,codeine phosphate,tibaine and papaverine hydrochloride in the range of their respective mass concentrations was good with correlation coefficient r≥0.9960.The average recoveries were 97.8%,96.9%,97.4%and 97.5%,respectively.The corresponding RSD were 1.2%,1.2%,1.6%,1.4%(n=9).The contents of morphine,codeine phosphate,dibaine and papaverine hydrochloride in 10 batches of Xuanfei Zhishou mixture were 0.078-0.160 mg·mL^(-1),0.008-0.025 mg·mL^(-1),0.0002-0.0013 mg·mL^(-1)and 0.010-0.025 mg·mL^(-1).Conclusion The method is simple and accurate,which can be used for the quality control of Xuanfei Zhisuo mixture and provide reference for the improvement of its quality standard.