止嗽青果丸质量控制

Quality Control of Zhisou Qingguo Pills

目的:为了提高止嗽青果丸的质量标准,建立止嗽青果丸质量控制的定性与定量方法。方法:采用薄层色谱法对处方中西青果以甲苯-乙酸乙酯-甲酸(5∶4∶1)、麻黄以三氯甲烷-甲醇-浓氨水(20∶5∶0.5)为展开剂进行色谱鉴别;采用高效液相色谱法进行定量分析,以乙腈-0.1%磷酸溶液[5∶95(内含0.1%三乙胺)]为流动相,色谱柱kromasil-C18(4.6 mm×250mm,5μm),流速0.8 mL·min-1,检测波长210 nm,柱温35℃。结果:薄层色谱图谱中能清晰检出西青果、麻黄;盐酸麻黄碱进样量在0.085～0.427 2μg线性关系良好(r=0.999 8);平均回收率为95.88%,RSD 1.17%。结论:本方法专属性强,准确、简便,可作为止嗽青果丸的质量控制。

Objective： For improving the quality level of Zhisou Qingguo pill,the qualitative and quantitative method for controlling the quality of Zhisou Qingguo pills was established.Method： Thin-layer chromatography was used for identifying the Fructus Terminaliae Immaturus which was developed with toluene-ethyl acetate-formic acid（5∶ 4∶ 1）,and ephedra developed with chloroform-methanol-strong ammonia（20∶ 5∶ 0.5）;HPLC method was used for quantitative analysis with Acetonitrile-0.1% phosphoric acid solution [5∶ 95（containing 0.1% triethylamine）] as mobile phase,the flow rate was 0.8 mL·min-1 flow rate,detection wavelength was at 210 nm and column temperature was at 350 ℃.Result： Fructus Terminaliae Immaturus and ephedra were clearly detected in Thin-layer chromatography atlas;Linear relationship was set up（r =0.999 8） within 0.085-0.427 2 μg as the sample size of Ephedrine hydrochloride;The average recovery was 95.88%;RSD was 1.17%.Conclusion： The method was exclusive,accurate,and simple,and it can be used for the quality control of Zhisou Qingguo pills.