止嗽青果丸质量控制

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,5 μm),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 ～0.4272 μg线性关系良好(r=0.9998)；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.

Quality Control of Zhisou Qingguo Pills

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.