消炎止咳胶囊质量标准研究

Quality Standards of Xiaoyan Zhike Capsules

目的:提升消炎止咳胶囊的质量标准。方法:制订民族药黄荆子和胡颓子叶的薄层色谱鉴别以及特殊管理药品罂粟壳中吗啡的HPLC法含量测定。吗啡含量测定的色谱条件:以Xtimate C_(8)色谱柱(250 mm×4.6 mm,5μm)为分离柱;以乙腈-0.01 mol/L磷酸氢二钾溶液-0.005 mol/L庚烷磺酸钠溶液(18∶41∶41)为流动相;检测波长为220 nm;柱温为30℃;流速1.0 mL/min。结果:薄层色谱鉴别中,供试品色谱在与黄荆子对照药材色谱相应的位置上,紫外灯光(365 nm)下显相同颜色主斑点;在与胡颓子叶对照药材色谱相应的位置上,紫外光灯(365 nm)下显相同颜色的荧光斑点。HPLC法含量测定中,吗啡的浓度在1.1890~23.7805μg/mL(R^(2)=0.9999)范围内与峰面积线性关系良好,平均加样回收率为99.7%(RSD=1.8%)。结论:建立了消炎止咳胶囊黄荆子和胡颓子叶的薄层色谱鉴别、吗啡的含量测定方法,可有效控制该制剂的质量。

Objective To improve the quality standard of Xiaoyan Zhike capsules.Methods To establish the thin layer chromatography(TLC)identification of the leaves of the national medicine vitex negundo and folium elaeagni and the determination of morphine in the special management drug poppy shell by HPLC.The chromatographic conditions for determination of morphine content were as follows:C_(8) column of Xtimate(250 mm×4.6 mm,5μm)was used for the separation,the mobile phase was acetonitrile-0.01 mol/L dipotassium hydrogen phosphate solution-0.005 mol/L sodium heptane sulfonate solution(18∶41∶41).The detection wavelength was 220nm.The column temperature was 30℃,the flow rate was 1.0 mL/min.Results TLC identification,son of the chromatography with vitex negundo contrast medicinal chromatographic corresponding position,under ultraviolet light(365 nm)show the same color the main spots;The same color spots were observed under ultraviolet light(365 nm)at the position corresponding to the control medicinal materials.The concentration of morphine showed a good linear relationship with the peak area in the range of 1.1890-23.7805μg/mL(R^(2)=0.9999),and the average recovery was 99.6%(RSD=1.8%).Conclusion The method of TLC identification and morphine content determination of Xiaoyan Zhike capsules can effectively control the quality of this preparation.