急支滴丸质量标准研究

Quality standard for Jizhi droppills

目的:建立急支滴丸质量标准。方法:采用薄层色谱法,对方中四季青、枳壳、麻黄进行定性鉴别;采用高效液相色谱法法测定枳壳中柚皮苷的含量:色谱柱为Kromasil C18(4.6 mm×200 mm,5μm),以甲醇-1%醋酸水溶液(40:60)为流动相,流速为1.0 mL.min-1,检测波长为283 nm。结果:柚皮苷在0.07～0.35μg之间具有良好的线性关系,r=0.9998,精密度试验RSD为0.3%,稳定性试验RSD为2.3%,重复性试验RSD为1.3%,平均回收率为98.9%。结论:所建标准可用于急支滴丸的质量控制。

Objective：To establish the quality criteria for Jizhi droppills.Methods：Ilex Chinensis,Fructus Aura,Ephedra in the formula were identified qualitatively by TLC and the content of naringin was determined by HPLC：Kromasil C18（4.6 mm×200 mm,5 μm）was used.The mobile phase was consisted of tonitrile-water（1% acetate）（40∶60）.The flow rate was 1.0 mL·min-1.The UV detection wavelength was at 283 nm.Results：Purslane Speedwell Herb Herba Veronicae Peregrinae,Bitter Orange Fructus Aurantii,Epigeal Srephaia Root Radix Stephaniae Epigaeae could be detected by TLC.The linear range for naringin was 0.07-0.35 μg,r=0.9998.The RSD of precision test was 0.3%.The RSD of stability test was 2.3%.The RSD of repeatability test was 1.3%.The average recovery was 98.9%.Conclusion：The establish criteria are suitable for the quality control of Jizhi droppills.