小儿泻痢片质量标准研究

Study on quality of Children's Dysentery tablet

目的:建立以高效液相色谱法同时测定小儿泻痢片中的葛根素、黄芩苷、盐酸小檗碱、和厚朴酚、厚朴酚含量的方法。方法:色谱柱Agilent C18(4.6 mm×100 mm,2.7μm);流动相为乙腈(A)-0.05 mol.L-1磷酸二氢钾溶液(B)梯度洗脱;流速:1.0 mL.min-1;检测波长285 nm、240 nm;柱温:35℃。结果:采用HPLC-DAD,以活性药理成分为指标,在一定线性范围内检测5个成分的含量,葛根素在2.5～25.5μg.mL-1,黄芩苷在2.5～24.6μg.mL-1,盐酸小檗碱在2.4～23.7μg.mL-1,和厚朴酚在0.86～8.6μg.mL-1,厚朴酚在0.86～8.6μg.mL-1质量浓度范围内,其质量浓度与峰面积之间呈良好的线性关系;r均大于0.999;实际样品中的加标回收率为93.5%～101.0%,RSD为2.3%～3.8%。结论:本法操作简便、重复性好,结果准确、经济高效,适用于小儿泻痢片的质量控制,推荐载入中国药典。

Objective：To develop a method for determining puerarin,baicalin,berberine hydrochloride,honokiol,magnolo of Children＇s Dysentery table by HPLC.Methods：Chromatographic column：Agilent C18（4.6mm×100mm,2.7μm）.The mobile phase was acetonitrile（A）-0.05mol·L-1 Potassium dihydrogen phosphate（B） in gradient mode.The flow rate was 1.0 mL·min-1.The detection wavelength was 285nm,240nm and column temperature was 35℃.Result：The method used HPLC-DAD and adopted the active pharmaceutical ingredient as the standard.It has a good linearity in the ranges of 2.5–25.5μg·mL-1 for puerarin,2.5–24.6μg·mL-1 for baicalin,2.4–23.7μg·mL-1 for berberine hydrochloride,0.86–8.6μg·mL-1 forhonokiol and0.86–8.6μg·mL-1 for magnolol.The correlation coefficients（r） were all above 0.999.The average recoveries were 93.5%–101.0%.The ranges of RSD was 2.3%–3.8%.Conclusion：This method is simple,reproducible,accurate,low cost and high efficiency testing methods for quality control of Children＇s Dysentery table.Recommending adopted by the Chinese Pharmacopoeia.