小儿泻痢片质量标准研究

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,2.7 μm);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2.5~25.5 μg·mL^-1 , 黄芩苷在2.5~24.6 μg·mL^-1 ,盐酸小檗碱在2.4~23.7 μg·mL^-1,和厚朴酚在0.86~8.6 μg·mL^-1,厚朴酚在0.86~8.6 μg·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℃. Results: 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.