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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 establish a method for the simultaneous determination of puerarin, baicalin, berberine hydrochloride, honokiol and magnolol in Xiaoer Xielie tablets by high performance liquid chromatography. Methods: Agilent C18 column (4.6 mm × 100 mm, 2.7 μm) was used as the mobile phase. The mobile phase consisted of a gradient of acetonitrile (A) -0.05 mol·L-1, potassium dihydrogen phosphate (B) 1; detection wavelength 285 nm, 240 nm; column temperature: 35 ℃. Results: The HPLC-DAD was used to detect the content of 5 components in a certain linear range with active pharmacological components as the standard. Puerarin at 2.5 ~ 25.5μg.mL-1, baicalin at 2.5 ~ 24.6μg.mL-1, The concentration of berberine in the range of 2.4 ~ 23.7μg.mL-1, honokiol in 0.86 ~ 8.6μg.mL-1, and magnolol 0.86 ~ 8.6μg.mL-1 mass concentration peak The linear range was linear with r> 0.999. The spiked recoveries of 93.5% ~ 101.0% and RSD of 2.3% ~ 3.8% were obtained. Conclusion: The method is simple, reproducible, accurate and cost-effective. It is suitable for the quality control of children’s diarrhea tablets. It is recommended to be included in the Chinese Pharmacopoeia.