儿童回春颗粒HPLC特征图谱研究

目的：建立儿童回春颗粒HPLC特征图谱及多指标成分含量测定方法，评价该制剂质量。方法：采用HPLC建立儿童回春颗粒特征图谱及多指标成分含量测定方法，并对6个特征峰进行指认。色谱柱：Kromasil C₁₈（250 mm×4.6 mm，5 μm）；流动相：乙腈（A）-0.05 moL·L^-1磷酸二氢钾溶液（B）系统，梯度洗脱；流速：1.0 mL·min^-1；检测波长：280 nm；柱温25 ℃。结果：建立了以黄芩苷为参照峰的HPLC特征图谱，并指认了葛根素、芍药苷、异阿魏酸、黄芩苷、牛蒡苷、盐酸小檗碱6个特征峰；分析的10批儿童回春颗粒与共有模式之间有良好的相似性，相似度在0.990以上；6个指标成分葛根素、芍药苷、异阿魏酸、黄芩苷、牛蒡苷、盐酸小檗碱的线性范围分别为2.86~57.2、0.248~4.95、0.021~0.421、2.16~43.2、2.03~40.6和0.780~15.6 μg·mL^-1；平均加样回收率在98.3%~101.6%范围内。葛根素、芍药苷、异阿魏酸、黄芩苷、牛蒡苷、盐酸小檗碱的含量分别为0.128~0.153、0.031~0.039、0.002~0.003、0.230~0.251、0.210~0.228和0.084~0.098 mg·g^-1。结论：本研究所建立的特征图谱及多指标成分含量测定方法能较好地评价儿童回春颗粒的质量，并可为提高该制剂的质量标准，保证产品质量奠定基础。

Objective: To establish the HPLC specific chromatograms and multi-component quantitative analysis of Ertong Huichun granules,so as to evaluate its quality.Methods: The specific chromatograms and quantitative analysis were performed by HPLC.Six characteristic peaks were also identified.The samples were separated on a Kromasil C₁₈ (250 mm×4.6 mm,5 μm) column;the mobile phase consisted of acetonitrile-0.05 moL·L^-1 potassium dihydrogen phosphate solution with gradient elute at the flow rate of 1.0 mL·min^-1;the wavelength was set 280 nm,and column temperature was maintained at 25 ℃.Results: The specific chromatogram of Ertong Huichun granules was established with baicalin as the reference peak.Six characteristic peaks in the specific chromatograms were identified as puerarin,paeoniflorin,isoferulic acid,baicalin,arctiin and berberine hydrochloride.There were good similarities between the standard specific chromatogram and each specific chromatogram of the ten samples with their similarity coefficients no less than 0.990.The linear ranges of puerarin,paeoniflorin,isoferulic acid,baicalin,arctiin and berberine hydrochloride were 2.86-57.2,0.248-4.95,0.021-0.421,2.16-43.2,2.03-40.6 and 0.780-15.6 μg·mL^-1 ,respectively.The average recoveries were between 98.3%-101.6%.The content of puerarin,paeoniflorin,Isoferulic acid,baicalin,Arctiin and berberine hydrochloride in different batches ranged in 0.128-0.153,0.031-0.039,0.002-0.003,0.230-0.251,0.210-0.228 and 0.084-0.098 mg·g^-1,respectively.Conclusion: The method of specific chromatograms and multi-component quantitative analysis established in this study could be applied in the quality control of Ertong Huichun granuls.This study also provides a basis for the improvement of the quality standard and insurance of the quality of preparation.