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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 C_(18)(250 mm×4.6 mm,5μm);流动相:乙腈(A)-0.05 mo L·L~(-1)磷酸二氢钾溶液(B)系统,梯度洗脱;流速:1.0 m L·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0.780~15.6μg·m L~(-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 a HPLC chromatogram of children’s rejuvenation granules and determination of multi-index components, and evaluate the quality of the preparation. Methods: A HPLC method was developed for the determination of the characteristics of children’s rejuvenation granules and the determination of multi-index components. Six characteristic peaks were identified. Column: Kromasil C18 (250 mm × 4.6 mm, 5 μm); mobile phase: acetonitrile (A) -0.05 mol L · L -1 potassium dihydrogen phosphate solution (B) Flow rate: 1.0 m L · min -1; detection wavelength: 280 nm; column temperature 25 ℃. Results: The HPLC fingerprint of baicalin was established, and six characteristic peaks of puerarin, paeoniflorin, isoferulic acid, baicalin, arctiin and berberine were identified. The analysis of 10 batches of children’s rejuvenation There was a good similarity between the particles and the common pattern with the similarity above 0.990. The linear ranges of puerarin, paeoniflorin, isoferulic acid, baicalin, arctiin and berberine were 686 ~ 57.2,0.248 ~ 4.95,0.021 ~ 0.421,2.16 ~ 43.2,2.03 ~ 40.6 and 0.780 ~ 15.6μg · m L ~ (-1). The average recoveries ranged from 98.3% to 101.6%. The contents of puerarin, paeoniflorin, isoferulic acid, baicalin, arctiin and berberine were 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). Conclusion: The characteristics map and multi-index content determination method established in this study can evaluate the quality of children’s rejuvenation granules better and lay a foundation for improving the quality standard of the preparation and ensuring the product quality.