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目的:建立复方扶芳藤制剂正丁醇部位HPLC-ELSD指纹图谱的检测方法,为该制剂的皂苷类成分指纹图谱质量控制提供新的方法。方法:采用Shim-Pack CLC-ODS色谱柱(6.0 mm×150 mm,5μm),流动相乙腈-水体系,梯度洗脱,流速1mL.min-1,PL-ELS2100型蒸发光散射检测器。选择10批合格样品的HPLC指纹图谱,进行峰位校正,使谱峰匹配,建立复方扶芳藤制剂正丁醇部位对照用HPLC-ELSD指纹图谱共有模式。结果:共标识了19个特征峰,这些特征峰与组方相关中药饮片具有较好的归属性,可以较好地反映制剂中主要皂苷类成分的情况。结论:该指纹图谱可用于复方扶芳藤制剂中皂苷类成分的质量控制。
OBJECTIVE: To establish a HPLC-ELSD method for the determination of n-butanol in Fufang Fufang preparations and to provide a new method for the quality control of the fingerprint of saponins in this preparation. Methods: A Shim-Pack CLC-ODS column (6.0 mm × 150 mm, 5 μm) was used. The mobile phase consisted of acetonitrile-water with gradient elution at a flow rate of 1 mL.min-1 and PL-ELS2100 evaporative light scattering detector. The HPLC fingerprints of 10 batches of eligible samples were selected for peak position correction and peak matching to establish the common mode of HPLC-ELSD fingerprinting for the control of n-butanol fraction of Euphorbia Fisheriacide. Results: A total of 19 characteristic peaks were identified. These characteristic peaks were related to the prescriptions of traditional Chinese medicine (Herbal Pieces), which could well reflect the main components of saponins in the preparation. Conclusion: The fingerprint can be used for the quality control of saponins in Fufang Fufang preparations.