川黄连多指标成分定量及特征图谱建立研究＊

目的 测定川黄连（味连、雅连、凤尾连）中7个生物碱（小檗碱、黄连碱、巴马汀、药根碱、表小檗碱、非洲防己碱、格陵兰黄连碱）的含量并建立3种川黄连的特征图谱,构建川黄连科学的质量控制方法,以提升川黄连药材、饮片及其中成药制剂的质量控制水平,保障临床用药安全有效。方法 建立了同时测定7个黄连生物碱成分的HPLC含量测定方法,经方法学验证该方法准确性、重现性、精密度、稳定性、线性均符合要求。测定6批味连、6批雅连、3批凤尾连的7个生物碱的含量以及总生物碱的含量;建立了黄连药材HPLC特征图谱测定方法,经方法学验证,该方法精密度、重现性、稳定性均符合要求。结果 味连的总生物碱含量最高,7个生物碱在味连、雅连、凤尾连中含量各不相同,差异较大;通过对15批黄连的特征图谱相似度的分析,找出共有特征峰15个,与黄连生物碱对照品比对后,指认了8个峰,均为黄连生物碱成分。结论 川黄连多指标成分定量结合特征图谱,可以有效控制川黄连药材的质量,为2020年版《中华人民共和国药典》黄连药材质量标准的完善与提高提供参考。

Study on Quality Control Method of Coptidis Rhizoma Based on Characteristic Chromatogram and Quantitative Analysis of Multi-components

Objective To determine the 7 alkaloids (berberine, coptisine, palmatine, jatrorrhizine, epi-berberine, adenine, and greening berberine) in Coptidis Rhizoma (Weiling, Yalian, Fengweilian), and to establish characteristics spectrum of 3 kinds of Coptidis Rhizoma, and to construct the quality control method of Coptidis Rhizoma to improve the quality control level of Coptidis Rhizoma medicine, decoction pieces and Chinese patent medicine preparations, and to ensure the safety and effectiveness of clinical medication.Methods The HPLC method for the determination of 7 alkaloids in Coptidis Rhizoma was established. The accuracy, reproducibility, precision, stability and linearity of the method were verified by the method. The content of 7 alkaloids and the content of total alkaloids in 6 batches of Weilian, 6 batches of yalian and 3 batches of Fengweilian were determined. The HPLC method analysis was established. The method proved that the precision of the method was reproducibility and stability, which in line with the requirements.Results The content of total alkaloids in Weilian was the highest. The contents of 7 alkaloids were different in Weilian, Yalian and Fengweilian. The difference was found in the analysis of the similarity of the characteristic maps of 15 batches of Coptidis Rhizoma. There were 15 characteristic peaks. After comparison with the reference substance of Coptidis Rhizoma alkaloids, 8 peaks were identified, all of which were Coptidis Rhizoma alkaloids.Conclusion The quantitative binding characteristics of Coptidis Rhizoma multi-index components can effectively control the quality of Coptidis Rhizoma medicine, and provide reference for the improvement and improvement of the quality standard of Coptidis Rhizoma medicinals in the 2020 edition of the Pharmacopoeia of the People"s Republic of China.