目的 建立UPLC法同时测定附子和川乌中苯甲酰新乌头原碱、苯甲酰乌头原碱、苯甲酰次乌头原碱、新乌头碱、乌头碱和次乌头碱6种生物碱含量的方法，并采用多元统计分析方法比较附子和川乌中的6种生物碱的含量差异。方法 采用0.05 mol/mL盐酸水超声提取附子和川乌中的生物碱类成分，BEH C₁₈（100 mm×2.1 mm，1.7 μm）色谱柱；乙腈-水梯度洗脱；体积流量0.1 mL/min，柱温35℃；进样体积4 μL；检测波长235 nm。采用差异显著性分析、效/毒值分析、毒性成分指数分析、相关性分析、聚类热图分析、主成分分析和TOPSIS分析进行数据处理，综合评价附子和川乌的质量。结果 方法学考察结果符合规定，附子和川乌中苯甲酰次乌头原碱、新乌头碱、次乌头碱和MDAs含量差异极显著，苯甲酰新乌头原碱和苯甲酰乌头原碱含量差异显著，乌头碱和双酯型生物碱（DDAs）含量差异不显著。以6种生物碱为评价指标，15号附子样品质量最优，7号川乌样品质量最优。结论 建立的方法操作简单、准确可靠，具有良好的精密度、稳定性、重复性，可用于附子和川乌中生物碱类化合物的定量测定；效/毒值、毒性成分指数的运用能更精确、简便地实现附子和川乌的质量控制；基于多元统计分析可更准确地进行药材质量评价。可为进一步完善《中国药典》附子和川乌中酯型生物碱的分析测定提供参考，为附子和川乌的质量控制及评价提供科学依据。

Objective To establish a UPLC method for the simultaneous determination of benzoylmesaconitine, benzoylaconitine, benzoylhypaconitine, mesaconitine, hypaconitine and aconitinein Aconiti Lateralis Radix Praeparata (ALRP) and Aconiti Radix (AR), and to compare the content difference of six alkaloids in the samples with multivariate statistical analysis. Methods Alkaloids in ALRP and AR were extracted with 0.05 mol/mL hydrochloric acid solution by ultrasonic extraction. The UPLC method was performed on a BEH C₁₈ (100 mm×2.1 mm, 1.7 μm) through a gradient elution of acetonitrile and water at a flow rate of 0.1 mL/min with column temperature at 35℃. The injection volume was set at 4.0 μL, and the detection wavelength was set at 235 nm. Difference significance analysis, activity ratio analysis, toxic constituents index analysis, correlation analysis, hierarchical cluster heatmap analysis, principal component analysis, and TOPSIS analysis were used for data processing to comprehensively evaluate the quality of ALRP and AR. Results The method was in accordance with the regulations. Compared with the content of six alkaloids in ALRP and AR, significant difference existed in mesaconitine, benzoylhypaconitine, aconitine, and monoester diterpenoid alkaloids (MDAs); Significant difference existed in benzoylmesaconitine and benzoylaconitine; There were no significant difference in hypaconitine and diester-diterpenoid alkaloids (DDAs). Taking the six alkaloids as indexes, the sample No. 15 of ALRP was the best in quality and the samples No. 7 of AR was the best in quality. Conclusion The established method is simple, accurate and reliable with good precision, repeatability and stability, which can be used for the simultaneous determination of six alkaloids in ALRP and AR. It is much more accurate and convenient to conduct the quality evaluation by using activity ratio, toxic constituents index and multivariate statistical analysis. The study could provide a reference for improving analysis and determination of ester-type alkaloids in ALRP and AR in ChP, and providing a reference for quality control and evaluation of ALRP and AR.

R286.2

国家中药标准化项目“川乌等2种中药材饮片标准化建设”（ZYBZH-Y-JX-28）