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作者中文名	作者英文名	单位中文名	单位英文名	E-Mail
王雪颖	WANG Xue-ying	河南大学药学院，河南开封 475004 河北省药品检验研究院，河北石家庄 050200	School of Pharmacy, Henan University, Kaifeng 475004, China Hebei Institute for Drug Control, Shijiazhuang 050200, China
刘臻茵	LIU Zhen-yin	河南大学药学院，河南开封 475004 河北省药品检验研究院，河北石家庄 050200	School of Pharmacy, Henan University, Kaifeng 475004, China Hebei Institute for Drug Control, Shijiazhuang 050200, China
王俊帅	WANG Jun-shuai	河南大学药学院，河南开封 475004 河北省药品检验研究院，河北石家庄 050200	School of Pharmacy, Henan University, Kaifeng 475004, China Hebei Institute for Drug Control, Shijiazhuang 050200, China
王雪仪	WANG Xue-yi	河南大学药学院，河南开封 475004 河北省药品检验研究院，河北石家庄 050200	School of Pharmacy, Henan University, Kaifeng 475004, China Hebei Institute for Drug Control, Shijiazhuang 050200, China
刘永利*	LIU Yong-li	河北省药品检验研究院，河北石家庄 050200	Hebei Institute for Drug Control, Shijiazhuang 050200, China
李挥*	LI Hui	河北省药品检验研究院，河北石家庄 050200	Hebei Institute for Drug Control, Shijiazhuang 050200, China

基金项目:河北省自然科学基金项目（H2022329003）

中文摘要:目的建立高效液相色谱法（HPLC）同时测定真武汤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、次乌头碱、乌头碱含量的方法。方法应用HPLC，使用XBridge C₁₈色谱柱（250 mm×4.6 mm，5 μm）梯度洗脱，对真武汤中生物碱成分进行含量测定，同时参照《中华人民共和国药典》2020年版对其双酯型生物碱进行限度检查。结果苯甲酰新乌头原碱、苯甲酰乌头原碱、苯甲酰次乌头原碱、新乌头碱、次乌头碱、乌头碱质量浓度分别为9.314~93.140（r=0.999 6）、10.596~105.960（r=0.999 7）、6.848~68.480（r=0.999 7）、1.515~151.540（r=0.999 7）、1.434~143.420（r=0.999 8）、1.520~152.020 μg·mL^–1（r=0.999 7）时与峰面积线性关系良好，加样回收率为98.41%~102.17%，RSD均小于3.00%。15批真武汤物质基准出粉率为10.86%~17.73%；其物质基准中单酯型生物碱（苯甲酰新乌头原碱、苯甲酰乌头原碱、苯甲酰次乌头原碱）质量分数分别为27.49~109.14、3.48~13.42、4.76~17.63 μg·g^–1，双酯型生物碱（新乌头碱、次乌头碱和乌头碱）的总质量分数为2.55~17.67 μg·g^–1。饮片中苯甲酰新乌头原碱、苯甲酰乌头原碱、苯甲酰次乌头原碱和次乌头碱到物质基准平均转移率分别为19.93%、22.34%、17.95%和26.39%。结论建立的HPLC简便、可靠、准确，可用于真武汤中单酯型生物碱和双酯型生物碱的含量测定，为真武汤相关制剂的质量控制提供参考。

中文关键词:真武汤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次乌头碱乌头碱含量测定

Determination of Alkaloid Content and Limit Check of Aconiti Lateralis Radix Praeparata in Classic Formula Zhenwu Decoction

Abstract:Objective To establish a high-performance liquid chromatography (HPLC) method for the simultaneous determination of benzoylmesaconine, benzoylaconine, benzoylhypaconitine, mesaconitine, hypaconitine, and aconitine in Zhenwu Decoction.Methods HPLC was applied using an XBridge C₁₈ column (250 mm×4.6 mm,5 μm) with gradient elution to measure the content of alkaloid components in Zhenwu Decoction. The method also referred to the 2020 edition of the pharmacopoeia of the people's republic of China for the limit check of diester alkaloids.Results The mass concentrations of benzoylmesaconine, benzoylaconitine, benzoylhypaconitine, mesaconitine, hypaconitine, and aconitine were in the ranges of 9.314-93.140 (r=0.999 6), 10.596-105.960 (r=0.999 7), 6.848-68.480 (r=0.999 7), 1.515-151.540 (r=0.999 7), 1.434-143.420 (r=0.999 8), and 1.520-152.020 μg·mL^–1 (r=0.999 7), respectively, showing a good linear relationship with peak areas. The spiked recovery rates ranged from 98.41%-102.17%, with RSDs less than 3.00%. In 15 batches of Zhenwu Decoction, the powder yield of the reference substance was 10.86%-17.73%. The mass fractions of single ester-type alkaloids, namely benzoylmesaconine, benzoylaconitine, and benzoylhypaconitine, were 27.49-109.14, 3.48-13.42, and 4.76-17.63 μg·g^–1, respectively. The total mass fractions of diester-type alkaloids (mesaconitine, hypaconitine, and aconitine) were 2.55-17.67 μg·g^–1. The average transfer rates of benzoylmesaconine, benzoylaconitine, benzoylhypaconitine, and hypaconitine from decoction pieces to the reference substance were 19.93%, 22.34%, 17.95%, and 26.39%, respectively.Conclusion The established HPLC method is simple, reliable, and accurate, and can be used for the determination of single ester-type and diester-type alkaloids in Zhenwu Decoction, which can provide a reference for quality control of related preparations of Zhenwu Decoction.

keywords:Zhenwu Decoction benzoylmesaconine benzoylaconine benzoylhypaconitine mesaconitine hypaconitine aconitine content determination

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