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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
赵振霞	ZHAO Zhen-xia	河北省药品医疗器械检验研究院河北省中药质量评价与标准研究重点实验室，河北石家庄 050227	Hebei Institute for Drug and Medical Device Control, Hebei Key Laboratory of Traditional Chinese Medicine Quality Evaluation and Standard Research, Shijiazhuang 050227, China
段琼	DUAN Qiong	河北省药品医疗器械检验研究院河北省中药质量评价与标准研究重点实验室，河北石家庄 050227	Hebei Institute for Drug and Medical Device Control, Hebei Key Laboratory of Traditional Chinese Medicine Quality Evaluation and Standard Research, Shijiazhuang 050227, China
孔亚萍	KONG Ya-ping	河北省药品医疗器械检验研究院河北省中药质量评价与标准研究重点实验室，河北石家庄 050227	Hebei Institute for Drug and Medical Device Control, Hebei Key Laboratory of Traditional Chinese Medicine Quality Evaluation and Standard Research, Shijiazhuang 050227, China
朱靖	ZHU Jing	河北省药品医疗器械检验研究院河北省中药质量评价与标准研究重点实验室，河北石家庄 050227 河北医科大学，河北石家庄 050017	Hebei Institute for Drug and Medical Device Control, Hebei Key Laboratory of Traditional Chinese Medicine Quality Evaluation and Standard Research, Shijiazhuang 050227, China Hebei Medical University, Shijiazhuang 050017, China
刘永利*	LIU Yong-li	河北省药品医疗器械检验研究院河北省中药质量评价与标准研究重点实验室，河北石家庄 050227	Hebei Institute for Drug and Medical Device Control, Hebei Key Laboratory of Traditional Chinese Medicine Quality Evaluation and Standard Research, Shijiazhuang 050227, China

基金项目:河北省市场监督管理局科研计划项目（2021YJ01）

中文摘要:目的改进《中华人民共和国药典》（以下简称《中国药典》）2020年版中制川乌含量测定方法，进一步优化固相萃取技术，建立同时测定制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、次乌头碱、乌头碱的高效液相色谱方法。方法采用强阳离子吸附树脂MCX固相萃取小柱对制川乌进行纯化，制备供试品溶液；使用COSMOSIL C₁₈色谱柱（250 mm×4.6 mm，5 μm），以甲醇、乙腈和0.1%磷酸水溶液为流动相梯度洗脱，流速为1.0 mL·min^–1，柱温为25 ℃，检测波长为232 nm。结果 6个成分分别在各自范围内线性关系良好（r=0.999 9），平均加样回收率分别为101.8%、100.2% 、100.8%、99.0%、99.7%、98.2%， RSD分别为0.9%、1.2%、0.9%、1.3%、1.5%、1.0%。结论改进了《中国药典》2020年版中制川乌含量测定的方法，解决了样品前处理复杂、使用有毒有害试剂较多的问题。建立了同时测定制川乌6个生物碱成分含量的方法，该方法准确、简便、快速、重复性好，对不同仪器和不同色谱柱的适应性好，可用于制川乌的质量控制。

中文关键词:制川乌乌头碱次乌头碱新乌头碱苯甲酰乌头原碱苯甲酰次乌头原碱苯甲酰新乌头原碱含量测定

Improvement of Determination Method of Aconiti Radix Cocta in Chinese Pharmacopoeia

Abstract:Objective To improvement the method of determination of Aconiti Radix Cocta in Chinese Pharmacopoeia (2020 edition), and further optimize the technology of solid-phase extraction, thereby establishing a new high-performance liquid chromatography (HPLC) for the simultaneous determination of benzoylmesaconine, benzoylaconine, benzoylhypaconine, mesaconitine, hypaconitine, and aconitine in Aconiti Radix Cocta.Methods The test solution was purified by solid-phase extraction using a strong cationic adsorption resin MCX column. The analysis was performed on COSMOSIL C₁₈ column (250 mm×4.6 mm, 5 μm), with methanol -acetonitrile-0.1% phosphoric acid solution as the mobile phase in gradient elution, and the flow rate was 1.0 mL·min^–1. The column temperature was 25℃ and the detection wavelength was 232 nm.Results Six constituents showed good linear relationships in their respective ranges (r=0.999 9), and the average recoveries were 101.8%, 100.2%, 100.8%, 99.0%, 99.7%, and 98.2% respectively. The relative standard deviation (RSD) were 0.9%, 1.2%, 0.9%, 1.3%, 1.5%, and 1.0%, respectively.Conclusion This experiment has improved the method for determination of Aconiti Radix Cocta in Chinese Pharmacopoeia (2020 edition) and also solved the problems such as the complex pretreatment of samples and excessive use of toxic and harmful reagents. The improved method for simultaneous determination of 6 alkaloids is established in this study, which is simple, rapid, and highly accurate. This method has good reproducibility and good adaptability to different instruments and chromatographic columns, which can be used for the quality control of Aconiti Radix Cocta.

keywords:Aconiti Radix Cocta aconitine hypaconitine mesaconitine benzoylaconine benzoylhypaconine benzoylmesaconine content determination

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