摘要
葛根芩连汤临床应用广泛,但目前缺乏系统的质量评价方法以确保葛根芩连汤在临床使用的安全性和有效性。因此本文建立了葛根芩连汤的UHPLC指纹图谱及多成分含量测定方法,为葛根芩连汤的质量控制与评价提供科学依据。采用UHPLC-DAD法检测,色谱柱为ZORBAX Eclipse Plus-C_(18)(150 mm×4.6 mm,3.5μm),流动相为乙腈(A)-20 mmol·L^(-1)乙酸铵(含0.8%乙酸及0.5%三乙胺,B),梯度洗脱,柱温25℃,流速为1.0 mL·min^(-1),检测波长为260 nm,建立10批葛根芩连汤的指纹图谱,结合中药色谱指纹图谱相似度评价系统进行全面分析,并对其中9个成分进行定量分析。在葛根芩连汤指纹图谱研究中,得到共有峰18个,通过对照品指认了其中12个峰对应的成分10批葛根芩连汤相似度良好,均大于0.99。多成分定量分析中9种成分在相应的质量浓度范围内与峰面积的线性关系良好(r≥0.999),平均加样回收率在94.4%~100.3%内,RSD在0.1%~1.4%内。本方法在同一波长下研究葛根芩连汤指纹图谱的同时能对其9个主要成分的含量进行测定,方法灵敏度高、专属性强,为全面评价葛根芩连汤的质量提供依据。
Gegen Qinlian decoction has a wide range of clinical applications.However,there is a lack of systematic quality evaluation methods to ensure the safety and effectiveness of Gegen Qinlian decoction in clinical use.The UHPLC fingerprint and multi-component determination method of Gegen Qinlian decoction were established to provide scientific basis for the quality control and evaluation of Gegen Qinlian decoction.The chromatography was performed on a ZORBAX Eclipse Plus-C_(18) column(150 mm×4.6 mm,3.5μm)with mobile phase consisted of acetonitrile(A)−20 mmol·L^(-1)ammonium acetate(containing 0.8%acetic acid and 0.5%triethylamine)(B)and gradient elution at a flow rate of 1.0 mL·min^(-1).The column temperature was 25℃,the detection wavelength was 260 nm,the fingerprint of 10 batches of Gegen Qinlian decoction was determined,and the similarity evaluation system of TCM chromatographic fingerprint was used for comprehensive analysis,and 9 components were quantitatively analyzed.In the fingerprint study of Gegen Qinlian decoction,a total of 18 peaks were obtained,12 of which were identified by reference substances.Moreover,the similarity of 10 batches of Gegen Qinlian decoction was good,and all of them were greater than 0.99.In the multi-component quantitative analysis,the linear relationship between the nine components and the peak area was good(r≥0.999)in the corresponding mass concentration range.The average recovery rate was 94.4%−100.3%,and the RSD was 0.1%−1.4%.The fingerprint of Gegen Qinlian decoction was studied under the same wavelength,and the content of 9 main components were determined by our established method.The method has high sensitivity and strong specificity,which provided a comprehensive scientific basis for the comprehensive evaluation of the quality of Gegen Qinlian decoction.
作者
谢娟
唐琪
张盼
李欣
毕开顺
李清
XIE Juan;TANG Qi;ZHANG Pan;LI Xin;BI Kai-shun;LI Qing(School of Pharmacy,Shenyang Pharmaceutical University,Shenyang 110016,China;School of Pharmacy,Southern Medical University,Guangzhou 510515,China)
出处
《药学学报》
CAS
CSCD
北大核心
2024年第8期2365-2371,共7页
Acta Pharmaceutica Sinica
基金
国家自然科学基金(81973464/H3203,8210142956/H3203,8210132176/H3410)
沈阳市中青年人才科技创新项目(RC190505)
辽宁省教育厅高校基础研究项目(LJKZ0929)
辽宁省教育厅高校基础研究项目(LJKQZ2021033)。
关键词
葛根芩连汤
指纹图谱
多成分定量
质量控制
Gegen Qinlian decoction
fingerprint
multicomponent quantification
quality control
