基于HPLC-Q-TOF/MS多成分含量和指纹图谱的加味二妙颗粒质量评价
Quality evaluation of Jiaweiermiao Granules based on HPLC-Q-TOF/MS,multi-component content and fingerprint profile
杨正清 1解雨欣 1肖莲莲 1朱喻波 1郑云枫 1黄胜良 2刘陶世 1程建明1
作者信息
- 1. 南京中医药大学 药学院,江苏 南京 210023;江苏省经典名方工程研究中心,江苏 南京 210023
- 2. 江苏融昱药业有限公司,江苏 淮安 223200
- 折叠
摘要
目的 建立加味二妙颗粒指纹图谱以及多成分含量测定方法,为其质量控制提供参考.方法 采用HPLC-Q-TOF/MS分析加味二妙颗粒中的化学成分.色谱柱为Wondasil C18 Superb(250 mm×4.6 mm,5 μm)柱,流动相为乙腈-体积分数0.1%甲酸溶液,梯度洗脱,对10 批加味二妙颗粒进行指纹图谱和4 种指标性成分含量测定.结果 HPLC-Q-TOF/MS技术共鉴定出加味二妙颗粒中144 个化合物,指纹图谱中标定了15 个共有峰,并通过对照品比对指认出(R,S)-告依春、去乙酰车叶草苷酸甲酯、盐酸黄柏碱、橙皮苷等9 个峰,加味二妙颗粒指纹图谱的相似度均>0.95;测定(R,S)-告依春、落新妇苷、橙皮苷和小檗碱 4 个指标性成分含量,质量分数分别为 0.021 1～0.056 8 mg·g-1、0.200 9～0.552 3 mg·g-1、0.274 1～0.719 1 mg·g-1、0.237 1～0.704 9 mg·g-1.结论 建立的加味二妙颗粒指纹图谱和多成分含量测定方法能够全面反映加味二妙颗粒的质量特征,亦为建立其制剂质量标准提供了依据.
Abstract
Objective This research aimed to develop a fingerprint profile and a method for determining the content of multiple components in Jiaweiermiao Granules,offering insights for quality control.Methods The chemical components of Jiaweiermiao Granules were analyzed using HPLC-Q-TOF/MS.HPLC method was employed with a Wondasil C18 Superb column(250 mm×4.6 mm,5 μm)and acetonitrile-0.1%formic acid water as the mobile phase in gradient elution.Fingerprint profiles and the content determination of four indicative components were conducted on ten batches of Jiaweiermiao Granules.Results A total of 144 compounds were identified in Jiaweiermiao Granules by HPLC-Q-TOF/MS technique.The fingerprint profiles of ten batches were standardized with 15 common peaks,including(R,S)-epigoitrin,deacetyl asperulosidic acid methyl ester,phellodendrine chloride,hesperidin and other 9 peaks identified by comparing with reference standards.The similarity of fingerprint profiles for 10 batches was all above 0.95.The content determination method was conducted for four indicative components(R,S)-epigoitrin,Berberine,Hesperidin and Astilbin.The contents were 0.021 1-0.056 8 mg·g-1,0.200 9-0.552 3 mg·g-1,0.274 1-0.719 1 mg·g-1,0.237 1-0.704 9 mg·g-1.Conclusion The established fingerprint profile and multi-component content determination method for Jiawei Ermiao Granules are accurate and stable,offering a comprehensive reflection of their quality characteristics.This provides a foundation for formulating quality standards and contributes to the quality control of Jiaweiermiao Granules in pharmaceutical applications.
关键词
加味二妙颗粒/化学成分/HPLC-Q-TOF/MS/指纹图谱/含量测定Key words
Jiaweiermiao Granules/chemical components/HPLC-Q-TOF/MS/fingerprint profile/content determination引用本文复制引用
基金项目
国家自然科学基金面上项目(81973482)
南京中医药大学校企合作资助项目(20220011)
出版年
2024
NETL
NSTL
万方数据