不同厂家雷公藤多苷片的超高效液相色谱指纹图谱研究

doi:10.19803/j.1672-8629.20210474

中国药物警戒 ›› 2023, Vol. 20 ›› Issue (2): 146-151.
DOI: 10.19803/j.1672-8629.20210474

不同厂家雷公藤多苷片的超高效液相色谱指纹图谱研究

王亚丹¹, 闫建功¹, 陈明慧¹, 逄瑜^2#, 戴忠¹, 马双成^1*

¹中国食品药品检定研究院中药民族药检定所,北京 100050;
²国家药品监督管理局药品评价中心,国家药品监督管理局药物警戒研究与评价重点实验室,北京 100022

收稿日期:2021-05-08 出版日期:2023-02-15 发布日期:2023-02-17
通讯作者: ^*马双成,男,研究员,中药质量评价和控制。E-mail: masc@nifdc.org.cn;^#为共同通信作者。
作者简介:王亚丹,女,副研究员,中药质量评价和控制。
基金资助:
国家科技重大专项重大新药创制（2018ZX09735-006）

UPLC fingerprints of tripterygium glycosides tablets from different manufacturers

WANG Yadan¹, YAN Jiangong¹, CHEN Minghui¹, PANG Yu^2#, DAI Zhong¹, MA Shuangcheng^1*

¹National Institutes for Food and Drug Control, Beijing 102629, China;
²Center for Drug Reevaluation, NMPA/NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance, Beijing 100022, China

Received:2021-05-08 Online:2023-02-15 Published:2023-02-17

摘要/Abstract

摘要： 目的建立超高效液相色谱（UPLC）指纹图谱结合化学计量学方法,评价不同厂家生产的雷公藤多苷片质量。方法采用Waters Cortecs T3色谱柱（2.1 mm×100 mm,1.6μm）;乙腈-水系统为流动相,梯度洗脱;流速0.4 mL·min^-1;检测波长220 nm。采用ChemPattern软件建立指纹图谱共有模式,并进行相似度评价、主成分分析和聚类分析。同时采用超高压液相色谱-飞行时间质谱（UPLC-QTOF-MS）技术对共有峰进行鉴定。结果建立了9个厂家共25批雷公藤多苷片的UPLC指纹图谱,标识51个共有峰,鉴定了其中23个色谱峰的结构,发现多数为生物碱类成分。25批样品的相似度为0.18~0.99,存在不同厂家制剂成分差异较大、部分厂家批次间质量不稳定的问题。主成分分析和聚类分析将9个厂家制剂分为3类,并筛选出3个主要差异性成分。结论 UPLC指纹图谱能够反映不同厂家雷公藤多苷片的成分差异,结合化学计量学方法,可为雷公藤多苷片的质量评价提供参考。

关键词: 雷公藤多苷片, 超高效液相色谱指纹图谱, 相似度, 主成分分析, 聚类分析, 质量评价

Abstract: Objective To establish UPLC fingerprints of tripterygium glycoside tablets, and to evaluate the quality of preparations from different manufacturers by chemometrics. Methods Chromatographic separation was performed on the Waters Cortecs T3 column (2.1 mm × 100 mm, 1.6 μm). Acetonitrile-water was adopted as the mobile phase for gradient elution. The flow rate was 0.4 mL/min and the detection wavelength 220 nm. ChemPattern software was used for the establishment of the common pattern of fingerprints, similarity evaluation, and for principal component analysis and cluster analysis. At the same time, the common peaks were identified using the UPLC-QTOF-MS method. Results The UPLC fingerprints of 25 batches of tripterygium glycoside tablets from 9 manufacturers were established, and 51 common peaks were determined. Among them, 23 were identified, and most of them were found to be alkaloids. The similarity of the tested samples ranged from 0.18 to 0.99, suggesting that the quality of the samples from different manufacturers and even that of samples of different batches from the same manufacturer varied greatly. Principal component analysis and cluster analysis divided the nine manufacturers’ preparations into three categories and screened out three main different components. Conclusion UPLC fingerprints can reflect the variations in tripterygium glycoside tablets from various manufacturers, which can provide reference for quality evaluation of the preparations based on chemometrics.

Key words: tripterygium glycoside tablets, UPLC fingerprints, similarity, principal component analysis, cluster analysis, quality evaluation

中图分类号:

R927.1

王亚丹, 闫建功, 陈明慧, 逄瑜, 戴忠, 马双成. 不同厂家雷公藤多苷片的超高效液相色谱指纹图谱研究[J]. 中国药物警戒, 2023, 20(2): 146-151.

WANG Yadan, YAN Jiangong, CHEN Minghui, PANG Yu, DAI Zhong, MA Shuangcheng. UPLC fingerprints of tripterygium glycosides tablets from different manufacturers[J]. Chinese Journal of Pharmacovigilance, 2023, 20(2): 146-151.

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不同厂家雷公藤多苷片的超高效液相色谱指纹图谱研究

UPLC fingerprints of tripterygium glycosides tablets from different manufacturers

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