天然产物研究与开发 ›› 2023, Vol. 35 ›› Issue (9): 1505-1517.

• 研究论文 • 上一篇    下一篇

基于UPLC指纹图谱和多成分定量的布渣叶饮片和标准汤剂量值传递研究

李振雨1,2*,何民友1,2,刘晓霞1,2,曲丽媛1,2,周湘媛1,2,黄彩莹1,2,陈向东1,2,孙冬梅1,2   

  1. 1广东一方制药有限公司;2广东省中药配方颗粒企业重点实验室,佛山 528244
  • 出版日期:2023-09-22 发布日期:2023-09-21
  • 基金资助:
    国家工信部2022年产业技术基础公共服务平台项目-中药全产业链质量技术服务平台(2022-230-221)

Study on the quantity value transfer of Microctis Folium decoction pieces and standard decoction based on UPLC fingerprint and multi-component quantification

LI Zhen-yu1,2*,HE Min-you1,2,LIU Xiao-xia1,2, QU Li-yuan1,2,ZHOU Xiang-yuan1,2,HUANG Cai-ying1,2,CHEN Xiang-dong1,2,SUN Dong-mei1,2   

  1. 1Guangdong Yifang Pharmaceutical Co.,Ltd.;2Guangdong Provincial Key Laboratory of Traditional Chinese Medicine Formula,Foshan 528244,China
  • Online:2023-09-22 Published:2023-09-21

摘要: 研究布渣叶饮片到标准汤剂量值传递规律,为布渣叶配方颗粒及其相关制剂质量标准的制定提供参考。采用15批布渣叶饮片制备标准汤剂,测定标准汤剂出膏率、浸出物含量,建立布渣叶饮片和标准汤剂超高效液相色谱(UPLC)指纹图谱,采用Thermo Fisher QE高分辨质谱对共有峰进行指认,并采用对照品确证。以相对峰面积为变量,对布渣叶饮片和标准汤剂指纹图谱进行正交偏最小二乘法判别分析(OPLS-DA),寻找差异变量,并对布渣叶标准汤剂中3种黄酮类成分的含量和转移率进行测定。结果显示,15批布渣叶标准汤剂出膏率范围在9.32%~14.22%,浸出物范围在37.61%~62.52%,建立15批布渣叶饮片和标准汤剂指纹图谱,相似度均在0.95以上,饮片和标准汤剂指纹图谱均标识出12个保留时间相一致的共有峰,并指认出其中10个化学成分,OPLS-DA分析共找到5个相对峰面积变化较大的色谱峰,分别为峰1、2、3、4、6,为酚酸和黄酮类成分。15批标准汤剂3种黄酮类成分的含量均在均值±3倍SD范围内。其中牡荆苷的转移率最高,其次为水仙苷和异牡荆苷。该研究能够为布渣叶配方颗粒及其相关制剂质量标准的制定提供重要参考。

关键词: 布渣叶, 饮片, 标准汤剂, 量值传递

Abstract:

To provide reference for quality control of Microctis Folium formula granules and related preparations,the quantity value transfer rule from Microctis Folium decoction pieces to Microctis Folium standard decoction was studied.The standard decoction was prepared from 15 batches of Microctis Folium decoction pieces.The paste rate and extracts of 15 batches of Microctis Folium standard decoction were measured and the fingerprints of Microctis Folium decoction pieces and standard decoction were established by ultra high performance liquid chromatography (UPLC).The common peaks were identified using Thermo Fisher QE high-resolution mass spectrometry and confirmed using reference materials.Using the relative peak area as a variable,orthogonal partial least square discriminant analysis (OPLS-DA) was performed on the fingerprints of Microctis Folium decoction pieces and standard decoction to find difference variables and three flavonoids in Microctis Folium standard decoction were determined.The results showed that the paste rate of 15 batches of Microctis Folium standard decoction ranged from 9.32% to 14.22% and the extracts ranged from 37.61% to 62.52%.The fingerprints of 15 batches of Microctis Folium decoction pieces and standard decoction were established with a similarity of more than 0.95.Twelve common peaks with consistent retention times were identified in the fingerprints of the decoction pieces and standard decoction and 10 chemical components were confirmed.OPLS-DA analysis found a total of 5 chromatographic peaks with significant changes in relative peak area,namely,peaks 1,2,3,4 and 6.All of them were phenolic acids and flavonoids.The contents of three flavonoids in 15 batches of standard decoction were within the mean ± 3 times SD range.The transfer rate of vitexin was the highest,followed by narcissin and isovitexin.This study can provide an important reference for the formulation of quality standards for Microctis Folium formula granules and related preparations.

Key words: Microctis Folium, decoction pieces, standard decoction, quantity value transfer

中图分类号:  R282.4 R927.1