中国药物警戒 ›› 2026, Vol. 23 ›› Issue (8): 880-886.
DOI: 10.19803/j.1672-8629.20250888

• 基础与临床研究 • 上一篇    下一篇

基于抗氧化作用的止咳枇杷颗粒生物活性质量控制方法建立

瞿水清1, 陈思妮2,Δ, 李瑞芸2, 曹春然1, 李铮2, 蔡彤3, 李文东1,*   

  1. 1北京市药品检验研究院,北京市疫苗检验中心药理毒理室,北京 102206;
    2北京市药品检验研究院,北京市疫苗检验中心中药室,北京 102206;
    3中国食品药品检定研究院化学药品检定所,北京 102629
  • 收稿日期:2025-12-10 出版日期:2026-08-15 发布日期:2026-08-17
  • 通讯作者: *李文东,男,博士,主任药师,药品标准与生物制品质量控制。E-mail: sxlwd76@163.com
  • 作者简介:瞿水清,女,博士,中药复方机制解析与质量控制。△为并列第一作者。
  • 基金资助:
    国家重点研发计划（2019YFC1200700）

A bioactivity assay method for quality control of Zhike Pipa granules based on antioxidant effects

Qu Shuiqing1, Chen Sini2,Δ, Li Ruiyun2, Cao Chunran1, Li Zheng2, Cai Tong3, Li Wendong1,*   

  1. 1Pharmacology and Toxicology Laboratory, Beijing Institute for Drug Control, Beijing Vaccine Inspection Center, Beijing 102206, China;
    2Department of Traditional Chinese Medicine, Beijing Institute for Drug Control, Beijing Vaccine Inspection Center, Beijing 102206, China;
    3Institute for Chemical Drug Control, National Institutes for Food and Drug Control, Beijing 102629, China
  • Received:2025-12-10 Online:2026-08-15 Published:2026-08-17

PDF (PC)

37

摘要： 目的 从止咳枇杷颗粒（Zhike Pipa Granules, ZPG）临床疗效出发,根据抗氧化应激可能是ZPG治疗支气管炎的主要机制之一,建立基于生物活性的ZPG质量控制新方法。方法 考察ZPG对超氧阴离子、羟自由基、DPPH自由基的清除和总抗氧化能力这4个生物活性指标的作用强度,选择线性关系和灵敏度最佳的指标进行方法学考察,以该法测定不同厂家来源的ZPG样品的生物活性,并通过皮尔逊相关性分析、灰色关联分析（GRA）和正交偏最小二乘法（OPLS）建立化学成分与抗氧化作用的谱效关系,筛选ZPG抗氧化的药效物质。结果 与另外3种指标相比,ZPG的DPPH自由基清除能力与其浓度之间线性关系良好,灵敏度高,且符合方法学对重复性和稳定性的要求。以该指标评价18个厂家来源的ZPG质量,发现不同厂家来源的ZPG在DPPH自由基清除能力上存在显著差异。谱效关系分析结果显示绿原酸、新绿原酸、隐绿原酸、金丝桃苷和异槲皮素在至少2种分析方法中表现出与DPPH自由基清除率的显著相关性,可作为ZPG体外抗氧化活性的主要贡献成分。结论 建立了以DPPH自由基清除能力为指标的ZPG生物活性质量控制方法。该方法线性关系良好、灵敏度高、重复性与稳定性符合要求。谱效关系结果显示绿原酸、新绿原酸、隐绿原酸、金丝桃苷和异槲皮素是ZPG抗氧化的关键活性成分,为基于临床疗效的ZPG质量控制提供一定的生物活性评价参考。

关键词: 止咳枇杷颗粒, 谱效关系, 抗氧化活性, 生物活性, 质量控制

Abstract: Objective To establish a novel bioactivity-based quality control method for Zhike Pipa granules based on clinical efficacy and the potential role of antioxidant stress activity. Methods The antioxidant activity of Zhike Pipa granules was evaluated using four bioactivity indicators: superoxide anion scavenging capacity, hydroxyl radical scavenging capacity, DPPH radical scavenging capacity, and total antioxidant capacity. The indicator with the optimal linearity and sensitivity was selected for methodological validation before the selected method was used to evaluate the bioactivity of samples of Zhike Pipa granules from different manufacturers to compare their quality. The spectrum-effect relationship between chemical components and antioxidant activity was established via Pearson correlation analysis, gray relational analysis (GRA), and orthogonal partial least squares analysis (OPLS), and the potent pharmaceutical ingredients responsible for ZPG’s antioxidant effect were screened. Results Compared with the other three indicators, the DPPH radical scavenging capacity of Zhike Pipa granules showed excellent linearity within the range of concentrations, were highly sensitive, and met methodological requirements for repeatability and stability. Using this indicator, the quality of Zhike Pipa granules from 18 manufacturers was evaluated. The DPPH scavenging capacity was found to vary widely. Spectrum-effect relationship analysis showed that chlorogenic acid, neo-chlorogenic acid, cryptochlorogenic acid, hyperoside, and isoquercitrin were significantly correlated with the DPPH free radical scavenging rate in at least two methods, which were regarded as the leading contributors to the antioxidant activity of ZPG. Conclusion This study has established a bioactivity-based quality control method for Zhike Pipa granules using the DPPH radical scavenging capacity as a key parameter. This method can lead to favorable linearity, a high sensitivity, and satisfactory repeatability and stability. Results of bioactivity screening indicate that chlorogenic acid, neo-chlorogenic acid, cryptochlorogenic acid, hyperoside, and isoquercitrin are the key active ingredients responsible for ZPG’s antioxidant effect. This study is expected to provide some reference for quality control of ZPG based on clinical efficacy.

Key words: Zhike Pipa Granules, Spectrum-Effect Relationship, Antioxidant Activity, Biological Activity, Quality Control

中图分类号: