Chinese Journal of Pharmacovigilance ›› 2026, Vol. 23 ›› Issue (8): 880-886.
DOI: 10.19803/j.1672-8629.20250888

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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

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

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