Evaluation of Allergic Reactions Caused by Indicator Components of Shuanghuanglian Injection

doi:10.19803/j.1672-8629.20250899

Abstract

Abstract: Objective To evaluate the pseudo-allergic reactions of Shuanghuanglian injection and its indicator components using an in vitro cell degranulation assay combined with molecular docking. Methods The indicator components of Shuanghuanglian injection were characterized using high-performance liquid chromatography. With the MrgprX2 receptor as the target protein and with four characteristic monomeric components—chlorogenic acid, caffeic acid, baicalin, and forsythin—as ligands, molecular docking was performed using AutoDock Vina and PyMOL software to screen for potentially anaphylactoid-inducing active ingredients. In vitro anaphylactoid testing was conducted using RBL-2H3 and P815 cells. The maximum non-toxic dose of Shuanghuanglian injection and four indicator components (chlorogenic acid, caffeic acid, baicalin, and forsythin) at 4, 2, 1, and 0.5-fold doses were used respectively, where the ingredients of the four indicator components at 1-fold dose were 0.097 mg·mL⁻¹ for chlorogenic acid, 0.032 mg·mL⁻¹ for caffeic acid, 0.25 mg·mL⁻¹ for baicalin, and 0.07 mg·mL⁻¹ for forsythin. By measuring the levels of histamine and β-hexosaminidase in the cell supernatant, the sensitization potential of the potential allergenic components of Shuanghuanglian injection was evaluated. Results The screening model established based on the MrgprX2 receptor could be used for preliminary screening of potential anaphylactoid components of the drug HPLC results showed that Shuanghuanglian injection contained four indicator components: chlorogenic acid, caffeic acid, baicalin, and forsythin. Baicalin, the main component identified from Shuanghuanglian injection screened by molecular docking, had high affinity for the MrgprX2 receptor, suggesting that chlorogenic acid, caffeic acid, baicalin, and forsythin carried potential anaphylactoid risks. Subsequent in vitro anaphylactoid activity assays using RBL-2H3 and P815 cells indicated that chlorogenic acid, caffeic acid, and baicalin were likely to increase the risk of anaphylactoid reactions. Conclusion Anaphylactoid reactions induced by Shuanghuanglian injection may result from the interactions between its indicator components.

Key words: Shuanghuanglian Injection, Traditional Chinese Medicine Injection, Allergic Reactions, MrgprX2, RBL-2H3 cell, P815 cell, Molecular Docking

CLC Number:

R978
R994.11

WU Yanlin, YU Sisi, WEN Miao, LI Huimin, YANG Zean, ZHANG Yuan, HE Qing. Evaluation of Allergic Reactions Caused by Indicator Components of Shuanghuanglian Injection[J]. Chinese Journal of Pharmacovigilance, 2026, 23(5): 539-546.

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URL: https://zgywjj.magtechjournal.com/EN/10.19803/j.1672-8629.20250899

https://zgywjj.magtechjournal.com/EN/Y2026/V23/I5/539

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