中国药物警戒 ›› 2026, Vol. 23 ›› Issue (5): 513-518.
DOI: 10.19803/j.1672-8629.20250873

• 基础与临床研究 • 上一篇    下一篇

基于体内外模型的中药注射液类过敏反应评价研究

姚紫莹1,2, 沈梦婷2, 马聪玉2, 胡赵良2, 赵漪2, 孟长虹2, 康安1#, 汪玉馨1,2,*   

  1. 1南京中医药大学药学院,江苏 南京 210023;
    2江苏省药品监督检验研究院药理毒理研究室,江苏 南京 210019
  • 收稿日期:2025-12-03 发布日期:2026-05-20
  • 通讯作者: *汪玉馨,女,博士,主任药师,药品质量控制与安全性评价。E-mail：wyx_carrie@163.com #为共同通信作者。
  • 作者简介:姚紫莹,女,在读硕士,药品质量控制。
  • 基金资助:
    国家自然科学基金资助项目（82374135）; 江苏省科技计划项目（BK20251150）; 江苏省药品监管科学科研计划项目（202547）

Evaluation of Anaphylactoid Reactions Induced by Traditional Chinese Medicine Injections Based on in vitro and in vivo Models

YAO Ziying1,2, SHEN Mengting2, MA Congyu2, HU Zhaoliang2, ZHAO Yi2, MENG Changhong2, KANG An1#, WANG Yuxin1,2,*   

  1. 1School of Pharmacy, Nanjing University of Traditional Chinese Medicine, Nanjing Jiangsu 210023, China;
    2Pharmacology and Toxicology Laboratory, Jiangsu Institute for Drug Control, Nanjing Jiangsu 210019, China
  • Received:2025-12-03 Published:2026-05-20

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摘要： 目的 建立中药注射液的类过敏反应体内外筛查模型,评估多种临床常用中药注射液的潜在类过敏风险。方法 基于大鼠嗜碱性粒细胞性白血病细胞（RBL-2H3细胞）脱颗粒模型,以β-氨基己糖苷酶释放率为评价指标,设置0.05、0.01 mL·mL-1 2个剂量组,对薄芝糖肽、蟾酥、丹参、生脉及醒脑静5种中药注射液进行体外类过敏筛查;同步建立小鼠耳廓蓝染模型,以耳廓蓝染发生率及伊文思蓝（Evans Blue, EB）升高率为指标,依据临床最大给药剂量设置薄芝糖肽（3.2 mL·kg-1）、蟾酥（16 mL·kg-1）、丹参（16 mL·kg-1）、生脉（25 mL·kg-1）及醒脑静（16 mL·kg-1）的给药剂量,评价上述注射液在体内诱发类过敏反应的可能性。结果 体外实验结果显示,丹参注射液和生脉注射液在0.05、0.01 mL·mL-1的给药剂量下均可诱导β-氨基己糖苷酶释放,与阴性对照组相比差异均具有统计学意义（P<0.01）。体内小鼠耳廓蓝染试验结果显示,在25 mL·kg-1的给药剂量下,生脉注射液组EB升高率与阴性组相比差异具有统计学意义（P<0.05）。结论 RBL-2H3细胞模型与小鼠耳廓蓝染模型在中药注射液类过敏风险筛查中具有良好的相关性与互补性,联合应用可为中药注射液上市后安全性研究和评价及临床合理用药提供参考。

关键词: 中药注射液, 类过敏反应, 嗜碱性粒细胞性白血病细胞（RBL-2H3细胞）, 耳廓蓝染试验, 小鼠

Abstract: Objective To establish in vivo and in vitro screening models for anaphylactoid reactions to evaluate the potential risk of anaphylactoid reactions to commonly used traditional Chinese medicine injections. Methods Based on the RBL-2H3 cell degranulation model and using the β-hexosaminidase (β-Hex) release rate as the index for evaluation, two dose groups (0.05 and 0.01 mL·mL-1) were established to screen for the in vitro anaphylactoid reaction risk of five traditional Chinese medicine injections, including Bozhi glycopeptide, Toad venom, Danshen, Shengmai and Xingnaojing. An experimental model of ear blue staining in mice was also established, where the rate of blue staining and that of increase of Evans Blue (EB) were used as indicators. Bozhi glycopeptide (3.2 mL·kg-1), Toad venom (16 mL·kg-1), Danshen (16 mL·kg-1), Shengmai (25 mL·kg-1) and Xingnaojing (16 mL·kg-1) were given at the maximum clinical dose before the possibility that the above injections could induce anaphylactoid reactions in vivo was evaluated. Results In vitro experiments showed that Danshen injection and Shengmai injection could induce the release of β-Hex at doses of 0.05 and 0.01 mL·mL-1, so the difference was statistically significant compared with the negative control group (P<0.01). The results of in vivo mouse ear blue staining tests suggested that EB increased more significantly at the dose of 25 mL·kg-1 in the Shengmai injection group than in the negative control group. Conclusion The RBL-2H3 cell model and the mouse ear blue staining model have proved to be well correlated and complementarity in the risk screening of anaphylactoid reactions to traditional Chinese medicine injections. The combination of the two models can provide a reference for research on post-marketing safety and for rational use of traditional Chinese medicine injections.

Key words: Traditional Chinese Medicine Injection, Anap-hylactoid Reaction, RBL-2H3 Cell, Ear Blue Staining Test, Mice

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