中国药物警戒 ›› 2026, Vol. 23 ›› Issue (4): 361-367.
DOI: 10.19803/j.1672-8629.20250848

• 专家论坛 • 上一篇    下一篇

中药注射液类过敏反应检测标准操作规程研究

柳辰玥1,2, 马琳1,2,3, 李春英1, 李芳2, 韩佳寅1, 王连嵋1, 李旭2, 易艳1, 赵雍1, 田婧卓1, 张宇实1, 崔爽1, 孟晶1, 肖伟2#, 梁爱华1,*   

  1. 1中国中医科学院中药研究所,中药安全用药风险评控与转化重点实验室,道地药材品质保障与资源持续利用全国重点实验室,北京 100070;
    2中药制药过程控制与智能制造技术全国重点实验室江苏康缘药业股份有限公司,江苏 连云港 222047;
    3黑龙江中医药大学附属第一医院,黑龙江 哈尔滨 150040
  • 收稿日期:2025-11-26 出版日期:2026-04-15 发布日期:2026-04-15
  • 通讯作者: *梁爱华,女,博士,研究员·博导,中药安全性评价与中药毒理学; 中国中医科学院首席研究员,岐黄学者,博士生导师; 兼任国家中医药管理局高水平重点学科带头人,中华中医药学会中药毒理学与安全性研究分会主任委员,中国中药协会中药注射剂研究发展专业委员会副主任委员,日本东京药科大学客座教授; 主要从事中药药效/毒性及其机制研究、中药安全性评价、中药新药研发; 曾主持国家重大科技专项、国家自然科学基金重大（重点）项目、国家科技支撑计划、国际科技合作计划等国家级项目30余项; 在国内外发表论文260余篇; 获发明专利15项; 作为第一完成人获北京市科技进步一等奖2项、中华中医药学会科学技术奖一等奖2项、省部级二等奖2项; 作为主要完成人获国家科技进步一等奖; E-mail: ahliang@icmm.ac.cn。 #为共同通信作者。
  • 作者简介:柳辰玥,女,博士,助理研究员,中药安全性评价与中医药治疗情志疾病。
  • 基金资助:
    道地药材品质保障与资源持续利用全国重点实验室（ZG2024001-03、CI2024E003KC-11）; 中国中医科学院科技创新工程项目（CI2023C006YG）; 国家自然科学基金资助项目（82192913）; 中央级公益性科研院所基本科研业务费专项资金（ZXKT25036、ZZ15-YQ-040）; 江苏省人才攻关联合体; 2025连云港花果山英才双创计划-博士后专项（LYGBSH2025009）; 国家重点研发计划（2023YFC3503403）

Standard Operating Procedures for Detecting Pseudo-Allergic Reactions to Traditional Chinese Medicine Injections

LIU Chenyue1,2, MA Lin1,2,3, LI Chunying1, LI Fang2, HAN Jiayin1, WANG Lianmei1, LI Xu2, YI Yan1, ZHAO Yong1, TIAN Jingzhuo1, ZHANG Yushi1, CUI Shuang1, MENG Jing1, XIAO Wei2#, LIANG Aihua1,*   

  1. 1Key Laboratory of TCM Safety Risk Assessment and Translation, Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100070, China;
    2State Key Laboratory of Pharmaceutics & Intelligent Manufacturing Technology for Traditional Chinese Medicine, Jiangsu Kanion Pharmaceutical Co., Ltd., Lianyungang Jiangsu 222047, China;
    3The First Affiliated Hospital of Heilongjiang University of Chinese Medicine, Harbin Heilongjiang 150040, China
  • Received:2025-11-26 Online:2026-04-15 Published:2026-04-15

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摘要： 目的 探索中药注射液（TCMI）类过敏反应检测的标准操作规程（SOP）,为TCMI类过敏反应检测提供参考。方法 以TCMI A为例,参考《静脉用TCMI类过敏反应检测技术规范》《9105中药生物活性测定指导原则》,设置A低剂量（4 mL·kg-1）、A中剂量（10 mL·kg-1）、A高剂量（20 mL·kg-1）3个剂量,以生理盐水或5%葡萄糖溶液为阴性对照和溶媒,组胺为阳性对照,通过考察实验动物的性别、周龄,用药方式（溶媒、剂量、注射速度）,实验室温度、生产批次等因素对类过敏反应的影响,以每组小鼠耳廓蓝染评分的动物只数判断反应程度。结果 在23~26℃的实验室温度下,以雄性幼年和成年ICR小鼠为对象,供试品与伊文思蓝（终浓度为0.4%）混合后现配现用,以0.2 mL·10 s-1速度进行尾静脉注射,并以生理盐水或5%葡萄糖溶液作为溶媒和阴性对照品,可作为TCMI A的类过敏反应检测条件。结论 形成TCMI类过敏反应检测标准,实现对类过敏反应的快速检测,及时识别并控制风险,提升其临床安全性。

关键词: 中药注射剂, 类过敏反应, 方法学研究, 标准操作规程, 小鼠

Abstract: Objective To establish a standard operating procedure (SOP) for the detection of TCMI allergic-like reactions in order to provide a reference for related testing. Methods By taking TCMI A, the effects of such factors as the gender and age of experimental animals, administration methods (vehicle, dosage, injection speed), laboratory temperatures, and batches of production on allergic-like reactions were investigated. The number of animals with scores of blue staining of ear auricles in each group was used to assess the severity of reactions. The Technical Specifications for Testing Anaphy-lactoid Reactions of Intravenous Traditional Chinese Medicine Injections and the Guidelines 9105: Principles for Bioactivity Testing of Traditional Chinese Medicine were referenced. Results At a laboratory temperature of 23-26°C and by using male juvenile and adult ICR mice as subjects, the test article was prepared immediately before use by mixing with Evans blue, and administered via tail vein injection at a rate of 0.2 mL per 10 seconds. Physiological saline or a 5% glucose solution served as both the vehicle and the negative control. This procedure could be adopted as a standard operating procedure (SOP) for testing TCMI A for allergic-like reactions. Conclusion An internal control standard for testing TCMI allergic-like reactions enables rapid detection of the reactions, which can contribute to quick identification, risk control and clinical safety.

Key words: Traditional Chinese Medicine Injection, Pseudo-Allergic Reaction, Methodological Study, Standard Operating Procedure(SOP), Mice

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