基于小鼠耳廓蓝染实验评价静注人免疫球蛋白（pH4.0）类过敏反应

doi:10.19803/j.1672-8629.20230514

中国药物警戒 ›› 2023, Vol. 20 ›› Issue (12): 1357-1361.
DOI: 10.19803/j.1672-8629.20230514

基于小鼠耳廓蓝染实验评价静注人免疫球蛋白（pH4.0）类过敏反应

柯兵兵, 李燕, 王平慧, 徐晓玲, 沈佳特, 吕晓君^*

湖北省药品监督检验研究院，湖北省药品质量检测与控制工程技术研究中心，国家药品监督管理局血液制品质量控制重点实验室，湖北武汉 430075

收稿日期:2023-06-28 出版日期:2023-12-15 发布日期:2023-12-15
通讯作者: ^*吕晓君,女,硕士,副主任药师,药理毒理研究。E-mail: 1012814506@qq.com
作者简介:柯兵兵,男,硕士,工程师,血液制品质量控制研究。
基金资助:
湖北省自然科学基金资助项目（2022CFB521）

Evaluation of anaphylactoid reactions induced by human immunoglobulin for intravenous injection(pH 4.0) based on mouse auricular blue staining experiments

KE Bingbing, LI Yan, WANG Pinghui, XU Xiaoling, SHEN Jiate, LYU Xiaojun^*

Hubei Institute for Drug Control, Hubei Engineering Research Center for Drug Quality Control, NMPA Key Laboratory of Quality Control of Blood Products, Wuhan Hubei 430075, China

Received:2023-06-28 Online:2023-12-15 Published:2023-12-15

摘要/Abstract

摘要： 目的采用小鼠耳廓蓝染实验评价静注人免疫球蛋白（pH4.0）的类过敏反应,考察不同多聚体含量的产品引发类过敏反应的情况。方法分别选取含有不同多聚体含量的3批产品,A（1.3%）、B（0.1%）、C（0.5%）,另通过加热制备多聚体含量升高的产品作为对照（C产品50℃水浴分别加热10 min、20 min）,以小鼠注射给药后的症状以及耳廓蓝染率、蓝染评分、伊文思蓝渗出量作为类过敏评价指标。结果不同多聚体含量的产品引发类过敏反应症状有明显差异,耳廓蓝染率、蓝染评分以及EB渗出量差异具有统计学意义。同时产品加热后,随着多聚体含量不断升高,类过敏反应症状愈发严重。结论小鼠耳廓蓝染实验可用于初步评价不同多聚体含量产品的类过敏反应,对静注人免疫球蛋白（pH4.0）的质量控制及安全评价具有指导意义。

关键词: 静注人免疫球蛋白（pH4.0）, 多聚体, 小鼠, 伊文思蓝, 耳廓蓝染, 类过敏反应, 安全评价

Abstract: Objective To evaluate the anaphylactoid reactions induced by human immunoglobulin for intravenous injection(pH4.0) via the mouse auricular blue staining experiments, and to investigate the anaphylactoid reactions induced by products with different proportions of polymers. Methods Three batches of products with different proportions of polymers, A(1.3%), B(0.1%) and C(0.5%), were selected respectively, and products with increased proportions of polymers were prepared by heating as the control (product C was heated in the water bath at 50℃ for 10 min and 20 min respectively). The symptoms of these mice after administration, the auricular blue staining rate, blue staining score, and Evans blue exudation were used as indicators for evaluation of anaphylactoid reactions. Results There were considerable differences in the symptoms of anaphylactoid reactions caused by products with different proportions of polymers, and there were statistically significant differences in the auricular blue staining rate, blue staining score, and Evans blue exudation. After the products were heated, the symptoms of anaphylactoid reactions deteriorated with the increase of proportions of polymers. Conclusion The mouse auricle blue staining experiment can be used to preliminarily evaluate the anaphylactoid reactions of products with different proportions of polymers, which can provide reference for quality control and safety evaluation of human immunoglobulin for intravenous injection(pH4.0).

Key words: human immunoglobulin for intravenous injection(pH4.0), polymer, mice, Evans blue, auricular blue staining, anaphylactoid reactions, safety evaluation

中图分类号:

R965

柯兵兵, 李燕, 王平慧, 徐晓玲, 沈佳特, 吕晓君. 基于小鼠耳廓蓝染实验评价静注人免疫球蛋白（pH4.0）类过敏反应[J]. 中国药物警戒, 2023, 20(12): 1357-1361.

KE Bingbing, LI Yan, WANG Pinghui, XU Xiaoling, SHEN Jiate, LYU Xiaojun. Evaluation of anaphylactoid reactions induced by human immunoglobulin for intravenous injection(pH 4.0) based on mouse auricular blue staining experiments[J]. Chinese Journal of Pharmacovigilance, 2023, 20(12): 1357-1361.

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基于小鼠耳廓蓝染实验评价静注人免疫球蛋白（pH4.0）类过敏反应

Evaluation of anaphylactoid reactions induced by human immunoglobulin for intravenous injection(pH 4.0) based on mouse auricular blue staining experiments

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