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

doi:10.19803/j.1672-8629.20230514

Abstract

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

CLC Number:

R965

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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