井冈山大学学报（自然科学版）2026，Vol.47Issue(3)：50-57,8.DOI:10.3969/j.issn.1674-8085.2026.03.007
基于辛酸-乙酸协同除杂的抗毒素血清制备工艺优化及其关键质量指标分析
Optimization of antitoxin serum preparation process based on caprylic acid-acetic acid synergistic impurity removal and analysis of its key quality indicators
摘要
Abstract
In this study,a simple operation,easily accessible,and low-cost antitoxin serum preparation method was established based on the caprylic acid-acetic acid synergistic impurity removal mechanism.Experiments were performed to prepare tetanus antitoxin serum,rabies antitoxin serum and Agkistrodon halys antivenin,respectively.Under identical experimental conditions,comparison with the traditional preparation process revealed that tetanus antitoxin serum exhibited a 19%-27%increase in F(ab')₂ content(with temperature stability improved by 3.6%-7%),a 55.8%-94.7%increase in specific activity(with temperature stability enhanced by up to 17.5%),and a 12.9%-40.0%increase in potency(with temperature stability elevated by up to 52%).Meanwhile,this method also showed superior performance in the preparation of rabies antitoxin serum and A.halys antivenin(F(ab')₂ content>85%,stability>84.7%).The results demonstrated that this method is applicable to the preparation of various antitoxin sera,yielding products with high safety,elevated F(ab')₂content,enhanced specific activity,and favorable stability.Through optimizing the critical process parameters and comprehensively analyzing the core quality indicators,the universality and reliability of the established method were validated.This study provides a theoretical basis and practical reference for further opimizing the purification technology of antitoxin serum.关键词
抗毒素血清/辛酸/F(ab')2含量/比活性/效价Key words
antitoxin serum/caprylic acid/F(ab')2 content/specific activity/potency分类
化学化工引用本文复制引用
姚晓东,苏海幼,季冲,刘根顺,钟玉玲,邓大义..基于辛酸-乙酸协同除杂的抗毒素血清制备工艺优化及其关键质量指标分析[J].井冈山大学学报（自然科学版）,2026,47(3):50-57,8.基金项目
江西省工业发展专项—2022 年产业关键共性技术攻关项目(赣工信投资字[2022]200 号) （赣工信投资字[2022]200 号）
