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OA

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.