摘要
目的为了更好地进行生产质量控制,快速准确地测定破伤风抗毒素(TAT)效价,以统计分析絮状单位测定法(体外法)和小鼠中和试验法(体内法)测定TAT效价的相关性。方法对2010—2013年破伤风抗毒素生产过程中的原料血浆、原液的絮状单位值与小鼠中和效价进行了统计分析和比较。结果体外法和体内法检测TAT原料血浆和原液效价的相关系数分别为r血浆=0.794 3,P<0.001和r原液=0.901 6,P<0.001,均呈显著性正相关。结论体外法可指导或替代体内法TAT效价测定应用于生产过程中间品的质量控制。
Objective In order to control the quality of TAT and detect titer for tetanus antitoxin quickly and accurately . Method TAT were investigated for crude plasmas and bulks from 2010 to 2013 , and the correlation was statistic analyzed between neutralization potency （ IU/mL） in vivo and levels of antibody titer measured by flocculation （ Lf/ml） in vitro for antitoxin.Result The coefficient of correlation between flocculation titers in vitro and neutralization potency in vivo for the crude plasma and bulk is rplasma=0.794 3（P〈0.001） and rbulk=0.901 6（P〈0.001）, respectively.There are both signifi-cantly correlated between the two methods .Conclusion The method in vitro could be used as quality control of TAT to guide and/or replace of the method in vivo .
出处
《微生物学免疫学进展》
2014年第1期36-39,共4页
Progress In Microbiology and Immunology
