CAJ | 학술논문

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＝0．7943，P＜0．001和r原液＝0．9016，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。
목적：위료경호지진행생산질량공제，쾌속준학지측정파상풍항독소（ TAT）효개，이통계분석서상단위측정법（체외법）화소서중화시험법（체내법）측정TAT효개적상관성。방법대2010-2013년파상풍항독소생산과정중적원료혈장、원액적서상단위치여소서중화효개진행료통계분석화비교。결과체외법화체내법검측TAT원료혈장화원액효개적상관계수분별위r혈장＝0．7943，P＜0．001화r원액＝0．9016，P＜0．001，균정현저성정상관。결론체외법가지도혹체대체내법TAT효개측정응용우생산과정중간품적질량공제。
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 .