国际生物制品学杂志
國際生物製品學雜誌
국제생물제품학잡지
INTERNATIONAL JOURNAL OF BIOLOGICALS
2014年
4期
161-163
,共3页
王公孝%王学林%许蓉华%熊慧玲
王公孝%王學林%許蓉華%熊慧玲
왕공효%왕학림%허용화%웅혜령
奈瑟球菌,脑膜炎,血清C群%多糖类,细菌%疫苗,结合%化学沉淀
奈瑟毬菌,腦膜炎,血清C群%多糖類,細菌%疫苗,結閤%化學沉澱
내슬구균,뇌막염,혈청C군%다당류,세균%역묘,결합%화학침정
Neisseria meningitidis,serogroup C%Polysaccharides,bacterial%Vaccines,conjugate%Chemical precipitation
目的 建立检测C群脑膜炎球菌多糖-破伤风类毒素结合疫苗(group C meningococcal polysaccharide-tetanus toxoid conjugate vaccine,CPS-TT)中游离多糖的脱氧胆酸钠沉淀法.方法 在不同pH条件下用脱氧胆酸钠(sodium deoxycholate,DOC)对CPS和TT进行沉淀,确定可有效分离游离多糖和结合多糖的最适沉淀条件,并对该法进行验证.结果 DOC沉淀法的最适pH为3.5,在此pH条件下用DOC沉淀法检测3批CPS-TT显示,上清TT含量平均为2.3％.DOC沉淀法具有较好的准确度和精密度,3批CPS-TT的批内变异系数均小于5％.结论 DOC沉淀法可用于C群脑膜炎球菌结合疫苗的质量控制.
目的 建立檢測C群腦膜炎毬菌多糖-破傷風類毒素結閤疫苗(group C meningococcal polysaccharide-tetanus toxoid conjugate vaccine,CPS-TT)中遊離多糖的脫氧膽痠鈉沉澱法.方法 在不同pH條件下用脫氧膽痠鈉(sodium deoxycholate,DOC)對CPS和TT進行沉澱,確定可有效分離遊離多糖和結閤多糖的最適沉澱條件,併對該法進行驗證.結果 DOC沉澱法的最適pH為3.5,在此pH條件下用DOC沉澱法檢測3批CPS-TT顯示,上清TT含量平均為2.3％.DOC沉澱法具有較好的準確度和精密度,3批CPS-TT的批內變異繫數均小于5％.結論 DOC沉澱法可用于C群腦膜炎毬菌結閤疫苗的質量控製.
목적 건립검측C군뇌막염구균다당-파상풍류독소결합역묘(group C meningococcal polysaccharide-tetanus toxoid conjugate vaccine,CPS-TT)중유리다당적탈양담산납침정법.방법 재불동pH조건하용탈양담산납(sodium deoxycholate,DOC)대CPS화TT진행침정,학정가유효분리유리다당화결합다당적최괄침정조건,병대해법진행험증.결과 DOC침정법적최괄pH위3.5,재차pH조건하용DOC침정법검측3비CPS-TT현시,상청TT함량평균위2.3％.DOC침정법구유교호적준학도화정밀도,3비CPS-TT적비내변이계수균소우5％.결론 DOC침정법가용우C군뇌막염구균결합역묘적질량공제.
Objective To establish a sodium deoxycholate (DOC) precipitation method for determination of free polysaccharide in group C meningococcal polysaccharide-tetanus toxoid conjugate vaccine (CPS-TT).Methods CPS and TT were treated by acid precipitation with DOC,and the optimum precipitation conditions to separate unconjugated and conjugated CPS were determined.The DOC precipitation method was validated.Results The optimum pH condition of the DOC precipitation method was 3.5.The results of 3 batches of CPS-TT determined by the DOC precipitation method showed that average content of TT in supernatant was 2.3 ％.The established method had better accuracy and precision,and the variation cofficients of intra-assay for 3 batches of CPS-TT were all ＜5％.Conclusion The DOC precipitation method can apply to quality control of group C meningococcal conjugate vaccine.
