CAJ | 학술논문

目的探讨吸附无细胞百白破-Sabin株脊髓灰质炎联合疫苗(DTaP-sIPV)的制备工艺,并比较不同配比的DTaP-sIPV中Sabin株脊髓灰质炎灭活疫苗(SabinIPV)三针基础免疫大鼠的中和抗体效价,为确定联合疫苗的最佳制备工艺及抗原剂量配比提供参考.方法用不同配比的SabinIPV,制备两批DTaP-sIPV,进行各项指标的检定及稳定性试验,并联合单独的Sabin IPV和GSK制备的DTaP-wIPV对56只Wistar大鼠进行3针免疫,每针间隔1个月,每次免疫后30 d采血并分离血清,采用微量中和试验测定血清中抗脊髓灰质炎病毒3个型别的中和抗体效价.结果两批DTaPsIPV的各项检定指标均符合<中国药典>三部(2005版)要求,且稳定性良好.大鼠经3针基础免疫后,其Ⅰ、Ⅱ、Ⅲ型脊髓灰质炎病毒中和抗体的几何平均滴度均显著上升,3针免疫后抗体阳转率已经达到100%.结论经此制备的DTaP-sIPV安全、稳定、有效,且DTaP-sIPV中的SabinIPV在大鼠中有良好的免疫效果,经3针免疫可产生高水平的中和抗体.
목적 탐토흡부무세포백백파-Sabin주척수회질염연합역묘(DTaP-sIPV)적제비공예,병비교불동배비적DTaP-sIPV중Sabin주척수회질염멸활역묘(SabinIPV)삼침기출면역대서적중화항체효개,위학정연합역묘적최가제비공예급항원제량배비제공삼고.방법 용불동배비적SabinIPV,제비량비DTaP-sIPV,진행각항지표적검정급은정성시험,병연합단독적Sabin IPV화GSK제비적DTaP-wIPV대56지Wistar대서진행3침면역,매침간격1개월,매차면역후30 d채혈병분리혈청,채용미량중화시험측정혈청중항척수회질염병독3개형별적중화항체효개.결과 량비DTaPsIPV적각항검정지표균부합<중국약전>삼부(2005판)요구,차은정성량호.대서경3침기출면역후,기Ⅰ、Ⅱ、Ⅲ형척수회질염병독중화항체적궤하평균적도균현저상승,3침면역후항체양전솔이경체도100%.결론 경차제비적DTaP-sIPV안전、은정、유효,차DTaP-sIPV중적SabinIPV재대서중유량호적면역효과,경3침면역가산생고수평적중화항체.
Objective In order to search the preparation process and optimazing dosage ratio of adsorbed diphtheria-tetanus-acellular pertussis and sabin inactivated poliovirus combined vaccine ( DTaPsIPV) , the neutralizing antibody titers of IPV induced by different concentration of DTaP-sIPV were investigated on rats. Methods Two batches of DTaP-sIPV were produced using different concentration of sIPV and the quality control was carried. Together with sabin-IPV and DTaP-wIPV ( boostriixTM-polio, GSK, Belgium) as control group,the DTaP-sIPV were administrated on three-dose schedule at 0,1,2 month on rats. Serum sample were collected 30 days after each dose and neutralizing antibody titers against three types poliovirus were determined using micro-neutralization test. Results Two batches of prepared DTaP-sIPV and control sIPV were according to the requirement of Chinese Pharmacopoeia ( Volume Ⅲ , 2005 edition) and showed good stability. The seropositivity rates were 100% for sabin inactivated poliovirus antigen in all groups. The GMTs( Geometric mean titers) of neutralizing antibodies against three types poliovirus increased. Conclusion The prepared DTaP-sIPV was safe, stable and effective and could induced high level neutralizing antibody against poliovirus on rats.