模拟振动后组分无细胞百白破联合疫苗的稳定性评价  

Evaluation on stability of diphtheria,tetanus,and acellular component pertussis combined vaccine after simulated vibration

作　　者：蔡路奎[1] 梁疆莉[1] 李婧妍 李婉西 刘双芹 吴易梅 周建平 周健[1] CAI Lu-kui;LIANG Jiang-li;LI Jing-yan;LI Wan-xi;LIU Shuang-qin;WU Yi-mei;ZHOU Jian-ping;ZHOU Jian(Institute of Medical Biology,Chinese Academy of Medical Sciences and Peking Union Medical College,Kunming 650118,Yunnan Province,China)

机构地区：[1]中国医学科学院北京协和医学院医学生物学研究所,云南昆明650118

出　　处：《中国生物制品学杂志》2022年第12期1422-1426,共5页Chinese Journal of Biologicals

基　　金：云南省科技创新人才计划(2019HC006);昆明市科技局重点项目(2019-1-N-25318000003332)。

摘　　要：目的评价模拟振动后组分无细胞百白破联合疫苗(diphtheria,tetanus,and acellular component pertussis combined vaccine,DTacP)的稳定性。方法选取3批中国医学科学院医学生物学研究所自主研制的DTacP,根据国家标准GB/T 4857.23-2012规定的方法进行随机振动试验。对振动前后的3批样品进行上清中抗原含量测定、Zeta电位测定、电镜观察、效价测定、鉴别试验、物理检查(外观、装量、渗透压摩尔浓度)、化学检定(pH、铝含量、游离甲醛含量)、无菌检查、特异性毒性检查及毒性逆转试验,评价疫苗的稳定性。结果振动前后,3批DTacP上清中百日咳毒素(pertussis toxin,PT)、丝状血凝素(filamentous hemagglutinin,FHA)及黏附素(pertactin,PRN)抗原含量均值差异均无统计学意义(t=0.16~1.73,P均>0.05),白喉类毒素(diphtheria toxoid,DT)及破伤风类毒素(tetanus toxoid,TT)均未检测到絮状反应;Zeta电位均值差异无统计学意义(t=0.40,P>0.05);电镜观察未见明显的结构变化;百日咳、白喉、破伤风疫苗效价均值差异均无统计学意义(t=0.37~0.97,P均>0.05);外观、装量、鉴别试验、无菌检查、特异性毒性检查、毒性逆转试验均未见明显变化;pH、氢氧化铝含量、游离甲醛含量、渗透压均值差异均无统计学意义(t=0.48~1.06,P均>0.05)。结论DTacP在模拟振动条件下稳定性良好。Objective To evaluate the stability of diphtheria,tetanus,and acellular component pertussis combined vaccine(DTacP)after simulated vibration.Methods Three batches of DTacPs independently developed by Institute of Medical Biology,Chinese Academy of Medical Sciences were selected for random vibration test according to the method specified in national standard GB/T 4857.23-2012,from which samples were taken before and after vibration respectively and determined for antigen content in supernatant,Zeta potential and titer and observed under electron microscope,while tested for identification,physical characteristics such as appearance,load and molarity of osmotic pressure,sterility,specific toxicity and reversion to toxicity,and determined for chemical characteristics such as pH value,aluminum content and free formaldehyde content.The results were compared to eraluate the stability.Results All the average contents of pertussis toxin(PT),filamentous hemagglutinin(FHA)and pertactin(PRN)antigen in the supernatant of 3 batches of DTacPs before and after vibration showed no significant difference(t=0.16~1.73,each P>0.05)and both of diphtheria toxoid(DT)and tetanus toxoid(TT)showed no flocculation reaction;The means of Zeta potential showed no significant difference(t=0.40,P>0.05);No obvious structure change was observed under electron microscope;The mean titers of pertussis,diphtheria and tetanus vaccines showed no significant difference(t=0.37~0.97,each P>0.05);No obvious changes were observed in appearance,load,identification,sterility,specific toxicity and reversion to toxicity and the means of pH value,aluminum hydroxide content,free formaldehyde content and osmotic pressure showed no significant difference(t=0.48~1.06,each P>0.05).Conclusion DTacP showed good stability under the simulated vibration.

关 键 词：组分无细胞百白破联合疫苗 振动 运输 稳定性 

分 类 号：R183.3[医药卫生—流行病学] R392-3[医药卫生—公共卫生与预防医学]