Effect of multiple punctures on quality of inactivated poliomyelitis vaccine made from Sabin strains in 5-dose vial presentation / 中国生物制品学杂志

ABSTRACT

@#ObjectiveTo evaluate the effect of multiple punctures on the quality of inactivated poliomyelitis vaccine made from Sabin strains(sIPV)in 5-dose vials.MethodsPre-puncture samples were sampled by opening the cover from 3batches of sIPV stored for about 24 months and balanced at room temperature at least 20 min;The same three batches of sIPV were punctured for the first to fifth needle on the 0,7,14,21 and 28 d respectively,which were balanced at room temperature at least 20 min before each sampling. After sampling,the remaining samples were returned to 2～8 ℃ for preservation. According to the requirements of enterprise registration standard(YBS01052021),all the samples before and after the fifth needle puncture were tested,and the other 4 needle puncture samples were tested for pH,osmotic molar concentration,aseptic test,bacterial endotoxin,D antigen content of typeⅠ,Ⅱ and Ⅲ virus,appearance,abnormal toxicity,protein content and 2-phenoxyethanol content. The relative change rates of 2-phenoxyethanol content,protein content,osmotic molar concentration and D antigen content of typeⅠ,Ⅱ and Ⅲ virus were calculated. SPSS 20 software was used to analyze the relative change rate of each index by one-way ANOVA,and the effect of multiple punctures on the quality of sIPV was evaluated.ResultsThe result of each test item was in compliance with enterprise registration standard before and after each puncture. There was no significant difference between each puncture on the relative rate of change of 2-phenoxyethanol content,protein content,D-antigen content of typeⅡ and Ⅲ virus(F = 2. 125,1. 155,1. 137 and 1. 882,P = 0. 152,0. 386,0. 393and 0. 190,respectively);There was a significant difference in the relative change rate of osmotic molar concentration and Dantigen content of TypeⅠvirus(F = 4. 750 and 4. 010,P = 0. 021 and 0. 034,respectively). The result of Duncan test showed that compared with the first puncture,the relative change rate of osmotic molar concentration after the second and third puncture showed no significant difference,while that after the fourth puncture showed significant difference and a relatively stable result was observed after the fifth puncture. Regarding the relative rate of change of D-antigen content of TypeⅠvirus,there was no significant difference among the first,second,fourth and fifth punctures,while a significant difference existed between the third and the other four punctures.ConclusionFive punctures within 28 days had no effect on the quality of sIPV in 5-dose vials.