ABSTRACT
@#Objective To evaluate the product quality of inactivated poliomyelitis vaccine made from Sabin strains(sIPV)after optimization of preparation formula.Methods The quality attributes of sIPV products after preparation optimization(no phenol red and no bacteriostatic agent)were evaluated,and the quality comparability with the listed sIPV products was analyzed;270 Wister rats of half male and half female were immunized with the finished products before and after preparation optimization simultaneously by intramuscular injection,measured for the level of neutralizing antibody in serum,evaluated for the immunogenicity,and analyzed for the compa-rability;The finished products with optimized preparation were placed at 37 ℃,room temperature(20～25 ℃)and 2～8 ℃ for accelerated and long-term stability tests separately,detected for the content of key indicator D antigen to evaluate the stability,and analyzed for the comparability with historical data of the listed products.Results After preparation formula optimization,the detection results of the sIPV vaccine for typeⅠ,Ⅱ,and Ⅲ D antigen content,protein content,pH value,Vero cell protein residue,bovine serum albumin residue,Vero cell DNA residue,and free formaldehyde content all conformed to the requirements of Chinese Pharmacopoeia Ⅲ (2020 edition)and the enterprise standard. Before and after the process optimization,the quality attributes,immunogenicity and accelerated and long-term stability trends were consi-stent.Conclusion The formulation of the optimized sIPV vaccine no longer contains phenol red and bacteriostatic agent ingredients,of which the safety has been improved;The quality attributes,immunogenicity,and stability of the product are highly similar to those before optimization;All indicators met the requirements during the validity period and the product has good stability.
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.