| The global use of poliovirus vaccines is one of the most effective methods to prevent and control of polio epidemics,according to the World Health Organization(WHO)Global Polio Eradication Initiative launched in 1988.There were 2 main poliovirus vaccine used in the world,the live-attenuated oral polio vaccine(OPV)and the inactivated poliovirus vaccine(IPV).However,OPV has some viral activity,it also could be the source of occasional vaccineassociated paralytic poliomyelitis(VAPP)cases or outbreaks of circulating vaccine-derived polioviruses(VDPVs).Therefore,inactivated poliovirus vaccine(IPV)might be a better choice to overcome restoration of virulence for longterm use.The production of IPV international manufacturers are using the traditional wild poliovirus(Salk strain)preparation,bio safety level in the production process of the demand is higher,so the price is expensive,therefore,according to the recommendations of the WHO,developed using poliomyelitis attenuated vaccine strains(Sabin strain)preparation of Sabin strains of polio vaccine(Sabin inactivated poliovirus vaccine,sIPV)and the use in the developing world,for maintaining polio free status and realize the goal of polio eradication worldwide ultimately has important significance.This paper aims to explore the sIPV scale production of two key processes(virus inhibitory effect of active agent preservative)effects of live agent formaldehyde on the inactivation of virus antigen and to destroy different;and adding two vaccine preservative phenoxyethanol to evaluate the inhibitory effect.In the actual production process,the establishment of internal control method of formalin inactivated effect and two phenoxy ethanol inhibition potency testing of internal control standards to provide a reference for the two phenoxetol guarantee for formaldehyde inactivated virus and used for bacteriostasis with technological requirements,at the same time,quality control and supply material and also destroy live vaccine preservative two key production process for sIPV virusProvide the basis for screening.In part 1 of study,We observe the inactivation effect of four different formaldehydes on poliovirus Ⅰ,Ⅱ,Ⅲ types Sabin strain.Methods Samples from three batches of poliovirus Ⅰ,Ⅱ,Ⅲ types Sabin strains were inactivated with four different formaldehydes(final concentration is 92.5 μg/ml),and determined for infectious titer of virus by microtitration and for D antigen contents by ELISA,and drawn out the inactivation curve.Results After three batchs of poliovirus Ⅰ,Ⅱ,Ⅲ type Sabin strain were inactivated with four different formaldehydes,infectious titers of virus were decreased.Infectious titers of virus was decreased linearly more 103 CCIDso/ml when virus were inactivated at 37 ℃ for 1 days,and no virus was detected for fourth days.The recovery rate of D antigen content of the inactivated virus exceeded 80%,which was no significantly difference between the four different formaldehydes(P>0.05).Conclusions The poliovirus Sabin strain samples were inactivated with four different formaldehyde completely,and showed less damage to D antigen of poliovirus Sabin strain and good protection to active constituents of vaccine.To provide the basis for formaldehyde of quality control and supplier selection.In part 2 of study,We demonstrate the effectiveness of antimicrobial preservatives that 2-phenoxyethanol were added to Sabin inactivate poliomyelitis vaccine(Sabine IPV).Methods Staphylococcus aureus,Escherichia coli,Pseudomonas aeruginosa,Candida albicans and aspergillus niger were used as challenging strains and added into Sabine IPV with concentrations of 2-phenoxyethanol at 5mg/ml,Survival rates of microbes were then examined at different points in time.Results The Sabine IPV with concentrations of 2-phenoxyethanol at 5mg/ml could inhibit the growth of microorganisms sufficiently,antimicrobial effectiveness of Sabine IPV using 2-phenoxyethanol as preservatives met the requirements in Chinese Pharmacopoeia(Volume Ⅲ,2015 edition).Conclusion 5mg/ml 2-phenoxyethanol can be used as antimicrobial preservative for Sabin inactivate poliomyelitis vaccine... |
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