The Optimization Of Emulsification Process Of Avian Influenza (H9 Subtype) Inactivated Vaccine

Avian influenza (Avian Influence, AI) is abbreviated as avian influenza.It is a kind of epidemic infectious disease which is caused by Orthomyxoviridae, type A influenza virus. AI can infect domestic poultry, wild birds, and some mammals. According to the pathogenicity of avian influenza, AI can be divided into non-pathogenic avian influenza (NPAI), low pathogenic avian influenza (LPAI) and highly pathogenic avian influenza (HPAI). In our country, H5N1 subtype is a representative of the highly pathogenic avian influenza, and H9N2 subtype is the mainly type of low pathogenic avian influenza. At present, oil emulsion inactivated vaccine for poultry is the best way to prevent the epidemic of avian flu. Because the oil emulsion vaccine belongs to the oil-water mixture, which belongs to the mechanical instability system, easy to cause the stratification, demulsification, emulsion vaccine is an important link to ensure the quality of vaccines, is the impact of one of the key steps in the stability of the vaccine, so the optimization of emulsification technology existing, and has very important realistic significance.To produce high quality of avian influenza(H9 subtype) inactivated vaccine, we must ensure the emulsifying process control. In this paper, production line of oil emulsion inactivated vaccine is as the research platform, we tested and analyzed the emulsifying time, oil-water ratio and emulsifying temperature which can effect the emulsifying process. The main contents and results are as follows:(1) The selection of best emulsification time The best emulsification time is discussed in this test. The different emulsification time was chosen after the oily phase and aquous phase were mixed completely. The agitation speed of the emulsifier was 7000rpm. Sample were taken when emulsification time was at 1 hour,2 hours and 3 hours. Then the effection of emulsification were verified by relevant physical and chemical tests. The results indicated that the best emulsification time was 3 hours that we could prepare the oil emulsion inactivated vaccine with higher stability.(2) The best ratio of oil-water test The rate of oily phase and aquous phase of the oil emulsion vaccine has severe interference on the vaccine viscosity. Vaccine formulation and emulsification thecnic not only interfere the physical status of the production, but also decide the immune effect of the vaccine. We prepared 3 groups of oily phase and aquous phase with the rate of 3:2,7:3 and 2:1, then took samples after emulsification. The results showed that the best rate of the oily phase and aquous phase was 7:3 decided by the physical and chemical tests.(3) The optimum emulsification temperature test 3 groups of oily phase and aquous phase with the same formula were prepared, sterilized in the autoclave and then cooled, mixed completely in the 12L prepare tank. Emulsified after the same time with the cold water jacket control to control the emulsification temperature.3 different temperatures (15-18℃,20-25℃,25-30℃) during emulsification were chosen and then samples from the 3 groups were carried on by the physical and chemical tests, safety and effect tests. The results showed that the optimum emulsification temperature was 20-25℃.We analyze the production process and control points of Avian influenza (H9 subtype) inactivated vaccine according to the requirement of the veterinary drug GMP in this article, and how to ensure the whole production process can go smoothly, so that the quality of the vaccine will be brought under effective control.