Study on the production process of single dose measles-rubella combined vaccine at polyvac

Nguyen Thuy Huong,Le Thi Hoa,Le Quoc Hung, Ngo Thu Huong, Nguyen Dang Hien

Tạp chí Y học Cộng đồng(2021)

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摘要
Center for Research and Production of Vaccines and Biologicals (POLYVAC) has conducted “Study on the production process of single dose measles-rubella combined vaccine (MRVAC)” (1dose/vial) in lyophilized form to make it convenient to use for vaccination services and export. The results have determined the formulation of MRVAC final bulk, freeze-dried process. The quality of researched products met WHO and Vietnam Pharmacopoeia V standards in both visual tests of lyophilized vaccine cake and after being reconstituted with sterile water for injection, the titer of measles virus ranges from 4.03 to 4.28 lgPFU/0.5mL and titer of rubella virus is from 3.79 to 3.98 lgPFU/0.5 mL. Results on thermal stability test when incubating the vaccine at 37oC/7days, the titer of measles virus decreased from 0.79 to 0.96 lgPFU/ 0.5mL and titer of rubella virus decreased from 0 to 0.18 lgPFU/0.5mL. Residual moisture content ranges from 0.35 to 0.72%. pH of vaccine is stable, ranges from 7.42 to 7.62.
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关键词
vaccine,measles-rubella
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