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The safe and effective human albumin-free live attenuated rubella vaccines were preparedLive attenuated rubella vaccine virus strain RA27/3 was inoculated to the monolayer of human diploid MRC-5 cells at an appropriate the multiplicity of infection (MOI) and incubated in serum-and protein-free CDM culture medium.The virus liquid was harvested and, after addition of polyvinylpyrrolidone as a stabilizer and protective agent, lyophilized.Perform overall control tests on the prepared vaccine.One batch of bulk was prepared into vaccine using polyvinylpyrrolidone and human albumin as stabilizers resp., then subjected to overall control tests.All the quality indexes of 5 batches of vaccines containing polyvinylpyrrolidone as stabilizer met the requirements in Chinese Pharmacopeia (Volume III, 2005 edition).The virus titer and stability of polyvinylpyrrolidone-containing vaccines showed no significant difference with those of human albumin-containing vaccines prepared with bulk of the same batch.After storage at 37°C for 6 wk, both the virus titers of vaccines containing 2 kinds of stabilizers were 3.63 LgCCID₅₀/mL.The quality of live attenuated rubella vaccine containing polyvinylpyrrolidone as stabilizer met the requirements in Chinese Pharmacopeia (Volume III, 2005 edition).

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