聚乙烯吡咯烷酮稳定剂风疹减毒活疫苗的研制

目的研制安全有效的不含人血白蛋白稳定剂的风疹减毒活疫苗。方法将风疹减毒活疫苗毒种RA27/3株按适当比例接种单层人二倍体细胞MRC-5株,使用无血清、无蛋白的CDM培养基培养病毒,收获病毒液,加入聚乙烯吡咯烷酮作为病毒稳定剂,制备疫苗原液,加入冻干保护剂,制备5批冻干疫苗,进行各项检定。另取1批原液样品,分别加入聚乙烯吡咯烷酮和人血白蛋白作为病毒稳定剂,制成疫苗,进行各项检测。结果5批疫苗各项指标均符合《中国药典》三部(2005版)要求。同1批原液制备的聚乙烯吡咯烷酮与人血白蛋白稳定剂疫苗的病毒滴度和热稳定性无明显差异。37℃放置6周,两种稳定剂疫苗的病毒滴度均为3.63LgCCID50/ml。结论聚乙烯吡咯烷酮稳定剂风疹减毒活疫苗质量符合《中国药典》三部(2005版)的要求。

Preparation of Live Attenuated Rubella Vaccine Containing Polyvinylpyrrolidone as Stabilizer

Objective To prepare safe and effective human albumin-free live attenuated rubella vaccine.Methods Live at-tenuated rubella vaccine virus strain RA27 /3 was inoculated to the monolayer of human diploid MRC-5 cells at an appropriate MOI and incubated in serum-and protein-free CDM culture medium.The virus liquid was harvested and,after addition of polyvinylpyrroli-done 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 respectively,then subjected to overall control tests.Results All the quality indexes of 5 batches of vaccine containing polyvinylpyrrolidone as stabilizer met the requirements in Chinese Pharmacopeia(Volume Ⅲ,2005 edition).The virus titer and stability of polyvinylpyrrolidone-containing vaccine showed no signifi-cant difference with those of human albumin-containing vaccine prepared with bulk of the same batch.After storage at 37℃ for 6 weeks,both the virus titers of vaccines containing 2 kinds of stabilizers were 3.63 LgCCID50 /ml.Conclusion The quality of live at-tenuated rubella vaccine containing polyvinylpyrrolidone as stabilizer met the requirements in Chinese Pharmacopeia(Volume Ⅲ,2005 edition).