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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。
Objective To develop a safe and effective rubella attenuated live vaccine without human albumin stabilizer. Methods Monolayer human diploid cells (MRC-5) were inoculated with live attenuated virulent strain RA27 / 3 strain at a suitable ratio. The virus was cultured in serum-free and protein-free CDM medium. The virus solution was harvested and added with polyvinylpyrrolidone As a virus stabilizer, a vaccine stock solution was prepared, and a lyoprotectant was added to prepare 5 batches of lyophilized vaccine for various tests. Another batch of stock solution samples were added polyvinylpyrrolidone and human serum albumin as a virus stabilizer, made of vaccines, the detection. Results All the five batches of vaccines met the requirements of the third edition of Chinese Pharmacopoeia (2005 edition). There was no significant difference in virus titers and thermal stability between the same PVP and human albumin stabilizer vaccine. At 37 ° C for 6 weeks, the viral titers of both stabilizer vaccines were 3.63Lg CCID50 / ml. Conclusion The quality of the live attenuated virulent polyvinylpyrrolidone (DVP) rubella vaccine conforms to the requirements of the third edition of Chinese Pharmacopoeia (2005 edition).