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目的为保障麻疹减毒活疫苗(Measles Attenuated Live Vaccin,MV)的安全性和有效性,通过对市场流通的MV进行评价性抽验,以了解流通环节和使用中的MV质量状况。方法从24个省(自治区、直辖市)、设区的市(地区、州、盟)、县(区、市、旗)级疾病预防控制中心(CDC)以及基层使用单位抽取MV样品,通过检测其病毒滴度,评价和分析MV在流通中的质量状况。结果在各级CDC及基层使用单位抽取的54批MV样品,其病毒滴度均符合2005年版《中国药典》三部的规定要求。在市场流通的MV的病毒滴度与其出厂时的病毒滴度比较,病毒滴度平均下降(0.2lg±0.3)。结论MV具有较好的稳定性,其质量均符合2005年版《中国药典》三部的规定要求,同时也表明疫苗运输和保藏的冷链系统较好。
Objective To evaluate the safety and effectiveness of Measles Attenuated Live Vaccin (MV) vaccine by conducting an evaluation test of the marketable MV to understand the quality of the MV in circulation and in service. Methods MV samples were collected from 24 provinces (autonomous regions and municipalities), districts (prefectures, prefectures and prefectures), counties (districts, cities and counties) CDC and grassroots units of use, Virus titer, evaluate and analyze the quality status of MV in circulation. Results The 54 batches of MV samples drawn from CDC and grassroots units at all levels had their virus titers in line with the requirements of the three editions of the 2005 edition of the Chinese Pharmacopoeia. Viral titers dropped by an average of 0.2 lg ± 0.3 compared to the virus titers of the MVs circulating in the market. Conclusion MV has good stability and its quality are in line with the requirements of the three editions of the 2005 edition of the Chinese Pharmacopoeia. It also shows that the cold-chain system of vaccine transport and preservation is better.