【摘要】 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。更多还原

【Abstract】 Objective To ensure the quality of live attenuated measles vaccine on the market,viral titers were determined as the market surveillance test.Methods The measles vaccine was sampled from sites located in 24 provinces (cities,autonomous regions) of China,including provincial CDC,municipal CDC,county CDC,and primary users.The virus titer of samples was tested to evaluate the quality status of measles vaccine on the market.Results For all the 54 lots of measles vaccine sampled in this study,the virus titers were in compliance with the requirements of the China Pharmacopeia Vol.III (2005 edition).In comparison with the original test results provided by the manufacturers,the mean virus titer was decreased 0.2 lg±0.3.Conclusion Viral titers of measles vaccine batches sampled from the market were all in compliance with the requirements of the China Pharmacopeia Vol.III (2005 edition).It showed that the measles vaccine in China market has good stability,and the cold chain system for measles vaccine conveyance and storage could ensure the vaccine efficacy.更多还原