{"title":"[Analysis and evaluation on quality of live attenuated measles vaccine from market surveillance sampling].","authors":"Han-hua Fang, Xiao-xin Wang, Min Yi","doi":"","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>To ensure the quality of live attenuated measles vaccine on the market, viral titers were determined as the market surveillance test.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":56402,"journal":{"name":"中国疫苗和免疫","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2009-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"中国疫苗和免疫","FirstCategoryId":"1085","ListUrlMain":"","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
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.
目的:为保证市场上麻疹减毒活疫苗的质量，采用病毒滴度作为市场监测指标。方法:在全国24个省(市、区)，包括省疾控中心、市疾控中心、县疾控中心和主要使用者，抽取麻疹疫苗样本。对样品进行病毒滴度检测，评价市场上麻疹疫苗的质量状况。结果:54批麻疹疫苗的病毒滴度均符合2005年版《中国药典》第三卷的要求。与制造商提供的原始测试结果相比，平均病毒滴度降低了0.2 lg +/- 0.3。结论:市场抽检的麻疹疫苗批次病毒滴度均符合《中国药典》第三卷(2005年版)的要求。说明中国市场麻疹疫苗具有良好的稳定性，麻疹疫苗冷链运输和储存系统可以保证疫苗的有效性。
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