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題 名 | The Relationship between the Cold Chain System and Vaccine Potency in Taiwan: (Ⅰ) Live Measles Vaccine and MMR Vaccine=臺灣地區疫苗效價與Cold Chain系統間之關係(1)減毒活病毒麻疹疫苗及麻疹、腮腺炎、德國麻疹混合疫苗 |
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作 者 | 王德原; 楊若英; 楊依珍; 葉昇炎; 陳作琳; 陳惠芳; 謝榮添; 林嘉伯; | 書刊名 | 藥物食品分析 |
卷 期 | 7:3 1999.09[民88.09] |
頁 次 | 頁233-242 |
分類號 | 418.293 |
關鍵詞 | cold chain系統; 麻疹疫苗; 麻疹; 腮腺炎; 德國麻疹混合疫苗; 效價試驗; 剩餘效期; Cold chain; MV; MMR vaccine; Potency test; Remaining term of validity; |
語 文 | 英文(English) |
中文摘要 | 臺灣地區使用疫苗來保護民眾免於受到某些特殊傳染病的侵害已有相當長的歷 史,其中將疫苗用於保護兒童不受小兒麻痺症、麻疹等惡性傳染病的感染已有相當良好的成 效。然而對於目前我國所使用的減毒活病毒麻疹疫苗及麻疹、腮腺炎、德國麻疹混合疫苗而 言,其為相當不安定的生物製劑,需要維持特定酸鹼度、避免光照、添加安定劑並儲存在特 定的低溫環境中。因此,特別是在處於熱帶/亞熱帶氣候的臺灣地區,這些活病毒疫苗在運 送儲存時將溫度維持在2到8℃之間是疫苗cold chain系統最重要的限制因子。本研究之 目的即在評估臺灣地區麻疹疫苗及麻疹、腮腺炎、德國麻疹混合疫苗在不同的儲存階層中 cold chain系統與疫苗效價間的關係。我們自民國86年9月起在臺灣各縣(含直轄巿)市中 隨機選擇衛生所、衛生室及合約醫院針對上述二種疫苗進行抽樣與效價試驗。我們從試驗結 果中發現,所有麻疹疫苗檢體的效價都能符合我國衛生署及世界衛生組織的相關規定;麻疹、 腮腺炎、德國麻疹混合疫苗檢體除了部份個案外,亦皆能符合我國衛生署及世界衛生組織的 相關規定,而混合疫苗中腮腺炎疫苗效價的降低可能與其較短之剩餘效期有關。本研究的結 果顯示臺灣地區所使用的cold chain系統已提供麻疹疫苗及麻疹、腮腺炎、德國麻疹混合 疫苗相當合適的儲存環境。 |
英文摘要 | Taiwan has a long history of using vaccines in order to protect people against certain infectious diseases. Several types of vaccines have been used successfully for protecting children from poliomyelitis, measles, and other acute infectious diseases. However, for the monovalent measles vaccine (MV), and the trivalent measles-mumps-rubella combined vaccine (MMR vaccine) which are made from live attenuated viruses, they are unstable unless stored at a proper low temperature, at a certain pH level, in darkness, and combined with some specific stabilizers. Maintaining these live virus vaccines at the recommended temperatures of +2 to +8 ℃ is one of the most important limiting factors in this respect, particularly in a subtropical climate such as in Taiwan. This study investigated and evaluated the vaccine cold chain system at different storage levels, and selected several health stations and local hospitals/pediatric offices in each County/City of Taiwan to take samples of the MV and MMR vaccines and test their potency during the autumn of 1997. Our results show that all of the MV samples meet the requirements for the potency test, showing titers higher than the criteria of the WHO and the ROC (Taiwan) national standard. The MMR vaccine also maintained its potency, with the exception of a few mumps vaccines. This study found that the shorter the remaining term of validity (RTV) of MMR vaccines is, the more inactivation of the mumps virus could occur. The reason why the mumps vaccine of MMR vaccine seems unstable in Taiwan needs further investigation. Nevertheless, the results of this study reveal that the cold chain system used in Taiwan is satisfactory for vaccine storage. |
本系統中英文摘要資訊取自各篇刊載內容。