頁籤選單縮合
題名 | 九十八年度疫苗與類毒素檢驗封緘案件分析=Survey on Batch Release of Vaccines and Toxoids in Taiwan During 2009 |
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作者 | 詹蕙嘉; 杜慧珍; 紀長文; 李家豪; 柳逸照; 黃玉卉; 許家銓; 楊依珍; 王德原; 羅吉方; | 書刊名 | 食品藥物研究年報 |
卷期 | 1 2010.11[民99.11] |
頁次 | 頁163-171 |
分類號 | 412.36 |
關鍵詞 | 疫苗; 類毒素; 檢驗封緘; Vaccine; Toxoid; Batch release; |
語文 | 中文(Chinese) |
中文摘要 | 摘 要 本報告係本局98年度執行輸入與國產疫苗及類毒素檢驗封緘案件之統計分析,以瞭解 國人98年度使用疫苗的整體品質概況,確保各疫苗之品質能符合中華藥典及各原產國規範 要求,98年度廠商申請疫苗檢驗封緘產品共202批,其中2批水痘疫苗及7批部分疫苗(包括 流感疫苗4批、水痘疫苗1批及B型肝炎疫苗2批)因運送過程不符規定,不予受理檢驗封緘 外,已完成檢驗者有200批,放行16,180,619劑,經逐批進行24項2,968次之檢驗與審查,結 果均符合中華藥典或原廠之規定,合格率100%,予以核發封緘證明書,提供國人接種以預 防相關之感染症。另2批未予放行者為水痘疫苗,由於運送溫度異常,該批產品全數不予以 受理檢驗封緘,並將產品銷毀或退運。已放行200批產品中193批疫苗及類毒素,分別來自8 家疫苗公司所持有之34張許可證,另外7批產品尚未領有許可證,係經衛生署疾病管制局申 請專案進口之特殊用途疫苗。此外,國內共有2家疫苗製造廠,其生產劑量佔98年檢驗封緘 數量之42.1%,其餘57.9%為輸入品;完成批次數及劑量數皆以國光生物科技股份有限公司 為最多。依疫苗預防的病源種類統計,封緘批數前3名依序為流行性感冒疫苗、吸著破傷風 類毒素及日本腦炎疫苗,封緘劑量前3名則為流行性感冒疫苗、吸著破傷風類毒素及B型肝 炎疫苗。在流感疫苗部分,98年度共完成62批6,736,163劑流感疫苗之逐批檢驗封緘,包括 55批4,445,333劑的季節性流感疫苗,及7批2,290,830劑A/H1N1流感疫苗,為流行性感冒疫 苗之接種計畫得以順利推展之關鍵。 |
英文摘要 | ABSTRACT This report presents the results of batch release of imported and domestic vaccines and toxoids during the period from January 1st to December 31st of 2009. Twenty four items and 2,968 tests were performed to analyze 200 batches which included 16,180,619 doses totally. The result of all complied with the Chinese pharmacopoeia and other regulations. These 200 batches of vaccines and toxoids belong to 34 licenses held individually by 8 vaccine companies. Forty two point one percent doses are domestic and 57.9% are imported. The number of certified batches and doses from Adimmune Corporation were the highest. In 16,180,619 doses of vaccines and toxoids, 26.9% doses are for bacteria, 69.5% for virus, and 3.6% for both virus and bacteria. Top 3 by batches are Influenza vaccines, tetanus toxoids and JE vaccines in order. Top 3 by dosages are Influenza vaccines, tetanus toxoids and HepB vaccines in order. Sixty two batches of 6,736,163 doses of influenza vaccines were certified in 2009. |
本系統之摘要資訊系依該期刊論文摘要之資訊為主。