頁籤選單縮合
題名 | 九十五年度疫苗與類毒素檢驗封緘之分析=Survey on Batch Release of Vaccines and Toxoids in Taiwan during 2006 |
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作者 | 傅淑卿; 杜慧珍; 詹蕙嘉; 柳逸照; 紀長文; 楊若英; 陳作琳; 林嘉伯; 孫慈悌; | 書刊名 | 藥物食品檢驗局調查研究年報 |
卷期 | 25 2007.10[民96.10] |
頁次 | 頁71-79 |
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 | 本局於95年度完成之輸入與國產疫苗及類毒素檢驗封緘案件之統計結果,共計169批12,253,203劑,經逐批進行共26項試驗項目2,894次之審查與檢驗,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放行後供國人接種以預防相關之感染。此169批疫苗及類毒素分別來自6家疫苗公司8個廠所持有之33張許可證,其中38.7%的劑量為國產品,61.3%為輸入品;完成批次數以荷商葛蘭素史克藥廠股份有限公司比利時廠為最多,劑量數則以賽諾菲安萬特股份有限公司法國廠為最多。依疫苗預防的病源種類統計,95年度完成檢驗封緘之疫苗及類毒素中,細菌類疫苗的劑量佔35.4%,病毒類疫苗佔60.7 %,病毒與細菌混合類則佔3.9%;封緘批數前3名,依序為流行性感冒疫苗、肝炎類疫苗及吸著破傷風類毒素,封緘劑量前3名依序為流行性感冒疫苗、吸著破傷風類毒素及口服小兒麻痺疫苗。此外,95年度本局共完成44批3,352,689劑流感疫苗之逐批檢驗封緘,使得流行性感冒疫苗之接種計畫得以順利推展,近來,我國因此被倫敦衛生及熱帶醫學院依WHO檢核表評估為流感大流行準備程度「高度準備」國家。95年共有四種新疫苗上市,包括成分型吸著白喉破傷風百日咳、注射型小兒麻痺及b型流行性感冒嗜血桿菌混合疫苗、同時核准的兩種口服輪狀病毒疫苗以及人類乳突病毒疫苗。 |
英文摘要 | This report presents the results of batch release of imported and domestic vaccines and toxoids during the period from January 1st to December 31st, 2006. There were 26 items and 2,894 tests of inspecting and analyzing 169 batches of 12,253,203 doses totally. All complied with the Chinese pharmacopoeia and other regulations. These 169 batches of vaccines and toxoids belong to 33 licenses held individually by 6 vaccine companies and 8 factories, 38.7% domestic and 61.3% imported. The certified number of batches from GlaxoSmithKline Biologicals Belgian factory is the highest and the certified number of doses from Sanofi Pasteur French factory is the highest. In 12,253,203 doses of vaccines and toxoids, 35.4% doses are for bacteria and 60.7% for virus, for both virus and bacterial are 3.9%. Top 3 by batches are influenza vaccines, tetanus toxoids and hepatitis vaccines in order. Top 3 by dosages are influenza vaccines, tetanus toxoids and oral polio vaccines in order. 44 batches of 3,352,689 doses of influenza vaccines were certified in 2006. |
本系統之摘要資訊系依該期刊論文摘要之資訊為主。