篇名:
禽用疫苗防腐劑含量及含濕度測定報告Preservatives Content and Residual Moisture Contents of Poultry Vaccines
作者:
葉修如;張家禎;許天來;趙欣如;邱文鴻;吳建志;鄺懋勁
中文摘要:
本研究以94 年4 月至95 年3 月送檢之禽用疫苗共427 批為樣本,疫苗種類分別為新城病、傳染性支氣管炎、傳染性華氏囊炎、傳染性鼻炎及產卵下降症等五種疾病之單價或混合疫苗,對禽用不活化疫苗進行的甲醛及硫柳汞含量檢測,而禽用活毒疫苗方面則檢測其含濕度,檢測所得數據結果進行變異數統計分析(analysis of variance, ANOVA),以了解與比較各疫苗廠牌疫苗的差異。於甲醛方面,共分析17組227個樣本,組間P值小於0.01(P = 8.92 × 10-53),各廠牌間甲醛含量具顯著性差異,其中國產疫苗甲醛含量高於0.1%者佔83.33%,進口疫苗佔9.09%,顯示國產禽用不活化疫苗普遍添加甲醛為防腐劑。於硫柳汞方面,共分析16組168個樣本,組間P值大於0.05(P = 0.0951),國內外各廠牌間硫柳汞含量無顯著性差異。於含濕度方面,共分析17組200個樣本,組間P值大於0.05(P = 0.6696),國內外各廠牌間含濕度含量無顯著性差異。
英文摘要:
For understanding of preservatives, formaldehyde and thimersol, in the inactivated vaccines or residual moisture in the live vaccines, totally 427 samples for statutory assay of poultry vaccines sold in Taiwan, including the imported and the domestic, were examined during April 2005 and March 2006. Poultry vaccine samples were consisted of monovalent or multivalent vaccines against Newcastle disease, infectious bronchitis, infectious bursal disease, infectious coryza or egg drop syndrome. Significance difference of results among manufacturers or between the imported and the domestic were tested by analysis of variance. In terms of preservatives used in inactivated vaccines, the results of the amount of formaldehyde in 227 samples from 17 manufacturers showed significant difference by manufacturer (p < 0.01). In addition, up to 83.33% of domestic inactivated vaccines and only 9.09% of the imported were tested containing formaldehyde in amount over 0.1%. This indicated that formaldehyde was commonly used as the preservative by domestic vaccine manufacturers. As regards the thimersol, 168 samples from 16 manufacturers were examined and the results showed that no significant difference among manufacturers or between the import and the domestic (p > 0.05). In regard to the results of residual moisture in live vaccines, 200 samples from 17 manufacturers were measured and no significant difference among manufacturers (p > 0.05) was found as well.
備註:
年份:西元 2006 年
期別: 第 41 期
詳細內容:
我國動物用生物藥品之管理,係採逐批檢驗方式,亦即不同批次之疫苗分別進行檢定。依據農委會公告之「動物用藥品檢驗標準」規定,無論國產或進口,不活化疫苗檢定時皆須檢驗防腐劑含量,而活毒疫苗皆須檢測其含濕度。以防腐劑含量標準而言,並非每種疫苗之標準皆一致。以禽用不活化疫苗甲醛含量為例,新城病疫苗必須為0.2%以下,雞傳染性鼻炎疫苗則為0.25%,而傳染性華氏囊炎疫苗則須0.3%以下。至於使用硫柳汞防腐者,各不同疫苗的硫柳汞含量規定皆為0.01%以下。此外,亦有部份疫苗如傳染性支氣管炎疫苗及產卵下降症疫苗,於「動物用藥品檢驗標準」中並未規定其防腐劑含量。至於活毒疫苗則須檢驗濕度含量,疫苗內含濕度依照規定須為4%以下。不活化疫苗添加防腐劑或活毒疫苗之乾燥,目的皆為延長疫苗之有效期限,故此二項試驗對疫苗之品質監測相當重要。本實驗室每年接檢之逐批檢驗疫苗批數約1,500 批,疫苗種類分別為禽用、豬用、牛用及小動物用等,其中以禽用疫苗檢驗批數最多,為了解國產與進口禽用不活化疫苗之防腐劑添加情形,以及為探討國產與進口禽用活毒疫苗含濕度品質,本報告收集最近一年之禽用疫苗檢定之防腐劑、含溼度之檢測數據,進行統計分析比較,以掌握國產疫苗之品質狀況。
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附件名稱:
禽用疫苗防腐劑含量及含濕度測定報告
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