【摘要】： 本論文的主要工作是對百日咳I相菌種(58003;CS)、白喉棒狀桿菌(38007)、破傷風芽孢桿菌菌種(64008)的種子庫建立及檢定,確認種子批的質(zhì)量完全符合現(xiàn)行藥典的質(zhì)量要求。 對無細胞百日咳原液、白喉精制類毒素和破傷風精制類毒素的培養(yǎng)基、培養(yǎng)條件、解毒工藝、分離提純工藝進行了比較試驗研究,對生產(chǎn)工藝進行了優(yōu)化,選擇并確定了能保持生產(chǎn)過程一致性、并且可適應(yīng)規(guī)�；a(chǎn)無細胞百日咳原液、白喉精制類毒素和破傷風精制類毒素的工藝條件。按照此工藝生產(chǎn)的疫苗各項指標完全符合藥典的質(zhì)量要求。 同時我們還對疫苗的安全性進行進行評價,動物急性特異性毒性、動物長期特異性毒性研究及動物異常毒性研究結(jié)果表明疫苗沒有外源性毒性物質(zhì),是安全的。
[Abstract]:The main work of this paper is to establish and verify the seed bank of pertussis phase I strain (58003CS), Corynebacterium diphtheria (38007) and Bacillus tetanus strain (64008). The culture medium, culture conditions, detoxification technology, separation and purification of acellular pertussis, diphtheria refined toxoid and tetanus toxoid were studied. The process conditions of producing acellular pertussis, diphtheria and tetanus toxoid were selected and determined. The vaccines produced according to this process meet the quality requirements of the Pharmacopoeia. At the same time, we also evaluated the safety of the vaccine. The results of animal acute specific toxicity, animal long-term specific toxicity study and animal abnormal toxicity study showed that the vaccine was safe without exogenous toxic substances.
【學位授予單位】：吉林大學
【學位級別】：碩士
【學位授予年份】：2007
【分類號】：R392

【參考文獻】

相關(guān)期刊論文 前1條

1 王克安!100050北京;中國免疫預防事業(yè)的成就與展望[J];中華流行病學雜志;1999年06期

，

本文編號：2161923