【摘要】： 本論文的主要工作是對(duì)百日咳I相菌種(58003;CS)、白喉棒狀桿菌(38007)、破傷風(fēng)芽孢桿菌菌種(64008)的種子庫(kù)建立及檢定,確認(rèn)種子批的質(zhì)量完全符合現(xiàn)行藥典的質(zhì)量要求。 對(duì)無(wú)細(xì)胞百日咳原液、白喉精制類毒素和破傷風(fēng)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(jìn)行了比較試驗(yàn)研究,對(duì)生產(chǎn)工藝進(jìn)行了優(yōu)化,選擇并確定了能保持生產(chǎn)過(guò)程一致性、并且可適應(yīng)規(guī)�；a(chǎn)無(wú)細(xì)胞百日咳原液、白喉精制類毒素和破傷風(fēng)精制類毒素的工藝條件。按照此工藝生產(chǎn)的疫苗各項(xiàng)指標(biāo)完全符合藥典的質(zhì)量要求。 同時(shí)我們還對(duì)疫苗的安全性進(jìn)行進(jìn)行評(píng)價(jià),動(dòng)物急性特異性毒性、動(dòng)物長(zhǎng)期特異性毒性研究及動(dòng)物異常毒性研究結(jié)果表明疫苗沒(méi)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(xué)位授予單位】：吉林大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2007
【分類號(hào)】：R392

【參考文獻(xiàn)】

相關(guān)期刊論文 前1條

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本文編號(hào)：2161923