王棋,吴建华,詹刚,宋彬,朱智勇,董关木,贾丽丽,岳广智,王志伟,郑铮,俞永新.流行性乙型脑炎疫苗纯化工艺的建立[J].Chinese journal of Epidemiology,2003,24(4):334 |
流行性乙型脑炎疫苗纯化工艺的建立 |
The establishment of epidemic encephalitis b vaccine purification process |
Received:February 28, 2003 |
DOI: |
KeyWord: 纯化工艺 流行性乙型脑炎 脑炎疫苗 生物制品检定所 去除率 股份有限公司 生物药业 乙脑疫苗 生产工艺 回收率 |
English Key Word: Purification process Epidemic encephalitis b Encephalitis vaccine Biological products offices shall Removal rate Co., LTD. Biological pharmaceutical co. Je vaccine The production process The recovery rate of |
FundProject: |
Author Name | Affiliation | Wang Qi | 320012, hangzhou, zhejiang tian yuan biological pharmaceutical co., LTD | Wu Chienhua | 320012, hangzhou, zhejiang tian yuan biological pharmaceutical co., LTD | Zhan Gang | 320012, hangzhou, zhejiang tian yuan biological pharmaceutical co., LTD | Song Bin | 320012, hangzhou, zhejiang tian yuan biological pharmaceutical co., LTD | Zhu Zhiyong | 320012, hangzhou, zhejiang tian yuan biological pharmaceutical co., LTD | Dong Guanmu | China offices shall of pharmaceutical and biological products | Jia Lili | China offices shall of pharmaceutical and biological products | Yue GuangZhi | China offices shall of pharmaceutical and biological products | Wang Zhiwei | China offices shall of pharmaceutical and biological products | Zheng Zheng | China offices shall of pharmaceutical and biological products | Yu Yongxin | China offices shall of pharmaceutical and biological products |
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Abstract: |
目前我国流行性乙型脑炎(乙脑)疫苗已形成规模化生产,并取得了较好的预防效果[1],但此种疫苗属粗制疫苗,其抗原含量较低,异源蛋白和亚细胞成分较多,临床应用存在一定副反应,因此有必要将疫苗进行浓缩纯化,以提高疫苗的免疫效果和降低副反应.经过几年的探索,我们建立了乙脑疫苗的纯化工艺,并在国内率先通过国家新药评审.现将纯化工艺报告如下. |
English Abstract: |
At present, the Japanese encephalitis (je) vaccine has formed a large-scale production, and achieved good preventive effect [1], but this vaccine crude vaccine, the antigen content is low, heterologous protein and subcellular components is more, there are some side effects, clinical application in so it is necessary to the vaccine for enrichment and purification, to improve the immune effect of vaccine and reduce side effects. After years of exploration, we establish the purification technology of je vaccine, and took the lead through the national new drug evaluation in China. Now the purification technology of report are as follows. |
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