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目的制备口服重组B亚单位O1/O139霍乱疫苗,并进行全面检定。方法制备O1、O139群霍乱弧菌灭活菌体原液及重组霍乱毒素B亚单位(recombinant cholera toxin B subunit,r CTB)原液,按比例混合制成口服重组B亚单位O1/O139霍乱疫苗,为保护r CTB免受胃酸的破坏,制备了碳酸氢钠抗酸泡腾颗粒,并按照制定的新制品原液及成品的质控标准,对原液及成品进行全面检定。结果制备的口服重组B亚单位O1/O139霍乱疫苗工艺稳定,各项指标均达到质控标准。结论口服重组B亚单位O1/O139霍乱疫苗安全、有效,且制备工艺可行,符合规模化生产的要求。
Objective To prepare oral recombinant B subunit O1 / O139 cholera vaccine and conduct a comprehensive test. Methods O1, O139 group Vibrio cholerae inactivated mycobacterial stock solution and recombinant cholera toxin B subunit (r CTB) stock solution were prepared and mixed in proportion to make oral recombinant B subunit O1 / O139 cholera vaccine. Protection of r CTB from gastric acid damage, prepared sodium bicarbonate effervescent effervescent particles, and in accordance with the development of new products and finished product quality control standards for liquid and finished products for a comprehensive test. Results The oral recombinant B subunit O1 / O139 cholera vaccine was stable and all the indexes reached the quality control standards. Conclusion Oral recombinant B subunit O1 / O139 cholera vaccine is safe and effective, and the preparation process is feasible, in line with the requirements of large-scale production.