口服重组B亚单位O1/O139霍乱疫苗的制备及检定

Preparation and quality control of oral bivalent recombinant cholera toxin B subunit-O1/O139 whole cell cholera vaccine

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 bivalent recombinant cholera toxin B subunit-O1 / O139 whole cell cholera vaccine and perform overall control tests. Methods Bulks of inactivated Vibrio cholera groups O1 and O139 as well as the bulk of recombinant cholera toxin B subunit（r CTB） were prepared and mixed at the specified proportion to obtain oral r CTBO1 / O139 whole cell cholrea vaccine. The vaccine was prepared into acid-resistant sodium bicarbonate effervescent particles to prevent r CTB from damage by gastric acid, and subjected to overall control tests according to the standard for qual-ity control of bulk and final product of novel preparations. Results The procedure for preparation of oral bivalent r CTBO1 / O139 whole cell cholera vaccine was stable, and all the quality indexes of prepared vaccine met the standard for quality control. Conclusion The oral bivalent r CTB-O1 / O139 whole cell cholera vaccine was safe and effective, of which the preparation procedure was feasible and met the requirements for large-scale production.