【摘要】 为了考察除菌过滤工序对三价轮状病毒疫苗质量属性的影响、评估在生产工艺中增加除菌过滤操作的可行性，分2个阶段进行了22批的半成品过滤试验。试验滤膜孔径为0.22μm，材质为聚偏二氟乙烯(PVDF)，考察除菌过滤对试验产品病毒滴度及外观、pH值、渗透压和澄清度的影响，并对拟选定的滤膜材质进行细菌截留试验。结果显示，采用PVDF材质、孔径为0.22μm的除菌滤器进行三价轮状病毒疫苗半成品的除菌过滤，对试验产品的病毒滴度、外观、pH值和渗透压的影响不显著(P>0.05)，但能显著提高试验产品的澄清度(P<0.05)。该研究为在三价轮状病毒疫苗半成品的配制工艺中增加除菌过滤工序积累了关键数据和经验。更多还原

【Abstract】 In order to explore the impact of sterilizing filtration in the produce process of semi-finished products on the quality attributes of trivalent rotavirus vaccines, and to evaluate the feasibility of implementing sterilizing filtration in this produce process, sterilizing filtration experiments of 22 batches of semi-finished product were conducted in two stages. The test filter membrane had a pore size of 0.22 μm and was made from polyvinylidene fluoride(PVDF). The effect of sterilizing filtration on virus titer, appearance, pH value, osmotic pressure, and clarity of the test products was investigated, and a bacterial interception test on the proposed selected filter membrane material was performed. The results indicated that the PVDF sterilizing filter with a pore size of 0.22 μm for the sterilizing filtration of the semi-finished trivalent rotavirus vaccines did not significantly affect the virus titer, appearance, pH value, and osmotic pressure of the test products(P>0.05), but notably enhanced the clarity of the test products(P<0.05). This research provides valuable data and insights for applying sterile filtration to the formulation process of the semi-finished trivalent rotavirus vaccines.更多还原