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目的:疫苗制品的无菌检查方法中薄膜过滤法的建立和方法学验证。方法:选取5个企业21个品种的疫苗制品,采用薄膜过滤法进行无菌检查,选取金黄色葡萄球菌、枯草芽孢杆菌、大肠埃希菌、生孢梭菌、白色念珠菌和黑曲霉作为验证菌进行方法学验证。结果:实验结果表明,疫苗类生物制品对真菌的抑菌作用较细菌更弱,疫苗类生物制品的敏感菌株为枯草芽孢杆菌,含防腐剂硫柳汞的疫苗的抑菌作用较其他类的疫苗更强。采用薄膜过滤法进行试验时,某些疫苗样品由于含氢氧化铝佐剂而不易通过薄膜,可将稀释液更换为磷酸盐缓冲液(pH 6.0),可使其顺利通过滤膜。结论:按照不同疫苗制品的特性,将其大致分为三类,并分别建立了无菌检查法。
OBJECTIVE: The establishment of membrane filtration method and methodological verification in the sterility test of vaccine products. Methods: 21 vaccine products from 5 enterprises were selected and sterilized by membrane filtration. Staphylococcus aureus, Bacillus subtilis, Escherichia coli, Clostridium sporogenes, Candida albicans and Aspergillus niger were selected as validation Methodological validation of bacteria. Results: The results showed that the bacteriostatic effect of the vaccine-based biological products on fungi was weaker than that on bacteria, the sensitive strain of the vaccine-based biological products was Bacillus subtilis, and the bacteriostatic effect of the vaccine containing thiomersal of the preservatives was stronger than that of other vaccines . When using thin-film filtration, some vaccine samples can not easily pass through the membrane due to the addition of aluminum hydroxide adjuvant, and the diluent can be changed to phosphate buffer (pH 6.0) to allow it to pass through the filter membrane. Conclusion: According to the characteristics of different vaccine products, it is divided into three categories, and the establishment of a sterile test.