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目的采用冰点下降法测定乙型脑炎减毒活疫苗、A群脑膜炎球菌多糖疫苗和ACYW135群脑膜炎球菌多糖疫苗及相应稀释剂的渗透压摩尔浓度。方法按照《中国药典》三部(2010版)附录渗透压摩尔浓度测定法,采用冰点下降法分别测定市售20批乙型脑炎减毒活疫苗、55批A群脑膜炎球菌多糖疫苗和7批ACYW135群脑膜炎球菌多糖疫苗及相应稀释剂的渗透压摩尔浓度。结果 3种疫苗之间的渗透压摩尔浓度存在较大的差异,在260~700 m Osmol/kg之间,其中乙型脑炎减毒活疫苗的批间和批次内渗透压摩尔浓度之间的差异较大,A群脑膜炎球菌多糖疫苗和ACYW135群脑膜炎球菌多糖疫苗各自的批间和批次内渗透压摩尔浓度差异不大;3种疫苗稀释剂的渗透压摩尔浓度也存在较大差异。结论在上述3种疫苗质量控制体系中应酌情增加渗透压摩尔浓度检查项。
Objective To determine the osmolality of attenuated live attenuated encephalitis B vaccine, group A meningococcal polysaccharide vaccine and group ACYW135 meningococcal polysaccharide vaccine and the corresponding diluents by freezing-point descent method. Methods According to the method of osmolality determination in the Appendix of Chinese Pharmacopoeia (2010 edition), 20 batches of attenuated live attenuated JE vaccine, 55 batches of group A meningococcal polysaccharide vaccine and 7 Batch of the ACYW135 meningococcal polysaccharide vaccine and corresponding diluent osmolality. Results There were great differences in osmolality between the three vaccines. Between 260 and 700 m Osmol / kg, among the live attenuated Japanese encephalitis vaccines and between-osmolality The differences between the intramuscular and intramuscular osmolality were not significantly different among the meningococcal polysaccharide vaccine group A and the ACYW135 meningococcal polysaccharide vaccine. The osmolality of the three vaccine diluents was also large difference. Conclusion In the above three kinds of vaccine quality control system should be increased as appropriate, osmolality check items.