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目的:考察国内流感病毒裂解疫苗的渗透压摩尔浓度,为提高该品种的国家标准提供依据。方法:按照中国药典2010年版三部附录,采用冰点下降法测定市售6家企业生产的54批流感病毒裂解疫苗的渗透压摩尔浓度。结果:所考察产品的渗透压摩尔浓度范围在261～308 mOsmol.kg-1之间。结论:所考察产品的渗透压摩尔浓度值存在一定差异,因渗透压摩尔浓度是考察流感病毒裂解疫苗安全性的一项重要指标,在流感病毒裂解疫苗成品质量标准中增加渗透压摩尔浓度检查项是必要的。
Objective: To investigate the molar concentration of osmotic pressure of domestic influenza virus lysis vaccine and provide the basis for improving the national standard of the variety. Methods: According to the Chinese Pharmacopoeia 2010 edition three appendix, freezing point descending method was used to determine the osmolality of 54 batches of influenza virus lysis vaccine produced by 6 companies on the market. Results: The osmolality of the investigated products ranged from 261 to 308 mOsmol.kg-1. Conclusion: The osmolality of the investigated products is different. The molar concentration of osmotic pressure is an important index for investigating the safety of the influenza virus vaccine. In the quality standard of influenza virus vaccine, the osmotic pressure is increased necessary.