冰点下降法测定流感病毒裂解疫苗的渗透压摩尔浓度

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 examine the osmolality of domestic influenza vaccine (split virion),based on which the national quality standard regarding this drug variety can be improved. Method: According to the appendix of Chinese pharmacopoeia 2010 edition part III,take 54 batches of influenza vaccine (split virion)which are produced by 6 manufacturers and sold at market,and determine their osmolality by freezing point osmometer. Results: The osmolality of examined influenza vaccine (split virion)ranges from 261 to 308 mOsmol·kg^-1. Conculsion: Some difference exists in osmolality of examined products.Since the osmolality is one of important indexes to examine the safety of influenza vaccine (split virion),it is very necessary to add the check item of osmolality into quality standard of influenza vaccine (split virion).

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