变应原疫苗的标准化

Standardization of allergen vaccine

全球范围生产和销售变应原疫苗,用来诊断和治疗IgE抗体介导的疾病。变应原疫苗是天然物质的混合物。每一种变应原提取物含有蛋白质、碳水化合物、酶、色素等物质,其中,具有变应原活性的物质只占一小部分。传统的变应原疫苗用投料比(重量/体积)标示疫苗,也有用凯氏定氮法测定蛋白氮标示疫苗,但是这两种标示疫苗的方法与疫苗的活性没有必然的关系。缺乏一致的方法来维持产品的一致性,疫苗批与批之间多样化是显然的。所以变应原疫苗的标准化是必须和必然的。变应原疫苗的标准化主要通过建立内部参考品,从变应原疫苗总蛋白组分、总蛋白含量、主要致敏蛋白的组成、主要致敏蛋白的含量、体内体外实验测定总活性这几个方面,每批产品与内部参考品相比较,达到产品批与批之间的一致性。在美国和欧洲的变应原标准化存在一定的差异,本文从美国和欧洲变应原疫苗的标准化历程介绍变应原疫苗标准化的方法和发展趋势。

Allergen vaccines are manufactured and sold world wide for diagnosis and treatment of immunoglobulin E-mediated allergic disease. These vaccines are complex mixtures of natural biomaterial. Each extract contains proteins, carbohydrates,enzymes, and pigments of which the allergens-presumaby the active ingredients may constitue only a small proportion. Traditionally, allergen vaccines have been labeled either with a designation of extraction ratio （W/V） or with a protein unit designation that is determined using the Kjeldahl methol. However, there is little correlation betwween these two designations and the biological measures of allergen potency. In the Absence of a concetred effort to maitain product consistency, lot-to-lot variations in allergen content may be considerable. So standardization of allergen vaccine is necessary. From history of standardization of allergen vaccine in Europe and the United States, we introduce the method and trend of standardization of allergen vaccine.