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建立和应用一种可靠的质量分析方法是所有生物制品质量和工艺一致性的保障。一种准确反应药物中特异组成成分的活性和结构,并且优化和验证了的方法,是所有生物医药领域研发和新药上市的一个核心目标。变应原疫苗是天然物质的混合物,每一种变应原疫苗含有多种活性成分和与变应原无关未知的非活性成分,其中,具有变应原活性的物质只占一小部分,而且主要变应原成分作用在患者与患者之间差异性很大。本文介绍了一种变应原疫苗分析和质控的方法,包括变应原疫苗总蛋白含量、总蛋白组分、主要致敏蛋白组成、主要致敏蛋白含量、总生物活性几方面。
Establishing and applying a reliable method of quality analysis is a guarantee of the quality and process consistency of all biological products. An accurate and validated method of accurately reflecting the activity and structure of specific constituents in pharmaceuticals is a central goal of all biopharmaceutical R & D and new drug listings. Allergen vaccines are mixtures of natural substances, each of which contains multiple active ingredients and inactive ingredients that are not known to be associated with allergens, of which allergen-containing substances make up only a small fraction, and The major allergen component effects vary greatly between patients and patients. This article describes a method of allergen vaccine analysis and quality control, including allergen vaccine total protein content, total protein components, the main allergenic protein composition, the main allergenic protein content, the total biological activity of several aspects.