生物效价检测研究进展.pdfVIP

生物效价检测研究进展 (浙江省中医院，杭州 310006) 摘要：目的 方法 结果和讨论 关键词 中图分类号：R927.31 文献标志码：A 文章编号：1007-7693(2011)06-0511-04 Progress in the Study of Biological Potency Detection ZHENG Minxia, SHEN Jie, FENG Sujuan(Traditional Chinese Medical Hospital of Zhejiang Province, Hangzhou 310006, China) ABSTRACT: OBJECTIVE To introduce the definition and determination of biological potency and process in the application in drugs of biochemicals, chemicals and herbs, and to provide ideas and references for studying the quality control of drugs. METHODS Describe the basic concepts of biological potency, including definition, classification and standard of determination, and detection ideas. Emphasize on the wide use of the application in drugs of biochemicals, chemicals and herbs. RESULTS AND CONCLUTION It is illustrated the importance of determination of biological potency as a routine analytical tool in quality control of drugs in the future. The model of combination biological potency detection with chemical analysis is a powerful tool for drug quality control. KEY WORDS: biological potency; analytical methods; quality control 生物效价检测主要提供了药品生物活性的信 [7]，因而亦被称为定量药理学。 的一种定量的方法 息(与临床疗效一致) ，目前主要应用于生化药物、 1.2 检测方法分类 生物制品领域[1] ，这类药物的主要活性成分有氨基 生物效价检测可分为体内检测(in vivo)和体 酸、肽、蛋白质、酶、多糖、脂类、核酸，部分 外检测(in vitro)两种途径[8] 。体内检测是以整体动 药物由动物脏器、微生物等提取制成或是生物技 物为生物体，能反映药物对人体的作用方式，是 术药物，其活性成分不明确，结构复杂多变；空 最经典的生物效价检测方法，因此中、外药典在 间结构的细微变化，都会影响药物的活性中心位 重组人生长激素(rhGH)、重组人胰高血糖素的工艺 [9-10] 点，因此