【酶制剂质量控制要求】。

T Tanimoto, T Hayakawa
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引用次数: 0

摘要

酶制剂是由天然酶和生物技术酶或改性酶制备的药物。该制剂的催化能力显示出药物的功效,其化学物质为蛋白质。从这些特点出发,评价酶制剂的质量必须从不同于合成药物的角度出发。酶制剂的质量应从以下几个方面进行评价和保证:1)酶源的定义,2)催化剂功能和蛋白质物质的鉴定,3)功能性酶蛋白的纯度,4)药理作用的生化证据,5)安全性,6)含量。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
[Requirement for quality control of enzyme preparations].

Enzyme preparations are medicine which prepared from natural and biotechnological enzymes or modified enzymes. The catalytic ability of the preparations display the efficacy of a medicine, and its chemical substance is protein. From these characteristics, the quality of enzyme preparations has to be evaluated at viewpoints what distinguish from synthetic drugs. Quality of enzyme preparations should be evaluated and assured from the following viewpoints: 1) definition of enzyme source, 2) identification of function for catalyst and substance as protein, 3) purity for functional enzyme protein, 4) biochemical evidence that justifies pharmacological action, 5) safety, and 6) contents.

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