冷冻干燥技术在基因工程药物中应用_于志江.pdf

May 2005 生 物 加 工 过 程 32 58 Chinese Journal of Bioprocess ngineering 2005 5 于志江, 陈 旭, 欧阳藩 ( 深圳国家生化工程技术开发中心, 深圳518057) : 冻干技术是基因工程药物制备的常用方法, 冻干技术的优点使其正发展成一项产业介 了冻干技术的 原理应用冻干制剂的生产过程, 结合工作实际探讨了冻干损伤和保护机理, 冻干曲线的确定原则, 以及在冻干过 程中要注意的重点问题 : 冷冻干燥; 冻干曲线;保护剂; 基因工程药物 :R944,TQ4606 :A : 1672- 3678( 2005)02- 0058- 06 Freeze drying ( lyophilization) of genetic engineering pharmaceuticals YU Zhijiang,CH N Xu, OUYANG Fan (National ngineering Centre for Biochemistry,Shenzhen 5180570,China) Abstract: Freeze drying ( lyophilization) is a common technology extensively used in the genetic engineering pharmaceutics field.It is growing up an industry ouring to its excellent characters. Basic principles operation process and application were related in this article.Key points of lyophilization in practicewere discussed con cerning the protection measures against the tissue damage and principles of the freezing curve. Key words:freezing drying;lyophilization;process;protectant; genetic engineering pharmaceutical , WTO , , , , ( ) , (Outsourcing) , , 2003 50 , 300 , 2004 , 340~ 350 26%, 20 90 , , , , () , , , , , , ; () , , ( / ) 20 , / , , , , , DSM , : : 于志江( 1965) , 男, 江苏南通人, 硕士, 工程师, 研究方向:基因工程药物中试开发 2005 5 : 59 , 12 2004 , 6 200 , : ( 11, 1) , 2 30 m ) , ; PATH ON 2) , , , , , , ;