Bristow A F, Jespersen A M
Division of Endocrinology, National Institute for Biological Standards and Control, Blanche Lane, South Mimms, Potters Bar, Herts, EN6 3QG, UK.
Biologicals. 2001 Jun;29(2):97-106. doi: 10.1006/biol.2001.0281.
A preparation of somatropin (recombinant DNA-derived human growth hormone) was prepared as lyophilised ampoules according to WHO procedures for international biological standards. The candidate preparation (98/574) was evaluated in an international collaborative study (16 laboratories, nine countries), with the following aims: (i) to determine the suitability of the preparation to serve as the International Standard for somatropin by studying its performance in the current range of physico-chemical and biological assay methods employed for somatropin; (ii) to assign a content in terms of the existing (first) International Standard for somatropin, using the currently recognised assay procedure (Size Exclusion High Performance Liquid Chromatography, SE HPLC); (iii) to confirm the specific biological activity of the candidate preparation; (iv) to confirm the stability of the candidate preparation. On the basis of the collaborative study WHO agreed that: the preparation in ampoules coded 98/574 is suitable to serve as the next WHO International Standard for somatropin; the preparation in ampoules coded 98/574 should be established as the second International Standard for somatropin, with a defined ampoule content of 1.95 mg total somatropin plus somatropin-related proteins per ampoule; the specific activity of the preparation should be defined as 3.0 IU/mg somatropin.
按照世界卫生组织国际生物标准的程序，制备了冻干安瓿装的生长激素（重组DNA衍生的人生长激素）制剂。候选制剂（98/574）在一项国际协作研究（16个实验室，9个国家）中进行了评估，目的如下：（i）通过研究其在目前用于生长激素的物理化学和生物学检测方法范围内的性能，确定该制剂作为生长激素国际标准的适用性；（ii）使用目前认可的检测程序（尺寸排阻高效液相色谱法，SE HPLC），根据现有的（首个）生长激素国际标准确定其含量；（iii）确认候选制剂的比生物活性；（iv）确认候选制剂的稳定性。基于协作研究，世界卫生组织同意：编码为98/574的安瓿装制剂适合作为世界卫生组织生长激素的下一个国际标准；编码为98/574的安瓿装制剂应确立为生长激素的第二个国际标准，每安瓿中总生长激素加生长激素相关蛋白的规定含量为1.95毫克；该制剂的比活性应定义为3.0 IU/毫克生长激素。
