Bristow A F, Gaines-Das R, Jeffcoate S L, Schulster D
National Institute for Biological Standards and Control, Potters Bar, Herts, UK.
Growth Regul. 1995 Sep;5(3):133-41.
Following an earlier decision to move away from the in vivo bioassay for determination of the potency of therapeutic somatropin (recombinant DNA human growth hormone), 18 laboratories in 12 countries participated in an international collaborative study designed to establish an international standard for somatropin, calibrated both by bioassay and by physicochemical assays of somatropin content. The mean in vivo biological potency of preparation studied, coded 88/624, was 6.75 IU/ampoule (fiducial limits 6.30-7.23). Determination of the protein content by quantitative amino-acid analysis yielded a mean estimate of 1.98 mg protein per ampoule. (Relative standard deviation = 2.88%). Data from the study also yielded mean values of 97.2% +/- 0.8% for the monomer content of the preparation, and 8.18 (RSD = 4.00%) for A1% at 276 nm. At its 45th meeting, in October 1994, the ECBS of WHO formally established the preparation 88/624 as the First International Standard for Somatropin, with a defined content of 2.0 mg protein per ampoule, and a defined specific activity of 3.0 International Units per milligram.
在早先决定不再采用体内生物测定法来测定治疗用生长激素（重组DNA人生长激素）的效价之后，来自12个国家的18个实验室参与了一项国际协作研究，旨在建立生长激素国际标准，该标准通过生物测定法以及生长激素含量的物理化学测定法进行校准。所研究的编码为88/624的制剂的体内平均生物效价为6.75国际单位/安瓿（置信限为6.30 - 7.23）。通过定量氨基酸分析测定蛋白质含量，得出每安瓿蛋白质的平均估计值为1.98毫克。（相对标准偏差 = 2.88%）。该研究的数据还得出该制剂单体含量的平均值为97.2% ± 0.8%，在276纳米处的A1%为8.18（相对标准偏差 = 4.00%）。1994年10月，世界卫生组织生物标准化专家委员会（ECBS）在其第45次会议上正式将制剂88/624确立为生长激素第一国际标准，每安瓿规定含量为2.0毫克蛋白质，规定比活性为每毫克3.0国际单位。
