THE INTERNATIONAL STANDARD FOR HUMAN GROWTH-HORMONE FOR BIOASSAY - CALIBRATION AND CHARACTERIZATION BY INTERNATIONAL COLLABORATIVE STUDY
THE INTERNATIONAL STANDARD FOR HUMAN GROWTH-HORMONE FOR BIOASSAY - CALIBRATION AND CHARACTERIZATION BY INTERNATIONAL COLLABORATIVE STUDY
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DOI：
10.1016/0303-7207(85)90058-9
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发表时间：
1985-01-01
影响因子：
4.1
通讯作者：
SCHULSTER, D
中科院分区：
文献类型：
--
作者：
BANGHAM, DR;DAS, REG;SCHULSTER, D
制备了两种人生长激素（hGH）制剂，作为生物测定用人生长激素国际标准品的候选制剂，并由10个国家的22个实验室在一项国际合作研究中进行了研究。根据生物测定用牛生长激素国际标准品（IS bGH），通过体内试验，根据免疫测定用人生长激素国际参比制剂（IRP hGH），通过受体、免疫测定和其他体外方法，以及通过各种方法相互对照，对2种候选制剂（在安瓿中冻干，编码为80/505和80/521）进行了测定。两种制剂均含有2种公认的主要生长激素组分（22 kDa和20 kDa形式）和其他组分，但编码为80/505的安瓿中的脱酰胺hGH和污染激素和热原少于编码为80/521的安瓿。使用未成熟垂体切除大鼠，通过体内生物测定法估计80/505的IS bGH效价不均匀（1-6 IU/ml），可能是因为牛和人GH制备物的不同。针对IRP hGH的受体和免疫测定法估计值为80/505，也存在异质性（3-9 IU/ml）。然而，所有试验的大多数估计值往往在3 - 6 IU/ml之间。尽管80/521和80/505在相对较小的方面存在差异。一种直接针对另一种的测定给出了体内测定的相对效力估计值，其与体内方法的估计值显著不同。在研究参与者的同意下，WHO生物标准化专家委员会将编码为80/505的安瓿制剂确定为第一个用于生物测定的人生长激素国际标准品，规定效价为4.4 IU/ml。这相当于约2.5 IU/mg hGH浸提液，并保持单位的合理连续性。
Two preparations of human growth hormone (hGH) were prepared as candidates for the International Standard for Human Growth Hormone for Bioassay and were studied by 22 laboratories in 10 countries in an international collaborative study. The 2 candidate preparations, freeze-dried in ampoules coded 80/505 and 80/521, were assayed against the International Standard for Growth Hormone, bovine, for Bioassay (IS bGH), by in vivo assays; against the International Refernce Preparation of Growth Hormone, human, for Immunoassay (IRP hGH), by receptor-, immunassays and other in vitro methods; and against each other by various methods. Both preparations contained the 2 recognized main growth hormone components (22 kDa and 20 kDa forms) and other components, but that in ampoules coded 80/505 had less deamidated hGH and contaminant hormones and pyrogen than that in ampoules coded 80/521. The estimates by in vivo bioassays, using immature hypophysectomized rats, of the potency of 80/505 in terms of the IS bGH were heterogeneous (1-6 IU/ampoule), probably because of the dissimilarity of the preparations of bovine and human GH. Estimates with receptor- and immunoassays of 80/505 against the IRP hGH were also heterogeneous (3-9 IU/ampoule). Nevertheless, the majority of estimates from all assays tended to be between 3 and 6 IU/ampoule. Although 80/521 and 80/505 differed in relatively minor respects. assays of one directly against the other gave relative potency estimates with in vivo assays which were significantly different from estimates with in vivo methods. With the agreement of the participants in the study, the WHO Expert Committee on Biological Standardization established the preparation in ampoules coded 80/505 as the First International Standard for Human Growth Hormone for Bioassay, with the defined potency of 4.4 IU/ampoule. This corresponds to an approximate 2.5 IU/mg of hGH extract and maintains reasonable continuity of the unit.