[The Human Insulin Reference Standard (Control 921) of the National Institute of Health Sciences].

C Yomota, M Ema, Y Ogawa, S Okada
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引用次数: 0

Abstract

Raw human insulin material was examined for preparation of the "Human Insulin Reference Standard". The candidate material was evaluated by a domestic collaborative study in which four laboratories participated. The biological activity was determined to be 26.0 Unit/mg against the International Human Insulin Reference Standard (Code 83/500), based on the rabbit blood-glucose method specified in the JP XII (1991). Because of the possibility of application as a chemical reference standard for assay by the HPLC method, a physico-chemical evaluation of the candidate material was also performed. The total desamide form, dimer and oligomer impurities were estimated to be about 1% by HPLC. Based on the above findings, this raw material was authorized as the Human Insulin Reference Standard of the National Institute of Health Sciences.

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[国家卫生科学研究所人胰岛素参考标准(Control 921)]。
为编制《人胰岛素参考标准》,对人胰岛素原料进行了检验。候选材料由四个实验室参与的国内合作研究进行评估。根据国际人胰岛素参考标准(代码83/500),以JP XII(1991)中兔血糖法测定生物活性为26.0 Unit/mg。由于有可能作为高效液相色谱法测定的化学参考标准,对候选物质也进行了理化评价。高效液相色谱法估计其去酰胺形式、二聚体和低聚物的总杂质约为1%。基于上述发现,该原料被授权为国家卫生科学研究所的人胰岛素参考标准。
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