[国家卫生科学研究所乌司他丁参考标准(Control 941)]。

K Maekawa, T Tanimoto, S Okada
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引用次数: 0

摘要

为编制《乌司他丁标准品》,对乌司他丁的原料进行了检验。与国内实验室合作对候选物质进行评价,确定胰蛋白酶抑制活性效价为3500单位/瓶。得到的其他分析数据如下:在276 nm处观察到紫外最大吸收,凝胶过滤法估计分子量约为66000 +/- 5000。采用jpxii的重量变异试验,10瓶样品的物质含量最大方差为6.52%。基于以上结果,该原料被授权为国家卫生科学研究院首个“乌司他丁参考标准品”。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
[Ulinastatin reference standard (Control 941) of the National Insutitute of Health Sciences].

The raw material of ulinastatin was examined for preparation of the "Ulinastatin Reference standard". The candidate material was evaluated in collaboration with one domestic laboratory, and the potency of trypsin inhibiting activity was determined to be 3500 unit/vial. Other analytical data obtained were as follows: UV maximum absorption was observed at 276 nm, the molecular weight was estimated to be about 66000 +/- 5000 by gel filtration method. Maximum variance of material contents in 10 vials was 6.52% by means of the weight variation test in JP XII. Based on the above results, this raw material was authorized to be the first "Ulinastatin Reference Standard" of the National Institute of Health Sciences.

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