[Elcatonin Reference Standard (Control 921) of National Institute of Health Sciences].

S Okada, C Yomota, M Ema, Y Ogawa
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Abstract

The raw material of elcatonin was examined for preparation of the "Elcatonin Reference Standard". The candidate material was evaluated by a domestic collaborative study in which five laboratories participated. The biological activity was determined to be 11.3 Unit/Amp. against the International Elcatonin Reference Standard (Code 84/614), based on one hour hypocalcaemia rat bioassay. In spite of the differences in rat strain, sex, administration method, dosage and assay method for serum calcium etc., the separately obtained biological activities for the candidate agreed closely with each other (95% confidence limits 11.08-11.53 Unit/Amp.). The physico-chemical evaluation of the candidate material was also performed, by using HPLC and amino acid chromatography. Based on the above results, this raw material was authorized to be the Elcatonin Reference Standard of the National Institute of Health Sciences.

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[国家卫生科学研究所艾曲宁参比标准(Control 921)]。
为编制《elcatonin标准品》,对elcatonin的原料进行了考察。候选材料由五个实验室参与的国内合作研究进行评估。测定其生物活性为11.3 Unit/Amp。根据一小时低钙大鼠生物测定,对照国际艾尔卡通素参考标准(代码84/614)。尽管在大鼠品系、性别、给药方式、给药剂量、血清钙测定方法等方面存在差异,但分别获得的候选药物的生物活性基本一致(95%置信限11.08 ~ 11.53 Unit/Amp.)。采用高效液相色谱法和氨基酸色谱法对候选材料进行了理化评价。基于上述结果,该原料被授权为国家卫生科学研究所艾卡藤素参考标准。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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