Yomota C, Okada S, Uchida E, Morimoto K, Hayakawa T
Eisei Shikenjo Hokoku. 1996(114):130-5.
Somatropin material was examined for preparation of the "Somatropin Reference Standard". The candidate material was evaluated by a domestic collaborative study in which eight laboratories participated. The protein content was determined to be 4.5 mg/Vial based on amino acid analysis. 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. By SE-HPLC, the content of polymer, dimer were determined to be 0.54%, 0.98%, respectively. By RP-HPLC, the early peak area ascribed to desamido and sulfoxide form was 1.07% of the total peak area. And for informational data, the potency of the candidate material, being estimated by three different biological methods, weight gain assay, tibia test and adiposeconversion assay is 14.8 IU/vial. Based on the above results, the candidate was authorized as the Somatropin Reference Standard of the National Institute of Health Sciences.
对生长激素原料进行了“生长激素参考标准品”的制备检测。候选原料由八个实验室参与的国内协作研究进行评估。基于氨基酸分析，确定蛋白质含量为每瓶4.5毫克。由于有可能用作高效液相色谱法测定的化学参考标准品，因此还对候选原料进行了物理化学评估。通过尺寸排阻高效液相色谱法，聚合物、二聚体的含量分别确定为0.54%、0.98%。通过反相高效液相色谱法，归因于脱酰胺和亚砜形式的早期峰面积占总峰面积的1.07%。作为信息数据，通过三种不同的生物学方法（体重增加试验、胫骨试验和脂肪转化试验）估计的候选原料效价为每瓶14.8国际单位。基于上述结果，该候选品被批准为国立卫生科学研究所的生长激素参考标准品。
