사람혈청알부민 20% 최종원액의 안정성에 관한 연구

Abstract

The major therapeutic human serum albumin was purified into three batches by cold ethanol precipitation method and albumin were studied for the stability. In storage over 39 months, the pH of albumin was slowly acidified from pH 7.0 to pH 6.8. The turbidity was not changed. However, the heme content in albumin was progressively increased with time in storage. Therefore, the color of albumin changed after 1-year of storage. The polymer and aggregates was investigated by HPLC techniques. The HPLC analysis are compared with the polymerization. The polymer form of albumin was increased during storage after the preparation. It is suggested that the denaturation of albumin is not dependent in temperature but dependent increased in fatty acids during storage. The results passed all the internal specifications at the albumin during the tentative expiration.