Nakae Hajime, Tomida Kouki, Kikuya Yoshihiro, Okuyama Manabu, Igarashi Toshiko
Department of Emergency and Critical Care Medicine Akita University Graduate School of Medicine Akita Japan.
Acute Med Surg. 2017 Mar 1;4(3):251-254. doi: 10.1002/ams2.259. eCollection 2017 Jul.
Human serum albumin (HSA) is known for its multiple functions, such as maintenance of colloid osmotic pressure, transport of endogenous and exogenous substances, and antioxidation. The aim of this study was to measure the redox state and concentrations of β-d-glucan and endotoxin to compare the quality of 5% HSA preparations from two different manufacturers.
The quality of 5% HSA preparations in two different pharmaceutical products (groups A and B) was compared in terms of the percentage of reduced and oxidized albumin and the contaminant level of β-d-glucan and endotoxin.
The percentage of human mercaptoalbumin in group A was significantly higher than that in group B ( < 0.01), whereas that of human non-mercaptoalbumin-2 in group A was significantly lower ( < 0.01). The concentration of β-d-glucan in group A was significantly lower than in group B ( < 0.01).
The present findings indicate the need for quality control of HSA preparations in applications involving the use of large volumes.
人血清白蛋白（HSA）以其多种功能而闻名，如维持胶体渗透压、运输内源性和外源性物质以及抗氧化作用。本研究的目的是测量β -d-葡聚糖和内毒素的氧化还原状态及浓度，以比较来自两家不同制造商的5% HSA制剂的质量。
根据还原型和氧化型白蛋白的百分比以及β -d-葡聚糖和内毒素的污染水平，比较两种不同药品（A组和B组）中5% HSA制剂的质量。
A组中人巯基白蛋白的百分比显著高于B组（<0.01），而A组中非巯基白蛋白-2的百分比显著低于B组（<0.01）。A组中β -d-葡聚糖的浓度显著低于B组（<0.01）。
目前的研究结果表明，在涉及大量使用的应用中，需要对HSA制剂进行质量控制。
