APPLICATION OF THE LIMULUS TEST FOR PRACTICAL QUALITY-CONTROL ON ENDOTOXIN CONTENT IN COMMERCIAL HUMAN SERUM-ALBUMIN (HSA) PRODUCTS - IN COMPARISON WITH THE RABBIT PYROGEN TEST

被引:7
作者
ASAKAWA, S
FUJIWARA, H
NAITO, S
HOMMA, R
ISHIDA, S
CHINO, F
TSUCHIYA, M
MATSUURA, S
TANAKA, S
OHKI, M
机构
[1] WAKO PURE CHEM IND LTD, OSAKA RES LABS, AKO, HYOGO 67802, JAPAN
[2] SEIKAGAKU CORP, TOKYO RES INST, HIGASHIYAMATO, TOKYO 207, JAPAN
来源
YAKUGAKU ZASSHI-JOURNAL OF THE PHARMACEUTICAL SOCIETY OF JAPAN | 1994年 / 114卷 / 11期
关键词
LIMULUS AMEBOCYTE LYSATE; RABBIT PYROGEN TEST; ENDOTOXIN; HUMAN SERUM ALBUMIN;
D O I
10.1248/yakushi1947.114.11_888
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
The bacterial endotoxin content in human serum albumin (HSA) products measured by two different Limulus amebocyte lysate (LAL) test methods, colorimetric and kinetic turbidimetric methods, were compared. So far as endotoxin-specific LAL reagents which do not show a false-positive reaction with (1-->3)-beta B-D-glucan are used, a definite correlation was found between the results with the two LAL test methods. Endotoxin added to HSA products was recovered in a quantitative manner showing neither inhibition nor enhancement by HSA to the both LAL test methods. Results of the LAL tests showed a significant correlation with that of the rabbit pyrogen test. The correlation was much improved with endotoxin-added HSA. The present results indicate the practical applicability of the LAL test as an alternative method for the rabbit pyrogen test.
引用
收藏
页码:888 / 893
页数:6
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