The application of the endotoxin test for globulin and other blood products

被引：4

作者：

Fujiwara, H

Kira, K

Asakawa, S

Naito, S

Tanaka, S

Aizawa, M

Tuchiya, M

Takaoka, A

Yamamoto, A

Ochiai, M

Horiuchi, Y

机构：

[1] Natl Inst Infect Dis, Tokyo 2080011, Japan

[2] Seikagaku Corp, Tokyo 2070021, Japan

[3] Wako Pure Chem Ind Ltd, Amagasaki, Hyogo 6610963, Japan

来源：

YAKUGAKU ZASSHI-JOURNAL OF THE PHARMACEUTICAL SOCIETY OF JAPAN | 1999年 / 119卷 / 06期

关键词：

endotoxin test; globulin; blood product;

D O I：

10.1248/yakushi1947.119.6_451

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

The application of the endotoxin test for globulin and other blood products were investigated by two different limulus amebocyte lysate (LAL) test methods, colorimetric and kinetic turbidimetric methods, using two endotoxin-specific reagents. By the dilution of the blood products in 40 times or more, spiked endotoxin in the products was recovered accurately showing neither inhibition nor enhancement. The definite difference was not shown between the results obtained by the two LAL test methods. According to the method of the endotoxin test described under General Tests of The Japanese Pharmacopeia (thirteenth edition), JPXIII, the maximum valid dilution (MVD) for these products will be calculated to be 40 or more, so it is capable to measure the endotoxin limit for each product. This study indicates that the endotoxin test is applicable to measure the endotoxin content in globulin and other blood products as an alternative method for the rabbit pyrogen test.

引用

页码：451 / 455

页数：5

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