Standardization of regional reference for mamushi (Gloydius blomhoffii) antivenom in Japan, Korea, and China.
The mamushi (Gloydius blomhoffii) snakes that inhabit Japan, Korea, and China produce venoms with similar serological characters to each other. Individual domestic standard mamushi antivenoms have been used for national quality control (potency testing) of mamushi antivenom products in these countries, because of the lack of an international standard material authorized by the World Health Organization. This precludes comparison of the results of product potency testing among countries. We established a regional reference antivenom for these three Asian countries. This collaborative study indicated that the regional reference mamushi antivenom has an anti-lethal titer of 33,000 U/vial and anti-hemorrhagic titer of 36,000 U/vial. This reference can be used routinely for quality control, including national control of mamushi antivenom products.
Fukuda
Tadashi
T
Department of Bacterial Pathogenesis and Infection Control, National Institute of Infectious Diseases, Tokyo 208-0011, Japan. yfukuda@nih.go.jp
Iwaki
Masaaki
M
Hong
Seung Hwa
SH
Oh
Ho Jung
HJ
Wei
Zhu
Z
Morokuma
Kazunori
K
Ohkuma
Kunio
K
Dianliang
Lei
L
Arakawa
Yoshichika
Y
Takahashi
Motohide
M
D000818:Animals; D000997:Antivenins / Q000627:therapeutic use*; D001681:Biological Assay; D001733:Bites and Stings / Q000188:drug therapy*; D002681:China; D006801:Humans; D007564:Japan; D007723:Korea; D051379:Mice; D011786:Quality Control; D011817:Rabbits; D012016:Reference Values; D012910:Snake Venoms / Q000627:therapeutic use*; D012911:Snakes; D014944:World Health Organization
D000997:Antivenins; D012910:Snake Venoms