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Sibutramine의 신규 염인 Sibutramine Mesilate Hemihydrate의 랫드와 비글견에 대한 단회 경구투여 독성
한수철(Su-Cheol Han),차신우(Shin-Woo Cha),서정은(Jeong-Eun Suh),서귀현(Kwee-Hyun Suh) 한국실험동물학회 2004 Laboratory Animal Research Vol.20 No.4
This study was to investigate single-dose toxicities of sibutramine mesilate hemihydrate (SIBMS), a new salt of sibutramine, in Sprague-Dawley (SD) rats and beagle dogs. The test article was administrated once by gavage to rats at dose levels of 43.1, 86.3, 172.5 and 345.0 ㎎/㎏/day, and to beagle dogs at dose levels of 23.0 and 43.0 ㎎/㎏/day, respectively. For comparison, sibutramine hydrochloride monohydrate (SIBCH) used clinically as anti-obesity agent was administrated to SD rats at dose levels of 37.5, 75.0, 150.0 and 300.0 ㎎/㎏/day and at dose levels of 20.0 and 40.0 ㎎/㎏/day to beagle dogs. In rats, deaths, temporary body weight loss, increased locomotive activity and salivation were observed and the approximate lethal dose of SIBMS was 345.0 ㎎/㎏ for males and 172.5 ㎎/㎏ for females and those of SIBCH was 300.0 ㎎/㎏ for males and 150.0 ㎎/㎏ for females, respectively. In beagle dog, death, temporary body weight loss, vomiting, salivation, hyperemic conjunctiva, anorexia and lacrimation were found. The toxic effect dose of SIBMS were 46.0 ㎎/㎏ and those of SIBCH were 40.0 ㎎/㎏ for both sexes.
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