ACUTE, SUBACUTE AND CHRONIC TOXICITY STUDIES OF SULTAMICILLIN

Acute, subacute and chronic toxicities of sultamicillin (SBTPC), a mutual prodrug of sulbactam and ampicillin were evaluated in Sprague-Dawley rats or ICR mice. The acute oral LD50 of SBTPC were estimated to be greater than 10000 mg/kg in rats and mice. In the subacute oral toxicity test, all rats t...

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Published inCHEMOTHERAPY Vol. 33; no. Supplement2; pp. 102 - 111
Main Authors TACHIBANA, MASAKATSU, NABATA, HIROSHI, IIJIMA, MORITAKE, OHTSUKI, ISAO
Format Journal Article
LanguageJapanese
Published Japanese Society of Chemotherapy 1985
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Abstract Acute, subacute and chronic toxicities of sultamicillin (SBTPC), a mutual prodrug of sulbactam and ampicillin were evaluated in Sprague-Dawley rats or ICR mice. The acute oral LD50 of SBTPC were estimated to be greater than 10000 mg/kg in rats and mice. In the subacute oral toxicity test, all rats treated with SBTPC (1000, 300, 100, 30mg/kg) for 1 month were well tolerated. Occasional soft stools were noted in the treated groups. The highest dose level (1000mg/kg) of SBTPC produced mild growth inhibition, slight decrease of the liver weight and enlarged cecum and a deposition of glycogen-like droplets in the hepatic cell cytoplasm without any functional abnormality and morphological lesions. The non-toxic dose of SBTPC is considered to be 300mg/kg. In the chronic toxicity test, the rats were treated orally with SBTPC (1000, 300, 100 and 30mg/kg) for 6 months. Deaths were noted in the high dose groups (1000 and 300 mg/kg). Other results were comparable to those in the subacute toxicity test. The non-toxic dose in the chronic toxicity test with SBTPC is considered to be 100mg/kg.
AbstractList Acute, subacute and chronic toxicities of sultamicillin (SBTPC), a mutual prodrug of sulbactam and ampicillin were evaluated in Sprague-Dawley rats or ICR mice. The acute oral LD50 of SBTPC were estimated to be greater than 10000 mg/kg in rats and mice. In the subacute oral toxicity test, all rats treated with SBTPC (1000, 300, 100, 30mg/kg) for 1 month were well tolerated. Occasional soft stools were noted in the treated groups. The highest dose level (1000mg/kg) of SBTPC produced mild growth inhibition, slight decrease of the liver weight and enlarged cecum and a deposition of glycogen-like droplets in the hepatic cell cytoplasm without any functional abnormality and morphological lesions. The non-toxic dose of SBTPC is considered to be 300mg/kg. In the chronic toxicity test, the rats were treated orally with SBTPC (1000, 300, 100 and 30mg/kg) for 6 months. Deaths were noted in the high dose groups (1000 and 300 mg/kg). Other results were comparable to those in the subacute toxicity test. The non-toxic dose in the chronic toxicity test with SBTPC is considered to be 100mg/kg.
Author TACHIBANA, MASAKATSU
NABATA, HIROSHI
OHTSUKI, ISAO
IIJIMA, MORITAKE
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References 5) BOYD, E. M. and M. J. SELLA: The chronic oral toxicity of benzylpenicillin. Antibiot. Chemotherapy 12: 249-262, 1962
3) GREEN, O. P. et al.: BRL14151K及びBRL25000のラットにおける慢性毒性試験. Chemotherapy 31: 180-202, 1983
1) 野口晏弘ほか: Sulbactam及びSulbactam/Cafoperazoneの毒性試験. Chemotherapy 32 (S-4): 97-107, 1984
2) 寺嶋祥亘ほか: BRL 14151K及びBRL25000の急性毒性及び亜急性毒性試験. Chemotherapy 31: 113-141, 1983
4) SAVAGE, D. C. and R. DUBOS: Alterations in the cecum and its flora produced by antibacterial drugs. J. Exptl. Med. 128: 97-110, 1968
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