Cefaclorの急性,亜急性ならびに慢性毒性試験 (Cefaclor(CCL)<特集>)
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Acute, subacute and chronic toxicities of cefaclor (CCL) were examined in mice and rats.<BR>LD<SUB>50</SUB> values (mg/kg) of CCL were as follows:(male, female) in SD strain rat;(p. o.)>20, 000, >20, 000, (i. p.) 1, 347, 1, 274, (s. c.) 6, 540, 7, 501, in Wistar strain rat;(p. o.)>20, 000, >20, 000, (i. p.) 1, 259, 1, 259, (s. c.) 4, 838, 6, 619, in ICR strain mouse;(p. o.)>20, 000, >20, 000 (i. p.) 1, 575, 1, 891, (s. c.) 6, 598, 7, 051, in ddY strain mouse;(p. o.)>20, 000, >20, 000, (i. p.) 1, 227, 1, 282, (s. c.) 4, 180, 4, 341. Reduced spontaneous locomotor activity, pilo-erection and proneness were observed in mice and rats given CCL orally, intraperitoneally or subcutaneously.<BR>Subacute toxicity study on CCL was carried out in SD rats by oral administration at the doses of 250, 500, 1, 000, 2, 000 and 4, 000 mg/kg/day for 35 days. Cephalexin (CEX) was also administered in the same manner at the doses of 250, 500, and 1, 000 mg/kg/day as a reference compound. Pilo-erection, salivation and slight diarrhea were noted in all rats at the doses of 2, 000 and 4, 000 mg/kg/day. Body weight gain was supressed in male rats given more than 1, 000 mg/kg/day of CCL and 500 mg/kg/day of CEX. These symptoms, however, ceased during the 35 day-recovery period. Death was observed in 7 male and 3 female rats at the dose of 4, 000 mg/kg/day of CCL. Histologically, protein cast in proximal renal tubular lumina was noticed in rats at the dose of 4, 000 mg/kg/day of CCL and 1, 000 mg/kg/day of CEX. This change was reversible in CCL-treated animals, but not in CEX-treated one.<BR>Chronic toxicity study on cefaclor was carried out in rats by oral administration at the doses of 250, 500, 1, 000 and 2, 000 mg/kg/day for 26 weeks. Pilo-erection, reduced spontaneous locomotor activity, slight diarrhea and suppression of body weight gain were found in male and female rats at the dose of more than 500 mg/kg/day. These symptoms were disappeared during the 13 week-recovery period. Histologically, protein cast in proximal tubular lumina and slight dilatation of renal tubular lumina were noticed in male and female rats at the doses of more than 500 and 1, 000 mg/kg/day, respectively. These changes were reversible as same as those in the case of subacute study.<BR>From these results, the maximum no-effect dose of cefaclor was assumed to be 500 mg/kg/day.
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