摘要
目的探讨新合成化合物8-十六烷基小檗碱的安全性评价。方法将8-十六烷基小檗碱设高中低剂量组,分别以临床拟用剂量的250、100和25倍剂量给大鼠灌胃给药,连续喂养90天,观察该化合物对大鼠的长期毒性反应,分别测量大鼠体重,计算脏器系数,测定血液学和血液生化学指标,并作组织病理学检查。结果长期毒性试验研究表明8-十六烷基小檗碱高、中、低剂量组动物的外观行为,体重,脏器系数,血液生化指标,与空白对照组比较,均无明显差异;病理检查未见与药物毒性相关的明显病变。结论 8-十六烷基小檗碱对大鼠大剂量长期用药无明显毒性,推论临床拟用剂量应是安全的。
Objective To study the security evaluation of 8-cetyl-berberine. Methods SD rats were divided into three dosage groups(n =20), which were administered 8-Ber-C16 with 250, 100 and 25 as much as clinical dose for 90 days. The effect of weights, organ coefficients, the indexes of hemotology and biochemistry, and the pathological examination were was observed to explore the long long-term toxicity of 8-Ber-C16. Results No death was found and little pathological changes were noticed in the physical appearance and weight, the blood test, the hepatic and renal of function, vzscera index of rat, compared with those of the control group. Conclusions 8-cetyl-berberine has no significant toxicity for long- term administration in rats, which infers that the drawing up doses in clinic will be safe.
出处
《齐齐哈尔医学院学报》
2016年第4期421-422,共2页
Journal of Qiqihar Medical University