盐酸多塞平乳膏对家兔的长期毒性试验

目的考察盐酸多塞平乳膏(Doxepin H ydrochloride Cream)连续30d家兔皮肤用药的长期毒性。方法40只家兔按体重随机分为4组,以0、25、50、100m g/kg·d,皮肤用药,连续给药30d,每天观察动物的外观和行为活动,并于用药30d及停药14d将各组动物耳动脉采血,测定血液学指标和血液生化指标;然后剖检动物,取其脏器称重,计算脏器系数并进行组织病理学检查。结果盐酸多塞平乳膏3个剂量组对家兔的进食量、行为、体重、脏器系数、血液学、血液生化学及组织病理学检查与对照组比较,均无显著性差异(P>0.05)。结论盐酸多塞平乳膏对家兔安全剂量为100m g/kg·d,为拟定人用安全剂量提供了实验依据。

Long-term toxicity of Doxepin Hydrochloride Cream in rabbits

Objective To observe the long-term toxicity of doxepin hydrochloride cream on local skin of rabbits for 30d.Methods 40 rabbits were randomly divided into 4 groups.Each group was administrated on their local skin with doxepin hydrochloride cream at dose of 0,25,50,100 mg/kg·d for up to 30 days,respectively. The change of appearance and behaviour of rabbits should be observed every day during experiment term. The blood was taken from auricular artery of rabbit respectively later 30 days and 14 days after drug stopping. The blood analysis and blood biochemical examination were proceeded. Then bodies of animals were dissected and examined. Their organs was weighted, then the organ coefficient was calculated and pathological examination was proceeded.Results There was no any abnormal change in volume of eaten forage,behavior,body weight, blood examination, blood biochemical examination, organ coefficient and organ pathology compared with control group(i.e, at dose of 0mg/kg·d).Conclusion The safety dose of doxepin hydrochloride cream for rabbits is 100 mg/kg·d,there by which provides the experimental basis in working out the safety dose for human.