【摘要】 目的 观察正二十二醇乳膏(Docosanol Cream)经皮肤给药对家兔产生的急性毒性反应，考察该制剂临床用药的安全性。方法 家兔16只，随机分为4组，完整皮肤给药组和赋形剂组、破损皮肤给药组和赋形剂组，采用皮肤涂药，药后连续观察14天家兔中毒表现和死亡情况，计算家兔最大耐受量。结果 正二十二醇乳膏家兔完整皮肤组和破损皮肤组活动状态良好，未见不良反应和死亡情况，最大耐受量为1000mg/kg。结论 正二十二醇乳膏急性毒性试验未显示毒性作用，预期临床应用安全性良好。

    【关键词】 正二十二醇乳膏；毒性试验；急性

    【Abstract】 Objective To observe the acute toxicity and to investigate the clinical safty of Docosanol Cream after skin topical administrations.Methods 16 Rabbits were randomly divided into 4 groups. Rabbits received normal and impaired topical administrations respectively. Observed the intoxication symptom and death after dosing for 14d. Calculated the maximum tolerance dose(MTD). Results Rabbits were active after administration of Docosanol Cream on normal and impaired skin. There was no adverse reactions and death. The MTD was 1000mg/kg.Conclusion There is no evidence of toxicity induced by Docosanol Cream in test. Docosanol Cream is effective and safe.

    【Key words】 Docosanol Cream;toxicity trail；acute

    正二十二醇(docosanol)是一种直链饱和脂肪醇 ......