目的:研究复方甘草次酸霜的长期毒性.方法:将188只SD大鼠随机分成6组,给药组分为:给予破损皮肤100 mg·kg-1复方甘草次酸霜小剂量组、500 mg· kg-1中剂量组、1 000 mg· kg-1大剂量组和给予完整皮肤1 000 mg· kg-1大剂量组;溶媒对照组分为:破损皮肤组和完整皮肤组,分别给予同体积空白基质.连续给药4周,停药4周,给药期间每日观察外观体征、称量大鼠体质量计算脏器系数,给药4周后测定血液学和血液生化学指标,并做病理组织学检查.结果:复方甘草次酸霜在100、500、1 000 mg· kg-1给药剂量下大鼠未出现死亡、体质量异常,血液学和血液生化学和病理组织学等指标均未见毒理学意义的异常改变.停药后也未见药物延迟性毒性反应.结论:复方甘草次酸霜经皮肤给药对大鼠无长期毒性.%Objective:To evaluate the long-term toxicity of compound glycyrrhetinic acid cream.Methods:One hundred and eightyeight SD rats were randomly divided into six groups:the drug administration groups were divided into small-dose group,abraded skin given 100 mg·kg-1 compound glycyrrhetinic acid cream,medium-dose group (500 mg·kg-1)and high-dose groups (1 000 mg ·kg-1)and normal skin group (given 1 000 mg·kg-1).Solvent control groups were divided into the damaged skin and normal skin groups,which were given the same volume of blank substrate,respectively.The appearance and sign of the rats were observed and body weight of rats were taken to calculate organ coefficient with successive 4-weeks drug administration and 4-weeks withdraw.After drug administration for 4 weeks,the organ coefficients were calculated and hematological as well as blood biochemical indexes were detected.And then the histopathologic examination was carried out.Results:There were no death,weight disorders and toxicological abnormal changes on hematology,biochemics of blood and histopathology for the rats given compound glycyrrhetinic acid cream at 100,500 and 1 000 mg ·kg-1.Also,there were no delayed toxic reactions after drug withdrawal.Conclusion:Compound glycyrrhetinic acid cream has no long-term toxicity in rats by skin administration.
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