CAJ | 학술논문

本文观察苎麻叶凝胶长期连续经皮肤给药对完整皮肤和破损皮肤实验大鼠可能产生的毒性反应,为临床应用提供毒理学依据。利用160只Wistar大鼠,随机分为完整皮肤凝胶基质对照组、完整皮肤苎麻叶凝胶低、中、高剂量组（相当于临床人用量的20、40、80倍）,破损皮肤凝胶基质对照组、破损皮肤苎麻叶凝胶低、中、高剂量组（相当于临床人用量的20、40、80倍）,每组20只,雌雄各半,每日涂药2次,连续给药4周,观察大鼠的一般状况、体重、摄食量,测定给药4周及停药2周后大鼠的血液生化指标,脏器系数、解剖学及病理组织学改变情况。结果表明,苎麻叶凝胶各组大鼠一般状况良好,体重增长、摄食情况、脏器系数、血常规、血液生化指标、解剖学和主要脏器的病理组织学检查均正常,与凝胶基质对照组比较无明显差异。苎麻叶凝胶在临床剂量范围内毒性小,使用安全。
본문관찰저마협응효장기련속경피부급약대완정피부화파손피부실험대서가능산생적독성반응,위림상응용제공독이학의거。이용160지Wistar대서,수궤분위완정피부응효기질대조조、완정피부저마협응효저、중、고제량조（상당우림상인용량적20、40、80배）,파손피부응효기질대조조、파손피부저마협응효저、중、고제량조（상당우림상인용량적20、40、80배）,매조20지,자웅각반,매일도약2차,련속급약4주,관찰대서적일반상황、체중、섭식량,측정급약4주급정약2주후대서적혈액생화지표,장기계수、해부학급병리조직학개변정황。결과표명,저마협응효각조대서일반상황량호,체중증장、섭식정황、장기계수、혈상규、혈액생화지표、해부학화주요장기적병리조직학검사균정상,여응효기질대조조비교무명현차이。저마협응효재림상제량범위내독성소,사용안전。
Objective： To observe the long-term toxicity of Ramie leaf gels.Methods： One hundred and sixty Wistar rats were randomly divided into 8 groups（20 in each group,male： female=1∶1）： intact skins gel control and low,moderate,and high dosages（equal to 20,40 and 80 times o f those of human dosages） of intact skins Ramie leaf gels;broken skins gel control and,low moderate,and high dosages（equal to 20,40 and 80 times o f those of human dosages） of broken skins Ramie leaf gels,resectively,twice a day for four weeks,and the intact and broken skins groups received gel as control.The experiment was carried out for consecutive 4 weeks,and general conditions,body weight and food intake of the animals were observed.The hematological and biochemistry parameters,organ coefficients and histomorphological figures were determined in 4 weeks of the experiment and in 2 weeks after the termination.Results： The general conditions of treated rats were normal during and after the experiment.The body weight,food intake,organ coefficients,main hemotology and biochemistry indexes of rats in treated groups were basically the same as those of the controls.The organ histopathological observation showed no significant difference between experimental rats and controls.Conclusion： Ramie leaf gels has no immediate or delayed toxicity in long-term administration on rats with dosages within clinical range,and is safe for use.