复方苦槿霜的毒理学实验研究

Toxicologic Study on Compound Kujin Cream(CKJC)

目的:观察动物外用复方苦槿霜的急性毒性和长期毒性,评价其安全性.方法:急性毒性试验:24小时内将40%、80%复方苫槿霜分别涂于家兔完整皮肤和破损皮肤2次;18小时内将80%复方苦槿霜1.0g涂于大鼠背部脱毛区2次。长期毒性试验:连续28天将40%、80%、200%的复方苦槿霜1 0g分别均匀涂于大鼠背部脱毛区。观察大鼠给药后第28天的生长发育、血液学、血液生化学、主要脏器系数、组织病理学变化及停药后14天上述指标的变化。结果:24小时内40%、80%复方苦槿霜外用在家兔完整皮肤或破损皮肤2次未引起急性毒性反应。18小时内将80%复方苦槿霜1.0g涂于大鼠背部脱毛区2次,7日内无一大鼠死亡。长期毒性试验中:复方苦槿霜高、中、低二个剂量组大鼠连续给药第28天及停药恢复第14天,与对照组比较上述各项观测指标均未见明显差异。结论:复方苫槿霜临床日用量是安全的。

Objective： Forestimating the safety of CKJC, we observe the acute and the long period toxicity of CKJC in rats and rabbits. Methods： The acute toxieitytest ：CKJC in 40% and 80% were used twice on the wounded and normal skin of rabbits within 24 hours;CKJC 1.0g in 80% was applied twice on the back of rats within 18 hours. Long- period toxicity：three groups of rats （in high, medium and low dosage of CKJC）were applied cream on the back skin respectively for 28 days. Body weight, hematological and hematobiochemical parameters; coefficient and histomorpholngical figure of organs （the heart, liver, spleen, lung, kidneys,adrenals, testis, prostate, ovary, uterus）would be examined in 28 days and 14 days after the cessation of CKJC. Results： The acute toxicity test showed that there was no acute toxicity effect to the rabbits and rats;The long period toxicity showed that the datas of hematobiochemical, pathological and cofficient of organ compared with the negative control group were not significant difference in 28 days and 14 days after the cessation of CKJC. Conclusion： It is safe to administer the prescribed dose of CKJC.