三黄片调和物外用安全性研究

Safety Study of External Application of Sanhuangpian Oil Concoction

目的:观察三黄片用油调和后外用对皮肤软组织感染的安全性。方法:用小鼠40只,设基质对照组和给药组,两组分别在脱毛区涂敷调和油0.2 mL、三黄片油调和物0.4 g进行急性毒性实验。豚鼠20只背两侧脱毛后,左侧均匀涂敷三黄片油调和物1.0 g/只,右侧涂敷调和油1.0 mL/只,进行皮肤刺激试验。豚鼠30只随机分三黄片调和物组,基质对照组,阳性对照组,各组左侧脱毛区分别均匀涂敷三黄片调和物0.5 g/只、调和油0.5 mL/只、1%的2,4-二硝基氯苯0.5 mL/只,进行皮肤过敏性试验。结果:三黄片油调和物外用对皮肤软组织无明显毒性,给受试物后小鼠饮食、活动均未出现异常,持续观察7d,未见动物死亡;皮肤刺激反应评分:1,24,48 h基质对照均为0分,调和物组分别为1,0,2分,判断为三黄片调和物无明显刺激性;皮肤过敏性实验中基质对照组、调和物组豚鼠皮肤均未出现红斑、水肿等过敏反应,致敏率分别为10%,0,即无明显过敏反应。结论:三黄片调和物临床外用安全,可临床推广。

Objective：To observe the safety on oil concoction of Sanhuangpian. Method： Acute toxicity test was made in 40 mice skin by smearing individually oil（0.2 mL per mice）on the bare skin of mice back for control group and the oil concoction of Sanhuangpian（0.4 g per mice） for treatment group. At same time we have made the skin irritation test through in 20 guinea pigs skin by smearing the oil concoction of Sanhuangpian（ 1.0 g per guinea pig）on the left bare skin of guinea pig back and oil（ 1.0 mL per guinea pig）on that of the right. Then the skin allergic test was made on 30 skin of guinea pig by smearing oil concoction of Sanhuangpian（0.5 g per guinea pig） on the bare skin of guinea pig back for treatment group, with oil （0. 5 mL per guinea pig ） and 2,4-dinitrochlorobenzene （0.5 mL guinea pig） respectively for control group. Result：The external application of Sanhuangpian oil concoction has no significant toxicity on skin, there was no animal death in the observing continuously of 7 days after using of Sanhuangpian oil concoction, theiy activities were not abnormal. There is no significant irritation on skin, no erythema of guinea pig skin, edema, allergic reactions, sensitization rates were 10% , 0, there is no skin irritation obvious allergic reactions. Conclusion： The oil concoction of Sanhuangpian has definite safety on clinical application,a more widespread use should been made to people.