复方苦参洗剂的安全性研究

Safety Evaluation of Compound Radix Sophorae Flavescentis Lotion

目的:评价复方苦参洗剂局部给药的安全性,为临床安全用药提供参考。方法:急性毒性实验:家兔12只,随机分为给药组和阴性对照组,每组6只,24 h内给药2次,每次给药4 mL,2次给药间隔4 h,观察复方苦参洗剂对家兔的急性毒性反应。直肠刺激性实验:家兔8只,随机分为给药组和阴性对照组,每组4只,每天上午饲喂之前直肠给药1次,每次给药2 mL,连续给药8 d,于末次给药后24 h处死家兔,分离直肠,观察黏膜变化并进行直肠黏膜的病理组织学检查,考察复方苦参洗剂对家兔的直肠刺激性。皮肤过敏实验:豚鼠40只,随机分为3组,即给药组(n=20)、2,4-二硝基氯苯组(n=10)和阴性对照组(n=10),于第0,7,14天致敏,共致敏3次,首次给药致敏28 d进行激发,在致敏后1和24 h及激发后24和48 h观察动物变态反应情况。结果:复方苦参洗剂对家兔未出现任何急性毒性反应;对家兔无直肠刺激性;对豚鼠皮肤未见变态反应。结论:复方苦参洗剂外用安全。

Objective:To evaluate the safety of Compound Radix Sophorae Flavescentis Lotion by local application and to supply reference for clinical safe use.Methods:Acute toxicity test:twelve rabbits were divided into the experimental group and the control group according to random principle.The rabbits were given 4 mL samples twice during 4 h within 24 h then observing the toxic reaction.Rectal stimulation experiment:eight rabbits were divided into the experimental group and the control group to test the rectum stimulus of Radix Sophorae Flavescentis Lotion.The rabbits were given 2ml sample once every morning before feeding for 8 days.The rabbits were sacrificed after 24hs of the last dose and get the rectum to observe the rectum mucosa and have histopathologic examination so as to examine the rectal mucous membrane irritation of Compound Radix Sophorae Flavescentis Lotion.Skin allergy experiment:40 Guinea pigs were divided into three groups medication administration group(20),2,4-dinitrochlorobenzene group(10)and negative control(10).They were sensitized at 0,7,14 d and were stimulated at 28 d.To observe whether allergic reactions occurred at 1 and 24 h after sensitization and at 24 and 48 h after stimulation.Results:Under the dosage,no acute toxicity,no rectum stimulus and guinea pigs showed no allergic responses.Conclusion:Compound Radix Sophorae Flavescentis Lotion was safety by external use.