复方苦参洗剂对家兔皮肤和阴道黏膜刺激性及对豚鼠皮肤致敏性实验研究

Experimental study of Fufang Kushen Lotion on irritation of skin and vaginal mucosa of rabbits and sensitization to skin of guinea pigs

目的对复方苦参洗剂进行安全性再评价,观察该药物对家兔皮肤和阴道黏膜的局部刺激反应和对豚鼠的皮肤致敏性。方法以复方苦参洗剂对家兔完整或破损皮肤多次给药,每日1次,每次0.5mL,连续7d局部涂抹给药。去除受试物后1,24,48和72h观察并记录红斑及水肿等刺激性症状;对家兔阴道内多次给药,每日1次,每次2mL,连续7d,观察其阴道黏膜刺激性。对健康豚鼠,通过致敏接触和激发接触给药进行皮肤过敏实验。结果对家兔完整或破损皮肤多次给药,所有家兔全身均未见异常反应,涂抹部位均未见红斑、水肿等现象;对家兔阴道内多次给药,阴部和阴道口均无异常分泌物,也无充血和水肿现象,阴道均未见有溃疡、坏死等异常病变,病理组织学检查无异常。致敏实验,复方苦参洗剂组给药部位的豚鼠皮肤均未见红斑或水肿等现象。结论复方苦参洗剂对家兔完整或破损皮肤及阴道黏膜无刺激性,对豚鼠皮肤无致敏作用。

Objective To reassess the safety of Fufang Kushen Lotion,to observe the irritation of skin and vaginal mucosa of rabbits and sensitization to skin of guinea pigs.Methods Fufang Kushen Lotion was apply to the healthy skin or damaged skin of New Zealand rabbits with multiple-dose for 7 dcontinuously,0.5 mL once daily.The irritation symptoms such as erythema and edema on the skin of rabbits at 1,24,48 and 72 hafter removing the lotion were observed and recorded.The lotion was apply to the vagina of rabbits with multiple-dose for 7 dcontinuously,2 mL once daily,and the irritation of vaginal mucosa was observed.Cutaneous anaphylaxis experiment was performed on healthy guinea pigs through sensitization contact and challenge exposure.Results No erythema and edema and abnormal systemic reaction was found in all rabbits after multiple-dose with the lotion to the healthy skin or damaged skin of rabbits.No abnormal secretion,hyperemia or edema was found in vagina and vaginal orifice;no abnormal pathological change such as ulceration and necrosis occurred in the vagina after multiple-dose with the lotion to the vagina of rabbits.The results of histopathologic examination were normal.Neither erythema nor edemas was found on the skin applied with Fufang Kushen Lotion to guinea pigs in the sensitization test.Conclusion Fufang Kushen Lotion will not cause irritation to the healthy skin or damaged skin and vagina mucosa of rabbits and neither will cause sensitization to the skin of guinea pigs.