咪康唑莫米松皮肤成膜凝胶皮肤用药安全性试验

Experimental Study on Safety of Miconazole / Mometasone Skin Membrane Gel in Skin Application

目的对咪康唑莫米松皮肤成膜凝胶进行皮肤刺激性试验和过敏性试验,为临床用药安全提供依据。方法采用家兔进行皮肤刺激试验,分为完整皮肤组和破损皮肤组,连续给药7 d后观察;采用豚鼠皮肤进行主动过敏性试验(ACA),观察咪康唑莫米松皮肤成膜凝胶是否引起豚鼠皮肤或全身过敏反应。结果家兔皮肤刺激性试验,完整皮肤组和破损皮肤组均未出现红斑、水肿等现象;豚鼠皮肤主动过敏性试验,未引起皮肤过敏反应或全身过敏反应。结论咪康唑莫米松皮肤成膜凝胶未引起家兔皮肤刺激性反应和豚鼠皮肤过敏性反应,其临床用药剂量安全可靠。

Objective To perform the irritation test and the allergy test of Miconazole/Mometasone Skin Membrane Gel to provide the evidence for the safety of clinical medication. Methods Rabbits were adopted to perform the skin irritation test and divided into the intact skin group and damaged skin group. The observation was conducted after for 7 d consecutive drug administration; guinea pig was adopted to perform the active allergic skin test（ACA） for observing whether Mieonazole/Mometasone Skin Membrane Gel could induce the skin or systemic allergic reactions in guinea pigs. Results In the rabbit skin irritation test, the intact skin group or the damaged skin group had no phenomena of erythema, edema, etc. ;the guinea pig active skin test did not induce the skin allergic reactions or the systemic allergic reactions. Condusion Mieonazole/Mometasone Skin Membrane Gel does not induce the skin irritation in rabbits and the allergic reactions in guinea pigs skin. Its clinical medication dosage is safe and reliable.