氢溴酸后马托品原位凝胶刺激性和药效学研究

目的:研究氢溴酸后马托品原位凝胶的眼刺激性和药效作用。方法:18只家兔被随机分为两组,分别进行眼刺激性试验和药效学研究。每组再分成氢溴酸后马托品原位凝胶组、氢溴酸后马托品滴眼液组和生理盐水对照组3个亚组,裂隙灯显微镜观察眼局部反应情况,斜视尺测量不同时间点瞳孔直径。结果:氢溴酸后马托品原位凝胶多次给药后,裂隙灯显微镜观察家兔眼角膜无混浊,虹膜和结膜未见红肿、充血、肿胀等异常现象。组织病理学检查显示,家兔眼给药后,与生理盐水组相比,给药组组织病理学改变无明显差异。药效学结果显示,氢溴酸后马托品原位凝胶散瞳时间长达8h。结论:氢溴酸后马托品原位凝胶是安全的,并能够有效地延长药物释放时间。

Irritation of and pharmacodynamics study on homatropine hydrobromide in situ gel

Objective To study the ocular irritation and pharmacodynamics of homatropine hydrobromide in situ gel.Methods Eighteen rabbits were randomly divided into two groups for the studying of irritation and pharmaco-dynamics,and then each group was divided randomly into such three subgroups as homatropine hydrobromide in situ gel,homatropine hydrobromide eye drops and normal saline.The rabbits were observed periodically for ocular redness,swelling,and watering with slit lamp microscope;the pupil diameter was measured periodically with strabismus ruler.Results The results of the tests indicated that the formulations were non-irritaing.No ocular damage or abnormal clinical signs of the cornea,iris or conjunctivae were visible.Histopathologic examination revealed no significant differences between rabbit eyes administratered with the drops and normal saline.Pharmacodynamic results showed that the release of homatropine hydrobromide in situ gel lasted for about 8 h.Conclusion Homatropine hydrobromide in situ gel causes no irritation,having a prolonged drug releasing time.