哌仑西平滴眼剂的刺激性和致敏性研究  

The Study on the Irritability and Allergic Effect of the Pirenzepine Ophthalmic Solution

作　　者：乐琦骅[1] 褚仁远[1] 程能能[2] 陈斌艳[2] 

机构地区：[1]复旦大学附属眼耳鼻喉科医院眼科,上海200031 [2]复旦大学药学院,上海200032

出　　处：《中国眼耳鼻喉科杂志》2005年第5期281-283,共3页Chinese Journal of Ophthalmology and Otorhinolaryngology

基　　金：上海市科委基金资助项目(034319243)

摘　　要：目的考察哌仑西平(pirenzepine,PIR)滴眼剂的眼部刺激性和致敏性,为临床安全用药提供依据。方法刺激性试验将动物(白兔)分四组,左眼分别点1%、2%、4%和8%的 PIR 滴眼液,右眼点0.9%NS。根据药物试验要求分别观察不同给药周期后双眼的眼睑、结膜、角膜和虹膜,根据 Draize 评分表的标准打分。致敏性试验将动物(豚鼠)背部脱毛后按照药物试验要求给药,观察受试区皮肤水肿和红斑的情况。结果 1%和2%PIR 溶液的眼部刺激性较小,单次、重复和长期给药的耐受性均较好;4%和8%PIR 溶液的重复和长期给药刺激性较大,耐受性较差。PIR 为弱致敏性。结论 2%PIR 是比较理想的制剂浓度,具有进一步开发和临床应用的前景。Purpose To evaluate the irritability and allergic effect of the pirenzepine ophthalmic solution and provide evidences for its clinical application. Methods The rabbits were divided into 4 groups, each of which was administered 1%, 2%, 4% or 8% pirenzepine ophthalmic solution in its left eye and 0.9% NS in its right eye. An independent researcher observed the lids, conjunctiva, cornea and iris through the slip lamp and gave grades according to Draize standards. The guinea pigs had their hack shaved and then the ophthalmic solution was applied to the hair-cut area. The degree of edema and erythema in the tested area was observed and graded. Results 1% and 2% pirenzepine ophthalmic solution had less irritancy and better tolerability to the ocular tissue compared with 4% and 8% pirencapine ophthalmic solution. The pirenzepine ophthalmic solution was weakly allergenic. Condusion 2% pirenzepine ophthalmic solution is suitable for further exploration and clinical application.

关 键 词：哌仑西平 滴眼剂 刺激性 致敏性 哌仑西平滴眼剂 刺激性试验 临床安全用药 药物试验 PIR 皮肤水肿 

分 类 号：R96[医药卫生—药理学]