贵州医科大学学报

2016, v.41;No.187(04) 474-478

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鼻通宁喷雾剂鼻黏膜及皮肤刺激性试验
Experimental Research of Irritation of Bitongning Spray on Nose Mucosa and Skin

陈燕;张金娟;张彦燕;许键炜;熊英;杨勤;
CHEN Yan;ZHANG Jinjuan;ZHANG Yanyan;XU Jianwei;XIONG Ying;YANG Qin;The Affiliated Baiyun Hospital of Guizhou Medical University;Functional Laboratory,Guizhou Medical University;Department of Pharmacology,Guizhou Medical University;Department of Pathophysiology,Guizhou Medical University;

摘要(Abstract):

目的:研究鼻通宁喷雾剂对鼻黏膜及皮肤刺激性。方法:将16只家兔分为对照组(8只)和给药组(8只),进行鼻腔黏膜刺激性试验,对照组予赋形剂鼻腔给药,给药组予鼻通宁鼻腔给药,观察给药后家兔的全身状况及局部刺激症状,于末次给药后24 h和7 d时分别处死各组半数家兔,观察呼吸道局部黏膜组织情况,并进行病理组织学检查;另将16只家兔随机分为皮肤完整组及皮肤破损组,采用自身对照的方法,于两组家兔背部两侧皮肤去毛处分别涂抹鼻通宁喷雾剂及赋形剂,每次给药前及末次给药后30~60 min、24、48和72 h观察皮肤情况,并进行皮肤刺激反应评分和强度评价,于末次给药后72 h和4 d时,处死各组半数家兔,取涂药部位皮肤行病理组织学检查。结果:鼻黏膜刺激性试验结果显示,给药组及对照组家兔均未出现全身反应及局部刺激症状,末次给药后24 h及7 d时所处死的两组家兔的鼻、喉、气管、支气管黏膜肉眼及镜下观察均未见异常;皮肤刺激性试验结果显示,皮肤完整组及皮肤破损组家兔给药部位皮肤均未见异常反应,皮肤刺激反应评分均为0分,皮肤刺激强度评价为无刺激性。结论:鼻通宁喷雾剂无明显鼻腔黏膜刺激性及皮肤刺激性。
Objective: To study the irritation of Bitongning spray on nose mucosa and skin in order to supply basis for administration of safe use. Methods: 16 rabbits were randomly divided into treatment group and control group). The treatment group received Bitongning spray by nasal cavity while control group was given excipients,3 times a day for 2 weeks,respectively. General condition and local irritation symptom in rabbits of two groups were observed and compared after drug administration. Half of the rabbits were executed at 24 h and 7 days after the last drug administration respectively,and the local mucosal tissue of the respiratory tract was observed,and the pathological changes were examined.Another 16 rabbits were randomly divided into intact skin group and damaged skin group. Self contrast method was adopted in the part. The back skin on both sides of the two groups was smeared with Bitongning nasal sprays and excipient respectively at unhairing place 3 times a day for 2 weeks. The skin was observed before each drug administration,30 ~ 60 min,24 h,48 h and 72 h after the last drug administration,and the skin irritation reaction score and intensity were evaluated. Also,half of the rabbits were executed at 24 h and 7 days after the last drug administration respectively,and the pathological changes of coating part of skin were examined. Result: Nasal mucous irritation test results showed that no systemic or local irritation appeared in treatment group and control group during the treatment. In the two group executed at 24 h and 7 days after the last drug administration,no abnormalities could be seen in nose,throat,trachea,the bronchial mucosa under naked eye or microscope.Skin irritation test results showed that intact skin group and damaged skin group had no abnormality during the treatment,the irritation reaction score was 0 and no skin stimulus intensity was showed.Conclusion: The Bitongning spray has no obvious irritation effect on rabbits' nose,mucosa and skin.

关键词(KeyWords): 中药;鼻通宁;鼻黏膜刺激性反应;皮肤刺激性反应;家兔
Traditional chinese medicine;bitongning;nose mucosa irritation;skin irritation;rabbits

Abstract:

Keywords:

基金项目(Foundation): 贵州省科学技术基金[黔科合J字(2011)2285号];; 贵州省中医药管理局中医药、民族医药科学技术研究课题合同书(No:QZYY2013-91)

作者(Author): 陈燕;张金娟;张彦燕;许键炜;熊英;杨勤;
CHEN Yan;ZHANG Jinjuan;ZHANG Yanyan;XU Jianwei;XIONG Ying;YANG Qin;The Affiliated Baiyun Hospital of Guizhou Medical University;Functional Laboratory,Guizhou Medical University;Department of Pharmacology,Guizhou Medical University;Department of Pathophysiology,Guizhou Medical University;

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DOI: 10.19367/j.cnki.1000-2707.2016.04.030

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