硝酸咪康唑搽剂多次皮肤刺激性试验及皮肤过敏试验研究
Study of the Skin Irritation and Skin Allergenic Effect of Miconazole Nitrate Liniment
摘要:
目的:对硝酸咪康唑搽剂皮肤的刺激性和致敏性进行了动物实验观察。方法:以家兔为模型进行多次给药皮肤刺激实验。以豚鼠为模型观察硝酸咪康唑搽剂的皮肤致敏作用。结果:硝酸咪康唑搽剂多次给药对家兔正常皮肤和损伤皮肤有轻度刺激性,不引起豚鼠出现过敏反应。结论:硝酸咪康唑搽剂在动物外用是相对安全的,这些动物实验结果为临床用药提供实验依据。
Abstract:
Objective: To study the skin irritation and skin allergenic effect of miconazole nitrate liniment. Methods: Multiple dosing skin irritation test was carried out with rabbit model, and skin sensitization experiment was observed with guinea pig. Results: Miconazole nitrate liniment had mild irritation on the normal skin and the wounded skin, and no allergic response was induced in guinea pig. Conclusion: Miconazole nitrate liniment is relatively safe for external use in animals. These animal experimental results provide experimental basis for clinical medication.
参考文献
|
[1]
|
国家食品药品监督管理局. 【H】GPT4-1《化学药物刺激性、过敏性和溶血性研究技术指导原则》[Z], 2005-03.
|
|
[2]
|
张秉华, 宋莉, 杜珊, 等. HPLC法测定硝酸咪康唑原料有关物质的研究[J]. 药物分析杂志, 2013, 33(4): 638-641.
|
|
[3]
|
李彩文, 陈宝泉, 骆红琴. 硝酸咪康唑乳膏的处方筛选及其质量控制[J]. 天津理工大学学报, 2007, 23(5): 43-45.
|
|
[4]
|
刘燕. 硝酸咪康唑乳膏中防腐剂测定方法的建立[J]. 中国药业, 2015, 20(24): 85-86.
|
|
[5]
|
杨立运, 杨其燕. 硝酸咪康硝酸咪康唑乳膏在新生儿臀红治疗中的效果观察[J]. 大家健康, 2017, 11(30): 185.
|