自制复方酮康唑软膏的药效学和安全性研究
投稿时间:2019-09-19  修订日期:2020-02-18  点此下载全文
引用本文:严佳,吴博,陶春,宋洪涛.自制复方酮康唑软膏的药效学和安全性研究[J].药学实践杂志,2020,38(4):322~327
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作者单位E-mail
严佳 中国人民解放军联勤保障部队第九〇〇医院药学科, 福建 福州 350025  
吴博 中国人民解放军联勤保障部队第九〇〇医院药学科, 福建 福州 350025
福建医科大学药学院, 福建 福州 350108 
 
陶春 中国人民解放军联勤保障部队第九〇〇医院药学科, 福建 福州 350025 sohoto@vip.163.com 
宋洪涛 中国人民解放军联勤保障部队第九〇〇医院药学科, 福建 福州 350025  
基金项目:福建省自然科学基金项目(编号2018J01347)
中文摘要:目的 评价自制复方酮康唑软膏的药效学和安全性。方法 采用纸片扩散法,选取6种真菌和2种细菌,考察自制软膏及3种市售制剂对抑菌圈直径的影响。另外,采用单次和多次给药的皮肤刺激性,及皮肤变态反应,评价自制软膏的安全性。结果 自制软膏与含酮康唑的市售制剂类似,均对6种真菌产生了显著的抑菌圈。对铜绿假单胞菌,各制剂均未产生抑菌圈;对金黄色葡萄球菌,自制软膏与市售莫匹罗星软膏的抑菌圈相似,且显著大于其他市售制剂。给予自制软膏后,皮肤刺激反应评分均小于0.5,致敏率为0,组织结构与正常皮肤无差异。结论 自制的复方酮康唑软膏的抑菌性能优于多数市售制剂,且具有良好的皮肤安全性,有望用于皮肤浅部真菌感染的治疗。
中文关键词:酮康唑  莫匹罗星  糠酸莫米松  软膏  抑菌性能  安全性
 
Study on pharmacodynamics and safety of self-made compound ketoconazole ointment
Abstract:Objective To evaluate the pharmacodynamics and safety of the self-made compound ketoconazole ointment.Methods Using the disk diffusion test, 6 kinds of fungi and 2 kinds of bacteria were selected to investigate the effect of the self-made ointment and 3 commercial products on the diameter of the bacteriostatic circle. In addition, the skin irritation and skin allergies of the single and multiple applications were used to evaluate the safety of the self-made ointment.Results The self-made ointment was similar to the commercial products containing ketoconazole. They all showed remarkable bacteriostatic circle against the 6 kinds of fungi. For pseudomonas aeruginosa, none of the preparations contributed to visible bacteriostatic circle. For staphylococcus aureus, the bacteriostatic circle of the self-made ointment was similar to that of commercial mupirocin ointment and was significantly larger than other commercial products. After the treatment with the self-made ointment, the score of the skin irritation was below 0.5 and the sensitization rate was 0. There was no difference in tissue structure between treated and normal skin.Conclusion The self-made compound ketoconazole ointment has better safety and better antibacterial property than the commercial products. It is expected to be used for the treatment of superficial skin fugle infections.
keywords:ketoconazole  mupirocin  mometasone furoate  ointment  antibacterial property  safety
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