苦蛇治霉滴耳剂的制备及其临床疗效观察  

Preparation of Kushen Antifungal Ear Drops and its clinical efficacy in the treatment of fungal otitis externa

作　　者：牟珊[1] 张勤修[1] 刘志庆[1] 朱聪[2] MU Shan;ZHANG Qinxiu;LIU Zhiqing;ZHU Cong(Dept of Otolaryngology,the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine,Sichuan,610072,China)

机构地区：[1]成都中医药大学附属医院耳鼻咽喉科,四川成都610072 [2]成都中医药大学附属医院药剂科,四川成都

出　　处：《中国中西医结合耳鼻咽喉科杂志》2024年第5期332-335,共4页Chinese Journal of Otorhinolaryngology in Integrative Medicine

基　　金：四川省中医药管理局中医药应用及开发研究专项课题(2021MS192)。

摘　　要：目的探讨苦蛇治霉滴耳剂的制备工艺与质量控制程序,观察该制剂治疗真菌性外耳道炎的临床疗效。方法采用常规制备工艺将该组方制备为滴耳剂,同时建立质量控制规范操作流程。收集在本院门诊就诊的真菌性外耳道炎患者300例,随机分为观察组160例和对照组140例。所有患者均彻底清洁外耳道,然后各组分别接受不同治疗。对照组患者以4%硼酸酒精滴耳液耳浴,治疗组患者则以苦蛇治霉滴耳剂耳浴,均为每日2次,7d为1疗程,共治疗2疗程。疗程结束后评定两组患者的治疗效果。结果该制剂生产工艺可行,质量控制良好。观察组有效率95.43%,明显优于对照组的有效率80.74%(P<0.01)。结论苦蛇治霉滴耳剂组方合理,质量标准稳定可控,治疗真菌性外耳道炎疗效确切,无明显毒副作用。Objective To investigate the preparation process and quality control standards of Kushen Antifungal Ear Drops(KAED)and its clinical efficacy in the treatment of fungus otitis externa(FOE).Methods KAED was prepared by using conventional preparation process,with quality control process established at the same time following standard operating procedures set up.Then,300 patients with FOE were collected from outpatient department in our hospital,randomly divided into the observation group(OG)and control group(CG).Cases in CG were treated by 4%boric acid alcohol in a form of ear canal soaking,while those in OG were treated by KAED,also in the form of ear canal soaking,both given twice a day and 7 days for a therapeutic course,two courses in total.Then,the therapeutic efficacy and safety of these two kinds of therapy were evaluated among these cases in a comparative way.Results The production process of the preparation was feasible and the quality control was satisfied.The total effective rate of OG was 95.43%,significantly higher than that of 80.74%in CG(P<0.01).Conclusion The preparation process and quality control standards of Kushen Ear Drops are practically feasible,with definite therapeutic effect on fungal otitis externa and no obvious toxic side effects when applied topically.

关 键 词：苦蛇治霉滴耳剂 制备工艺 质量控制 真菌性外耳道炎 临床疗效 

分 类 号：R283.6[医药卫生—中药学]