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目的:研制复方联苯苄唑涂膜剂,观察复方联苯苄唑涂膜剂对手足癣的临床疗效。复方联苯苄唑涂膜剂。方法:将1%联苯苄唑和6%间苯二酚配伍,以聚乙烯醇-124为基质制成涂膜剂。分别对联苯苄唑和间苯二酚进行鉴别和含量测定。临床设研究组和对照组对比观察疗效,研究组用复方联苯苄唑涂膜剂,对照组用联苯苄唑凝胶,外用,qd,4周为1个疗程。并作真菌学检查。结果:质量控制符合标准。1个疗程后,研究组痊愈率69%,总有效率92%,2组比较差异有显著性(P<0.05)。对335例常见致病菌,复方联苯苄唑涂膜剂的MIC为1.6~13.1mg.L-1。结论:药物质量可控,疗效显著,不良反应少,使用方便,值得临床推广。
OBJECTIVE: To develop a compound bifonazole film-coating agent and observe the clinical effect of compound bifonazole film-coating agent on hand, foot and ringworm. Compound bifonazole coating agent. Methods: 1% bifonazole and 6% resorcinol compatibility, with polyvinyl alcohol-124 as a coating agent. Differentiation and determination of bifonazole and resorcinol were carried out respectively. Clinical study group and control group compared the efficacy of observation, the study group with bifonazole compound film, the control group with bifonazole gel, topical, qd, 4 weeks for a course of treatment. And for mycological examination. Result: Quality control meets the standards. After one course of treatment, the study group had a cure rate of 69% and a total effective rate of 92%. There was a significant difference between the two groups (P <0.05). 335 cases of common pathogens, compound bifonazole coated film MIC of 1.6 ~ 13.1mg.L-1. Conclusion: Drug quality control, significant effect, less adverse reactions, easy to use, is worth clinical promotion.