司帕沙星耳用原位凝胶的制备及质量评价

目的：制备司帕沙星（SF）温敏性耳用原位凝胶（ISG），对其体外性质进行考察，为研发SF新制剂奠定基础。方法：以泊洛沙＂~407与188（质量比为3：4）为基质，用冷法制备SF-ISG。对其体外胶凝温度、胶凝强度及生物黏附性等主要物理性质进行考察，并对其质量控制进行了初步探索。结果：本品具有耳用ISG要求的合适的胶凝温度，胶凝强度理想，生物黏附性较强。主要质量评价指标简单易行，并符合相关规定。结论：SF温敏性耳用ISG制备简单，性质理想，值得进一步研发。

Study on the Preparation and Quality Evaluation of Sparfloxacin In-situ Gel for Ear Application

Objective:To prepare sparfloxacin(SF)temperature-sensitive in-situ gel(ISG)for ear application and study its quality in vitro in order to develop a new preparation of SF.Method:SF-ISG was prepared by cooling method using poloxmer 407 and 188 with mass ratio of 3:4 as the base.The in vitro properties of the gel,including gelling temperature,gelling strength and bioadhesive were studied and the quality of the gel was also evaluated.Result:The main in vitro properties of the gel were all promising for ear appl...