论文部分内容阅读
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:以泊洛沙姆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。
OBJECTIVE: To prepare temperature sensitive in situ gels (ISG) of sparfloxacin (SF) and investigate its in vitro properties to lay the foundation for the development of new SF preparations. Methods: Poloxamer 407 and 188 (mass ratio of 3: 4) as a substrate, prepared by cold SF-ISG. In vitro gel temperature, gel strength and bioadhesion and other major physical properties were investigated, and its quality control was initially explored. Results: This product has the appropriate gelation temperature required for ear ISG, gel strength ideal, strong bio-adhesive. The main quality evaluation index is simple and easy, and in line with the relevant provisions. Conclusion: SF temperature-sensitive ear ISG preparation is simple, ideal properties, worth further research and development.