替硝唑温敏性阴道用原位凝胶的制备及其质量控制

Preparation and Quality Control of Tinidazole T-sensitive In-situ Gel for Vaginal Application

目的:制备替硝唑温敏性阴道用原位凝胶,并对其体外性质进行考察,为其体内研究奠定基础。方法:以泊洛沙姆P407与P188为基质,用冷法制备替硝唑原位凝胶。对其胶凝温度、胶凝强度及生物黏附性等主要物理性质进行考察,并对其质量进行控制。结果:本品具有合适的胶凝温度,胶凝强度理想,生物黏附性较强,适合阴道给药。主要质量评价指标简单易行,符合相关规定。结论:替硝唑温敏性阴道用原位凝胶制备简单,性质理想,值得进一步研发。

Objective： To prepare tinidazole T-sensitive in-situ gel for vaginal application and study its quality in vitro in order to lay foundation for the study in vivo. Method： Tinidazole in-situ gel was prepared by cooling method,peloxmer P407 and P188 were used as base. The properties of the gel,including gelling temperature, gelling strength and bio-adhesive were studied and the quality of the gel was also controlled. Result： The main properties of the gel were all promising for vaginal application. The quality of the gel in vitro met the rel- ative rtdes. Conclusion： Tinidazole T-sensitive in-situ gel with simple preparation and good quality is valuable to be studied further.