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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 thermosensitive vaginal in situ gels, and to investigate their in vitro properties, which laid the foundation for their in vivo studies. Methods: Poloxamer P407 and P188 were used as matrix to prepare tinidazole in situ gel by cold method. The gelation temperature, gel strength and bioadhesion and other major physical properties were investigated, and its quality control. Results: This product has a suitable gelation temperature, ideal gel strength, strong bioadhesion, suitable for vaginal administration. The main quality evaluation index is simple and easy, in line with the relevant provisions. Conclusion: Tinidazole thermosensitive vaginal in situ gel preparation is simple, the nature of ideal, worthy of further research and development.