氟康唑温敏型原位眼用凝胶基质处方优化

Formulation Optimization of Fluconazole Ophthalmic Thermosensitive Gels

目的优选氟康唑温敏型原位眼用凝胶基质处方。方法采用正交实验法,选取泊洛沙姆407、泊洛沙姆188和丙二醇等辅料用量为考察因素,凝胶温度(T_1)和被模拟泪液稀释后的胶凝温度(T_2)的综合评分为指标,按L9(3~4)正交表进行设计,对基质处方进行优化。结果氟康唑温敏型原位眼用凝胶最佳基质处方为(质量体积比):泊洛沙姆407(P407) 22%、泊洛沙姆188(P188) 4%和丙二醇6%。结论正交设计法优选出的氟康唑温敏型原位眼用凝胶基质性能良好,性质稳定。

Objective To optimize the formulation of fluconazole ophthalmic thermosensitive gel. Methods The matrix formulation was optimized by L9（34） orthogonal design, using the amounts of Poloxamer407（P407）, Poloxamer188（P188） and propylene glycol as factors, gelation temperature （T1） and gelatinization temperature （T2） after diluted by simulated tear as index. Results The best formulation of fluconazole ophthalmic thermosensitive gel （mass to volume ratio） was： Poloxamer407 （P407） 22%, Poloxamer188 （P188） 4%, propylene glycol 6%. Conclusion The prescription of fluconazole ophthalmic thermosensitive gel was reasonable, and the quality of the ophthalmic gel is stable.