雌二醇阴道用生物黏附性温敏型凝胶的处方筛选及流变学考察

发布时间：2018-09-12 19:21

【摘要】：目的:研制雌二醇阴道用生物黏附性温敏型凝胶(E2-VTISG),并进行热力学和流变学考察。方法:采用冷法工艺制备E2-VTISG。采用倒试管法测定胶凝温度(Tgel),以Tgel为考察指标,泊洛沙姆P407,泊洛沙姆P188为主要影响因素,用星点设计-效应面法进行处方筛选。采用黏度计测定表观粘度,采用动态流变学实验测定温敏凝胶在相变过程中的流变参数。结果:雌二醇阴道用生物黏附性温敏型凝胶的最优处方的基质配比为P407∶P188∶甘油∶PCP∶尼泊金乙酯=18∶2.96∶5∶0.2∶0.2,实测胶凝温度为33.4℃。结论:星点设计-效应面法筛选E2-VTISG处方预测性良好,流变学结果显示优化后的雌二醇温敏凝胶符合阴道局部用药要求。
[Abstract]:Objective: to study the thermodynamics and rheology of bioadhesive thermosensitive gel (E2-VTISG) for estradiol vagina. Methods: E2-VTISG was prepared by cold method. The gelation temperature (Tgel),) was determined by reverse test tube method. Tgel was used as the index, Poloxamer P407 and Poloxamer P188 as the main influencing factors. The prescription was screened by star design-effect surface method. The apparent viscosity was measured by viscometer and the rheological parameters of thermo-sensitive gel during phase transition were measured by dynamic rheological experiment. Results: the optimum matrix ratio of bioadhesive thermo-sensitive gel for estradiol vagina was: P407: P188: glycerol: PCP: Nipagin ethyl ester 18: 2. 96: 5: 0.2: 0.2. 2. The actual gelation temperature was 33.4 鈩，

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