【摘要】：目的:研制雌二醇陰道用生物黏附性溫敏型凝膠(E2-VTISG),并進行熱力學(xué)和流變學(xué)考察。方法:采用冷法工藝制備E2-VTISG。采用倒試管法測定膠凝溫度(Tgel),以Tgel為考察指標,泊洛沙姆P407,泊洛沙姆P188為主要影響因素,用星點設(shè)計-效應(yīng)面法進行處方篩選。采用黏度計測定表觀粘度,采用動態(tài)流變學(xué)實驗測定溫敏凝膠在相變過程中的流變參數(shù)。結(jié)果:雌二醇陰道用生物黏附性溫敏型凝膠的最優(yōu)處方的基質(zhì)配比為P407∶P188∶甘油∶PCP∶尼泊金乙酯=18∶2.96∶5∶0.2∶0.2,實測膠凝溫度為33.4℃。結(jié)論:星點設(shè)計-效應(yīng)面法篩選E2-VTISG處方預(yù)測性良好,流變學(xué)結(jié)果顯示優(yōu)化后的雌二醇溫敏凝膠符合陰道局部用藥要求。
[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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