【摘要】：目的:制備辛苯聚醇陰道用溫敏凝膠[(O-9)-VTG],并對(duì)其釋放機(jī)制進(jìn)行探討。方法:采用冷溶法以泊洛沙姆407(P407)和泊洛沙姆188(P188)為溫敏凝膠材料制備凝膠,倒置法測(cè)定其膠凝溫度(TGEL),再應(yīng)用星點(diǎn)設(shè)計(jì)-效應(yīng)面法優(yōu)化處方,并采用無(wú)膜溶出模型考察其體外溶蝕及釋藥情況。結(jié)果:優(yōu)化的處方基質(zhì)配比為P407∶P188∶甘油∶殼聚糖=16.3∶5.7∶5∶0.6,膠凝溫度為33℃,膠凝時(shí)間約1.6 min;辛苯聚醇體外釋放符合零級(jí)動(dòng)力學(xué)方程。結(jié)論:效應(yīng)面法篩選辛苯聚醇溫敏凝膠處方合理,(O-9)-VTG作為新型陰道用避孕制劑前景良好。
[Abstract]:Aim: to prepare (O-9)-VTG for octylbenzene polyol vagina and to investigate its release mechanism. Methods: Poloxamer 407 (P407) and Poloxamer 188 (P188) were used as thermosensitive gels to prepare gels. The gelation temperature (TGEL) was determined by inversion method. The formulation was optimized by star design-effect surface method. The dissolution and drug release in vitro were investigated by using film-free dissolution model. Results: the optimized formulation matrix ratio was P407: P188: glycerol: chitosan: 16.3: 5.7: 5: 0.6, the gelation temperature was 33 鈩，

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