【摘要】 目的:制备他克莫司自微乳并对其质量进行初步评价。方法:通过处方筛选和优化确定了他克莫司自微乳的处方组成,并对制备的他克莫司自微乳进行了质量评价。结果:制备的他克莫司自微乳稀释200倍后的粒径为(29.2±0.5)nm;30℃时的黏度为290mPa·s;15min时溶出度为80.2%,1h为92.5%;他克莫司自微乳在(25±2)℃,相对湿度(60±10)%的条件下放置12个月,含量降低1.92%,有关物质增长0.44%。结论:制备了他克莫司自微乳,并对开发他克莫司新制剂奠定了基础。更多还原

【Abstract】 OBJECTIVE To prepare tacrolimus self-microemulsion and evaluate its qualityMETHODS By screening and optimizing tests,the prescription of FK506 self-microemulsion(FK506 SME) was confirmed and the quality of FK506 SME was evaluated.RESULTS The mean particle size of FK506 SME was 29.2 nm 0.5 nm diluted 200 times by water;the viscosity was 290 mPa s at 30 ℃;the dissolution rate of FK506 SME was 80.2% in 15 min,92.5% in 1 hour;the content of FK506 SME reduced 1.92% and related substances increased 0.44% under the condition of(25±2)℃ and(60± 10)% relative humidity 12 months later.CONCLUSION The preparation of tacrolimus self-microemulsion laid the foundations of developing tacrolimus new dosage form.更多还原