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。
OBJECTIVE To prepare tacrolimus self-microemulsion and evaluate its qualityMETHOl）S By screening and op- timizing 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 hu midity 12 months later. CONCLUSION The preparation of tacrolimus self-microemulsion laid the foundations of developing tacrolimus new dosage form.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2012年第24期1975-1979,共5页
Chinese Journal of Hospital Pharmacy
关键词
他克莫司
自微乳
溶出度
稳定性
tacrolimus
self-microemulsion
dissolution rate
stability
