丹参酮ⅡA二元载体固体分散体的研究  

Study on solid dispersion of binary vector of tanshinone Ⅱ_A

作　　者：蒋艳荣[1,2] 张振海[1] 陆艳[2] 唐静[2] 马甜甜[2] 贾晓斌[1,2] 

机构地区：[1]江苏省中医药研究院国家中医药管理局中药释药系统重点研究室,江苏南京210028 [2]南京中医药大学,江苏南京210046

出　　处：《中国中药杂志》2012年第10期1383-1387,共5页China Journal of Chinese Materia Medica

基　　金：国家自然科学基金项目(30572372,30973944);江苏省高等学校大学生创新训练计划项目(011042004000)

摘　　要：目的:将纳米二氧化硅(nano-silica)和泊洛沙姆188联合应用于丹参酮ⅡA(TSⅡA)固体分散体的制备,考察丹参酮ⅡA固体分散体的溶出度和稳定性。方法:以纳米二氧化硅和泊洛沙姆188为二元载体,采用溶剂法制备丹参酮ⅡA固体分散体,对其物相特征、溶出行为和稳定性进行了研究。结果:纳米二氧化硅和泊洛沙姆188按1∶3比例制备的丹参酮ⅡA固体分散体,经差示扫描量热分析,固体分散体中药物以非晶形式存在于载体中;60 min时药物的体外累积溶出率达到90%以上;经过3个月稳定性加速试验后,固体分散体中药物溶出和含量未发生明显变化。结论:丹参酮ⅡA二元载体固体分散体能显著改善丹参酮ⅡA的溶出,其稳定性好,具有实际应用价值。Objective： To prepare the solid dispersion of tanshinone ⅡA （TS ⅡA） by the combined application of nano-silica and poloxamer 188 （F68）, in order to observe its dissolution and stability. Method： Tanshinone ⅡA solid dispersion was prepared by the solvent method with nano-silica and poloxamer 188 as binary vectors. Its physical characteristics, in vitro dissolution and stability were further assessed. Result： The tanshinone ⅡA solid dispersion was prepared with the weight ratio of nano-silica and poloxamer 188 of 1 ： 3. The differential scanning calorimetry （DSC） demonstrated that Tanshinone ⅡA existed in vectors as amorphous state. The in vitro dissolution of tanshinone ⅡAsolid dispersion is up to 90% at 60 min. Accelerating experiment showed that content and in vitro dissolution of tanshinone ⅡA solid dispersion did not change after storage over 3 months. Conclusion： Solid dispersion of binary vector of tanshinone ⅡA can obviously improve the dissolution and stability of tanshinone Ⅱ in practice.

关 键 词：丹参酮ⅡA 纳米二氧化硅 固体分散体 溶出度 稳定性 

分 类 号：R283[医药卫生—中药学]