丹参酮ⅡA-聚乙烯吡咯烷酮K30固体分散体的稳定性考察  

Stability of TanshinoneⅡ_A-PVPK30 Solid Dispersion

作　　者：何丹[1] 杨翠平[2] 杨林 范琦[1] 

机构地区：[1]重庆医科大学药学院,重庆市400016 [2]中山大学生命科学学院,广州市510275 [3]重庆市药品检验所,重庆市400015

出　　处：《中国药房》2008年第18期1408-1409,共2页China Pharmacy

摘　　要：目的:考察温度、湿度及光照对丹参酮ⅡA-聚乙烯吡咯烷酮(PVP)K30固体分散体质量的影响。方法:以丹参酮ⅡA为指标成分,选用影响因素稳定性试验,在不同温度、湿度及光照条件下,用高效液相色谱法进行含量测定。结果:高温及强光均能降低丹参酮ⅡA-PVPK30固体分散体中丹参酮ⅡA的含量;而湿度虽未影响丹参酮ⅡA的含量,但由于PVP的引湿性,可引起丹参酮ⅡA-PVPK30固体分散体自身质量的增加。结论:丹参酮ⅡA-PVPK30固体分散体应干燥、常温、避光贮存。OBJECTIVE： To study the influence of temperature, humidity and illumination on Tanshinone ⅡA- PVPK30 solid dispersion. METHODS： Using Tanshinone ⅡA as testing index to study the stability of Tanshinone ⅡA -PvPK30 solid dispersion at different temperature, humidity and illumination. The content of Tanshinone ⅡA was determiend by HPLC. RESULTS： The content of Tanshinone ⅡA in Tanshinone HA- PVPK30 solid dispersion decreased in high temperature and strong illumination, but which was free from the influence of the humidity. Due to the hygroscopicity of PVP, the mass of Tanshinone ⅡA- PVPK30 solid dispersion increased in itself. CONCLUSION： The Tanshinone ⅡA- PVPK30 solid dispersion should be kept in dryness, normal temperature and away from light.

关 键 词：丹参酮ⅡA 固体分散体 稳定性 

分 类 号：R283.62[医药卫生—中药学] R927.11[医药卫生—中医学]