丹参酮Ⅱ_A固体分散体制备工艺研究

Study on Preparation Technology of Solid Dispersion of TanshinoneⅡA-PVP by Orthogonal Test

目的研究减压干燥法制备丹参酮ⅡA-聚乙烯吡咯烷酮K30(PVPK30)固体分散体的最佳工艺。方法采用减压干燥法制备,正交试验优化,以丹参酮ⅡA为检测指标,用高效液相色谱法进行体外溶出度的测定。结果制备丹参酮ⅡA-PVPK30固体分散体的最佳工艺为用5倍量的载体、4倍量的粮食酒精溶解,减压干燥1h。丹参酮ⅡA的体外溶出百分比为60.1%。结论用减压干燥法成功制备了丹参酮ⅡA-PVPK30固体分散体,该固体分散体对丹参酮ⅡA有很好的增溶效果。

Objective To study the optimum procedure of the tanshinone ⅡA-PVP K30 solid dispersions by the decompression dryness.Methods The decompression dryness was used to prepare the solid dispersions of tanshinone ⅡA-PVP K30.The optimum preparing process method was selected and optimized by the orthogonal test.The dissolution characteristics of the solid dispersions in vitro were analyzed by HPLC method,using tanshinoneⅡA as testing index.Results The optimum condition of decompression dryness was follows：with 5 times amount of carriers,dissolved in 4 times amount of grain alcohol,decompressing dryness for 1 h,the in vitro dissolution rates of tanshinoneⅡA PVP solid dispersion were up to 60.1%.Conclusion The decompression dryness can be used to prepare the solid dispersions of tanshinone ⅡA-PVP K30 successfully and the solid dispersions prepared with PVP can increase the dissolution of the tanshinoneⅡA obviously.