隐丹参酮固体分散体制备工艺研究

Technology Study for Preparation of Cryptotanshinone-PVP Solid Dispersion

目的研究隐丹参酮-聚乙烯吡咯烷酮(PVP)固体分散体的最佳制备工艺。方法采用减压干燥法制备,正交试验优化,以隐丹参酮为检测指标,用高效液相色谱法测定体外溶出度。结果最佳制备工艺为5倍量的载体、4倍量的粮食酒精溶解、减压干燥1h,隐丹参酮的体外溶出百分率为72.5%。结论用减压干燥法成功地制备了隐丹参酮-PVP固体分散体,其对隐丹参酮有很好的增溶效果。

Objective To study the optimum procedure of the cryptotanshinone-PVP solid dispersions. Methods The decompress dryness was used to prepare the solid dispersions of cryptotanshinone- PVP. The optimum preparing process was selected by the orthogonal test. The dissolution characteristics of the solid dispersions in vitro were analyzed by HPLC method, using cryptotanshinone as testing index. Results The optimum condition of decompress dryness was as follows： with 5 times carriers, dissolved in 4 times food alcohol, decompress dryness for 1 h, the in vitro dissolution rates of cryptotanshinone-PVP solid dispersion were up to 72. 5%. Conclusion The decompress dryness can be used to prepare the solid dispersions of cryptotanshinone- PVP successfully and the solid dispersion prepared with PVP can increase the dissolution of the cryptotanshinone obviously.