57柚皮素PVP固体分散体制备及体外特性研究.docVIP

柚皮素-PVPk-30固体分散体的制备及体外特性研究 廖正根， 戴春兰， 王光发， 赵国巍， 梁新丽， 张南 （江西中医学院现代中药制剂教育部重点实验室，江西，南昌，330004） 关键词： 柚皮素；喷雾干燥；固体分散体；溶出度 摘要：目的：采用固体分散技术提高柚皮素的体外溶出度。方法：以PVPk-30为载体采用喷雾干燥法制备柚皮素固体分散体，进行饱和溶解度和体外溶出度实验；采用差示扫描量热法（DSC）和X-射线衍射法分析药物的存在状态，红外光谱法（IR）分析药物与载体间的相互作用。结果：与原料药及物理混合物相比，固体分散体的溶解度、溶出速度和程度均有明显提高，DSC和X-射线衍射法分析表明药物在载体中以无定形或分子状态存在，红外光谱法测定结果显示柚皮素与PVPK-30可能以分子间氢键结合在一起。结论：采用喷雾干燥法制备的柚皮素- PVPk-30 固体分散体可显著提高柚皮素的溶解度及溶出速度。 Study on Preraration of Naringenin-PVPk-30 Solid Dispersion and its Characteristics in Vitro Zheng-Gen Liao, Chun-Lan Dai, Guang-Fa Wang , Guo-Wei Zhao,Xin-Li Liang, Nan Zhang Key Laboratory of Modern Preparation of TCM (JiangXi University of Traditional Chinese Medicine), Ministry of Education, jiangxi Nanchang, 330004, China Key words: Naringenin; Spray Drying; Solid dispersion; Dissolution Abstract: Objective: The dissolution of naringenin was improved by solid technology. Methods: Solid dispersion of Naringenin was prepared by spray-drying technique with PVPk-30 as the carrier, and the saturation solubility and In vitro dissolution of naringenin was studied; The physical state was characterized by Differential Scanning Calorimetry(DSC) 、X-ray diffractometry and the possible molecular interaction between Naringenin and PVPk-30 was characterized by.infrared spectroscopy (IR). 基金项目：江西省卫生厅中医药科研基金(2008A012) ，国家科技重大专项(重大新药创制2009ZX09310-005) 作者简介：廖正根（1967~），男，博士，教授，从事药物新剂型与新技术研究，电话：0791-7119011，E-mail：lyzlyg@163.com Results: The results showed that the vitro dissolution rate and extent of naringenin was significantly improved by solid dispersion compared to that of the pure drug and physical mixture, Solubility studies revealed a markedly increase in the solubility of naringenin, The results of DSC and X-ray diffractometry showed that the naringenin in solid dispersion was amorphous form, The results of infrared spectroscopy showed that naringenin is possibly interacted with PVPk-30 via intermolecular hydrogen bond.Conclusion: The solubility and dissolution of naringenin