白藜芦醇-泊洛沙姆188固体分散体的制备及其性能研究

发布时间：2019-01-04 18:41

【摘要】：目的:制备白藜芦醇-泊洛沙姆188固体分散体(RES-P188-SD),并对其体外溶出特性及抑菌性进行研究。方法:以P188为载体,采用溶剂法制备RES-P188-SD。以药物与载体质量比、熔融温度、筛孔目数为考察因素,以RES溶解度与收率为考察指标,设计L9(34)正交试验优选其制备工艺。以考察指标的综合评分进行结果分析,并进行验证试验。根据最优工艺制备RES-P188-SD后采用篮法测定其溶出度并计算累积溶出度,扫描电镜法分析物相表征,管碟法测定其抑菌性。结果:最优工艺为药物与载体质量比1∶10,熔融温度70℃,筛孔目数80目。按最优工艺所制样品的平均溶解度为0.51 mg/ml(RSD=1.96%,n=3),平均收率为91%(RSD=0.64%,n=3),15 min的平均累积溶出度即达83%(RSD=0.69%,n=3);其药物以非晶形式均匀分散在载体中;RES-P188-SD对金黄色葡萄球菌和大肠埃希菌均有抑制作用。结论:优选工艺稳定、可行。成功制得RES-P188-SD,可为提高RES的溶解度、溶出速率及抑菌性提供依据。
[Abstract]:Aim: to prepare resveratrol-Poloxamer 188 solid dispersion (RES-P188-SD) and study its dissolution and bacteriostatic properties in vitro. Methods: using P188 as carrier, RES-P188-SD. was prepared by solvent method. The preparation process of L9 (34) orthogonal experiment was designed with the mass ratio of drug to carrier, melting temperature and mesh number as the factors, and the solubility and yield of RES as the indexes. The results were analyzed with the comprehensive score of the inspection index, and the validation test was carried out. The dissolution of RES-P188-SD was determined by basket method, the cumulative dissolution was calculated, the phase characterization was analyzed by scanning electron microscope, and the bacteriostasis was determined by tube disc method. Results: the optimum conditions were as follows: the mass ratio of drug to carrier was 1: 10, the melting temperature was 70 鈩，

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