【摘要】：目的:制備白藜蘆醇-泊洛沙姆188固體分散體(RES-P188-SD),并對其體外溶出特性及抑菌性進(jìn)行研究。方法:以P188為載體,采用溶劑法制備RES-P188-SD。以藥物與載體質(zhì)量比、熔融溫度、篩孔目數(shù)為考察因素,以RES溶解度與收率為考察指標(biāo),設(shè)計(jì)L9(34)正交試驗(yàn)優(yōu)選其制備工藝。以考察指標(biāo)的綜合評分進(jìn)行結(jié)果分析,并進(jìn)行驗(yàn)證試驗(yàn)。根據(jù)最優(yōu)工藝制備RES-P188-SD后采用籃法測定其溶出度并計(jì)算累積溶出度,掃描電鏡法分析物相表征,管碟法測定其抑菌性。結(jié)果:最優(yōu)工藝為藥物與載體質(zhì)量比1∶10,熔融溫度70℃,篩孔目數(shù)80目。按最優(yōu)工藝所制樣品的平均溶解度為0.51 mg/ml(RSD=1.96%,n=3),平均收率為91%(RSD=0.64%,n=3),15 min的平均累積溶出度即達(dá)83%(RSD=0.69%,n=3);其藥物以非晶形式均勻分散在載體中;RES-P188-SD對金黃色葡萄球菌和大腸埃希菌均有抑制作用。結(jié)論:優(yōu)選工藝穩(wěn)定、可行。成功制得RES-P188-SD,可為提高RES的溶解度、溶出速率及抑菌性提供依據(jù)。
[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，

本文編號：2400652