【摘要】 采用液相中药物球型结聚技术制备了阿司匹林结聚颗粒和微丸,二硝酸异山醇酯(消心痛)微丸,并考察了实验主要影响因素。结果表明,溶剂体系种类和比例的选择为主要关键,药物浓度,操作温度和搅拌转速等也影响制剂的质量。制备过程不改变阿司匹林和二硝酸异山梨醇酯的化学结构。结聚颗粒中阿司匹林的溶出优于原料结晶,加有乙基纤维素的阿司匹林微丸在体外有一定程度的延缓释药效果。更多还原

【Abstract】 The method of drug agglomeration by spherical crystallization technique was established and the major influence factors were examined. The agglomerated particles and micropellets of aspirin and the micropellets of isosorbide dinitrate were successfully prepared in experiments. It was found that the main influences on drug agglomeration were the physical and chemical properties of drugs and solvent systems used. Drug concentrations, experimental temperatures and agitation patterns also showed important effects on drug agglomeration. The analytical results by different means indicated that the procedures of preparation exerted no effects on the chemical and crystal properties of aspirin and isosorbide dinitrate in the formulations. The studies on the products showed that the agglomerated particles of aspirin possessed a faster dissolution rate than the raw crystals, while a sustained release effect was obtained by the addition of ethyl cellulose to the formulations.更多还原