阿司匹林脉冲控释片的研制

Preparation of Pulsed Controlled-release Aspirin Tablets

以阿司匹林为模型药物制备脉冲片,并考察各处方因素对脉冲片释放度的影响.以主药和崩解剂为片芯,乙基纤维素(EC)为包衣材料,聚乙二醇6000(PEG6000)为致孔剂,羟丙甲基纤维素(HPMC)为增塑剂,采用压制包衣法制备含阿司匹林50 mg的脉冲控释片.各辅料的比例及包衣层厚度对阿司匹林片的脉冲释放均有影响.通过对处方的优化,得最终处方为主药50 mg、崩解剂30 mg,EC 180 mg,PEG6000 60 mg,HPMC 30 mg的阿司匹林脉冲控释片.通过选择片芯中的崩解剂、调整包衣层组成和厚度,可以用压制包衣的方法得到不同时间脉冲释药的阿司匹林片剂.

Pulsatile tablets of aspirin as a model drug was prepared,and all the factor that could influence the results of release are investigated.The pulsatile-release tablets containing aspirin 50 mg were prepared by press-coated methods using aspirin and disintegrants as core,ethylcellulose（EC） as coating material,PEG 6000 as pore former and HPMC as plasticizer.The pulsatile release of aspirin was influenced by the formulation of the core and the composition and thickness of the coating film.By optimizing the prescription,the final prescription was determined as aspirin 50 mg,CMS-Na 30 mg,EC 180 mg,PEG6000 60 mg,HPMC 30 mg.The pulsatile release of aspirin could be controlled by selection of disintegrants of the core and changing composition and thickness of the coating material.