摘要
目的:采用定时释药技术制备复方中药舒胸缓释制剂。方法:以崩解时间、加水后片剂体积膨胀率为指标,筛选片芯处方。采用压制包衣技术,选用聚乙二醇6000、氢化蓖麻油和乙烯-醋酸乙烯共聚物作为包衣材料制备定时控释片并考察处方、工艺、体外溶出条件对药物释放的影响。结果:经过筛选确定片芯处方为原药30%、微晶纤维素50%、羧甲基淀粉钠20%。外包衣层中聚乙二醇6000含量、包衣层用量、片剂硬度对定时控释片的释药时滞具有显著影响,溶出介质黏度和转蓝转速对时滞影响不大,但对时滞期后的释药速率有较大影响。结论:以优化处方压制的片芯,具有较好的膨胀性和崩解能力。通过调整外包衣层处方可获得不同时滞的定时控释片。由片芯、时滞为3h和6h的定时控释片组合而成的舒胸缓释制剂在体外可于0,3,6h依次释药,理化性质不同的各成分在不同时间达到了同步释放。
Objective： To prepare a sustained-release formulation of traditional Chinese medicine compound recipe by adopting time-controlled release techniques. Method： Shuxiong tablets were chosen as model drug. The prescription and technique of core tablets were formulated with selecting disintegrating time and swelling volume of core tablets in water as index. The time-controlled release tablets were prepared by adopting press-coated techniques, using PEG6000, HCO and EVA as coating materials. The influences of compositions, preparation process and dissolution conditions in vitro on the lag time （Tlag） of drug release were investigated. Result： The composition of core tablets was as follow： 30% of drug, 50% MCC and 20% CMS-Na. The Tlag of time-controlled release tablets was altered remarkably by PEG6000 content of the outer layer, the amount of outer layer and hardness of tablet. The viscosity of dissolution media and basket rotation had less influence on the Tlag but more on rate of drug release. Conclusion： The core tablets pressed with the optimized composition had preferable swelling and disintegrating properties. The shuxiong sustained-release formulations which contained core tablet and two kinds of time-controlled release tablets with 3 h and 6 h of Tlag could release drug successively at 0 h, 3 h and 6 h in vitro. The technique made it possible that various components with extremely different physicoehemieal properties in these preparations could release synchronously.
出处
《中国中药杂志》
CAS
CSCD
北大核心
2006年第17期1413-1417,共5页
China Journal of Chinese Materia Medica
基金
国家自然科学基金资助项目(30200363)
辽宁省博士启动基金资助项目(2001102042)
关键词
复方中药
缓释制剂
定时释药
压制包衣
舒胸片
traditional Chinese medicine
compound recipe
sustained-release formulations
time-controlled release
pressed-coated
shuxiongtablet
