摘要
目的:研究布洛芬骨架缓释片从研试处方到生产处方的放大过程中,工艺参数对药物释放性能的影响。方法:通过测定不同时间点药物累积释药量,考察布洛芬缓释片的释药机制;并考察了致孔剂、制粒工艺和压片设备等因素对药物释放的影响,还对骨架片进行了6个月的加速试验。结果:布洛芬不溶性骨架缓释片的药物释放规律符合Higuchi方程;致孔剂羟丙甲纤维素(HPMC)的加入可以提高药物释放速率;不同制粒工艺和压片设备对药物释放的均匀性有一定影响;在一定压力范围内,药物释放对压力敏感。结论:布络芬缓释片的大生产中,制粒工艺、致孔剂用量和压片设备对药物释放有影响,可以通过优化上述工艺参数来提高产品质量。
Objective:To investigate the effects of manufacture parameters on susta ined release ibuprofen matrix tablets during the course of testing prescription to producing prescription.Methods:Estimated the accumulative total release dosag es in different time points to inspect the release mechanism of sustained releas e ibuprofen matrix tablets;the experiment inspected influence factors of pore fo rmer,techniques about granule and troche equipment to the release dosages of the drug,and have done the accelerated experiment with the matrix tablets for six m onths.Results:The release behavior of the tablets follows the Higuchi equation;t he release rate could be raised by adding pore former (low viscosity HPMC);diffe rent techniques about granule and troche equipment influence the release of matr ix tablets to some degree;the compression force has susceptive to release rate w ithin certain range.Conclusion:The techniques about granule,the quantity of pore former and troche equipment influence the release dosages of matrix tablets in producing of sustained release ibuprofen tablets,we can optimize the manufacture parameters above to rise quality of products.
出处
《中国药业》
CAS
2005年第7期51-53,共3页
China Pharmaceuticals
基金
重庆市应用基础研究项目
项目编号:[2003]7974
关键词
布洛芬
致孔剂
骨架片
释放速率
ibuprofen
pore former
matrix tablet
release degree
