洛伐他汀缓释片的制备及其体外释放度的评价  

The preparation and evaluation of releasing rate in vitro of Lovastation

作　　者：张宏梅[1] 崔佰吉[1] 邰红娟 ZHANG Hongmei CUI Baiji TAI Hongjuan(Jilin Medical University,Jilin City,Jilin Province ,132013 , China)

机构地区：[1]吉林医药学院药学院,吉林吉林132013

出　　处：《吉林医药学院学报》2017年第2期87-90,共4页Journal of Jilin Medical University

摘　　要：目的优选洛伐他汀缓释片的处方和最佳制备工艺。方法通过单因素试验和正交试验,以释放度和休止角为指标,选择羟丙甲纤维素(HPMC)、微晶纤维素(MCC)、乳糖、十二烷基硫酸钠(SDS)、微粉硅胶和硬脂酸镁的用量。结果主药与HPMC的最佳配比为1∶2,与乳糖的最佳配比为1∶3,与MCC的最佳配比为1∶1.5,与SDS的最佳配比为1∶0.1,微粉硅胶用量为0.2%,硬脂酸镁用量为0.5%。结论制剂处方合理,制备工艺简单,稳定性好,质量可控。Objective To optimize the prescription and best preparation process of Lovastation sustained-relese Tables. Methods The amount of the hydroxypropyl methyl fiber,microcrystalline cellulose,lactose,sodium dodecyl sulfate,Micro powder silica gel and magnesium stearate were chosen by the single factor and orthogonal experiments,and angle of repose was chosen as an index and release rate of tables was also evaluated. Results The best formation was the mass ratio of drug / HPMC 1∶ 2,drug / lactose 1∶ 3,drug / microcrystalline cellulose 1∶ 1. 5,drug / sodium dodecyl sulfate 1∶ 0. 1,PVPK30 5% ethanol solution,micro powder silica gel for flow aid 0. 2%,magnesium stearate as lubricant accounted for 0. 5% of the grain weight. Conclusion Formulation design and the preparation process is reasonable and simple. The stability and the quality of Lovastation sustained-release table is controllable.

关 键 词：洛伐他汀 缓释片 体外释放度 正交设计 

分 类 号：R913[医药卫生—药学]