洛伐他汀缓释片的制备及体内外评价  

Preparation and in vitro / in vivo Evaluation of Lovastatin Sustained-release Tablets

作　　者：陆裕德 苏博 白菊民 

机构地区：[1]上海天赐福生物工程有限公司,上海201206

出　　处：《中国医药工业杂志》2006年第5期329-331,342,共4页Chinese Journal of Pharmaceuticals

摘　　要：以羟丙甲纤维素为亲水凝胶骨架材料,体外释放特性为考察指标,研制了洛伐他汀缓释片。体外释放度试验结果表明,自制品前8h的释放特性与国外样品相似。以洛伐他汀片为参比制剂,研究了自制洛伐他汀缓释片在18名男性健康志愿者中的单剂量和多剂量的药物动力学,相对生物利用度分别为(145.83±24.47)%和(144.97±18.63)%。Lovastatin sustained-release tablets were prepared using HPMC as excipient. The in vitro release profile was evaluated and compared with ALTOCOR. The results showed that in vitro release profiles of the two products were similar during the initial 8h. The single dose and multi-dose pharmacokinetics of the prepared tablets were investigated in eighteen healthy male volunteers, with lovastatin tablets as reference. The result showed that the relative bioavailability were （145.83±24.47） % and （144.97±18.63） %, respectively.

关 键 词：洛伐他汀缓释片 羟丙甲纤维素 药物动力学 

分 类 号：R944.9[医药卫生—药剂学]