卡维地洛片的制备及体外溶出度研究  

Preparation and dissolution of carvedilol tablets in vitro

作　　者：方方 沈晨 徐朗 史朝晖[1] 王东凯[1] 丁平田[1] FANG Fang;SHEN Chen;XU Lang;SHI Zhaohui;WANG Dongkai;DING Pingtian(Shenyang Pharmaceutical University,Shenyang 110016,China;Hainan Bikai Pharmaceutical Co.,Ltd.,Haikou 570311,China;Hainan Bikai Institute of Materia Medica Co.,Ltd.,Haikou 570311,China)

机构地区：[1]沈阳药科大学药学院,辽宁沈阳110016 [2]海南碧凯药业有限公司,海南海口570311 [3]海南碧凯药物研究所有限公司,海南海口570311

出　　处：《中国药剂学杂志》2020年第4期187-193,202,共8页Chinese Journal of Pharmaceutics

摘　　要：目的制备卡维地洛片,测定体外溶出度以及进行溶出曲线评价。方法采用单因素考察法,以颗粒流动性、可压性及崩解时限等为指标优化处方;采用紫外-可见分光光度法测定自制片与参比制剂体外溶出度,用ƒ2相似因子法评价自制片与市售片溶出曲线的相似性。结果最优基质处方为玉米淀粉与一水乳糖质量比1∶5、羟丙纤维素用量为4%、二氧化硅用量为1%、硬脂酸镁用量为1%,自制片与参比制剂在不同介质中ƒ2相似因子均大于50。结论自制卡维地洛片处方可压性好,制备工艺稳定,自制片与参比制剂在不同溶出介质中体外溶出行为一致。Objective To prepare carvedilol tablets and evaluate the dissolution and dissolution curves in vitro.Methods The single factor method was used to optimize the prescription by using particle flowability,compressibility and disintegration time limit.The in vitro dissolution of self-made tablets and reference preparations was determined by UV-visible spectrophotometry.The similarity of the dissolution curves between the prepared tablets and commercial tablets were evaluated by theƒ2 similarity factor method.Results The optimal matrix formulation was corn starch:lactose monohydrate(w/w)=1:5,hydroxypropylcellulose 4%,silica 1%,magnesium stearate 1%.The similarity factors(ƒ2)in both the prepared tablets and commercial tablets were greater than 50 in different media,indicating the consistency of dissolution in vitro.Conclusion The self-made carvedilol tablets had good compressibility and stable preparation process.The in vitro dissolution behavior of self-made tablets and reference preparations in different dissolution media was consistent.

关 键 词：卡维地洛片 紫外可见分光光度法 溶出度 ƒ2相似因子法 

分 类 号：R94[医药卫生—药剂学]