卡托普利-地高辛双层片百分含量测定方法研究  

Preparation of captopril sustained release-digoxin rapid release double-layer tablet and establishment of content determination method

作　　者：马晓星[1] 孔欣 张华[3] 韩翠艳[1] 潘虹[1] 隋小宇[1] 刘畅[1] 袁橙[1] MAXiao- xing;KONGXin;ZHANGHua;HANCui- yan;PAN Hong;SUI Xiao- yu;LIU Chang;YUAN Cheng(School of Pharmaceutical,Qiqihar Medical University,Qiqihar 161006,China;Jinzhou Jiutai PJinzhou 121000,China;The First Affiliated Hospital of Qiqihar Medical University,Qiqihar 161041,China)

机构地区：[1]齐齐哈尔医学院药学院,黑龙江齐齐哈尔161006 [2]锦州九泰药业有限公司,辽宁锦州121000 [3]齐齐哈尔医学院第一附属医院,黑龙江齐齐哈尔161041

出　　处：《哈尔滨商业大学学报（自然科学版）》2018年第3期264-266,270,共4页Journal of Harbin University of Commerce：Natural Sciences Edition

基　　金：黑龙江省教育厅科学技术研究项目(12541923)

摘　　要：制备卡托普利-地高辛缓速释双层片并建立双层片中含两种主药量的测定方法.以羟丙甲基纤维素、微晶纤维素为辅料制备卡托普利缓释层;以低取代羟丙基纤维素为辅料,采用空白颗粒法制备地高辛速释层.采用高效液相色谱法测定百分含量.卡托普利和地高辛检测波长为220 nm,地高辛回归方程:y=22.665x+23.632,在40~200μg/m L的质量浓度范围内,线性良好;卡托普利回归方程:y=9.2601x+355.72,在0.15~0.75 mg/m L的质量浓度范围内,线性良好.本方法专属性强,精密度、回收率良好,可用于该制剂中含两种主药的测定.To prepare captopril sustained release-digoxin rapid release double-layer tablet and establish content determination method. Captopril sustained release layer was prepared with hydroxy propyl methyl cellulose and microcrystalline cellulose as main adjuvants. Digoxin rapid release layer was prepared by the method of blank pellet with low-substituted hydroxypropyl cellulose. A high performance liquid chromatography method（ HPLC） was used for the content assaying. The detective wave length of captopril and digoxin was220 nm. The regression equations and linear ranges of digoxin and captopril were： y = 22. 665 x＋ 23. 632,40 - 200 μg/m L; y = 9. 2601 x ＋ 355. 72,0. 15 - 0. 75 mg/m L,they had a good linear relationship. The method has good specificity,precision and recovery. It can be used to detect the digoxin and captopril drug content.

关 键 词：卡托普利-地高辛缓速释双层片 HPLC 百分含量测定 

分 类 号：R284[医药卫生—中药学]