摘要
目的:建立奥美拉唑肠溶胶囊溶出样品检测方法,考察6个不同厂家生产的奥美拉唑肠溶胶囊在5种不同溶出介质中的溶出行为,比较其体外溶出特性,为评价药品质量提供参考。方法:采用桨法,以5种不同溶剂作为溶出介质,转速100 r/min,温度37℃,以高效液相色谱法测定溶出曲线,并进行比较分析。结果:6种奥美拉唑肠溶胶囊在pH1.2、pH4.5的溶出介质中耐酸性较好;在pH6.0、pH6.8、水的溶出介质中国产厂家生产的胶囊与参比制剂的体外溶出不相似。结论:国产的奥美拉唑肠溶胶囊与参比制剂的溶出行为有差异,其质量存在差异,建议提高国产奥美拉唑肠溶胶囊的质量。
Objective:To establish dissolution test method of omeprazole enteric-coated capsules.To investigate the dissolu?tion behavior of omeprazole enteric-coated capsules produced from six different manufacturers in five dissolution media,and compare their in vitro dissolution characteristics,so as to provide the reference for drug quality evaluation.Method:The paddle method was adopted for five different dissolution media at 100 r/min and temperature of 37℃.The dissolution curves were determined by HPLC and compared.Results:The acid resistance of omeprazole enteric-coated capsules from six manufacturers in pH1.2 and pH4.5 media was preferable.The dissolution curves of omeprazole enteric-coated capsules from domestic manufacturers were not similar with reference preparations in the media of pH6.0,pH6.8 and water.Conclu?sion:The dissolution behavior and quality of domestic omeprazole enteric-coated capsules were different from those of ref?erence preparations.It suggests that the quality of domestic omeprazole enteric-coated capsules was promoted.
作者
陈有钟
郑孝贤
林斌
周璟明
陈秀明
王海龙
徐兰
方东升
Chen You-zhong;Zheng Xiao-xian;Lin Bin;Zhou Jing-ming;Chen Xiu-ming;Wang Hai-long;Xu Lan;Fang Dong-sheng(Fujian Institute of Microbiology,Fuzhou,Fujian 350007,China)
出处
《福建分析测试》
CAS
2019年第6期43-46,共4页
Fujian Analysis & Testing
基金
福建省公益类科研院所基本科研专项(2017R1009-4)
