雷贝拉唑钠肠溶微丸在不同服用介质中的稳定性研究  

Stability of Rabeprazole Sodium Delayed Release Pellets in Different Medium

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作  者:刘杰 谢斌 关东 黄俊鹏 Liu Jie;Xie Bin;Guan Dong;Huang Junpeng(Zhuhai Rundu Pharmaceutical Co.,Ltd.,Zhuhai 519000,China)

机构地区:[1]珠海润都制药股份有限公司,广东珠海519000

出  处:《广东化工》2020年第22期229-230,共2页Guangdong Chemical Industry

摘  要:测定雷贝拉唑钠肠溶微丸在不同服用介质中稳定性,为临床应用提供更多科学指导。方法:采用HPLC法测定,溶出采用桨法、转速为100 r·min^-1。结果:雷贝拉唑钠肠溶微丸在酸奶、橙汁、苹果汁、自来水和纯化水中先浸泡30 min后再按质量标准规定方法进行溶出度试验,结果保留量均大于90%,在牛奶中保留量仅为70%。结论:本次试验通过模仿人体内消化系统的生理条件,测试出雷贝拉唑钠在除牛奶外的服用介质中均表现出较稳定的性质。Determine the stability of Rabeprazole Sodium delayed release pellets in different media and provide more scientific guidance for clinical application.Methods:A high performance liquid chromatography method was used to determine Rabeprazole Sodium contents.The dissolution Apparatus 2 was used with 100 r·min^-1.Results:Rabeprazole Sodium delayed release pellets soak in yogurt,orange juice,apple juice,tap water and purified water for 30 minutes,then the dissolution test is determined according to the quality standard,the retentionin was greater than 90%,and the retention in milk was only 70%.Conclusion:By mimicking the physiological conditions of the digestive system in the human body,the test showed that the rabeprazole Sodium was relatively stable in the medium except milk.

关 键 词:雷贝拉唑钠 肠溶微丸 介质 稳定性 

分 类 号:TQ[化学工程]

 

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