复方奥美拉唑碳酸氢钠胶囊的释放度对比分析

Comparative analysis of release degree of compound omeprazole sodium bicarbonate capsule

目的:对复方奥美拉唑碳酸氢钠胶囊在几种溶出介质中的释放度进行对比分析,为临床用药提供参考。方法:采用桨法进行体外溶出曲线测定试验,以高效液相色谱法进行含量测定,制备溶出曲线对比图谱。结果:复方奥美拉唑碳酸氢钠胶囊体外溶出度符合《中华人民共和国药典》(2015年版)规定,制备出复方奥美拉唑碳酸氢钠胶囊中奥美拉唑在几种溶出介质中的累计释放曲线图。结论:复方奥美拉唑碳酸氢钠胶囊在溶出介质pH=7.4中释放效果较好,在pH=5.8溶出介质中累计释放量会随着时间的增加而降低。

Objective:The release degree of compound omeprazole sodium bicarbonate capsules in several dissolving medium was compared and analyzed to provide reference for clinical medication.Methods:In vitro dissolution curve determination test was carried out by paddle method,and the content was determined by HPLC to prepare the dissolution curve comparative map.Results:The in vitro dissolution of compound omeprazole sodium bicarbonate capsules conformed to the regulations of Chinese pharmacopoeia(2015 edition),and the cumulative release curves of omeprazole in several dissolution media in compound omeprazole sodium bicarbonate capsules were prepared.Conclusion:Compound omeprazole sodium bicarbonate capsule had good release effect in the dissolution medium pH7.4,and the accumulated release amount in pH5.8 dissolution medium would decrease with time.