奥美拉唑肠溶胶囊溶出曲线测定方法的建立The Dissolution Curve of Omeprazole Enteric-coated Capsules
冯伟霞,贝伟剑,谢斌,周理英
FENG Weixia,BEI Weijian,XIE Bin,ZHOU Liying
摘要(Abstract)：
目的建立奥美拉唑肠溶胶囊溶出曲线测定方法,为该品种仿制药一致性评价工作提供理论依据。方法采用中国药典2015年版4部0931第一法(篮法),分别对不同转速在不同溶出介质进行考察,并对4种溶出介质进行方法学确认。结果以p H1.2氯化钠的盐酸溶液、水、pH 6.8磷酸盐缓冲液、pH 6.0磷酸盐缓冲液为溶出介质,转速分别为50,75,100 r·min~(-1),采用在线滤头过滤样品;奥美拉唑在4种溶出介质中的线性范围分别为2.02~24.30,2.02~24.30,1.69~20.28,1.98~23.73μg·mL~(-1),平均回收率分别为99.04%(RSD=0.7%,n=9),99.04%(RSD=0.7%,n=9),100.10%(RSD=1.0%,n=9),100.02%(RSD=0.9%,n=9);pH 1.2氯化钠的盐酸溶液、水、p H6.8磷酸盐缓冲液的对照品溶液和供试品溶液室温放置24 h内稳定,p H6.0磷酸盐缓冲液对照品溶液和供试品溶液室温放置3 h内稳定,样品精密度良好。结论建立的测定方法准确、可靠,可用于奥美拉唑肠溶胶囊溶出曲线的测定。
OBJECTIVE To establish the dissolution curve of Omeprazole enteric-coated capsules,and to provide theoretical basis for the consistency evaluation of reference preparations and generic drugs. METHODS The first dissolution method(basket method) stated in 0931 of Chinese pharmacopoeia 2015 edition was adopted,different rotation speed and the methodology of four media were investigated. RESULTS The four releasing media are respectively pH1. 2 Hydrochloric acid solution with Sodium chloride、water、pH6.8 phosphate buffer and pH6.0 phosphate buffer,which sample was determined with online filteration. The rotation speed was respectively 50,75,100 r·min~(-1).The linear of omeprazole was 2.02 ~ 24.30,2.02 ~ 24.30,1.69 ~ 20.28,1.98 ~ 23. 73 μg·m L~(-1) with the average recovery of 99.04%( RSD = 0.7%,n = 9),99.04%( RSD = 0.7%,n = 9),100.10%( RSD = 1.0%,n = 9),100.02%( RSD = 0.9%,n = 9) respectively in the four media.Reference solution and test solution in pH1.2 Hydrochloric acid solution with Sodium chloride and water as so as pH 6.8 phosphate buffer is stable for 24 hours in the room temperature while is stable for 3 hours in p H6.0 phosphate buffer and the sample had good precision. CONCLUSION The method is accurate and reliable,which can be used to measure the dissolution profile of omeprazole enteric-coated capsules.
关键词(KeyWords)：
奥美拉唑肠溶胶囊;溶出曲线;一致性评价
omeprazole enteric-coated capsules;dissolution curve;consistency evaluation
基金项目(Foundation):
作者(Author):
冯伟霞,贝伟剑,谢斌,周理英
FENG Weixia,BEI Weijian,XIE Bin,ZHOU Liying
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