萘普生钠片质量标准提升研究  

Study on Improving the Quality Standards of Naproxen Sodium Tablets

作　　者：熊欣 刘慧 裴昆 林凯鹏 钟振华 XIONG Xin;LIU Hui;PEI Kun;LIN Kaipeng;ZHONG Zhenhua(Jiangxi Institute for Drug Control,NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine,Jiangxi Province Engineering Research Center of Drug and Medical Device Quality,Nanchang Jiangxi 330029,China)

机构地区：[1]江西省药品检验检测研究院,国家药品监督管理局中成药质量评价重点实验室,江西省药品与医疗器械质量工程技术研究中心,江西南昌330029

出　　处：《药品评价》2023年第8期933-937,共5页Drug Evaluation

基　　金：江西省药品监督管理局科研项目(2020JS05)。

摘　　要：目的筛选并优化萘普生钠片质量标准检验项目的具体试验参数,节约试验成本,简化试验操作,保证结果真实可靠。方法通过比较各国药典标准与企业注册标准,优化萘普生钠片质量标准中有关物质、溶出度、含量测定方法。结果提升了萘普生钠片有关物质、含量测定方法,筛选溶出度方法。各项目方法准确度高,重现性好,为萘普生钠片合理控制质量提供数据依据。结论优化的方法进一步提升了萘普生钠片质量标准,完善了各项目检验方法,保证了测定结果的真实可靠性,进而能确保临床用药的质量及安全性。Objective To screen and optimize the specific experimental parameters for the quality standard inspection items of naproxen sodium tablets,save the test cost and simplify the test operation to ensure the authenticity and reliability of the results.Methods By comparing the pharmacopoeia standards and enterprise's registered standards,to optimize the determination method of the relevant substances,dissolution,and assay of the quality standards for naproxen sodium tablets.Results Improved the related substances and content determination methods of naproxen sodium tablets,and screened dissolution methods.The methods of each project has high accuracy and good reproducibility,providing a data basis for rational quality control of naproxen sodium tablets.Conclusion The optimize method further improve the quality standards of naproxen sodium tablets,and the testing methods of each item,ensure the authenticity and reliability of the results to insure the quality and safety of clinical medication.

关 键 词：萘普生 质量标准 有关物质 含量测定 

分 类 号：R927.1[医药卫生—药学]