摘要
空心胶囊作为药物的常用载体,具有掩盖药物不良气味、提高生物利用度,便于吞服等优点。《中国药典》2020年版、EP10.8、USP44-NF39、JP18均收载了对不同空心胶囊及其原料进行质量控制的相关标准。本文通过比较不同国家之间收载标准的差异,将空心胶囊及其原料检查项目进行了梳理,研究表明,国外药典对胶囊和胶囊原材料的质量控制更为精细,可为我国对空心胶囊及其原料标准的完善和提高提供参考。
As a common carrier of drugs,hollow capsules have the advantages of masking the bad smell of drugs,improving bioavailability,and making them easy to swallow.The 2020 edition of the Chinese Pharmacopoeia,EP10.8,USP44-NF39,JP18 all contain relevant standards for quality control of different hollow capsules and their raw materials.By comparing the differences in inclusion standards between different countries,this paper sorts out the inspection items of hollow capsules and their raw materials,and the results show that the quality control of capsules and capsule raw materials in foreign pharmacopoeias is more fine,which can provide a reference for the improvement and improvement of hollow capsules and their raw material standards in China.
作者
郭文旭
王丹丹
陈悦
俞辉
柳文媛
GUO Wenxu;WANG Dandan;CHEN Yue;YU Hui;LIU Wenyuan(China Pharmaceutical University,Nanjing 210009,China;Zhejiang Institute for Food and Drug Control,Key Laboratory of Drug Contacting Materials Quality Control of Zhejiang Province,Hangzhou 310004,China)
出处
《中国药品标准》
CAS
2023年第2期200-204,共5页
Drug Standards of China
基金
浙江省药品监管系统科技计划项目(编号2022004)。
关键词
空心胶囊
药典
胶囊原料
限度标准
比较研究
hollow capsules
pharmacopoeia
capsule raw materials
limit standards
comparative studies
