药物制剂辅料在儿童群体中的安全性考量

Review of Excipients Safety in Pediatric Patients

辅料是药物制剂的重要组成,通常认为是惰性成分,较少受到关注。然而,由于儿童群体机体的生长发育及对药物辅料药动学的特殊性,不可否认,儿童正在面临某些药物辅料的危害风险。笔者旨在通过总结对儿童群体确定及可能有危害的药物辅料,回顾国内外药物辅料的使用现状,探讨药物制剂辅料在儿童群体的安全性,以供药师、医生等医务工作者及药品研发生产者参考。

Excipients are essential components of pharmaceutical products for use in adults and children. They are generally considered to be inert ingredients and are therefore rarely concerned due to the growth and development of the body of children and the specificity of the pharmacokinetics of pharmaceutical excipients,it is undeniable that children are facing risks of excipient toxicity. This article summarizes some excipients of defined and potential hazardous risks in the pediatric population,and reviews the current status of pediatric use of excipients in China and other countries,therefore to discuss the safety of excipients in children,and to provide a reference to healthcare professionals including pharmacists,physicians,as well as pharmaceutical manufacturers.