儿童药物的剂型设计  

Design of Formulations for Pediatric Drugs

作　　者：苏敏 SU Min(R&D Center o f Precision Medicine and Nutrition,Chongqing Energy College,Chongqing 402260,China)

机构地区：[1]重庆能源学院精准医药与营养研究中心

出　　处：《药学进展》2019年第9期655-666,共12页Progress in Pharmaceutical Sciences

摘　　要：目前,临床上大部分儿童用药并非专为儿童设计或研发,且超说明书使用,这些药物缺少在儿童体内的吸收、分布、代谢、生物利用度以及安全性等信息。儿童具有不同于成人的生理发育特点和药动学特性,且由于尚处于生长发育过程,不同年龄的儿童对于药物的安全性阈值各不相同。此外,儿童对于药物的给药方式、剂型等也有自身的特点和要求。因此,开发儿童药物及儿童适合的剂型对药学家是一个巨大的挑战。简要分析了儿童的生理发育特点及其对药物药动学特性的影响,并综述了儿童药物剂型的设计方法和制剂处方原理。The majority of medicines taken by children are unlicensed for children and off-label, with a lack of information regarding absorption, distribution, metabolism, bioavailability, safety, etc.. Pediatric medications are quite different from those for adults because of their unique characteristics of physiological development and pharmacokinetic behaviors. Children of different ages have their own safety threshold because of continuous maturation process;besides, children have their distinctive routes and requirements of administration during medication. Development of pediatric medicines with suitable formulations is a great challenge for pharmaceutical scientists. This paper briefly analyzes children’s physiological development characteristics and their influence on the pharmacokinetic profile, and summarizes the methods of designing suitable dosage forms and the formulation principles for pediatric medicines.

关 键 词：儿童药物 剂型 处方设计 

分 类 号：R94[医药卫生—药剂学] R958[医药卫生—药学]