儿童口服凝胶剂的研究进展与应用概况

Research progress and application overview of pediatric oral gels

我国儿童用药规模超600亿例,但现有儿童专用制剂数量少、品种单一,其研发、创新尤为必要。儿童食道狭窄、呼吸系统发育不完善、服药依从性低,传统药物剂型如胶囊剂、片剂、汤剂等易导致儿童喉部堵塞、呛咳甚至窒息。针对儿童服药特点,国外提出了口服凝胶剂的概念,以改善儿童患者的服药感受、降低误吸风险。本文通过查阅国内外相关文献资料,归纳了儿童口服凝胶剂的常用基质及制备方法,总结了该剂型的性质特点与质量控制方式,举例展示了其国内外应用研究概况及注册上市情况,以期推动国内儿童口服凝胶剂的发展,拓宽儿童专用药的研发空间,促进新型儿童制剂的开发,为儿童健康保驾护航。

The scale of pediatric drug use in China exceeds 60 billion,but the quantity of pediatric drugs is limited and the variety is few,making the R&D and drug innovation is particularly necessary.Since children's esophagus is narrow,the respiratory tracts prematurely develop and the medication compliance is low,traditional drug dosage forms such as capsule,tablet,and decoction are easy to cause throat blockage,choking and even suffocation.According to the characteristics of children when taking medicine,the concept of oral gels has been put forward in foreign countries to improve the compliance of pediatric patients to take medicine and reduce the risk of aspiration.Based on the review of related literature in China and abroad,we conclude the common matrix and preparation methods of children's oral gels,summarize the characteristics and quality control methods of the dosage forms.Examples are given to show the general research situation of application both in China and abroad,as well as the situation of registration and listing,in order to promote the development of domestic pediatric oral gels,broaden the space of pediatric drugs'research and development,promote the exploitation of new pediatric drugs to protect children's health.