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儿童口服给药固体新剂型研究进展
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引用本文:孙军娣,张自强,何淑旺,姚静.儿童口服给药固体新剂型研究进展[J].中国药科大学学报,2019,50(6):631-640.
Cite:SUN Jundi,ZHANG Ziqiang,HE Shuwang,YAO Jing.Progress on novel pediatric oral solid dosage forms[J].J China Pharm Univ,2019,50(6):631-640.
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作者单位
孙军娣 中国药科大学药学院 
张自强 南京泽恒医药技术开发有限公司 
何淑旺 山东达因海洋生物制药股份有限公司 
姚静 中国药科大学药学院 
基金项目:国家重大新药创制科技重大专项资助项目(No.2018ZX09721003-007-005)
中文摘要:中国儿童药物不良反应发生率是成人的两倍,新生儿更是成年人的4倍,其主要原因是儿童生理指标处于不断变化的过程中,临床上缺乏适合于各个年龄阶段的儿童药物。儿童药,尤其是便于服用、方便贮存的儿童口服固体制剂的开发成为新药研究人员关注的焦点。本文从多微粒制剂、口崩片、咀嚼片等方面综述了适用于儿童的各种新型口服固体制剂,同时指出高效的掩味技术和准确的给药剂量有助于儿童口服给药固体剂型的开发,是今后该类药物进一步研究的方向,以期对今后儿童口服给药固体剂型的研究提供理论参考。
中文关键词:儿童用药  口服固体制剂  掩味技术  精准剂量控制  进展
 
Progress on novel pediatric oral solid dosage forms
Abstract:In China, the incidence of adverse reactions of drugs in children is twice that in adults; especially in the newborns, it is four times that in adults. The main reason is that the physiological characteristics of children are changing constantly due to that they are in a constant process of growth and development; while the pediatric medicines cannot meet the clinical needs of children in different age states. Accordingly, the development of pediatric medicines, especially oral solid preparations which are convenient for administration and storage, has attracted a lot of attention. This review introduced various pediatric oral solid dosage forms such as multiparticulates, orally disintegrating tablets(ODT)and chewable tablets. In addition, the efficient taste masking technology and accurate dose control were the further research directions for development of pediatric medicines, which would provide important theoretical references for studies on pediatric oral solid dosage forms in future.
keywords:pediatric medicines  oral solid dosage forms  taste masking technology  accurate dose control  advances
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