| 引用本文: | 钱建钦,陶巧凤,吴纪恒,倪韶青.儿科临时调配口服制剂发展现状[J].中国现代应用药学,2022,39(12):1565-1571. |
| QIAN Jianqin,TAO Qiaofeng,WU Jiheng,NI Shaoqing.Current Status of Oral Extemporaneous Compounding for Pediatrics[J].Chin J Mod Appl Pharm(中国现代应用药学),2022,39(12):1565-1571. |
|
| 摘要: |
| 儿童不是成人的缩小版。国内外普遍缺乏适合儿科人群的药物剂型和规格，导致现阶段分剂量用药不可避免。临时调配口服制剂属于分剂量用药的一种，具有显著的优点，适合各年龄段的儿科人群。本文概述了目前儿童分剂量用药的现状，介绍了临时调配口服制剂的特点和潜在风险点，以及国外针对临时调配口服制剂的法律规范和实践经验，旨在为中国确立临时调配制剂的合法地位，建立相应的技术标准和管理模式提供参考。 |
| 关键词: 临时调配 分剂量 口服调配溶媒 儿科 |
| DOI：10.13748/j.cnki.issn1007-7693.2022.12.009 |
| 分类号:R943 |
| 基金项目: |
|
| Current Status of Oral Extemporaneous Compounding for Pediatrics |
|
QIAN Jianqin1, TAO Qiaofeng2, WU Jiheng1, NI Shaoqing1
|
|
1.National Clinical Trial Institute, The Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou 310052, China;2.Zhejiang Institutes for Food and Drug Control, Hangzhou 310052, China
|
| Abstract: |
| Children are not small adults. There is a lack of drug dosage forms and specifications suitable for the pediatric population at home and abroad, which makes it unavoidable to use divided-dose at the present. Temporary preparation of oral preparations is a type of divided dose which has a great advantage over other approaches and could be used by all the pediatric population. This paper summarizes the current status on drug manipulation for pediatrics, and introduced the features and potential risks of oral extemporaneous compounding, the regularities, practices and experiences of oral extemporaneous compounding overseas were also presented, which may be useful for obtaining legal authority permission and establishing corresponding technical standards and management models of extemporaneous compounding in China. |
| Key words: extemporaneous compounding divided-dose oral compounding vehicle pediatric |
