新生儿用药分剂量操作及其国际管理现状

Divided-dose Operation of Neonatal Medicines and Its International Management Status

关键词:  新生儿用药  分剂量  辅料  临时配制  标准

Key words:  neonatal medicines  divided-dose  excipients  extemporaneous preparation  standard

摘要:

新生儿作为儿科的特殊人群，其生理特点决定其药动学、药效学与成人存在很大不同，用药剂量变异性大，具有胎龄、体质量依赖性等特点。目前很多剂型不适用于新生儿治疗，一般通过对儿童或成人制剂分剂量操作、临时配制液体制剂等方法来改善，但分剂量操作存在辅料的安全性，复配溶液的稳定性、有效性等问题。本文主要对国内外新生儿用药分剂量操作现状及相关的操作规范和标准进行概述，旨在为国内新生儿分剂量操作提供参照，提高国内新生儿用药的安全性和可及性。

Abstract:

As a special population in pediatrics, neonatal pharmacokinetics and pharmacodynamics are very different from adults due to their physiological characteristics. The drug dose is highly variable and has the characteristics of gestational age and body weight dependence. At present, many dosage forms are not suitable for neonatal treatment. Generally, they can be improved by sub-dosing operation of children or adults, temporary preparation of liquid preparations and other issues. This article mainly summarized the current status of the domestic and foreign neonatal drug administration and related operating norms and standards, aiming to provide a reference for the domestic neonatal divided dose operation and improve the safety and accessibility of domestic neonatal medication.