【CODEX翻译】YYT 1550.1-2017 一次性使用输液器具与药物相容性研究指南 第1部分：药物吸附研究
发布日期：2022-02-08
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【CODEX翻译】YY-T 1550.1-2017 一次性使用输液器具与药物相容性
研究指南 第1部分：药物吸附研究-双语版
YY-T YYT 1550.1-2017 一次性使用输液器具与药物相容性
研究指南 第1部分：药物吸附研究
Guidance of study on the compatibility of infusion equipments and pharmaceutical products - Part 1: Drug sorption
1 范围
1 Scope
YY/T 1550的本部分给出了在模拟临床输液条作下或临床实际输液条作下，一次性使用输液器具与药物接触过程中对药物吸附的研究方法。
本部分适用于特定输液器械与拟输注的药物或经论证所选择的典型药物进行相容性研究中的药物吸附研究。
This part of YY/T 1550 presents the research method of drug adsorption during the contact process of single-use infusion equipments with drugs under simulated clinical infusion conditions or clinical practice conditions.
This part is applicable to the drug adsorption study of the compatibility study between a specific infusion equipment and the drug to be infused or the typical drug selected through demonstration.
2 规范性引用文件
2 Normative Reference
下列文件对于本文件的应用是必不可少的。凡是注日期的引用文件，仅注日期的版本适用于本文件。凡是不注日期的引用文件，其最新版本（包括所有的修改单）适用于本文件。
The following referenced documents are indispensable for the application of this document. For dated references, only the dated edition is applicable to this document. For undated references, the latest edition (including all the revisions) is applicable to this document.
GB/T 6682 分析实验室用水规格和试验方法
GB/T 6682 Water for analytical laboratory use - Specification and test methods
3 术语与定义
3 Terms and definitions
下列术语和定义适用于本文件。
The following terminologies and definitions are applicable to this document.
3.1 药物相容性
3.1 Drug compatibility
输液器具和药物之间未发生导致药效及稳定性改变或发生导致毒理学风险的严重相互作用的证据。
There is no evidence of serious interactions between the infusion equipment and the drug leading to changes in efficacy and stability or to toxicological risks.
3.2 吸咐
3.2 Sorption
指药物制剂中的溶质与输液器具的理化结合现象，这种现象与输液器具材料的性质及药物中活性成分或其他可溶解物质的化学性质有关。
Refers to the phenomenon of physicochemical combination between solute in pharmaceutical preparation and infusion equipment, which is related to the nature of the material of the equipment and the chemical properties of the active ingredients or other soluble substances in the drug.
3.3 输液载体
3.3 Infusion carrier
需要通过静脉途径输入人体的注射剂药物的给药载体，如氯化钠注射液、葡萄糖注射液等。
Carriers for injection drugs, such as sodium chloride injection, glucose injection, etc., which need to be introduced into the human body through the intravenous route.
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