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【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

Date:2022-02-08
¥447.15
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【CODEX】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.




      CODEX北京科译翻译有限公司是一家专业提供生命科学翻译和本地化服务的公司,作为中国专业的生命科学翻译公司之一以及国内为数不多的通过国际ISO17100: 2015认证的医学翻译提供商,CODEX科译拥有更多的医学资深语言专家,能实现40多种语言对的互译,接受更高难度的医学领域的项目挑战,并在最短时间内适应以给出最合理的解决方案。保证最高质量,100%按时交付,高效、完善的售后保障是CODEX科译给客户的用心承诺。

CODEX is a leading provider of cross-border communications based in Beijing. With our exclusive database in life science, and ISO 17100:2015 certified, CODEX has the required expertise and experience in localization, documentation, and medical literature to deliver a full range of end-to-end content and consulting services in many languages. We closely work with clients to deliver solutions to the challenges of engaging markets, consumers, and regulatory and patent environments worldwide.


      以上是免费内容,查看更多可立即购买

【CODEX】YYT 1550.1-2017 Guidance of study on the compatibility of infusion equipments and pharmaceutical products - Part 1: Drug sorption
Date:2022-02-08
¥447.15
Download

【CODEX】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.




      CODEX北京科译翻译有限公司是一家专业提供生命科学翻译和本地化服务的公司,作为中国专业的生命科学翻译公司之一以及国内为数不多的通过国际ISO17100: 2015认证的医学翻译提供商,CODEX科译拥有更多的医学资深语言专家,能实现40多种语言对的互译,接受更高难度的医学领域的项目挑战,并在最短时间内适应以给出最合理的解决方案。保证最高质量,100%按时交付,高效、完善的售后保障是CODEX科译给客户的用心承诺。

CODEX is a leading provider of cross-border communications based in Beijing. With our exclusive database in life science, and ISO 17100:2015 certified, CODEX has the required expertise and experience in localization, documentation, and medical literature to deliver a full range of end-to-end content and consulting services in many languages. We closely work with clients to deliver solutions to the challenges of engaging markets, consumers, and regulatory and patent environments worldwide.


      以上是免费内容,查看更多可立即购买

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