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YY/T 1550.1-2017: Guidance of study on the compatibility of infusion equipments and pharmaceutical products—Part 1: Drug sorption
YY/T 1550.1-2017
Guidance of study on the compatibility of infusion equipments and pharmaceutical products-Part 1. Drug sorption
ICS 11.040.30
C31
People's Republic of China Pharmaceutical Industry Standard
Disposable infusion device and drug compatibility
Research Guide Part 1. Drug Adsorption Studies
pharmaceuticalproducts-Part 1. Drugsorption
Published on.2017-02-28
2018-01-01 Implementation
The State Food and Drug Administration issued
Foreword
YY/T 1550 "Guidelines for Compatibility of Disposable Infusion Sets and Medications" consists of three parts.
--- Part 1. Drug adsorption studies;
--- Part 2. Leachables studies - known;
--- Part 3. Leachables studies - unknowns.
This section is Part 1 of YY/T 1550
This section was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuing agency of this document does not assume responsibility for identifying these patents.
This section was proposed by the State Food and Drug Administration.
This part is under the jurisdiction of the National Standardization Technical Committee for Medical Infusion Devices (SAC/TC106).
This part was drafted by Shandong Provincial Medical Device Product Quality Inspection Center and Shandong Xinhua Ande Medical Products Co., Ltd. participated in the drafting.
The main drafters of this section. Luo Hongyu, Tian Xiaolei, Wu Changyan.
introduction
Infusion device and drug compatibility studies include studies of drug adsorption by devices during infusion, and leaching of devices into drugs
Research, etc. This section only deals with drug adsorption studies for infusion devices. The research guide for leachables that migrate to drugs will be
This series of standards is given elsewhere.
Intravenous infusion is a unique drug delivery method that allows drugs to enter the body's blood circulation system without any biological barrier. Infusion set
Adsorption of the drug during clinical use directly affects the therapeutic effect of the drug, ie effectiveness, especially for low doses
Drug. In addition, some treatments that require precise administration, such as insulin or certain highly toxic drugs, occur during infusion.
Adsorption and resolution of the attachments can easily lead to doses that exceed the expected dose at some point in time, thereby posing a potential risk to the patient. Thus, establishing
And to develop guidelines for the study of the compatibility of drugs and devices, and to scientifically and standardly evaluate the compatibility of devices and drugs during drug infusion
Significance.
Due to the wide variety of infusion drugs and the great differences in the clinical application of different infusion devices, this section cannot give a
Test method for compatibility of all drugs and infusion devices. Drug compatibility studies on specific drugs and infusion devices
When referring to the method given in YY/T 1550, other tests with sufficient precision, accuracy, linearity, and sensitivity may also be selected.
method.
Disposable infusion device and drug compatibility
Research Guide Part 1. Drug Adsorption Studies
1 Scope
This part of YY/T 1550 gives a one-time use of infusion apparatus under simulated clinical infusion conditions or clinical actual infusion conditions.
Study method for drug adsorption during contact with drugs.
This section applies to specific infusion devices and drugs that are to be infused or drugs that have been demonstrated to be compatible with typical drugs for compatibility studies.
Adsorption studies.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB/T 6682 Analysis Laboratory Water Specifications and Test Methods
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Drug compatibility drugcompatibility
No serious interaction between the infusion device and the drug resulted in changes in efficacy and stability or in toxicological risks
evidence.
3.2
Adsorption sorption
Refers to the physicochemical binding of solutes and infusion devices in pharmaceutical preparations. This phenomenon is related to the nature of the infusion device materials and the activities of the drugs.
Chemical composition of sexual ingredients or other soluble substances.
3.3
Infusioncarrier Infusioncarrier
It is necessary to input a human injection drug carrier such as sodium chloride injection, glucose injection and the like through an intravenous route.
4 test methods
4.1 Preparation of test solution
4.1.1 General
Infusion devices and drug compatibility studies should consider the use of the medical device in clinical practice with the proposed infusion drug contact process
The parameter conditions for the preparation of the extract, such as time, temperature, mode of action, etc.
4.1.2 Reagents
Unless otherwise specified, the reagents used shall be analytically pure, and the test water shall meet the requirements for secondary water specified in GB/T 6682.
4.1.3 Preparation method for test solution
Take the research equipment and drugs, and prepare the test solution according to the commonly used infusion method given in the drug instruction manual or clinical research. preparation
Parameters need to consider the dose, infusion carrier, dilution method, infusion method, infusion rate, infusion temperature. If necessary, use clinically applicable inputs
Liquid carrier, preparation of clinically compatible drug infusion liquid 3 copies. Two of the infusion fluids were passed through the infusion apparatus, according to the drug instruction manual
Or the infusion method commonly used in clinical investigations is used for infusion, and the effluent is collected as a test solution. Another prepared drug infusion solution
The body was stored under the same conditions for the same time as a drug control solution.
4.2 Adsorption studies
Adsorption studies typically characterize changes in drug efficacy by measuring changes in drug concentration in infusion fluids. For some need for precise drug delivery
In the treatment process, such as the administration of insulin or certain highly toxic drugs, it is particularly advisable to consider determining the appropriate sampling time point to examine different drug administrations.
Intermittent infusion apparatus for drug adsorption and analysis of appendix.
4.2.1 Methodology Study Project
It is advisable to adopt a validated test method for the determination of drug concentration changes in drug components in infusion fluids.
Study methods for the determination of drug content in pharmaceutical preparations. Commonly used drug content analysis methods include high performance liquid chromatography (HPLC) and gas chromatography
Spectrometry (GC or GC/MS), Vis-UV spectrophotometry, etc. The proposed method for concentration determination should consider at least the following phases
Close the methodology study project.
4.2.1.1 Specific Properties
The excipients, related substances in the pharmaceutical preparations, infusion carriers during the preparation of the extracts, and potential leachable substances in the infusion instruments should not contain drugs.
Measurements interfere. Appropriate methods should be used to verify the specificity of the method to be used for the determination of the content, such as HPLC determination of drug
When the substance content, the degree of separation of the suitability test of the system, and the ratio of the chromatograms flowing through the transfusion apparatus before and after the pharmaceutical preparation is added to the infusion carrier
More equal.
4.2.1.2 Precision
Appropriate methods should be used to examine the precision of the method to be used for determination of the content of the same test solution, for example, not less than 6 consecutive times
The determination of the relative standard deviation (RSD) is calculated.
4.2.1.3 Stability
At least before the start of the experiment and at the end of the experiment, the change in drug concentration of the drug control solution was determined to confirm that the entire test cycle was not
The stability of the drug control solution itself that was in contact with the infusion device.
4.2.1.4 Linearity
When the linear range in the referenced Pharmacopoeia method or literature method cannot cover the concentration of the test solution, or adopt a new method
During the experiment, linear confirmation should be based on the actual dilution of the sample solution.
4.3 drug adsorption rate test
Take the test solution and drug control solution prepared under item 4.1.2, according to the content determination method confirmed by method study of 4.2.1
Determine the response signal value (such as peak area, absorbance value, etc.) for the test solution and drug control solution, and use drug pairs if necessary.
Calculate the drug concentration as either a standard or a standard solution.
4.4 Result Calculation
The following formula is used to calculate the drug response signal value (such as the peak area and absorbance value) of the test solution relative to the drug control solution at each time point.
Etc.) or the rate of change of drug concentration.
A=
C0-Ci
C0 ×
100%
In the formula.
A --- drug adsorption rate,%;
C0 --- drug response signal value (such as peak area, absorbance, etc.) or drug concentration in the drug control group;
Ci --- Drug response signal value (such as peak area, absorbance, etc.) or drug concentration in the test solution.
5 Research Report Content
5.1 Basic information includes.
a) information on the source and batch number of drugs and infusion devices, including information on drug standards or reference products;
b) Descriptive information for drug packaging that is in direct contact with the drug;
c) Accessory information in the formulation of the pharmaceutical preparation, if any (generally available from the drug insert).
5.2 Detailed experimental process descriptions and experimental results, including the equipment used, reagents, test method parameters, and methodology studies
The experimental results and conclusions are mentioned.
5.3 Results and analysis of adsorption studies.
5.4 References for the study.