KR20220111799A - Method for preparing medical article formed antibacterial coating layer - Google Patents

Method for preparing medical article formed antibacterial coating layer Download PDF

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KR20220111799A
KR20220111799A KR1020210014741A KR20210014741A KR20220111799A KR 20220111799 A KR20220111799 A KR 20220111799A KR 1020210014741 A KR1020210014741 A KR 1020210014741A KR 20210014741 A KR20210014741 A KR 20210014741A KR 20220111799 A KR20220111799 A KR 20220111799A
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medical article
antibacterial
coating solution
coating layer
manufacturing
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박순용
원승연
최지훈
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주식회사 인성메디칼
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/08Materials for coatings
    • A61L29/085Macromolecular materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/04Macromolecular materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14Materials characterised by their function or physical properties, e.g. lubricating compositions
    • A61L29/16Biologically active materials, e.g. therapeutic substances
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04Macromolecular materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/08Materials for coatings
    • A61L31/10Macromolecular materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/16Biologically active materials, e.g. therapeutic substances
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0009Making of catheters or other medical or surgical tubes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0017Catheters; Hollow probes specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08JWORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J7/00Chemical treatment or coating of shaped articles made of macromolecular substances
    • C08J7/04Coating
    • C08J7/0427Coating with only one layer of a composition containing a polymer binder
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08KUse of inorganic or non-macromolecular organic substances as compounding ingredients
    • C08K5/00Use of organic ingredients
    • C08K5/16Nitrogen-containing compounds
    • C08K5/29Compounds containing one or more carbon-to-nitrogen double bonds
    • C08K5/31Guanidine; Derivatives thereof
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L39/00Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a single or double bond to nitrogen or by a heterocyclic ring containing nitrogen; Compositions of derivatives of such polymers
    • C08L39/04Homopolymers or copolymers of monomers containing heterocyclic rings having nitrogen as ring member
    • C08L39/06Homopolymers or copolymers of N-vinyl-pyrrolidones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/404Biocides, antimicrobial agents, antiseptic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2420/00Materials or methods for coatings medical devices
    • A61L2420/02Methods for coating medical devices

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
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Abstract

The present invention relates to a method for manufacturing a medical article having an antibacterial coating layer, and relates to a method for manufacturing an antibacterial medical article by forming the antibacterial coating layer having excellent antibacterial properties on a medical plastic material. A medical device coated by the method according to the present invention exhibits excellent antibacterial activity due to the formation of the antibacterial coating layer.

Description

항균 코팅층이 형성된 의료 물품의 제조 방법{METHOD FOR PREPARING MEDICAL ARTICLE FORMED ANTIBACTERIAL COATING LAYER}Method for manufacturing a medical article formed with an antibacterial coating layer {METHOD FOR PREPARING MEDICAL ARTICLE FORMED ANTIBACTERIAL COATING LAYER}

본 발명은 항균 코팅층이 형성된 의료 물품의 제조 방법에 관한 것으로서, 의료용 플라스틱 소재에 우수한 항균 특성을 갖는 항균 코팅층을 형성시켜 항균 의료 물품을 제조하는 방법에 관한 것이다. The present invention relates to a method for manufacturing a medical article having an antibacterial coating layer, and to a method for manufacturing an antibacterial medical article by forming an antibacterial coating layer having excellent antibacterial properties on a medical plastic material.

최근 5년간 발생한 병원내 집단 감염의 원인으로 혈류 감염이 지목되고 있다. 혈류 감염의 원인은 다양하지만, IV 요법에서 많이 활용되는 중심정맥 카테터가 주요 원인이다. 중식점맥 카테터는 패핼성 정맥염, 심내막염 및 전이성 감염(폐농약, 뇌농양, 골수염 등)의 국소 또는 전신 세균감염을 유발할 수 있다. 혈류 감염을 예방하기 위하여 카테터 부위에 멸균된 거즈나 드레싱을 덮거나, 항생제나 소독제를 도포한 카테터를 사용하기도 한다. Blood flow infection has been pointed out as the cause of group infections in hospitals that have occurred in the past five years. Although the causes of bloodstream infection are diverse, central venous catheterization, which is widely used in IV therapy, is the main cause. Midpoint catheters can cause local or systemic bacterial infections of phlebitis, endocarditis, and metastatic infections (such as pulmonary pesticides, brain abscesses, osteomyelitis). To prevent bloodstream infection, a catheter with sterile gauze or dressing or antibiotics or disinfectant applied to the catheter area is sometimes used.

하지만, 항생제의 사용은 다약제 내성을 갖는 균주를 발생시킬 수 있고, 소독제의 사용은 환자에게 알레르기와 같은 과민성 반응과 독성을 유발할 수 있다. However, the use of antibiotics can cause strains with multidrug resistance, and the use of disinfectants can cause hypersensitivity reactions and toxicity such as allergies in patients.

한국공개특허 제2017-0079684호에서는 실리케이트를 이용하여 의료장비의 항균성 코팅층을 형성하는 방법을 개시한다. Korean Patent Application Laid-Open No. 2017-0079684 discloses a method of forming an antimicrobial coating layer for medical equipment using silicate.

한국등록특허 제10-2196034호에서는 고분자 기재의 표면 개질 및 항균코팅 방법 및 이를 이용한 항균코팅 구강용 의료기기를 개시한다. 상기 특허에서는 고분자 기재를 산 용액과 염기 용액에 차례로 담지하고, 과산화 수소로 처리하여 의료기기에 항균 특성을 부여하는 방법을 개시한다. Korean Patent Registration No. 10-2196034 discloses a method for surface modification and antibacterial coating of a polymer substrate and an antibacterial coated oral medical device using the same. The above patent discloses a method of imparting antibacterial properties to a medical device by sequentially supporting a polymer substrate in an acid solution and a base solution, and treating it with hydrogen peroxide.

본 발명은 항균성을 갖는 의료 물품의 제조를 위한 코팅 방법을 제공하는 것을 목적으로 한다. An object of the present invention is to provide a coating method for the production of a medical article having antibacterial properties.

상기한 과제는, 프리폴리머와 용매를 혼합하여 프라이머 코팅용액을 제조하는 단계; 폴리비닐피롤리돈과 구아니딘을 용매에 용해시켜 항균 코팅용액을 제조하는 단계; The above-described task, mixing a prepolymer and a solvent to prepare a primer coating solution; Dissolving polyvinylpyrrolidone and guanidine in a solvent to prepare an antibacterial coating solution;

의료 물품을 상기 프라이머 코팅용액에 침지한 후 건조 및 UV 경화시켜 의료 물품의 표면을 개질하는 단계; 상기 표면이 개질된 의료 물품을 항균 코팅 용액 B(탑 코팅용액)에 침지한 후 건조시키는 단계; 및 상기 건조된 의료 물품에 UV를 조사하여 경화시키는 단계를 포함하는, 항균 의료 물품의 제조 방법에 의해 달성된다.dipping the medical article in the primer coating solution and then drying and UV curing to modify the surface of the medical article; dipping the surface-modified medical article in an antibacterial coating solution B (top coating solution) and then drying; And it is achieved by a method of manufacturing an antibacterial medical article, comprising the step of curing by irradiating UV to the dried medical article.

또한 바람직하게는, 상기 의료 물품은 저밀도폴리에틸렌, 폴리프로필렌, 폴리카보네이트 및 열가소성 폴리우레탄으로 이루어진 군에서 선택된 1종 이상의 폴리머를 포함하는 카테터, 스텐트 또는 의료용 튜브일 수 있다. Also preferably, the medical article may be a catheter, stent, or medical tube including at least one polymer selected from the group consisting of low-density polyethylene, polypropylene, polycarbonate and thermoplastic polyurethane.

또한 바람직하게는, 상기 폴리비닐피롤리돈 및 구아니딘는 1:1 내지 1:2의 중량비로 혼합되어 항균 코팅용액 총 중량 대비 1 중량% 내지 20.0 중량%로 포함될 수 있다.Also preferably, the polyvinylpyrrolidone and guanidine may be mixed in a weight ratio of 1:1 to 1:2 and included in an amount of 1 wt% to 20.0 wt% based on the total weight of the antibacterial coating solution.

또한 바람직하게는, 상기 용매는 정제수, 탄소수 1~4개를 갖는 알코올 또는 이소프로판올일 수 있다.Also preferably, the solvent may be purified water, an alcohol having 1 to 4 carbon atoms, or isopropanol.

본 발명에 따른 방법으로 코팅된 의료기기는 항균 코팅층이 형성되어 우수한 항균 활성을 나타낸다. The medical device coated by the method according to the present invention exhibits excellent antibacterial activity by forming an antibacterial coating layer.

도 1은 본 발명에 따른 코팅층이 형성된 카테터의 항균 효과에 대한 시험 결과를 나타낸 것이다. 1 shows the test results for the antibacterial effect of the catheter formed with a coating layer according to the present invention.

본 발명에서 사용되는 모든 기술용어는, 달리 정의되지 않는 이상, 하기의 정의를 가지며 본 발명의 관련 분야에서 통상의 당업자가 일반적으로 이해하는 바와 같은 의미에 부합된다. 또한, 본 명세서에는 바람직한 방법이나 시료가 기재되나, 이와 유사하거나 동등한 것들도 본 발명의 범주에 포함된다.All technical terms used in the present invention, unless otherwise defined, have the following definitions and have the meanings as commonly understood by one of ordinary skill in the art in the relevant field of the present invention. In addition, although preferred methods and samples are described herein, similar or equivalent ones are also included in the scope of the present invention.

용어 "약"이라는 것은 참조 양, 수준, 값, 수, 빈도, 퍼센트, 치수, 크기, 양, 중량 또는 길이에 대해 30, 25, 20, 15, 10, 9, 8, 7, 6, 5, 4, 3, 2 또는 1% 정도로 변하는 양, 수준, 값, 수, 빈도, 퍼센트, 치수, 크기, 양, 중량 또는 길이를 의미한다.The term "about" means 30, 25, 20, 15, 10, 9, 8, 7, 6, 5, means an amount, level, value, number, frequency, percentage, dimension, size, amount, weight or length varying by 4, 3, 2 or 1%.

본 명세서를 통해, 문맥에서 달리 필요하지 않으면, "포함하다" 및 "포함하는"이란 말은 제시된 단계 또는 구성요소, 또는 단계 또는 구성요소들의 군을 포함하나, 임의의 다른 단계 또는 구성요소, 또는 단계 또는 구성요소들의 군이 배제되지는 않음을 내포하는 것으로 이해하여야 한다.Throughout this specification, unless the context requires otherwise, the terms "comprises" and "comprising" include the steps or elements presented, or groups of steps or elements, but include any other step or element, or It is to be understood as implying that a step or group of elements is not excluded.

본 발명은 항균 의료 물품의 제조 방법에 관한 것이다. The present invention relates to a method of making an antibacterial medical article.

상기 방법은, 프리폴리머와 용매를 혼합하여 프라이머 코팅용액을 제조하는 단계; 폴리비닐피롤리돈과 구아니딘을 용매에 용해시켜 항균 코팅용액을 제조하는 단계; 의료 물품을 상기 프라이머 코팅용액에 침지한 후 건조 및 UV 경화시켜 의료 물품의 표면을 개질하는 단계; 표면이 개질된 의료 물품을 상기 항균 코팅용액 B(탑 코팅용액)에 침지한 후 건조시키는 단계; 및 상기 건조된 의료 물품에 UV를 조사하여 경화시키는 단계를 포함한다.The method comprises the steps of preparing a primer coating solution by mixing a prepolymer and a solvent; Dissolving polyvinylpyrrolidone and guanidine in a solvent to prepare an antibacterial coating solution; modifying the surface of the medical article by drying and UV curing after immersing the medical article in the primer coating solution; dipping the surface-modified medical article in the antibacterial coating solution B (top coating solution) and then drying; and curing the dried medical article by irradiating UV.

상기 프라이머 코팅용액은 프리폴리머와 이소프로판올 등의 용매를 1:1의 중량비로 혼합하여 제조할 수 있다. 상기 프리폴리머는 폴리우레탄 프리폴리머일 수 있다. The primer coating solution may be prepared by mixing a prepolymer and a solvent such as isopropanol in a weight ratio of 1:1. The prepolymer may be a polyurethane prepolymer.

상기 폴리비닐피롤리돈은 흡습성을 갖고, 독성이나 자극이 없고 우수한 안정성을 갖는다. 장기간 피부에 접촉하여 자극을 유발하는 제품에 자극완화제로 사용된다. 상기 구아니딘은 강한 염기성을 갖는 결정성의 고체로서, 구아니디노기를 이용하여 큰 분자량의 단백질과 인공분자를 세포 내고 쉽게 침투시킬 수 있어, 의약이나 생화학 분야에 이용되고 있다. 본 발명에서는 폴리비닐피롤리돈과 구아니딘을 용매에 용해시킨 후, 이를 코팅용액으로 사용하는 것을 특징으로 한다.The polyvinylpyrrolidone has hygroscopicity, has no toxicity or irritation, and has excellent stability. It is used as an emollient in products that cause irritation in contact with the skin for a long period of time. The guanidine is a crystalline solid having strong basicity, and can easily penetrate large molecular weight proteins and artificial molecules into cells using a guanidino group, and is used in medicine and biochemistry. The present invention is characterized in that polyvinylpyrrolidone and guanidine are dissolved in a solvent and then used as a coating solution.

본 발명의 일 실시형태에 따르면, 상기 폴리비닐피롤리돈과 구아니딘는 1:1의 중량비로 혼합되어 항균 코팅용액 총 중량 대비 1 내지 20.0 중량%로 포함될 수 있다.According to an embodiment of the present invention, the polyvinylpyrrolidone and guanidine may be mixed in a weight ratio of 1:1 and included in an amount of 1 to 20.0 wt% based on the total weight of the antibacterial coating solution.

상기 용매는 정제수, 탄소수 1~4개의 알코올일 수 있으며, 보다 바람직하게는 에탄올을 사용할 수 있다. The solvent may be purified water, an alcohol having 1 to 4 carbon atoms, and more preferably ethanol.

항균 코팅용액에 의료 물품을 침지한 후, UV를 조사하여 경화시킴으로써, 다중 양이온성 물질로 가교시켜, 물품의 표면에 항균 특성을 부여한다. After immersing the medical article in the antibacterial coating solution, by irradiating UV and curing it, it is crosslinked with a polycationic material, thereby imparting antibacterial properties to the surface of the article.

본 발명에서 항균 코팅층이 형성되는 의료 물품은 저밀도폴리에틸렌, 폴리프로필렌, 폴리카보네이트 및 열가소성 폴리우레탄으로 이루어진 군에서 선택된 1종 이상의 폴리머를 포함하는 카테터, 스텐트 또는 의료용 튜브일 수 있다.In the present invention, the medical article on which the antibacterial coating layer is formed may be a catheter, stent, or medical tube containing one or more polymers selected from the group consisting of low-density polyethylene, polypropylene, polycarbonate and thermoplastic polyurethane.

이하에서 실시예를 들어 본 발명을 상세하게 설명하지만, 이들 실시예에 의해 본 발명의 권리범위가 제한되는 것은 아니다. Hereinafter, the present invention will be described in detail with reference to Examples, but the scope of the present invention is not limited by these Examples.

실시예 1: 항균 코팅층이 형성된 카테터 제조 Example 1: Preparation of catheter with antibacterial coating layer

이소프로판올과 프리폴리머를 1:1의 중량비로 혼합하여 프라이머 코팅용액인 코팅용액 A를 제조하였다. 폴리비닐피롤리돈 및 구아니딘을 1:1의 중량비로 에탄올에 용해시켜 10중량% 농도의 코팅용액 B(항균 코팅용액)를 제조하였다. 폴리우레탄 재질의 의료용 카테터 1g을 준비하였다. 카테터 튜브의 표면을 개질하기 위하여 코팅용액 A에 상기 카테터를 1분간 침지하고 1분간 건조 후 건조된 카테터에 UV를 조사하여 경화시켰다.A coating solution A, which is a primer coating solution, was prepared by mixing isopropanol and prepolymer in a weight ratio of 1:1. Polyvinylpyrrolidone and guanidine were dissolved in ethanol in a weight ratio of 1:1 to prepare a coating solution B (antibacterial coating solution) with a concentration of 10% by weight. 1 g of a medical catheter made of polyurethane was prepared. In order to modify the surface of the catheter tube, the catheter was immersed in the coating solution A for 1 minute, dried for 1 minute, and then cured by irradiating UV to the dried catheter.

경화가 완료되면 카테터 튜브의 표면에 항균 기능을 부여하기 위하여 코팅용액 B(탑 코팅용액)에 상기 카테터를 10초간 침지하고 3분간 건조 후 건조된 카테터에 UV를 조사하여 경화시켰다.When curing was completed, the catheter was immersed in coating solution B (top coating solution) for 10 seconds in order to impart an antibacterial function to the surface of the catheter tube, dried for 3 minutes, and then cured by irradiating UV to the dried catheter.

실험예 1: 항균성 시험 Experimental Example 1 : Antimicrobial test

실시예 1에서 제조된 카테터에 대한 항균성 시험(ASTM E 2149)을 실시하였다. E. coli 균주를 액체 배양한 후 적정 농도(1.5~3.0 x 105 CFU/ml)로 희석하고 시험용액 50 mL를 2개를 준비하여 각각 플라스크에 넣었다. 상기 플라스크에 실시예 1의 카테터 1g을 넣고 120 rpm으로 1시간 동안 진탕 배양하였고(시험구), 시료를 넣지 않은 플라스크도 120 rpm으로 1시간 동안 진탕 배양하였다(대조군). 시험구와 대조군을 각각 0.1 ml씩 채취하고 LB agar plate에 도말하였다. 24시간 인큐베이터에서 배양한 후 시험구와 대조군의 콜로니 생성 여부를 관찰하였다. 그 결과를 도 1에 나타냈다. An antimicrobial test (ASTM E 2149) was performed on the catheter prepared in Example 1. After liquid culture of the E. coli strain, it was diluted to an appropriate concentration (1.5-3.0 x 10 5 CFU/ml), and two 50 mL test solutions were prepared and placed in each flask. 1 g of the catheter of Example 1 was placed in the flask and cultured with shaking at 120 rpm for 1 hour (test group), and the flask without the sample was also cultured with shaking at 120 rpm for 1 hour (control group). 0.1 ml of each test group and control group were collected and spread on an LB agar plate. After culturing in an incubator for 24 hours, colony formation of the test group and the control group was observed. The results are shown in FIG. 1 .

도 1을 보면, 대조군의 경우 다수의 콜로니가 생성되었지만, 실시예 1의 카테터는 항균제의 영향으로 E. coli 균주는 1시간(1H) 경과 시에 대부분 사멸하는 것을 확인할 수 있다(99%). Referring to Figure 1, in the case of the control group, although a number of colonies were generated, the catheter of Example 1 under the influence of the antibacterial agent E. coli strain can be confirmed that most of the time lapse of 1 hour (1H) is killed (99%).

Claims (4)

프리폴리머와 용매를 혼합하여 프라이머 코팅용액을 제조하는 단계;
폴리비닐피롤리돈과 구아니딘을 용매에 용해시켜 항균 코팅용액을 제조하는 단계;
의료 물품을 상기 프라이머 코팅용액에 침지한 후 건조 및 UV 경화시켜 의료 물품의 표면을 개질하는 단계;
상기 표면이 개질된 의료 물품을 항균 코팅 용액 B(탑 코팅용액)에 침지한 후 건조시키는 단계; 및
상기 건조된 의료 물품에 UV를 조사하여 경화시키는 단계를 포함하는, 항균 의료 물품의 제조 방법.
preparing a primer coating solution by mixing a prepolymer and a solvent;
Dissolving polyvinylpyrrolidone and guanidine in a solvent to prepare an antibacterial coating solution;
modifying the surface of the medical article by drying and UV curing after immersing the medical article in the primer coating solution;
dipping the surface-modified medical article in an antibacterial coating solution B (top coating solution) and then drying; and
A method of manufacturing an antibacterial medical article, comprising the step of curing the dried medical article by irradiating UV.
제1항에 있어서, 상기 의료 물품은 저밀도폴리에틸렌, 폴리프로필렌, 폴리카보네이트 및 열가소성 폴리우레탄으로 이루어진 군에서 선택된 1종 이상의 폴리머를 포함하는 카테터, 스텐트 또는 의료용 튜브인 것을 특징으로 하는, 항균 의료 물품의 제조 방법.The antibacterial medical article of claim 1, wherein the medical article is a catheter, stent, or medical tube comprising at least one polymer selected from the group consisting of low-density polyethylene, polypropylene, polycarbonate and thermoplastic polyurethane. manufacturing method. 제1항에 있어서, 상기 폴리비닐피롤리돈 및 구아니딘는 1:1 내지 1:2의 중량비로 혼합되어 항균 코팅용액 총 중량 대비 1 중량% 내지 20.0 중량%로 포함되는 것을 특징으로 하는, 항균 의료 물품의 제조 방법.The antibacterial medical article according to claim 1, wherein the polyvinylpyrrolidone and guanidine are mixed in a weight ratio of 1:1 to 1:2 and included in an amount of 1% to 20.0% by weight based on the total weight of the antibacterial coating solution. manufacturing method. 제1항에 있어서, 상기 용매는 정제수, 탄소수 1~4개를 갖는 알코올 또는 이소프로판올인 것을 특징으로 하는. 항균 의료 물품의 제조 방법.According to claim 1, wherein the solvent is characterized in that purified water, alcohol or isopropanol having 1 to 4 carbon atoms. A method of manufacturing an antibacterial medical article.
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