CN109045336A - A kind of ethylene oxide sterilizing indicant - Google Patents

A kind of ethylene oxide sterilizing indicant Download PDF

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Publication number
CN109045336A
CN109045336A CN201811099232.1A CN201811099232A CN109045336A CN 109045336 A CN109045336 A CN 109045336A CN 201811099232 A CN201811099232 A CN 201811099232A CN 109045336 A CN109045336 A CN 109045336A
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CN
China
Prior art keywords
ethylene oxide
acid
sterilizing
indicant
sterilizing indicant
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN201811099232.1A
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Chinese (zh)
Inventor
王卫
钟明伟
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Nanjing Jusha Display Technology Co Ltd
Nanjing Jusha Medical Technology Co Ltd
Nanjing Jusha Commercial and Trading Co Ltd
Original Assignee
Nanjing Jusha Display Technology Co Ltd
Nanjing Jusha Medical Technology Co Ltd
Nanjing Jusha Commercial and Trading Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Nanjing Jusha Display Technology Co Ltd, Nanjing Jusha Medical Technology Co Ltd, Nanjing Jusha Commercial and Trading Co Ltd filed Critical Nanjing Jusha Display Technology Co Ltd
Priority to CN201811099232.1A priority Critical patent/CN109045336A/en
Publication of CN109045336A publication Critical patent/CN109045336A/en
Pending legal-status Critical Current

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Classifications

    • 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
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/26Accessories or devices or components used for biocidal treatment
    • A61L2/28Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour
    • 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
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/20Gaseous substances, e.g. vapours
    • A61L2/206Ethylene oxide
    • CCHEMISTRY; METALLURGY
    • C09DYES; PAINTS; POLISHES; NATURAL RESINS; ADHESIVES; COMPOSITIONS NOT OTHERWISE PROVIDED FOR; APPLICATIONS OF MATERIALS NOT OTHERWISE PROVIDED FOR
    • C09DCOATING COMPOSITIONS, e.g. PAINTS, VARNISHES OR LACQUERS; FILLING PASTES; CHEMICAL PAINT OR INK REMOVERS; INKS; CORRECTING FLUIDS; WOODSTAINS; PASTES OR SOLIDS FOR COLOURING OR PRINTING; USE OF MATERIALS THEREFOR
    • C09D11/00Inks
    • C09D11/50Sympathetic, colour changing or similar inks
    • 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
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20Targets to be treated
    • A61L2202/24Medical instruments, e.g. endoscopes, catheters, sharps

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Wood Science & Technology (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Materials Engineering (AREA)
  • Engineering & Computer Science (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
  • Medicinal Preparation (AREA)

Abstract

The invention discloses a kind of ethylene oxide sterilizing indicants, belong to medical reagent technical field, including following components: azo active dyestuff 0.5%-5%, thickener 0.2%-10%, organic acid 1%-10%, aluminum magnesium silicate 1%-30%, isopropanol 10%-50%, auxiliary agent 1%-20%, surplus are water.A kind of ethylene oxide provided by the invention sterilizing indicant, uses azo active dyestuff to indicate ingredient, under the conditions of being exposed to ethylene oxide, the electron density of azo active dyestuff can change, so as to cause the variation of color.Color change time and depth can be adjusted by changing additive amount, the type of thickener, organic acid and auxiliary agent.The another present invention is isopropanol-water system, environmentally protective without containing hazardous solvents such as ester, ketone, benzene, aldehyde, ether, alkane.

Description

A kind of ethylene oxide sterilizing indicant
Technical field
The present invention relates to a kind of ethylene oxide to be used to indicate ethylene oxide sterilizing knot with sterilizing indicant more particularly to one kind The indicant of fruit belongs to medical reagent technical field.
Background technique
The effective sterilizing of medical treatment packet is the key link for avoiding sufferer postoperative infection.Currently used sterilization method is high pressure Steam sterilizing, but for the instrument of some non-refractories, such as optical instrument, electronic equipments, scope, dialyzer, ethylene oxide Sterilizing is main mode.If changing colour unstable or putting after the medical treatment packet containing ethylene oxide sterilizing instruction ink is sterilized Instruction ink colors change after setting a period of time, will all will lead to clinical erroneous judgement, to cause human and material resources, time On waste, while also affecting the normal work of department, therefore need to occur a kind of discoloration stabilization, environmentally protective ring at present Oxidative ethane indicates ink.At present ethylene oxide sterilizing indicator on the market mainly using acid-base indicator dyestuff as change colour at Point, the color that the Acid-base Gas of the pH of substrate, storage condition and production environment easily lead to instruction ink changes automatically.
Summary of the invention
The technical problem to be solved by the invention is to provide a kind of ethylene oxide sterilizings environmentally protective, discoloration is stable Indicant.
In order to solve the above technical problems, the technical solution adopted by the present invention are as follows:
A kind of ethylene oxide sterilizing indicant, including following components: azo active dyestuff 0.5%-5%, thickener 0.2%-10%, organic acid 1%-10%, aluminum magnesium silicate 1%-30%, isopropanol 10%-50%, auxiliary agent 1%-20%, surplus For water.
The azo active dyestuff has following structure formula,
In formula, R1Selected from-H ,-SO3Na ,-Cl ,-CH3,-NO2,-CONH2,-NH2,-N (CH2CH3)2,-NHCH2CH2OH ,- OCH2CH3In any one;
R2, R4, R5, R6Selected from-H ,-OH ,-CH3,-NO2,-SO3Any one in Na ,-COONa;
R3Selected from-H ,-OH ,-CH3In any one.
The thickener is by modified starch, guar gum, xanthan gum, Arabic gum, pectin, carragheen, gellan gum, locust bean One of glue, cellulose and gelatin or a variety of compositions.
The organic acid by maleic acid, ascorbic acid, caffeic acid, malic acid, ethylenediamine tetra-acetic acid, hydroxyacetic acid, One of lactic acid, gluconic acid, acetic acid, butyl octanoic acid or a variety of compositions.
The auxiliary agent is by titanium dioxide, magnesium bromide, C24-C34Aliphatic ester lotion and its derivative, acrylate copolymer One or more of lotion, bromocresol green, bromophenol blue, bromine cresols, ethyl alcohol composition.
The acrylate polymer emulsion includes Neocryl A-2099 or Neocryl A-2092.
The present invention uses azo active dyestuff to indicate ingredient, under the conditions of being exposed to ethylene oxide, azo active dyestuff Electron density can change, so as to cause the variation of color.The addition of change thickener, organic acid and auxiliary agent can be passed through Amount, type adjust color change time and depth.
The another present invention is isopropanol-water system, environmentally protective without containing hazardous solvents such as ester, ketone, benzene, aldehyde, ether, alkane.
Biggest advantage of the present invention is that instruction composition formula is environmentally protective, and color change results are intuitive, accurate and stable, be can satisfy The needs that hospital and industry monitor ethylene oxide sterilizing.
Specific embodiment
The present invention will be further explained below.
Embodiment 1
A kind of ethylene oxide sterilizing indicant, the weight composition of ingredient are as follows: azo active dyestuff 4.5%, pectin 1%, gelatin 0.5%, oxalic acid 1.0%, aluminum magnesium silicate 2%, isopropanol 35%, titanium dioxide 0.25%, Neocryl A-2099 10%, bromocresol green 0.3%, surplus is water.
Wherein azo active dyestuff structural formula are as follows:
Wherein Neocryl A-2099 is a kind of acrylate polymer emulsion, is Royal DSM product.
Embodiment 2
A kind of ethylene oxide sterilizing indicant, the weight composition of ingredient are as follows: azo active dyestuff 1%, Methyl cellulose Element 1.0%, gluconic acid 1.5%, aluminum magnesium silicate 5%, magnesium bromide 3%, isopropanol 15%, titanium dioxide 0.1%, Neocryl A-2092 15%, C24-C34Aliphatic ester lotion 2%, bromophenol blue 0.5%, surplus is water.
Wherein azo dyes structural formula are as follows:
Wherein Neocryl A-2092 is a kind of acrylate polymer emulsion, is Royal DSM product.
After the above component is stirred, it is ground to coating material of the partial size less than 3 μm of active constituent, is then blocked in white Adagio printing or silk-screen printing are on piece paper or plastic sheet to get ethylene oxide sterilizing indicant.
In use, above-mentioned ethylene oxide to be placed in packed together with sterilizing indicant, biological indicator and instrument subject to sterilization In material, and packed using Closed process.It is put in 3M STERI-VAC 5XL sterilizer and sterilizes after packaging.It goes out Bacterium temperature is 54 DEG C, ethylene oxide concentration 735mg/L, sterilization time 6h.Above-mentioned package is taken out after sterilizing, chemistry refers to Show that object discoloration is obvious, and biological indicator asepsis growth, it was demonstrated that the instrument in this packet has passed through sterilizing.By the instruction after sterilizing Object is placed in be placed 30 days at room temperature, and the indicant color that sterilizes is without any significant change.
It was found from above-mentioned test result: ethylene oxide sterilizing indicant changes colour stabilization in practical applications, is easy to deposit Storage and interpretation.
Embodiment 3
A kind of ethylene oxide sterilizing indicant, the weight composition of ingredient are as follows: azo active dyestuff 0.5%, it is modified to form sediment Powder 5%, guar gum 5%, ascorbic acid 5%, caffeic acid 2%, malic acid 3%, aluminum magnesium silicate 30%, isopropanol 10%, bromine phenol Indigo plant 0.2%, bromine cresols 0.5%, ethyl alcohol 0.3%, surplus is water.
Wherein azo active dyestuff structural formula are as follows: R1For-H;R2For-COONa;R3For-CH3;R4For-NO2;R5For-H, R6 For-OH.
Embodiment 4
A kind of ethylene oxide sterilizing indicant, the weight composition of ingredient are as follows: azo active dyestuff 5%, Arabic gum 0.2%, gluconic acid 1%, aluminum magnesium silicate 1%, isopropanol 50%, titanium dioxide 5%, magnesium bromide 5%, surplus is water.
Wherein azo active dyestuff structural formula are as follows: R1For-CONH2;R2For-CH3;R3For-OH;R4For-NO2;R5For- SO3Na, R6For-H.
The above is only a preferred embodiment of the present invention, it should be pointed out that: for the ordinary skill people of the art For member, various improvements and modifications may be made without departing from the principle of the present invention, these improvements and modifications are also answered It is considered as protection scope of the present invention.

Claims (6)

1. a kind of ethylene oxide sterilizing indicant, it is characterised in that: including following components: azo active dyestuff 0.5%-5%, Thickener 0.2%-10%, organic acid 1%-10%, aluminum magnesium silicate 1%-30%, isopropanol 10%-50%, auxiliary agent 1%- 20%, surplus is water.
2. a kind of ethylene oxide according to claim 1 sterilizing indicant, it is characterised in that: the azo active dyestuff Have following structure formula,
In formula, R1Selected from-H ,-SO3Na ,-Cl ,-CH3,-NO2,-CONH2,-NH2,-N (CH2CH3)2,-NHCH2CH2OH ,- OCH2CH3In any one;
R2, R4, R5, R6Selected from-H ,-OH ,-CH3,-NO2,-SO3Any one in Na ,-COONa;
R3Selected from-H ,-OH ,-CH3In any one.
3. a kind of ethylene oxide according to claim 1 sterilizing indicant, it is characterised in that: the thickener is by being modified One of starch, guar gum, xanthan gum, Arabic gum, pectin, carragheen, gellan gum, locust bean gum, cellulose and gelatin or A variety of compositions.
4. a kind of ethylene oxide according to claim 1 sterilizing indicant, it is characterised in that: the organic acid is by along fourth Enedioic acid, ascorbic acid, caffeic acid, malic acid, ethylenediamine tetra-acetic acid, hydroxyacetic acid, lactic acid, gluconic acid, acetic acid, oxalic acid, One of butyl octanoic acid or a variety of compositions.
5. a kind of ethylene oxide according to claim 1 sterilizing indicant, it is characterised in that: the auxiliary agent is by titanium dioxide Titanium, magnesium bromide, C24-C34Aliphatic ester lotion and its derivative, acrylate polymer emulsion, bromocresol green, bromophenol blue, bromine One or more of cresols, ethyl alcohol composition.
6. a kind of ethylene oxide according to claim 1 sterilizing indicant, it is characterised in that: the acrylate copolymer Lotion includes Neocryl A-2099 or Neocryl A-2092.
CN201811099232.1A 2018-09-20 2018-09-20 A kind of ethylene oxide sterilizing indicant Pending CN109045336A (en)

Priority Applications (1)

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CN201811099232.1A CN109045336A (en) 2018-09-20 2018-09-20 A kind of ethylene oxide sterilizing indicant

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CN109045336A true CN109045336A (en) 2018-12-21

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111378328A (en) * 2020-04-23 2020-07-07 南京巨鲨显示科技有限公司 Indicator and indicator card for low-temperature ethylene oxide sterilization
CN111410869A (en) * 2020-04-23 2020-07-14 南京巨鲨显示科技有限公司 Indicator and indicator label for low-temperature ethylene oxide sterilization
CN113429828A (en) * 2021-06-22 2021-09-24 山东新华医疗器械股份有限公司 Water-based environment-friendly ethylene oxide sterilization indicating ink and preparation method thereof

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1367384A (en) * 2001-12-31 2002-09-04 阎宁 Oxirane sterilization chemical indicator composition, its preparation method and application
US20080267811A1 (en) * 2004-03-30 2008-10-30 Sakura Color Products Corporation Ink Composition for Sensing Gas Exposure and Gas Exposure Indicator
CN105885541A (en) * 2016-06-02 2016-08-24 南京巨鲨显示科技有限公司 Ethylene oxide sterilization indicating ink and preparing method thereof
CN106318016A (en) * 2016-08-19 2017-01-11 南京巨鲨显示科技有限公司 Antioxidant ethylene oxide indicative ink

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1367384A (en) * 2001-12-31 2002-09-04 阎宁 Oxirane sterilization chemical indicator composition, its preparation method and application
US20080267811A1 (en) * 2004-03-30 2008-10-30 Sakura Color Products Corporation Ink Composition for Sensing Gas Exposure and Gas Exposure Indicator
CN105885541A (en) * 2016-06-02 2016-08-24 南京巨鲨显示科技有限公司 Ethylene oxide sterilization indicating ink and preparing method thereof
CN106318016A (en) * 2016-08-19 2017-01-11 南京巨鲨显示科技有限公司 Antioxidant ethylene oxide indicative ink

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
冯新德: "《高分子辞典》", 30 June 1998, 中国石化出版社 *

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111378328A (en) * 2020-04-23 2020-07-07 南京巨鲨显示科技有限公司 Indicator and indicator card for low-temperature ethylene oxide sterilization
CN111410869A (en) * 2020-04-23 2020-07-14 南京巨鲨显示科技有限公司 Indicator and indicator label for low-temperature ethylene oxide sterilization
CN113429828A (en) * 2021-06-22 2021-09-24 山东新华医疗器械股份有限公司 Water-based environment-friendly ethylene oxide sterilization indicating ink and preparation method thereof

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Application publication date: 20181221