CN109675069A - A kind of medical sterilization ultrasonic coupling agent and preparation method thereof - Google Patents

A kind of medical sterilization ultrasonic coupling agent and preparation method thereof Download PDF

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Publication number
CN109675069A
CN109675069A CN201910145795.8A CN201910145795A CN109675069A CN 109675069 A CN109675069 A CN 109675069A CN 201910145795 A CN201910145795 A CN 201910145795A CN 109675069 A CN109675069 A CN 109675069A
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China
Prior art keywords
coupling agent
ultrasonic coupling
solution
medical sterilization
medical
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Pending
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CN201910145795.8A
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Chinese (zh)
Inventor
杨丹红
王世豪
田波
时英峰
王勇山
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Shandong Kehong Medical Technology Co Ltd
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Shandong Kehong Medical Technology Co Ltd
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Priority to CN201910145795.8A priority Critical patent/CN109675069A/en
Publication of CN109675069A publication Critical patent/CN109675069A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00Preparations for testing in vivo
    • A61K49/22Echographic preparations; Ultrasound imaging preparations ; Optoacoustic imaging preparations
    • A61K49/222Echographic preparations; Ultrasound imaging preparations ; Optoacoustic imaging preparations characterised by a special physical form, e.g. emulsions, liposomes
    • A61K49/226Solutes, emulsions, suspensions, dispersions, semi-solid forms, e.g. hydrogels
    • AHUMAN NECESSITIES
    • A01AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01NPRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N37/00Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids
    • A01N37/36Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids containing at least one carboxylic group or a thio analogue, or a derivative thereof, and a singly bound oxygen or sulfur atom attached to the same carbon skeleton, this oxygen or sulfur atom not being a member of a carboxylic group or of a thio analogue, or of a derivative thereof, e.g. hydroxy-carboxylic acids
    • A01N37/38Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids containing at least one carboxylic group or a thio analogue, or a derivative thereof, and a singly bound oxygen or sulfur atom attached to the same carbon skeleton, this oxygen or sulfur atom not being a member of a carboxylic group or of a thio analogue, or of a derivative thereof, e.g. hydroxy-carboxylic acids having at least one oxygen or sulfur atom attached to an aromatic ring system
    • A01N37/40Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids containing at least one carboxylic group or a thio analogue, or a derivative thereof, and a singly bound oxygen or sulfur atom attached to the same carbon skeleton, this oxygen or sulfur atom not being a member of a carboxylic group or of a thio analogue, or of a derivative thereof, e.g. hydroxy-carboxylic acids having at least one oxygen or sulfur atom attached to an aromatic ring system having at least one carboxylic group or a thio analogue, or a derivative thereof, and one oxygen or sulfur atom attached to the same aromatic ring system
    • AHUMAN NECESSITIES
    • A01AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01NPRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N43/00Biocides, pest repellants or attractants, or plant growth regulators containing heterocyclic compounds
    • A01N43/72Biocides, pest repellants or attractants, or plant growth regulators containing heterocyclic compounds having rings with nitrogen atoms and oxygen or sulfur atoms as ring hetero atoms
    • A01N43/80Biocides, pest repellants or attractants, or plant growth regulators containing heterocyclic compounds having rings with nitrogen atoms and oxygen or sulfur atoms as ring hetero atoms five-membered rings with one nitrogen atom and either one oxygen atom or one sulfur atom in positions 1,2
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/045Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/047Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates having two or more hydroxy groups, e.g. sorbitol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/21Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/235Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids having an aromatic ring attached to a carboxyl group
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/425Thiazoles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/06Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/02Local antiseptics

Abstract

The present invention relates to a kind of medical sterilization ultrasonic coupling agents and preparation method thereof.The medical sterilization ultrasonic coupling agent, including effective component are cross-linked polyacrylic resin, glycerol, propylene glycol, isothiazolinone, p-hydroxybenzoate, neutralizer and purified water.Medical sterilization ultrasonic coupling agent of the present invention is in aqueous, good water solubility, has disinfection to medical ultrasonic probe, skin, is provided simultaneously with good acoustic performance, safety and stability;In addition, ultrasonic coupling agent of the invention belongs to gel-like disinfection couplant, disinfection can reach without impregnating, sterilizing time is short, realizes the sterilizing in entire detection process to ultrasonic probe, easy to use;Possible cross-infection risk during ultrasound detection is effectively reduced.

Description

A kind of medical sterilization ultrasonic coupling agent and preparation method thereof
Technical field
The present invention relates to a kind of medical sterilization ultrasonic coupling agents and preparation method thereof, belong to the technology of medical ultrasonic coupling agent Field.
Background technique
Medical ultrasonic coupling agent is the gel preparation that must be used when human body makees ultrasonic examination.It is to reduce ultrasound that it, which is acted on, Acoustic reactance resistance between probe and skin is poor, to reduce the reflection loss of ultrasonic energy, furthermore also acts as lubricating action, makes ultrasound Probe, which can be slided flexibly, to be detected.
" Regulations of sterilization management " Article 6 that the 27th command of Ministry of Health of the People's Republic of China 2002 is promulgated and 2006 " hospital infection management method " chapter 3 Article 12 that 48th command is promulgated provides: the Medical treatment device of all contact skin and mucous membrane Tool, utensil and article must reach sterilisation level.
Now widely used medical ultrasonic coupling agent majority does not have sterilizing function, and the subject of different health status makees During ultrasound detection, it is inevitably present the risk of cross-infection, ultrasonic probe is propagated as nosocomial infection pathogen Important medium, feel bacterium and drug-fast bacteria for institute and provide diffusion conditions.
In order to efficiently solve the sterilization problems in ultrasound detection, industry personnel is conducted extensive research.Chinese patent The disclosed medical ultrasonic coupling agent with disinfection function of publication number CN101219223A, is killed wherein joined triclosan class Microbial inoculum;Ultrasonic coupling agent disclosed in China Patent Publication No. CN1679968A is using chlorhexidine acetate as disinfectant;It is Chinese special Medical sterilization ultrasonic coupling agent disclosed in sharp publication number CN101773673A selects to be disinfectant to chloroxylenol;It is Chinese special Ultrasonic coupling agent disclosed in sharp publication number CN101249268A then uses poly hexamethylene biguanide, benzalkonium chloride, benzalkonium bromide, vinegar One of sour Chlorhexidine, triclosan and nano silver or combinations thereof.The disclosed couplant with sterilizing function of the prior art is more With gel-type vehicle cross-linked polyacrylic resin, sodium alginate, Sodium Polyacrylate and clean new, the acetic acid chlorine of disinfectant triclosan, phenol oneself The compatibilities such as fixed, quaternary ammonium salt, provide disinfection function.These disinfectants or poorly water-soluble, or prohibit with gel-type vehicle with compatibility Avoid, then will affect transparency, safety and the stability of gel products using higher dosage.
Therefore, research and development are safe and stable, and easy to use and with disinfecting and sterilizing functions medical ultrasonic coupling agents have Very important meaning.
Summary of the invention
In view of the deficiencies of the prior art, the present invention provides a kind of medical sterilization ultrasonic coupling agent.
The present invention also provides a kind of preparation methods of above-mentioned medical sterilization ultrasonic coupling agent.
Term explanation:
Cross-linked polyacrylic resin: product name carbomer is a kind of outstanding gel-type vehicle, there is the important use such as thickening, suspension On the way, it is widely used in lotion, cream, in gel.
Purified water: drinking water is through hyoscine made from the way of distillation, ion-exchange, hyperfiltration or other suitable methods Water, be free of any additive.
The technical solution of the present invention is as follows:
A kind of medical sterilization ultrasonic coupling agent, the weight percent including effective component be, cross-linked polyacrylic resin 0.3~ 1.2%, glycerol 2.0~10.0%, propylene glycol 2.0~10.0%, isothiazolinone 0.01~0.1%, p-hydroxybenzoate 0.1~1.0%, neutralizer 0.2~1.5%, surplus are purified water.
The effect of cross-linked polyacrylic resin is to form water soluble polymer gel, and glycerol functions as moisturizer, Have effects that water conservation and greasy skin;The solvent for functioning as fungicide of propylene glycol is also used as moisturizer, propylene glycol sheet Body has moistening effect, but moistening effect is not so good as glycerol, and propylene glycol is used in mixed way with glycerol, and moistening effect is more preferable;Isothiazole The effect of quinoline ketone and p-hydroxybenzoate is to kill bacterium, mould and virus;The effect of neutralizer is to neutralize crosslinked polypropylene Acid resin adjusts couplant product pH value;
Preferred according to the present invention, the neutralizer is the mixing of triethanolamine or sodium hydroxide or both arbitrary proportion.
A kind of preparation method of medical sterilization ultrasonic coupling agent, includes the following steps:
1) cross-linked polyacrylic resin and purified water are weighed respectively by weight percentage, cross-linked polyacrylic resin is dissolved in purifying In water, solution A is obtained, indwelling is spare;
2) p-hydroxybenzoate and propylene glycol are weighed respectively by weight percentage, p-hydroxybenzoate is dissolved in into propylene glycol In, stirring obtains solution B, indwelling is spare;
3) isothiazolinone weighed by weight percentage is added in the solution B, obtains solution C, indwelling is spare;
4) the resulting solution C of step 3) is continued to stir after being added under stirring in the resulting solution A of step 1) 30~60 minutes, evenly spread to solution C in solution A;Glycerol weighed by weight percentage and neutralizer are added, finally Purified water is supplemented, pH value is adjusted 5.5~8.0, obtains colorless and transparent gel;
5) clear gel obtained by filling step 4), obtains medical sterilization ultrasonic coupling agent finished product.
The invention has the benefit that
1. medical sterilization ultrasonic coupling agent of the present invention is in aqueous, good water solubility, there is disinfection to medical ultrasonic probe, skin Effect, is provided simultaneously with good acoustic performance, safety and stability;Disappear in addition, ultrasonic coupling agent of the invention belongs to gel-like Malicious couplant can reach disinfection without impregnating, and sterilizing time is short, realizes and kills in entire detection process to ultrasonic probe Bacterium disinfection, it is easy to use;Possible cross-infection risk during ultrasound detection is effectively reduced, protection subject's body is strong Health, and it is free from environmental pollution;
2. medical sterilization ultrasonic coupling agent of the present invention maintains the character and coupling function of conventional medical ultrasonic coupling agent, Select to human body and it is environmentally friendly, to the non-corrosive isothiazolinone of silastic product, p-hydroxybenzoate as sterilization The medical ultrasonic coupling agent with disinfection function of transparent gel-form is prepared in agent;It is verified, all originals of inventive formulation Material is that incompatibility is not present between disinfectant and thickener to human body and environmentally friendly product in use scope, His ingredient does not occur chemical reaction between each other yet and generates harmful substance, meets YY0299-2016's " medical ultrasonic coupling agent " Professional standard;
3. medical sterilization ultrasonic coupling agent of the present invention, low using concentration, sterilizing ability is strong, good with gel-type vehicle compatibility, The transparency of gel products will not be influenced because additive amount increases;
4. the preparation method of medical sterilization ultrasonic coupling agent of the present invention, simple process, raw material are easy to get, investment of production equipment Few, operating cost is low, is conducive to industrialized production.
Detailed description of the invention
Fig. 1 is the preparation flow figure of medical sterilization ultrasonic coupling agent of the present invention.
Specific embodiment
Below with reference to embodiment and Figure of description, the present invention will be further described, but not limited to this.
Embodiment 1
The medical sterilization ultrasonic coupling agent of 100g, including effective component are cross-linked polyacrylic resin 1g, glycerol 15g, propylene glycol 15g, isothiazolinone 0.05g, p-hydroxybenzoate 0.5g, neutralizer 1g, surplus are purified water.Its neutralizer is three ethyl alcohol The mixing of amine and sodium hydroxide 1:1 ratio.
The effect of cross-linked polyacrylic resin is to form water soluble polymer gel, and glycerol functions as moisturizer, Have effects that water conservation and greasy skin;The solvent for functioning as fungicide of propylene glycol is also used as moisturizer, propylene glycol sheet Body has moistening effect, but moistening effect is not so good as glycerol, and propylene glycol is used in mixed way with glycerol, and moistening effect is more preferable;Isothiazole The effect of quinoline ketone and p-hydroxybenzoate is to kill bacterium, mould and virus;The effect of neutralizer is to neutralize crosslinked polypropylene Acid resin adjusts couplant product pH value.
Embodiment 2
As shown in Figure 1.
The preparation method of medical sterilization ultrasonic coupling agent, includes the following steps: as described in implementing 1
1) cross-linked polyacrylic resin 1g and purified water 30g are weighed respectively, cross-linked polyacrylic resin is dissolved in purified water, are obtained To solution A, indwelling is spare;
2) p-hydroxybenzoate 0.5g and propylene glycol 15g are weighed respectively, p-hydroxybenzoate is dissolved in propylene glycol, are stirred It mixes, obtains solution B, indwelling is spare;
3) it weighs isothiazolinone 0.05g to be added in the solution B, obtains solution C, indwelling is spare;
4) the resulting solution C of step 3) is continued to stir after being added under stirring in the resulting solution A of step 1) 50 minutes, evenly spread to solution C in solution A;Glycerol 15g and neutralizer 1g are added, purified water 37.45 is finally supplemented, PH value is adjusted 5.5~8.0, obtains colorless and transparent gel;
5) clear gel obtained by filling step 4), obtains medical sterilization ultrasonic coupling agent finished product.
To medical sterilization ultrasonic coupling agent made from the present embodiment, performance indicator, sanitary index and functional parameter carry out Sampling Detection, testing result meet the requirements.Test results in the following table:
Upper table data show, all properties index of the present embodiment product all meet " disinfection technology standard " (version in 2002) and The requirement of YY0299-2016 medical ultrasonic coupling agent.

Claims (3)

1. a kind of medical sterilization ultrasonic coupling agent, which is characterized in that the weight percent including effective component is crosslinked polypropylene Acid resin 0.3~1.2%, glycerol 2.0~10.0%, propylene glycol 2.0~10.0%, isothiazolinone 0.01~0.1%, to hydroxyl Yl benzoic acid ester 0.1~1.0%, neutralizer 0.2~1.5%, surplus are purified water.
2. medical sterilization ultrasonic coupling agent according to claim 1, which is characterized in that the neutralizer be triethanolamine or The mixing of sodium hydroxide or both arbitrary proportion.
3. the preparation method of medical sterilization ultrasonic coupling agent as claimed in claim 1 or 2, which is characterized in that including walking as follows It is rapid:
1) cross-linked polyacrylic resin and purified water are weighed respectively by weight percentage, cross-linked polyacrylic resin is dissolved in purifying In water, solution A is obtained, indwelling is spare;
2) p-hydroxybenzoate and propylene glycol are weighed respectively by weight percentage, p-hydroxybenzoate is dissolved in into propylene glycol In, stirring obtains solution B, indwelling is spare;
3) isothiazolinone weighed by weight percentage is added in the solution B, obtains solution C, indwelling is spare;
4) the resulting solution C of step 3) is continued to stir after being added under stirring in the resulting solution A of step 1) 30~60 minutes, evenly spread to solution C in solution A;Glycerol weighed by weight percentage and neutralizer are added, finally Purified water is supplemented, pH value is adjusted 5.5~8.0, obtains colorless and transparent gel;
5) clear gel obtained by filling step 4), obtains medical sterilization ultrasonic coupling agent finished product.
CN201910145795.8A 2019-02-26 2019-02-26 A kind of medical sterilization ultrasonic coupling agent and preparation method thereof Pending CN109675069A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113769119A (en) * 2021-10-15 2021-12-10 山东科宏医疗科技有限公司 Medical ultrasonic coupling agent and preparation method thereof

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101773673A (en) * 2010-03-18 2010-07-14 薛海燕 Medical sterilization ultrasonic coupling agent and preparation method thereof
CN106620734A (en) * 2016-12-20 2017-05-10 江西宜信堂医疗科技有限公司 Sterile medical ultrasonic coupling patch and preparation method thereof
CN108078959A (en) * 2016-11-22 2018-05-29 北京赛特瑞科技发展有限公司 A kind of antibacterial and protective film and its preparation method and application

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101773673A (en) * 2010-03-18 2010-07-14 薛海燕 Medical sterilization ultrasonic coupling agent and preparation method thereof
CN108078959A (en) * 2016-11-22 2018-05-29 北京赛特瑞科技发展有限公司 A kind of antibacterial and protective film and its preparation method and application
CN106620734A (en) * 2016-12-20 2017-05-10 江西宜信堂医疗科技有限公司 Sterile medical ultrasonic coupling patch and preparation method thereof

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113769119A (en) * 2021-10-15 2021-12-10 山东科宏医疗科技有限公司 Medical ultrasonic coupling agent and preparation method thereof

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