CN117427188A - Non-irritating antibacterial ultrasonic coupling agent - Google Patents

Non-irritating antibacterial ultrasonic coupling agent Download PDF

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Publication number
CN117427188A
CN117427188A CN202311672821.5A CN202311672821A CN117427188A CN 117427188 A CN117427188 A CN 117427188A CN 202311672821 A CN202311672821 A CN 202311672821A CN 117427188 A CN117427188 A CN 117427188A
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couplant
parts
ultrasonic
irritating
temperature
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孙波
孙浩铭
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Shandong Yuanke Biotechnology Co ltd
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Shandong Yuanke Biotechnology Co ltd
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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
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/075Ethers or acetals
    • A61K31/085Ethers or acetals having an ether linkage to aromatic ring nuclear carbon
    • 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
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7016Disaccharides, e.g. lactose, lactulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/716Glucans
    • A61K31/722Chitin, chitosan
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/47Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
    • 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • AHUMAN NECESSITIES
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    • 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
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    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12YENZYMES
    • C12Y302/00Hydrolases acting on glycosyl compounds, i.e. glycosylases (3.2)
    • C12Y302/01Glycosidases, i.e. enzymes hydrolysing O- and S-glycosyl compounds (3.2.1)
    • C12Y302/01017Lysozyme (3.2.1.17)

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Abstract

The invention belongs to the technical field of ultrasonic couplants, and particularly relates to a non-irritating antibacterial ultrasonic couplant. The ultrasonic coupling agent comprises the following components in parts by weight: 0.2-0.8 part of carbomer, 0.05-0.4 part of nephelometric ethyl ester, 0.01-0.04 part of DPP-300, 0.02-0.06 part of chitosan, 0.01-0.05 part of lysozyme, 0.1-0.5 part of trehalose, 0.1-0.5 part of gelatin and 1-3 parts of temperature sensitive hydrogel. The ultrasonic couplant has good sterilization and antibacterial effects and excellent antibacterial stability, the state of the couplant can be changed along with the temperature, the couplant can flow when the temperature of the couplant approaches to the body temperature of a human body and can be smoothly extruded onto an ultrasonic probe or the skin of the body surface of a patient, and the temperature difference between the couplant and the skin surface of the patient infant is eliminated, so that the irritation to the skin of the patient is reduced, and the use comfort of the couplant is improved.

Description

Non-irritating antibacterial ultrasonic coupling agent
Technical Field
The invention belongs to the technical field of ultrasonic couplants, and particularly relates to a non-irritating antibacterial ultrasonic couplant.
Background
Ultrasonic examination is a non-invasive imaging examination method widely applied in clinic, and can observe the pathological tissue morphology of subcutaneous and viscera. The medical ultrasonic couplant is a gelatinous preparation which is needed by human body for ultrasonic examination, and aims to eliminate air between an ultrasonic probe and skin, strengthen the coupling between the ultrasonic probe and the skin, reduce attenuation and reduce interference of noise on a detection result so as to obtain a reliable detection result and provide a basis for correct diagnosis of doctors. The medical couplant is a medical product composed of a new generation of aqueous polymer gel, most of medical ultrasonic couplants applied to the market at present are carbomer gel type, the pH value of the medical ultrasonic couplant is neutral, the medical ultrasonic couplant is nontoxic and harmless to human bodies, is not easy to dry and rancidity, the ultrasonic imaging is clear, the viscosity is proper, the probe is not greasy, the probe is easy to slide, the skin can be moistened, the air on the surface of the skin is eliminated, the lubricating performance is good, and the medical ultrasonic couplant is easy to spread; the ultrasonic probe is free from corrosion and damage.
However, the ultrasonic couplant in the prior art has the defect of poor sterilization efficiency, and cannot realize long-term sterilization effect. Secondly, the ultrasonic couplant used in ultrasonic examination is generally stored in a room temperature environment, and when the couplant contacts the skin surface of a patient, particularly in autumn and winter, certain irritation can be caused to the skin of the patient due to the fact that the temperature of the couplant is lower than that of the skin of the patient, so that the use comfort of the couplant is affected.
Disclosure of Invention
In order to solve the problems in the prior art, the invention provides the non-irritating antibacterial ultrasonic couplant which has good sterilizing and antibacterial effects and excellent antibacterial stability, the state of the couplant can be changed along with the temperature, the couplant can flow when the temperature of the couplant approaches to the body temperature of a human body, the couplant can be smoothly extruded onto an ultrasonic probe or the skin of a patient body surface, and the temperature difference between the couplant and the skin surface of the patient child patient is eliminated, so that the irritation to the skin of the patient is reduced, and the use comfort of the couplant is improved.
In order to achieve the above purpose, the invention adopts the following technical scheme:
the non-irritating antibacterial ultrasonic coupling agent comprises the following components in parts by weight: 0.2-0.8 part of carbomer, 0.05-0.4 part of nephelometric ethyl ester, 0.01-0.04 part of DPP-300, 0.02-0.06 part of chitosan, 0.01-0.05 part of lysozyme, 0.1-0.5 part of trehalose, 0.1-0.5 part of gelatin and 1-3 parts of temperature sensitive hydrogel.
As the nepal gold ethyl ester, DPP-300, chitosan and lysozyme are used as the combined bactericide, the ultrasonic coupling agent has good sterilization and antibacterial effects and excellent antibacterial stability.
Lysozyme can effectively hydrolyze peptidoglycan of bacterial cell wall, and can be used as a natural anti-infective substance with bactericidal effect. Has antibacterial, antiviral, hemostatic, repercussive, analgesic, and tissue restoring effects.
Trehalose can form a special protective film on the surface layer of skin, and mucus precipitated from the film not only moistens skin cells, but also has the function of radiating out external heat, thereby protecting the skin from damage.
The gelatin and the temperature-sensitive hydrogel are matched after being mixed to synthesize an oversized gel network structure, and the space and the temperature response performance of the gel network are regulated, so that the gel network can control the form within the conversion temperature range to adapt to different application environments. The state of the couplant can be changed along with the temperature, the couplant can flow when the temperature of the couplant reaches the body temperature of a human body, and can be smoothly extruded onto the ultrasonic probe or the skin of the body surface of a patient, so that the temperature difference between the couplant and the skin surface of the patient infant is eliminated, the direct contact of the couplant with the body with the excessively low temperature is avoided, the discomfort of the patient is reduced, the irritation to the skin of the patient is reduced, and the use comfort is improved.
Preferably, the gel transition temperature of the temperature-sensitive hydrogel is between 35 ℃ and 37 ℃, the ultrasonic couplant is in a liquid state below the gel transition temperature, and the ultrasonic couplant is in a gel state above the gel transition temperature.
Preferably, the temperature sensitive hydrogel comprises poloxamer and/or derivatives thereof.
Preferably, the poloxamer derivative comprises one or more of products modified by sulfhydrylation, carboxylation, amination, etherization, carboxymethylation or hydroxypropylation.
Preferably, the viscosity of the ultrasonic couplant is 100-800 Pa.s in liquid state; in the gel state, the viscosity of the ultrasonic couplant is 10000-80000 Pa.s.
Preferably, the non-irritating antibacterial ultrasonic coupling agent comprises the following components in parts by weight: carbomer 0.2 parts, gold ethyl nephelate 0.054 parts, DPP-300.01 parts, chitosan 0.02 parts, lysozyme 0.01 parts, trehalose 0.1 parts, gelatin 0.1 parts and thermosensitive hydrogel 1 part.
Preferably, the non-irritating antibacterial ultrasonic coupling agent comprises the following components in parts by weight: 0.8 part of carbomer, 0.4 part of nepal gold ethyl ester, 0.04 part of DPP-300, 0.06 part of chitosan, 0.05 part of lysozyme, 0.5 part of trehalose, 0.5 part of gelatin and 3 parts of thermosensitive hydrogel.
Preferably, the non-irritating antibacterial ultrasonic coupling agent comprises the following components in parts by weight: 0.5 part of carbomer, 0.2 part of nepal gold ethyl ester, 0.02 part of DPP-300, 0.04 part of chitosan, 0.03 part of lysozyme, 0.3 part of trehalose, 0.3 part of gelatin and 2 parts of thermosensitive hydrogel.
Advantageous effects
The invention discloses a non-irritating antibacterial ultrasonic coupling agent, which has the following advantages:
(1) As the nepal gold ethyl ester, DPP-300, chitosan and lysozyme are used as the combined bactericide, the ultrasonic coupling agent has good sterilization and antibacterial effects and excellent antibacterial stability. The lysozyme can effectively hydrolyze peptidoglycan of bacterial cell walls, can be used as a natural anti-infective substance with bactericidal effect, and has the functions of resisting bacteria and viruses, stopping bleeding, detumescence and pain, accelerating tissue recovery and the like.
(2) The gelatin and the temperature-sensitive hydrogel are matched after being mixed to synthesize an oversized gel network structure, and the space and the temperature response performance of the gel network are regulated, so that the gel network can control the form within the conversion temperature range to adapt to different application environments. The state of the couplant can be changed along with the temperature, the couplant can flow when the temperature of the couplant reaches the body temperature of a human body, and can be smoothly extruded onto the ultrasonic probe or the skin of the body surface of a patient, so that the temperature difference between the couplant and the skin surface of the patient infant is eliminated, the direct contact of the couplant with the body with the excessively low temperature is avoided, the discomfort of the patient is reduced, the irritation to the skin of the patient is reduced, and the use comfort is improved.
(3) The ultrasonic probe and the skin can be well infiltrated to thoroughly exhaust the air; can keep moist for a long time without drying, and keep viscosity and adhesiveness for a long time, so that the probe can slide smoothly along the skin; does not irritate the skin and does not cause sensitization even after long-term contact; the adhesive force is not reduced after the skin is smeared in clinical environment, and the adhesive has the sound transmission and electrical insulation capability.
Detailed Description
Hereinafter, the present invention will be described in detail. Before the description, it is to be understood that the terms used in this specification and the appended claims should not be construed as limited to general and dictionary meanings, but interpreted based on the meanings and concepts corresponding to technical aspects of the present invention on the basis of the principle that the inventor is allowed to define terms appropriately for the best explanation. Accordingly, the description set forth herein is merely a preferred example for the purpose of illustration and is not intended to limit the scope of the invention, so that it should be understood that other equivalents or modifications may be made thereto without departing from the spirit and scope of the invention.
The following examples are merely illustrative of embodiments of the present invention and are not intended to limit the invention in any way, and those skilled in the art will appreciate that modifications may be made without departing from the spirit and scope of the invention. Unless otherwise specified, reagents and equipment used in the following examples are commercially available products.
Poloxamer chemical name is polyoxyethylene polyoxypropylene ether segmented copolymer, molecular formula is HO (C) 2 H 4 O)m·(C 3 H 6 O) n.H, which is a pharmaceutical compound approved by the FDA in the United states, has excellent biocompatibility and safety.
Example 1
The non-irritating antibacterial ultrasonic coupling agent comprises the following components in parts by weight: carbomer 0.2 parts, gold ethyl nephelate 0.054 parts, DPP-300.01 parts, chitosan 0.02 parts, lysozyme 0.01 parts, trehalose 0.1 parts, gelatin 0.1 parts and thermosensitive hydrogel 1 part.
The gel transition temperature of the temperature-sensitive hydrogel is between 35 and 37 ℃, the ultrasonic couplant is in a liquid state below the gel transition temperature, and the ultrasonic couplant is in a gel state above the gel transition temperature. The temperature sensitive hydrogel comprises poloxamer and/or derivatives thereof. The poloxamer derivative comprises one or more of products modified by sulfhydrylation, carboxylation, amination, etherization, carboxymethylation or hydroxypropylation. When in a liquid state, the viscosity of the ultrasonic couplant is 100-800 Pa.s; in the gel state, the viscosity of the ultrasonic couplant is 10000-80000 Pa.s.
Example 2
The non-irritating antibacterial ultrasonic coupling agent comprises the following components in parts by weight: 0.8 part of carbomer, 0.4 part of nepal gold ethyl ester, 0.04 part of DPP-300, 0.06 part of chitosan, 0.05 part of lysozyme, 0.5 part of trehalose, 0.5 part of gelatin and 3 parts of thermosensitive hydrogel.
Example 3
The non-irritating antibacterial ultrasonic coupling agent comprises the following components in parts by weight: 0.5 part of carbomer, 0.2 part of nepal gold ethyl ester, 0.02 part of DPP-300, 0.04 part of chitosan, 0.03 part of lysozyme, 0.3 part of trehalose, 0.3 part of gelatin and 2 parts of thermosensitive hydrogel.
The above embodiments are only for illustrating the technical solution of the present invention, and are not limiting; although the invention has been described in detail with reference to the foregoing embodiments, it will be apparent to one skilled in the art that modifications may be made to the technical solutions described in the foregoing embodiments, or equivalents may be substituted for some of the technical features thereof; such modifications and substitutions do not depart from the spirit and scope of the corresponding technical solutions.

Claims (8)

1. The non-irritating antibacterial ultrasonic coupling agent is characterized by comprising the following components in parts by weight: 0.2-0.8 part of carbomer, 0.05-0.4 part of nephelometric ethyl ester, 0.01-0.04 part of DPP-300, 0.02-0.06 part of chitosan, 0.01-0.05 part of lysozyme, 0.1-0.5 part of trehalose, 0.1-0.5 part of gelatin and 1-3 parts of temperature sensitive hydrogel.
2. The non-irritating antimicrobial ultrasound couplant of claim 1, wherein the temperature sensitive hydrogel has a gel transition temperature between 35 ℃ and 37 ℃ below which the ultrasound couplant is in a liquid state and above which the ultrasound couplant is in a gel state.
3. The non-irritating antimicrobial ultrasound couplant of claim 2, wherein the temperature sensitive hydrogel comprises poloxamer and/or derivatives thereof.
4. A non-irritating antimicrobial ultrasound couplant according to claim 3 wherein the poloxamer derivatives include one or more of thiolated, carboxylated, aminated, etherified, carboxymethylated or hydroxypropylated modified products.
5. The non-irritating antimicrobial ultrasonic couplant of claim 2 wherein the viscosity of the ultrasonic couplant is 100-800Pa s when in liquid form; in the gel state, the viscosity of the ultrasonic couplant is 10000-80000 Pa.s.
6. The non-irritating antibacterial ultrasonic couplant of claim 1, comprising the following components in parts by weight: carbomer 0.2 parts, gold ethyl nephelate 0.054 parts, DPP-300.01 parts, chitosan 0.02 parts, lysozyme 0.01 parts, trehalose 0.1 parts, gelatin 0.1 parts and thermosensitive hydrogel 1 part.
7. The non-irritating antibacterial ultrasonic couplant of claim 1, comprising the following components in parts by weight: 0.8 part of carbomer, 0.4 part of nepal gold ethyl ester, 0.04 part of DPP-300, 0.06 part of chitosan, 0.05 part of lysozyme, 0.5 part of trehalose, 0.5 part of gelatin and 3 parts of thermosensitive hydrogel.
8. The non-irritating antibacterial ultrasonic couplant of claim 1, comprising the following components in parts by weight: 0.5 part of carbomer, 0.2 part of nepal gold ethyl ester, 0.02 part of DPP-300, 0.04 part of chitosan, 0.03 part of lysozyme, 0.3 part of trehalose, 0.3 part of gelatin and 2 parts of thermosensitive hydrogel.
CN202311672821.5A 2023-12-07 2023-12-07 Non-irritating antibacterial ultrasonic coupling agent Pending CN117427188A (en)

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102178962A (en) * 2011-04-13 2011-09-14 枣庄汇康医疗用品有限公司 Medical disinfection/sterilization ultrasound couplant and preparation method thereof
CN114028589A (en) * 2021-12-06 2022-02-11 江苏开源康达医疗器械有限公司 Composite lysozyme sterilization and disinfection type ultrasonic coupling agent and preparation method thereof
CN114984252A (en) * 2022-05-16 2022-09-02 中国人民解放军陆军军医大学第二附属医院 Application of poloxamer in-vivo ultrasonic coupling agent and ultrasonic coupling agent
CN116549675A (en) * 2023-05-10 2023-08-08 苏州大学附属儿童医院 Non-irritating medical ultrasonic coupling agent and preparation method thereof

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102178962A (en) * 2011-04-13 2011-09-14 枣庄汇康医疗用品有限公司 Medical disinfection/sterilization ultrasound couplant and preparation method thereof
CN114028589A (en) * 2021-12-06 2022-02-11 江苏开源康达医疗器械有限公司 Composite lysozyme sterilization and disinfection type ultrasonic coupling agent and preparation method thereof
CN114984252A (en) * 2022-05-16 2022-09-02 中国人民解放军陆军军医大学第二附属医院 Application of poloxamer in-vivo ultrasonic coupling agent and ultrasonic coupling agent
CN116549675A (en) * 2023-05-10 2023-08-08 苏州大学附属儿童医院 Non-irritating medical ultrasonic coupling agent and preparation method thereof

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