CN115590985B - Sterile medical ultrasonic coupling agent and preparation method thereof - Google Patents

Sterile medical ultrasonic coupling agent and preparation method thereof Download PDF

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Publication number
CN115590985B
CN115590985B CN202111578921.2A CN202111578921A CN115590985B CN 115590985 B CN115590985 B CN 115590985B CN 202111578921 A CN202111578921 A CN 202111578921A CN 115590985 B CN115590985 B CN 115590985B
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China
Prior art keywords
medical ultrasonic
sterile medical
coupling agent
carbomer
sterile
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CN115590985A (en
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邹贤信
张万国
李懋
周鑫鑫
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Likang Pharmaceutical Technology Jiangsu Co ltd
Shanghai Likang Disinfection High Tech Co ltd
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Likang Pharmaceutical Technology Jiangsu Co ltd
Shanghai Likang Disinfection High Tech 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
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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  • Health & Medical Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Acoustics & Sound (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)

Abstract

The invention discloses a sterile medical ultrasonic couplant and a preparation method thereof, wherein the sterile medical ultrasonic couplant comprises the following components: 0.3-0.8% carbomer, 5-15% humectant, 0.1-1% preservative, 0.5-5% urea, 0.001-0.01% urease and the balance purified water. The invention also discloses a preparation method of the aseptic medical ultrasonic coupling agent. The sterile medical ultrasonic couplant is colorless, nontoxic and non-irritating, has good thermal stability, good lubricating performance and clear ultrasonic imaging, and can meet various requirements of the sterile medical ultrasonic couplant of medical industry standard YY0299-2016 of medical ultrasonic couplant. In addition, the sterile medical ultrasonic coupling agent has the advantages of simple manufacturing process, no need of vacuumizing to remove bubbles, no need of cobalt-60 irradiation sterilization and other processes, simple manufacturing process, low cost and easy market popularization and application.

Description

Sterile medical ultrasonic coupling agent and preparation method thereof
Technical Field
The invention belongs to the technical field of medical ultrasonic diagnosis and detection, and particularly relates to a sterile medical ultrasonic coupling agent and a preparation method thereof.
Technical Field
Medical ultrasound examination is a visual medical imaging diagnosis technology based on ultrasonic waves, which has been applied only in the 20 th century, and has been widely used in the current medicine, because ultrasonic waves can generate reflection phenomena when being incident on the interface between two different media, and reduce the size of sound energy penetrating into the other medium, filling an intermediate substance between the body of a patient and a probe becomes a necessary means for reducing the loss of sound energy, the intermediate substance is called a medical ultrasonic couplant, and gradually becomes one of the most frequently used medical supplies in clinic, and in practical application, the ultrasonic couplant has a plurality of performance requirements: 1. no irritation to skin, and no anaphylaxis caused by long-time contact; 2. the thixotropic property is good, and the air is thoroughly removed; 3. the sound velocity is proper, the attenuation coefficient is small, the acoustic impedance is moderate, so that the definition of ultrasonic imaging is improved; 4. good lubricating performance, proper viscosity, no flow and easy erasure; 5. can wet skin and is not easy to dry; 6. has thermal stability, and the adhesive force is not reduced under clinical conditions; 7. has no corrosion to the ultrasonic probe.
To date, the medical industry standard YY0299-2016 named as medical ultrasonic couplant is established in China in the couplant industry, and the standard specifically limits and prescribes the classification and the use as well as the components of the medical ultrasonic couplant, and provides related technical requirements and test methods for products.
According to the classification of medical ultrasonic couplants, at present, the non-sterile medical ultrasonic couplants in the market are more in variety, most of the non-sterile products are also sterile products, for example, CN105983107A provides a novel medical sterilizing ultrasonic couplant, takes magnolol as a main sterilizing component, and takes eugenol, anisic acid, dipotassium glycyrrhizinate and vanillin for synergistic sterilization; for example, CN104189927A is compounded by 6 Chinese herbal medicine essential oils to achieve the sterilization effect, and the mixed smell of the various Chinese herbal medicine essential oils is mixed, and the preparation process is complex; and as another example, the chemical components are used as bactericides: CN101219223A uses (0.2% -2%) 2, 4-trichloro-2-hydroxydiphenyl ether as sterilizing component, can not be biodegraded, and has a large amount of chemical sterilizing agent, and can remain on skin after ultrasonic diagnosis, thus having certain stimulation effect on skin.
Meanwhile, the aseptic medical ultrasonic couplant meeting the requirements of medical ultrasonic couplant is relatively few.
Disclosure of Invention
The invention provides a sterile medical ultrasonic couplant and a preparation method thereof, aiming at the defects of the existing medical ultrasonic couplant products. The invention adopts the raw materials meeting the standard requirements and is assisted by a physical and chemical combination mode, thereby meeting the requirements of medical ultrasonic couplant.
The invention is realized in such a way that a sterile medical ultrasonic coupling agent comprises the following components in percentage by weight:
carbomer 0.3-0.8%,
5-15% of humectant,
preservative phenoxyethanol 0.1-1%
Urea 0.5-5%
Urease 0.001-0.01%
Purifying water, and the balance.
The carbomer is a water-soluble gelling agent.
The sterile medical ultrasonic couplant adopts urea as a pH adjusting and skin care agent.
The aseptic medical ultrasonic couplant comprises the following components: the wetting agent is one or more of glycerol, propylene glycol and polyethylene glycol.
A preparation method of an aseptic medical ultrasonic coupling agent comprises the following steps:
(1) Carbomer is weighed according to the proportion and added into purified water to be stirred and dissolved for 40 to 60 minutes, thus obtaining solution A.
(2) And adding the humectant, the preservative and the urea in the proportion into the solution A, and uniformly stirring to obtain the solution B.
(3) Adding urease into the solution B, stirring for 10 minutes, and standing to obtain the solution C.
(4) And (3) filling the liquid C, and then, thickening the liquid C for 30 to 60 minutes at the temperature of 75 to 85 ℃ to obtain the sterile medical ultrasonic coupling agent.
Compared with the prior art, the following test examples prove that the invention has the following advantages:
the invention adopts urea as a pH regulator, the urea is used as a skin moisturizer, naturally exists in the horny layer of skin, belongs to the main component of natural skin moisturizing factor NMF, and has double effects of moisturizing and softening the horny layer of skin. The principle of the invention is that urea is decomposed into ammonia and carbon dioxide under the action of urease to finally form ammonium bicarbonate, so that the pH value of the solution is kept between neutral 6.5 and 7.5, the aim of thickening a system can be achieved, and the skin cannot be stimulated.
The invention adopts urease as a urea decomposition catalyst, and the urease is used as an absolute and specific urea decomposition enzyme widely existing in microorganisms and animal and plant tissues, so that the urea can be rapidly catalyzed and decomposed, the activity of the urease can be controlled by pH and temperature, the pH of an initial system is lower than 3.0, the decomposition speed is very slow, and the decomposition speed can be accelerated when the temperature is increased, thereby achieving the purpose of controlling the thickening time and the steps.
The invention adopts the production process of filling before thickening, because the viscosity of the medical ultrasonic coupling agent is very high, the requirement on filling equipment is high in actual production, and bubbles are easy to generate during filling, so that a degassing device is needed.
The invention adopts a physical and chemical combination mode that the final packaging product is kept for 30-60 minutes at 75-85 ℃ for thickening and sterilizing, does not need cobalt-60 irradiation sterilization, reduces the sterilization treatment difficulty and improves the application range of the product.
The medical ultrasonic couplant can meet various requirements of the medical industry standard YY0299-2016 of medical ultrasonic couplant, and has simple manufacturing process and no need of vacuumizing, bubble removing and other processes.
Detailed Description
The invention will be further illustrated with reference to specific examples. These examples should be construed as merely illustrative of the present invention and not limiting the scope of the present invention. Various changes and modifications to the present invention may be made by one skilled in the art after reading the description herein, and such equivalent changes and modifications are intended to fall within the scope of the present invention as defined in the appended claims.
Example 1
The preparation process of the sterile medical ultrasonic coupling agent comprises the following steps:
(1) 4kg of carbomer was weighed and added to 873kg of purified water, and the mixture was dissolved by stirring for 40 minutes to obtain solution A.
(2) Weighing 100kg of glycerol, 8kg of phenoxyethanol and 15kg of urea, adding into the solution A, and stirring uniformly to obtain solution B.
(3) 10g of urease was added to the solution B, and after stirring for 10 minutes, the mixture was allowed to stand to obtain a solution C.
(4) And (3) filling the liquid C, and then, thickening the liquid C at 78 ℃ for 60 minutes to obtain the sterile medical ultrasonic coupling agent.
Example 2
The preparation process of the sterile medical ultrasonic coupling agent comprises the following steps:
(1) 7kg of carbomer is weighed and added into 900kg of purified water to be stirred and dissolved for 60 minutes, thus obtaining solution A.
(2) Weighing 50kg of glycerol, 3kg of phenoxyethanol and 40kg of urea, adding into the solution A, and stirring uniformly to obtain solution B.
(3) 50g of urease was added to the solution B, and after stirring for 10 minutes, the mixture was allowed to stand to obtain a solution C.
(4) And (3) filling the liquid C, and then, thickening the liquid C at 82 ℃ for 30 minutes to obtain the sterile medical ultrasonic coupling agent.
Test example 1-microbiological test:
taking the aseptic medical ultrasonic couplant samples of the above embodiments, and according to the inspection results of the 'aseptic inspection method' of the appendix XI H of 2010 edition of the pharmacopoeia of the people's republic of China', the blank control tube is aseptically grown, and the results conform to the regulations of the aseptic inspection method.
Test example 2-performance test:
taking the aseptic medical ultrasonic couplant samples of the embodiments, and detecting the main performances of the aseptic medical ultrasonic couplant samples to show that: the acoustic resistance (35 ℃) is 1560-1580 m/s, the acoustic attenuation (35 ℃) is less than or equal to 0.05 dB/(cm.MHz), the pH value is 6.7-7.2, and all indexes meet the requirements of the medical industry standard YY0299-2016 of medical ultrasonic couplant. The ultrasonic probe field simulation experiment shows that: good lubricating performance and clear images.
In conclusion, the sterile medical ultrasonic couplant is colorless, nontoxic, non-irritating, good in thermal stability, good in lubricating performance and clear in ultrasonic imaging, and can meet various requirements of the sterile medical ultrasonic couplant of medical industry standard YY0299-2016 of medical ultrasonic couplant. In addition, the sterile medical ultrasonic coupling agent has the advantages of simple manufacturing process, no need of vacuumizing to remove bubbles, no need of cobalt-60 irradiation sterilization and other processes, simple manufacturing process, low cost and easy market popularization and application.

Claims (3)

1. The aseptic medical ultrasonic coupling agent is characterized by comprising the following components in percentage by weight:
carbomer 0.3-0.8%,
5-15% of humectant,
0.1 to 1 percent of preservative phenoxyethanol,
urea 0.5-5 wt%,
urease 0.001-0.01%,
purified water, the balance,
the carbomer is a water-soluble gelling agent, and the carboxyl content of the carbomer is 56.0-68.0%.
2. The sterile medical ultrasound couplant of claim 1, wherein: the humectant is one or more of glycerol, propylene glycol and polyethylene glycol.
3. A method for preparing a sterile medical ultrasound couplant according to any of claims 1-2 and comprising the steps of:
(1) Weighing carbomer according to the proportion, adding the carbomer into purified water, stirring and dissolving for 40-60 minutes to obtain solution A;
(2) Adding a proportioning humectant, a preservative and urea into the solution A, and uniformly stirring to obtain solution B;
(3) Adding urease into the solution B, stirring for 10 minutes, and standing to obtain solution C;
(4) And (3) filling the liquid C, and then, thickening the liquid C for 30 to 60 minutes at the temperature of 75 to 85 ℃ to obtain the sterile medical ultrasonic coupling agent.
CN202111578921.2A 2021-12-22 2021-12-22 Sterile medical ultrasonic coupling agent and preparation method thereof Active CN115590985B (en)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101966134A (en) * 2010-09-28 2011-02-09 广东海洋大学 Liquid soap with sterilizing and skin protecting functions and preparation method thereof
CN104208726A (en) * 2014-02-28 2014-12-17 张维芬 Chitosan quaternary ammonium salt couplant and preparation method thereof
CN104721845A (en) * 2015-03-13 2015-06-24 湖北大学 Disinfecting and sterilizing medical ultrasonic coupling agent with moisturizing and skin-moistening effects and preparation method of disinfecting and sterilizing medical ultrasonic coupling agent

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9615750B2 (en) * 2012-06-14 2017-04-11 Seno Medical Instruments, Inc. Methods and compositions for carrier agents and clearing agents used in optoacoustic imaging systems

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101966134A (en) * 2010-09-28 2011-02-09 广东海洋大学 Liquid soap with sterilizing and skin protecting functions and preparation method thereof
CN104208726A (en) * 2014-02-28 2014-12-17 张维芬 Chitosan quaternary ammonium salt couplant and preparation method thereof
CN104721845A (en) * 2015-03-13 2015-06-24 湖北大学 Disinfecting and sterilizing medical ultrasonic coupling agent with moisturizing and skin-moistening effects and preparation method of disinfecting and sterilizing medical ultrasonic coupling agent

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
卡波姆水凝胶的处方筛选与质量考察;郑增娟等;《医药导报》;20150228;第34卷(第2期);第244-248页 *

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