CN115590985A - 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
CN115590985A
CN115590985A CN202111578921.2A CN202111578921A CN115590985A CN 115590985 A CN115590985 A CN 115590985A CN 202111578921 A CN202111578921 A CN 202111578921A CN 115590985 A CN115590985 A CN 115590985A
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China
Prior art keywords
medical ultrasonic
sterile medical
solution
couplant
sterile
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CN202111578921.2A
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CN115590985B (en
Inventor
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% of carbomer, 5-15% of humectant, 0.1-1% of preservative, 0.5-5% of urea, 0.001-0.01% of urease and the balance of purified water. The invention also discloses a preparation method of the sterile medical ultrasonic coupling agent. The sterile medical ultrasonic couplant is colorless, nontoxic, non-irritating, good in thermal stability, good in lubricating property 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 disclosed by the invention is simple in preparation process, free of processes of vacuumizing to remove bubbles, free of cobalt-60 irradiation sterilization and the like, simple in preparation process, low in cost and easy to popularize and apply in the market.

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 ultrasonic examination is an ultrasonic-based visual medical imaging diagnostic technique which is started to be applied in the 20 th century, and is widely applied in the current medical science, because ultrasonic waves can generate a reflection phenomenon when being incident on an interface of two different media, and the size of sound energy penetrating into the other medium is reduced, a medium substance is filled between a patient body and a probe to become a necessary means for reducing the loss of the sound energy, the medium substance is called a medical ultrasonic couplant and gradually becomes one of medical supplies which are used most frequently in clinic, and the ultrasonic couplant has multiple performance requirements in practical application: 1. the skin is not stimulated, and the anaphylactic reaction can not be caused after the skin is contacted for a long time; 2. the thixotropic property is good, and air is thoroughly removed; 3. the sound velocity is proper, the attenuation coefficient is small, and the acoustic impedance is moderate, so that the ultrasonic image definition is improved; 4. the lubricating property is good, the viscosity is proper, the flowing is avoided, and the erasing is easy; 5. can moisten skin, and is not easy to dry; 6. the adhesive has thermal stability, and the adhesion force is not reduced under clinical conditions; 7. has no corrosion effect on the ultrasonic probe.
So far, the couplant industry has a medical industry standard YY0299-2016 named medical ultrasonic couplant, which is established in China, and the standard makes specific limits and regulations on classification, application and components of the medical ultrasonic couplant and puts forward related technical requirements and test methods for products.
According to the classification of medical ultrasonic couplants, currently, the types of non-sterile medical ultrasonic couplants in the market are more, most of the non-sterile medical ultrasonic couplants are non-sterile products, and a sterile product is also available, for example, CN105983107A provides a novel medical sterilizing ultrasonic couplant, magnolol is used as a main sterilizing component, and syringic acid, anisic acid, dipotassium glycyrrhizinate and vanillin are used for synergistic sterilization; for example, CN104189927A is compounded by 6 Chinese herbal medicine essential oils to achieve the sterilization effect, the mixed smell of various Chinese herbal medicine essential oils is mixed, and the preparation process is complex; and if the chemical components are taken as bactericides: CN101219223A takes (0.2% -2%) 2, 4-trichloro-2-hydroxydiphenyl ether as a bactericidal component, can not be biodegraded, and the chemical bactericide is added in a large amount, and remains on the skin after ultrasonic diagnosis, and has a certain stimulation effect on the skin.
Meanwhile, the sterile medical ultrasonic couplant meeting the requirements of medical ultrasonic couplant is relatively few.
Disclosure of Invention
Aiming at the defects of the existing medical ultrasonic coupling agent product, the invention provides a sterile medical ultrasonic coupling agent and a preparation method thereof. The invention adopts raw materials meeting the standard requirements and is assisted with a mode of combining physics and chemistry to meet 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:
0.3 to 0.8 percent of carbomer,
5 to 15 percent of humectant,
0.1 to 1 percent of preservative phenoxyethanol
0.5 to 5 percent of urea
Urease 0.001-0.01%
Purified water, balance.
The sterile medical ultrasonic couplant is characterized in that carbomer is a water-soluble gelling agent.
The sterile medical ultrasonic couplant adopts urea as a pH adjusting and skin caring agent.
The sterile medical ultrasonic coupling agent comprises the following components: the wetting agent is one or more of glycerol, propylene glycol and polyethylene glycol.
A preparation method of a sterile medical ultrasonic couplant comprises the following steps:
(1) And weighing carbomer according to the proportion, adding the carbomer into the purified water, and stirring for dissolving for 40-60 minutes to obtain solution A.
(2) And adding the humectant, the preservative and the urea in proportion into the solution A, and uniformly stirring to obtain solution B.
(3) And adding urease into the solution B, stirring for 10 minutes, and standing to obtain solution C.
(4) And filling the solution C, and thickening the filled solution C at the temperature of between 75 and 85 ℃ for 30 to 60 minutes to obtain the sterile medical ultrasonic couplant.
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, and the urea as a skin humectant naturally exists in the horny layer of the skin, belongs to the main component of the natural moisturizing factor NMF of the skin, and has double effects of moisturizing and softening cutin on the 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, thereby achieving the purpose of thickening the system and causing no stimulation to skin.
The invention adopts urease as a decomposition catalyst of urea, the urease is used as absolute specific urea decomposing enzyme which is widely existed in microorganisms and animal and plant tissues, urea can be rapidly catalytically decomposed, simultaneously the activity of the urea 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 steps.
The invention adopts a production process of firstly filling and then thickening, and the viscosity of the medical ultrasonic couplant is very high, so that the requirement on filling equipment is high in the actual production, and air bubbles are easily generated during filling, so that a degassing device is needed.
The invention adopts a physical and chemical combination mode that the final packaged product is kept for 30-60 minutes at 75-85 ℃ for thickening and sterilization, does not need cobalt-60 irradiation sterilization, reduces the difficulty of aseptic treatment and improves the application range of the product.
The medical ultrasonic couplant can meet various requirements of sterile medical ultrasonic couplants in medical industry standard YY0299-2016 of medical ultrasonic couplant, and is simple in manufacturing process and free of processes of vacuumizing, bubble removing and the like.
Detailed Description
The invention will be further illustrated with reference to the following specific examples. These examples are to be construed as merely illustrative and not limitative of the remainder of the disclosure in any way whatsoever. After reading the description of the invention, one skilled in the art can make various changes and modifications to the invention, and such equivalent changes and modifications also fall into the scope of the invention defined by the claims.
Example 1
The preparation process of the sterile medical ultrasonic couplant comprises the following steps:
(1) 4kg of carbomer is weighed and added into 873kg of purified water to be stirred and dissolved for 40 minutes, so as to obtain solution A.
(2) And (3) weighing 100kg of glycerol, 8kg of phenoxyethanol and 15kg of urea, adding the mixture into the solution A, and uniformly stirring to obtain solution B.
(3) And adding 10g of urease into the solution B, stirring for 10 minutes, and standing to obtain a solution C.
(4) And filling the solution C, and thickening the solution C at 78 ℃ for 60 minutes to obtain the sterile medical ultrasonic couplant.
Example 2
The preparation process of the sterile medical ultrasonic couplant 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, so as to obtain solution A.
(2) And (3) weighing 50kg of glycerol, 3kg of phenoxyethanol and 40kg of urea, adding the mixture into the solution A, and uniformly stirring to obtain a solution B.
(3) And adding 50g of urease into the solution B, stirring for 10 minutes, and standing to obtain a solution C.
(4) And filling the solution C, and thickening the filled solution C at 82 ℃ for 30 minutes to obtain the sterile medical ultrasonic couplant.
Test example 1-microbiological assay:
taking the sterile medical ultrasonic couplant samples in the embodiments, the examination results of appendix XI H (2010 edition) of pharmacopoeia of the people's republic of China (second part) in the "sterility test method" show that blank reference tubes grow aseptically, and the results meet the regulations of sterility test laws.
Test example 2-performance testing:
the main performance of the sterile medical ultrasonic couplant samples taken in the above embodiments is shown by the following detection results: the sound resistance (35 ℃) is 1560-1580 m/s, the sound 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 medical industry standard YY0299-2016 of medical ultrasonic couplant. The ultrasonic probe field simulation experiment shows that: the lubricating property is good, and the image is clear.
In conclusion, the sterile medical ultrasonic couplant is colorless, nontoxic, non-irritating, good in thermal stability, good in lubricating property 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 disclosed by the invention is simple in preparation process, free of processes of vacuumizing to remove bubbles, free of cobalt-60 irradiation sterilization and the like, simple in preparation process, low in cost and easy to popularize and apply in the market.

Claims (4)

1. A sterile medical ultrasonic couplant is characterized by comprising the following components in percentage by weight:
0.3 to 0.8 percent of carbomer,
5 to 15 percent of humectant,
0.1 to 1 percent of preservative phenoxyethanol
0.5 to 5 percent of urea
Urease 0.001-0.01%
Purified water, balance.
2. The sterile medical ultrasonic couplant of claim 1, wherein: the carbomer is a water-soluble gelling agent, and the carboxyl content of the carbomer is 56.0-68.0%.
3. The sterile medical ultrasound couplant of claim 1, wherein: the wetting agent is one or more of glycerol, propylene glycol and polyethylene glycol.
4. A method for preparing the sterile medical ultrasound couplant of any one of claims 1-3, 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 the humectant, the preservative and the urea into the solution A in proportion, and uniformly stirring to obtain a solution B;
(3) Adding urease into the solution B, stirring for 10 minutes, and standing to obtain solution C;
(4) And filling the solution C, and thickening the filled solution C at the temperature of between 75 and 85 ℃ for 30 to 60 minutes to obtain the sterile medical ultrasonic couplant.
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 (4)

* 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
US20130338476A1 (en) * 2012-06-14 2013-12-19 Seno Medical Instruments, Inc. Methods and compositions for carrier agents and clearing agents used in optoacoustic imaging systems
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

Patent Citations (4)

* 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
US20130338476A1 (en) * 2012-06-14 2013-12-19 Seno Medical Instruments, Inc. Methods and compositions for carrier agents and clearing agents used in optoacoustic imaging systems
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
郑增娟等: "卡波姆水凝胶的处方筛选与质量考察", 《医药导报》, vol. 34, no. 2, 28 February 2015 (2015-02-28), pages 244 - 248 *

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