Ultrasonic coupling agent as well as preparation method and application thereof

Abstract

The invention provides an ultrasonic coupling agent as well as a preparation method and application thereof, and belongs to the technical field of medical materials. The invention aims to provide the ultrasonic coupling agent which is not easy to lose water in the use process and has excellent safety. The ultrasonic coupling agent provided by the invention can help ultrasonic waves penetrate through an object and form an image, and meanwhile, air between a probe and the detected object is eliminated, so that the ultrasonic waves can effectively penetrate through the object and the detection purpose is achieved; and the definition and accuracy of the image can be improved by improving the ultrasonic coupling effect between the probe and the patient. The ultrasonic coupling agent prepared by the preparation method has a multi-network structure, the water loss condition can be remarkably reduced, the influence on the accuracy in the long-time ultrasonic detection process is avoided, and meanwhile, the workload of doctors and the use amount of materials are reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of medical materials, and in particular to an ultrasonic coupling agent and a preparation method and application thereof. Background Art

[0002] Medical coupling agent is a medical product composed of a new generation of water-based polymer gel. It has a neutral pH value, is non-toxic and harmless to the human body, is not easy to dry or become rancid, has clear ultrasound imaging, has appropriate viscosity, is non-greasy, and is easy for the probe to slide. It can moisten the skin, eliminate air on the skin surface, has good lubrication properties, and is easy to deploy. It does not corrode or damage the ultrasound probe. Ultrasonic coupling agents with sterilization and disinfection functions have appeared on the market. Compared with traditional ordinary coupling agents, they are more stringent in production environment and have a wider range of applications.

[0003] Since the frequency of medical ultrasound is 2.5-5M, it cannot be transmitted in the air. If there is air between the probe and the skin, the ultrasound will return when it encounters the air and cannot enter the human body to perform the inspection function. During ultrasound examination, the air between the probe and the patient's skin will prevent the ultrasound from entering the human body. In order to obtain high-quality and clear images, an ultrasonic coupling agent is required to connect the probe to the patient's body surface.

[0004] The purpose of using ultrasonic coupling agent is first to fill the tiny gaps between the contact surfaces, so that the trace air in these gaps does not affect the penetration of ultrasound; secondly, through the "transition" effect of the coupling agent, the acoustic impedance difference between the probe and the skin is reduced, thereby reducing the reflection loss of ultrasonic energy at this interface. In addition, it also plays a "lubricating" role, reducing the friction between the probe surface and the skin, so that the probe can slide flexibly for exploration.

[0005] Medical coupling agent can be used for A-type, B-type, M-type ultrasonic diagnostic instruments, Doppler blood flowmeters, and is suitable for obstetrics and gynecology, digestive system, urinary system, nervous system, newborn, thyroid and breast examinations. It can couple with ultrasonic probes to improve display clarity and has excellent results; it does not need to be applied repeatedly, which helps save diagnosis time. The quality of the coupling agent is closely related to the quality of the obtained sonogram. Poor quality coupling agent can cause ultrasonic energy loss, reduced resolution, blurred images, and even irritation to the skin and damage to the probe.

[0006] Chinese patent CN104189927B discloses an ultrasonic coupling agent, which includes compound essential oil, aromatic hydrosol, NaOH solution, carbomer, glycerin, and sterile deionized water. The compound essential oil is a mixture of lavender essential oil, peppermint essential oil, eucalyptus essential oil, sandalwood essential oil, aloe essential oil, and calendula essential oil, and the ratio between the components is: 2:1:3:2:1:1, and the aromatic hydrosol is a mixed solution of byproducts when the essential oils are extracted by distillation. The essential oil can penetrate into the skin, further enhancing its effect of eliminating air on the skin surface, with good conduction effect, good lubrication performance, and easy to unfold. It not only has good safety, imaging effect, and image resolution, but also has a fragrant smell, and also has the effects of sterilization, anti-inflammatory effect, and softening and delicate skin.

[0007] However, some inferior coupling agents in the existing technology may contain ingredients that are difficult to degrade and excrete. If they remain in the body for a long time, they may cause inflammation or allergic reactions, or even lead to serious health problems. In addition, many coupling agents on the market are prone to drying out during use and need to be applied frequently, which not only increases the workload of doctors, but may also lead to increased usage and increased department costs. Summary of the invention

[0008] The object of the present invention is to provide an ultrasonic coupling agent which is not easy to lose water during use and has excellent safety.

[0009] In order to achieve the above-mentioned object of the invention, the present invention provides the following technical solutions:

[0010] The present invention provides an ultrasonic coupling agent, which is made of the following raw materials in parts by weight:

[0011] 1.5-2.5 parts of polyvinyl alcohol, 1.5-2.5 parts of hyaluronic acid, 0.8-1.2 parts of carbomer, 0.8-1.2 parts of pectin, 0.3-0.8 parts of glycerin, 5-15 parts of propylene glycol and 100-300 parts of water.

[0012] Preferably, it is made of the following raw materials in parts by weight: 2 parts of polyvinyl alcohol, 2 parts of hyaluronic acid, 1 part of carbomer, 1 part of pectin, 0.5 parts of glycerol, 10 parts of propylene glycol and 200 parts of water.

[0013] Preferably, the ultrasonic coupling agent also includes a disinfectant.

[0014] Preferably, the disinfectant is a chemical disinfectant, a traditional Chinese medicine antibacterial agent or a polymer antibacterial agent.

[0015] Preferably, the added amount of the disinfectant is 0.05% to 0.2% of the total weight of all raw materials of the ultrasonic coupling agent.

[0016] The present invention also provides a method for preparing the ultrasonic coupling agent, comprising the following steps:

[0017] All raw materials are mixed and stirred, and allowed to stand for more than 10 hours to obtain the ultrasonic coupling agent.

[0018] Preferably, the stirring speed is 300-900 rpm.

[0019] Preferably, the stirring time is 2 to 6 hours.

[0020] Preferably, the standing time is 12 to 24 hours.

[0021] The present invention also provides the use of the ultrasonic coupling agent in combination with an A-type ultrasonic diagnostic instrument, a B-type ultrasonic diagnostic instrument, an M-type ultrasonic diagnostic instrument or a Doppler blood flow meter.

[0022] Technical effects and advantages of the present invention:

[0023] The ultrasonic coupling agent provided by the present invention can help ultrasonic waves pass through objects and form images, while removing the air between the probe and the object to be tested, ensuring that the ultrasonic waves can effectively penetrate the object and achieve the purpose of detection; it can also improve the clarity and accuracy of the image by improving the ultrasonic coupling effect between the probe and the patient. The ultrasonic coupling agent prepared by the present invention has a multiple network structure, which can significantly reduce water loss, avoid affecting the accuracy of long-term ultrasonic testing, and reduce the workload of doctors and the amount of materials used. DETAILED DESCRIPTION

[0024] The present invention provides an ultrasonic coupling agent, which is made of the following raw materials in parts by weight:

[0025] 1.5-2.5 parts of polyvinyl alcohol, 1.5-2.5 parts of hyaluronic acid, 0.8-1.2 parts of carbomer, 0.8-1.2 parts of pectin, 0.3-0.8 parts of glycerin, 5-15 parts of propylene glycol and 100-300 parts of water.

[0026] Preferably, it is made of the following raw materials in parts by weight: 2 parts of polyvinyl alcohol, 2 parts of hyaluronic acid, 1 part of carbomer, 1 part of pectin, 0.5 parts of glycerol, 10 parts of propylene glycol and 200 parts of water.

[0027] In the present invention, the polyvinyl alcohol is an organic compound with the chemical formula [C2H4O] nThe appearance is white flake, flocculent or powdery solid, odorless. Soluble in water (above 95°C), slightly soluble in dimethyl sulfoxide, insoluble in gasoline, kerosene, vegetable oil, benzene, toluene, ethylene dichloride, carbon tetrachloride, acetone, ethyl acetate, methanol, ethylene glycol, etc. Polyvinyl alcohol is an important chemical raw material, used to make polyvinyl acetal, gasoline-resistant pipes and vinylon, fabric treatment agents, emulsifiers, paper coatings, adhesives, glues, etc.

[0028] In the present invention, the hyaluronic acid, also known as hyaluronic acid, has a molecular formula of (C 14 H 21 NO 11 ) n , is a disaccharide unit glycosaminoglycan composed of D-glucuronic acid and N-acetylglucosamine. Hyaluronic acid is an acidic mucopolysaccharide. With its unique molecular structure and physical and chemical properties, it shows a variety of important physiological functions in the body, such as lubricating joints, regulating the permeability of blood vessel walls, regulating protein, water and electrolyte diffusion and operation, and promoting wound healing. Hyaluronic acid is the main component of connective tissues such as human intercellular matrix, vitreous body, and synovial fluid. It plays an important physiological function in the body, such as water retention, maintaining extracellular space, regulating osmotic pressure, lubrication, and promoting cell repair. Hyaluronic acid molecules contain a large number of carboxyl and hydroxyl groups, which form intramolecular and intermolecular hydrogen bonds in aqueous solution, which makes it have a strong water retention effect and can bind more than 400 times its own water; at higher concentrations, due to the complex tertiary network structure formed by its intermolecular action, its aqueous solution has significant viscoelasticity. As the main component of the intercellular matrix, hyaluronic acid is directly involved in the regulation of electrolyte exchanges inside and outside cells, and plays a filter role in physical and molecular information. Hyaluronic acid has unique physical and chemical properties and physiological functions. It has been widely used in medicine. It can be used as a viscoelastic agent for intraocular lens implantation surgery, a filler for joint surgery such as osteoarthritis and rheumatoid arthritis, and is widely used as a medium in eye drops. It is also used to prevent postoperative adhesions and promote the healing of skin wounds. The compounds formed by the reaction of hyaluronic acid with other drugs have a sustained release effect on the drugs, which can achieve the purpose of directional and timed release. With the development of medical technology, the application of hyaluronic acid in medicine will become more and more extensive.

[0029] In the present invention, the carbomer is a high molecular polymer of allyl sucrose or pentaerythritol allyl ether bonded with acrylic acid. Calculated on a dry basis, the carboxylic acid group (—COOH) should be 56.0% to 68.0%. Carbomer, also known as carbomer, is an acrylic acid cross-linked resin obtained by cross-linking pentaerythritol and acrylic acid. It is a very important rheology modifier. Carbomer is an excellent gel matrix with important uses such as thickening and suspension. It has a simple process and good stability and is widely used in lotions, creams, and gels.

[0030] In the present invention, the pectin is a polysaccharide, which is composed of two types: homogeneous polysaccharides and heteropolysaccharides. They are mostly present in plant cell walls and cell inner layers, and are present in large quantities in the peels of citrus, lemons, grapefruits, etc. It is white to yellow powder, with a relative molecular mass of about 20,000 to 400,000, and is tasteless. It is more stable in acidic solutions than in alkaline solutions, and is usually divided into high-ester pectin and low-ester pectin according to its degree of esterification. Pectin is a type of heteropolysaccharide widely found in the primary wall and the middle cell layer of plant cell walls. Pectin is mainly an acidic heteropolysaccharide composed of D-galacturonic acid (D-Galacturonic Acids, D-Gal-A) connected by α-1,4-glycosidic bonds. In addition to D-Gal-A, it also contains neutral sugars such as L-rhamnose, D-galactose, and D-arabinose. In addition, it also contains up to 12 types of monosaccharides such as D-mannose and L-fucose, but the content of these monosaccharides in pectin is very small. In the specific implementation of the present invention, the raw material pectin used is purchased from Xi'an Langsifu Biotechnology Co., Ltd.

[0031] In the present invention, the glycerol, also known as propanetriol, is an organic compound with a chemical formula of C3H8O3, and is a simple polyol compound. It is a colorless, odorless, sweet, viscous liquid and is non-toxic. The glycerol backbone is present in lipids called glycerides. Because it has antibacterial and antiviral properties, it is widely used in FDA-approved wound and burn treatments. It can be used as an effective marker for measuring liver disease. It is also widely used as a sweetener in the food industry and a humectant in drug formulations. Because it has three hydroxyl groups, glycerol is miscible with water and has hygroscopicity.

[0032] In the present invention, the scientific name of the propylene glycol is "1,2-propylene glycol". There is a chiral carbon atom in the molecule. The racemic body is a hygroscopic viscous liquid with a slightly spicy taste. It is miscible in water, acetone, ethyl acetate and chloroform, and soluble in ether. It can be dissolved in many essential oils, but is immiscible with petroleum ether, paraffin and grease. It is relatively stable to heat and light, and is more stable at low temperatures. Propylene glycol can be oxidized to propionaldehyde, lactic acid, pyruvic acid and acetic acid at high temperatures.

[0033] In the present invention, the water is preferably sterile water, which refers to water without bacteria obtained by physical treatment, such as steam method, UHT heat method, ultraviolet sterilization, ozone method and physical filtration method, in which the water is obtained by killing microorganisms in the water and filtering, and the inorganic salts in the water are generally not reduced.

[0034] In the present invention, the ultrasonic coupling agent may also include anti-inflammatory active ingredients, moisturizers, pH regulators, antioxidants, soothing agents, etc., and may also add biologically active substances, such as biological enzymes, amino acids, vitamins, etc., to enhance the relevant therapeutic effects, or add plant extracts: commonly used plant extracts include peppermint oil, Sophora japonica, wax gourd vines, etc., which have the effects of clearing away heat and detoxifying, reducing swelling and relieving pain; animal extracts: commonly used animal extracts include honey, beeswax, fish gall oil, etc., which have antibacterial and moisturizing effects; chemical drugs: commonly used chemical drugs include antibiotics, anti-inflammatory drugs, antifungal drugs, etc., which are used to treat external diseases such as infection and inflammation; natural drugs: commonly used natural drugs include Coptis chinensis, Houttuynia cordata, etc., which have antibacterial and antipruritic effects.

[0035] In the present invention, preferably, the ultrasonic coupling agent also includes a disinfectant. Preferably, the disinfectant is a chemical disinfectant, a Chinese medicine antibacterial agent or a polymer antibacterial agent. The chemical disinfectant includes alcohol disinfectants, chlorine-containing disinfectants, iodine-containing disinfectants, quaternary ammonium salt disinfectants, and more preferably trichlorohydroxydiphenyl ether, polyhexamethyleneguanidine hydrochloride, and chlorhexidine gluconate; the Chinese medicine antibacterial agent contains many active ingredients, such as flavonoids, alkaloids, polysaccharides, etc. These ingredients can exert antibacterial effects by inhibiting the growth of bacteria, changing their metabolic pathways and membrane permeability. The polymer antibacterial agent is also called antibacterial polymer. The antibacterial properties of polymer materials are obtained by adding antibacterial agents to them to make composite materials or surface treating polymer materials. Synthetic polymer antibacterial agents can overcome the shortcomings of natural antibacterial agents such as poor heat resistance, and antibacterial materials are obtained by melt blending. Antibacterial agents refer to chemical substances that can keep the growth or reproduction of certain microorganisms below the necessary level within a certain period of time. Antimicrobial agents are substances or products with antibacterial and bactericidal properties. Antimicrobial agents interfere with and destroy the physiological, biochemical reactions and metabolic activities related to microbial cells by affecting the growth of microbial hyphae, spore germination, the formation of various seed bodies, cell permeability, mitosis, respiration, cell expansion, disintegration of cell protoplasts and damage to cell walls, thereby killing or inhibiting the growth and reproduction of microorganisms. In the present invention, preferably, the amount of the disinfectant added is 0.05% to 0.2% of the total weight of all raw materials of the ultrasonic coupling agent, which can be adjusted in specific applications according to the effective concentration of different disinfectants and relevant standards.

[0036] The present invention also provides a method for preparing the ultrasonic coupling agent, comprising the following steps: mixing and stirring all raw materials, and standing for more than 10 hours to obtain the ultrasonic coupling agent; preferably, the stirring speed is 300 to 900 rpm; preferably, the stirring time is 2 to 6 hours; preferably, the standing time is 12 to 24 hours.

[0037] The present invention also provides the use of the above-mentioned ultrasonic coupling agent in cooperation with a type A ultrasonic diagnostic instrument, a type B ultrasonic diagnostic instrument, an M ultrasonic diagnostic instrument or a Doppler blood flowmeter. Type A ultrasonic diagnostic instrument: used to measure distance and speed, commonly used in the examination of the heart, blood vessels and other parts. Type B ultrasonic diagnostic instrument: used to display two-dimensional images of organs, widely used in obstetrics and gynecology, digestive system, urinary system, nervous system, newborns, thyroid and breast examinations. Type M ultrasonic diagnostic instrument: used to display the movement of organs such as the heart, commonly used in the diagnosis of heart disease. Doppler blood flowmeter: used to measure the speed and direction of blood flow, commonly used in the diagnosis of vascular diseases.

[0038] When the ultrasonic coupling agent described in the present invention is produced and used, the relevant standards of "Pharmaceutical Industry Standard of the People's Republic of China YY0299-2016-Medical Ultrasonic Coupling Agent" are adopted for quality control.

[0039] The technical solutions provided by the present invention are described in detail below in conjunction with the embodiments, but they should not be construed as limiting the protection scope of the present invention.

[0040] Example 1

[0041] The raw materials: 2kg of polyvinyl alcohol, 2kg of hyaluronic acid, 1kg of carbomer, 1kg of pectin, 0.5kg of glycerol, 10kg of propylene glycol and 200kg of sterile water were mixed, and then 0.2% of the weight of all materials as a disinfectant trichlorohydroxydiphenyl ether was added, and the mixture was fully stirred at 600rpm (3h), and then allowed to stand for 12h to obtain an ultrasonic coupling agent.

[0042] The product is a colorless and transparent gel. The sound velocity, acoustic characteristic impedance and acoustic attenuation indicators of the product are tested in accordance with the relevant standards of "Pharmaceutical Industry Standard of the People's Republic of China YY 0299-2016-Medical Ultrasonic Coupling Agent". The test results show that they all meet the standards.

[0043] Example 2

[0044] The raw materials: 2kg of polyvinyl alcohol, 2kg of hyaluronic acid, 1kg of carbomer, 1kg of pectin, 0.5kg of glycerol, 10kg of propylene glycol and 200kg of sterile water were mixed, and then 0.2% of the weight of all materials as a disinfectant polyhexamethylene guanidine hydrochloride was added, and the mixture was stirred thoroughly at 600rpm (3h), and then allowed to stand for 12h to obtain an ultrasonic coupling agent.

[0045] The product is a colorless and transparent gel. The sound velocity, acoustic characteristic impedance and acoustic attenuation indicators of the product are tested in accordance with the relevant standards of "Pharmaceutical Industry Standard of the People's Republic of China YY 0299-2016-Medical Ultrasonic Coupling Agent". The test results show that they all meet the standards.

[0046] Example 3

[0047] The raw materials: 2kg of polyvinyl alcohol, 2kg of hyaluronic acid, 1kg of carbomer, 1kg of pectin, 0.5kg of glycerol, 10kg of propylene glycol and 200kg of sterile water were mixed, and then 0.2% of the weight of all materials as a disinfectant chlorhexidine gluconate was added, and the mixture was stirred thoroughly at 600rpm (3h), and then allowed to stand for 12h to obtain an ultrasonic coupling agent.

[0048] The product is a colorless and transparent gel. The sound velocity, acoustic characteristic impedance and acoustic attenuation indicators of the product are tested in accordance with the relevant standards of "Pharmaceutical Industry Standard of the People's Republic of China YY 0299-2016-Medical Ultrasonic Coupling Agent". The test results show that they all meet the standards.

[0049] Example 4

[0050] The raw materials: 2.5 kg of polyvinyl alcohol, 2.5 kg of hyaluronic acid, 1.2 kg of carbomer, 1.2 kg of pectin, 0.3 kg of glycerol, 10 kg of propylene glycol and 200 kg of sterile water were mixed, and then 0.2% of the weight of all materials as a disinfectant trichlorohydroxydiphenyl ether was added, and the mixture was fully stirred at 500 rpm (3.5 h), and then allowed to stand for 24 h to obtain an ultrasonic coupling agent.

[0051] The product is a colorless and transparent gel. The sound velocity, acoustic characteristic impedance and acoustic attenuation indicators of the product are tested in accordance with the relevant standards of "Pharmaceutical Industry Standard of the People's Republic of China YY 0299-2016-Medical Ultrasonic Coupling Agent". The test results show that they all meet the standards.

[0052] Example 5

[0053] The raw materials: 1.5 kg of polyvinyl alcohol, 1.5 kg of hyaluronic acid, 0.8 kg of carbomer, 0.8 kg of pectin, 0.8 kg of glycerol, 10 kg of propylene glycol and 200 kg of sterile water were mixed, and then 1.2% of the weight of all materials as a disinfectant trichlorohydroxydiphenyl ether was added, and the mixture was fully stirred at 800 rpm (2 h), and then allowed to stand for 36 h to obtain an ultrasonic coupling agent.

[0054] The product is a colorless and transparent gel. The sound velocity, acoustic characteristic impedance and acoustic attenuation indicators of the product are tested in accordance with the relevant standards of "Pharmaceutical Industry Standard of the People's Republic of China YY 0299-2016-Medical Ultrasonic Coupling Agent". The test results show that they all meet the standards.

[0055] Example 6

[0056] The raw materials: 2.2 kg of polyvinyl alcohol, 1.8 kg of hyaluronic acid, 1 kg of carbomer, 1 kg of pectin, 0.5 kg of glycerol, 10 kg of propylene glycol and 230 kg of sterile water were mixed, and then 0.2% of the weight of all materials as a disinfectant trichlorohydroxydiphenyl ether was added, and the mixture was stirred thoroughly at 600 rpm (3 h), and then allowed to stand for 12 h to obtain an ultrasonic coupling agent.

[0057] Example 7

[0058] The raw materials: 1.8 kg of polyvinyl alcohol, 2.2 kg of hyaluronic acid, 1 kg of carbomer, 1 kg of pectin, 0.5 kg of glycerol, 10 kg of propylene glycol and 170 kg of sterile water were mixed, and then 0.2% of the weight of all materials as a disinfectant trichlorohydroxydiphenyl ether was added, and the mixture was stirred thoroughly at 600 rpm (3 h), and then allowed to stand for 12 h to obtain an ultrasonic coupling agent.

[0059] Example 8

[0060] The raw materials: 2kg of polyvinyl alcohol, 2kg of hyaluronic acid, 0.8kg of carbomer, 1.2kg of pectin, 0.5kg of glycerol, 10kg of propylene glycol and 200kg of sterile water were mixed, and then 0.2% of the weight of all materials as a disinfectant trichlorohydroxydiphenyl ether was added, and the mixture was stirred thoroughly at 650rpm (3h), and then allowed to stand for 12h to obtain an ultrasonic coupling agent.

[0061] Example 9

[0062] The raw materials: 2kg of polyvinyl alcohol, 2kg of hyaluronic acid, 1.2kg of carbomer, 0.8kg of pectin, 0.3kg of glycerol, 10kg of propylene glycol and 200kg of sterile water were mixed, and then 0.15% of the weight of all materials of the disinfectant trichlorohydroxydiphenyl ether was added, and the mixture was stirred thoroughly at 550rpm (3.5h), and then the ultrasonic coupling agent was obtained after standing for 24h.

[0063] Example 10

[0064] The raw materials: 2kg of polyvinyl alcohol, 2kg of hyaluronic acid, 1kg of carbomer, 1kg of pectin, 0.5kg of glycerol, 13kg of propylene glycol and 220kg of sterile water were mixed, and then 0.1% of the weight of all materials as a disinfectant trichlorohydroxydiphenyl ether was added, and the mixture was fully stirred at 450rpm (2.5h), and then allowed to stand for 36h to obtain an ultrasonic coupling agent.

[0065] Comparative Example 1

[0066] The raw materials: 3 kg of polyvinyl alcohol, 3 kg of hyaluronic acid, 0.5 kg of glycerol, 10 kg of propylene glycol and 200 kg of sterile water were mixed, and then 0.2% of the weight of all materials of the disinfectant trichlorohydroxydiphenyl ether was added, and the mixture was stirred thoroughly at 600 rpm (3 h), and then allowed to stand for 12 h to obtain the ultrasonic coupling agent.

[0067] Comparative Example 2

[0068] The raw materials: 5 kg of polyvinyl alcohol, 1 kg of pectin, 0.5 kg of glycerol, 10 kg of propylene glycol and 200 kg of sterile water were mixed, and then 0.2% of the weight of all materials of the disinfectant trichlorohydroxydiphenyl ether was added, and the mixture was stirred thoroughly at 600 rpm (3 h), and then allowed to stand for 12 h to obtain the ultrasonic coupling agent.

[0069] Comparative Example 3

[0070] The raw materials: 5 kg of carbomer, 1 kg of pectin, 0.5 kg of glycerol, 10 kg of propylene glycol and 200 kg of sterile water were mixed, and then 0.2% of the weight of all materials of the disinfectant trichlorohydroxydiphenyl ether was added, and the mixture was fully stirred at 600 rpm (3 h), and then allowed to stand for 12 h to obtain an ultrasonic coupling agent.

[0071] Comparative Example 4

[0072] The raw materials: 1 kg of polyvinyl alcohol, 1 kg of hyaluronic acid, 4 kg of carbomer, 0.5 kg of glycerol, 10 kg of propylene glycol and 200 kg of sterile water were mixed, and then 0.2% of the weight of all materials of the disinfectant trichlorohydroxydiphenyl ether was added, and the mixture was stirred thoroughly at 600 rpm (3 h), and then allowed to stand for 12 h to obtain an ultrasonic coupling agent.

[0073] Comparative Example 5

[0074] The raw materials: 3 kg of hyaluronic acid, 2 kg of carbomer, 0.5 kg of glycerol, 10 kg of propylene glycol and 200 kg of sterile water were mixed, and then 0.2% of the weight of all materials of the disinfectant trichlorohydroxydiphenyl ether was added, and the mixture was fully stirred at 600 rpm (3 h), and then allowed to stand for 12 h to obtain an ultrasonic coupling agent.

[0075] Experimental Example 1 Safety Testing

[0076] The experiment was set up with 3 adult male mice in each group, and the irritation test was performed on the ultrasonic coupling agents of Examples 1 to 3, and physiological saline was used as a negative control.

[0077] The hair on the back of each mouse was shaved 1 cm. 2 , the positions are chosen randomly.

[0078] The mice in the experimental group were smeared with the ultrasound coupling agent of Examples 1 to 3, and the mice in the control group were smeared with physiological saline.

[0079] The skin irritation reaction was observed 1 day after the sample was administered, and the following four results were recorded according to the severity:

[0080] No irritation: The skin is intact, without erythema, edema, erosion, ulcer, etc.;

[0081] Mild irritation: slight redness of the skin, without edema, erosion or ulcer, etc.;

[0082] Moderate irritation: redness and swelling of the skin, possible erosions and ulcers;

[0083] Severe irritation: severe redness and swelling of the skin, erosion and ulceration, and even bleeding.

[0084] The results are shown in Table 1:

[0085] Table 1 Skin irritation results

[0086]

[0087] The results show that the ultrasonic coupling agent provided by the present invention has almost no irritation to the skin, has excellent safety, and has better prospects in clinical application.

[0088] Experimental Example 2: Water loss detection

[0089] The drying method was used to detect the water loss rate of the coupling agent samples provided in Examples 1 to 3 and Comparative Examples 1 to 5 when placed at the bottom of a container at 35±1° C. (close to the human skin temperature during inspection) and an ambient temperature of 26±1° C. for different periods of time.

[0090] A high-precision weighing balance was used to weigh the initial sample weight m0 and the sample weight M after being placed for different times (10 min, 20 min, 30 min, 40 min, 50 min, 1 h, 1.5 h, 2 h), and the water loss rate of the product was calculated.

[0091] The water loss rate calculation formula is as follows:

[0092] Water loss rate = (M-m0) / m0×100%

[0093] The results are shown in Table 2:

[0094] Table 2 Water loss rate results

[0095]

[0096]

[0097] The results show that the ultrasonic coupling agent provided by the present invention will not evaporate and lose water within 1.5 hours, and is suitable for ultrasonic inspections that take a long time, with better detection accuracy. The raw material formula used in the present invention can achieve multiple gel networks, improve product stability, and reduce the inconvenience caused by replacing the coupling agent during long ultrasonic inspections.

[0098] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. An ultrasonic coupling agent, characterized in that: Made from the following raw materials in parts by weight: 1.5-2.5 parts of polyvinyl alcohol, 1.5-2.5 parts of hyaluronic acid, 0.8-1.2 parts of carbomer, 0.8-1.2 parts of pectin, 0.3-0.8 parts of glycerin, 5-15 parts of propylene glycol and 100-300 parts of water.

2. The ultrasonic coupling agent according to claim 1, characterized in that: The invention is prepared from the following raw materials in parts by weight: 2 parts of polyvinyl alcohol, 2 parts of hyaluronic acid, 1 part of carbomer, 1 part of pectin, 0.5 parts of glycerol, 10 parts of propylene glycol and 200 parts of water.

3. The ultrasonic coupling agent according to claim 1, characterized in that: The ultrasonic coupling agent also includes a disinfectant.

4. The ultrasonic coupling agent according to claim 3, characterized in that: The disinfectant is a chemical disinfectant, a traditional Chinese medicine antibacterial agent or a polymer antibacterial agent.

5. The ultrasonic coupling agent according to claim 3, characterized in that: The added amount of the disinfectant is 0.05% to 0.2% of the total weight of all raw materials of the ultrasonic coupling agent.

6. The method for preparing the ultrasonic coupling agent according to any one of claims 1 to 5, characterized in that: The following steps are involved: All raw materials are mixed and stirred, and allowed to stand for more than 10 hours to obtain the ultrasonic coupling agent.

7. The preparation method according to claim 6, characterized in that: The stirring speed is 300-900 rpm.

8. The preparation method according to claim 6, characterized in that: The stirring time is 2 to 6 hours.

9. The preparation method according to claim 6, characterized in that: The standing time is 12 to 24 hours.

10. Use of the ultrasonic coupling agent according to any one of claims 1 to 5 in combination with an A-type ultrasonic diagnostic instrument, a B-type ultrasonic diagnostic instrument, an M-type ultrasonic diagnostic instrument or a Doppler blood flowmeter.

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