CN109289059B - Sterilizing medical ultrasonic coupling agent and preparation method thereof - Google Patents
Sterilizing medical ultrasonic coupling agent and preparation method thereof Download PDFInfo
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- CN109289059B CN109289059B CN201811437423.4A CN201811437423A CN109289059B CN 109289059 B CN109289059 B CN 109289059B CN 201811437423 A CN201811437423 A CN 201811437423A CN 109289059 B CN109289059 B CN 109289059B
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- 230000001954 sterilising effect Effects 0.000 title claims abstract description 39
- 238000002360 preparation method Methods 0.000 title claims abstract description 16
- 239000007822 coupling agent Substances 0.000 title abstract description 23
- 230000000844 anti-bacterial effect Effects 0.000 claims abstract description 32
- XEFQLINVKFYRCS-UHFFFAOYSA-N Triclosan Chemical compound OC1=CC(Cl)=CC=C1OC1=CC=C(Cl)C=C1Cl XEFQLINVKFYRCS-UHFFFAOYSA-N 0.000 claims abstract description 23
- 229960003500 triclosan Drugs 0.000 claims abstract description 23
- IBGBGRVKPALMCQ-UHFFFAOYSA-N 3,4-dihydroxybenzaldehyde Chemical compound OC1=CC=C(C=O)C=C1O IBGBGRVKPALMCQ-UHFFFAOYSA-N 0.000 claims abstract description 22
- 239000002904 solvent Substances 0.000 claims abstract description 16
- 239000003899 bactericide agent Substances 0.000 claims abstract description 14
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 12
- NIXOWILDQLNWCW-UHFFFAOYSA-N Acrylic acid Chemical compound OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 claims abstract description 11
- 229920002125 Sokalan® Polymers 0.000 claims abstract description 11
- GSEJCLTVZPLZKY-UHFFFAOYSA-N Triethanolamine Chemical compound OCCN(CCO)CCO GSEJCLTVZPLZKY-UHFFFAOYSA-N 0.000 claims abstract description 11
- 229960001631 carbomer Drugs 0.000 claims abstract description 11
- 229960003371 protocatechualdehyde Drugs 0.000 claims abstract description 11
- 239000000080 wetting agent Substances 0.000 claims abstract description 10
- 239000002994 raw material Substances 0.000 claims abstract description 8
- 238000003756 stirring Methods 0.000 claims description 24
- 239000004359 castor oil Substances 0.000 claims description 18
- 235000019438 castor oil Nutrition 0.000 claims description 18
- ZEMPKEQAKRGZGQ-XOQCFJPHSA-N glycerol triricinoleate Natural products CCCCCC[C@@H](O)CC=CCCCCCCCC(=O)OC[C@@H](COC(=O)CCCCCCCC=CC[C@@H](O)CCCCCC)OC(=O)CCCCCCCC=CC[C@H](O)CCCCCC ZEMPKEQAKRGZGQ-XOQCFJPHSA-N 0.000 claims description 18
- VLDFMKOUUQYFGF-UHFFFAOYSA-N 4-(butoxymethyl)-2-methoxyphenol Chemical compound CCCCOCC1=CC=C(O)C(OC)=C1 VLDFMKOUUQYFGF-UHFFFAOYSA-N 0.000 claims description 14
- 229940078465 vanillyl butyl ether Drugs 0.000 claims description 14
- 229920003171 Poly (ethylene oxide) Polymers 0.000 claims description 9
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 9
- -1 polyoxyethylene Polymers 0.000 claims description 9
- 229940051841 polyoxyethylene ether Drugs 0.000 claims description 9
- 229920000056 polyoxyethylene ether Polymers 0.000 claims description 9
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- 238000002156 mixing Methods 0.000 claims description 6
- 238000010438 heat treatment Methods 0.000 claims description 4
- 238000001816 cooling Methods 0.000 claims description 3
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims description 3
- 229920000053 polysorbate 80 Polymers 0.000 claims description 3
- 230000008961 swelling Effects 0.000 claims description 3
- 239000003906 humectant Substances 0.000 claims description 2
- 230000003115 biocidal effect Effects 0.000 claims 1
- 239000003139 biocide Substances 0.000 claims 1
- 238000004659 sterilization and disinfection Methods 0.000 abstract description 32
- 230000000694 effects Effects 0.000 abstract description 13
- 230000002195 synergetic effect Effects 0.000 abstract description 4
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- 239000003814 drug Substances 0.000 abstract description 2
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- 239000000243 solution Substances 0.000 description 16
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- ZEYHEAKUIGZSGI-UHFFFAOYSA-N 4-methoxybenzoic acid Chemical compound COC1=CC=C(C(O)=O)C=C1 ZEYHEAKUIGZSGI-UHFFFAOYSA-N 0.000 description 2
- 241000222122 Candida albicans Species 0.000 description 2
- 206010011409 Cross infection Diseases 0.000 description 2
- 241000588724 Escherichia coli Species 0.000 description 2
- 206010029803 Nosocomial infection Diseases 0.000 description 2
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- VVOAZFWZEDHOOU-UHFFFAOYSA-N magnolol Chemical compound OC1=CC=C(CC=C)C=C1C1=CC(CC=C)=CC=C1O VVOAZFWZEDHOOU-UHFFFAOYSA-N 0.000 description 2
- 229920000642 polymer Polymers 0.000 description 2
- 230000008313 sensitization Effects 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- JMSVCTWVEWCHDZ-UHFFFAOYSA-N syringic acid Chemical compound COC1=CC(C(O)=O)=CC(OC)=C1O JMSVCTWVEWCHDZ-UHFFFAOYSA-N 0.000 description 2
- NOOLISFMXDJSKH-UTLUCORTSA-N (+)-Neomenthol Chemical compound CC(C)[C@@H]1CC[C@@H](C)C[C@@H]1O NOOLISFMXDJSKH-UTLUCORTSA-N 0.000 description 1
- NOOLISFMXDJSKH-UHFFFAOYSA-N DL-menthol Natural products CC(C)C1CCC(C)CC1O NOOLISFMXDJSKH-UHFFFAOYSA-N 0.000 description 1
- 102000004190 Enzymes Human genes 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- BIVBRWYINDPWKA-VLQRKCJKSA-L Glycyrrhizinate dipotassium Chemical compound [K+].[K+].O([C@@H]1[C@@H](O)[C@H](O)[C@H](O[C@@H]1O[C@H]1CC[C@]2(C)[C@H]3C(=O)C=C4[C@@H]5C[C@](C)(CC[C@@]5(CC[C@@]4(C)[C@]3(C)CC[C@H]2C1(C)C)C)C(O)=O)C([O-])=O)[C@@H]1O[C@H](C([O-])=O)[C@@H](O)[C@H](O)[C@H]1O BIVBRWYINDPWKA-VLQRKCJKSA-L 0.000 description 1
- 206010070834 Sensitisation Diseases 0.000 description 1
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- RQFQJYYMBWVMQG-IXDPLRRUSA-N chitotriose Chemical compound O[C@@H]1[C@@H](N)[C@H](O)O[C@H](CO)[C@H]1O[C@H]1[C@H](N)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O2)N)[C@@H](CO)O1 RQFQJYYMBWVMQG-IXDPLRRUSA-N 0.000 description 1
- 238000013329 compounding Methods 0.000 description 1
- 239000002537 cosmetic Substances 0.000 description 1
- 230000000249 desinfective effect Effects 0.000 description 1
- 238000003745 diagnosis Methods 0.000 description 1
- 229940101029 dipotassium glycyrrhizinate Drugs 0.000 description 1
- 239000010410 layer Substances 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 229940041616 menthol Drugs 0.000 description 1
- 244000000010 microbial pathogen Species 0.000 description 1
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- 239000002324 mouth wash Substances 0.000 description 1
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- 231100000299 mutagenicity Toxicity 0.000 description 1
- 230000007886 mutagenicity Effects 0.000 description 1
- 239000012466 permeate Substances 0.000 description 1
- 239000000419 plant extract Substances 0.000 description 1
- 239000008213 purified water Substances 0.000 description 1
- 238000011076 safety test Methods 0.000 description 1
- 230000035807 sensation Effects 0.000 description 1
- 230000036556 skin irritation Effects 0.000 description 1
- 231100000475 skin irritation Toxicity 0.000 description 1
- 231100000370 skin sensitisation Toxicity 0.000 description 1
- 239000000344 soap Substances 0.000 description 1
- 239000002344 surface layer Substances 0.000 description 1
- YIBXWXOYFGZLRU-UHFFFAOYSA-N syringic aldehyde Natural products CC12CCC(C3(CCC(=O)C(C)(C)C3CC=3)C)C=3C1(C)CCC2C1COC(C)(C)C(O)C(O)C1 YIBXWXOYFGZLRU-UHFFFAOYSA-N 0.000 description 1
- 230000002110 toxicologic effect Effects 0.000 description 1
- 231100000027 toxicology Toxicity 0.000 description 1
- MWOOGOJBHIARFG-UHFFFAOYSA-N vanillin Chemical compound COC1=CC(C=O)=CC=C1O MWOOGOJBHIARFG-UHFFFAOYSA-N 0.000 description 1
- FGQOOHJZONJGDT-UHFFFAOYSA-N vanillin Natural products COC1=CC(O)=CC(C=O)=C1 FGQOOHJZONJGDT-UHFFFAOYSA-N 0.000 description 1
- 235000012141 vanillin Nutrition 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K49/00—Preparations for testing in vivo
- A61K49/22—Echographic preparations; Ultrasound imaging preparations ; Optoacoustic imaging preparations
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/075—Ethers or acetals
- A61K31/085—Ethers or acetals having an ether linkage to aromatic ring nuclear carbon
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/11—Aldehydes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/02—Local antiseptics
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Abstract
The invention belongs to the field of medicine and health, and particularly relates to a sterilization type medical ultrasonic coupling agent and a preparation method thereof. The ultrasonic couplant is mainly prepared from the following raw materials in percentage by weight: 0.1-2.0% of carbomer, 2-20% of wetting agent, 0.1-1.0% of triethanolamine, 0.5-2.0% of bactericide, 0.06-1.50% of solubilizer, 73-96% of tween-800.5 and 73-96% of water. The invention takes protocatechualdehyde and triclosan as main sterilization components, has the synergistic effect, can obviously improve the overall sterilization effect of the coupling agent, and the added solubilizer can obviously improve the effective content of triclosan in aqueous solution and greatly improve the sterilization effect of the overall coupling agent.
Description
Technical Field
The invention belongs to the field of medicine and health, and particularly relates to a sterilization type medical ultrasonic coupling agent and a preparation method thereof.
Background
When ultrasonic waves are incident on a boundary between two different media, the larger the impedance difference between the two media, the larger the reflection coefficient, and the less acoustic energy passes through the interface and enters the other medium. For medical ultrasound, if the probe is in dry contact with the skin, the ultrasound emitted by the probe cannot enter the human body at all due to the strong reflection of the air layer between the probe and the skin, and therefore, a certain substance must be filled between the surface of the probe and the skin to expel air and form a channel for smooth and undistorted propagation of the ultrasound, and the substance is called as a medical ultrasound coupling agent. Since the ultrasonic couplant is directly coated on the surface of the skin and directly contacts with the probe, the ultrasonic couplant can not stimulate the skin and damage the probe, and also needs to have good acoustic performance, and needs to have certain bacteriostatic and bactericidal performance in order to prevent clinical cross infection.
Chinese patent application CN105983107A discloses a novel medical ultrasonic couplant for disinfection and sterilization, which adopts magnolol as a main quick disinfection and sterilization component, takes syringic acid, anisic acid, dipotassium glycyrrhizinate and vanillin as synergistic components, improves the disinfection and sterilization efficiency of ultrasonic detection and the like through prescription compounding, reduces the cytotoxicity, skin irritation and sensitization of the medical ultrasonic couplant, avoids the problems of cross infection and the like of clinical ultrasonic instrument detection, but mainly takes plant extracts as sterilization active components, has low stability and low sterilization rate, and the sterilization effect needs to be improved.
Triclosan is one of the common names of triclosan, has the characteristics of strong surface activity, high stability to strong acid, strong base and heat, wide bactericidal and bacteriostatic action, no irritation to skin and the like, is widely applied to personal care products such as perfumed soaps, mouthwash, cosmetics and the like as a bactericide, and is also used for disinfecting instruments, hands and skin, and the sterilization principle is as follows: the bactericidal effect is achieved by damaging the bacterial cell membrane and denaturing the enzyme protein. Chinese patent application CN104258427A discloses a sterilization type medical ultrasonic couplant for wound ultrasonic diagnosis and treatment, which comprises carbomer, propylene glycol, glycerol, triethanolamine, triclosan, chitosan oligosaccharide, menthol and purified water, and the sterilization type medical ultrasonic couplant has the advantages of broad-spectrum sterilization effect, good acoustic performance, clear graph and high resolution; the biocompatibility is good, the cytotoxicity, sensitization and mutagenicity are avoided, and the skin wound surface is not stimulated; does not corrode the medical ultrasonic probe. In practical application, however, triclosan is low in toxicity according to toxicological acute toxicity grading standards, the specified addition amount is not more than 0.3%, and when the triclosan is used alone, pathogenic microorganisms are difficult to kill in a short time (3min), and the sterilization effect cannot meet the requirement. And the compatibility of triclosan and the aqueous polymer gel preparation is poor, so that the bactericidal product is caked and turbid, and the quality and the using effect of the product are influenced.
In addition, the couplant is easy to cause skin discomfort due to low temperature when used in winter, and a heating device is often adopted to heat or keep warm when used, so that the operation is complicated.
Therefore, the medical coupling agent with good acoustic performance, good biocompatibility, rapid and efficient sterilization and good comfort in use and the preparation method thereof are urgently needed to be provided.
Disclosure of Invention
The invention aims to provide a medical coupling agent with good acoustic performance, good biocompatibility, capability of quickly and efficiently sterilizing and good comfort when in use and a preparation method thereof.
In order to achieve the purpose, the invention adopts the following technical scheme:
a sterilization type medical ultrasonic couplant is mainly prepared from the following raw materials in percentage by weight: 0.1-2.5% of carbomer, 2-20% of wetting agent, 0.1-1.0% of triethanolamine, 0.5-2.0% of bactericide, 0.06-1.50% of solubilizer, 73-96% of tween-800.5 and 73-96% of water.
Further, the ultrasonic couplant also comprises 0.001-0.01% of vanillyl butyl ether.
Furthermore, the ultrasonic couplant is mainly prepared from the following raw materials in percentage by weight: 0.5-1.5% of carbomer, 5-15% of wetting agent, 0.2-1.0% of triethanolamine, 1.0-2.0% of bactericide, 0.5-1.5% of solubilizer, 0. 800.5-0.8% of tween-890.008% of vanillyl butyl ether and 80-96% of water.
Further, the ultrasonic couplant is prepared from the following raw materials in percentage by weight: carbomer 0.6%, wetting agent 11%, triethanolamine 0.3%, bactericide 1.2%, solubilizer 1.2%, tween-800.8%, vanillyl butyl ether 0.005% and balance of water.
Furthermore, the bactericide comprises protocatechuic aldehyde and triclosan according to the weight ratio of 1 (0.05-1.5).
Further, the bactericide consists of protocatechuic aldehyde and triclosan in a weight ratio of 1: 0.2.
Furthermore, the solubilizer is composed of polyoxyethylene ether-40 hydrogenated castor oil and castor oil polyoxyethylene ether according to the weight ratio of 1 (0.01-10).
Further, the solubilizer is composed of polyoxyethylene ether-40 hydrogenated castor oil and castor oil polyoxyethylene ether according to the weight ratio of 1: 0.5.
Still further, the humectant is selected from one or both of propylene glycol and glycerin.
In addition, the invention also provides a preparation method of the ultrasonic couplant, which comprises the following steps:
s1, dissolving a corresponding amount of carbomer in a corresponding amount of water, and swelling for 5-7 hours to obtain a solution A;
s2, uniformly mixing and stirring a corresponding amount of solubilizer and Tween-80, adding a corresponding amount of vanillyl butyl ether, heating to 70-80 ℃, stirring for 5-15 min, and cooling to obtain a solution B;
s3, uniformly mixing and stirring the wetting agent and the bactericide in corresponding amounts, adding the solution B obtained in the step S2, stirring for 20-30 min until the solution B is clear, standing for defoaming, and stirring for 10-20 min at 10-30 rpm to obtain a solution C;
s4, adding the solution C obtained in the step S3 into the solution A obtained in the step S1, stirring in vacuum for 30-60 min, dropwise adding corresponding amount of triethanolamine, stirring to form a transparent gel, adjusting the pH value of the solution to 6-8, stirring at 10-30 rpm for 15-25 min, inspecting quality, filling and sterilizing to obtain the finished product.
The invention combines protocatechuic aldehyde and triclosan, and has the synergistic effect: on one hand, the combination of the two can obviously improve the whole sterilization effect; on the other hand, the combined use of the two can also obviously shorten the sterilization time and achieve the effect of quick sterilization. It can be seen from example 1 that the sterilizing rates of the couplant prepared in examples 1-4 of the present invention on escherichia coli, staphylococcus aureus and candida albicans within 2min are all as high as 99%, which is significantly better than the standard requirement that the sterilizing rate is not less than 90% in 3min, while the sterilizing effect of the couplant prepared in comparative example 2 (with triclosan removed) is significantly reduced, the standard requirement cannot be met within 3min, and the content of triclosan in comparative example 1 (with protocatechualdehyde removed) is as high as 1.2%, which has certain toxicity.
In addition, triclosan is insoluble in water and has poor compatibility with aqueous polymer gel preparations, so that the bactericidal product is caked and turbid, and the bactericidal effect is influenced. As can be seen from the experimental example 1, the sterilizing effect of the coupling agent prepared in the comparative example 3 or 4 (polyoxyethylene ether-40 hydrogenated castor oil and castor oil polyoxyethylene ether are respectively removed) is obviously reduced, and the standard requirement can not be met within 3 min.
In order to improve the use feeling of a user, the invention also adds the vanillyl butyl ether which can permeate into the lower part of the skin surface layer to slowly emit heat from inside to outside, has low irritation and mild thermal sensation, reduces the uncomfortable feeling of the user caused by temperature difference in cold weather in winter, and leads the skin to feel warm and comfortable. From the experimental example 2, it can be seen that the clinical feedback comfort levels of the coupling agents prepared in the embodiments 1 to 4 of the invention are all over 95%, so that the cold and the irritation caused by the temperature difference between the environment and the skin can be obviously improved, and the comfort level is brought to the user. Whereas example 5 (with the vanillyl butyl ether removed) experienced a significant increase in discomfort to 57%.
The invention has the following advantages:
(1) the sterilization type medical ultrasonic couplant provided by the invention takes protocatechuic aldehyde and triclosan as main sterilization components, has a synergistic effect, can remarkably improve the overall sterilization effect of the couplant, and can reach a sterilization rate of more than 99% within 2 min.
(2) The medical sterilization ultrasonic couplant provided by the invention takes polyoxyethylene ether-40 hydrogenated castor oil and castor oil polyoxyethylene ether in a certain proportion as solubilizers, can obviously improve the effective content of triclosan in an aqueous solution, and greatly improves the sterilization effect of the whole couplant.
(3) According to the bactericidal medical ultrasonic couplant, a certain amount of vanillyl butyl ether is added, so that discomfort of a user caused by temperature difference in cold weather in winter can be remarkably reduced, and the skin feels warm and comfortable.
Detailed Description
The present invention will be described in further detail with reference to the following examples. It should not be understood that the scope of the above-described subject matter of the present invention is limited to the following examples.
The reagents used in the invention are all common reagents and can be purchased from conventional reagent production and sale companies.
Examples 1 to 4 Bactericidal medical ultrasonic coupling agent
The bactericidal medical ultrasonic couplant disclosed by the embodiments 1-4 of the invention is prepared from the components shown in the table 1 in percentage by weight.
TABLE 1 EXAMPLES 1-4 Bactericidal medical ultrasonic couplant raw materials and weight percentages thereof
The preparation method comprises the following steps:
s1, dissolving a corresponding amount of carbomer in a corresponding amount of water, and swelling for 6 hours to obtain a solution A;
s2, uniformly mixing and stirring a corresponding amount of solubilizer and Tween-80, adding a corresponding amount of vanillyl butyl ether, heating to 75 ℃, stirring for 10min, and cooling to obtain a solution B;
s3, uniformly mixing and stirring the wetting agent and the bactericide in corresponding amount, adding the solution B obtained in the step S2, stirring for 25min until the solution B is clear, standing for defoaming, and stirring for 15min at a speed of 20 revolutions per minute to obtain a solution C;
s4, adding the solution C obtained in the step S3 into the solution A obtained in the step S1, stirring in vacuum for 30-60 min, dropwise adding corresponding amount of triethanolamine, stirring to form a transparent gel, adjusting the pH value of the solution to 7, stirring at 20 rpm for 20min, inspecting quality, filling and sterilizing to obtain the finished product.
Example 5 an ultrasonic coupling agent
The difference from example 3 is that in example 5 the vanillyl butyl ether is removed and the remaining parameters and preparation are referred to in example 3.
Comparative example 1 an ultrasonic coupling agent
The difference from example 3 is that comparative example 1 removes protocatechuic aldehyde, increases the weight percentage of triclosan to 1.2%, and references example 3 for the remaining parameters and preparation method.
Comparative example 2 an ultrasonic coupling agent
The difference from example 3 is that comparative example 2 removes triclosan, increases the weight percentage of protocatechualdehyde to 1.2%, and references example 3 for the remaining parameters and preparation method.
Comparative example 3 an ultrasonic coupling agent
Except for example 3, in comparative example 3, polyoxyethylene ether-40 hydrogenated castor oil (RH-40) was removed, and the weight percentage of castor oil polyoxyethylene ether (EL-40) was increased to 1.2%, and the rest of the parameters and the preparation method refer to example 3.
Comparative example 4 an ultrasonic coupling agent
Except for example 3, in comparative example 4, castor oil polyoxyethylene ether (EL-40) was removed, polyoxyethylene ether-40 hydrogenated castor oil (RH-40) was added to 1.2% by weight, and the rest of parameters and preparation method were referenced to example 3.
Experimental example 1 detection of Couplant Performance
Physical property detection, acoustic detection and safety detection are carried out on the bactericidal medical ultrasonic couplant prepared in the embodiments 1-4, and bactericidal performance detection is carried out on the ultrasonic couplant prepared in the embodiments 1-4 and the comparative examples 1-4, wherein the acoustic detection refers to YY0299-2009, the safety detection refers to GB16886.5-2003 and GB16886.10-2005, the physical property detection, the acoustic detection and the safety detection refer to Table 2, and the bactericidal performance detection refers to Table 3.
TABLE 2 physical Properties, Acoustic and safety test results
TABLE 3 results of the measurement of bactericidal properties
As can be seen from tables 2 and 3, each index of the coupling agent prepared in the embodiments 1 to 3 of the invention meets the national standard requirement for the coupling agent. In the bactericidal performance detection, the coupling agents prepared in the embodiments 1 to 4 of the invention have the bactericidal rate of over 99% to escherichia coli, staphylococcus aureus and candida albicans within 2min, and are obviously better than the standard requirement that the bactericidal rate is more than or equal to 90% in 3 min. Compared with the comparative example 1 (removing protocatechuic aldehyde), the standard sterilization requirement can be met within 3min by using high-concentration triclosan, but the triclosan is high in concentration and has certain toxicity, and the sterilization effect of the coupling agent prepared in the comparative examples 2-4 (removing triclosan, polyoxyethylene ether-40 hydrogenated castor oil and castor oil polyoxyethylene ether respectively) is remarkably reduced, and the standard requirement cannot be met within 3 min.
Experimental example 2 Couplant clinical test
Clinical tests were conducted on 150 patients who required B-mode ultrasound examination, five groups of the coupling agents prepared in examples 1 to 5 of the present invention were used, and the use feeling of the patients was recorded, and the results are shown in Table 4.
TABLE 4 Couplant clinical trial results
| Effect | Example 1 | Example 2 | Example 3 | Example 4 | Example 5 |
| (Comfort) | 98％ | 97％ | 100％ | 100％ | 43％ |
| Discomfort | 2％ | 3％ | 0 | 0 | 57％ |
As can be seen from Table 4, the coupling agents prepared in the embodiments 1 to 4 of the present invention have a clinical feedback comfort level of 95% or more, and can significantly improve the cold and irritation caused by the temperature difference between the environment and the skin, and bring a comfortable feeling to the user. Whereas example 5 (with the vanillyl butyl ether removed) experienced a significant increase in discomfort to 57%.
The foregoing embodiments are merely illustrative of the principles and utilities of the present invention and are not intended to limit the invention. Any person skilled in the art can modify or change the above-mentioned embodiments without departing from the spirit and scope of the present invention. Accordingly, it is intended that all equivalent modifications or changes which can be made by those skilled in the art without departing from the spirit and technical spirit of the present invention be covered by the claims of the present invention.
Claims (9)
1. The bactericidal medical ultrasonic couplant is characterized by being mainly prepared from the following raw materials in percentage by weight: 0.1-2.0% of carbomer, 2-20% of wetting agent, 0.1-1.0% of triethanolamine, 0.5-2.0% of bactericide, 0.06-1.50% of solubilizer, 0-1.0% of tween-800.5 and 73-96% of water, wherein the bactericide is composed of protocatechualdehyde and triclosan according to the weight ratio of 1 (0.05-1.5).
2. The ultrasonic couplant of claim 1 further comprising 0.001-0.01% vanillyl butyl ether.
3. The ultrasonic couplant of claim 2, wherein the ultrasonic couplant is prepared from the following raw materials in percentage by weight: 0.5-1.5% of carbomer, 5-15% of wetting agent, 0.2-1.0% of triethanolamine, 1.0-2.0% of bactericide, 0.5-1.5% of solubilizer, 0. 800.5-0.8% of tween-890.008% of vanillyl butyl ether and 80-96% of water.
4. The ultrasonic couplant of claim 3, wherein the ultrasonic couplant is prepared from the following raw materials in percentage by weight: carbomer 0.6%, wetting agent 11%, triethanolamine 0.3%, bactericide 1.2%, solubilizer 1.2%, tween-800.8%, vanillyl butyl ether 0.005% and balance of water.
5. The ultrasonic couplant of claim 1, wherein the biocide consists of protocatechuic aldehyde and triclosan in a weight ratio of 1: 0.2.
6. The ultrasonic couplant of any one of claims 1 to 4, wherein the solubilizer consists of polyoxyethylene ether-40 hydrogenated castor oil and castor oil polyoxyethylene ether in a weight ratio of 1 (0.01-10).
7. The ultrasonic couplant of claim 6, wherein the solubilizer consists of polyoxyethylene ether-40 hydrogenated castor oil and castor oil polyoxyethylene ether in a weight ratio of 1: 0.5.
8. The ultrasonic couplant of any one of claims 1 to 4, wherein the humectant is one or two selected from the group consisting of propylene glycol and glycerol.
9. The preparation method of the ultrasonic couplant according to any one of claims 2 to 8, comprising the following steps:
s1, dissolving a corresponding amount of carbomer in a corresponding amount of water, and swelling for 5-7 hours to obtain a solution A;
s2, uniformly mixing and stirring a corresponding amount of solubilizer and Tween-80, adding a corresponding amount of vanillyl butyl ether, heating to 70-80 ℃, stirring for 5-15 min, and cooling to obtain a solution B;
s3, uniformly mixing and stirring the wetting agent and the bactericide in corresponding amounts, adding the solution B obtained in the step S2, stirring for 20-30 min until the solution B is clear, standing for defoaming, and stirring for 10-20 min at 10-30 rpm to obtain a solution C;
s4, adding the solution C obtained in the step S3 into the solution A obtained in the step S1, stirring in vacuum for 30-60 min, dropwise adding corresponding amount of triethanolamine, stirring to form a transparent gel, adjusting the pH value of the solution to 6-8, stirring at 10-30 rpm for 15-25 min, inspecting quality, filling and sterilizing to obtain the finished product.
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