CN117679537B - Medical sterile ultrasonic coupling agent and preparation method thereof - Google Patents
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- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 22
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- LMDZBCPBFSXMTL-UHFFFAOYSA-N 1-ethyl-3-(3-dimethylaminopropyl)carbodiimide Chemical compound CCN=C=NCCCN(C)C LMDZBCPBFSXMTL-UHFFFAOYSA-N 0.000 claims description 14
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Natural products CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims description 14
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- FJKROLUGYXJWQN-UHFFFAOYSA-N papa-hydroxy-benzoic acid Natural products OC(=O)C1=CC=C(O)C=C1 FJKROLUGYXJWQN-UHFFFAOYSA-N 0.000 claims description 9
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- 125000000218 acetic acid group Chemical group C(C)(=O)* 0.000 claims 1
- 238000013019 agitation Methods 0.000 claims 1
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- 238000003745 diagnosis Methods 0.000 description 2
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- 241000411851 herbal medicine Species 0.000 description 2
- 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
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- 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
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- MWOOGOJBHIARFG-UHFFFAOYSA-N vanillin Chemical compound COC1=CC(C=O)=CC=C1O MWOOGOJBHIARFG-UHFFFAOYSA-N 0.000 description 1
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- Polysaccharides And Polysaccharide Derivatives (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention provides a medical sterile ultrasonic coupling agent and a preparation method thereof, and belongs to the technical field of ultrasonic coupling agents. The composite material is prepared from the following raw materials in parts by weight: 5-10 parts of modified chitosan, 12-15 parts of carbomer, 10-20 parts of propylene glycol, 5-7 parts of glycerol, 2-4 parts of triethanolamine and 100-120 parts of purified water. The medical sterile ultrasonic couplant prepared by the invention is a hydrogel which is degradable, good in lubricating performance, proper in viscosity, free from flowing and easy to erase, can meet various requirements of the medical industry standard YY0299-2016 of medical ultrasonic couplant, is simple in manufacturing process, does not need vacuumizing, bubble removing and other processes, is excellent in antibacterial performance, safe and free from stimulation, and has wide application prospect.
Description
Technical Field
The invention relates to the technical field of ultrasonic couplants, in particular to a medical sterile ultrasonic couplant and a preparation method thereof.
Background
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, magnolol is used as a main sterilizing component, and eugenol, anisic acid, dipotassium glycyrrhizinate and vanillin are used for synergistic sterilization; if CN104189927A is compounded by 6 Chinese herbal medicine essential oils to achieve the sterilization effect, 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-hydroxy diphenyl ether as sterilizing component, can not be biodegraded, and has a large amount of chemical sterilizing agent, and can be remained on skin after ultrasonic diagnosis, and has a certain stimulation effect on skin.
Disclosure of Invention
The invention aims to provide a medical sterile ultrasonic couplant and a preparation method thereof, which have the advantages of degradability, good lubricating property, proper viscosity, no flow and easy erasure, can meet various requirements of the sterile medical ultrasonic couplant of medical industry standard YY0299-2016 of medical ultrasonic couplant, and has the advantages of simple preparation process, no need of vacuumizing, bubble removal and other processes, excellent antibacterial property, safety, no stimulation and wide application prospect.
The technical scheme of the invention is realized as follows:
The invention provides a medical sterile ultrasonic coupling agent which is prepared from the following raw materials in parts by weight: 5-10 parts of modified chitosan, 12-15 parts of carbomer, 10-20 parts of propylene glycol, 5-7 parts of glycerol, 2-4 parts of triethanolamine and 100-120 parts of purified water.
As a further improvement of the invention, the invention is prepared from the following raw materials in parts by weight: 7 parts of modified chitosan, 13 parts of carbomer, 15 parts of propylene glycol, 6 parts of glycerol, 3 parts of triethanolamine and 110 parts of purified water.
As a further improvement of the invention, the preparation method of the modified chitosan comprises the following steps:
s1, dissolving chitosan in acid liquor to obtain chitosan solution;
s2, mixing lipoic acid and salicylic acid, adding the mixture into water, adding 1-ethyl-3- (3-dimethylaminopropyl) carbodiimide, and stirring at room temperature for reaction to obtain a modifier solution;
S3, adding the modifier solution into the chitosan solution, adjusting the pH value of the solution, stirring at room temperature for reaction, and drying to obtain the modified chitosan.
As a further improvement of the invention, the acid liquid in the step S1 is acetic acid solution with the concentration of 2-4wt%, and the concentration of chitosan in the chitosan solution is 10-12wt%.
As a further improvement of the invention, the mass ratio of lipoic acid, salicylic acid, 1-ethyl-3- (3-dimethylaminopropyl) carbodiimide and water in the step S2 is 2-4:3-5:10-15:200-300.
As a further improvement of the invention, the stirring reaction at room temperature in the step S2 is carried out for 0.5-1h.
As a further improvement of the invention, the mass ratio of the modifier solution to the chitosan solution in the step S3 is 10-15:100, the pH value of the solution is regulated to 6-6.5, and the stirring reaction time at room temperature is 2-4h.
The invention further provides a preparation method of the medical sterile ultrasonic coupling agent, which comprises the following steps:
(1) Dissolving the modified chitosan and carbomer in purified water, and stirring and mixing uniformly;
(2) Adding propylene glycol, glycerol and triethanolamine, homogenizing, and sterilizing to obtain medical aseptic ultrasonic coupling agent.
As a further improvement of the invention, the stirring speed in the step (1) is 1000-1200r/min.
As a further improvement of the invention, the homogenizing rotation speed in the step (2) is 8000-10000r/min, and the time is 5-7min.
The invention has the following beneficial effects:
Chitosan is a hydrophilic polymer organic matter with amino groups, and is usually prepared from chitin through alkaline hydrolysis or enzymolysis deacetylation, and because of excellent biodegradability, biocompatibility, bioadhesion and antibacterial activity, the amino groups on the main chain of chitosan are required to be converted into ammonium ions by using an acidic solution due to the strong hydrogen bonding action of the amino groups, so that the water solubility and antibacterial activity of the chitosan can be improved. However, the ultrasonic coupling agent is usually in a neutral environment, and the beta-1, 4-glycosidic bond of chitosan dissolved in an acid solution is easy to degrade, so that the antibacterial performance of the ultrasonic coupling agent on staphylococcus aureus, fusarium oxysporum, escherichia coli and the like is reduced, and the application of the ultrasonic coupling agent is limited. According to the invention, lipoic acid and salicylic acid are adopted to carry out synergistic modification on chitosan, so that the water solubility and the antibacterial property of the chitosan are improved, the reaction conditions are mild, the time consumption is short, the performance is excellent, the large-scale production can be realized, the introduction of disulfide bonds changes the original arrangement mode among molecules, the crystallinity is reduced, and the antibacterial property is improved.
The medical sterile ultrasonic couplant prepared by the invention is a hydrogel which is degradable, good in lubricating performance, proper in viscosity, free from flowing and easy to erase, can meet various requirements of the medical industry standard YY0299-2016 of medical ultrasonic couplant, is simple in manufacturing process, does not need vacuumizing, bubble removing and other processes, is excellent in antibacterial performance, safe and free from stimulation, and has wide application prospect.
Detailed Description
The following description of the technical solutions in the embodiments of the present invention will be clear and complete, and it is obvious that the described embodiments are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
Preparation example 1 preparation of modified chitosan
The method comprises the following steps:
S1, dissolving chitosan in 2wt% of acetic acid solution to obtain chitosan solution, wherein the concentration of chitosan is 10wt%;
s2, mixing 2 parts by weight of lipoic acid and 3 parts by weight of salicylic acid, adding 200 parts by weight of water, adding 10 parts by weight of 1-ethyl-3- (3-dimethylaminopropyl) carbodiimide, and stirring at room temperature for reacting for 0.5h to obtain a modifier solution;
S3, adding 10 parts by weight of modifier solution into 100 parts by weight of chitosan solution, adjusting the pH value of the solution to 6, stirring at room temperature for reaction for 2 hours, and drying to obtain the modified chitosan.
Preparation example 2 preparation of modified chitosan
The method comprises the following steps:
s1, dissolving chitosan in 4wt% acetic acid solution to obtain chitosan solution, wherein the concentration of chitosan is 12wt%;
s2, mixing 4 parts by weight of lipoic acid and 5 parts by weight of salicylic acid, adding 300 parts by weight of water, adding 15 parts by weight of 1-ethyl-3- (3-dimethylaminopropyl) carbodiimide, and stirring at room temperature for reacting for 1h to obtain a modifier solution;
s3, adding 15 parts by weight of modifier solution into 100 parts by weight of chitosan solution, adjusting the pH value of the solution to 6.5, stirring at room temperature for reaction for 4 hours, and drying to obtain the modified chitosan.
Preparation example 3 preparation of modified chitosan
The method comprises the following steps:
S1, dissolving chitosan in 3wt% of acetic acid solution to obtain chitosan solution, wherein the concentration of chitosan is 11wt%;
S2, mixing 3 parts by weight of lipoic acid and 4 parts by weight of salicylic acid, adding 250 parts by weight of water, adding 12 parts by weight of 1-ethyl-3- (3-dimethylaminopropyl) carbodiimide, and stirring at room temperature for reacting for 1h to obtain a modifier solution;
s3, adding 12 parts by weight of modifier solution into 100 parts by weight of chitosan solution, adjusting the pH value of the solution to 6.2, stirring at room temperature for reaction for 3 hours, and drying to obtain the modified chitosan.
Comparative preparation example 1
The difference from preparation example 3 is that lipoic acid was not added in step S2.
Comparative preparation example 2
In comparison with preparation example 3, the difference is that salicylic acid was not added in step S2.
Example 1
The preparation method of the medical sterile ultrasonic couplant comprises the following steps:
(1) Dissolving 5 parts by weight of the modified chitosan prepared in preparation example 1 and 12 parts by weight of carbomer in 100 parts by weight of purified water, and stirring and mixing for 20min at 1000 r/min;
(2) Adding 10 parts by weight of propylene glycol, 5 parts by weight of glycerol and 2 parts by weight of triethanolamine into the system in the step (1), homogenizing for 5min at 8000r/min, and sterilizing to obtain the medical sterile ultrasonic coupling agent.
Example 2
The preparation method of the medical sterile ultrasonic couplant comprises the following steps:
(1) 10 parts by weight of the modified chitosan prepared in preparation example 2 and 15 parts by weight of carbomer are dissolved in 120 parts by weight of purified water, and are stirred and mixed for 20min at 1200 r/min;
(2) Adding 20 parts by weight of propylene glycol, 7 parts by weight of glycerol and 4 parts by weight of triethanolamine into the system in the step (1), homogenizing for 7min at 10000r/min, and sterilizing to obtain the medical sterile ultrasonic coupling agent.
Example 3
The preparation method of the medical sterile ultrasonic couplant comprises the following steps:
(1) 7 parts by weight of the modified chitosan prepared in preparation example 3 and 13 parts by weight of carbomer are dissolved in 110 parts by weight of purified water, and the mixture is stirred and mixed for 20 minutes at 1100 r/min;
(2) Adding 15 parts by weight of propylene glycol, 6 parts by weight of glycerol and 3 parts by weight of triethanolamine into the system in the step (1), homogenizing for 6min at 9000r/min, and sterilizing to obtain the medical sterile ultrasonic coupling agent.
Comparative example 1
The difference compared to example 3 is that the modified chitosan was prepared from comparative preparation 1.
The method comprises the following steps:
(1) 7 parts by weight of the modified chitosan prepared in comparative preparation example 1 and 13 parts by weight of carbomer are dissolved in 110 parts by weight of purified water, and the mixture is stirred and mixed for 20 minutes at 1100 r/min;
(2) Adding 15 parts by weight of propylene glycol, 6 parts by weight of glycerol and 3 parts by weight of triethanolamine into the system in the step (1), homogenizing for 6min at 9000r/min, and sterilizing to obtain the medical sterile ultrasonic coupling agent.
Comparative example 2
The difference compared to example 3 is that modified chitosan was prepared from comparative preparation 2.
The method comprises the following steps:
(1) 7 parts by weight of the modified chitosan prepared in comparative preparation example 2 and 13 parts by weight of carbomer are dissolved in 110 parts by weight of purified water, and the mixture is stirred and mixed for 20 minutes at 1100 r/min;
(2) Adding 15 parts by weight of propylene glycol, 6 parts by weight of glycerol and 3 parts by weight of triethanolamine into the system in the step (1), homogenizing for 6min at 9000r/min, and sterilizing to obtain the medical sterile ultrasonic coupling agent.
Comparative example 3
The difference compared to example 3 is that no modified chitosan was added.
The method comprises the following steps:
(1) 13 parts by weight of carbomer is dissolved in 110 parts by weight of purified water, and the mixture is stirred and mixed for 20 minutes at 1100 r/min;
(2) Adding 15 parts by weight of propylene glycol, 6 parts by weight of glycerol and 3 parts by weight of triethanolamine into the system in the step (1), homogenizing for 6min at 9000r/min, and sterilizing to obtain the medical sterile ultrasonic coupling agent.
Test example 1
The medical sterile ultrasonic couplant prepared in the examples 1-3 and the comparative examples 1-3 is subjected to performance test by referring to the medical industry standard YY0299-2016 of medical ultrasonic couplant. The results are shown in Table 1.
TABLE 1
As can be seen from the above table, the medical sterile ultrasonic couplant prepared in examples 1-3 of the present invention has good comprehensive properties.
Test example 2
The medical sterile ultrasonic couplant prepared in the examples 1-3 and the comparative examples 1-3 were subjected to a bacteria content test by referring to the medical industry standard YY0299-2016 of medical ultrasonic couplant, and the results are shown in Table 2.
TABLE 2
As can be seen from the above table, the medical sterile ultrasonic couplant prepared in the embodiments 1-3 of the invention has better antibacterial performance.
The foregoing description of the preferred embodiments of the invention is not intended to be limiting, but rather is intended to cover all modifications, equivalents, alternatives, and improvements that fall within the spirit and scope of the invention.
Claims (6)
1. The medical sterile ultrasonic coupling agent is characterized by being prepared from the following raw materials in parts by weight: 5-10 parts of modified chitosan, 12-15 parts of carbomer, 10-20 parts of propylene glycol, 5-7 parts of glycerol, 2-4 parts of triethanolamine and 100-120 parts of purified water;
the preparation method of the modified chitosan comprises the following steps:
s1, dissolving chitosan in acid liquor to obtain chitosan solution; the acid liquor is acetic acid solution with the concentration of 2-4wt%, and the concentration of chitosan in the chitosan solution is 10-12wt%;
S2, mixing lipoic acid and salicylic acid, adding the mixture into water, adding 1-ethyl-3- (3-dimethylaminopropyl) carbodiimide, and stirring at room temperature for reaction to obtain a modifier solution; the mass ratio of the lipoic acid to the salicylic acid to the 1-ethyl-3- (3-dimethylaminopropyl) carbodiimide to the water is 2-4:3-5:10-15:200-300;
s3, adding the modifier solution into the chitosan solution, adjusting the pH value of the solution, stirring at room temperature for reaction, and drying to obtain modified chitosan; the mass ratio of the modifier solution to the chitosan solution is 10-15:100, the pH value of the solution is regulated to 6-6.5, and the stirring reaction time at room temperature is 2-4h.
2. The medical sterile ultrasonic couplant according to claim 1, wherein the couplant is prepared from the following raw materials in parts by weight: 7 parts of modified chitosan, 13 parts of carbomer, 15 parts of propylene glycol, 6 parts of glycerol, 3 parts of triethanolamine and 110 parts of purified water.
3. The medical sterile ultrasound couplant according to claim 1, wherein the room temperature agitation reaction time in step S2 is 0.5-1h.
4. A method of preparing a medical sterile ultrasound couplant according to any of claims 1-3, comprising the steps of:
(1) Dissolving the modified chitosan and carbomer in purified water, and stirring and mixing uniformly;
(2) Adding propylene glycol, glycerol and triethanolamine, homogenizing, and sterilizing to obtain medical aseptic ultrasonic coupling agent.
5. The method according to claim 4, wherein the stirring in the step (1) is carried out at a rotational speed of 1000 to 1200r/min.
6. The method according to claim 4, wherein the homogenizing in the step (2) is carried out at a rotational speed of 8000-10000r/min for 5-7min.
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| CN106075482A (en) * | 2016-08-16 | 2016-11-09 | 青岛云天生物技术有限公司 | A kind of medical ultrasonic coupling agent |
| CN110623870A (en) * | 2018-06-21 | 2019-12-31 | 刘方圆 | Moisturizing gel mask and preparation method thereof |
| KR20220018417A (en) * | 2020-08-06 | 2022-02-15 | (주)코스모덱 | Bioactive Composites Stabilized by Polymeric Network Structure, and Preparation Method Thereof |
| KR20220043992A (en) * | 2020-09-28 | 2022-04-06 | 손태원 | Hydro-responsive Biofoam Comprising Chitosan Organolytes |
| CN115475257A (en) * | 2022-08-29 | 2022-12-16 | 广州市一杰医药科技有限公司 | Medical ultrasonic coupling agent and preparation method thereof |
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