CN115845112A - Medical sodium hyaluronate repair patch and preparation method thereof - Google Patents
Medical sodium hyaluronate repair patch and preparation method thereof Download PDFInfo
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- CN115845112A CN115845112A CN202211482447.8A CN202211482447A CN115845112A CN 115845112 A CN115845112 A CN 115845112A CN 202211482447 A CN202211482447 A CN 202211482447A CN 115845112 A CN115845112 A CN 115845112A
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Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses a medical sodium hyaluronate restoration paste, which comprises a sodium hyaluronate stock solution, a matrix and an aluminum foil membrane, wherein the matrix is soaked in the sodium hyaluronate stock solution, the sodium hyaluronate stock solution and the matrix are sealed in the aluminum foil membrane after being irradiated and sterilized, and the sodium hyaluronate solution comprises the following components in percentage by weight: 0.1-5% of sodium hyaluronate, 0.01-0.3% of silver nitrate, 0.1-0.6% of squalane, 0.01-1% of allantoin, 0.01-0.1% of sorbic acid, 0.1-0.2% of sodium benzoate, 0.05-0.3% of carboxymethyl cellulose and the balance of purified water; the sodium hyaluronate is matched with silver nitrate, squalane and allantoin, so that the sodium hyaluronate has a good synergistic effect, can promote the proliferation and differentiation of epidermal cells, and can promote the regeneration of skin at an injured part.
Description
Technical Field
The invention relates to the technical field of medical repair, in particular to a medical sodium hyaluronate repair patch and a preparation method thereof.
Background
The repair of human skin injury is a complex physiological process, and the healing speed of wounds and the formation and proliferation of scars after healing are always puzzled by people. For this reason, there are efforts to find ideal dressings, including good biocompatibility, controlling and absorbing the exudate of the wound, preventing the invasion of bacteria and inhibiting the growth and reproduction of bacteria, protecting the new tissues, accelerating the healing of the wound, preventing and reducing scars, stopping bleeding and easing pain, good mechanical properties, and the like.
With the development of molecular biology, the application research of biological materials in medical dressings is increasing, and a great deal of results are obtained. Sodium hyaluronate, also known as hyaluronic acid, is a disaccharide unit composed of D-glucuronic acid and N-acetylglucosamine, has wide physicochemical properties and rich biological functions, and is particularly suitable for repairing, protecting and caring skin. Sodium hyaluronate shows various important physiological functions in organisms by virtue of unique molecular structure and physicochemical properties, such as joint lubrication, regulation of permeability of blood vessel walls, regulation of protein and water electrolyte diffusion and operation, promotion of wound healing and the like. More importantly, sodium hyaluronate has a special water retention effect, is a substance which is found to have the best moisture retention in nature at present, is called an ideal natural moisture retention factor, is a good transdermal absorption promoter while retaining moisture, and is widely applied to the fields of clinical medicine, cosmetic production and the like.
At present, most of products in the market are prepared from sodium hyaluronate or several kinds of sodium hyaluronate with different molecular weights are randomly matched, the barrier protection and repair effects of the sodium hyaluronate on skin cannot be maximized, and most of substrates are non-woven fabrics, the non-woven fabrics are prepared from chemical fibers, plant fibers and the like on a wet method paper machine or a dry method paper machine under the condition that water or air is used as a suspension medium, but the non-woven fabrics are poor in durability and low in liquid absorption rate. Therefore, in order to coordinate the matrix and the sodium hyaluronate stock solution, the invention provides a medical sodium hyaluronate repair patch and a preparation method thereof.
Disclosure of Invention
Aiming at the defects of the prior art, the invention aims to provide a medical sodium hyaluronate repairing paste and a preparation method thereof, so as to solve the problems in the background technology.
The technical scheme adopted by the invention for solving the technical problems is as follows:
the invention provides a medical sodium hyaluronate restoration paste, which comprises a sodium hyaluronate stock solution, a matrix and an aluminum foil membrane, wherein the matrix is soaked in the sodium hyaluronate stock solution, the sodium hyaluronate stock solution and the matrix are sealed in the aluminum foil membrane after being irradiated and sterilized, and the sodium hyaluronate solution comprises the following components in percentage by weight: 0.1-5% of sodium hyaluronate, 0.01-0.3% of silver nitrate, 0.1-0.6% of squalane, 0.01-1% of allantoin, 0.01-0.1% of sorbic acid, 0.1-0.2% of sodium benzoate, 0.05-0.3% of carboxymethyl cellulose and the balance of purified water.
Preferably, the molecular weight of the sodium hyaluronate is 400-800 kDa, and the specification is pharmaceutical grade.
Preferably, the substrate is a non-woven fabric, the raw materials of the non-woven fabric comprise plant flock, adhesive fiber and chitosan, and the preparation method of the non-woven fabric comprises the following steps:
cleaning plant flock, removing impurities, and then performing vacuum drying at 55-65 ℃;
step two, processing the plant flock and the viscose into flock/viscose non-woven fabric;
step three, preparing chitosan treatment solution with the mass fraction of 0.05-0.3 g/mL;
step four, performing secondary soaking and secondary rolling after-treatment on the flocked/viscose non-woven fabric by using the chitosan treatment solution prepared in the step three;
and step five, drying the finished flocked/viscose non-woven fabric at 85-100 ℃ for 8-16min.
Preferably, the plant wadding is catkin, the viscose fiber raw material is prepared by wet spinning of wood, cotton linter and bagasse, and the mass ratio of the wadding to the viscose is (15-35): (85-65).
Catkin as a natural material can be made into plant fibers, and meanwhile catkin has the functions of cooling blood, stopping bleeding, relieving swelling and pain, according to the Ben Jing: abscess due to ulceration, pus and blood; according to the bibliography: scabies, malignant sores and incised sores.
Preferably, the second step comprises a forming process and a needling process, wherein the forming process is sequentially provided with an opener, a cotton feeder, a carding machine and a lapping machine from the processing direction, and the needling process is sequentially provided with a feeding machine, a pre-needling machine, a pre-rolling machine, an inverted needling machine and a main needling machine from the processing direction.
Preferably, the third step comprises the following steps: adding chitosan into an acetic acid solution, stirring at 50-60 ℃ until the chitosan is fully dissolved, then adding the acetic acid solution into the fully dissolved chitosan solution for dilution by adopting a bath ratio of 1.
Preferably, the second dipping and second rolling in the fourth step comprises the following steps: placing the plant flock/viscose non-woven fabric in the chitosan treatment solution, uniformly covering the treatment solution on the non-woven fabric at 50-60 ℃ for 25-45min under the mechanical stirring, carrying out first rolling, then placing the non-woven fabric at 45-55 ℃ for 15-25min, and carrying out second rolling.
Preferably, the pH value of the sodium hyaluronate stock solution is 5.0-7.0, the content of heavy metal is not more than 10ug/g, and the mass of the matrix in square meter is not less than 20g/m < 2 >.
Preferably, the shape of the sodium hyaluronate repair patch is round, oval or square, and the size of the sodium hyaluronate repair patch is (based on the narrowest part) with an allowable deviation of 15%: l:150-280mm, M:60-149mm, S:5-59mm.
After the product is used, the shortest time of wound surface healing of the white mouse is 13 +/-2 days, which shows that the product has obvious effect of promoting wound surface healing.
The invention also provides a preparation method of the medical sodium hyaluronate restoration paste, which comprises the following steps:
s1: adding sodium hyaluronate, silver nitrate, sorbic acid and sodium benzoate into purified water, mixing uniformly, heating to 75-85 ℃, and keeping the temperature for 60-120min to obtain a mixed solution A;
s2: adding squalane, allantoin and carboxymethyl cellulose into the mixed solution A prepared in the step S1, uniformly stirring, and reducing the system temperature to 22-40 ℃ to obtain a mixed solution 2;
s3: adjusting pH to 5.0-7.0 to obtain sodium hyaluronate stock solution;
and S4, filling the sodium hyaluronate stock solution prepared in the step S3 into an aluminum foil film, putting a substrate into the aluminum foil film for sufficient adsorption, sealing the aluminum foil film, performing Co60 irradiation sterilization, and packaging the aluminum foil film to obtain the medical sodium hyaluronate restoration patch.
Compared with the prior art, the invention has the following beneficial effects:
the silver nitrate, squalane and allantoin are cooperated to sterilize, moisturize and promote wound healing, and a protective barrier can be formed at the wound, so that the effect of the product is greatly improved.
The substrate of the invention adopts plant flock, adhesive fiber and chitosan, and the non-woven fabric is prepared by a reasonable production process, thereby changing waste into valuable; the catkin is a natural material, has sufficient raw materials and biodegradability; the catkin has a high hollow structure, can absorb a large amount of water, and has high water absorption and hemostatic functions; the chitosan has an antibacterial effect, so that the repairing paste prepared by post-treating the chitosan treatment liquid has an antibacterial function.
Detailed Description
The technical solutions in the embodiments of the present invention are clearly and completely described below with reference to specific embodiments, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
The invention provides a medical sodium hyaluronate repairing paste, which comprises a sodium hyaluronate stock solution, a matrix and an aluminum foil membrane, wherein the matrix is soaked in the sodium hyaluronate stock solution, the sodium hyaluronate stock solution and the matrix are sealed in the aluminum foil membrane after being irradiated and sterilized, and the sodium hyaluronate solution comprises the following components in percentage by weight: 0.1-5% of sodium hyaluronate, 0.01-0.3% of silver nitrate, 0.1-0.6% of squalane, 0.01-1% of allantoin, 0.01-0.1% of sorbic acid, 0.1-0.2% of sodium benzoate, 0.05-0.3% of carboxymethyl cellulose and the balance of purified water.
The molecular weight of the sodium hyaluronate is 400-800 kDa, and the specification is pharmaceutical grade.
The substrate of the embodiment is a non-woven fabric, the raw materials of the non-woven fabric comprise plant flock, adhesive fiber and chitosan, and the preparation method of the non-woven fabric comprises the following steps:
cleaning plant flock, removing impurities, and then performing vacuum drying at 55-65 ℃;
step two, processing the plant flock and the viscose into flock/viscose non-woven fabric;
step three, preparing chitosan treatment fluid with the mass fraction of 0.05-0.3 g/mL;
step four, performing secondary soaking and secondary rolling after-treatment on the flocked/viscose non-woven fabric by using the chitosan treatment solution prepared in the step three;
and step five, drying the finished flocked/viscose non-woven fabric for 8-16min at 85-100 ℃.
The plant wadding of the embodiment is catkin, the viscose fiber raw materials are wood, cotton linter and bagasse, and the wet spinning is carried out on the wood, the cotton linter and the bagasse, and the mass ratio of the wadding to the viscose is (15-35): (85-65).
The second step of this embodiment includes a forming process and a needling process, the forming process is sequentially provided with an opener, a cotton feeder, a carding machine and a lapping machine from the processing direction, and the needling process is sequentially provided with a feeder, a pre-needling machine, a pre-rolling machine, a reverse needling machine and a main needling machine from the processing direction.
The third step of this embodiment includes the following steps: adding chitosan into an acetic acid solution, stirring at 50-60 ℃ until the chitosan is fully dissolved, then adding the acetic acid solution into the fully dissolved chitosan solution for dilution by adopting a bath ratio of 1.
The second dipping and second rolling in the fourth step of this embodiment includes the following steps: putting the plant flock/viscose non-woven fabric into the chitosan treatment solution, uniformly covering the treatment solution on the non-woven fabric at 50-100r/min under mechanical stirring, soaking for 25-45min at 50-60 ℃, then carrying out first rolling, then soaking the non-woven fabric for 15-25min at 45-55 ℃, and then carrying out second rolling.
The pH value of the sodium hyaluronate stock solution is 5.0-7.0, the content of heavy metal is not more than 10ug/g, and the mass of the matrix in square meter is not less than 20g/m < 2 >.
The shape of the sodium hyaluronate restoration paste of the embodiment is round, oval or square, and the size of the sodium hyaluronate restoration paste is (measured at the narrowest part), the allowable deviation is 15%: l:150-280mm, M:60-149mm, S:5-59mm
The preparation method of the medical sodium hyaluronate restoration paste of the embodiment comprises the following steps:
s1: adding sodium hyaluronate, silver nitrate, sorbic acid and sodium benzoate into purified water, mixing uniformly, heating to 75-85 ℃, and keeping the temperature for 60-120min to obtain a mixed solution A;
s2: adding squalane, allantoin and carboxymethyl cellulose into the mixed solution A prepared in S1, stirring uniformly, and reducing the system temperature to 22-40 deg.C to obtain mixed solution 2;
s3: adjusting pH to 5.0-7.0 to obtain sodium hyaluronate stock solution;
and S4, filling the sodium hyaluronate stock solution prepared in the step S3 into an aluminum foil film, putting the aluminum foil film into a substrate for sufficient adsorption, sealing, performing Co60 irradiation sterilization, and packaging to obtain the medical sodium hyaluronate restoration patch.
Example 1.
The invention provides a medical sodium hyaluronate repairing paste, which comprises a sodium hyaluronate stock solution, a matrix and an aluminum foil membrane, wherein the matrix is soaked in the sodium hyaluronate stock solution, the sodium hyaluronate stock solution and the matrix are sealed in the aluminum foil membrane after being irradiated and sterilized, and the sodium hyaluronate solution comprises the following components in percentage by weight: 0.1% of sodium hyaluronate, 0.01% of silver nitrate, 0.1% of squalane, 0.01% of allantoin, 0.01% of sorbic acid, 0.1% of sodium benzoate, 0.05% of carboxymethyl cellulose and the balance of purified water.
The molecular weight of the sodium hyaluronate of the embodiment is 400kDa, and the specification is pharmaceutical grade.
The substrate of this example is a nonwoven fabric, the raw materials of which include plant flock, adhesive fiber and chitosan, and the preparation method of the nonwoven fabric includes the following steps:
cleaning plant flock, removing impurities, and then drying in vacuum at 55 ℃;
step two, processing the plant flock and the viscose into flock/viscose non-woven fabric;
step three, preparing chitosan treatment solution with the mass fraction of 0.05 g/mL;
step four, performing secondary soaking and secondary rolling after-treatment on the flocked/viscose non-woven fabric by using the chitosan treatment solution prepared in the step three;
and step five, drying the finished flocked/viscose non-woven fabric for 8min at 85 ℃.
The plant wadding of the embodiment is catkin, the viscose fiber raw materials are wood, cotton linter and bagasse, and are prepared by wet spinning, and the mass ratio of the wadding to the viscose is 15:85.
the second step of this embodiment includes a forming process and a needling process, the forming process is sequentially provided with an opener, a cotton feeder, a carding machine and a lapping machine from the processing direction, and the needling process is sequentially provided with a feeder, a pre-needling machine, a pre-rolling machine, a reverse needling machine and a main needling machine from the processing direction.
The third step of this embodiment includes the following steps: adding chitosan into an acetic acid solution, stirring at 50 ℃ until the chitosan is fully dissolved, then adding the acetic acid solution into the fully dissolved chitosan solution for dilution by adopting a bath ratio of 1.
The second dipping and second rolling in the fourth step of the present embodiment includes the following steps: placing the plant flock/viscose non-woven fabric in the chitosan treatment solution, uniformly covering the treatment solution on the non-woven fabric at 50r/min under mechanical stirring, soaking for 25min at 50 ℃, performing first rolling, soaking the non-woven fabric at 45 ℃ for 15min, and performing second rolling.
The pH value of the sodium hyaluronate stock solution is 5.0, the content of heavy metal is not more than 10ug/g, and the mass of the matrix in square meter is not less than 20g/m < 2 >.
The shape of the sodium hyaluronate restoration paste of the embodiment is round, oval or square, and the size of the sodium hyaluronate restoration paste is (measured at the narrowest part), the allowable deviation is 15%: l:150mm, M:60mm, S:5mm
The preparation method of the medical sodium hyaluronate restoration paste of the embodiment comprises the following steps:
s1: adding sodium hyaluronate, silver nitrate, sorbic acid and sodium benzoate into purified water, uniformly mixing, then heating to 75 ℃, and preserving heat for 60min to obtain mixed liquor A;
s2: adding squalane, allantoin and carboxymethyl cellulose into the mixed solution A prepared in the step S1, uniformly stirring, and reducing the system temperature to 22 ℃ to obtain a mixed solution 2;
s3: adjusting the pH value to 5.0 to obtain a sodium hyaluronate stock solution;
and S4, filling the sodium hyaluronate stock solution prepared in the step S3 into an aluminum foil film, putting the aluminum foil film into a substrate for sufficient adsorption, sealing, performing Co60 irradiation sterilization, and packaging to obtain the medical sodium hyaluronate restoration patch.
Example 2.
The invention provides a medical sodium hyaluronate repairing paste, which comprises a sodium hyaluronate stock solution, a matrix and an aluminum foil membrane, wherein the matrix is soaked in the sodium hyaluronate stock solution, the sodium hyaluronate stock solution and the matrix are sealed in the aluminum foil membrane after being irradiated and sterilized, and the sodium hyaluronate solution comprises the following components in percentage by weight: 5% of sodium hyaluronate, 0.3% of silver nitrate, 0.6% of squalane, 1% of allantoin, 0.1% of sorbic acid, 0.2% of sodium benzoate, 0.3% of carboxymethyl cellulose and the balance of purified water.
The molecular weight of the sodium hyaluronate of the embodiment is 800 kDa, and the specification is pharmaceutical grade.
The substrate of this example is a nonwoven fabric, the raw materials of which include plant flock, adhesive fiber and chitosan, and the preparation method of the nonwoven fabric includes the following steps:
cleaning plant flock, removing impurities, and then performing vacuum drying at 65 ℃;
step two, processing the plant flock and the viscose into flock/viscose non-woven fabric;
step three, preparing chitosan treatment fluid with the mass fraction of 0.3 g/ml;
step four, performing secondary soaking and secondary rolling after-treatment on the flocked/viscose non-woven fabric by using the chitosan treatment solution prepared in the step three;
and step five, drying the finished flocked/viscose non-woven fabric at 100 ℃ for 16min.
The plant wadding of the embodiment is catkin, the viscose fiber raw materials are wood, cotton linter and bagasse, and the cotton linter/viscose fiber raw materials are prepared by wet spinning, and the mass ratio of the wadding to the viscose is 35: -65.
The second step of this embodiment includes a forming process and a needling process, the forming process is sequentially provided with an opener, a cotton feeder, a carding machine and a lapping machine from the processing direction, and the needling process is sequentially provided with a feeder, a pre-needling machine, a pre-rolling machine, a reverse needling machine and a main needling machine from the processing direction.
The third step of the present embodiment includes the following steps: adding chitosan into an acetic acid solution, stirring at 60 ℃ until the chitosan is fully dissolved, then adding the acetic acid solution into the fully dissolved chitosan solution for dilution by adopting a bath ratio of 1.
The second dipping and second rolling in the fourth step of the present embodiment includes the following steps: the plant flock/viscose non-woven fabric is placed in the chitosan treatment solution, the treatment solution is uniformly covered on the non-woven fabric at the speed of 100r/min under the condition of mechanical stirring, the non-woven fabric is soaked for 45min at the temperature of 60 ℃, then, the first rolling is carried out, and then, the non-woven fabric is soaked for 25min at the temperature of 45-55 ℃, and then, the second rolling is carried out.
The pH value of the sodium hyaluronate stock solution is 7.0, the content of heavy metal is not more than 10ug/g, and the mass of the matrix in square meter is not less than 20g/m < 2 >.
The shape of the sodium hyaluronate restoration paste of the embodiment is round, oval or square, and the size of the sodium hyaluronate restoration paste is (measured at the narrowest part), the allowable deviation is 15%: l:280mm, M:149mm, S:59mm
The preparation method of the medical sodium hyaluronate restoration paste of the embodiment comprises the following steps:
s1: adding sodium hyaluronate, silver nitrate, sorbic acid and sodium benzoate into purified water, uniformly mixing, then heating to 85 ℃, and preserving heat for 120min to obtain a mixed solution A;
s2: adding squalane, allantoin and carboxymethyl cellulose into the mixed solution A prepared in the step S1, uniformly stirring, and reducing the system temperature to 40 ℃ to obtain a mixed solution 2;
s3: adjusting the pH value to 7.0 to obtain a sodium hyaluronate stock solution;
and S4, filling the sodium hyaluronate stock solution prepared in the step S3 into an aluminum foil film, putting a substrate into the aluminum foil film for sufficient adsorption, sealing the aluminum foil film, performing Co60 irradiation sterilization, and packaging the aluminum foil film to obtain the medical sodium hyaluronate restoration patch.
Example 3.
The invention provides a medical sodium hyaluronate repairing paste, which comprises a sodium hyaluronate stock solution, a matrix and an aluminum foil membrane, wherein the matrix is soaked in the sodium hyaluronate stock solution, the sodium hyaluronate stock solution and the matrix are sealed in the aluminum foil membrane after being irradiated and sterilized, and the sodium hyaluronate solution comprises the following components in percentage by weight: 2.5 percent of sodium hyaluronate, 0.15 percent of silver nitrate, 0.3 percent of squalane, 0.05 percent of allantoin, 0.05 percent of sorbic acid, 0.15 percent of sodium benzoate, 0.14 percent of carboxymethyl cellulose, and the balance of purified water.
The molecular weight of the sodium hyaluronate of the embodiment is 600 kDa, and the specification is pharmaceutical grade.
The substrate of this example is a nonwoven fabric, the raw materials of which include plant flock, adhesive fiber and chitosan, and the preparation method of the nonwoven fabric includes the following steps:
step one, cleaning plant flock, removing impurities, and then performing vacuum drying at 60 ℃;
step two, processing the plant flock and the viscose into flock/viscose non-woven fabric;
step three, preparing chitosan treatment fluid with the mass fraction of 0.14 g/ml;
step four, performing secondary soaking and secondary rolling after-treatment on the flocked/viscose non-woven fabric by using the chitosan treatment solution prepared in the step three;
and step five, drying the finished flocked/viscose non-woven fabric at 93 ℃ for 12min.
The plant wadding of the embodiment is catkin, the viscose fiber raw materials are wood, cotton linter and bagasse, and are prepared by wet spinning, and the mass ratio of the wadding to the viscose is 25:75.
the second step of the embodiment comprises a forming process and a needling process, wherein the forming process is sequentially provided with an opener, a cotton feeder, a carding machine and a lapping machine in the processing direction, and the needling process is sequentially provided with a feeder, a pre-needling machine, a pre-rolling machine, an inverted needling machine and a main needling machine in the processing direction.
The third step of the present embodiment includes the following steps: adding chitosan into an acetic acid solution, stirring at 55 ℃ until the chitosan is fully dissolved, then adding the acetic acid solution into the fully dissolved chitosan solution for dilution by adopting a bath ratio of 1.
The second dipping and second rolling in the fourth step of this embodiment includes the following steps: placing the plant flock/viscose non-woven fabric in the chitosan treatment solution, uniformly covering the treatment solution on the non-woven fabric at the speed of 80r/min under the condition of mechanical stirring, soaking for 35min at the temperature of 55 ℃, performing first rolling, soaking the non-woven fabric at the temperature of 50 ℃ for 20min, and performing second rolling.
The pH value of the sodium hyaluronate stock solution is 6.0, the content of heavy metal is not more than 10ug/g, and the mass of the matrix in square meter is not less than 20g/m < 2 >.
The shape of the sodium hyaluronate repairing paste of the embodiment is round, oval or square, the size of the sodium hyaluronate repairing paste is (calculated by the narrowest part), the allowable deviation is 15%: l:215mm, M:105mm, S:23mm
The preparation method of the medical sodium hyaluronate restoration paste of the embodiment comprises the following steps:
s1: adding sodium hyaluronate, silver nitrate, sorbic acid and sodium benzoate into purified water, uniformly mixing, then heating to 80 ℃, and preserving heat for 90min to obtain a mixed solution A;
s2: adding squalane, allantoin and carboxymethyl cellulose into the mixed solution A prepared in the step S1, uniformly stirring, and reducing the system temperature to 31 ℃ to obtain a mixed solution 2;
s3: adjusting the pH value to 6.0 to obtain a sodium hyaluronate stock solution;
and S4, filling the sodium hyaluronate stock solution prepared in the step S3 into an aluminum foil film, putting a substrate into the aluminum foil film for sufficient adsorption, sealing the aluminum foil film, performing Co60 irradiation sterilization, and packaging the aluminum foil film to obtain the medical sodium hyaluronate restoration patch.
The surface of the product of the invention is clean and flat, and has no obvious color spots, no stains and no degumming points; the product is easy to tear off and has neat edges; the single package of the product should not be damaged, and no visible foreign matter should be in the single package.
The product is divided into aseptic type and non-aseptic type, and the aseptic type product is aseptic; wherein the microorganism indexes of the non-sterile product are tested according to the method specified in appendix B in GB 15979-2002 hygienic Standard for Disposable sanitary articles, and the result is as follows: the total number of non-sterile bacterial colonies should not be greater than 10 CFU/g, the total number of molds and yeasts should not be greater than 100CFU/g, and the following microorganisms should not be detected: heat-resistant coliform bacteria, pseudomonas aeruginosa, staphylococcus aureus and hemolytic streptococcus.
The sterile detection method comprises the following steps: 10 samples of the test article were taken, each package was unpacked aseptically, 2 samples of about 1cm by 3cm were cut at different sites of the dressing, and inoculated into 30mL of thioglycolate fluid medium and 30mL of modified Martin medium, respectively, and the test article was completely submerged, 10 tubes for each medium. Another 1 test sample is taken for aseptic operation, 1cm x 3cm of sample is cut and inoculated into 30mL of thioglycolate fluid medium, the test sample is completely immersed, and staphylococcus aureus with the density less than 100cfu is inoculated as a positive control. The test was carried out according to the direct inoculation method specified in appendix XI H sterile examination method of the second part of the pharmacopoeia of the people's republic of China, edition 2010: the result should be sterile.
The heavy metal content detection method of the product comprises the following steps: the extruded liquid of the product is measured according to the third method 0821 of the pharmacopoeia of the people's republic of China (the fourth part of 2020 edition), and the requirement that the content of heavy metal is not more than 10ug/g is met.
The pH value detection method of the product comprises the following steps: the pH value of the extruded liquid is determined by a method specified in general rule 0631 of pharmacopoeia of the people's republic of China (2020 edition four), and is in accordance with 5.0-7.0.
Comparative example 1.
In contrast to example 3, sodium hyaluronate was not added.
Comparative example 2.
In contrast to example 3, sodium hyaluronate has a molecular weight of 400kDa.
Comparative example 3.
The difference from example 3 is that the substrate was plain gauze.
Comparative example 4.
Different from the embodiment 3, the mass ratio of the flock/viscose glue is 10:90.
comparative example 5.
Different from the embodiment 3, the mass ratio of the flock/viscose glue is 45:55.
the products of examples 1-3 and comparative examples 1-5 were subjected to a performance test;
40 Wistar white rats with the weight of about 120g are taken, divided into 8 groups randomly, and then are subjected to back unhairing treatment by using a 6.5% sodium sulfide solution, wherein the unhairing area is 2.5 cm multiplied by 2 cm, and the mice are normally fed for 12 hours after being washed clean by distilled water. The laser beam is used for cutting the wound surface along the unhairing part after ether anesthesia, the cutting speed is 0.4m/min, and the postoperative wound surface of the laser beam is formed.
The medical sodium hyaluronate repair patch prepared in example-3 and comparative examples 1-5 was applied to the back of each mouse and wound with a sterile bandage, and the dressing was changed once a day, and the final healing time of the wound surface (taking decrustation as the final healing point) was observed; the results are shown in the following table.
As can be seen from examples 1-3; after the product is used, the shortest time of wound surface healing of the white mouse is 13 +/-2 days, which shows that the product has obvious effect of promoting wound surface healing;
as can be seen from the comparative example 1 and the example 3, the healing time of the wound surface is greatly reduced without adding the sodium hyaluronate, and compared with the product, the effect of the product after use is more obvious; from the comparative example 2 and the example 3, the molecular weight of the sodium hyaluronate has great influence on the efficacy of the product, and the reasonable molecular weight of the sodium hyaluronate can improve the healing speed of the wound surface;
in addition, from examples 1-2 and comparative examples 4-5, it is found that the product has a certain influence on the product by adopting different mass ratios of the flock/the viscose, when the content of the flock is below 15%, the air permeability of the non-woven fabric is obviously reduced along with the increase of the content of the flock, and the air permeability is reduced more slowly after the content of the flock exceeds 15%. The liquid absorption rate of the non-woven fabric is increased along with the gradual increase of the content of the catkin, and when the weight ratio of the catkin reaches 15%, the liquid absorption rate of the non-woven fabric is obviously increased, so that the hemostatic effect is achieved. In view of air permeability and liquid absorption rate, the content of catkin is not lower than 15%, and the medical property of catkin can be better reflected. Therefore, the ratio of catkin to viscose is in the range of 15/85-35/65, and the medical sodium hyaluronate repair patch is used; meanwhile, the comparison example 3 shows that the common gauze replaces the matrix in the example 3, so that the healing time of the wound surface of the white mouse is long, although the air permeability of the common gauze is strong, the liquid absorption rate of the common gauze is obviously reduced, and the air permeability of the common gauze is strong, namely, the pores among yarns are enlarged, so that external bacteria can easily invade the common gauze.
The innovation points of the invention are as follows:
the silver nitrate, squalane and allantoin are cooperated to sterilize, moisturize and promote wound healing, and a protective barrier can be formed at the wound, so that the effect of the product is greatly improved.
The substrate of the invention adopts plant flock, adhesive fiber and chitosan, and the non-woven fabric is prepared by a reasonable production process, thereby changing waste into valuable; the catkin is a natural material, has sufficient raw materials and biodegradability; the catkin has a high hollow structure, can absorb a large amount of water, and has high water absorption and hemostatic functions; the chitosan has an antibacterial effect, so that the repairing paste prepared by post-treating the chitosan treatment liquid has an antibacterial function.
It will be evident to those skilled in the art that the invention is not limited to the details of the foregoing illustrative embodiments, and that the present invention may be embodied in other specific forms without departing from the spirit or essential attributes thereof. The present embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.
Furthermore, it should be understood that although the present description refers to embodiments, not every embodiment may contain only a single embodiment, and such description is for clarity only, and those skilled in the art should integrate the description, and the embodiments may be combined as appropriate to form other embodiments understood by those skilled in the art.
Claims (10)
1. The medical sodium hyaluronate repairing paste is characterized by comprising a sodium hyaluronate stock solution, a matrix and an aluminum foil membrane, wherein the matrix is soaked in the sodium hyaluronate stock solution, the sodium hyaluronate stock solution and the matrix are sealed in the aluminum foil membrane after being irradiated and sterilized, and the sodium hyaluronate solution comprises the following components in percentage by weight: 0.1-5% of sodium hyaluronate, 0.01-0.3% of silver nitrate, 0.1-0.6% of squalane, 0.01-1% of allantoin, 0.01-0.1% of sorbic acid, 0.1-0.2% of sodium benzoate, 0.05-0.3% of carboxymethyl cellulose and the balance of purified water.
2. The medical sodium hyaluronate restoration patch as claimed in claim 1, wherein the molecular weight of the sodium hyaluronate is 400-800 kDa, and the specification is pharmaceutical grade.
3. The medical sodium hyaluronate restoration patch as claimed in claim 1, wherein the substrate is a non-woven fabric, the raw materials of the non-woven fabric comprise plant flock, adhesive fiber and chitosan, and the preparation method of the non-woven fabric comprises the following steps:
cleaning plant flock, removing impurities, and then performing vacuum drying at 55-65 ℃;
step two, processing the plant flock and the viscose into flock/viscose non-woven fabric;
step three, preparing chitosan treatment solution with the mass fraction of 0.05-0.3 g/mL;
step four, performing secondary soaking and secondary rolling after-treatment on the flocked/viscose non-woven fabric by using the chitosan treatment solution prepared in the step three;
and step five, drying the finished flocked/viscose non-woven fabric for 8-16min at 85-100 ℃.
4. The medical sodium hyaluronate restoration patch as claimed in claim 3, wherein the plant flock is catkin, the viscose fiber raw material is wood, cotton linter and bagasse, and is prepared by wet spinning, and the mass ratio of flock/viscose is (15-35): (85-65).
5. The medical sodium hyaluronate restoration patch as claimed in claim 3, wherein said two steps comprise a forming process and a needling process, wherein the forming process comprises an opener, a cotton feeder, a carding machine and a lapping machine which are arranged in sequence from the processing direction, and the needling process comprises a feeder, a pre-needling machine, a pre-coiling machine, an inverted needling machine and a main needling machine which are arranged in sequence from the processing direction.
6. The medical sodium hyaluronate restoration patch as claimed in claim 3, wherein said step three comprises the following steps: adding chitosan into an acetic acid solution, stirring at 50-60 ℃ until the chitosan is fully dissolved, then adding the acetic acid solution into the fully dissolved chitosan solution for dilution by adopting a bath ratio of 1.
7. The medical sodium hyaluronate restoration patch as claimed in claim 3, wherein the second dipping and the second rolling in the fourth step comprises the following steps: placing the plant flock/viscose non-woven fabric in the chitosan treatment solution, uniformly covering the treatment solution on the non-woven fabric at 50-60 ℃ for 25-45min under the mechanical stirring, carrying out first rolling, then placing the non-woven fabric at 45-55 ℃ for 15-25min, and carrying out second rolling.
8. The medical sodium hyaluronate restoration patch as claimed in claim 1, wherein the sodium hyaluronate stock solution has a PH of 5.0-7.0, a heavy metal content of not more than 10ug/g, and the matrix has a mass per square meter of not less than 20g/m2.
9. The medical sodium hyaluronate patch according to claim 1, wherein the shape of the sodium hyaluronate patch is circular, oval or square, and the size of the sodium hyaluronate patch is (measured at the narrowest point) with an allowable deviation of 15%: l:150-280mm, M:60-149mm, S:5-59mm.
10. The preparation method of the medical sodium hyaluronate restoration paste is characterized by comprising the following steps:
s1: adding sodium hyaluronate, silver nitrate, sorbic acid and sodium benzoate into purified water, mixing uniformly, heating to 75-85 ℃, and keeping the temperature for 60-120min to obtain a mixed solution A;
s2: adding squalane, allantoin and carboxymethyl cellulose into the mixed solution A prepared in S1, stirring uniformly, and reducing the system temperature to 22-40 deg.C to obtain mixed solution 2;
s3: adjusting pH to 5.0-7.0 to obtain sodium hyaluronate stock solution;
and S4, filling the sodium hyaluronate stock solution prepared in the step S3 into an aluminum foil film, putting a substrate into the aluminum foil film for sufficient adsorption, sealing the aluminum foil film, performing Co60 irradiation sterilization, and packaging the aluminum foil film to obtain the medical sodium hyaluronate restoration patch.
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| DE20205544U1 (en) * | 2002-04-10 | 2002-08-08 | Kluegel Ulrich | Wound dressing for wounds with impaired healing |
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| CN106606798A (en) * | 2016-12-07 | 2017-05-03 | 武汉医佳宝生物材料有限公司 | Medical hyaluronic acid bioremediation plaster and preparation method thereof |
| FR3062062A3 (en) * | 2017-01-25 | 2018-07-27 | Jola Int Co Ltd | SKIN CARE PRODUCT INTENDED FOR TOPICAL APPLICATION |
| CN109234911A (en) * | 2018-09-28 | 2019-01-18 | 杭州电子科技大学 | A kind of preparation method of biodegradable medical dressing |
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| DE20205544U1 (en) * | 2002-04-10 | 2002-08-08 | Kluegel Ulrich | Wound dressing for wounds with impaired healing |
| CN105536027A (en) * | 2015-12-24 | 2016-05-04 | 南阳市汇博生物技术有限公司 | Scar treatment strip capable of lowering tissue tension and preparation method thereof |
| CN106606798A (en) * | 2016-12-07 | 2017-05-03 | 武汉医佳宝生物材料有限公司 | Medical hyaluronic acid bioremediation plaster and preparation method thereof |
| FR3062062A3 (en) * | 2017-01-25 | 2018-07-27 | Jola Int Co Ltd | SKIN CARE PRODUCT INTENDED FOR TOPICAL APPLICATION |
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