CN110882413A - Water-soluble long-acting physical antibacterial liquid dressing and preparation method thereof - Google Patents
Water-soluble long-acting physical antibacterial liquid dressing and preparation method thereof Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
- A61L26/0061—Use of materials characterised by their function or physical properties
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- A—HUMAN NECESSITIES
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
- A61L26/0009—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials
- A61L26/0014—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
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- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
- A61L2300/204—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials with nitrogen-containing functional groups, e.g. aminoxides, nitriles, guanidines
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- A—HUMAN NECESSITIES
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- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
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Abstract
The invention provides a water-soluble long-acting physical antibacterial material and a preparation method thereof, belonging to the technical field of medical supplies. The water-soluble long-acting physical antibacterial material is prepared from the following components in percentage by mass: 0.2-0.4% of polyvinyl alcohol, 0.025-0.05% of octenidine; the balance is water solvent. The water-soluble long-acting physical antibacterial material has the functions of film forming, isolation, broad spectrum, rapidness and long-acting antibiosis, has the antibacterial activity on gram-negative bacteria, gram-positive bacteria and fungi of more than 99.9 percent, is non-toxic and non-irritant, has high safety, is coated on a wound in a smearing or wet dressing mode, is convenient to use, forms a protective barrier on the wound after being coated on the wound, prevents infection, creates a low-oxygen moist environment, and promotes the repair of the wound of epithelium, mucous membrane and tissue.
Description
Technical Field
The invention relates to the technical field of medical supplies, in particular to a water-soluble long-acting physical antibacterial material and a preparation method thereof.
Background
Wounds mainly include skin and mucosal wound injuries. Common skin injuries of human bodies include burns, scalds, acute and chronic ulcers, mechanical scratches, operation wounds and the like. The dressing has the advantages that a series of symptoms such as wound infection and the like can be caused after the wound, the traditional dressing is poor in air permeability, easy to adhere and irritant, and general in antibacterial performance, and the special requirements of patients cannot be met. As medical conditions increase, liquid dressings come in variety, but most have certain limitations.
For example, the invention patent application with publication number of CN104548485B, published as 2017.08.08, discloses a liquid dressing and a preparation method thereof, wherein the liquid dressing is composed of a liquid matrix and powder, wherein the liquid matrix comprises: 50 g/L-120 g/L of polyvinyl alcohol, 30 g/L-80 g/L of gum rosin, 750mL/L of absolute ethyl alcohol, 100 mL/L-200 mL/L of turpentine and 10 g/L-50 g/L of menthol; the powder consists of growth factors and excipients, and through adding gum rosin and gum turpentine (thickening agent) into a matrix, the film forming performance is improved after the growth factors are mixed with a liquid matrix, and the growth factors contained in the powder can obviously improve the speed of wound healing and shorten the time of skin repair and regeneration, but the product is an organic solvent dressing, such as absolute ethyl alcohol, gum turpentine and the like, and has high cytotoxicity.
For another example, the Chinese patent invention with application publication No. of 2019.10.25 and application publication No. of CN110368520A discloses a liquid dressing and a preparation method thereof, wherein the liquid dressing comprises α -cyanoacrylate 30-70%, silicon dioxide 10-40%, ethyl ether 15-40%, citric acid anhydrous 0.1-2%, salicylic acid 0.1-0.5%, and ethyl ether 15-40%, 0.1-0.5%.
Disclosure of Invention
The invention aims to provide a water-soluble long-acting physical antibacterial material, aiming at the technical problems of poor antibacterial performance, short antibacterial time, high cytotoxicity and irritation of a liquid dressing in the prior art; meanwhile, the invention also aims to provide two preparation methods of the water-soluble long-acting physical antibacterial material.
In order to realize the purpose, the water-soluble long-acting physical antibacterial material adopts the technical scheme that: the water-soluble long-acting physical antibacterial material is prepared from the following components in percentage by mass: 0.2-0.4% of polyvinyl alcohol, 0.025-0.05% of octenidine and the balance of a water solvent.
Preferably, the water-soluble long-acting physical antibacterial material is prepared from the following components in percentage by mass: 0.25% of polyvinyl alcohol, 0.025% of octenidine and the balance of water solvent.
Preferably, the alcoholysis degree of the polyvinyl alcohol is 86.0-90.0%.
Preferably, the polyvinyl alcohol has a polymerization degree of 500 and a viscosity of 4.5 to 6.5 mPas.
Preferably, the aqueous solvent is purified water.
The first preparation method of the water-soluble long-acting physical antibacterial material comprises the following preparation steps:
(1) respectively weighing polyvinyl alcohol and octenidine in proportion between weighing;
(2) adding 1/2-60-80 ℃ aqueous solvent into a concentration tank, sequentially adding polyvinyl alcohol and octenidine into the concentration tank, stirring until the polyvinyl alcohol and the octenidine are fully dissolved, and filtering for 15-20 min to obtain concentrated filtrate; starting a pump to convey the concentrated filtrate into a diluting preparation tank, flushing the concentrating preparation tank and a conveying pipeline by using a 60-80 ℃ water solvent until no residue exists, conveying flushing water into the diluting preparation tank, and conveying the flushing water into the diluting preparation tank;
(3) checking the feed liquid amount of a diluting preparation tank, adding 60-80 ℃ water solvent to full amount, starting diluting preparation and stirring for 5-10 min, and performing filtration circulation for 20-30 min to obtain diluted filtrate;
(4) sampling and detecting the dilute filtrate, wherein the detection standard is as follows: clarifying the solution without foreign matters, controlling the pH value to be between 4.0 and 8.0 and controlling the heavy metal content to be not more than 20 mu g/ml (calculated by lead), and pumping the dilute filtrate into a filling area after the detection is qualified;
(5) conveying the polyethylene bottles to a filling room through a bottle straightening machine, adjusting a filling pump, and filling a cock;
(6) and (3) detecting the limit of the finished product microorganism, wherein the detection standard is as follows: the total number of aerobic bacteria is less than or equal to 100cfu/ml, the total number of mould and microzyme is less than or equal to 20cfu/ml, and staphylococcus aureus and pseudomonas aeruginosa can not be detected.
Preferably, the alcoholysis degree of the polyvinyl alcohol is 86.0-90.0%.
Preferably, the polyvinyl alcohol has a polymerization degree of 500 and a viscosity of 4.5 to 6.5 mPas.
Preferably, the aqueous solvent is purified water.
The second preparation method of the water-soluble long-acting physical antibacterial material comprises the following preparation steps:
(1) respectively weighing polyvinyl alcohol and octenidine in proportion between weighing;
(2) adding 1/4 aqueous solvent into a concentration tank, sequentially adding polyvinyl alcohol and octenidine into the concentration tank, soaking and swelling for 20-30 min, adding 1/4 aqueous solvent into the concentration tank, stirring until the aqueous solvent is fully dissolved, and filtering for 15-20 min to obtain concentrated filtrate; starting a pump to convey the concentrated filtrate into a diluting preparation tank, flushing the concentrating preparation tank and a conveying pipeline with a water solvent until no residue exists, conveying flushing water into the diluting preparation tank, and conveying the flushing water into the diluting preparation tank;
(3) checking the feed liquid amount of a diluting preparation tank, adding a water solvent to full amount, starting diluting preparation and stirring for 5-10 min, and performing filtration circulation for 20-30 min to obtain a diluted filtrate;
(4) sampling and detecting the dilute filtrate, wherein the detection standard is as follows: clarifying the solution without foreign matters, controlling the pH value to be between 4.0 and 8.0 and controlling the heavy metal content to be not more than 20 mu g/ml (calculated by lead), and pumping the dilute filtrate into a filling area after the detection is qualified;
(5) conveying the polyethylene bottles to a filling room through a bottle straightening machine, adjusting a filling pump, and filling a cock;
(6) and (3) detecting the limit of the finished product microorganism, wherein the detection standard is as follows: the total number of aerobic bacteria is less than or equal to 100cfu/ml, and the total number of mould and microzyme is less than or equal to 20 cfu/ml; staphylococcus aureus and Pseudomonas aeruginosa were not detected.
Preferably, the alcoholysis degree of the polyvinyl alcohol is 86.0-90.0%.
Preferably, the polyvinyl alcohol has a polymerization degree of 500 and a viscosity of 4.5 to 6.5 mPas.
Preferably, the aqueous solvent is purified water.
In the water-soluble long-acting physical antibacterial material, the effects and the functions of the components are as follows:
octenidine: is a novel cationic antibacterial agent, binds to negatively charged cell membranes, disturbs the cellular functions of microorganisms, and causes cell death. Has good antibacterial effect on gram-positive bacteria, gram-negative bacteria, chlamydia, mycoplasma and fungi. Octenidine has good stability under different physical and chemical conditions, and is not easy to hydrolyze. The molecular structure is stable within the range of pH value of 1.6-12.2, so that the antibacterial effect is not influenced by the change of the pH value of the wound. The composition has good tolerance to skin, mucous membrane and wound, and does not have adverse effect on human epithelium or wound tissue; the water solution prepared does not reduce the curative effect at 130 ℃.
Polyvinyl alcohol: is a high molecular material polymer with extremely high water absorption and solubility, is a medical grade raw material which is non-toxic and harmless to organisms and has good biocompatibility; the polyvinyl alcohol with low polymerization degree and low viscosity has good air permeability and strong fluidity.
The invention has the beneficial effects that: the preparation method of the water-soluble long-acting physical antibacterial material is designed according to the properties of the components, is simple and easy to produce, the prepared liquid dressing has the functions of film forming, isolation, broad spectrum, quick, long-acting antibacterial and fungal virus killing, the antibacterial activity to gram-negative bacteria, gram-positive bacteria and fungi is more than 99.9%, the dressing is non-toxic, non-irritant and high in safety, the dressing is applied to a wound in a smearing or wet dressing mode, the use is convenient and environment-friendly, and after the dressing is applied to the wound, a protective barrier is formed on the wound, infection is prevented, a low-oxygen moist environment is created, and the repair of the wound of epithelium, mucous membrane and tissue is promoted.
Detailed Description
The present invention will be further described with reference to the following specific examples.
Example 1
The water-soluble long-acting physical antibacterial material is prepared from the following components in percentage by mass: polyvinyl alcohol 0.25%, octenidine 0.025%, and purified water in balance. Wherein the polyvinyl alcohol has an alcoholysis degree of 86.0%, a polymerization degree of 500 and a viscosity of 4.7 mPaS.
The preparation method of the water-soluble long-acting physical antibacterial material of the embodiment comprises the following steps,
(1) respectively weighing 500g of polyvinyl alcohol and 50g of octenidine according to the proportion;
(2) adding 1/2 purified water of 80 ℃ into a thickening tank, sequentially adding polyvinyl alcohol and octenidine into the thickening tank, stirring while adding raw materials to disperse uniformly as much as possible, stirring for 15min to dissolve completely, filtering for 15min to obtain a concentrated filtrate, and checking whether the feed liquid has no visible foreign matters; starting a pump to convey the concentrated filtrate into a diluting preparation tank, washing the concentrating preparation tank and a conveying pipeline with purified water at 80 ℃ until no residue exists, conveying the washing water into the diluting preparation tank, and conveying the washing water into the diluting preparation tank;
(3) checking the amount of the feed liquid in the diluting preparation tank, adding 80 deg.C purified water to full volume, starting diluting preparation and stirring for 10min, and filtering for 20min to obtain diluted filtrate;
(4) sampling and detecting the dilute filtrate, wherein the detection standard is as follows: the solution is clear without foreign matters, the pH value is between 4.0 and 8.0, and the content of heavy metal is not more than 20 mu g/ml (calculated by lead); the detected solution is clear and free of foreign matters, the pH value is 6.12, the heavy metal content is 8 mug/ml, and the dilute filtrate is detected to be qualified and is injected into a filling area;
(5) conveying the polyethylene bottles to a filling room through a bottle straightening machine, adjusting a filling pump, and filling a cock;
(6) detecting the limit of finished product microorganism, wherein the total amount of aerobic bacteria is less than 1cfu/ml, and the total amount of mycete and saccharomycete is less than 1 cfu/ml; staphylococcus aureus and Pseudomonas aeruginosa were not detected (detection standard: total aerobic bacteria count is less than or equal to 100cfu/ml, total mold and yeast count is less than or equal to 20 cfu/ml; Staphylococcus aureus and Pseudomonas aeruginosa were not detected).
Example 2
The water-soluble long-acting physical antibacterial material is prepared from the following components in percentage by mass: 0.3% of polyvinyl alcohol, 0.03% of octenidine and the balance of purified water. Wherein the polyvinyl alcohol has an alcoholysis degree of 90.0%, a polymerization degree of 500 and a viscosity of 5.1 mPaS.
The preparation method of the water-soluble long-acting physical antibacterial material comprises the following steps:
(1) respectively weighing 600g of polyvinyl alcohol and 60g of octenidine according to the proportion;
(2) adding 1/2 purified water of 60 deg.C into a thickening tank, sequentially adding polyvinyl alcohol and octenidine into the thickening tank while stirring, dispersing uniformly as much as possible, stirring for 20min for completely dissolving, filtering for 20min to obtain a concentrated filtrate, and checking whether the feed liquid has no visible foreign matter; starting a pump to convey the concentrated filtrate into a diluting preparation tank, washing the concentrating preparation tank and a conveying pipeline with purified water at 60 ℃ until no residue exists, conveying the washing water into the diluting preparation tank, and conveying the washing water into the diluting preparation tank;
(3) checking the amount of the feed liquid in the diluting preparation tank, adding 60 deg.C purified water to full volume, starting diluting preparation and stirring for 8min, and filtering for 25min to obtain diluted filtrate;
(4) sampling and detecting the dilute filtrate, wherein the detection standard is as follows: the solution is clear without foreign matters, the pH value is between 4.0 and 8.0, and the content of heavy metal is not more than 20 mu g/ml (calculated by lead); the detected solution is clear and free of foreign matters, the pH value is 6.18, the heavy metal content is 10 mug/ml, and the dilute filtrate is detected to be qualified and is injected into a filling area;
(5) the polyethylene bottles are conveyed to a filling room through a bottle straightening machine, a filling pump is adjusted, and a filling cock is carried out.
(6) Detecting the limit of finished product microorganism, wherein the total amount of aerobic bacteria is less than 1cfu/ml, and the total amount of mycete and saccharomycete is less than 1 cfu/ml; staphylococcus aureus and Pseudomonas aeruginosa were not detected (detection standard: total aerobic bacteria count is less than or equal to 100cfu/ml, total mold and yeast count is less than or equal to 20 cfu/ml; Staphylococcus aureus and Pseudomonas aeruginosa were not detected).
Example 3
The water-soluble long-acting physical antibacterial material is prepared from the following components in percentage by mass: 0.4% of polyvinyl alcohol, 0.05% of octenidine and the balance of purified water. Wherein the polyvinyl alcohol has an alcoholysis degree of 88.0%, a polymerization degree of 500 and a viscosity of 5.6 mPas.
The preparation method of the water-soluble long-acting physical antibacterial material comprises the following steps:
(1) respectively weighing 800g of polyvinyl alcohol and 100g of octenidine according to the proportion;
(2) adding 1/2 purified water of 70 ℃ into a thickening tank, sequentially adding polyvinyl alcohol and octenidine into the thickening tank while stirring, uniformly dispersing as much as possible, stirring for 25min to completely dissolve, filtering for 18min to obtain a concentrated filtrate, and checking whether the feed liquid has no visible foreign matters; starting a pump to convey the concentrated filtrate into a diluting preparation tank, washing the concentrating preparation tank and a conveying pipeline with purified water at 70 ℃ until no residue exists, conveying the washing water into the diluting preparation tank, and conveying the washing water into the diluting preparation tank;
(3) checking the amount of the material liquid in the diluting preparation tank, adding 70 deg.C purified water to full amount, starting diluting preparation and stirring for 10min, and filtering and circulating for 30min to obtain diluted filtrate;
(4) sampling and detecting the dilute filtrate, wherein the detection standard is as follows: the solution is clear without foreign matters, the pH value is between 4.0 and 8.0, and the content of heavy metal is not more than 20 mu g/ml (calculated by lead); the detected solution is clear and free of foreign matters, the pH value is 6.26, the heavy metal content is 11 microgram/ml, and the dilute filtrate is detected to be qualified and is injected into a filling area;
(5) the polyethylene bottles are conveyed to a filling room through a bottle straightening machine, a filling pump is adjusted, and a filling cock is carried out.
(6) Detecting the limit of finished product microorganism, wherein the total amount of aerobic bacteria is less than 1cfu/ml, and the total amount of mycete and saccharomycete is less than 1 cfu/ml; staphylococcus aureus and Pseudomonas aeruginosa were not detected (detection standard: total aerobic bacteria count is less than or equal to 100cfu/ml, total mold and yeast count is less than or equal to 20 cfu/ml; Staphylococcus aureus and Pseudomonas aeruginosa were not detected).
Example 4
The water-soluble long-acting physical antibacterial material is prepared from the following components in percentage by mass: polyvinyl alcohol 0.25%, octenidine 0.025%, and purified water in balance. Wherein the polyvinyl alcohol has an alcoholysis degree of 86.0%, a polymerization degree of 500 and a viscosity of 4.7 mPaS.
The preparation method of the water-soluble long-acting physical antibacterial material comprises the following steps:
(1) 500g of polyvinyl alcohol and 50g of octenidine are weighed in a weighing room according to a proportion;
(2) adding 1/4 purified water into a thickening tank, sequentially adding polyvinyl alcohol and octenidine into the thickening tank, uniformly dispersing when adding, soaking and swelling for 20min, adding 1/4 purified water into the thickening tank, stirring for 15min to dissolve, and filtering for 15min to obtain a concentrated filtrate; starting a pump to convey the concentrated filtrate into a diluting preparation tank, washing the concentrating preparation tank and a conveying pipeline with purified water until no residue exists, conveying the washing water into the diluting preparation tank, and conveying the washing water into the diluting preparation tank;
(3) checking the amount of the material liquid in the diluting preparation tank, adding purified water to full amount, starting diluting preparation and stirring for 5min, and performing filtration circulation for 25min to obtain diluted filtrate;
(4) sampling and detecting the dilute filtrate, wherein the detection standard is as follows: the solution is clear without foreign matters, the pH value is between 4.0 and 8.0, the heavy metal content is not more than 20 mu g/ml (calculated by lead), the solution is clear without foreign matters through detection, the pH value is 6.15, the heavy metal content is 11 mu g/ml, and the dilute filtrate is injected into a filling area after the detection is qualified;
(5) the polyethylene bottles are conveyed to a filling room through a bottle straightening machine, a filling pump is adjusted, and a filling cock is carried out.
(6) Detecting the limit of finished product microorganism, wherein the total amount of aerobic bacteria is less than 1cfu/ml, and the total amount of mycete and saccharomycete is less than 1 cfu/ml; staphylococcus aureus and Pseudomonas aeruginosa were not detected (detection standard: total aerobic bacteria count is less than or equal to 100cfu/ml, total mold and yeast count is less than or equal to 20 cfu/ml; Staphylococcus aureus and Pseudomonas aeruginosa were not detected).
Example 5
The water-soluble long-acting physical antibacterial material is prepared from the following components in percentage by mass: 0.3% of polyvinyl alcohol, 0.03% of octenidine and the balance of purified water. Wherein the polyvinyl alcohol has an alcoholysis degree of 90.0%, a polymerization degree of 500 and a viscosity of 5.1 mPaS.
The preparation method of the water-soluble long-acting physical antibacterial material comprises the following steps:
(1) respectively weighing 600g of polyvinyl alcohol and 60g of octenidine according to the proportion;
(2) adding 1/4 purified water into a thickening tank, sequentially adding polyvinyl alcohol and octenidine into the thickening tank, uniformly dispersing when adding, soaking and swelling for 25min, adding 1/4 purified water into the thickening tank, stirring for 20min to dissolve, and filtering for 18min to obtain a concentrated filtrate; starting a pump to convey the concentrated filtrate into a diluting preparation tank, washing the concentrating preparation tank and a conveying pipeline with purified water until no residue exists, conveying the washing water into the diluting preparation tank, and conveying the washing water into the diluting preparation tank;
(3) checking the amount of the material liquid in the diluting preparation tank, adding purified water to full amount, starting diluting preparation and stirring for 10min, and performing filtration circulation for 20min to obtain diluted filtrate;
(4) sampling and detecting the dilute filtrate, wherein the detection standard is as follows: the solution is clear without foreign matters, the pH value is between 4.0 and 8.0, the heavy metal content is not more than 20 mu g/ml (calculated by lead), the solution is clear without foreign matters through detection, the pH value is 6.18, the heavy metal content is 10 mu g/ml, and the dilute filtrate is injected into a filling area after the detection is qualified;
(5) the polyethylene bottles are conveyed to a filling room through a bottle straightening machine, a filling pump is adjusted, and a filling cock is carried out.
(6) Detecting the limit of finished product microorganism, wherein the total amount of aerobic bacteria is less than 1cfu/ml, and the total amount of mycete and saccharomycete is less than 1 cfu/ml; staphylococcus aureus and Pseudomonas aeruginosa were not detected (detection standard: total aerobic bacteria count is less than or equal to 100cfu/ml, total mold and yeast count is less than or equal to 20 cfu/ml; Staphylococcus aureus and Pseudomonas aeruginosa were not detected).
Example 6
The water-soluble long-acting physical antibacterial material is prepared from the following components in percentage by mass: 0.4% of polyvinyl alcohol, 0.05% of octenidine and the balance of purified water. Wherein the polyvinyl alcohol has an alcoholysis degree of 88.0%, a polymerization degree of 500 and a viscosity of 5.6 mPas.
(1) Weighing 800g of polyvinyl alcohol and 100g of octenidine in proportion between weighing;
(2) adding 1/4 purified water into a thickening tank, sequentially adding polyvinyl alcohol and octenidine into the thickening tank, uniformly dispersing when adding, soaking and swelling for 30min, adding 1/4 purified water into the thickening tank, stirring for 18min to dissolve, and filtering for 20min to obtain a concentrated filtrate; starting a pump to convey the concentrated filtrate into a diluting preparation tank, washing the concentrating preparation tank and a conveying pipeline with purified water until no residue exists, conveying the washing water into the diluting preparation tank, and conveying the washing water into the diluting preparation tank;
(3) checking the amount of the material liquid in the diluting preparation tank, adding purified water to full amount, starting diluting preparation and stirring for 10min, and performing filtration circulation for 25min to obtain diluted filtrate;
(4) sampling and detecting the dilute filtrate, wherein the detection standard is as follows: the solution is clear without foreign matters, the pH value is between 4.0 and 8.0, the heavy metal content is not more than 20 mu g/ml (calculated by lead), the solution is clear without foreign matters through detection, the pH value is 6.30, the heavy metal content is 10 mu g/ml, and the dilute filtrate is injected into a filling area after the detection is qualified;
(5) the polyethylene bottles are conveyed to a filling room through a bottle straightening machine, a filling pump is adjusted, and a filling cock is carried out.
(6) Detecting the limit of finished product microorganism, wherein the total amount of aerobic bacteria is less than 1cfu/ml, and the total amount of mycete and saccharomycete is less than 1 cfu/ml; staphylococcus aureus and Pseudomonas aeruginosa were not detected (detection standard: total aerobic bacteria count is less than or equal to 100cfu/ml, total mold and yeast count is less than or equal to 20 cfu/ml; Staphylococcus aureus and Pseudomonas aeruginosa were not detected).
And performing biological evaluation on the water-soluble environment-friendly long-acting physical antibacterial dressing prepared in the embodiments 1 to 6.
Test items
Test 1: cytotoxicity
Taking the samples prepared in the examples 1-6, preparing a leaching solution according to the proportion of 0.2mL/mL leaching medium (37 +/-1) DEG C and (24 +/-2) h, wherein the leaching medium: serum-containing MEM culture medium, leaching liquor is taken to carry out the test according to the test method specified in GB/T16886.5-2017, the test results are shown in Table 1, and the results show that the liquid dressing prepared by the invention has no cytotoxicity.
Test 2 skin sensitization test
The liquid dressing stock solutions prepared in the examples 1 to 6 are taken and carried out according to a guinea pig maximum dose test method specified in GB/T16886.10-2017, the test results are shown in Table 1, and the liquid dressings prepared by the invention have no skin sensitization
Test 3: intradermal reaction
1. The method comprises the following steps: carrying out intradermal test examination on the liquid dressings prepared in examples 1-6; 4-8h before test, removing hair on both sides of spinal column of back of each animal with a hair cutter, sterilizing in about 10cm × 20cm area, sucking 1ml of test sample, and intradermally injecting 0.2ml of test sample into 5 points on one side of spinal column of rabbit. Also, 1ml of purified water was aspirated and 0.2ml of purified water was injected intradermally into 5 spots below the same side of the spinal column of the rabbit.
2. As a result: each injection site condition was recorded immediately after injection and observed at 24h, 48h, and 72 h. And (3) carrying out scoring record according to a test method specified in GB/T16886.10-2017, wherein the test scoring results are shown in Table 2.
3. Evaluation: the difference between the average scores of the sample and the solvent control was not more than 1.0, and the evaluation results are shown in Table 1.
TABLE 1 test and evaluation results
| Test items | Example 1 | Example 2 | Example 3 | Example 4 | Example 5 | Example 6 |
| Cytotoxicity | Is free of | Is free of | Is free of | Is free of | Is free of | Is free of |
| Skin sensitization | Is free of | Is free of | Is free of | Is free of | Is free of | Is free of |
| Index of skin irritation | 1/6 | 1/6 | 1/6 | 1/6 | 1/3 | 1/6 |
TABLE 2 test scoring results
Test 4: test of bacteriostatic Property
1. Preparing bacterial liquid: a proper amount of escherichia coli, staphylococcus aureus, candida albicans, pseudomonas aeruginosa and bacillus subtilis plate culture which is cultured for 24 hours at 34 ℃ is taken to be inoculated into 1ml of 0.9 percent sterile NaCl solution (hereinafter referred to as solvent), and the solvent is used for continuously diluting 100 times to prepare bacterial liquid of 5 multiplied by 105 to 5 multiplied by 106cfu/ml for later use.
2. The test method comprises the following steps: 5ml of each of the liquid dressings prepared in examples 1 to 6 and 5ml of a control solution (sterile water) were taken out, 3 bottles of the prepared bacterial solution were taken, 100. mu.l of each sample and control solution were respectively added dropwise, and the mixture was uniformly mixed, and timing was started to act for 20 min. Diluting the affected bacterial liquid with sterile water by 20 times, respectively taking 0.25ml of diluted bacterial liquid, and uniformly coating on TSA (Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, Bacillus subtilis) or SDA (Candida albicans) plate. And placing the TSA plate at 34 ℃ for culturing for 1-2 days, placing the SDA plate at 25 ℃ for culturing for 2-3 days, counting bacterial colonies and calculating the bacteriostasis rate.
3. Calculating the bacteria rate of the bacteriostasis rate:
4. evaluating that the bacteriostasis rate is more than or equal to 50-90 percent and the product has bacteriostasis; the bacteriostasis rate is more than or equal to 90 percent, and the product has stronger bacteriostasis.
5. The test results are shown in Table 3.
TABLE 3 test results
The data in table 3 show that the liquid dressings prepared in examples 1 to 6 have extremely strong bacteriostatic action on staphylococcus aureus, escherichia coli, candida albicans, pseudomonas aeruginosa and bacillus subtilis, and the bacterial colonies do not recover to grow after being placed for 24 hours.
Claims (7)
1. The water-soluble long-acting physical antibacterial material is characterized in that: the paint is prepared from the following components in percentage by mass: 0.2-0.4% of polyvinyl alcohol, 0.025-0.05% of octenidine and the balance of a water solvent.
2. The water-soluble long-acting physical antibacterial material according to claim 1, characterized in that: the composition is prepared from the following components in percentage by mass: 0.25% of polyvinyl alcohol, 0.025% of octenidine and the balance of water solvent.
3. The water-soluble long-acting physical antibacterial material according to claims 1-2, characterized in that: the alcoholysis degree of the polyvinyl alcohol is 86.0-90.0%.
4. The water-soluble long-acting physical antibacterial material according to claims 1-2, characterized in that: the polyvinyl alcohol has a polymerization degree of 500 and a viscosity of 4.5 to 6.5 mPas.
5. The water-soluble long-acting physical antibacterial material according to claims 1-2, characterized in that: the aqueous solvent is purified water.
6. The method for preparing a water-soluble long-acting physical antibacterial material according to any one of claims 1 to 5, characterized in that: the method comprises the following steps:
(1) respectively weighing polyvinyl alcohol and octenidine according to a proportion;
(2) adding 1/2-60-80 ℃ aqueous solvent into a concentration tank, sequentially adding polyvinyl alcohol and octenidine into the concentration tank, stirring until the polyvinyl alcohol and the octenidine are fully dissolved, and filtering for 15-20 min to obtain concentrated filtrate; starting a pump to convey the concentrated filtrate into a diluting preparation tank, flushing the concentrating preparation tank and a conveying pipeline by using a 60-80 ℃ water solvent until no residue exists, conveying flushing water into the diluting preparation tank, and conveying the flushing water into the diluting preparation tank;
(3) checking the feed liquid amount of a diluting preparation tank, adding 60-80 ℃ water solvent to full amount, starting diluting preparation and stirring for 5-10 min, and performing filtration circulation for 20-30 min to obtain diluted filtrate;
(4) sampling and detecting the dilute filtrate, wherein the detection standard is as follows: clarifying the solution without foreign matters, adjusting the pH value to 4.0-8.0, and adjusting the heavy metal content to no more than 20 [ mu ] g/ml (calculated by lead), and injecting the dilute filtrate into a filling area after the detection is qualified;
(5) conveying the polyethylene bottles to a filling room through a bottle straightening machine, adjusting a filling pump, and filling a cock;
(6) and (3) detecting the limit of the finished product microorganism, wherein the detection standard is as follows: the total number of aerobic bacteria is less than or equal to 100cfu/ml, the total number of mould and microzyme is less than or equal to 20cfu/ml, and staphylococcus aureus and pseudomonas aeruginosa can not be detected.
7. The method for preparing a water-soluble long-acting physical antibacterial material according to any one of claims 1 to 5, wherein the method comprises the following steps: the method comprises the following steps:
(1) respectively weighing polyvinyl alcohol and octenidine according to a proportion;
(2) adding 1/4 aqueous solvent into a concentration tank, sequentially adding polyvinyl alcohol and octenidine into the concentration tank, soaking and swelling for 20-30 min, adding 1/4 aqueous solvent into the concentration tank, stirring until the aqueous solvent is fully dissolved, and filtering for 15-20 min to obtain concentrated filtrate; starting a pump to convey the concentrated filtrate into a diluting preparation tank, flushing the concentrating preparation tank and a conveying pipeline with a water solvent until no residue exists, conveying flushing water into the diluting preparation tank, and conveying the flushing water into the diluting preparation tank;
(3) checking the feed liquid amount of a diluting preparation tank, adding a water solvent to full amount, starting diluting preparation and stirring for 5-10 min, and performing filtration circulation for 20-30 min to obtain a diluted filtrate;
(4) sampling and detecting the dilute filtrate, wherein the detection standard is as follows: clarifying the solution without foreign matters, adjusting the pH value to 4.0-8.0, and adjusting the heavy metal content to no more than 20 [ mu ] g/ml (calculated by lead), and injecting the dilute filtrate into a filling area after the detection is qualified;
(5) conveying the polyethylene bottles to a filling room through a bottle straightening machine, adjusting a filling pump, and filling a cock;
(6) and (3) detecting the limit of the finished product microorganism, wherein the detection standard is as follows: the total number of aerobic bacteria is less than or equal to 100cfu/ml, and the total number of mould and microzyme is less than or equal to 20 cfu/ml; staphylococcus aureus and Pseudomonas aeruginosa were not detected.
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Application publication date: 20200317 |