CN109701088B - Antibacterial and anti-inflammatory hernia repair patch and preparation method thereof - Google Patents
Antibacterial and anti-inflammatory hernia repair patch and preparation method thereof Download PDFInfo
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Abstract
The invention belongs to the technical field of medical materials, and particularly relates to an antibacterial and anti-inflammatory hernia repair patch and a preparation method thereof. The antibacterial and anti-inflammatory hernia repair patch provided by the invention comprises a polypropylene substrate, wherein a polymer film layer made of a degradable polymer material and a biocompatible polymer material composite solution is arranged outside the polypropylene substrate. The antibacterial and anti-inflammatory hernia repair patch provided by the invention has the advantages of light weight, good biocompatibility, no foreign body sensation when being implanted into a body, and difficult adhesion; the preparation method is simple, the antibacterial and anti-inflammatory effects are good, and the infection rate is low, so that the probability of complications is reduced, the pain and the recurrence probability of patients are relieved, and the antibacterial and anti-inflammatory agent has a strong practical value and a wide application prospect.
Description
Technical Field
The invention belongs to the technical field of medical materials, and particularly relates to an antibacterial and anti-inflammatory hernia repair patch and a preparation method thereof.
Background
Hernia, also known as hernia, is a hernia in which some tissues or organs of some parts of the human body leave the original position and enter another part through some defects, gaps and weak points of the human body, and some organs are dysfunctional. The most common site for hernia is the abdomen. The abdominal internal organs or the omentum are rotated away from the original position through normal or abnormal orifices and fissures in the abdominal cavity to form the abdominal hernia, which cannot be seen in visual inspection, such as the hernia of the foramen reticulum and diaphragmatic hernia. The abdominal internal organs protrude through congenital or acquired defects or weak areas of the abdominal wall to the body surface, and locally form a tumor, which is called as an extraabdominal hernia. Extraabdominal hernias are more common than intra-abdominal hernias and can occur in all ages from children to the elderly, who are high-risk groups of the disease. The causes of extraabdominal hernias are associated with weakness in the abdominal wall and increased abdominal pressure. Weakness of the abdominal wall is typically congenital and may be caused by acquired factors such as old age, weakness, muscular atrophy, etc. The common conditions of increased abdominal pressure include chronic cough, constipation, dysuria, and infantile crying.
Although not a fatal disease, hernia causes great pain to patients, seriously affects quality of life, can have various complications, and can endanger life in severe cases. Surgical treatment is the most effective way to treat hernia, and includes two major procedures, conventional suture repair and tension-free hernia repair using a repair material. The traditional repair mode has the defects of easy relapse, long repair time, postoperative pain and the like.
The tension-free hernia repair operation is to repair a hernia gap by using a patch, thereby avoiding the defects of postoperative pain and easy recurrence of the traditional hernia repair operation. The hernia repair patch commonly used at present is a polyester patch, a polypropylene substrate and an expanded polytetrafluoroethylene patch. Over the past 50 years, polypropylene substrates have had a tremendous impact on the surgical field, with countless patients continuing their lives, and many surgical problems resolved by their use, which have proven to be the most popular implants in the surgical field today. However, polypropylene substrates also present problems in application.
Chinese patent application CN103263693A discloses a preparation method and application of an immobilized antibacterial medicament hernia repair patch, and the invention discloses an immobilized antibacterial medicament hernia repair patch with a sustained and controlled release function, a preparation method medicament, a high polymerization method and application. In particular to an antibacterial material and a polymer patch material which are prepared into an immobilized antibacterial medicament hernia repair patch by a dip coating method, a spraying method or a coating method, and application of the hernia repair patch in treating bacterial infection caused after hernia repair. The immobilized antibacterial medicament hernia repair patch has good biocompatibility and simple preparation, but has poor mechanical property, unsatisfactory antibacterial property, obvious foreign body sensation after being implanted into a body, poor antibacterial and anti-inflammatory effects and easy infection of wounds.
Chinese patent application CN102205151A discloses an immobilized antibacterial medicine hernia repair patch and a preparation method thereof, wherein the hernia repair patch comprises medicine carrying microspheres, a patch and a propping agent, and the medicine is sandwiched between a patch layer and a film layer; and the repairing sheet has serious adhesion with internal organs, the preparation process is complex, and the popularization is difficult.
In conclusion, the hernia repair patch in the prior art still has the problems of poor mechanical properties, foreign body sensation when being implanted into a body, serious adhesion between the repair patch and internal organs, complex preparation process, poor antibacterial and anti-inflammatory properties and the like.
Disclosure of Invention
In order to solve the problems in the prior art, the invention aims to provide an antibacterial and anti-inflammatory hernia repair patch and a preparation method thereof. The antibacterial and anti-inflammatory hernia repair patch provided by the invention has the advantages of light weight, good biocompatibility, no foreign body sensation when being implanted into a body, and difficult adhesion; and the preparation method is simple, the antibacterial and anti-inflammatory effects are good, and the infection rate is low.
The technical scheme of the invention is as follows:
the antibacterial and anti-inflammatory hernia repair patch is characterized by comprising a polypropylene substrate, wherein a polymer film layer made of a degradable polymer material and a biocompatible polymer material composite solution is arranged outside the polypropylene substrate.
Furthermore, the polypropylene substrate is a tension-free polypropylene substrate and is a mesh-shaped braided fabric.
Further, the degradable high polymer material is polylactic acid.
Further, the polymer film layer is made of 65-88% by mass of degradable polymer material and 12-35% by mass of biocompatible polymer material composite solution.
Further, the polymer film layer is made of 76% by mass of degradable polymer material and 24% by mass of biocompatible polymer material composite solution.
Further, the biocompatible polymer material composite solution is prepared from chitosan, sodium alginate and antibacterial peptide according to a mass ratio of 7-18:1-5: 2-5.
Further, the composite solution of the biocompatible polymer material is prepared from chitosan, sodium alginate and antibacterial peptide according to the mass ratio of 12:4: 7.
Further, the preparation method of the biocompatible polymer material composite solution comprises the following steps:
s1 molecular weight of 3.7-5.3X 105The chitosan is dissolved in citric acid solution with the concentration of 0.3-0.5mol/L to ensure that the mass concentration of the chitosan in the solution is 15-24%, and the chitosan solution is obtained by stirring and mixing evenly under a closed condition and ultrasonic defoaming;
s2 adding sodium alginate into distilled water, stirring to dissolve completely, adding antibacterial peptide with molecular weight of 3500-6500 and the chitosan solution obtained in step S1, and stirring.
In addition, the invention also provides a preparation method of the antibacterial and anti-inflammatory hernia repair patch, which comprises the following steps:
s1 molecular weight of 1-5 × 105Dissolving the degradable high molecular material in a high molecular material solvent, stirring under a closed condition to completely dissolve the degradable high molecular material, and performing ultrasonic defoaming to obtain a degradable high molecular solution;
s2, uniformly mixing the biocompatible polymer material composite solution with the degradable polymer solution prepared in the step S1, pouring the mixture on a flat plate, and evaporating and volatilizing to obtain a polymer film layer;
s3, the polypropylene substrate and the polymer film layer are opposite to each other and are hot-pressed into a whole, and the polypropylene film is obtained.
Further, in step S1, the polymer material solvent is one of acetone, ethyl acetate, and chloroform.
In the antibacterial and anti-inflammatory hernia repair patch provided by the invention, the polypropylene substrate is of a single-sheet net structure, is easy to infiltrate by connective tissues, and has no foreign body sensation in an implant. The polylactic acid has good degradation performance, can be gradually degraded after entering a human body, enters the human body for metabolism in a micromolecule form, and is safe and reliable.
In the antibacterial and anti-inflammatory hernia repair patch provided by the invention, the biocompatible polymer material composite solution is composed of chitosan, sodium alginate and antibacterial peptide according to a certain weight ratio, wherein the chitosan has good film forming property and biocompatibility, and can inhibit the growth of fibroblasts, promote the growth of epidermal cells and promote wound healing. The antibacterial peptide has broad-spectrum bactericidal action, and has obvious inhibiting and killing effects on gram-positive bacteria and gram-negative bacteria, particularly drug-resistant strains. The added sodium alginate can enable the patch to form a hydrophilic hydrogel form, can prevent the hernia repair patch from being adhered to the viscera, and the formed polymer network system has soft property, but can still keep a certain shape, so that the mechanical property of the hernia repair patch is improved. The components of the invention have synergistic effect, the antibacterial and anti-inflammatory effects are obviously improved, the adhesion of internal organs and hernia repair patches is effectively prevented, and the occurrence probability of complications is reduced.
Compared with the prior art, the antibacterial and anti-inflammatory hernia repair patch provided by the invention has the following advantages:
(1) the antibacterial and anti-inflammatory hernia repair patch provided by the invention has the advantages of simple preparation method, good biocompatibility, no foreign body sensation when being implanted into a body, and difficult adhesion with viscera, thereby reducing the probability of complications, relieving the pain and the recurrence probability of patients, and having stronger practical value.
(2) The biocompatible polymer material composite solution is added into the antibacterial and anti-inflammatory hernia repair patch provided by the invention, so that the healing of a wound can be effectively promoted, the antibacterial and anti-inflammatory effects of the hernia repair patch are improved, when the hernia repair patch provided by the invention is applied to hernia treatment, antibiotics are not required to be applied to the whole body of a patient to prevent infection, the hernia repair patch is safe and free of side effects, and the hernia repair patch has a wide application prospect.
Detailed Description
The present invention is further illustrated by the following description of specific embodiments, which are not intended to limit the invention, and various modifications and improvements can be made by those skilled in the art based on the basic idea of the invention, but the invention is within the protection scope of the invention.
Antimicrobial peptides, purchased from Kyoja leaf Biotech, Inc.
Example 1 an antibacterial and anti-inflammatory hernia repair patch
The antibacterial and anti-inflammatory hernia repair patch comprises a polypropylene substrate, wherein a polymer film layer made of polylactic acid and a biocompatible polymer material composite solution is arranged outside the polypropylene substrate.
The polypropylene substrate is a non-tension polypropylene substrate and is a mesh-shaped braided fabric.
The polymer film layer is prepared from 65% by mass of polylactic acid and 35% by mass of a biocompatible polymer material composite solution.
The biocompatible polymer material composite solution is prepared from chitosan, sodium alginate and antibacterial peptide according to the weight ratio of 7:5: 5.
The preparation method of the biocompatible polymer material composite solution comprises the following steps:
s1 molecular weight of 3.7X 105The chitosan is dissolved in citric acid solution with the concentration of 0.3mol/L to ensure that the mass concentration of the chitosan in the solution is 15 percent, and the chitosan solution is obtained by stirring, uniformly mixing and ultrasonic defoaming under the closed condition;
s2, adding sodium alginate into distilled water, stirring until the amount of the distilled water is 5 times of the mass of the sodium alginate, dissolving completely, adding antimicrobial peptide with molecular weight of 3500 and the chitosan solution obtained in the step S1, and stirring uniformly.
The preparation method of the antibacterial and anti-inflammatory hernia repair patch comprises the following steps:
s1 molecular weight of 1 × 105Dissolving the polylactic acid in an ethyl acetate solution, stirring under a closed condition to completely dissolve the polylactic acid, and performing ultrasonic defoaming to obtain a polylactic acid solution;
s2, uniformly mixing the biocompatible polymer material composite solution with the polylactic acid solution prepared in the step S1, pouring the mixture on a flat plate, and evaporating and volatilizing to obtain a polymer film layer;
s3, the polypropylene substrate and the polymer film layer are opposite to each other and are hot-pressed into a whole, and the polypropylene film is obtained.
Example 2 an antibacterial and anti-inflammatory hernia repair patch
The antibacterial and anti-inflammatory hernia repair patch comprises a polypropylene substrate, wherein a polymer film layer made of polylactic acid and a biocompatible polymer material composite solution is arranged outside the polypropylene substrate.
The polypropylene substrate is a non-tension polypropylene substrate and is a mesh-shaped braided fabric.
The polymer film layer is prepared from 76% by mass of polylactic acid and 24% by mass of biocompatible polymer material composite solution.
The composite solution of the biocompatible polymer material is prepared from chitosan, sodium alginate and antibacterial peptide according to the weight ratio of 12:4: 3.
The preparation method of the biocompatible polymer material composite solution comprises the following steps:
s1 molecular weight of 4.6X 105The chitosan is dissolved in citric acid solution with the concentration of 0.4mol/L to ensure that the mass concentration of the chitosan in the solution is 20 percent, and the chitosan solution is obtained by stirring, uniformly mixing and ultrasonic defoaming under the closed condition;
s2, adding sodium alginate into distilled water, stirring until the amount of the distilled water is 5 times of the mass of the sodium alginate, dissolving completely, adding the antibacterial peptide with the molecular weight of 5200 and the chitosan solution obtained in the step S1, and stirring uniformly to obtain the product.
In addition, the invention also provides a preparation method of the antibacterial and anti-inflammatory hernia repair patch, which comprises the following steps:
s1 molecular weight of 3 × 105Dissolving the polylactic acid in an acetone solution, stirring under a closed condition to completely dissolve the polylactic acid, and performing ultrasonic defoaming to obtain a polylactic acid solution;
s2, uniformly mixing the biocompatible polymer material composite solution with the polylactic acid solution prepared in the step S1, pouring the mixture on a flat plate, and evaporating and volatilizing to obtain a polymer film layer;
s3, the polypropylene substrate and the polymer film layer are opposite to each other and are hot-pressed into a whole, and the polypropylene film is obtained.
Example 3 an antibacterial and anti-inflammatory hernia repair patch
The antibacterial and anti-inflammatory hernia repair patch comprises a polypropylene substrate, wherein a polymer film layer made of polylactic acid and a biocompatible polymer material composite solution is arranged outside the polypropylene substrate.
The polypropylene substrate is a non-tension polypropylene substrate and is a mesh-shaped braided fabric.
The polymer film layer is prepared from 88 mass percent of polylactic acid and 12 mass percent of biocompatible polymer material composite solution.
The biocompatible polymer material composite solution is prepared from chitosan, sodium alginate and antibacterial peptide according to the weight ratio of 18:1: 2.
The preparation method of the biocompatible polymer material composite solution comprises the following steps:
s1 molecular weight 5.3X 105The chitosan is dissolved in citric acid solution with the concentration of 0.5mol/L to ensure that the mass concentration of the chitosan in the solution is 24 percent, and the chitosan solution is obtained by stirring, uniformly mixing and ultrasonic defoaming under the closed condition;
s2 adding sodium alginate into distilled water, stirring to dissolve completely, adding antibacterial peptide with molecular weight of 6500 and the chitosan solution obtained in step S1, and stirring.
In addition, the invention also provides a preparation method of the antibacterial and anti-inflammatory hernia repair patch, which comprises the following steps:
s1 molecular weight of 5 × 105Dissolving the polylactic acid in a trichloromethane solution, stirring under a closed condition to completely dissolve the polylactic acid, and performing ultrasonic defoaming to obtain a polylactic acid solution;
s2, uniformly mixing the biocompatible polymer material composite solution with the polylactic acid solution prepared in the step S1, pouring the mixture on a flat plate, and evaporating and volatilizing to obtain a polymer film layer;
s3, the polypropylene substrate and the polymer film layer are opposite to each other and are hot-pressed into a whole, and the polypropylene film is obtained.
Comparative example 1 an antibacterial and anti-inflammatory hernia repair patch
The antibacterial and anti-inflammatory hernia repair patch comprises a polypropylene substrate, wherein a polymer film layer made of polylactic acid and a biocompatible polymer material composite solution is arranged outside the polypropylene substrate.
The polypropylene substrate is a non-tension polypropylene substrate and is a mesh-shaped braided fabric.
The polymer film layer is prepared from 76% by mass of polylactic acid and 24% by mass of biocompatible polymer material composite solution.
The composite solution of the biocompatible polymer material is prepared from chitosan and sodium alginate according to the weight ratio of 12: 4.
The biocompatible polymer composite solution was prepared in a similar manner to example 2.
The preparation method of the antibacterial and anti-inflammatory hernia repair patch is similar to that of example 2.
The difference from example 2 is that the polymer material composite solution is not added with antibacterial peptide.
Comparative example 2 an antibacterial and anti-inflammatory hernia repair patch
The antibacterial and anti-inflammatory hernia repair patch comprises a polypropylene substrate, wherein a polymer film layer made of polylactic acid and a biocompatible polymer material composite solution is arranged outside the polypropylene substrate.
The polypropylene substrate is a non-tension polypropylene substrate and is a mesh-shaped braided fabric.
The polymer film layer is prepared from 76% by mass of polylactic acid and 24% by mass of biocompatible polymer material composite solution.
The composite solution of the biocompatible polymer material is prepared from chitosan and antibacterial peptide according to the weight ratio of 12: 3.
The biocompatible polymer composite solution was prepared in a similar manner to example 2.
The preparation method of the antibacterial and anti-inflammatory hernia repair patch is similar to that of example 2.
The difference from example 2 is that the polymer material composite solution is not added with sodium alginate.
Comparative example 3 an antibacterial and anti-inflammatory hernia repair patch
The antibacterial and anti-inflammatory hernia repair patch comprises a polypropylene substrate, wherein a polymer film layer made of polylactic acid and a biocompatible polymer material composite solution is arranged outside the polypropylene substrate.
The polypropylene substrate is a non-tension polypropylene substrate and is a mesh-shaped braided fabric.
The polymer film layer is prepared from 76% by mass of polylactic acid and 24% by mass of biocompatible polymer material composite solution.
The composite solution of the biocompatible polymer material is prepared from chitosan, sodium alginate and antibacterial peptide according to the weight ratio of 1:1: 1.
The biocompatible polymer composite solution was prepared in a similar manner to example 2.
The preparation method of the antibacterial and anti-inflammatory hernia repair patch is similar to that of example 2.
The difference from the embodiment 2 is that the high polymer material composite solution is prepared from chitosan, sodium alginate and antibacterial peptide according to the weight ratio of 1:1: 1.
Test example I, anti-adhesion Performance test
1. Test materials: example 2, and comparative examples 1-3.
2. The test method comprises the following steps: 30 New Zealand white rabbits, each of which weighs 2.5-3.6Kg during operation, are taken. The left abdomen was anesthetized, a 20mm × 20mm full thickness muscle layer was cut out, and then the repair was performed using 30mm × 30mm pure polypropylene patches (commercially available, 6, good release), the hernia repair patch prepared in example 2 (6) and the hernia repair patches prepared in comparative examples 1 to 3 (6 each), and the patch was fixed to the abdominal wall with 4-0prolene sutures and the wound was sutured. The experimental animals were euthanized 3 months after the surgery and their anti-adhesion properties, including adhesion area, adhesion severity and adhesion incidence, were evaluated.
The grading standard of the blocking degree is as follows: 0 min-no adhesion; 1 minute-the tissue adheres to and can separate with the gravity; 2 min-tissue adhesion requires blunt separation; 3 min-tissue adhesion requires sharp separation.
Grading standard of adhesion area: 0 min-no adhesion; 1 minute-less than or equal to 25 percent of the surface has adhesion, and the average is 12.5 percent; 2 min to 26 to 50 percent of the surface has adhesion, and the average is 37.5 percent; 3 min-51-75% of the surface has adhesion, and the average is 63%; 4 min-more than or equal to 76% of the surface has adhesion, and the average is 88%. And (3) vertically shooting the patch with the adhesion with high definition, and processing the patch with the adhesion with Photoshop and SiConImage software to calculate the adhesion area. The incidence of adhesions is the percentage ratio of the number of animals with adhesions to the total number of the same group.
3. Test results
The test results are shown in table 1.
TABLE 1 blocking results after repair
As can be seen from table 1, the anti-inflammatory and bacteriostatic hernia repair patch prepared in example 2 of the present invention has a very good effect of preventing the adhesion between the organs in the abdominal cavity and the patch in the abdominal cavity, and completely avoids the adhesion phenomenon. The test results of example 2 and comparative examples 1 to 3 show that the hernia repair patches prepared in comparative examples 1 to 3 can adhere to internal organs in the abdominal cavity when the composition and the ratio of the biocompatible polymer composite solution are changed.
Test example two, antibacterial property test
1. Test materials: examples 1 to 3, and comparative examples 1 to 3.
2. Test subjects: escherichia coli, Candida albicans, Staphylococcus aureus.
3. The test method comprises the following steps: and (3) antibacterial experiment: the 50mm × 50mm hernia repair patches prepared in examples 1-3 and comparative examples 1-3 were placed in sterile conical flasks, and 70mL of phosphate buffer (0.03 mol. L.) was added thereto-1) And 5mL of bacterial liquid, after the liquid permeates into the culture medium, culturing at 37 ℃ for 24h, and then counting colonies.
The formula for calculating the bacteriostasis rate is as follows: and X is (A-B)/A multiplied by 100 percent, wherein X is the bacteriostasis rate, A is the average colony number of the sample before oscillation, and B is the average colony number of the sample after oscillation.
4. Test results
The test results are shown in table 2.
TABLE 2 antibacterial and anti-inflammatory hernia repair patch test results
As shown in the antibacterial performance test results in table 2, the hernia repair patch prepared in examples 1 to 3 of the present invention has significant inhibitory effects on escherichia coli, candida albicans and staphylococcus aureus, and the inhibitory rates after 24 hours contact are all 97% or more, wherein the highest inhibitory rate of example 2, which is 98% or more, is the best example of the present invention. The hernia repair patch prepared in the comparative examples 1 to 3 has a relatively weak bacteriostatic effect, and the comparative results of the comparative examples 1 to 3 and the examples show that the biocompatible polymer material composite solution added in the antibiotic and anti-inflammatory hernia repair patch prepared in the invention has a synergistic effect of all components, has a broad-spectrum and strong antibacterial property, can effectively prevent wounds from being infected by bacteria, and has a high bacteriostatic rate.
The foregoing embodiments are merely illustrative of the principles and utilities of the present invention and are not intended to limit the invention. Any person skilled in the art can modify or change the above-mentioned embodiments without departing from the spirit and scope of the present invention. Accordingly, it is intended that all equivalent modifications or changes which can be made by those skilled in the art without departing from the spirit and technical spirit of the present invention be covered by the claims of the present invention.
Claims (4)
1. An antibacterial and anti-inflammatory hernia repair patch is characterized by comprising a polypropylene substrate, wherein a polymer film layer made of a degradable polymer material and a biocompatible polymer material composite solution is arranged outside the polypropylene substrate;
the polymer film layer is prepared from 76% of degradable polymer material and 24% of biocompatible polymer material composite solution;
the degradable high polymer material is polylactic acid;
the biocompatible polymer material composite solution is prepared from chitosan, sodium alginate and antibacterial peptide according to the mass ratio of 12:4: 3;
the preparation method of the biocompatible polymer material composite solution comprises the following steps:
s1 molecular weight of 3.7-5.3X 105The chitosan is dissolved in citric acid solution with the concentration of 0.3-0.5mol/L to ensure that the solution isThe mass concentration of the chitosan is 15-24%, stirring and mixing evenly under a closed condition, and performing ultrasonic defoaming to obtain a chitosan solution;
s2 adding sodium alginate into distilled water, stirring to dissolve completely, adding antibacterial peptide with molecular weight of 3500-6500 and the chitosan solution obtained in step S1, and stirring.
2. The anti-bacterial and anti-inflammatory hernia repair patch according to claim 1, wherein the polypropylene substrate is a non-tension polypropylene substrate and is a mesh-type woven fabric.
3. A method for preparing the antibacterial and anti-inflammatory hernia repair patch according to claim 1 or 2, comprising the steps of:
s1 molecular weight of 1-5 × 105Dissolving the degradable high molecular material in a high molecular material solvent, stirring under a closed condition to completely dissolve the degradable high molecular material, and performing ultrasonic defoaming to obtain a degradable high molecular solution;
s2, uniformly mixing the biocompatible polymer material composite solution with the degradable polymer solution prepared in the step S1, pouring the mixture on a flat plate, and evaporating and volatilizing to obtain a polymer film layer;
s3, the polypropylene substrate and the polymer film layer are opposite to each other and are hot-pressed into a whole, and the polypropylene film is obtained.
4. The method for preparing the anti-bacterial and anti-inflammatory hernia repair patch according to claim 3, wherein the polymer material solvent in the step S1 is one or more of acetone, ethyl acetate and chloroform.
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| CN114681684A (en) * | 2020-12-30 | 2022-07-01 | 宁波新跃医疗科技股份有限公司 | Antibacterial hernia repair patch and preparation method thereof |
| CN114366850A (en) * | 2022-01-19 | 2022-04-19 | 复旦大学附属华山医院 | Artificial rotator cuff patch based on drug-loaded silk protein and preparation method thereof |
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