Articular cavity puncture needle with antibacterial coating and preparation method of articular cavity puncture needle

Abstract

The invention provides an articular cavity puncture needle with an antibacterial coating and a preparation method of the articular cavity puncture needle, and belongs to the technical field of medical instruments. The preparation method of the articular cavity puncture needle with the antibacterial coating comprises the following steps: (1) mixing a polyacrylamide solution, a sodium carboxymethyl cellulose solution and a surfactant solution to obtain an antibacterial coating solution; and (2) coating an articular cavity puncture needle with the antibacterial coating liquid obtained in the step (1) to obtain the articular cavity puncture needle with the antibacterial coating. The surface of the articular cavity puncture needle is coated with the antibacterial coating liquid, the antibacterial performance of the articular cavity puncture needle can be remarkably improved, good stability can be kept in an organic solvent (such as ethyl alcohol), and the prepared articular cavity puncture needle with the antibacterial coating is more suitable for the complex internal environment of a human body.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a joint cavity puncture needle with an antibacterial coating and a preparation method thereof. Background Art

[0002] Joint cavity puncture technology is a method of using a joint cavity puncture needle to insert into the joint cavity to extract effusion or inject drugs into the joint cavity after extracting fluid. It has the advantages of relieving patients' pain and swelling symptoms, reducing inflammation and causing less damage to the tissues around the joint. However, using a joint cavity puncture needle to extract effusion or inject drugs is prone to bacterial infection. Therefore, providing a joint cavity puncture needle that can effectively reduce the bacterial infection rate is conducive to improving the safety of joint cavity puncture technology.

[0003] Most of the existing technologies use the method of covering the surface of the puncture needle with an antibacterial surface layer to improve the antibacterial performance of the puncture needle. For example, the patent application with application number 202310522269.5 discloses an antibacterial puncture needle, which is obtained by immersing the pretreated puncture needle in an antibacterial silica sol, and covering the surface of the puncture needle with a layer of antibacterial silica sol by a pulling method, and reacting under high temperature conditions. Although the puncture needle prepared has certain antibacterial properties, its stability in organic solvents is poor. Therefore, it is necessary to provide a joint cavity puncture needle that not only has a good antibacterial effect, but also can maintain good stability in organic solvents, so that the prepared joint cavity puncture needle is more suitable for the complex human body environment of patients. Summary of the invention

[0004] The object of the present invention is to provide a joint cavity puncture needle with an antibacterial coating and a preparation method thereof, so that the prepared joint cavity puncture needle not only has a good antibacterial effect, but also can maintain good stability in organic solvents.

[0005] In order to achieve the above-mentioned object of the invention, the present invention provides the following technical solutions:

[0006] The present invention provides a method for preparing a joint cavity puncture needle with an antibacterial coating, comprising the following steps:

[0007] (1) mixing a polyacrylamide solution, a sodium carboxymethyl cellulose solution and a surfactant solution to obtain an antibacterial coating solution;

[0008] (2) coating the antibacterial coating liquid obtained in step (1) on the joint cavity puncture needle to obtain a joint cavity puncture needle with an antibacterial coating.

[0009] Preferably, the polyacrylamide solution is prepared by mixing polyacrylamide with water to obtain a polyacrylamide solution;

[0010] The dosage of the polyacrylamide is 0.1-0.2% of the mass of water; the temperature during the mixing is 30-50° C., the speed is 200-400 rpm, and the time is 20-40 minutes.

[0011] Preferably, the preparation method of the sodium carboxymethyl cellulose is: mixing sodium carboxymethyl cellulose with water to obtain a sodium carboxymethyl cellulose solution;

[0012] The dosage of the sodium carboxymethyl cellulose is 0.8-1.2% of the mass of water, the temperature during the mixing is 50-70° C., the speed is 200-400 rpm, and the time is 40-80 min.

[0013] Preferably, the surfactant includes benzalkonium chloride or didecyldimethylammonium chloride; the surfactant is mixed with water in an amount 15 to 25 times the mass of the surfactant to obtain a surfactant solution.

[0014] Preferably, the volume ratio of the polyacrylamide solution, the sodium carboxymethyl cellulose solution and the surfactant solution when mixed is 0.8-1.2:0.8-1.2:1.6-2.4; when mixing, the polyacrylamide solution and the sodium carboxymethyl cellulose solution are first mixed, and then the surfactant solution is added; the temperature during mixing is 30-50°C, the speed is 80-120rpm, and the time is 20-40min.

[0015] Preferably, the antibacterial coating liquid also includes antibacterial drugs.

[0016] Preferably, the antibacterial drugs include ciprofloxacin, metronidazole or norfloxacin.

[0017] Preferably, the coating method in step (2) is dipping or spraying.

[0018] Preferably, in step (2), the obtained joint cavity puncture needle with antibacterial coating is dried using a pressure air gun.

[0019] The invention also provides a joint cavity puncture needle with an antibacterial coating prepared according to the method.

[0020] The present invention provides a joint cavity puncture needle with an antibacterial coating and a preparation method thereof. A polyacrylamide solution, a sodium carboxymethyl cellulose solution and a surfactant solution are mixed according to a certain concentration and volume to prepare an antibacterial coating liquid with good antibacterial performance and stability. The antibacterial coating liquid is coated on the surface of the joint cavity puncture needle to significantly improve the antibacterial performance of the joint cavity puncture needle, and can maintain good stability in an organic solvent (such as ethanol), so that the prepared joint cavity puncture needle with an antibacterial coating is more suitable for the complex internal environment of the human body. DETAILED DESCRIPTION

[0021] The present invention provides a method for preparing a joint cavity puncture needle with an antibacterial coating, comprising the following steps:

[0022] (1) mixing a polyacrylamide solution, a sodium carboxymethyl cellulose solution and a surfactant solution to obtain an antibacterial coating solution;

[0023] (2) coating the antibacterial coating liquid obtained in step (1) on the joint cavity puncture needle to obtain a joint cavity puncture needle with an antibacterial coating.

[0024] In the present invention, the preparation method of the polyacrylamide solution is: mixing polyacrylamide with water to obtain the polyacrylamide solution;

[0025] The amount of polyacrylamide used is 0.1-0.2% of the water mass, preferably 0.12-0.18%, more preferably 0.14-0.16%, and more preferably 0.15%; the temperature during mixing is 30-50°C, preferably 35-45°C, and more preferably 40°C; the speed is 200-400rpm, preferably 250-350rpm, and more preferably 300rpm; the time is 20-40min, preferably 25-35min, and more preferably 30min.

[0026] In the present invention, the preparation method of sodium carboxymethyl cellulose is: mixing sodium carboxymethyl cellulose with water to obtain a sodium carboxymethyl cellulose solution;

[0027] The amount of sodium carboxymethyl cellulose used is 0.8-1.2% of the water mass, preferably 0.9-1.1%, and more preferably 1%. The temperature during mixing is 50-70°C, preferably 55-65°C, and more preferably 60°C. The speed is 200-400rpm, preferably 250-350rpm, and more preferably 300rpm. The time is 40-80min, preferably 50-70min, and more preferably 55-65min, and more preferably 60min.

[0028] In the present invention, the surfactant includes benzalkonium chloride or didecyldimethylammonium chloride; the surfactant is mixed with water in an amount 15 to 25 times the mass of the surfactant to obtain a surfactant solution.

[0029] In the present invention, it is preferred that the surfactant be mixed with water in an amount 18 to 22 times the mass of the surfactant, and it is more preferred that the surfactant be mixed with water in an amount 20 times the mass of the surfactant.

[0030] In the present invention, the volume ratio of the polyacrylamide solution, the sodium carboxymethyl cellulose solution and the surfactant solution when mixed is 0.8-1.2:0.8-1.2:1.6-2.4, preferably 0.9-1.1:0.9-1.1:1.8-2.2, and more preferably 1:1:2; when mixing, the polyacrylamide solution and the sodium carboxymethyl cellulose solution are first mixed, and then the surfactant solution is added; the temperature during mixing is 30-50°C, preferably 35-45°C, and more preferably 40°C, the speed is 80-120rpm, preferably 90-110rpm, and more preferably 100rpm, and the time is 20-40min, preferably 25-35min, and more preferably 30min.

[0031] In the present invention, the antibacterial coating liquid also includes antibacterial drugs.

[0032] In the present invention, the antibacterial drugs include ciprofloxacin, metronidazole or norfloxacin.

[0033] In the present invention, the coating method in step (2) is dip coating or spray coating, preferably dip coating.

[0034] In the present invention, step (2) further comprises drying the obtained joint cavity puncture needle with antibacterial coating using a pressure air gun.

[0035] The invention also provides a joint cavity puncture needle with an antibacterial coating prepared according to the method.

[0036] The technical solutions provided by the present invention are described in detail below in conjunction with the embodiments, but they should not be construed as limiting the protection scope of the present invention.

[0037] Example 1

[0038] A method for preparing a joint cavity puncture needle with an antibacterial coating, comprising the following steps:

[0039] (1) mixing 0.1 parts by weight of polyacrylamide with 100 parts by weight of deionized water at a temperature of 30° C. and a speed of 200 rpm for 20 minutes to obtain a polyacrylamide solution;

[0040] (2) mixing 0.8 parts by mass of sodium carboxymethyl cellulose with 100 parts by mass of deionized water at a temperature of 50° C. and a speed of 200 rpm for 40 minutes to obtain a sodium carboxymethyl cellulose solution;

[0041] (3) dissolving didecyl dimethyl ammonium chloride in deionized water with a mass 15 times that of didecyl dimethyl ammonium chloride to obtain a surfactant solution;

[0042] (4) after mixing the polyacrylamide solution prepared in step (1) with the sodium carboxymethyl cellulose solution prepared in step (2), slowly adding the surfactant solution prepared in step (3), and mixing for 20 minutes at a temperature of 30° C. and a speed of 80 rpm to obtain an antibacterial coating liquid; wherein the volume ratio of the polyacrylamide solution, the sodium carboxymethyl cellulose solution and the surfactant solution when mixed is 1:1:2;

[0043] (5) The joint cavity puncture needle is soaked in the antibacterial coating liquid prepared in step (4) for 2 hours, then taken out and dried with a pressure air gun to obtain a joint cavity puncture needle with an antibacterial coating.

[0044] Example 2

[0045] A method for preparing a joint cavity puncture needle with an antibacterial coating, comprising the following steps:

[0046] (1) mixing 0.2 parts by weight of polyacrylamide with 100 parts by weight of deionized water at a temperature of 50° C. and a speed of 400 rpm for 40 minutes to obtain a polyacrylamide solution;

[0047] (2) mixing 1.2 parts by mass of sodium carboxymethyl cellulose with 100 parts by mass of deionized water at a temperature of 70° C. and a speed of 400 rpm for 80 min to obtain a sodium carboxymethyl cellulose solution;

[0048] (3) dissolving didecyl dimethyl ammonium chloride in deionized water 25 times the mass of didecyl dimethyl ammonium chloride to obtain a surfactant solution;

[0049] (4) after mixing the polyacrylamide solution prepared in step (1) with the sodium carboxymethyl cellulose solution prepared in step (2), slowly adding the surfactant solution prepared in step (3), and mixing for 40 minutes at a temperature of 50° C. and a speed of 120 rpm to obtain an antibacterial coating liquid; wherein the volume ratio of the polyacrylamide solution, the sodium carboxymethyl cellulose solution and the surfactant solution when mixed is 1:1:2;

[0050] (5) The joint cavity puncture needle is soaked in the antibacterial coating liquid prepared in step (4) for 2 hours, then taken out and dried with a pressure air gun to obtain a joint cavity puncture needle with an antibacterial coating.

[0051] Example 3

[0052] A method for preparing a joint cavity puncture needle with an antibacterial coating, comprising the following steps:

[0053] (1) mixing 0.15 parts by weight of polyacrylamide with 100 parts by weight of deionized water at a temperature of 40° C. and a speed of 300 rpm for 30 minutes to obtain a polyacrylamide solution;

[0054] (2) mixing 1 part by mass of sodium carboxymethyl cellulose with 100 parts by mass of deionized water at a temperature of 60° C. and a speed of 300 rpm for 60 min to obtain a sodium carboxymethyl cellulose solution;

[0055] (3) dissolving didecyl dimethyl ammonium chloride in deionized water 20 times the mass of didecyl dimethyl ammonium chloride to obtain a surfactant solution;

[0056] (4) after mixing the polyacrylamide solution prepared in step (1) with the sodium carboxymethyl cellulose solution prepared in step (2), slowly adding the surfactant solution prepared in step (3), and mixing for 30 minutes at a temperature of 40° C. and a speed of 100 rpm to obtain an antibacterial coating liquid; wherein the volume ratio of the polyacrylamide solution, the sodium carboxymethyl cellulose solution and the surfactant solution when mixed is 1:1:2;

[0057] (5) The joint cavity puncture needle is soaked in the antibacterial coating liquid prepared in step (4) for 2 hours, then taken out and dried with a pressure air gun to obtain a joint cavity puncture needle with an antibacterial coating.

[0058] Example 4

[0059] The difference between this embodiment and embodiment 3 is that in step (4) of this embodiment, ciprofloxacin is further added to the antibacterial coating liquid, and the mass volume ratio of ciprofloxacin to the antibacterial coating liquid is 0.5 μg:1 mL. The remaining steps are the same as those in embodiment 3.

[0060] Comparative Example 1

[0061] The difference between this comparative example and Example 3 is that no polyacrylamide solution is added to the antibacterial coating liquid of this comparative example, and the remaining steps are the same as those of Example 3.

[0062] Comparative Example 2

[0063] The difference between this comparative example and Example 3 is that the concentration of the polyacrylamide solution is different. In this comparative example, 0.5 parts by mass of polyacrylamide and 100 parts by mass of deionized water are mixed at a temperature of 40° C. and a speed of 300 rpm for 30 minutes to obtain a polyacrylamide solution. The remaining steps are the same as in Example 3.

[0064] Test Example 1

[0065] The purpose of this test example is to study the antibacterial effect of the joint cavity puncture needle with antibacterial coating prepared in Examples 1 to 4 and Comparative Examples 1 to 2.

[0066] The concentration was 1×10 6CFU / mL of Staphylococcus aureus solution and Escherichia coli solution were added dropwise to the surface of the prepared joint cavity puncture needle with antibacterial coating. After incubation in a 37°C incubator for 24 hours, the antibacterial effect of each group of joint cavity puncture needles was calculated according to the method specified in GB 4789.2-2022. The calculation results are shown in Table 1.

[0067] Table 1 Antibacterial effect of joint puncture needle

[0068] Staphylococcus aureus (%) Escherichia coli (%) Example 1 99.1 99.0 Example 2 98.9 98.7 Example 3 99.5 99.5 Example 4 99.8 99.9 Comparative Example 1 98.4 97.8 Comparative Example 2 86.6 72.9

[0069] It can be seen from Table 1 that the joint cavity puncture needles prepared in Examples 1 to 4 and Comparative Example 1 have good inhibitory effects on Staphylococcus aureus and Escherichia coli; compared with Example 3, the inhibitory effect of the joint cavity puncture needle prepared in Comparative Example 2 on Staphylococcus aureus and Escherichia coli is significantly reduced, indicating that adding a high concentration of polyacrylamide solution to the antibacterial coating liquid will reduce the antibacterial effect of the joint cavity puncture needle.

[0070] Test Example 2

[0071] The purpose of this test example is to study the stability of the joint cavity puncture needle with antibacterial coating prepared in Examples 1 to 4 and Comparative Examples 1 to 2.

[0072] The joint cavity puncture needle was soaked in 75% ethanol solution for 4 hours and then taken out. The antibacterial effect of each group of joint cavity puncture needles was determined according to the method of Experimental Example 1. The calculation results are shown in Table 2.

[0073] Table 2 Antibacterial effect of joint cavity puncture needle after ethanol treatment

[0074] Staphylococcus aureus (%) Escherichia coli (%) Example 1 98.7 98.3 Example 2 98.2 98.1 Example 3 99.0 99.1 Example 4 99.7 99.7 Comparative Example 1 86.8 87.2 Comparative Example 2 64.3 49.8

[0075] It can be seen from Table 2 that after being treated with ethanol solution, the joint cavity puncture needles prepared in Examples 1 to 4 still have good antibacterial effect, indicating that the joint cavity puncture needles with antibacterial coatings prepared by the present invention can maintain good stability in organic solvents; compared with Example 3, the antibacterial effect of the joint cavity puncture needles prepared in Comparative Examples 1 to 2 is significantly reduced. The reason for this may be that the polyacrylamide solution and the sodium carboxymethyl cellulose solution in the antibacterial coating liquid have a certain cross-linking reaction at a specific concentration, which significantly improves the stability of the antibacterial coating liquid.

[0076] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A method for preparing a joint cavity puncture needle with an antibacterial coating, characterized in that: The steps include: (1) mixing a polyacrylamide solution, a sodium carboxymethyl cellulose solution and a surfactant solution to obtain an antibacterial coating solution; (2) coating the antibacterial coating liquid obtained in step (1) on the joint cavity puncture needle to obtain a joint cavity puncture needle with an antibacterial coating.

2. The method according to claim 1, characterized in that The preparation method of the polyacrylamide solution is: mixing polyacrylamide with water to obtain the polyacrylamide solution; The dosage of the polyacrylamide is 0.1-0.2% of the mass of water; the temperature during the mixing is 30-50° C., the speed is 200-400 rpm, and the time is 20-40 minutes.

3. The method according to claim 2, characterized in that The preparation method of sodium carboxymethyl cellulose comprises: mixing sodium carboxymethyl cellulose with water to obtain a sodium carboxymethyl cellulose solution; The dosage of the sodium carboxymethyl cellulose is 0.8-1.2% of the mass of water, the temperature during the mixing is 50-70° C., the speed is 200-400 rpm, and the time is 40-80 min.

4. The method according to claim 3, characterized in that The surfactant includes benzalkonium chloride or didecyldimethylammonium chloride; the surfactant is mixed with water having a mass of 15 to 25 times that of the surfactant to obtain a surfactant solution.

5. The method according to claim 4, characterized in that The volume ratio of the polyacrylamide solution, the sodium carboxymethyl cellulose solution and the surfactant solution when mixed is 0.8-1.2:0.8-1.2:1.6-2.4; when mixing, the polyacrylamide solution and the sodium carboxymethyl cellulose solution are first mixed, and then the surfactant solution is added; the temperature during mixing is 30-50°C, the speed is 80-120rpm, and the time is 20-40min.

6. The method according to claim 5, characterized in that The antibacterial coating liquid also includes antibacterial drugs.

7. The method according to claim 6, characterized in that The antibacterial drugs include ciprofloxacin, metronidazole or norfloxacin.

8. The method according to claim 7, characterized in that The coating method in step (2) is dipping or spraying.

9. The method according to any one of claims 1 to 8, characterized in that: In step (2), the obtained joint cavity puncture needle with antibacterial coating is dried using a pressure air gun.

10. An articular puncture needle with an antibacterial coating prepared according to the method of any one of claims 1 to 9.