Antibacterial urinary catheter composition, antibacterial urinary catheter and preparation method of antibacterial urinary catheter
By combining polymer antibacterial materials, zinc organic acid and medical polymer materials, the prepared antibacterial urinary catheters solve the problem of insufficient antibacterial and biocompatibility of existing urinary catheters, achieving excellent water resistance and long-term antibacterial properties. Reduced the risk of catheter-associated urinary tract infection.
Patent Information
- Application Number
- CN202411651091.5
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-11-19
- Publication Date
- 2024-12-17
- Estimated Expiration
- Not applicable · inactive patent
AI Technical Summary
The existing urinary catheters cannot take into account both antibacterial and biocompatible, and there is also the problem of insufficient water resistance, which leads to the inability to effectively prevent catheter-related urinary tract infection.
Using a composition combining polymer antibacterial materials, zinc organic acid and medical polymer materials, an antibacterial urinary catheter is prepared by a specific preparation method, including mixing zinc oxide with organic acid, filtering and vacuum drying after reaction, forming an excellent organism with excellent organisms. Antibacterial urinary catheter with compatibility and antibacterial properties.
The prepared antibacterial urinary catheter has long-acting antibacterial properties and good water resistance, which can maintain excellent biocompatibility and antibacterial properties during long-term use, reducing the risk of infection.
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Abstract
Description
Technical Field
[0001] The present invention belongs to the field of medical devices, and in particular relates to an antibacterial urinary catheter composition, an antibacterial urinary catheter and a preparation method thereof. Background Art
[0002] Bacterial infection caused by medical device implants is a common complication after surgery, which not only affects the patient's physical health, but also may become a heavy financial burden for the patient in the follow-up treatment. The risk of infection undoubtedly increases the complexity and uncertainty of the medical process.
[0003] Hospital infection has become one of the leading causes of morbidity and mortality in patients worldwide. Among all hospital-acquired infections, urinary tract infections account for a particularly high proportion, accounting for about 40%, leading to hospital-acquired infections. Among them, urinary tract infections associated with indwelling catheters account for 80%, which is called catheter-associated urinary tract infection (CAUTI). CAUTI can cause a series of serious complications, including pyelonephritis, bacteremia, sepsis, catheter obstruction, stone formation, urethral stricture, urethritis, periurethral abscess, prostatitis, and Candida and drug-resistant bacterial infections. Medical catheters provide a favorable environment for bacterial colonization, and bacteria will form biofilms on the surface of catheters, which is also one of the main reasons for the high infection rate of CAUTI. Once bacterial biofilms are formed, they will resist the human immune system and hinder the effective effect of antibiotics, chemical disinfectants and disinfectants.
[0004] In order to prevent the formation of biofilms, researchers have developed a variety of new technologies. For example, the existing patent mixes antibacterial materials with inorganic zinc salts to produce composite antibacterial materials. However, the inorganic zinc salts will dissolve and disappear in the aqueous solution, resulting in a lack of lasting antibacterial properties and an inability to achieve excellent biofilm prevention effects.
[0005] Therefore, the development of efficient, safe, water-resistant and antibacterial urinary catheters is of great significance in the clinical prevention and treatment of catheter-related urinary tract infections. Summary of the invention
[0006] Therefore, the technical problem to be solved by the present invention is to overcome the defects of the existing urinary catheters that cannot take into account both antibacterial properties and biocompatibility, and also have insufficient water resistance, thereby providing an antibacterial urinary catheter composition, an antibacterial urinary catheter and a preparation method thereof.
[0007] To this end, the present invention provides the following technical solutions: The first aspect of the present invention protects an antibacterial urinary catheter composition, wherein the composition comprises a polymer antibacterial material, an organic acid zinc, a medical polymer material and a solvent; Wherein, the organic acid zinc includes at least one of zinc acetate, zinc glutarate, zinc adipate, zinc pimelate and zinc octadecanoate.
[0008] In the present invention, the organic acid zinc can be commercially available or prepared. When preparing, typically but not limitingly, 20 mmol of zinc oxide and 19-19.5 mmol of organic acid are mixed, with a slight excess of zinc oxide to make the reaction more complete, and the reaction is carried out at 70-90° C. for 10-20 hours, and then the precipitate is filtered out and vacuum-dried at 100-120° C. to obtain the organic acid zinc.
[0009] According to the present invention, the organic acid zinc is zinc pimelate and / or zinc octadecanoate.
[0010] According to the present invention, the antibacterial urinary catheter composition comprises, by weight, 1-20 parts of polymer antibacterial material, 1-5 parts of organic acid zinc, 50-100 parts of medical polymer material, and 50-200 parts of solvent.
[0011] According to the present invention, the polymer antibacterial material is a cationic polymer antibacterial material.
[0012] According to the present invention, the polymer antibacterial material includes polyhexamethylene biguanidine hydrochloride and / or polyhexamethylene monoguanidine hydrochloride.
[0013] According to the present invention, the medical polymer material comprises at least one of polyurethane, silicone rubber and polyvinyl chloride; typically, but not limitedly, Pellethane manufactured by Lubrizol is used. ® 2363-65D brand polyurethane, SH-2250A / B brand silicone rubber from Beiteli, and M-1000 brand polyvinyl chloride from Shanghai Chlor-Alkali Chemical Co., Ltd.
[0014] According to the present invention, the solvent comprises water and / or ethanol.
[0015] The second aspect of the present invention protects an antibacterial urinary catheter, wherein the raw material of the antibacterial urinary catheter includes the aforementioned composition.
[0016] The third aspect of the present invention protects a method for preparing the aforementioned antibacterial urinary catheter, wherein the preparation method comprises: S1, preparing a polymer antibacterial material solution by adding a solubilizing agent, and preparing an organic acid zinc solution by adding a solubilizing agent; S2, dropping the organic acid zinc solution into the polymer antibacterial material solution, and obtaining an insoluble polymer material A after reaction; S3, mixing the insoluble polymer material A with a medical polymer material, and processing and molding them to obtain an antibacterial urinary catheter.
[0017] In the present invention, the solvent can fully dissolve the polymer antibacterial material and the organic acid zinc. Typically, but not limited to, water is used to dissolve the polymer antibacterial material, and ethanol is used to dissolve the organic acid zinc. The dripping speed is at a conventional level in the art, and can allow the reaction to proceed fully.
[0018] According to the present invention, the reaction temperature is 30-100° C. and the reaction time is 10-60 min.
[0019] According to the present invention, the reaction further includes a drying and crushing step, wherein the drying temperature is 100-150° C. and the drying time is 1-5 hours.
[0020] In the present invention, the processing and molding method is conventional extrusion molding in the art.
[0021] The technical solution of the present invention has the following advantages: 1. The present invention provides an antibacterial urinary catheter composition, wherein the composition comprises a polymer antibacterial material, an organic acid zinc, a medical polymer material and a solvent; wherein the organic acid zinc is at least one of zinc acetate, zinc glutarate, zinc adipate, zinc pimelate and zinc octadecanoate. The antibacterial urinary catheter prepared by the composition of the present invention has excellent biocompatibility and antibacterial properties, and the organic acid zinc is used to modify the hydrophobicity of the polymer antibacterial material, thereby improving the water resistance of the antibacterial urinary catheter, and has long-term antibacterial properties, and can be used for a long time.
[0022] 2. In the present invention, when the organic acid zinc is zinc pimelate or zinc octadecanoate, as the molecular weight increases, the hydrophilicity becomes poorer, the water resistance can be further improved and the cytotoxicity becomes lower.
[0023] 3. The specific dosage of each component in the present invention can further improve the antibacterial property, biocompatibility and water resistance of the catheter made of the antibacterial urinary catheter composition.
[0024] 4. The present invention provides a method for preparing an antibacterial urinary catheter, wherein the preparation method comprises: S1, preparing a polymer antibacterial material solution by adding a solubilizing agent to a polymer antibacterial material, and preparing an organic acid zinc solution by adding a solubilizing agent to an organic acid zinc solution; S2, dripping the organic acid zinc solution into the polymer antibacterial material solution, and obtaining an insoluble polymer material A after the reaction; S3, mixing the insoluble polymer material A with a medical polymer material, and processing and molding to obtain an antibacterial urinary catheter; The preparation method of the present invention is simple, low-cost, and easy to realize process, and the obtained antibacterial urinary catheter has excellent biocompatibility, antibacterial performance and water resistance. Dropping the organic acid zinc solution into the polymer antibacterial material solution can ensure that the polymer antibacterial material is excessive, so that the reaction is fully carried out, and the polymer antibacterial material reacts with the organic acid zinc to generate water-soluble zinc chloride and water-insoluble polymer materials, which promotes the continuous reaction. The obtained insoluble polymer material can exist stably, and there will be no precipitation of raw materials, and it has excellent water resistance. DETAILED DESCRIPTION
[0025] The following examples are provided for a better understanding of the present invention, but are not intended to limit the best mode of implementation, nor to limit the content and protection scope of the present invention. Any product identical or similar to the present invention obtained by anyone under the inspiration of the present invention or by combining the features of the present invention with other prior arts shall fall within the protection scope of the present invention.
[0026] If no specific experimental steps or conditions are specified in the examples, the conventional experimental steps or conditions described in the literature in the field can be used. If no manufacturer is specified for the reagents or instruments used, they are all conventional reagent products that can be obtained commercially.
[0027] Using Pellethane from Lubrizol ® The 2363-65D brand polyurethane uses the M-1000 brand polyvinyl chloride of Shanghai Chlor-Alkali Chemical Co., Ltd.
[0028] Example 1 This embodiment provides a method for preparing an antibacterial urinary catheter, which is as follows: S1, dissolving 10 g of polyhexamethylene biguanide hydrochloride in 50 g of water, stirring continuously to prepare a polymer antibacterial material solution, dissolving 5 g of zinc glutarate in 50 g of ethanol to prepare an organic acid zinc solution; S2, slowly adding the organic acid zinc solution to the polymer antibacterial material solution at a dropping rate of 60 drops / min, reacting at a temperature of 60°C, a reaction time of 24 hours, and a rotation speed of 100 rpm / min to obtain insoluble matter, separating the insoluble matter, drying it at 150°C for 5 hours, and crushing it to obtain an insoluble polymer material A; S3, mixing the insoluble polymer material A obtained in S1 and 100 g of polyvinyl chloride, and preparing an antibacterial urinary catheter through an extrusion molding process.
[0029] Example 2 This embodiment provides a method for preparing an antibacterial urinary catheter, which is as follows: The method of Example 1 is followed, except that "zinc glutarate" is replaced by "zinc pimelate".
[0030] Example 3 This embodiment provides a method for preparing an antibacterial urinary catheter, which is as follows: The method of Example 1 is followed, except that "zinc glutarate" is replaced by "zinc acetate".
[0031] Example 4 This embodiment provides a method for preparing an antibacterial urinary catheter, which is as follows: S1, dissolving 10 g of polyhexamethyleneguanidine hydrochloride in 100 g of water, stirring continuously to prepare a polymer antibacterial material solution, dissolving 2 g of zinc glutarate, 2 g of zinc adipate and 1 g of zinc acetate in 50 g of ethanol to prepare an organic acid zinc solution; S2, slowly adding the organic acid zinc solution to the polymer antibacterial material solution at a dropping rate of 60 drops / min, reacting at a temperature of 60°C, a reaction time of 24 hours, and a rotation speed of 100 rpm / min to obtain insoluble matter, separating the insoluble matter, drying it at 150°C for 5 hours, and crushing it to obtain an insoluble polymer material A; S3, mixing the insoluble polymer material A obtained in S1 and 100 g of polyurethane, and preparing an antibacterial urinary catheter through an extrusion molding process.
[0032] Example 5 This embodiment provides a method for preparing an antibacterial urinary catheter, which is as follows: S1, dissolving 5 g of polyhexamethylene biguanide hydrochloride in 100 g of water, stirring continuously to prepare a polymer antibacterial material solution, dissolving 5 g of zinc glutarate in 100 g of ethanol to prepare an organic acid zinc solution; S2, slowly adding the organic acid zinc solution to the polymer antibacterial material solution at a dropping rate of 60 drops / min, reacting at a temperature of 60°C, a reaction time of 24 hours, and a rotation speed of 100 rpm / min to obtain insoluble matter, separating the insoluble matter, drying it at 150°C for 5 hours, and crushing it to obtain an insoluble polymer material A; S3, mixing the insoluble polymer material A obtained in S1 and 100 g of polyvinyl chloride, and preparing an antibacterial urinary catheter through an extrusion molding process.
[0033] Example 6 This embodiment provides a method for preparing an antibacterial urinary catheter, which is as follows: The method of Example 1 is the same, except that "polyvinyl chloride" is replaced by "polyurethane".
[0034] Comparative Example 1 This comparative example provides a method for preparing an antibacterial urinary catheter, which is as follows: The method of Example 1 was followed except that polyhexamethylene biguanide hydrochloride was not added.
[0035] Comparative Example 2 This comparative example provides a method for preparing an antibacterial urinary catheter, which is as follows: The procedure of Example 1 was followed except that no zinc glutarate was added.
[0036] Comparative Example 3 This comparative example provides a method for preparing an antibacterial urinary catheter, which is as follows: The method of Example 3 is followed, except that "zinc glutarate" is replaced by "zinc chloride".
[0037] The surfaces of the antibacterial urinary catheters prepared in the above embodiments and comparative examples were subjected to relevant biological evaluations according to ISO 22196-2011 "Evaluation method for antibacterial properties of surfaces of plastic products and other non-porous products" and the national standard GB / T 16886.5-2017 "Biological evaluation of medical devices Part 5 In vitro cytotoxicity test"; the cytotoxicity of the embodiments and comparative examples to L929 (mouse fibroblasts) for 7 days was evaluated to characterize the biocompatibility, among which grades 0 and 1 met the requirements for biomedical materials.
[0038] The specific results are shown in Table 1.
[0039] Table 1
[0040] The test method for water resistance is: GB / T31410-2015 200 wet scrubbing cycles on the coating, the specific results are shown in Table 2.
[0041] Table 2
[0042] It can be seen from the data in Table 1 that, compared with the comparative example, the embodiment of the present invention can take into account both antibacterial properties and biocompatibility; and by comparing the data in Table 1 with that in Table 2, it can be seen that the embodiment of the present invention still maintains excellent antibacterial properties and biocompatibility after wiping 200 times, proving that the catheter prepared by the antibacterial urinary catheter composition of the present invention has good water resistance.
[0043] Obviously, the above embodiments are merely examples for the purpose of clear explanation, and are not intended to limit the implementation methods. For those skilled in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the implementation methods here. The obvious changes or modifications derived from these are still within the scope of protection of the invention.
Claims
1. An antimicrobial urinary catheter composition, It is characterized in that The composition comprises a polymer antibacterial material, an organic acid zinc, a medical polymer material and a solvent; Wherein, the organic acid zinc includes at least one of zinc acetate, zinc glutarate, zinc adipate, zinc pimelate and zinc octadecanoate.
2. The composition according to claim 1, It is characterized in that The organic acid zinc is zinc pimelate and / or zinc octadecanoate.
3. The composition according to claim 1 or 2, It is characterized in that In parts by weight, the antibacterial urinary catheter composition comprises 1-20 parts of polymer antibacterial material, 1-5 parts of organic acid zinc, 50-100 parts of medical polymer material and 50-200 parts of solvent.
4. The composition according to claim 1, It is characterized in that The polymer antibacterial material is a cationic polymer antibacterial material; And / or, the medical polymer material includes at least one of polyurethane, silicone rubber and polyvinyl chloride.
5. The composition according to claim 4, It is characterized in that The cationic polymer antibacterial material includes polyhexamethylene biguanidine hydrochloride and / or polyhexamethylene monoguanidine hydrochloride.
6. The composition according to claim 1, It is characterized in that The solvent includes water and / or ethanol.
7. An antimicrobial urinary catheter, It is characterized in that The raw material of the antibacterial urinary catheter comprises the composition according to any one of claims 1-6.
8. A method for preparing the antibacterial urinary catheter according to claim 7, It is characterized in that The preparation method comprises: S1, adding a solubilizing agent to a polymer antibacterial material to prepare a polymer antibacterial material solution, and adding a solubilizing agent to an organic acid zinc to prepare an organic acid zinc solution; S2, adding an organic acid zinc solution to the polymer antibacterial material solution, and obtaining an insoluble polymer material A after reaction; S3, mixing the insoluble polymer material A with a medical polymer material, and processing and molding them to obtain an antibacterial urinary catheter.
9. The preparation method according to claim 8, It is characterized in that The reaction temperature is 30-100°C and the reaction time is 10-60 minutes.
10. The preparation method according to claim 8, It is characterized in that After the reaction, the method further comprises a drying and crushing step, wherein the drying temperature is 100-150° C. and the drying time is 1-5 hours.