Composite nano-aqueous lubricant for medical devices and method of making

Abstract

The present application relates to the field of medical instrument cleaning protection. A kind of composite nano aqueous lubricant for medical instrument, it includes nano particle, non-ionic surfactant, corrosion inhibitor, co-surfactant, defoaming agent, base oil;The nano particle is polylactic acid nano particle;Its mass fraction is 0.2-0.4%. The particle size of the polylactic acid nano particle is 10-50nm;The corrosion inhibitor is quaternary aminated polyethyleneimine;The defoaming agent is polyoxyethylene polyoxypropylene block copolymer;The base oil is castor oil. The preparation method of the composite nano aqueous lubricant for medical instrument, it includes respectively (1) quaternary aminated polyethyleneimine preparation, (2) polylactic acid nano particle preparation after (3) polylactic acid / quaternary aminated polyethyleneimine composite nano particle preparation again (4) polylactic acid / quaternary aminated polyethyleneimine composite nano aqueous lubricant preparation. The present application protects metal friction surface, prolongs the service life of medical instrument;Environment-friendly.

Description

Technical Field

[0001] This invention relates to the field of medical device cleaning and protection, and discloses a lubricant for medical devices and its preparation method. Background Technology

[0002] Medical devices are instruments, equipment, materials, and other similar items that are used directly or indirectly on the human body. In hospitals and community health centers at all levels across the country, the long-term and frequent use of medical devices can damage the protective layer on their surface, leading to problems such as corrosion and joint failure. This significantly increases the hospital's operating costs and surgical risks. In order to extend the service life of medical devices, reduce potential surgical risks, and lower hospital operating costs, it is necessary to use lubricants for protective treatment after rust removal and cleaning.

[0003] Most medical lubricants on the market are currently emulsion-type and contain added silicone, resulting in poor stability, poor lubrication performance, and difficulty in biodegradation, thus imposing a significant burden on the environment. Therefore, developing a water-based medical device lubricant with good stability, excellent lubrication performance, and easy biodegradability for surgical medical devices has great market application potential. Summary of the Invention

[0004] This invention aims to address the shortcomings of existing technologies and provides a composite nano-aqueous lubricant for medical devices and its preparation method, which protects metal friction surfaces, extends the service life of medical devices, and is environmentally friendly.

[0005] The present invention is achieved as follows: a composite nano-aqueous lubricant for medical devices comprises nanoparticles, a nonionic surfactant, a corrosion inhibitor, a co-surfactant, a defoamer, and a base oil; wherein the nanoparticles are polylactic acid nanoparticles; and the mass fraction of the polylactic acid nanoparticles in the composite nano-aqueous lubricant for medical devices is 0.2-0.4%.

[0006] Preferably, the polylactic acid nanoparticles have a particle size of 10-50 nm;

[0007] Preferably, the nonionic surfactant is one or more of Tween-80, Span-60, fatty alcohol polyoxyethylene ether, and glucoside.

[0008] Preferably, the corrosion inhibitor is quaternized polyethyleneimine;

[0009] Preferably, the co-surfactant is one or more of polyethylene glycol 400, n-butanol, and monoglyceride;

[0010] Preferably, the defoamer is a polyoxyethylene-polyoxypropylene block copolymer;

[0011] Preferably, the base oil is castor oil.

[0012] The preparation method of the composite nano-aqueous lubricant for medical devices includes:

[0013] (1) Preparation of Quaternized Polyethyleneimine

[0014] Under stirring, propylene oxide was slowly added dropwise to the polyethyleneimine solution. After the addition was complete, the mixture was stirred at room temperature for 6-8 hours, and then heated and stirred at 30-40°C for 1-2 hours to obtain a tertiary amination polyethyleneimine solution. Excess benzyl chloride was added to the tertiary amination polyethyleneimine solution, and the mixture was stirred at 50-55°C for 6-8 hours. The excess benzyl chloride was then extracted with diethyl ether, and the mixture was dried under vacuum to obtain quaternary amination polyethyleneimine.

[0015] (2) Preparation of polylactic acid nanoparticles

[0016] Polylactic acid (PLA) is added to a mixture of acetone and ethanol at a ratio of 100:1. The mixture is sonicated for 10-15 minutes to fully dissolve the PLA. The dissolved PLA is then slowly added dropwise to deionized water under stirring. The mixture is homogenized at high speed for 5-10 minutes. After the organic solvent evaporates, PLA nanoparticles with uniform particle size are formed.

[0017] (3) Preparation of polylactic acid / quaternized polyethyleneimine composite nanoparticles

[0018] By weight percentage, 35% quaternized polyethyleneimine and 65% polylactic acid nanoparticles are mixed evenly and then melt-blended and extruded at 120-160℃ to obtain polylactic acid / quaternized polyethyleneimine composite nanoparticles.

[0019] (4) Preparation of polylactic acid / quaternized polyethyleneimine composite nano-aqueous lubricant

[0020] ① Weigh 0.4-0.6g of polylactic acid / quaternized polyethyleneimine composite nanoparticles, 4-6g of co-surfactant, and 10-20g of base oil, heat to 80-90℃, and stir rapidly to obtain solution A;

[0021] ② Weigh 8-10g of nonionic surfactant, 5-8g of defoamer, and 55-75g of deionized water, stir well, and prepare solution B;

[0022] ③ Slowly add solution B to solution A, continue heating and stirring for 2-3 hours, and after cooling, obtain polylactic acid / quaternized polyethyleneimine composite nano water-based lubricant;

[0023] The preferred stirring speed in steps ① and ③ is 800-1000 r / min.

[0024] Compared with the prior art, the present invention has the following advantages:

[0025] The composite nano-aqueous lubricant for medical devices provided by this invention utilizes the synergistic effect of nano-polylactic acid particles and quaternized polyethyleneimine to improve the structural stability of the nanoparticles. The nanoparticles are stably dispersed, and the addition of polylactic acid nanoparticles and quaternized polyethyleneimine provides excellent anti-wear and friction-reducing properties, and also plays a certain role in repairing worn surfaces. The nanoparticles contain a large number of hydroxyl groups and unsaturated bonds, which can form a strong chemical adsorption film on the friction surface. The molecular chain of the quaternized polyethyleneimine corrosion inhibitor has dense quaternary ammonium ions, which generate a strong physical adsorption effect with the metal surface, thereby forming a strong and dense adsorption film on the metal surface. The synergistic effect of the two protects the metal friction surface and extends the service life of medical devices. The polylactic acid nanoparticles have good biodegradability, and the quaternized polyethyleneimine has good sustained-release properties for metal materials, making it environmentally friendly.

[0026] The lubricant provided by this invention is a water-soluble lubricant with good stability. It leaves no white residue after cleaning and has excellent lubrication effect. It also has good biodegradability, enabling comprehensive lubrication protection for medical devices. Detailed Implementation

[0027] The present invention provides a composite nano-aqueous lubricant for medical devices, comprising nanoparticles, a nonionic surfactant, a corrosion inhibitor, a co-surfactant, a defoamer, and a base oil; wherein the nanoparticles are polylactic acid nanoparticles with a mass fraction of 0.2-0.4%. The particle size of the polylactic acid nanoparticles is 10-50 nm; the corrosion inhibitor is quaternized polyethyleneimine; the defoamer is a polyoxyethylene-polyoxypropylene block copolymer; and the base oil is castor oil. The preparation method of the composite nano-aqueous lubricant for medical devices includes (1) preparation of quaternized polyethyleneimine, (2) preparation of polylactic acid nanoparticles, (3) preparation of polylactic acid / quaternized polyethyleneimine composite nanoparticles, and (4) preparation of polylactic acid / quaternized polyethyleneimine composite nano-aqueous lubricant.

[0028] The present invention will be further described below with reference to the preparation examples:

[0029] Example 1

[0030] A composite nano-aqueous lubricant for medical devices and its preparation method

[0031] (1) Preparation of Quaternized Polyethyleneimine

[0032] Under stirring, propylene oxide was slowly added dropwise to the polyethyleneimine solution. After the addition was complete, the mixture was stirred at room temperature for 6 hours, and then heated and stirred at 40°C for 1 hour to obtain a tertiary amination polyethyleneimine solution. Excess benzyl chloride was added to the tertiary amination polyethyleneimine solution, and the mixture was stirred at 55°C for 6 hours. The excess benzyl chloride was extracted with diethyl ether and dried under vacuum to obtain quaternary amination polyethyleneimine.

[0033] (2) Preparation of polylactic acid nanoparticles

[0034] Polylactic acid (PLA) was added to a mixture of acetone and ethanol at a ratio of 100:1. The mixture was sonicated for 15 minutes to fully dissolve the PLA. The dissolved PLA was then slowly added dropwise to deionized water under stirring. The mixture was homogenized at high speed for 5 minutes. After the organic solvent evaporated, PLA nanoparticles with uniform particle size were formed.

[0035] (3) Preparation of polylactic acid / quaternized polyethyleneimine composite nanoparticles

[0036] By weight percentage, 35% quaternized polyethyleneimine and 65% polylactic acid nanoparticles are mixed evenly and then melt-blended and extruded at 140°C to obtain polylactic acid / quaternized polyethyleneimine composite nanoparticles.

[0037] (4) Preparation of polylactic acid / quaternized polyethyleneimine composite nano-aqueous lubricant

[0038] ① Weigh 0.4g of polylactic acid / quaternized polyethyleneimine composite nanoparticles, 4g of polyethylene glycol 400, 4g of Span-60, and 20g of castor oil, heat to 90℃, and stir rapidly to obtain solution A;

[0039] ② Weigh out 6g of Tween-80, 6g of polyoxyethylene-polyoxypropylene block copolymer, and 57.6g of deionized water, stir well, and prepare solution B;

[0040] ③ Slowly add solution B to solution A, continue heating and stirring for 3 hours, and after cooling, obtain polylactic acid / quaternized polyethyleneimine composite nano water-based lubricant;

[0041] The preferred stirring speed in steps ① and ③ is 800-1000 r / min.

[0042] Example 2

[0043] A composite nano-aqueous lubricant for medical devices and its preparation method

[0044] (1) Preparation of Quaternized Polyethyleneimine

[0045] Under stirring, propylene oxide was slowly added dropwise to the polyethyleneimine solution. After the addition was complete, the mixture was stirred at room temperature for 6 hours, and then heated and stirred at 40°C for 1 hour to obtain a tertiary amination polyethyleneimine solution. Excess benzyl chloride was added to the tertiary amination polyethyleneimine solution, and the mixture was stirred at 55°C for 6 hours. The excess benzyl chloride was extracted with diethyl ether and dried under vacuum to obtain quaternary amination polyethyleneimine.

[0046] (2) Preparation of polylactic acid nanoparticles

[0047] Polylactic acid (PLA) was added to a mixture of acetone and ethanol at a ratio of 100:1. The mixture was sonicated for 15 minutes to fully dissolve the PLA. The dissolved PLA was then slowly added dropwise to deionized water under stirring. The mixture was homogenized at high speed for 10 minutes. After the organic solvent evaporated, PLA nanoparticles with uniform particle size were formed.

[0048] (3) Preparation of polylactic acid / quaternized polyethyleneimine composite nanoparticles

[0049] By weight percentage, 35% quaternized polyethyleneimine and 65% polylactic acid nanoparticles are mixed evenly and then melt-blended and extruded at 140°C to obtain polylactic acid / quaternized polyethyleneimine composite nanoparticles.

[0050] (4) Preparation of polylactic acid / quaternized polyethyleneimine composite nano-aqueous lubricant

[0051] ① Weigh 0.5g of polylactic acid / quaternized polyethyleneimine composite nanoparticles, 5g of n-butanol, and 15g of castor oil, heat to 90℃, and stir rapidly to obtain solution A;

[0052] ② Weigh 10g of fatty alcohol polyoxyethylene ether, 6g of polyoxyethylene polyoxypropylene block copolymer, and 63.5g of deionized water, stir evenly, and prepare solution B;

[0053] ③ Slowly add solution B to solution A, continue heating and stirring for 3 hours, and after cooling, obtain polylactic acid / quaternized polyethyleneimine composite nano water-based lubricant;

[0054] The preferred stirring speed in steps ① and ③ is 800-1000 r / min.

[0055] Example 3

[0056] A composite nano-aqueous lubricant for medical devices and its preparation method

[0057] (1) Preparation of Quaternized Polyethyleneimine

[0058] Under stirring, propylene oxide was slowly added dropwise to the polyethyleneimine solution. After the addition was complete, the mixture was stirred at room temperature for 6 hours, and then heated and stirred at 40°C for 1 hour to obtain a tertiary amination polyethyleneimine solution. Excess benzyl chloride was added to the tertiary amination polyethyleneimine solution, and the mixture was stirred at 55°C for 6 hours. The excess benzyl chloride was extracted with diethyl ether and dried under vacuum to obtain quaternary amination polyethyleneimine.

[0059] (2) Preparation of polylactic acid nanoparticles

[0060] Polylactic acid (PLA) was added to a mixture of acetone and ethanol at a ratio of 100:1. The mixture was sonicated for 15 minutes to fully dissolve the PLA. The dissolved PLA was then slowly added dropwise to deionized water under stirring. The mixture was homogenized at high speed for 10 minutes. After the organic solvent evaporated, PLA nanoparticles with uniform particle size were formed.

[0061] (3) Preparation of polylactic acid / quaternized polyethyleneimine composite nanoparticles

[0062] By weight percentage, 35% quaternized polyethyleneimine and 65% polylactic acid nanoparticles are mixed evenly and then melt-blended and extruded at 140°C to obtain polylactic acid / quaternized polyethyleneimine composite nanoparticles.

[0063] (4) Preparation of polylactic acid / quaternized polyethyleneimine composite nano-aqueous lubricant

[0064] ① Weigh 0.6g of polylactic acid / quaternized polyethyleneimine composite nanoparticles, 4g of monoglyceride, and 15g of castor oil, heat to 90℃, and stir rapidly to obtain solution A;

[0065] ② Weigh 8g of glucoside, 6g of polyoxyethylene-polyoxypropylene block copolymer, and 66.4g of deionized water, stir well, and prepare solution B;

[0066] ③ Slowly add solution B to solution A, continue heating and stirring for 3 hours, and after cooling, obtain polylactic acid / quaternized polyethyleneimine composite nano water-based lubricant;

[0067] The preferred stirring speed in steps ① and ③ is 800-1000 r / min.

[0068] The performance of the lubricants described in Examples 1-3 was tested below, including friction performance and whether white spots were left.

[0069] Stainless steel test strips measuring 50mm*50mm*0.2mm were placed in the lubricant samples, control samples (without composite nanoparticles), and blank samples (tap water) described in Examples 1-3, respectively, and completely immersed for 30 seconds. After immersion, the strips were removed and allowed to air dry naturally, and the presence of white spots was observed. The coefficient of friction was measured using a KES-SE-STP friction detector according to the test conditions in Table 1. The average friction force over a 20mm interval was recorded as the average coefficient of friction (MIU), and the average deviation of the MIU was represented by MMD.

[0070] Table 1

[0071] speed 1.0mm / sec Friction sensor silicon .

[0072] Figure 1 The higher the MIU value, the greater the friction and the rougher the surface.

[0073] Table 2 shows the residual status of vitiligo.

[0074] Hand washing No white spots No white spots No white spots White spots Machine cleaning No white spots No white spots No white spots White spots .

[0075] As can be seen, compared with emulsion-type lubricants, the instrument surface after cleaning with this invention does not have white spots.

[0076] Those skilled in the art should understand that the above embodiments are merely illustrative and not intended to limit the scope of protection of the invention. After reading the description of this invention, those skilled in the art can make various alterations or modifications to the invention, and these equivalent changes and modifications also fall within the scope defined by the claims of this invention.

Claims

1. A composite nano-aqueous lubricant for medical devices, characterized in that, It is composed of nanoparticles, nonionic surfactants, corrosion inhibitors, co-surfactants, defoamers, and base oil; the nanoparticles are a composite of polylactic acid nanoparticles and quaternized polyethyleneimine nanoparticles, with a mass fraction of 0.2-0.4%; the particle size of the polylactic acid nanoparticles is 10-50 nm; the corrosion inhibitor is quaternized polyethyleneimine; the defoamer is polyoxyethylene-polyoxypropylene block copolymer; and the base oil is castor oil.

2. The composite nano-aqueous lubricant for medical devices according to claim 1, characterized in that, The nonionic surfactant is one or more of Tween-80, Span-60, fatty alcohol polyoxyethylene ether, and glucosinolate.

3. The composite nano-aqueous lubricant for medical devices according to claim 1, characterized in that, The co-surfactant is one or more combinations selected from polyethylene glycol 400, n-butanol, and monoglycerides.

4. The preparation method of the composite nano-aqueous lubricant for medical devices according to claim 1, characterized in that, It includes the preparation of (1) quaternized polyethyleneimine, (2) polylactic acid nanoparticles, (3) polylactic acid / quaternized polyethyleneimine composite nanoparticles, and then (4) polylactic acid / quaternized polyethyleneimine composite nano-waterborne lubricant.

5. The preparation method of the composite nano-aqueous lubricant for medical devices according to claim 4, characterized in that, The preparation of (1) quaternized polyethyleneimine includes: under stirring, propylene oxide is slowly added dropwise to a polyethyleneimine solution. After the addition is complete, the solution is stirred at room temperature for 6-8 hours, and then heated and stirred at 30-40°C for 1-2 hours to obtain a tertiary-amined polyethyleneimine solution. Excess benzyl chloride is added to the tertiary-amined polyethyleneimine solution, and the solution is stirred at 50-55°C for 6-8 hours. Excess benzyl chloride is extracted with diethyl ether, and the solution is dried under vacuum to obtain quaternized polyethyleneimine.

6. The preparation method of the composite nano-aqueous lubricant for medical devices according to claim 4, characterized in that, The preparation of polylactic acid nanoparticles (2) includes adding polylactic acid to a mixed phase of acetone and ethanol, with a ratio of 100:1 between the mixed phase and polylactic acid. The polylactic acid is fully dissolved by sonication for 10-15 minutes. Under stirring conditions, the dissolved polylactic acid is slowly added dropwise to deionized water and homogenized at high speed for 5-10 minutes. After the organic solvent evaporates, polylactic acid nanoparticles with uniform particle size are formed.

7. The preparation method of the composite nano-aqueous lubricant for medical devices according to claim 4, characterized in that, The preparation of polylactic acid / quaternary ammonium polyethyleneimine composite nanoparticles (3) includes mixing 35% quaternary ammonium polyethyleneimine and 65% polylactic acid nanoparticles by weight percentage, followed by melt blending and extrusion at 120-160°C to obtain polylactic acid / quaternary ammonium polyethyleneimine composite nanoparticles.

8. The preparation method of the composite nano-aqueous lubricant for medical devices according to claim 4, characterized in that, The preparation of the polylactic acid / quaternized polyethyleneimine composite nano-aqueous lubricant (4) includes: ① Weigh 0.4-0.6g of polylactic acid / quaternized polyethyleneimine composite nanoparticles, 4-6g of co-surfactant, and 10-20g of base oil, heat to 80-90℃, and stir rapidly to obtain solution A; ② Weigh 8-10g of nonionic surfactant, 5-8g of defoamer, and 55-75g of deionized water, stir well, and prepare solution B; ③ Slowly add solution B to solution A, continue heating and stirring for 2-3 hours, and after cooling, obtain polylactic acid / quaternized polyethyleneimine composite nano-waterborne lubricant.

9. The preparation method of the composite nano-aqueous lubricant for medical devices according to claim 8, characterized in that, Preferably, the stirring speed in steps ① and ③ is 800-1000 rpm.

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