High-barrier and anti-leakage packaging bag for storing medical equipment and preparation method of high-barrier and anti-leakage packaging bag

Abstract

The invention discloses a high-barrier anti-leakage packaging bag for storing medical instruments and a preparation method, and belongs to the technical field of packaging bag preparation. The high-barrier and anti-leakage packaging bag for storing the medical instruments is composed of an isolation layer, an adhesion layer and an inner wall layer, the isolation layer, the adhesion layer and the inner wall layer are sequentially arranged from outside to inside, the isolation layer is composed of composite polyester, the adhesion layer is composed of ethylene acrylic resin, and the inner wall layer is composed of polypropylene and an antibacterial agent. The packaging bag prepared by the method has excellent high-barrier anti-permeation performance, and also has excellent flame-retardant and antibacterial performance.

Description

Technical Field

[0001] The invention belongs to the technical field of packaging bag preparation, and in particular relates to a high-barrier and anti-leakage packaging bag for storing medical devices and a preparation method thereof. Background Art

[0002] The selection of packaging materials is crucial in the storage and transportation of medical devices. This is not only related to the safety and effectiveness of medical devices, but also directly affects the overall quality of medical services and the health and safety of patients. With the continuous advancement of medical technology and the growing demand for medical care, higher requirements are placed on the packaging of medical devices, especially in terms of barrier properties, anti-leakage properties and environmental protection.

[0003] There are many kinds of medical devices, including surgical instruments, diagnostic equipment, implantable devices, etc. These devices are made of different materials and have different packaging requirements. For example, some precision electronic medical devices need to be moisture-proof and dust-proof to avoid performance degradation or damage caused by environmental humidity and dust; while some devices that come into contact with human tissue or body fluids require packaging materials with excellent barrier properties to prevent the invasion of external microorganisms, moisture and oxygen, so as to ensure the sterility of the device and the effectiveness of long-term storage. Although traditional packaging materials such as polyolefins and PVC can meet the packaging needs of medical devices to a certain extent, they have obvious deficiencies in barrier properties, environmental protection and safety. The barrier properties of polyolefin packaging materials are not ideal, and it is difficult to effectively block the penetration of moisture and oxygen, which affects the shelf life and performance stability of medical devices. PVC materials are gradually being eliminated by the market due to their insufficient environmental protection and safety performance. Therefore, the development of a new type of high-barrier and leak-proof packaging bag has become an urgent problem to be solved in the field of medical device packaging.

[0004] Patent CN111483202A discloses a high-barrier anti-seepage heavy-duty packaging film and a preparation method thereof. The high-barrier anti-seepage heavy-duty packaging film comprises an outer layer, a middle layer and an inner layer which are co-extruded in sequence, wherein the outer layer comprises low-density polyethylene, linear low-density polyethylene, medium-density polyethylene, high-density polyethylene and ethylene-vinyl acetate copolymer; the middle layer comprises an adhesive resin; and the inner layer comprises a polyamide resin. The obtained high-barrier anti-seepage heavy-duty packaging film has not only mechanical properties but also excellent barrier properties. However, the barrier properties, anti-leakage properties and antibacterial properties of the packaging bag prepared by this method still have room for improvement. Summary of the invention

[0005] The object of the present invention is to provide a high-barrier and anti-leakage packaging bag for storing medical devices and a preparation method thereof, so as to solve the technical problems of poor barrier performance, anti-leakage performance and antibacterial performance of packaging bags in the prior art.

[0006] In order to achieve the above object, the present invention adopts the following technical solutions:

[0007] The present invention provides a high-barrier and anti-leakage packaging bag for storing medical devices. The packaging bag consists of an insulation layer, an adhesion layer and an inner wall layer, and the insulation layer, the adhesion layer and the inner wall layer are arranged in sequence from the outside to the inside. The insulation layer is composed of composite polyester, the adhesion layer is composed of ethylene acrylic resin, and the inner wall layer is composed of polypropylene and an antibacterial agent.

[0008] Preferably, the method for preparing the composite polyester comprises the following steps:

[0009] Q1: Add dimethyl methylphosphonate to a container, then add monobutyltin oxide, assemble a straight condenser, control the rotation speed and increase the temperature, then drop 1,5-pentanediol into the container, control the dropping speed, continue stirring the reaction, and after the reaction is completed, perform vacuum distillation to obtain intermediate product 1;

[0010] Q2: Add 5-amino-thiophene-2-carboxylic acid methyl ester, 2,5-thiophenedicarboxylic acid and intermediate product 1 into a container equipped with a nitrogen inlet, a mechanical stirring paddle and a hot water reflux spherical condenser, add titanium dioxide, heat to react, and after the reaction is completed, increase the temperature and reduce the pressure to carry out a condensation reaction. After the reaction is completed, a composite polyester is obtained.

[0011] In the above process, the synthetic reaction formula of the composite polyester is as follows:

[0012]

[0013] Preferably, in Q1, the molar ratio of dimethyl methylphosphonate, monobutyltin oxide and 1,5-pentanediol is (1-1.5): (0.03-0.05): (2-2.8), the rotation speed is controlled to be 300-350 rpm, the heating temperature is 170-180°C, the dropping speed is 2-3 drops / s, the stirring reaction time is 4-6h, and the reduced pressure distillation temperature is 140-145°C.

[0014] Preferably, in Q2, the molar ratio of 5-amino-thiophene-2-carboxylic acid methyl ester, 2,5-thiophenedicarboxylic acid, intermediate 1 and titanium dioxide is (0.8-1.3): (0.9-1.3): (2-2.5): (0.03-0.045), the heating reaction temperature is 180-200°C, the reaction time is 4-5h, the heating temperature is 230-240°C, the pressure is reduced to below 100Pa, and the reaction time is 3-5h.

[0015] Preferably, the method for preparing the antibacterial agent comprises the following steps:

[0016] S1: Add formoyl hydrazide and acetonitrile to a container, stir evenly, then add triphenylphosphine, then heat the container, add carbon tetrachloride dropwise using a constant pressure dropping funnel under a constant temperature environment, control the dropping time, continue to stir the reaction after the addition is completed, cool, filter, wash, and dry to obtain compound A;

[0017] S2: Sodium hydrosulfide is added to a container, followed by anhydrous ethanol, and stirred at low temperature. At the same time, 4-chlorobenzamide is slowly added dropwise using a constant pressure dropping funnel, and the dropping time is controlled. After the dropping is completed, the reaction is continued. After the reaction is completed, acidification, extraction, and the organic layers are combined, dried, and rotary evaporated to obtain compound B;

[0018] S3: Add phenylacetaldehyde and diethylamine to a container, then add dichloromethane, stir to dissolve, add compound A, and dropwise add a dichloromethane solution containing compound B at room temperature to react. After the reaction is completed, perform rotary evaporation and purification to obtain an antibacterial agent.

[0019] In the above process, formoyl hydrazide is first used as a raw material to react with triphenylphosphine, and then reflux dehydration is carried out under the action of carbon tetrachloride to obtain compound A. Subsequently, 4-chlorobenzamide and sodium hydrosulfide are used as raw materials to undergo a nucleophilic substitution reaction to prepare compound B. Finally, phenylacetaldehyde, diethylamine, compound A and compound B are reacted in dichloromethane as a solvent at room temperature to obtain an antibacterial agent.

[0020] Preferably, in S1, the dosage ratio of formic hydrazide, acetonitrile, triphenylphosphine and carbon tetrachloride is (10-20) g: (200-250) mL: (62.3-100) g: (40-80) mL, the heating temperature is 50-60°C, the dropwise addition time is 1-2 h, the stirring reaction temperature is continued at 50-60°C, the time is 2-3 h, the temperature is cooled to 30-35°C, and the mixture is washed with a mixed solution of petroleum ether and distilled water in a volume ratio of 20:1.

[0021] Preferably, in S2, the volume fraction of sodium hydrosulfide is 70vt%, the dosage ratio of sodium hydrosulfide, anhydrous ethanol and 4-chlorobenzamide is (0.21-0.4)g: (80-140)mL: (0.2-0.4)g, the low temperature environment is 10-12°C, the dropwise addition time is 2-3h, the continued reaction time is 1-2h, acidification is performed with 0.6mol / L hydrochloric acid, extraction is performed with ether, and drying is performed with anhydrous sodium sulfate.

[0022] Preferably, in S3, the molar ratio of phenylacetaldehyde, diethylamine, compound A and compound B is (1-2): (1.1-1.9): (1.1-1.8): (1-2.1), the stirring and dissolving time is 30-45 min, the reaction time is 1-1.5 h, and the eluent in the purification process is a mixed solution of petroleum ether and ethyl acetate in a volume ratio of 40:1.

[0023] Preferably, the method for preparing the high barrier and leak-proof packaging bag for storing medical devices comprises the following steps:

[0024] Step 1: adding the composite polyester and ethylene acrylic resin into the first screw extruder and the second screw extruder respectively, extruding and molding, and obtaining the insulating layer material and the adhesive layer material;

[0025] Step 2: After the polypropylene and the antibacterial agent are evenly mixed, they are added into a third screw extruder, extruded, and formed to obtain an inner wall layer material;

[0026] Step 3: Evenly apply the adhesive layer material between the insulating layer material and the inner wall layer material by hot pressing, and then bond, cool, shape, cut, make bags, and sterilize to obtain a high-barrier and leak-proof packaging bag for storing medical devices.

[0027] In summary, due to the adoption of the above technical solution, the beneficial effects of the present invention are:

[0028] 1. The present invention first uses dimethyl methylphosphonate, 1,5-pentanediol, 5-amino-thiophene-2-carboxylic acid methyl ester and 2,5-thiophene dicarboxylic acid as raw materials to prepare a composite polyester, and then uses formoyl hydrazide 、 Triphenylphosphine 、 Sodium Hydrosulfide 、 4-Chlorobenzamide 、 An antibacterial agent is prepared by using phenylacetaldehyde and diethylamine as raw materials. Using the composite polyester as the insulating layer of the packaging bag can effectively improve its barrier and anti-leakage performance, and can also improve its toughness and flame retardant properties. After mixing the antibacterial agent with polypropylene, an inner wall layer is prepared and applied to the packaging bag, which can effectively improve its antibacterial performance and avoid contamination of medical devices.

[0029] 2. The present invention uses the obtained composite polyester as an insulating layer of a packaging bag, so that it has excellent barrier and anti-leakage performance, toughness and flame retardancy. The intermediate product 1 obtained by the reaction of dimethyl methylphosphonate and 1,5-pentanediol contains high-energy phosphorus-oxygen bonds and ester bonds, thereby making the molecular chain of the intermediate product 1 more stable and not easily penetrated by gas molecules. The presence of phosphorus can also form a cross-linked structure with other elements in the polyester molecular chain, further enhancing the compactness and stability of the molecular chain and improving the gas barrier performance of the packaging bag; and the intermediate product 1, 5-amino-thiophene-2-carboxylic acid methyl ester and 2 The molecular structure of the composite polyester prepared by the reaction of 5-thiophenedicarboxylic acid contains functional groups such as thiophene rings and ester bonds. The presence of these functional groups can form complex intermolecular interactions, further enhancing the compactness and stability of the molecular chain. The random arrangement of these functional groups requires gas molecules to pass through longer paths and obstacles when penetrating the packaging bag, thereby improving the gas barrier performance. At the same time, the composite polyester has a random copolyester molecular chain with excellent toughness, which enables the packaging bag to better resist deformation and fracture when subjected to external forces, thereby improving toughness. The presence of phosphorus and thiophene rings can effectively improve its flame retardant properties.

[0030] 3. The present invention mixes the prepared antibacterial agent with polypropylene to obtain the inner wall layer of the packaging bag, which has excellent antibacterial properties. The active groups contained in the antibacterial agent can be continuously released and react with the bacteria in contact to inhibit the growth and reproduction of bacteria. Polypropylene, as the main material of the inner wall layer of the packaging bag, has good physical properties and chemical stability, can protect the antibacterial agent from the influence of the external environment, and extend the service life of the packaging bag. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0032] Figure 1 It is a cross-sectional view of a high-barrier and leak-proof packaging bag for storing medical devices prepared by the present invention.

[0033] Description of the drawings: 1. Isolation layer, 2. Adhesion layer, 3. Inner wall layer. DETAILED DESCRIPTION

[0034] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0035] Embodiment 1: This embodiment discloses a method for preparing a composite polyester, comprising the following steps:

[0036] Q1: 1.55 g of dimethyl methylphosphonate was added to a container, followed by 0.078 g of monobutyltin oxide, and a straight condenser was assembled. The rotation speed was controlled to 350 rpm and the temperature was raised to 180°C. Then 2.5 g of 1,5-pentanediol was added dropwise to the container, and the dropwise addition rate was controlled to 2 drops / s. The reaction was continued by stirring for 6 h. After the reaction was completed, the reaction was performed under reduced pressure distillation at 145°C to obtain an intermediate product 1.

[0037] Q2: 0.83 g of 5-amino-thiophene-2-carboxylic acid methyl ester, 0.95 g of 2,5-thiophenedicarboxylic acid and 2.21 g of intermediate product 1 were added to a container equipped with a nitrogen inlet, a mechanical stirring paddle and a hot water reflux spherical condenser, and 0.015 g of titanium dioxide was added. The mixture was heated at 200°C for 5 h. After the reaction, the temperature was raised to 230°C and the pressure was reduced to below 100 Pa. The polycondensation reaction was carried out for 4 h. After the reaction was completed, a composite polyester was obtained.

[0038] This embodiment discloses a method for preparing an antibacterial agent, comprising the following steps:

[0039] S1: 15 g of formic hydrazide and 225 mL of acetonitrile were added to a container, and 81 g of triphenylphosphine was added after stirring evenly. The container was then heated to 60°C. Under a constant temperature environment, 60 mL of carbon tetrachloride was added dropwise using a constant pressure dropping funnel. The dropping time was controlled to be 1 h. After the dropping was completed, the reaction was continued at 60°C with stirring for 3 h. After the reaction was completed, the temperature was lowered to 35°C, filtered, washed with a mixed solution of petroleum ether and distilled water in a volume ratio of 20:1, and dried to obtain compound A;

[0040] S2: 0.3 g of sodium hydrosulfide with a volume fraction of 70 vt% was added to the container, followed by 110 mL of anhydrous ethanol, and stirred at a low temperature of 10°C. At the same time, 0.3 g of 4-chlorobenzamide was slowly added dropwise using a constant pressure dropping funnel, and the dropping time was controlled to be 2 h. After the addition was completed, the reaction was continued for 2 h. After the reaction was completed, it was acidified with 0.6 mol / L hydrochloric acid, extracted with ether, the organic layers were combined, dried with anhydrous sodium sulfate, and rotary evaporated to obtain compound B;

[0041] S3: Add 0.9g of phenylacetaldehyde and 0.55g of diethylamine to a container, then add 5mL of dichloromethane, stir and dissolve for 45 minutes, then add 1.4g of compound A, and drop 3mL of dichloromethane solution containing 1.34g of compound B at room temperature. React for 1.5h. After the reaction is completed, perform rotary evaporation and purification. The eluent in the purification process is a mixed solution of petroleum ether and ethyl acetate in a volume ratio of 40:1 to obtain an antibacterial agent.

[0042] This embodiment discloses a method for preparing a high-barrier and leak-proof packaging bag for storing medical devices, comprising the following steps:

[0043] Step 1: Add 40 parts of composite polyester and 15 parts of ethylene acrylic acid resin into the first screw extruder and the second screw extruder respectively according to weight, extrude and shape, and obtain an insulating layer material and an adhesive layer material;

[0044] Step 2: According to weight parts, 45 parts of polypropylene and 10 parts of antibacterial agent are mixed evenly, and then added into a third screw extruder, extruded, and formed to obtain an inner wall layer material;

[0045] Step 3: Evenly apply the adhesive layer material between the insulating layer material and the inner wall layer material by hot pressing, and then bond, cool, shape, cut, make bags, and sterilize to obtain a high-barrier and leak-proof packaging bag for storing medical devices.

[0046] Embodiment 2: This embodiment discloses a method for preparing a composite polyester, comprising the following steps:

[0047] Q1: 1.24 g of dimethyl methylphosphonate was added to a container, followed by 0.058 g of monobutyltin oxide, a straight condenser was assembled, the rotation speed was controlled to 350 rpm and the temperature was raised to 180°C, and then 2.08 g of 1,5-pentanediol was added dropwise to the container, the dropwise addition rate was controlled to 2 drops / s, and the reaction was continued with stirring for 6 h. After the reaction was completed, the reaction was distilled under reduced pressure at 145°C to obtain intermediate 1;

[0048] Q2: 0.63 g of 5-amino-thiophene-2-carboxylic acid methyl ester, 0.77 g of 2,5-thiophenedicarboxylic acid and 1.96 g of intermediate product 1 were added to a container equipped with a nitrogen inlet, a mechanical stirring paddle and a hot water reflux spherical condenser, and 0.012 g of titanium dioxide was added. The mixture was heated at 200°C for 5 h. After the reaction, the temperature was raised to 230°C and the pressure was reduced to below 100 Pa. The polycondensation reaction was carried out for 4 h. After the reaction was completed, a composite polyester was obtained.

[0049] This embodiment discloses a method for preparing an antibacterial agent, comprising the following steps:

[0050] S1: 10 g of formic hydrazide and 200 mL of acetonitrile were added to a container, and 62.3 g of triphenylphosphine was added after stirring evenly. The container was then heated to 60°C. Under a constant temperature environment, 40 mL of carbon tetrachloride was added dropwise using a constant pressure dropping funnel. The dropping time was controlled to be 1 h. After the dropping was completed, the reaction was continued at 60°C with stirring for 3 h. After the reaction was completed, the temperature was lowered to 35°C, filtered, washed with a mixed solution of petroleum ether and distilled water in a volume ratio of 20:1, and dried to obtain compound A;

[0051] S2: 0.21 g of sodium hydrosulfide with a volume fraction of 70 vt% was added to the container, followed by 80 mL of anhydrous ethanol, and stirred at a low temperature of 10°C. At the same time, 0.4 g of 4-chlorobenzamide was slowly added dropwise using a constant pressure dropping funnel, and the dropping time was controlled to be 2 h. After the addition was completed, the reaction was continued for 2 h. After the reaction was completed, it was acidified with 0.6 mol / L hydrochloric acid, extracted with ether, the organic layers were combined, dried with anhydrous sodium sulfate, and rotary evaporated to obtain compound B;

[0052] S3: Add 0.6g of phenylacetaldehyde and 0.4g of diethylamine to a container, then add 5mL of dichloromethane, stir and dissolve for 45 minutes, then add 1.1g of compound A, and drop 3mL of dichloromethane solution containing 0.86g of compound B at room temperature. React for 1.5h. After the reaction is completed, perform rotary evaporation and purification. The eluent in the purification process is a mixed solution of petroleum ether and ethyl acetate in a volume ratio of 40:1 to obtain an antibacterial agent.

[0053] This embodiment discloses a method for preparing a high-barrier and leak-proof packaging bag for storing medical devices, comprising the following steps:

[0054] Step 1: Add 30 parts of composite polyester and 10 parts of ethylene acrylic resin into the first screw extruder and the second screw extruder respectively according to weight, extrude and shape, and obtain an insulating layer material and an adhesive layer material;

[0055] Step 2: According to weight parts, 50 parts of polypropylene and 8 parts of antibacterial agent are mixed evenly, and then added into a third screw extruder, extruded, and formed to obtain an inner wall layer material;

[0056] Step 3: Evenly apply the adhesive layer material between the insulating layer material and the inner wall layer material by hot pressing, and then bond, cool, shape, cut, make bags, and sterilize to obtain a high-barrier and leak-proof packaging bag for storing medical devices.

[0057] Embodiment 3: This embodiment discloses a method for preparing a composite polyester, comprising the following steps:

[0058] Q1: 1.86 g of dimethyl methylphosphonate was added to a container, followed by 0.097 g of monobutyltin oxide, a straight condenser was assembled, the rotation speed was controlled to 350 rpm and the temperature was raised to 180°C, and then 2.91 g of 1,5-pentanediol was added dropwise to the container, the dropwise addition rate was controlled to 2 drops / s, and the reaction was continued by stirring for 6 h. After the reaction was completed, the reaction was distilled under reduced pressure at 145°C to obtain an intermediate product 1;

[0059] Q2: 1.02 g of 5-amino-thiophene-2-carboxylic acid methyl ester, 1.12 g of 2,5-thiophenedicarboxylic acid and 2.45 g of intermediate product 1 were added to a container equipped with a nitrogen inlet, a mechanical stirring paddle and a hot water reflux spherical condenser, and 0.018 g of titanium dioxide was added. The mixture was heated at 200°C for 5 h. After the reaction, the temperature was raised to 230°C and the pressure was reduced to below 100 Pa. The polycondensation reaction was carried out for 4 h. After the reaction was completed, a composite polyester was obtained.

[0060] This embodiment discloses a method for preparing an antibacterial agent, comprising the following steps:

[0061] S1: Add 20 g of formic hydrazide and 250 mL of acetonitrile to a container, stir evenly, then add 100 g of triphenylphosphine, then heat the container to 60°C, add 80 mL of carbon tetrachloride dropwise with a constant pressure dropping funnel under a constant temperature environment, and control the dropping time to be 1 h. After the dropping is completed, continue to stir and react at 60°C for 3 h. After the reaction is completed, cool to 35°C, filter, wash with a mixed solution of petroleum ether and distilled water with a volume ratio of 20:1, and dry to obtain compound A;

[0062] S2: 0.4 g of sodium hydrosulfide with a volume fraction of 70 vt% was added to the container, followed by 140 mL of anhydrous ethanol, and stirred at a low temperature of 10°C. At the same time, 0.2 g of 4-chlorobenzamide was slowly added dropwise using a constant pressure dropping funnel, and the dropping time was controlled to be 2 h. After the addition was completed, the reaction was continued for 2 h. After the reaction was completed, it was acidified with 0.6 mol / L hydrochloric acid, extracted with ether, the organic layers were combined, dried with anhydrous sodium sulfate, and rotary evaporated to obtain compound B;

[0063] S3: Add 1.2g of phenylacetaldehyde and 0.7g of diethylamine to a container, then add 5mL of dichloromethane, stir and dissolve for 45 minutes, then add 1.7g of compound A, and drop 3mL of dichloromethane solution containing 1.81g of compound B at room temperature. React for 1.5h. After the reaction is completed, perform rotary evaporation and purification. The eluent in the purification process is a mixed solution of petroleum ether and ethyl acetate in a volume ratio of 40:1 to obtain an antibacterial agent.

[0064] This embodiment discloses a method for preparing a high-barrier and leak-proof packaging bag for storing medical devices, comprising the following steps:

[0065] Step 1: Add 50 parts of composite polyester and 20 parts of ethylene acrylic resin into the first screw extruder and the second screw extruder respectively according to weight, extrude and shape, and obtain an insulating layer material and an adhesive layer material;

[0066] Step 2: According to weight parts, 40 parts of polypropylene and 12 parts of antibacterial agent are mixed evenly, and then added into a third screw extruder, extruded, and formed to obtain an inner wall layer material;

[0067] Step 3: Evenly apply the adhesive layer material between the insulating layer material and the inner wall layer material by hot pressing, and then bond, cool, shape, cut, make bags, and sterilize to obtain a high-barrier and leak-proof packaging bag for storing medical devices.

[0068] Embodiment 4: This embodiment discloses a method for preparing a composite polyester, comprising the following steps:

[0069] Q1: 1.34 g of dimethyl methylphosphonate was added to a container, followed by 0.063 g of monobutyltin oxide, a straight condenser was assembled, the rotation speed was controlled to 350 rpm and the temperature was raised to 180°C, and then 2.29 g of 1,5-pentanediol was added dropwise to the container, the dropwise addition rate was controlled to 2 drops / s, and the reaction was continued with stirring for 6 h. After the reaction was completed, the reaction was distilled under reduced pressure at 145°C to obtain an intermediate product 1;

[0070] Q2: 0.75 g of 5-amino-thiophene-2-carboxylic acid methyl ester, 0.83 g of 2,5-thiophenedicarboxylic acid and 2.11 g of intermediate product 1 were added to a container equipped with a nitrogen inlet, a mechanical stirring paddle and a hot water reflux spherical condenser, and 0.013 g of titanium dioxide was added. The mixture was heated at 200°C for 5 h. After the reaction, the temperature was raised to 230°C and the pressure was reduced to below 100 Pa. The polycondensation reaction was carried out for 4 h. After the reaction was completed, a composite polyester was obtained.

[0071] This embodiment discloses a method for preparing an antibacterial agent, comprising the following steps:

[0072] S1: Add 12g of formic hydrazide and 210mL of acetonitrile to a container, stir evenly, then add 75g of triphenylphosphine, then heat the container to 60°C, add 50mL of carbon tetrachloride dropwise with a constant pressure dropping funnel under a constant temperature environment, and control the dropping time to be 1h. After the dropping is completed, continue to stir and react at 60°C for 3h. After the reaction is completed, cool to 35°C, filter, wash with a mixed solution of petroleum ether and distilled water with a volume ratio of 20:1, and dry to obtain compound A;

[0073] S2: 0.28 g of sodium hydrosulfide with a volume fraction of 70 vt% was added to the container, followed by 120 mL of anhydrous ethanol, and stirred at a low temperature of 10°C. At the same time, 0.25 g of 4-chlorobenzamide was slowly added dropwise using a constant pressure dropping funnel, and the dropping time was controlled to be 2 h. After the addition was completed, the reaction was continued for 2 h. After the reaction was completed, it was acidified with 0.6 mol / L hydrochloric acid, extracted with ether, the organic layers were combined, dried with anhydrous sodium sulfate, and rotary evaporated to obtain compound B;

[0074] S3: Add 0.8g of phenylacetaldehyde and 0.5g of diethylamine to a container, then add 5mL of dichloromethane, stir and dissolve for 45 minutes, then add 1.3g of compound A, and drop 3mL of dichloromethane solution containing 0.95g of compound B at room temperature. React for 1.5h. After the reaction is completed, perform rotary evaporation and purification. The eluent in the purification process is a mixed solution of petroleum ether and ethyl acetate in a volume ratio of 40:1 to obtain an antibacterial agent.

[0075] This embodiment discloses a method for preparing a high-barrier and leak-proof packaging bag for storing medical devices, comprising the following steps:

[0076] Step 1: Add 35 parts of composite polyester and 18 parts of ethylene acrylic resin into a first screw extruder and a second screw extruder respectively according to weight, extrude and shape, and obtain an insulating layer material and an adhesive layer material;

[0077] Step 2: According to weight parts, 43 parts of polypropylene and 9 parts of antibacterial agent are mixed evenly, and then added into a third screw extruder, extruded, and formed to obtain an inner wall layer material;

[0078] Step 3: Evenly apply the adhesive layer material between the insulating layer material and the inner wall layer material by hot pressing, and then bond, cool, shape, cut, make bags, and sterilize to obtain a high-barrier and leak-proof packaging bag for storing medical devices.

[0079] Embodiment 5: This embodiment discloses a method for preparing a composite polyester, comprising the following steps:

[0080] Q1: 1.71 g of dimethyl methylphosphonate was added to a container, followed by 0.082 g of monobutyltin oxide, and a straight condenser was assembled. The rotation speed was controlled to 350 rpm and the temperature was raised to 180°C. Then 2.73 g of 1,5-pentanediol was added dropwise to the container, and the dropwise addition rate was controlled to 2 drops / s. The reaction was continued by stirring for 6 h. After the reaction was completed, the reaction was distilled under reduced pressure at 145°C to obtain an intermediate product 1.

[0081] Q2: 0.93 g of 5-amino-thiophene-2-carboxylic acid methyl ester, 1.05 g of 2,5-thiophenedicarboxylic acid and 2.35 g of intermediate product 1 were added to a container equipped with a nitrogen inlet, a mechanical stirring paddle and a hot water reflux spherical condenser, and 0.016 g of titanium dioxide was added. The mixture was heated at 200°C for 5 h. After the reaction, the temperature was raised to 230°C and the pressure was reduced to below 100 Pa. The polycondensation reaction was carried out for 4 h. After the reaction was completed, a composite polyester was obtained.

[0082] This embodiment discloses a method for preparing an antibacterial agent, comprising the following steps:

[0083] S1: 18 g of formic hydrazide and 240 mL of acetonitrile were added to a container, and 92 g of triphenylphosphine was added after stirring evenly. The container was then heated to 60°C. Under a constant temperature environment, 70 mL of carbon tetrachloride was added dropwise using a constant pressure dropping funnel. The dropping time was controlled to be 1 h. After the dropping was completed, the reaction was continued at 60°C with stirring for 3 h. After the reaction was completed, the temperature was lowered to 35°C, filtered, washed with a mixed solution of petroleum ether and distilled water in a volume ratio of 20:1, and dried to obtain compound A;

[0084] S2: 0.35 g of sodium hydrosulfide with a volume fraction of 70 vt% was added to the container, followed by 90 mL of anhydrous ethanol, and stirred at a low temperature of 10°C. At the same time, 0.35 g of 4-chlorobenzamide was slowly added dropwise using a constant pressure dropping funnel, and the dropping time was controlled to be 2 h. After the addition was completed, the reaction was continued for 2 h. After the reaction was completed, it was acidified with 0.6 mol / L hydrochloric acid, extracted with ether, the organic layers were combined, dried with anhydrous sodium sulfate, and rotary evaporated to obtain compound B;

[0085] S3: Add 1.1g of phenylacetaldehyde and 0.6g of diethylamine to a container, then add 5mL of dichloromethane, stir and dissolve for 45 minutes, then add 1.5g of compound A, and drop 3mL of dichloromethane solution containing 1.47g of compound B at room temperature. React for 1.5h. After the reaction is completed, perform rotary evaporation and purification. The eluent in the purification process is a mixed solution of petroleum ether and ethyl acetate in a volume ratio of 40:1 to obtain an antibacterial agent.

[0086] This embodiment discloses a method for preparing a high-barrier and leak-proof packaging bag for storing medical devices, comprising the following steps:

[0087] Step 1: Add 45 parts of composite polyester and 12 parts of ethylene acrylic resin into a first screw extruder and a second screw extruder respectively according to weight, extrude and shape, and obtain an insulating layer material and an adhesive layer material;

[0088] Step 2: According to weight parts, 47 parts of polypropylene and 11 parts of antibacterial agent are mixed evenly, and then added into a third screw extruder, extruded, and formed to obtain an inner wall layer material;

[0089] Step 3: Evenly apply the adhesive layer material between the insulating layer material and the inner wall layer material by hot pressing, and then bond, cool, shape, cut, make bags, and sterilize to obtain a high-barrier and leak-proof packaging bag for storing medical devices.

[0090] Comparative Example 1: Compared with Example 1, in Comparative Example 1, during the preparation of the composite polyester, dimethyl methylphosphonate was not added, and other conditions remained unchanged.

[0091] Comparative Example 2: Compared with Example 1, in the preparation process of the antibacterial agent in Comparative Example 2, no triphenylphosphine was added, and other conditions remained unchanged.

[0092] Comparative Example 3: Compared with Example 1, in the preparation process of the packaging bag in Comparative Example 3, polypropylene is used instead of composite polyester, and other conditions remain unchanged.

[0093] Comparative Example 4: Compared with Example 1, in Comparative Example 4, no antibacterial agent is added during the preparation of the packaging bag, and other conditions remain unchanged.

[0094] Experimental example: The barrier properties of the samples were tested according to HG / T 4302-2012, the antibacterial properties of the samples were tested according to GB / T43722.1-2024, the flame retardant properties of the samples were tested according to GB / T 10707-2008, and the elongation at break of the samples was tested according to HG / T 2580-2022. The test results are shown in Table 1:

[0095] Table 1

[0096] project <![CDATA[Water vapor transmission rate / (g / (m 2 ·24 h))]]> Antibacterial rate / % Vertical burning level Elongation at break / % Example 1 0.019 99.5 FV-0 164.3 Example 2 0.021 99.3 FV-0 163.6 Example 3 0.020 99.4 FV-0 163.2 Example 4 0.021 99.1 FV-0 161.3 Example 5 0.020 99.2 FV-0 162.4 Comparative Example 1 0.035 99.1 FV-1 146.9 Comparative Example 2 0.022 94.1 FV-0 162.3 Comparative Example 3 0.038 99.0 FV-1 145.7 Comparative Example 4 0.022 93.2 FV-0 162.1

[0097] From the test results in Table 1, it can be seen that the packaging bags prepared in Examples 1-5 of the present invention have excellent barrier and anti-leakage performance, antibacterial performance, flame retardant performance and toughness. From the comparison between Comparative Example 1 and Examples 1-5, it can be seen that the addition of dimethyl methylphosphonate can make the packaging bag have excellent anti-leakage performance, flame retardant performance and toughness; from the comparison between Comparative Example 2 and Examples 1-5, it can be seen that the addition of triphenylphosphine can make the packaging bag have excellent antibacterial performance; from the comparison between Comparative Example 3 and Examples 1-5, it can be seen that the addition of composite polyester can make the packaging bag have excellent anti-leakage performance, flame retardant performance and toughness; from the comparison between Comparative Example 4 and Examples 1-5, it can be seen that the addition of an antibacterial agent can make the packaging bag have excellent antibacterial performance.

[0098] The above description is only a preferred specific implementation manner of the present invention, but the protection scope of the present invention is not limited thereto. Any technician familiar with the technical field can make equivalent replacements or changes according to the technical scheme and inventive concept of the present invention within the technical scope disclosed by the present invention, which should be covered by the protection scope of the present invention.

[0099] The preferred embodiments of the present invention disclosed above are only used to help explain the present invention. The preferred embodiments do not describe all the details in detail, nor do they limit the invention to only specific implementation methods. Obviously, many modifications and changes can be made according to the content of this specification. This specification selects and specifically describes these embodiments in order to better explain the principles and practical applications of the present invention, so that those skilled in the art can understand and use the present invention well. The present invention is limited only by the claims and their full scope and equivalents.

Claims

1. A high barrier and leak-proof packaging bag for storing medical devices, characterized in that: The packaging bag consists of an insulation layer, an adhesion layer and an inner wall layer, and the insulation layer, adhesion layer and inner wall layer are arranged in sequence from the outside to the inside. The insulation layer is composed of composite polyester, the adhesion layer is composed of ethylene acrylic resin, and the inner wall layer is composed of polypropylene and an antibacterial agent.

2. The high barrier and anti-leakage packaging bag for storing medical devices according to claim 1, characterized in that: The preparation method of the composite polyester comprises the following steps: Q1: Add dimethyl methylphosphonate to a container, then add monobutyltin oxide, assemble a straight condenser, control the rotation speed and increase the temperature, then drop 1,5-pentanediol into the container, control the dropping speed, continue stirring the reaction, and after the reaction is completed, perform vacuum distillation to obtain intermediate product 1; Q2: Add 5-amino-thiophene-2-carboxylic acid methyl ester, 2,5-thiophenedicarboxylic acid and intermediate product 1 into a container equipped with a nitrogen inlet, a mechanical stirring paddle and a hot water reflux spherical condenser, add titanium dioxide, heat to react, and after the reaction is completed, increase the temperature and reduce the pressure to carry out a condensation reaction. After the reaction is completed, a composite polyester is obtained.

3. The high barrier and anti-leakage packaging bag for storing medical devices according to claim 2, characterized in that: In the Q1, the molar ratio of dimethyl methylphosphonate, monobutyltin oxide and 1,5-pentanediol is (1-1.5): (0.03-0.05): (2-2.8), the rotation speed is controlled to be 300-350 rpm, the heating temperature is 170-180°C, the dropping speed is 2-3 drops / s, the stirring reaction time is 4-6h, and the reduced pressure distillation temperature is 140-145°C.

4. The high barrier and anti-leakage packaging bag for storing medical devices according to claim 2, characterized in that: In Q2, the molar ratio of 5-amino-thiophene-2-carboxylic acid methyl ester, 2,5-thiophenedicarboxylic acid, intermediate 1 and titanium dioxide is (0.8-1.3): (0.9-1.3): (2-2.5): (0.03-0.045), the heating reaction temperature is 180-200°C, the reaction time is 4-5h, the heating temperature is 230-240°C, the pressure is reduced to below 100Pa, and the reaction time is 3-5h.

5. The high barrier and anti-leakage packaging bag for storing medical devices according to claim 1, characterized in that: The preparation method of the antibacterial agent comprises the following steps: S1: Add formoyl hydrazide and acetonitrile to a container, stir evenly, then add triphenylphosphine, then heat the container, add carbon tetrachloride dropwise using a constant pressure dropping funnel under a constant temperature environment, control the dropping time, continue to stir the reaction after the addition is completed, cool, filter, wash, and dry to obtain compound A; S2: Sodium hydrosulfide is added to a container, followed by anhydrous ethanol, and stirred at low temperature. At the same time, 4-chlorobenzamide is slowly added dropwise using a constant pressure dropping funnel, and the dropping time is controlled. After the dropping is completed, the reaction is continued. After the reaction is completed, acidification, extraction, and the organic layers are combined, dried, and rotary evaporated to obtain compound B; S3: Add phenylacetaldehyde and diethylamine to a container, then add dichloromethane, stir to dissolve, add compound A, and dropwise add a dichloromethane solution containing compound B at room temperature to react. After the reaction is completed, perform rotary evaporation and purification to obtain an antibacterial agent.

6. The high barrier and anti-leakage packaging bag for storing medical devices according to claim 5, characterized in that: In the S1, the dosage ratio of formoyl hydrazide, acetonitrile, triphenylphosphine and carbon tetrachloride is (10-20) g: (200-250) mL: (62.3-100) g: (40-80) mL, the heating temperature is 50-60°C, the dropwise addition time is 1-2 h, the stirring reaction temperature is continued at 50-60°C, the time is 2-3 h, the temperature is lowered to 30-35°C, and the mixture is washed with a mixed solution of petroleum ether and distilled water in a volume ratio of 20:

1.

7. The high barrier and anti-leakage packaging bag for storing medical devices according to claim 5, characterized in that: In the S2, the volume fraction of sodium hydrosulfide is 70vt%, the dosage ratio of sodium hydrosulfide, anhydrous ethanol and 4-chlorobenzamide is (0.21-0.4)g: (80-140)mL: (0.2-0.4)g, the low temperature environment is 10-12°C, the dropwise addition time is 2-3h, the continued reaction time is 1-2h, acidification is performed with 0.6mol / L hydrochloric acid, extraction is performed with ether, and drying is performed with anhydrous sodium sulfate.

8. The high barrier and anti-leakage packaging bag for storing medical devices according to claim 5, characterized in that: In S3, the molar ratio of phenylacetaldehyde, diethylamine, compound A and compound B is (1-2): (1.1-1.9): (1.1-1.8): (1-2.1), the stirring and dissolving time is 30-45 minutes, the reaction time is 1-1.5 hours, and the eluent in the purification process is a mixed solution of petroleum ether and ethyl acetate in a volume ratio of 40:

1.

9. The method for preparing the high barrier and anti-leakage packaging bag for storing medical devices according to any one of claims 1 to 8, characterized in that: The following steps are involved: Step 1: adding the composite polyester and ethylene acrylic resin into the first screw extruder and the second screw extruder respectively, extruding and molding, and obtaining the insulating layer material and the adhesive layer material; Step 2: After the polypropylene and the antibacterial agent are evenly mixed, they are added into a third screw extruder, extruded, and formed to obtain an inner wall layer material; Step 3: Evenly apply the adhesive layer material between the insulating layer material and the inner wall layer material by hot pressing, and then bond, cool, shape, cut, make bags, and sterilize to obtain a high-barrier and leak-proof packaging bag for storing medical devices.

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