A high-barrier leakage-proof packaging bag for medical instrument storage and a preparation method thereof

Abstract

The application discloses a high-barrier anti-leakage packaging bag for medical instrument storage and a preparation method thereof, and belongs to the technical field of packaging bag preparation. The high-barrier anti-leakage packaging bag for medical instrument storage is composed of an isolation layer, a adhesion layer and an inner wall layer, and 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 acid 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 properties.

Description

Technical Field

[0001] This invention belongs to the field of packaging bag preparation technology, specifically relating to a high-barrier, leak-proof packaging bag for storing medical devices and its preparation method. Background Technology

[0002] The selection of packaging materials is crucial in the storage and transportation of medical devices. This not only concerns the safety and effectiveness of the medical devices but also directly impacts the overall quality of medical services and patient health and safety. With the continuous advancement of medical technology and the increasing demands for healthcare, higher requirements are being placed on medical device packaging, particularly in terms of barrier properties, leak-proof performance, and environmental friendliness.

[0003] Medical devices are diverse, including surgical instruments, diagnostic equipment, and implantable devices. These devices vary in materials and therefore have different packaging requirements. For example, some precision electronic medical devices require moisture and dust protection to prevent performance degradation or damage caused by environmental humidity and dust. Devices that come into contact with human tissue or bodily fluids require packaging materials with excellent barrier properties to prevent the intrusion of external microorganisms, moisture, and oxygen, thus ensuring the sterility and long-term preservation of the devices. Traditional packaging materials such as polyolefins and PVC, while meeting the packaging needs of medical devices to some extent, have significant shortcomings in terms of barrier properties, environmental friendliness, and safety. Polyolefin packaging materials have insufficient barrier properties, failing to effectively prevent the penetration of moisture and oxygen, affecting the shelf life and performance stability of medical devices. PVC materials, on the other hand, are gradually being phased out of the market due to insufficient environmental and safety performance. Therefore, developing a new type of high-barrier, 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, leak-proof heavy-duty packaging film and its preparation method. The high-barrier, leak-proof heavy-duty packaging film includes an outer layer, a middle layer, and an inner layer that are co-extruded sequentially. The outer layer contains low-density polyethylene, linear low-density polyethylene, medium-density polyethylene, high-density polyethylene, and ethylene-vinyl acetate copolymer. The middle layer contains an adhesive resin. The resulting high-barrier, leak-proof heavy-duty packaging film not only has mechanical properties but also excellent barrier properties. However, there is still room for improvement in the barrier properties, leak-proof properties, and antibacterial properties of the packaging bags prepared by this method. Summary of the Invention

[0005] The purpose of this invention is to provide a high-barrier, leak-proof packaging bag for storing medical devices and a method for preparing it, in order to solve the technical problems of poor barrier performance, leak-proof performance and antibacterial performance of packaging bags in the prior art.

[0006] To achieve the above objectives, the present invention adopts the following technical solution:

[0007] This invention provides a high-barrier, leak-proof packaging bag for storing medical devices. The packaging bag consists of an insulating layer, an adhesive layer, and an inner wall layer, which are arranged sequentially from the outside to the inside. The insulating layer is composed of composite polyester, the adhesive layer is composed of ethylene acrylate resin, and the inner wall layer is composed of polypropylene and an antibacterial agent.

[0008] Preferably, the method for preparing the composite polyester includes 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 add 1,5-pentanediol dropwise to the container, control the dropping rate, continue stirring the reaction, after the reaction is completed, distill under reduced pressure to obtain intermediate product 1;

[0010] Q2: Methyl 5-amino-thiophene-2-carboxylate, 2,5-thiophene dicarboxylic acid and intermediate product 1 are added to a container equipped with a nitrogen inlet, a mechanical stirrer and a hot water reflux spherical condenser. Titanium dioxide is added and the mixture is heated to react. After the reaction is completed, the temperature is increased and the pressure is decreased to carry out a polycondensation reaction. After the reaction is completed, a composite polyester is obtained.

[0011] The synthesis reaction formula for the composite polyester in the above process 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 at 300-350 rpm, the heating temperature is 170-180℃, the dropping rate is 2-3 drops / s, the stirring reaction time is 4-6 h, and the vacuum distillation temperature is 140-145℃.

[0014] Preferably, in Q2, the molar ratio of methyl 5-amino-thiophene-2-carboxylate, 2,5-thiophene dicarboxylic 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℃, the reaction time is 4-5h, the heating temperature is 230-240℃, the pressure is reduced to below 100Pa, and the reaction time is 3-5h.

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

[0016] S1: Add formyl hydrazine and acetonitrile to a container, stir well, then add triphenylphosphine, and then heat the container. Under constant temperature conditions, add carbon tetrachloride dropwise using a constant pressure dropping funnel, controlling the dropping time. After the dropping is completed, continue stirring the reaction. After the reaction is completed, cool down, filter, wash, and dry to obtain compound A.

[0017] S2: Sodium hydrosulfide was added to the container, followed by anhydrous ethanol. The mixture was stirred at low temperature while 4-chlorobenzamide was slowly added dropwise using a constant pressure dropping funnel. The addition time was controlled. After the addition was completed, the reaction was continued. After the reaction was completed, the mixture was acidified, extracted, and the organic layers were 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 add a dichloromethane solution containing compound B dropwise at room temperature. After the reaction is complete, rotary evaporate and purify to obtain the antibacterial agent.

[0019] In the above process, formyl hydrazine was first reacted with triphenylphosphine as a raw material, and then dehydrated by reflux under the action of carbon tetrachloride to obtain compound A. Subsequently, 4-chlorobenzamide and sodium hydrosulfide were used as raw materials to undergo a nucleophilic substitution reaction to prepare compound B. Finally, phenylacetaldehyde, diethylamine, compound A and compound B were reacted with dichloromethane as a solvent at room temperature to obtain the antibacterial agent.

[0020] Preferably, in step S1, the ratio of formyl hydrazine, 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℃, the dropping time is 1-2 h, the reaction temperature is continued at 50-60℃ for 2-3 h, the temperature is lowered to 30-35℃, and the mixture is washed with a mixed solution of petroleum ether and distilled water at a volume ratio of 20:1.

[0021] Preferably, in S2, the volume fraction of sodium hydrosulfide is 70 wt%, and the 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℃, the dropping time is 2-3 h, the reaction time is 1-2 h, acidification is performed with 0.6 mol / L hydrochloric acid, extraction is performed with diethyl 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 dissolution 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 with a volume ratio of 40:1.

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

[0024] Step 1: Add the composite polyester and ethylene acrylic resin to the first screw extruder and the second screw extruder respectively, extrude and mold to obtain the barrier layer material and the adhesive layer material;

[0025] Step 2: After mixing the polypropylene and antibacterial agent evenly, add it to the third screw extruder, extrude and shape it to obtain the inner wall layer material;

[0026] Step 3: The adhesive layer material is evenly coated between the barrier layer material and the inner wall layer material by hot pressing, then bonded, cooled, shaped, cut, bagged, and sterilized to obtain a high-barrier, 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. This invention first prepares a composite polyester using dimethyl methylphosphonate, 1,5-pentanediol, methyl 5-amino-thiophene-2-carboxylate, and 2,5-thiophene dicarboxylic acid as raw materials, and then uses formyl hydrazine as a raw material. 、 Triphenylphosphine 、 Sodium hydrosulfide 、 4-Chlorobenzamide 、 An antibacterial agent is prepared using phenylacetaldehyde and diethylamine as raw materials. Using composite polyester as the insulating layer of the packaging bag can effectively improve its barrier and leak-proof performance, as well as 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. This invention uses the obtained composite polyester as the barrier layer of the packaging bag, giving it excellent barrier and leak-proof performance, toughness, and flame retardancy. The intermediate product 1 obtained from the reaction of dimethyl methylphosphonate and 1,5-pentanediol contains highly energetic phosphorus-oxygen bonds and ester bonds, thus making the molecular chain of intermediate product 1 more stable and less susceptible to gas molecule penetration. Furthermore, the presence of phosphorus can 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. Moreover, the mixture of intermediate product 1, methyl 5-aminothiophene-2-carboxylate, and 2... The composite polyester molecular structure prepared by the reaction of 5-thiophene dicarboxylic 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. Moreover, its random arrangement requires gas molecules to pass through longer paths and obstacles when penetrating the packaging bag, thus improving 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 breakage when subjected to external forces, improving toughness. Furthermore, the presence of phosphorus and thiophene rings can effectively improve its flame retardant properties.

[0030] 3. In this invention, the prepared antibacterial agent is mixed with polypropylene to obtain the inner wall layer of the packaging bag, giving it excellent antibacterial properties. The active groups contained in the antibacterial agent can be continuously released and interact with the bacteria they come into contact with, inhibiting the growth and reproduction of bacteria. Moreover, polypropylene, as the main material of the inner wall layer of the packaging bag, has good physical properties and chemical stability, which can protect the antibacterial agent from the influence of the external environment and extend the service life of the packaging bag. Attached Figure Description

[0031] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0032] Figure 1 This is a cross-sectional view of the high-barrier, leak-proof packaging bag for storing medical devices prepared according to the present invention.

[0033] Figure descriptions: 1. Insulation layer, 2. Adhesive layer, 3. Inner wall layer. Detailed Implementation

[0034] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0035] Example 1: This example discloses a method for preparing a composite polyester, including the following steps:

[0036] Q1: Add 1.55g of dimethyl methylphosphonate to a container, then add 0.078g of monobutyltin oxide, assemble a straight condenser, control the rotation speed at 350rpm and heat to 180℃, then add 2.5g of 1,5-pentanediol dropwise to the container, controlling the dropping rate at 2 drops / s, and continue stirring the reaction for 6h. After the reaction is completed, distill under reduced pressure at 145℃ to obtain intermediate product 1;

[0037] Q2: Add 0.83g of methyl 5-amino-thiophene-2-carboxylate, 0.95g of 2,5-thiophene dicarboxylic acid, and 2.21g of intermediate product 1 to a container equipped with a nitrogen inlet, a mechanical stirrer, and a hot water reflux spherical condenser. Add 0.015g of titanium dioxide and heat at 200℃ for 5 hours. After the reaction is complete, raise the temperature to 230℃, lower the pressure to below 100Pa, and perform polycondensation for 4 hours. After the reaction is complete, a composite polyester is obtained.

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

[0039] S1: Add 15g of formyl hydrazine and 225mL of acetonitrile to a container, stir well, then add 81g of triphenylphosphine. Heat the container to 60℃, and under constant temperature, add 60mL of carbon tetrachloride dropwise using a constant pressure dropping funnel, controlling the dropping time to 1h. After the dropping is completed, continue stirring at 60℃ for 3h. After the reaction is completed, cool to 35℃, 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;

[0040] S2: 0.3 g of sodium hydrosulfide with a volume fraction of 70 vt% was added to a container, followed by 110 mL of anhydrous ethanol. The mixture was stirred at 10 °C, while 0.3 g of 4-chlorobenzamide was slowly added dropwise using a constant pressure dropping funnel over a period of 2 h. After the addition was complete, the reaction was continued for another 2 h. After the reaction was complete, the mixture was acidified with 0.6 mol / L hydrochloric acid, extracted with diethyl ether, and the organic layers were combined. The mixture was dried with anhydrous sodium sulfate and then rotary evaporated to obtain compound B.

[0041] S3: Add 0.9g phenylacetaldehyde and 0.55g diethylamine to a container, then add 5mL dichloromethane. Stir and dissolve for 45min, then add 1.4g compound A. At room temperature, add 3mL of dichloromethane solution containing 1.34g compound B dropwise. React for 1.5h. After the reaction is complete, rotary evaporate and purify. The eluent during the purification process is a mixed solution of petroleum ether and ethyl acetate with a volume ratio of 40:1 to obtain the antibacterial agent.

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

[0043] Step 1: According to the weight proportions, 40 parts of composite polyester and 15 parts of ethylene acrylic resin are added to the first screw extruder and the second screw extruder respectively, extruded and molded to obtain the barrier layer material and the adhesive layer material.

[0044] Step 2: Mix 45 parts polypropylene and 10 parts antibacterial agent evenly according to the weight ratio, add them to the third screw extruder, extrude and shape to obtain the inner wall layer material;

[0045] Step 3: The adhesive layer material is evenly coated between the barrier layer material and the inner wall layer material by hot pressing, then bonded, cooled, shaped, cut, bagged, and sterilized to obtain a high-barrier, leak-proof packaging bag for storing medical devices.

[0046] Example 2: This example discloses a method for preparing a composite polyester, including the following steps:

[0047] Q1: Add 1.24g of dimethyl methylphosphonate to a container, then add 0.058g of monobutyltin oxide, assemble a straight condenser, control the rotation speed at 350rpm and heat to 180℃, then add 2.08g of 1,5-pentanediol dropwise to the container, controlling the drop rate at 2 drops / s, and continue stirring the reaction for 6h. After the reaction is completed, distill under reduced pressure at 145℃ to obtain intermediate product 1;

[0048] Q2: Add 0.63g of methyl 5-amino-thiophene-2-carboxylate, 0.77g of 2,5-thiophene dicarboxylic acid, and 1.96g of intermediate product 1 to a container equipped with a nitrogen inlet, a mechanical stirrer, and a hot water reflux spherical condenser. Add 0.012g of titanium dioxide and heat at 200℃ for 5 hours. After the reaction is complete, raise the temperature to 230℃, lower the pressure to below 100Pa, and perform polycondensation for 4 hours. After the reaction is complete, a composite polyester is obtained.

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

[0050] S1: Add 10g of formyl hydrazine and 200mL of acetonitrile to a container, stir well, then add 62.3g of triphenylphosphine. Heat the container to 60℃, and under constant temperature, add 40mL of carbon tetrachloride dropwise using a constant pressure dropping funnel, controlling the dropping time to 1h. After the dropping is completed, continue stirring at 60℃ for 3h. After the reaction is completed, cool to 35℃, 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.

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

[0052] S3: Add 0.6g phenylacetaldehyde and 0.4g diethylamine to a container, then add 5mL dichloromethane. Stir and dissolve for 45min, then add 1.1g compound A. Add 3mL of dichloromethane solution containing 0.86g compound B dropwise at room temperature. React for 1.5h. After the reaction is complete, rotary evaporate and purify. The eluent during the purification process is a mixed solution of petroleum ether and ethyl acetate with a volume ratio of 40:1 to obtain the antibacterial agent.

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

[0054] Step 1: According to the weight proportions, 30 parts of composite polyester and 10 parts of ethylene acrylic resin are added to the first screw extruder and the second screw extruder respectively, extruded and molded to obtain the barrier layer material and the adhesive layer material.

[0055] Step 2: Mix 50 parts polypropylene and 8 parts antibacterial agent evenly according to the weight ratio, add them to the third screw extruder, extrude and shape to obtain the inner wall layer material;

[0056] Step 3: The adhesive layer material is evenly coated between the barrier layer material and the inner wall layer material by hot pressing, then bonded, cooled, shaped, cut, bagged, and sterilized to obtain a high-barrier, leak-proof packaging bag for storing medical devices.

[0057] Example 3: This example discloses a method for preparing a composite polyester, including the following steps:

[0058] Q1: Add 1.86g of dimethyl methylphosphonate to a container, then add 0.097g of monobutyltin oxide, assemble a straight condenser, control the rotation speed at 350rpm and heat to 180℃, then add 2.91g of 1,5-pentanediol dropwise to the container, controlling the drop rate at 2 drops / s, and continue stirring the reaction for 6h. After the reaction is completed, distill under reduced pressure at 145℃ to obtain intermediate product 1;

[0059] Q2: Add 1.02g of methyl 5-amino-thiophene-2-carboxylate, 1.12g of 2,5-thiophene dicarboxylic acid and 2.45g of intermediate product 1 to a container equipped with a nitrogen inlet, a mechanical stirrer and a hot water reflux spherical condenser. Add 0.018g of titanium dioxide and heat at 200℃ for 5h. After the reaction is complete, raise the temperature to 230℃, lower the pressure to below 100Pa, and perform polycondensation reaction for 4h. After the reaction is complete, a composite polyester is obtained.

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

[0061] S1: Add 20g of formyl hydrazine and 250mL of acetonitrile to a container, stir well, then add 100g of triphenylphosphine. Heat the container to 60℃, and under constant temperature, add 80mL of carbon tetrachloride dropwise using a constant pressure dropping funnel, controlling the dropping time to 1h. After the dropping is completed, continue stirring at 60℃ for 3h. After the reaction is completed, cool to 35℃, 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 a container, followed by 140 mL of anhydrous ethanol. The mixture was stirred at 10 °C, while 0.2 g of 4-chlorobenzamide was slowly added dropwise using a constant pressure dropping funnel over a period of 2 h. After the addition was complete, the reaction was continued for another 2 h. After the reaction was complete, the mixture was acidified with 0.6 mol / L hydrochloric acid, extracted with diethyl ether, and the organic layers were combined. The mixture was dried with anhydrous sodium sulfate and rotary evaporated to obtain compound B.

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

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

[0065] Step 1: According to the weight proportions, 50 parts of composite polyester and 20 parts of ethylene acrylic resin are added to the first screw extruder and the second screw extruder respectively, extruded and molded to obtain the barrier layer material and the adhesive layer material.

[0066] Step 2: Mix 40 parts polypropylene and 12 parts antibacterial agent evenly according to the weight ratio, add them to the third screw extruder, extrude and shape to obtain the inner wall layer material;

[0067] Step 3: The adhesive layer material is evenly coated between the barrier layer material and the inner wall layer material by hot pressing, then bonded, cooled, shaped, cut, bagged, and sterilized to obtain a high-barrier, leak-proof packaging bag for storing medical devices.

[0068] Example 4: This example discloses a method for preparing a composite polyester, including the following steps:

[0069] Q1: Add 1.34g of dimethyl methylphosphonate to a container, then add 0.063g of monobutyltin oxide, assemble a straight condenser, control the rotation speed at 350rpm and heat to 180℃, then add 2.29g of 1,5-pentanediol dropwise to the container, controlling the drop rate at 2 drops / s, and continue stirring the reaction for 6h. After the reaction is completed, distill under reduced pressure at 145℃ to obtain intermediate product 1;

[0070] Q2: Add 0.75g of methyl 5-amino-thiophene-2-carboxylate, 0.83g of 2,5-thiophene dicarboxylic acid, and 2.11g of intermediate product 1 to a container equipped with a nitrogen inlet, a mechanical stirrer, and a hot water reflux spherical condenser. Add 0.013g of titanium dioxide and heat at 200℃ for 5 hours. After the reaction is complete, raise the temperature to 230℃, lower the pressure to below 100Pa, and perform polycondensation for 4 hours. After the reaction is complete, a composite polyester is obtained.

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

[0072] S1: Add 12g of formyl hydrazine and 210mL of acetonitrile to a container, stir well, then add 75g of triphenylphosphine. Heat the container to 60℃, and under constant temperature, add 50mL of carbon tetrachloride dropwise using a constant pressure dropping funnel, controlling the dropping time to 1h. After the dropping is completed, continue stirring at 60℃ for 3h. After the reaction is completed, cool to 35℃, 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 a container, followed by 120 mL of anhydrous ethanol. The mixture was stirred at 10 °C, while 0.25 g of 4-chlorobenzamide was slowly added dropwise using a constant pressure dropping funnel over a period of 2 h. After the addition was complete, the reaction was continued for another 2 h. After the reaction was complete, the mixture was acidified with 0.6 mol / L hydrochloric acid, extracted with diethyl ether, and the organic layers were combined. The mixture was dried with anhydrous sodium sulfate and rotary evaporated to obtain compound B.

[0074] S3: Add 0.8g phenylacetaldehyde and 0.5g diethylamine to a container, then add 5mL dichloromethane. Stir and dissolve for 45min, then add 1.3g compound A. Add 3mL of dichloromethane solution containing 0.95g compound B dropwise at room temperature. React for 1.5h. After the reaction is complete, rotary evaporate and purify. The eluent during the purification process is a mixed solution of petroleum ether and ethyl acetate with a volume ratio of 40:1 to obtain the antibacterial agent.

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

[0076] Step 1: According to the weight proportions, 35 parts of composite polyester and 18 parts of ethylene acrylic resin are added to the first screw extruder and the second screw extruder respectively, extruded and molded to obtain the barrier layer material and the adhesive layer material.

[0077] Step 2: Mix 43 parts polypropylene and 9 parts antibacterial agent evenly according to the weight ratio, add them to the third screw extruder, extrude and shape to obtain the inner wall layer material;

[0078] Step 3: The adhesive layer material is evenly coated between the barrier layer material and the inner wall layer material by hot pressing, then bonded, cooled, shaped, cut, bagged, and sterilized to obtain a high-barrier, leak-proof packaging bag for storing medical devices.

[0079] Example 5: This example discloses a method for preparing a composite polyester, including the following steps:

[0080] Q1: Add 1.71g of dimethyl methylphosphonate to a container, then add 0.082g of monobutyltin oxide, assemble a straight condenser, control the rotation speed at 350rpm and heat to 180℃, then add 2.73g of 1,5-pentanediol dropwise to the container, controlling the dropping rate at 2 drops / s, and continue stirring the reaction for 6h. After the reaction is completed, distill under reduced pressure at 145℃ to obtain intermediate product 1;

[0081] Q2: Add 0.93g of methyl 5-amino-thiophene-2-carboxylate, 1.05g of 2,5-thiophene dicarboxylic acid and 2.35g of intermediate product 1 to a container equipped with a nitrogen inlet, a mechanical stirrer and a hot water reflux spherical condenser. Add 0.016g of titanium dioxide and heat at 200℃ for 5 hours. After the reaction is complete, raise the temperature to 230℃, lower the pressure to below 100Pa, and perform polycondensation for 4 hours. After the reaction is complete, a composite polyester is obtained.

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

[0083] S1: Add 18g of formyl hydrazine and 240mL of acetonitrile to a container, stir well, then add 92g of triphenylphosphine. Heat the container to 60℃, and under constant temperature, add 70mL of carbon tetrachloride dropwise using a constant pressure dropping funnel, controlling the dropping time to 1h. After the dropping is completed, continue stirring at 60℃ for 3h. After the reaction is completed, cool to 35℃, 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.

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

[0085] S3: Add 1.1g phenylacetaldehyde and 0.6g diethylamine to a container, then add 5mL dichloromethane. Stir and dissolve for 45min, then add 1.5g compound A. Add 3mL of dichloromethane solution containing 1.47g compound B dropwise at room temperature. React for 1.5h. After the reaction is complete, rotary evaporate and purify. The eluent during the purification process is a mixed solution of petroleum ether and ethyl acetate with a volume ratio of 40:1 to obtain the antibacterial agent.

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

[0087] Step 1: According to the weight proportions, 45 parts of composite polyester and 12 parts of ethylene acrylic resin are added to the first screw extruder and the second screw extruder respectively, extruded and molded to obtain the barrier layer material and the adhesive layer material.

[0088] Step 2: Mix 47 parts polypropylene and 11 parts antibacterial agent evenly according to the weight ratio, add them to the third screw extruder, extrude and shape to obtain the inner wall layer material;

[0089] Step 3: The adhesive layer material is evenly coated between the barrier layer material and the inner wall layer material by hot pressing, then bonded, cooled, shaped, cut, bagged, and sterilized to obtain a high-barrier, leak-proof packaging bag for storing medical devices.

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

[0091] Comparative Example 2: Compared with Example 1, Comparative Example 2 did not add triphenylphosphine during the preparation of the antibacterial agent, and all other conditions remained unchanged.

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

[0093] Comparative Example 4: Compared with Example 1, Comparative Example 4 did not add antibacterial agents during the preparation of the packaging bag, and all other conditions remained unchanged.

[0094] Experimental Example: The barrier properties of the samples were tested according to HG / T 4302-2012, the antibacterial properties according to GB / T43722.1-2024, the flame retardant properties according to GB / T 10707-2008, and the elongation at break 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 flammability rating 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] As shown in Table 1, the packaging bags prepared in Examples 1-5 of this invention exhibit excellent barrier properties, antibacterial properties, flame retardant properties, and toughness. A comparison between Comparative Example 1 and Examples 1-5 shows that adding dimethyl methylphosphonate can give the packaging bags excellent barrier properties, flame retardant properties, and toughness; a comparison between Comparative Example 2 and Examples 1-5 shows that adding triphenylphosphine can give the packaging bags excellent antibacterial properties; a comparison between Comparative Example 3 and Examples 1-5 shows that adding composite polyester can give the packaging bags excellent barrier properties, flame retardant properties, and toughness; a comparison between Comparative Example 4 and Examples 1-5 shows that adding an antibacterial agent can give the packaging bags excellent antibacterial properties.

[0098] The above description is only a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and inventive concept of the present invention, should be covered within the scope of protection of the present invention.

[0099] The preferred embodiments of the present invention disclosed above are merely illustrative of the invention. These preferred embodiments do not exhaustively describe all details, nor do they limit the invention to specific implementations. Clearly, many modifications and variations can be made based on the content of this specification. This specification selects and specifically describes these embodiments to better explain the principles and practical applications of the invention, thereby enabling those skilled in the art to better understand and utilize the invention. The invention is limited only by the claims and their full scope and equivalents.

Claims

1. A high-barrier, leak-proof packaging bag for storing medical devices, characterized in that, The packaging bag consists of an insulating layer, an adhesive layer, and an inner wall layer, arranged sequentially from the outside to the inside. The insulating layer is composed of composite polyester, the adhesive layer is composed of ethylene acrylate resin, and the inner wall layer is composed of polypropylene and an antibacterial agent. The method for preparing the composite polyester includes 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 add 1,5-pentanediol dropwise to the container, control the dropping rate, continue stirring the reaction, after the reaction is completed, distill under reduced pressure to obtain intermediate product 1; Q2: Methyl 5-amino-thiophene-2-carboxylate, 2,5-thiophene dicarboxylic acid and intermediate product 1 are added to a container equipped with a nitrogen inlet, a mechanical stirrer and a hot water reflux spherical condenser. Titanium dioxide is added and the mixture is heated to react. After the reaction is completed, the temperature is increased and the pressure is decreased to carry out a polycondensation reaction. After the reaction is completed, a composite polyester is obtained. The method for preparing the antibacterial agent includes the following steps: S1: Add formyl hydrazine and acetonitrile to a container, stir well, then add triphenylphosphine, and then heat the container. Under constant temperature conditions, add carbon tetrachloride dropwise using a constant pressure dropping funnel, controlling the dropping time. After the dropping is completed, continue stirring the reaction. After the reaction is completed, cool down, filter, wash, and dry to obtain compound A. S2: Sodium hydrosulfide was added to the container, followed by anhydrous ethanol. The mixture was stirred at low temperature while 4-chlorobenzamide was slowly added dropwise using a constant pressure dropping funnel. The addition time was controlled. After the addition was completed, the reaction was continued. After the reaction was completed, the mixture was acidified, extracted, and the organic layers were 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 add a dichloromethane solution containing compound B dropwise at room temperature. After the reaction is complete, rotary evaporate and purify to obtain the antibacterial agent.

2. The high-barrier, leak-proof packaging bag for storing medical devices according to claim 1, characterized in that, 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 at 300-350 rpm, the heating temperature is 170-180℃, the dropping rate is 2-3 drops / s, the stirring reaction time is 4-6 h, and the vacuum distillation temperature is 140-145℃.

3. The high-barrier, leak-proof packaging bag for storing medical devices according to claim 1, characterized in that, In Q2, the molar ratio of methyl 5-amino-thiophene-2-carboxylate, 2,5-thiophene dicarboxylic 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℃, the reaction time is 4-5h, the heating temperature is 230-240℃, the pressure is reduced to below 100Pa, and the reaction time is 3-5h.

4. The high-barrier, leak-proof packaging bag for storing medical devices according to claim 1, characterized in that, In S1, the ratio of formyl hydrazine, 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℃, the dropping time is 1-2 h, the reaction temperature is continued at 50-60℃ for 2-3 h, the temperature is lowered to 30-35℃, and the mixture is washed with a mixed solution of petroleum ether and distilled water at a volume ratio of 20:

1.

5. The high-barrier, leak-proof packaging bag for storing medical devices according to claim 1, characterized in that, In the S2 process, the low-temperature environment is 10-12℃, the dropping time is 2-3h, the reaction time is 1-2h, the acidification is performed with 0.6mol / L hydrochloric acid, the extraction is performed with diethyl ether, and the drying is performed with anhydrous sodium sulfate.

6. The high-barrier, leak-proof packaging bag for storing medical devices according to claim 1, 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 dissolution 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 with a volume ratio of 40:

1.

7. The method for preparing a high-barrier, leak-proof packaging bag for storing medical devices as described in any one of claims 1-6, characterized in that, Includes the following steps: Step 1: Add the composite polyester and ethylene acrylic resin to the first screw extruder and the second screw extruder respectively, extrude and mold to obtain the barrier layer material and the adhesive layer material; Step 2: After mixing the polypropylene and antibacterial agent evenly, add it to the third screw extruder, extrude and shape it to obtain the inner wall layer material; Step 3: The adhesive layer material is evenly coated between the barrier layer material and the inner wall layer material by hot pressing, then bonded, cooled, shaped, cut, bagged, and sterilized to obtain a high-barrier, leak-proof packaging bag for storing medical devices.

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