Light-shielding blocking type vein nutrition bag and manufacturing method thereof

Abstract

The invention relates to a light-proof blocking type vein nutrition bag and a manufacturing method thereof. The light-proof blocking type vein nutrition bag comprises a bag body, the lower end of the bag body is provided with a liquid inlet end and an infusion end, and the bag body is made of a light-proof blocking type film layer; the liquid inlet end comprises a sealing end, a liquid inlet pipeline and a two-way joint connected with the liquid inlet pipeline and the sealing end, and the sealing end is arranged between the bag body and the two-way joint; the light-proof barrier type film comprises an inner layer, a secondary inner layer, a secondary outer layer and an outer layer from inside to outside, the secondary inner layer is an inner bonding layer, and the secondary outer layer comprises a barrier layer close to one side of the secondary inner layer and a light-proof bonding layer close to one side of the outer layer; wherein the material of the inner layer is EVA, the material of the inner bonding layer is EVA, the material of the blocking layer is EVOH, and the material of the light-proof bonding layer is composed of EVA and PP. The bag body is simple in structure, parts on the liquid inlet pipeline are simplified, the material cost and the assembly cost of products are greatly reduced, and heat seal selection is diversified, stable and reliable; the bag body material can achieve the light-proof function without adding auxiliaries, and the nutrition bag is good in safety performance.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and particularly relates to a light-shielding and barrier-type intravenous nutrition bag and a manufacturing method thereof. Background Art

[0002] Currently, commercially available intravenous nutrition infusion bags are all prepared in the hospital's intravenous admixture service center and then transported to the ward for infusion to patients. The infusion needs to be completed within 24 hours after the preparation of the nutrient solution. When used at home, intravenous nutrition infusion requires batch preparation in a professional medical institution. Patients store the nutrient solution for a certain period at home and perform back-infusion according to the doctor's advice. Usually, when used in home nutrition, the intravenous nutrient solution needs to be stored at low temperature and protected from light in the bag for more than 7 days.

[0003] Conventional intravenous nutrition infusion bags are difficult to meet the above-mentioned requirements for long-term storage and have the following problems:

[0004] 1. For those with a single-layer structure of the bag body on the market, they are generally welded with a film made of ethylene-vinyl acetate copolymer (EVA). The EVA film layer does not have the functions of light shielding and barrier. Vitamins in the nutrient solution are sensitive to light, and fat emulsion and amino acids are sensitive to oxygen. The above components are prone to degradation during long-term storage, resulting in problems such as changes in the components of the medicinal liquid and reduction of the active ingredients.

[0005] 2. For those with a multi-layer structure of the bag body on the market, the currently common barrier multi-layer coextruded film needs to add a large amount of adhesives for bonding the ethylene-vinyl alcohol copolymer (EVOH) of the barrier layer to other layers. The adhesives usually use maleic anhydride grafted polyethylene (PE-G-MAH), or for the multi-layer coextruded film provided by Chinese Patent CN105419058B, the adhesive layer uses maleic anhydride modified ethylene octene copolymer (POE-g-MAH). However, whether it is modification or grafting, a large amount of small molecule additives such as initiators, antioxidants, and grafting agents usually need to be added during the preparation of the adhesive. The use of these small molecule substances in medical packaging has great risks.

[0006] 3. Currently, the structure of the intravenous nutrition infusion bag used clinically is as Figure 1 shown. The liquid inlet end structure connected to several liquid inlet pipelines is complex. After the intravenous nutrition infusion bag is filled with liquid, it is necessary to separate the liquid inlet pipeline from the bag body through the detachable locking inner and outer cones on the bag body. The operation is relatively cumbersome and there is a risk of liquid leakage at the locking inner and outer cones. Summary of the Invention

[0007] The technical problem to be solved by the present invention is: aiming at the above defects, the present invention provides a light-shielding and barrier-type intravenous nutrition bag and its manufacturing method, to solve the potential drug safety hazards caused by problems such as the complex structure of the liquid inlet pipeline of the existing intravenous nutrition bag, short storage time of the nutrient solution, and many additives in the multi-layer film structure.

[0008] The technical solution adopted by the present invention to solve its technical problems is as follows: A light-shielding and barrier-type intravenous nutrition bag, including a bag body, an inlet end and an infusion end are provided at the lower end of the bag body, and the bag body is made of a light-shielding and barrier-type film layer; the inlet end includes a sealing end communicated with the bag body, a liquid inlet pipeline communicated with the filling device, and a two-way joint connecting the liquid inlet pipeline and the sealing end, and a pipeline locking member is provided at the two-way joint, and the sealing end is between the bag body and the two-way joint;

[0009] The light-shielding and barrier-type film includes an inner layer, a sub-inner layer, a sub-outer layer and an outer layer from the inside to the outside. The sub-inner layer is an inner adhesive layer, and the sub-outer layer includes a barrier layer on the side close to the sub-inner layer and a light-shielding adhesive layer on the side close to the outer layer; among them, the material of the inner layer is ethylene-vinyl acetate copolymer (EVA), the material of the inner adhesive layer is ethylene-vinyl acetate copolymer (EVA), the material of the barrier layer is ethylene-vinyl alcohol copolymer (EVOH), and the material of the light-shielding adhesive layer is composed of ethylene-vinyl acetate copolymer (EVA) and polypropylene (PP).

[0010] Further, the material of the outer layer is one or more of polyethylene (PE), polypropylene (PP), polyethylene terephthalate (PET), and polyamide (PA).

[0011] Further, the mass ratio of ethylene-vinyl acetate copolymer (EVA) to polypropylene (PP) in the material of the light-shielding adhesive layer is 1:(1.1 - 2.5).

[0012] Further, the total thickness of the light-shielding and barrier-type film is 0.08 mm - 0.50 mm; the thicknesses of the inner layer, the inner adhesive layer, the barrier layer, the light-shielding adhesive layer, and the outer layer respectively account for 20% - 40%, 10% - 25%, 6% - 20%, 30% - 50%, and 25% - 40% of the light-shielding.

[0013] Further, the content of vinyl acetate in the ethylene-vinyl acetate copolymer (EVA) of the inner layer material is 12% - 28%; the content of vinyl acetate in the ethylene-vinyl acetate copolymer (EVA) of the inner adhesive layer material is 18% - 40%; the content of vinyl acetate in the ethylene-vinyl acetate copolymer (EVA) of the light-shielding adhesive layer material is 18% - 40%.

[0014] Further, the infusion end includes an infusion pipeline and an infusion socket, and the infusion socket is arranged at the end of the infusion pipeline;

[0015] Hanging holes are also provided on the bag body.

[0016] A manufacturing method of a light-shielding and barrier-type intravenous nutrition bag includes the following steps:

[0017] Step S1, preparation of light-shielding and barrier-type film raw materials: Put the ethylene-vinyl acetate copolymer (EVA) used for the inner layer, the ethylene-vinyl acetate copolymer (EVA) used for the inner adhesive layer, the ethylene-vinyl alcohol copolymer (EVOH) used for the barrier layer, the blend formed by ethylene-vinyl acetate copolymer (EVA) and polypropylene (PP) used for the light-shielding adhesive layer, and the outer layer material used for the outer layer on the stock table respectively;

[0018] Step S2, preparation of light-shielding and barrier-type film: The vacuum feeder sucks the raw materials on the stock table into the hopper of the multi-hole extruder respectively, and produces a light-shielding and barrier-type film through co-extrusion blow molding or casting process. After the light-shielding and barrier-type film is extruded, it is irradiated; the film layer structure is an inner layer formed by ethylene-vinyl acetate copolymer (EVA), an inner adhesive layer formed by ethylene-vinyl acetate copolymer (EVA), a barrier layer formed by ethylene-vinyl alcohol copolymer (EVOH), a light-shielding adhesive layer formed by the blend, and an outer layer formed by the outer layer material arranged in this order;

[0019] Step S3, forming of the nutrition bag: The light-shielding and barrier-type film roll is unrolled, hot stamping, heat sealed, cooled, and shaped cut to obtain a formed nutrition bag;

[0020] Step S4, airtight detection of the nutrition bag: Blow sterile air into the bag body of the formed nutrition bag prepared in step S3 through the sealed end.

[0021] Further, the radiation dose of the irradiation in step S2 is 5-15 Mard; the hot stamping temperature in step S3 is 150-180 °C, and the pressure is 0.2-0.4 Mpa; the pressure of blowing sterile air in step S4 is 4-6 pa.

[0022] Further, the ethylene-vinyl acetate copolymer, ethylene-vinyl alcohol copolymer, polypropylene, and outer layer material are respectively pretreated before use. The pretreatment process is as follows: Add the materials to be pretreated into an organic solvent respectively, soak them ultrasonically, remove the organic solvent, and then vacuum dry the pretreated materials to complete the preliminary pretreatment; Immerse the materials that have completed the preliminary pretreatment in water, ultrasonically oscillate for 1-3 h, and then remove the water and vacuum dry.

[0023] Furthermore, the organic solvent used for the pretreatment of the ethylene-vinyl acetate copolymer (EVA) is N,N-dimethylformamide (DMF); the organic solvent used for the pretreatment of the ethylene-vinyl alcohol copolymer (EVOH) is N,N-dimethylformamide (DMF); the organic solvent used for the pretreatment of the polypropylene (PP) is a mixed solution of ethanol and acetone.

[0024] The beneficial effects of the present invention are as follows:

[0025] 1. The light-blocking and barrier-type intravenous nutrition bag provided by the present invention is made of a light-blocking and barrier-type film. The inner layer in direct contact with the liquid medicine is made of EVA material, which is an infusion material for long-term clinical application, ensuring the safety of the nutrition bag.

[0026] 2. The barrier layer uses EVOH. This material is easy to stretch and has good heat resistance, meeting the requirements for processing the nutrition bag and producing it as a sterile packaging bag, ensuring the safety of the nutrition bag.

[0027] 3. The sub-outer layer is a barrier layer and a light-blocking adhesive layer. The light-blocking adhesive layer is made of a safe and reliable mixture of EVA and PP. These two materials are incompatible with each other and show a matte effect when forming a film. The transmittance of the formed film layer is <15%, which can achieve the light-blocking function in the full wavelength range of 290 - 450 nm, meeting the light-blocking requirements of the bag body. Without adding other additives, the safety performance of the nutrition bag is good. The polarity of vinyl acetate in the EVA structure is similar to the structure of EVOH in the barrier layer, with high bonding strength, effectively avoiding the delamination problem of the multi-layer light-blocking and barrier-type film.

[0028] 4. The inner adhesive layer uses EVA as the raw material. On the one hand, the EVA structure is similar to that of EVOH in the barrier layer, with high bonding strength and good bonding function. On the other hand, the material of the inner adhesive layer is the same as that of the inner layer, which is equivalent to increasing the thickness of the inner layer, improving the safety of the liquid medicine contact layer and avoiding the migration of small molecule substances in the material to the inside of the bag body when using modified materials in the outer layer.

[0029] 5. The EVA material is one of the components of the inner adhesive layer or the light-blocking adhesive layer. Its high bonding strength can meet the safety requirements of the multi-layer structure and avoid using modified adhesive resins, reducing the use of small molecule substances from the source and improving the safety of the intravenous nutrition bag.

[0030] 6. The structure of the intravenous nutrition bag provided by the present invention is simple. Only a liquid inlet end and an infusion end are provided at the lower end of the bag body. The canning device is connected to the liquid inlet pipeline, and the bag body is connected to the sealing end. A two-way valve is arranged in the liquid inlet pipeline, and the opening and closing of the two-way valve and the size of the liquid flow are controlled by a pipeline locking part, thereby controlling the filling of the liquid. The liquid filling is simple and reliable. After the liquid canning is completed, it is sealed by heat sealing. After sealing, the liquid inlet pipeline and the bag body are automatically cut off. This structure simplifies the components on the liquid inlet pipeline, greatly reducing the material cost and assembly cost of the product.

[0031] 7. The heat-sealed end of the intravenous nutrition bag can be either on the catheter connected to the bag body or on the liquid inlet pipeline between the bag body and the two-way connector, providing diverse choices and convenient use. The inner layer of the bag body is made of EVA material and can be heat-sealed by high-frequency welding or thermal welding, facilitating different production scenarios and convenient to use.

[0032] 8. The outer layer of the bag body membrane layer of the intravenous nutrition bag is a protective layer, which functions to protect the bag body and for label printing. Using polyolefins such as PE and PP as materials can improve the softness of the bag body; using materials such as PET and PA can enhance the barrier effect of the bag body, ensuring the mechanical properties of the bag body, and the overall thickness of the light-blocking and barrier film can be controlled to reduce production costs.

[0033] 9. The inner layer, sub-inner layer, and sub-outer layer of the bag body of the present invention only include EVA, EVOH, and PP, with simple materials and low costs. Among them, the PP material with relatively low adhesion is used in combination with the thermosetting adhesive EVA, and other layers have certain adhesiveness in the hot state, and the multi-layer structure of the bag body is firmly bonded and not easily delaminated. PP has excellent chemical resistance, anti-fatigue property, and good heat resistance, and can be sterilized at a temperature above 100 °C, avoiding the contamination of the liquid medicine caused by the melting or decomposition of the bag body close to the liquid medicine during high-temperature disinfection. The intravenous nutrition bag provided by the present invention is safe and reliable, avoiding problems such as poor heat resistance of PE materials, high permeability of COC materials, high prices of other medical plastics, drug corrosion, and many heat-sealed migration substances.

[0034] 10. For the light-blocking and barrier-type intravenous nutrition bag provided by the present invention, the thickness of the bag body membrane layer can be controlled while maintaining good mechanical properties.

[0035] 11. The ethylene-vinyl acetate copolymer (EVA) used in the inner layer, inner adhesive layer, and light-blocking adhesive layer can ensure the flexibility and chemical resistance of the bag body by controlling the vinyl acetate content; the inner adhesive layer has good physical adhesion ability, and at the same time is consistent with the inner layer material, and there is an intermolecular force between the layer films, so the bonding is firm; the light-blocking adhesive layer not only has a bonding function but also can ensure the uniform dispersion of polypropylene, and the light-blocking performance is stable and reliable. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] Through the following detailed description in conjunction with the drawings, the foregoing and other objects, features, and advantages of the present invention will become apparent.

[0037] Figure 1 is a schematic structural diagram of an intravenous nutrition bag in the prior art;

[0038] Figure 2 is a schematic diagram of the membrane layer structure of the bag body of the intravenous nutrition bag of the present invention using a light-blocking and barrier-type membrane;

[0039] Figure 3Schematic diagram of the structure of the intravenous nutrition bag in Example 1;

[0040] Figure 4 Schematic diagram of the structure of the intravenous nutrition bag in Example 2;

[0041] Wherein: 1 is the hanging hole of the bag, 2 is the bag body, 21 is the inner layer, 22 is the inner adhesive layer, 23 is the barrier layer, 24 is the light-blocking adhesive layer, 25 is the outer layer, 3 is the infusion pipeline, 4 is the infusion socket, 5 is the sealing end, 5a is the first seal, 5b is the second seal, 6 is the pipeline locking member, 7 is the two-way joint, and 8 is the liquid inlet pipeline. Detailed implementation mode

[0042] In order to make the objectives, technical solutions and advantages of the present invention clearer, the present invention will be further described in detail below with reference to the accompanying drawings and examples. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.

[0043] Example 1

[0044] A light-blocking and barrier-type intravenous nutrition bag, as Figure 2 shown, includes a bag body 2. The lower end of the bag body 2 is provided with a liquid inlet end and an infusion end. The bag body 2 is made of a light-blocking and barrier-type film layer; the infusion end includes an infusion pipeline 3 and an infusion socket 4. The liquid inlet end includes a sealing end 5 communicated with the bag body 2, a liquid inlet pipeline 8 communicated with the filling device, and a two-way joint 7 connecting the liquid inlet pipeline 8 and the first seal 5a. A pipeline locking member 6 is provided at the two-way joint 7. The sealing end 5 is between the bag body 2 and the two-way joint 7; the first seal 5a is essentially a catheter connecting the sealing end 5 to the bag body 2, and a heat-sealed port A, that is, seal A, is formed after subsequent liquid filling; the infusion socket 4 is arranged at the end of the infusion pipeline 3; and a hanging hole 1 is also provided on the bag body 2.

[0045] As Figure 3 shown, the light-blocking and barrier-type film includes an inner layer 21, a sub-inner layer, a sub-outer layer and an outer layer 25 from the inside to the outside. The sub-inner layer is the inner adhesive layer 22. The sub-outer layer includes a barrier layer 23 on the side close to the sub-inner layer and a light-blocking adhesive layer 24 on the side close to the outer layer 25; wherein the material of the inner layer is ethylene-vinyl acetate copolymer (EVA), the material of the inner adhesive layer is ethylene-vinyl acetate copolymer (EVA), the material of the barrier layer is ethylene-vinyl alcohol copolymer (EVOH), and the material of the light-blocking adhesive layer is composed of ethylene-vinyl acetate copolymer (EVA) and polypropylene (PP); the material of the outer layer is polypropylene (PP).

[0046] Among them, the total thickness of the light-blocking and barrier-type film is 0.08 mm - 0.50 mm; 0.08 mm is preferably selected in this embodiment, and the thicknesses of the inner layer, the inner adhesive layer, the barrier layer, the light-blocking adhesive layer, and the outer layer are 22%, 10%, 8%, 30%, and 30% respectively.

[0047] The vinyl acetate content in the inner layer material ethylene-vinyl acetate copolymer (EVA) is 12%-28%; the vinyl acetate content in the inner adhesive layer material ethylene-vinyl acetate copolymer (EVA) is 18%-40%; the vinyl acetate content in the light-blocking adhesive layer material ethylene-vinyl acetate copolymer (EVA) is 18%-40%; the mass ratio of ethylene-vinyl acetate copolymer (EVA) to polypropylene (PP) in the material of the light-blocking adhesive layer is 1:1.1, and the light transmittance of the prepared light-blocking and barrier film is 13%.

[0048] A manufacturing method of a light-blocking and barrier type intravenous nutrition bag, comprising the following steps:

[0049] Step S1, preparation of raw materials for the light-blocking and barrier film: respectively put the ethylene-vinyl acetate copolymer (EVA) used for the inner layer, the ethylene-vinyl acetate copolymer (EVA) used for the inner adhesive layer, the ethylene-vinyl alcohol copolymer (EVOH) used for the barrier layer, the blend formed by ethylene-vinyl acetate copolymer (EVA) and polypropylene (PP) used for the light-blocking adhesive layer, and the outer layer material used for the outer layer on the material preparation table; wherein the ethylene-vinyl acetate copolymer, ethylene-vinyl alcohol copolymer, polypropylene, and outer layer material are respectively pretreated before being added to the material preparation table, and the pretreatment process is as follows: respectively add the materials to be pretreated into an organic solvent, ultrasonically soak, remove the organic solvent, and then vacuum dry the pretreated materials to complete the preliminary pretreatment; immerse the materials that have completed the preliminary pretreatment in water, ultrasonically oscillate for 1-3 h, remove the water, and then vacuum dry.

[0050] The organic solvent used for the pretreatment of the ethylene-vinyl acetate copolymer (EVA) is N,N-dimethylformamide (DMF); the organic solvent used for the pretreatment of the ethylene-vinyl alcohol copolymer (EVOH) is N,N-dimethylformamide (DMF); the organic solvent used for the pretreatment of the polypropylene (PP) is a mixed solution of ethanol and acetone;

[0051] Step S2, preparation of the light-blocking and barrier film: a vacuum suction machine respectively sucks the raw materials on the material preparation table into the hopper of a multi-hole extruder, and produces a light-blocking and barrier film through a co-extrusion blow molding or casting process. After the light-blocking and barrier film is extruded, it is irradiated, and the radiation dose of the irradiation is controlled between 5-15 Mard; the film layer structure is an inner layer 21 formed by ethylene-vinyl acetate copolymer (EVA), an inner adhesive layer 22 formed by ethylene-vinyl acetate copolymer (EVA), a barrier layer 23 formed by ethylene-vinyl alcohol copolymer (EVOH), a light-blocking adhesive layer 24 formed by a blend, and an outer layer 25 formed by an outer layer material arranged in this order;

[0052] Step S3, forming the nutrient bag: Pass the light-shielding and barrier film roll through unrolling, hot stamping, heat sealing, cooling, and shaped cutting to obtain the formed nutrient bag. The hot stamping temperature is 150 - 180°C, and the pressure is 0.2 - 0.4 Mpa;

[0053] Step S4, airtightness detection of the nutrient bag: Blow sterile air into the bag body of the formed nutrient bag prepared in Step S3 through the sealed end. The pressure of the blown sterile air is 4 - 6 pa.

[0054] Before the production of the light-shielding and barrier film, the raw materials are pretreated. Through the treatment methods of washing with organic solvents, washing with water, and then drying, small molecule substances on the surface of the raw materials can be effectively removed to prevent small molecule materials from adhering to the surface of the raw materials and migrating into the nutrient solution along with the filling of the nutrient solution after bag forming, solving the problem from the source; Through irradiation, the crosslinking degree between raw materials can be improved, the biocompatibility can be enhanced, and at the same time, it also has a sterilization function; After the preparation of the nutrient bag, through airtightness inspection and blowing sterile air through the sealed end, the safety and production efficiency during use are reduced.

[0055] Example 2

[0056] As Figure 4 shown, the difference in structure between this example and Example 1 is that the sealed end 5 is at the second seal 5b close to the bag body 2 and communicating with the liquid inlet pipeline 8. The second seal 5b is between the bag body 2 and the two-way joint 7. After subsequent liquid filling, a heat-sealed joint B, that is, seal B, is formed.

[0057] Example 3

[0058] The difference between this example and Example 1 is that the materials used for the light-shielding and barrier film and the total thickness of the film are different, specifically as follows:

[0059] The total thickness of the light-shielding and barrier film is 0.08 mm - 0.50 mm; In this example, 0.2 mm is preferred. The thicknesses of the inner layer, inner adhesive layer, barrier layer, light-shielding adhesive layer, and outer layer are 25%, 10%, 6%, 30%, and 29% respectively.

[0060] The material of the inner layer is ethylene-vinyl acetate copolymer (EVA), the material of the inner adhesive layer is ethylene-vinyl acetate copolymer (EVA), the material of the barrier layer is ethylene-vinyl alcohol copolymer (EVOH), the material of the light-shielding adhesive layer is composed of ethylene-vinyl acetate copolymer (EVA) and polypropylene (PP); The material of the outer layer is a combination of polyethylene (PE) and polyamide (PA) in a mass ratio of 1:1.

[0061] The vinyl acetate content in the ethylene-vinyl acetate copolymer (EVA) used as the inner layer material is 12%-28%; the vinyl acetate content in the ethylene-vinyl acetate copolymer (EVA) used as the inner adhesive layer material is 18%-40%; the vinyl acetate content in the ethylene-vinyl acetate copolymer (EVA) used as the light-blocking adhesive layer material is 18%-40%; the mass ratio of ethylene-vinyl acetate copolymer (EVA) to polypropylene (PP) in the material of the light-blocking adhesive layer is 1:1.5. The light transmittance of the light-blocking barrier film prepared in this example is 10%.

[0062] Example 4

[0063] The difference between this example and Example 1 lies in that the materials used for the light-blocking barrier film and the total thickness of the film are different, specifically as follows:

[0064] The total thickness of the light-blocking barrier film is 0.08 mm - 0.50 mm; 0.4 mm is preferably used in this example, and the thicknesses of the inner layer, inner adhesive layer, barrier layer, light-blocking adhesive layer, and outer layer are 20%, 10%, 10%, 35%, and 25% respectively.

[0065] The material of the inner layer is ethylene-vinyl acetate copolymer (EVA), the material of the inner adhesive layer is ethylene-vinyl acetate copolymer (EVA), the material of the barrier layer is ethylene-vinyl alcohol copolymer (EVOH), the material of the light-blocking adhesive layer is composed of ethylene-vinyl acetate copolymer (EVA) and polypropylene (PP); the material of the outer layer is a combination of polypropylene (PP) and polyethylene terephthalate (PET) in a mass ratio of 1:1.

[0066] The vinyl acetate content in the ethylene-vinyl acetate copolymer (EVA) used as the inner layer material is 12%-28%; the vinyl acetate content in the ethylene-vinyl acetate copolymer (EVA) used as the inner adhesive layer material is 18%-40%; the vinyl acetate content in the ethylene-vinyl acetate copolymer (EVA) used as the light-blocking adhesive layer material is 18%-40%; the mass ratio of ethylene-vinyl acetate copolymer (EVA) to polypropylene (PP) in the material of the light-blocking adhesive layer is 1:2.0. The light transmittance of the light-blocking barrier film prepared in this example is 6%.

[0067] The structure of the intravenous nutrition bag provided by the present invention is simple. Only a liquid inlet end and an infusion end are provided at the lower end of the bag body. The canning device is communicated with the liquid inlet pipeline, and the bag body is communicated with the sealing end. A two-way valve is arranged in the liquid inlet pipeline, and the opening and closing of the two-way valve and the size of the liquid flow are controlled by a pipeline locking member, so as to control the pouring of the liquid. The liquid filling is simple and reliable. After the liquid canning is completed, heat sealing is carried out, and after sealing, automatic cutting is completed to separate the liquid inlet pipeline and the bag body. This kind of structure simplifies the components on the liquid inlet pipeline, greatly reducing the material cost and assembly cost of the product. The heat-sealing end of the intravenous nutrition bag can be either on the catheter connected to the bag body or on the liquid inlet pipeline between the bag body and the two-way valve, with diverse choices and convenient use. The inner layer of the bag body is made of EVA material, and heat sealing can be carried out by high-frequency welding or thermal welding, which is convenient for different production scenarios and easy to use.

[0068] The bag body of the light-shielding and barrier-type intravenous nutrition bag provided by the present invention is made of a light-shielding and barrier-type film. The inner layer in direct contact with the medicinal liquid is made of EVA material, which is an infusion material for long-term clinical application, ensuring the safety of the nutrition bag. After testing, the transmittance of the prepared film layer is <15%, and the light-shielding function in the full wavelength range of 290 - 450 nm can be achieved, meeting the light-shielding requirements of the bag body without adding other additives, and the safety performance of the nutrition bag is good. The adhesion between layers is firm, and there is no delamination problem of the multi-layer structure. Using EVA material as one of the components of the inner adhesive layer or the light-shielding adhesive layer group, its adhesion strength is high, which can meet the substitution safety of the multi-layer structure and avoid using modified adhesive resins, reducing the use of small-molecule substances from the source, avoiding the migration of small-molecule substances into the bag body, and improving the safety of the intravenous nutrition bag.

[0069] Taking the above ideal embodiments based on the present invention as inspiration, through the above description, relevant staff can completely make various changes and modifications within the scope not deviating from the technical idea of this invention patent. The technical scope of this invention patent is not limited to the content in the specification, and its technical scope must be determined according to the scope of the claims.

Claims

1. A light-shielding barrier type intravenous nutrition bag, comprising a bag body (2), wherein a liquid inlet end and a liquid infusion end are arranged at the lower end of the bag body (2), characterized in that: The bag body (2) is made of a light-proof barrier film layer; the liquid inlet end comprises a sealing end (5) connected to the bag body (2), a liquid inlet pipeline (8) connected to a filling device, and two connections (7) connecting the liquid inlet pipeline (8) and the sealing end (5), wherein the two connections are provided with pipeline locking members (6), and the sealing end (5) is between the bag body (2) and the two connections (7); The light-proof barrier film comprises, from inside to outside, an inner layer (21), a sub-inner layer, a sub-outer layer and an outer layer (25); the sub-inner layer is an inner adhesive layer (22); the sub-outer layer comprises a barrier layer (23) close to the sub-inner layer and a light-proof adhesive layer (24) close to the outer layer (25); wherein the material of the inner layer is ethylene-vinyl acetate copolymer (EVA); the material of the inner adhesive layer is ethylene-vinyl acetate copolymer (EVA); the material of the barrier layer is ethylene-vinyl alcohol copolymer (EVOH); and the material of the light-proof adhesive layer is composed of ethylene-vinyl acetate copolymer (EVA) and polypropylene (PP).

2. The light-shielding barrier intravenous nutrition bag according to claim 1, characterized in that: The outer layer material is one or more of polyethylene (PE), polypropylene (PP), polyethylene terephthalate (PET), and polyamide (PA).

3. The light-shielding barrier intravenous nutrition bag according to claim 1, characterized in that: The mass ratio of ethylene-vinyl acetate copolymer (EVA) to polypropylene (PP) in the material of the light-proof adhesive layer is 1:(1.1-2.5).

4. The light-shielding barrier intravenous nutrition bag according to claim 1, characterized in that: The total thickness of the light-shielding barrier film is 0.08mm-0.50mm; the thickness of the inner layer, inner adhesive layer, barrier layer, light-shielding adhesive layer and outer layer respectively accounts for 20%-40%, 10%-25%, 6%-20%, 30%-50% and 25%-40% of the light-shielding portion.

5. The light-shielding barrier intravenous nutrition bag according to claim 1, characterized in that: The vinyl acetate content of the inner layer material ethylene-vinyl acetate copolymer (EVA) is 12%-28%; the vinyl acetate content of the inner adhesive layer material ethylene-vinyl acetate copolymer (EVA) is 18%-40%; the vinyl acetate content of the light-shielding adhesive layer material ethylene-vinyl acetate copolymer (EVA) is 18%-40%.

6. The light-shielding barrier intravenous nutrition bag according to claim 1, characterized in that: The infusion end comprises an infusion pipeline (3) and an infusion socket (4), and the infusion socket (4) is arranged at the end of the infusion pipeline (3); The bag body is also provided with a bag hanging hole (1).

7. The method for manufacturing a light-shielding barrier type intravenous nutrition bag according to any one of claims 1 to 6, comprising the following steps: Step S1, preparing raw materials for the light-shielding barrier film: placing ethylene-vinyl acetate copolymer (EVA) for the inner layer, ethylene-vinyl acetate copolymer (EVA) for the inner adhesive layer, ethylene-vinyl alcohol copolymer (EVOH) for the barrier layer, a blend of ethylene-vinyl acetate copolymer (EVA) and polypropylene (PP) for the light-shielding adhesive layer, and outer layer materials for the outer layer on a preparation table respectively; Step S2, preparation of a light-shielding barrier film: a vacuum suction machine sucks the raw materials on the preparation table into the hopper of a porous extruder, and produces a light-shielding barrier film through a co-extrusion blown film or a cast film process, and the light-shielding barrier film is irradiated after extrusion; the film layer structure is an inner layer (21) formed by ethylene-vinyl acetate copolymer (EVA), an inner adhesive layer (22) formed by ethylene-vinyl acetate copolymer (EVA), a barrier layer (23) formed by ethylene-vinyl alcohol copolymer (EVOH), a light-shielding adhesive layer (24) formed by a blend, and an outer layer (25) formed by an outer layer material, and the obtained light-shielding barrier film is rolled up; Step S3, forming the nutrient bag: unwinding, hot stamping, heat sealing, cooling, and cutting the light-shielding barrier film roll into a shaped nutrient bag; Step S4, air tightness test of the nutrition bag: blowing a sterile air flow into the bag body through the sealing end of the shaped nutrition bag obtained in step S3.

8. The light-shielding barrier intravenous nutrition bag according to claim 7, characterized in that: The radiation dose of the irradiation in step S2 is 5-15 Mard; the hot stamping temperature in step S3 is 150-180°C and the pressure is 0.2-0.4 MPa; the pressure of the sterile air flow blown in step S4 is 4-6 Pa.

9. The light-shielding barrier intravenous nutrition bag according to claim 7, characterized in that: The ethylene-vinyl acetate copolymer, ethylene-vinyl alcohol copolymer, polypropylene and outer layer material are pretreated respectively before use, and the pretreatment process is as follows: the materials to be pretreated are added into organic solvents respectively, and ultrasonically immersed. After removing the organic solvent, the pretreated materials are vacuum dried to complete the preliminary pretreatment; the materials that have completed the preliminary pretreatment are immersed in water, ultrasonically oscillated for 1-3 hours, and then vacuum dried after removing the water.

10. The light-shielding barrier intravenous nutrition bag according to claim 9, characterized in that: The organic solvent used in the pretreatment of ethylene-vinyl acetate copolymer (EVA) is N,N-dimethylformamide (DMF); the organic solvent used in the pretreatment of ethylene-vinyl alcohol copolymer (EVOH) is N,N-dimethylformamide (DMF); the organic solvent used in the pretreatment of polypropylene (PP) is a mixed solution of ethanol and acetone.

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