Peritoneal dialysis solution bag

Abstract

The present application belongs to the technical field of packaging materials, and particularly relates to a peritoneal dialysis solution bag. The peritoneal dialysis solution bag comprises, from inside to outside, an inner layer, a heat preservation layer and an outer layer. The heat preservation layer is prepared from hollow fibers. The hollow fibers are obtained by spinning raw materials including chitosan, silk fibroin and hydroxyapatite. The prepared peritoneal dialysis solution bag has good heat preservation performance and barrier performance.

Description

Technical Field

[0001] This application belongs to the field of packaging materials technology, specifically relating to a peritoneal dialysis fluid bag. Background Technology

[0002] Peritoneal dialysis has become an important renal replacement therapy for uremia patients due to its advantages such as being green, low-carbon, allowing for home-based treatment, and protecting residual kidney function. Commonly used dialysis bags are made of two types: polyvinyl chloride (PVC) and three-layered plastic. The latter is synthesized from polypropylene, polyamide, and polyethylene using a polymerized urethane binder. Among these substances, vinyl chloride monomer, phthalates, caprolactam, and diaminodiphenylmethane can produce toxic reactions through specific biological structural interactions, such as peritoneal sclerosis, bone disease, granulocytopenia, allergic reactions, and carcinogenicity. Furthermore, the temperature of the peritoneal dialysis fluid is a crucial factor affecting dialysis efficiency. Increasing the peritoneal dialysis fluid temperature from 20°C to 37°C can increase dialysis efficiency by 35%. However, the incidence of peritoneal dialysis fluid temperature-related adverse events remains relatively high during peritoneal dialysis treatment.

[0003] Chinese Patent Publication No. CN106273957A discloses a co-extruded membrane for peritoneal dialysis bags and its preparation method. The co-extruded membrane comprises, from the inside out, a heat-sealing layer A, an inner adhesive layer B, a structural layer C, an outer adhesive layer D, and an outer layer E. The heat-sealing layer A is made of a mixed resin composed of modified polypropylene (PP) and ethylene octene copolymer (POE). The inner adhesive layer B is made of ethylene-vinyl acetate (EVA), the structural layer C is made of polyethylene (PE), and the outer adhesive layer D is made of a mixture of ethylene-vinyl acetate copolymer (EVA) and ethylene-methyl acrylate copolymer. The peritoneal dialysis bag uses a mixed resin composed of EMA (ethylene ethylene glycol), with the outer layer being modified polypropylene (PP). The materials used in the inner and outer layers of the co-extruded membrane are inexpensive, resulting in low manufacturing costs. All layers possess strong low-temperature impact resistance and radiation crosslinking properties, effectively preventing damage and leakage during transportation. The layers exhibit good compatibility, strong adhesion, high radiation crosslinking efficiency, and a low bag breakage rate. However, no improvements have been made to its thermal insulation performance. Therefore, developing a peritoneal dialysis bag with good biocompatibility and thermal insulation is of great significance for improving the efficiency and safety of peritoneal dialysis. Summary of the Invention

[0004] To solve at least one of the above-mentioned technical problems, the present invention provides a peritoneal dialysis fluid bag, comprising an inner layer, an insulation layer and an outer layer arranged sequentially from the inside to the outside, wherein the thickness ratio of the inner layer, the insulation layer and the outer layer is 4-6:1-2:3-4, and the insulation layer is made of hollow fiber, wherein the hollow fiber is obtained by spinning raw materials including chitosan, silk fibroin and hydroxyapatite.

[0005] In the above technical solution, the inner and outer layers are prepared using raw materials commonly used in the preparation of dialysis fluid bags in the prior art. The insulation layer in the middle layer is obtained by coaxial wet spinning. The weaving holes formed by spinning and the hollow structure of the hollow fiber itself form a closed cavity in the peritoneal dialysis fluid bag. Since the inside of the closed cavity is still air, and air itself is a poor conductor of heat, it can effectively block heat from being directly transferred through the solid material in a closed state, thereby improving the insulation effect.

[0006] Preferably, the inner layer is made of one or a mixture of polyethylene, polypropylene, polyester, ethylene-vinyl alcohol copolymer, polyvinyl chloride, polylactic acid, and polyvinyl alcohol, preferably polypropylene, which has strong chemical inertness and flexibility, can avoid reaction with the dialysate, and can adapt to the deformation requirements during filling, transportation, and use; the outer layer is made of one or a mixture of polyethylene, polypropylene, polyester, ethylene-vinyl alcohol copolymer, polyvinyl chloride, polylactic acid, and polyvinyl alcohol, preferably polyester, which has high strength, high barrier properties, and sterilization compatibility, and is suitable for storage in multiple environments.

[0007] This invention provides a method for preparing a peritoneal dialysis fluid bag, comprising the following steps:

[0008] S100: Using raw materials including chitosan and sodium periodate, dialdehyde chitosan is obtained through an oxidation reaction;

[0009] S200. Using raw materials including raw silkworm silk, a silk fibroin dispersion is prepared.

[0010] S300 uses raw materials including dialdehyde chitosan, silk fibroin dispersion and hydroxyapatite as precursors, and obtains hollow fibers through spinning. The collected hollow fiber membrane is the heat insulation layer.

[0011] S400: The inner layer material is extruded through an extruder to obtain a molten inner layer material, which is then cast to obtain an inner layer film.

[0012] S500: The outer layer material is extruded through an extruder to obtain a molten outer layer material, which is then cast to obtain an outer layer film.

[0013] S600, The inner film, the insulation layer and the outer film are combined to obtain the peritoneal dialysis bag.

[0014] Preferably, S100 specifically involves: dissolving chitosan in an aqueous acetic acid solution, stirring at room temperature until dissolved, adding sodium periodate powder, stirring in the dark for 6-12 hours, adding ethylene glycol solution, and after the reaction is complete, loading the reaction solution into a dialysis bag, and obtaining dialdehyde chitosan after dialysis and freeze-drying.

[0015] In the above technical solution, chitosan is dissolved in an aqueous acetic acid solution and stirred thoroughly to ensure complete dissolution. Under light-protected conditions, an aluminum foil container can be wrapped to create a light-protected environment. Sodium periodate is added and stirred to prevent its decomposition by light. Excess ethylene glycol solution is added to terminate the reaction and prevent further oxidation of residual sodium periodate. The reaction solution is placed in a dialysis bag (MW7000) and dialyzed in deionized water for 72 hours, with the deionized water being replaced every 3-5 hours to remove small molecules such as sodium periodate and ethylene glycol. The resulting dialdehyde chitosan is placed in a desiccator for later use to prevent it from absorbing moisture and affecting its performance.

[0016] Preferably, S200 specifically comprises:

[0017] S210. Place the raw silkworm silk in a urea solution and slowly heat it to 85-95℃ for 2-4 hours to degumme. After degumming, wash and dry it with deionized water to obtain degummed silkworm silk, and store it away from light.

[0018] S220. Place degummed silk in LiBr solution and heat at 50-60℃ for 3-5 hours to obtain a transparent yellow liquid. After centrifugation, put it into a dialysis bag and dialyze it in deionized water for 60-84 hours. After dialysis, a silk fibroin dispersion is obtained.

[0019] In the aforementioned technical solution, raw silk is an important natural protein fiber, mainly composed of two proteins: fibroin and sericin. In raw silk, sericin coats the surface of two parallel fibroin fibers. However, the amino acids constituting fibroin and sericin differ significantly in type, molecular structure, and arrangement, leading to substantial differences in their properties. Besides good biocompatibility and biodegradability, fibroin also exhibits excellent mechanical properties. Existing technologies typically use alkaline sodium carbonate solutions for degumming silk; however, boiling sodium carbonate solutions cause severe breakage of the fibroin peptide chains. This leads to a decrease in its mechanical properties. Therefore, in this invention, the use of a non-alkaline urea degumming system can reduce damage to the silk fibroin peptide chain and improve the structure and properties of the silk fibroin material. In step S210, after degumming, the degummed silk is thoroughly washed with deionized water until there is no slippery feeling, and then dried in an oven at 35-45℃ until constant weight to obtain degummed silk. In step S220, after centrifugation to remove impurities from the solution, it is placed in a dialysis bag with a molecular weight cutoff of 2000 and dialyzed in deionized water. The deionized water is changed every 12 hours. After dialysis, a silk fibroin dispersion is obtained and stored at a low temperature of -20-4℃ for later use.

[0020] Preferably, S300 specifically refers to:

[0021] S310. Add dialdehyde chitosan to an aqueous acetic acid solution and stir until dissolved under light-protected conditions. Then add silk fibroin dispersion and mix evenly. Add hydroxyapatite modified with silane coupling agent and stir under light-protected conditions for 4-6 hours to obtain spinning solution.

[0022] S320. The spinning solution and core layer solution are respectively loaded into two syringes. The syringe pump is used to continuously wet spin the nascent hollow fibers into the coagulation bath at the same injection rate through the outer and inner needles. The collected nascent fibers are then washed and dried to obtain a hollow fiber membrane, which is the insulation layer.

[0023] In the above technical solution, hollow fibers are prepared by coaxial wet spinning. The hollow fibers themselves can form a closed cavity structure, which restricts the movement of air molecules and results in a low heat conduction rate. In addition, the hollow fiber membrane prepared by coaxial wet spinning has a large number of braided holes, which also form a closed cavity under the composite of the inner and outer layers. The presence of a large number of closed cavities in the middle insulation layer can effectively improve the heat insulation performance. The spinning solution is composed of raw materials including dialdehyde chitosan, silk fibroin dispersion, and hydroxyapatite. Chitosan is a partially deacetylated product of chitin, which has excellent biocompatibility, biodegradability, and low toxicity. By using sodium periodate to oxidize chitosan into dialdehyde chitosan, it can be cross-linked with silk fibroin to enhance fiber strength. Hydroxyapatite is a calcium phosphate complex with good biocompatibility and high thermal stability. It can form hydrogen bonds with dialdehyde chitosan and silk fibroin in the spinning solution, further improving the tensile strength and toughness of hollow fibers and enhancing the mechanical properties of the insulation layer.

[0024] Preferably, the method for preparing hydroxyapatite modified with silane coupling agent is as follows: hydroxyapatite is dispersed in an aqueous ethanol solution, a silane coupling agent is added, the mixture is ultrasonically dispersed for 40-60 min, and then heated to 50-60℃ for 6-8 h to obtain hydroxyapatite modified with silane coupling agent.

[0025] In the above technical solution, by modifying the surface of hydroxyapatite with a silane coupling agent, its inorganic end undergoes a condensation reaction with the hydroxyl groups on the surface of hydroxyapatite through hydrolysis, forming a stable covalent bond anchored on the surface of hydroxyapatite. Its organic end can form hydrogen bonds or covalent bonds with the active groups in silk fibroin or chitosan, thereby enhancing the interfacial bonding force between hydroxyapatite and the organic matrix.

[0026] Preferably, S600 specifically refers to:

[0027] S610. After applying an adhesive to the surface in contact with the inner film and the insulation layer, hot pressing is performed to obtain an inner layer / insulation layer composite layer.

[0028] S620. After applying an adhesive to the surface in contact with the inner / insulation layer composite layer and the outer film, hot-press composite layer is formed to obtain the inner / insulation layer / outer composite layer, and the peritoneal dialysis bag is obtained by bag making.

[0029] In the above technical solution, the adhesive needs to meet the characteristics of sterilization resistance, biocompatibility, flexibility and long-term sealing. Preferably, the adhesive is one or a mixture of several of the following: medical-grade polyurethane adhesive, acrylate copolymer adhesive, hydrocolloid adhesive, and epoxy resin adhesive.

[0030] The present invention has the following beneficial effects:

[0031] The peritoneal dialysis bag prepared by this invention is composed of an inner layer, an insulation layer, and an outer layer. The insulation layer, located in the middle, is obtained by coaxial wet spinning. The weave holes formed by spinning and the hollow structure of the hollow fiber itself form a closed cavity in the peritoneal dialysis bag, which restricts the movement of air molecules and has a low heat conduction rate, thus providing good insulation performance. The spinning solution is composed of raw materials including dialdehyde chitosan, silk fibroin dispersion, and hydroxyapatite. Silk fibroin has good biocompatibility and biodegradability. When blended with dialdehyde chitosan, it can cross-link to enhance fiber strength. The addition of hydroxyapatite can further improve the tensile strength and toughness of the hollow fiber and enhance the mechanical properties of the insulation layer. Detailed Implementation

[0032] The technical solutions in the embodiments of this application will be clearly and completely described below with reference to the embodiments of this application. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of this application.

[0033] Chitosan (AR) and sodium periodate (purity: 99.5%) used in this invention were purchased from Shanghai Maclean Biochemical Technology Co., Ltd., dialysis bags were purchased from Shanghai Yuanye Biotechnology Co., Ltd., raw silk was purchased from Anhui Qingyang Sanfang Silk Co., Ltd., urea (AR), lithium bromide (AR), polypropylene (P110853), and polyester (P303203) were purchased from Shanghai Aladdin Reagent Co., Ltd., and hydroxyapatite (superior grade) was purchased from Hubei Zhida Biomedical Co., Ltd. All reagents were commercially available.

[0034] Example 1

[0035] This embodiment provides a peritoneal dialysis fluid bag, comprising an inner layer, an insulation layer, and an outer layer arranged sequentially from the inside out. The thickness ratio of the inner layer, the insulation layer, and the outer layer is 4-6:1-2:3-4. The insulation layer is made of hollow fiber, which is obtained by spinning raw materials including chitosan, silk fibroin, and hydroxyapatite.

[0036] The inner layer is made of one or more of polyethylene, polypropylene, polyester, ethylene-vinyl alcohol copolymer, polyvinyl chloride, polylactic acid, and polyvinyl alcohol, preferably polypropylene, which has strong chemical inertness and flexibility, can avoid reaction with dialysate, and can adapt to deformation requirements during filling, transportation, and use; the outer layer is made of one or more of polyethylene, polypropylene, polyester, ethylene-vinyl alcohol copolymer, polyvinyl chloride, polylactic acid, and polyvinyl alcohol, preferably polyester, which has high strength, high barrier properties, and sterilization compatibility, and is suitable for storage in multiple environments.

[0037] Example 2

[0038] This embodiment provides a method for preparing a peritoneal dialysis fluid bag, including the following steps:

[0039] S1. Dissolve 2 parts by weight of chitosan in 110 parts by weight of 3% acetic acid aqueous solution. Stir at room temperature for 6 hours until the chitosan is completely dissolved. Then, add 1 part by weight of sodium periodate powder and stir for 8 hours under light-protected conditions to fully oxidize the chitosan. Then, add 12 parts by weight of 0.15 mol / L ethylene glycol solution to terminate the reaction. After the reaction is completed, put the reaction solution into a dialysis bag with a molecular weight cutoff of 7000 and dialyze in deionized water for 72 hours. Change the deionized water every 4 hours. After dialysis, freeze-dry to obtain dialdehyde chitosan and store it in a desiccator for later use.

[0040] S2. Place 2 parts by weight of raw silk into 75 parts by weight of urea solution with a concentration of 6 mol / L, slowly heat to 90°C, and maintain this temperature for degumming for 4 hours. After degumming, wash with deionized water until there is no slippery feeling, and then place in an oven at 45°C to dry to constant weight to obtain degummed silk. Store in the dark for later use.

[0041] S3. Place 1.2 parts by weight of dried degummed silk into 15 parts by weight of 9 mol / L LiBr solution, raise the temperature to 55℃ and heat for 4 hours to obtain a transparent yellow liquid. Centrifuge at 8000 rpm for 20 minutes using a high-speed dispersion centrifuge to remove impurities. Then, put it into a dialysis bag with a molecular weight cutoff of 2000 and dialyze it in deionized water for 72 hours. Change the deionized water every 12 hours. After dialysis, a silk fibroin dispersion is obtained and stored at 4℃ for later use.

[0042] S4. The preparation method of hydroxyapatite modified by silane coupling agent is as follows: 1 part by weight of hydroxyapatite is dispersed in 90 parts by weight of 90% ethanol aqueous solution, 0.1 part by weight of silane coupling agent KH550 is added, ultrasonically dispersed for 50 min, heated to 55℃ and reacted for 7 h, centrifuged and washed 3 times, and freeze-dried to obtain hydroxyapatite modified by silane coupling agent.

[0043] S5. Add 1.2 parts by weight of dialdehyde chitosan to 24 parts by weight of 1% acetic acid aqueous solution, stir for 6 hours in the dark, then add 1.8 parts by weight of silk fibroin dispersion, mix evenly, then add 0.1 parts by weight of hydroxyapatite modified with silane coupling agent, stir for 5 hours in the dark to obtain spinning solution.

[0044] S6. The spinning solution and core layer solution (deionized water) are respectively loaded into two 10mL syringes. Using a syringe pump, the fibers are continuously wet-spun into the coagulation bath (pure water) at the same injection rate of 300μL / min through the outer needle (17G) and inner needle (23G). The fibers are continuously collected at a linear velocity of 2.0m / min. The collected nascent hollow fibers are soaked in deionized water for 2 hours and then air-dried at room temperature to obtain a hollow fiber membrane. The dried hollow fiber membrane is placed in a 55℃ oven and dried to constant weight, which is the insulation layer.

[0045] S7. Add 10 parts by weight of the inner layer raw material polypropylene to an extruder and extrude to obtain molten inner layer raw material. The temperatures of zones 1-8 of the barrel are 160℃, 170℃, 180℃, 190℃, 200℃, 210℃, 220℃, and 230℃ respectively, and the die temperature is 210℃. Cast the obtained molten inner layer raw material to obtain an inner layer film. The casting extrusion temperature is 210-220℃, the cooling temperature is controlled at 25-35℃, and the processing speed is 110m / min.

[0046] S8. Add 10 parts by weight of the outer layer raw material polyester to an extruder and extrude to obtain a molten outer layer raw material. The temperatures of the barrel zones 1-8 are 240℃, 250℃, 260℃, 270℃, 275℃, 285℃, 290℃, and 300℃, respectively, and the die temperature is 290℃. Cast the obtained molten outer layer raw material to obtain an outer layer film. The casting extrusion temperature is 260-280℃, the cooling temperature is 90-100℃ in the high-temperature pre-cooling section and 18-25℃ in the low-temperature setting section, and the processing speed is 110m / min.

[0047] S9. After coating the surface of the inner film and the insulation layer in contact with each other with medical-grade polyurethane adhesive, hot-press composite is performed to obtain the inner layer / insulation layer composite layer. The hot-pressing temperature is 140℃-160℃, the composite pressure is 0.2-0.5MPa, the holding time is 15-20s, and the cooling rate is 10℃ / min.

[0048] S10. After coating the surface of the inner / insulation layer composite layer in contact with the outer film with medical-grade polyurethane adhesive, hot-press composite layer is obtained to obtain inner / insulation layer / outer layer composite layer. The peritoneal dialysis bag is then made. The hot-pressing temperature is 160℃-180℃, the composite pressure is 0.2-0.5MPa, the holding time is 15-20s, the cooling rate is 10℃ / min, and the thickness ratio of the inner layer, insulation layer and outer layer is 5:1.5:3.

[0049] Example 3

[0050] This embodiment provides a peritoneal dialysis fluid bag, which differs from Embodiment 2 in that:

[0051] In the preparation of the spinning solution, 2.4 parts by weight of dialdehyde chitosan were added to 24 parts by weight of 1% acetic acid aqueous solution, and stirred for 6 hours in the dark. Then, 1.8 parts by weight of silk fibroin dispersion was added and mixed evenly. Finally, 0.2 parts by weight of hydroxyapatite modified with silane coupling agent was added and stirred for 5 hours in the dark.

[0052] Example 4

[0053] This embodiment provides a peritoneal dialysis fluid bag, which differs from Embodiment 2 in that:

[0054] In the preparation of the spinning solution, 1 part by weight of dialdehyde chitosan was added to 24 parts by weight of 1% acetic acid aqueous solution, and stirred for 6 hours in the dark. Then, 1.8 parts by weight of silk fibroin dispersion was added, and after mixing evenly, 0.06 parts by weight of hydroxyapatite modified with silane coupling agent was added, and stirred for 5 hours in the dark.

[0055] Example 5

[0056] This embodiment provides a peritoneal dialysis fluid bag, which differs from Embodiment 2 in that: in the preparation of the spinning solution, the dialdehyde chitosan is replaced with chitosan.

[0057] Example 6

[0058] This embodiment provides a peritoneal dialysis fluid bag, which differs from Embodiment 2 in that the hydroxyapatite modified with silane coupling agent is replaced with hydroxyapatite in the preparation of the spinning solution.

[0059] Example 7

[0060] This embodiment provides a peritoneal dialysis fluid bag, which differs from Embodiment 2 in that hydroxyapatite modified with silane coupling agent is not added during the preparation of the spinning solution.

[0061] Related tests

[0062] The heat retention performance of the peritoneal dialysis bags prepared in Examples 2 to 7 was tested, and the results are shown in Table 1.

[0063] Table 1 Thermal insulation performance test results

[0064] As can be seen from the test results in Table 1, the peritoneal dialysis fluid bags prepared in Examples 2 to 4 have relatively good heat preservation performance, especially the peritoneal dialysis fluid bag prepared in Example 2 has the best heat preservation performance.

[0065] The peritoneal dialysis bags prepared in Examples 2 to 7 were tested for water vapor permeability (test conditions: 38℃, 90%RH; test method: Method 3 of General Chapter (4010) of the 2020 edition of the Chinese Pharmacopoeia, Part IV, "Determination of Water Vapor Permeability"), oxygen permeability (test conditions: 23℃; test method: Method 2 of General Chapter (4007) of the 2020 edition of the Chinese Pharmacopoeia, Part IV, "Determination of Gas Permeability"), and solvent residue (YBB00312004-2015, not detected because it was below the method detection limit; the method detection limit for benzene and benzene-related solvent residues was 0.01 mg / m³). 2 The test results are shown in Table 2.

[0066] Table 2. Test results of water vapor transmission rate, oxygen transmission rate, and solvent residue.

[0067] As can be seen from the test results in Table 2, the peritoneal dialysis bags prepared by the present invention all meet the standards, especially Example 2, which has relatively low water vapor permeation, oxygen permeation and solvent residue.

[0068] The transmittance of the peritoneal dialysis bags prepared in Examples 2 to 7 was measured after high-temperature (100°C) steam sterilization. The test results are shown in Table 3.

[0069] Table 3. Transmittance Test Results

[0070] As can be seen from the test results in Table 3, the peritoneal dialysis bags prepared by the present invention can all remain transparent after high-temperature steam sterilization, which makes it easy to observe the state of the substances inside the bag. Among them, the peritoneal dialysis bags prepared without modification of hydroxyapatite during the preparation process (Example 6) have slightly lower transparency, which may be because the unmodified hydroxyapatite has relatively poor dispersibility, which affects the transparency of the product.

[0071] It should be noted that, in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such process, method, article, or apparatus.

[0072] Although embodiments of this application have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and variations can be made to these embodiments without departing from the principles and spirit of this application, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A peritoneal dialysis fluid bag, characterized in that, It includes an inner layer, an insulation layer, and an outer layer arranged from the inside out. The thickness ratio of the inner layer, the insulation layer, and the outer layer is 4-6:1-2:3-4. The insulation layer is made of hollow fiber, which is obtained by spinning raw materials including chitosan, silk fibroin, and hydroxyapatite. The method for preparing the peritoneal dialysis bag includes the following steps: S100: Using raw materials including chitosan and sodium periodate, dialdehyde chitosan is obtained through an oxidation reaction; S200. Using raw materials including raw silkworm silk, a silk fibroin dispersion is prepared. S300 uses raw materials including dialdehyde chitosan, silk fibroin dispersion and hydroxyapatite as precursors, and obtains hollow fibers through spinning. The collected hollow fiber membrane is the heat insulation layer. S400: The inner layer material is extruded through an extruder to obtain a molten inner layer material, which is then cast to obtain an inner layer film. S500: The outer layer material is extruded through an extruder to obtain a molten outer layer material, which is then cast to obtain an outer layer film. S600, The inner film, the insulation layer and the outer film are combined to obtain the peritoneal dialysis bag; The S300 specifically refers to: S310. Add dialdehyde chitosan to an aqueous acetic acid solution and stir until dissolved under light-protected conditions. Then add silk fibroin dispersion and mix evenly. Add hydroxyapatite modified with silane coupling agent and stir under light-protected conditions for 4-6 hours to obtain spinning solution. S320. The spinning solution and core layer solution are respectively loaded into two syringes. The syringe pump is used to continuously wet spin the nascent hollow fibers into the coagulation bath at the same injection rate through the outer and inner needles. The collected nascent fibers are then washed and dried to obtain a hollow fiber membrane, which is the insulation layer. The preparation method of silane coupling agent modified hydroxyapatite is as follows: hydroxyapatite is dispersed in an aqueous ethanol solution, a silane coupling agent is added, and the mixture is ultrasonically dispersed for 40-60 min. Then, it is heated to 50-60℃ and reacted for 6-8 h to obtain silane coupling agent modified hydroxyapatite.

2. The peritoneal dialysis fluid bag according to claim 1, characterized in that, The inner layer is made of one or more of the following raw materials: polyethylene, polypropylene, polyester, ethylene-vinyl alcohol copolymer, polyvinyl chloride, polylactic acid, and polyvinyl alcohol; the outer layer is made of one or more of the following raw materials: polyethylene, polypropylene, polyester, ethylene-vinyl alcohol copolymer, polyvinyl chloride, polylactic acid, and polyvinyl alcohol.

3. The peritoneal dialysis fluid bag according to claim 1, characterized in that, S100 is specifically as follows: Chitosan is dissolved in an aqueous acetic acid solution, stirred at room temperature until dissolved, sodium periodate powder is added, stirred in the dark for 6-12 hours, ethylene glycol solution is added, and after the reaction is completed, the reaction solution is put into a dialysis bag, and after dialysis and freeze-drying, dialdehyde chitosan is obtained.

4. The peritoneal dialysis fluid bag according to claim 1, characterized in that, S200 specifically refers to: S210. Place the raw silkworm silk in a urea solution and slowly heat it to 85-95℃ for 2-4 hours to degumme. After degumming, wash and dry it with deionized water to obtain degummed silkworm silk, and store it away from light. S220. Place degummed silk in LiBr solution and heat at 50-60℃ for 3-5 hours to obtain a transparent yellow liquid. After centrifugation, put it into a dialysis bag and dialyze it in deionized water for 60-84 hours. After dialysis, a silk fibroin dispersion is obtained.

5. A peritoneal dialysis fluid bag according to claim 1, characterized in that, The S600 specifically refers to: S610. After applying an adhesive to the surface in contact with the inner layer and the insulation layer, hot pressing is performed to obtain an inner layer / insulation layer composite layer. S620. After applying an adhesive to the surface of the inner / insulation layer composite layer in contact with the outer layer, hot-press composite layer is formed to obtain the inner / insulation layer / outer layer composite layer, and the peritoneal dialysis fluid bag is obtained by bag making.

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