Powder-liquid dual-chamber hemodialysis concentrate packaging bag with filtering system

Abstract

The application discloses a powder-liquid dual-chamber hemodialysis concentrate packaging bag with a filtering system. The packaging bag comprises a three-layer co-extrusion film bag body, a filtering assembly, a sealing strip and an interface assembly. The bag body is divided into an upper cavity, a filtering cavity and a lower cavity. The filtering cavity is provided with a filtering screen with a filtering precision of 0.1 microns. The filtering screen periphery is welded and sealed with the inner wall of the bag body. The upper cavity and the lower cavity are separated by peelable upper and lower sealing strips. The top of the bag body is provided with double-layer hanging holes with a bearing capacity of not less than 5 kg. The application realizes the integration of "dissolution-filtering-liquid preparation" in the bag, the filtering precision is 0.1 microns, the insoluble particle and endotoxin levels are significantly reduced, and the hemodialysis concentrate preparation system can be cooperated to realize the present preparation and use and individualized dialysis.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a powder-liquid dual-chamber hemodialysis concentrate packaging bag with a filtration system, which can be used in conjunction with a dialysis concentrate preparation system for on-site preparation and use in clinical hemodialysis settings. Background Technology

[0002] Chronic kidney disease (CKD) is a common and frequently occurring disease in my country. When it progresses to end-stage renal disease, renal replacement therapy is necessary, and hemodialysis is one of the main alternative treatments. The composition and quality of the dialysate directly affect the survival rate and quality of life of hemodialysis patients.

[0003] The current main methods of supplying clinical dialysis fluid have the following shortcomings:

[0004] (1) Barrel-packaged dialysis concentrate: Hard plastic barrels have high storage and transportation costs, large barrel weight, high damage rate during transportation, large storage space, and electrolytes (such as sodium bicarbonate) are prone to crystallization during long-term storage and transportation, which changes the physicochemical properties and affects the dialysis quality.

[0005] (2) Centralized supply of dialysis powder: The concentrated solution after dissolution needs to be transported to each dialysis machine through a long pipeline, which poses a risk of pipeline contamination and cross-contamination, and is not convenient for personalized prescriptions.

[0006] (3) Although the existing powder-liquid dual-chamber bags (such as peritoneal dialysis dual-chamber bags CN1919700A) have solved the storage and transportation cost problem, they only have one internal separation sealing strip and do not have the function of online filtration inside the bag. They cannot remove particles, undissolved powder clumps and endotoxins that may be introduced during the dissolution process. Filter cartridges still need to be installed at the pipeline end for filtration, which poses risks such as filtration lag and filter cartridge contamination backflow.

[0007] (4) The existing multi-chamber hemodialysis powder packaging bag (CN207693914U) discloses a multi-chamber bag body for dispensing different dialysis powders. The chambers are separated by a peelable weld, but all chambers only contain powder and do not include liquid chambers. It has no online filtration function and does not involve filter components inside the bag.

[0008] (5) Existing technologies (such as CN100591369C) disclose a scheme to set a "dedicated filter" at the end of the liquid collection tube of the dialysis bag. However, the filter is located at the end of the liquid collection tube outside the bag body, rather than an independent filtration chamber inside the bag. Moreover, the filtration accuracy is not clearly defined, and the cleanliness of the dialysis fluid after dissolution inside the bag body cannot be guaranteed.

[0009] (6) The patent CN120285329A owned by the same applicant discloses a dialysis concentrate preparation system and a dynamic preparation control method, which uses a flexible single-chamber bag to hold dialysis dry powder and dissolves it through an external multimodal dissolution device. However, the bag has a single-chamber structure, and the filtration function depends on the dialysis machine suction tube filter (pore size 20μm). The filtration accuracy is limited and the filter is located outside the bag, which cannot effectively guarantee the cleanliness of the dialysis solution after dissolution inside the bag.

[0010] In addition, existing dual-chamber bags typically use heat sealing for the secondary sealing process after filtration. However, this method has the following problems when applied to bags that already contain dialysate: heat is conducted to the liquid through the bag wall, which may cause heat-sensitive components such as sodium bicarbonate to decompose (NaHCO3 decomposes into Na2CO3+ CO2+ H2O at 60~80℃), altering the ion balance; wet heat sealing strength is much lower than dry heat sealing, resulting in poor reliability; repeated heat history may cause trace amounts of precipitates to be released from the inner layer of polyethylene, affecting biocompatibility.

[0011] Therefore, there is an urgent need for a high-quality packaging bag with a reasonable structure that can integrate "powder filling - dissolution - online filtration - cold secondary sealing - liquid preparation" and work in conjunction with the liquid preparation system. Summary of the Invention

[0012] To address the aforementioned problems, this invention provides a dual-chamber packaging bag for powder and liquid hemodialysis concentrate with a filtration system. The filtration components are integrated inside the bag body, forming a three-chamber structure consisting of an upper chamber, a filtration chamber, and a lower chamber. This enables precise online filtration within the bag, improving the cleanliness and quality of the dialysis concentrate.

[0013] This invention provides a dual-chamber packaging bag for hemodialysis concentrate with a filtration system, comprising a bag body, a filter assembly, a sealing strip, and an interface assembly. The bag body is formed by heat sealing multiple layers of co-extruded film and is divided along its length into three independent chambers: an upper chamber, a filter chamber, and a lower chamber, which are sequentially connected. The upper chamber is used to hold hemodialysis dry powder, and the lower chamber is used to hold the dissolved and filtered dialysis concentrate. The filter chamber is located between the upper and lower chambers and contains a filter assembly. The filter assembly includes a filter screen, the periphery of which is welded to the inner wall of the bag body to form a sealed connection. The filtration accuracy of the filter screen is 0.1 μm. The sealing strip includes an upper sealing strip located between the upper and filter chambers and a lower sealing strip located between the filter chamber and the lower chamber. Both the upper and lower sealing strips are peelable and easy-to-open sealing strips with an opening pressure of 0. 0.5~0.2MPa; The composite sealing structure consists of two layers connected in series: a peelable heat-sealing sealing strip and a mechanical convex-concave interlocking buckle strip arranged sequentially along the material flow direction; The peelable heat-sealing sealing strip serves as the initial seal; The mechanical convex-concave interlocking buckle strip includes convex and concave buckle strips pre-installed on both sides of the inner wall of the bag, which can be aligned and interlocked under external pressure. The cross-section of the convex buckle strip is mushroom-shaped, including a neck and a head. After interlocking, it forms an irreversible mechanical lock with an interlocking force ≥15N / cm; The upper sealing strip is heat-sealed, and the lower sealing strip is mechanical, allowing for secondary sealing; The interface assembly includes a liquid inlet interface communicating with the upper cavity and a liquid outlet interface communicating with the lower cavity. Both the liquid inlet and outlet interfaces are standard interfaces adapted to the dialysis machine suction tube; The top of the bag body is provided with double-layer hanging holes, and the load-bearing capacity of the double-layer hanging holes is not less than 5kg.

[0014] According to one embodiment of the present invention, the bag body is composed of three co-extruded film layers: an inner layer, a middle barrier layer, and an outer layer. The inner layer is a polyethylene (PE) layer with a thickness of 50-80 μm; the middle barrier layer is an ethylene-vinyl alcohol copolymer (EVOH) layer or a polyvinylidene chloride (PVDC) layer with a thickness of 15-30 μm; the outer layer is a polyethylene terephthalate (PET) layer or a polyamide (PA) layer with a thickness of 60-80 μm; and the total thickness of the bag body is 0.15-0.20 mm.

[0015] According to one embodiment of the present invention, the filter screen is made of any one of polyethersulfone (PES), polyvinylidene fluoride (PVDF), or polytetrafluoroethylene (PTFE), and the effective filtration area of ​​the filter screen is 80-150 cm². The filter assembly further includes a support frame located on the upstream side of the filter screen. The support frame is made of medical-grade polypropylene (PP), is mesh-shaped, and has a mesh aperture of 2-5 mm, which is used to prevent the filter screen from collapsing or becoming clogged during the filtration process.

[0016] According to one embodiment of the present invention, both the upper sealing strip and the lower sealing strip are formed by heat sealing through the inner wall of the bag, the heat sealing temperature is 120~150℃, the heat sealing width is 3~6mm, and the peel strength is 3~10N / 15mm; the peel strength of the upper sealing strip is less than that of the lower sealing strip.

[0017] According to one embodiment of the present invention, the volume ratio of the upper cavity to the lower cavity is 1:3 to 1:5; the inner wall of the upper cavity is provided with multiple guide ribs extending along its length direction, the height of the guide ribs is 1 to 3 mm, the width is 2 to 4 mm, and the spacing between adjacent guide ribs is 10 to 20 mm, which is used to promote turbulent mixing of dialysis dry powder and dialysis water.

[0018] According to one embodiment of the present invention, the bottom of the lower cavity is an inverted conical confluence structure, and the liquid outlet is located at the lowest point of the inverted conical confluence structure.

[0019] According to one embodiment of the present invention, the inlet port is provided with a one-way check valve, and the outlet port is provided with a tearable sterile protective film; the outer surface of the bag is also provided with a radio frequency identification RFID tag or QR code for recording powder batch, formula information and filtration status.

[0020] According to one embodiment of the present invention, a solubility visualization indicator label is also affixed to the outer surface of the bag. The solubility visualization indicator label is a conductivity-sensitive color-changing membrane or a pH-sensitive color-changing membrane, which is used to indicate that the dialysis concentrate has reached a qualified state through color change after dissolution and filtration.

[0021] The technical solution of the present invention has the following advantages: (1) The three-chamber structure inside the bag integrates online filtration function with a filtration accuracy of 0.1μm. It can effectively remove particles, undissolved powder agglomerates and potential endotoxins that may be introduced during the dissolution process. Compared with the 20μm external filter cartridge located at the pipeline end in the existing technology, the filtration accuracy is improved by 200 times. Moreover, the filtration process is completed in the sealed bag, avoiding secondary pollution. (2) The upper cavity has built-in guide ribs, which, together with the external multimodal dissolution device, can significantly improve the dissolution efficiency and shorten the dissolution time by more than 30% compared with the traditional static dissolution. (3) The inverted conical conical conical merging structure at the bottom of the lower chamber, in conjunction with the liquid outlet, can reduce the residual liquid volume in the lower chamber to less than 3 mL, thereby reducing drug waste; (4) The multilayer co-extruded membrane has barrier properties, mechanical strength and biocompatibility, meets the requirements of USP Class VI and ISO10993, and does not react with the components of the dialysate; (5) The double-layer hanging holes can bear a load of not less than 5kg to meet the requirements for hanging dialysis machines; (6) It can be used with the dialysis concentrate preparation system to identify powder, retrieve parameters and dynamically prepare solutions via RFID tags, so as to realize on-the-spot preparation and personalized dialysis. Attached Figure Description

[0022] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments consistent with the invention and, together with the description, serve to explain the principles of the invention.

[0023] 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, those skilled in the art can obtain other drawings based on these drawings without creative effort.

[0024] Figure 1 This is a schematic diagram of the overall structure of the packaging bag provided in an embodiment of the present invention; Figure 2 A partial cross-sectional view of a filtering component provided in an embodiment of the present invention; Figure 3 This is a schematic diagram of the lower cavity inverted cone-shaped manifold structure provided in an embodiment of the present invention; Figure 4 This is a schematic diagram of the distribution of the upper cavity guide ribs provided in an embodiment of the present invention; Figure 5 This is a schematic diagram of the interface component structure provided in an embodiment of the present invention; Figure 6 This is a schematic diagram of the usage method provided in an embodiment of the present invention.

[0025] Reference numerals: 1-Bag body; 11-Upper cavity; 111-Guiding rib; 12-Filter cavity; 13-Lower cavity; 131-Inverted conical confluence structure; 2-Filter assembly; 21-Filter screen; 22-Support frame; 3-Sealing strip; 31-Upper sealing strip; 32-Lower sealing strip; 4-Interface assembly; 41-Inlet port; 411-One-way check valve; 42-Outlet port; 421-Sterile protective membrane; 5-Double-layer hanging hole; 6-RFID tag / QR code identification; 7-Solubility visualization indicator tag. Detailed Implementation

[0026] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0027] Example 1: Standard Three-Chamber Filter Bag like Figure 1 As shown, the powder-liquid dual-chamber hemodialysis concentrate packaging bag with filtration system in this embodiment includes a bag body 1, a filter assembly 2, a sealing strip 3, an interface assembly 4, and double-layer hanging holes 5.

[0028] The bag body 1 is a flat bag-shaped structure made of three co-extruded films heat-sealed together, with a length of 350mm and a width of 220mm. The three co-extruded films, from the inside out, are: an inner PE layer (70μm thick, conforming to USP Class VI and ISO 10993 biocompatibility certification), a middle EVOH barrier layer (20μm thick), and a middle EVOH barrier layer. ³ / m²·24h·atm), outer PET layer (70μm thick), The total thickness of the bag is 0.16mm.

[0029] The bag body 1 is divided into three independent chambers along its length by two transverse heat-sealed lines: an upper chamber 11 near the top (with a volume of about 80 mL, used to hold hemodialysis dry powder), a filtration chamber 12 in the middle (with a volume of about 15 mL), and a lower chamber 13 near the bottom (with a volume of about 320 mL, used to hold the dissolved and filtered dialysis concentrate). The volume ratio of the upper chamber 11 to the lower chamber 13 is about 1:4.

[0030] like Figure 2 As shown, a filter assembly 2 is fixedly installed inside the filter chamber 12. The filter assembly 2 includes a filter screen 21 and a support frame 22. The filter screen 21 is made of polyethersulfone (PES) membrane with a pore size of 0.1 μm and an effective filtration area of ​​120 cm². Its periphery is connected to the inner wall of the bag body 1 by ultrasonic welding with a welding width of 4 mm, ensuring that the filter chamber 12 is completely isolated from the upper chamber 11 and the lower chamber 13 when the sealing strip 3 is not opened. The support frame 22 is located on the upstream side of the filter screen 21 (i.e., the side facing the upper chamber), is made of medical-grade PP, and has a mesh structure with a mesh pore size of 3 mm. It is used to prevent the filter screen 21 from collapsing or sticking to the downstream inner wall and causing blockage during solution impact.

[0031] The sealing strip 3 includes an upper sealing strip 31 and a lower sealing strip 32. The upper sealing strip 31 is a peelable, easy-open sealing strip, formed by heat-sealing the inner PE layer of the bag body 1 at 120℃ and 0.3MPa pressure. The heat-sealed width is 4mm, the peel strength is 4N / 15mm, and the opening pressure is approximately 0.08MPa. The lower sealing strip 32 is also a peelable sealing strip, with a heat-sealing temperature of 140℃, a heat-sealed width of 5mm, a peel strength of 7N / 15mm, and an opening pressure of approximately 0.15MPa. The peel strength of the lower sealing strip 32 is greater than that of the upper sealing strip 31, which ensures that the upper sealing strip is opened first during use, and then the timing of opening the lower sealing strip is controlled to avoid misaligned opening.

[0032] like Figure 4 As shown, the inner wall of the upper cavity 11 is provided with 8 flow guiding ribs 111 along the length direction. The ribs are 2mm high, 3mm wide, and 15mm apart. They are used to form turbulence during external shaking or stirring to improve the dissolution efficiency of dialysis dry powder.

[0033] like Figure 3 As shown, the bottom of the lower chamber 13 has an inverted conical confluence structure 131 with a cone angle of about 30°. The liquid outlet 42 is located at the lowest point of the conical structure, which can control the residual liquid in the lower chamber 13 to less than 3mL.

[0034] like Figure 5 As shown, interface component 4 includes an inlet port 41 and an outlet port 42, both of which are medical quick connectors conforming to ISO 8536-4 standards. The inlet port 41 is located on one side of the top of the upper chamber 11 and has a built-in silicone one-way check valve 411 to prevent the dissolving solution from flowing back and contaminating the solution preparation system. The outlet port 42 is located at the lowest point of the cone at the bottom of the lower chamber 13 and has a tearable sterile protective film 421 (made of aluminum-plastic composite film) on the outside, which can be torn open before use to connect to the dialysis machine suction tubing.

[0035] The double-layer hanging hole 5 is located at the top of the bag body 1 and consists of two elliptical punches with a diameter of 15mm and a spacing of 40mm. The holes are reinforced by heat sealing. The load-bearing test result is 6.5kg (standard filling lower cavity 300mL + suspension self-weight), which meets the requirements for suspension of the dialysis machine.

[0036] An RFID tag 6 is affixed to the front of the bag 1 to record the powder prescription number, batch number, production date, expiration date, and target dissolution parameters; a solubility visualization indicator tag 7 (conductivity-sensitive color-changing film) is set on the side of the bag 1. When the conductivity of the dialysis concentrate in the lower chamber 13 reaches the set value, the tag changes from white to blue, making it easy for operators to visually confirm.

[0037] Example 2: Usage Method The specific steps for preparing hemodialysis concentrate for immediate use using the packaging bag described in Example 1 are as follows: S1 Powder Filling and Sealing: In a Class 10,000 cleanroom, 500g of quantitative hemodialysis dry powder (such as a prescription combination of powder A and powder B) is filled into the upper cavity 11 through the powder filling port reserved at the top of the upper cavity 11, and then the powder filling port is sealed by heat sealing. At this time, the upper sealing strip 31, filter screen 21, and lower sealing strip 32 have all been formed together in the bag forming stage, and the three-cavity structure is completely sealed.

[0038] S2 Dissolving with Water: The packaging bag is installed on the dissolving station of the dialysis concentrate preparation system described in reference CN120285329A, and is self-locked to the inlet interface 41 by a pneumatic gripper. The preparation system reads the powder type code from the RFID tag 6, controls the temperature-controlled circulation pipeline to heat the RO water to 32°C, and then injects 2L of the solution into the upper chamber 11 through the inlet interface 41. The preparation system starts the multimodal dissolving device (mechanical shaking amplitude 3mm / frequency 3Hz, ultrasonic 28kHz / 200W, magnetic stirring 300rpm), and executes the dissolving program according to the optimal parameter combination corresponding to the pre-stored database.

[0039] S3 filtration enters the lower chamber: The solution preparation system monitors the solubility in real time through a transmittance sensor located on the side of the bag 11. When the transmittance reaches a set threshold (e.g., When the dissolution is complete (%), the upper chamber 11 is then subjected to a pressure of approximately 0.1 MPa by the roller pressing mechanism of the dispensing system. The upper sealing strip 31 is peeled off and opened, and the dissolved dialysate flows into the lower chamber 13 after being filtered through the support frame 22 and the filter screen 21 (pore size 0.1 μm) under the action of gravity and pressure. During the filtration process, the filter chamber 12 briefly serves as a buffer transition chamber.

[0040] S4 Closing the lower chamber: After filtration, the liquid preparation system applies secondary heat sealing or mechanical clamping to the area where the lower sealing strip 32 is located, so as to close the passage between the filter chamber 12 and the lower chamber 13 and prevent the backflow of the filtered dialysate in the lower chamber 13.

[0041] S5 Solution output: The operator suspends the packaging bag on the dialysis machine through the double-layer hanging hole 5, tears open the sterile protective film 421 of the liquid outlet 42, connects it to the dialysis machine's suction tube, and the dialysis machine draws the dialysis concentrate from the lower chamber 13 for hemodialysis.

[0042] Example 3: Verification of Technical Effect The packaging bags used in Example 1 were compared with those of traditional single-chamber rigid drum dialysis solution (control group 1) and existing double-chamber bags (control group 2, without online filtration). After each bag of dialysis concentrate was prepared, it was tested according to the Chinese Pharmacopoeia and standards such as YY0793.3-2023.

[0043] Experimental results show that the present invention is significantly superior to the prior art in terms of filtration accuracy, control of insoluble particles, endotoxin level, dissolution time and residual liquid volume.

[0044] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A packaging bag for a dual-chamber hemodialysis concentrate with a filtration system, characterized in that, It includes a bag body (1), a filter assembly (2), a sealing strip (3), and an interface assembly (4); The bag body (1) is made of multiple co-extruded films heat-sealed together, and is divided into three independent chambers along its length: an upper chamber (11), a filter chamber (12), and a lower chamber (13) connected in sequence; wherein the upper chamber (11) is used to hold hemodialysis dry powder, and the lower chamber (13) is used to hold the dissolved and filtered dialysis concentrate. The filter chamber (12) is located between the upper chamber (11) and the lower chamber (13). The filter chamber (12) is provided with a filter assembly (2). The filter assembly (2) includes a filter screen (21). The periphery of the filter screen (21) and the inner wall of the bag body (1) are sealed together by welding. The filter screen (21) has a filtration accuracy of 0.1 μm. The sealing strip (3) includes an upper sealing strip (31) located between the upper cavity (11) and the filter cavity (12) and a lower sealing strip (32) located between the filter cavity (12) and the lower cavity (13). Both the upper sealing strip (31) and the lower sealing strip (32) are peelable and easy-to-open sealing strips with an opening pressure of 0.05~0.2MPa. The composite sealing structure (32) consists of two layers connected in series: a peelable heat-sealing sealing strip (321) and a mechanical convex-concave interlocking buckle (322) arranged sequentially along the material flow direction. The peelable heat-sealing sealing strip (321) serves as the initial seal. The mechanical convex-concave interlocking buckle (322) includes a convex buckle (322a) and a concave buckle (322b) that are pre-set on both sides of the inner wall of the bag and can be aligned and interlocked under external pressure. The cross-section of the convex buckle (322a) is mushroom-shaped, including a neck and a head. After interlocking, it forms an irreversible mechanical lock with an interlocking force ≥15N / cm. The upper sealing strip is heat-sealed, while the lower sealing strip is mechanically sealed, allowing for secondary sealing. The interface component (4) includes an inlet port (41) communicating with the upper chamber (11) and an outlet port (42) communicating with the lower chamber (13). Both the inlet port (41) and the outlet port (42) are standard interfaces adapted to the dialysis machine suction tube. The top of the bag (1) is provided with double-layer hanging holes (5), and the load-bearing capacity of the double-layer hanging holes (5) is not less than 5kg.

2. The packaging bag according to claim 1, characterized in that, The bag body (1) is composed of three co-extruded film layers: an inner layer, a middle barrier layer, and an outer layer. The inner layer is a polyethylene (PE) layer with a thickness of 50-80 μm; the middle barrier layer is an ethylene-vinyl alcohol copolymer (EVOH) layer or a polyvinylidene chloride (PVDC) layer with a thickness of 15-30 μm; the outer layer is a polyethylene terephthalate (PET) layer or a polyamide (PA) layer with a thickness of 60-80 μm; and the total thickness of the bag body (1) is 0.15-0.20 mm.

3. The packaging bag according to claim 1, characterized in that, The filter screen (21) is made of any one of polyethersulfone (PES), polyvinylidene fluoride (PVDF), or polytetrafluoroethylene (PTFE), and the effective filtration area of ​​the filter screen (21) is 80~150cm². The filter assembly (2) also includes a support frame (22) located upstream of the filter screen (21). The support frame (22) is made of medical-grade polypropylene (PP), is mesh-shaped, and has a mesh aperture of 2~5mm. It is used to prevent the filter screen (21) from collapsing or becoming clogged during the filtration process.

4. The packaging bag according to claim 1, characterized in that, The upper sealing strip (31) and the lower sealing strip (32) are both formed by heat sealing through the inner wall of the bag body (1). The heat sealing temperature is 120~150℃, the heat sealing width is 3~6mm, and the peel strength is 3~10N / 15mm. The peel strength of the upper sealing strip (31) is less than that of the lower sealing strip (32).

5. The packaging bag according to claim 1, characterized in that, The volume ratio of the upper cavity (11) to the lower cavity (13) is 1:3 to 1:5; the inner wall of the upper cavity (11) is provided with multiple guide ribs (111) extending along its length direction. The height of the guide ribs (111) is 1 to 3 mm, the width is 2 to 4 mm, and the spacing between adjacent guide ribs (111) is 10 to 20 mm, which is used to promote the turbulent mixing of dialysis dry powder and dialysis water.

6. The packaging bag according to claim 1, characterized in that, The bottom of the lower cavity (13) is an inverted conical confluence structure (131), and the liquid outlet (42) is located at the lowest point of the inverted conical confluence structure (131).

7. The packaging bag according to claim 1, characterized in that, The inlet port (41) is equipped with a one-way check valve (411), and the outlet port (42) is equipped with a tearable sterile protective film (421). The outer surface of the bag (1) is also equipped with a radio frequency identification RFID tag (6) or a QR code (6) for recording powder batch, formula information and filtration status.

8. The packaging bag according to claim 1, characterized in that, The outer surface of the bag (1) is also affixed with a solubility visualization indicator label (7), which is a conductivity-sensitive color-changing membrane or a pH-sensitive color-changing membrane, used to indicate that the dialysis concentrate has reached a qualified state by color change after dissolution and filtration.

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