Process for preparing hemodialysis concentrated solution A

Abstract

The invention discloses a process for preparing a hemodialysis concentrated solution A. The process comprises the following steps: S1, preparing raw materials; s2, weighing the materials; s3, dissolving; s4, filtering; s5, adjusting the pH value; s6, checking the quality; s7, packaging and storing, in the step S1, sodium chloride, potassium chloride, calcium chloride, magnesium chloride, a conditioning agent and water are prepared, the conditioning agent specifically comprises glacial acetic acid, hydrochloric acid and sodium bicarbonate according to the ratio of (1-8): (1-3): (1-4), in the step S2, sodium chloride, potassium chloride, calcium chloride, magnesium chloride, the conditioning agent and water are accurately weighed according to the ratio, and in the step S3, the sodium chloride, potassium chloride, calcium chloride, magnesium chloride, the conditioning agent and water are weighed according to the ratio of (1-8): (1-3): (1-4). Sodium chloride, potassium chloride, calcium chloride, magnesium chloride, a conditioning agent and water are added to the inner side of stirring equipment to be fully stirred, the dialysis concentrated solution A is prepared through reasonable burdening and proportioning, and the safety and quality of the dialysis concentrated solution A can be greatly improved by strictly requiring preparation equipment and detecting follow-up screening of the dialysis concentrated solution A.

Description

Technical Field

[0001] The present invention relates to the technical field of hemodialysis concentrated liquid A, and in particular to a process for preparing hemodialysis concentrated liquid A. Background Art

[0002] Hemodialysis (HD) is a form of renal replacement therapy for patients with acute and chronic renal failure. It drains blood from the body to the outside of the body through a dialyzer composed of countless hollow fibers. The blood and an electrolyte solution (dialysate) containing electrolytes at similar concentrations to the body are exchanged inside and outside the hollow fibers through diffusion, ultrafiltration, adsorption and convection principles to remove metabolic waste from the body, maintain electrolyte and acid-base balance, and remove excess water from the body. The entire process of returning the purified blood is called hemodialysis.

[0003] According to the current industry standard YY0598-2015 "Concentrates for Hemodialysis and Related Therapies", there is a note regarding particulate contamination of dialysis concentrates: the concentrate should be filtered through a 1μm (or finer) filter, and the filter should use a membrane that does not release fibers and does not contain polyethersulfone resins and polypropylene materials that are known to be harmful to the human body;

[0004] The preparation process of hemodialysis concentrate A solution is very important and directly related to the effect of dialysis treatment and the safety of patients. As one of the core components of hemodialysis fluid, A solution has the main function of regulating electrolytes and acid-base balance in the body and helping to remove metabolic wastes in the blood.

[0005] The invention with the announcement number: CN109172901A discloses a process for preparing a hemodialysis concentrate. The present invention is a process for preparing a hemodialysis concentrate, wherein the semi-finished product of the dialysis concentrate is filtered with a filter element with a pore size of 0.45 μm or less, with the purpose of effectively delaying the crystallization time of the dialysis solution after the dialysis solution is prepared clinically. Hemodialysis is based on the principle of Gibbs-Donan membrane equilibrium, and the patient's blood and the dialysis solution supplied by the dialysis machine are simultaneously introduced into the inner and outer chambers of the dialyzer (artificial kidney) membrane, and move in opposite directions on both sides of the dialysis membrane. The present invention is a process for preparing a hemodialysis concentrate, wherein the semi-finished product of the dialysis concentrate is filtered with a filter membrane with a pore size of 0.45 μm or less, with the purpose of effectively delaying the crystallization time of the dialysis solution after the dialysis solution is prepared clinically;

[0006] The preparation process of hemodialysis concentrated liquid A in the prior art is relatively simple, and the process requirements are not strict enough, so that the safety and quality of hemodialysis concentrated liquid A need to be improved. Therefore, the present invention proposes a process for preparing hemodialysis concentrated liquid A to solve the above problems. Summary of the invention

[0007] Based on the technical problem that the preparation process of hemodialysis concentrated liquid A is relatively simple and the process requirements are not strict enough, so that the safety and quality of hemodialysis concentrated liquid A need to be improved, the present invention proposes a process for preparing hemodialysis concentrated liquid A.

[0008] The present invention provides a process for preparing hemodialysis concentrate A, comprising the following steps:

[0009] S1: Raw material preparation;

[0010] S2: Material weighing;

[0011] S3: dissolution;

[0012] S4: Filter;

[0013] S5: adjust pH value;

[0014] S6: Check quality;

[0015] S7: Packaging and storage.

[0016] Preferably, in the step S1, the following materials are prepared: sodium chloride, potassium chloride, calcium chloride, magnesium chloride, a regulator and water. The regulator is specifically glacial acetic acid, hydrochloric acid and sodium bicarbonate, and the ratio is 1-8:1-3:1-4. Sodium ions (Na+), usually in the form of sodium chloride (NaCl), are used to adjust the sodium concentration in the blood. Potassium ions (K+), usually in the form of potassium chloride (KCl), are used to control the potassium concentration in the blood. Calcium ions (Ca2+): usually in the form of calcium chloride (CaCl2), are used to adjust the calcium concentration in the blood. Bicarbonate ions (HCO3-), usually in the form of sodium bicarbonate (NaHCO3), are used to adjust the acid-base balance in the blood. Chloride ions (Cl-), are regulated by substances such as sodium chloride in hemodialysis. Regulators refer to substances used to adjust various components in the dialysate to ensure that the patient's physiological indicators such as electrolyte balance and acid-base balance are maintained within the normal range. These regulators are usually used to adjust the pH value, electrolyte concentration and calcium-magnesium ratio of the hemodialysis fluid.

[0017] Preferably, in the step S2, sodium chloride, potassium chloride, calcium chloride, magnesium chloride, a regulator and water are accurately weighed according to the ratio. Before preparing the hemodialysis concentrate A, it is necessary to ensure that the equipment, containers, raw materials and environment used meet strict hygiene standards, contamination should be avoided during the preparation process, and all tools and equipment need to be disinfected in advance.

[0018] Preferably, in the step S3, sodium chloride, potassium chloride, calcium chloride, magnesium chloride, a regulator and water are added to the inner side of a stirring device and stirred sufficiently to dissolve the raw materials. The stirring speed of the stirring device is 120-150 revolutions per minute, and the stirring is performed for 5-20 minutes to ensure that the solution is uniform, thereby obtaining a dialysis concentrate A solution.

[0019] Preferably, in the step S4, the dialysis concentrate A is filtered through a filter membrane having a pore size of 0.45 μm or less, which has no fiber release and does not contain polyethersulfone resin and polypropylene material filter elements that are known to be harmful to the human body.

[0020] Preferably, in step S5, the pH value of the concentrated dialysate A is between 7.2 and 7.4. If it is unqualified, the pH value can be adjusted by adding a regulator.

[0021] Preferably, in the step S6, it is ensured that the electrolyte concentration and pH value of the solution meet the standards and do not contain any impurities or microorganisms. After the concentrate is prepared into dialysate with water for bacterial endotoxin test, the bacterial endotoxin content of the dialysate should be less than 0.5EU / mL.

[0022] Preferably, in the step S7, the filtered semi-finished concentrated liquid is filled, capped, and labeled. The prepared liquid A needs to be stored at an appropriate temperature, usually 4-20 degrees Celsius, away from direct sunlight, in a well-ventilated place, and should not be mixed with toxic, polluting, and unpleasant-smelling items.

[0023] Beneficial effects of the present invention:

[0024] The present invention prepares dialysis concentrated A liquid through reasonable ingredients and proportions, and strictly requires preparation equipment and subsequent screening and detection of dialysis concentrated A liquid, which can greatly improve the safety and quality of dialysis concentrated A liquid. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 The working flow chart proposed by the present invention. DETAILED DESCRIPTION

[0026] The present invention will be further explained below in conjunction with specific embodiments.

[0027] Reference Figure 1 , Embodiment 1

[0028] This embodiment proposes a process for preparing hemodialysis concentrate A, comprising the following steps:

[0029] S1: Raw material preparation, prepare the following materials: sodium chloride, potassium chloride, calcium chloride, magnesium chloride, regulator and water. The regulator is specifically glacial acetic acid, hydrochloric acid and sodium bicarbonate, and the ratio is 6:3:1. Sodium ion (Na+), usually exists in the form of sodium chloride (NaCl), is used to adjust the sodium concentration in the blood. Potassium ion (K+), usually exists in the form of potassium chloride (KCl), is used to control the potassium concentration in the blood. Calcium ion (Ca2+): usually exists in the form of calcium chloride (CaCl2), is used to adjust the calcium concentration in the blood. Bicarbonate ion (HCO3-), usually exists in the form of sodium bicarbonate (NaHCO3), is used to adjust the acid-base balance in the blood. Chloride ion (Cl-), is adjusted by sodium chloride and other substances. Regulators refer to those substances used to adjust the various components in the dialysate to ensure that the patient's electrolyte balance, acid-base balance and other physiological indicators are maintained within the normal range. These regulators are usually used to adjust the pH value, electrolyte concentration and calcium-magnesium ratio of the hemodialysis fluid;

[0030] S2: Weigh the materials. According to the ratio, accurately weigh the sodium chloride, potassium chloride, calcium chloride, magnesium chloride, regulator and water. Before preparing the hemodialysis concentrate A, it is necessary to ensure that the equipment, containers, raw materials and environment used meet the strict hygiene standards. Contamination should be avoided during the preparation process, and all tools and equipment need to be disinfected in advance;

[0031] S3: dissolving, adding sodium chloride, potassium chloride, calcium chloride, magnesium chloride, a regulator and water into a stirring device and stirring them thoroughly to dissolve the raw materials. The stirring device rotates at 140 revolutions per minute for 12 minutes to ensure that the solution is uniform, and a dialysis concentrate A solution is obtained;

[0032] S4: Filtration, filtering the dialysis concentrate A through a filter membrane with a pore size of 0.45 μm or less, which does not release fibers and does not contain polyethersulfone resin and polypropylene material filter elements known to be harmful to the human body;

[0033] S5: Adjust the pH value. The pH value of concentrated dialysate A is 7.2. If it is not up to standard, the pH value can be adjusted by adding a regulator.

[0034] S6: Check the quality to ensure that the electrolyte concentration and pH value of the solution meet the standards and do not contain any impurities or microorganisms. After the concentrate is prepared into dialysis fluid with water for bacterial endotoxin test, the bacterial endotoxin content of the dialysis fluid should be less than 0.5EU / mL;

[0035] S7: Packaging and storage: The filtered semi-finished concentrated liquid is bottled, capped, and labeled. The prepared liquid A needs to be stored at an appropriate temperature, usually 10 degrees Celsius, away from direct sunlight and in a well-ventilated place. It should not be stored together with toxic, polluting, or smelly items.

[0036] Reference Figure 1 , Embodiment 2

[0037] This embodiment proposes a process for preparing hemodialysis concentrate A, comprising the following steps:

[0038] S1: Raw material preparation, prepare the following materials: sodium chloride, potassium chloride, calcium chloride, magnesium chloride, regulator and water. The regulator is specifically glacial acetic acid, hydrochloric acid and sodium bicarbonate, and the ratio is 7:2:1. Sodium ion (Na+), usually exists in the form of sodium chloride (NaCl), is used to adjust the sodium concentration in the blood. Potassium ion (K+), usually exists in the form of potassium chloride (KCl), is used to control the potassium concentration in the blood. Calcium ion (Ca2+): usually exists in the form of calcium chloride (CaCl2), is used to adjust the calcium concentration in the blood. Bicarbonate ion (HCO3-), usually exists in the form of sodium bicarbonate (NaHCO3), is used to adjust the acid-base balance in the blood. Chloride ion (Cl-), is adjusted by sodium chloride and other substances. Regulators refer to those substances used to adjust the various components in the dialysate to ensure that the patient's electrolyte balance, acid-base balance and other physiological indicators are maintained within the normal range. These regulators are usually used to adjust the pH value, electrolyte concentration and calcium-magnesium ratio of the hemodialysis fluid;

[0039] S2: Weigh the materials. According to the ratio, accurately weigh the sodium chloride, potassium chloride, calcium chloride, magnesium chloride, regulator and water. Before preparing the hemodialysis concentrate A, it is necessary to ensure that the equipment, containers, raw materials and environment used meet the strict hygiene standards. Contamination should be avoided during the preparation process, and all tools and equipment need to be disinfected in advance;

[0040] S3: Dissolving, adding sodium chloride, potassium chloride, calcium chloride, magnesium chloride, a regulator and water into a stirring device and stirring them thoroughly to dissolve the raw materials. The stirring device rotates at 130 revolutions per minute for 10 minutes to ensure that the solution is uniform, and a dialysis concentrate A solution is obtained;

[0041] S4: Filtration, filtering the dialysis concentrate A through a filter membrane with a pore size of 0.45 μm or less, which does not release fibers and does not contain polyethersulfone resin and polypropylene material filter elements known to be harmful to the human body;

[0042] S5: Adjust the pH value. The pH value of the concentrated dialysate A is 7.2. If it is not up to standard, the pH value can be adjusted by adding a regulator.

[0043] S6: Check the quality to ensure that the electrolyte concentration and pH value of the solution meet the standards and do not contain any impurities or microorganisms. After the concentrate is prepared into dialysis fluid with water for bacterial endotoxin test, the bacterial endotoxin content of the dialysis fluid should be less than 0.5EU / mL;

[0044] S7: Packaging and storage: The filtered semi-finished concentrated liquid is bottled, capped, and labeled. The prepared liquid A needs to be stored at an appropriate temperature, usually 15 degrees Celsius, away from direct sunlight and in a well-ventilated place. It should not be stored together with toxic, polluting, or smelly items.

[0045] Reference Figure 1 , Embodiment 3

[0046] In this embodiment, a process for preparing hemodialysis concentrate A is proposed, comprising the following steps: S1: raw material preparation, preparing the following materials: sodium chloride, potassium chloride, calcium chloride, magnesium chloride, a regulator and water, wherein the regulator is specifically glacial acetic acid, hydrochloric acid and sodium bicarbonate, and the ratio thereof is 6:2:2, sodium ions (Na+), usually in the form of sodium chloride (NaCl), are used to adjust the sodium concentration in the blood, potassium ions (K+), usually in the form of potassium chloride (KCl), are used to control the potassium concentration in the blood, calcium ions (Ca2+): usually in the form of calcium chloride (CaCl2), are used to adjust the calcium concentration in the blood, bicarbonate ions (HCO3-), usually in the form of sodium bicarbonate (NaHCO3), are used to adjust the acid-base balance in the blood, chloride ions (Cl-), are adjusted by substances such as sodium chloride, regulators refer to substances used to adjust various components in the dialysate to ensure that the patient's physiological indicators such as electrolyte balance and acid-base balance are maintained within the normal range, and these regulators are usually used to adjust the pH value, electrolyte concentration and calcium-magnesium ratio of the hemodialysis fluid;

[0047] S2: Weigh the materials. According to the ratio, accurately weigh the sodium chloride, potassium chloride, calcium chloride, magnesium chloride, regulator and water. Before preparing the hemodialysis concentrate A, it is necessary to ensure that the equipment, containers, raw materials and environment used meet the strict hygiene standards. Contamination should be avoided during the preparation process, and all tools and equipment need to be disinfected in advance;

[0048] S3: dissolving, adding sodium chloride, potassium chloride, calcium chloride, magnesium chloride, a regulator and water into a stirring device and stirring them thoroughly to dissolve the raw materials. The stirring device rotates at 140 revolutions per minute for 13 minutes to ensure that the solution is uniform, and a dialysis concentrate A solution is obtained;

[0049] S4: Filtration, filtering the dialysis concentrate A through a filter membrane with a pore size of 0.45 μm or less, which does not release fibers and does not contain polyethersulfone resin and polypropylene material filter elements known to be harmful to the human body;

[0050] S5: Adjust the pH value. The pH value of the concentrated dialysate A is 7.4. If it is not up to standard, the pH value can be adjusted by adding a regulator.

[0051] S6: Check the quality to ensure that the electrolyte concentration and pH value of the solution meet the standards and do not contain any impurities or microorganisms. After the concentrate is prepared into dialysis fluid with water for bacterial endotoxin test, the bacterial endotoxin content of the dialysis fluid should be less than 0.5EU / mL;

[0052] S7: Packaging and storage: The filtered semi-finished concentrated liquid should be filled, capped and labeled. The prepared liquid A should be stored at an appropriate temperature, usually 12 degrees Celsius, away from direct sunlight and in a well-ventilated place. It should not be stored together with toxic, polluting or smelly items.

[0053] Reference Figure 1 , Embodiment 4

[0054] In this embodiment, a process for preparing hemodialysis concentrate A is proposed, comprising the following steps: S1: raw material preparation, preparing the following materials: sodium chloride, potassium chloride, calcium chloride, magnesium chloride, a regulator and water, wherein the regulator is specifically glacial acetic acid, hydrochloric acid and sodium bicarbonate, and the ratio thereof is 5:3:2, sodium ion (Na+), usually in the form of sodium chloride (NaCl), used to adjust the sodium concentration in the blood, potassium ion (K+), usually in the form of potassium chloride (KCl), used to control the potassium concentration in the blood, calcium ion (Ca2+): usually in the form of calcium chloride (CaCl2), used to adjust the calcium concentration in the blood, bicarbonate ion (HCO3-), usually in the form of sodium bicarbonate (NaHCO3), used to adjust the acid-base balance in the blood, chloride ion (Cl-), adjusted by substances such as sodium chloride, regulator refers to substances used to adjust various components in the dialysate to ensure that the patient's physiological indicators such as electrolyte balance and acid-base balance are maintained within the normal range, and these regulators are usually used to adjust the pH value, electrolyte concentration and calcium-magnesium ratio of the hemodialysis fluid;

[0055] S2: Weigh the materials. According to the ratio, accurately weigh the sodium chloride, potassium chloride, calcium chloride, magnesium chloride, regulator and water. Before preparing the hemodialysis concentrate A, it is necessary to ensure that the equipment, containers, raw materials and environment used meet the strict hygiene standards. Contamination should be avoided during the preparation process, and all tools and equipment need to be disinfected in advance;

[0056] S3: Dissolving, adding sodium chloride, potassium chloride, calcium chloride, magnesium chloride, a regulator and water into a stirring device and stirring them thoroughly to dissolve the raw materials. The stirring device rotates at 130 revolutions per minute for 15 minutes to ensure that the solution is uniform, and a dialysis concentrate A solution is obtained;

[0057] S4: Filtration, filtering the dialysis concentrate A through a filter membrane with a pore size of 0.45 μm or less, which does not release fibers and does not contain polyethersulfone resin and polypropylene material filter elements known to be harmful to the human body;

[0058] S5: Adjust the pH value. The pH value of the concentrated dialysate A is 7.2. If it is not up to standard, the pH value can be adjusted by adding a regulator.

[0059] S6: Check the quality to ensure that the electrolyte concentration and pH value of the solution meet the standards and do not contain any impurities or microorganisms. After the concentrate is prepared into dialysis fluid with water for bacterial endotoxin test, the bacterial endotoxin content of the dialysis fluid should be less than 0.5EU / mL;

[0060] S7: Packaging and storage: The filtered semi-finished concentrated liquid is bottled, capped, and labeled. The prepared liquid A needs to be stored at an appropriate temperature, usually 18 degrees Celsius, away from direct sunlight and in a well-ventilated place. It should not be stored together with toxic, polluting, or smelly items.

[0061] Reference Figure 1 Embodiment 5

[0062] In this embodiment, a process for preparing hemodialysis concentrate A is proposed, comprising the following steps: S1: raw material preparation, preparing the following materials: sodium chloride, potassium chloride, calcium chloride, magnesium chloride, a regulator and water, wherein the regulator is specifically glacial acetic acid, hydrochloric acid and sodium bicarbonate, and the ratio thereof is 4:3:3, sodium ion (Na+), usually in the form of sodium chloride (NaCl), used to adjust the sodium concentration in the blood, potassium ion (K+), usually in the form of potassium chloride (KCl), used to control the potassium concentration in the blood, calcium ion (Ca2+): usually in the form of calcium chloride (CaCl2), used to adjust the calcium concentration in the blood, bicarbonate ion (HCO3-), usually in the form of sodium bicarbonate (NaHCO3), used to adjust the acid-base balance in the blood, chloride ion (Cl-), adjusted by substances such as sodium chloride, regulator refers to substances used to adjust various components in the dialysate to ensure that the patient's physiological indicators such as electrolyte balance and acid-base balance are maintained within the normal range, and these regulators are usually used to adjust the pH value, electrolyte concentration and calcium-magnesium ratio of the hemodialysis fluid;

[0063] S2: Weigh the materials. According to the ratio, accurately weigh the sodium chloride, potassium chloride, calcium chloride, magnesium chloride, regulator and water. Before preparing the hemodialysis concentrate A, it is necessary to ensure that the equipment, containers, raw materials and environment used meet the strict hygiene standards. Contamination should be avoided during the preparation process, and all tools and equipment need to be disinfected in advance;

[0064] S3: dissolving, adding sodium chloride, potassium chloride, calcium chloride, magnesium chloride, a regulator and water into a stirring device and stirring them thoroughly to dissolve the raw materials. The stirring device rotates at 140 revolutions per minute for 17 minutes to ensure that the solution is uniform, and a dialysis concentrate A solution is obtained;

[0065] S4: Filtration, filtering the dialysis concentrate A through a filter membrane with a pore size of 0.45 μm or less, which does not release fibers and does not contain polyethersulfone resin and polypropylene material filter elements known to be harmful to the human body;

[0066] S5: Adjust the pH value. The pH value of concentrated dialysate A is 7.3. If it is not up to standard, the pH value can be adjusted by adding a regulator.

[0067] S6: Check the quality to ensure that the electrolyte concentration and pH value of the solution meet the standards and do not contain any impurities or microorganisms. After the concentrate is prepared into dialysis fluid with water for bacterial endotoxin test, the bacterial endotoxin content of the dialysis fluid should be less than 0.5EU / mL;

[0068] S7: Packaging and storage: The filtered semi-finished concentrated liquid is bottled, capped, and labeled. The prepared liquid A needs to be stored at an appropriate temperature, usually 18 degrees Celsius, away from direct sunlight and in a well-ventilated place. It should not be stored together with toxic, polluting, or smelly items.

[0069] Comparing conventional hemodialysis concentrate A liquid with the hemodialysis concentrate A liquid prepared in Examples 1 to 5, the hemodialysis concentrate A liquid prepared in Examples 1 to 5 is shown in the following table:

[0070]

[0071] It can be seen from the above table that the process for preparing hemodialysis concentrate A solution proposed by the present invention has obvious improvement, and implementation 1 is the best embodiment.

[0072] The above description is only a preferred specific implementation manner of the present invention, but the protection scope of the present invention is not limited thereto. Any technician familiar with the technical field can make equivalent replacements or changes according to the technical scheme and inventive concept of the present invention within the technical scope disclosed by the present invention, which should be covered by the protection scope of the present invention.

Claims

1. A process for preparing hemodialysis concentrate A, characterized in that: The following steps are involved: S1: Raw material preparation; S2: Material weighing; S3: dissolution; S4: Filter; S5: adjust pH value; S6: Check quality; S7: Packaging and storage.

2. A process for preparing hemodialysis concentrate A according to claim 1, characterized in that: In the step S1, the following materials are prepared: sodium chloride, potassium chloride, calcium chloride, magnesium chloride, a regulator and water. The regulator is specifically glacial acetic acid, hydrochloric acid and sodium bicarbonate, and the ratio thereof is 1-8:1-3:1-4.

3. A process for preparing hemodialysis concentrate A according to claim 1, characterized in that: In the step S2, sodium chloride, potassium chloride, calcium chloride, magnesium chloride, a regulator and water are accurately weighed according to the ratio. Before preparing the hemodialysis concentrate A, it is necessary to ensure that the equipment, containers, raw materials and environment used meet strict hygiene standards. Contamination should be avoided during the preparation process, and all tools and equipment need to be disinfected in advance.

4. A process for preparing hemodialysis concentrate A according to claim 1, characterized in that: In the step S3, sodium chloride, potassium chloride, calcium chloride, magnesium chloride, a regulator and water are added to the inner side of a stirring device and stirred sufficiently to dissolve the raw materials. The stirring speed of the stirring device is 120-150 revolutions per minute, and the stirring is performed for 5-20 minutes to ensure that the solution is uniform, thereby obtaining a dialysis concentrate A solution.

5. A process for preparing hemodialysis concentrate A according to claim 1, characterized in that: In the step S4, the dialysis concentrate A is filtered through a filter membrane with a pore size of 0.45 μm or less, which has no fiber release and does not contain polyethersulfone resin and polypropylene material filter elements that are known to be harmful to the human body.

6. A process for preparing hemodialysis concentrate A according to claim 1, characterized in that: In step S5, the pH value of the concentrated dialysate A is between 7.2 and 7.

4. If it is unqualified, the pH value can be adjusted by adding a regulator.

7. The process for preparing hemodialysis concentrate A according to claim 1, characterized in that: In the step S6, it is ensured that the electrolyte concentration and pH value of the solution meet the standards and do not contain any impurities or microorganisms. After the concentrate is prepared into a dialysate with water for bacterial endotoxin test, the bacterial endotoxin content of the dialysate should be less than 0.5EU / mL.

8. The process for preparing hemodialysis concentrate A according to claim 1, characterized in that: In the step S7, the filtered semi-finished concentrated liquid is filled, capped, and labeled. The prepared liquid A needs to be stored at a suitable temperature, usually 4-20 degrees Celsius, away from direct sunlight, with good ventilation, and should not be mixed with toxic, polluting, and unpleasant odorous items.

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