Preparation method capable of effectively inhibiting proliferation of bacteria in hemodialysis concentrated solution
By using a specific proportion of powder A, powder B and antibacterial liquid in the preparation of hemodialysis concentrate, and stirring, filtration and ultraviolet sterilization treatment, the problem of bacteria reproduction in the hemodialysis concentrate is solved, and the product's efficient antibacterial effect is achieved.
Patent Information
- Application Number
- CN202411866839.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-12-18
- Publication Date
- 2025-03-28
AI Technical Summary
After the production of the hemodialysis concentrate is completed, the bacteria may still remain and reproduce and proliferate again, and there is a lack of effective inhibitory measures.
A powder composed of sodium chloride, potassium chloride, calcium chloride, magnesium chloride, glacial acetic acid and sodium acetate, B powder composed of sodium bicarbonate, and antibacterial liquid composed of citrate and silver ion antibacterial agent were prepared by mixing and processing in specific proportions, including stirring, filtration and ultraviolet sterilization, to prepare a hemodialysis concentrate with strong antibacterial properties.
It effectively inhibits the proliferation of bacteria in the hemodialysis concentrate, significantly improves the antibacterial properties of the product, and ensures the safety of the product during storage and use.
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Figure CN119701038A_ABST
Abstract
Description
Technical Field
[0001] The invention relates to the technical field of hemodialysis, and in particular to a preparation method capable of effectively inhibiting bacterial proliferation in hemodialysis concentrate. Background Art
[0002] The Chinese patent document with application number 202111244994.8 discloses a hemodialysis concentrate and a method for preparing the same, including step one: taking hemodialysis concentrate A liquid and hemodialysis concentrate B liquid related solutions, putting them into a liquid preparation tank in a certain proportion, and then injecting an appropriate amount of purified water into it for mixing and stirring; step two: filtering the stirred liquid obtained in step one, filtering it through a filter pore size of 0.3μm; step three: disinfecting and sterilizing the solution obtained in step two and putting it into a filling barrel for sealed storage; step four: sampling and testing the sealed storage product in step three. This kind of hemodialysis concentrate and its preparation method can effectively inhibit the growth and proliferation of bacteria and viruses in the hemodialysis concentrate, and the preparation steps are simple and novel.
[0003] However, there are also some problems with the hemodialysis concentrate and the preparation method thereof. For example, no matter how the hemodialysis concentrate is processed, some bacteria will still remain inside it. After the hemodialysis concentrate is produced, these bacteria are no longer inhibited and can easily multiply again. Summary of the invention
[0004] Based on the problem in the background technology that bacteria are no longer inhibited after production and filling and are prone to multiply again, the present invention proposes a preparation method that can effectively inhibit the proliferation of bacteria in hemodialysis concentrate.
[0005] The present invention provides a preparation method for effectively inhibiting bacterial proliferation in hemodialysis concentrate, comprising the following steps: S1: The materials of hemodialysis concentrate include A powder, B powder, dialysis water and antibacterial liquid. In terms of weight, the raw materials of A powder include 46.00% to 48.00% sodium chloride, 0.85% to 0.95% potassium chloride, 0.65% to 0.75% calcium chloride, 0.20% to 0.25% magnesium chloride, 48.00% to 49.00% glacial acetic acid and 3.00% to 4.00% sodium acetate. The raw materials of B powder include sodium bicarbonate. The raw materials of antibacterial liquid include citrate and silver ion antibacterial agent. S2: inject part of the dialysis water into the reactor, then pour in sodium bicarbonate, start the reactor to stir, and stir evenly to obtain liquid B; S3: Weigh sodium chloride, potassium chloride, calcium chloride, magnesium chloride, glacial acetic acid and sodium acetate according to the proportion, then inject part of the dialysis water into another reactor, then pour sodium chloride, potassium chloride, calcium chloride, magnesium chloride, glacial acetic acid and sodium acetate into the reactor, start the reactor to stir, and stir evenly to obtain liquid A; S4: Pour liquid A, liquid B and antibacterial liquid into a liquid preparation tank and mix them evenly to obtain a preliminary hemodialysis solution, and then introduce nitrogen gas into the preliminary hemodialysis solution through the gas injection port at the bottom of the liquid preparation tank, while performing filtering circulation; S5: Finally, after a period of circulating filtration and ultraviolet sterilization, the hemodialysis concentrate is obtained, which is filled. A powder composed of sodium chloride, potassium chloride, calcium chloride, magnesium chloride, glacial acetic acid and sodium acetate, B powder composed of sodium bicarbonate, and antibacterial liquid composed of citrate and silver ion antibacterial agent can eliminate bacteria in the hemodialysis concentrate as much as possible, and at the same time, the citrate and silver ion antibacterial agent can enhance the antibacterial property of the hemodialysis concentrate and inhibit the proliferation of bacteria in the hemodialysis concentrate.
[0006] Preferably, in S1, the weight ratio of A powder, B powder, dialysis water and antibacterial liquid in the materials of the hemodialysis concentrate is controlled at 1:1.225:32.775:4, which can enhance the antibacterial effect.
[0007] Preferably, in S1, the preparation method of dialysis water is as follows: distilled water is obtained, and particulate impurities in the water are removed successively by a sand filter and a precision filter. The sand filter can remove larger particles and generally can retain particles with a particle size greater than 10 microns. The precision filter can further remove tiny particles with a particle size of about 1-10 microns, which can effectively protect subsequent water treatment equipment and prevent large particle impurities from clogging or damaging them; then, pressure is applied to both sides of the semipermeable membrane to allow water to penetrate from the high-concentration side, which is usually the raw water side containing various solutes, to the low-concentration side, which is the fresh water side. The reverse osmosis membrane can retain most of the solutes in the water, including inorganic salts, organic matter, bacteria, and viruses. The pore size of the reverse osmosis membrane is between 0.1-1 nanometers, and it can effectively block substances with a molecular weight greater than 100-200 Daltons. Then, the remaining ions in the water are removed by anion and cation exchange resins. The cation exchange resin hydrogen type resin can remove cations in the water, and the hydrogen ions in its exchange group will exchange with the cations in the water. The anion exchange resin hydroxide type resin is used to remove anions in the water, and the exchange group quaternary amino The hydroxide ions in the water are exchanged with the anions in the water; then, the solutes are selectively filtered using an ultrafiltration membrane. The pore size of the ultrafiltration membrane is between 1-100 nanometers, which can allow small molecular solutes to pass through, while retaining large molecular solute proteins, bacteria and viruses. In the production process of dialysis water, ultrafiltration can be used as the last purification step to remove large molecular impurities and endotoxins that may remain in the water, further improve the quality of dialysis water, and ensure the safety and purity of dialysis water; storage after disinfection can reduce the growth of bacteria.
[0008] Preferably, in S1, the weight ratio of citrate and silver ion antibacterial agent in the antibacterial liquid is controlled at 2:1, and the silver ion antibacterial agent is one of silver nitrate, silver acetate, nano silver, zeolite-loaded silver and zirconium phosphate-loaded silver, which can exert antibacterial properties.
[0009] Preferably, in S2, the reactor adopts a two-way stirring setting, the stirring rate is 240 rpm to 360 rpm, and the stirring time is 15 minutes to 30 minutes, which can enhance the mixing effect.
[0010] Preferably, in S3, the stirring speed is controlled at 360 rpm to 420 rpm, and the stirring time is 15 minutes to 30 minutes, which can improve the mixing efficiency.
[0011] Preferably, in S4, before the liquid preparation tank is used, the liquid preparation tank needs to be sterilized by high-temperature steam, the temperature of the sterilization treatment needs to be controlled at 120°C to 190°C, and the sterilization time is 20 minutes to 45 minutes, which can avoid external bacterial contamination.
[0012] Preferably, in S4, the filtration needs to be performed under sterile conditions, and a nylon filter element with a filtration pore size of 0.3 μm is used for filtration, which can ensure the filtration effect.
[0013] Preferably, in S4, the liquid preparation tank and the circulating filtration pipeline are made of high-quality stainless steel and other corrosion-resistant materials. Before each preparation, the liquid preparation tank is thoroughly cleaned and then sterilized with 121°C steam. The circulating filtration pipeline is regularly cleaned and disinfected using special pipeline cleaning equipment, acidic or alkaline cleaning agents, and then disinfected with disinfectants to ensure that there are no bacterial residues inside the pipeline, thereby ensuring the effect of the preparation.
[0014] Preferably, in S5, the hemodialysis concentrate is packaged in a material having good gas barrier properties and microbial barrier properties, including a multi-layer co-extruded plastic film, to ensure filtering effect.
[0015] Beneficial effects of the present invention: Powder A composed of sodium chloride, potassium chloride, calcium chloride, magnesium chloride, glacial acetic acid and sodium acetate, powder B composed of sodium bicarbonate, and antibacterial liquid composed of citrate and silver ion antibacterial agent can eliminate bacteria in hemodialysis concentrate as much as possible, and at the same time, citrate and silver ion antibacterial agent can enhance the antibacterial property of hemodialysis concentrate and inhibit the proliferation of bacteria in hemodialysis concentrate. BRIEF DESCRIPTION OF THE DRAWINGS
[0016] Figure 1 The working flow chart proposed by the present invention. DETAILED DESCRIPTION
[0017] The present invention will be further explained below in conjunction with specific embodiments.
[0018] Reference Figure 1 , Embodiment 1 This embodiment proposes a preparation method that can effectively inhibit bacterial proliferation in hemodialysis concentrate, comprising the following steps: S1: The materials of hemodialysis concentrate include A powder, B powder, dialysis water and antibacterial liquid. In terms of weight, the raw materials of A powder include 46.15% sodium chloride, 0.85% potassium chloride, 0.75% calcium chloride, 0.25% magnesium chloride, 48.00% glacial acetic acid and 4.00% sodium acetate. The raw materials of B powder include sodium bicarbonate. The raw materials of antibacterial liquid include citrate and silver ion antibacterial agent. The weight ratio of A powder, B powder, dialysis water and antibacterial liquid in the materials of hemodialysis concentrate is controlled at 1:1.225:32.775:4. The preparation method of dialysis water is as follows: obtain distilled water, and remove particulate impurities in the water by sand filter and precision filter in turn. The sand filter can remove larger particles and generally can intercept particles with a particle size greater than 10 microns. The precision filter can further remove Tiny particles with a particle size of about 1-10 microns can effectively protect subsequent water treatment equipment and prevent large particles from blocking or damaging them. Then, pressure is applied on both sides of the semipermeable membrane to allow water to penetrate from the high-concentration side, which is usually the raw water side containing various solutes, to the low-concentration side, which is the fresh water side. The reverse osmosis membrane can intercept most of the solutes in the water, including inorganic salts, organic matter, bacteria, and viruses. The pore size of the reverse osmosis membrane is between 0.1-1 nanometers, which can effectively block substances with a molecular weight greater than 100-200 Daltons. Then, the remaining ions in the water are removed by anion and cation exchange resins. Cation exchange resin hydrogen-type resins can remove cations in water, and the hydrogen ions in its exchange group will exchange with cations in water. Anion exchange resin hydroxide-type resins are used to remove anions in water, and the exchange group quaternary amino The hydroxide ions in the water are exchanged with the anions in the water; then, the solute is selectively filtered using an ultrafiltration membrane, the pore size of which is between 1-100 nanometers, which can allow small molecular solutes to pass through, while retaining large molecular solute proteins, bacteria and viruses. In the production process of dialysis water, ultrafiltration can be used as the last purification step to remove large molecular impurities, endotoxins, etc. that may remain in the water, further improve the quality of dialysis water, and ensure the safety and purity of dialysis water; after disinfection, the weight ratio of citrate and silver ion antibacterial agent in the antibacterial solution is controlled at 2:1, and the silver ion antibacterial agent is nanosilver; S2: inject part of the dialysis water into the reactor, then pour in sodium bicarbonate, start the reactor to stir, stir evenly to obtain liquid B, the reactor adopts a two-way stirring setting, the stirring rate is 320 rpm, and the stirring time is 20 minutes; S3: Sodium chloride, potassium chloride, calcium chloride, magnesium chloride, glacial acetic acid and sodium acetate were weighed in proportion, and then part of the dialysis water was injected into another reactor, and then sodium chloride, potassium chloride, calcium chloride, magnesium chloride, glacial acetic acid and sodium acetate were poured into the reactor, and the reactor was started to stir, and the stirring was uniform to obtain liquid A, the stirring speed was controlled at 370 rpm, and the stirring time was 21 minutes; S4: Pour liquid A, liquid B and antibacterial liquid into the liquid preparation tank and mix them evenly to obtain a preliminary hemodialysis solution. Then, nitrogen gas is introduced into the preliminary hemodialysis solution through the gas injection port at the bottom of the liquid preparation tank, and filtering circulation is performed at the same time. Before the liquid preparation tank is used, the liquid preparation tank needs to be sterilized with high-temperature steam. The temperature of the sterilization treatment needs to be controlled at 160°C, and the sterilization time is 35 minutes. The filtration needs to be performed under sterile conditions. The nylon filter element used for filtration has a filtration pore size of 0.3μm. The liquid preparation tank and the circulating filtration pipeline are made of high-quality stainless steel and other corrosion-resistant materials. Before each preparation, the liquid preparation tank is thoroughly cleaned first, and then sterilized with 121°C steam. The circulating filtration pipeline is regularly cleaned and disinfected. Use special pipeline cleaning equipment, clean it with acidic or alkaline cleaning agents, and then disinfect it with disinfectants to ensure that there are no bacteria residues inside the pipeline; S5: Finally, after a period of circulating filtration and ultraviolet sterilization, the hemodialysis concentrate is obtained and filled. The hemodialysis concentrate is packaged using packaging materials with good gas barrier properties and microbial barrier properties, including multi-layer co-extruded plastic films.
[0019] Reference Figure 1 , Embodiment 2 This embodiment proposes a preparation method that can effectively inhibit bacterial proliferation in hemodialysis concentrate, comprising the following steps: S1: The materials of hemodialysis concentrate include A powder, B powder, dialysis water and antibacterial liquid. In terms of weight, the raw materials of A powder include 46.00% sodium chloride, 0.85% potassium chloride, 0.70% calcium chloride, 0.20% magnesium chloride, 48.65% glacial acetic acid and 3.60% sodium acetate. The raw materials of B powder include sodium bicarbonate. The raw materials of antibacterial liquid include citrate and silver ion antibacterial agent. The weight ratio of A powder, B powder, dialysis water and antibacterial liquid in the materials of hemodialysis concentrate is controlled at 1:1.225:32.775:4. The preparation method of dialysis water is as follows: obtain distilled water, and remove particulate impurities in the water by sand filter and precision filter in turn. The sand filter can remove larger particles and generally can retain particles with a particle size greater than 10 microns. The precision filter can further remove Tiny particles with a particle size of about 1-10 microns can effectively protect subsequent water treatment equipment and prevent large particles from blocking or damaging them. Then, pressure is applied on both sides of the semipermeable membrane to allow water to penetrate from the high-concentration side, which is usually the raw water side containing various solutes, to the low-concentration side, which is the fresh water side. The reverse osmosis membrane can intercept most of the solutes in the water, including inorganic salts, organic matter, bacteria, and viruses. The pore size of the reverse osmosis membrane is between 0.1-1 nanometers, which can effectively block substances with a molecular weight greater than 100-200 Daltons. Then, the remaining ions in the water are removed by anion and cation exchange resins. Cation exchange resin hydrogen-type resins can remove cations in water, and the hydrogen ions in its exchange group will exchange with cations in water. Anion exchange resin hydroxide-type resins are used to remove anions in water, and the exchange group quaternary amino The hydroxide ions in the water are exchanged with the anions in the water; then, the solute is selectively filtered using an ultrafiltration membrane, the pore size of which is between 1-100 nanometers, which can allow small molecular solutes to pass through, while retaining large molecular solute proteins, bacteria and viruses. In the production process of dialysis water, ultrafiltration can be used as the last purification step to remove large molecular impurities, endotoxins, etc. that may remain in the water, further improve the quality of dialysis water, and ensure the safety and purity of dialysis water; after disinfection, the weight ratio of citrate and silver ion antibacterial agent in the antibacterial solution is controlled at 2:1, and the silver ion antibacterial agent is nanosilver; S2: inject part of the dialysis water into the reactor, then pour in sodium bicarbonate, start the reactor to stir, stir evenly to obtain liquid B, the reactor adopts a two-way stirring setting, the stirring rate is 320 rpm, and the stirring time is 20 minutes; S3: Sodium chloride, potassium chloride, calcium chloride, magnesium chloride, glacial acetic acid and sodium acetate were weighed in proportion, and then part of the dialysis water was injected into another reactor, and then sodium chloride, potassium chloride, calcium chloride, magnesium chloride, glacial acetic acid and sodium acetate were poured into the reactor, and the reactor was started to stir, and the stirring was uniform to obtain liquid A, the stirring speed was controlled at 370 rpm, and the stirring time was 21 minutes; S4: Pour liquid A, liquid B and antibacterial liquid into the liquid preparation tank and mix them evenly to obtain a preliminary hemodialysis solution. Then, nitrogen gas is introduced into the preliminary hemodialysis solution through the gas injection port at the bottom of the liquid preparation tank, and filtering circulation is performed at the same time. Before the liquid preparation tank is used, the liquid preparation tank needs to be sterilized with high-temperature steam. The temperature of the sterilization treatment needs to be controlled at 160°C, and the sterilization time is 35 minutes. The filtration needs to be performed under sterile conditions. The nylon filter element used for filtration has a filtration pore size of 0.3μm. The liquid preparation tank and the circulating filtration pipeline are made of high-quality stainless steel and other corrosion-resistant materials. Before each preparation, the liquid preparation tank is thoroughly cleaned first, and then sterilized with 121°C steam. The circulating filtration pipeline is regularly cleaned and disinfected. Use special pipeline cleaning equipment, clean it with acidic or alkaline cleaning agents, and then disinfect it with disinfectants to ensure that there are no bacteria residues inside the pipeline; S5: Finally, after a period of circulating filtration and ultraviolet sterilization, the hemodialysis concentrate is obtained and filled. The hemodialysis concentrate is packaged using packaging materials with good gas barrier properties and microbial barrier properties, including multi-layer co-extruded plastic films.
[0020] Reference Figure 1 , Embodiment 3 This embodiment proposes a preparation method that can effectively inhibit bacterial proliferation in hemodialysis concentrate, comprising the following steps: S1: The materials of hemodialysis concentrate include A powder, B powder, dialysis water and antibacterial liquid. In terms of weight, the raw materials of A powder include 46.40% sodium chloride, 0.91% potassium chloride, 0.69% calcium chloride, 0.20% magnesium chloride, 48.40% glacial acetic acid and 3.40% sodium acetate. The raw materials of B powder include sodium bicarbonate. The raw materials of antibacterial liquid include citrate and silver ion antibacterial agent. The weight ratio of A powder, B powder, dialysis water and antibacterial liquid in the materials of hemodialysis concentrate is controlled at 1:1.225:32.775:4. The preparation method of dialysis water is as follows: obtain distilled water, and remove particulate impurities in the water by sand filter and precision filter in turn. The sand filter can remove larger particles and generally can retain particles with a particle size greater than 10 microns. The precision filter can further remove Tiny particles with a particle size of about 1-10 microns can effectively protect subsequent water treatment equipment and prevent large particles from blocking or damaging them. Then, pressure is applied on both sides of the semipermeable membrane to allow water to penetrate from the high-concentration side, which is usually the raw water side containing various solutes, to the low-concentration side, which is the fresh water side. The reverse osmosis membrane can intercept most of the solutes in the water, including inorganic salts, organic matter, bacteria, and viruses. The pore size of the reverse osmosis membrane is between 0.1-1 nanometers, which can effectively block substances with a molecular weight greater than 100-200 Daltons. Then, the remaining ions in the water are removed by anion and cation exchange resins. Cation exchange resin hydrogen-type resins can remove cations in water, and the hydrogen ions in its exchange group will exchange with cations in water. Anion exchange resin hydroxide-type resins are used to remove anions in water, and the exchange group quaternary amino The hydroxide ions in the water are exchanged with the anions in the water; then, the solute is selectively filtered using an ultrafiltration membrane, the pore size of which is between 1-100 nanometers, which can allow small molecular solutes to pass through, while retaining large molecular solute proteins, bacteria and viruses. In the production process of dialysis water, ultrafiltration can be used as the last purification step to remove large molecular impurities, endotoxins, etc. that may remain in the water, further improve the quality of dialysis water, and ensure the safety and purity of dialysis water; after disinfection, the weight ratio of citrate and silver ion antibacterial agent in the antibacterial solution is controlled at 2:1, and the silver ion antibacterial agent is nanosilver; S2: inject part of the dialysis water into the reactor, then pour in sodium bicarbonate, start the reactor to stir, stir evenly to obtain liquid B, the reactor adopts a two-way stirring setting, the stirring rate is 320 rpm, and the stirring time is 20 minutes; S3: Sodium chloride, potassium chloride, calcium chloride, magnesium chloride, glacial acetic acid and sodium acetate were weighed in proportion, and then part of the dialysis water was injected into another reactor, and then sodium chloride, potassium chloride, calcium chloride, magnesium chloride, glacial acetic acid and sodium acetate were poured into the reactor, and the reactor was started to stir, and the stirring was uniform to obtain liquid A, the stirring speed was controlled at 370 rpm, and the stirring time was 21 minutes; S4: Pour liquid A, liquid B and antibacterial liquid into the liquid preparation tank and mix them evenly to obtain a preliminary hemodialysis solution. Then, nitrogen gas is introduced into the preliminary hemodialysis solution through the gas injection port at the bottom of the liquid preparation tank, and filtering circulation is performed at the same time. Before the liquid preparation tank is used, the liquid preparation tank needs to be sterilized with high-temperature steam. The temperature of the sterilization treatment needs to be controlled at 160°C, and the sterilization time is 35 minutes. The filtration needs to be performed under sterile conditions. The nylon filter element used for filtration has a filtration pore size of 0.3μm. The liquid preparation tank and the circulating filtration pipeline are made of high-quality stainless steel and other corrosion-resistant materials. Before each preparation, the liquid preparation tank is thoroughly cleaned first, and then sterilized with 121°C steam. The circulating filtration pipeline is regularly cleaned and disinfected. Use special pipeline cleaning equipment, clean it with acidic or alkaline cleaning agents, and then disinfect it with disinfectants to ensure that there are no bacteria residues inside the pipeline; S5: Finally, after a period of circulating filtration and ultraviolet sterilization, the hemodialysis concentrate is obtained and filled. The hemodialysis concentrate is packaged using packaging materials with good gas barrier properties and microbial barrier properties, including multi-layer co-extruded plastic films.
[0021] Reference Figure 1 , Embodiment 4 This embodiment proposes a preparation method that can effectively inhibit bacterial proliferation in hemodialysis concentrate, comprising the following steps: S1: The materials of hemodialysis concentrate include A powder, B powder, dialysis water and antibacterial liquid. In terms of weight, the raw materials of A powder include 46.15% sodium chloride, 0.85% potassium chloride, 0.75% calcium chloride, 0.25% magnesium chloride, 48.80% glacial acetic acid and 3.20% sodium acetate. The raw materials of B powder include sodium bicarbonate. The raw materials of antibacterial liquid include citrate and silver ion antibacterial agent. The weight ratio of A powder, B powder, dialysis water and antibacterial liquid in the materials of hemodialysis concentrate is controlled at 1:1.225:32.775:4. The preparation method of dialysis water is as follows: obtain distilled water, and remove particulate impurities in the water by sand filter and precision filter in turn. The sand filter can remove larger particles and generally can retain particles with a particle size greater than 10 microns. The precision filter can further remove Tiny particles with a particle size of about 1-10 microns can effectively protect subsequent water treatment equipment and prevent large particles from blocking or damaging them. Then, pressure is applied on both sides of the semipermeable membrane to allow water to penetrate from the high-concentration side, which is usually the raw water side containing various solutes, to the low-concentration side, which is the fresh water side. The reverse osmosis membrane can intercept most of the solutes in the water, including inorganic salts, organic matter, bacteria, and viruses. The pore size of the reverse osmosis membrane is between 0.1-1 nanometers, which can effectively block substances with a molecular weight greater than 100-200 Daltons. Then, the remaining ions in the water are removed by anion and cation exchange resins. Cation exchange resin hydrogen-type resins can remove cations in water, and the hydrogen ions in its exchange group will exchange with cations in water. Anion exchange resin hydroxide-type resins are used to remove anions in water, and the exchange group quaternary amino The hydroxide ions in the water are exchanged with the anions in the water; then, the solute is selectively filtered using an ultrafiltration membrane, the pore size of which is between 1-100 nanometers, which can allow small molecular solutes to pass through, while retaining large molecular solute proteins, bacteria and viruses. In the production process of dialysis water, ultrafiltration can be used as the last purification step to remove large molecular impurities, endotoxins, etc. that may remain in the water, further improve the quality of dialysis water, and ensure the safety and purity of dialysis water; after disinfection, the weight ratio of citrate and silver ion antibacterial agent in the antibacterial solution is controlled at 2:1, and the silver ion antibacterial agent is nanosilver; S2: inject part of the dialysis water into the reactor, then pour in sodium bicarbonate, start the reactor to stir, stir evenly to obtain liquid B, the reactor adopts a two-way stirring setting, the stirring rate is 320 rpm, and the stirring time is 20 minutes; S3: Sodium chloride, potassium chloride, calcium chloride, magnesium chloride, glacial acetic acid and sodium acetate were weighed in proportion, and then part of the dialysis water was injected into another reactor, and then sodium chloride, potassium chloride, calcium chloride, magnesium chloride, glacial acetic acid and sodium acetate were poured into the reactor, and the reactor was started to stir, and the stirring was uniform to obtain liquid A, the stirring speed was controlled at 370 rpm, and the stirring time was 21 minutes; S4: Pour liquid A, liquid B and antibacterial liquid into the liquid preparation tank and mix them evenly to obtain a preliminary hemodialysis solution. Then, nitrogen gas is introduced into the preliminary hemodialysis solution through the gas injection port at the bottom of the liquid preparation tank, and filtering circulation is performed at the same time. Before the liquid preparation tank is used, the liquid preparation tank needs to be sterilized with high-temperature steam. The temperature of the sterilization treatment needs to be controlled at 160°C, and the sterilization time is 35 minutes. The filtration needs to be performed under sterile conditions. The nylon filter element used for filtration has a filtration pore size of 0.3μm. The liquid preparation tank and the circulating filtration pipeline are made of high-quality stainless steel and other corrosion-resistant materials. Before each preparation, the liquid preparation tank is thoroughly cleaned first, and then sterilized with 121°C steam. The circulating filtration pipeline is regularly cleaned and disinfected. Use special pipeline cleaning equipment, clean it with acidic or alkaline cleaning agents, and then disinfect it with disinfectants to ensure that there are no bacteria residues inside the pipeline; S5: Finally, after a period of circulating filtration and ultraviolet sterilization, the hemodialysis concentrate is obtained and filled. The hemodialysis concentrate is packaged using packaging materials with good gas barrier properties and microbial barrier properties, including multi-layer co-extruded plastic films.
[0022] Reference Figure 1 Embodiment 5 This embodiment proposes a preparation method that can effectively inhibit bacterial proliferation in hemodialysis concentrate, comprising the following steps: S1: The materials of hemodialysis concentrate include A powder, B powder, dialysis water and antibacterial liquid. In terms of weight, the raw materials of A powder include 47.20% sodium chloride, 0.89% potassium chloride, 0.71% calcium chloride, 0.20% magnesium chloride, 48.00% glacial acetic acid and 3.00% sodium acetate. The raw materials of B powder include sodium bicarbonate. The raw materials of antibacterial liquid include citrate and silver ion antibacterial agent. The weight ratio of A powder, B powder, dialysis water and antibacterial liquid in the materials of hemodialysis concentrate is controlled at 1:1.225:32.775:4. The preparation method of dialysis water is as follows: obtain distilled water, and remove particulate impurities in the water by sand filter and precision filter in turn. The sand filter can remove larger particles and generally can retain particles with a particle size greater than 10 microns. The precision filter can further remove Tiny particles with a particle size of about 1-10 microns can effectively protect subsequent water treatment equipment and prevent large particles from blocking or damaging them. Then, pressure is applied on both sides of the semipermeable membrane to allow water to penetrate from the high-concentration side, which is usually the raw water side containing various solutes, to the low-concentration side, which is the fresh water side. The reverse osmosis membrane can intercept most of the solutes in the water, including inorganic salts, organic matter, bacteria, and viruses. The pore size of the reverse osmosis membrane is between 0.1-1 nanometers, which can effectively block substances with a molecular weight greater than 100-200 Daltons. Then, the remaining ions in the water are removed by anion and cation exchange resins. Cation exchange resin hydrogen-type resins can remove cations in water, and the hydrogen ions in its exchange group will exchange with cations in water. Anion exchange resin hydroxide-type resins are used to remove anions in water, and the exchange group quaternary amino The hydroxide ions in the water are exchanged with the anions in the water; then, the solute is selectively filtered using an ultrafiltration membrane, the pore size of which is between 1-100 nanometers, which can allow small molecular solutes to pass through, while retaining large molecular solute proteins, bacteria and viruses. In the production process of dialysis water, ultrafiltration can be used as the last purification step to remove large molecular impurities, endotoxins, etc. that may remain in the water, further improve the quality of dialysis water, and ensure the safety and purity of dialysis water; after disinfection, the weight ratio of citrate and silver ion antibacterial agent in the antibacterial solution is controlled at 2:1, and the silver ion antibacterial agent is nanosilver; S2: inject part of the dialysis water into the reactor, then pour in sodium bicarbonate, start the reactor to stir, stir evenly to obtain liquid B, the reactor adopts a two-way stirring setting, the stirring rate is 320 rpm, and the stirring time is 20 minutes; S3: Sodium chloride, potassium chloride, calcium chloride, magnesium chloride, glacial acetic acid and sodium acetate were weighed in proportion, and then part of the dialysis water was injected into another reactor, and then sodium chloride, potassium chloride, calcium chloride, magnesium chloride, glacial acetic acid and sodium acetate were poured into the reactor, and the reactor was started to stir, and the stirring was uniform to obtain liquid A, the stirring speed was controlled at 370 rpm, and the stirring time was 21 minutes; S4: Pour liquid A, liquid B and antibacterial liquid into the liquid preparation tank and mix them evenly to obtain a preliminary hemodialysis solution. Then, nitrogen gas is introduced into the preliminary hemodialysis solution through the gas injection port at the bottom of the liquid preparation tank, and filtering circulation is performed at the same time. Before the liquid preparation tank is used, the liquid preparation tank needs to be sterilized with high-temperature steam. The temperature of the sterilization treatment needs to be controlled at 160°C, and the sterilization time is 35 minutes. The filtration needs to be performed under sterile conditions. The nylon filter element used for filtration has a filtration pore size of 0.3μm. The liquid preparation tank and the circulating filtration pipeline are made of high-quality stainless steel and other corrosion-resistant materials. Before each preparation, the liquid preparation tank is thoroughly cleaned first, and then sterilized with 121°C steam. The circulating filtration pipeline is regularly cleaned and disinfected. Use special pipeline cleaning equipment, clean it with acidic or alkaline cleaning agents, and then disinfect it with disinfectants to ensure that there are no bacteria residues inside the pipeline; S5: Finally, after a period of circulating filtration and ultraviolet sterilization, the hemodialysis concentrate is obtained and filled. The hemodialysis concentrate is packaged using packaging materials with good gas barrier properties and microbial barrier properties, including multi-layer co-extruded plastic films.
[0023] Comparing the conventional hemodialysis concentrate with the hemodialysis concentrate prepared in Examples 1 to 5, the hemodialysis concentrate prepared in Examples 1 to 5 are shown in the following table: Comparative Example Embodiment 1 Embodiment 2 Embodiment 3 Embodiment 4 Embodiment 5 Check for bacterial growth one month after filling have none none none none none Before filling, check for bacteria none none none none none none It can be seen from the above table that the antibacterial property of the hemodialysis concentrate prepared by the present invention is significantly improved.
[0024] 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 preparation method that can effectively inhibit bacterial proliferation in hemodialysis concentrate, characterized in that: The following steps are involved: S1: The materials of hemodialysis concentrate include A powder, B powder, dialysis water and antibacterial liquid. In terms of weight, the raw materials of A powder include 46.00% to 48.00% sodium chloride, 0.85% to 0.95% potassium chloride, 0.65% to 0.75% calcium chloride, 0.20% to 0.25% magnesium chloride, 48.00% to 49.00% glacial acetic acid and 3.00% to 4.00% sodium acetate. The raw materials of B powder include sodium bicarbonate. The raw materials of antibacterial liquid include citrate and silver ion antibacterial agent. S2: inject part of the dialysis water into the reactor, then pour in sodium bicarbonate, start the reactor to stir, and stir evenly to obtain liquid B; S3: Weigh sodium chloride, potassium chloride, calcium chloride, magnesium chloride, glacial acetic acid and sodium acetate according to the proportion, then inject part of the dialysis water into another reactor, then pour sodium chloride, potassium chloride, calcium chloride, magnesium chloride, glacial acetic acid and sodium acetate into the reactor, start the reactor to stir, and stir evenly to obtain liquid A; S4: Pour liquid A, liquid B and antibacterial liquid into a liquid preparation tank and mix them evenly to obtain a preliminary hemodialysis solution, and then introduce nitrogen gas into the preliminary hemodialysis solution through the gas injection port at the bottom of the liquid preparation tank, while performing filtering circulation; S5: Finally, after a period of circulating filtration and ultraviolet sterilization, the hemodialysis concentrate is obtained and bottled.
2. A preparation method for effectively inhibiting bacterial proliferation in hemodialysis concentrate according to claim 1, characterized in that: In S1, the weight ratio of A powder, B powder, dialysis water and antibacterial liquid in the materials of hemodialysis concentrate is controlled to be 1:1.225:32.775:
4.
3. A preparation method for effectively inhibiting bacterial proliferation in hemodialysis concentrate according to claim 1, characterized in that: In S1, the preparation method of dialysis water is as follows: distilled water is obtained, and particulate impurities in the water are removed successively through a sand filter and a precision filter. The sand filter can remove larger particles and generally can retain particles with a particle size greater than 10 microns. The precision filter can further remove tiny particles with a particle size of about 1-10 microns, which can effectively protect subsequent water treatment equipment and prevent large particle impurities from clogging or damaging them; then, pressure is applied to both sides of the semipermeable membrane to allow water to penetrate from the high-concentration side, which is usually the raw water side containing various solutes, to the low-concentration side, which is the fresh water side. The reverse osmosis membrane can retain most of the solutes in the water, including inorganic salts, organic matter, bacteria, and viruses. The pore size of the reverse osmosis membrane is between 0.1-1 nanometers, and it can effectively block substances with a molecular weight greater than 100-200 Daltons. Then, the remaining ions in the water are removed by anion and cation exchange resins. The cation exchange resin hydrogen type resin can remove cations in the water, and the hydrogen ions in its exchange group will exchange with the cations in the water. The anion exchange resin hydroxide type resin is used to remove anions in the water, and the exchange group quaternary amino The hydroxide ions in the water are exchanged with the anions in the water; then, the solutes are selectively filtered using an ultrafiltration membrane. The pore size of the ultrafiltration membrane is between 1-100 nanometers, which can allow small molecular solutes to pass through, while retaining large molecular solute proteins, bacteria and viruses. In the production process of dialysis water, ultrafiltration can be used as the last purification step to remove large molecular impurities and endotoxins that may remain in the water, further improve the quality of dialysis water, and ensure the safety and purity of dialysis water; store after disinfection.
4. The method for preparing a hemodialysis concentrate that can effectively inhibit bacterial proliferation according to claim 1, characterized in that: In S1, the weight ratio of citrate and silver ion antibacterial agent in the antibacterial liquid is controlled at 2:1, and the silver ion antibacterial agent is one of silver nitrate, silver acetate, nano silver, zeolite-supported silver and zirconium phosphate-supported silver.
5. The method for preparing a hemodialysis concentrate that can effectively inhibit bacterial proliferation according to claim 1, characterized in that: In S2, the reactor is set up with bidirectional stirring, the stirring rate is 240 rpm to 360 rpm, and the stirring time is 15 minutes to 30 minutes.
6. The method for preparing a hemodialysis concentrate that can effectively inhibit bacterial proliferation according to claim 1, characterized in that: In S3, the stirring speed is controlled at 360 rpm to 420 rpm, and the stirring time is 15 minutes to 30 minutes.
7. A preparation method for effectively inhibiting bacterial proliferation in hemodialysis concentrate according to claim 1, characterized in that: In S4, before the liquid preparation tank is used, it needs to be sterilized by high-temperature steam. The temperature of the sterilization treatment needs to be controlled at 120° C. to 190° C., and the sterilization time is 20 minutes to 45 minutes.
8. The method for preparing a hemodialysis concentrate that can effectively inhibit bacterial proliferation according to claim 1, characterized in that: In S4, filtration needs to be performed under sterile conditions, and a nylon filter element is used for filtration, and the filtration pore size is 0.3 μm.
9. The method for preparing a hemodialysis concentrate that can effectively inhibit bacterial proliferation according to claim 1, characterized in that: In S4, the liquid preparation tank and the circulating filtration pipeline are made of high-quality stainless steel and other corrosion-resistant materials. Before each preparation, the liquid preparation tank is thoroughly cleaned and then sterilized with 121°C steam. The circulating filtration pipeline is regularly cleaned and disinfected using special pipeline cleaning equipment, acidic or alkaline cleaning agents, and then disinfected with disinfectants to ensure that there are no bacterial residues inside the pipeline.
10. The method for preparing a hemodialysis concentrate that can effectively inhibit bacterial proliferation according to claim 1, characterized in that: In S5, the hemodialysis concentrate is packaged in a material having good gas barrier properties and microbial barrier properties, including a multi-layer co-extruded plastic film.
Citation Information
Patent Citations
Hemodialysis concentrated solution and preparation method thereof
CN113842394A