CN113827800A - Ultrapure hemodialysis concentrated solution and preparation process thereof - Google Patents

Ultrapure hemodialysis concentrated solution and preparation process thereof Download PDF

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Publication number
CN113827800A
CN113827800A CN202111244990.XA CN202111244990A CN113827800A CN 113827800 A CN113827800 A CN 113827800A CN 202111244990 A CN202111244990 A CN 202111244990A CN 113827800 A CN113827800 A CN 113827800A
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China
Prior art keywords
solution
hemodialysis
concentrated solution
hemodialysis concentrated
liquid
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CN202111244990.XA
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Chinese (zh)
Inventor
徐林立
尚超
曹金花
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Changzhou Huayue Minimally Invasive Medical Devices Co ltd
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Changzhou Huayue Minimally Invasive Medical Devices Co ltd
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Priority to CN202111244990.XA priority Critical patent/CN113827800A/en
Publication of CN113827800A publication Critical patent/CN113827800A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1654Dialysates therefor
    • A61M1/1656Apparatus for preparing dialysates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/168Sterilisation or cleaning before or after use
    • CCHEMISTRY; METALLURGY
    • C02TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02FTREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F9/00Multistage treatment of water, waste water or sewage
    • CCHEMISTRY; METALLURGY
    • C02TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02FTREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F1/00Treatment of water, waste water, or sewage
    • C02F1/001Processes for the treatment of water whereby the filtration technique is of importance
    • CCHEMISTRY; METALLURGY
    • C02TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02FTREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F1/00Treatment of water, waste water, or sewage
    • C02F1/28Treatment of water, waste water, or sewage by sorption
    • C02F1/283Treatment of water, waste water, or sewage by sorption using coal, charred products, or inorganic mixtures containing them
    • CCHEMISTRY; METALLURGY
    • C02TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02FTREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F1/00Treatment of water, waste water, or sewage
    • C02F1/30Treatment of water, waste water, or sewage by irradiation
    • C02F1/32Treatment of water, waste water, or sewage by irradiation with ultraviolet light
    • CCHEMISTRY; METALLURGY
    • C02TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02FTREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F1/00Treatment of water, waste water, or sewage
    • C02F1/44Treatment of water, waste water, or sewage by dialysis, osmosis or reverse osmosis
    • C02F1/441Treatment of water, waste water, or sewage by dialysis, osmosis or reverse osmosis by reverse osmosis
    • CCHEMISTRY; METALLURGY
    • C02TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02FTREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F5/00Softening water; Preventing scale; Adding scale preventatives or scale removers to water, e.g. adding sequestering agents

Abstract

The invention discloses an ultrapure hemodialysis concentrated solution and a preparation process thereof, comprising the following steps: preparing materials such as a liquid preparation tank, a connecting pipe, a filter and the like, firstly carrying out disinfection and sterilization treatment on the materials, then injecting dialysis water into the liquid preparation tank, and simultaneously taking corresponding hemodialysis concentrated A liquid and hemodialysis concentrated B liquid according to a certain proportion; step two: conveying the solution obtained in the step one to a liquid storage tank through a connecting pipe, and simultaneously setting carbon dioxide release at the bottom of the liquid storage tank, and performing the step three: inputting the solution obtained in the step two into the solution by ozone generated by an ozone generator; step four: filtering the solution obtained in the third step by using a precision filter; step five: the filtered solution is transferred to a storage bucket through a connecting pipe, and the storage bucket is pressurized. The ultrapure hemodialysis concentrated solution and the preparation process thereof reduce initial pollution bacteria in the concentrated solution, prolong the storage period, better ensure the quality of products and ensure the use safety of patients.

Description

Ultrapure hemodialysis concentrated solution and preparation process thereof
Technical Field
The invention relates to the technical field of hemodialysis concentrated solution, in particular to ultrapure hemodialysis concentrated solution and a preparation process thereof.
Background
The hemodialysis concentrated solution comprises a concentrated solution A and a concentrated solution B, wherein the concentrated solution A mainly comprises sodium chloride, potassium chloride, calcium chloride, magnesium chloride, acetic acid and purified water, and the concentrated solution B comprises sodium bicarbonate and purified water. The A concentrated solution and the B concentrated solution are matched to form a dialyzate in hemodialysis, and the dialyzate mainly has the functions of correcting electrolyte and acid-base balance disorder of a dialysis patient and removing metabolic wastes in a body.
During hemodialysis, substances are exchanged between the dialysate and the blood through the dialyzer filter membrane, and some low molecular substances can freely pass through the dialyzer filter membrane, enter the dialysate from the blood or enter the blood from the dialysate. Therefore, the quality of the dialyzate directly influences the quality of hemodialysis, so that the life quality of a dialysis patient is influenced, the traditional process for preparing the hemodialysis concentrated solution has short preservation time, and bacteria are easily generated. Therefore, we improve the technology and propose an ultra-pure hemodialysis concentrated solution and a preparation technology.
Disclosure of Invention
In order to solve the technical problems, the invention provides the following technical scheme:
the invention relates to an ultra-pure hemodialysis concentrated solution, which comprises a hemodialysis concentrated solution A and a hemodialysis concentrated solution B, wherein the content of each component of the hemodialysis concentrated solution A is 9.56-16.48g/L of potassium chloride, 17-19.80g/L of magnesium chloride, 55.45-90.55g/L of sodium chloride, 2.56-8.50g/L, pH of calcium chloride and 14.25-26.35g/L of glacial acetic acid aqueous solution.
As a preferred technical scheme of the invention, the hemodialysis concentrated B solution comprises the following components in percentage by weight: 12.80-18.50g/L sodium bicarbonate or 8.25-28.55g/L sodium bicarbonate and 4.35-25.55g/L sodium chloride aqueous solution.
A preparation process of an ultrapure hemodialysis concentrated solution comprises the following steps:
the method comprises the following steps: preparing materials such as a liquid preparation tank, a connecting pipe, a filter and the like, firstly carrying out disinfection and sterilization treatment on the materials, then injecting dialysis water into the liquid preparation tank, simultaneously taking corresponding hemodialysis concentrated solution A and hemodialysis concentrated solution B according to a certain proportion, and putting the materials into the liquid preparation tank;
step two: conveying the solution obtained in the step one to a liquid storage tank through a connecting pipe, and simultaneously setting carbon dioxide release at the bottom of the liquid storage tank to obtain a mixed solution;
step three: inputting the ozone generated by the ozone generator into the solution obtained in the step two, wherein the concentration of the ozone is 0.04-0.07 mg/L;
step four: filtering the solution obtained in the third step by using a precision filter;
step five: the filtered solution is transferred to a storage bucket through a connecting pipe, and the storage bucket is pressurized.
In the first step, the solution in the solution preparation tank is stirred and simultaneously heated to a certain temperature of 35-40 ℃.
As a preferred technical scheme of the invention, the first step sterilization temperature is 100-130 ℃, and the sterilization time is 30-45 min.
As a preferred technical scheme of the invention, the dialysis water obtained in the first step is prepared by a sand filter, softening, activated carbon adsorption and reverse osmosis, the reverse osmosis water generated by filtration in the first step can be used as dialysis water after being irradiated by ultraviolet rays, and the water temperature is controlled to be 30-45 ℃.
As a preferable technical scheme of the invention, the time for introducing the carbon dioxide in the second step is 25-45 min.
In a preferred embodiment of the present invention, the precision filter in the fourth step is a 0.22 μm sterilizing grade filter.
As a preferred technical scheme of the invention, when the precision filter is used in the fourth step, the circulation is repeated three times, and the filtering pore diameter of the sterilizing grade filter adopted in the three times of circulation is 0.22 micron, 0.15 micron and 0.10 micron.
As a preferable technical scheme of the invention, the adsorption pressure of the activated carbon is 0.20MPa-0.35MPa, and the particle size of the activated carbon is 20-80 μm.
The invention has the beneficial effects that:
the method comprises the following steps: preparing materials such as a liquid preparation tank, a connecting pipe, a filter and the like, firstly carrying out disinfection and sterilization treatment on the materials, then injecting dialysis water into the liquid preparation tank, simultaneously taking corresponding hemodialysis concentrated solution A and hemodialysis concentrated solution B according to a certain proportion, and putting the materials into the liquid preparation tank; step two: conveying the solution obtained in the step one to a liquid storage tank through a connecting pipe, and simultaneously setting carbon dioxide release at the bottom of the liquid storage tank to obtain a mixed solution; step three: inputting the ozone generated by the ozone generator into the solution obtained in the step two, wherein the concentration of the ozone is 0.04-0.07 mg/L; step four: filtering the solution obtained in the third step by using a precision filter; step five: the filtered solution is conveyed into the storage barrel through the connecting pipe, and the storage barrel is pressurized to obtain the hemodialysis concentrated solution, so that the life quality of a patient undergoing maintenance dialysis is improved, the service life is prolonged, the bacterial infection is reduced, the accumulation of harmful substances in the body is avoided, and the life span of the patient undergoing maintenance dialysis is prolonged.
Drawings
The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and together with the description serve to explain the principles of the invention and not to limit the invention. In the drawings:
figure 1 is a method step diagram of an ultrapure hemodialysis concentrate and process of making the same of the present invention.
Detailed Description
The preferred embodiments of the present invention will be described in conjunction with the accompanying drawings, and it will be understood that they are described herein for the purpose of illustration and explanation and not limitation.
Example (b): as shown in figure 1, the ultrapure hemodialysis concentrate comprises a hemodialysis concentrate A liquid and a hemodialysis concentrate B liquid, wherein the content of each component of the hemodialysis concentrate A liquid is 9.56-16.48g/L of potassium chloride, 17-19.80g/L of magnesium chloride, 55.45-90.55g/L of sodium chloride, 2.56-8.50g/L, pH of calcium chloride, 9.6-12.5g/L of a value regulator and 14.25-26.35g/L of a glacial acetic acid aqueous solution.
Wherein, the hemodialysis concentrated solution B comprises the following components in percentage by weight: 12.80-18.50g/L sodium bicarbonate or 8.25-28.55g/L sodium bicarbonate and 4.35-25.55g/L sodium chloride aqueous solution.
A preparation process of an ultrapure hemodialysis concentrated solution comprises the following steps:
the method comprises the following steps: preparing materials such as a liquid preparation tank, a connecting pipe, a filter and the like, firstly carrying out disinfection and sterilization treatment on the materials, then injecting dialysis water into the liquid preparation tank, simultaneously taking corresponding hemodialysis concentrated solution A and hemodialysis concentrated solution B according to a certain proportion, and putting the materials into the liquid preparation tank;
step two: conveying the solution obtained in the step one to a liquid storage tank through a connecting pipe, and simultaneously setting carbon dioxide release at the bottom of the liquid storage tank to obtain a mixed solution;
step three: inputting the ozone generated by the ozone generator into the solution obtained in the step two, wherein the concentration of the ozone is 0.04-0.07 mg/L;
step four: filtering the solution obtained in the third step by using a precision filter;
step five: the filtered solution is transferred to a storage bucket through a connecting pipe, and the storage bucket is pressurized.
In the first step, the solution in the liquid preparation tank is stirred and is subjected to certain heating treatment at the temperature of 35-40 ℃, and the solution is quickly dissolved by heating operation.
Wherein the sterilization temperature in the first step is 100-.
The dialysis water obtained in the first step is obtained through sand filtration, softening, activated carbon adsorption and reverse osmosis, the reverse osmosis water generated through filtration in the first step can be used as dialysis water after being irradiated by ultraviolet rays, and the water temperature is controlled to be 30-45 ℃.
And C, introducing carbon dioxide for 25-45 min, wherein the breeding of bacteria and viruses can be effectively inhibited by introducing the carbon dioxide.
Wherein the precision filter in the fourth step is a 0.22 micron sterilizing grade filter, and the precision filter can be used for carrying out more precise filtering operation.
Wherein, when the precision filter is used in the fourth step, the circulation is repeated for three times, and the filtering pore diameter of the sterilization grade filter adopted in the third circulation is 0.22 micron, 0.15 micron and 0.10 micron.
Wherein the adsorption pressure of the activated carbon is 0.20MPa-0.35MPa, and the particle size of the activated carbon is 20-80 μm.
The working principle is as follows:
the first embodiment is as follows: the method comprises the following steps: preparing materials such as a liquid preparation tank, a connecting pipe, a filter and the like, firstly carrying out disinfection and sterilization treatment on the materials, then injecting dialysis water into the liquid preparation tank, simultaneously taking corresponding hemodialysis concentrated A liquid and hemodialysis concentrated B liquid according to a certain proportion, taking 9.56-16.48g/L of potassium chloride, 17-19.80g/L of magnesium chloride, 55.45-90.55g/L of sodium chloride, 2.56-8.50g/L, pH value regulator 9.6-12.5g/L of calcium chloride and 4.35-25.55g/L of glacial acetic acid aqueous solution to form the materials, putting the materials into the liquid preparation tank, wherein the sterilization temperature is 100-130 ℃, the sterilization time is 30-45 min, the dialyzed water passes through a sand filter, and the filter, Softening, adsorbing by activated carbon and reverse osmosis, wherein the reverse osmosis water generated by filtration in the steps can be used as dialysis water after being irradiated by ultraviolet rays; step two: conveying the solution obtained in the step one to a liquid storage tank through a connecting pipe, and simultaneously setting carbon dioxide release at the bottom of the liquid storage tank to obtain a mixed solution; step three: inputting the ozone generated by the ozone generator into the solution obtained in the step two, wherein the concentration of the ozone is 0.04-0.07 mg/L; step four: filtering the solution obtained in the third step by using a precision filter, wherein the precision filter is a 0.22 micron sterilization grade filter; step five: conveying the filtered solution into a storage barrel through a connecting pipe, and pressurizing the storage barrel;
example two: the method comprises the following steps: preparing materials such as a liquid preparation tank, a connecting pipe, a filter and the like, firstly carrying out disinfection and sterilization treatment on the materials, then injecting dialysis water into the liquid preparation tank, simultaneously taking corresponding hemodialysis concentrated A liquid and hemodialysis concentrated B liquid according to a certain proportion, taking 13.56-20.48g/L of potassium chloride, 21-23.80g/L of magnesium chloride, 59.45-94.55g/L of sodium chloride, 6.56-12.50g/L, pH value regulator, 13.6-16.5g/L of calcium chloride and 8.35-29.55g/L of glacial acetic acid aqueous solution to form the materials, putting the materials into the liquid preparation tank, wherein the sterilization temperature is 130-150 ℃, the sterilization time is 40-60 min, the dialysis water passes through a sand filter, and the filter, Softening, adsorbing by activated carbon and reverse osmosis, wherein the reverse osmosis water generated by filtration in the steps can be used as dialysis water after being irradiated by ultraviolet rays; step two: conveying the solution obtained in the step one to a liquid storage tank through a connecting pipe, and simultaneously setting carbon dioxide release at the bottom of the liquid storage tank to obtain a mixed solution; step three: inputting the ozone generated by the ozone generator into the solution obtained in the step two, wherein the concentration of the ozone is 0.04-0.07 mg/L; step four: filtering the solution obtained in the third step by using a precision filter, wherein the precision filter is a 0.22 micron sterilization grade filter; step five: delivering the filtered solution to a storage barrel through a connecting pipe, and pressurizing the storage barrel
Finally, it should be noted that: in the description of the present invention, it should be noted that the terms "vertical", "upper", "lower", "horizontal", and the like indicate orientations or positional relationships based on those shown in the drawings, and are only for convenience of describing the present invention and simplifying the description, but do not indicate or imply that the referred device or element must have a specific orientation, be constructed in a specific orientation, and be operated, and thus, should not be construed as limiting the present invention.
In the description of the present invention, it should also be noted that, unless otherwise explicitly specified or limited, the terms "disposed," "mounted," "connected," and "connected" are to be construed broadly and may, for example, be fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.
Although the present invention has been described in detail with reference to the foregoing embodiments, it will be apparent to those skilled in the art that changes may be made in the embodiments and/or equivalents thereof without departing from the spirit and scope of the invention. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims (10)

1. An ultra-pure hemodialysis concentrated solution comprises a hemodialysis concentrated solution A and a hemodialysis concentrated solution B, and is characterized in that the content of each component of the hemodialysis concentrated solution A is 9.56-16.48g/L of potassium chloride, 17-19.80g/L of magnesium chloride, 55.45-90.55g/L of sodium chloride, 2.56-8.50g/L, pH of calcium chloride, 9.6-12.5g/L of a value regulator and 14.25-26.35g/L of a glacial acetic acid aqueous solution.
2. The hemodialysis concentrate of claim 1, wherein the hemodialysis concentrate B comprises the following components in parts by weight: 12.80-18.50g/L sodium bicarbonate or 8.25-28.55g/L sodium bicarbonate and 4.35-25.55g/L sodium chloride aqueous solution.
3. A preparation process of an ultrapure hemodialysis concentrated solution is characterized by comprising the following steps:
the method comprises the following steps: preparing materials such as a liquid preparation tank, a connecting pipe, a filter and the like, firstly carrying out disinfection and sterilization treatment on the materials, then injecting dialysis water into the liquid preparation tank, simultaneously taking corresponding hemodialysis concentrated solution A and hemodialysis concentrated solution B according to a certain proportion, and putting the materials into the liquid preparation tank;
step two: conveying the solution obtained in the step one to a liquid storage tank through a connecting pipe, and simultaneously setting carbon dioxide release at the bottom of the liquid storage tank to obtain a mixed solution;
step three: inputting the ozone generated by the ozone generator into the solution obtained in the step two, wherein the concentration of the ozone is 0.04-0.07 mg/L;
step four: filtering the solution obtained in the third step by using a precision filter;
step five: the filtered solution is transferred to a storage bucket through a connecting pipe, and the storage bucket is pressurized.
4. The process of claim 3, wherein in the first step, the solution in the solution preparation tank is stirred and heated at a temperature of 35-40 ℃.
5. The ultra-pure hemodialysis concentrate and the preparation process thereof as claimed in claim 1, wherein the first sterilization temperature is 100 ℃ and the sterilization time is 30min to 45 min.
6. The process of claim 3, wherein the dialysis water obtained in the first step is subjected to sand filtration, softening, activated carbon adsorption and reverse osmosis, and the reverse osmosis water obtained by filtration in the first step can be used as dialysis water after being irradiated by ultraviolet rays, and the water temperature is controlled to be 30-45 ℃.
7. The process of claim 3, wherein the carbon dioxide is introduced for a period of about 25 to 45 minutes.
8. The process of claim 3, wherein the ultrafilter of step four is a 0.22 micron sterilizing grade filter.
9. The process of claim 3, wherein the microfiltration filter used in step four is repeated three times, and wherein the filtration pore size of the microfiltration membrane used in the three cycles is 0.22 microns, 0.15 microns or 0.10 microns.
10. The process of claim 6, wherein the pressure of the activated carbon adsorption is 0.20MPa to 0.35MPa, and the particle size of the activated carbon is 20 to 80 μm.
CN202111244990.XA 2021-10-26 2021-10-26 Ultrapure hemodialysis concentrated solution and preparation process thereof Pending CN113827800A (en)

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102038978A (en) * 2009-10-20 2011-05-04 上海和亭商贸有限公司 Hemodialysis concentrate
CN105641764A (en) * 2015-12-28 2016-06-08 天津市标准生物制剂有限公司 Ultra-pure hemodialysis concentrated solution manufacturing system and manufacturing technology
CN105726566A (en) * 2016-03-25 2016-07-06 吉林省富生医疗器械有限公司 Hemodialysis condensate capable of being used online
CN108066356A (en) * 2018-02-05 2018-05-25 济泰(上海)生物科技有限公司 A kind of haemodialysis concentrate
CN110917422A (en) * 2019-12-05 2020-03-27 长春海伯尔生物技术有限责任公司 Ultrapure hemodialysis concentrated solution and preparation process thereof

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102038978A (en) * 2009-10-20 2011-05-04 上海和亭商贸有限公司 Hemodialysis concentrate
CN105641764A (en) * 2015-12-28 2016-06-08 天津市标准生物制剂有限公司 Ultra-pure hemodialysis concentrated solution manufacturing system and manufacturing technology
CN105726566A (en) * 2016-03-25 2016-07-06 吉林省富生医疗器械有限公司 Hemodialysis condensate capable of being used online
CN108066356A (en) * 2018-02-05 2018-05-25 济泰(上海)生物科技有限公司 A kind of haemodialysis concentrate
CN110917422A (en) * 2019-12-05 2020-03-27 长春海伯尔生物技术有限责任公司 Ultrapure hemodialysis concentrated solution and preparation process thereof

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