CN109172901A - A kind of hemodialysis concentrated solution making technology - Google Patents
A kind of hemodialysis concentrated solution making technology Download PDFInfo
- Publication number
- CN109172901A CN109172901A CN201811140751.8A CN201811140751A CN109172901A CN 109172901 A CN109172901 A CN 109172901A CN 201811140751 A CN201811140751 A CN 201811140751A CN 109172901 A CN109172901 A CN 109172901A
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- CN
- China
- Prior art keywords
- liquid
- dialysis
- concentrate
- concentrated solution
- solution making
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1654—Dialysates therefor
- A61M1/1656—Apparatus for preparing dialysates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1654—Dialysates therefor
- A61M1/1656—Apparatus for preparing dialysates
- A61M1/1668—Details of containers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1654—Dialysates therefor
- A61M1/1656—Apparatus for preparing dialysates
- A61M1/1672—Apparatus for preparing dialysates using membrane filters, e.g. for sterilising the dialysate
Abstract
The invention discloses a kind of hemodialysis concentrated solution making technologies, the present invention is a kind of hemodialysis concentrated solution making technology, it is 0.45 μm with aperture and filter core below is filtered that it, which is in the semi-finished product for concentrate of dialysing, purpose is effectively to delay clinically to carry out the dialyzate crystallization generation time after dialyzate preparation, haemodialysis is the principle according to Gibbs-Donan membrane equilibrium, the blood of patient and the dialyzate that dialysis machine supplies are introduced into the interior of dialyzer (artificial kidney) film simultaneously, mistress, and it is moved backward respectively in the two sides of dialysis membrane, the present invention is a kind of hemodialysis concentrated solution making technology, it is that aperture is respectively adopted in the semi-finished product for concentrate of dialysing to be 0.45 μm and be filtered with the filter membrane of lower filter, purpose is effectively to delay clinically to carry out the dialysis after dialyzate preparation Liquid crystallizes generation time.
Description
Technical field
The present invention relates to field of medical technology, specifically a kind of hemodialysis concentrated solution making technology.
Background technique
Haemodialysis (HD) is the one of acute or chronic renal failure kidneys of patients Replacement Therapy, it is by by internal blood
Liquid is drained in vitro, through one by the dialyzer that is formed without several hollow fibres, blood electrolysis similar with concentration containing body
Matter solution (dialyzate) carries out mass exchange inside and outside hollow fibre one by one, through disperse, ultrafiltration, absorption and convective principles,
It removes intracorporal metabolic waste, maintain electrolyte and acid-base balance；Moisture excessive in vivo is removed simultaneously, and will be by purification
The whole process of blood recovery is known as haemodialysis.
According to existing professional standard YY 0598-2015 " haemodialysis and associated treatment concentrate " (detailed See Attachment 1), needle
Particle pollution to dialysate concentrate, have a remarks: concentrate should be filtered by 1 μm (or finer) of filter,
Filter should use no fiber to discharge and be free of the film of the known polyethersulfone resin and polypropylene material haveing damage to human body；With
Existing professional standard is only used for preventing the particle pollution of dialysis concentrate, does not describe this technique for the process conditions of filtering
For improve prepare after dialyzate crystallization situation, and professional standard only specification pore size filter be 1 μm hereinafter, for make dialyse quality
Promoted and dialysis procedure allowed to extend using device longevity, filter pore size filter used in processing procedure up to 0.45 μm and with
Under.
Summary of the invention
The purpose of the present invention is to provide a kind of hemodialysis concentrated solution making technologies, to solve to mention in above-mentioned background technique
Out the problem of.
To achieve the above object, the invention provides the following technical scheme:
A kind of hemodialysis concentrated solution making technology, patient will use to two kinds of hemodialysis liquids, respectively in dialysis procedure
Acid concentrate (abbreviation A liquid) and bicarbonate concentrate (abbreviation B liquid), A liquid and B liquid must be connected wash kidney machine before,
It is diluted in proportion with water for dialysis by washing kidney machine, can just obtain final dialyzate and be used for patient, specific production craft step
It is as follows:
S1, match liquid: the carbon that sodium, potassium, calcium, magnesium, chlorine, acetate, glucose ion raw material and B liquid that A liquid contains are contained
Sour hydrogen radical ion raw material carries out the weighing of formulation dosage respectively, then is separately added into water for dialysis mixed preparing, obtains A liquid and B liquid
Semi-finished product solution；
S2, filtering: the semi-finished product that will be obtained are respectively 0.45 μm with aperture and following no fiber discharges and without known
The membrane filtration of the polyethersulfone resin and polypropylene materials filter core that had damage to human body；
S3, packaging processing: will be filling by the semi-finished product concentrate after 0.45 μm and filter element filtering below, into
Packaging mark is pasted in row capping processing；
S4, detection storage: the product that packaging is completed carries out the sampling Detection of final step.
As a further solution of the present invention: the filter membrane in the step S2 uses aperture for 0.45 μm and filter below
Core.
As a further solution of the present invention: testing result must be in strict accordance with Chinese people's republicanism in the detection storage
State's medicine professional standard " haemodialysis and associated treatment concentrate " could be put in storage to be used for patient.
Compared with prior art, the beneficial effects of the present invention are: design innovation of the present invention, improves the dialysis after the completion of preparing
When liquid crystallizes generation time, A liquid and B liquid and water for dialysis mixed preparing, when calcium ion, magnesium ion and bicarbonate radical pass through some
Between can generate calcium carbonate and magnesium carbonate crystallization；Haemodialysis is according to the principle of Gibbs-Donan membrane equilibrium, by the blood of patient
Introduce the inside and outside room of dialyzer (artificial kidney) film simultaneously with the dialyzate of dialysis machine supply, and anti-in the two sides of dialysis membrane respectively
To movement, therefore crystallization will affect dialysis machine, the service life of dialyzer and dialysis-effect, in order to reduce crystallization, therefore add in A liquid
Enter acetate adjustment pH value to reduce precipitating, but because excessive acetate easily causes patient's sense of discomfort in dialysis, so can not
Be added to and occur entirely without precipitating, however with membrane filtration in the processing procedure of concentrate, be verified by experiments with 0.45 μm of aperture and
The dialyzate that concentrate after 0.45 μm or less membrane filtration is configured, wherein can effectively delay dialyzate again with 0.45 μm or less
Crystallization time.
Specific embodiment
Below in conjunction with the embodiment of the present invention, technical scheme in the embodiment of the invention is clearly and completely described,
Obviously, described embodiments are only a part of the embodiments of the present invention, instead of all the embodiments.Based in the present invention
Embodiment, every other embodiment obtained by those of ordinary skill in the art without making creative efforts, all
Belong to the scope of protection of the invention.
In the embodiment of the present invention, a kind of hemodialysis concentrated solution making technology, patient is will use in dialysis procedure to two
Kind of hemodialysis liquid, respectively acid concentrate (abbreviation A liquid) and bicarbonate concentrate (abbreviation B liquid), before must by A liquid and
B liquid, which connects, washes kidney machine, is diluted in proportion with water for dialysis by washing kidney machine, can just obtain final dialyzate and use for patient, tool
Body production craft step is as follows:
S1, match liquid: the carbon that sodium, potassium, calcium, magnesium, chlorine, acetate, glucose ion raw material and B liquid that A liquid contains are contained
Sour hydrogen radical ion raw material carries out the weighing of formulation dosage respectively, then is separately added into water for dialysis mixed preparing, obtains A liquid and B liquid
Semi-finished product solution；
S2, filtering: the semi-finished product that will be obtained are respectively 0.45 μm with aperture and no fiber below discharges and without known
The polyethersulfone resin that human body is had damage and polypropylene material filter core membrane filtration；
S3, packaging processing: will be filling by the semi-finished product concentrate after 0.45 μm and filter element filtering below, into
Packaging mark is pasted in row capping processing；
S4, detection storage: the product that packaging is completed carries out the sampling Detection of final step.
In carrying out process of the invention, need to test to semi-finished product obtained in step S1: by obtain half at
Product with aperture are respectively 0.45 μm and with the membrane filtration of lower filter after, show that configured dialyzate generates the time of crystallization
And number, it is 1h, 2h, 3h, 22h, the knot of generation in the time that result, which is directly with semi-finished product and the dialyzate of water for dialysis configuration,
Brilliant number is respectively a small amount of, on a small quantity, on a small quantity, and on a small quantity, using the dialyzate of water for dialysis and 0.45 μm of filter core in time 1h, 2h,
The crystallization number of 3h, 22h, generation are respectively micro, micro, on a small quantity, on a small quantity, using water for dialysis and 0.45 μm with lower filter
For dialyzate in time 1h, 2h, 3h, 22h, the crystallization number of generation is respectively nothing, micro, micro, on a small quantity, therefore obtains direct use
Semi-finished product, which are prepared, just generated obvious crystallization at first hour, with only having micro crystallization after 0.45 μm of filter element filtering, arrived third hour
It is slightly more to crystallize number, with 0.45 μm or less filter element filtering, although first hour occurs as soon as crystallization, to the 4th hour crystallization number
Still also fewer than crossing 0.45 μm of filter core this group, the 22nd hour crystallization quantity is not obviously improved, thus it is speculated that reason is washed to be prepared
Kidney liquid, the carbonic acid in ingredient can volatilize because time of repose elongates, cause to wash kidney liquid meta-alkalescence and crystallize, therefore dense in dialyzate
When contracting production, need by filter.
Filter membrane in the step S2 uses aperture for 0.45 μm and filter core below, is directed to filter membrane with existing professional standard
Process conditions prevent the particle of dialysis concentrate to be contaminated.
Testing result must be in strict accordance with People's Republic of China's pharmaceuticals industry standard " haemodialysis in the detection storage
And associated treatment concentrate " could be put in storage for patient's use, guarantee the safety of finished product, protects the life security of patient.
It is obvious to a person skilled in the art that invention is not limited to the details of the above exemplary embodiments, Er Qie
In the case where without departing substantially from spirit or essential attributes of the invention, the present invention can be realized in other specific forms.Therefore, no matter
From the point of view of which point, the present embodiments are to be considered as illustrative and not restrictive, and the scope of the present invention is by appended power
Benefit requires rather than above description limits, it is intended that all by what is fallen within the meaning and scope of the equivalent elements of the claims
Variation is included within the present invention.
In addition, it should be understood that although this specification is described in terms of embodiments, but not each embodiment is only wrapped
Containing an independent technical solution, this description of the specification is merely for the sake of clarity, and those skilled in the art should
It considers the specification as a whole, the technical solutions in the various embodiments may also be suitably combined, forms those skilled in the art
The other embodiments being understood that.
Claims (3)
1. a kind of hemodialysis concentrated solution making technology, which is characterized in that patient is will use in dialysis procedure to two kinds of hemodialysis
Liquid, respectively acid concentrate (abbreviation A liquid) and bicarbonate concentrate (abbreviation B liquid), must connect A liquid and B liquid before
On wash kidney machine, be diluted in proportion with water for dialysis by washing kidney machine, can just obtain final dialyzate and be used for patient, it is specific to produce
Processing step is as follows:
S1, match liquid: the bicarbonate that sodium, potassium, calcium, magnesium, chlorine, acetate, glucose ion raw material and B liquid that A liquid contains are contained
Radical ion raw material carries out the weighing of formulation dosage respectively, then is separately added into water for dialysis mixed preparing, obtains A liquid and B liquid half
Final mean annual increment solution；
S2, filtering: the semi-finished product that will be obtained are respectively 0.45 μm with aperture and no fiber below discharges and without known right
The membrane filtration of polyethersulfone resin and polypropylene material filter core that human body is had damage；
S3, packaging processing: will be filling by the semi-finished product concentrate after 0.45 μm and filter element filtering below, it is sealed
Packaging mark is pasted in lid processing；
S4, detection storage: the product that packaging is completed carries out the sampling Detection of final step.
2. a kind of hemodialysis concentrated solution making technology according to claim 1, which is characterized in that in the step S2
Filter membrane uses aperture for 0.45 μm and filter core below.
3. a kind of a kind of preparation method of hemodialysis concentrated solution making technology as described in claim 1, which is characterized in that institute
State detection storage in testing result must be in strict accordance with the People's Republic of China (PRC) pharmaceuticals industry standard " haemodialysis and associated treatment
With concentrate " it could be put in storage for patient's use.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811140751.8A CN109172901A (en) | 2018-09-28 | 2018-09-28 | A kind of hemodialysis concentrated solution making technology |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811140751.8A CN109172901A (en) | 2018-09-28 | 2018-09-28 | A kind of hemodialysis concentrated solution making technology |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN109172901A true CN109172901A (en) | 2019-01-11 |
Family
ID=64907635
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201811140751.8A Pending CN109172901A (en) | 2018-09-28 | 2018-09-28 | A kind of hemodialysis concentrated solution making technology |
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| Country | Link |
|---|---|
| CN (1) | CN109172901A (en) |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN201692711U (en) * | 2010-05-10 | 2011-01-05 | 天津市标准生物制剂有限公司 | Dialysis concentrate refining filter |
| CN103751867A (en) * | 2014-01-20 | 2014-04-30 | 广州康盛生物科技有限公司 | Hemodialysis concentrated solution and preparation method thereof |
| CN104994894A (en) * | 2013-02-02 | 2015-10-21 | 美敦力公司 | Sodium management system for hemodialysis |
| US20170112991A1 (en) * | 2013-01-09 | 2017-04-27 | Medtronic, Inc. | Recirculating dialysate fluid circuit for blood measurement |
-
2018
- 2018-09-28 CN CN201811140751.8A patent/CN109172901A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN201692711U (en) * | 2010-05-10 | 2011-01-05 | 天津市标准生物制剂有限公司 | Dialysis concentrate refining filter |
| US20170112991A1 (en) * | 2013-01-09 | 2017-04-27 | Medtronic, Inc. | Recirculating dialysate fluid circuit for blood measurement |
| CN104994894A (en) * | 2013-02-02 | 2015-10-21 | 美敦力公司 | Sodium management system for hemodialysis |
| CN103751867A (en) * | 2014-01-20 | 2014-04-30 | 广州康盛生物科技有限公司 | Hemodialysis concentrated solution and preparation method thereof |
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| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20190111 |
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| RJ01 | Rejection of invention patent application after publication |