CN105641764A - Ultra-pure hemodialysis concentrated solution manufacturing system and manufacturing technology - Google Patents
Ultra-pure hemodialysis concentrated solution manufacturing system and manufacturing technology Download PDFInfo
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- CN105641764A CN105641764A CN201511010480.0A CN201511010480A CN105641764A CN 105641764 A CN105641764 A CN 105641764A CN 201511010480 A CN201511010480 A CN 201511010480A CN 105641764 A CN105641764 A CN 105641764A
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- Prior art keywords
- concentrated solution
- ultrapure
- adsorber
- hemodialysis concentrated
- modified resin
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- 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
- A61M1/166—Heating
-
- 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
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- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Urology & Nephrology (AREA)
- Anesthesiology (AREA)
- Vascular Medicine (AREA)
- Engineering & Computer Science (AREA)
- Emergency Medicine (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- External Artificial Organs (AREA)
Abstract
The invention relates to a hemodialysis solution manufacturing system and a manufacturing technology, in particular to an ultra-pure hemodialysis concentrated solution manufacturing system and a manufacturing technology. The amount of endotoxin is smaller than or equal to 0.03 eu/ml, and the number of formed bacterial colonies is smaller than or equal to 0.1 cfu/ml. The ultra-pure hemodialysis concentrated solution manufacturing system comprises a dynamic mixing and dissolving tank (1), an activated-charcoal adsorber (2), a modified resin adsorber (3), a precise filter (4) and a liquid storage tank (5). The dynamic mixing and dissolving tank has a heating function. The system has the advantages that the activated charcoal adsorption and modified resin adsorption technology is adopted additionally, the technology is adopted for adsorbing endotoxin and the bacterial colonies in products, and after adsorption, endotoxin and the bacterial colonies are eliminated.
Description
Technical field:
The present invention relates to a kind of blood dialysis solution and manufacture system and manufacturing process, be specifically related to endotoxin��0.03eu/ml and bacterium colony forms ultrapure hemodialysis concentrated solution manufacture system and the manufacturing process of number��0.1cfu/ml.
Background technology:
In prior art, the technological process of production of hemodialysis concentrated solution is as shown in Figure 1. This production hemodialysis concentrated solution, endotoxin content and bacterium colony in finished product form one of number technical barrier always being puzzlement, and the top level that generally can reach is: endotoxin��0.25eu/ml, bacterium colony form number��100cfu/ml. Because composition blood dialysis solution is made up of multiple raw and auxiliary material, these raw and auxiliary materials are not super cleans, inherently contain endotoxin and the clump count (for ultrapure blood dialysis solution) of higher level; Process of manufacture also has contaminated risk.
Endotoxin and clump count in hemodialysis concentrated solution are to cause dialysis patient chronic injury, topmost stealthy killer. Through long-term hemodialysis, in dialysis solution, the endotoxin of higher level and bacterium colony form number (for super clean dialysis solution) and can the kidney of patient, liver and hemogram be impacted. So developing super clean hemodialysis concentrated solution and using in medical institutions, it is possible to the toxic and side effects improving hemodialysis, the quality of life improving dialysis patient, prolongation patient's life-span.
Summary of the invention:
It is an object of the invention to provide a kind of endotoxin��0.03eu/ml and bacterium colony forms the ultrapure hemodialysis concentrated solution of number��0.1cfu/ml and manufactures system and manufacturing process.
Ultrapure hemodialysis concentrated solution manufactures system, including: dynamically mixed dissolution tank 1, active carbon adsorber 2, modified resin adsorber 3, accurate filter 4, fluid reservoir 5; Described dynamic mixed dissolution tank has heating function. The mixed dissolution of dynamic mixed dissolution tank, molten material dynamic response hybrid system adopt the scheme described in open source literature (CN102228814A). The ultrapure hemodialysis concentrated solution manufacturing process realized in above-mentioned manufacture system, the material of use is: sodium chloride, potassium chloride, calcium chloride, magnesium chloride, glacial acetic acid, sodium bicarbonate; Manufacture process includes: mixing of materials dissolving, constant volume, the inspection of semifinished product; Subsequent technique process is followed successively by: activated carbon adsorption, resin absorption, secondary filter;Temperature when described mixing of materials is dissolved controls at 35 DEG C �� 1.5 DEG C; Described accurate filter filtering accuracy is :��0.12 ��m.
Preferably, also include: the first pressure regulating pump 6 being arranged between dynamic mixed dissolution tank and active carbon adsorber, be arranged on the second pressure regulating pump 7 between modified resin adsorber and accurate filter; The operating pressure of described activated carbon adsorption and resin absorption controls all at 0.1MPa �� 0.05MPa.
As it is preferred that one of scheme, described activated carbon iodine number >=1000; In described active carbon absorption technology, activated carbon is filled into the 2/3 of activated carbon container volume.
As it is preferred that scheme two, the model of the described modified resin used by resin absorption is HB-H-7, and modified resin is filled into the 2/3 of modified resin container volume.
The invention has the beneficial effects as follows:
(1) adding activated carbon adsorption and modified resin absorbing process, add endotoxin and bacterium colony that this technique is used exclusively in adsorption production, after absorption, endotoxin and bacterium colony obtain removing.
(2) prescription of hemodialysis concentrated solution and haemodialysis control unit match, because the dilution ratio of dialysis machine is different so the concentrated solution ion concentration used also can be had any different. The present invention only relates to the adsorption removal of endotoxin and bacterium colony, and does not affect the ion concentration of product, it is possible to the product for various ion concentrations is purged processing.
Accompanying drawing illustrates:
Fig. 1 is the process chart of prior art.
Fig. 2 is the process chart of the present invention.
Fig. 3 is the structural representation that the present invention manufactures system; In figure, 1 represents dynamic mixed dissolution tank, and 2 represent active carbon adsorber, and 3 represent modified resin adsorber, and 4 represent accurate filter, and 5 represent fluid reservoir, 6 represents the first pressure regulating pump, 7 represents the second pressure regulating pump.
Detailed description of the invention:
Embodiment:
Below in conjunction with Figure of description 2,3, super clean hemodialysis concentrated solution of the present invention is manufactured system and technique is described in detail:
As shown in Figure 3, ultrapure hemodialysis concentrated solution manufactures system, including: dynamically mixed dissolution tank, active carbon adsorber, modified resin adsorber, accurate filter, fluid reservoir, it is arranged on the first pressure regulating pump between dynamic mixed dissolution tank and active carbon adsorber, is arranged on the second pressure regulating pump between modified resin adsorber and accurate filter; Described dynamic mixed dissolution tank has heating function; The material used is: sodium chloride, potassium chloride, calcium chloride, magnesium chloride, glacial acetic acid, sodium bicarbonate; Manufacture process includes: mixing of materials dissolving, constant volume, the inspection of semifinished product; Subsequent technique process is followed successively by: activated carbon adsorption, resin absorption, secondary filter; Temperature when described mixing of materials is dissolved controls at 35 DEG C �� 1.5 DEG C; Described accurate filter filtering accuracy is :��0.12 ��m.
The mixed dissolution of described dynamic mixed dissolution tank, molten material dynamic response hybrid system adopt the scheme described in open source literature (CN102228814A).
The internal activated carbon of described active carbon adsorber 2 is filled into 2/3 place of volume.
Described resin absorption device 3 inter-modification resin is filled into 2/3 place of volume.
Described first pressure regulating pump 6 and the second pressure regulating pump 7 take automatically to compensate linkage work, remain that the pressure within active carbon adsorber and modified resin adsorber is maintained at 0.1MPa �� 0.05MPa during work
Manufacture process comprises the steps:
(1) pure water being put into dynamic mixed dissolution tank, amount of water is the 2/3 of the amount of producing;Open heater;
(2) open the agitating function of dynamic mixed dissolution tank, feed intake by proportioning; Continue stirring until whole material dissolutions;
(3) after temperature reaches 35 DEG C, stirring is stopped, open the first pressure regulating pump and the second pressure regulating pump, by the dialysis solution for preparing through active carbon adsorber and modified resin adsorber, the Stress control of active carbon adsorber and modified resin adsorber is at 0.1MPa �� 0.05MPa;
(4) it is filtered processing then through accurate filter through the product of absorption; Accurate filter filter sizes��0.12 ��m;
(5) final products enter fluid reservoir.
Hemodialysis concentrated solution at appropriate temperature, apply to be fully contacted with activated carbon and modified resin under certain pressure condition, adsorption effect dramatically increases. The endotoxin and the bacterium colony that arrive concentrated solution during the outlet of resin absorption device form number and can meet: endotoxin��0.03eu/ml, bacterium colony form number��0.1cfu/ml.
Claims (9)
1. ultrapure hemodialysis concentrated solution manufactures system, it is characterized in that, including: dynamically mixed dissolution tank (1), active carbon adsorber (2), modified resin adsorber (3), accurate filter (4), fluid reservoir (5); Described dynamic mixed dissolution tank has heating function.
2. manufacture system according to ultrapure hemodialysis concentrated solution according to claim 1, its feature, also include: the first pressure regulating pump (6) being arranged between dynamic mixed dissolution tank and active carbon adsorber, be arranged on the second pressure regulating pump (7) between modified resin adsorber and accurate filter.
3. the ultrapure hemodialysis concentrated solution manufacturing process realized in manufacture system described in claim 1, the material of use is: sodium chloride, potassium chloride, calcium chloride, magnesium chloride, glacial acetic acid, sodium bicarbonate; Manufacture process includes: mixing of materials dissolving, constant volume, the inspection of semifinished product; It is characterized in that, subsequent technique process is followed successively by: activated carbon adsorption, resin absorption, secondary filter; Temperature when described mixing of materials is dissolved controls at 35 DEG C �� 1.5 DEG C; Described accurate filter filtering accuracy is :��0.12 ��m.
4. ultrapure hemodialysis concentrated solution manufacturing process according to claim 3, it is characterised in that the operating pressure of described activated carbon adsorption and resin absorption controls all at 0.1MPa �� 0.05MPa.
5. ultrapure hemodialysis concentrated solution manufacturing process according to claim 4, it is characterised in that described activated carbon iodine number >=1000.
6. ultrapure hemodialysis concentrated solution manufacturing process according to claim 5, it is characterised in that in described active carbon absorption technology, activated carbon is filled into the 2/3 of activated carbon container volume.
7. ultrapure hemodialysis concentrated solution manufacturing process according to claim 4, it is characterised in that the model of the described modified resin used by resin absorption is HB-H-7.
8. ultrapure hemodialysis concentrated solution manufacturing process according to claim 7, it is characterised in that in described resin absorption technique, modified resin is filled into the 2/3 of modified resin container volume.
9. the ultrapure hemodialysis concentrated solution manufacturing process realized in manufacture system described in claim 2, the material of use is: sodium chloride, potassium chloride, calcium chloride, magnesium chloride, glacial acetic acid, sodium bicarbonate; Manufacture process comprises the steps:
(1) pure water being put into dynamic mixed dissolution tank, amount of water is the 2/3 of the amount of producing; Open heater;
(2) open the agitating function of dynamic mixed dissolution tank, feed intake by proportioning; Continue stirring until whole material dissolutions;
(3) after temperature reaches 35 DEG C, stirring is stopped, open the first pressure regulating pump and the second pressure regulating pump, by the dialysis solution for preparing through active carbon adsorber and modified resin adsorber, the Stress control of active carbon adsorber and modified resin adsorber is at 0.1MPa �� 0.05MPa;
(4) it is filtered processing then through accurate filter through the product of absorption; Accurate filter filter sizes��0.12 ��m;
(5) final products enter fluid reservoir.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201511010480.0A CN105641764A (en) | 2015-12-28 | 2015-12-28 | Ultra-pure hemodialysis concentrated solution manufacturing system and manufacturing technology |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201511010480.0A CN105641764A (en) | 2015-12-28 | 2015-12-28 | Ultra-pure hemodialysis concentrated solution manufacturing system and manufacturing technology |
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| CN105641764A true CN105641764A (en) | 2016-06-08 |
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| CN201511010480.0A Pending CN105641764A (en) | 2015-12-28 | 2015-12-28 | Ultra-pure hemodialysis concentrated solution manufacturing system and manufacturing technology |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108295326A (en) * | 2018-02-09 | 2018-07-20 | 海口喆云医疗科技合伙企业（有限合伙） | A kind of ultrapure haemodialyser of two-chamber |
| 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 |
| CN113827800A (en) * | 2021-10-26 | 2021-12-24 | 常州华岳微创医疗器械有限公司 | Ultrapure hemodialysis concentrated solution and preparation process thereof |
Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS5545437A (en) * | 1978-09-25 | 1980-03-31 | Nissho Kk | Purifier for artificial kidney |
| US20020012619A1 (en) * | 2000-07-26 | 2002-01-31 | Yoshihiko Sano | Solution preparing apparatus |
| CN1366462A (en) * | 2000-02-16 | 2002-08-28 | 帝人株式会社 | Dialyzing fluid preparing device and powder dialyzing fluid preparing chemical |
| CN102038980A (en) * | 2011-01-06 | 2011-05-04 | 刘思波 | Manual preparation device of kidney dialysis liquid |
| CN103432638A (en) * | 2013-04-01 | 2013-12-11 | 刘志敏 | Production equipment for hemodialysis concentrated solution and production method for hemodialysis concentrated solution |
| CN205434507U (en) * | 2015-12-28 | 2016-08-10 | 天津市标准生物制剂有限公司 | Ultrapure hemodialysis concentrate manufacturing system |
-
2015
- 2015-12-28 CN CN201511010480.0A patent/CN105641764A/en active Pending
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS5545437A (en) * | 1978-09-25 | 1980-03-31 | Nissho Kk | Purifier for artificial kidney |
| CN1366462A (en) * | 2000-02-16 | 2002-08-28 | 帝人株式会社 | Dialyzing fluid preparing device and powder dialyzing fluid preparing chemical |
| US20020012619A1 (en) * | 2000-07-26 | 2002-01-31 | Yoshihiko Sano | Solution preparing apparatus |
| CN102038980A (en) * | 2011-01-06 | 2011-05-04 | 刘思波 | Manual preparation device of kidney dialysis liquid |
| CN103432638A (en) * | 2013-04-01 | 2013-12-11 | 刘志敏 | Production equipment for hemodialysis concentrated solution and production method for hemodialysis concentrated solution |
| CN205434507U (en) * | 2015-12-28 | 2016-08-10 | 天津市标准生物制剂有限公司 | Ultrapure hemodialysis concentrate manufacturing system |
Non-Patent Citations (2)
| Title |
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| 张文福: "《医学消毒学》", 31 July 2002, 军事医学科学出版社 * |
| 李兰娟: "《人工肝脏》", 30 September 2012, 浙江大学出版社 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108295326A (en) * | 2018-02-09 | 2018-07-20 | 海口喆云医疗科技合伙企业（有限合伙） | A kind of ultrapure haemodialyser of two-chamber |
| 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 |
| CN113827800A (en) * | 2021-10-26 | 2021-12-24 | 常州华岳微创医疗器械有限公司 | Ultrapure hemodialysis concentrated solution and preparation process thereof |
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Application publication date: 20160608 |
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| RJ01 | Rejection of invention patent application after publication |