CN101181649A - Hemodialysis liquid as well as enclosed soft package bag thereof - Google Patents

Hemodialysis liquid as well as enclosed soft package bag thereof Download PDF

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Publication number
CN101181649A
CN101181649A CNA200710031790XA CN200710031790A CN101181649A CN 101181649 A CN101181649 A CN 101181649A CN A200710031790X A CNA200710031790X A CN A200710031790XA CN 200710031790 A CN200710031790 A CN 200710031790A CN 101181649 A CN101181649 A CN 101181649A
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China
Prior art keywords
liquid
bag
dialysis
package bag
dialysis solution
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CNA200710031790XA
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Chinese (zh)
Inventor
古英明
高建胜
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GUANGZHOU BAIYUN SHAN MING XING PHARMACEUTICAL CO Ltd
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GUANGZHOU BAIYUN SHAN MING XING PHARMACEUTICAL CO Ltd
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Priority to CNA200710031790XA priority Critical patent/CN101181649A/en
Publication of CN101181649A publication Critical patent/CN101181649A/en
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Abstract

The invention relates to haemodialysis solution and the closed soft package bag. The haemodialysis is characterized in that the haemodialysis solution comprises independent closed softly packaged concentrated solution A and B; the concentrated solution A and B are diluted into isotonic hermodialysis solution by a dialysis machine and dialysis water according to proportion. The closed soft package bag is characterized in that the closed soft package bag comprises a soft bag body and a stream guidance tube which is integrally connected with the soft bag; the upper end of the stream guidance tube is provided with a connecting head communicated with the dialysis machine; the soft bag body and the stream guidance tube can be pressed and molded by nontoxic polyvinyl chloride, or nontoxic polyethylene, or nontoxic polypropylene, or nontoxic complex film, or nontoxic aluminum foil. The invention can prevent problems existing between supply and demand and can satisfy the patients with various dialysis demands; the closed soft package bag adopts various complex film and aluminum foil to be made into dialysis solution adopting package bag with high temperature resisting function, tensile resistance and pressing resistance, thereby having the effect of wide application range.

Description

Blood dialysis solution and enclosed soft package bag thereof
Technical field
The present invention relates to blood dialysis solution and enclosed soft package bag thereof, belong to hemodialysis preparation and packing technique field thereof.
Background technology
Blood dialysis is exactly that the solute of blood in dialyzer and dialysis solution exchanges, and reaches to remove the body metabolism refuse and correct Water-Electrolyte and the purpose of acid base imbalance state.The moving of solute between blood and the dialysis solution removed outside the Pass characteristic with dialyzer has, and also character and the composition with dialysis solution has substantial connection.The medical institutions of domestic application bicarbonate blood dialysis solution use dialysis solution under open state, thereby cause the CO in the dialysis solution 2Gas evolution, the sodium bicarbonate lowering of concentration.In order to solve foregoing problems, the closed blood dialysis solution has appearred at present, disclose name as Chinese patent and be called " enclosed soft package formula blood dialysis solution and special packing bag thereof and purposes ", the patent No. patent of invention, can overcome that (1) preparation is inhomogeneous, quality cannot say for sure that card and (2) are used under open state, the CO in the dialysis solution for " 00114166.X " 2Gas evolution, cause sodium bicarbonate lowering of concentration two aspect shortcomings.But also there are two aspect shortcomings in this patent: the proportioning of the blood dialysis solution each component of (1) regulation is few, narrow application range.(2) structure of special packing bag and materials are unreasonable, cause sterilization method and means restricted.
Summary of the invention
First purpose of the present invention is in order to increase specification, to enlarge the ratio range that blood dialysis solution is suitable for.
Second purpose of the present invention is unreasonable for the structure and the materials that overcome existing special packing bag, causes the restricted shortcoming of sterilization method and means, for the blood dialysis solution of different size provides a kind of enclosed soft package bag.
First purpose of the present invention can reach by taking following measure:
Blood dialysis solution is characterized in that: comprise independent closed flexible package formula concentrated liquid A liquid and B liquid, be provided with the interface that is connected with dialysis machine in the flexible package of A liquid and B liquid; Concentrated liquid A liquid and B liquid spend water for dialysis by dialysis machine and the oozing of blood hemodialysis liquid such as are diluted in proportion; Described hemodialysis liquid such as oozing of blood such as grade is the acetic acid type dialysis solution, potassium concentration K +=0~2.99mmol/L or 3.01~4.5mmol/L, Na ion concentration Na +=136~144mmol/L or 146~150mmol/L; Perhaps waiting the oozing of blood hemodialysis liquid is no acetic acid type dialysis solution, potassium concentration K +=0~4.5mmol/L, Na ion concentration Na +=136~150mmol/L.
One embodiment of the present invention are:
A liquid is acid solution, is made by sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium acetate, glacial acetic acid or aminoacid and water for dialysis; B liquid is alkali liquor, is made or is made by sodium bicarbonate, sodium chloride and water for dialysis by sodium bicarbonate and water for dialysis; Through the mixed blood dialysis solution of special-purpose dialysis machine is the acetic acid type dialysis solution, ion concentration (unit: mmol/L) and pH value be:
Na +=136~144mmol/L or 146~150mmol/L,
K +=0~2.99mmol/L or 3.01~4.5mmol/L,
Ca ++=1.25~1.74mmol/L or 1.76~1.85mmol/L,
Mg ++=0.5~1.0mmol/L,
Cl -=105~115mmol/L,
CH 3COO -=2.0~8.0mmol/L,
HCO 3 -=30~39mmol/L,
PH=7.0~7.8
One embodiment of the present invention are:
A liquid is acid solution, is made by sodium chloride, potassium chloride, calcium chloride, magnesium chloride, aminoacid and water for dialysis; B liquid is alkali liquor, is made or is made by sodium bicarbonate, sodium chloride and water for dialysis by sodium bicarbonate and water for dialysis; Through the mixed blood dialysis solution of special-purpose dialysis machine is no acetic acid type dialysis solution, its ion concentration (unit: mmol/L) and pH value be:
Na +=136~150mmol/L,
K +=0~4.5mmol/L,
Ca ++=1.25~1.85mmol/L,
Mg ++=0.5~1.0mmol/L,
Cl -=105~115mmol/L,
CH 3COO -=2.0~8.0mmol/L,
HCO 3 -=30~39mmol/L,
PH=7.0~7.8
One embodiment of the present invention are: described water for dialysis meets Chinese water for dialysis industry standard.
Second purpose of the present invention can reach by taking following measure:
Enclosed soft package bag, its construction features is: comprise soft bag and mozzle, mozzle and soft bag are connected as a single entity, the bottom that soft bag is outer, the lower end extends to soft bag is stretched out in the upper end of mozzle, the lower end of mozzle is provided with flow-guiding mouth and is communicated with the inner chamber of soft bag by this flow-guiding mouth, the upper end of mozzle is provided with the union joint that is communicated with dialysis machine, and described union joint is elasticity plece-cliped type structure or spiral syndeton.
One embodiment of the present invention are: soft bag and mozzle are one compression moulding structure, and perhaps soft bag and mozzle divide body formed back repress to make integrative-structure.
One embodiment of the present invention are: soft bag and mozzle can be by non-toxic polyvinyl chloride PVC compression mouldings.
One embodiment of the present invention are: soft bag and mozzle can be by non-toxic polyethylene PE compression mouldings.
One embodiment of the present invention are: soft bag and mozzle can be by nonpoisonous polypropylene PP compression mouldings.
One embodiment of the present invention are: soft bag and mozzle can be by nontoxic composite membrane compression mouldings, and this composite membrane can be to comprise PP TYPE, Tropical cooking film or paper aluminum-plastic composite membrane.
One embodiment of the present invention are: soft bag and mozzle can be by nontoxic aluminium foil compression mouldings.
Adopt the present invention to have following beneficial effect:
1. because the dialysis solution among the present invention is divided into airtight soft packaging bags, the mozzle at the built-in fixed-site of used airtight soft packaging bag and the straight-through bag end, the end of mozzle is provided with that flow-guiding mouth, head end expose and input port that can external dialysis machine, therefore, dialysis solution all is in and the air state of isolation in whole dialysis procedure on the one hand, thereby makes the CO in the dialysis solution 2Gas can not overflowed, the sodium bicarbonate constant concentration is constant, guarantees the quality of dialysis solution.A liquid, two kinds of concentrated liquids of B liquid have been prefabricated on the other hand before use, as long as will will make required dialysis solution automatically in this A liquid, the B liquid access dialysis machine, thereby guarantee that the dialysis solution preparation is even, easy to use, need not rely on medical department and modulate temporarily, thereby avoid imbalance between supply and demand.
2, the present invention is because with Na in the dialysis solution +Concentration is decided to be 136~144mmol/L or 146~150mmol/L (containing acetic acid type) and Na ion concentration Na +=136~150mmol/L (no acetic acid type) K +Concentration is decided to be 0~2.99mmol/L or 3.01~4.5mmol/L (containing acetic acid type) and potassium concentration K +In the scope of=0~4.5mmol/L (no acetic acid type), guaranteeing the suitable percentage composition of adjusting other each components on the liquid pH value basis of constant of analysing, promptly dialysis solution can be arranged to multiple combinations such as the low potassium of low sodium, the low high potassium of sodium, the low potassium of high sodium or the high potassium of high sodium, thereby satisfy the patient of various different dialysis demands, have effect applied widely.
3, the present invention is owing to adopt various composite membranes or aluminium foil making dialysis solution special packing bag, make special packing bag have high temperature resistant function on the one hand, increase tension, anti-pressure ability, can carry out the high-temperature sterilization sterilization method different, help guaranteeing that dialysis solution is clean, sanitary with other; On the other hand, help improving special packing bag production and processing method, enhance productivity.In addition, soft packaging bag is provided with plece-cliped type and spiral union joint, can be suitable for the dialysis machine with different input port structures, and instant packed bag is connected with dialysis machine, has effect applied widely, easy to use.
Description of drawings
Fig. 1 is the structural representation of soft package bag of the present invention.
Fig. 2 is an application example sketch map of the present invention.
The specific embodiment
Describe the present invention below in conjunction with example:
Specific embodiment 1:
This instantiation is patient's dialysis consumption once, comprises the liquid A liquid and the B liquid that are packaged in enclosed soft package bag, wherein:
(1) Main Ingredients and Appearance of A liquid, B liquid:
1.A the prescription of liquid
The every bag consumption of component title
Sodium chloride nacl 900~1000g
Potassium chloride (KCl) 35~40g
Calcium chloride CaCl 22H 2O 40~50g
Magnesium chloride Mg Cl 26H 2O 20~30g
Sodium acetate CH 3COONa 80~100g
Glacial acetic acid CH 3COOH 18~25g
2.B the prescription of liquid:
The every bag consumption of component title
Sodium bicarbonate NaHCO 3400~500g
(2) processing technology of A liquid, B liquid:
1. the various supplementary materials of aforementioned prescription are worn into fine powder, by 10 mesh sieves, standby;
2. accurately weigh (being accurate to 0.01g) sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium acetate, glacial acetic acid by recipe quantity successively, add appropriate amount of deionized water (or distilled water), be stirred to dissolving fully with agitator, and be diluted to 4.5~5L with above-mentioned water, mix homogeneously, pack in the soft sealing bags 1, tube sealing is made into A liquid;
3. accurately weigh sodium bicarbonate by prescription, add appropriate amount of deionized water (or distilled water), be stirred to dissolving fully, and be diluted to 5.5~6.5L with above-mentioned water with agitator, mix homogeneously, in the soft sealing bags 1 of packing into, tube sealing is made into B liquid;
(3) usage and consumption:
Referring to Fig. 2, during use, the input of A liquid and B liquid and special-purpose dialysis machine is connected, by special-purpose dialysis machine with A liquid and B liquid and water for dialysis by a certain percentage mixed diluting become etc. to ooze dialysis solution, this dialysis solution is for containing the acetic acid type dialysis solution, its ion concentration and pH value are:
Na +=136,138,140 or 144mmol/L,
K +=3.01,3.05,3.25,3.55,3.95,4.15,4.35 or 4.5mmol/L,
Ca ++=1.76,1.78,1.80,1.82 or 1.85mmol/L,
Mg ++=0.5,0.6,0.75,0.9 or 1.0mmol/L,
Cl -=105,107,109,110,112 or 115mmol/L,
CH 3COO -=2.0,3.0,4.0,5.0,6.0,7.0 or 8.0mmol/L,
HCO 3 -=30,31,32,33,35,37 or 39mmol/L,
pH=7.0~7.8。
Specific embodiment 2:
(1) Main Ingredients and Appearance of A liquid, B liquid:
1.A the prescription of liquid
The every bag consumption of component title
Sodium chloride nacl 1030~1100g
Potassium chloride (KCl) 25~30g
Calcium chloride CaCl 22H 2O 40~50g
Magnesium chloride Mg Cl 26H 2O 20~30g
Sodium acetate CH 3COONa 80~100g
Glacial acetic acid CH 3COOH 18~25g
2.B the prescription of liquid:
The every bag consumption of component title
Sodium bicarbonate NaHCO 3400~500g
The A liquid of this enforcement is identical with embodiment 1 with the compound method of B liquid, and different is inequality by the ion concentration of the blood dialysis solution that forms after the dialysis machine mixing.Referring to Fig. 2, during use, the input of A liquid and B liquid and special-purpose dialysis machine is connected, A liquid and B liquid mixed and form blood dialysis solution by special-purpose dialysis machine, the ion concentration of this dialysis solution (unit: mmol/L) and pH value be:
Na +=146,147,148,149 or 150mmol/L,
K +=0,0.1,0.5,0.8,1.5,1.8,2.0,2.5 or 2.99mmol/L,
Ca ++=1.25,1.35,1.45,1.55,1.6,1.70 or 1.74mmol/L,
Mg ++=0.5,0.6,0.7,0.8,0.9 or 1.0mmol/L,
Cl -=105,107,109,110,112 or 115mmol/L,
CH 3COO -=2.0,3.0,4.0,5.0,6.0,7.0 or 8.0mmol/L,
HCO 3 -=30,31,32,35,36,37,38 or 39mmol/L,
pH=7.0~7.8。
Specific embodiment 3:
(1) Main Ingredients and Appearance of A liquid, B liquid:
1.A the prescription of liquid
The every bag consumption of component title
Sodium chloride nacl 750~850g
Potassium chloride (KCl) 20~30g
Calcium chloride CaCl 22H 2O 40~50g
Magnesium chloride Mg Cl 26H 2O 15~30g
Aminoacid aminoacid 75~95g
2.B the prescription of liquid:
The every bag consumption of component title
Sodium bicarbonate NaHCO 3250~350g
Sodium chloride nacl 120~160g
The A liquid of this enforcement is identical with embodiment 1 with the compound method of B liquid, and different is inequality by the ion concentration of the blood dialysis solution that forms after the dialysis machine mixing.Referring to Fig. 2, during use, the input of A liquid and B liquid and special-purpose dialysis machine is connected, A liquid and B liquid mixed and form blood dialysis solution by special-purpose dialysis machine, this dialysis solution is no acetic acid type dialysis solution, its ion concentration (unit: mmol/L) and pH value be:
Na +=136,138,140 or 144mmol/L,
K +=3.01,3.05,3.25,3.55,3.95,4.15,4.35 or 4.5mmol/L,
Ca ++=1.76,1.78,1.80,1.82 or 1.85mmol/L,
Mg ++=0.5,0.6,0.75,0.9 or 1.0mmol/L,
Cl -=105,107,109,110,112 or 115mmol/L,
CH 3COO -=2.0,3.0,4.0,5.0,6.0,7.0 or 8.0mmol/L,
HCO 3 -=30,31,32,33,35,37 or 39mmol/L,
pH=7.0~7.8。
Application example 1, application example 2, application example 3 employed airtight soft packaging bags, comprise soft bag 1 and mozzle 2, mozzle 2 is connected as a single entity with soft bag 1, the bottom that the upper end of mozzle 2 is stretched out outside the soft bag 1, the lower end extends to soft bag 1, the lower end of mozzle 2 is provided with flow-guiding mouth 21 and is communicated with the inner chamber of soft bag 1 by this flow-guiding mouth, the upper end of mozzle is provided with the union joint 22 that is communicated with the input pipe 31 of dialysis machine 3, and described union joint 22 is elasticity plece-cliped type structure or spiral syndeton.Soft bag 1 is an one compression moulding structure with mozzle 2, and 2 fens body formed backs of perhaps soft bag 1 and mozzle repress is made integrative-structure.
Soft bag 1 and mozzle 2 can be by non-toxic polyvinyl chloride PVC compression mouldings; Perhaps by non-toxic polyethylene PE compression moulding; Perhaps by nonpoisonous polypropylene PP compression moulding; Perhaps by nontoxic composite membrane compression moulding, this composite membrane can be to comprise PP TYPE, Tropical cooking film or paper aluminum-plastic composite membrane; Perhaps by nontoxic aluminium foil compression moulding.
Other embodiments:
The characteristics of other embodiments of the present utility model are: during use, the input of A liquid and B liquid and special-purpose dialysis machine is connected, A liquid and B liquid are mixed and form blood dialysis solution by special-purpose dialysis machine, this dialysis solution is no acetic acid type dialysis solution, its ion concentration (unit: mmol/L) and pH value be: potassium concentration K +=0~4.5mmol/L, Na ion concentration Na +=136~150mmol/L, pH=7.0~7.8.

Claims (10)

1. blood dialysis solution is characterized in that: comprise independent closed flexible package formula concentrated liquid A liquid and B liquid, be provided with the interface that is connected with dialysis machine in the flexible package of A liquid and B liquid; Concentrated liquid A liquid and B liquid spend water for dialysis by dialysis machine and the oozing of blood hemodialysis liquid such as are diluted in proportion; Described hemodialysis liquid such as oozing of blood such as grade is the acetic acid type dialysis solution, potassium concentration K +=0~2.99mmol/L or 3.01~4.5mmol/L, Na ion concentration Na +=136~144mmol/L or 146~150mmol/L; Perhaps waiting the oozing of blood hemodialysis liquid is no acetic acid type dialysis solution, potassium concentration K +=0~4.5mmol/L, Na ion concentration Na +=136~150mmol/L.
2. blood dialysis solution as claimed in claim 1 is characterized in that: A liquid is acid solution, is made by sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium acetate, glacial acetic acid or aminoacid and water for dialysis; B liquid is bicarbonate solution, is made or is made by sodium bicarbonate, sodium chloride and water for dialysis by sodium bicarbonate and water for dialysis; Through the ion concentration of the mixed blood dialysis solution of special-purpose dialysis machine (unit: mmol/L) and pH value be:
Na +=136~144mmol/L or 146~150mmol/L,
K +=0~2.99mmol/L or 3.01~4.5mmol/L,
Ca ++=1.25~1.74mmol/L or 1.76~1.85mmol/L,
Mg ++=0.5~1.0mmol/L,
Cl -=105~115mmol/L,
CH 3COO -=2.0~8.0mmol/L,
HCO 3 -=30~39mmol/L,
PH=7.0~7.8
3. blood dialysis solution as claimed in claim 1 is characterized in that: described water for dialysis is deionized water or distilled water.
4. blood dialysis solution enclosed soft package bag, it is characterized in that: comprise soft bag (1) and mozzle (2), mozzle (2) is connected as a single entity with soft bag (1), the bottom that soft bag (1) is outer, the lower end extends to soft bag (1) is stretched out in the upper end of mozzle (2), the lower end of mozzle (2) is provided with flow-guiding mouth (21) and is communicated with the inner chamber of soft bag (1) by this flow-guiding mouth, the upper end of mozzle is provided with the union joint (22) that is communicated with dialysis machine, and described union joint (22) is elasticity plece-cliped type structure or spiral syndeton.
5. blood dialysis solution enclosed soft package bag as claimed in claim 4 is characterized in that: soft bag (1) is an one compression moulding structure with mozzle (2), and perhaps soft bag (1) and mozzle (2) divide body formed back repress to make integrative-structure.
6. blood dialysis solution enclosed soft package bag as claimed in claim 4 is characterized in that: enclosed soft package bag is by non-toxic polyvinyl chloride PVC compression moulding.
7. blood dialysis solution enclosed soft package bag as claimed in claim 4 is characterized in that: enclosed soft package bag is by non-toxic polyethylene PE compression moulding.
8. blood dialysis solution enclosed soft package bag as claimed in claim 4 is characterized in that: enclosed soft package bag is by nonpoisonous polypropylene PP compression moulding.
9. blood dialysis solution enclosed soft package bag as claimed in claim 4 is characterized in that: enclosed soft package bag is by nontoxic composite membrane compression moulding, and this composite membrane can be to comprise PP TYPE, Tropical cooking film or paper aluminum-plastic composite membrane.
10. blood dialysis solution enclosed soft package bag as claimed in claim 4 is characterized in that: enclosed soft package bag is by nontoxic aluminium foil compression moulding.
CNA200710031790XA 2007-11-29 2007-11-29 Hemodialysis liquid as well as enclosed soft package bag thereof Pending CN101181649A (en)

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103394139A (en) * 2011-12-29 2013-11-20 富田制药株式会社 Preparation apparatus and preparation method for dialysis fluid of variable bicarbonate ion concentration type, dialysate, and dialysis system
CN103720708A (en) * 2012-10-10 2014-04-16 富田制药株式会社 Dialysis agent a containing acetic acid and acetate salt, and a two-part dialysis agent using thereof
CN106727678A (en) * 2016-12-14 2017-05-31 吉林省富生医疗器械有限公司 Haemodialysis A concentrates and its special self-supporting packaging bag
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
CN108992460A (en) * 2018-08-31 2018-12-14 山东威高药业股份有限公司 A kind of preparation process of haemodialysis concentration B liquid

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103394139A (en) * 2011-12-29 2013-11-20 富田制药株式会社 Preparation apparatus and preparation method for dialysis fluid of variable bicarbonate ion concentration type, dialysate, and dialysis system
CN103394139B (en) * 2011-12-29 2017-03-01 富田制药株式会社 The preparation facilitiess of the dialysis solution of bicarbonate ion concentration changeable type and preparation method, dialyzate fluid and dialysis system
CN103720708A (en) * 2012-10-10 2014-04-16 富田制药株式会社 Dialysis agent a containing acetic acid and acetate salt, and a two-part dialysis agent using thereof
CN103720708B (en) * 2012-10-10 2018-08-10 富田制药株式会社 Dialysis containing acetic acid and acetate A agent and the two dosage form dialysis agent for having used dialysis A agent
CN106727678A (en) * 2016-12-14 2017-05-31 吉林省富生医疗器械有限公司 Haemodialysis A concentrates and its special self-supporting packaging bag
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
CN108992460A (en) * 2018-08-31 2018-12-14 山东威高药业股份有限公司 A kind of preparation process of haemodialysis concentration B liquid

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