CN106092848B - Dialyzer ultrafiltration performance test fluid - Google Patents

Dialyzer ultrafiltration performance test fluid Download PDF

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Publication number
CN106092848B
CN106092848B CN201610163783.4A CN201610163783A CN106092848B CN 106092848 B CN106092848 B CN 106092848B CN 201610163783 A CN201610163783 A CN 201610163783A CN 106092848 B CN106092848 B CN 106092848B
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test fluid
parts
dialyzer
albumin
ultrafiltration performance
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CN106092848A (en
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牟倡骏
曲佳伟
于亚楠
钟霜霜
李焕钊
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Shandong Weigao Blood Purification Products Co Ltd
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Weihai Weigao Blood Purified Product Co Ltd
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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N15/00Investigating characteristics of particles; Investigating permeability, pore-volume or surface-area of porous materials
    • G01N15/08Investigating permeability, pore-volume, or surface area of porous materials
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N15/00Investigating characteristics of particles; Investigating permeability, pore-volume or surface-area of porous materials
    • G01N15/08Investigating permeability, pore-volume, or surface area of porous materials
    • G01N2015/086Investigating permeability, pore-volume, or surface area of porous materials of films, membranes or pellicules

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  • Chemical & Material Sciences (AREA)
  • Dispersion Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
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  • Pathology (AREA)
  • External Artificial Organs (AREA)
  • Separation Using Semi-Permeable Membranes (AREA)

Abstract

A kind of dialyzer ultrafiltration performance test fluid, is related to haemodialyser testing field, is mixed by the raw material comprising following proportion by weight:1000 parts of physiological saline, 19 parts of albumin, 30 80 parts of glucide;The viscosity of test fluid is 2~6 millipascal seconds.Inventive formulation is simple, simple for production, and performance is stable, of low cost, and test data precision is high, is starched instead of ox blood of the prior art.

Description

Dialyzer ultrafiltration performance test fluid
Technical field
The present invention relates to haemodialyser testing fields, and it is that one kind can substitute ox blood slurry, be formulated simple, making to elaborate Simplicity, performance is stable, of low cost, the high dialyzer ultrafiltration performance test fluid of test data precision.
Background technology
Ultrafiltration rate is one of performance of hollow fiber dialyzer, the main water-scavenging capability for reflecting hollow fiber dialyzer, It is the important performance indexes for evaluating hollow fiber dialyzer.In external performance evaluation, the prior art is to starch to test using ox blood The ultrafiltration rate of hollow fiber dialyzer.With the production-scale continuous expansion of China's dialyzer, also exist to the demand of ox blood slurry It is continuously increased.But ox blood slurry in use there is it is many problem of, for example, ox blood slurry quality influenced by Niu Zishen It is bigger, the particularity of having differences property, blood plasma itself between different batches blood plasma, can not multigelation use, can only be primary Property use, blood plasma for a long time exposure in air and and dialyzer membrane material it can all be generated certain influence and then Interference is generated to test result, the accurate data degree of test is low.In addition, due to the limitation in ox blood slurry source, the cost of ox blood slurry Compare high, according to the quotation of largest domestic ox blood slurry manufacturing enterprise Guangzhou stamen spy, the market quotes that every liter of ox blood is starched is up to 1000 yuan Left and right.And ox blood is starched inevitably there are Carried bacteria and the risk of virus during production and use, and It is also relative complex in the processing of ox blood slurry after use.
Invention content
The present invention provides the test fluids that a kind of alternative ox plasma solutions carry out ultrafiltration rate test, it is intended to solve above-mentioned ox The deficiency of blood plasma in use.Testing cost can be reduced by carrying out the evaluation of ultrafiltration rate using solution provided by the invention, be ensured Measuring accuracy, while also avoid pollution of the discharge of ox blood slurry to environment.
The test fluid that the invention provides is suitable for field of blood purification small throughput, low pass efficient, high throughput, ultra-high throughput etc. The performance evaluation of hemodialysis membrane.
Technical solution is used by the present invention solves above-mentioned the deficiencies in the prior art:
A kind of dialyzer ultrafiltration performance test fluid, it is characterised in that:It is mixed by the raw material comprising following proportion by weight It is made:1000 parts of physiological saline, 1-9 parts of albumin, 30-80 parts of glucide.
Raw material preferred mass part of heretofore described dialyzer ultrafiltration performance test fluid matches:Physiological saline 1000 Part, 2-5 parts of albumin, 40-60 parts of glucide.
The viscosity of heretofore described dialyzer ultrafiltration performance test fluid is 2~6 millipascal seconds;Preferably 2.5-5.5 millis Pa/second.
Heretofore described glucide is at least one of glucan, hydroxyethyl starch.
Heretofore described albumin is bovine serum albumin(BSA), human serum albumins, in porcine serum albumin at least It is a kind of.
Preparation method is:Physiological saline, glucide and albumin are weighed by proportion by weight, by glucide and in vain Albumen and physiological saline are put into container, are stirred evenly, until dissolving to get finished product.
Dialyzer ultrafiltration performance test fluid finished product produced by the present invention needs matching while using, prepares the finished product of completion in room temperature Under used in best 6 hours, be otherwise affected to test result, test errors or failure even occur.
In the use of the present invention, test the super of hollow fiber dialyzer according to the method for 5.6.3.2 in ISO8637-2010 Filter performance.
Compared with prior art, technical advantage of the invention is:
(1)Data stabilization.Due to using only commercialized albumin, carbohydrate and physiological saline in solution process for preparation, Ingredient is simple for the composition of ox blood slurry, ratio is precisely controllable, and performance is stable, the influence to test result is small, surveys The accurate data degree obtained is high.
(2)It is of low cost.The price of one liter of ox blood slurry is at 1000 yuan or so, and price prepared by the present invention is only 150 yuan Left and right, it is of low cost.
(3)Environmental protection.Inevitably there are Carried bacteria and the wind of virus during production and use for ox blood slurry Danger, and it is also relative complex in the processing of ox blood slurry after use;The present invention overcomes ox bloods to starch these shortcomings.
Description of the drawings
Fig. 1 is the polyether sulfone product for selecting company A in the market, is used according to the method for 5.6.3.2 in ISO8637-2010 The test fluid that ox blood is starched and prepared by embodiment 1 carries out the result table of comparisons that the test of ultrafiltration rate performance obtains;
Fig. 2 is the polyether sulfone product for selecting company A in the market, is used according to the method for 5.6.3.2 in ISO8637-2010 The test fluid that ox blood is starched and prepared by embodiment 2 carries out the result table of comparisons that the test of ultrafiltration rate performance obtains;
Fig. 3 is the polysulfones product for selecting B companies in the market, and ox is used according to the method for 5.6.3.2 in ISO8637-2010 Test fluid prepared by blood plasma and embodiment 3 carries out the result table of comparisons that the test of ultrafiltration rate performance obtains;
Fig. 4 is the polysulfones product for selecting C companies in the market, and ox is used according to the method for 5.6.3.2 in ISO8637-2010 Test fluid prepared by blood plasma and embodiment 4 carries out the result table of comparisons that the test of ultrafiltration rate performance obtains.
Specific embodiment
A kind of dialyzer ultrafiltration performance test fluid, it is characterised in that:It is mixed by the raw material comprising following proportion by weight It is made:40-60 parts of 1000 parts of physiological saline, 2-5 parts of bovine serum albumin(BSA), glucan and hydroxyethyl starch;Dialyzer obtained The viscosity of ultrafiltration performance test fluid is 4-5.5 millipascal seconds.
Preparation method is:Physiological saline, hydroxyethyl starch and bovine serum albumin(BSA) are weighed by proportion by weight, by hydroxyl second Base starch and bovine serum albumin(BSA) are put into physiological saline, are stirred evenly, until dissolving to get finished product.It dialyses to hollow fibre When device is tested, its ultrafiltration performance is tested according to the method for 5.6.3.2 in ISO8637-2010.
The measure of existing three kinds of haemodialysers progress ultrafiltration performance on the market is selected below, compares ox blood slurry ultrafiltration rate With the consistency for substituting solution ultrafiltration rate data.
Embodiment one
30 parts of glucans and 8 parts of porcine serum albumin are weighed by proportion by weight, are dissolved in 1000 parts of physiological saline In, stirring is until be completely dissolved;The polyether sulfone product of company A in the market is selected, according to the side of 5.6.3.2 in ISO8637-2010 The test that method carries out ultrafiltration rate performance obtains that the results are shown in Table 1.
The product ultrafiltration performance contrast table of 1 company A of table
Embodiment two
40 parts of hydroxyethyl starch and 5 parts of bovine serum albumin(BSA)s are weighed by proportion by weight, are dissolved in 1000 parts of physiology In brine, stirring is until be completely dissolved;The polyether sulfone product of company A in the market is selected, according to 5.6.3.2 in ISO8637-2010 Method carry out the test of ultrafiltration rate performance and obtain that the results are shown in Table 2.
The product ultrafiltration performance contrast table of 2 company A of table
Embodiment three
60 parts of glucans, 3 parts of bovine serum albumin(BSA)s are weighed by proportion by weight, are dissolved in 1000 parts of physiological saline In, stirring is until be completely dissolved;The polysulfones product of B companies in the market is selected, according to the method for 5.6.3.2 in ISO8637-2010 The test for carrying out ultrafiltration rate performance obtains that the results are shown in Table 3.
The product ultrafiltration performance contrast table of 3 B companies of table
Example IV
40 parts of glucans, 40 parts of hydroxyethyl starch, 1 part of bovine serum albumin(BSA) and 1 part of Swine serum are weighed by proportion by weight Albumin is dissolved in 1000 parts of physiological saline, and stirring is until be completely dissolved;The polysulfones product of C companies in the market is selected, The test that method according to 5.6.3.2 in ISO8637-2010 carries out ultrafiltration rate performance obtains that the results are shown in Table 4.
The product ultrafiltration performance contrast table of 4 C companies of table
Analyzing above-mentioned experimental data can obtain, and the hollow fiber dialyzer ultrafiltration rate experimental data measured using the present invention is with making The ultrafiltration rate experimental data of like products measured with ox blood slurry differs very little, in the range of data error permission.Therefore, originally Invention can replace ox blood slurry to test dialyzer ultrafiltration performance completely, and simple, simple for production with being formulated, and performance is steady It is fixed, of low cost, the advantages that test data precision is high.

Claims (5)

1. a kind of dialyzer ultrafiltration performance test fluid, it is characterised in that:It mixes system by the raw material comprising following proportion by weight Into:1000 parts of physiological saline, 1-9 parts of albumin, 30-80 parts of glucide;The glucide is glucan, ethoxy forms sediment At least one of powder.
2. dialyzer ultrafiltration performance test fluid according to claim 1, it is characterised in that the albumin is cow's serum At least one of albumin, human serum albumins, porcine serum albumin.
3. dialyzer ultrafiltration performance test fluid according to claim 2, it is characterised in that:The dialyzer ultrafiltration performance The viscosity of test fluid is 2~6 millipascal seconds.
4. dialyzer ultrafiltration performance test fluid according to claim 3, it is characterised in that:The dialyzer ultrafiltration performance The viscosity of test fluid is preferably 2.5-5.5 millipascal seconds.
5. the preparation method of dialyzer ultrafiltration performance test fluid according to claim 1, it is characterised in that:Match by mass parts Than weighing physiological saline, carbohydrate and albumin, carbohydrate and albumin are put into physiological saline, stirred evenly, until dissolving, i.e., Obtain finished product.
CN201610163783.4A 2016-03-22 2016-03-22 Dialyzer ultrafiltration performance test fluid Active CN106092848B (en)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107153037B (en) * 2017-05-17 2019-11-26 自然资源部天津海水淡化与综合利用研究所 A kind of ultrafiltration membrane rejection detection method based on narrow ditribution chitosan
CN108645597A (en) * 2018-05-30 2018-10-12 威海威高血液净化制品有限公司 dialyzer pressure drop performance test liquid
CN108760233A (en) * 2018-05-30 2018-11-06 威海威高血液净化制品有限公司 dialyzer pressure drop performance test liquid

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1127476A (en) * 1993-06-04 1996-07-24 生物时间公司 Plasma-like solution
US5589197A (en) * 1993-10-04 1996-12-31 Baxter International, Inc. Low sodium peritoneal dialysis solution
CN101991595A (en) * 2009-08-26 2011-03-30 温州医学院 Plasma substitute and preparation method thereof
CN102065926A (en) * 2008-02-04 2011-05-18 纽约市哥伦比亚大学理事会 Fluid separation devices, systems and methods
JP2013031835A (en) * 2011-07-01 2013-02-14 Japan Organo Co Ltd Method of evaluating filter
CN103418249A (en) * 2012-10-31 2013-12-04 上海理工大学 Ultrafiltration rate measurement device of hollow fiber hemodialyzer

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1127476A (en) * 1993-06-04 1996-07-24 生物时间公司 Plasma-like solution
US5589197A (en) * 1993-10-04 1996-12-31 Baxter International, Inc. Low sodium peritoneal dialysis solution
CN102065926A (en) * 2008-02-04 2011-05-18 纽约市哥伦比亚大学理事会 Fluid separation devices, systems and methods
CN101991595A (en) * 2009-08-26 2011-03-30 温州医学院 Plasma substitute and preparation method thereof
JP2013031835A (en) * 2011-07-01 2013-02-14 Japan Organo Co Ltd Method of evaluating filter
CN103418249A (en) * 2012-10-31 2013-12-04 上海理工大学 Ultrafiltration rate measurement device of hollow fiber hemodialyzer

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Address after: No.20, Xingshan Road, Weihai Torch hi tech Industrial Development Zone, Weihai City, Shandong Province, 264210

Patentee after: Shandong Weigao blood purification products Co.,Ltd.

Address before: 264200 Weigao Industrial Park, No.20 Xingshan Road, chucun Town, torch hi tech Development Zone, Weihai City, Shandong Province

Patentee before: WEIHAI WEIGAO BLOOD PURIFICATION PRODUCTS Co.,Ltd.

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