CN113049508B - Hemolytic test method for dialyzer hollow fiber - Google Patents
Hemolytic test method for dialyzer hollow fiber Download PDFInfo
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- CN113049508B CN113049508B CN202110263665.1A CN202110263665A CN113049508B CN 113049508 B CN113049508 B CN 113049508B CN 202110263665 A CN202110263665 A CN 202110263665A CN 113049508 B CN113049508 B CN 113049508B
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- 239000012510 hollow fiber Substances 0.000 title claims abstract description 73
- 238000010998 test method Methods 0.000 title claims abstract description 10
- 230000002949 hemolytic effect Effects 0.000 title abstract description 8
- 238000012360 testing method Methods 0.000 claims abstract description 48
- 206010018910 Haemolysis Diseases 0.000 claims abstract description 45
- 230000008588 hemolysis Effects 0.000 claims abstract description 45
- 210000003743 erythrocyte Anatomy 0.000 claims abstract description 44
- 230000003068 static effect Effects 0.000 claims abstract description 28
- 238000000034 method Methods 0.000 claims abstract description 25
- 239000000725 suspension Substances 0.000 claims abstract description 23
- 238000012216 screening Methods 0.000 claims abstract description 5
- 238000002386 leaching Methods 0.000 claims description 19
- 210000004369 blood Anatomy 0.000 claims description 17
- 239000008280 blood Substances 0.000 claims description 17
- 230000002035 prolonged effect Effects 0.000 claims description 14
- 241000283973 Oryctolagus cuniculus Species 0.000 claims description 12
- 239000002504 physiological saline solution Substances 0.000 claims description 9
- 238000002156 mixing Methods 0.000 claims description 7
- 238000002835 absorbance Methods 0.000 claims description 5
- 239000000243 solution Substances 0.000 claims description 5
- 239000006228 supernatant Substances 0.000 claims description 5
- 238000010008 shearing Methods 0.000 claims description 4
- 210000001367 artery Anatomy 0.000 claims description 3
- 239000001509 sodium citrate Substances 0.000 claims description 3
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 claims description 3
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 6
- 238000002791 soaking Methods 0.000 claims 2
- 238000005303 weighing Methods 0.000 claims 1
- 230000002411 adverse Effects 0.000 abstract description 23
- 238000001514 detection method Methods 0.000 abstract description 12
- 238000004519 manufacturing process Methods 0.000 abstract description 3
- 239000000463 material Substances 0.000 abstract description 3
- 238000003908 quality control method Methods 0.000 abstract description 3
- 238000012827 research and development Methods 0.000 abstract description 3
- 238000000502 dialysis Methods 0.000 description 10
- 239000006285 cell suspension Substances 0.000 description 5
- 239000013642 negative control Substances 0.000 description 5
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 5
- 238000006073 displacement reaction Methods 0.000 description 4
- 239000013641 positive control Substances 0.000 description 4
- 239000000126 substance Substances 0.000 description 4
- 239000012620 biological material Substances 0.000 description 2
- 230000015271 coagulation Effects 0.000 description 2
- 238000005345 coagulation Methods 0.000 description 2
- 238000001631 haemodialysis Methods 0.000 description 2
- 230000000322 hemodialysis Effects 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 238000002360 preparation method Methods 0.000 description 2
- 239000008354 sodium chloride injection Substances 0.000 description 2
- 238000011282 treatment Methods 0.000 description 2
- 208000037157 Azotemia Diseases 0.000 description 1
- 206010010071 Coma Diseases 0.000 description 1
- 240000007711 Peperomia pellucida Species 0.000 description 1
- 208000007536 Thrombosis Diseases 0.000 description 1
- 239000003153 chemical reaction reagent Substances 0.000 description 1
- 230000000295 complement effect Effects 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 239000008358 core component Substances 0.000 description 1
- 238000010790 dilution Methods 0.000 description 1
- 239000012895 dilution Substances 0.000 description 1
- 239000012153 distilled water Substances 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 230000036512 infertility Effects 0.000 description 1
- 238000011221 initial treatment Methods 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 239000008213 purified water Substances 0.000 description 1
- 239000002510 pyrogen Substances 0.000 description 1
- 238000012959 renal replacement therapy Methods 0.000 description 1
- 230000029058 respiratory gaseous exchange Effects 0.000 description 1
- 208000009852 uremia Diseases 0.000 description 1
- 238000012795 verification Methods 0.000 description 1
Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
- G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
- G01N21/31—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
- G01N1/286—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q involving mechanical work, e.g. chopping, disintegrating, compacting, homogenising
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
- G01N1/30—Staining; Impregnating ; Fixation; Dehydration; Multistep processes for preparing samples of tissue, cell or nucleic acid material and the like for analysis
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
- G01N1/38—Diluting, dispersing or mixing samples
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
- G01N1/286—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q involving mechanical work, e.g. chopping, disintegrating, compacting, homogenising
- G01N2001/2873—Cutting or cleaving
Abstract
The invention relates to a hemolytic test method for hollow fibers of a dialyzer, which can be used for screening dialyzers with adverse events. Current methods of dialyzer hollow fiber hemolysis do not in some cases screen out dialyzers that have adverse events. The invention increases the static contact time of the hollow fiber and the erythrocyte suspension on the basis of the current hemolysis method, and increases the dynamic contact of the hollow fiber and the erythrocyte suspension after the static contact. When the method is used for detection, the hemolysis rate of the hollow fibers of the dialyzer with adverse events is far greater than that of the hollow fibers of the dialyzer without adverse events, so the method can improve the reliability of judging whether the adverse events occur in the dialyzer by means of hemolysis tests. The method is applied to research and development of a new hollow fiber material, factory quality control of dialyzer production enterprises and preclinical detection of dialyzers of a supervision center, so that dialyzers with risks of adverse events can be reduced from entering the market, and the clinical application safety of dialyzers is improved.
Description
Technical Field
The invention relates to the technical field of safety evaluation of medical biomaterials, in particular to a hemolytic test method for hollow fibers of a dialyzer, which can be used for screening adverse events of the dialyzer and improving the use safety of the dialyzer.
Background
By 2020, about 300 million uremia patients in China exist. Hemodialysis is the primary treatment for uremic patients. Dialysis patients will be dialyzed 3 times a week on average, 4 hours per dialysis, and if no renal replacement therapy is performed, dialysis will continue for a lifetime. The dialyzer is a core component in hemodialysis, and the exchange of substances between blood and dialysate is completed through hollow fibers in the dialyzer, so that the treatment purpose is achieved. Because the blood and the hollow fiber are contacted repeatedly in a large area for a long time and throughout the life, the blood compatibility of the hollow fiber directly influences the life quality and the life time of dialysis patients. At present, the average life of dialysis patients in China is 5 years, and is only half of that of dialysis patients in developed countries.
For many years, the incidence of adverse events in clinical dialyzers has been quite high. More than 3000 dialyzer adverse events are reported by using institutions and operating institutions from early 2019 to middle 10 of 2020. Many dialyzers with serious adverse events (difficult breathing, dying feeling and even coma) in the same treatment unit in a short time usually have the intervention of a supervision department, and the dialyzers are sent to a detection institution for quality detection. The registration test of the dialyzer includes tests of mechanical properties, usability, sterility, pyrogen, biological tests and chemical properties. Such adverse events often occur in dialyzers, which are tested for safety, such as biological tests and chemical properties. The results found that the chemical properties and most of the biological tests were acceptable, and only the tests for platelets and the coagulation system in the blood compatibility test (only a few testing agencies developed such tests) were statistically different from the control product (the dialyzer which had been marketed without adverse events). Hemocompatibility includes coagulation, platelets, complement, hematology, thrombosis. Among all the hemocompatibility tests, only the hemolysis test is the most popular among the test facilities, and the method thereof is clear and has specific criteria (GB/T14233.2-2005), which is part of hematology. However, the results of the dialyzers with serious adverse events were all qualified by the conventional hemolytic test method. Therefore, there is an urgent need to improve the existing hemolysis test method in order to efficiently screen out high-risk dialyzers.
Disclosure of Invention
The invention aims to provide a dialyzer hollow fiber hemolysis test method capable of discriminating dialyzers with risks of adverse events so as to improve the use safety of the dialyzers.
The method for testing the hemolysis of the hollow fiber of the dialyzer comprises the following steps: the time of the static contact between the hollow fiber and the red blood cell suspension in the existing detection method is prolonged, and the dynamic contact is increased after the static contact is finished.
Wherein, the static contact means that: adding the erythrocyte suspension into the hollow fiber leaching liquor, standing, wherein the erythrocyte and the hollow fiber do not have relative displacement, and the hollow fiber leaching liquor can act on the erythrocyte;
the dynamic contact refers to: sliding the hollow fiber in the erythrocyte suspension to make the hollow fiber and the erythrocyte generate relative displacement, so as to break the fragile erythrocyte which is statically contacted with the hollow fiber leaching liquor for a period of time.
The existing detection method refers to a 7.6 test method in GB/T14233.2-2005, namely, 5g of test sample is added into each tube of a test sample group, and 10mL of sodium chloride injection is added; adding 10mL of sodium chloride injection into each tube of the negative control group; adding 10mL of distilled water into each tube of the positive control group, and operating 3 tubes in parallel in each group; placing all test tubes in a constant temperature water bath (37 + -1) deg.C, keeping the temperature for 30min, adding 0.2mL diluted rabbit blood into each test tube, mixing, and placing in a water bath (37 + -1) deg.C for continuously keeping the temperature for 60min; pouring out the liquid in the tube, and centrifuging for 5min at 800 g; absorbing the supernatant, transferring the supernatant into a cuvette, and measuring absorbance at 545nm by using a spectrophotometer; wherein, the red blood cell suspension and the leaching solution only statically contact for 60min after being continuously kept in a water bath at the temperature of 37 +/-1 ℃ for 60min;
specifically, the method for testing hemolysis of the hollow fiber of the dialyzer provided by the invention comprises the following steps: the static contact time of the hollow fiber leaching solution and the erythrocyte suspension is prolonged from 60min to 80-120min (preferably prolonged to 90-110min, more preferably prolonged to 100 min), dynamic contact is further carried out after the static contact,
wherein the dynamic contact is specifically as follows: the hollow fiber is slid 10-30 times (preferably 15-25 times, more preferably 20 times) in the erythrocyte suspension, wherein the sliding speed can be 2-6cm/s (preferably 2-4cm/s, more preferably 3 cm/s).
The application of the method for testing the hemolysis of the hollow fibers in the dialyzer in the screening of the dialyzer with the risk of adverse events also belongs to the protection scope of the invention.
The invention also provides a method for discriminating whether the dialyzer is at risk of hemolysis.
The method for discriminating whether the dialyzer has hemolysis risk provided by the invention comprises the following steps: taking out the hollow fiber of the dialyzer to be tested, shearing, leaching with physiological saline, adding erythrocyte suspension, uniformly mixing, standing, sliding the hollow fiber in the erythrocyte suspension, centrifuging, collecting supernatant, detecting absorbance value, calculating hemolysis rate, judging that the dialyzer to be tested has hemolysis risk if the hemolysis rate is more than 5%, and judging that the dialyzer to be tested has no hemolysis risk if the hemolysis rate is less than or equal to 5%.
In the above method, the erythrocyte suspension may be anticoagulated rabbit blood;
the standing time can be 80-120min,
the sliding can be carried out for 10-30 times, and the sliding speed is 2-6cm/s.
According to the invention, the static contact time is prolonged and the dynamic contact is further increased by improving the current hemolysis test, and compared with the existing detection method, the improved method can effectively screen out the high-risk dialyzer. Without further dynamic contact, the delicate red blood cells do not rupture if the red blood cell suspension is centrifuged directly after static contact. On the basis of increasing dynamic contact, after the static contact time is prolonged, the hemolysis rate of the hollow fiber of the dialyzer with an adverse event is far greater than that of the hollow fiber of the dialyzer without the adverse event, so that the reliability of judging whether the dialyzer has the adverse event or not by means of a hemolysis test can be improved. The method can be applied to research and development of novel hollow fiber materials of dialyzers, factory quality control of dialyzers manufacturing enterprises and clinical pre-detection of dialyzers of supervision centers, can reduce the possibility that dialyzers with adverse events occur risks flow into the market, improves the safety of clinical application of dialyzers, and further improves the living quality of dialysis patients and prolongs the life of dialysis patients.
Detailed Description
The present invention will be described below with reference to specific examples, but the present invention is not limited thereto.
The experimental methods used in the following examples are all conventional methods unless otherwise specified; reagents, biomaterials, etc. used in the following examples are commercially available unless otherwise specified.
The invention provides a hemolytic test method for hollow fibers of a dialyzer, which comprises the following steps: the time of the static contact of the hollow fiber and the erythrocyte suspension in the existing detection method is prolonged, and the dynamic contact is increased after the static contact is finished.
Wherein, the static contact means: adding the erythrocyte suspension into the hollow fiber leaching liquor, standing still, wherein no relative displacement exists between the erythrocytes and the hollow fiber, and the hollow fiber leaching liquor can act on the erythrocytes;
the dynamic contact refers to: sliding the hollow fiber in the erythrocyte suspension to make the hollow fiber and erythrocyte generate relative displacement, so as to break the fragile erythrocyte which is contacted with the hollow fiber leaching liquor for a period of time.
Specifically, the method for testing hemolysis of the hollow fiber of the dialyzer provided by the invention comprises the following operations: the static contact time of the hollow fiber leaching solution and the erythrocyte suspension is prolonged from 60min to 80-120min (preferably prolonged to 90-110min, more preferably prolonged to 100 min), dynamic contact is further carried out after the static contact,
wherein the dynamic contact is specifically as follows: the hollow fibers are slid 10-30 times (preferably 15-25 times, more preferably 20 times) in the suspension of red blood cells, wherein the sliding speed may be 2-6cm/s (preferably 2-4cm/s, more preferably 3 cm/s).
The application of the method for testing the hemolysis of the hollow fibers in the dialyzer in the screening of the dialyzer with the risk of adverse events also belongs to the protection scope of the invention.
According to the invention, the static contact time is prolonged and the dynamic contact is further increased by improving the current hemolysis test, and compared with the existing detection method, the improved method can effectively screen out the high-risk dialyzer. Without further dynamic contact, the erythrocyte suspension was centrifuged directly after the static contact, and the fragile erythrocytes were not disrupted. On the basis of increasing dynamic contact, after the static contact time is prolonged, the hemolysis rate of the hollow fiber of the dialyzer with an adverse event is far greater than that of the hollow fiber of the dialyzer without the adverse event, so that the reliability of judging whether the dialyzer has the adverse event or not by means of a hemolysis test can be improved. The method can be applied to research and development of novel hollow fiber materials of dialyzers, factory quality control of dialyzers production enterprises and clinical pre-detection of dialyzers in supervision centers, can reduce the possibility that the dialyzers with adverse events occur risks flow into the market, improves the safety of clinical application of the dialyzers, and further improves the life quality of dialysis patients and prolongs the life of the dialysis patients.
Example 1
Hemolysis test
Preparation of a test group and a control group
Test group: sawing the dialyzer, taking out the hollow fiber therein, and shearing to 1-2cm long. 0.5g was weighed into a wide-bottomed container, and 8.5mL of physiological saline was added (of which 3.5mL of physiological saline was used to wet the hollow fibers, and another 5mL of physiological saline was added as a leaching solution based on a leaching ratio of 0.1 g/mL). 3 parts are prepared.
Negative control group: the same wide-bottomed container was filled with 5mL of physiological saline as a negative control. 3 parts are prepared.
Positive control group: 5mL of purified water was added to the same wide-bottomed container as a positive control. 3 parts are prepared.
Preparation of two-dilution anticoagulated rabbit blood
Fresh blood was taken from rabbit ear artery and anticoagulated with 3.8% sodium citrate 1. And mixing the physiological saline and the anticoagulated rabbit blood according to the volume ratio of 5.
Contacting the three hollow fibers with diluted anticoagulated rabbit blood
1 standing the prepared test group and the control group at 37 ℃ for 30min.
2, respectively adding 100 mul of diluted anticoagulated rabbit blood into containers of the test group and the control group, lightly mixing, standing for 100min at 37 ℃, and sliding the hollow fiber of the test group back and forth in a wide-bottom container for 20 times by using a sample adding gun head or other instruments, wherein the sliding speed is about 3cm/s.
Four-detection absorbance value
1, sucking the liquid in the test group and each control group into a centrifuge tube, centrifuging for 5min at 800 g.
2 taking the supernatant, carrying out color comparison under the condition of 545nm wavelength, and measuring the absorbance value.
Calculation of the five hemolysis rates
Hemolysis rate (%) = (OD) of test sample Test article -OD Negative control )/(OD Positive control -OD Negative control )×100
Verification of the Effect of the invention
The following 4 tables are the results of 4 haemolysis tests on 5 dialyzers. Wherein the hemolysis test conditions of Table 1 are static contact of the hollow fiber with erythrocytes for 60min; the hemolysis test conditions of table 2 are static contact of the hollow fiber with red blood cells for 100min; the hemolysis test conditions in Table 3 are that the hollow fiber is statically contacted with the red blood cells for 60min and then dynamically contacted (the hollow fiber slides in the red blood cell suspension 20 times at a speed of about 3 cm/s); the hemolysis test conditions in Table 4 are that the hollow fiber is statically contacted with the red blood cells for 100min and then dynamically contacted (the hollow fiber is slid in the red blood cell suspension 20 times at a speed of about 3 cm/s).
TABLE 5 dialyzer hemolysis test results (60 min static contact)
TABLE 2 haemolysis test results for dialyzers (100 min static contact)
TABLE 3 hemolyzing test results of dialyzers (60 min static contact + dynamic contact)
TABLE 4 hemolyzing test results of dialyzers (100 min static contact + dynamic contact)
Of the 5 dialyzers, dialyzers numbered 1 and 2 were dialyzers in which adverse events had occurred in the clinic. As can be seen from the test results in tables 1 and 2, the damage of the hollow fibers of the dialyzer to erythrocytes caused by a bad event cannot be detected by a simple static contact, either for 60min or for 100min, which is specified in the current hemolysis standard. However, after increasing the dynamic contact, as shown by the hemolysis test results in tables 3, 4: two dialyzer hollow fibers with adverse events destroyed erythrocytes more than the other 3 dialyzer hollow fibers without adverse events. After the static contact time is prolonged to 100min and the dynamic contact is increased, the hemolysis rate of the two dialyzer hollow fibers with adverse events is much higher than that of the other 3 dialyzer hollow fibers without adverse events.
Claims (5)
1. A dialyzer hollow fiber hemolysis test method comprises the following steps: the static contact time of the hollow fiber leaching liquor and the erythrocyte suspension is prolonged from 60min to 80-120min, and dynamic contact is further carried out after the static contact; the dynamic contact is as follows: sliding the hollow fiber in the erythrocyte suspension for 10-30 times at the sliding speed of 2-6cm/s;
the hollow fiber leaching liquor is prepared by the following method: sawing the dialyzer, taking out the hollow fiber in the dialyzer, and shearing the dialyzer to be 1-2cm long; weighing 0.5g of the extract, placing the extract in a wide-bottom container, and adding 8.5mL of normal saline, wherein 3.5mL of normal saline is used for soaking the hollow fibers, and the other 5mL of normal saline is the added leaching liquor based on the leaching proportion of 0.1 g/mL;
the erythrocyte suspension is diluted anticoagulated rabbit blood and is prepared by the following method: fresh blood is taken from the ear artery of the rabbit for the test, and 3.8% sodium citrate 1; and (3) mixing the physiological saline and the anticoagulated rabbit blood according to the volume ratio of 5.
2. The method of claim 1, wherein: the hollow fiber slides in the erythrocyte suspension for 15-25 times at the sliding speed of 2-4cm/s.
3. The method of claim 2, wherein: the hollow fiber slides 20 times in the erythrocyte suspension at a speed of 3cm/s.
4. Use of the method of any one of claims 1 to 3 for the screening of dialyzers at risk of an adverse event.
5. A method for discriminating whether a dialyzer is at risk of hemolysis, comprising: taking out the hollow fiber of the dialyzer to be tested, shearing, leaching with physiological saline, adding erythrocyte suspension, mixing uniformly, standing, sliding the hollow fiber in the erythrocyte suspension, centrifuging, collecting supernatant, detecting absorbance value, calculating hemolysis rate, judging that the dialyzer to be tested has hemolysis risk if the hemolysis rate is more than 5%, and judging that the dialyzer to be tested has no hemolysis risk if the hemolysis rate is less than or equal to 5%;
the standing time is 80-120min,
the sliding is carried out for 10-30 times, and the sliding speed is 2-6cm/s;
adding 8.5mL of normal saline to 0.5g of the hollow fibers, wherein 3.5mL of normal saline is used for soaking the hollow fibers, and the other 5mL of normal saline is a leaching solution added based on a leaching ratio of 0.1 g/mL;
the erythrocyte suspension is diluted anticoagulated rabbit blood and is prepared by the following method: fresh blood is taken from the ear artery of the rabbit for the test, and 3.8% sodium citrate 1; and mixing the physiological saline and the anticoagulated rabbit blood according to the volume ratio of 5.
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| EP3205403A1 (en) * | 2016-02-09 | 2017-08-16 | Technische Universität München | Apparatus and method for dynamically testing of blood interaction properties of planar materials |
| CN109499389A (en) * | 2013-06-27 | 2019-03-22 | 曼·胡默尔有限公司 | Ceramic whole blood doughnut membrane filter media and its for from whole blood separated plasma/serum purposes |
| CN110743392A (en) * | 2019-11-08 | 2020-02-04 | 杭州师范大学 | PVDF hollow fiber membrane material with anticoagulation property for hemodialysis and preparation method thereof |
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2021
- 2021-03-11 CN CN202110263665.1A patent/CN113049508B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109499389A (en) * | 2013-06-27 | 2019-03-22 | 曼·胡默尔有限公司 | Ceramic whole blood doughnut membrane filter media and its for from whole blood separated plasma/serum purposes |
| EP3205403A1 (en) * | 2016-02-09 | 2017-08-16 | Technische Universität München | Apparatus and method for dynamically testing of blood interaction properties of planar materials |
| CN110743392A (en) * | 2019-11-08 | 2020-02-04 | 杭州师范大学 | PVDF hollow fiber membrane material with anticoagulation property for hemodialysis and preparation method thereof |
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| Title |
|---|
| 冠脉支架***的血液相容性测试;许建霞等;《中国药事》;20200820(第08期);940-948 * |
| 医疗器械溶血性能三种评价方法的比较;乔春霞等;《中国医疗器械信息》;20130725(第07期);61-65 * |
| 生物材料不同接触方式和条件对溶血作用影响的研究;孙皎等;《生物医学工程学杂志》;20030325(第01期);12-14 * |
| 许建霞等.冠脉支架***的血液相容性测试.《中国药事》.2020,(第08期), * |
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