CN109307770B - Blood sugar calibration solution preparation method - Google Patents
Blood sugar calibration solution preparation method Download PDFInfo
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- CN109307770B CN109307770B CN201710630219.3A CN201710630219A CN109307770B CN 109307770 B CN109307770 B CN 109307770B CN 201710630219 A CN201710630219 A CN 201710630219A CN 109307770 B CN109307770 B CN 109307770B
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- 239000012482 calibration solution Substances 0.000 title claims abstract description 39
- 239000008280 blood Substances 0.000 title claims abstract description 32
- 210000004369 blood Anatomy 0.000 title claims abstract description 32
- 238000002360 preparation method Methods 0.000 title claims abstract description 11
- 239000003085 diluting agent Substances 0.000 claims abstract description 37
- 238000003756 stirring Methods 0.000 claims abstract description 33
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims abstract description 31
- 229960001031 glucose Drugs 0.000 claims abstract description 31
- 239000008363 phosphate buffer Substances 0.000 claims abstract description 28
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 12
- QYYMDNHUJFIDDQ-UHFFFAOYSA-N 5-chloro-2-methyl-1,2-thiazol-3-one;2-methyl-1,2-thiazol-3-one Chemical compound CN1SC=CC1=O.CN1SC(Cl)=CC1=O QYYMDNHUJFIDDQ-UHFFFAOYSA-N 0.000 claims abstract description 11
- VWDWKYIASSYTQR-UHFFFAOYSA-N sodium nitrate Chemical compound [Na+].[O-][N+]([O-])=O VWDWKYIASSYTQR-UHFFFAOYSA-N 0.000 claims abstract description 10
- 239000002904 solvent Substances 0.000 claims abstract description 10
- RHCSKNNOAZULRK-APZFVMQVSA-N 2,2-dideuterio-2-(3,4,5-trimethoxyphenyl)ethanamine Chemical compound NCC([2H])([2H])C1=CC(OC)=C(OC)C(OC)=C1 RHCSKNNOAZULRK-APZFVMQVSA-N 0.000 claims abstract description 9
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 claims abstract description 9
- 239000012153 distilled water Substances 0.000 claims abstract description 7
- 238000011049 filling Methods 0.000 claims abstract description 7
- 229910021642 ultra pure water Inorganic materials 0.000 claims abstract description 7
- 239000012498 ultrapure water Substances 0.000 claims abstract description 7
- 229910000402 monopotassium phosphate Inorganic materials 0.000 claims abstract description 5
- 235000019796 monopotassium phosphate Nutrition 0.000 claims abstract description 5
- 235000010344 sodium nitrate Nutrition 0.000 claims abstract description 5
- ZGTMUACCHSMWAC-UHFFFAOYSA-L EDTA disodium salt (anhydrous) Chemical compound [Na+].[Na+].OC(=O)CN(CC([O-])=O)CCN(CC(O)=O)CC([O-])=O ZGTMUACCHSMWAC-UHFFFAOYSA-L 0.000 claims abstract description 4
- KDQPSPMLNJTZAL-UHFFFAOYSA-L disodium hydrogenphosphate dihydrate Chemical compound O.O.[Na+].[Na+].OP([O-])([O-])=O KDQPSPMLNJTZAL-UHFFFAOYSA-L 0.000 claims abstract description 4
- 239000001103 potassium chloride Substances 0.000 claims abstract description 4
- 235000011164 potassium chloride Nutrition 0.000 claims abstract description 4
- 239000004317 sodium nitrate Substances 0.000 claims abstract description 4
- PJNZPQUBCPKICU-UHFFFAOYSA-N phosphoric acid;potassium Chemical compound [K].OP(O)(O)=O PJNZPQUBCPKICU-UHFFFAOYSA-N 0.000 claims abstract description 3
- 239000000243 solution Substances 0.000 claims description 36
- 238000012360 testing method Methods 0.000 claims description 29
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims description 14
- 239000008103 glucose Substances 0.000 claims description 14
- 239000000126 substance Substances 0.000 claims description 12
- 238000000034 method Methods 0.000 claims description 11
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 claims description 8
- 230000000844 anti-bacterial effect Effects 0.000 claims description 7
- 239000003899 bactericide agent Substances 0.000 claims description 7
- 239000011259 mixed solution Substances 0.000 claims description 7
- 238000012795 verification Methods 0.000 claims description 7
- 238000001914 filtration Methods 0.000 claims description 6
- 238000001556 precipitation Methods 0.000 claims description 6
- 238000005070 sampling Methods 0.000 claims description 6
- 229910019142 PO4 Inorganic materials 0.000 claims description 4
- 238000004090 dissolution Methods 0.000 claims description 4
- 239000004310 lactic acid Substances 0.000 claims description 4
- 235000014655 lactic acid Nutrition 0.000 claims description 4
- JPMIIZHYYWMHDT-UHFFFAOYSA-N octhilinone Chemical compound CCCCCCCCN1SC=CC1=O JPMIIZHYYWMHDT-UHFFFAOYSA-N 0.000 claims description 4
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims description 4
- 239000010452 phosphate Substances 0.000 claims description 4
- 229920006221 acetate fiber Polymers 0.000 claims description 3
- 239000012528 membrane Substances 0.000 claims description 3
- LOKCTEFSRHRXRJ-UHFFFAOYSA-I dipotassium trisodium dihydrogen phosphate hydrogen phosphate dichloride Chemical compound P(=O)(O)(O)[O-].[K+].P(=O)(O)([O-])[O-].[Na+].[Na+].[Cl-].[K+].[Cl-].[Na+] LOKCTEFSRHRXRJ-UHFFFAOYSA-I 0.000 claims description 2
- 239000002953 phosphate buffered saline Substances 0.000 claims description 2
- 239000003153 chemical reaction reagent Substances 0.000 abstract description 8
- 239000006260 foam Substances 0.000 abstract description 4
- 230000000694 effects Effects 0.000 abstract description 3
- 238000012123 point-of-care testing Methods 0.000 abstract description 3
- 239000000203 mixture Substances 0.000 abstract description 2
- 239000000654 additive Substances 0.000 description 9
- 230000000996 additive effect Effects 0.000 description 9
- 238000007865 diluting Methods 0.000 description 5
- 230000001954 sterilising effect Effects 0.000 description 4
- 238000001514 detection method Methods 0.000 description 3
- 238000000338 in vitro Methods 0.000 description 3
- 239000007788 liquid Substances 0.000 description 3
- 239000012530 fluid Substances 0.000 description 2
- 238000009776 industrial production Methods 0.000 description 2
- 238000002347 injection Methods 0.000 description 2
- 239000007924 injection Substances 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- GNSKLFRGEWLPPA-UHFFFAOYSA-M potassium dihydrogen phosphate Chemical compound [K+].OP(O)([O-])=O GNSKLFRGEWLPPA-UHFFFAOYSA-M 0.000 description 2
- ZDWSNKPLZUXBPE-UHFFFAOYSA-N 3,5-ditert-butylphenol Chemical compound CC(C)(C)C1=CC(O)=CC(C(C)(C)C)=C1 ZDWSNKPLZUXBPE-UHFFFAOYSA-N 0.000 description 1
- 206010067484 Adverse reaction Diseases 0.000 description 1
- 239000007836 KH2PO4 Substances 0.000 description 1
- 235000008331 Pinus X rigitaeda Nutrition 0.000 description 1
- 235000011613 Pinus brutia Nutrition 0.000 description 1
- 241000018646 Pinus brutia Species 0.000 description 1
- 230000006838 adverse reaction Effects 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 239000000872 buffer Substances 0.000 description 1
- 239000013064 chemical raw material Substances 0.000 description 1
- 238000004140 cleaning Methods 0.000 description 1
- 239000012141 concentrate Substances 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- XLYOFNOQVPJJNP-ZSJDYOACSA-N heavy water Substances [2H]O[2H] XLYOFNOQVPJJNP-ZSJDYOACSA-N 0.000 description 1
- MGIYRDNGCNKGJU-UHFFFAOYSA-N isothiazolinone Chemical compound O=C1C=CSN1 MGIYRDNGCNKGJU-UHFFFAOYSA-N 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 231100000053 low toxicity Toxicity 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 244000005700 microbiome Species 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 125000000963 oxybis(methylene) group Chemical group [H]C([H])(*)OC([H])([H])* 0.000 description 1
- LWIHDJKSTIGBAC-UHFFFAOYSA-K potassium phosphate Substances [K+].[K+].[K+].[O-]P([O-])([O-])=O LWIHDJKSTIGBAC-UHFFFAOYSA-K 0.000 description 1
- 238000003825 pressing Methods 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- 238000005063 solubilization Methods 0.000 description 1
- 230000007928 solubilization Effects 0.000 description 1
- 238000004659 sterilization and disinfection Methods 0.000 description 1
- 230000000007 visual effect Effects 0.000 description 1
- 238000005303 weighing Methods 0.000 description 1
Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/66—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood sugars, e.g. galactose
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Hematology (AREA)
- Molecular Biology (AREA)
- Urology & Nephrology (AREA)
- Biomedical Technology (AREA)
- Chemical & Material Sciences (AREA)
- Immunology (AREA)
- Food Science & Technology (AREA)
- Diabetes (AREA)
- Microbiology (AREA)
- Cell Biology (AREA)
- Biotechnology (AREA)
- Medicinal Chemistry (AREA)
- Physics & Mathematics (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- General Physics & Mathematics (AREA)
- Pathology (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Abstract
The invention provides a preparation method of blood sugar calibration solution, which comprises the following steps: filling 3L of phosphate buffer diluent into a 5L measuring cup, placing the measuring cup on a magnetic stirrer, and enabling a stirring rotor to rotate at a constant speed, wherein the phosphate buffer diluent comprises: 0.055% of potassium dihydrogen phosphate, 0.237% -0.238% of disodium hydrogen phosphate dihydrate, 0.15% of potassium chloride, 0.019% -0.020% of sodium nitrate, 0.038% -0.040% of disodium edetate dihydrate, 0.005% -0.0055% of TritonX-100 and 0.05% -0.06% of Kathon WT, and distilled water or ultrapure water is used as a solvent; (2) then slowly adding 45.04-45.10 g of beta-D (+) anhydrous glucose into a 5000ml measuring cup, and continuously stirring the mixture on a magnetic stirrer for about 30 min. The preparation method provided by the invention can not generate a large amount of foam, can be used for calibrating POCT glucometers of various brands, has a good calibration effect, and simultaneously saves the use cost of the total reagent.
Description
Technical Field
The invention relates to the field of in-vitro diagnostic reagents for medical instruments.
Background
The 5.0mmol/L blood sugar calibration solution is the most widely used calibration solution in biochemical research, the main components of the calibration solution are anhydrous glucose, Na2HPO4.2H2O, KH2PO4, NaNO3, KCL, K40 bactericides and the like, the balance is ultrapure water, the calibration solution is used as a 12mmol/L calibration solution used as an in vitro diagnostic reagent, the researched technical indexes mainly relate to accuracy and precision, according to related technologies, the calibration solution with the accuracy of +/-10 percent and the precision of not more than 2.00 percent is found to be suitable for POCT blood sugar analyzers in various styles on the market, and the test effect is better than that of reagents matched with some blood sugar analyzers.
A5.0 mmol/L blood glucose calibration solution of a glucometer on the market generally adopts a solvent as injection water as the solvent, the pH value of the injection water is 5.0-7.0, and the conductivity is 1.3us/cm, the calibration solution produced by the method has more clinical adverse reactions and poor stability due to larger conductivity, and the technical index of the water quality used by the prepared calibration solution is 6.0-7.0, the water quality is closer to neutrality, and the conductivity is 0.65us/cm, so that the influence of microorganisms on the quality of the calibration solution is avoided. Meanwhile, the whole blood calibrator on the market is preserved at 2-8 ℃ for a limited period of 6 months, and can be preserved at 2-8 ℃ for a stable week after being opened, but 5 times of Kathon wt is contained in the diluent used by the prepared calibrator, so that the possibility of long-term stability of the calibrator is ensured, the whole blood calibrator is preserved at 2-8 ℃ for a valid period of 9 months in a sealed manner, and is preserved at 2-8 ℃ for a stable month after being opened, which is longer than the valid period of a common calibrator, so that the result of testing blood on an instrument is quite optimistic.
The technical index accuracy of the calibration solution prepared by the method is +/-5%, the precision is less than or equal to 1.5%, the calibration solution is not easily influenced by the air environment during instrument detection, and the detection result is more accurate and reliable, so that the calibration solution required by testing of some full-automatic blood glucose/lactic acid analyzers in the market can be obtained through a large amount of experimental verification data on the addition amount of each chemical raw material in the concentrated solution.
Disclosure of Invention
The invention provides a preparation method of blood sugar calibration solution, which comprises the following steps:
(1) putting 3000ml of phosphate buffered diluent into a 5000ml measuring cup, placing the measuring cup on a magnetic stirrer, and enabling a stirring rotor to rotate at a constant speed, wherein the phosphate buffered diluent comprises: 0.055% of monopotassium phosphate, 0.237% -0.238% of disodium hydrogen phosphate dihydrate, 0.15% of potassium chloride, 0.019% -0.020% of sodium nitrate, 0.038% -0.040% of disodium edetate dihydrate, 0.005% -0.0055% of TritonX-100 and 0.05% -0.06% of Kathon WT, and distilled water or ultrapure water is used as a solvent; wherein TritonX-100 is triton-100, and the molecular formula is as follows: (C14H22O (C2H4O) n) which mainly plays a role of solubilization in the mixed solution, Kathon WT (Kathon pine) is a high-efficiency and low-toxicity bactericide, and the main component of the bactericide is a mixture consisting of isothiazolinone,
(2) slowly adding 45.04-45.10 g of beta-D (+) anhydrous glucose into a 5000ml measuring cup, and continuously stirring for about 30min on a magnetic stirrer;
(3) after the chemicals are completely dissolved, adding phosphate buffer diluent into a 5L measuring cup to the scale mark;
(4) transferring 500ml of the mixed solution into a new 5L measuring cup, adding phosphate buffer diluent to the position of a 5L scale mark, continuously stirring on a magnetic stirrer for 30min, and standing for 30 min;
(5) dissolving uniformly to obtain a solution before filling, putting a 0.22um acetate fiber filter membrane soaked in triple distilled water into a filter, and filtering for three times to obtain the required calibration solution;
(6) if the solution is clear and transparent, sampling and detecting, continuously making three batches, starting to test the accuracy of the solution, and if precipitation and turbidity phenomena exist, removing the solution and reconfiguring;
(7) after the test is qualified, the 5.00mmol/L calibration solution is used for on-machine verification test, and a glucose/lactic acid analyzer and a blood glucose analyzer are used for performing calibration test on a blood sample and comparing the blood sample with a standard calibrator and performing clinical verification on consistency.
Preferably, 60% of the volume of solvent is pre-dissolved prior to dissolving the phosphate buffered saline.
Preferably, in the step (2), 45.04g to 45.10g of beta-D (+) anhydrous glucose is weighed and poured into a 5L measuring cup which is pre-filled with 3000ml of phosphate buffer diluent containing 5 times of Kathon wt bactericide, the stirring is continuously carried out for about 30min, and then the phosphate buffer diluent is added to the 5L scale mark.
The configuration method provided by the invention has the following advantages:
1. a large amount of foam is not generated in the preparation process;
2. the preparation process of the 12mmol/L calibration solution is simple to operate, the efficiency is greatly improved, and the accuracy and the precision of the calibration solution are easy to control;
3. the repeatability is within +/-1%;
4. the calibration solution of 12mmol/L has good stability and is not easily influenced by air;
5. the calibration method can be used for calibrating POCT glucometers of various brands, has good calibration effect, and saves the use cost of the total reagent.
Detailed Description
The technical solution of the present invention is further explained by the following embodiments. It is to be understood that the specific embodiments described herein are merely illustrative of the invention and are not to be construed as limiting the invention. It should be further noted that, for the convenience of description, only some but not all of the relevant aspects of the present invention are shown in the specific embodiments.
The phase targets of the invention:
designing a technical formula of a diluent containing 5 times of Kathon WT bactericide in the first stage;
preparing 12mmol/L blood sugar calibration solution at the second stage;
establishing a mature process flow according to the formula;
in the fourth stage, the blood glucose meter and other instruments are used for accuracy test, precision test, repeated test and clinical calibration consistency test, and the blood glucose meter and other instruments are put into production formally.
The final purpose is as follows: a method for preparing 5.00mmol/L blood sugar calibration solution for detecting a whole blood sample.
1. The concentrates studied by the invention have the following accessories:
(1) analytical balance (0.0001g)
(1) A magnetic stirrer;
(2) a digital temperature controller;
(3) a pH meter;
(4) a conductivity meter;
(5) a 5L large measuring cup;
(6) the prepared phosphate buffer diluent is placed in a small 100ml beaker;
(7) after the PH meter and the conductivity meter are calibrated, inserting electrodes of the PH meter and the conductivity meter into the solution;
(8) pressing the 'reading' buttons of the PH meter and the conductivity meter respectively;
(9) waiting for 1min-2min, and recording the reading on the PH meter and the reading on the conductivity;
(10) preparing 50 mmol/L10-fold blood glucose calibration with the prepared buffer diluent
Diluting the solution by 10 times again to obtain 5.00mmol/L calibration solution to obtain sample,
and carrying out technical comparison and clinical test analysis with a calibration solution of a standard substance.
2. The key technical key is as follows:
(1) the additive concentration and the additive amount of each chemical in 5L of phosphate buffer diluent are that the additive amount of potassium dihydrogen phosphate is 0.055%, the additive amount of disodium hydrogen phosphate dihydrate is 0.237% -0.238%, the additive amount of potassium chloride is 0.15%, the additive amount of sodium nitrate is 0.019% -0.020%, the additive amount of disodium edetate dihydrate is 0.038% -0.040%, the additive amount of TritonX-100 is 0.005% -0.0055%, the additive amount of Kathon WT is 0.05% -0.06%, and ultrapure water is used as a solvent;
(2) dissolving all the inorganic salts mentioned above should be prepared beforehand for preliminary dissolution of 60% of the volume of the solvent, in order to avoid the generation of foam;
(3) for organic substances Kathon WT and TritonX-100, one plays a role in sterilization, and the other is dispersing cells in a blood sample to facilitate instrument detection, and simultaneously, the surface tension of diluent is reduced to reduce the generation of bubbles and eliminate the interference of the bubbles on measurement, and the substance also has a sheath fluid function; the adding sequence is that TritonX-100 is added first and then Kathon WT is added;
(4) accurately weighing about 45.04g to 45.10g of beta-D (+) anhydrous glucose, pouring the beta-D (+) anhydrous glucose into a 5L measuring cup which is pre-filled with 3000ml of phosphate buffer diluent containing 5 times of Kathon WT bactericide, continuously stirring for about 30min, and adding the phosphate buffer diluent to 5L of scale marks;
(5) transferring 500ml of 50mmol/L concentrated calibration solution into a new 5L measuring cup, diluting by 10 times to obtain a 5L scale mark, continuously stirring on a magnetic stirrer for about 30min, and standing for 30 min;
(6) the invention adopts a low-rotating-speed stirring and dissolving method, the prepared beta-D (+) anhydrous glucose belongs to hydrophilic substances and is easy to dissolve, the homogeneity of the solution is not influenced, and meanwhile, the low-rotating-speed energy-saving method is low in rotating speed and suitable for industrial production requirements;
(7) the content of Kathon WT is 0.05% -0.06%, the prepared calibration solution is better in stability, and the test result is more accurate;
(8) the water quality is preferably three-stage distilled water or ultrapure water.
3. The preparation method comprises the following steps:
(1) putting 3000ml of phosphate buffer diluent into a 5000ml measuring cup (the volume of the phosphate buffer diluent needs to be calibrated), putting the measuring cup on a magnetic stirrer, and enabling a stirring rotor to rotate at a constant speed;
(2) slowly adding 45.04-45.10 g of beta-D (+) anhydrous glucose into a 5000ml measuring cup, and continuously stirring on a magnetic stirrer for about 30 min;
(3) after the chemicals are completely dissolved, adding phosphate buffer diluent into a 5L measuring cup to the scale mark;
(4) transferring 500ml of the mixed solution into a new 5L measuring cup, adding phosphate buffer diluent to the position of a 5L scale mark, continuously stirring on a magnetic stirrer for about 30min, and standing for 30 min;
(5) dissolving uniformly to obtain a solution before filling, putting a 0.22um acetate fiber filter membrane soaked in triple distilled water into a filter, and filtering for three times to obtain the required calibration solution;
(6) if the solution is clear and transparent, sampling and detecting, continuously making three batches, starting to test the accuracy of the solution, and if precipitation and turbidity phenomena exist, removing the solution and reconfiguring;
(7) after the test is qualified, the 5.00mmol/L calibration solution is used for on-machine verification test, and a glucose/lactic acid analyzer and a blood glucose analyzer are used for performing calibration test on a blood sample and comparing the blood sample with a standard calibrator and performing clinical verification on consistency.
1. The testing requirements of the calibration solution on instruments such as a glucometer and the like are more accurately realized;
2. the simple and visual configuration in production is convenient;
3. according to the invention, a low-rotation-speed stirring and dissolving method is adopted, stirring is carried out for 30min after preparation, anhydrous glucose belongs to a hydrophilic substance, the dissolution is easy, the uniformity of the solution is not influenced, foam and bubbles are prevented from being generated due to high rotation speed, the low rotation speed is energy-saving, and the industrial production requirement is met;
4. the Kathon WT with the content of 5 times is added, so that the stability of the calibration solution is easy to control, and the test result is more accurate;
5. the ultrapure water is used as a solvent of the phosphate buffer diluent, so that the accuracy and precision of the preparation of the calibration solution are improved.
Citation: YYT 0456.1-2014 reagent part 1 for hematology analyzers: cleaning fluid; YYT 0456.3-2014 reagent part 3 for hematology analyzers: a diluent; ISO18113-2 part 2: professional in vitro diagnostic reagents; standard (GB) YYT 0701 of GBT 26124-
GBT1.1-2009 Standard work guide, part 1: standard construction and writing (Abstract)
Example one
1. Putting 3000ml of phosphate buffer diluent into a 5000ml measuring cup (the volume needs to be calibrated and is calibrated), putting the measuring cup under a stirrer, extending a stirring rod to 1/2 parts of the liquid level, stirring at a constant speed, continuously adding anhydrous glucose into the 5000ml measuring cup, after chemical products such as the anhydrous glucose and the like are completely dissolved, then adding the phosphate buffer diluent into a 5L measuring cup to a scale mark (calibrated scale mark), continuously stirring, stirring for 30min, standing for 30min, transferring 500ml of mixed solution into a new 5L measuring cup, continuously adding the phosphate buffer diluent to the scale mark, stirring for 30min, standing for 30min, sterilizing and filtering the solution after the completion to obtain the required blood glucose calibration solution,
2. standing for 1h to obtain solution before filling, testing pH value and conductivity of the obtained concentrated solution if the obtained concentrated solution is clear and transparent and has no precipitation and turbidity, diluting into system solution after the concentrated solution is qualified, performing on-machine test, sampling and detecting, and performing three batches continuously, wherein the batches are 20161220, 20161221 and 20161222 respectively;
3. and (4) conclusion:
example two
1. Putting 3000ml of phosphate buffer diluent into a 5000ml measuring cup (the volume needs to be calibrated and is calibrated), putting the measuring cup under a stirrer, extending a stirring rod to 1/2 parts of the liquid level, stirring at a constant speed, continuously adding anhydrous glucose into the 5000ml measuring cup, after chemical products such as the anhydrous glucose and the like are completely dissolved, then adding the phosphate buffer diluent into a 5L measuring cup to a scale mark (calibrated scale mark), continuously stirring, stirring for 30min, standing for 30min, transferring 500ml of mixed solution into a new 5L measuring cup, continuously adding the phosphate buffer diluent to the scale mark, stirring for 30min, sterilizing and filtering the solution after standing for 30min to obtain the required blood glucose calibration solution,
2. standing for 1h to obtain solution before filling, testing pH value and conductivity of the obtained concentrated solution if the obtained concentrated solution is clear and transparent and has no precipitation and turbidity, diluting into system solution after the concentrated solution is qualified, performing on-machine test, sampling and detecting, and performing three batches continuously, wherein the batches are 20161223, 20161224 and 20161225 respectively;
3. and (4) conclusion:
EXAMPLE III
1. Putting 3000ml of phosphate buffer diluent into a 5000ml measuring cup (the volume needs to be calibrated and is calibrated), putting the measuring cup under a stirrer, extending a stirring rod to 1/2 parts of the liquid level, stirring at a constant speed, continuously adding anhydrous glucose into the 5000ml measuring cup, after chemical products such as the anhydrous glucose and the like are completely dissolved, then adding the phosphate buffer diluent into a 5L measuring cup to a scale mark (calibrated scale mark), continuously stirring, stirring for 30min, standing for 30min, transferring 500ml of mixed solution into a new 5L measuring cup, continuously adding the phosphate buffer diluent to the scale mark, stirring for 30min, standing for 30min, sterilizing and filtering the solution after the completion to obtain the required blood glucose calibration solution,
2. standing for 1h to obtain solution before filling, testing pH value and conductivity of the obtained concentrated solution if the obtained concentrated solution is clear and transparent and has no precipitation and turbidity, diluting into system solution after the concentrated solution is qualified, performing on-machine test, sampling and detecting, and performing three batches continuously, wherein the batches are 20161228, 20170103 and 20170105 respectively;
3. and (4) conclusion:
the contents% referred to in the present invention are all mass wt%.
The present invention is not limited to the above preferred embodiments, and any modifications, equivalent replacements, improvements, etc. within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (3)
1. A preparation method of a blood sugar calibration solution is characterized by comprising the following steps:
(1) placing 3000ml of phosphate buffered diluent in a 5000ml measuring cup, placing the measuring cup on a magnetic stirrer, and enabling a stirring rotor to rotate at a constant speed, wherein the phosphate buffered diluent comprises: 0.055% of potassium dihydrogen phosphate, 0.237% -0.238% of disodium hydrogen phosphate dihydrate, 0.15% of potassium chloride, 0.019% -0.020% of sodium nitrate, 0.038% -0.040% of disodium edetate dihydrate, 0.005% -0.0055% of TritonX-100 and 0.05% -0.06% of Kathon WT; and distilled water or ultrapure water is used as a solvent;
(2) then slowly adding 45.04-45.10 g of beta-D (+) anhydrous glucose into a 5L measuring cup, and continuously stirring for about 30min on a magnetic stirrer;
(3) after the chemicals are completely dissolved, adding phosphate buffer diluent into a 5L measuring cup to the scale mark;
(4) transferring 500ml of the mixed solution into a new 5L measuring cup, adding phosphate buffer diluent to the position of a 5L scale mark, continuously stirring on a magnetic stirrer for 30min, and standing for 30 min;
(5) dissolving uniformly to obtain a solution before filling, putting a 0.22um acetate fiber filter membrane soaked in triple distilled water into a filter, and filtering for three times to obtain the required calibration solution;
(6) if the solution is clear and transparent, sampling and detecting, continuously making three batches, starting to test the accuracy of the solution, and if precipitation and turbidity phenomena exist, removing the solution and reconfiguring;
(7) after the test is qualified, the 5.00mmol/L calibration solution is used for on-machine verification test, and a glucose/lactic acid analyzer and a blood glucose analyzer are used for performing calibration test on a blood sample and comparing the blood sample with a standard calibrator and performing clinical verification on consistency.
2. The configuration method of claim 1, wherein: the phosphate buffered saline was previously prepared for pre-dissolution of 60% of the solvent volume prior to dissolution.
3. The configuration method according to claim 1, characterized in that: in the step (2), 45.04g to 45.10g of beta-D (+) anhydrous glucose is weighed and poured into a 5L measuring cup which is pre-filled with 3L of phosphate buffer diluent containing 5 times of Kathon wt bactericide, the stirring is continuously carried out for about 30min, and then the phosphate buffer diluent is added to the 5L scale mark.
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