CN112067399A - Preparation method of urine chemical analysis quality control product - Google Patents
Preparation method of urine chemical analysis quality control product Download PDFInfo
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- CN112067399A CN112067399A CN202010989321.4A CN202010989321A CN112067399A CN 112067399 A CN112067399 A CN 112067399A CN 202010989321 A CN202010989321 A CN 202010989321A CN 112067399 A CN112067399 A CN 112067399A
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- 238000003908 quality control method Methods 0.000 title claims abstract description 90
- 210000002700 urine Anatomy 0.000 title claims abstract description 80
- 239000000126 substance Substances 0.000 title claims abstract description 59
- 238000004458 analytical method Methods 0.000 title claims abstract description 53
- 238000002360 preparation method Methods 0.000 title claims abstract description 36
- 239000000047 product Substances 0.000 claims abstract description 70
- 238000003756 stirring Methods 0.000 claims abstract description 48
- 239000011265 semifinished product Substances 0.000 claims abstract description 44
- OBHRVMZSZIDDEK-UHFFFAOYSA-N urobilinogen Chemical compound CCC1=C(C)C(=O)NC1CC1=C(C)C(CCC(O)=O)=C(CC2=C(C(C)=C(CC3C(=C(CC)C(=O)N3)C)N2)CCC(O)=O)N1 OBHRVMZSZIDDEK-UHFFFAOYSA-N 0.000 claims abstract description 32
- BPYKTIZUTYGOLE-IFADSCNNSA-N Bilirubin Chemical compound N1C(=O)C(C)=C(C=C)\C1=C\C1=C(C)C(CCC(O)=O)=C(CC2=C(C(C)=C(\C=C/3C(=C(C=C)C(=O)N\3)C)N2)CCC(O)=O)N1 BPYKTIZUTYGOLE-IFADSCNNSA-N 0.000 claims abstract description 28
- DGLRDKLJZLEJCY-UHFFFAOYSA-L disodium hydrogenphosphate dodecahydrate Chemical compound O.O.O.O.O.O.O.O.O.O.O.O.[Na+].[Na+].OP([O-])([O-])=O DGLRDKLJZLEJCY-UHFFFAOYSA-L 0.000 claims abstract description 22
- 238000000034 method Methods 0.000 claims abstract description 20
- 229910000402 monopotassium phosphate Inorganic materials 0.000 claims abstract description 20
- 235000019796 monopotassium phosphate Nutrition 0.000 claims abstract description 20
- LPXPTNMVRIOKMN-UHFFFAOYSA-M sodium nitrite Chemical compound [Na+].[O-]N=O LPXPTNMVRIOKMN-UHFFFAOYSA-M 0.000 claims abstract description 20
- 150000002576 ketones Chemical class 0.000 claims abstract description 19
- PJNZPQUBCPKICU-UHFFFAOYSA-N phosphoric acid;potassium Chemical compound [K].OP(O)(O)=O PJNZPQUBCPKICU-UHFFFAOYSA-N 0.000 claims abstract description 18
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims abstract description 16
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 15
- 108010088751 Albumins Proteins 0.000 claims abstract description 13
- 102000009027 Albumins Human genes 0.000 claims abstract description 13
- 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 abstract description 11
- 239000008103 glucose Substances 0.000 claims abstract description 11
- 210000000265 leukocyte Anatomy 0.000 claims abstract description 11
- 239000003755 preservative agent Substances 0.000 claims abstract description 10
- 230000002335 preservative effect Effects 0.000 claims abstract description 10
- 235000010288 sodium nitrite Nutrition 0.000 claims abstract description 10
- 210000003743 erythrocyte Anatomy 0.000 claims abstract description 8
- 239000011780 sodium chloride Substances 0.000 claims abstract description 8
- 102000001554 Hemoglobins Human genes 0.000 claims description 7
- 108010054147 Hemoglobins Proteins 0.000 claims description 7
- IPBNQYLKHUNLQE-UHFFFAOYSA-N 8-anilinonaphthalene-1-sulfonic acid;azane Chemical group [NH4+].C=12C(S(=O)(=O)[O-])=CC=CC2=CC=CC=1NC1=CC=CC=C1 IPBNQYLKHUNLQE-UHFFFAOYSA-N 0.000 claims description 6
- 241000283690 Bos taurus Species 0.000 claims description 6
- 108091003079 Bovine Serum Albumin Proteins 0.000 claims description 6
- 229940098773 bovine serum albumin Drugs 0.000 claims description 6
- 239000000872 buffer Substances 0.000 claims description 6
- XBPJVSRTTKVMEN-UHFFFAOYSA-N 2,4-dimethyl-1h-pyrrole-3-carboxylic acid Chemical compound CC1=CNC(C)=C1C(O)=O XBPJVSRTTKVMEN-UHFFFAOYSA-N 0.000 claims description 5
- 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 description 5
- JOOXCMJARBKPKM-UHFFFAOYSA-N 4-oxopentanoic acid Chemical compound CC(=O)CCC(O)=O JOOXCMJARBKPKM-UHFFFAOYSA-N 0.000 claims description 4
- -1 leukocyte substitute Chemical compound 0.000 claims description 4
- AGCGGNCZCFZBNN-UHFFFAOYSA-M sodium;2-methyl-3-oxobutanoate Chemical compound [Na+].CC(=O)C(C)C([O-])=O AGCGGNCZCFZBNN-UHFFFAOYSA-M 0.000 claims description 4
- LGAFIBCWNKPENX-UHFFFAOYSA-N 3,5-dimethyl-1h-pyrrole-2,4-dicarboxylic acid Chemical compound CC=1NC(C(O)=O)=C(C)C=1C(O)=O LGAFIBCWNKPENX-UHFFFAOYSA-N 0.000 claims description 3
- MDWJZBVEVLTXDE-UHFFFAOYSA-N 2-methyl-1h-indol-5-ol Chemical compound OC1=CC=C2NC(C)=CC2=C1 MDWJZBVEVLTXDE-UHFFFAOYSA-N 0.000 claims description 2
- BSYNRYMUTXBXSQ-FOQJRBATSA-N 59096-14-9 Chemical compound CC(=O)OC1=CC=CC=C1[14C](O)=O BSYNRYMUTXBXSQ-FOQJRBATSA-N 0.000 claims description 2
- 108090000371 Esterases Proteins 0.000 claims description 2
- SECXISVLQFMRJM-UHFFFAOYSA-N N-Methylpyrrolidone Chemical compound CN1CCCC1=O SECXISVLQFMRJM-UHFFFAOYSA-N 0.000 claims description 2
- 239000003633 blood substitute Substances 0.000 claims description 2
- JDPRRECMRPCSIF-UHFFFAOYSA-N ethyl 3-oxobutanoate;sodium Chemical compound [Na].CCOC(=O)CC(C)=O JDPRRECMRPCSIF-UHFFFAOYSA-N 0.000 claims description 2
- 229940040102 levulinic acid Drugs 0.000 claims description 2
- 229940058349 sodium levulinate Drugs 0.000 claims description 2
- RDKYCKDVIYTSAJ-UHFFFAOYSA-M sodium;4-oxopentanoate Chemical compound [Na+].CC(=O)CCC([O-])=O RDKYCKDVIYTSAJ-UHFFFAOYSA-M 0.000 claims description 2
- 238000004519 manufacturing process Methods 0.000 claims 1
- 238000001514 detection method Methods 0.000 abstract description 18
- 230000008569 process Effects 0.000 abstract description 9
- 238000005353 urine analysis Methods 0.000 abstract description 4
- 239000000243 solution Substances 0.000 description 45
- 238000012360 testing method Methods 0.000 description 25
- 238000011156 evaluation Methods 0.000 description 16
- 239000000463 material Substances 0.000 description 13
- 239000002994 raw material Substances 0.000 description 10
- 238000011835 investigation Methods 0.000 description 8
- 239000007788 liquid Substances 0.000 description 7
- 238000013112 stability test Methods 0.000 description 7
- 210000004369 blood Anatomy 0.000 description 5
- 239000008280 blood Substances 0.000 description 5
- 230000000694 effects Effects 0.000 description 5
- 108090001060 Lipase Proteins 0.000 description 4
- 102000004882 Lipase Human genes 0.000 description 4
- 239000004367 Lipase Substances 0.000 description 4
- 235000019421 lipase Nutrition 0.000 description 4
- 238000012986 modification Methods 0.000 description 4
- 230000004048 modification Effects 0.000 description 4
- 239000008363 phosphate buffer Substances 0.000 description 4
- 230000035945 sensitivity Effects 0.000 description 4
- IOVCWXUNBOPUCH-UHFFFAOYSA-M Nitrite anion Chemical compound [O-]N=O IOVCWXUNBOPUCH-UHFFFAOYSA-M 0.000 description 3
- 239000006184 cosolvent Substances 0.000 description 3
- 230000006378 damage Effects 0.000 description 3
- 230000005484 gravity Effects 0.000 description 3
- 238000011160 research Methods 0.000 description 3
- 238000012216 screening Methods 0.000 description 3
- 239000003381 stabilizer Substances 0.000 description 3
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 description 2
- SIKJAQJRHWYJAI-UHFFFAOYSA-N Indole Chemical compound C1=CC=C2NC=CC2=C1 SIKJAQJRHWYJAI-UHFFFAOYSA-N 0.000 description 2
- 241001465754 Metazoa Species 0.000 description 2
- KAESVJOAVNADME-UHFFFAOYSA-N Pyrrole Chemical compound C=1C=CNC=1 KAESVJOAVNADME-UHFFFAOYSA-N 0.000 description 2
- 239000013064 chemical raw material Substances 0.000 description 2
- 239000002131 composite material Substances 0.000 description 2
- 238000005034 decoration Methods 0.000 description 2
- 238000003745 diagnosis Methods 0.000 description 2
- 201000010099 disease Diseases 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 238000004090 dissolution Methods 0.000 description 2
- 239000011159 matrix material Substances 0.000 description 2
- GNSKLFRGEWLPPA-UHFFFAOYSA-M potassium dihydrogen phosphate Chemical compound [K+].OP(O)([O-])=O GNSKLFRGEWLPPA-UHFFFAOYSA-M 0.000 description 2
- LWIHDJKSTIGBAC-UHFFFAOYSA-K potassium phosphate Substances [K+].[K+].[K+].[O-]P([O-])([O-])=O LWIHDJKSTIGBAC-UHFFFAOYSA-K 0.000 description 2
- PZPFXRQPPDCUQY-LNKPDPKZSA-M sodium;(z)-4-methoxy-4-oxobut-2-en-2-olate Chemical compound [Na+].COC(=O)\C=C(\C)[O-] PZPFXRQPPDCUQY-LNKPDPKZSA-M 0.000 description 2
- 239000004094 surface-active agent Substances 0.000 description 2
- 238000010257 thawing Methods 0.000 description 2
- 238000012795 verification Methods 0.000 description 2
- 235000001892 vitamin D2 Nutrition 0.000 description 2
- 238000008789 Direct Bilirubin Methods 0.000 description 1
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 238000003912 environmental pollution Methods 0.000 description 1
- XYIBRDXRRQCHLP-UHFFFAOYSA-N ethyl acetoacetate Chemical compound CCOC(=O)CC(C)=O XYIBRDXRRQCHLP-UHFFFAOYSA-N 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- PZOUSPYUWWUPPK-UHFFFAOYSA-N indole Natural products CC1=CC=CC2=C1C=CN2 PZOUSPYUWWUPPK-UHFFFAOYSA-N 0.000 description 1
- RKJUIXBNRJVNHR-UHFFFAOYSA-N indolenine Natural products C1=CC=C2CC=NC2=C1 RKJUIXBNRJVNHR-UHFFFAOYSA-N 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- PSZYNBSKGUBXEH-UHFFFAOYSA-M naphthalene-1-sulfonate Chemical compound C1=CC=C2C(S(=O)(=O)[O-])=CC=CC2=C1 PSZYNBSKGUBXEH-UHFFFAOYSA-M 0.000 description 1
- 239000003960 organic solvent Substances 0.000 description 1
- 230000001575 pathological effect Effects 0.000 description 1
- 229960000502 poloxamer Drugs 0.000 description 1
- 229920001983 poloxamer Polymers 0.000 description 1
- 229920000136 polysorbate Polymers 0.000 description 1
- 238000004321 preservation Methods 0.000 description 1
- FGVVTMRZYROCTH-UHFFFAOYSA-N pyridine-2-thiol N-oxide Chemical compound [O-][N+]1=CC=CC=C1S FGVVTMRZYROCTH-UHFFFAOYSA-N 0.000 description 1
- 238000013441 quality evaluation Methods 0.000 description 1
- 159000000000 sodium salts Chemical class 0.000 description 1
- 230000002485 urinary effect Effects 0.000 description 1
- 239000002699 waste material Substances 0.000 description 1
Classifications
-
- 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
- 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
-
- 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
- G01N2001/2893—Preparing calibration standards
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Immunology (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- General Physics & Mathematics (AREA)
- Physics & Mathematics (AREA)
- Pathology (AREA)
- Analytical Chemistry (AREA)
- Biomedical Technology (AREA)
- General Health & Medical Sciences (AREA)
- Urology & Nephrology (AREA)
- Hematology (AREA)
- Biotechnology (AREA)
- Microbiology (AREA)
- Cell Biology (AREA)
- Food Science & Technology (AREA)
- Medicinal Chemistry (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Abstract
The invention relates to the field of urine analysis and detection, in particular to a preparation method of a chemical analysis quality control product for urine. The method comprises the following steps: adding part of disodium hydrogen phosphate dodecahydrate into part of water, and stirring to dissolve; adding ketone substitute into the solution, stirring and dissolving; adding the urobilinogen substitute into the solution, and stirring for dissolving; sequentially adding sodium chloride, bilirubin substitute, sodium nitrite and part of potassium dihydrogen phosphate according to the formula amount into the solution, and stirring for dissolving to obtain a semi-finished product A; adding the rest of disodium hydrogen phosphate dodecahydrate into the rest of water, and stirring for dissolving; adding a leukocyte substitute and the balance of potassium dihydrogen phosphate into the solution, and stirring for dissolving; adding glucose, red blood cell substitute, albumin substitute and preservative into the solution in sequence, stirring for dissolving, and standing to obtain a semi-finished product B; mixing the semi-finished product A and the semi-finished product B. The urine chemical analysis quality control product prepared by the preparation method has the advantages of small pollution, low cost, simple process and good stability.
Description
Technical Field
The invention relates to the field of urine analysis and detection, in particular to a preparation method of a chemical analysis quality control product for urine.
Background
The routine of urine as one of the three routine examinations is not only the first choice and the absolute necessity of the diagnosis and the observation of the curative effect of the diseases of the urinary system, but also the diagnosis and the treatment of other system diseases which can cause the change of the biochemical components of blood. Each level of clinical examination centers can carry out quality evaluation activities in the urine chemical analysis project every year. The urine chemical analysis quality control product is used for the quality control of a urine analyzer and a urine analysis test strip. Can be used for quality control of pH, albumin, glucose, ketone body, blood, nitrite, bilirubin, urobilinogen, leukocyte, and specific gravity. Compared with blood and biochemical detection, the urine analysis quality control difficulty is higher, besides the method is not standardized, the steps of taking, collecting, transporting and storing the urine sample are more, the control is difficult, the sensitivity and the fixed value standards of test strips and analyzers of various manufacturers are different, and the test strips and the analyzers can be relatively easily monitored by using quality control products.
Yunlong (urine quality control substance preparation and clinical preliminary application experience, Shanxi journal of medicine, 1986, 15 (3): 185) uses normal human urine as basic liquid to prepare urine quality control substance, eliminating matrix effect to a certain extent, but a large amount of normal human urine with stable quality is difficult to obtain, and simultaneously, due to differences of individual living habits, the urine of normal people also has differences, so that the lot-to-lot differences of quality control substances are large. The use of a large amount of urine can cause pollution to the environment, and the treatment of pathological urine can also bring threats to the health of operators. The urine treatment and preservation cost is high. These are drawbacks of such techniques.
The freeze-dried powder-shaped quality control product is generally used in China, and a certain amount of water is needed to be used for dissolving the quality control product before use, and then the quality control product is poured into a container for use. Such quality control materials are inconvenient to use and are liable to cause operational errors. The liquid is needed to be used in time after being dissolved into liquid, is very unstable and can not be stored, thereby causing waste.
The problems of difficult quality control, environmental pollution and the like caused by adopting urine as a basic matrix liquid to prepare a urine quality control product are solved. The prior art also commonly adopts chemical raw materials as substitutes of various detection indexes of urine to prepare the urine quality control product. For example, chinese patent publication No. CN106771112A discloses a multi-item composite urine quality control liquid. Acetone, ethyl acetoacetate and the like are adopted as ketone body substitutes, direct bilirubin, 1-naphthalene sulfonate and the like are adopted as bilirubin substitutes, and indole, pyrrole and derivatives thereof are adopted as urobilinogen substitutes to prepare the multi-item composite urine quality control liquid. However, as more organic chemical raw materials are adopted, in order to solve the problems of solubility of the raw materials and stability of the product, the product is added with cosolvents such as tween and poloxamer and stabilizers, so that the cost is increased, the stability is not ideal, and meanwhile, the use of the sodium salt of 2-mercaptopyridine oxide can cause false positive of ketone bodies and interfere the detection of hemoglobin. In the preparation of such urine quality control products in the literature and patents, in consideration of the problems of solubility of raw materials and stability of products, cosolvents such as surfactants and stabilizers are often used or used.
Disclosure of Invention
In view of the above, the invention provides a preparation method of a quality control product for chemical analysis of urine. The urine chemical analysis quality control product prepared by the preparation method has the advantages of small pollution, low cost, simple process and good stability.
In order to achieve the above object, the present invention provides the following technical solutions:
the invention provides a preparation method of a chemical analysis quality control material for urine, and the quality control material comprises the following steps: buffer pair, ketone body substitute, urobilinogen substitute, sodium chloride, leukocyte substitute, bilirubin substitute, sodium nitrite, glucose, erythrocyte substitute, albumin substitute, preservative and water;
the ketone body substitute is one or more of acetylsalicylic acid, sodium levulinate, levulinic acid, ethyl acetoacetate sodium salt, methyl acetoacetate sodium salt and triacetylacetone aluminum;
the urobilinogen substitute is one or more of 2, 4-dimethyl-1H-pyrrole-3-carboxylic acid, 2, 4-dimethyl pyrrole-3, 5-dicarboxylic acid, N-methyl pyrrolidone and 5-hydroxy-2-methyl-indole;
the bilirubin substitute is 8-phenylaminonaphthalene-1-sulfonic acid ammonium salt;
the buffer pair consists of disodium hydrogen phosphate dodecahydrate and potassium dihydrogen phosphate;
the preparation method comprises the following steps:
step 1, preparing a semi-finished product A:
(1) adding part of disodium hydrogen phosphate dodecahydrate of the formula amount into part of water of the formula amount, and stirring for dissolving;
(2) adding a ketone substitute into the solution prepared in the step (1), and stirring and dissolving for 5-20 minutes;
(3) adding a urobilinogen substitute into the solution prepared in the step (2), and stirring and dissolving for 10-30 minutes;
(4) sequentially adding sodium chloride, a bilirubin substitute, sodium nitrite and a part of potassium dihydrogen phosphate according to the formula amount into the solution prepared in the step (3), and stirring and dissolving for 5-15 minutes to obtain a semi-finished product A;
step 2, preparing a semi-finished product B:
(1) adding the rest of disodium hydrogen phosphate dodecahydrate into the rest of water, and stirring for dissolving;
(2) adding a leukocyte substitute and the balance of potassium dihydrogen phosphate into the solution prepared in the step (1), and stirring and dissolving for 5-15 minutes;
(3) sequentially adding glucose, a red blood cell substitute, an albumin substitute and a preservative into the solution prepared in the step (2), stirring and dissolving for 5-30 minutes, and standing for 2-3 hours to obtain a semi-finished product B;
and 3, mixing the semi-finished product A and the semi-finished product B to obtain the urine chemical analysis quality control product.
Preferably, the concentration of each component in the quality control product is as follows:
preferably, the concentration of each component in the quality control product is as follows:
preferably, the leukocyte substitute is an esterase.
Preferably, the red blood cell substitute is bovine hemoglobin.
Preferably, the albumin substitute is bovine serum albumin.
Preferably, the preservative is Proclin 300.
Preferably, the pH value of the urine chemical analysis quality control product is 6.0-8.5.
Preferably, in the preparation of the semi-finished product A, the dosage of the disodium hydrogen phosphate dodecahydrate in the step (1) is 1/7-6/7 of the formula amount; in the step (4), the dosage of the potassium dihydrogen phosphate is 1/8.5-7.5/8.5 of the formula.
Preferably, in the preparation of the semi-finished product A, the pH value of the solution prepared in the step (2) is 9.5-11.5; the pH value of the solution prepared in the step (3) is 8.0-9.5; the pH value of the semi-finished product A prepared in the step (4) is 5.5-8.5;
in the preparation of the semi-finished product B, the pH value of the solution prepared in the step (2) is 7.0-8.5; the pH value of the solution prepared in the step (3) is 6.0-8.5.
The invention provides a preparation method of a chemical analysis quality control product for urine. The preparation method comprises the following steps: adding part of disodium hydrogen phosphate dodecahydrate of the formula amount into part of water of the formula amount, and stirring for dissolving; adding a ketone substitute into the solution, and stirring and dissolving for 5-20 minutes; adding a urobilinogen substitute into the solution, and stirring and dissolving for 10-30 minutes; sequentially adding sodium chloride, bilirubin substitutes, sodium nitrite and part of potassium dihydrogen phosphate according to the formula amount into the solution, and stirring and dissolving for 5-15 minutes to obtain a semi-finished product A; adding the rest of disodium hydrogen phosphate dodecahydrate into the rest of water, and stirring for dissolving; adding a leukocyte substitute and the balance of potassium dihydrogen phosphate into the solution, and stirring and dissolving for 5-15 minutes; adding glucose, a red blood cell substitute, an albumin substitute and a preservative into the solution in sequence, stirring and dissolving for 5-30 minutes, and standing for 2-3 hours to obtain a semi-finished product B; and mixing the semi-finished product A and the semi-finished product B to obtain the urine chemical analysis quality control product. Due to the adoption of the technical scheme, compared with the prior art, the invention has the following technical effects:
the urine chemical analysis quality control product and the preparation method thereof provided by the invention do not use organic solvent, surfactant, stabilizer, cosolvent and other raw materials, and have the advantages of small pollution, low cost, simple process and good product stability. According to the invention, a large number of researches find that the urine chemical analysis quality control product is not only related to screening of preparation raw materials, but also the preparation process of the urine quality control liquid has important influence on the stability and quality control accuracy of the product. The invention adopts the process of preparing the solution A by using a chemical raw material substitute, preparing the solution B by using an animal-derived raw material, and mixing the solution A and the solution B to prepare the chemical analysis quality control product for urine. Not only eliminates the influence of chemical raw material substitutes on animal-derived raw material substitutes in the preparation process. And the process conditions such as the addition sequence, the dissolution pH condition, the dissolution time and the like of each substitute are controlled, so that the stability of each detection index and the stability of the product are obviously improved.
Detailed Description
The invention discloses a preparation method of a chemical analysis quality control material for urine, and a person skilled in the art can appropriately improve process parameters by referring to the content. It is expressly intended that all such similar substitutes and modifications which would be obvious to one skilled in the art are deemed to be included in the invention. While the methods and applications of this invention have been described in terms of preferred embodiments, it will be apparent to those of ordinary skill in the art that variations and modifications in the methods and applications described herein, as well as other suitable variations and combinations, may be made to implement and use the techniques of this invention without departing from the spirit and scope of the invention.
The raw materials used in the preparation method of the urine chemical analysis quality control product provided by the invention can be purchased from the market.
The invention is further illustrated by the following examples:
example 1
The embodiment provides a chemical analysis quality control material for urine, which comprises:
wherein the buffer pair is phosphate buffer pair, and the phosphate buffer pair is disodium hydrogen phosphate dodecahydrate and potassium dihydrogen phosphate; the ketone body substitute is methyl acetoacetate sodium salt; the said urobilinogen substitute is 2, 4-dimethyl-1H-pyrrole-3-carboxylic acid; the leukocyte substitute is lipase; the bilirubin substitute is 8-phenylaminonaphthalene-1-sulfonic acid ammonium salt; the red blood cell substitute is bovine hemoglobin; the albumin substitute is bovine serum albumin; the pH value of the urine chemical analysis quality control product is 7.5-8.5.
The preparation method comprises the following steps:
1. the preparation of the semi-finished product A of the quality control product of the urine chemical analysis comprises the following steps:
(1) adding 12g of disodium hydrogen phosphate dodecahydrate into 500mL of water, and stirring to fully dissolve the disodium hydrogen phosphate dodecahydrate;
(2) adding 12g of sodium methyl acetoacetate into the solution prepared in the step (1), stirring and dissolving for 20 minutes, fully dissolving, and controlling the pH value of the solution to be 10.6-11.5;
(3) adding 1.2g of 2, 4-dimethyl-1H-pyrrole-3 carboxylic acid into the solution prepared in the step (2), stirring for 30 minutes, fully dissolving, and controlling the pH value of the solution to be 8.8-9.5;
(4) stirring the solution prepared in the step (3) while sequentially adding 5g of sodium chloride; 1g of ammonium 8-phenylaminonaphthalene-1-sulfonate; stirring 10mg of sodium nitrite and 3g of potassium dihydrogen phosphate for 15 minutes to fully dissolve the sodium nitrite and the potassium dihydrogen phosphate to obtain a semi-finished product A of the urine chemical analysis quality control product, wherein the pH value of the solution of the semi-finished product A is 7.0-8.5;
2. urine chemical analysis quality control material preparation of a semi-finished product B of a quality control material comprises the following steps:
(1) adding 2g of disodium hydrogen phosphate dodecahydrate into 500mL of water, and stirring to fully dissolve the disodium hydrogen phosphate dodecahydrate;
(2) adding 0.4g of lipase and 0.4g of monopotassium phosphate into the solution prepared in the step (1), and controlling the pH value of the solution to be 7.8-8.5;
(3) and (3) sequentially adding 20g of glucose, 0.05g of bovine hemoglobin, 1g of bovine serum albumin and 0.5g of a preservative Proclin300 into the solution prepared in the step (2) while stirring, stirring for 5 minutes, fully dissolving, and standing for 2-3 hours to obtain a semi-finished product B of the urine chemical analysis quality control product, wherein the pH value of the solution of the semi-finished product B is 6.0-7.0.
3. And (3) mixing and stirring the semi-finished product A of the urine chemical analysis quality control product and the semi-finished product B of the urine chemical analysis quality control product obtained in the steps 1 and 2 uniformly to obtain the urine chemical analysis quality control product. The pH value of the obtained urine chemical analysis quality control product is 7.5-8.5.
And (3) stability verification test:
the prepared solution was investigated for homogeneity, 2-8 ℃ decap stability, 37 ℃ accelerated stability, simulated transport stability, tandem stability, freeze-thaw stability, room temperature stability, and post-transport real-time stability, with the following results:
uniformity investigation: 10 bottles of the quality control product for chemical analysis of urine prepared in example 1 were taken, each bottle of the quality control product was tested 1 time, and the consistency degree of the test results of specific gravity, pH, albumin, glucose, ketone body, blood, nitrite, bilirubin, urobilinogen and leucocyte with the nominal value was 100%. The results are detailed in table 1.
TABLE 1 results of homogeneity examination
Note: the positive strength range is represented by + to + and the positive strength range is evaluated by the test strip evaluation standard of mainstream manufacturers, and the positive strength range is represented by the + quantity; ± means weak positive; negative is indicated.
2-8 ℃ unsealing stability investigation: the chemical analysis quality control material for urine prepared in example 1 was taken, 3 bottles were opened, sealed and stored at 2-8 ℃ in the dark, and examined for 1 time per bottle for 7 days, 14 days, 21 days, 28 days and 35 days, respectively, and the measured values of the items were measured, with the results being within the given ranges. The results are detailed in table 2.
Table 2 unsealing stability test results
Note: the positive strength range is represented by + to + and the positive strength range is evaluated by the test strip evaluation standard of mainstream manufacturers, and the positive strength range is represented by the + quantity; ± means weak positive; negative is indicated.
Accelerated stability study at 37 ℃: taking 3 bottles of the urine chemical analysis quality control product prepared in the example 1, and examining the bottles for 1 time in3 days, 7 days, 10 days, 14 days and 18 days respectively at 37 ℃; the results of the 37 ℃ accelerated destruction 14 test were also within the nominal range and are detailed in table 3.
Table 337 ℃ accelerated stability test results
Note: the positive strength range is represented by + to + and the positive strength range is evaluated by the test strip evaluation standard of mainstream manufacturers, and the positive strength range is represented by the + quantity; ± means weak positive; negative is indicated.
And (3) inspecting transportation stability: the 3 bottles of the quality control product prepared in the example 1 are taken and transported in a simulated vehicle at 37 ℃, and are examined for 1 time per bottle for 7 days, 14 days and 18 days respectively, and the measured values of all items are detected, wherein the results are all in a given range. The results are detailed in Table 4.
Table 4 transportation stability test results
Note: the positive strength range is represented by + to + and the positive strength range is evaluated by the test strip evaluation standard of mainstream manufacturers, and the positive strength range is represented by the + quantity; ± means weak positive; negative is indicated.
And (3) inspecting the series stability: the 3 bottles of the urine chemical analysis quality control product prepared in the example 1 are taken to simulate vehicle-mounted examination for 14 days respectively in the environment of 37 ℃, then the bottles are sealed and stored for 18 days at the temperature of 2-8 ℃ in a dark place, the detection is carried out for 1 time in each bottle, and the measured values of all the items meet the requirements. The results are detailed in Table 5.
TABLE 5 results of tandem stability investigation
Note: the positive strength range is represented by + to + and the positive strength range is evaluated by the test strip evaluation standard of mainstream manufacturers, and the positive strength range is represented by the + quantity; ± means weak positive; negative is indicated.
And (3) investigating freeze-thaw stability: 3 bottles of the urine quality control product prepared in the example 1 are taken and subjected to freeze thawing for 3 times, 7 times, 10 times and 14 times respectively at the temperature of-20 ℃, each bottle is subjected to detection for 1 time, the measured values of all items are detected, and the detection results are all in a given range. The results are detailed in Table 6.
TABLE 6 Freeze-thaw stability test results
Note: the positive strength range is represented by + to + and the positive strength range is evaluated by the test strip evaluation standard of mainstream manufacturers, and the positive strength range is represented by the + quantity; ± means weak positive; negative is indicated.
And (3) investigating the stability at room temperature: 3 bottles of the urine quality control product prepared in the example 1 are examined for 3 days, 7 days, 14 days, 21 days, 28 days and 35 days respectively at the room temperature of 25 ℃, the detection is carried out for 1 time in each bottle, the measured values of all items are detected, and the detection results are all in a given range. The results are detailed in Table 7.
Table 7 room temperature stability study
Note: the positive strength range is represented by + to + and the positive strength range is evaluated by the test strip evaluation standard of mainstream manufacturers, and the positive strength range is represented by the + quantity; ± means weak positive; negative is indicated.
And (3) investigating the real-time stability after transportation: the 3 bottles of the urine quality control product prepared in the example 1 are taken and immediately detected 7 days after simulated vehicle-mounted transportation, and are stored at the temperature of 2-8 ℃ for 1 time per bottle at the 8 th month, the 12 th month, the 18 th month and the 24 th month after transportation, and the detection result is within the given range. The results are detailed in Table 8.
TABLE 8 post-Transportment real-time stability
Note: the positive strength range is represented by + to + and the positive strength range is evaluated by the test strip evaluation standard of mainstream manufacturers, and the positive strength range is represented by the + quantity; ± means weak positive; negative is indicated.
From the stability investigation result, the quality control of the chemical analysis of the urine prepared in the example 1 has good stability.
Example 2
The embodiment provides a chemical analysis quality control material for urine, which comprises:
wherein the buffer pair is phosphate buffer pair, and the phosphate buffer pair is disodium hydrogen phosphate dodecahydrate and potassium dihydrogen phosphate; the ketone body substitute is methyl acetoacetate sodium salt; the said urobilinogen substitute is 2, 4-dimethyl-1H-pyrrole-3-carboxylic acid; the leukocyte substitute is lipase; the bilirubin substitute is 8-phenylaminonaphthalene-1-sulfonic acid ammonium salt; the red blood cell substitute is bovine hemoglobin; the albumin substitute is bovine serum albumin; the pH value of the urine chemical analysis quality control product is 7.5-8.5.
The preparation method comprises the following steps:
1. the preparation of the semi-finished product A of the quality control product of the urine chemical analysis comprises the following steps:
(1) adding 2g of disodium hydrogen phosphate dodecahydrate into 500mL of water, and stirring to fully dissolve the disodium hydrogen phosphate dodecahydrate;
(2) adding 3g of sodium methyl acetoacetate into the solution prepared in the step (1), stirring and dissolving for 20 minutes, fully dissolving, and controlling the pH value of the solution to be 9.5-10.5;
(3) adding 0.2g of 2, 4-dimethylpyrrole-3, 5-dicarboxylic acid into the solution prepared in the step (2), stirring for 10 minutes, fully dissolving, and controlling the pH value of the solution to be 8.0-9.0;
(4) stirring and sequentially adding 15g of sodium chloride into the solution prepared in the step (3); 0.1g of ammonium 8-phenylaminonaphthalene-1-sulfonate; stirring 20mg of sodium nitrite and 0.4g of potassium dihydrogen phosphate for 5-15 minutes to fully dissolve the sodium nitrite and the potassium dihydrogen phosphate to obtain a semi-finished product A of the urine chemical analysis quality control product, wherein the pH value of the solution of the semi-finished product A is 6.0-7.0, and standing for later use.
2. Urine chemical analysis quality control material preparation of a semi-finished product B of a quality control material comprises the following steps:
(1) adding 12g of disodium hydrogen phosphate dodecahydrate into 500mL of water, and stirring to fully dissolve the disodium hydrogen phosphate dodecahydrate;
(2) adding 1g of lipase and 3g of monopotassium phosphate into the solution prepared in the step (1), and controlling the pH value of the solution to be 7.0-7.8;
(3) and (3) sequentially adding 4g of glucose, 1g of bovine hemoglobin, 6g of bovine serum albumin and 5g of a preservative Proclin300 into the solution prepared in the step (2) while stirring, stirring for 30 minutes, fully dissolving, and standing for 2-3 hours to obtain a semi-finished product B of the urine chemical analysis quality control product, wherein the pH value of the solution of the semi-finished product B is 7.0-8.5.
3. And (3) mixing and uniformly stirring the urine chemical analysis quality control product semi-finished product A and the urine chemical analysis quality control product semi-finished product B prepared in the steps (1) and (2) to obtain the urine chemical analysis quality control product, wherein the pH value of the obtained urine chemical analysis quality control product is 7.5-8.5.
And (3) stability verification test:
the prepared solution was investigated for homogeneity, 2-8 ℃ decap stability, 37 ℃ accelerated stability, simulated transport stability, tandem stability, freeze-thaw stability, room temperature stability, and post-transport real-time stability, with the following results:
uniformity investigation: 10 bottles of the quality control product for chemical analysis of urine prepared in example 1 were taken, each bottle of the quality control product was tested 1 time, and the consistency degree of the test results of specific gravity, pH, albumin, glucose, ketone body, blood, nitrite, bilirubin, urobilinogen and leucocyte with the nominal value was 100%. The results are detailed in Table 9.
TABLE 9 results of uniformity examination
Note: the positive strength range is represented by + to + and the positive strength range is evaluated by the test strip evaluation standard of mainstream manufacturers, and the positive strength range is represented by the + quantity; ± means weak positive; negative is indicated.
2-8 ℃ unsealing stability investigation: the chemical analysis quality control material for urine prepared in example 1 was taken, 3 bottles were opened, sealed and stored at 2-8 ℃ in the dark, and examined for 1 time per bottle for 7 days, 14 days, 21 days, 28 days and 35 days, respectively, and the measured values of the items were measured, with the results being within the given ranges. The results are detailed in Table 10.
TABLE 10 examination results of opening stability
Note: the positive strength range is represented by + to + and the positive strength range is evaluated by the test strip evaluation standard of mainstream manufacturers, and the positive strength range is represented by the + quantity; ± means weak positive; negative is indicated.
Accelerated stability study at 37 ℃: taking 3 bottles of the urine chemical analysis quality control product prepared in the example 1, and examining the bottles for 1 time in3 days, 7 days, 10 days, 14 days and 18 days respectively at 37 ℃; the results of the 37 ℃ accelerated destruction 14 test were also within the nominal range and are detailed in Table 11.
Table 1137 ℃ accelerated stability test results
Note: the positive strength range is represented by + to + and the positive strength range is evaluated by the test strip evaluation standard of mainstream manufacturers, and the positive strength range is represented by the + quantity; ± means weak positive; negative is indicated.
And (3) inspecting transportation stability: the 3 bottles of the quality control product prepared in the example 1 are taken and transported in a simulated vehicle at 37 ℃, and are examined for 1 time per bottle for 7 days, 14 days and 18 days respectively, and the measured values of all items are detected, wherein the results are all in a given range. The results are detailed in Table 12.
TABLE 12 transportation stability test results
Note: the positive strength range is represented by + to + and the positive strength range is evaluated by the test strip evaluation standard of mainstream manufacturers, and the positive strength range is represented by the + quantity; ± means weak positive; negative is indicated.
And (3) inspecting the series stability: the 3 bottles of the urine chemical analysis quality control product prepared in the example 1 are taken to simulate vehicle-mounted examination for 14 days respectively in the environment of 37 ℃, then the bottles are sealed and stored for 18 days at the temperature of 2-8 ℃ in a dark place, the detection is carried out for 1 time in each bottle, and the measured values of all the items meet the requirements. The results are detailed in Table 13.
TABLE 13 results of series stability investigation
Note: the positive strength range is represented by + to + and the positive strength range is evaluated by the test strip evaluation standard of mainstream manufacturers, and the positive strength range is represented by the + quantity; ± means weak positive; negative is indicated.
And (3) investigating freeze-thaw stability: 3 bottles of the urine quality control product prepared in the example 1 are taken and subjected to freeze thawing for 3 times, 7 times, 10 times and 14 times respectively at the temperature of-20 ℃, each bottle is subjected to detection for 1 time, the measured values of all items are detected, and the detection results are all in a given range. The results are detailed in Table 14.
TABLE 14 Freeze thaw stability test results
Note: the positive strength range is represented by + to + and the positive strength range is evaluated by the test strip evaluation standard of mainstream manufacturers, and the positive strength range is represented by the + quantity; ± means weak positive; negative is indicated.
And (3) investigating the stability at room temperature: 3 bottles of the urine quality control product prepared in the example 1 are examined for 3 days, 7 days, 14 days, 21 days, 28 days and 35 days respectively at the room temperature of 25 ℃, the detection is carried out for 1 time in each bottle, the measured values of all items are detected, and the detection results are all in a given range. The results are detailed in Table 15.
TABLE 15 Room temperature stability Studies
Note: the positive strength range is represented by + to + and the positive strength range is evaluated by the test strip evaluation standard of mainstream manufacturers, and the positive strength range is represented by the + quantity; ± means weak positive; negative is indicated.
And (3) investigating the real-time stability after transportation: the 3 bottles of the urine quality control product prepared in the example 1 are taken and immediately detected 7 days after simulated vehicle-mounted transportation, and are stored at the temperature of 2-8 ℃ for 1 time per bottle at the 8 th month, the 12 th month, the 18 th month and the 24 th month after transportation, and the detection result is within the given range. The results are detailed in Table 16.
TABLE 16 post-Transportment real-time stability
Note: the positive strength range is represented by + to + and the positive strength range is evaluated by the test strip evaluation standard of mainstream manufacturers, and the positive strength range is represented by the + quantity; ± means weak positive; negative is indicated.
From the stability investigation result, the quality control of the chemical analysis of the urine prepared in the example 2 has good stability.
Comparative example
In the process of technical development, the applicant not only makes a large amount of research on screening of the urine quality control index substitutes. Through screening the raw materials of the urine quality control index substitutes, the pollution harm is reduced as much as possible, and the technical cost is reduced. There has also been a great deal of research into the effect of formulation technology on product performance. Taking example 1 as an example, if the ketone body substitute is added to the aqueous solution in the process of preparing the solution A, the ketone body sensitivity is not high, the stability is extremely poor, and the signal value of the ketone body is reduced to be negative after being placed for 1 day at normal temperature. In the preparation of solution A in example 1, too short stirring time for dissolving ketone body leads to insufficient sensitivity, and too long stirring time leads to reduced stability. If the urobilinogen substitute is added in the process of preparing the solution A, the urobilinogen substitute is difficult to dissolve, the sensitivity is lower, the appearance of the product is poorer, and the stability is obviously reduced. If other conditions are not changed, all the materials are sequentially added into the solution to prepare the finished product of the quality control product for the chemical analysis of the urine, the stability of all indexes is reduced, and the appearance is poor.
The foregoing is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, various modifications and decorations can be made without departing from the principle of the present invention, and these modifications and decorations should also be regarded as the protection scope of the present invention.
Claims (9)
1. A preparation method of a quality control product for chemical analysis of urine is characterized in that the quality control product comprises: buffer pair, ketone body substitute, urobilinogen substitute, sodium chloride, leukocyte substitute, bilirubin substitute, sodium nitrite, glucose, erythrocyte substitute, albumin substitute, preservative and water;
the ketone body substitute is one or more of acetylsalicylic acid, sodium levulinate, levulinic acid, ethyl acetoacetate sodium salt, methyl acetoacetate sodium salt and triacetylacetone aluminum;
the urobilinogen substitute is one or more of 2, 4-dimethyl-1H-pyrrole-3-carboxylic acid, 2, 4-dimethyl pyrrole-3, 5-dicarboxylic acid, N-methyl pyrrolidone and 5-hydroxy-2-methyl-indole;
the bilirubin substitute is 8-phenylaminonaphthalene-1-sulfonic acid ammonium salt;
the buffer pair consists of disodium hydrogen phosphate dodecahydrate and potassium dihydrogen phosphate;
the preparation method comprises the following steps:
step 1, preparing a semi-finished product A:
(1) adding part of disodium hydrogen phosphate dodecahydrate of the formula amount into part of water of the formula amount, and stirring for dissolving;
(2) adding a ketone substitute into the solution prepared in the step (1), and stirring and dissolving for 5-20 minutes;
(3) adding a urobilinogen substitute into the solution prepared in the step (2), and stirring and dissolving for 10-30 minutes;
(4) sequentially adding sodium chloride, a bilirubin substitute, sodium nitrite and a part of potassium dihydrogen phosphate according to the formula amount into the solution prepared in the step (3), and stirring and dissolving for 5-15 minutes to obtain a semi-finished product A;
step 2, preparing a semi-finished product B:
(1) adding the rest of disodium hydrogen phosphate dodecahydrate into the rest of water, and stirring for dissolving;
(2) adding a leukocyte substitute and the balance of potassium dihydrogen phosphate into the solution prepared in the step (1), and stirring and dissolving for 5-15 minutes;
(3) sequentially adding glucose, a red blood cell substitute, an albumin substitute and a preservative into the solution prepared in the step (2), stirring and dissolving for 5-30 minutes, and standing for 2-3 hours to obtain a semi-finished product B;
and 3, mixing the semi-finished product A and the semi-finished product B to obtain the urine chemical analysis quality control product.
2. The preparation method according to claim 1, wherein the concentration of each component in the quality control product is as follows:
3. the method of claim 1, wherein the leukocyte substitute is an esterase.
4. The method of claim 1, wherein the red blood cell substitute is bovine hemoglobin.
5. The method of claim 1, wherein the albumin substitute is bovine serum albumin.
6. The method of claim 1, wherein the preservative is Proclin 300.
7. The preparation method of claim 1, wherein the pH value of the urine chemical analysis quality control substance is 6.0-8.5.
8. The method according to any one of claims 1 to 8, wherein in the preparation of the semi-finished product A, the disodium hydrogen phosphate dodecahydrate used in the step (1) is 1/7 to 6/7; the dosage of the potassium dihydrogen phosphate in the step (4) is 1/8.5-7.5/8.5 of the formula.
9. The production method according to any one of claims 1 to 8,
in the preparation of the semi-finished product A, the pH value of the solution prepared in the step (2) is 9.5-11.5; the pH value of the solution prepared in the step (3) is 8.0-9.5; the pH value of the semi-finished product A prepared in the step (4) is 5.5-8.5;
in the preparation of the semi-finished product B, the pH value of the solution prepared in the step (2) is 7.0-8.5; the pH value of the solution prepared in the step (3) is 6.0-8.5.
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