CN112067399B - 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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- CN112067399B CN112067399B CN202010989321.4A CN202010989321A CN112067399B CN 112067399 B CN112067399 B CN 112067399B CN 202010989321 A CN202010989321 A CN 202010989321A CN 112067399 B CN112067399 B CN 112067399B
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- 210000002700 urine Anatomy 0.000 title claims abstract description 91
- 238000003908 quality control method Methods 0.000 title claims abstract description 86
- 239000000126 substance Substances 0.000 title claims abstract description 58
- 238000004458 analytical method Methods 0.000 title claims abstract description 55
- 238000002360 preparation method Methods 0.000 title claims abstract description 33
- 239000000047 product Substances 0.000 claims abstract description 74
- 239000011265 semifinished product Substances 0.000 claims abstract description 45
- 238000003756 stirring Methods 0.000 claims abstract description 44
- 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 30
- 238000000034 method Methods 0.000 claims abstract description 22
- 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 21
- 150000002576 ketones Chemical class 0.000 claims abstract description 21
- 229910000402 monopotassium phosphate Inorganic materials 0.000 claims abstract description 19
- 235000019796 monopotassium phosphate Nutrition 0.000 claims abstract description 19
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims abstract description 18
- LPXPTNMVRIOKMN-UHFFFAOYSA-M sodium nitrite Chemical compound [Na+].[O-]N=O LPXPTNMVRIOKMN-UHFFFAOYSA-M 0.000 claims abstract description 18
- GNSKLFRGEWLPPA-UHFFFAOYSA-M potassium dihydrogen phosphate Chemical compound [K+].OP(O)([O-])=O GNSKLFRGEWLPPA-UHFFFAOYSA-M 0.000 claims abstract description 15
- LWIHDJKSTIGBAC-UHFFFAOYSA-K potassium phosphate Substances [K+].[K+].[K+].[O-]P([O-])([O-])=O LWIHDJKSTIGBAC-UHFFFAOYSA-K 0.000 claims abstract description 15
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 15
- 108010088751 Albumins Proteins 0.000 claims abstract description 14
- 102000009027 Albumins Human genes 0.000 claims abstract description 14
- 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 12
- 239000008103 glucose Substances 0.000 claims abstract description 12
- 239000003755 preservative agent Substances 0.000 claims abstract description 11
- 230000008569 process Effects 0.000 claims abstract description 11
- 230000002335 preservative effect Effects 0.000 claims abstract description 10
- AXMKEYXDFDKKIO-UHFFFAOYSA-N bilane Chemical compound C=1C=C(CC=2NC(CC=3NC=CC=3)=CC=2)NC=1CC1=CC=CN1 AXMKEYXDFDKKIO-UHFFFAOYSA-N 0.000 claims abstract description 9
- 210000003743 erythrocyte Anatomy 0.000 claims abstract description 9
- 239000011780 sodium chloride Substances 0.000 claims abstract description 9
- 235000010288 sodium nitrite Nutrition 0.000 claims abstract description 9
- 210000000265 leukocyte Anatomy 0.000 claims abstract description 8
- 238000004090 dissolution Methods 0.000 claims abstract description 7
- 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 description 16
- 102000001554 Hemoglobins Human genes 0.000 claims description 7
- 108010054147 Hemoglobins Proteins 0.000 claims description 7
- 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
- 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
- PJNZPQUBCPKICU-UHFFFAOYSA-N phosphoric acid;potassium Chemical compound [K].OP(O)(O)=O PJNZPQUBCPKICU-UHFFFAOYSA-N 0.000 claims description 4
- 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 3
- 108090000371 Esterases Proteins 0.000 claims description 2
- SECXISVLQFMRJM-UHFFFAOYSA-N N-Methylpyrrolidone Chemical group CN1CCCC1=O SECXISVLQFMRJM-UHFFFAOYSA-N 0.000 claims description 2
- 239000003633 blood substitute Substances 0.000 claims description 2
- -1 leukocyte substitute Chemical compound 0.000 claims description 2
- 125000005273 2-acetoxybenzoic acid group Chemical group 0.000 claims 1
- 229960001138 acetylsalicylic acid Drugs 0.000 claims 1
- 238000001514 detection method Methods 0.000 abstract description 14
- 238000005353 urine analysis Methods 0.000 abstract description 4
- 239000000243 solution Substances 0.000 description 47
- 238000012360 testing method Methods 0.000 description 21
- 238000011835 investigation Methods 0.000 description 18
- 238000011156 evaluation Methods 0.000 description 16
- 230000000007 visual effect Effects 0.000 description 12
- 239000002994 raw material Substances 0.000 description 10
- 239000007788 liquid Substances 0.000 description 7
- 238000010257 thawing Methods 0.000 description 6
- 210000004369 blood Anatomy 0.000 description 5
- 239000008280 blood Substances 0.000 description 5
- 230000000694 effects Effects 0.000 description 5
- AGCGGNCZCFZBNN-UHFFFAOYSA-M sodium;2-methyl-3-oxobutanoate Chemical compound [Na+].CC(=O)C(C)C([O-])=O AGCGGNCZCFZBNN-UHFFFAOYSA-M 0.000 description 5
- 238000013112 stability test Methods 0.000 description 5
- XBPJVSRTTKVMEN-UHFFFAOYSA-N 2,4-dimethyl-1h-pyrrole-3-carboxylic acid Chemical compound CC1=CNC(C)=C1C(O)=O XBPJVSRTTKVMEN-UHFFFAOYSA-N 0.000 description 4
- 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
- 238000005259 measurement Methods 0.000 description 4
- 239000008363 phosphate buffer Substances 0.000 description 4
- 238000007789 sealing Methods 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
- 230000005484 gravity Effects 0.000 description 3
- 239000011159 matrix material Substances 0.000 description 3
- 238000012986 modification Methods 0.000 description 3
- 230000004048 modification 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
- 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 description 2
- JOOXCMJARBKPKM-UHFFFAOYSA-N 4-oxopentanoic acid Chemical compound CC(=O)CCC(O)=O JOOXCMJARBKPKM-UHFFFAOYSA-N 0.000 description 2
- 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
- 238000003745 diagnosis Methods 0.000 description 2
- 238000007710 freezing Methods 0.000 description 2
- 230000008014 freezing Effects 0.000 description 2
- 238000007689 inspection Methods 0.000 description 2
- 239000000843 powder Substances 0.000 description 2
- 239000004094 surface-active agent Substances 0.000 description 2
- 238000012795 verification Methods 0.000 description 2
- MDWJZBVEVLTXDE-UHFFFAOYSA-N 2-methyl-1h-indol-5-ol Chemical compound OC1=CC=C2NC(C)=CC2=C1 MDWJZBVEVLTXDE-UHFFFAOYSA-N 0.000 description 1
- BSYNRYMUTXBXSQ-FOQJRBATSA-N 59096-14-9 Chemical compound CC(=O)OC1=CC=CC=C1[14C](O)=O BSYNRYMUTXBXSQ-FOQJRBATSA-N 0.000 description 1
- 238000008789 Direct Bilirubin Methods 0.000 description 1
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 description 1
- XDILZEPJCPEDLT-UHFFFAOYSA-N [Na].[O-][N+]1=CC=CC=C1S Chemical compound [Na].[O-][N+]1=CC=CC=C1S XDILZEPJCPEDLT-UHFFFAOYSA-N 0.000 description 1
- 230000006978 adaptation Effects 0.000 description 1
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 1
- 229910052782 aluminium Inorganic materials 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 238000010876 biochemical test Methods 0.000 description 1
- 238000009534 blood test Methods 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
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 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
- JDPRRECMRPCSIF-UHFFFAOYSA-N ethyl 3-oxobutanoate;sodium Chemical compound [Na].CCOC(=O)CC(C)=O JDPRRECMRPCSIF-UHFFFAOYSA-N 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
- 229940040102 levulinic acid Drugs 0.000 description 1
- 239000000463 material Substances 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
- 238000013441 quality evaluation Methods 0.000 description 1
- 229940058349 sodium levulinate Drugs 0.000 description 1
- RDKYCKDVIYTSAJ-UHFFFAOYSA-M sodium;4-oxopentanoate Chemical compound [Na+].CC(=O)CCC([O-])=O RDKYCKDVIYTSAJ-UHFFFAOYSA-M 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 208000014001 urinary system disease Diseases 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
Abstract
The invention relates to the field of urine analysis and detection, in particular to a preparation method of a urine chemical analysis quality control product. The method comprises the following steps: adding part of disodium hydrogen phosphate dodecahydrate into part of water, stirring and dissolving; adding ketone body substitute into the solution, stirring and dissolving; adding a urine bilinogen substitute into the solution, and stirring for dissolution; sequentially adding sodium chloride, bilirubin substitutes, sodium nitrite and partial formula amount of monopotassium phosphate into the solution, and stirring and dissolving to obtain a semi-finished product A; adding the balance of disodium hydrogen phosphate dodecahydrate into the balance of water, stirring and dissolving; adding a white blood cell substitute and the balance of monopotassium phosphate into the solution, stirring and dissolving; sequentially adding glucose, red blood cell substitute, albumin substitute and preservative into the solution, stirring and 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 urine chemical analysis quality control product.
Background
Urine routine is used as one of three routine examination, is not only the first choice and absolute necessity of diagnosis and curative effect observation of urinary system diseases, but also is helpful for diagnosis and treatment of other system diseases which can cause the change of biochemical components of blood. Urine chemical analysis project inter-room quality evaluation activities are carried out by all levels of temporary examination centers each year. The urine chemical analysis quality control product is used for quality control of a urine analyzer and a urine analysis test strip. The quality control can be performed on the detection of pH, albumin, glucose, ketone body, blood, nitrite, bilirubin, urobilinogen, leucocyte and specific gravity items. Compared with blood and biochemical tests, the urine analysis quality control difficulty is high, besides the method is not standardized, the steps of collecting, transporting and storing urine specimens are more, the control is difficult, the sensitivity and the fixed value standard of test strips and analyzers of various manufacturers are different, and the test strips and the analyzers can be monitored relatively easily by using the quality control product.
Cui Yunlong (preparation of urine quality control substance and clinical preliminary application experience. Shanxi J.medicine, 1986, 15 (3): 185) the urine quality control substance is prepared by taking normal human urine as a basic matrix solution, so that the matrix effect is eliminated to a certain extent, but a large amount of normal human urine with stable quality is difficult to obtain, and meanwhile, the urine of normal human is different due to the difference of individual living habits, so that the batch-to-batch difference of the quality control substance is larger. The use of a large amount of urine can pollute the environment, and the treatment of pathological urine can also pose a threat to the health of operators. The urine is high in treatment and preservation cost. These are drawbacks of such techniques.
Before using, a certain amount of water is needed to dissolve the freeze-dried powder quality control product, and then the freeze-dried powder quality control product is poured into a container for use. Such quality control is inconvenient to use and is prone to causing operational errors. The liquid is dissolved into the liquid and then needs to be used in time, so that the liquid is unstable and can not be stored, and waste is caused.
In order to avoid the problems of difficult quality control, environmental pollution and the like caused by adopting urine as a basic matrix liquid to prepare the urine quality control product. The prior art also commonly adopts chemical raw materials as substitutes for various detection indexes of urine to prepare urine quality control products. For example, chinese patent publication No. CN106771112A discloses a multi-item composite urine quality control liquid. Acetone, ethyl acetoacetate and the like are used as ketone body substitutes, direct bilirubin, 1-naphthalene sulfonate and the like are used as bilirubin substitutes, indole, pyrrole and derivatives thereof are used as urine bilinogen substitutes, and a plurality of composite urine quality control liquids are prepared. However, because more organic chemical raw materials are adopted, in order to solve the problems of raw material solubility and product stability, the product is added with cosolvent and stabilizer such as tween, poloxamer and the like, so that the cost is increased, the stability is not ideal, meanwhile, the use of 2-mercaptopyridine oxide sodium salt can cause false positive of ketone bodies and also can interfere with the detection of hemoglobin. In the preparation of urine quality control products in documents and patents, cosolvents such as surfactants and stabilizers or use are often used in consideration of the problems of raw material solubility and product stability.
Disclosure of Invention
In view of the above, the invention provides a preparation method of a urine chemical analysis quality control product. 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 urine chemical analysis quality control product, which comprises the following steps: buffer pair, ketone body substitute, urine bilinogen 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 aluminum triacetylacetonate;
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-ammonium sulfonate;
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 the formula amount of disodium hydrogen phosphate dodecahydrate into part of the formula amount of water, and stirring for dissolution;
(2) Adding the ketone body substitute into the solution prepared in the step (1), and stirring and dissolving for 5-20 minutes;
(3) Adding a urine bilinogen substitute into the solution prepared in the step (2), and stirring and dissolving for 10-30 minutes;
(4) Sequentially adding sodium chloride, bilirubin substitutes, sodium nitrite and partial formula amount of monopotassium phosphate 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 balance of disodium hydrogen phosphate dodecahydrate into the balance of water, stirring and dissolving;
(2) Adding a white blood cell substitute and the balance of monopotassium phosphate into the solution prepared in the step (1), and stirring and dissolving for 5-15 minutes;
(3) Sequentially adding glucose, red blood cell substitutes, albumin substitutes and preservatives 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 dosage; the dosage of the monopotassium phosphate in the step (4) is 1/8.5-7.5/8.5 of the formula dosage.
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 urine chemical analysis quality control product. The preparation method comprises the following steps: adding part of the formula amount of disodium hydrogen phosphate dodecahydrate into part of the formula amount of water, and stirring for dissolution; adding ketone body substitutes into the solution, stirring and dissolving for 5-20 minutes; adding a urine bilinogen substitute into the solution, stirring and dissolving for 10-30 minutes; sequentially adding sodium chloride, bilirubin substitutes, sodium nitrite and partial formula amount of monopotassium phosphate into the solution, stirring and dissolving for 5-15 minutes to obtain a semi-finished product A; adding the balance of disodium hydrogen phosphate dodecahydrate into the balance of water, stirring and dissolving; adding a white blood cell substitute and the balance of monopotassium phosphate into the solution, stirring and dissolving for 5-15 minutes; sequentially adding glucose, a red blood cell substitute, an albumin substitute and a preservative into the solution, 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. By adopting 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 solvents, surfactants, stabilizers, cosolvents and other raw materials, and have the advantages of small pollution, low cost, simple process and good product stability. According to the invention, a great number of researches show that the urine chemical analysis quality control product is not only related to screening of preparation raw materials, but also has important influence on product stability and quality control accuracy due to the preparation process of urine quality control liquid. The invention adopts the technology that the chemical raw material substitute is firstly prepared into the solution A, the animal source raw material is prepared into the solution B, and then the solution A and the solution B are mixed to prepare the urine chemical analysis quality control product. Not only eliminates the influence of chemical raw material substitutes on animal-derived raw material substitutes in the preparation process. And the addition sequence, dissolution pH condition, dissolution time and other process conditions 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 urine chemical analysis quality control product, and a person skilled in the art can properly improve the process parameters by referring to the content of the invention. It is expressly noted that all such similar substitutions and modifications will be apparent to those skilled in the art, and are deemed to be included in the present invention. While the methods and applications of this invention have been described in terms of preferred embodiments, it will be apparent to those skilled in the relevant art that variations and modifications can be made in the methods and applications described herein, and in the practice and application of the techniques of this invention, without departing from the spirit or 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 urine chemical analysis quality control article, which comprises:
wherein the buffer pair is a 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 urobilinogen substitute is 2, 4-dimethyl-1H-pyrrole-3-carboxylic acid; the leucocyte substitute is lipase; the bilirubin substitute is 8-anilinonaphthalene-1-ammonium sulfonate; 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 urine chemical analysis quality control product 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 methyl acetoacetate sodium salt 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) Sequentially adding 5g of sodium chloride into the solution prepared in the step (3) while stirring; 1g of 8-phenylaminonaphthalene-1-sulfonic acid ammonium salt; 10mg of sodium nitrite and 3g of monopotassium phosphate are stirred for 15 minutes to be fully dissolved, thus obtaining a semi-finished product A of the urine chemical analysis quality control product, wherein the pH value of the semi-finished product A solution is 7.0-8.5;
2. the preparation of the semi-finished product B of the urine chemical analysis quality control product comprises the following steps:
(1) 2g of disodium hydrogen phosphate dodecahydrate is added into 500mL of water and stirred to be fully dissolved;
(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) Sequentially adding 20g of glucose, 0.05g of bovine hemoglobin, 1g of bovine serum albumin and 0.5g of preservative Proclin 300 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 semi-finished product B solution is 6.0-7.0.
3. And (3) mixing and uniformly 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 prepared in the step (1) and the step (2) 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.
Stability verification test:
the prepared solution is subjected to uniformity, unsealing stability at 2-8 ℃, accelerating stability at 37 ℃, simulated transportation stability, serial stability, freeze thawing stability, room temperature stability and real-time stability after transportation, and the results are as follows:
uniformity investigation: taking 10 bottles of the urine chemical analysis quality control product prepared in the example 1, detecting the quality control product for 1 time, wherein the consistency degree of detection results of specific gravity, pH, albumin, glucose, ketone body, blood, nitrite, bilirubin, urobilinogen and leucocytes and the nominal value is 100%. The results are detailed in Table 1.
Table 1 results of homogeneity investigation
Note that: the positive intensity range is evaluated by test paper strip evaluation standards of mainstream manufacturers, and the positive intensity is represented by the number of the positive intensity; + -indicates weak positives; -negative.
2-8deg.C unsealing stability investigation: taking 3 bottles of the urine chemical analysis quality control product prepared in the example 1, unsealing, sealing and storing at 2-8 ℃ in a dark place, checking for 7 days, 14 days, 21 days, 28 days and 35 days respectively, detecting 1 time per bottle, and detecting each visual fixed value, wherein the results are all within a given range. The results are detailed in Table 2.
Table 2 results of examining the opening stability
Note that: the positive intensity range is evaluated by test paper strip evaluation standards of mainstream manufacturers, and the positive intensity is represented by the number of the positive intensity; + -indicates weak positives; -negative.
Accelerated stability investigation at 37℃: taking 3 bottles of the urine chemical analysis quality control product prepared in the example 1, and checking each bottle for 1 time in 3 days, 7 days, 10 days, 14 days and 18 days respectively at 37 ℃; the results of the accelerated failure 14 at 37℃are also within the range of nominal values, and are shown in Table 3.
TABLE 3 results of accelerated stability studies at 37℃
Note that: the positive intensity range is evaluated by test paper strip evaluation standards of mainstream manufacturers, and the positive intensity is represented by the number of the positive intensity; + -indicates weak positives; -negative.
Transportation stability investigation: taking 3 bottles of the quality control product prepared in the example 1, simulating vehicle-mounted transportation in 37 ℃ environment, respectively checking for 7 days, 14 days and 18 days, checking each bottle for 1 time, and checking each visual fixed value, wherein the results are all within a given range. The results are detailed in Table 4.
Table 4 transport stability test results
Note that: the positive intensity range is evaluated by test paper strip evaluation standards of mainstream manufacturers, and the positive intensity is represented by the number of the positive intensity; + -indicates weak positives; -negative.
Series stability investigation: taking 3 bottles of the urine chemical analysis quality control product prepared in the embodiment 1, respectively simulating vehicle-mounted examination for 14 days at 37 ℃, unsealing, sealing and storing for 18 days at 2-8 ℃ in a dark place, detecting for 1 time in each bottle, and ensuring that all visual examination values meet the requirements. The results are detailed in Table 5.
Table 5 series stability test results
Note that: the positive intensity range is evaluated by test paper strip evaluation standards of mainstream manufacturers, and the positive intensity is represented by the number of the positive intensity; + -indicates weak positives; -negative.
Freeze thawing stability investigation: taking 3 bottles of the urine quality control product prepared in the example 1, respectively checking freezing and thawing for 3 times, 7 times, 10 times and 14 times under the environment of-20 ℃, detecting 1 time for each bottle, and detecting each visual measurement value, wherein the detection results are all in a given range. The results are detailed in Table 6.
TABLE 6 freeze-thaw stability investigation results
Note that: the positive intensity range is evaluated by test paper strip evaluation standards of mainstream manufacturers, and the positive intensity is represented by the number of the positive intensity; + -indicates weak positives; -negative.
Room temperature stability study: taking 3 bottles of the urine quality control product prepared in the example 1, and checking for 3 days, 7 days, 14 days, 21 days, 28 days and 35 days respectively under the environment of room temperature and 25 ℃, detecting for 1 time per bottle, and detecting each visual measurement value, wherein the detection results are all in a given range. The results are detailed in Table 7.
Table 7 examination of room temperature stability
Note that: the positive intensity range is evaluated by test paper strip evaluation standards of mainstream manufacturers, and the positive intensity is represented by the number of the positive intensity; + -indicates weak positives; -negative.
Real-time stability inspection after transportation: taking 3 bottles of the urine quality control product prepared in the embodiment 1, immediately detecting after 7 days of simulated vehicle transportation, storing in 8 th month, 12 th month, 18 th month and 24 th month after transportation at the temperature of 2-8 ℃, detecting 1 time per bottle, and detecting each visual fixed value, wherein the detection results are all in a given range. The results are detailed in Table 8.
Table 8 real-time stability after shipping
Note that: the positive intensity range is evaluated by test paper strip evaluation standards of mainstream manufacturers, and the positive intensity is represented by the number of the positive intensity; + -indicates weak positives; -negative.
From the stability investigation result, the urine chemical analysis quality control level prepared in the example 1 has good stability.
Example 2
The embodiment provides a urine chemical analysis quality control article, which comprises:
wherein the buffer pair is a 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 urobilinogen substitute is 2, 4-dimethyl-1H-pyrrole-3-carboxylic acid; the leucocyte substitute is lipase; the bilirubin substitute is 8-anilinonaphthalene-1-ammonium sulfonate; 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 urine chemical analysis quality control product comprises the following steps:
(1) 2g of disodium hydrogen phosphate dodecahydrate is added into 500mL of water and stirred to be fully dissolved;
(2) Adding 3g of methyl acetoacetate sodium salt 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) Sequentially stirring 15g of sodium chloride into the solution prepared in the step (3); 0.1g of 8-anilinonaphthalene-1-sulfonic acid ammonium salt; 20mg of sodium nitrite and 0.4g of monopotassium phosphate are stirred for 5 to 15 minutes, so that the semi-finished product A of the urine chemical analysis quality control product is obtained, the pH value of the semi-finished product A solution is 6.0 to 7.0, and the semi-finished product A solution is placed for standby.
2. The preparation of the semi-finished product B of the urine chemical analysis quality control product 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) Adding 4g of glucose, 1g of bovine hemoglobin, 6g of bovine serum albumin and 5g of preservative Proclin 300 into the solution prepared in the step (2) in sequence while stirring, stirring for 30 minutes, fully dissolving, and standing for 2-3 hours to obtain a semi-finished product B of urine chemical analysis quality control, wherein the pH value of the solution of the semi-finished product B is 7.0-8.5.
3. And (3) uniformly 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 prepared in the step (1) and the step (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.
Stability verification test:
the prepared solution is subjected to uniformity, unsealing stability at 2-8 ℃, accelerating stability at 37 ℃, simulated transportation stability, serial stability, freeze thawing stability, room temperature stability and real-time stability after transportation, and the results are as follows:
uniformity investigation: taking 10 bottles of the urine chemical analysis quality control product prepared in the example 1, detecting the quality control product for 1 time, wherein the consistency degree of detection results of specific gravity, pH, albumin, glucose, ketone body, blood, nitrite, bilirubin, urobilinogen and leucocytes and the nominal value is 100%. The results are detailed in Table 9.
Table 9 results of uniformity investigation
Note that: the positive intensity range is evaluated by test paper strip evaluation standards of mainstream manufacturers, and the positive intensity is represented by the number of the positive intensity; + -indicates weak positives; -negative.
2-8deg.C unsealing stability investigation: taking 3 bottles of the urine chemical analysis quality control product prepared in the example 1, unsealing, sealing and storing at 2-8 ℃ in a dark place, checking for 7 days, 14 days, 21 days, 28 days and 35 days respectively, detecting 1 time per bottle, and detecting each visual fixed value, wherein the results are all within a given range. The results are detailed in Table 10.
Table 10 results of examination of opening stability
Note that: the positive intensity range is evaluated by test paper strip evaluation standards of mainstream manufacturers, and the positive intensity is represented by the number of the positive intensity; + -indicates weak positives; -negative.
Accelerated stability investigation at 37℃: taking 3 bottles of the urine chemical analysis quality control product prepared in the example 1, and checking each bottle for 1 time in 3 days, 7 days, 10 days, 14 days and 18 days respectively at 37 ℃; the results of the accelerated failure 14 at 37℃are also within the range of the nominal values, and the results are shown in Table 11.
Table 11 results of accelerated stability test at 37 ℃
Note that: the positive intensity range is evaluated by test paper strip evaluation standards of mainstream manufacturers, and the positive intensity is represented by the number of the positive intensity; + -indicates weak positives; -negative.
Transportation stability investigation: taking 3 bottles of the quality control product prepared in the example 1, simulating vehicle-mounted transportation in 37 ℃ environment, respectively checking for 7 days, 14 days and 18 days, checking each bottle for 1 time, and checking each visual fixed value, wherein the results are all within a given range. The results are detailed in Table 12.
Table 12 transport stability test results
Note that: the positive intensity range is evaluated by test paper strip evaluation standards of mainstream manufacturers, and the positive intensity is represented by the number of the positive intensity; + -indicates weak positives; -negative.
Series stability investigation: taking 3 bottles of the urine chemical analysis quality control product prepared in the embodiment 1, respectively simulating vehicle-mounted examination for 14 days at 37 ℃, unsealing, sealing and storing for 18 days at 2-8 ℃ in a dark place, detecting for 1 time in each bottle, and ensuring that all visual examination values meet the requirements. The results are detailed in Table 13.
TABLE 13 series stability test results
Note that: the positive intensity range is evaluated by test paper strip evaluation standards of mainstream manufacturers, and the positive intensity is represented by the number of the positive intensity; + -indicates weak positives; -negative.
Freeze thawing stability investigation: taking 3 bottles of the urine quality control product prepared in the example 1, respectively checking freezing and thawing for 3 times, 7 times, 10 times and 14 times under the environment of-20 ℃, detecting 1 time for each bottle, and detecting each visual measurement value, wherein the detection results are all in a given range. The results are detailed in Table 14.
TABLE 14 freeze-thaw stability investigation results
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Note that: the positive intensity range is evaluated by test paper strip evaluation standards of mainstream manufacturers, and the positive intensity is represented by the number of the positive intensity; + -indicates weak positives; -negative.
Room temperature stability study: taking 3 bottles of the urine quality control product prepared in the example 1, and checking for 3 days, 7 days, 14 days, 21 days, 28 days and 35 days respectively under the environment of room temperature and 25 ℃, detecting for 1 time per bottle, and detecting each visual measurement value, wherein the detection results are all in a given range. The results are detailed in Table 15.
Table 15 examination of room temperature stability
Note that: the positive intensity range is evaluated by test paper strip evaluation standards of mainstream manufacturers, and the positive intensity is represented by the number of the positive intensity; + -indicates weak positives; -negative.
Real-time stability inspection after transportation: taking 3 bottles of the urine quality control product prepared in the embodiment 1, immediately detecting after 7 days of simulated vehicle transportation, storing in 8 th month, 12 th month, 18 th month and 24 th month after transportation at the temperature of 2-8 ℃, detecting 1 time per bottle, and detecting each visual fixed value, wherein the detection results are all in a given range. The results are detailed in Table 16.
Table 16 real-time stability after shipping
Note that: the positive intensity range is evaluated by test paper strip evaluation standards of mainstream manufacturers, and the positive intensity is represented by the number of the positive intensity; + -indicates weak positives; -negative.
From the stability investigation result, the urine chemical analysis quality control level prepared in the example 2 has good stability.
Comparative example
In the technical development process, the applicant has conducted a great deal of research on screening of urine quality control index substitutes. Through screening the urine quality control index substitute raw materials, pollution hazard is reduced as much as possible, and technical cost is reduced. A great deal of research is also being conducted on the effect of the formulation process on the product performance. Taking example 1 as an example, in the process of preparing the solution A, firstly, ketone body substitutes are added into the aqueous solution, so that the sensitivity of the ketone body is low, the stability is extremely poor, and the signal value of the ketone body is reduced to be negative after the ketone body is placed for 1 day at normal temperature. In the preparation of the solution A in example 1, the sensitivity is insufficient when the dissolution and stirring time of the ketone body is too short, and the stability is lowered when the stirring time is too long. If the urine bilinogen substitute is added in the process of preparing the solution A, the urine bilinogen substitute is difficult to dissolve, has lower sensitivity, and has poor appearance and obviously reduced stability. If other conditions are unchanged, each material is sequentially added into the solution to prepare the finished product of the urine chemical analysis quality control product, the stability of each index is reduced, and the appearance is poor.
The foregoing is merely a preferred embodiment of the present invention and it should be noted that modifications and adaptations to those skilled in the art may be made without departing from the principles of the present invention, which are intended to be comprehended within the scope of the present invention.
Claims (7)
1. A method for preparing a urine chemistry analysis quality control product, which is characterized in that the urine chemistry analysis quality control product comprises: buffer pair, ketone body substitute, urine bilinogen substitute, sodium chloride, leukocyte substitute, bilirubin substitute, sodium nitrite, glucose, erythrocyte substitute, albumin substitute, preservative and water;
the ketone body substitute is acetylsalicylic acid;
the urobilinogen substitute is N-methyl pyrrolidone;
the bilirubin substitute is 8-anilinonaphthalene-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 the formula amount of disodium hydrogen phosphate dodecahydrate into part of the formula amount of water, and stirring for dissolution;
(2) Adding the ketone body substitute into the solution prepared in the step (1), and stirring and dissolving for 5-20 minutes;
(3) Adding a urine bilinogen substitute into the solution prepared in the step (2), and stirring and dissolving for 10-30 minutes;
(4) Sequentially adding sodium chloride, bilirubin substitutes, sodium nitrite and partial formula amount of monopotassium phosphate 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:
(I) Adding the balance of disodium hydrogen phosphate dodecahydrate into the balance of water, stirring and dissolving;
(II) adding a white blood cell substitute and the balance of monopotassium phosphate into the solution prepared in the step (I), and stirring and dissolving for 5-15 minutes;
(III) sequentially adding glucose, a red blood cell substitute, an albumin substitute and a preservative into the solution prepared in the step (II), stirring and dissolving for 5-30 minutes, and standing for 2-3 hours to obtain a semi-finished product B;
step 3, mixing the semi-finished product A and the semi-finished product B to obtain a urine chemical analysis quality control product;
the urine chemical analysis quality control product comprises the following components in concentration:
5-25 g/L of disodium hydrogen phosphate dodecahydrate;
0.7-6 g/L of monopotassium phosphate;
3-12 g/L of ketone body substitute;
0.2-1.2 g/L of urobilinogen substitute;
5-15 g/L of sodium chloride;
0.4-1.0 g/L of leucocyte substitute;
0.1-1.0 g/L of bilirubin substitute;
10-20 mg/L of sodium nitrite;
glucose 4-20 g/L;
0.05-1 g/L of red blood cell substitute;
1-6 g/L of albumin substitute;
0.5-5 g/L of preservative;
the pH value of the urine chemical analysis quality control product is 6.0-8.5.
2. The method of claim 1, wherein the leukocyte substitute is an esterase.
3. The method of claim 1, wherein the red blood cell substitute is bovine hemoglobin.
4. The method of claim 1, wherein the albumin substitute is bovine serum albumin.
5. The method of claim 1, wherein the preservative is Proclin 300.
6. The process according to any one of claims 1 to 5, wherein in the preparation of the semifinished product a, the amount of disodium hydrogen phosphate dodecahydrate in step (1) is 1/7~6/7 of the formula amount; the dosage of the monopotassium phosphate in the step (4) is 1/8.5-7.5/8.5 of the formula dosage.
7. The process according to any one of claim 1 to 5, wherein,
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 (II) is 7.0-8.5; the pH value of the solution prepared in the step (III) is 6.0-8.5.
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