CN114134201A - Production process of 1, 5-dehydration-D-sorbitol detection reagent by adopting enzyme method - Google Patents

Production process of 1, 5-dehydration-D-sorbitol detection reagent by adopting enzyme method Download PDF

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CN114134201A
CN114134201A CN202111351153.7A CN202111351153A CN114134201A CN 114134201 A CN114134201 A CN 114134201A CN 202111351153 A CN202111351153 A CN 202111351153A CN 114134201 A CN114134201 A CN 114134201A
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reagent
solution
sorbitol
product
production
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袁嘉扬
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Suzhou Precise Biotechnology Co ltd
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Suzhou Precise Biotechnology Co ltd
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    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/48—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving transferase
    • C12Q1/485—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving transferase involving kinase
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/26—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving oxidoreductase
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/26—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving oxidoreductase
    • C12Q1/28—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving oxidoreductase involving peroxidase
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q2326/00—Chromogens for determinations of oxidoreductase enzymes
    • C12Q2326/90—Developer
    • C12Q2326/96—4-Amino-antipyrine
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/90—Enzymes; Proenzymes
    • G01N2333/902—Oxidoreductases (1.)
    • G01N2333/904—Oxidoreductases (1.) acting on CHOH groups as donors, e.g. glucose oxidase, lactate dehydrogenase (1.1)
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/90—Enzymes; Proenzymes
    • G01N2333/91—Transferases (2.)
    • G01N2333/912—Transferases (2.) transferring phosphorus containing groups, e.g. kinases (2.7)
    • G01N2333/91205—Phosphotransferases in general
    • G01N2333/9121—Phosphotransferases in general with an alcohol group as acceptor (2.7.1), e.g. general tyrosine, serine or threonine kinases
    • G01N2333/91215—Phosphotransferases in general with an alcohol group as acceptor (2.7.1), e.g. general tyrosine, serine or threonine kinases with a definite EC number (2.7.1.-)

Abstract

The invention provides a production process of a1, 5-dehydration-D-sorbitol detection reagent by adopting an enzyme method, and relates to the field. The production process of the 1, 5-dehydration-D-sorbitol detection reagent based on the enzyme method comprises the processes of preparing a reagent R1 and a reagent R2, preparing a calibrator and a quality control product, subpackaging and assigning, checking and checking, labeling and assembling. According to the invention, by marking key working procedures and detection control points, each operation step is standardized, the reliability and consistency of product production are ensured, the production efficiency is improved, the defective rate is reduced, and the practicability of the process is improved.

Description

Production process of 1, 5-dehydration-D-sorbitol detection reagent by adopting enzyme method
Technical Field
The invention relates to the technical field of detection reagent production processes, in particular to a production process of a1, 5-dehydration-D-sorbitol detection reagent by adopting an enzyme method.
Background
1, 5-anhydrosorbitol (1,5-AG), also known as 1, 5-anhydroglucitol, is a six-carbon monosaccharide having a pyranoid ring structure. The content of 1, 5-sorbitan in human blood and the existing diabetes indexes (such as glucose, glycosylated hemoglobin and glycosylated albumin) show obvious negative correlation, can accurately reflect the average blood sugar level of a patient from several days to a week, and is an important index for diagnosing and confirming the treatment effect of diabetes. In addition, 1,5-AG has other clinical applications, for example, as an indicator of the incidence of postprandial hyperglycemia-related cardiovascular risk in non-diabetic patients; can also well reflect the renal tubule reabsorption function of the chronic renal failure patients, and the like.
The existing production process of the 1, 5-dehydration-D-sorbitol detection reagent has the advantages of low production efficiency, high defective rate, low detection precision, production cost improvement and further improvement space.
Disclosure of Invention
Technical problem to be solved
Aiming at the defects of the prior art, the invention provides a production process of a1, 5-dehydration-D-sorbitol detection reagent by adopting an enzyme method, which solves the problems of high defective rate, low detection precision and increased production cost.
(II) technical scheme
In order to achieve the purpose, the invention is realized by the following technical scheme: a production process of a1, 5-dehydration-D-sorbitol detection reagent by adopting an enzyme method comprises the following specific process flows:
s1, calculating and issuing a production instruction according to the order requirement, and issuing a production instruction list to a production part according to the production instruction;
s2, preparing a reagent R1 and a reagent R2 according to the production instruction list;
s3, preparing, subpackaging and assigning a calibration product and a quality control product simultaneously when preparing the reagent R1 and the reagent R2;
s4, after the reagent R1 and the reagent R2 are prepared, the prepared solution is stored in a semi-finished product tank for marking, and the semi-finished product is inspected by quality department inspectors;
s5, after the product is qualified, respectively subpackaging the reagent R1 and the reagent R2 by a liquid transfer device according to the product specification of the production instruction list;
s6, after subpackaging, labeling and assembling R1, R2, a calibrator and a quality control product according to the specification requirements on the product production instruction sheet, and performing finished product inspection and spot check by quality department inspectors;
and S7, warehousing the qualified product as a qualified product by using the kit which passes the finished product inspection by the quality department.
Preferably, the preparation process of the reagent R1 is as follows:
A1. production volume V of reagent R1 on production order sheet1(L) and concentration of the recipe TableCalculating to obtain the amount of the materials to be weighed;
A2. preparing a marked liquid preparation tank, firstly adding purified water with the preparation amount of 70% into the liquid preparation tank, accurately weighing trihydroxymethyl aminomethane, glucokinase, pyruvate kinase, phosphoenolpyruvate potassium, adenosine triphosphate and ProClin 950, putting into the liquid preparation tank, and putting onto a magnetic stirrer;
A3. turning on a power switch of the magnetic stirrer, adjusting a stirrer to 400 r/min to keep the solution in a rotating state, and stirring for 10 min;
A4. when the materials are completely dissolved, the solution is clear and transparent, no precipitate is left at the bottom of the solution preparation tank, and the pH value is adjusted to 7.30-7.50 by using 6 mol/L HCl. And adding purified water into the solution with the pH adjusted to the preparation amount.
Preferably, the preparation process of the reagent R2 is as follows:
B1. calculating the amount of the materials to be weighed according to the amount V2(L) of the produced reagent R2 on the production order sheet and the concentration of the process formula table;
B2. preparing an identified liquid preparation tank, firstly adding purified water with the preparation amount of 70% into the liquid preparation tank, accurately weighing trihydroxymethyl aminomethane, 4-aminoantipyrine, 3-hydroxy-2, 4, 6-triiodobenzoic acid, pyranose oxidase, peroxidase and ProClin 950, putting into the liquid preparation tank, and putting onto a magnetic stirrer;
B3. turning on a power switch of the magnetic stirrer, adjusting a stirrer to 400 r/min to keep the solution in a rotating state, and stirring for 10 min;
B4. when the materials are completely dissolved, the solution is clear and transparent, no precipitate is left at the bottom of the solution preparation tank, and the pH value is adjusted to 7.30-7.50 by using 6 mol/L HCl. And adding purified water into the solution with the pH adjusted to the preparation amount.
Preferably, the preparation process of the calibrator comprises the following steps:
C1. based on the target concentration of the calibrant and the projected production volume V of the calibrant3(L) calculating the amount of 1, 5-anhydro-D-sorbitol V1, 5-anhydro-D-sorbitols(L) the amount of production V of the calibrator on the basis of the production instruction sheet3(L) multiplying by 1.2 times to obtain the amount V of the diluentDiluent liquid(L)；
C2. Weighing and calculating stationDiluting the obtained material to obtain diluent, and calculating volume V according to calculated data3(L) - V1, 5-anhydro-D-sorbitols(L) dilution and volume V1, 5-anhydro-D-sorbitolsUniformly mixing the 1, 5-dehydration-D-sorbitol in the step (L), putting the mixture on a magnetic stirrer, turning on a power switch of the magnetic stirrer, adjusting a stirrer to 400 r/min, keeping the solution in a medium-speed rotating state, and stirring for 10 min;
C3. after blending, scaling by using a working calibrator, using a semi-finished reagent prepared in the same production batch as the reagent, taking 0.3 mL of the prepared calibrator, performing on-machine detection for three times, and calculating the average value of the three detection results;
C4. if the detection result exceeds the preparation concentration range, calculating and adding 1, 5-dehydration-D-sorbitol or diluent according to the difference between the result and the target concentration, and increasing or decreasing the concentration of the 1, 5-dehydration-D-sorbitol in the solution. After fully mixing, executing the steps until the calibrator is in the specified concentration range;
C5. storing the prepared calibrator solution in a semi-finished product tank, marking, subpackaging by using a pipettor according to specifications, and assigning values after subpackaging is finished;
C6. and after the assignment is completed, the quality part performs semi-finished product sampling inspection.
Preferably, the preparation process of the diluent comprises the following steps:
D1. calculating the amount of the materials to be weighed for preparing the diluent according to the concentration of the diluent process formula table;
D2. preparing an identified liquid preparation tank, firstly adding purified water with the preparation amount of 70% into the liquid preparation tank, accurately weighing trihydroxymethyl aminomethane, bovine albumin and ProClin 950, putting into the liquid preparation tank, and putting onto a magnetic stirrer;
D3. turning on a power switch of the magnetic stirrer, adjusting a stirrer to 400 r/min to keep the solution in a rotating state, and stirring for 10 min;
D4. when the materials are completely dissolved, the solution is clear and transparent, no precipitate is left at the bottom of the solution preparation tank, and the pH value is adjusted to 7.30-7.50 by using 6 mol/L HCl. And adding purified water into the solution with the pH adjusted to the preparation amount.
Preferably, the preparation process of the quality control product is the same as that of the calibrator, and the rotating speed of a stirrer of a magnetic stirrer during stirring of the diluent of the quality control product is 250 r/min.
Preferably, the target concentration of the calibrator is 30.0. mu.g/mL, and the product error is + -9.0. mu.g/mL.
Preferably, the target concentration of the quality control product is 20.0 mu g/mL, and the product error is +/-6.0 mu g/mL.
(III) advantageous effects
The invention provides a production process of a1, 5-dehydration-D-sorbitol detection reagent by adopting an enzyme method. The method has the following beneficial effects:
1. according to the invention, by marking key working procedures and detection control points, each operation step is standardized, the reliability and consistency of product production are ensured, the production efficiency is improved, the defective rate is reduced, and the practicability of the process is improved.
2. The kit produced by the invention utilizes the biological enzyme in the reagent for catalysis, has higher detection efficiency, improves the detection precision and enhances the practicability of the invention.
Drawings
FIG. 1 is a process flow diagram of the present invention.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
The first embodiment is as follows:
as shown in fig. 1, an embodiment of the present invention provides a production process of a1, 5-anhydro-D-sorbitol detection reagent using an enzymatic method, which comprises the following specific process flows:
s1, calculating and issuing a production instruction according to the order requirement, and issuing a production instruction list to a production part according to the production instruction;
s2, preparing a reagent R1 and a reagent R2 according to the production instruction list;
s3, preparing, subpackaging and assigning a calibration product and a quality control product simultaneously when preparing the reagent R1 and the reagent R2;
s4, after the reagent R1 and the reagent R2 are prepared, the prepared solution is stored in a semi-finished product tank for marking, and the semi-finished product is inspected by quality department inspectors;
s5, after the product is qualified, respectively subpackaging the reagent R1 and the reagent R2 by a liquid transfer device according to the product specification of the production instruction list;
s6, after subpackaging, labeling and assembling R1, R2, a calibrator and a quality control product according to the specification requirements on the product production instruction sheet, and performing finished product inspection and spot check by quality department inspectors;
and S7, warehousing the qualified product as a qualified product by using the kit which passes the finished product inspection by the quality department.
The process formula table of the reagent R1 is as follows:
Figure DEST_PATH_IMAGE001
the preparation process of the reagent R1 comprises the following steps:
A1. production volume V of reagent R1 on production order sheet1(L) calculating the concentration of the process formula table to obtain the amount of the materials to be weighed;
A2. preparing a marked liquid preparation tank, firstly adding purified water with the preparation amount of 70% into the liquid preparation tank, accurately weighing trihydroxymethyl aminomethane, glucokinase, pyruvate kinase, phosphoenolpyruvate potassium, adenosine triphosphate and ProClin 950, putting into the liquid preparation tank, and putting onto a magnetic stirrer;
A3. turning on a power switch of the magnetic stirrer, adjusting a stirrer to 400 r/min to keep the solution in a rotating state, and stirring for 10 min;
A4. when the materials are completely dissolved, the solution is clear and transparent, no precipitate is left at the bottom of the solution preparation tank, and the pH value is adjusted to 7.30-7.50 by using 6 mol/L HCl. Adding purified water into the solution after the pH is adjusted to a preparation amount;
reagent R2
Figure 86178DEST_PATH_IMAGE002
The preparation process of the reagent R2 comprises the following steps:
B1. calculating the amount of the materials to be weighed according to the amount V2(L) of the produced reagent R2 on the production order sheet and the concentration of the process formula table;
B2. preparing an identified liquid preparation tank, firstly adding purified water with the preparation amount of 70% into the liquid preparation tank, accurately weighing trihydroxymethyl aminomethane, 4-aminoantipyrine, 3-hydroxy-2, 4, 6-triiodobenzoic acid, pyranose oxidase, peroxidase and ProClin 950, putting into the liquid preparation tank, and putting onto a magnetic stirrer;
B3. turning on a power switch of the magnetic stirrer, adjusting a stirrer to 400 r/min to keep the solution in a rotating state, and stirring for 10 min;
B4. when the materials are completely dissolved, the solution is clear and transparent, no precipitate is left at the bottom of the solution preparation tank, and the pH value is adjusted to 7.30-7.50 by using 6 mol/L HCl. And adding purified water into the solution with the pH adjusted to the preparation amount.
The preparation process of the calibrator comprises the following steps:
C1. based on the target concentration of the calibrant and the projected production volume V of the calibrant3(L) calculating the amount of 1, 5-anhydro-D-sorbitol V1, 5-anhydro-D-sorbitols(L) the amount of production V of the calibrator on the basis of the production instruction sheet3(L) multiplying by 1.2 times to obtain the amount V of the diluentDiluent liquid(L)；
C2. Weighing the materials obtained by calculation, preparing a diluent, and after the preparation is finished, according to the calculation data, obtaining the volume V3(L) - V1, 5-anhydro-D-sorbitols(L) dilution and volume V1, 5-anhydro-D-sorbitolsUniformly mixing the 1, 5-dehydration-D-sorbitol in the step (L), putting the mixture on a magnetic stirrer, turning on a power switch of the magnetic stirrer, adjusting a stirrer to 400 r/min, keeping the solution in a medium-speed rotating state, and stirring for 10 min;
C3. after blending, scaling by using a working calibrator, using a semi-finished reagent prepared in the same production batch as the reagent, taking 0.3 mL of the prepared calibrator, performing on-machine detection for three times, and calculating the average value of the three detection results;
C4. if the detection result exceeds the preparation concentration range, calculating and adding 1, 5-dehydration-D-sorbitol or diluent according to the difference between the result and the target concentration, and increasing or decreasing the concentration of the 1, 5-dehydration-D-sorbitol in the solution. After fully mixing, executing the steps until the calibrator is in the specified concentration range;
C5. storing the prepared calibrator solution in a semi-finished product tank, marking, subpackaging by using a pipettor according to specifications, and assigning values after subpackaging is finished;
C6. after assignment is completed, the quality part is used for carrying out semi-finished product sampling inspection;
the formula table of the diluent process is as follows:
Figure DEST_PATH_IMAGE003
the preparation process of the diluent comprises the following steps:
D1. calculating the amount of the materials to be weighed for preparing the diluent according to the concentration of the diluent process formula table;
D2. preparing an identified liquid preparation tank, firstly adding purified water with the preparation amount of 70% into the liquid preparation tank, accurately weighing trihydroxymethyl aminomethane, bovine albumin and ProClin 950, putting into the liquid preparation tank, and putting onto a magnetic stirrer;
D3. turning on a power switch of the magnetic stirrer, adjusting a stirrer to 400 r/min to keep the solution in a rotating state, and stirring for 10 min;
D4. when the materials are completely dissolved, the solution is clear and transparent, no precipitate is left at the bottom of the solution preparation tank, and the pH value is adjusted to 7.30-7.50 by using 6 mol/L HCl. Adding purified water into the solution after the pH is adjusted to a preparation amount;
the preparation process of the quality control product is the same as that of the calibrator, the rotating speed of a stirrer of a magnetic stirrer is 250 r/min when the diluent of the quality control product is stirred, the target concentration of the calibrator is 30.0 mu g/mL, the product error is +/-9.0 mu g/mL, the target concentration of the quality control product is 20.0 mu g/mL, and the product error is +/-6.0 mu g/mL.
Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that changes, modifications, substitutions and alterations can be made in these embodiments without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.

Claims (8)

1. A production process of a1, 5-dehydration-D-sorbitol detection reagent by adopting an enzyme method comprises the following specific process flows:
s1, calculating and issuing a production instruction according to the order requirement, and issuing a production instruction list to a production part according to the production instruction;
s2, preparing a reagent R1 and a reagent R2 according to the production instruction list;
s3, preparing, subpackaging and assigning a calibration product and a quality control product simultaneously when preparing the reagent R1 and the reagent R2;
s4, after the reagent R1 and the reagent R2 are prepared, the prepared solution is stored in a semi-finished product tank for marking, and the semi-finished product is inspected by quality department inspectors;
s5, after the product is qualified, respectively subpackaging the reagent R1 and the reagent R2 by a liquid transfer device according to the product specification of the production instruction list;
s6, after subpackaging, labeling and assembling R1, R2, a calibrator and a quality control product according to the specification requirements on the product production instruction sheet, and performing finished product inspection and spot check by quality department inspectors;
and S7, warehousing the qualified product as a qualified product by using the kit which passes the finished product inspection by the quality department.
2. The process for producing a1, 5-anhydro-D-sorbitol detection reagent according to claim 1, wherein the step of using an enzymatic method comprises: the preparation process of the reagent R1 comprises the following steps:
A1. production volume V of reagent R1 on production order sheet1(L) calculating the concentration of the process formula table to obtain the amount of the materials to be weighed;
A2. preparing a marked liquid preparation tank, firstly adding purified water with the preparation amount of 70% into the liquid preparation tank, accurately weighing trihydroxymethyl aminomethane, glucokinase, pyruvate kinase, phosphoenolpyruvate potassium, adenosine triphosphate and ProClin 950, putting into the liquid preparation tank, and putting onto a magnetic stirrer;
A3. turning on a power switch of the magnetic stirrer, adjusting a stirrer to 400 r/min to keep the solution in a rotating state, and stirring for 10 min;
A4. when the materials are completely dissolved, the solution is clear and transparent, no precipitate is generated at the bottom of the solution preparation tank, the pH value is adjusted to 7.30-7.50 by using 6 mol/L HCl, and purified water is added into the solution after the pH value is adjusted to the preparation amount.
3. The process for producing a1, 5-anhydro-D-sorbitol detection reagent according to claim 1, wherein the step of using an enzymatic method comprises: the preparation process of the reagent R2 comprises the following steps:
B1. calculating the amount of the materials to be weighed according to the amount V2(L) of the produced reagent R2 on the production order sheet and the concentration of the process formula table;
B2. preparing an identified liquid preparation tank, firstly adding purified water with the preparation amount of 70% into the liquid preparation tank, accurately weighing trihydroxymethyl aminomethane, 4-aminoantipyrine, 3-hydroxy-2, 4, 6-triiodobenzoic acid, pyranose oxidase, peroxidase and ProClin 950, putting into the liquid preparation tank, and putting onto a magnetic stirrer;
B3. turning on a power switch of the magnetic stirrer, adjusting a stirrer to 400 r/min to keep the solution in a rotating state, and stirring for 10 min;
B4. when the materials are completely dissolved, the solution is clear and transparent, no precipitate is generated at the bottom of the solution preparation tank, the pH value is adjusted to 7.30-7.50 by using 6 mol/L HCl, and purified water is added into the solution after the pH value is adjusted to the preparation amount.
4. The process for producing a1, 5-anhydro-D-sorbitol detection reagent according to claim 1, wherein the step of using an enzymatic method comprises: the preparation process of the calibrator comprises the following steps:
C1. based on the target concentration of the calibrant and the projected production volume V of the calibrant3(L) calculating the amount of 1, 5-anhydro-D-sorbitol V1, 5-anhydro-D-sorbitols(L) the amount of production V of the calibrator on the basis of the production instruction sheet3(L) multiplying by 1.2 times to obtain the amount V of the diluentDiluent liquid(L)；
C2. Weighing the materials obtained by calculation, preparing a diluent, and after the preparation is finished, according to the calculation data, obtaining the volume V3(L) - V1, 5-anhydro-D-sorbitols(L) dilution and volume V1, 5-anhydro-D-sorbitolsUniformly mixing the 1, 5-dehydration-D-sorbitol in the step (L), putting the mixture on a magnetic stirrer, turning on a power switch of the magnetic stirrer, adjusting a stirrer to 400 r/min, keeping the solution in a medium-speed rotating state, and stirring for 10 min;
C3. after blending, scaling by using a working calibrator, using a semi-finished reagent prepared in the same production batch as the reagent, taking 0.3 mL of the prepared calibrator, performing on-machine detection for three times, and calculating the average value of the three detection results;
C4. if the detection result exceeds the preparation concentration range, calculating and adding 1, 5-dehydration-D-sorbitol or diluent according to the difference value between the result and the target concentration, increasing or decreasing the concentration of the 1, 5-dehydration-D-sorbitol in the solution, and performing the steps after fully mixing until the calibrator is in the specified concentration range;
C5. storing the prepared calibrator solution in a semi-finished product tank, marking, subpackaging by using a pipettor according to specifications, and assigning values after subpackaging is finished;
C6. and after the assignment is completed, the quality part performs semi-finished product sampling inspection.
5. The process for producing a1, 5-anhydro-D-sorbitol detection reagent according to claim 4, wherein the step of performing the enzymatic method comprises: the preparation process of the diluent comprises the following steps:
D1. calculating the amount of the materials to be weighed for preparing the diluent according to the concentration of the diluent process formula table;
D2. preparing an identified liquid preparation tank, firstly adding purified water with the preparation amount of 70% into the liquid preparation tank, accurately weighing trihydroxymethyl aminomethane, bovine albumin and ProClin 950, putting into the liquid preparation tank, and putting onto a magnetic stirrer;
D3. turning on a power switch of the magnetic stirrer, adjusting a stirrer to 400 r/min to keep the solution in a rotating state, and stirring for 10 min;
D4. when the materials are completely dissolved, the solution is clear and transparent, no precipitate is generated at the bottom of the solution preparation tank, the pH value is adjusted to 7.30-7.50 by using 6 mol/L HCl, and purified water is added into the solution after the pH value is adjusted to the preparation amount.
6. The process for producing a1, 5-anhydro-D-sorbitol detection reagent according to claim 5, wherein the step of performing the enzymatic method comprises: the preparation process of the quality control product is the same as that of the calibrator, and the rotating speed of a stirrer of a magnetic stirrer is 250 r/min when the diluent of the quality control product is stirred.
7. The process for producing a1, 5-anhydro-D-sorbitol detection reagent according to claim 1, wherein the step of using an enzymatic method comprises: the target concentration of the calibrator is 30.0 mu g/mL, and the product error is +/-9.0 mu g/mL.
8. The process for producing a1, 5-anhydro-D-sorbitol detection reagent according to claim 1, wherein the step of using an enzymatic method comprises: the target concentration of the quality control product is 20.0 mu g/mL, and the error of the product is +/-6.0 mu g/mL.
CN202111351153.7A 2021-11-16 2021-11-16 Production process of 1, 5-dehydration-D-sorbitol detection reagent by adopting enzyme method Pending CN114134201A (en)

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CN1190188A (en) * 1996-12-04 1998-08-12 第一化学药品株式会社 Quantitative method of 1,5-dehydrated sorbic alcohol and dosing reagent thereof
CN102154442A (en) * 2010-12-30 2011-08-17 北京九强生物技术股份有限公司 Method for detecting 1,5-anhydro sorbitol and related diagnostic kit
CN110763840A (en) * 2019-11-01 2020-02-07 苏州普瑞斯生物科技有限公司 Detection kit for plasminogen activator inhibitor and preparation method thereof
CN110846378A (en) * 2019-11-01 2020-02-28 苏州普瑞斯生物科技有限公司 1, 5-sorbitan detection kit and preparation method thereof
CN111455020A (en) * 2020-02-25 2020-07-28 深圳市安帝宝科技有限公司 1, 5-sorbitan detection kit and detection method
CN111886246A (en) * 2017-12-29 2020-11-03 艾莱克特有限责任公司 anti-TMEM 106B antibodies and methods of use thereof
CN113525827A (en) * 2021-06-30 2021-10-22 河北安克生物科技有限公司 Alpha-amylase reagent production line
CN113624316A (en) * 2021-06-30 2021-11-09 河北安克生物科技有限公司 Standardized biochemical reagent manufacturing process flow

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1190188A (en) * 1996-12-04 1998-08-12 第一化学药品株式会社 Quantitative method of 1,5-dehydrated sorbic alcohol and dosing reagent thereof
CN102154442A (en) * 2010-12-30 2011-08-17 北京九强生物技术股份有限公司 Method for detecting 1,5-anhydro sorbitol and related diagnostic kit
CN111886246A (en) * 2017-12-29 2020-11-03 艾莱克特有限责任公司 anti-TMEM 106B antibodies and methods of use thereof
CN110763840A (en) * 2019-11-01 2020-02-07 苏州普瑞斯生物科技有限公司 Detection kit for plasminogen activator inhibitor and preparation method thereof
CN110846378A (en) * 2019-11-01 2020-02-28 苏州普瑞斯生物科技有限公司 1, 5-sorbitan detection kit and preparation method thereof
CN111455020A (en) * 2020-02-25 2020-07-28 深圳市安帝宝科技有限公司 1, 5-sorbitan detection kit and detection method
CN113525827A (en) * 2021-06-30 2021-10-22 河北安克生物科技有限公司 Alpha-amylase reagent production line
CN113624316A (en) * 2021-06-30 2021-11-09 河北安克生物科技有限公司 Standardized biochemical reagent manufacturing process flow

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