CN115261354A - Creatine kinase isoenzyme quality control product, preparation method thereof and detection kit - Google Patents

Creatine kinase isoenzyme quality control product, preparation method thereof and detection kit Download PDF

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CN115261354A
CN115261354A CN202210889010.XA CN202210889010A CN115261354A CN 115261354 A CN115261354 A CN 115261354A CN 202210889010 A CN202210889010 A CN 202210889010A CN 115261354 A CN115261354 A CN 115261354A
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creatine kinase
quality control
kinase isoenzyme
control product
content
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CN115261354B (en
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陆浩
徐珂
张哲蓉
张国家
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Orient Immunoassay Suzhou Medical Technology Co ltd
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    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/10—Transferases (2.)
    • C12N9/12—Transferases (2.) transferring phosphorus containing groups, e.g. kinases (2.7)
    • C12N9/1223—Phosphotransferases with a nitrogenous group as acceptor (2.7.3)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/96—Stabilising an enzyme by forming an adduct or a composition; Forming enzyme conjugates
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y207/00—Transferases transferring phosphorus-containing groups (2.7)
    • C12Y207/03—Phosphotransferases with a nitrogenous group as acceptor (2.7.3)
    • C12Y207/03002—Creatine kinase (2.7.3.2)
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/531—Production of immunochemical test materials
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/573—Immunoassay; Biospecific binding assay; Materials therefor for enzymes or isoenzymes
    • 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
    • G01N2333/9123—Phosphotransferases in general with a nitrogenous group as acceptor (2.7.3), e.g. histidine kinases

Abstract

The invention relates to a creatine jubase isoenzyme quality control product, a preparation method thereof and a detection kit. The creatine kinase isoenzyme quality control product is a freeze-dried product of a protein mixed solution of creatine kinase isoenzyme antigen, the protein mixed solution further comprises trehalose, polyethylene glycol and a buffer solution, and the content of the trehalose and the content of the polyethylene glycol are respectively 30-300 mM and 2-20 mM. The creatine kinase isoenzyme quality control product has a good forming effect, does not have the bad phenomena of wall hanging and the like after freeze-drying, and has good stability and long quality guarantee period.

Description

Creatine kinase isoenzyme quality control product, preparation method thereof and detection kit
Technical Field
The invention belongs to the technical field of creatine kinase isoenzyme detection, and particularly relates to a creatine kinase isoenzyme quality control product, a preparation method thereof and a detection kit.
Background
The quality control material as a quality control material in an in vitro diagnostic reagent has functions of evaluating or verifying measurement precision and measurement accuracy, and can also analyze deviations that may be generated due to changes in the reagent or analytical instrument. There are two general methods for storing quality control products: one is to mix with glycerol in equal volume and store at-20 deg.C; one method is to freeze-dry the quality control product in vacuum for storage. The two quality control product storage methods have a certain prolonging effect on the stability of the protein in the quality control product, but the long-time storage requirement of the kit is difficult to meet. The freeze-dried powder obtained by the existing vacuum freeze-drying method is generally divided into two types, one type is loose powder, the other type is powder which is combined relatively tightly, namely, the freeze-dried powder can form a good shape, generally is a cake shape, the former is easy to obtain, but the freeze-dried powder is easy to float out when a cover is opened, and the latter is obtained by optimizing a formula under the action of an excipient and the like, and can cause the forming problems such as collapse and the like. In addition, in actual production, it is found that different proteins have significant differences in preservation effects exhibited by the same lyophilized liquid, and thus it is necessary to develop the most suitable lyoprotectant for different proteins.
Creatine kinase isoenzyme MB (CK-MB) in serum is derived from myocardial cells, and is widely applied to Acute Myocardial Infarction (AMI) detection as a myocardial injury diagnosis marker. Clinical studies show that when myocardial cells are damaged, CK-MB is released into blood circulation and rises within 6 hours, reaches a peak within 24 hours and returns to normal within 3-4 days, so that the CK-MB has very important significance in clinical diagnosis of myocardial infarction. At present, although CK-MB quality control products exist, the forming effect of some quality control products is not good enough, and the quality control products are easy to splash when the quality control products are opened; and some quality control products have poor stability.
Disclosure of Invention
The invention aims to provide a creatine kinase isoenzyme quality control product and a preparation method thereof, which have good forming effect, do not have the bad phenomena of wall hanging and the like after freeze-drying, and have good stability and long quality guarantee period.
The invention also aims to provide a creatine kinase isoenzyme detection kit, wherein the creatine kinase isoenzyme quality control product has a better forming effect and better stability.
In order to achieve the purpose, the invention adopts the technical scheme that:
the creatine jubase isoenzyme quality control product is a freeze-dried product of a protein mixed liquor of creatine jubase isoenzyme antigen, the protein mixed liquor further comprises trehalose, polyethylene glycol and a buffer solution, and the content of the trehalose and the content of the polyethylene glycol are respectively 30-300 mM and 2-20 mM.
Preferably, the molecular weight of the polyethylene glycol is 2000 to 8000. More preferably, the polyethylene glycol is selected from one or more of polyethylene glycol 2000, polyethylene glycol 4000 and polyethylene glycol 8000. Further, the polyethylene glycol is polyethylene glycol 4000.
Preferably, the trehalose is contained in an amount of 100 to 200mM. More preferably, the trehalose is present in an amount of 130 to 170mM. Optionally, trehalose is present in an amount of 100mM, 110mM, 120mM, 130mM, 140mM, 150mM, 160mM, 170mM, 180mM, 190mM or 200mM.
Preferably, the content of the polyethylene glycol is 5-15 mM. More preferably, the content of the polyethylene glycol is 8 to 12mM. Optionally, the polyethylene glycol is present in an amount of 5mM, 7.5mM, 10mM, 12.5mM or 15mM.
Preferably, the buffer is selected from one of borate buffer and PIPES.
Preferably, the content of the buffer is 10 to 50mM. More preferably, the content of the buffer is 15 to 30mM. Optionally, the buffer is present in an amount of 10mM, 15mM, 20mM, 25mM, 30mM, 35mM, 40mM, 45mM, or 50mM.
Preferably, the protein mixed solution also comprises 10-50 mM of trihydroxymethyl aminomethane, 0.2-1.5 mM of serum albumin and 0.6-6 mM of preservative.
More preferably, the tris content is 20 to 30mM. Optionally, the trihydroxymethylaminomethane is present in an amount of 10mM, 20mM, 30mM, 40mM, or 50mM.
More preferably, the content of the serum protein is 0.5-1.2 mM. Optionally, the serum protein is present in an amount of 0.5mM, 0.7mM, 0.9mM, 1.0mM, 1.2mM, or 1.5mM.
More preferably, the serum protein is human serum albumin or bovine serum albumin.
More preferably, the preservative is present in an amount of 2 to 4mM. Optionally, the preservative is present in an amount of 0.6mM, 1.5mM, 3mM, 4mM, 5mM or 6mM.
More preferably, the preservative is ProClin300.
Preferably, the content of the creatine kinase isoenzyme antigen is 1-400 ng/mL. More preferably, the content of the creatine kinase isoenzyme antigen is 10-200 ng/mL; furthermore, the content of the creatine jubase isoenzyme antigen is 10-100 ng/mL. Optionally, the creatine kinase isoenzyme is present in an amount of 10ng/mL, 20ng/mL, 30ng/mL, 40ng/mL, 50ng/mL, 60ng/mL, 70ng/mL, 80ng/mL, or 100ng/mL.
The other technical scheme adopted by the invention is as follows:
a preparation method of the creatine kinase isoenzyme quality control product comprises the steps of mixing the raw materials to prepare a protein mixed solution, subpackaging the protein mixed solution in penicillin bottles and freeze-drying; wherein the raw materials comprise creatine kinase isoenzyme antigen, 30-300 mM trehalose, 2-20 mM polyethylene glycol and buffer solution.
Preferably, the raw materials also comprise 10-50 mM of tris, 0.2-1.5M of albumin and 0.6-6 mM of preservative.
Preferably, the content of the creatine kinase isoenzyme antigen is 1-400 ng/mL. More preferably, the content of the creatine kinase isoenzyme antigen is 10-200 ng/mL; further, the content of the creatine kinase isoenzyme antigen is 10-100 ng/mL.
Preferably, the volume of the mixture dispensed in the vial is less than one third of the volume of the vial.
The invention adopts another technical scheme as follows:
a creatine jubase isoenzyme detection kit comprises the creatine jubase isoenzyme quality control product.
Due to the application of the technical scheme, compared with the prior art, the invention has the following advantages:
according to the creatine kinase isoenzyme (CK-MB) quality control product, raw materials containing creatine kinase isoenzyme antigen, trehalose, polyethylene glycol and the like are mixed and then freeze-dried to prepare a freeze-dried product, so that the membrane formation of CK-MB protein is facilitated, the wall hanging phenomenon of the freeze-dried powder after freeze-drying is reduced, the forming rate of the freeze-dried powder is improved, the CK-MB quality control product formed by freeze-drying is in a cake shape, the product appearance is good, meanwhile, the quality control product has good stability and long shelf life (up to two years).
Detailed Description
The technical solutions of the present invention will be described clearly and completely below, and it should be apparent that the described embodiments are some, but not all, embodiments of the present invention. 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.
As described above, in view of the defects of the prior art, the present inventors have made extensive studies and extensive practices to propose the technical solution of the present invention. The following detailed description will more fully understand the invention. Detailed embodiments of the present invention are disclosed herein; however, it is to be understood that the disclosed embodiments are merely exemplary of the invention, which can be embodied in various forms. Therefore, specific functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present invention in virtually any appropriately detailed embodiment.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. In the event that a definition used herein conflicts or disagrees with a definition contained in another publication, the definition used herein shall govern.
The endpoints of the ranges and any values disclosed herein are not limited to the precise range or value, and such ranges or values should be understood to encompass values close to those ranges or values. For numerical ranges, each range between its endpoints and individual point values, and each individual point value can be combined with each other to give one or more new numerical ranges, and such numerical ranges should be construed as specifically disclosed herein.
When an amount, or other value or parameter, is given as either a range, preferred range or a list of upper preferable values and lower preferable values, this is to be understood as specifically disclosing all ranges formed from any pair of any upper range limit or preferred value and any lower range limit or preferred value, regardless of whether ranges are separately disclosed. For example, when a range is recited as "1 to 5," the recited range should be understood to include the ranges "1 to 4," "1 to 3," "1 to 2," and so forth. If a range of values is recited in this specification, unless otherwise stated, the range is intended to include the endpoints thereof, and all integers and fractions within the range.
1. Examples 1 to 7
The raw materials were dissolved in pure water in the amounts shown in Table 1 to prepare a mixture.
Table 1 examples mix formula composition
Figure BDA0003766728750000041
The mixed solution prepared according to the table 1 is mixed with 100 mug/mL creatine kinase isoenzyme MB antigen solution and diluted to a target concentration to obtain diluted protein mixed solution, 0.5mL of the protein mixed solution is added into a 3mL penicillin bottle, and the mixture is placed into a vacuum freeze dryer to be freeze-dried completely, wherein the freeze-drying conditions are shown in the table 2.
TABLE 2 Freeze drying conditions
Temperature of -50 -50 -40 -30 -20 -10 0 10 20 25
Time min 0 120 420 660 740 860 920 1100 1220 1280
The preparation process of the creatine kinase isoenzyme MB quality control product specifically comprises the following steps:
s1, precooling freeze-dried related equipment to 4 ℃, wherein the related equipment comprises a penicillin bottle, a shelf, a tray and the like;
s2, diluting the protein mixed solution prepared in the last step to a target concentration (comprising a high concentration value and a low concentration value) to obtain a diluted solution, wherein the target concentration (namely the concentration of the CK-MB antigen) is 100ng/mL and 10ng/mL;
s3, subpackaging the diluted solution obtained in the step S2 into pre-cooled penicillin bottles with the volume of 3mL in the step S1, and adding 0.5mL of protein solution into each penicillin bottle;
and S4, placing the penicillin bottle containing the protein solution in the S3 in a vacuum freeze dryer for freeze drying until the penicillin bottle is completely dried, and obtaining the high-value freeze-dried quality control product and the low-value freeze-dried quality control product of the creatine kinase isoenzyme MB.
2. Comparative examples 1 to 5
The raw materials were dissolved in pure water in the amounts shown in Table 3 to prepare a mixed solution.
Table 3 comparative example mixture formula composition
Comparative example 1 Comparative example 2 Comparative example 3 Comparative example 4 Comparative example 5
Tris (hydroxymethyl) aminomethane 20mM 20mM 20mM / /
Trehalose / 150mM 150mM 150mM 150mM
Polyethylene glycol 4000 10mM / 10mM 10mM 10mM
Human serum albumin 0.7M 0.7M / 0.7M 0.7M
Preservative Proclin-300 3mM 3mM 3mM 3mM 3mM
Borate buffer 20mM 20mM 20mM 20mM /
Phosphate buffer / / / / 20mM
High-value freeze-dried quality control products and low-value freeze-dried quality control products of creatine kinase isoenzyme MB are prepared according to the preparation processes of the examples.
3. Contour inspection
3.1 Experimental methods
The creatine kinase isoenzyme MB quality control products obtained in examples 1 to 7 and comparative examples 1 to 5 were subjected to appearance observation, and the molding rate and dissolution (ultrapure water dissolution) were counted.
3.2 results of the experiment
The results of the profile inspection are shown in table 4.
TABLE 4 appearance, molding ratio and results of dissolution test
Figure BDA0003766728750000061
As can be seen from Table 4, the examples have better appearance, better molding rate and better redissolution effect than the comparative examples.
4. Protein aging test
4.1 Experimental methods
The creatine kinase isoenzyme MB (CK-MB) detection kit (enzyme immunoassay method) is adopted to test the activity of the high-low value quality control product protein of the creatine kinase isoenzyme MB prepared in the embodiment and the comparative example, each quality control product is tested with 6 samples, the samples are placed in an incubator at 37 ℃ for 14 days to carry out an accelerated aging experiment (the accelerated aging experiment is carried out at 37 ℃ for 14 days according to the Arrhenius formula, which is equivalent to the accelerated aging experiment carried out at 4 ℃ for 2 years), and the activity detection values before and after the accelerated aging experiment is carried out for 14 days after freeze-drying are compared.
4.2 results of the experiment
The ratio of the activity value of the quality control materials of examples and comparative examples after accelerated aging for 14 days to the activity value before accelerated aging is shown in Table 5.
TABLE 5 ratio of Activity measurement after 14 days of accelerated aging/Activity measurement before accelerated aging
Figure BDA0003766728750000071
As can be seen from table 5, the lyophilized solution containing trehalose and polyethylene glycol can improve the preservation effect of creatine kinase isoenzyme MB. The activity loss rate before and after freeze-drying is less than 10%, and the creatine kinase isoenzyme MB quality control preparation prepared by the method can be stored for more than 2 years at 4 ℃ when being used in a creatine kinase isoenzyme MB (CK-MB) detection kit (enzyme immunoassay method) according to the conclusion of an Arrhenius formula. The freeze-dried standard of the comparative example which does not contain trehalose or polyethylene glycol or the like has high activity loss rate after accelerated aging and short storage time.
In conclusion, the formula of the freeze-drying protective agent is reasonably matched, the forming of the creatine kinase isoenzyme MB quality control preparation is facilitated through the synergistic effect of the trehalose and the polyethylene glycol, the product appearance is good, the wall hanging phenomenon cannot occur after freeze-drying, the stability is better, and the quality guarantee period of the quality control preparation is prolonged.
The above embodiments are merely illustrative of the technical ideas and features of the present invention, and the purpose thereof is to enable those skilled in the art to understand the contents of the present invention and implement the present invention, and not to limit the protection scope of the present invention. All equivalent changes and modifications made according to the spirit of the present invention should be covered within the protection scope of the present invention.

Claims (10)

1. The creatine kinase isoenzyme quality control product is characterized by being a freeze-dried product of a protein mixed solution of creatine kinase isoenzyme antigen, wherein the protein mixed solution further comprises trehalose, polyethylene glycol and a buffer solution, and the content of the trehalose and the content of the polyethylene glycol are respectively 30-300 mM and 2-20 mM.
2. The creatine kinase isoenzyme quality control product according to claim 1, wherein the molecular weight of the polyethylene glycol is 2000 to 8000.
3. The creatine kinase isoenzyme quality control product according to claim 1, wherein the content of trehalose is 100 to 200mM, and the content of polyethylene glycol is 5 to 15mM.
4. The creatine kinase isoenzyme quality control product according to claim 1, wherein the buffer solution is selected from one of borate buffer solution and PIPES, and the content of the buffer solution is 10-50 mM.
5. The creatine kinase isoenzyme quality control product of claim 1, wherein the protein mixture further comprises 10-50 mM of tris, 0.2-1.5 mM of serum albumin, and 0.6-6 mM of preservative.
6. The creatine kinase isoenzyme quality control product according to claim 5, wherein the content of the trihydroxymethyl aminomethane is 20 to 30mM, the content of the serum protein is 0.5 to 1.2mM, and the content of the preservative is 2 to 4mM.
7. The creatine kinase isoenzyme quality control product according to claim 5, wherein the preservative is ProClin300.
8. The creatine kinase isoenzyme quality control product according to claim 1, wherein the content of the creatine kinase isoenzyme antigen is 1-400 ng/mL.
9. A method for preparing the creatine kinase isoenzyme quality control product according to any one of claims 1 to 8, wherein raw materials are mixed to prepare a protein mixed solution, and the protein mixed solution is subpackaged in a penicillin bottle for freeze-drying; wherein the raw materials comprise creatine kinase isoenzyme antigen, 30-300 mM trehalose, 2-20 mM polyethylene glycol and buffer solution.
10. A creatine kinase isoenzyme detection kit, comprising the creatine kinase isoenzyme quality control product according to any one of claims 1 to 8.
CN202210889010.XA 2022-07-27 2022-07-27 Creatine kinase isoenzyme quality control product, preparation method thereof and detection kit Active CN115261354B (en)

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109298176A (en) * 2018-10-29 2019-02-01 深圳天深医疗器械有限公司 Myocarditis quality-control product and preparation method thereof, myocarditis detection kit and myocarditis detection device
CN111909922A (en) * 2020-06-28 2020-11-10 浙江清华长三角研究院 High-stability creatine kinase protective matrix
US20210063397A1 (en) * 2018-03-22 2021-03-04 Beijing Strong Biotechnologies, Inc. Creatine kinase isoenzyme assay kit
CN114487420A (en) * 2022-01-14 2022-05-13 广西康柏莱科技有限公司 Creatine kinase isoenzyme detection kit

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20210063397A1 (en) * 2018-03-22 2021-03-04 Beijing Strong Biotechnologies, Inc. Creatine kinase isoenzyme assay kit
CN109298176A (en) * 2018-10-29 2019-02-01 深圳天深医疗器械有限公司 Myocarditis quality-control product and preparation method thereof, myocarditis detection kit and myocarditis detection device
CN111909922A (en) * 2020-06-28 2020-11-10 浙江清华长三角研究院 High-stability creatine kinase protective matrix
CN114487420A (en) * 2022-01-14 2022-05-13 广西康柏莱科技有限公司 Creatine kinase isoenzyme detection kit

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