CN114354304A - Easily degradable protein preservation matrix liquid and application thereof - Google Patents
Easily degradable protein preservation matrix liquid and application thereof Download PDFInfo
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- CN114354304A CN114354304A CN202111494919.7A CN202111494919A CN114354304A CN 114354304 A CN114354304 A CN 114354304A CN 202111494919 A CN202111494919 A CN 202111494919A CN 114354304 A CN114354304 A CN 114354304A
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Abstract
The invention discloses an easily degradable protein preservation matrix solution which comprises the following components in percentage by mass: 1-1L, HEPES 10 mmol/L of ultrapure water, 100mmol/L of salt substance, 200mmol/L of carbohydrate substance, 1-10% of protein, 5-50mmol/L of amino acid, 0.5-10% of macromolecular substance, 0.5-5% of stabilizing agent and 0.01-0.5% of preservative. Also discloses application of the degradable protein preservation matrix liquid in preparing a gastrin 17 quality control product, a cardiac troponin I quality control product and a serum amyloid protein A quality control product. The invention can solve the defects of easy loss of activity and poor stability of the existing quality control product, and is used for clinical detection.
Description
Technical Field
The invention relates to the technical field of biochemical detection, in particular to an easily degradable protein preservation matrix liquid and application thereof.
Background
China is a big country with stomach diseases, patients with gastrointestinal diseases account for more than 10%, the incidence rate of peptic ulcer is 10%, and the incidence rate of chronic gastritis is 30%. If the stomach diseases cannot be treated in time, the condition deterioration will be developed into stomach cancer. Although China has achieved certain achievements in the prevention and control of gastric cancer in recent years, compared with developed countries, the prevention and screening system for gastric cancer in China is still not sound, and the early diagnosis and treatment rate of gastric cancer is only less than 10%. Therefore, the early screening work of the gastric cancer is developed, the early screening concept of the national gastric cancer is improved, the social medical burden can be reduced, and the goal of improving the five-year survival rate of the total cancer by 15% in 2030 is realized.
Gastrin (gastrin) is an acidic gastrointestinal hormone and plays an important role in regulating the function of the digestive tract and maintaining the structural integrity. More than 95% of the biologically active gastrins in humans are α -amidated gastrins which can be classified into two isoforms, gastrin 17(gastrin 17, G-17) and gastrin 34(gastrin 34, G34), of which 80-90% are G17. Studies have shown that G-17 is secreted only by G cells in the antrum of the stomach, and thus G-17 is considered to be an important indicator of the extent and extent of atrophic gastritis in response to the gastric mucosa.
G-17 is a key index for diagnosing the functional state of the stomach, is closely related to atrophic gastritis, peptic ulcer, infection of helicobacter pylori in the stomach, inflammation of the stomach, gastric polyp and the like, is also an important index for health physical examination of the stomach and the canceration risk of the stomach, and can be used as an important basis for early screening of the stomach cancer.
The quality control material is a quality control material for in vitro diagnosis, and can evaluate and verify the precision and accuracy of a measurement program or performance characteristics such as deviation generated by changes of reagents and analytical instruments. The stability of the quality control product is an important performance for maintaining the correction effect, so that the development of a gastrin 17 quality control product which has good stability and can be suitable for in-vitro diagnostic reagent detection is necessary. The matrix liquid contained in the quality control product is a storage medium of the antigen protein, and the matrix liquid which has good stability and effectively ensures the activity of the antigen protein is very important.
Disclosure of Invention
The invention aims to solve the technical problem of providing the easily degradable protein preservation matrix solution and the preparation method and application thereof, and can overcome the defects of easy loss of activity and poor stability of the existing quality control product for clinical detection.
In order to solve the technical problems, the first technical scheme adopted by the invention is as follows: the degradable protein preservation matrix solution comprises the following components in percentage by mass:
in order to solve the above technical problems, the second technical solution adopted by the present invention is: the degradable protein preservation matrix solution comprises the following components in percentage by mass:
in a preferred embodiment of the present invention, the protein is one or more of bovine serum albumin, bovine immunoglobulin, and human immunoglobulin, and the addition of the protein can reduce the matrix effect, so that the matrix fluid is closer to the real sample.
In a preferred embodiment of the invention, the amino acid is one or more of histidine, lysine, glycine and glutamic acid, and has an antioxidant effect.
In a preferred embodiment of the invention, the macromolecular substance is one or more of 2-hydroxypropyl-beta-cyclodextrin, polyethylene glycol, polyvinyl alcohol and polyvinylpyrrolidone, and the macromolecular substance can form a protective film on the surface of the protein, so that the protein structure is prevented from being damaged.
In a preferred embodiment of the invention, the stabilizing agent is one or more of high methoxyl pectin, protease inhibitor and propylene glycol alginate, and can make the conformation of the protein more stable by reducing aggregation of the protein.
In a preferred embodiment of the present invention, the salt substance is one or more of sodium chloride, magnesium chloride, zinc chloride and potassium chloride; the saccharide is one or more of trehalose, sucrose and dextran, and can provide stabilization effect by replacing hydrogen bond between protein and water, and in addition, the high viscosity of saccharide can reduce protein denaturation rate; the preservative is gentamicin or proClin 300, and the preservative can prevent the pollution of microorganisms.
In a preferred embodiment of the invention, the pH of the matrix liquid is 7.0-8.5.
The preparation method of the easily degradable protein preservation matrix solution comprises the following steps:
firstly, adding ultrapure water into a clean container, and adding the substances with the content ratio of the claim 1 into the container while stirring until the substances are completely dissolved;
secondly, adjusting the obtained solution to the required pH value by using an alkaline solution;
finally, the obtained solution was filtered with a 0.22 μm filter membrane to remove impurities, and a matrix solution was obtained.
In order to solve the above technical problems, the third technical solution adopted by the present invention is: provides the application of the easily degradable protein preservation matrix liquid in preparing a gastrin 17 quality control product, a cardiac troponin I quality control product and a serum amyloid protein A quality control product.
Further, the gastrin 17 quality control product, the cardiac troponin I quality control product and the serum amyloid A quality control product comprise the easily degradable protein preservation matrix liquid and gastrin 17 protein, cardiac troponin I and serum amyloid A with different concentrations.
The invention has the beneficial effects that: the matrix solution prepared by adding specific substance components according to a specific proportion has excellent stability, and the gastrin 17 quality control product, the cardiac troponin I quality control product and the serum amyloid protein A quality control product prepared from the easily degradable protein storage matrix solution have the advantages of difficult loss of activity, good stability, storage at 2-8 ℃ for 14 months and stability at 37 ℃ for 42 days.
Detailed Description
The following detailed description of the preferred embodiments of the present invention is provided to enable those skilled in the art to more readily understand the advantages and features of the present invention, and to clearly and unequivocally define the scope of the present invention.
The embodiment of the invention takes the example of adding the gastrin 17 protein into the easily degradable protein preservation matrix liquid as an example to illustrate the better stability of the matrix liquid of the invention, but the invention is not limited to the gastrin 17 quality control product in the example, and the matrix liquid can also be applied to other easily degradable antigen proteins, such as cardiac troponin I and serum amyloid protein A.
Example 1:
a gastrin 17 quality control product comprises a gastrin 17 protein and a gastrin 17 preservation matrix liquid, and comprises the following components in mass fraction:
according to the content ratio: purified water was added to a clean vessel, the above materials were added sequentially, stirred until completely dissolved, adjusted to pH 7.5(25 ℃ C.) with NaOH, and filtered through a 0.22 μm filter. And adding the gastrin 17 protein according to the concentration, so that the concentration of the quality control product target point is L1-5 pmol/L, and L2-20 pmol/L.
The actual storage stability and the heat damage resistance stability of the gastrin 17 quality controls L1 and L2 were measured using a gastrin 17 assay kit (chemiluminescence method), and the measurement results are shown in tables 1 and 2:
TABLE 1
TABLE 2
The G-17 quality control product of example 1 has good stability, can be stored for 14 months at 2-8 ℃ and can be stabilized for 42 days at 37 ℃ under acceleration.
Example 2:
a gastrin 17 quality control product comprises a gastrin 17 protein and a gastrin 17 preservation matrix liquid, and comprises the following components in mass fraction:
according to the content ratio: purified water was added to a clean vessel, the above materials were added sequentially, stirred until completely dissolved, adjusted to pH 8.0(25 ℃ C.) with NaOH, and filtered through a 0.22 μm filter. Gastrin 17 protein was added at a concentration such that the concentration of the target of the quality control product was 2.5pmol/L at L3 and 25pmol/L at L4.
The actual storage stability and the heat damage resistance stability of the gastrin 17 quality controls L3 and L4 were measured using a gastrin 17 assay kit (chemiluminescence method), and the measurement results are shown in tables 3 and 4:
TABLE 3
TABLE 4
The effect of the example 2 is equivalent to that of the example 1, the G-17 quality control product has good stability, can be stored for 14 months at the temperature of 2-8 ℃, and can be stabilized for 42 days at the accelerated temperature of 37 ℃.
Example 3:
a gastrin 17 quality control product comprises a gastrin 17 protein and a gastrin 17 preservation matrix liquid, and comprises the following components in mass fraction:
according to the content ratio: purified water was added to a clean vessel, the above materials were added sequentially, stirred until completely dissolved, adjusted to pH 7.5(25 ℃ C.) with NaOH, and filtered through a 0.22 μm filter. The gastrin 17 protein was added to the base solution to prepare a high-concentration quality control substance L5(20pmol/L) and a low-concentration quality control substance L6(5 pmol/L). The quality control products were stored at 2-8 ℃ and tested for stability at 37 ℃ in the same manner as in the examples, and the results are shown in tables 5 and 6:
TABLE 5
TABLE 6
As can be seen from the above table, the quality control material of this formulation begins to decrease in performance after being stored at 2-8 ℃ for 10 months, and begins to decrease in target value after being stored at 37 ℃ for 21 days.
In the description herein, references to the description of "one embodiment," "an example," "a specific example" or the like are intended to mean that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the invention. In this specification, the schematic representations of the terms used above do not necessarily refer to the same embodiment or example. Furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples.
The preferred embodiments of the invention disclosed above are intended to be illustrative only. The preferred embodiments are not intended to be exhaustive or to limit the invention to the precise embodiments disclosed. Obviously, many modifications and variations are possible in light of the above teaching. The embodiments were chosen and described in order to best explain the principles of the invention and the practical application, to thereby enable others skilled in the art to best utilize the invention. The invention is limited only by the claims and their full scope and equivalents.
Claims (10)
1. The easily degradable protein preservation matrix solution is characterized by comprising the following components in percentage by mass:
2. the easily degradable protein preservation matrix solution is characterized by comprising the following components in percentage by mass:
3. the degradable protein preservation matrix solution according to claim 1, wherein the protein is one or more of bovine serum albumin, bovine immunoglobulin and human immunoglobulin.
4. The degradable protein preservation matrix according to claim 1, wherein the amino acid is one or more of histidine, lysine, glycine, and glutamic acid.
5. The degradable protein preserving matrix solution of claim 1, wherein the macromolecular substance is one or more of 2-hydroxypropyl- β -cyclodextrin, polyethylene glycol, polyvinyl alcohol and polyvinylpyrrolidone.
6. The degradable protein preserving matrix fluid of claim 1, wherein the stabilizer is one or more of high methoxyl pectin, protease inhibitor and propylene glycol alginate.
7. The degradable protein preservation matrix solution according to claim 1, wherein the salt is one or more of sodium chloride, magnesium chloride, zinc chloride and potassium chloride; the saccharide is one or more of trehalose, sucrose and dextran; the preservative is gentamicin or proClin 300.
8. The degradable protein preserving matrix of claim 1 wherein the pH of the matrix is from 7.0 to 8.5.
9. The use of the degradable protein storage matrix of claims 1 to 8 in the preparation of gastrin 17 quality control products, cardiac troponin I quality control products, serum amyloid a quality control products.
10. The use according to claim 9, wherein the gastrin 17 quality control product, cardiac troponin I quality control product, and serum amyloid a quality control product comprise the degradable protein preservation matrix fluid according to claims 1 to 7, and gastrin 17 protein, cardiac troponin I, and serum amyloid a at different concentrations.
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Cited By (1)
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| CN117110601A (en) * | 2023-08-11 | 2023-11-24 | 江苏奥雅生物科技有限公司 | Immune magnetic bead preservation solution, preparation method and application thereof |
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