CN111505317B - Quality control product of adiponectin determination reagent and preparation method thereof - Google Patents
Quality control product of adiponectin determination reagent and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a quality control product of an adiponectin determination reagent, which comprises a freeze-dried product of the following components: 50-80 parts of phosphate buffer solution, 1-2 parts of sodium iodide, 0.02-0.1 part of vitamin B1, 0.01-0.05 part of sodium citrate, 5-10 parts of bovine serum, 0.1-0.5 part of adiponectin protein, 2-5 parts of sucrose and 1-2 parts of preservative. The quality control product is a freeze-dried product, so that the stability of the quality control product before use can be greatly improved, and the quality control product is easy to store; the phosphate buffer solution can facilitate the preparation and molding of quality control products, the preservative prolongs the quality of the quality control products, the sodium iodide, the vitamin B1 and the sodium citrate can improve the stability of the products, and the sucrose can prevent the pure adiponectin from being inactivated in the preparation process. The invention also discloses a preparation method of the quality control product, which comprises the steps of uniformly mixing raw materials, and performing freeze drying to obtain the adiponectin determination reagent quality control product.
Description
Technical Field
The invention relates to the technical field of biochemical detection, in particular to an adiponectin determination reagent quality control product and a preparation method thereof.
Background
The adiponectin assay kit is used for quantitatively detecting the adiponectin content in serum and plasma in vitro and is clinically used for evaluating the risks of type 2 diabetes and cardiovascular diseases.
The kit comprises an adiponectin determination reagent, a calibrator and a quality control product, wherein the calibrator is used for calibrating a sample, a calibration system can be generated by using the calibrator, and then whether the calibration system is qualified or not is detected by using the quality control product, so that the quality control product is required to have higher precision and stability. At present, an adiponectin determination reagent quality control product mainly comprises adiponectin protein and phosphate buffer.
The existing adiponectin determination reagent quality control product has single components, is mostly liquid, is difficult to preserve after being unsealed, and is required to be discarded if not used, so that resource waste is caused.
Disclosure of Invention
The invention aims to provide a quality control product of an adiponectin determination reagent which is stable and easy to store.
An adiponectin assay reagent quality control product comprising a lyophilized product of:
50-80 parts of phosphate buffer solution,
1-2 parts of sodium iodide,
0.02-0.1 part of vitamin B1,
0.01 to 0.05 part of sodium citrate,
5 to 10 parts of bovine serum,
0.1 to 0.5 part of adiponectin protein,
2-5 parts of sucrose and the balance of the total weight of the compound,
1-2 parts of preservative.
The beneficial effects of the invention are as follows: the quality control product is a freeze-dried product, so that the stability of the quality control product before use can be greatly improved, and the quality control product is easy to store; the phosphate buffer solution can facilitate the preparation and molding of quality control products, the preservative prolongs the quality of the quality control products, the sodium iodide, the vitamin B1 and the sodium citrate can improve the stability of the products, and the sucrose can prevent the pure adiponectin from being inactivated in the preparation process.
In addition, the quality control product of the adiponectin determination reagent provided by the invention can also have the following additional technical characteristics:
further, the phosphate buffer solution consists of disodium hydrogen phosphate and potassium dihydrogen phosphate, and the mass ratio of the disodium hydrogen phosphate to the potassium dihydrogen phosphate is 4:1.
The invention also provides a preparation method of the quality control product of the adiponectin determination reagent, which comprises the following steps:
(1) Taking the adiponectin protein, and adding phosphate buffer solution for dilution to obtain a diluent;
(2) Adding sodium citrate into the diluent, carrying out heat preservation and stirring, and equally dividing the obtained mixed solution into a first mixed solution and a second mixed solution, wherein the mass ratio of the first mixed solution to the second mixed solution is 5:1-2;
(3) Adding sodium iodide into the first mixed solution, uniformly mixing, and dripping vitamin B1, wherein oxygen is continuously introduced into the first mixed solution in the process to obtain a first freeze-dried solution;
(4) Adding bovine serum into the second mixed solution, uniformly stirring, and continuously introducing carbon dioxide into the second mixed solution in the stirring process to obtain a second freeze-dried solution;
(5) And mixing the first freeze-dried liquid and the second freeze-dried liquid, adding sucrose and a preservative, and performing freeze drying to obtain the quality control product of the adiponectin determination reagent.
Further, the concentration of the phosphate buffer solution is 50-400 mmol/L, the concentration of sodium iodide is 0.5-1 mol/L, the concentration of vitamin B1 is 100-500 mmol/L, the concentration of sodium citrate is 50-200 mmol/L, the concentration of adiponectin protein is 50-100 mg/L, and the concentration of bovine serum is 30-95%.
Further, the heat-preserving stirring in the step (2) is carried out for 10-20 min at a constant temperature of 30 ℃.
Further, the speed of dropping the vitamin B1 in the step (3) is 1-5 mg/min.
Further, the amount of the introduced oxygen in the step (3) is 50-100 mL/min, and the concentration of the oxygen is 85%.
Further, the amount of carbon dioxide introduced in the step (4) is 10-60 mL/min, and the concentration of the carbon dioxide is 50%.
Further, the step of freeze-drying in the step (5) includes:
the first pre-freezing, the freeze-drying liquid is placed in an environment of minus 30 ℃ to minus 70 ℃ and kept for 8 to 12 hours;
second pre-freezing, namely placing the to-be-freeze-dried liquid in an environment of minus 60 ℃ to minus 100 ℃ for 1 to 3 hours;
vacuum freeze drying, and maintaining the freeze-dried liquid in negative pressure environment of-20 deg.c to-60 deg.c for 24-48 hr.
Further, the negative pressure environment of the vacuum freeze drying is 5-10 Pa, and the temperature is increased from-60 ℃ at a heating rate of 0.5-1 ℃/h until the vacuum freeze drying is finished.
Additional aspects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention.
Detailed Description
The following detailed description of the present invention will provide further understanding of the objects, features and advantages of the present invention by way of example. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.
Example 1
The quality control product of the adiponectin determination reagent is characterized by comprising a freeze-dried product of the following components:
50 parts of phosphate buffer solution, which is used for preparing the high-purity silicon dioxide,
1 part of sodium iodide, and the total weight of the sodium iodide,
0.02 part of vitamin B1,
0.01 part of sodium citrate, which is used for preparing the sodium citrate,
5 parts of bovine serum,
0.1 part of adiponectin protein,
2 parts of sucrose, namely a mixture of two or more of sucrose,
1 part of preservative.
The invention has the advantages that the quality control product is a freeze-dried product, can greatly improve the stability of the quality control product before use, and is easy to store; the phosphate buffer solution can facilitate the preparation and molding of quality control products, the preservative prolongs the quality of the quality control products, the sodium iodide, the vitamin B1 and the sodium citrate can improve the stability of the products, and the sucrose can prevent the pure adiponectin from being inactivated in the preparation process.
Specifically, the phosphate buffer solution consists of disodium hydrogen phosphate and potassium dihydrogen phosphate, the mass ratio of the disodium hydrogen phosphate to the potassium dihydrogen phosphate is 4:1, and under the condition, the pH value of the phosphate buffer solution is 7.4, so that the phosphate buffer solution can protect adiponectin protein.
In this embodiment, the preservative is sorbic acid.
The preparation method of the adiponectin determination reagent quality control product comprises the following steps:
(1) Taking the adiponectin protein, and adding phosphate buffer solution for dilution to obtain a diluent;
(2) Adding sodium citrate into the diluent, carrying out heat preservation and stirring, and equally dividing the obtained mixed solution into a first mixed solution and a second mixed solution, wherein the mass ratio of the first mixed solution to the second mixed solution is 5:1;
(3) Adding sodium iodide into the first mixed solution, uniformly mixing, and dripping vitamin B1, wherein oxygen is continuously introduced into the first mixed solution in the process to obtain a first freeze-dried solution;
(4) Adding bovine serum into the second mixed solution, uniformly stirring, and continuously introducing carbon dioxide into the second mixed solution in the stirring process to obtain a second freeze-dried solution;
(5) And mixing the first freeze-dried liquid and the second freeze-dried liquid, adding sucrose and a preservative, and performing freeze drying to obtain the quality control product of the adiponectin determination reagent.
In the preparation method, the other components except sucrose and the preservative are solid solutions.
In the embodiment, the diluent is divided into two parts, and more parts of sodium iodide and vitamins are added to improve the stability of the adiponectin protein, oxygen is introduced to promote the stability of the adiponectin protein, and carbon dioxide is introduced to adjust the acidity of the solution, so that the preservation effect is improved.
Further, the concentration of the phosphate buffer solution is 50mmol/L, the concentration of the sodium iodide is 0.5mol/L, the concentration of the vitamin B1 is 100mmol/L, the concentration of the sodium citrate is 50mmol/L, the concentration of the adiponectin protein is 50mg/L, and the concentration of the bovine serum is 60%.
Specifically, the heat-preserving stirring in the step (2) is stirring at a constant temperature of 30 ℃ for 15min.
In addition, the speed of dropping vitamin B1 in the step (3) is 1mg/min, the amount of the introduced oxygen is 50mL/min, and the concentration of the oxygen is 85%.
In addition, the carbon dioxide is introduced into the step (4) in an amount of 10mL/min, the concentration of the carbon dioxide is 50%, and the rest components are nitrogen and oxygen.
Specifically, the step of freeze-drying in the step (5) includes:
the first pre-freezing, the freeze-drying liquid is placed in an environment with the temperature of minus 30 ℃ for 8 hours;
second pre-freezing, namely placing the to-be-freeze-dried liquid in an environment of minus 60 ℃ for 1 hour;
and (3) vacuum freeze drying, namely placing the liquid to be freeze-dried in a negative pressure environment for 36 hours, wherein the negative pressure environment for vacuum freeze drying is 5Pa, and the temperature is increased from-60 ℃ to the end of vacuum freeze drying at a heating rate of 0.5 ℃/h.
Example 2
The quality control product of the adiponectin determination reagent is characterized by comprising a freeze-dried product of the following components:
80 parts of phosphate buffer solution, and the total weight of the phosphate buffer solution,
2 parts of sodium iodide,
0.1 part of vitamin B1,
0.05 part of sodium citrate, and the like,
10 parts of bovine serum,
0.5 part of adiponectin protein,
5 parts of sucrose, and the total weight of the mixture is equal to 5 parts,
2 parts of preservative.
Specifically, the phosphate buffer solution consists of disodium hydrogen phosphate and potassium dihydrogen phosphate, the mass ratio of the disodium hydrogen phosphate to the potassium dihydrogen phosphate is 4:1, and under the condition, the pH value of the phosphate buffer solution is 7.4, so that the phosphate buffer solution can protect adiponectin protein.
The preparation method of the adiponectin determination reagent quality control product comprises the following steps:
(1) Taking the adiponectin protein, and adding phosphate buffer solution for dilution to obtain a diluent;
(2) Adding sodium citrate into the diluent, carrying out heat preservation and stirring, and equally dividing the obtained mixed solution into a first mixed solution and a second mixed solution, wherein the mass ratio of the first mixed solution to the second mixed solution is 5:1;
(3) Adding sodium iodide into the first mixed solution, uniformly mixing, and dripping vitamin B1, wherein oxygen is continuously introduced into the first mixed solution in the process to obtain a first freeze-dried solution;
(4) Adding bovine serum into the second mixed solution, uniformly stirring, and continuously introducing carbon dioxide into the second mixed solution in the stirring process to obtain a second freeze-dried solution;
(5) And mixing the first freeze-dried liquid and the second freeze-dried liquid, adding sucrose, and performing freeze drying to obtain the quality control product of the adiponectin determination reagent.
Specifically, the concentration of the phosphate buffer solution is 400mmol/L, the concentration of sodium iodide is 1mol/L, the concentration of vitamin B1 is 500mmol/L, the concentration of sodium citrate is 200mmol/L, the concentration of adiponectin protein is 100mg/L, and the concentration of bovine serum is 95%.
Further, the heat-preserving stirring in the step (2) is stirring at a constant temperature of 30 ℃ for 15min.
Further, the dropping rate of vitamin B1 in the step (3) is 5mg/min.
Further, the amount of oxygen introduced in the step (3) is 100mL/min, and the concentration of oxygen is 85%.
Further, the amount of carbon dioxide introduced in the step (4) is 60mL/min, and the concentration of carbon dioxide is 50%.
Further, the step of freeze-drying in the step (5) includes:
first pre-freezing, and placing the to-be-freeze-dried liquid in an environment of-70 ℃ for 12 hours;
second pre-freezing, and placing the to-be-freeze-dried liquid in an environment of minus 100 ℃ for 3 hours;
and (3) vacuum freeze drying, namely placing the liquid to be freeze-dried in a negative pressure environment for 36 hours, wherein the negative pressure environment for vacuum freeze drying is 5Pa, and the temperature is increased from-60 ℃ at a heating rate of 1 ℃/h until the vacuum freeze drying is finished.
Example 3
The quality control product of the adiponectin determination reagent is characterized by comprising a freeze-dried product of the following components:
60 parts of phosphate buffer solution, and the total weight of the solution,
2 parts of sodium iodide,
0.1 part of vitamin B1,
0.02 part of sodium citrate, which is used for preparing the medicine,
7 parts of bovine serum,
0.5 part of adiponectin protein,
5 parts of sucrose, and the total weight of the mixture is equal to 5 parts,
1 part of preservative.
Specifically, the phosphate buffer solution consists of disodium hydrogen phosphate and potassium dihydrogen phosphate, the mass ratio of the disodium hydrogen phosphate to the potassium dihydrogen phosphate is 4:1, and under the condition, the pH value of the phosphate buffer solution is 7.4, so that the phosphate buffer solution can protect adiponectin protein.
The preparation method of the adiponectin determination reagent quality control product comprises the following steps:
(1) Taking the adiponectin protein, and adding phosphate buffer solution for dilution to obtain a diluent;
(2) Adding sodium citrate into the diluent, carrying out heat preservation and stirring, and equally dividing the obtained mixed solution into a first mixed solution and a second mixed solution, wherein the mass ratio of the first mixed solution to the second mixed solution is 5:1;
(3) Adding sodium iodide into the first mixed solution, uniformly mixing, and dripping vitamin B1, wherein oxygen is continuously introduced into the first mixed solution in the process to obtain a first freeze-dried solution;
(4) Adding bovine serum into the second mixed solution, uniformly stirring, and continuously introducing carbon dioxide into the second mixed solution in the stirring process to obtain a second freeze-dried solution;
(5) And mixing the first freeze-dried liquid and the second freeze-dried liquid, adding sucrose, and performing freeze drying to obtain the quality control product of the adiponectin determination reagent.
Further, the concentration of the phosphate buffer solution is 200mmol/L, the concentration of the sodium iodide is 1mol/L, the concentration of the vitamin B1 is 200mmol/L, the concentration of the sodium citrate is 50mmol/L, the concentration of the adiponectin protein is 100mg/L, and the concentration of the bovine serum is 60%.
Specifically, the heat-preserving stirring in the step (2) is stirring at a constant temperature of 30 ℃ for 20min.
In addition, the speed of dropping vitamin B1 in the step (3) is 5mg/min, the amount of the introduced oxygen is 100mL/min, and the concentration of the oxygen is 85%.
In addition, the amount of carbon dioxide introduced in the step (4) is 60mL/min, and the concentration of carbon dioxide is 50%.
Specifically, the step of freeze-drying in the step (5) includes:
first pre-freezing, and placing the to-be-freeze-dried liquid in an environment of-50 ℃ for 12 hours;
second pre-freezing, and placing the to-be-freeze-dried liquid in an environment of-80 ℃ for 3 hours;
and (3) vacuum freeze drying, namely placing the liquid to be freeze-dried in a negative pressure environment for 36 hours, wherein the negative pressure environment for vacuum freeze drying is 5Pa, and the temperature is increased from-60 ℃ to the end of vacuum freeze drying at a heating rate of 0.5 ℃/h.
Comparative example 1
This comparative example is substantially identical to example 3, except that:
in this control, the dilution was not divided into two parts and no oxygen or carbon dioxide was introduced.
Comparative example 2
This comparative example is substantially identical to example 3, except that:
in this comparative example, vitamin B1 was directly mixed with the first mixed solution.
Comparative example 3
This comparative example is substantially identical to example 3, except that:
in this control, no oxygen or carbon dioxide was introduced.
Comparative example 4
This comparative example is substantially identical to example 3, except that:
the freeze drying steps are as follows:
pre-freezing, and placing the freeze-dried material in an environment of-70 ℃ for 24 hours;
vacuum freeze drying, and maintaining the freeze-dried liquid under negative pressure for 36 hours, wherein the negative pressure is 5Pa, and the ambient temperature is-60 ℃.
The quality control products obtained in the above examples and comparative examples were divided into a low value group, a medium value group and a high value group, and were reconstituted by adding water, the initial concentrations thereof were 30mg/L, 60mg/L and 120mg/L, respectively, and the concentrations were continuously measured for 7 days, and the coefficient of variation CV was calculated, and the results were shown in Table 1.
TABLE 1
| Grouping | Low value set CV (%) | Median group CV (%) | High value group CV (%) |
| Example 1 | 2.53 | 2.11 | 0.95 |
| Example 2 | 1.83 | 1.94 | 0.57 |
| Example 3 | 0.88 | 1.37 | 0.48 |
| Comparative example 1 | 5.06 | 5.64 | 3.38 |
| Comparative example 2 | 2.55 | 2.97 | 2.31 |
| Comparative example 3 | 2.16 | 2.37 | 1.85 |
| Comparative example 4 | 2.82 | 3.10 | 2.69 |
Because the accuracy requirement on the quality control product is higher, the quality control product is measured according to different ADPN concentrations, and the adiponectin measuring reagent quality control product is proved to be a qualified product when the measured results meet the requirements. The invention adopts a low value group, a medium value group and a high value group to detect respectively, and takes the variation coefficient of ADPN concentration change within 7 days as a reference to evaluate the stability of the quality control product. The smaller CV value indicates that the quality control is more stable and easier to preserve, and when all three groups meet CV <3%, they are judged to be acceptable products.
As can be seen from Table 1, examples 1 to 3 all achieve better effects than comparative examples 1 to 4, i.e., CV values of examples are generally lower than those of comparative examples, indicating that the technical scheme of the present invention can achieve better effects.
In addition, as is clear from comparative example 3 and comparative examples 1 to 4, the CV value of example 3 is significantly lower than that of comparative example, and the quality of the quality control product is degraded when the conditions of example 3 are discarded.
In the description of the present specification, a description referring to terms "one embodiment," "some embodiments," "examples," "specific examples," or "some examples," etc., means 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 present invention. In this specification, schematic representations of the above terms do not necessarily refer to the same embodiments or examples. 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 foregoing examples illustrate only a few embodiments of the invention and are described in detail herein without thereby limiting the scope of the invention. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the invention, which are all within the scope of the invention. Accordingly, the scope of protection of the present invention is to be determined by the appended claims.
Claims (6)
1. The preparation method of the adiponectin determination reagent quality control product is characterized in that the adiponectin determination reagent quality control product comprises freeze-dried products of the following components:
50-80 parts of phosphate buffer solution,
1-2 parts of sodium iodide,
0.02-0.1 part of vitamin B1,
0.01 to 0.05 part of sodium citrate,
5 to 10 parts of bovine serum,
0.1 to 0.5 part of adiponectin protein,
2-5 parts of sucrose and the balance of the total weight of the compound,
1-2 parts of preservative;
the preparation method comprises the following steps:
(1) Taking the adiponectin protein, and adding phosphate buffer solution for dilution to obtain a diluent;
(2) Adding sodium citrate into the diluent, carrying out heat preservation and stirring, and dividing the obtained mixed solution into a first mixed solution and a second mixed solution, wherein the mass ratio of the first mixed solution to the second mixed solution is 5:1-2;
(3) Adding sodium iodide into the first mixed solution, uniformly mixing, and dripping vitamin B1, continuously introducing oxygen into the first mixed solution in the process to obtain a first freeze-dried solution, wherein the amount of the introduced oxygen in the step (3) is 50-100 mL/min, and the concentration of the oxygen is 85%;
(4) Adding bovine serum into the second mixed solution, uniformly stirring, continuously introducing carbon dioxide into the second mixed solution in the stirring process to obtain a second freeze-dried solution, wherein the amount of carbon dioxide introduced in the step (4) is 10-60 mL/min, and the concentration of carbon dioxide is 50%;
(5) And mixing the first freeze-dried liquid and the second freeze-dried liquid, adding sucrose and a preservative, and performing freeze drying to obtain the quality control product of the adiponectin determination reagent.
2. The method for preparing a quality control product of an adiponectin assay reagent according to claim 1, wherein the concentration of the phosphate buffer is 50-400 mmol/L, the concentration of sodium iodide is 0.5-1 mol/L, the concentration of vitamin B1 is 100-500 mmol/L, the concentration of sodium citrate is 50-200 mmol/L, the concentration of adiponectin protein is 50-100 mg/L, and the concentration of bovine serum is 30-95%.
3. The method for preparing a quality control product for adiponectin assay reagent according to claim 1, wherein the heat-insulating stirring in the step (2) is stirring at a constant temperature of 30 ℃ for 10 to 20 minutes.
4. The method for preparing a quality control product for adiponectin assay reagent according to claim 1, wherein the rate of dropping vitamin B1 in step (3) is 1 to 5mg/min.
5. The method for preparing a quality control product for adiponectin assay reagent according to claim 1, wherein the step of freeze-drying in step (5) comprises:
the first pre-freezing, the freeze-drying liquid is placed in an environment of minus 30 ℃ to minus 70 ℃ and kept for 8 to 12 hours;
second pre-freezing, namely placing the to-be-freeze-dried liquid in an environment of minus 60 ℃ to minus 100 ℃ for 1 to 3 hours;
vacuum freeze drying, and maintaining the freeze-dried liquid in negative pressure environment of-20 deg.c to-60 deg.c for 24-48 hr.
6. The method for producing a quality control product for an adiponectin measurement reagent according to claim 5, wherein the negative pressure environment for vacuum freeze-drying is 5 to 10Pa, and the temperature is increased from-60℃at a rate of increase of 0.5 to 1 ℃/h to the end of vacuum freeze-drying.
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