CN111505317A - Adiponectin determination reagent quality control product and preparation method thereof - Google Patents
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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, 2-5 parts of sucrose and 1-2 parts of preservative. 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 forming of quality control products, the preservative can prolong 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 inactivation of pure adiponectin in the preparation process. The invention also discloses a preparation method of the quality control product, which comprises the steps of uniformly mixing the 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 a quality control product of an adiponectin determination reagent and a preparation method thereof.
Background
The adiponectin determination kit is used for in vitro quantitative detection of adiponectin content in serum and plasma, and is clinically used for evaluating 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, the calibrator can be used for generating a calibration system, and then the quality control product is used for detecting whether the calibration system is qualified or not, so that the quality control product is required to have higher precision and stability. At present, the quality control product of the adiponectin determination reagent mainly comprises adiponectin and phosphate buffer.
The existing adiponectin determination reagent quality control product has single component and is mostly liquid, the product is difficult to store after being unsealed, and the product needs to be discarded if not used, so that the resource waste is caused.
Disclosure of Invention
The invention aims to provide a stable and easily-preserved quality control product of an adiponectin measuring reagent.
A quality control product of an adiponectin determination reagent 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 parts of vitamin B1,
0.01 to 0.05 parts of sodium citrate,
5-10 parts of bovine serum,
0.1 to 0.5 parts of adiponectin protein,
2-5 parts of cane sugar,
1-2 parts of a preservative.
The invention has the beneficial effects 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 forming of quality control products, the preservative can prolong 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 inactivation of pure adiponectin in the preparation process.
In addition, the quality control product of the adiponectin measurement 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.
Another object of the present invention is to provide a method for preparing the quality control product of the adiponectin measurement reagent, comprising the steps of:
(1) taking the adiponectin, and adding a phosphate buffer solution to dilute to obtain a diluent;
(2) adding sodium citrate into the diluent, stirring at a constant temperature, 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-drying solution;
(4) adding bovine serum into the second mixed solution, uniformly stirring, and continuously introducing carbon dioxide into the second mixed solution during stirring to obtain a second freeze-drying 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 adiponectin determination reagent quality control product.
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 is 50-100 mg/L, and the concentration of bovine serum is 30-95%.
Further, the heat preservation stirring in the step (2) is constant temperature stirring at 30 ℃ for 10-20 min.
Further, the vitamin B1 dropping rate in the step (3) is 1-5 mg/min.
Further, the amount of oxygen introduced in the step (3) is 50-100 m L/min, and the concentration of the oxygen is 85%.
Further, the amount of carbon dioxide introduced in the step (4) is 10-60 m L/min, and the concentration of the carbon dioxide is 50%.
Further, the step of freeze-drying in the step (5) comprises:
first pre-freezing, namely, keeping the solution to be lyophilized for 8 to 12 hours at the temperature of between 30 ℃ below zero and 70 ℃ below zero;
second pre-freezing, namely keeping the solution to be lyophilized for 1-3 hours at the temperature of-60-100 ℃;
and (3) performing vacuum freeze drying, and keeping the solution to be freeze-dried for 24-48 hours in a negative pressure environment at the temperature of-20 to-60 ℃.
Further, the negative pressure environment of the vacuum freeze drying is 5-10 Pa, the temperature is increased from minus 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
In order to make the objects, features and advantages of the present invention comprehensible, specific embodiments accompanied with examples are described in detail below. 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
A quality control product of an adiponectin determination reagent is characterized by comprising a freeze-dried product of the following components:
50 parts of phosphate buffer solution, namely,
1 part of sodium iodide, namely sodium iodide,
0.02 part of vitamin B1,
0.01 part of sodium citrate, and the balance of sodium citrate,
5 parts of bovine serum, namely, bovine serum,
0.1 part of adiponectin protein,
2 parts of cane sugar, namely 2 parts of cane sugar,
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 forming of quality control products, the preservative can prolong 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 inactivation of pure adiponectin 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.
In this example, the preservative is sorbic acid.
The preparation method of the adiponectin determination reagent quality control product comprises the following steps:
(1) taking the adiponectin, and adding a phosphate buffer solution to dilute to obtain a diluent;
(2) adding sodium citrate into the diluent, stirring at a constant temperature, 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-drying solution;
(4) adding bovine serum into the second mixed solution, uniformly stirring, and continuously introducing carbon dioxide into the second mixed solution during stirring to obtain a second freeze-drying 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 adiponectin determination reagent quality control product.
In the preparation method, the sucrose and the preservative are in solid state, and the other components are in solution.
In this embodiment, divide the diluent into two parts, more one part adds sodium iodide and vitamin and can improve adiponectin protein's stability, lets in oxygen and can promote adiponectin protein's stability, lets in carbon dioxide and can adjust the acidity of solution, promotes the save effect.
Further, the concentration of the phosphate buffer solution is 50 mmol/L, the concentration of sodium iodide is 0.5 mol/L, the concentration of vitamin B1 is 100 mmol/L, the concentration of sodium citrate is 50 mmol/L, the concentration of adiponectin is 50 mg/L, and the concentration of bovine serum is 60%.
Specifically, the stirring in the step (2) is carried out at a constant temperature of 30 ℃ for 15 min.
In addition, the vitamin B1 dropping speed in the step (3) is 1mg/min, the oxygen amount is 50m L/min, and the oxygen concentration is 85%.
In addition, the amount of carbon dioxide introduced in the step (4) is 10m L/min, the concentration of carbon dioxide is 50%, and the rest components are nitrogen and oxygen.
Specifically, the step of freeze-drying in the step (5) includes:
pre-freezing, namely, keeping the freeze-dried solution at the temperature of minus 30 ℃ for 8 hours;
second pre-freezing, namely, keeping the solution to be lyophilized for 1 hour at the temperature of-60 ℃;
and (3) performing vacuum freeze drying, namely placing the solution to be freeze-dried in a negative pressure environment for 36 hours, wherein the negative pressure environment of the vacuum freeze drying is 5Pa, and the temperature is increased from-60 ℃ at a heating rate of 0.5 ℃/h until the vacuum freeze drying is finished.
Example 2
A quality control product of an adiponectin determination reagent is characterized by comprising a freeze-dried product of the following components:
80 parts of phosphate buffer solution, namely 80 parts of phosphate buffer solution,
2 parts of sodium iodide, namely sodium iodide,
0.1 part of vitamin B1,
0.05 part of sodium citrate, and the balance,
10 parts of bovine serum, wherein the bovine serum is selected,
0.5 part of adiponectin protein,
5 parts of cane sugar, namely 5 parts of cane sugar,
and 2 parts of a 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.
The preparation method of the adiponectin determination reagent quality control product comprises the following steps:
(1) taking the adiponectin, and adding a phosphate buffer solution to dilute to obtain a diluent;
(2) adding sodium citrate into the diluent, stirring at a constant temperature, 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-drying solution;
(4) adding bovine serum into the second mixed solution, uniformly stirring, and continuously introducing carbon dioxide into the second mixed solution during stirring to obtain a second freeze-drying solution;
(5) and mixing the first freeze-drying liquid and the second freeze-drying liquid, adding sucrose, and performing freeze drying to obtain the adiponectin determination reagent quality control product.
Specifically, the concentration of the phosphate buffer solution is 400 mmol/L, the concentration of sodium iodide is 1 mol/L, the concentration of vitamin B1 is 500 mmol/L, the concentration of sodium citrate is 200 mmol/L, the concentration of adiponectin protein is 100 mg/L, and the concentration of bovine serum is 95%.
Further, the stirring at constant temperature in the step (2) is constant-temperature stirring at 30 ℃ for 15 min.
Further, the dropping rate of the vitamin B1 in the step (3) is 5 mg/min.
Further, the amount of oxygen introduced in the step (3) is 100m L/min, and the concentration of oxygen is 85%.
Further, the amount of carbon dioxide introduced in the step (4) is 60m L/min, and the concentration of carbon dioxide is 50%.
Further, the step of freeze-drying in the step (5) comprises:
pre-freezing, namely, keeping the liquid to be lyophilized in an environment with the temperature of 70 ℃ below zero for 12 hours;
second pre-freezing, namely keeping the solution to be lyophilized in an environment of-100 ℃ for 3 hours;
and (3) performing vacuum freeze drying, namely placing the solution to be freeze-dried in a negative pressure environment for 36 hours, wherein the negative pressure environment of the vacuum freeze drying is 5Pa, and the temperature is raised from-60 ℃ at the heating rate of 1 ℃/h until the vacuum freeze drying is finished.
Example 3
A quality control product of an adiponectin determination reagent is characterized by comprising a freeze-dried product of the following components:
60 parts of phosphate buffer solution, namely phosphate buffer solution,
2 parts of sodium iodide, namely sodium iodide,
0.1 part of vitamin B1,
0.02 part of sodium citrate, and the balance of sodium citrate,
7 parts of bovine serum, wherein the bovine serum is,
0.5 part of adiponectin protein,
5 parts of cane sugar, namely 5 parts of cane sugar,
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.
The preparation method of the adiponectin determination reagent quality control product comprises the following steps:
(1) taking the adiponectin, and adding a phosphate buffer solution to dilute to obtain a diluent;
(2) adding sodium citrate into the diluent, stirring at a constant temperature, 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-drying solution;
(4) adding bovine serum into the second mixed solution, uniformly stirring, and continuously introducing carbon dioxide into the second mixed solution during stirring to obtain a second freeze-drying solution;
(5) and mixing the first freeze-drying liquid and the second freeze-drying liquid, adding sucrose, and performing freeze drying to obtain the adiponectin determination reagent quality control product.
Further, the concentration of the phosphate buffer solution is 200 mmol/L, the concentration of sodium iodide is 1 mol/L, the concentration of vitamin B1 is 200 mmol/L, the concentration of sodium citrate is 50 mmol/L, the concentration of adiponectin is 100 mg/L, and the concentration of bovine serum is 60%.
Specifically, the stirring in the step (2) is carried out at a constant temperature of 30 ℃ for 20 min.
In addition, the vitamin B1 dropping speed in the step (3) is 5mg/min, the oxygen introducing amount is 100m L/min, and the oxygen concentration is 85%.
In addition, the amount of carbon dioxide introduced in the step (4) is 60m L/min, and the concentration of carbon dioxide is 50%.
Specifically, the step of freeze-drying in the step (5) includes:
pre-freezing, namely, keeping the liquid to be lyophilized in an environment with the temperature of 50 ℃ below zero for 12 hours;
second pre-freezing, namely keeping the solution to be lyophilized in an environment with the temperature of 80 ℃ below zero for 3 hours;
and (3) performing vacuum freeze drying, namely placing the solution to be freeze-dried in a negative pressure environment for 36 hours, wherein the negative pressure environment of the vacuum freeze drying is 5Pa, and the temperature is increased from-60 ℃ at a heating rate of 0.5 ℃/h until the vacuum freeze drying is finished.
Comparative example 1
This comparative example is substantially the same as example 3 except that:
in this comparative example, the diluent was not divided into two portions, and oxygen and carbon dioxide were not introduced.
Comparative example 2
This comparative example is substantially the same as 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 the same as example 3 except that:
oxygen and carbon dioxide were not introduced in this comparative example.
Comparative example 4
This comparative example is substantially the same as example 3 except that:
the steps of freeze drying are as follows:
pre-freezing, namely, keeping the freeze-dried material at the temperature of-70 ℃ for 24 hours;
vacuum freeze drying, and keeping the freeze-drying solution under negative pressure environment of 5Pa and-60 deg.C for 36 hr.
The quality control products obtained in the above examples and comparative examples were divided into low value group, medium value group and high value group, and were reconstituted with water, the initial concentrations were 30 mg/L, 60 mg/L and 120 mg/L, and the coefficient of variation CV was calculated by continuously measuring the concentration for 7 days, and the results are shown in Table 1.
TABLE 1
| Grouping | Low value set CV (%) | Median value group CV (%) | High value set 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 precision requirement on the quality control product is higher, different ADPN concentrations need to be measured aiming at the quality control product, and the quality control product of the adiponectin measuring reagent is proved to be a qualified product when the measured results meet the requirement. The invention adopts a low value group, a middle group and a high value group to carry out detection respectively, and evaluates the stability of the quality control product by taking the variation coefficient of ADPN concentration change within 7 days as reference. The smaller the CV value is, the more stable the quality control product is, the easier the quality control product is to be stored, and when the three groups all meet the CV of less than 3%, the quality control product is judged to be a qualified product.
As can be seen from table 1, examples 1 to 3 all achieve better effects than comparative examples 1 to 4, that is, the CV value of the examples is generally lower than that of the comparative examples, which shows that the technical scheme of the present invention can achieve better effects.
In addition, it is understood from comparative example 3 and comparative examples 1 to 4 that the CV value of example 3 is significantly lower than that of the comparative example, and the comparative example causes the quality of the quality control product to be deteriorated when the conditions of example 3 are abandoned.
In the description herein, references to the description of the term "one embodiment," "some embodiments," "an example," "a specific example," or "some examples," etc., 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 above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the present invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.
Claims (10)
1. A quality control product of an adiponectin determination reagent is characterized by comprising 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 parts of vitamin B1,
0.01 to 0.05 parts of sodium citrate,
5-10 parts of bovine serum,
0.1 to 0.5 parts of adiponectin protein,
2-5 parts of cane sugar,
1-2 parts of a preservative.
2. The adiponectin measurement reagent quality control product according to claim 1, wherein the phosphate buffer solution is composed of disodium hydrogen phosphate and potassium dihydrogen phosphate in a mass ratio of 4: 1.
3. The method for preparing a quality control product of a adiponectin measurement reagent according to any one of claims 1 to 3, characterized by comprising the steps of:
(1) taking the adiponectin, and adding a phosphate buffer solution to dilute to obtain a diluent;
(2) adding sodium citrate into the diluent, stirring at a constant temperature, 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-drying solution;
(4) adding bovine serum into the second mixed solution, uniformly stirring, and continuously introducing carbon dioxide into the second mixed solution during stirring to obtain a second freeze-drying 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 adiponectin determination reagent quality control product.
4. The method for preparing the adiponectin determination reagent quality control product according to claim 3, wherein the concentration of the phosphate buffer is 50 to 400 mmol/L, the concentration of sodium iodide is 0.5 to 1 mol/L, the concentration of vitamin B1 is 100 to 500 mmol/L, the concentration of sodium citrate is 50 to 200 mmol/L, the concentration of adiponectin protein is 50 to 100 mg/L, and the concentration of bovine serum is 30 to 95%.
5. The method for preparing the quality control product of the adiponectin measurement reagent according to claim 3, wherein the stirring at constant temperature in the step (2) is performed at 30 ℃ for 10-20 min.
6. The method for preparing a quality control product of an adiponectin measurement reagent according to claim 3, wherein the rate of dropping vitamin B1 in step (3) is 1 to 5 mg/min.
7. The method for preparing the adiponectin measurement reagent quality control material according to claim 3, wherein the amount of oxygen introduced in step (3) is 50 to 100m L/min, and the concentration of oxygen is 85%.
8. The method for preparing the quality control product of the adiponectin measurement reagent according to claim 3, wherein the amount of carbon dioxide introduced in the step (4) is 10 to 60m L/min, and the concentration of carbon dioxide is 50%.
9. The method for preparing a quality control product of an adiponectin measurement reagent according to claim 3, wherein the step of freeze-drying in the step (5) comprises:
first pre-freezing, namely, keeping the solution to be lyophilized for 8 to 12 hours at the temperature of between 30 ℃ below zero and 70 ℃ below zero;
second pre-freezing, namely keeping the solution to be lyophilized for 1-3 hours at the temperature of-60-100 ℃;
and (3) performing vacuum freeze drying, and keeping the solution to be freeze-dried for 24-48 hours in a negative pressure environment at the temperature of-20 to-60 ℃.
10. The method for preparing a quality control product of a adiponectin measurement reagent according to claim 9, wherein the vacuum freeze-drying is performed under a negative pressure of 5 to 10Pa at a temperature from-60 ℃ and at a temperature rise rate of 0.5 to 1 ℃/h until the completion of the vacuum freeze-drying.
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