Uric acid quality control liquid and application thereof

Abstract

The invention discloses a uric acid quality control liquid, which comprises cysteine hydrochloride and sodium 3-carboxybenzenesulfonate. The required high-concentration (more than 600 [mu] mol / L) quality control liquid can be easily prepared, the problem of dissolution does not exist, a large number of solubilizing substances do not need to be added, and the quality control liquid has excellent stability and long storage life, can be well applied to an electrochemical detection system, and ensures the accuracy and precision of a quality control result. The method can be applied to a uric acid detection system.

Description

Technical Field

[0001] The present invention relates to the field of biological detection technology, and in particular to a uric acid quality control solution and application thereof. Background Art

[0002] Uric acid is the final product of purine metabolism in the human body and is mainly excreted from the body through the kidneys. An imbalance between the production and excretion of uric acid in the body will lead to elevated uric acid levels, which is the main cause of gout. Uric acid testing is one of the main means of medical diagnosis and clinical testing of the patient's condition. Existing methods for detecting uric acid content mainly include chemical methods, enzymatic methods, and electrochemical methods. The electrochemical method has the characteristics of simple operation, low cost, high sensitivity, and low detection limit.

[0003] The quality control solution is a solution containing the substance to be tested or a substance with the same properties as the substance to be tested. Its function is to confirm whether the electrochemical detection system functions normally. When there are large deviations or questionable results during the detection process, the detection system's test results on the quality control solution can be used as a basis to confirm whether the detection system is in a normal detection state.

[0004] Uric acid test strips made by electrochemical method can be divided into two categories, enzyme electrode test strips and non-enzyme electrode test strips. The commercially available uric acid quality control solution of enzyme electrode test strips is usually prepared by dissolving uric acid in a strong alkaline solution or using sodium urate. The solubility of uric acid in water is extremely low, and it needs to be dissolved in a strong alkaline solution; the solubility of sodium urate in water is very small. According to relevant experimental measurements, the solubility of sodium urate in physiological saline at 37°C is 416μmol / L, and the solubility is even less at room temperature (25°C). The quality control solution is usually stored at 4°C-30°C. At this temperature, it is impossible to obtain a high concentration (above 600μmol / L) quality control solution. A large amount of solubilizing substances such as surfactants and stabilizers need to be added, which makes the preparation of the quality control solution troublesome. If the addition of solubilizing substances is unreasonable, the dissolution of sodium urate in the quality control solution will be affected during the storage process. The above-mentioned quality control solutions have the problems of poor stability and short storage time, and are easily affected by temperature, and can usually only be stored at low temperatures. Moreover, the strong alkaline solution affects the enzyme activity in the electrochemical electrode strip, and will also have a certain impact on the accuracy of the detection signal, resulting in a certain difference between the quality control test results and the true value. Summary of the invention

[0005] In view of the above shortcomings, the present invention provides a uric acid quality control solution, which has a long shelf life, high stability, and its components are easily soluble in water. It can be well applied to the electrochemical detection system to ensure the accuracy and precision of the quality control results. The specific technical scheme is as follows:

[0006] A uric acid quality control solution comprises cysteine ​​hydrochloride and sodium 3-carboxybenzenesulfonate.

[0007] Preferably, the uric acid quality control solution also includes a preservative.

[0008] Preferably, the uric acid quality control solution comprises, by weight percentage: 0.01%-1% cysteine ​​hydrochloride, 1%-10% sodium 3-carboxybenzenesulfonate, 0.01%-0.1% preservative,

[0009] More preferably, the uric acid quality control solution comprises, by weight percentage: 0.02%-0.3% cysteine ​​hydrochloride, 3%-5% sodium 3-carboxybenzenesulfonate, and 0.03%-0.07% preservative.

[0010] Most preferably, the uric acid quality control solution comprises, by weight percentage: 0.02%-0.3% cysteine ​​hydrochloride, 3%-5% sodium 3-carboxybenzenesulfonate, and 0.05% preservative.

[0011] Cysteine ​​hydrochloride is an amino acid derivative, colorless to white crystals or crystalline powder. Compared with uric acid, which needs to be dissolved in a strong alkaline solution, cysteine ​​hydrochloride is easily soluble in water, with a solubility of 50 mg / ml, and is stable under acidic conditions. Sodium 3-carboxybenzenesulfonate has good water solubility, and its aqueous solution is strongly acidic. Cysteine ​​hydrochloride and sodium 3-carboxybenzenesulfonate have a synergistic effect, and sodium 3-carboxybenzenesulfonate can maintain the pH of the quality control solution within the range where cysteine ​​hydrochloride can be stably stored.

[0012] Preferably, the preservative is sodium azide. The function of the preservative is to prevent the production of bacteria and extend the shelf life of the quality control solution.

[0013] Preferably, the uric acid quality control solution also includes a thickener, including one or more of polyvinyl pyrrolidone K30, sodium alginate, gelatin, and hydroxyethyl cellulose. The thickener mainly simulates the viscosity of blood to prevent the quality control solution from flowing too fast when used, thereby affecting the test stability.

[0014] Preferably, the mass concentration of the thickener is 0.1%-1%, more preferably 0.2%-0.5%, and most preferably 0.4%.

[0015] Preferably, the pH of the uric acid quality control solution is 0.8-3, and most preferably, the pH of the uric acid quality control solution is 1-3.

[0016] On the other hand, the present invention also provides application of the above-mentioned uric acid quality control solution in a uric acid detection system.

[0017] Compared with the prior art, the present invention has the following beneficial effects:

[0018] 1. In the uric acid quality control solution of the present invention, cysteine ​​hydrochloride is used to replace uric acid or sodium urate in the traditional quality control solution. Cysteine ​​hydrochloride is easily soluble in water, and it is easy to prepare the required high concentration (600 μmol / L or more) quality control solution without dissolution problems. The quality control solution obtained by combining sodium 3-carboxybenzenesulfonate has excellent stability and a long shelf life, and does not affect the enzyme activity in the electrochemical electrode strip. The enzyme of the electrochemical electrode strip has high activity in an acidic system, so it will not interfere with the reaction signal of the electrochemical electrode strip, thereby not affecting the accuracy of the detection signal of the electrochemical electrode strip.

[0019] 2. The uric acid quality control solution provided by the present invention adopts cysteine ​​hydrochloride to participate in the reaction instead of uric acid or sodium urate in the traditional quality control solution. Since the potassium ferrocyanide in the uric acid test paper oxidizes cysteine ​​hydrochloride, a weak current will be generated during the reaction. The current change is measured by the built-in instrument of the supporting instrument and converted and displayed as the corresponding uric acid concentration value. It can be well applied to the electrochemical detection system to ensure the accuracy and precision of the quality control results. DETAILED DESCRIPTION

[0020] The specific embodiments of the present invention are described in detail below, but it should be understood that the protection scope of the present invention is not limited by the specific embodiments.

[0021] Example 1

[0022] (1) The formula and pH of uric acid quality control solution are shown in Table 1.

[0023] Table 1

[0024] Concentration 1 Concentration 2 Concentration 3 p-Cysteine ​​hydrochloride 0.02g 0.05g 0.1g Sodium 3-carboxybenzenesulfonate 3.5g 3.5g 3.5g Sodium alginate 0.4g 0.4g 0.4g Sodium Azide 0.05g 0.05g 0.05g Purified water 96.03g 96.0g 96.0g pH 1.6 1.6 1.6

[0025] Three concentration levels of uric acid quality control solutions were prepared according to the formula in Table 1. The pH of each concentration was measured with a pH meter. The quality control solutions of each concentration were tested using a uric acid meter and uric acid test strips. Each concentration of quality control solution was tested 10 times and the average value was calculated. Concentration 1 was 238±14μmol / L, concentration 2 was 562±33μmol / L, and concentration 3 was 1089±65μmol / L.

[0026] Comparative Example 1: The commercially available uric acid quality control solution produced by Nanjing Jingjie Biotechnology Co., Ltd. was used to prepare the quality control solution with the above concentration of 1 for testing.

[0027] (2) Stability test

[0028] The uric acid quality control solution of the three concentration levels of Example 1 and the uric acid quality control solution of Comparative Example 1 were divided into small bottles with a volume of 3 mL per portion, and placed in a constant temperature box at 2 ° C and 50 ° C after sealing. Take one bottle of uric acid quality control solution of different concentration levels in a constant temperature box at 2 ° C and 50 ° C every other week, and use the BeneCheck uric acid biochemical analyzer (electrochemical method) and uric acid test paper of Suzhou Puchuntang Biotechnology Co., Ltd. to test each concentration of quality control solution. After the test is completed, the deviation of the uric acid meter test value of the uric acid quality control solution placed under each 50 ° C condition and the uric acid quality control solution placed under 2 ° C conditions is calculated respectively, and the test is continued for 10 weeks. The test results are shown in Table 2 below.

[0029] Table 2

[0030]

[0031] According to the quality control test results in Table 2 above, the uric acid quality control solution provided in the embodiment of the present invention has good storage stability at 50°C. After accelerated aging at 50°C for 10 weeks, the deviation is within 8% compared with the uric acid quality control solution under refrigerated conditions.

[0032] (3) Accuracy test

[0033] The method of Example 1 was used to prepare a uric acid quality control solution, and the prepared uric acid quality control solution was tested using a Mindray BS450 biochemical analyzer (photoelectric colorimetry) produced by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. and a uric acid test paper produced by Suzhou Puchuntang Biotechnology Co., Ltd. The deviation between the biochemical test value of the uric acid quality control solution and the theoretical concentration value was calculated based on the quality control test results. The results are shown in Table 3:

[0034] Table 3

[0035]

[0036]

[0037] According to the quality control test results in the above table, the uric acid quality control solution provided in the embodiment of the present invention has a very small deviation between the biochemical test value and the theoretical concentration value, and therefore can effectively ensure the accuracy and precision of the quality control test results.

[0038] The foregoing description of specific exemplary embodiments of the present invention is for the purpose of illustration and demonstration. These descriptions are not intended to limit the present invention to the precise form disclosed, and it is clear that many changes and variations can be made based on the above teachings. The purpose of selecting and describing the exemplary embodiments is to explain the specific principles of the present invention and its practical application, so that those skilled in the art can realize and utilize various different exemplary embodiments of the present invention and various different selections and changes. The scope of the present invention is intended to be limited by the claims and their equivalents.

Claims

1. A uric acid quality control solution, characterized in that: Including cysteine ​​hydrochloride and sodium 3-carboxybenzenesulfonate.

2. A uric acid quality control solution according to claim 1, characterized in that: The uric acid quality control solution also includes a preservative.

3. A uric acid quality control solution according to any one of claims 1 to 2, characterized in that: The uric acid-control solution comprises, by weight percentage, 0.01%-1% of cysteine ​​hydrochloride, 1%-10% of sodium 3-carboxylbenzenesulfonate, and 0.01%-0.1% of a preservative.

4. A uric acid quality control solution according to claim 3, characterized in that: The uric acid quality control solution comprises, by weight percentage, 0.02%-0.3% of cysteine ​​hydrochloride, 3%-5% of sodium 3-carboxybenzenesulfonate, and 0.03%-0.07% of a preservative.

5. A uric acid quality control solution according to claim 2, characterized in that: The preservative is sodium azide.

6. A uric acid quality control solution according to any one of claims 1 to 5, characterized in that: The uric acid quality control solution also includes a thickener.

7. A uric acid quality control solution according to claim 6, characterized in that: The thickener includes one or more of polyvinyl pyrrolidone K30, sodium alginate, gelatin, and hydroxyethyl cellulose.

8. A uric acid quality control solution according to claim 6, characterized in that: The mass concentration of the thickener is 0.1%-1%.

9. A uric acid quality control solution according to any one of claims 1 to 8, characterized in that: The pH of the uric acid quality control solution is 0.8-3.

10. Use of the uric acid quality control solution according to any one of claims 1 to 9 in a uric acid detection system.

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