Rapid and accurate dialyzer inulin detection method

Abstract

The invention discloses a rapid and accurate dialyzer inulin detection method, which comprises a sulfuric acid system, and the sulfuric acid system comprises the following steps: 1, preparing a to-be-detected mixed solution, respectively taking an inulin stock solution and an inulin test sample, placing the inulin stock solution and the inulin test sample in a test tube, adding an anthrone sulfate solution, and fully and uniformly mixing to obtain the to-be-detected mixed solution; 2, putting the to-be-detected mixed solution into a constant-temperature water bath kettle for heating; 3, after cooling, measuring absorbance under the wavelength of 627 nm, and calculating the content of the inulin in the sample according to the linear relation between the mass concentration of the inulin and the absorbance; the method has the beneficial effects that a dual detection mode of'process inspection sulfuric acid system rapid screening and finished product inspection hydrochloric acid-TBA system accurate constant value 'is established aiming at the quality control requirement of the whole flow of dialyzer production, so that the efficient circulation requirement of the production link is met, the quality compliance of outgoing products is guaranteed, and rapid and accurate organic unification is realized.

Description

Technical Field

[0001] This invention relates to the field of hemodialysis machine technology, and in particular to a method for detecting inulin in dialyzers that combines speed and accuracy. Background Technology

[0002] The inulin removal rate test of a dialyzer is a core indicator for evaluating its ability to remove medium-molecular substances. This test quantifies the dialyzer's inulin removal efficiency by simulating an in vitro circulatory system, and directly reflects the dialyzer's filtration performance for medium-molecular toxins. Currently, the main methods for determining inulin include two categories: chromatography and colorimetry. Although chromatography has high accuracy and precision, the equipment is expensive and the operation is complex, making it difficult to meet routine testing needs. In contrast, colorimetry is widely used because it is simple to operate and inexpensive. Among the many colorimetric methods, the colorimetric method based on sodium thiosulfate has attracted attention due to its unique advantages. Studies have shown that inulin can be determined by colorimetric analysis using sodium thiosulfate prepared from sulfuric acid or sodium thiosulfate prepared from hydrochloric acid and thiobarbituric acid. However, these two methods have their own characteristics in practical applications, and choosing the appropriate method is crucial for obtaining accurate and reliable analytical results. In view of the above, it is necessary to improve the existing inulin detection methods for dialyzers so that they can meet the current needs of inulin detection. Summary of the Invention

[0003] To address the aforementioned technical problems, this invention provides a method for detecting inulin in dialyzers that combines speed and accuracy, comprising a sulfuric acid system, wherein the sulfuric acid system includes the following steps: Step 1: Prepare the test mixture. Take the inulin stock solution and inulin sample into test tubes, add anthrone sulfate solution, and mix thoroughly to obtain the test mixture. Step 2: Place the mixture to be tested into a constant temperature water bath and heat it.

[0004] Step 3: After cooling, measure the absorbance at a wavelength of 627 nm. Calculate the inulin content in the sample based on the linear relationship between inulin mass concentration and absorbance.

[0005] As a further supplement to this technical solution, in step one, 0.1 ml of inulin stock solution and 0.1 ml of inulin sample are respectively placed in test tubes.

[0006] As a further supplement to this technical solution, 4 ml of anthrone sulfate solution is added in step one.

[0007] As a further supplement to this technical solution, the temperature of the constant temperature water bath in step two is 60°C.

[0008] As a further supplement to this technical solution, the heating time in step two is 10 minutes.

[0009] A further supplement to this technical solution includes a hydrochloric acid-TBA system, which comprises the following steps: Step (1): Dilute 0.3 ml of inulin stock solution and 0.3 ml of inulin test solution to 10 ml; Step (2): Take 2.0 ml of the diluent, add 2.0 ml of 0.02 mol / L thiobarbituric acid and 2.0 ml of concentrated hydrochloric acid, mix well, and then heat in a boiling water bath for 60 min. Step (3): After cooling, measure the absorbance at 432 nm. Calculate the inulin content in the sample based on the linear relationship between inulin mass concentration and absorbance.

[0010] Its beneficial effect lies in the fact that this solution establishes a dual detection mode of "rapid screening of sulfuric acid system for process inspection + accurate determination of hydrochloric acid-TBA system for finished product inspection" to meet the quality control needs of the entire dialyzer production process. This mode not only meets the needs of efficient flow in the production process, but also ensures the quality compliance of the products leaving the factory, achieving an organic unity of speed and accuracy. Detailed Implementation

[0011] To facilitate a clearer understanding of this technical solution by those skilled in the art, the technical solution of the present invention will be described in detail below: A method for detecting inulin in dialyzers that combines speed and accuracy includes a sulfuric acid system, wherein the sulfuric acid system comprises the following steps: Step 1: Prepare the test mixture. Take the inulin stock solution and inulin sample into test tubes, add anthrone sulfate solution, and mix thoroughly to obtain the test mixture. Step 2: Place the mixture to be tested into a constant temperature water bath and heat it.

[0012] Step 3: After cooling, measure the absorbance at a wavelength of 627 nm. Calculate the inulin content in the sample based on the linear relationship between inulin mass concentration and absorbance.

[0013] In step one, 0.1 ml of inulin stock solution and 0.1 ml of inulin sample are respectively placed in test tubes.

[0014] In step one, 4 ml of anthrone sulfate solution is added.

[0015] In step two, the temperature of the constant temperature water bath is 60℃.

[0016] In step two, the heating time is 10 minutes.

[0017] Process inspection targets semi-finished products after key processes such as dialyzer membrane forming and assembly. Its core task is to quickly determine whether inulin removal performance is within the preset range and to promptly detect issues such as equipment parameter drift and raw material fluctuations. The sulfuric acid system testing cycle is controlled within 30 minutes, achieving the high-frequency monitoring requirement of sampling every 2 hours and promptly preventing the flow of substandard semi-finished products. The operation is simple, low-cost, and fast, allowing for the processing of large numbers of samples in a short time.

[0018] This technical solution also includes a hydrochloric acid-TBA system, which comprises the following steps: Step (1): Dilute 0.3 ml of inulin stock solution and 0.3 ml of inulin test solution to 10 ml; Step (2): Take 2.0 ml of the diluent, add 2.0 ml of 0.02 mol / L thiobarbituric acid and 2.0 ml of concentrated hydrochloric acid, mix well, and then heat in a boiling water bath for 60 min. Step (3): After cooling, measure the absorbance at 432 nm. Calculate the inulin content in the sample based on the linear relationship between inulin mass concentration and absorbance.

[0019] Finished product inspection, as the final quality control step before dialyzers leave the factory, requires precise quantification of inulin removal rate to eliminate cumulative errors and matrix interference throughout the production process. The hydrochloric acid-TBA system (hydrochloric acid-thiobarbituric acid) achieves precise quantification of inulin through a specific reaction, making it suitable for final quality verification of the finished product. The hydrochloric acid-TBA system exhibits a relative error of ≤2% in finished product detection, a linear range of 0.1-100 μg / mL, and a recovery rate of 98%-102%. In addition to high accuracy, it also demonstrates good reproducibility, meeting the precision requirements for finished medical device inspection.

[0020] The above technical solutions only embody the preferred technical solutions of the present invention. Any modifications that may be made by those skilled in the art to certain parts thereof embody the principles of the present invention and fall within the protection scope of the present invention.

Claims

1. A method for detecting inulin in dialyzers that combines speed and accuracy, characterized in that, The sulfuric acid system includes the following steps: Step 1: Prepare the test mixture. Take the inulin stock solution and inulin sample into test tubes, add anthrone sulfate solution, and mix thoroughly to obtain the test mixture. Step 2: Place the mixture to be tested into a constant temperature water bath and heat it. Step 3: After cooling, measure the absorbance at a wavelength of 627 nm. Calculate the inulin content in the sample based on the linear relationship between inulin mass concentration and absorbance.

2. The method for detecting inulin in a dialyzer, which combines speed and accuracy, as described in claim 1, is characterized in that... In step one, 0.1 ml of inulin stock solution and 0.1 ml of inulin sample are respectively placed in test tubes.

3. The method for detecting inulin in a dialyzer, which combines speed and accuracy, as described in claim 2, is characterized in that... In step one, 4 ml of anthrone sulfate solution is added.

4. The method for detecting inulin in a dialyzer, which combines speed and accuracy, as described in claim 3, is characterized in that... The temperature of the constant temperature water bath in step two is 60℃.

5. The method for detecting inulin in a dialyzer, which combines speed and accuracy, as described in claim 4, is characterized in that... The heating time in step two is 10 minutes.

6. A method for detecting inulin in a dialyzer that combines speed and accuracy according to any one of claims 1-5, characterized in that, It also includes a hydrochloric acid-TBA system, which comprises the following steps: Step (1): Dilute 0.3 ml of inulin stock solution and 0.3 ml of inulin test solution to 10 ml; Step (2): Take 2.0 ml of the diluent, add 2.0 ml of 0.02 mol / L thiobarbituric acid and 2.0 ml of concentrated hydrochloric acid, mix well, and then heat in a boiling water bath for 60 min. Step (3): After cooling, measure the absorbance at 432 nm. Calculate the inulin content in the sample based on the linear relationship between inulin mass concentration and absorbance.