Quality control test paper for warming meridians granules, preparation method and application thereof

Abstract

This invention relates to the field of traditional Chinese medicine quality control technology, and discloses a quality control test strip for Wenjing granules, its preparation method, and its application. The gold label layer in this test strip is composed of a gold label carrier. One side surface of the gold label carrier has a cavity arrangement composed of void units, with adjacent void units connected by flow channels. This structure of the gold label layer can achieve the technical effect of quantitatively loading specific adsorbent particles, thereby achieving the purpose of accurate quality control of the components of traditional Chinese medicine preparations with known component contents. The gold label layer is prepared using an etching method, which forms void units, void arrangements, and flow channel structures on the surface of the gold label carrier. Loading the specific adsorbent particles onto the gold label layer involves preparing a suspension of the specific adsorbent particles and rinsing the side surface of the gold label carrier with void units using the suspension, causing the specific adsorbent particles to embed into the void units, thus achieving quantitative loading of specific adsorbent particles. This method is simple to operate, low in cost, and easy to promote industrially.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine quality control technology, and in particular to a quality control test paper for Wenjing granules, its preparation method, and its application. Background Technology

[0002] Quality control of the components of traditional Chinese medicine (TCM) preparations is a crucial aspect of TCM preparation production. Currently, the main methods for quality control of TCM preparation components include high-performance liquid chromatography (HPLC), thin-layer chromatography (TLC), gas chromatography (GC), and high-performance capillary electrophoresis (HPLC). Among these, HPLC is the most commonly used method for the quantitative and qualitative detection of TCM preparation components, offering advantages such as high sensitivity, fast separation speed, wide applicability, and good repeatability. It remains irreplaceable in the initial quantitative and qualitative analysis of TCM preparations. However, when detecting known TCM preparation components, it suffers from problems such as long sample pretreatment cycles, complex operations, time-consuming and labor-intensive processes, and high detection costs. Therefore, to overcome these problems, existing technologies disclose TCM preparation quality control test strips. These test strips achieve rapid detection and are simple to operate, highly specific, low in cost, and fast in detection speed, significantly improving the speed of quality control detection and increasing production efficiency.

[0003] Currently, publicly available quality control test strips for traditional Chinese medicine preparations include fluorescently labeled quality control test strips and gold-labeled monoclonal antibody quality control test strips. Among them, gold-labeled monoclonal antibody-labeled quality control test strips are a quality control method that has been extensively studied in recent years. For example, CN113030476A discloses a test strip for detecting class 0 auramine drugs, its preparation method and its application, and CN115308406A discloses a dual-sample pad colloidal gold immunochromatographic test strip. The gold-labeled monoclonal antibody quality control test strip mainly consists of a gold label layer loaded with colloidal gold monoclonal antibody complex, a cellulose acetate membrane for chromatographic separation, a primary antibody (detection line) for detecting the antigen, and a secondary antibody (control line) for quality control. Currently, the preparation process of gold-labeled monoclonal antibody-labeled quality control test strips typically involves spraying different concentrations of colloidal gold monoclonal antibody onto glass fiber and drying it. During use, the detection limit of the test strip is determined by standard components. Therefore, in practical applications, the presence or absence of the target traditional Chinese medicine preparation component can only be determined by the color intensity and presence or absence of the detection line, and the content of the target traditional Chinese medicine preparation component can be roughly estimated. Thus, only semi-quantitative and qualitative analysis can be achieved, and quantitative quality control of traditional Chinese medicine preparations cannot be completed. Summary of the Invention

[0004] To overcome the limitations of existing gold-labeled monoclonal antibody quality control test strips, which can only achieve semi-quantitative and qualitative analysis and cannot accurately determine the quality of traditional Chinese medicine preparations, a quality control test strip for Wenjing granules, its preparation method, and its application are provided. The structure of the gold label layer of this test strip is that one side surface of the gold label carrier has a cavity arrangement composed of cavity units and several channels connecting the cavities. By accommodating specific adsorbed particles through the cavity units, the gold label carrier can achieve the technical effect of quantitatively loading specific adsorbed particles. The quantitatively loaded gold label layer can accurately perform quality control detection of components in traditional Chinese medicine preparations with known component contents. It is simple to use, highly efficient and rapid, and has low detection cost.

[0005] The specific technical solution of this invention is as follows:

[0006] A temperature-controlled particle quality control test strip includes a base plate and a filter layer, a gold label layer, a detection layer, and an absorbent layer located on the base plate. The gold label layer includes specific adsorbent particles and a gold label carrier loaded with the specific adsorbent particles. One side surface of the gold label carrier is provided with a plurality of cavities and a plurality of channels. The cavities include a plurality of cavity units with channels connected to each other. The channels connect adjacent cavity units. The specific adsorbent particles are located within the cavity units.

[0007] Preferably, the particle size of the specific adsorption particles matches the inner diameter of the cavitation unit, and the ratio of the inner diameter of the flow channel to the inner diameter of the cavity is 2.8 to 3.5:4.

[0008] Preferably, the gold label carrier is made of glass fiber; the detection layer is provided with detection lines and control lines. This application provides a quality control test strip for warm-natured particles, which consists of a base plate, a filter layer, a gold label layer, a detection layer, and an absorbent layer. The gold label layer in this test strip is composed of a gold label carrier, and one side surface of the gold label carrier has a cavity arrangement composed of vacuoles. Adjacent vacuoles are connected through flow channels. This structure of the gold label layer can achieve the technical effect of quantitatively loading and specifically adsorbing particles, thereby achieving the purpose of accurately controlling the quality of components in traditional Chinese medicine preparations with known component contents. Currently, when loading specific adsorbent particles onto a gold labeling layer, a specific concentration of these particles is sprayed onto the layer, which fails to achieve a quantitative loading effect. The specific adsorbent particles are a complex of colloidal gold and monoclonal antibodies. The colloidal gold particles have a uniform size, and their size is directly proportional to the number of monoclonal antibodies that can be loaded. Therefore, the final number of monoclonal antibodies loaded can be determined by the number of specific adsorbent particles loaded. In this invention, the inner diameter of the hole unit matches the particle size of the specific adsorbent particles. During loading, one hole unit loads one specific adsorbent particle. By controlling the number of hole units, a quantitative loading effect of specific adsorbent particles can be achieved. Therefore, when loading traditional Chinese medicine with known component content... When detecting the components of a pharmaceutical preparation, monoclonal antibodies can be prepared according to the components to be detected. These monoclonal antibodies are then combined with colloidal gold to form specific adsorption particles. The inner diameter and number of hole units are determined based on the particle size of the specific adsorption particles and the content of the component to be detected. When using the gold label layer provided by this invention to detect the target traditional Chinese medicine preparation components, the control line is used to check whether the test strip is ineffective. Color development of the control line indicates that the test strip is not ineffective; no color development indicates that the test strip is ineffective. The detection line is used for quantitative and qualitative detection of the target traditional Chinese medicine components. Color development of both the control line and the detection line indicates that the content of the target traditional Chinese medicine component in the sample is insufficient; color development of both the control line and the detection line indicates that the content of the target traditional Chinese medicine component in the sample meets the standard content.

[0009] A method for preparing the above-mentioned temperature-controlled particle quality control test paper, characterized by comprising the following steps:

[0010] Step 1: React monoclonal antibodies with colloidal gold to prepare specific adsorption particles;

[0011] Step 2: Use etching to form a gold label layer by creating hole units, hole arrangement and flow channels on one side surface of the gold label carrier;

[0012] Step 3: Disperse the specific adsorption particles from Step 1 in a buffer solution to prepare a specific adsorption particle suspension. Use the specific adsorption particle suspension to wash the gold labeling carrier from Step 2 to obtain a gold labeling carrier loaded with specific adsorption particles. After drying, a gold labeling layer is obtained.

[0013] Step 4: Spray the primary antibody onto the nitrocellulose membrane and dry it to form a detection line. Spray the secondary antibody on the other side at a distance of 2-3 mm from the detection line and dry it to form a quality control line, thus obtaining the detection layer.

[0014] Step 5: Place the test layer on the base plate, laminate an absorbent layer onto one end of the test layer, laminate a gold label layer onto the other end, laminate a filter layer onto the top of the gold label layer, and set a shell layer on the base plate to obtain the temperature-controlled particle quality control test paper.

[0015] Preferably, the etching method described in step 2 is laser etching.

[0016] Preferably, the rinsing step in step 3 includes: injecting a specific adsorbent particle suspension into a rinsing device, tilting the surface of the gold label carrier with cavities facing upwards at an angle of 30 to 60°, and uniformly spraying the specific adsorbent particle suspension onto the surface of the gold label carrier using the rinsing device.

[0017] Preferably, the buffer solution is selected from PBS buffer solution and Tris buffer solution; the drying temperature is 25-35°C and the time is 2-5 hours.

[0018] Preferably, the primary antibody is a conjugated antigen, and the secondary antibody is goat anti-mouse IgG.

[0019] This invention also provides a method for preparing the above-mentioned Wenjing particle quality control test strip. The method includes five steps: preparing specific adsorbent particles, preparing a gold label layer by etching, loading specific adsorbent particles onto the gold label layer, preparing a detection layer, and assembling the Wenjing particle quality control test strip. The specific adsorbent particles are a colloidal gold-monoclonal antibody complex prepared by reacting a monoclonal antibody with colloidal gold. The gold label layer is prepared by etching, which forms hole units, hole arrangements, and flow channel structures on the surface of the gold label carrier. Because the structure of the gold label layer in this invention is a gold label carrier with hole units, a special loading process is used when loading specific adsorbent particles onto the gold label layer. This process involves dispersing the specific adsorbent particles in a buffer solution to prepare a suspension of specific adsorbent particles, and then rinsing the gold label carrier containing the hole units with the suspension. On the side surface, during rinsing, since the inner diameter of the cavity unit is the same as the inner diameter of the specific adsorbent particles, when the specific adsorbent particle suspension flows on the surface of the gold label carrier, the specific adsorbent particles will embed into the cavity unit, thereby achieving quantitative loading of specific adsorbent particles. In preparing the detection layer, a coupled antigen is used as the primary antibody to make the detection line. The role of the coupled antibody is that when the antigen content in the test sample is insufficient, some of the specific adsorbent particles will not be bound. These unbound specific adsorbent particles will bind to the coupled antigen and thus aggregate at the detection line position and develop color. Goat anti-mouse IgG is used as the secondary antibody, and its role is to bind to the monoclonal antibody. In order to ensure that the specific adsorbent particles are not deactivated and to ensure the effectiveness of the test strip, the above method is simple in process, convenient in operation, and highly industrialized.

[0020] The application of the above-mentioned temperature-sensitive particle quality control test paper and its preparation method in the quality control of temperature-sensitive particles includes the following steps:

[0021] Step A: Determine the characteristic spectrum of the warm-textured particles;

[0022] Step B: Determine the characteristic peak area and characteristic peak composition based on the characteristic spectrum from Step 1;

[0023] Step C: Prepare temperature-controlled particle quality control test strips based on characteristic peak components;

[0024] Step D: Grind the Wenjing particle sample and dissolve it in a solvent to prepare the test sample. Use Wenjing particle quality control test paper to test the test sample. The test results of Wenjing particle quality control test paper include compliance, non-compliance and test paper failure.

[0025] The standard is met when the test line shows no color development and the quality control line shows color development.

[0026] The failure to meet the standard is due to both the testing line and the quality control line showing color development.

[0027] The test strip failed because the control line did not develop color.

[0028] Preferably, step A includes the following steps: using high performance liquid chromatography to test the characteristic spectrum of the Wenjing particles, with mobile phase A being acetonitrile and mobile phase B being a phosphoric acid solution.

[0029] This invention also provides a method for applying the above-mentioned Wenjing granule quality control test paper in the quality control of Wenjing granules. In this method, high performance liquid chromatography is used to determine the characteristic components and content of Wenjing granules, and Wenjing granule quality control test paper is prepared according to the content of characteristic components. Then, the Wenjing granule quality control test paper is used to perform quality control detection on the produced Wenjing granules.

[0030] Compared with the prior art, the present invention has the following advantages:

[0031] (1) In the Wenjing Granule Quality Control Test Paper provided by the present invention: the gold label layer is composed of a gold label carrier. One side surface of the gold label carrier is provided with a cavity arrangement composed of cavity units. Adjacent cavity units are connected through a flow channel. The gold label layer with this structure can achieve the technical effect of quantitative loading of specific adsorbed particles, thereby achieving the purpose of accurate quality control of Chinese medicine preparations with known component content.

[0032] (2) In the preparation method of the temperature-controlled particle quality control test paper provided by the present invention: the gold label layer is prepared by etching method, and the cavity unit, cavity arrangement and flow channel structure are formed on the surface of the gold label carrier by etching method;

[0033] (3) In the preparation method of the Wenjing particle quality control test paper provided by the present invention: a special loading process is adopted when loading the gold label layer with specific adsorbent particles. The process is to disperse the specific adsorbent particles in the buffer solution to make a suspension of specific adsorbent particles, and then use the suspension to rinse the side surface of the gold label carrier with the hole unit. When the specific adsorbent particle suspension flows on the surface of the gold label carrier, the specific adsorbent particles will embed into the hole unit, thereby realizing the quantitative loading of specific adsorbent particles. Attached Figure Description

[0034] Figure 1 This is a schematic diagram of the structure of the present invention.

[0035] Figure 2 This is a cross-sectional view of the gold label carrier of the present invention.

[0036] Figure 3 This is a high-performance liquid chromatogram of the Wenjing particles of the present invention.

[0037] Figure 4 These are high-performance liquid chromatography (HPLC) spectra of Examples 1-8 of this invention.

[0038] In the figure, the components are: base plate 1, filter layer 2, gold label layer 3, gold label carrier 301, cavity arrangement 302, flow channel 303, cavity unit 304, detection layer 4, water absorption layer 5, shell 6, detection hole 601, observation window 602, detection line 7, and quality control line 8. Detailed Implementation

[0039] The present invention will be further described below with reference to embodiments.

[0040] General Implementation Examples:

[0041] like Figure 1 and Figure 2 As shown, a temperature-controlled particle quality control test strip includes a base plate 1 and a filter layer 2, a gold label layer 3, a detection layer 4, and an absorbent layer 5 located on the base plate. The detection layer is located on the base plate and has a detection line 7 and a control line 8. The absorbent layer is laminated at one end of the detection layer, and the gold label layer is laminated at the end of the detection layer away from the absorbent layer. A filter layer is laminated on top of the gold label layer. A housing 6 is attached to the base plate, and the housing has a detection hole 601 and an observation window 602. The detection hole communicates with the filter layer, and the detection line and control line are located at the observation window. Inside the observation window, the gold label layer includes specific adsorbed particles and a gold label carrier 301 loaded with the specific adsorbed particles. One side surface of the gold label carrier is provided with several hole arrangements 302 and several flow channels 303. The hole arrangement includes several hole units 304 with flow channels connected. The flow channels connect adjacent hole units. The specific adsorbed particles are located in the hole units. The particle size of the specific adsorbed particles is 40 nm, and the particle size of the specific adsorbed particles matches the inner diameter of the hole units. The material of the gold label carrier is glass fiber.

[0042] A method for preparing the above-mentioned particle-based quality control test strip includes the following steps:

[0043] Step 1: React monoclonal antibodies with colloidal gold to prepare specific adsorption particles;

[0044] Step 2: Use etching to form a gold label layer by creating hole units, hole arrangement and flow channels on one side surface of the gold label carrier;

[0045] Step 3: Disperse the specific adsorbent particles from Step 1 in a buffer solution to prepare a specific adsorbent particle suspension. Use the specific adsorbent particle suspension to wash the gold labeling carrier from Step 2 to obtain a gold labeling carrier loaded with specific adsorbent particles. After drying, a gold labeling layer is obtained. The washing steps include: injecting the specific adsorbent particle suspension into a washing device, tilting the gold labeling carrier with the vacuoles facing upward at an angle of 45°, and uniformly spraying the specific adsorbent particle suspension onto the surface of the gold labeling carrier using the washing device; the drying temperature is 30°C and the time is 3 hours; the buffer solution is a Tris buffer solution.

[0046] Step 4: Using a single-dimensional planar gold spraying instrument HM3010, the primary antibody is sprayed onto a nitrocellulose membrane and dried to form a detection line. The secondary antibody is sprayed onto the other side at a distance of 3 mm from the detection line and dried to form a control line, thus obtaining the detection layer. The primary antibody is a conjugated antigen diluted to 0.5 mg / ml with 0.01 mol / L PBS. The conjugated antigen is an ovalbumin-coated antigen. The secondary antibody is 1 mg / ml goat anti-mouse IgG.

[0047] Step 5: Place the detection layer on the base plate, laminate an absorbent layer onto one end of the detection layer, laminate a gold label layer onto the other end, laminate a filter layer onto the top of the gold label layer, and set a shell layer on the base plate to obtain the temperature and particle quality control test paper.

[0048] The application of the above-mentioned quality control test strip and preparation method for the quality control of Wenjing granules includes the following steps: Step A: The characteristic spectrum of Wenjing granules is determined by high performance liquid chromatography (HPLC). Mobile phase A is acetonitrile, and mobile phase B is 0.05% phosphoric acid solution. HPLC analysis revealed 12 characteristic peaks in the Wenjing granules. The characteristic peak spectrum is shown in the figure. Figure 3 The figure shows that the warm particles have a total of 12 characteristic peaks;

[0049] Step B: Based on the characteristic spectrum in Step 1, determine the specific components of the characteristic peaks. The main characteristic peaks are: Peak 3: paeoniflorin, Peak 4: glycyrrhizin, Peak 5: ferulic acid, Peak 6: β-ecdysterone, Peak 8: cinnamaldehyde, Peak 9: paeonol, Peak 10: glycyrrhizic acid, and Peak 12: ligustilide. Separate the specific components of the above characteristic peaks as antigens to prepare monoclonal antibodies for reaction with colloidal gold. Determine the content of the specific components of the above characteristic peaks by the peak area of ​​the characteristic spectrum.

[0050] Step C: Prepare temperature-controlled particle quality control test strips based on characteristic peak components;

[0051] Step D: Lay the Wenjing granule quality control test strip flat, weigh 1g of Wenjing granule sample, grind and dissolve it in dilute ethanol to prepare the test sample, use a pipette to add 100μL of the test sample into the detection well of the Wenjing granule quality control test strip, and observe the changes of the detection line and control line in the observation window of the Wenjing granule quality control test strip after 10 minutes. The standard is met when the detection line does not show color and the control line shows color; the standard is not met when both the detection line and the control line show color; the test strip is invalid when the control line does not show color.

[0052] Example 1: (Antigen is paeoniflorin)

[0053] A temperature-controlled particle quality control test paper, with the same structure as the general embodiment;

[0054] In a method for preparing the above-mentioned particle quality control test strip, the antigen of the monoclonal antibody in step 1 is paeoniflorin in the Wenjing particle sample, and the other conditions are the same as in the general examples.

[0055] The application of the above-mentioned temperature-controlled particle quality control test paper and preparation method in the quality control of temperature-controlled particles, wherein the testing steps and implementation of the temperature-controlled particle quality control test paper are the same as those in the general embodiment.

[0056] Example 2: (Antigen is glycyrrhizin)

[0057] A temperature-controlled particle quality control test paper, with the same structure as the general embodiment;

[0058] In a method for preparing the above-mentioned particle quality control test strip, the antigen of the monoclonal antibody in step 1 is glycyrrhizin in the particle sample, and the other conditions are the same as in the general examples.

[0059] The application of the above-mentioned temperature-controlled particle quality control test paper and preparation method in the quality control of temperature-controlled particles, wherein the testing steps and implementation of the temperature-controlled particle quality control test paper are the same as those in the general embodiment.

[0060] Example 3: (Antigen is ferulic acid)

[0061] A temperature-controlled particle quality control test paper, with the same structure as the general embodiment;

[0062] In a method for preparing the above-mentioned particle quality control test strip, the antigen of the monoclonal antibody in step 1 is ferulic acid in the particle sample, and the other conditions are the same as in the general examples.

[0063] The application of the above-mentioned temperature-controlled particle quality control test paper and preparation method in the quality control of temperature-controlled particles, wherein the testing steps and implementation of the temperature-controlled particle quality control test paper are the same as those in the general embodiment.

[0064] Example 4: (Antigen is β-ecdysterone)

[0065] A temperature-controlled particle quality control test paper, with the same structure as the general embodiment;

[0066] In a method for preparing the above-mentioned particle quality control test strip, the antigen of the monoclonal antibody in step 1 is β-ecdysterone in the particle sample, and the other conditions are the same as in the general examples.

[0067] The application of the above-mentioned temperature-controlled particle quality control test paper and preparation method in the quality control of temperature-controlled particles, wherein the testing steps and implementation of the temperature-controlled particle quality control test paper are the same as those in the general embodiment.

[0068] Example 5: (Antigen is cinnamaldehyde)

[0069] A temperature-controlled particle quality control test paper, with the same structure as the general embodiment;

[0070] In a method for preparing the above-mentioned particle quality control test strip, the antigen of the monoclonal antibody in step 1 is cinnamaldehyde in the particle sample, and the other conditions are the same as in the general examples.

[0071] The application of the above-mentioned temperature-controlled particle quality control test paper and preparation method in the quality control of temperature-controlled particles, wherein the testing steps and implementation of the temperature-controlled particle quality control test paper are the same as those in the general embodiment.

[0072] Example 6: (Antigen is paeonol)

[0073] A temperature-controlled particle quality control test paper, with the same structure as the general embodiment;

[0074] In a method for preparing the above-mentioned particle quality control test strip, the antigen of the monoclonal antibody in step 1 is paeonol from the Wenjing particle sample, and the other conditions are the same as in the general examples.

[0075] The application of the above-mentioned temperature-controlled particle quality control test paper and preparation method in the quality control of temperature-controlled particles, wherein the testing steps and implementation of the temperature-controlled particle quality control test paper are the same as those in the general embodiment.

[0076] Example 7: (Antigen is glycyrrhizic acid)

[0077] A temperature-controlled particle quality control test paper, with the same structure as the general embodiment;

[0078] In a method for preparing the above-mentioned particle quality control test strip, the antigen of the monoclonal antibody in step 1 is glycyrrhizic acid from the particle sample, and the remaining conditions are the same as in the general examples.

[0079] The application of the above-mentioned temperature-controlled particle quality control test paper and preparation method in the quality control of temperature-controlled particles, wherein the testing steps and implementation of the temperature-controlled particle quality control test paper are the same as those in the general embodiment.

[0080] Example 8: (Antigen is ligustilide)

[0081] A temperature-controlled particle quality control test paper, with the same structure as the general embodiment;

[0082] A method for preparing the above-mentioned particle quality control test strip, wherein the antigen of the monoclonal antibody in step 1 is ligustilide in the Wenjing particle sample, and the other conditions are the same as in the general embodiment. An application of the above-mentioned Wenjing particle quality control test strip and preparation method in the quality control of Wenjing particles, wherein the testing steps and implementation of the Wenjing particle quality control test strip are the same as in the general embodiment.

[0083] Comparative Example 1:

[0084] Compared with Example 1, no hole cells were set in the gold label layer in Comparative Example 1, and the conditions were the same as in Example 1.

[0085] Comparative Example 2: (Flow channel inner diameter too small)

[0086] Compared with Example 1, the ratio of the inner diameter of the flow channel to the inner diameter of the cavity in Comparative Example 2 is 2:4, and the other conditions are the same as in Example 1.

[0087] Comparative Example 3: (Inner diameter of the flow channel is too large)

[0088] Compared with Example 1, the ratio of the inner diameter of the flow channel to the inner diameter of the cavity in Comparative Example 3 is 3.8:4, and the other conditions are the same as in Example 1.

[0089] Detection example

[0090] After eluting the components from the test strips in Examples 1-8, quantitative and qualitative analysis was performed using high-performance liquid chromatography (HPLC) to obtain the HPLC chromatograms and relative peak area tables for Examples 1-8. The HPLC chromatograms for Examples 1-8 are shown below. Figure 3 The results of the relative peak areas of Examples 1 to 8 are shown in Table 1.

[0091]

[0092] As shown in Table 1, the RSD of the relative peak area in Examples 1-8 is less than 4%, indicating that the particle quality control test strip provided in this application has good repeatability. Figure 3 and Figure 4 As shown, after comparing the high performance liquid chromatography of Examples 1-8 with the standard liquid chromatography of Wenjing granules, the characteristic peaks of Examples 1-8 overlap with the characteristic peaks of the main components in Wenjing granules, indicating that the Wenjing granule quality control test strip provided in this application can accurately detect the quality control of each main component in known Wenjing granule samples, with good repeatability and high accuracy.

[0093] This application investigated the influencing factors of the gold label layer structure in Comparative Examples 1 to 3. The test methods included: using Tris solution to test and observing whether the control line of the test strip showed color. The test results are shown in Table 2.

[0094] Table 2. Color development status of Example 1 and Comparative Examples 1-3

[0095] Color development status Example 1 Quality control line color development Comparative Example 1 The quality control line did not develop color. Comparative Example 2 The quality control line did not develop color. Comparative Example 3 The quality control line did not develop color.

[0096] As shown in Table 2, the control line of the test strip in Example 1 showed color, while the control lines of the test strips in Comparative Examples 1 to 3 did not show color. The above results indicate that without the presence of cavitation units, the loading method of this application cannot adsorb specific adsorbed particles. Furthermore, the ratio of the inner diameter of the flow channel to the inner diameter of the cavitation unit has a significant impact on the loading of specific adsorbed particles. When the ratio is too high, the specific particles cannot remain in the cavitation unit, while when the ratio is too low, the specific particles cannot flow after loading. When the ratio of the inner diameter of the flow channel to the inner diameter of the cavitation unit is not within the range specified in this application, the test strip for warm particles may fail.

[0097] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Any simple modifications, alterations, and equivalent transformations made to the above embodiments based on the technical essence of the present invention shall still fall within the protection scope of the present invention.

Claims

1. A quality control test paper for Wenjing granules, characterized in that, It includes a base plate (1) and a filter layer (2), a gold label layer (3), a detection layer (4) and an absorbent layer (5) located on the base plate. The gold label layer includes specific adsorption particles and a gold label carrier (301) loaded with specific adsorption particles. One side surface of the gold label carrier is provided with a plurality of cavities (302) and a plurality of channels (303). The cavities include a plurality of cavity units (304) with channels connected. The channels connect adjacent cavity units. The specific adsorption particles are located in the cavity units. The particle size of the specific adsorption particles matches the inner diameter of the cavity units. The ratio of the inner diameter of the channels to the inner diameter of the cavities is 2.8~3.5:

4.

2. The quality control test paper of the Wenjing granules according to claim 1, characterized in that, The gold standard carrier is made of glass fiber; the detection layer is provided with detection lines (7) and quality control lines (8).

3. A method for preparing a temperature-controlled particle quality control test paper according to any one of claims 1 to 2, characterized in that, Includes the following steps: Step 1: React monoclonal antibodies with colloidal gold to prepare specific adsorption particles; Step 2: Use etching to form a gold label layer by creating hole units, hole arrangement and flow channels on one side surface of the gold label carrier; Step 3: Disperse the specific adsorption particles from Step 1 in a buffer solution to prepare a specific adsorption particle suspension. Use the specific adsorption particle suspension to wash the gold labeling carrier from Step 2 to obtain a gold labeling carrier loaded with specific adsorption particles. After drying, a gold labeling layer is obtained. Step 4: Spray the primary antibody onto the nitrocellulose membrane and dry it to form a detection line. Spray the secondary antibody on the other side at a distance of 2-3 mm from the detection line and dry it to form a quality control line, thus obtaining the detection layer. Step 5: Place the test layer on the base plate, laminate an absorbent layer onto one end of the test layer, laminate a gold label layer onto the other end, laminate a filter layer onto the top of the gold label layer, and set a shell layer on the base plate to obtain the temperature-controlled particle quality control test paper.

4. The preparation method according to claim 3, characterized in that, The etching method described in step 2 is laser etching.

5. The preparation method according to claim 3, characterized in that, The rinsing step described in step 3 includes: injecting a specific adsorbent particle suspension into a rinsing device, tilting the surface of the gold label carrier with cavities facing upwards at an angle of 30-60°, and uniformly spraying the specific adsorbent particle suspension onto the surface of the gold label carrier using the rinsing device.

6. The preparation method according to claim 3, characterized in that, The buffer solution is a Tris buffer solution; the drying temperature is 25~35℃ and the time is 2~5h.

7. The preparation method according to claim 3, characterized in that, The primary antibody is a conjugated antigen, and the secondary antibody is goat anti-mouse IgG.

8. The application of the temperature-sensitive particle quality control test paper according to any one of claims 1-2 and the preparation method of the temperature-sensitive particle quality control test paper according to any one of claims 3-7 in the quality control of temperature-sensitive particles, comprising the following steps: Step A: Determine the characteristic spectrum of the warm-textured particles; Step B: Determine the characteristic peak area and characteristic peak composition based on the characteristic spectrum from Step 1; Step C: Prepare temperature-controlled particle quality control test strips based on characteristic peak components; Step D: Grind the Wenjing particle sample and dissolve it in a solvent to prepare the test sample. Use Wenjing particle quality control test paper to test the test sample. The test results of Wenjing particle quality control test paper include qualified, unqualified and defective. The standard is met when the test line shows no color development and the quality control line shows color development. The failure to meet the standard is due to both the testing line and the quality control line showing color development. The test strip failed because the control line did not develop color.

9. The application as described in claim 8, characterized in that, Step A includes the following steps: using high performance liquid chromatography to test the characteristic spectrum of the Wenjing particles, with mobile phase A being acetonitrile and mobile phase B being phosphoric acid solution.

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