Preparation method of quality control product based on multiple substances

Abstract

The invention relates to the technical field of preparation of quality control products, in particular to a preparation method of a quality control product based on multiple substances. The method comprises the following steps: acquiring biomarkers corresponding to different individuals and carrying out substance sample purification treatment to obtain biological substance component samples corresponding to the biomarkers; obtaining target detection items, and carrying out on-demand combination standardized proportioning and substance mixing preparation to obtain a biomass control mixed solution corresponding to each target detection item; carrying out freeze-drying treatment on the biomass control product mixed solution corresponding to each target detection item, recording in real time, and carrying out freeze-drying activity optimization control preparation and quality control product rehydration treatment by adding a stability enhancer to obtain a quality control product rehydration solution corresponding to each target detection item; and sub-packaging the quality control product rehydration solution into standard kits corresponding to each target detection item, and executing corresponding experimental detection operation. The accuracy and reliability of detection and preparation of the quality control product can be improved.

Description

Technical Field

[0001] The present invention relates to the technical field of quality control product preparation, and in particular to a quality control product preparation method based on multiple substances. Background Art

[0002] In recent years, with the development of multi-component material science, the preparation method of quality control products based on multiple substances has gradually received attention. By selecting different combinations of substances, the representativeness and applicability of quality control products can be improved. By analyzing the characteristics and quality standards of the products to be tested, the required main ingredients and excipients are determined, and based on literature research and experimental data, a formula database of multi-component materials is constructed, and the interaction and synergistic effect of the materials are utilized to optimize the formula design and improve the comprehensive performance of quality control products. In this way, by adopting standardized process flow, including material pretreatment, mixing, molding and post-processing steps, the quality consistency of each batch of quality control products is ensured. By introducing real-time monitoring technology, the preparation conditions are dynamically adjusted to adapt to the characteristics of different materials and changes in the external environment, ensuring the stability and reliability of the final product. However, traditional quality control product preparation methods often rely on a single substance or standard substance. The characteristics of a single substance cannot fully reflect the complexity of the quality control products to be tested. Different batches of quality control products differ due to different raw material sources, formula ratios or preparation conditions, which affects the reliability and accuracy of quality control product preparation. Summary of the invention

[0003] Based on this, it is necessary for the present invention to provide a method for preparing quality control products based on multiple substances to solve at least one of the above technical problems.

[0004] To achieve the above purpose, a method for preparing a quality control product based on multiple substances comprises the following steps:

[0005] Step S1: Obtain biomarkers corresponding to different individuals, including serum, cell components and nucleic acids corresponding to healthy individuals and individuals with specific diseases, and perform material sample purification on the biomarkers corresponding to different individuals to obtain biological material component samples corresponding to each biomarker; obtain target detection items, and perform standardized proportion combination of biological material component samples corresponding to each biomarker based on the target detection items to obtain standard proportion combination of biological component samples corresponding to each target detection item;

[0006] Step S2: Based on the preset phosphate buffer and under sterile test tube conditions, a standard ratio combination of biological component samples corresponding to each target detection item is mixed and prepared to obtain a mixed solution of biomass control products corresponding to each target detection item; the mixed solution of biomass control products corresponding to each target detection item is freeze-dried and recorded in real time to generate a freeze-drying process of quality control products corresponding to each target detection item; freeze-drying activity optimization control preparation is performed on the freeze-drying process of quality control products corresponding to each target detection item by adding a stability enhancer to generate a biological freeze-dried quality control product corresponding to each target detection item;

[0007] Step S3: rehydrating the biological freeze-dried quality control products corresponding to each target detection item using physiological saline to obtain quality control product rehydration solutions corresponding to each target detection item;

[0008] Step S4: The rehydrated solutions of the quality control products corresponding to the target detection items are packaged into the standard test kits corresponding to the target detection items, so as to perform the experimental detection operations corresponding to the corresponding target detection items.

[0009] Further, step S1 includes the following steps:

[0010] Step S11: Obtaining biomarkers corresponding to different individuals, including serum, cell components, and nucleic acids corresponding to healthy individuals and individuals with specific diseases;

[0011] Step S12: performing material centrifugal separation and impurity removal processing on the biomarkers corresponding to different individuals to obtain samples of biological material separation and impurity removal components corresponding to different individuals;

[0012] Step S13: performing material sample purification processing on the biological material separation and impurity removal component samples corresponding to different individuals to obtain biological material component samples corresponding to each biomarker, including protein component samples, enzyme component samples and hormone component samples corresponding to serum, red blood cell component samples, white blood cell component samples and platelet component samples corresponding to cell components, and DNA component samples and RNA component samples corresponding to nucleic acid;

[0013] Step S14: Obtain target detection items, wherein the target detection items include liver function test, blood sugar test and hepatitis B nucleic acid test, and configure the material component requirements of the biological material component samples corresponding to each biomarker based on the target detection items to obtain the required combination of biological component samples corresponding to each target detection item;

[0014] Step S15: Performing experimental quantitative standardized ratio processing on each material component in the required combination of biological component samples corresponding to each target detection item, and obtaining a standard ratio combination of biological component samples corresponding to each target detection item.

[0015] Further, step S15 includes the following steps:

[0016] Step S151: Perform biological component characteristic analysis on each material component in the required combination of biological component samples corresponding to each target detection project, and obtain a material component characteristic list corresponding to the biological components required for each target detection project;

[0017] Step S152: Based on the material component characteristic list corresponding to the biological components required for each target detection project, experimental matching conditions are designed for each material component in the required combination of biological component samples corresponding to each target detection project, so as to generate different biological component sample matching experimental conditions corresponding to each target detection project;

[0018] Step S153: using enzyme-linked immunosorbent assay and PCR technology to perform biological component activity experimental tests on different biological component sample ratio experimental conditions corresponding to each target detection item, so as to generate a biological component activity test experimental table corresponding to each target detection item under different biological component ratio conditions;

[0019] Step S154: Based on the biological component activity test experiment table corresponding to each target detection project under different biological component ratio conditions, each material component in the required combination of biological component samples corresponding to each target detection project is optimized and confirmed in a standardized ratio combination to obtain the standard ratio combination of biological component samples corresponding to each target detection project.

[0020] Further, step S2 includes the following steps:

[0021] Step S21: Obtain the stability and solubility of each biological component sample by combining the standard proportions of the biological component samples corresponding to each target detection item, and optimize the pH and ionic strength configuration of the preset phosphate buffer based on the stability and solubility of each biological component sample, so as to obtain the phosphate optimized buffer under the optimized pH and ionic strength conditions corresponding to each target detection item;

[0022] Step S22: using a sterile pipette and a transfer device to aseptically transfer the standard proportion combination of biological component samples corresponding to each target detection item to a sterile test tube in a predetermined proportion and order, and configuring corresponding sterile operating environment conditions to obtain the sterile test tube operating environment conditions corresponding to each target detection item;

[0023] Step S23: Based on the sterile test tube operating environment conditions corresponding to each target detection item and the phosphate optimized buffer under the conditions of pH value and ionic strength optimization, the corresponding standard proportion combination of biological component samples is mixed and prepared to obtain the biomass control product mixed solution corresponding to each target detection item;

[0024] Step S24: freeze-drying the biomass control product mixed solution corresponding to each target detection item and recording it in real time to generate the freeze-drying process of the quality control product corresponding to each target detection item;

[0025] Step S25: by adding a stability enhancer, the freeze-drying activity of the quality control product corresponding to each target detection item is optimized and controlled to prepare the freeze-drying activity, so as to generate a biological freeze-dried quality control product corresponding to each target detection item.

[0026] Further, step S24 includes the following steps:

[0027] Step S241: Analyze the composition and characteristics of each biological component sample in the biomass control product mixed solution corresponding to each target detection item to obtain the biological component composition and biological component characteristics of the control product solution corresponding to each target detection item;

[0028] Step S242: performing thermosensitive interaction mining analysis between the biological component samples in the biomass control product mixed solution corresponding to each target detection project according to the biological component composition and biological component characteristics of the quality control product solution corresponding to each target detection project, so as to obtain the thermosensitive interaction relationship between different biological components in the quality control product solution corresponding to each target detection project;

[0029] Step S243: setting pre-freezing conditions for the corresponding biomass control product mixed solution based on the thermosensitive interaction relationship between different biological components in the quality control product solution corresponding to each target detection item, so as to generate pre-freezing parameter conditions corresponding to the quality control product solution of each target detection item;

[0030] Step S244: freeze-drying the corresponding biomass control product mixed solution according to the pre-freezing parameter conditions corresponding to the quality control product solution of each target detection item and recording in real time to generate the quality control product freeze-drying process corresponding to each target detection item.

[0031] Further, step S243 includes the following steps:

[0032] Based on the thermosensitive interaction relationship between different biological components in the quality control solution corresponding to each target detection item, the pre-freezing temperature curve and vacuum level of the corresponding biomass control mixed solution are designed to design and generate the pre-freezing temperature change curve and pre-freezing vacuum level corresponding to the quality control solution of each target detection item;

[0033] Perform temperature amplitude statistical analysis on the pre-freezing temperature change curve corresponding to the quality control solution of each target detection item, and obtain the fluctuation range of the pre-freezing temperature corresponding to the quality control solution of each target detection item;

[0034] Based on the fluctuation range of the pre-freezing temperature corresponding to the quality control solution of each target detection item, the corresponding pre-freezing temperature change curve is optimized and determined for the pre-freezing temperature level and time, so as to obtain the pre-freezing temperature change level and pre-freezing time step corresponding to the quality control solution of each target detection item;

[0035] The pre-freezing vacuum level, temperature change level and pre-freezing time step corresponding to the quality control solution of each target detection item are set for pre-freezing conditions to generate the pre-freezing parameter conditions corresponding to the quality control solution of each target detection item.

[0036] Further, step S244 includes the following steps:

[0037] According to the pre-freezing vacuum level within the pre-freezing parameter conditions corresponding to the quality control solution of each target detection item, the corresponding biomass control product mixed solution is vacuum extracted and controlled, and a pre-freezing vacuum extraction execution control program corresponding to the quality control solution of each target detection item is generated;

[0038] According to the temperature change level within the pre-freezing parameter conditions and the pre-freezing time step of the quality control product solution of each target detection item, the corresponding biomass control product mixed solution is set to gradually increase the temperature, and a pre-freezing time step-by-step temperature increase execution control program corresponding to the quality control product solution of each target detection item is generated;

[0039] Based on the pre-freezing vacuum extraction execution control program corresponding to the quality control solution of each target detection item and the pre-freezing time gradual heating execution control program, the freeze-drying process of the corresponding biomass control product mixed solution is executed and recorded in real time to generate the freeze-drying processing process of the quality control product corresponding to each target detection item.

[0040] Further, step S25 includes the following steps:

[0041] Step S251: real-time monitoring of the freeze-drying process of the quality control product corresponding to each target detection item to obtain the freeze-drying temperature, freeze-drying pressure and freeze-drying duration corresponding to the freeze-drying process of each target detection item;

[0042] Step S252: Based on the freeze-drying temperature, freeze-drying pressure and freeze-drying duration corresponding to the freeze-drying process of each target detection item, the activity attenuation calculation formula of the quality control product activity is used to calculate the activity attenuation of the corresponding quality control product freeze-drying process, so as to obtain the activity attenuation coefficient of the quality control product corresponding to each target detection item;

[0043] Step S253: According to the attenuation coefficient of the damaged activity of the quality control product corresponding to each target detection item, the concentration conditions corresponding to the stability enhancer are configured, and the freeze-drying activity optimization control preparation is performed on the freeze-drying process of the quality control product corresponding to each target detection item by adding the stability enhancer under the corresponding concentration conditions to generate the biological freeze-dried quality control product corresponding to each target detection item.

[0044] Furthermore, the calculation formula for the activity impairment attenuation of the quality control product in step S252 is specifically:

[0045]

[0046] In the formula, k i is the attenuation coefficient of the quality control product activity damage corresponding to the i-th target detection item, t is the duration of the freeze-drying process, T i is the temperature of the ith target detection item during the freeze-drying process, A i (t) is the real-time activity of the quality control product of the i-th target detection item at time t, is the initial activity of the quality control product corresponding to the i-th target detection item, P i is the pressure corresponding to the i-th target detection item during the freeze-drying process, is the standard pressure corresponding to the i-th target detection item, m i (t) is the activity time decay influence coefficient of the i-th target detection item at time t, η i is the correction coefficient of the activity impairment attenuation coefficient of the quality control product corresponding to the i-th target detection item.

[0047] Further, step S3 includes the following steps:

[0048] Step S31: rehydrating the physiological saline concentration and additive components based on the biological freeze-dried quality control products corresponding to each target detection item to obtain a physiological saline reconstituted rehydration solution corresponding to the quality control products of each target detection item;

[0049] Step S32: rehydrating and dissolving the corresponding biological freeze-dried quality control product based on the physiological saline rehydration solution corresponding to each target detection item quality control product to obtain a sample of the biological mass control product rehydration solution corresponding to each target detection item;

[0050] Step S33: Performing biological activity detection and evaluation on the rehydrated solution samples of the biomass control products corresponding to each target detection item, and obtaining the biological activity evaluation results corresponding to the rehydrated quality control products of each target detection item;

[0051] Step S34: setting appropriate solution storage conditions according to the biological activity evaluation results corresponding to the rehydrated quality control products of each target detection item, and performing solution storage management on the biomass control product rehydrated solution samples corresponding to each target detection item based on the appropriate storage conditions to obtain the quality control product rehydrated solution corresponding to each target detection item.

[0052] Beneficial effects of the present invention:

[0053] The method for preparing quality control products based on multiple substances proposed in the present invention, compared with the prior art, has the beneficial effect of obtaining biomarkers corresponding to different individuals, which can come from healthy individuals and individuals with specific diseases, mainly including serum, cell components and nucleic acids. By collecting these biological samples, rich biological information can be obtained, laying the foundation for subsequent analysis. The samples of healthy individuals provide biomarker characteristics under normal physiological conditions, while the samples of diseased individuals show changes under specific pathological conditions. This comparative analysis helps to identify potential disease biomarkers and provides a basis for the subsequent target detection project biological component combination process. By purifying the material samples of biomarkers corresponding to different individuals, the specific components of various biomarkers can be obtained, including proteins, enzymes, hormones in serum, and red blood cells, white blood cells and platelet components in cell components, and even DNA and RNA in nucleic acids. This meticulous purification process not only helps researchers obtain high-purity samples, but also ensures that each type of biological component has clear characteristics and quantitative basis in subsequent analysis, which is convenient for identifying key biomarkers in target detection projects. At the same time, the purpose of acquiring target detection items (such as liver function tests, blood sugar tests, and hepatitis B nucleic acid tests) is to clarify the research direction and application goals, and according to the needs of each target detection item, the component samples of each biomarker are combined and standardized on demand. Through precise quantitative matching, it can be ensured that the proportion of each component in the sample meets the experimental requirements, thereby improving the comparability and reproducibility of the analysis results. This standardized processing is crucial to the accuracy and effectiveness of various detection items, can reduce experimental errors, and ensure the comparability between different samples. This not only improves the efficiency and reliability of the detection of various biomass control products, but also helps to promote the application of biomarkers in clinical practice. Secondly, by mixing the standard proportion combination of biological component samples corresponding to each target detection project based on the preset phosphate buffer and under sterile test tube conditions, the optimal synergistic effect of each component can be ensured by mixing in the buffer and under sterile conditions, thereby improving the overall performance of the quality control product. The standardization and normalization of the mixing preparation process can not only improve the operating efficiency, but also ensure the repeatability and consistency of each experiment. The successful implementation of this process has laid a solid foundation for the stability and effectiveness of subsequent quality control products, and also provided a strong guarantee for the accurate detection of various target detection projects. By freeze-drying the mixed solution of the biomass control product corresponding to each target detection project and recording it in real time, in this process, real-time recording of each link of the freeze-drying process can provide detailed data support for the subsequent quality control of the quality control product. The freeze-drying process can not only extend the shelf life of the biomass control product, but also facilitate subsequent operation and use while maintaining its activity and function.The freeze-drying process of the quality control product is also optimized and controlled by adding a stability enhancer, which can significantly improve the stability and activity of the final quality control product. The selection and use of the stability enhancer needs to be accurately formulated according to the characteristics of different biological components, so as to minimize the activity loss during the freeze-drying process. In this process, the optimization control can not only improve the storage resistance of the quality control product, but also improve its adaptability in various environments, thereby improving the accuracy and reliability of the quality control product preparation process. Then, the biological freeze-dried quality control products corresponding to each target detection project are rehydrated by using physiological saline to accurately adjust the concentration and additive components of physiological saline to achieve rehydration. This process is crucial because different quality control products have different sensitivities to concentration and composition. Through reasonable configuration, it is ensured that the rehydration solution can effectively dissolve the freeze-dried quality control product while maintaining its biological activity. The optimized rehydration solution not only improves the stability of the quality control product, but also improves the reliability of subsequent experimental results. This can provide stable quality control product support for each target detection project, thereby enhancing the credibility of the experimental data and improving the availability and consistency of the results in practical applications. Finally, packaging the rehydrated solutions of the quality control products corresponding to each target detection item into the standard test kits corresponding to each target detection item is the key link in converting laboratory research results into practical applications. The design of the standard test kit not only improves the convenience of experimental operations, but also provides experimenters with clear instructions and standardized operating procedures, reducing operational errors. By integrating the rehydrated quality control products into the test kit, it is easy to carry and store, and ensures that it is used quickly and effectively in actual testing. This method helps to realize large-scale quality control product testing applications, thereby better eliminating the problems of differences in quality control product preparation due to differences in raw material sources, formula ratios or preparation conditions. BRIEF DESCRIPTION OF THE DRAWINGS

[0054] Other features, objects and advantages of the present invention will become more apparent from the detailed description of non-limiting embodiments thereof made with reference to the following drawings:

[0055] Figure 1 The figure is a schematic diagram of the steps of the method for preparing quality control products based on multiple substances of the present invention;

[0056] Figure 2 for Figure 1 Detailed step flow diagram of step S1;

[0057] Figure 3 for Figure 2 Detailed step flow diagram of step S15;

[0058] Figure 4 It is a schematic diagram of the experimental results of the biological component activity test table of the present invention. DETAILED DESCRIPTION

[0059] The technical method of the present invention is described clearly and completely below in conjunction with the accompanying drawings. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by technicians in this field without creative work are within the scope of protection of the present invention.

[0060] In addition, the accompanying drawings are only schematic illustrations of the present invention and are not necessarily drawn to scale. The same reference numerals in the figures represent the same or similar parts, and their repeated description will be omitted. Some of the block diagrams shown in the accompanying drawings are functional entities and do not necessarily correspond to physically or logically independent entities. The functional entities can be implemented in software form, or implemented in one or more hardware modules or integrated circuits, or implemented in different networks and / or processor methods and / or microcontroller methods.

[0061] It should be understood that, although the terms "first", "second", etc. may be used herein to describe various units, these units should not be limited by these terms. These terms are used only to distinguish one unit from another unit. For example, without departing from the scope of the exemplary embodiments, the first unit may be referred to as the second unit, and similarly the second unit may be referred to as the first unit. The term "and / or" used herein includes any and all combinations of one or more of the listed associated items.

[0062] To achieve this, please refer to Figures 1 to 3 The present invention provides a method for preparing a quality control product based on multiple substances, the method comprising the following steps:

[0063] Step S1: Obtain biomarkers corresponding to different individuals, including serum, cell components and nucleic acids corresponding to healthy individuals and individuals with specific diseases, and perform material sample purification on the biomarkers corresponding to different individuals to obtain biological material component samples corresponding to each biomarker; obtain target detection items, and perform standardized proportion combination of biological material component samples corresponding to each biomarker based on the target detection items to obtain standard proportion combination of biological component samples corresponding to each target detection item;

[0064] Step S2: Based on the preset phosphate buffer and under sterile test tube conditions, a standard ratio combination of biological component samples corresponding to each target detection item is mixed and prepared to obtain a mixed solution of biomass control products corresponding to each target detection item; the mixed solution of biomass control products corresponding to each target detection item is freeze-dried and recorded in real time to generate a freeze-drying process of quality control products corresponding to each target detection item; freeze-drying activity optimization control preparation is performed on the freeze-drying process of quality control products corresponding to each target detection item by adding a stability enhancer to generate a biological freeze-dried quality control product corresponding to each target detection item;

[0065] Step S3: rehydrating the biological freeze-dried quality control products corresponding to each target detection item using physiological saline to obtain quality control product rehydration solutions corresponding to each target detection item;

[0066] Step S4: The rehydrated solutions of the quality control products corresponding to the target detection items are packaged into the standard test kits corresponding to the target detection items, so as to perform the experimental detection operations corresponding to the corresponding target detection items.

[0067] In the embodiment of the present invention, please refer to Figure 1 FIG. 1 is a schematic diagram of the steps of the method for preparing a quality control product based on multiple substances of the present invention. In this example, the method for preparing a quality control product based on multiple substances includes the following steps:

[0068] Step S1: Obtain biomarkers corresponding to different individuals, including serum, cell components and nucleic acids corresponding to healthy individuals and individuals with specific diseases, and perform material sample purification on the biomarkers corresponding to different individuals to obtain biological material component samples corresponding to each biomarker; obtain target detection items, and perform standardized proportion combination of biological material component samples corresponding to each biomarker based on the target detection items to obtain standard proportion combination of biological component samples corresponding to each target detection item;

[0069] In an embodiment of the present invention, biomarker samples from different individuals are collected, and these samples include serum, cellular components and nucleic acids of healthy individuals, as well as corresponding samples of individuals with specific diseases (such as diabetic patients or liver disease patients). Sample collection can obtain blood by venipuncture, and then obtain serum by appropriate separation technology (such as gel separation tube). In terms of cellular components, whole blood centrifugation is used to separate the blood into red blood cells, white blood cells and platelet components. Nucleic acid samples are obtained by extracting DNA and RNA from cells, usually using commercial extraction kits to ensure efficient and pollution-free sample acquisition, thereby obtaining biomarkers corresponding to different individuals. The biomarker samples obtained from different individuals are centrifuged and removed. The specific operations include placing the collected serum, cell components and nucleic acid samples in a centrifuge tube, using a high-speed centrifuge to set an appropriate speed and time (for example, 4000rpm, centrifugation for 10 minutes), so that the cell components are precipitated at the bottom of the tube and the nucleic acid is in the middle layer, and the supernatant is separated. At the same time, the material sample purification treatment is performed on the biological material component samples corresponding to different individuals, so that the protein, enzyme and hormone components in the serum are separated by using chromatography technology (such as gel filtration chromatography or ion exchange chromatography) to ensure high purity and activity retention. For the cell components, the intracellular components are released by cell disruption technology, and the red blood cells, white blood cells and platelets are separated by density gradient centrifugation. The nucleic acid part uses a specific extraction reagent and phenol-chloroform extraction is performed to remove protein and other impurities. The obtained biological material component samples include the protein components, enzyme components, and hormone components of the serum, the red blood cells, white blood cells, and platelet components in the cell components, and the DNA and RNA components in the nucleic acid, so as to obtain the biological material component samples corresponding to each biomarker. At the same time, by defining target detection items, including liver function test, blood glucose test and hepatitis B nucleic acid test, for each detection item, the material component requirement configuration is formulated based on the pre-extracted biological material component samples. For example, liver function test requires components such as alanine aminotransferase, aspartate aminotransferase and total bilirubin, blood glucose test requires glucose and insulin components in serum, and hepatitis B nucleic acid test requires the extraction of specific hepatitis B virus nucleic acid. In the configuration process, combined with relevant literature and experimental data, based on the requirements of each detection item, the standardized ratio principle is applied to formulate the best component ratio. For example, in liver function test, the ratio of alanine aminotransferase or aspartate aminotransferase may be determined as 1:3 to reflect the clinical significance, forming a standard ratio combination of biological component samples corresponding to each target detection item, and ensuring that these ratios remain consistent in the preparation of different batches to ensure the reliability and repeatability of the experimental results, and finally obtaining a standard ratio combination of biological component samples corresponding to each target detection item.

[0070] Step S2: Based on the preset phosphate buffer and under sterile test tube conditions, a standard ratio combination of biological component samples corresponding to each target detection item is mixed and prepared to obtain a mixed solution of biomass control products corresponding to each target detection item; the mixed solution of biomass control products corresponding to each target detection item is freeze-dried and recorded in real time to generate a freeze-drying process of quality control products corresponding to each target detection item; freeze-drying activity optimization control preparation is performed on the freeze-drying process of quality control products corresponding to each target detection item by adding a stability enhancer to generate a biological freeze-dried quality control product corresponding to each target detection item;

[0071] In an embodiment of the present invention, the stability and solubility of each biological component sample are first determined by the standard ratio combination of biological component samples required for each target detection item. This process uses spectral analysis and centrifugation methods to conduct multiple experiments on each biological component sample to evaluate its performance under different pH values ​​and ionic strengths, and select a suitable phosphate buffer according to the experimental results, and systematically optimize its pH value and ionic strength to ensure the best performance of each target detection item under ideal conditions. This optimization is performed by gradually adjusting different concentrations of phosphate (for example, Na2HPO4 and NaH2PO4) and other additives (such as KCl), and by using a sterile pipette and transfer equipment, the standard ratio combination of biological component samples corresponding to each target detection item is aseptically transferred in a predetermined ratio and order to ensure that no exogenous contamination is introduced during the configuration process, so that the biological component samples of each target detection item are transferred to a sterile test tube in a predetermined ratio and order. The test tube used It is necessary to rinse with sterile saline in advance and handle it under a sterile environment. During the operation, ensure that the transfer process is fast and effective to prevent the sample from being exposed to the air. The sterile operating environment can be achieved by using a biological safety cabinet to ensure that the air flow in the laboratory is filtered, such as a temperature of 25°C and a humidity of 20, etc., and prepare the material mixing by combining the corresponding standard proportions of the biological component samples according to the aforementioned sterile test tube operating environment and the optimized phosphate buffer, so that each biological component sample is evenly added to the sterile test tube according to the predetermined standard proportion, and then the configured phosphate optimization buffer is added. During the mixing process, a magnetic stirrer is used to stir at a low speed to ensure that all components are fully mixed without generating bubbles. During the entire mixing operation, the temperature of the sample is continuously monitored to avoid affecting the stability of the biological component due to temperature fluctuations, and to ensure that the obtained mixed solution meets the quality control requirements of each target detection item, thereby obtaining the biomass control product mixed solution corresponding to each target detection item. At the same time, the mixed solution of biomass control products for each target detection item is freeze-dried. First, the mixed solution is evenly distributed into pre-prepared freeze-drying bottles, and the bottle mouths are sealed with sterile caps. Then, a freeze dryer is used for freezing and drying operations to freeze the mixed solution at -40°C and keep it for a certain period of time to ensure the formation of uniform ice crystals. The temperature is gradually increased to start the freeze-drying process, and the water is evaporated by sublimation under vacuum conditions. During this process, the temperature changes, vacuum degree and time parameters are recorded in real time, thereby recording the freeze-drying process of the quality control products corresponding to each target detection item.Then, through the freeze-drying process of the quality control product, stability enhancers are added to optimize the freeze-drying activity. Stability enhancers such as glycerol or polyvinyl alcohol need to be evenly mixed with the mixed solution in the pretreatment stage to ensure their uniform distribution. During the freeze-drying process, the pressure and temperature in the freeze-drying bottle are monitored to adjust the operating parameters of the freeze dryer in real time to ensure that the activity of each biological component is maintained during the freeze-drying process. After freeze-drying is completed, the necessary physical and chemical properties of the freeze-dried quality control product are tested to ensure that the final biological freeze-dried quality control product meets the expected quality standards and testing requirements, and finally the biological freeze-dried quality control product corresponding to each target detection item is prepared.

[0072] Step S3: rehydrating the biological freeze-dried quality control products corresponding to each target detection item using physiological saline to obtain quality control product rehydration solutions corresponding to each target detection item;

[0073] In an embodiment of the present invention, the concentration of the corresponding physiological saline and the additive components are configured for the rehydration components by combining the characteristic requirements of each biological component in the biological freeze-dried quality control product corresponding to each target detection item after the previous freeze-drying treatment, so as to accurately weigh the required physiological saline concentration and additive components, configure the rehydration solution, and perform the rehydration dissolution treatment on the corresponding biological freeze-dried quality control product by combining the previously configured rehydration solution, so as to prepare the previously prepared physiological saline rehydration solution, ensure that it is allowed to stand at room temperature to eliminate bubbles, take an appropriate amount of the biological freeze-dried quality control product corresponding to the target detection item, use the aseptic operation procedure, place it in a pre-prepared sterile test tube, slowly add the physiological saline rehydration solution, keep shaking gently to avoid foaming, ensure that the quality control product is evenly dissolved, the temperature and time during the dissolution process must be strictly controlled to ensure the activity of the biomass control product, and then place it in a designated refrigeration equipment for management, regularly check the temperature and humidity of the storage equipment, ensure that the quality control product maintains its biological activity during the entire storage period, ensure the accuracy and reliability of subsequent detection, and finally obtain the quality control product rehydration solution corresponding to each target detection item.

[0074] Step S4: The rehydrated solutions of the quality control products corresponding to the target detection items are packaged into the standard test kits corresponding to the target detection items, so as to perform the experimental detection operations corresponding to the corresponding target detection items.

[0075] In an embodiment of the present invention, the rehydrated solutions of the quality control products corresponding to the target detection items are packaged in standard test kits. First, the standard test kits are prepared to ensure that the internal environment is clean, and the prepared rehydrated solutions are packaged into small containers of each test kit using a pipette, and distributed according to a preset standardized concentration to ensure the consistency of the quality control products in each test kit. After the packaging is completed, the kits are sealed and labeled to ensure that each test kit clearly identifies its corresponding detection items and validity periods. This process ensures that the quality control products can be effectively used in experimental tests and have good stability and reliability.

[0076] Further, step S1 includes the following steps:

[0077] Step S11: Obtaining biomarkers corresponding to different individuals, including serum, cell components, and nucleic acids corresponding to healthy individuals and individuals with specific diseases;

[0078] Step S12: performing material centrifugal separation and impurity removal processing on the biomarkers corresponding to different individuals to obtain samples of biological material separation and impurity removal components corresponding to different individuals;

[0079] Step S13: performing material sample purification processing on the biological material separation and impurity removal component samples corresponding to different individuals to obtain biological material component samples corresponding to each biomarker, including protein component samples, enzyme component samples and hormone component samples corresponding to serum, red blood cell component samples, white blood cell component samples and platelet component samples corresponding to cell components, and DNA component samples and RNA component samples corresponding to nucleic acid;

[0080] Step S14: Obtain target detection items, wherein the target detection items include liver function test, blood sugar test and hepatitis B nucleic acid test, and configure the material component requirements of the biological material component samples corresponding to each biomarker based on the target detection items to obtain the required combination of biological component samples corresponding to each target detection item;

[0081] Step S15: Performing experimental quantitative standardized ratio processing on each material component in the required combination of biological component samples corresponding to each target detection item, and obtaining a standard ratio combination of biological component samples corresponding to each target detection item.

[0082] As an embodiment of the present invention, refer to Figure 2 As shown, Figure 1 Detailed step flow diagram of step S1 in FIG. 1 , in this embodiment, step S1 includes the following steps:

[0083] Step S11: Obtaining biomarkers corresponding to different individuals, including serum, cell components, and nucleic acids corresponding to healthy individuals and individuals with specific diseases;

[0084] In an embodiment of the present invention, biomarker samples from different individuals are collected, and these samples include serum, cellular components and nucleic acids of healthy individuals, as well as corresponding samples of individuals with specific diseases (such as diabetic patients or liver disease patients). Sample collection can obtain blood by venipuncture, and then obtain serum by appropriate separation technology (such as gel separation tube). In terms of cellular components, whole blood centrifugation is used to separate the blood into red blood cells, white blood cells and platelet components. Nucleic acid samples are obtained by extracting DNA and RNA from cells, usually using commercial extraction kits to ensure efficient and pollution-free sample acquisition, and finally biomarkers corresponding to different individuals are obtained.

[0085] Step S12: performing material centrifugal separation and impurity removal processing on the biomarkers corresponding to different individuals to obtain samples of biological material separation and impurity removal components corresponding to different individuals;

[0086] In an embodiment of the present invention, centrifugal separation and impurity removal treatment are performed on biomarker samples obtained from different individuals. The specific operations include placing the collected serum, cell components and nucleic acid samples in a centrifuge tube, using a high-speed centrifuge to set an appropriate speed and time (for example, 4000 rpm, centrifugation for 10 minutes), so that the cell components are precipitated at the bottom of the tube and the nucleic acids are in the middle layer, and the supernatant is separated. At the same time, the suspended matter and other impurities are removed by re-centrifugation. After the treatment is completed, the clear upper layer of liquid is taken out to form biological material separation and impurity removal component samples corresponding to different individuals, and finally the biological material separation and impurity removal component samples corresponding to different individuals are obtained.

[0087] Step S13: performing material sample purification processing on the biological material separation and impurity removal component samples corresponding to different individuals to obtain biological material component samples corresponding to each biomarker, including protein component samples, enzyme component samples and hormone component samples corresponding to serum, red blood cell component samples, white blood cell component samples and platelet component samples corresponding to cell components, and DNA component samples and RNA component samples corresponding to nucleic acid;

[0088] In an embodiment of the present invention, the material sample is purified by separating and removing impurity component samples corresponding to different individuals, so as to separate the protein, enzyme and hormone components in the serum by using chromatography technology (such as gel filtration chromatography or ion exchange chromatography) to ensure high purity and activity retention. For cellular components, the intracellular components are released by cell disruption technology, and red blood cells, white blood cells and platelets are separated by density gradient centrifugation, while the nucleic acid part is extracted with phenol-chloroform using a specific extraction reagent to remove protein and other impurities. The obtained biological material component samples include protein components, enzyme components, hormone components of serum, red blood cells, white blood cells, platelet components in the cellular components and DNA and RNA components in the nucleic acid, and finally the biological material component samples corresponding to each biomarker are obtained.

[0089] Step S14: Obtain target detection items, wherein the target detection items include liver function test, blood sugar test and hepatitis B nucleic acid test, and configure the material component requirements of the biological material component samples corresponding to each biomarker based on the target detection items to obtain the required combination of biological component samples corresponding to each target detection item;

[0090] In an embodiment of the present invention, by defining target detection items, including liver function test, blood sugar test and hepatitis B nucleic acid test, for each detection item, a material component requirement configuration is formulated based on the pre-extracted biological material component samples. For example, liver function test requires components such as alanine aminotransferase, aspartate aminotransferase and total bilirubin, blood sugar test requires glucose and insulin components in serum, and hepatitis B nucleic acid test requires extraction of specific hepatitis B virus nucleic acid. During the configuration process, relevant literature and experimental data are combined to confirm the component ratio and characteristics required for each detection item, ensure that each target detection item is targeted and effective, form the required combination of biological component samples for each item, and finally obtain the required combination of biological component samples corresponding to each target detection item.

[0091] Step S15: Performing experimental quantitative standardized ratio processing on each material component in the required combination of biological component samples corresponding to each target detection item, and obtaining a standard ratio combination of biological component samples corresponding to each target detection item.

[0092] In an embodiment of the present invention, an experimental quantitative standardized ratio processing is performed on the combination of biological component samples required for each target detection item. In the specific implementation, each biological substance component is first quantitatively analyzed, and its concentration is determined by high performance liquid chromatography (HPLC) or mass spectrometry (MS) and other technologies. Then, based on the requirements of each detection item, the standardized ratio principle is applied to formulate the best component ratio. For example, in liver function testing, the ratio of alanine aminotransferase or aspartate aminotransferase may be determined as 1:3 to reflect the clinical significance, forming a standard ratio combination of biological component samples corresponding to each target detection item, and ensuring that these ratios remain consistent in the preparation of different batches to ensure the reliability and repeatability of the experimental results, and finally obtaining a standard ratio combination of biological component samples corresponding to each target detection item.

[0093] Further, step S15 includes the following steps:

[0094] Step S151: Perform biological component characteristic analysis on each material component in the required combination of biological component samples corresponding to each target detection project, and obtain a material component characteristic list corresponding to the biological components required for each target detection project;

[0095] Step S152: Based on the material component characteristic list corresponding to the biological components required for each target detection project, experimental matching conditions are designed for each material component in the required combination of biological component samples corresponding to each target detection project, so as to generate different biological component sample matching experimental conditions corresponding to each target detection project;

[0096] Step S153: using enzyme-linked immunosorbent assay and PCR technology to perform biological component activity experimental tests on different biological component sample ratio experimental conditions corresponding to each target detection item, so as to generate a biological component activity test experimental table corresponding to each target detection item under different biological component ratio conditions;

[0097] Step S154: Based on the biological component activity test experiment table corresponding to each target detection project under different biological component ratio conditions, each material component in the required combination of biological component samples corresponding to each target detection project is optimized and confirmed in a standardized ratio combination to obtain the standard ratio combination of biological component samples corresponding to each target detection project.

[0098] As an embodiment of the present invention, refer to Figure 3 As shown, Figure 2 Detailed step flow diagram of step S15 in FIG. 1 , in this embodiment, step S15 includes the following steps:

[0099] Step S151: Perform biological component characteristic analysis on each material component in the required combination of biological component samples corresponding to each target detection project, and obtain a material component characteristic list corresponding to the biological components required for each target detection project;

[0100] In the embodiment of the present invention, for each target detection project, it is necessary to first collect and analyze the biological components required for each project. This process involves literature research and experimental data summary of the biological components corresponding to the target detection project, identifying key material components, such as proteins, enzymes, nucleic acids, etc., and using gas chromatography (GC), liquid chromatography (LC) and other analytical techniques to determine the physical and chemical properties of these biological components, including molecular weight, solubility, stability and reactivity. At the same time, the material components are accurately identified in combination with mass spectrometry (MS) technology, and finally a list of material component characteristics corresponding to the biological components required for each target detection project is obtained.

[0101] Step S152: Based on the material component characteristic list corresponding to the biological components required for each target detection project, experimental matching conditions are designed for each material component in the required combination of biological component samples corresponding to each target detection project, so as to generate different biological component sample matching experimental conditions corresponding to each target detection project;

[0102] In an embodiment of the present invention, by combining the list of material component characteristics corresponding to the biological components required for each target detection item generated by previous analysis, the matching conditions of each material component in the required combination of the corresponding biological component sample are designed to design the experimental matching conditions. In order to ensure the effectiveness of each material component in the combination, statistical analysis tools such as response surface method (RSM) are used to determine the concentration and proportion of different material components through multi-factor experimental design. The specific operation includes selecting suitable solvents and buffers, setting different temperatures, pH values ​​and reaction times, and ensuring that under these conditions, each biological component can maintain its activity and effectively interact with each other. The purpose of this process is to generate a series of biological component sample matching experimental conditions for different target detection items, and finally design and generate different biological component sample matching experimental conditions corresponding to each target detection item.

[0103] Step S153: using enzyme-linked immunosorbent assay and PCR technology to perform biological component activity experimental tests on different biological component sample ratio experimental conditions corresponding to each target detection item, so as to generate a biological component activity test experimental table corresponding to each target detection item under different biological component ratio conditions;

[0104] In the embodiment of the present invention, by using enzyme-linked immunosorbent assay (ELISA) and polymerase chain reaction (PCR) technology, the activity experimental test of the biological component sample ratio conditions of each target detection item is carried out. In the specific implementation, first, according to the designed ratio conditions, the corresponding biological sample is prepared, and then the concentration of the specific antigen or antibody in the sample is determined by the ELISA method, and the absorbance data is obtained by the photometer. At the same time, PCR amplification is performed to detect specific DNA or RNA sequences, and its amplification efficiency and specificity are analyzed. The activity of the biological component under each ratio condition is recorded, and a detailed experimental table is generated, including the activity value and corresponding conditions of each sample. Finally, the experiment generates the biological component activity test experimental table corresponding to each target detection item under different biological component ratio conditions (such as Figure 4 shown).

[0105] Step S154: Based on the biological component activity test experiment table corresponding to each target detection project under different biological component ratio conditions, each material component in the required combination of biological component samples corresponding to each target detection project is optimized and confirmed in a standardized ratio combination to obtain the standard ratio combination of biological component samples corresponding to each target detection project.

[0106] In an embodiment of the present invention, by combining the biological component activity test experiment table corresponding to each target detection project under different biological component ratio conditions generated by previous experiments, each material component in the required combination of the biological component sample is optimized in a standardized ratio combination. The specific steps include statistical analysis of the activity test results, and using methods such as multivariate regression analysis to identify the material components that have a significant impact on biological activity and their optimal ratios. On this basis, the combination is finely adjusted using an optimization algorithm to ensure that each material component achieves the best effect in the standard configuration. A verification experiment is performed on the final ratio combination to ensure that the combination has repeatability and stability in each target detection project, and the obtained standard ratio combination of biological component samples is confirmed, and finally the standard ratio combination of biological component samples corresponding to each target detection project is obtained.

[0107] Further, step S2 includes the following steps:

[0108] Step S21: Obtain the stability and solubility of each biological component sample by combining the standard proportions of the biological component samples corresponding to each target detection item, and optimize the pH and ionic strength configuration of the preset phosphate buffer based on the stability and solubility of each biological component sample, so as to obtain the phosphate optimized buffer under the optimized pH and ionic strength conditions corresponding to each target detection item;

[0109] In an embodiment of the present invention, the stability and solubility of each biological component sample are first determined by combining the standard ratios of the biological component samples required for each target detection item. This process uses spectral analysis and centrifugation methods to conduct multiple experiments on each biological component sample to evaluate its performance under different pH values ​​and ionic strengths. Based on the experimental results, a suitable phosphate buffer is selected, and its pH value and ionic strength are systematically optimized to ensure the best performance of each target detection item under ideal conditions. This optimization is carried out by gradually adjusting different concentrations of phosphate (for example, Na2HPO4 and NaH2PO4) and other additives (such as KCl), and the pH value and ionic strength changes of the solution are monitored by high performance liquid chromatography (HPLC) to ensure that it meets the preset standards, and finally the phosphate optimized buffer corresponding to each target detection item under the optimized conditions of pH value and ionic strength is obtained.

[0110] Step S22: using a sterile pipette and a transfer device to aseptically transfer the standard proportion combination of biological component samples corresponding to each target detection item to a sterile test tube in a predetermined proportion and order, and configuring corresponding sterile operating environment conditions to obtain the sterile test tube operating environment conditions corresponding to each target detection item;

[0111] In an embodiment of the present invention, a sterile pipette and transfer instruments are used to perform aseptic transfer operations on the standard ratio combinations of biological component samples corresponding to each target detection item in a predetermined ratio and sequence to ensure that no exogenous contamination is introduced during the configuration process. All instruments must be sterilized at high temperature and high pressure before operation to transfer the biological component samples of each target detection item to a sterile test tube in a predetermined ratio and sequence. The test tubes used must be rinsed with sterile saline in advance and processed in a sterile environment. During the operation, the transfer process is ensured to be fast and effective to prevent the samples from being exposed to the air. The sterile operating environment can be achieved by using a biological safety cabinet to ensure that the air flow in the laboratory is filtered, such as a temperature of 25°C, a humidity of 20, etc., and finally the sterile test tube operating environment conditions corresponding to each target detection item are configured.

[0112] Step S23: Based on the sterile test tube operating environment conditions corresponding to each target detection item and the phosphate optimized buffer under the conditions of pH value and ionic strength optimization, the corresponding standard proportion combination of biological component samples is mixed and prepared to obtain the biomass control product mixed solution corresponding to each target detection item;

[0113] In an embodiment of the present invention, a material mixing preparation is performed by mixing corresponding standard ratio combinations of biological component samples according to the aforementioned sterile test tube operating environment and the optimized phosphate buffer, so that each biological component sample is evenly added to a sterile test tube according to a predetermined standard ratio, and then the configured phosphate optimization buffer is added. During the mixing process, a magnetic stirrer is used to stir at a low speed to ensure that all components are fully mixed without generating bubbles. During the entire mixing operation, the temperature of the sample is continuously monitored to avoid affecting the stability of the biological components due to temperature fluctuations, to ensure that the obtained mixed solution meets the quality control requirements of each target detection item, and finally obtains a mixed solution of biomass control products corresponding to each target detection item.

[0114] Step S24: freeze-drying the biomass control product mixed solution corresponding to each target detection item and recording it in real time to generate the freeze-drying process of the quality control product corresponding to each target detection item;

[0115] In an embodiment of the present invention, a mixed solution of a biomass control product for each target detection item is freeze-dried. First, the mixed solution is evenly distributed into pre-prepared freeze-drying bottles, and the bottle mouths are sealed with sterile caps. Next, a freeze dryer is used to perform freezing and drying operations to freeze the mixed solution at -40°C and keep it for a certain period of time to ensure the formation of uniform ice crystals. The temperature is gradually increased to start the freeze-drying process, and the water is evaporated by sublimation under vacuum conditions. During this process, the temperature changes, vacuum degree and time parameters are recorded in real time to ensure the standardization and repeatability of the freeze-drying process. Finally, the freeze-drying process of the quality control product corresponding to each target detection item is recorded and generated.

[0116] Step S25: by adding a stability enhancer, the freeze-drying activity of the quality control product corresponding to each target detection item is optimized and controlled to prepare the freeze-drying activity, so as to generate a biological freeze-dried quality control product corresponding to each target detection item.

[0117] In an embodiment of the present invention, a stability enhancer is added to the freeze-drying process of the quality control product to optimize the freeze-drying activity. The stability enhancer, such as glycerol or polyvinyl alcohol, needs to be evenly mixed with the mixed solution in the pretreatment stage to ensure its uniform distribution. During the freeze-drying process, the pressure and temperature in the freeze-drying bottle are monitored to adjust the operating parameters of the freeze dryer in real time to ensure that the activity of each biological component is maintained during the freeze-drying process. After freeze-drying is completed, the necessary physical and chemical properties are tested on the freeze-dried quality control product to ensure that the final biological freeze-dried quality control product meets the expected quality standards and detection requirements, and finally the biological freeze-dried quality control product corresponding to each target detection item is prepared.

[0118] Further, step S24 includes the following steps:

[0119] Step S241: Analyze the composition and characteristics of each biological component sample in the biomass control product mixed solution corresponding to each target detection item to obtain the biological component composition and biological component characteristics of the control product solution corresponding to each target detection item;

[0120] In an embodiment of the present invention, composition analysis is performed on each biological component sample in the biomass control product mixed solution corresponding to each target detection item, so as to quantitatively detect the concentration of each biological component by utilizing analytical techniques such as high performance liquid chromatography (HPLC) and gas chromatography (GC), and perform structural analysis on the biological component by mass spectrometry (MS) to obtain its molecular weight and chemical properties. These data are processed to obtain detailed biological component composition information and characteristic description. For example, when analyzing samples containing proteins, carbohydrates and lipids, HPLC is used to separate proteins, while GC is used to analyze lipid components, so as to obtain the specific proportions and characteristics of different components, and finally obtain the biological component composition and biological component characteristics of the quality control product solution corresponding to each target detection item.

[0121] Step S242: performing thermosensitive interaction mining analysis between the biological component samples in the biomass control product mixed solution corresponding to each target detection project according to the biological component composition and biological component characteristics of the quality control product solution corresponding to each target detection project, so as to obtain the thermosensitive interaction relationship between different biological components in the quality control product solution corresponding to each target detection project;

[0122] In an embodiment of the present invention, the thermosensitive interactions between the biological component samples in the mixed solution of the biomass control product corresponding to each target detection item are mined and analyzed based on the composition and characteristics of the biological components obtained by previous analysis, so as to study the interaction between different biological components by using differential scanning calorimetry (DSC), record the relationship between temperature change and heat flow, observe the phase change and thermal effect of different biological components during the heating process through experiments, and perform data analysis to calculate the thermosensitive parameters of the interaction. For example, when analyzing a mixed solution of sugar and protein, DSC can reveal the thermal effect of the interaction within a specific temperature range, and finally obtain the thermosensitive interaction relationship between different biological components in the quality control product solution corresponding to each target detection item.

[0123] Step S243: setting pre-freezing conditions for the corresponding biomass control product mixed solution based on the thermosensitive interaction relationship between different biological components in the quality control product solution corresponding to each target detection item, so as to generate pre-freezing parameter conditions corresponding to the quality control product solution of each target detection item;

[0124] In an embodiment of the present invention, the pre-freezing conditions of the corresponding biomass control product mixed solution are set by combining the thermosensitive interaction relationship between different biological components in the quality control product solution corresponding to each target detection item determined by previous analysis, and the pre-freezing temperature curve is set from -40°C to -80°C based on the thermal analysis results. According to the thermosensitivity of different components, a suitable vacuum level is selected, such as 0.1 mbar. The pre-freezing time is determined to be 8 hours through experiments to ensure that each component is fully freeze-dried, and all parameters are recorded and integrated to form a pre-freezing parameter condition document, and finally the pre-freezing parameter conditions corresponding to the quality control product solution of each target detection item are generated.

[0125] Step S244: freeze-drying the corresponding biomass control product mixed solution according to the pre-freezing parameter conditions corresponding to the quality control product solution of each target detection item and recording in real time to generate the quality control product freeze-drying process corresponding to each target detection item.

[0126] In an embodiment of the present invention, the corresponding biomass control product mixed solution is freeze-dried according to the previously determined pre-freezing parameter conditions. The freeze-drying equipment is set to first perform vacuum extraction and then freeze-dry according to the set temperature curve. The whole process uses a data recorder to monitor the changes in temperature, pressure and time in real time to ensure that the parameters of each stage meet the preset conditions. The recorded data will be used for subsequent analysis to generate freeze-drying process records of quality control products for each target detection project to ensure that the quality and stability of the quality control products are effectively guaranteed. Finally, the freeze-drying process of the quality control products corresponding to each target detection project is recorded.

[0127] Further, step S243 includes the following steps:

[0128] Based on the thermosensitive interaction relationship between different biological components in the quality control solution corresponding to each target detection item, the pre-freezing temperature curve and vacuum level of the corresponding biomass control mixed solution are designed to design and generate the pre-freezing temperature change curve and pre-freezing vacuum level corresponding to the quality control solution of each target detection item;

[0129] In an embodiment of the present invention, the thermosensitive interaction relationship between biological components in the quality control solutions of different target detection items obtained by combining the previous analysis, and using a thermal analyzer to perform differential scanning calorimetry (DSC) test on the corresponding biomass control mixed solution to determine the melting point and glass transition temperature of each component. For example, when performing a hepatitis B detection project, by combining these data, a pre-freezing temperature curve is designed, and a temperature change is set from -40°C to -80°C step by step. The target vacuum level is set, for example, 0.1 mbar, through the cooperation of a vacuum pump and a vacuum gauge to achieve an ideal freeze-drying effect. Finally, a pre-freezing temperature change curve and a pre-freezing vacuum level corresponding to the quality control solution of each target detection item are designed and generated.

[0130] Preferably, a temperature amplitude statistical analysis is performed on the pre-freezing temperature change curve corresponding to the quality control solution of each target detection item to obtain the fluctuation change amplitude of the pre-freezing temperature corresponding to the quality control solution of each target detection item;

[0131] In an embodiment of the present invention, based on the pre-freezing temperature change curve generated in the previous step, the temperature amplitude statistical analysis is performed on the quality control solution of each target detection item, and the temperature change data input is graphically displayed using data analysis software to calculate the temperature fluctuation amplitude of each item. During the analysis process, the temperature value at each time point is recorded, and the standard deviation is calculated to obtain the temperature fluctuation range of each item. This process ensures a clear understanding of the temperature stability of different quality control solutions in the pre-freezing stage, and finally the pre-freezing temperature fluctuation amplitude corresponding to the quality control solution of each target detection item is obtained.

[0132] Preferably, based on the pre-freezing temperature fluctuation change amplitude corresponding to each target detection item quality control solution, the corresponding pre-freezing temperature change curve is optimized and determined for the pre-freezing temperature level and time, so as to obtain the pre-freezing temperature change level and pre-freezing time step corresponding to each target detection item quality control solution;

[0133] In an embodiment of the present invention, the pre-freezing temperature change curve is further optimized based on the temperature fluctuation amplitude obtained by the previous analysis. In this process, the influence of temperature fluctuation on the activity of the quality control product is analyzed, and the optimal pre-freezing temperature level and time step are determined using experimental design methods, such as response surface analysis. For example, a new pre-freezing time is set to 8 hours, and the temperature is gradually reduced to a change curve of -60°C to optimize the freeze-drying effect and product stability. The optimized parameters are verified through multiple experiments, and finally the pre-freezing temperature change level and pre-freezing time step corresponding to the quality control product solution of each target detection item are obtained.

[0134] Preferably, the pre-freezing vacuum level, temperature change level and pre-freezing time step corresponding to each target detection item quality control solution are set for pre-freezing conditions to generate pre-freezing parameter conditions corresponding to each target detection item quality control solution.

[0135] In an embodiment of the present invention, a complete pre-freezing condition is formed by comprehensively setting the pre-freezing vacuum level, temperature change level and pre-freezing time step of each target detection item. First, the vacuum level is set to 0.1 mbar, and the temperature is maintained at a set -60°C for 8 hours. During the operation, a high-precision temperature control system and a vacuum monitoring instrument are configured to ensure that the temperature and vacuum are maintained within the set range during the entire pre-freezing stage. All parameters are recorded in a dedicated software to generate a pre-freezing parameter condition document to ensure the accurate execution of subsequent freeze-drying processing. Finally, the pre-freezing parameter conditions corresponding to the quality control solution of each target detection item are recorded and generated.

[0136] Further, step S244 includes the following steps:

[0137] According to the pre-freezing vacuum level within the pre-freezing parameter conditions corresponding to the quality control solution of each target detection item, the corresponding biomass control product mixed solution is vacuum extracted and controlled, and a pre-freezing vacuum extraction execution control program corresponding to the quality control solution of each target detection item is generated;

[0138] In an embodiment of the present invention, a corresponding vacuum extraction process control setting is performed according to the corresponding pre-freezing vacuum level within the pre-freezing parameter conditions of the quality control product solution of each target detection item. This process adopts a high-precision vacuum pump, and the preset vacuum level is adjusted by adjusting the control valve. In specific operations, the biomass control product mixed solution is first placed in a container of a vacuum extraction device to ensure that the container is well sealed. After starting the vacuum pump, the pressure change on the vacuum gauge is monitored in real time to ensure that the preset vacuum level is reached. After the setting is completed, a corresponding pre-freezing vacuum extraction execution control program is generated to ensure that this parameter can be accurately achieved in the subsequent freeze-drying process, and finally a pre-freezing vacuum extraction execution control program corresponding to the quality control product solution of each target detection item is generated.

[0139] Preferably, the corresponding biomass control product mixed solution is set to gradually increase the temperature according to the temperature change level within the pre-freezing parameter conditions and the pre-freezing time step corresponding to each target detection item quality control product solution, and a pre-freezing time corresponding to each target detection item quality control product solution is generated. Gradually increase the temperature and execute a control program;

[0140] In an embodiment of the present invention, the corresponding quality control product mixed solution is gradually heated up according to the temperature change level and pre-freezing time step within the pre-freezing parameter conditions corresponding to the quality control product solutions of each target detection item obtained in advance, so as to formulate a control scheme for temperature change and time step based on the pre-freezing parameter conditions of each target detection item, and a temperature curve is set from -40°C to -10°C gradually through the temperature control system, and the heating rate is set to 5°C per hour. During operation, the biomass control product mixed solution is placed in a temperature control device, and the temperature change is monitored in real time by a built-in temperature sensor, and a gradual heating execution control program is written to ensure that the temperature change is achieved as planned within the set time step, and the mixed solution is evenly heated, and finally a gradual heating execution control program corresponding to the pre-freezing time of the quality control product solutions of each target detection item is generated.

[0141] Preferably, based on the pre-freezing vacuum extraction execution control program corresponding to the quality control solution of each target detection item and the pre-freezing time gradual heating execution control program, the freeze-drying process of the corresponding biomass control product mixed solution is executed and recorded in real time to generate the quality control product freeze-drying processing process corresponding to each target detection item.

[0142] In an embodiment of the present invention, the corresponding biomass control product mixed solution is freeze-dried by combining the pre-freezing vacuum extraction execution control program and the pre-freezing time gradual heating execution control program generated by the previous control, so that the vacuum extraction and gradual heating control programs are imported into the freeze dryer, the freeze drying equipment is started, and the freeze drying process begins. During this process, the equipment will automatically adjust the vacuum and temperature parameters according to the preset vacuum and temperature control programs. The entire freeze-drying process records the changes of various parameters in real time through the data acquisition system, including temperature, pressure and time, and generates freeze-drying process records of quality control products corresponding to each target detection item, and finally records the freeze-drying process of quality control products corresponding to each target detection item.

[0143] Further, step S25 includes the following steps:

[0144] Step S251: real-time monitoring of the freeze-drying process of the quality control product corresponding to each target detection item to obtain the freeze-drying temperature, freeze-drying pressure and freeze-drying duration corresponding to the freeze-drying process of each target detection item;

[0145] In an embodiment of the present invention, in the freeze-drying process of the quality control products of the target detection items, high-precision freeze-drying equipment is used, and temperature and pressure sensors are equipped to realize real-time monitoring of the freeze-drying process. The quality control products are placed in the freeze-dryer, the initial temperature is set to -40°C, and the vacuum pump is turned on to reduce the internal pressure to 0.1 mbar. The changes in temperature, pressure and time during the freeze-drying process are recorded in real time through the data acquisition system to ensure that the temperature and pressure of the equipment fluctuate within a preset range. The monitoring system collects data at regular intervals to form a data log for subsequent analysis of the freeze-drying effects of each target detection item, and finally the freeze-drying temperature, freeze-drying pressure and freeze-drying duration corresponding to the freeze-drying process of each target detection item are obtained.

[0146] Step S252: Based on the freeze-drying temperature, freeze-drying pressure and freeze-drying duration corresponding to the freeze-drying process of each target detection item, the activity attenuation calculation formula of the quality control product activity is used to calculate the activity attenuation of the corresponding quality control product freeze-drying process, so as to obtain the activity attenuation coefficient of the quality control product corresponding to each target detection item;

[0147] In an embodiment of the present invention, a suitable quality control product activity impairment attenuation calculation formula is formed by combining the duration of the freeze-drying process, the temperature and pressure during the freeze-drying process, the real-time activity of the quality control product, the initial activity of the quality control product, the standard pressure, the activity time decay influence coefficient and related parameters. The activity decay calculation of the quality control product is performed on the corresponding quality control product freeze-drying process to quantitatively calculate the activity decay coefficient of each target detection item, and finally the quality control product activity impairment attenuation coefficient corresponding to each target detection item is obtained.

[0148] Step S253: According to the attenuation coefficient of the damaged activity of the quality control product corresponding to each target detection item, the concentration conditions corresponding to the stability enhancer are configured, and the freeze-drying activity optimization control preparation is performed on the freeze-drying process of the quality control product corresponding to each target detection item by adding the stability enhancer under the corresponding concentration conditions to generate the biological freeze-dried quality control product corresponding to each target detection item.

[0149] In an embodiment of the present invention, a stability enhancer is configured by a specific preparation method in combination with the previously quantitatively calculated attenuation coefficient of the quality control product activity corresponding to each target detection item, and a suitable chemical substance, such as glycerol or sucrose, is selected as an enhancer according to the experimental results, and an enhancer of corresponding concentration is weighed using a precise electronic balance and dissolved in physiological saline. Then, during the freeze-drying process, the configured stability enhancer is added to the quality control product solution in a uniform proportion and stirred evenly to ensure that the enhancer is fully dissolved and evenly distributed. The freeze-drying equipment is used again to freeze-dry the quality control product with the added stability enhancer to optimize the freeze-dried activity, thereby preparing the desired biological freeze-dried quality control product, and finally preparing and generating the biological freeze-dried quality control product corresponding to each target detection item.

[0150] Furthermore, the calculation formula for the activity impairment attenuation of the quality control product in step S252 is specifically:

[0151]

[0152] In the formula, k i is the attenuation coefficient of the quality control product activity damage corresponding to the i-th target detection item, t is the duration of the freeze-drying process, T i is the temperature of the ith target detection item during the freeze-drying process, A i (t) is the real-time activity of the quality control product of the i-th target detection item at time t, is the initial activity of the quality control product corresponding to the i-th target detection item, P i is the pressure corresponding to the i-th target detection item during the freeze-drying process, is the standard pressure corresponding to the i-th target detection item, m i (t) is the activity time decay influence coefficient of the i-th target detection item at time t, η i is the correction coefficient of the activity impairment attenuation coefficient of the quality control product corresponding to the i-th target detection item.

[0153] The present invention obtains a quality control product activity impairment attenuation calculation formula by using a specific mathematical model and after verification, which is used to calculate the activity attenuation of the corresponding quality control product freeze-drying process. The quality control product activity impairment attenuation calculation formula can quantify the activity change of the quality control product during the freeze-drying process. Through the various parameters in the formula (such as initial activity, real-time activity, etc.), the activity loss of the quality control product under different conditions can be dynamically evaluated, helping scientific researchers understand the influence of different freeze-drying parameters on the activity. According to the obtained activity impairment attenuation coefficient, the parameters (such as temperature and pressure) in the freeze-drying process can be adjusted to optimize the processing process of the quality control product. The optimized freeze-drying conditions help to improve the activity and stability of the final product, thereby improving the quality of the quality control product. Through the calculated activity attenuation coefficient, the concentration conditions of the stability enhancer can be scientifically configured. After understanding the activity attenuation characteristics of different detection items, a suitable enhancer can be selected to ensure its effectiveness during the freeze-drying process. The result after applying this formula helps to improve the overall preparation process of the quality control product, ensure that the generated biological freeze-dried quality control product has higher activity and stability, which not only improves the consistency and reliability of the product, but also helps to reduce the scrap rate and production cost. In summary, this formula fully considers the attenuation coefficient k of the quality control product activity damage corresponding to the i-th target detection item i , the duration of the freeze-drying process is t, and the temperature T corresponding to the i-th target detection item during the freeze-drying process is i , the real-time activity A of the quality control product of the i-th target detection item at time t i(t), the initial activity of the quality control product corresponding to the i-th target detection item The i-th target detection item corresponds to the pressure P during the freeze-drying process i , the standard pressure corresponding to the i-th target detection item The activity time decay influence coefficient m of the i-th target detection item at time t i (t), the correction coefficient η of the attenuation coefficient of the quality control product activity damage corresponding to the i-th target detection item i , according to the quality control product activity impairment attenuation coefficient k corresponding to the i-th target detection item i The correlation between the above parameters constitutes a functional relationship This formula can realize the calculation process of the activity attenuation of the corresponding quality control product during the freeze-drying process. At the same time, the correction coefficient η of the quality control product activity damage attenuation coefficient corresponding to the i-th target detection item is used. i The introduction of can be adjusted according to the errors occurring in the calculation process, thereby improving the accuracy and applicability of the calculation formula for the activity damage attenuation of quality control products.

[0154] Further, step S3 includes the following steps:

[0155] Step S31: rehydrating the physiological saline concentration and additive components based on the biological freeze-dried quality control products corresponding to each target detection item to obtain a physiological saline reconstituted rehydration solution corresponding to the quality control products of each target detection item;

[0156] In an embodiment of the present invention, the concentration of the corresponding physiological saline and the additive components are configured for the rehydration components in combination with the characteristic requirements of each biological component in the biological freeze-dried quality control product corresponding to each target detection item that has been previously freeze-dried, so as to accurately weigh the required physiological saline concentration and additive components to configure the rehydration solution. In the specific operation, a high-precision electronic balance is used to measure the mass of each component, and the physiological saline and the additive are fully mixed in a sterile container to ensure the uniformity of the solution. The mixed solution is treated with an ultrasonic cleaning machine to ensure that all components are fully dissolved and reach the required concentration. The obtained physiological saline reconstitution and rehydration solution is transferred to a clearly marked storage bottle, and finally the physiological saline reconstitution and rehydration solution corresponding to the quality control product of each target detection item is obtained.

[0157] Step S32: rehydrating and dissolving the corresponding biological freeze-dried quality control product based on the physiological saline rehydration solution corresponding to each target detection item quality control product to obtain a sample of the biological mass control product rehydration solution corresponding to each target detection item;

[0158] In an embodiment of the present invention, the corresponding biological freeze-dried quality control product is rehydrated and dissolved by combining the physiological saline reconstitution and rehydration solution previously configured, so as to prepare the physiological saline reconstitution and rehydration solution previously prepared, ensure that it is left standing at room temperature to eliminate bubbles, take an appropriate amount of the biological freeze-dried quality control product corresponding to the target detection item, use aseptic operating procedures, place it in a pre-prepared sterile test tube, slowly add the physiological saline reconstitution and rehydration solution, keep shaking gently to avoid foaming, ensure that the quality control product is evenly dissolved, the temperature and time during the dissolution process must be strictly controlled to ensure the activity of the biomass control product, and finally obtain the biomass control product rehydration solution sample corresponding to each target detection item.

[0159] Step S33: Performing biological activity detection and evaluation on the rehydrated solution samples of the biomass control products corresponding to each target detection item, and obtaining the biological activity evaluation results corresponding to the rehydrated quality control products of each target detection item;

[0160] In an embodiment of the present invention, a bioactivity test is performed on a sample of a rehydrated solution of a biomass control product of each target detection item, and a suitable detection method is selected, such as a cell proliferation experiment or an enzyme activity assay, and the detection conditions are set according to the specific needs of the project. During the experiment, a spectrophotometer is used to measure the absorbance of the solution to evaluate the activity of the biomass control product, and the test results are recorded in an experimental record sheet. The bioactivity index of each sample is calculated, and statistical analysis is performed to ensure the accuracy and reliability of the data. This process needs to be carried out in a laboratory environment that meets biosafety standards to ensure the validity of the experimental results, and ultimately the bioactivity evaluation results corresponding to the rehydrated quality control products of each target detection item are obtained.

[0161] Step S34: setting appropriate solution storage conditions according to the biological activity evaluation results corresponding to the rehydrated quality control products of each target detection item, and performing solution storage management on the biomass control product rehydrated solution samples corresponding to each target detection item based on the appropriate storage conditions to obtain the quality control product rehydrated solution corresponding to each target detection item.

[0162] In an embodiment of the present invention, the corresponding optimal storage conditions are obtained by analyzing the biological activity evaluation results corresponding to the rehydrated quality control products of each target detection item obtained from the previous detection and evaluation, and using environmental monitoring equipment to detect environmental parameters such as temperature and humidity, set corresponding storage conditions, and package the rehydrated solution samples into suitable sterile storage containers. Labels are used to clearly indicate the storage conditions and sample information, and then they are placed in designated refrigeration equipment for management. The temperature and humidity of the storage equipment are checked regularly to ensure that the quality control products maintain their biological activity during the entire storage period, ensure the accuracy and reliability of subsequent tests, and finally obtain the quality control product rehydrated solutions corresponding to each target detection item.

[0163] Therefore, the embodiments should be regarded as illustrative and non-restrictive from all points, and the scope of the present invention is limited by the appended claims rather than the above description, and it is therefore intended that all changes falling within the meaning and range of equivalent elements of the application documents are included in the present invention.

[0164] The above description is only a specific embodiment of the present invention, so that those skilled in the art can understand or implement the present invention. Various modifications to these embodiments will be apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to the embodiments shown herein, but should conform to the widest scope consistent with the principles and novel features invented herein.

Claims

1. A method for preparing a quality control product based on multiple substances, characterized in that: The following steps are involved: Step S1: Obtain biomarkers corresponding to different individuals, including serum, cell components and nucleic acids corresponding to healthy individuals and individuals with specific diseases, and perform material sample purification on the biomarkers corresponding to different individuals to obtain biological material component samples corresponding to each biomarker; obtain target detection items, and perform standardized proportion combination of biological material component samples corresponding to each biomarker based on the target detection items to obtain standard proportion combination of biological component samples corresponding to each target detection item; Step S2: Based on the preset phosphate buffer and under sterile test tube conditions, a standard ratio combination of biological component samples corresponding to each target detection item is mixed to prepare a mixed solution of biomass control products corresponding to each target detection item; The mixed solution of biomass control products corresponding to each target detection item is freeze-dried and recorded in real time to generate the freeze-drying process of the quality control products corresponding to each target detection item; The freeze-drying activity of the quality control products corresponding to each target detection item is optimized and controlled by adding a stability enhancer to the freeze-drying process to generate biological freeze-dried quality control products corresponding to each target detection item; Step S3: rehydrating the biological freeze-dried quality control products corresponding to each target detection item using physiological saline to obtain quality control product rehydration solutions corresponding to each target detection item; Step S4: The rehydrated solutions of the quality control products corresponding to the target detection items are packaged into the standard test kits corresponding to the target detection items, so as to perform the experimental detection operations corresponding to the corresponding target detection items.

2. The method for preparing a quality control product based on multiple substances according to claim 1, characterized in that: Step S1 includes the following steps: Step S11: Obtaining biomarkers corresponding to different individuals, including serum, cell components and nucleic acids corresponding to healthy individuals and individuals with specific diseases; Step S12: performing material centrifugal separation and impurity removal treatment on the biomarkers corresponding to different individuals to obtain samples of biological material separation and impurity removal components corresponding to different individuals; Step S13: performing material sample purification processing on the biological material separation and impurity removal component samples corresponding to different individuals to obtain biological material component samples corresponding to each biomarker, including protein component samples, enzyme component samples and hormone component samples corresponding to serum, red blood cell component samples, white blood cell component samples and platelet component samples corresponding to cell components, and DNA component samples and RNA component samples corresponding to nucleic acid; Step S14: Obtain target detection items, wherein the target detection items include liver function test, blood sugar test and hepatitis B nucleic acid test, and configure the material component requirements of the biological material component samples corresponding to each biomarker based on the target detection items to obtain the required combination of biological component samples corresponding to each target detection item; Step S15: Performing experimental quantitative standardized ratio processing on each material component in the required combination of biological component samples corresponding to each target detection item, and obtaining a standard ratio combination of biological component samples corresponding to each target detection item.

3. The method for preparing a quality control product based on multiple substances according to claim 2, characterized in that: Step S15 includes the following steps: Step S151: Perform biological component characteristic analysis on each material component in the required combination of biological component samples corresponding to each target detection project, and obtain a material component characteristic list corresponding to the biological components required for each target detection project; Step S152: Based on the material component characteristic list corresponding to the biological components required for each target detection project, experimental matching conditions are designed for each material component in the required combination of biological component samples corresponding to each target detection project, so as to generate different biological component sample matching experimental conditions corresponding to each target detection project; Step S153: using enzyme-linked immunosorbent assay and PCR technology to perform biological component activity experimental tests on different biological component sample ratio experimental conditions corresponding to each target detection item, so as to generate a biological component activity test experimental table corresponding to each target detection item under different biological component ratio conditions; Step S154: Based on the biological component activity test experiment table corresponding to each target detection project under different biological component ratio conditions, each material component in the required combination of biological component samples corresponding to each target detection project is optimized and confirmed in a standardized ratio combination to obtain the standard ratio combination of biological component samples corresponding to each target detection project.

4. The method for preparing a quality control product based on multiple substances according to claim 1, characterized in that: Step S2 includes the following steps: Step S21: Obtain the stability and solubility of each biological component sample by combining the standard proportions of the biological component samples corresponding to each target detection item, and optimize the pH and ionic strength configuration of the preset phosphate buffer based on the stability and solubility of each biological component sample, so as to obtain the phosphate optimized buffer under the optimized pH and ionic strength conditions corresponding to each target detection item; Step S22: using a sterile pipette and a transfer device to aseptically transfer the standard proportion combination of biological component samples corresponding to each target detection item to a sterile test tube in a predetermined proportion and order, and configuring corresponding sterile operating environment conditions to obtain the sterile test tube operating environment conditions corresponding to each target detection item; Step S23: Based on the sterile test tube operating environment conditions corresponding to each target detection item and the phosphate optimized buffer under the conditions of pH value and ionic strength optimization, the corresponding standard proportion combination of biological component samples is mixed and prepared to obtain the biomass control product mixed solution corresponding to each target detection item; Step S24: freeze-drying the biomass control product mixed solution corresponding to each target detection item and recording it in real time to generate the freeze-drying process of the quality control product corresponding to each target detection item; Step S25: by adding a stability enhancer, the freeze-drying activity of the quality control product corresponding to each target detection item is optimized and controlled to prepare the freeze-drying activity, so as to generate a biological freeze-dried quality control product corresponding to each target detection item.

5. The method for preparing a quality control product based on multiple substances according to claim 4, characterized in that: Step S24 includes the following steps: Step S241: Analyze the composition and characteristics of each biological component sample in the biomass control product mixed solution corresponding to each target detection item to obtain the biological component composition and biological component characteristics of the control product solution corresponding to each target detection item; Step S242: performing thermosensitive interaction mining analysis between the biological component samples in the biomass control product mixed solution corresponding to each target detection project according to the biological component composition and biological component characteristics of the quality control product solution corresponding to each target detection project, so as to obtain the thermosensitive interaction relationship between different biological components in the quality control product solution corresponding to each target detection project; Step S243: setting pre-freezing conditions for the corresponding biomass control product mixed solution based on the thermosensitive interaction relationship between different biological components in the quality control product solution corresponding to each target detection item, so as to generate pre-freezing parameter conditions corresponding to the quality control product solution of each target detection item; Step S244: freeze-drying the corresponding biomass control product mixed solution according to the pre-freezing parameter conditions corresponding to the quality control product solution of each target detection item and recording in real time to generate the quality control product freeze-drying process corresponding to each target detection item.

6. The method for preparing a quality control product based on multiple substances according to claim 5, characterized in that: Step S243 includes the following steps: Based on the thermosensitive interaction relationship between different biological components in the quality control solution corresponding to each target detection item, the pre-freezing temperature curve and vacuum level of the corresponding biomass control mixed solution are designed to design and generate the pre-freezing temperature change curve and pre-freezing vacuum level corresponding to the quality control solution of each target detection item; Perform temperature amplitude statistical analysis on the pre-freezing temperature change curve corresponding to the quality control solution of each target detection item, and obtain the fluctuation range of the pre-freezing temperature corresponding to the quality control solution of each target detection item; Based on the fluctuation range of the pre-freezing temperature corresponding to the quality control solution of each target detection item, the corresponding pre-freezing temperature change curve is optimized and determined for the pre-freezing temperature level and time, so as to obtain the pre-freezing temperature change level and pre-freezing time step corresponding to the quality control solution of each target detection item; The pre-freezing vacuum level, temperature change level and pre-freezing time step corresponding to the quality control solution of each target detection item are set for pre-freezing conditions to generate the pre-freezing parameter conditions corresponding to the quality control solution of each target detection item.

7. The method for preparing a quality control product based on multiple substances according to claim 5, characterized in that: Step S244 includes the following steps: According to the pre-freezing vacuum level within the pre-freezing parameter conditions corresponding to the quality control solution of each target detection item, the corresponding biomass control product mixed solution is vacuum extracted and controlled, and a pre-freezing vacuum extraction execution control program corresponding to the quality control solution of each target detection item is generated; According to the temperature change level within the pre-freezing parameter conditions and the pre-freezing time step of the quality control product solution of each target detection item, the corresponding biomass control product mixed solution is set to gradually increase the temperature, and a pre-freezing time step-by-step temperature increase execution control program corresponding to the quality control product solution of each target detection item is generated; Based on the pre-freezing vacuum extraction execution control program corresponding to the quality control solution of each target detection item and the pre-freezing time gradual heating execution control program, the freeze-drying process of the corresponding biomass control product mixed solution is executed and recorded in real time to generate the freeze-drying processing process of the quality control product corresponding to each target detection item.

8. The method for preparing a quality control product based on multiple substances according to claim 4, characterized in that: Step S25 includes the following steps: Step S251: real-time monitoring of the freeze-drying process of the quality control product corresponding to each target detection item to obtain the freeze-drying temperature, freeze-drying pressure and freeze-drying duration corresponding to the freeze-drying process of each target detection item; Step S252: Based on the freeze-drying temperature, freeze-drying pressure and freeze-drying duration corresponding to the freeze-drying process of each target detection item, the activity attenuation calculation formula of the quality control product activity is used to calculate the activity attenuation of the corresponding quality control product freeze-drying process, so as to obtain the activity attenuation coefficient of the quality control product corresponding to each target detection item; Step S253: According to the attenuation coefficient of the damaged activity of the quality control product corresponding to each target detection item, the concentration conditions corresponding to the stability enhancer are configured, and the freeze-drying activity optimization control preparation is performed on the freeze-drying process of the quality control product corresponding to each target detection item by adding the stability enhancer under the corresponding concentration conditions to generate the biological freeze-dried quality control product corresponding to each target detection item.

9. The method for preparing a quality control product based on multiple substances according to claim 8, characterized in that: The specific calculation formula for the activity impairment attenuation of the quality control product in step S252 is: In the formula, k i is the attenuation coefficient of the quality control product activity damage corresponding to the i-th target detection item, t is the duration of the freeze-drying process, T i is the temperature of the ith target detection item during the freeze-drying process, A i (t) is the real-time activity of the quality control product of the i-th target detection item at time t, is the initial activity of the quality control product corresponding to the i-th target detection item, P i is the pressure corresponding to the i-th target detection item during the freeze-drying process, is the standard pressure corresponding to the i-th target detection item, m i (t) is the activity time decay influence coefficient of the i-th target detection item at time t, η i is the correction coefficient of the activity impairment attenuation coefficient of the quality control product corresponding to the i-th target detection item.

10. The method for preparing a quality control product based on multiple substances according to claim 1, characterized in that: Step S3 includes the following steps: Step S31: rehydrating the physiological saline concentration and additive components based on the biological freeze-dried quality control products corresponding to each target detection item to obtain a physiological saline reconstituted rehydration solution corresponding to the quality control products of each target detection item; Step S32: rehydrating and dissolving the corresponding biological freeze-dried quality control product based on the physiological saline rehydration solution corresponding to each target detection item quality control product to obtain a sample of the biological mass control product rehydration solution corresponding to each target detection item; Step S33: Performing biological activity detection and evaluation on the rehydrated solution samples of the biomass control products corresponding to each target detection item, and obtaining the biological activity evaluation results corresponding to the rehydrated quality control products of each target detection item; Step S34: setting appropriate solution storage conditions according to the biological activity evaluation results corresponding to the rehydrated quality control products of each target detection item, and performing solution storage management on the biomass control product rehydrated solution samples corresponding to each target detection item based on the appropriate storage conditions to obtain the quality control product rehydrated solution corresponding to each target detection item.

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