Production quality control method of Poria cocos drug composition based on intelligent monitoring technology

Abstract

The present invention discloses a method for controlling the production quality of a Poria cocos drug composition based on intelligent monitoring technology, and relates to the technical field of quality detection of Poria cocos drug production. The method for controlling the production quality of a Poria cocos drug composition based on intelligent monitoring technology comprises the following steps: drug data collection, quality standard judgment, process monitoring judgment, and process optimization judgment. The present invention evaluates the quality standard characteristics of preset raw materials in the Poria cocos drug composition through Poria cocos drug characteristic data to determine whether to perform the production process monitoring of the Poria cocos drug composition, then evaluates the effect of the production process monitoring of the Poria cocos drug composition, and determines whether to perform the production process optimization of the Poria cocos drug composition, and finally determines whether to perform the intelligent monitoring of the production and storage of the Poria cocos drug composition, thereby achieving a more accurate effect of controlling the production quality of the Poria cocos drug composition, and solving the problem of inaccurate quality monitoring in the production process of the Poria cocos drug composition in the prior art.

Description

Technical Field

[0001] The present invention relates to the technical field of quality detection of Poria cocos drug production, and in particular to a production quality control method of a Poria cocos drug composition based on intelligent monitoring technology. Background Art

[0002] Poria cocos is a common Chinese medicinal material with multiple pharmacological effects. It is widely used in Chinese medicine formulas, especially in the treatment of edema, spleen deficiency, insomnia, etc. With the development of the Chinese medicine industry, the production quality control of Poria cocos and its related pharmaceutical compositions has become increasingly important. The promotion and application of traditional Chinese medicines around the world face the problem of insufficient modern standards. Modern Chinese medicine products need to meet strict quality control standards to ensure the stability, consistency and safety of the drugs. As an important part of the Chinese medicine industry, Poria cocos lacks accurate quality monitoring methods in the production of its pharmaceutical compositions, which is prone to problems such as fluctuations in efficacy and excessive impurities. The introduction of intelligent monitoring technology can achieve real-time monitoring and data analysis, and improve the transparency and controllability of the production process.

[0003] The existing quality control of Poria cocos drug composition production is the product of the combination of traditional technology and modern detection technology, emphasizing the control of the entire chain from raw materials to finished products. First, the authenticity and quality of raw materials are judged through traditional appearance identification and modern detection methods (such as DNA barcode technology and microscopic identification). Secondly, during the production process, each link is strictly monitored to ensure the stability of production conditions and the consistency of drug quality. For example, by regularly detecting indicators such as extraction temperature, time, solvent dosage and pH value, the stability of the active ingredients in the extract is guaranteed. By gradually introducing intelligent monitoring technology to improve production efficiency and quality consistency, the foundation is laid for subsequent intelligent production control.

[0004] For example, a patent application with publication number: CN117825561A discloses a method for evaluating and controlling the quality of tobacco flavors and fragrances, including: selection of flavors and fragrances, selecting high-quality flavors and fragrances that have been strictly screened and tested to ensure stable ingredients and quality, and classifying and numbering samples; analysis of flavor and fragrance components, in-depth analysis of the selected flavors and fragrances, including testing their ingredients, physical and chemical indicators, and harmful substances, and formulating a specific ingredient analysis report; quality evaluation, based on the analysis report on the flavor and fragrance components, a detailed quality evaluation and standard is formulated, including evaluation and testing of their taste type, aroma intensity, and stability, among which the purity, stability, taste and aroma of the flavors and fragrances should be considered to ensure that the quality of the flavors and fragrances meets the requirements; quality grade classification, all evaluated samples are divided into four grades according to quality, namely, high quality, good, general and poor quality.

[0005] For example, the invention patent with announcement number: CN116794181B announces an intelligent detection method for the quality of traditional Chinese medicine pharmaceutical process based on spectral transformation and fusion, including: spectral data preprocessing and multi-spectral data transformation and fusion steps, the spectral data preprocessing method is Z-score standardization, and the multi-spectral data transformation and fusion method is to perform matrix multiplication operation on at least two spectral data; the spectral data is selected from at least two of ultraviolet-visible spectral data, near-infrared spectral data, Raman spectral data, and hyperspectral data.

[0006] However, in the process of implementing the technical solution of the invention in the embodiments of the present application, the present application found that the above technology has at least the following technical problems:

[0007] As a medicinal fungus, the active ingredients of Poria cocos will vary due to differences in natural environment such as origin, climate, and soil conditions. The standardized control of raw materials is difficult. At the same time, some non-destructive testing methods (such as near-infrared spectroscopy) are fast but may have insufficient resolution for mixed samples, especially when detecting complex components of Chinese medicinal materials, resulting in large errors.

[0008] It is also necessary to consider that under different process conditions, the extraction rate and stability of Poria cocos active ingredients fluctuate greatly. In addition, Poria cocos drugs are sensitive to environmental changes, which may cause the drugs to deteriorate due to environmental factors. There is a problem of inaccurate quality monitoring during the production process of Poria cocos drug compositions. Summary of the invention

[0009] The embodiment of the present application solves the problem of inaccurate production quality control of Poria cocos pharmaceutical compositions in the prior art by providing a production quality control method of Poria cocos pharmaceutical compositions based on intelligent monitoring technology, thereby achieving more accurate production quality control of Poria cocos pharmaceutical compositions.

[0010] The embodiment of the present application provides a production quality control method for a Poria cocos pharmaceutical composition based on intelligent monitoring technology, comprising the following steps: S1, collecting Poria cocos drug property data of preset raw materials in the Poria cocos pharmaceutical composition; S2, evaluating the quality standard characteristics of the preset raw materials in the Poria cocos pharmaceutical composition according to the Poria cocos drug property data to obtain a Poria cocos raw material property index, and judging whether to perform production process monitoring of the Poria cocos pharmaceutical composition based on the Poria cocos raw material property index, wherein the Poria cocos raw material property index is used to quantitatively evaluate the degree of compliance with the quality of the preset raw materials in the Poria cocos pharmaceutical composition; S3, after performing the production process monitoring of the Poria cocos pharmaceutical composition, evaluating the effect of the production process monitoring of the Poria cocos pharmaceutical composition to obtain a Poria cocos process effect index, based on the Poria cocos raw material property index. The process effect index of Poria cocos is used to judge whether to perform the optimization of the production process of the Poria cocos drug composition, and the Poria cocos process effect index is used to comprehensively quantify the effect of the monitoring of the production process of the Poria cocos drug composition; S4, obtaining the Poria cocos process optimization index after the optimization of the production process of the Poria cocos drug composition is performed, and judging whether to perform the intelligent monitoring of the production and storage of the Poria cocos drug composition according to the Poria cocos raw material characteristic index, the Poria cocos process effect index and the Poria cocos process optimization index, and the Poria cocos process optimization index is used to quantitatively evaluate the effect of the optimization of the production process of the Poria cocos drug composition; the specific steps of evaluating the quality standard characteristics of the preset raw materials in the Poria cocos drug composition according to the Poria cocos drug characteristic data to obtain the Poria cocos raw material characteristic index are as follows: according to the obtained chemical The chemical property index is obtained by combining the property measurement values ​​and the reference chemical property values ​​obtained from the preset database; the chemical property measurement values ​​include the measurement value of the polysaccharide content of the Poria cocos drug, the measurement value of the pH value of the Poria cocos drug, and the measurement value of the moisture content of the Poria cocos drug; the reference chemical property values ​​include the reference value of the polysaccharide content of the Poria cocos drug, the reference value of the pH value of the Poria cocos drug, the reference maximum deviation of the pH value of the Poria cocos drug, the reference value of the moisture content of the Poria cocos drug, and the reference maximum deviation of the moisture content of the Poria cocos drug; the physical property index is obtained according to the obtained physical property measurement values ​​and the reference physical property values ​​obtained from the preset database; the physical property measurement values ​​include the measurement value of the particle size of the Poria cocos drug, the measurement value of the specific surface area of ​​the Poria cocos drug, and the measurement value of the hardness of the Poria cocos drug; The reference physical property values ​​include the reference value of the maximum specific surface area of ​​the Poria cocos drug and the reference hardness of the Poria cocos drug; the biological property index is obtained according to the obtained biological property measurement value and the reference biological property value obtained from the preset database; the biological property measurement value includes the Poria cocos drug antioxidant activity measurement value and the Poria cocos drug anti-inflammatory activity measurement value; the reference biological property value includes the reference Poria cocos drug minimum antioxidant activity and the reference Poria cocos drug minimum anti-inflammatory activity; the chemical property index, the physical property index, the biological property index and the quality index evaluation weight obtained from the preset database are combined to obtain the Poria cocos raw material property index, and the quality index evaluation weight includes the chemical index evaluation weight, the physical index evaluation weight and the biological index evaluation weight;The specific steps of evaluating the effect of the production process monitoring of the Poria cocos pharmaceutical composition to obtain the Poria cocos process effect index are as follows: obtaining a process monitoring evaluation value after executing the production process monitoring of the Poria cocos pharmaceutical composition, the process monitoring evaluation value including the characteristic index of the Poria cocos raw material to be monitored, the standard deviation of the Poria cocos process temperature, the standard deviation of the Poria cocos process pressure and the standard deviation of the Poria cocos process humidity; combining the process monitoring evaluation value with the process monitoring reference value obtained from a preset database to obtain the Poria cocos process effect index; the process monitoring reference value includes a process monitoring reference maximum value and a process monitoring reference minimum value; the process monitoring reference maximum value includes a reference process maximum temperature standard deviation, a reference process maximum pressure standard deviation and a reference process maximum humidity standard deviation; the process monitoring reference minimum value includes a reference process minimum temperature standard deviation, a reference process minimum pressure standard deviation and a reference process minimum humidity standard deviation; the method for obtaining the Poria cocos process effect index is as follows:;

[0011] In the formula, Indicates the process effect index of Poria cocos. Indicates the characteristic index of Poria cocos raw material to be monitored. represents the standard deviation of the Poria process temperature, represents the maximum temperature standard deviation of the reference process, represents the standard deviation of the Poria process pressure, represents the standard deviation of the maximum pressure of the reference process, It represents the standard deviation of the humidity of the Poria cocos process. represents the maximum humidity standard deviation of the reference process, Indicates the preset characteristic indicator threshold range, represents the minimum temperature standard deviation of the reference process, Indicates the standard deviation of the minimum pressure of the reference process, Indicates the minimum humidity standard deviation of the reference process.

[0012] Furthermore, the Poria cocos drug property data include Poria cocos drug chemical property data, Poria cocos drug physical property data and Poria cocos drug biological property data; the Poria cocos drug chemical property data include Poria cocos drug polysaccharide content, Poria cocos drug pH and Poria cocos drug water content; the Poria cocos drug physical property data include Poria cocos drug particle size, Poria cocos drug specific surface area and Poria cocos drug hardness; the Poria cocos drug biological property data include Poria cocos drug antioxidant activity and Poria cocos drug anti-inflammatory activity.

[0013] Furthermore, the specific process of judging whether to execute the production process monitoring of the Poria cocos pharmaceutical composition based on the Poria cocos raw material characteristic index is: comparing the Poria cocos raw material characteristic index with the preset characteristic index threshold range obtained from the preset database; if the Poria cocos raw material characteristic index is within the preset characteristic index threshold range, then executing the production process monitoring of the Poria cocos pharmaceutical composition, and evaluating the effect of the production process monitoring of the Poria cocos pharmaceutical composition to obtain the Poria cocos process effect index; if the Poria cocos raw material characteristic index exceeds the preset characteristic index threshold range, then not executing the production process monitoring of the Poria cocos pharmaceutical composition, and reminding the preset personnel to re-acquire the Poria cocos drug characteristic data.

[0014] Furthermore, the specific process of judging whether to execute the optimization of the production process of the Poria cocos pharmaceutical composition based on the Poria cocos process effect index is: comparing the Poria cocos process effect index with the preset process effect threshold range obtained from the preset database; if the Poria cocos process effect index is within the preset process effect threshold range, the optimization of the production process of the Poria cocos pharmaceutical composition is not executed, and at the same time, the Poria cocos drug characteristic data, the Poria cocos raw material characteristic indicators and the Poria cocos process effect indicators are uploaded to the preset database; if the Poria cocos process effect index exceeds the preset process effect threshold range, the optimization of the production process of the Poria cocos pharmaceutical composition is executed, and the Poria cocos process optimization index is obtained at the same time.

[0015] Furthermore, the specific process of optimizing the production process of the Poria cocos pharmaceutical composition is as follows: A1, optimizing the production index of the Poria cocos pharmaceutical composition, when the Poria cocos process effect index after the production index optimization is within the preset process effect threshold range, stopping the optimization of the production process of the Poria cocos pharmaceutical composition, otherwise executing A2; A2, optimizing the solvent dosage of the Poria cocos pharmaceutical composition, when the Poria cocos process effect index after the production index optimization is within the preset process effect threshold range, stopping the optimization of the production process of the Poria cocos pharmaceutical composition, otherwise executing A3; A3, optimizing and adjusting the energy of the Poria cocos pharmaceutical composition production, and simultaneously obtaining the Poria cocos process optimization index after the optimization of the production process of the Poria cocos pharmaceutical composition.

[0016] Furthermore, the specific steps for obtaining the Poria cocos process optimization index after the optimization of the Poria cocos drug composition production process are as follows: obtaining the initial dissolution rate of the Poria cocos drug composition before the optimization of the Poria cocos drug composition production process and the process optimization evaluation value after the optimization of the Poria cocos drug composition production process; the process optimization evaluation value includes the Poria cocos process effect index to be optimized, the actual production cycle of the process and the optimized dissolution rate of the Poria cocos drug composition; the Poria cocos process optimization index is obtained according to the initial dissolution rate of the Poria cocos drug composition, the process optimization evaluation value and the process production cycle influencing factor obtained from a preset database, the reference to the best Poria cocos process effect index and the reference to the maximum process production cycle.

[0017] Furthermore, the specific steps for determining whether to execute the intelligent monitoring of the production and storage of the Poria cocos pharmaceutical composition are as follows: M1, determining whether the acquired Poria cocos raw material characteristic index is within the preset characteristic index threshold range, if the Poria cocos raw material characteristic index is within the preset characteristic index threshold range, then executing M2, otherwise, the intelligent monitoring of the production and storage of the Poria cocos pharmaceutical composition is not executed; M2, determining whether the acquired Poria cocos process effect index is within the preset process effect threshold range, if the Poria cocos process effect index exceeds the preset process effect threshold range, then executing M3, otherwise, executing the intelligent monitoring of the production and storage of the Poria cocos pharmaceutical composition; M3, determining whether the acquired Poria cocos process optimization index is within the preset process optimization threshold range, if the Poria cocos process optimization index is within the preset process optimization threshold range, then executing the intelligent monitoring of the production and storage of the Poria cocos pharmaceutical composition, otherwise, not executing the intelligent monitoring of the production and storage of the Poria cocos pharmaceutical composition; the intelligent monitoring of the production and storage of the Poria cocos pharmaceutical composition indicates monitoring the production and storage conditions of the Poria cocos pharmaceutical composition.

[0018] One or more technical solutions provided in the embodiments of the present application have at least the following technical effects or advantages:

[0019] 1. The quality standard characteristics of the preset raw materials in the Poria cocos drug composition are evaluated through the Poria cocos drug characteristic data to determine whether to implement the production process monitoring of the Poria cocos drug composition, and then the effect of the production process monitoring of the Poria cocos drug composition is evaluated, and it is determined whether to implement the production process optimization of the Poria cocos drug composition, and finally it is determined whether to implement the intelligent monitoring of the production and storage of the Poria cocos drug composition, thereby realizing the evaluation and optimization of the effect of the production process monitoring of the Poria cocos drug composition, and then achieving more accurate production quality control of the Poria cocos drug composition, effectively solving the problem of inaccurate quality monitoring in the production process of the Poria cocos drug composition in the prior art.

[0020] 2. By obtaining the process monitoring evaluation value after executing the production process monitoring of the Poria cocos drug composition, and then combining the process monitoring evaluation value with the process monitoring reference value obtained from the preset database, the Poria cocos process effect index is obtained, thereby realizing the numerical evaluation of the production process monitoring effect of the Poria cocos drug composition, and then realizing a more accurate evaluation of the production process monitoring effect of the Poria cocos drug composition.

[0021] 3. By obtaining the initial dissolution rate of the Poria cocos pharmaceutical composition before the optimization of the production process of the Poria cocos pharmaceutical composition and the process optimization evaluation value after the optimization of the production process of the Poria cocos pharmaceutical composition, and then combining it with the process production cycle influencing factors obtained from the preset database, the reference best Poria cocos process effect index and the reference maximum process production cycle, the Poria cocos process optimization index is obtained, thereby realizing the numerical evaluation of the optimization effect of the production process of the Poria cocos pharmaceutical composition, and further realizing a more accurate evaluation of the optimization effect of the production process of the Poria cocos pharmaceutical composition. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 A flow chart of a method for controlling the production quality of a Poria cocos pharmaceutical composition based on intelligent monitoring technology provided in an embodiment of the present application;

[0023] Figure 2 A schematic diagram of the change of the Poria cocos process optimization index with the optimized dissolution rate of the Poria cocos pharmaceutical composition provided in the examples of the present application;

[0024] Figure 3 A schematic diagram of changes in the Poria cocos process optimization indicators provided in the embodiments of the present application along with the actual production cycle of the process. DETAILED DESCRIPTION

[0025] The embodiment of the present application solves the problem of inaccurate quality monitoring in the production process of the Poria cocos pharmaceutical composition in the prior art by providing a Poria cocos pharmaceutical composition production quality control method based on intelligent monitoring technology. The quality standard characteristics of the preset raw materials in the Poria cocos pharmaceutical composition are evaluated through the Poria cocos pharmaceutical characteristic data to obtain the Poria cocos raw material characteristic index, and whether to execute the production process monitoring of the Poria cocos pharmaceutical composition is determined based on the Poria cocos raw material characteristic index. Then, after executing the production process monitoring of the Poria cocos pharmaceutical composition, the effect of the production process monitoring of the Poria cocos pharmaceutical composition is evaluated to obtain the Poria cocos process effect index and determine whether to execute the production process optimization of the Poria cocos pharmaceutical composition. Finally, the Poria cocos process optimization index after executing the production process optimization of the Poria cocos pharmaceutical composition is obtained, and it is determined whether to execute the intelligent monitoring of the production and storage of the Poria cocos pharmaceutical composition, thereby achieving more accurate production quality control of the Poria cocos pharmaceutical composition.

[0026] The technical solution in the embodiment of the present application is to solve the problem of inaccurate quality monitoring during the production process of the above-mentioned Poria cocos pharmaceutical composition. The overall idea is as follows:

[0027] By evaluating the quality standard characteristics of the preset raw materials in the Poria cocos pharmaceutical composition to determine whether to implement the production process monitoring of the Poria cocos pharmaceutical composition, then evaluating the effect of the production process monitoring of the Poria cocos pharmaceutical composition, and determining whether to implement the production process optimization of the Poria cocos pharmaceutical composition, and finally determining whether to implement intelligent monitoring of the production and storage of the Poria cocos pharmaceutical composition, a more accurate effect of controlling the production quality of the Poria cocos pharmaceutical composition is achieved.

[0028] In order to better understand the above technical solution, the above technical solution will be described in detail below in conjunction with the accompanying drawings and specific implementation methods.

[0029] like Figure 1As shown, it is a flow chart of a method for controlling the production quality of a Poria cocos drug composition based on intelligent monitoring technology provided in an embodiment of the present application, and the method comprises the following steps: S1, collecting Poria cocos drug property data of preset raw materials in the Poria cocos drug composition; S2, evaluating the quality standard characteristics of the preset raw materials in the Poria cocos drug composition according to the Poria cocos drug property data to obtain a Poria cocos raw material property index, judging whether to perform the production process monitoring of the Poria cocos drug composition based on the Poria cocos raw material property index, and using the Poria cocos raw material property index to evaluate the degree of compliance with the quality of the preset raw materials in the Poria cocos drug composition; S3, after performing the production process monitoring of the Poria cocos drug composition, evaluating the effect of the production process monitoring of the Poria cocos drug composition to obtain a Poria cocos process effect index, judging whether to perform the production process optimization of the Poria cocos drug composition based on the Poria cocos process effect index, and the Poria cocos process effect index is used to comprehensively quantify the effect of the production process monitoring of the Poria cocos drug composition; S4, obtaining the Poria cocos process optimization index after performing the production process optimization of the Poria cocos drug composition, judging whether to perform the intelligent monitoring of the production and storage of the Poria cocos drug composition according to the Poria cocos raw material property index, the Poria cocos process effect index and the Poria cocos process optimization index, and the Poria cocos process optimization index is used to quantitatively evaluate the effect of the production process optimization of the Poria cocos drug composition.

[0030] It should be added that the drug property data of Poria cocos include the drug chemical property data of Poria cocos, the drug physical property data of Poria cocos and the drug biological property data of Poria cocos; the drug chemical property data of Poria cocos include the drug polysaccharide content of Poria cocos, the drug pH value of Poria cocos and the drug water content of Poria cocos.

[0031] Specifically, the polysaccharide content of the Poria cocos drug is obtained by an ultraviolet-visible spectrophotometer, the pH value of the Poria cocos drug is obtained by a pH meter, and the water content of the Poria cocos drug is obtained by an infrared moisture meter.

[0032] The physical property data of Poria cocos drugs include the particle size of Poria cocos drugs, the specific surface area of ​​Poria cocos drugs and the hardness of Poria cocos drugs; specifically, the particle size of Poria cocos drugs is obtained by a laser particle size analyzer, the specific surface area of ​​Poria cocos drugs is obtained by a specific surface area analyzer, and the hardness of Poria cocos drugs is obtained by a hardness tester.

[0033] The biological property data of Poria cocos drugs include the antioxidant activity and anti-inflammatory activity of Poria cocos drugs. Specifically, the antioxidant activity of Poria cocos drugs is obtained by the DPPH (1,1-Diphenyl-2-picrylhydrazyl) free radical scavenging method (calculating the half inhibition concentration of Poria cocos drugs on the antioxidant activity), and the anti-inflammatory activity of Poria cocos drugs is obtained by the cytokine assay method (calculating the half inhibition concentration of Poria cocos drugs on the release of inflammatory factors).

[0034] By obtaining the drug property data of Poria cocos, the quality compliance degree of preset raw materials in the Poria cocos drug composition can be evaluated, thereby improving the reliability of the quality compliance evaluation of preset raw materials in the production quality control process of the Poria cocos drug composition.

[0035] Further, the specific steps of evaluating the quality standard characteristics of the preset raw materials in the Poria cocos drug composition according to the Poria cocos drug property data to obtain the Poria cocos raw material property index are as follows: obtaining the chemical property index (i.e., the Poria cocos raw material property index) according to the obtained chemical property measurement value and the reference chemical property value obtained from the preset database; ); chemical property measurement values ​​include the measurement value of the polysaccharide content of Poria cocos, the measurement value of the pH value of Poria cocos, and the measurement value of the moisture content of Poria cocos; reference chemical property values ​​include the reference value of the polysaccharide content of Poria cocos, the reference value of the pH value of Poria cocos, the reference maximum deviation of the pH value of Poria cocos, the reference value of the moisture content of Poria cocos, and the reference maximum deviation of the moisture content of Poria cocos; physical property indicators (i.e., the Poria cocos raw material characteristic indicators) are obtained based on the obtained physical property measurement values ​​and the reference physical property values ​​obtained from the preset database. ); physical property measurement values ​​include the particle size measurement value of Poria cocos, the specific surface area measurement value of Poria cocos, and the hardness measurement value of Poria cocos; reference physical property values ​​include the maximum specific surface area reference value of Poria cocos and the reference hardness of Poria cocos; biological property indexes (i.e., the Poria cocos raw material property indexes) are obtained based on the obtained biological property measurement values ​​and the reference biological property values ​​obtained from the preset database. ); biological property measurement values ​​include the measurement values ​​of the antioxidant activity of Poria cocos drugs and the measurement values ​​of the anti-inflammatory activity of Poria cocos drugs; reference biological property values ​​include the minimum antioxidant activity of reference Poria cocos drugs and the minimum anti-inflammatory activity of reference Poria cocos drugs; the chemical property indicators, physical property indicators, and biological property indicators are combined with the quality indicator evaluation weights obtained from the preset database to obtain the Poria cocos raw material characteristic indicators, and the quality indicator evaluation weights include the chemical indicator evaluation weights, the physical indicator evaluation weights, and the biological indicator evaluation weights.

[0036] The method for obtaining the characteristic index of Poria cocos raw material is as follows:

[0037] ; ; ; In the formula, Indicates the characteristic index of Poria cocos raw material. represents the evaluation weight of chemical indicators, represents the physical indicator evaluation weight, represents the biological indicator assessment weight, Indicates the chemical properties of Poria raw materials. Indicates the physical properties of Poria raw materials. Indicates the biological characteristic index of Poria cocos raw material. Indicates the measured value of the polysaccharide content of Poria cocos. Indicates the reference value of the polysaccharide content of Poria cocos. Indicates the pH measurement value of Poria cocos medicine. Indicates the reference value of pH of Poria cocos medicine. Indicates the maximum reference deviation of the pH value of Poria cocos drugs. Indicates the measured value of the moisture content of Poria cocos. Indicates the reference value of water content of Poria cocos medicine. Indicates the maximum reference deviation of the moisture content of Poria cocos. Indicates the measured value of the particle size of Poria cocos drug. Indicates the measured value of the specific surface area of ​​Poria cocos drug, Indicates the maximum specific surface area reference value of Poria cocos drug, Indicates the hardness measurement value of Poria cocos. Indicates the hardness of the reference Poria cocos drug, Indicates the measured value of the antioxidant activity of Poria cocos drugs, Indicates the minimum antioxidant activity of the reference Poria drug, It indicates the measured value of the anti-inflammatory activity of Poria cocos drugs. Indicates the minimum anti-inflammatory activity of the reference Poria drug.

[0038] In this embodiment, the chemical property measurement value is the measurement value of the chemical property data of the Poria cocos drug, the physical property measurement value is the measurement value of the physical property data of the Poria cocos drug, and the biological property measurement value is the measurement value of the biological property data of the Poria cocos drug, wherein the particle size of the Poria cocos drug is de-unitized to obtain the particle size measurement value of the Poria cocos drug.

[0039] The reference value of the polysaccharide content of the Poria cocos drug is represented by summing and averaging the collected historical Poria cocos drug polysaccharide content measurement values, the reference value of the pH value of the Poria cocos drug is represented by summing and averaging the collected historical Poria cocos drug pH measurement values, and the reference value of the moisture content of the Poria cocos drug is represented by summing and averaging the collected historical Poria cocos drug moisture content reference values.

[0040] The maximum deviation of the Poria drug pH reference is represented by the maximum value of the difference between the collected historical Poria drug pH measurement values ​​and the Poria drug pH reference values. The maximum deviation of the Poria drug moisture content reference is represented by the maximum value of the difference between the collected historical Poria drug moisture content reference values ​​and the Poria drug moisture content reference values.

[0041] The maximum value of the historical Poria cocos drug specific surface area measurement values ​​collected is used to represent the reference value of the maximum specific surface area of ​​the Poria cocos drug, and the reference Poria cocos drug hardness is represented by summing and averaging the historical Poria cocos drug hardness measurement values ​​collected.

[0042] The minimum antioxidant activity of the reference Poria cocos drug is represented by the minimum value of the historical Poria cocos drug antioxidant activity measurement values ​​collected, and the minimum anti-inflammatory activity of the reference Poria cocos drug is represented by the minimum value of the historical Poria cocos drug anti-inflammatory activity measurement values ​​collected.

[0043] In this example, the value range of the chemical indicator evaluation weight, the physical indicator evaluation weight and the biological indicator evaluation weight are all [0, 1], and the sum is 1. Specifically, they can be directly obtained from the preset database when used, wherein the chemical property indicators, physical property indicators and biological property indicators of the real-time Poria cocos raw material are input into the preset mapping set in the database to obtain the corresponding weights, wherein the mapping relationship can be one-to-one or many-to-one. The chemical indicator evaluation weight, physical indicator evaluation weight and biological indicator evaluation weight are used to reflect the influence of the chemical property indicators, physical property indicators and biological property indicators of Poria cocos raw material on the characteristic indicators of Poria cocos raw material.

[0044] The characteristic index of Poria cocos raw materials is used to quantitatively evaluate the degree of compliance of the quality of preset raw materials in the Poria cocos drug composition. Among them, the chemical characteristic index, physical characteristic index and biological characteristic index of Poria cocos raw materials all affect the characteristic index of Poria cocos raw materials. Specifically, with the increase of the chemical characteristic index, physical characteristic index and biological characteristic index of Poria cocos raw materials, the characteristic index of Poria cocos raw materials increases accordingly; in addition, the characteristic index of Poria cocos raw materials includes parameters in multiple aspects, and the various parameters are related and do not exist independently. For example, polysaccharides and moisture affect the crystallization and dispersibility of Poria cocos particles, thereby affecting the particle size and specific surface area of ​​Poria cocos. Specifically, with the increase of the measured value of the moisture content of Poria cocos drugs, agglomeration occurs on the surface of the particles, which leads to an increase in the measured value of the moisture particle size of the Poria cocos drugs and a decrease in the measured value of the specific surface area of ​​the Poria cocos drugs. , which leads to a decrease in the physical property indicators of Poria cocos raw materials, and the characteristic indicators of Poria cocos raw materials also decrease accordingly; at the same time, with the increase in the measured value of the specific surface area of ​​Poria cocos drugs, the release efficiency of active substances increases, thereby increasing the measured values ​​of the antioxidant activity of Poria cocos drugs and the measured values ​​of the anti-inflammatory activity of Poria cocos drugs, which leads to an increase in the biological property indicators of Poria cocos raw materials, and the characteristic indicators of Poria cocos raw materials also increase accordingly; therefore, through a quantitative approach, the correlation and mutual influence between various factors are taken into account, and the characteristic indicators of Poria cocos raw materials are obtained through a comprehensive analysis, so as to realize the evaluation of the quality compliance degree of the preset raw materials in the Poria cocos drug composition, and the quality compliance degree of the preset raw materials in the Poria cocos drug composition is judged through numerical evaluation, thereby realizing the improvement of the accuracy of the evaluation of the quality compliance degree of the preset raw materials in the Poria cocos drug composition.

[0045] Furthermore, the specific process of judging whether to execute the production process monitoring of the Poria cocos pharmaceutical composition based on the Poria cocos raw material characteristic index is as follows: comparing the Poria cocos raw material characteristic index with the preset characteristic index threshold range obtained from the preset database; if the Poria cocos raw material characteristic index is within the preset characteristic index threshold range, then executing the production process monitoring of the Poria cocos pharmaceutical composition, and evaluating the effect of the production process monitoring of the Poria cocos pharmaceutical composition to obtain the Poria cocos process effect index; if the Poria cocos raw material characteristic index exceeds the preset characteristic index threshold range, then not executing the production process monitoring of the Poria cocos pharmaceutical composition, and reminding the preset personnel to re-acquire the Poria cocos drug characteristic data.

[0046] In this embodiment, specifically, the preset characteristic index threshold range is set by professionals according to standards in the field. For example, the preset characteristic index threshold range is set to 0.769 to 1.

[0047] Among them, the programmable logic controller and SCADA (Supervisory Control and Data Acquisition) system are used to monitor the operating data in the production process of the Poria cocos pharmaceutical composition (such as the temperature in the production process of the Poria cocos pharmaceutical composition) in real time to realize the production process monitoring of the Poria cocos pharmaceutical composition; by combining the preset characteristic indicator threshold range to make judgments and conduct production process monitoring of the Poria cocos pharmaceutical composition, more accurate monitoring of the preset raw material quality compliance in the Poria cocos pharmaceutical composition is achieved.

[0048] Furthermore, the specific steps for evaluating the effect of the production process monitoring of the Poria cocos pharmaceutical composition to obtain the Poria cocos process effect index are as follows: obtain the process monitoring evaluation value after executing the production process monitoring of the Poria cocos pharmaceutical composition, the process monitoring evaluation value including the characteristic index of the Poria cocos raw material to be monitored, the Poria cocos process temperature standard deviation, the Poria cocos process pressure standard deviation and the Poria cocos process humidity standard deviation; combine the process monitoring evaluation value with the process monitoring reference value obtained from a preset database to obtain the Poria cocos process effect index; the process monitoring reference value includes the process monitoring reference maximum value and the process monitoring reference minimum value; the process monitoring reference maximum value includes the reference process maximum temperature standard deviation, the reference process maximum pressure standard deviation and the reference process maximum humidity standard deviation; the process monitoring reference minimum value includes the reference process minimum temperature standard deviation, the reference process minimum pressure standard deviation and the reference process minimum humidity standard deviation.

[0049] The method for obtaining the process effect index of Poria cocos is as follows:

[0050] In the formula, Indicates the process effect index of Poria cocos. Indicates the characteristic index of Poria cocos raw material to be monitored. represents the standard deviation of the Poria process temperature, represents the maximum temperature standard deviation of the reference process, represents the standard deviation of the Poria process pressure, represents the standard deviation of the maximum pressure of the reference process, It represents the standard deviation of the humidity of the Poria cocos process. represents the maximum humidity standard deviation of the reference process, Indicates the preset characteristic indicator threshold range, represents the minimum temperature standard deviation of the reference process, Indicates the standard deviation of the minimum pressure of the reference process, Indicates the minimum humidity standard deviation of the reference process.

[0051] In this embodiment, the characteristic index of the Poria cocos raw material to be monitored refers to the characteristic index of the Poria cocos raw material after the production process monitoring of the Poria cocos pharmaceutical composition is executed. The Poria cocos process temperature data, Poria cocos process pressure data and Poria cocos process humidity data are obtained by deploying temperature sensors, pressure sensors and humidity sensors in the production process environment of the Poria cocos pharmaceutical composition. According to the obtained Poria cocos process temperature data, Poria cocos process pressure data and Poria cocos process humidity data, the Poria cocos process temperature standard deviation, Poria cocos process pressure standard deviation and Poria cocos process humidity standard deviation are obtained through data processing tools (such as Excel, Python or MATLAB).

[0052] The maximum and minimum values ​​of the collected historical Poria cocos process temperature standard deviations represent the maximum temperature standard deviation and the minimum temperature standard deviation of the reference process; the maximum and minimum values ​​of the collected historical Poria cocos process pressure standard deviations represent the maximum pressure standard deviation and the minimum pressure standard deviation of the reference process; the maximum and minimum values ​​of the collected historical Poria cocos process humidity standard deviations represent the maximum humidity standard deviation and the minimum humidity standard deviation of the reference process.

[0053] Specific assumptions: the maximum temperature standard deviation of the reference process is 3 (°C), the minimum temperature standard deviation of the reference process is 0.5 (°C), the maximum pressure standard deviation of the reference process is 2 (MPa), the minimum pressure standard deviation of the reference process is 0.1 (MPa), the maximum humidity standard deviation of the reference process is 4 (%), and the minimum humidity standard deviation of the reference process is 2 (%); the above method can be used to calculate the Poria cocos process effect index, and the statistical table of the changes in the Poria cocos process effect index is shown in Table 1:

[0054] Table 1 Statistics of changes in the processing effect indicators of Poria cocos

[0055]

[0056] It can be seen from the first and second groups of data in Table 1 that with the decrease of the characteristic indicators of the monitored Poria cocos raw materials, the Poria cocos process effect indicators decrease accordingly; at the same time, the standard deviation of the Poria cocos process temperature, the standard deviation of the Poria cocos process pressure and the standard deviation of the Poria cocos process humidity also affect the Poria cocos process effect indicators, specifically, as shown in the second and third groups of data, with the increase of the standard deviation of the Poria cocos process temperature, the standard deviation of the Poria cocos process pressure and the standard deviation of the Poria cocos process humidity, the Poria cocos process effect indicators decrease accordingly; as shown in the fourth group of data, when the standard deviation of the Poria cocos process temperature, the standard deviation of the Poria cocos process pressure and the standard deviation of the Poria cocos process humidity are all less than the corresponding minimum value of process monitoring, the Poria cocos process effect index is zero.

[0057] The Poria cocos process effect index is used to comprehensively quantify the effect of the production process monitoring of the Poria cocos pharmaceutical composition, among which the changes in the characteristic indicators of the Poria cocos raw materials to be monitored, the standard deviation of the Poria cocos process temperature, the standard deviation of the Poria cocos process pressure and the standard deviation of the Poria cocos process humidity all have an impact on the Poria cocos process effect index. Specifically, for example, with the increase of the characteristic indicators of the Poria cocos raw materials to be monitored, the Poria cocos process effect index increases accordingly. When the standard deviation of the Poria cocos process temperature, the standard deviation of the Poria cocos process pressure and the standard deviation of the Poria cocos process humidity are all greater than the corresponding minimum value of the process monitoring, with the increase of the standard deviation of the Poria cocos process temperature, the standard deviation of the Poria cocos process pressure and the standard deviation of the Poria cocos process humidity, the Poria cocos process effect index decreases accordingly.

[0058] It should be added that the Poria process effect index includes multiple parameters, and each parameter is related and does not exist independently. For example, temperature changes affect the evaporation rate of water, thereby changing the gas volume and pressure. For example, rapid temperature rise during the heating process may cause steam expansion, resulting in increased pressure, that is, as the standard deviation of the Poria process temperature increases, the standard deviation of the Poria process pressure increases. As the standard deviation of the Poria process temperature and the standard deviation of the Poria process pressure increase, the Poria process effect index decreases. In addition, pressure fluctuations may change the gas density in the environment, thereby affecting the humidity distribution. For example, under a high-pressure environment, the volume change of water vapor may affect the humidity distribution in the air and cause humidity fluctuations, that is, as the standard deviation of the Poria cocos process pressure increases, the standard deviation of the Poria cocos process humidity also increases accordingly, and as the standard deviation of the Poria cocos process pressure and the standard deviation of the Poria cocos process humidity increase, the Poria cocos process effect index decreases accordingly; therefore, through a quantitative approach, the correlation and mutual influence between various factors are taken into account, and the Poria cocos process effect index is obtained through a comprehensive analysis, thereby realizing a numerical evaluation of the monitoring effect of the production process of the Poria cocos pharmaceutical composition, and judging the monitoring effect of the production process of the Poria cocos pharmaceutical composition through numerical evaluation, thereby realizing a more accurate evaluation of the monitoring effect of the production process of the Poria cocos pharmaceutical composition.

[0059] Furthermore, the specific process of judging whether to execute the optimization of the production process of the Poria cocos pharmaceutical composition based on the Poria cocos process effect index is as follows: compare the Poria cocos process effect index with the preset process effect threshold range obtained from the preset database; if the Poria cocos process effect index is within the preset process effect threshold range, the optimization of the production process of the Poria cocos pharmaceutical composition will not be executed, and at the same time, the Poria cocos drug characteristic data, Poria cocos raw material characteristic indicators and Poria cocos process effect indicators will be uploaded to the preset database; if the Poria cocos process effect index exceeds the preset process effect threshold range, the optimization of the production process of the Poria cocos pharmaceutical composition will be executed, and the Poria cocos process optimization index will be obtained at the same time.

[0060] In this embodiment, the preset process effect threshold range is set by professionals according to the standards in the field, for example, the standard deviation range of the Poria process temperature is set (generally ), standard deviation range of Poria process pressure (generally ) and the standard deviation range of the humidity of the Poria cocos process (generally ) to determine the preset process effect threshold range; by making a judgment based on the preset process effect threshold range, a more accurate judgment of the production process monitoring effect of the Poria cocos drug composition is achieved.

[0061] It should be added that the specific process of optimizing the production process of the Poria cocos pharmaceutical composition is as follows: A1, optimizing the production indicators of the Poria cocos pharmaceutical composition. When the Poria cocos process effect index after the optimization of the production indicators is within the preset process effect threshold range, the optimization of the production process of the Poria cocos pharmaceutical composition is stopped, otherwise A2 is executed; A2, optimizing the solvent dosage of the Poria cocos pharmaceutical composition. When the Poria cocos process effect index after the optimization of the production indicators is within the preset process effect threshold range, the optimization of the production process of the Poria cocos pharmaceutical composition is stopped, otherwise A3 is executed; A3, optimizing and adjusting the energy of the Poria cocos pharmaceutical composition production, and at the same time obtaining the Poria cocos process optimization index after the optimization of the production process of the Poria cocos pharmaceutical composition.

[0062] In this embodiment, the response surface method is used to optimize the production index. For example, the optimal value of the response variable is obtained by generating a response surface diagram and a contour diagram. The solvent dosage is optimized by using intelligent optimization algorithms such as genetic algorithms and particle swarm optimization. For example, the solvent dosage and other related parameters are encoded (such as binary encoding or real number encoding), and the fitness evaluation and evolution process are repeated until the stop condition is met (such as reaching the maximum number of iterations). Energy optimization regulation is achieved through regression analysis and Bayesian optimization. For example, the objective function (energy consumption) and the search space (production parameter range such as temperature) are defined and the kernel function (such as Gaussian function) is used to initialize the iteration to obtain the minimized energy consumption. The production process of the Poria cocos pharmaceutical composition is optimized to improve the production quality of the Poria cocos pharmaceutical composition under abnormal conditions of the production process.

[0063] Furthermore, the specific steps for obtaining the Poria cocos process optimization index after the optimization of the Poria cocos pharmaceutical composition production process are as follows: obtain the initial dissolution rate of the Poria cocos pharmaceutical composition before the optimization of the Poria cocos pharmaceutical composition production process and the process optimization evaluation value after the optimization of the Poria cocos pharmaceutical composition production process; the process optimization evaluation value includes the Poria cocos process effect index to be optimized, the actual production cycle of the process and the optimized dissolution rate of the Poria cocos pharmaceutical composition; the Poria cocos process optimization index is obtained according to the initial dissolution rate of the Poria cocos pharmaceutical composition, the process optimization evaluation value and the process production cycle influencing factor obtained from the preset database, the reference to the best Poria cocos process effect index and the reference to the maximum process production cycle.

[0064] The method for obtaining the optimization index of Poria cocos process is as follows:

[0065] In the formula, It represents the optimization index of Poria cocos process. Indicates that the process effect index of Poria cocos needs to be optimized. It refers to the best Poria cocos process effect index. Represents the influencing factor of process production cycle, Indicates the reference maximum process production cycle, Indicates the actual production cycle of the process. It indicates that the dissolution rate of the Poria drug composition is optimized. It indicates the initial dissolution rate of the Poria cocos drug composition.

[0066] In this embodiment, the initial dissolution rate of the Poria cocos pharmaceutical composition refers to the dissolution rate before the optimization of the production process of the Poria cocos pharmaceutical composition is performed, and the optimized dissolution rate of the Poria cocos pharmaceutical composition refers to the dissolution rate after the optimization of the production process of the Poria cocos pharmaceutical composition is performed. The initial dissolution rate of the Poria cocos pharmaceutical composition and the optimized dissolution rate of the Poria cocos pharmaceutical composition are obtained by a dissolution test method and a dissolution test equipment including a rotating basket method.

[0067] The Poria cocos process effect index to be optimized refers to the Poria cocos process effect index after the optimization of the production process of the Poria cocos pharmaceutical composition, and the actual production cycle of the process is obtained through the automation system in the process flow (such as SCADA, Supervisory Control and Data Acquisition system).

[0068] The process production cycle influencing factor is obtained from the preset database, and the value range is [0, 1]. It is used to reflect the influence of the process production cycle influencing factors (such as noise intensity in process production) on the Poria cocos process optimization index. The real-time process production cycle influencing factors (such as noise intensity in process production) are input into the preset mapping set in the database to obtain the corresponding influencing factors; the reference best Poria cocos process effect index is generally set to the middle value of the preset process effect threshold range, and the maximum value in the actual production cycle of the collected historical process is used to represent the reference maximum process production cycle.

[0069] The following settings are made: the process effect index of the Poria cocos to be optimized is 52, the reference best process effect index of Poria cocos is 58, the process production cycle influencing factor is 0.9, the reference maximum process production cycle is 200 hours, and the initial dissolution rate of the Poria cocos drug composition is 0.5 mg / min; Figure 2 As shown, it is a schematic diagram of the change of the Poria process optimization index with the optimized dissolution rate of the Poria drug composition provided in the embodiment of the present application. Specifically, the actual production cycle of the process is set to 150 hours. As the optimized dissolution rate of the Poria drug composition increases, the Poria process optimization index increases accordingly; Figure 3 As shown, it is a schematic diagram of the change of the Poria cocos process optimization index with the actual production cycle of the process provided in the embodiment of the present application. Specifically, the optimized dissolution rate of the Poria cocos drug composition is set to 1.2 mg / min. As the actual production cycle of the process decreases, the Poria cocos process optimization index also increases accordingly.

[0070] The Poria process optimization index is used to quantitatively evaluate the effect of the optimization of the production process of the Poria drug composition. Specifically, the Poria process optimization index includes parameters in multiple aspects, and the various parameters are related to each other and do not exist independently. For example, with the increase of the Poria process effect index to be optimized, the optimized dissolution rate of the Poria drug composition increases, and then the Poria process optimization index also increases; in addition, there is also a correlation between the Poria process effect index to be optimized and the actual production cycle of the process. Specifically, with the decrease of the actual production cycle of the process, the Poria process effect index to be optimized increases, and then the Poria process optimization index also increases; therefore, the correlation and mutual influence between various factors are taken into account, and the Poria process optimization index is obtained through comprehensive analysis, which realizes the numerical evaluation of the optimization effect of the production process of the Poria drug composition. The optimization effect of the production process of the Poria drug composition is judged through numerical evaluation, thereby realizing the improvement of the accuracy of the evaluation of the optimization effect of the production process of the Poria drug composition based on intelligent monitoring.

[0071] Furthermore, the specific steps for determining whether to execute the intelligent monitoring of the production and storage of the Poria cocos pharmaceutical composition are as follows: M1, determining whether the acquired Poria cocos raw material characteristic index is within the preset characteristic index threshold range, if the Poria cocos raw material characteristic index is within the preset characteristic index threshold range, then executing M2, otherwise, the intelligent monitoring of the production and storage of the Poria cocos pharmaceutical composition is not executed; M2, determining whether the acquired Poria cocos process effect index is within the preset process effect threshold range, if the Poria cocos process effect index exceeds the preset process effect threshold range, then executing M3, otherwise, executing the intelligent monitoring of the production and storage of the Poria cocos pharmaceutical composition; M3, determining whether the acquired Poria cocos process optimization index is within the preset process optimization threshold range, if the Poria cocos process optimization index is within the preset process optimization threshold range, then executing the intelligent monitoring of the production and storage of the Poria cocos pharmaceutical composition, otherwise, not executing the intelligent monitoring of the production and storage of the Poria cocos pharmaceutical composition; intelligent monitoring of the production and storage of the Poria cocos pharmaceutical composition means monitoring the production and storage conditions of the Poria cocos pharmaceutical composition.

[0072] In this embodiment, the preset process optimization threshold range is obtained from a preset database. Specifically, the preset process optimization threshold range is set by professionals according to standards in the field. For example, the range of Poria cocos process effect indicators to be optimized (generally 50 to 100), the range of the actual production cycle of the process (generally 50h to 200h), the optimized dissolution rate range of the Poria cocos drug composition (generally 1mg / min to 2mg / min), and the initial dissolution rate range of the Poria cocos drug composition (generally 0.2mg / min to 1mg / min) are set to determine the preset process optimization threshold range.

[0073] Among them, the intelligent monitoring of the production and storage of Poria cocos pharmaceutical compositions uses wireless temperature and humidity sensors to monitor the temperature and humidity of the production and storage environment of the Poria cocos pharmaceutical compositions (the monitoring data, such as temperature and humidity, obtained by the wireless temperature and humidity sensors deployed in the production and storage environment of the Poria cocos pharmaceutical compositions are transmitted to the cloud platform), and the image recognition technology is used to detect abnormal conditions in the production and storage environment of the Poria cocos pharmaceutical compositions (such as pollution sources, such as dust particles in the air). Among them, the color distribution of different areas in the image of the Poria cocos pharmaceutical composition is analyzed to identify abnormal conditions, and dust particles are usually displayed as pixel values ​​different from the background color in the RGB color space; by combining the preset process optimization threshold range for judgment and performing intelligent monitoring of the production and storage of the Poria cocos pharmaceutical compositions, a more accurate judgment of the optimization effect of the production process of the Poria cocos pharmaceutical composition based on intelligent monitoring is achieved.

[0074] In summary, the embodiment of the present application evaluates the quality standard characteristics of the preset raw materials in the Poria cocos pharmaceutical composition through the Poria cocos drug characteristic data to determine whether to implement the production process monitoring of the Poria cocos pharmaceutical composition, then evaluates the effect of the production process monitoring of the Poria cocos pharmaceutical composition, and determines whether to implement the production process optimization of the Poria cocos pharmaceutical composition, and finally determines whether to implement the intelligent monitoring of the production and storage of the Poria cocos pharmaceutical composition, thereby realizing the evaluation and optimization of the effect of the production process monitoring of the Poria cocos pharmaceutical composition, and then realizing more accurate production quality control of the Poria cocos pharmaceutical composition, effectively solving the problem of inaccurate quality monitoring in the production process of the Poria cocos pharmaceutical composition in the prior art.

[0075] It will be appreciated by those skilled in the art that embodiments of the present invention may be provided as methods, systems, or computer program products. Therefore, the present invention may take the form of a complete hardware embodiment, a complete software embodiment, or an embodiment combining software and hardware. Furthermore, the present invention may take the form of a computer program product implemented on one or more computer-usable storage media (including but not limited to disk storage, CD-ROM, optical storage, etc.) containing computer-usable program code.

[0076] The present invention is described with reference to flowcharts and / or block diagrams of methods, devices (systems), and computer program products according to embodiments of the present invention. It should be understood that each process and / or block in the flowchart and / or block diagram, as well as the combination of processes and / or blocks in the flowchart and / or block diagram, can be implemented by computer program instructions. These computer program instructions can be provided to a processor of a general-purpose computer, a special-purpose computer, an embedded processor, or other programmable data processing device to produce a machine, so that the instructions executed by the processor of the computer or other programmable data processing device generate instructions for implementing the processes in the flowchart and / or block diagram. Figure 1 A process or multiple processes and / or boxes Figure 1 A device that provides the functions specified in a block or multiple blocks.

[0077] These computer program instructions may also be stored in a computer-readable memory capable of directing a computer or other programmable data processing device to operate in a specific manner, so that the instructions stored in the computer-readable memory produce an article of manufacture comprising an instruction device, which implements the process Figure 1 A process or multiple processes and / or boxes Figure 1 A function specified in one or more boxes.

[0078] These computer program instructions can also be loaded onto a computer or other programmable data processing device so that a series of operating steps are executed on the computer or other programmable device to produce a computer-implemented process, thereby providing instructions for implementing the process in the computer or other programmable device. Figure 1A process or multiple processes and / or boxes Figure 1 The steps for the functions specified in one or more boxes.

[0079] Although the preferred embodiments of the present invention have been described, those skilled in the art may make other changes and modifications to these embodiments once they have learned the basic creative concept. Therefore, the appended claims are intended to be interpreted as including the preferred embodiments and all changes and modifications that fall within the scope of the present invention.

[0080] Obviously, those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include these modifications and variations.

Claims

1. A method for controlling the production quality of a Poria cocos drug composition based on intelligent monitoring technology, characterized in that: The following steps are involved: S1, collecting the drug property data of Poria cocos of the preset raw materials in the Poria cocos drug composition; S2, evaluating the quality standard characteristics of the preset raw materials in the Poria cocos pharmaceutical composition according to the Poria cocos drug characteristic data to obtain a Poria cocos raw material characteristic index, and judging whether to perform the production process monitoring of the Poria cocos pharmaceutical composition based on the Poria cocos raw material characteristic index, wherein the Poria cocos raw material characteristic index is used to quantitatively evaluate the compliance degree of the preset raw material quality in the Poria cocos pharmaceutical composition; S3, after performing the production process monitoring of the Poria cocos pharmaceutical composition, evaluating the effect of the production process monitoring of the Poria cocos pharmaceutical composition to obtain a Poria cocos process effect index, and judging whether to perform the production process optimization of the Poria cocos pharmaceutical composition based on the Poria cocos process effect index, wherein the Poria cocos process effect index is used to comprehensively quantify the effect of the production process monitoring of the Poria cocos pharmaceutical composition; S4, obtaining the Poria cocos process optimization index after the optimization of the production process of the Poria cocos pharmaceutical composition is performed, and judging whether to perform intelligent monitoring of the production and storage of the Poria cocos pharmaceutical composition according to the Poria cocos raw material characteristic index, the Poria cocos process effect index and the Poria cocos process optimization index, wherein the Poria cocos process optimization index is used to quantitatively evaluate the effect of the optimization of the production process of the Poria cocos pharmaceutical composition; The specific steps of evaluating the quality standard characteristics of the preset raw materials in the Poria cocos drug composition according to the Poria cocos drug characteristic data to obtain the Poria cocos raw material characteristic index are as follows: Obtaining a chemical property index according to the obtained chemical property measurement value and a reference chemical property value obtained from a preset database; The chemical property measurement values ​​include the measurement value of the polysaccharide content of the Poria cocos drug, the measurement value of the pH value of the Poria cocos drug, and the measurement value of the water content of the Poria cocos drug; The reference chemical property values ​​include a reference value for the polysaccharide content of a Poria cocos drug, a reference value for the pH value of a Poria cocos drug, a reference maximum deviation for the pH value of a Poria cocos drug, a reference value for the moisture content of a Poria cocos drug, and a reference maximum deviation for the moisture content of a Poria cocos drug; Obtaining a physical property index according to the obtained physical property measurement value and a reference physical property value obtained from a preset database; The physical property measurements include the particle size measurement value of the Poria cocos drug, the specific surface area measurement value of the Poria cocos drug, and the hardness measurement value of the Poria cocos drug; The reference physical property values ​​include a reference value of the maximum specific surface area of ​​the Poria cocos drug and a reference value of the hardness of the Poria cocos drug; Obtaining a biological characteristic index according to the obtained biological characteristic measurement value and a reference biological characteristic value obtained from a preset database; The biological property measurement values ​​include the measurement value of the antioxidant activity of the Poria cocos drug and the measurement value of the anti-inflammatory activity of the Poria cocos drug; The reference biological property values ​​include the reference Poria drug minimum antioxidant activity and the reference Poria drug minimum anti-inflammatory activity; The chemical property index, the physical property index, the biological property index and the quality index evaluation weight obtained from the preset database are combined to obtain the Poria cocos raw material property index, wherein the quality index evaluation weight includes the chemical index evaluation weight, the physical index evaluation weight and the biological index evaluation weight; The specific steps of evaluating the effect of the production process monitoring of the Poria cocos pharmaceutical composition to obtain the Poria cocos process effect index are as follows: Obtaining a process monitoring evaluation value after executing the production process monitoring of the Poria cocos pharmaceutical composition, wherein the process monitoring evaluation value includes a characteristic index of the Poria cocos raw material to be monitored, a standard deviation of the Poria cocos process temperature, a standard deviation of the Poria cocos process pressure, and a standard deviation of the Poria cocos process humidity; The process monitoring evaluation value is combined with the process monitoring reference value obtained from the preset database to obtain the Poria cocos process effect index; The process monitoring reference value includes a process monitoring reference maximum value and a process monitoring reference minimum value; The process monitoring reference maximum value includes a reference process maximum temperature standard deviation, a reference process maximum pressure standard deviation, and a reference process maximum humidity standard deviation; The process monitoring reference minimum value includes a reference process minimum temperature standard deviation, a reference process minimum pressure standard deviation, and a reference process minimum humidity standard deviation; The method for obtaining the Poria cocos process effect index is as follows: In the formula, Indicates the process effect index of Poria cocos. Indicates the characteristic index of Poria cocos raw material to be monitored. represents the standard deviation of the Poria process temperature, represents the maximum temperature standard deviation of the reference process, represents the standard deviation of the Poria process pressure, represents the standard deviation of the maximum pressure of the reference process, It represents the standard deviation of the humidity of Poria cocos process. represents the maximum humidity standard deviation of the reference process, Indicates the preset characteristic indicator threshold range, represents the minimum temperature standard deviation of the reference process, Indicates the standard deviation of the minimum pressure of the reference process, Indicates the minimum humidity standard deviation of the reference process, Indicates the characteristic index of Poria cocos raw material; The specific steps of obtaining the Poria process optimization index after the optimization of the production process of the Poria drug composition are as follows: Obtaining the initial dissolution rate of the Poria cocos pharmaceutical composition before the optimization of the production process of the Poria cocos pharmaceutical composition and the process optimization evaluation value after the optimization of the production process of the Poria cocos pharmaceutical composition; The Poria cocos process optimization index is obtained according to the initial dissolution rate of the Poria cocos drug composition, the process optimization evaluation value, the process production cycle influencing factors obtained from the preset database, the best Poria cocos process effect index and the maximum process production cycle.

2. The method for controlling the production quality of the Poria cocos drug composition based on intelligent monitoring technology according to claim 1, characterized in that: The Poria cocos drug property data includes Poria cocos drug chemical property data, Poria cocos drug physical property data and Poria cocos drug biological property data; The chemical property data of the Poria cocos drug include the polysaccharide content of the Poria cocos drug, the pH value of the Poria cocos drug, and the water content of the Poria cocos drug; The physical property data of the Poria cocos drug include the particle size of the Poria cocos drug, the specific surface area of ​​the Poria cocos drug and the hardness of the Poria cocos drug; The biological property data of the Poria cocos drug include the antioxidant activity of the Poria cocos drug and the anti-inflammatory activity of the Poria cocos drug.

3. The method for controlling the production quality of the Poria cocos drug composition based on intelligent monitoring technology according to claim 1, characterized in that: The specific process of judging whether to perform the production process monitoring of the Poria cocos drug composition based on the Poria cocos raw material characteristic index is as follows: comparing the characteristic index of the Poria cocos raw material with a preset characteristic index threshold range obtained from a preset database; If the characteristic index of the Poria cocos raw material is within the preset characteristic index threshold range, the production process monitoring of the Poria cocos pharmaceutical composition is performed, and the effect of the production process monitoring of the Poria cocos pharmaceutical composition is evaluated to obtain the Poria cocos process effect index; If the characteristic index of the Poria cocos raw material exceeds the preset characteristic index threshold range, the production process monitoring of the Poria cocos drug composition will not be performed, and the preset personnel will be reminded to re-acquire the Poria cocos drug characteristic data.

4. The method for controlling the production quality of the Poria cocos drug composition based on intelligent monitoring technology according to claim 1, characterized in that: The specific process of judging whether to perform the optimization of the production process of the Poria cocos pharmaceutical composition based on the Poria cocos process effect index is as follows: comparing the Poria cocos process effect index with a preset process effect threshold range obtained from a preset database; If the Poria cocos process effect index is within the preset process effect threshold range, the Poria cocos drug composition production process optimization is not performed, and at the same time, the Poria cocos drug property data, the Poria cocos raw material property index and the Poria cocos process effect index are uploaded to the preset database; If the Poria cocos process effect index exceeds the preset process effect threshold range, the Poria cocos pharmaceutical composition production process optimization is performed, and the Poria cocos process optimization index is obtained at the same time.

5. The method for controlling the production quality of the Poria cocos drug composition based on intelligent monitoring technology as claimed in claim 4, characterized in that: The specific process of optimizing the production process of the Poria cocos drug composition is as follows: A1, optimize the production index of the Poria cocos drug composition production. When the Poria cocos process effect index after the production index optimization is within the preset process effect threshold range, stop the optimization of the Poria cocos drug composition production process, otherwise execute A2; A2, optimizing the amount of solvent used in the production of the Poria cocos pharmaceutical composition. When the Poria cocos process effect index after the production index optimization is within the preset process effect threshold range, the optimization of the production process of the Poria cocos pharmaceutical composition is stopped, otherwise A3 is executed; A3, optimize and adjust the energy of the production of the Poria cocos drug composition, and obtain the Poria cocos process optimization index after the production process of the Poria cocos drug composition is optimized.

6. The method for controlling the production quality of the Poria cocos drug composition based on intelligent monitoring technology as claimed in claim 5, characterized in that: The step of obtaining the Poria process optimization index after the optimization of the production process of the Poria drug composition is performed also includes: The process optimization evaluation value includes the Poria cocos process effect index to be optimized, the actual production cycle of the process and the optimized dissolution rate of the Poria cocos drug composition. The Poria cocos process effect index to be optimized refers to the Poria cocos process effect index after the optimization of the Poria cocos drug composition production process.

7. The method for controlling the production quality of the Poria cocos drug composition based on intelligent monitoring technology according to claim 1, characterized in that: The specific steps of determining whether to perform intelligent monitoring of the production and storage of the Poria cocos drug composition are as follows: M1, judging whether the acquired characteristic index of the Poria cocos raw material is within the preset characteristic index threshold range, if the characteristic index of the Poria cocos raw material is within the preset characteristic index threshold range, executing M2, otherwise, not executing the intelligent monitoring of the production and storage of the Poria cocos drug composition; M2, judging whether the obtained Poria cocos process effect index is within the preset process effect threshold range, if the Poria cocos process effect index exceeds the preset process effect threshold range, executing M3, otherwise, executing the intelligent monitoring of the production and storage of the Poria cocos drug composition; M3, judging whether the obtained Poria cocos process optimization index is within the preset process optimization threshold range, if the Poria cocos process optimization index is within the preset process optimization threshold range, then executing the intelligent monitoring of the production and storage of the Poria cocos drug composition, otherwise, not executing the intelligent monitoring of the production and storage of the Poria cocos drug composition; The intelligent monitoring of the production and storage of the Poria cocos pharmaceutical composition means monitoring the production and storage conditions of the Poria cocos pharmaceutical composition.

Images