Safety evaluation method and system for traditional Chinese medicine uric acid reducing preparation

Abstract

The invention discloses a safety evaluation method and system for a traditional Chinese medicine uric acid reducing preparation, and relates to the technical field of medicine safety detection. The safety evaluation method of the traditional Chinese medicine preparation for reducing uric acid comprises the following steps: S1, acquiring data of raw materials of the preparation; s2, safety judgment of preparation raw materials; s3, preparation process safety judgment; and S4, preparation storage safety judgment. According to the method, the raw material safety characteristics of the preset preparation raw materials in the traditional Chinese medicine uric acid-reducing preparation are evaluated through the preparation raw material safety data to judge whether to execute the traditional Chinese medicine uric acid-reducing preparation process safety detection, and the preparation process safety characteristic indexes are obtained to judge whether to execute the traditional Chinese medicine uric acid-reducing preparation storage safety detection; and finally, whether storage safety optimization of the traditional Chinese medicine uric acid reducing preparation is executed or not is judged, the effect of improving the storage safety of the traditional Chinese medicine uric acid reducing preparation is achieved, and the problem that in the prior art, storage safety evaluation of the traditional Chinese medicine uric acid reducing preparation is not sufficiently associated with preparation raw materials is solved.

Description

Technical Field

[0001] The present invention relates to the technical field of drug safety detection, and in particular to a safety evaluation method and system for a traditional Chinese medicine uric acid-lowering preparation. Background Art

[0002] With the increasing incidence of uric acid-related diseases, the demand for effective uric acid-lowering drugs has increased. Traditional Chinese medicine has been favored in treatment due to its natural ingredients and pleiotropic effects. However, with the widespread use of traditional Chinese medicine preparations, safety issues have become increasingly prominent. The safety evaluation of traditional Chinese medicine uric acid-lowering preparations is not only to verify the short-term safety of the drug, but also includes possible chronic toxicity, cumulative toxicity, and drug interactions during long-term use. Through a comprehensive and multi-dimensional evaluation method, the quality and safety of traditional Chinese medicine preparations can be ensured, providing patients with reliable treatment options. At the same time, it also promotes the process of modernization of traditional Chinese medicine, promotes the development and application of traditional Chinese medicine on the international stage, and is of great significance to promoting the health of the whole people and the sustainable development of the traditional Chinese medicine industry.

[0003] The safety evaluation of existing traditional Chinese medicine uric acid-lowering preparations is to understand their safety and effectiveness by collecting and analyzing existing research literature on the traditional Chinese medicine preparations, including clinical trials, animal experiments and toxicology studies. The components of traditional Chinese medicine preparations are qualitatively and quantitatively analyzed in combination with modern analytical techniques (such as high-performance liquid chromatography, gas chromatography, mass spectrometry, etc.) to identify possible active ingredients and harmful ingredients. At the same time, animal models are used for experiments to observe the effects of traditional Chinese medicine preparations on different organs. Finally, the safety of traditional Chinese medicine preparations in different populations is evaluated, including the incidence and severity of adverse reactions. Through a series of scientific methods and experiments, the safety of the drug in different usage situations is ensured, providing sufficient scientific basis for the safe application of traditional Chinese medicine uric acid-lowering preparations.

[0004] For example, the patent application with publication number: CN105300907A discloses a method for detecting an intermediate of a pharmaceutical preparation having the effects of dispelling exterior pathogens, removing dampness, regulating qi and harmonizing the middle, comprising: selecting an extraction solvent, an amount of extraction solvent, an extraction method, etc., so that the total flavonoids of Atractylodes macrocephala in the intermediate of the pharmaceutical preparation are extracted to the maximum extent, thereby accurately determining its content.

[0005] For example, the invention patent with announcement number: CN104502518B discloses a detection method for a traditional Chinese medicine preparation for treating anorexia in children, comprising: using thin layer chromatography to qualitatively identify astragalus, hawthorn, white atractylodes and wolfberry in the traditional Chinese medicine preparation; using gas chromatography to check the content of the auxiliary material glycerol in the traditional Chinese medicine preparation; and using high performance liquid chromatography to determine the content of astragaloside I in the traditional Chinese medicine preparation.

[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: The quality of Chinese medicine preparations is affected by many factors, including the source of raw materials, preparation process, growth environment, etc. If the quality standards of medicinal materials (such as content determination, impurity limits, etc.) are not clear and the quality control of Chinese medicine preparations is not strict, it will lead to instability and safety problems in the final preparations.

[0007] It is also necessary to consider that the storage conditions of Chinese medicine raw materials and preparations have an important impact on the efficacy and stability of the medicine. The active ingredients of the medicine may degrade or change during long-term storage. There is a problem that the storage safety assessment of Chinese medicine uric acid-lowering preparations is not sufficiently linked to the raw materials of the preparations. Summary of the invention

[0008] The embodiments of the present application provide a safety evaluation method and system for a traditional Chinese medicine uric acid-lowering preparation, thereby solving the problem in the prior art that the storage safety evaluation of traditional Chinese medicine uric acid-lowering preparations is not sufficiently associated with the preparation raw materials, thereby improving the storage safety of traditional Chinese medicine uric acid-lowering preparations.

[0009] The embodiment of the present application provides a safety evaluation method for a traditional Chinese medicine uric acid-lowering preparation, comprising the following steps: S1, obtaining raw material safety data of a preset raw material in the traditional Chinese medicine uric acid-lowering preparation; S2, evaluating the raw material safety characteristics of the preset raw material in the traditional Chinese medicine uric acid-lowering preparation according to the raw material safety data to obtain a raw material safety characteristic index, and judging whether to perform a process safety test for the traditional Chinese medicine uric acid-lowering preparation based on the raw material safety characteristic index, wherein the raw material safety characteristic index is used to quantitatively evaluate the degree of compliance with the preset raw material safety characteristics in the traditional Chinese medicine uric acid-lowering preparation; S3, obtaining a process safety characteristic index after performing the process safety test for the traditional Chinese medicine uric acid-lowering preparation, judging whether to perform a storage safety test for the traditional Chinese medicine uric acid-lowering preparation based on the process safety characteristic index, wherein the process safety characteristic index is used to comprehensively quantify the degree of compliance with the process safety test for the traditional Chinese medicine uric acid-lowering preparation; S4, obtaining a storage safety characteristic index after performing the storage safety test for the traditional Chinese medicine uric acid-lowering preparation, judging whether to perform storage safety optimization for the traditional Chinese medicine uric acid-lowering preparation based on the storage safety characteristic index, wherein the storage safety characteristic index is used to comprehensively quantify the degree of compliance with the storage safety test for the traditional Chinese medicine uric acid-lowering preparation.

[0010] Furthermore, the specific steps of evaluating the raw material safety characteristics of the preset preparation raw materials in the traditional Chinese medicine uric acid lowering preparation according to the preparation raw material safety data to obtain the preparation raw material safety characteristic index are as follows: obtaining the preparation raw material physicochemical index according to the obtained preparation raw material physicochemical data of the preset preparation raw materials in the traditional Chinese medicine uric acid lowering preparation and the preparation raw material physicochemical data reference data obtained from a preset database; the preparation raw material physicochemical data include the preparation raw material water content, the preparation raw material ash content and the preparation raw material particle size, and the preparation raw material physicochemical data reference data include the preparation raw material physicochemical data reference value and the preparation raw material physicochemical data reference deviation; the preparation raw material physicochemical data reference deviation includes reference value Consider the maximum deviation of the moisture content of the preparation raw materials, the maximum deviation of the ash content of the reference preparation raw materials, and the maximum deviation of the particle size of the reference preparation raw materials; obtain the safety characteristic index of the preparation raw materials according to the total number of colonies of the preparation raw materials, the heavy metal content of the preparation raw materials, the physicochemical indicators of the preparation raw materials, and the safety assessment data of the preparation raw materials obtained from the preset database, the preparation raw material safety assessment data including the preparation raw material safety assessment value and the preparation raw material safety assessment weight; the preparation raw material safety assessment value includes the reference maximum preparation raw material colony number and the reference maximum heavy metal content, and the preparation raw material safety assessment weight includes the raw material physicochemical assessment weight, the raw material colony assessment weight and the raw material heavy metal assessment weight.

[0011] Furthermore, the specific process of judging whether to execute the process safety test of the traditional Chinese medicine uric acid lowering preparation based on the safety characteristic index of the preparation raw materials is: comparing the safety characteristic index of the preparation raw materials with the preset preparation raw material threshold range obtained from the preset database; if the safety characteristic index of the preparation raw materials is within the preset preparation raw material threshold range, then executing the process safety test of the traditional Chinese medicine uric acid lowering preparation, and obtaining the preparation process safety characteristic index after executing the process safety test of the traditional Chinese medicine uric acid lowering preparation; if the safety characteristic index of the preparation raw materials exceeds the preset preparation raw material threshold range, then not executing the process safety test of the traditional Chinese medicine uric acid lowering preparation, and reminding the preset personnel to re-obtain the preparation raw material safety data.

[0012] Furthermore, the specific steps for obtaining the preparation process safety characteristic index after executing the process safety test of the traditional Chinese medicine uric acid lowering preparation are as follows: obtaining the preparation process measured value at a preset time within a preset time interval, the preparation process measured value including the safety characteristic index of the preparation raw material to be tested, the preparation process temperature measured value, the preparation process pH measured value and the preparation process solvent concentration; obtaining the preparation process safety characteristic index according to the preparation process measured value combined with the preparation process reference data obtained from a preset database, the preparation process reference data including the preparation process reference optimal value, the preparation process reference maximum value and the preparation process reference minimum value; the preparation process reference minimum value includes the reference preparation process temperature minimum value, the reference preparation process pH minimum value and the reference preparation process solvent concentration minimum value.

[0013] Furthermore, the specific process of judging whether to execute the storage safety test of the traditional Chinese medicine uric acid lowering preparation based on the preparation process safety characteristic index is as follows: if the preparation process safety characteristic index is within the preset preparation process threshold range, the storage safety test of the traditional Chinese medicine uric acid lowering preparation is executed, and the preparation storage safety characteristic index after executing the storage safety test of the traditional Chinese medicine uric acid lowering preparation is obtained; if the preparation process safety characteristic index exceeds the preset preparation process threshold range, the storage safety test of the traditional Chinese medicine uric acid lowering preparation is not executed, and the preset personnel are reminded to optimize the process safety of the traditional Chinese medicine uric acid lowering preparation; the process safety optimization of the traditional Chinese medicine uric acid lowering preparation includes preparation process safety adaptive optimization and preparation process safety monitoring optimization.

[0014] Furthermore, the specific steps for obtaining the preparation storage safety characteristic index after performing the storage safety test of the traditional Chinese medicine uric acid lowering preparation are as follows: obtaining the preparation storage-related data after performing the storage safety test of the traditional Chinese medicine uric acid lowering preparation, the preparation storage-related data including the safety characteristic index of the preparation raw materials to be stored, the safety characteristic index of the preparation process to be stored, the preparation storage safety time and the light intensity of the preparation storage environment; obtaining the preparation storage influencing factor according to the obtained preparation storage environment light intensity combined with the environment-related reference data obtained from a preset database, the environment-related reference data including the preparation storage environment correction factor, the storage environment light intensity threshold range, the reference storage environment light intensity and the reference environment light intensity maximum deviation; obtaining the preparation storage safety characteristic index according to the preparation storage influencing factor, the preparation storage-related data and the storage-related reference data obtained from the preset database; the storage-related reference data including the reference maximum preparation raw material safety characteristic index, the reference optimal preparation raw material safety characteristic index, the reference minimum preparation raw material safety characteristic index, the reference optimal preparation process safety characteristic index and the reference preparation storage time.

[0015] Furthermore, the method for obtaining the storage safety characteristic index of the preparation is as follows: ; In the formula, Indicates the storage safety characteristics of the preparation. Indicates the reference maximum safety characteristic index of the preparation raw material, Indicates the safety characteristics of the raw materials of the preparation to be stored. Indicates the reference to the optimal safety characteristics index of the preparation raw material. Indicates the reference minimum safety characteristic index of the raw material of the preparation, Indicates the process safety characteristic index of the preparation to be stored. It refers to the optimal formulation process safety characteristic index. Indicates the safe storage time of the preparation. Indicates the storage time of the reference preparation, Represents the storage impact factor of the preparation.

[0016] Furthermore, the specific process of judging whether to execute the storage safety optimization of the traditional Chinese medicine uric acid lowering preparation based on the preparation storage safety characteristic index is as follows: if the preparation storage safety characteristic index is within the preset preparation storage threshold range, the storage safety optimization of the traditional Chinese medicine uric acid lowering preparation will not be executed, and at the same time, the preparation safety evaluation data will be uploaded to the preset shared database, and the preparation safety evaluation data includes preparation raw material safety data, preparation raw material safety characteristic index, preparation process safety characteristic index and preparation storage safety characteristic index; if the preparation storage safety characteristic index exceeds the preset preparation storage threshold range, the storage safety optimization of the traditional Chinese medicine uric acid lowering preparation will be executed.

[0017] Furthermore, the specific process of optimizing the storage safety of Chinese herbal uric acid-lowering preparations is as follows: A1, optimizing the storage environment monitoring equipment for the storage of Chinese herbal uric acid-lowering preparations, when the preparation storage safety characteristic index after the storage environment monitoring equipment optimization is within the preset preparation storage threshold range, then stopping the optimization of the storage safety of Chinese herbal uric acid-lowering preparations, otherwise executing A2; A2, adaptively optimizing the storage environment for the storage of Chinese herbal uric acid-lowering preparations, when the preparation storage safety characteristic index after the storage environment adaptive optimization is within the preset preparation storage threshold range, then stopping the optimization of the storage safety of Chinese herbal uric acid-lowering preparations, otherwise executing A3; A3, optimizing the storage environment monitoring for the storage of Chinese herbal uric acid-lowering preparations, when the preparation storage safety characteristic index after the storage environment monitoring optimization is within the preset preparation storage threshold range, then stopping the optimization of the storage safety of Chinese herbal uric acid-lowering preparations, otherwise, reminding the preset personnel to change the storage environment of Chinese herbal uric acid-lowering preparations.

[0018] The embodiment of the present application provides a safety evaluation system for a traditional Chinese medicine uric acid-lowering preparation, comprising: a preparation raw material data acquisition module, a preparation raw material safety judgment module, a preparation process safety judgment module, and a preparation storage safety judgment module; wherein the preparation raw material data acquisition module is used to obtain the preparation raw material safety data of the preset preparation raw materials in the traditional Chinese medicine uric acid-lowering preparation; the preparation raw material safety judgment module is used to evaluate the raw material safety characteristics of the preset preparation raw materials in the traditional Chinese medicine uric acid-lowering preparation according to the preparation raw material safety data to obtain a preparation raw material safety characteristic index, and judge whether to perform the traditional Chinese medicine uric acid-lowering preparation process safety detection based on the preparation raw material safety characteristic index, and the preparation raw material safety characteristic index is used to quantitatively evaluate the preset preparation raw materials in the traditional Chinese medicine uric acid-lowering preparation The degree of compliance with the safety characteristics of raw materials; the preparation process safety judgment module is used to obtain the preparation process safety characteristic indicators after executing the process safety test of Chinese medicine uric acid lowering preparations, and judge whether to execute the storage safety test of Chinese medicine uric acid lowering preparations based on the preparation process safety characteristic indicators, and the preparation process safety characteristic indicators are used to comprehensively quantify the degree of compliance with the process safety test of Chinese medicine uric acid lowering preparations; the preparation storage safety judgment module is used to obtain the preparation storage safety characteristic indicators after executing the storage safety test of Chinese medicine uric acid lowering preparations, and judge whether to execute the storage safety optimization of Chinese medicine uric acid lowering preparations based on the preparation storage safety characteristic indicators, and the preparation storage safety characteristic indicators are used to comprehensively quantify the degree of compliance with the storage safety test of Chinese medicine uric acid lowering preparations.

[0019] One or more technical solutions provided in the embodiments of the present application have at least the following technical effects or advantages: 1. Evaluate the raw material safety characteristics of the preset raw materials in the traditional Chinese medicine uric acid lowering preparation through the raw material safety data to determine whether to perform the process safety test of the traditional Chinese medicine uric acid lowering preparation, and obtain the preparation process safety characteristic indicators to determine whether to perform the storage safety test of the traditional Chinese medicine uric acid lowering preparation, and finally determine whether to perform the storage safety optimization of the traditional Chinese medicine uric acid lowering preparation, thereby realizing the evaluation of the raw materials and storage safety compliance of the traditional Chinese medicine uric acid lowering preparation, and then realizing the improvement of the storage safety of the traditional Chinese medicine uric acid lowering preparation, and effectively solving the problem of insufficient correlation between the storage safety evaluation of the traditional Chinese medicine uric acid lowering preparation and the raw materials in the prior art.

[0020] 2. The safety characteristic index of the preparation raw materials is obtained by obtaining the total colony count of the preparation raw materials, the heavy metal content of the preparation raw materials, the physical and chemical indicators of the preparation raw materials and the safety assessment data of the preparation raw materials obtained from the preset database, thereby realizing a numerical evaluation of the degree of compliance with the preset safety characteristics of the preparation raw materials in the traditional Chinese medicine uric acid lowering preparation, and then realizing a more accurate evaluation of the degree of compliance with the preset safety characteristics of the preparation raw materials in the traditional Chinese medicine uric acid lowering preparation.

[0021] 3. By obtaining the preparation storage-related data after executing the storage safety test of the traditional Chinese medicine uric acid-lowering preparation, and then obtaining the preparation storage safety characteristic index according to the preparation storage influencing factors, the preparation storage-related data and the storage-related reference data obtained from the preset database, the numerical evaluation of the compliance degree of the storage safety test of the traditional Chinese medicine uric acid-lowering preparation is realized, thereby realizing a more accurate evaluation of the compliance degree of the storage safety test of the traditional Chinese medicine uric acid-lowering preparation. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 A flow chart of a method for evaluating the safety of a traditional Chinese medicine uric acid-lowering preparation provided in an embodiment of the present application; Figure 2 A schematic diagram showing changes in the safety characteristic index of the preparation process provided in the embodiment of the present application along with the safety characteristic index of the preparation raw material to be tested; Figure 3 A schematic diagram showing changes in the formulation process safety characteristic index provided in the embodiments of the present application along with the actual measured value of the formulation process temperature; Figure 4 A schematic diagram of the structure of a safety evaluation system for a traditional Chinese medicine uric acid-lowering preparation provided in an embodiment of the present application. DETAILED DESCRIPTION

[0023] The embodiments of the present application provide a method and system for evaluating the safety of a traditional Chinese medicine uric acid lowering preparation, thereby solving the problem in the prior art that the storage safety assessment of a traditional Chinese medicine uric acid lowering preparation is not sufficiently associated with the preparation raw materials. The raw material safety characteristics of preset preparation raw materials in the traditional Chinese medicine uric acid lowering preparation are evaluated through the preparation raw material safety data to obtain preparation raw material safety characteristic indicators. Based on the preparation raw material safety characteristic indicators, it is determined whether to perform a process safety test on the traditional Chinese medicine uric acid lowering preparation. Then, the preparation process safety characteristic indicators after the process safety test on the traditional Chinese medicine uric acid lowering preparation are obtained and it is determined whether to perform a storage safety test on the traditional Chinese medicine uric acid lowering preparation. Finally, the preparation storage safety characteristic indicators after the storage safety test on the traditional Chinese medicine uric acid lowering preparation are obtained to determine whether to perform storage safety optimization of the traditional Chinese medicine uric acid lowering preparation, thereby improving the storage safety of the traditional Chinese medicine uric acid lowering preparation.

[0024] The technical solution in the embodiment of the present application is to solve the problem that the storage safety assessment of the above-mentioned traditional Chinese medicine uric acid-lowering preparation is not sufficiently associated with the preparation raw materials. The overall idea is as follows: The raw material safety characteristics of the preset raw materials in the traditional Chinese medicine uric acid lowering preparations are evaluated through the preparation raw material safety data to determine whether to perform the process safety testing of the traditional Chinese medicine uric acid lowering preparations. Then, the preparation process safety characteristic indicators are obtained and it is determined whether to perform the storage safety testing of the traditional Chinese medicine uric acid lowering preparations. Finally, it is determined whether to perform the storage safety optimization of the traditional Chinese medicine uric acid lowering preparations, thereby achieving the effect of improving the storage safety of the traditional Chinese medicine uric acid lowering preparations.

[0025] 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.

[0026] like Figure 1 As shown, it is a flow chart of a safety evaluation method for a traditional Chinese medicine uric acid-lowering preparation provided in an embodiment of the present application, the method comprising the following steps: S1, obtaining the preparation raw material safety data of the preset preparation raw material in the traditional Chinese medicine uric acid-lowering preparation; S2, evaluating the raw material safety characteristics of the preset preparation raw material in the traditional Chinese medicine uric acid-lowering preparation according to the preparation raw material safety data to obtain the preparation raw material safety characteristic index, judging whether to perform the process safety detection of the traditional Chinese medicine uric acid-lowering preparation based on the preparation raw material safety characteristic index, and the preparation raw material safety characteristic index is used to quantitatively evaluate the compliance degree of the preset preparation raw material safety characteristics in the traditional Chinese medicine uric acid-lowering preparation; S3, obtaining the preparation process safety characteristic index after performing the process safety detection of the traditional Chinese medicine uric acid-lowering preparation, judging whether to perform the storage safety detection of the traditional Chinese medicine uric acid-lowering preparation based on the preparation process safety characteristic index, and the preparation process safety characteristic index is used to comprehensively quantify the compliance degree of the process safety detection of the traditional Chinese medicine uric acid-lowering preparation; S4, obtaining the preparation storage safety characteristic index after performing the storage safety detection of the traditional Chinese medicine uric acid-lowering preparation, judging whether to perform the storage safety optimization of the traditional Chinese medicine uric acid-lowering preparation based on the preparation storage safety characteristic index, and the preparation storage safety characteristic index is used to comprehensively quantify the compliance degree of the storage safety detection of the traditional Chinese medicine uric acid-lowering preparation.

[0027] In the present embodiment, the preset preparation raw materials in the traditional Chinese medicine uric acid lowering preparation are specifically such as angelica, Glauber's salt, cassia twig, etc.; it should be supplemented that the preparation raw material safety data include the preparation raw material physical and chemical data, the total colony count of the preparation raw material and the heavy metal content of the preparation raw material, and the preparation raw material physical and chemical data include the preparation raw material water content, the preparation raw material ash content and the preparation raw material particle size.

[0028] Specifically, the water content of the preparation raw materials is obtained by a Karl Fischer moisture meter, the ash content of the preparation raw materials is obtained by direct combustion in a high-temperature muffle furnace, and the particle size of the preparation raw materials is obtained by a laser particle size analyzer; the total colony count of the preparation raw materials is obtained by a colony counter, and the heavy metal content of the preparation raw materials is obtained by an atomic absorption spectrophotometer.

[0029] By obtaining the safety data of preparation raw materials, the evaluation of the raw material safety characteristics of the preset preparation raw materials in the traditional Chinese medicine uric acid-lowering preparation is achieved, thereby improving the reliability of the evaluation of the raw material safety characteristics of the preset preparation raw materials in the traditional Chinese medicine uric acid-lowering preparation.

[0030] Further, the specific steps of evaluating the raw material safety characteristics of the preset raw materials in the traditional Chinese medicine uric acid lowering preparation according to the raw material safety data to obtain the raw material safety characteristic index are as follows: obtaining the raw material physicochemical index of the preparation (i.e., the raw material safety characteristic index of the preparation) according to the raw material physicochemical data of the preset raw materials in the traditional Chinese medicine uric acid lowering preparation and the raw material physicochemical data reference data obtained from the preset database ); the physicochemical data of preparation raw materials include the water content of preparation raw materials, the ash content of preparation raw materials and the particle size of preparation raw materials; the reference data of physicochemical data of preparation raw materials include the reference value of physicochemical data of preparation raw materials and the reference deviation of physicochemical data of preparation raw materials; the reference deviation of physicochemical data of preparation raw materials includes the maximum deviation of reference water content of preparation raw materials, the maximum deviation of reference ash content of preparation raw materials and the maximum deviation of reference particle size of preparation raw materials; the safety characteristic index of preparation raw materials is obtained according to the total number of colonies of preparation raw materials, the heavy metal content of preparation raw materials, the physicochemical indexes of preparation raw materials and the safety assessment data of preparation raw materials obtained from the preset database; the safety assessment data of preparation raw materials include the safety assessment value of preparation raw materials and the safety assessment weight of preparation raw materials; the safety assessment value of preparation raw materials includes the reference maximum colony number of preparation raw materials and the reference maximum heavy metal content; the safety assessment weight of preparation raw materials includes the physicochemical assessment weight of raw materials, the colony assessment weight of raw materials and the heavy metal assessment weight of raw materials.

[0031] The method for obtaining the safety characteristic index of the preparation raw material is as follows: ; ; ; In the formula, Indicates the safety characteristics of the raw materials of the preparation. The number indicating the type of raw material of the preset preparation in the traditional Chinese medicine uric acid-lowering preparation. , Indicates the total number of preset preparation raw material types in traditional Chinese medicine uric acid-lowering preparations. It indicates the safety characteristic index of the nth preset raw material in the traditional Chinese medicine for lowering uric acid. Indicates the weight of the physical and chemical evaluation of raw materials, Indicates the raw material colony assessment weight, Indicates the assessment weight of heavy metals in raw materials, Indicates the physical and chemical indexes of the nth preset preparation raw material, Indicates the total number of bacterial colonies of the nth preset preparation raw material, Indicates the reference maximum preparation raw material colony count of the nth preset preparation raw material, Indicates the heavy metal content of the nth preset preparation raw material, Indicates the reference maximum heavy metal content of the nth preset preparation raw material, Indicates the water content of the reference preparation raw material of the nth preset preparation raw material, Indicates the water content of the nth preset preparation raw material, Indicates the maximum deviation of the water content of the reference preparation raw material of the nth preset preparation raw material, Indicates the reference preparation raw material ash content of the nth preset preparation raw material, Indicates the ash content of the nth preset preparation raw material, Indicates the maximum deviation of the ash content of the reference preparation raw material of the nth preset preparation raw material, represents the reference preparation raw material particle size of the nth preset preparation raw material, represents the particle size of the nth preset preparation raw material, Represents the maximum deviation of the particle size of the reference preparation raw material of the nth preset preparation raw material.

[0032] In this embodiment, the reference values ​​of the physical and chemical data of the preparation raw materials include the reference preparation raw material water content, the reference preparation raw material ash content and the reference preparation raw material particle size. The reference preparation raw material water content corresponding to the preset preparation raw material is represented by summing and averaging the preparation raw material water contents of the preset preparation raw materials in the collected historical Chinese medicine uric acid lowering preparations, the reference preparation raw material ash content corresponding to the preset preparation raw material is represented by summing and averaging the preparation raw material ash content of the preset preparation raw materials in the collected historical Chinese medicine uric acid lowering preparations, and the reference preparation raw material particle size corresponding to the preset preparation raw material is represented by summing and averaging the preparation raw material particle sizes of the preset preparation raw materials in the collected historical Chinese medicine uric acid lowering preparations.

[0033] The maximum absolute value of the difference between the moisture content of the preset raw materials in the historical Chinese herbal uric acid-lowering preparations and the corresponding reference raw materials represents the maximum deviation of the moisture content of the reference raw materials corresponding to the preset raw materials. The maximum absolute value of the difference between the ash content of the preset raw materials in the historical Chinese herbal uric acid-lowering preparations and the corresponding reference raw materials represents the maximum deviation of the ash content of the reference raw materials corresponding to the preset raw materials. The maximum absolute value of the difference between the particle size of the preset raw materials in the historical Chinese herbal uric acid-lowering preparations and the corresponding reference raw materials represents the maximum deviation of the particle size of the reference raw materials corresponding to the preset raw materials.

[0034] The maximum value of the total number of colonies of the preparation raw materials of the preset preparation raw materials in the historical traditional Chinese medicine uric acid lowering preparations collected is used to represent the reference maximum number of colonies of the preparation raw materials corresponding to the preset preparation raw materials. The maximum value of the heavy metal content of the preparation raw materials of the preset preparation raw materials in the historical traditional Chinese medicine uric acid lowering preparations collected is used to represent the reference maximum heavy metal content corresponding to the preset preparation raw materials. In this example, the value ranges of the raw material physicochemical evaluation weight, the raw material colony evaluation weight and the raw material heavy metal evaluation weight are all [0, 1], and the sum is 1. Specifically, they can be directly obtained from the preset database when used. For example, the real-time physicochemical indicators of the preparation raw materials, the total number of colonies of the preparation raw materials and the heavy metal content of the preparation raw materials are input into the preset mapping set in the database to obtain the corresponding weights.

[0035] The safety characteristic index of preparation raw materials is used to quantitatively evaluate the degree of compliance with the preset safety characteristics of preparation raw materials in traditional Chinese medicine uric acid-lowering preparations. Among them, the physical and chemical indicators of preparation raw materials, the total colony count of preparation raw materials and the heavy metal content of preparation raw materials all have an impact on the safety characteristic index of preparation raw materials. Specifically, with the increase of the physical and chemical indicators of preparation raw materials, the safety characteristic index of preparation raw materials increases accordingly. With the decrease of the total colony count of preparation raw materials and the heavy metal content of preparation raw materials, the safety characteristic index of preparation raw materials also increases accordingly.

[0036] In addition, the safety characteristics index of preparation raw materials includes parameters from multiple aspects, and each parameter is related to each other and does not exist independently. For example, the water content of preparation raw materials is one of the key factors affecting the total colony count of preparation raw materials. For example, high water content provides good conditions for the growth and reproduction of microorganisms (bacteria, molds, etc.). That is, as the water content of preparation raw materials increases, the deviation between the water content of preparation raw materials and the water content of reference preparation raw materials increases, which leads to an increase in the total colony count of preparation raw materials, and then the safety characteristics index of preparation raw materials decreases accordingly; in addition, the water content of preparation raw materials also affects the particle size of preparation raw materials. For example, when the water content is too high, the particles are prone to adhesion or aggregation, resulting in an increase in particle size. That is, as the water content of preparation raw materials increases, the water content of preparation raw materials deviates from that of reference preparation raw materials. The degree of deviation of the water content of the preparation raw materials increases, which leads to an increase in the particle size of the preparation raw materials, that is, the degree of deviation of the particle size of the preparation raw materials and the particle size of the reference preparation raw materials increases, which in turn leads to a decrease in the safety characteristic indicators of the preparation raw materials; therefore, the correlation and mutual influence between various factors are taken into consideration, and the safety characteristic indicators of the preparation raw materials are obtained through a quantitative and comprehensive analysis, thereby realizing the evaluation of the degree of compliance with the safety characteristics of the preset preparation raw materials in the traditional Chinese medicine uric acid lowering preparations, and judging the degree of compliance with the safety characteristics of the preset preparation raw materials in the traditional Chinese medicine uric acid lowering preparations through numerical evaluation, thereby realizing the improvement of the accuracy of the evaluation of the degree of compliance with the safety characteristics of the preset preparation raw materials in the traditional Chinese medicine uric acid lowering preparations.

[0037] Furthermore, the specific process for determining whether to perform process safety testing of traditional Chinese medicine uric acid lowering preparations based on the safety characteristic indicators of preparation raw materials is as follows: comparing the safety characteristic indicators of preparation raw materials with the preset preparation raw material threshold range obtained from the preset database; if the safety characteristic indicators of preparation raw materials are within the preset preparation raw material threshold range (including the corresponding upper and lower limits), then performing process safety testing of traditional Chinese medicine uric acid lowering preparations, and obtaining the preparation process safety characteristic indicators after performing process safety testing of traditional Chinese medicine uric acid lowering preparations; if the safety characteristic indicators of preparation raw materials exceed the preset preparation raw material threshold range, then not performing process safety testing of traditional Chinese medicine uric acid lowering preparations, and reminding the preset personnel to re-acquire the preparation raw material safety data.

[0038] In this embodiment, the process safety detection of Chinese herbal uric acid lowering preparations is achieved through control charts (X-bar charts, R charts, etc.). For example, the mean change of process data in the process of Chinese herbal uric acid lowering preparations (such as the temperature in the process of Chinese herbal uric acid lowering preparations) is monitored through a mean control chart; wherein, the preset threshold range of preparation raw materials is set by professionals according to standards in the field, for example, the total colony count range of preparation raw materials is generally set to 100 CFU / g to 10000 CFU / g, the heavy metal content range of preparation raw materials is 0.2 mg / kg to 5 mg / kg, the water content range of preparation raw materials is 5% to 15%, the ash range of preparation raw materials is 3% to 10%, and the particle size range of preparation raw materials is 100 microns to 500 microns, thereby determining the preset threshold range of preparation raw materials; by combining the preset threshold range of preparation raw materials for judgment and conducting process safety detection of Chinese herbal uric acid lowering preparations, a more accurate judgment of the degree of compliance with the preset safety characteristics of preparation raw materials in Chinese herbal uric acid lowering preparations is achieved.

[0039] Furthermore, the specific steps for obtaining the preparation process safety characteristic index after executing the process safety test of the traditional Chinese medicine uric acid lowering preparation are as follows: obtaining the actual measured value of the preparation process at a preset time within a preset time interval, the actual measured value of the preparation process includes the safety characteristic index of the preparation raw material to be tested, the actual measured value of the preparation process temperature, the actual measured value of the preparation process pH and the preparation process solvent concentration; obtaining the preparation process safety characteristic index according to the actual measured value of the preparation process combined with the preparation process reference data obtained from a preset database, the preparation process reference data includes the preparation process reference optimal value, the preparation process reference maximum value and the preparation process reference minimum value; the preparation process reference optimal value includes the reference best preparation raw material safety characteristic index, the reference preparation process optimal temperature value, the reference preparation process optimal pH value and the reference preparation process optimal solvent concentration value; the preparation process reference maximum value includes the reference preparation process temperature maximum value, the reference preparation process pH maximum value and the reference preparation process solvent concentration maximum value; the preparation process reference minimum value includes the reference preparation process temperature minimum value, the reference preparation process pH minimum value and the reference preparation process solvent concentration minimum value.

[0040] The method for obtaining the process safety characteristic index of the preparation is as follows: ; In the formula, Indicates the process safety characteristic index of the preparation. Indicates the reference to the best safety characteristics of the raw materials for the preparation. Indicates the safety characteristic index of the drug raw material to be tested, where the safety characteristic index of the drug raw material is within the preset drug raw material threshold range. Indicates the number of the preset time in the preset time interval, , Indicates the total number of preset moments in a preset time interval. represents the measured value of the preparation process temperature at the ath preset time, represents the optimal process temperature of the reference preparation, represents the maximum process temperature of the reference preparation, Indicates the minimum process temperature of the reference preparation, represents the actual measured pH value of the preparation process at the a-th preset time, Indicates the optimal pH value of the reference preparation process, Indicates the maximum pH value of the reference preparation process, Indicates the minimum process pH value of the reference preparation, represents the concentration of the preparation process solvent at the ath preset time, Indicates the optimal concentration of the reference preparation process solvent, Indicates the maximum concentration of the reference preparation process solvent, Indicates the minimum concentration of the reference preparation process solvent.

[0041] In this embodiment, the safety characteristic index of the preparation raw material to be tested refers to the safety characteristic index of the preparation raw material after the process safety test of the traditional Chinese medicine uric acid lowering preparation is carried out; wherein, the actual measured temperature value and the actual measured pH value of the preparation process are obtained by means of temperature sensors and pH sensors deployed on the traditional Chinese medicine uric acid lowering preparation process equipment, and the concentration of the preparation process solvent is obtained by means of a refractometer or a spectrophotometer.

[0042] The reference optimal formulation raw material safety characteristic index is generally set to the middle value of the preset formulation raw material threshold range. The optimal value of the reference formulation process temperature is represented by summing and averaging the collected historical formulation process temperature measured values. The optimal value of the reference formulation process pH is represented by summing and averaging the collected historical formulation process pH measured values. The optimal value of the reference formulation process solvent concentration is represented by summing and averaging the collected historical formulation process solvent concentrations.

[0043] The maximum value of the historical formulation process temperature measured value collected represents the maximum value of the reference formulation process temperature, the maximum value of the historical formulation process pH measured value collected represents the maximum value of the reference formulation process pH, and the maximum value of the historical formulation process solvent concentration measured value collected represents the maximum value of the reference formulation process solvent concentration.

[0044] The minimum value of the reference preparation process temperature is represented by the minimum value of the historical formulation process temperature measured values, the minimum value of the reference preparation process pH is represented by the minimum value of the historical formulation process pH measured values, and the minimum value of the reference preparation process solvent concentration is represented by the minimum value of the historical formulation process solvent concentration measured values.

[0045] The following are set: the reference optimal preparation raw material safety characteristic index is 1, the total number of preset moments within the preset time interval is 1, the reference preparation process temperature optimal value is 45 degrees Celsius, the reference preparation process temperature maximum value is 60 degrees Celsius, the reference preparation process temperature minimum value is 30 degrees Celsius, the preparation process pH measured value is 7.2, the reference preparation process pH optimal value is 7, the reference preparation process pH maximum value is 8, the reference preparation process pH minimum value is 6, the preparation process solvent concentration is 0.6 mg / mL, the reference preparation process solvent concentration optimal value is 0.5 mg / mL, the reference preparation process solvent concentration maximum value is 1 mg / mL, and the reference preparation process solvent concentration minimum value is 0.1 mg / mL; Figure 2 As shown, it is a schematic diagram of the change of the preparation process safety characteristic index with the safety characteristic index of the preparation raw material to be tested provided in the embodiment of the present application. Specifically, the measured value of the preparation process temperature is set to 50 degrees Celsius. As the safety characteristic index of the preparation raw material to be tested increases, the preparation process safety characteristic index increases accordingly; Figure 3 As shown, it is a schematic diagram of the change of the preparation process safety characteristic index with the actual measured value of the preparation process temperature provided in the embodiment of the present application. Specifically, the safety characteristic index of the preparation raw material to be tested is set to 1. As the deviation degree between the actual measured value of the preparation process temperature and the optimal value of the reference preparation process temperature decreases, the preparation process safety characteristic index also increases. Similarly, as the deviation degree between the actual measured value of the preparation process temperature and the optimal value of the reference preparation process temperature increases, the preparation process safety characteristic index decreases.

[0046] The preparation process safety characteristic index is used to comprehensively quantify the compliance degree of the process safety test of traditional Chinese medicine uric acid-lowering preparations. Specifically, the preparation process safety characteristic index includes multiple parameters, among which the safety characteristic index of the preparation raw materials to be tested, the actual measured value of the preparation process temperature, the actual measured value of the preparation process pH and the preparation process solvent concentration all have an impact on the preparation process safety characteristic index; specifically, as the deviation degree of the safety characteristic index of the preparation raw materials to be tested, the actual measured value of the preparation process temperature, the actual measured value of the preparation process pH and the preparation process solvent concentration from the corresponding preparation process reference optimal value decreases, the preparation process safety characteristic index increases accordingly.

[0047] It should be added that the various parameters in the formulation process safety characteristic index are related to each other and do not exist independently. For example, changes in temperature will affect the stability of pH. For example, high temperature will cause the chemical reaction rate to accelerate and change the acidity and alkalinity of the formulation. That is, as the measured value of the formulation process temperature increases, the deviation between the measured value of the formulation process temperature and the optimal value of the reference formulation process temperature increases, which leads to an increase in the deviation between the measured value of the formulation process pH and the optimal value of the reference formulation process pH, which in turn leads to a decrease in the formulation process safety characteristic index. In addition, the measured value of the formulation process temperature also affects the concentration of the formulation process solvent. For example, as the temperature increases, the solubility of the solvent in the raw material increases, which also leads to the evaporation of the volatile solvent. That is, as the measured value of the preparation process temperature increases, the deviation degree of the measured value of the preparation process temperature from the optimal value of the reference preparation process temperature increases, which leads to an increase in the deviation degree of the preparation process solvent concentration from the optimal value of the reference preparation process solvent concentration, and then leads to a decrease in the preparation process safety characteristic index; therefore, through a quantitative approach, the correlation and mutual influence between various factors are taken into account, and the preparation process safety characteristic index is obtained through comprehensive analysis, which realizes the numerical evaluation of the compliance degree of the process safety test of traditional Chinese medicine uric acid lowering preparations, and the compliance degree of the process safety test of traditional Chinese medicine uric acid lowering preparations is judged through numerical evaluation, thereby realizing a more accurate evaluation of the compliance degree of the process safety test of traditional Chinese medicine uric acid lowering preparations.

[0048] Furthermore, the specific process for determining whether to perform the storage safety test of Chinese herbal uric acid lowering preparations based on the preparation process safety characteristic index is as follows: compare the preparation process safety characteristic index with the preset preparation process threshold range obtained from the preset database; if the preparation process safety characteristic index is within the preset preparation process threshold range (including the corresponding upper and lower limits), then perform the storage safety test of Chinese herbal uric acid lowering preparations, and simultaneously obtain the preparation storage safety characteristic index after performing the storage safety test of Chinese herbal uric acid lowering preparations; if the preparation process safety characteristic index exceeds the preset preparation process threshold range, then do not perform the storage safety test of Chinese herbal uric acid lowering preparations, and simultaneously remind the preset personnel to optimize the process safety of Chinese herbal uric acid lowering preparations; the process safety optimization of Chinese herbal uric acid lowering preparations includes preparation process safety adaptive optimization and preparation process safety monitoring optimization.

[0049] In this embodiment, accelerated and long-term stability tests are performed in a stability test chamber (specifically, temperature and humidity settings: 40°C / 75%RH accelerated test, 25°C / 60%RH long-term test) to achieve storage safety testing of traditional Chinese medicine uric acid-lowering preparations; adaptive optimization of preparation process safety is achieved through an adaptive optimization algorithm (such as a particle swarm optimization algorithm to search for the optimal solution); and optimization of preparation process safety monitoring is achieved through anomaly detection algorithms (such as Isolation Forest) or digital twin technology.

[0050] Specifically, the preset formulation process threshold range is set by professionals based on standards in the field. For example, the preset formulation process threshold range is set to 0.72 to 0.89. By making judgments based on the preset formulation process threshold range and optimizing the process safety of traditional Chinese medicine uric acid-lowering preparations, the accuracy of judging the degree of compliance with process safety testing of traditional Chinese medicine uric acid-lowering preparations is improved.

[0051] Furthermore, the specific steps for obtaining the preparation storage safety characteristic index after the storage safety test of the traditional Chinese medicine uric acid lowering preparation are as follows: obtaining the preparation storage related data after the storage safety test of the traditional Chinese medicine uric acid lowering preparation is performed, the preparation storage related data including the safety characteristic index of the raw materials of the preparation to be stored, the process safety characteristic index of the preparation to be stored, the preparation storage safety time and the light intensity of the preparation storage environment; obtaining the preparation storage influencing factor (i.e., the preparation storage safety characteristic index) according to the obtained preparation storage environment light intensity combined with the environment-related reference data obtained from the preset database ), environment-related reference data include preparation storage environment correction factor, storage environment light intensity threshold range, reference storage environment light intensity and reference environment light intensity maximum deviation; preparation storage safety characteristic indicators are obtained according to preparation storage influencing factors, preparation storage-related data and storage-related reference data obtained from a preset database; storage-related reference data include reference maximum preparation raw material safety characteristic indicators, reference optimal preparation raw material safety characteristic indicators, reference minimum preparation raw material safety characteristic indicators, reference optimal preparation process safety characteristic indicators and reference preparation storage time.

[0052] The method for obtaining the storage safety characteristic index of the preparation is as follows: ; ; In the formula, Indicates the storage safety characteristics of the preparation. Indicates the reference maximum safety characteristic index of the preparation raw material, Indicates the safety characteristics of the raw materials of the preparation to be stored. Indicates the reference to the optimal safety characteristics index of the preparation raw material. Indicates the reference minimum safety characteristic index of the raw material of the preparation, Indicates the process safety characteristic index of the preparation to be stored. It means that the reference is to the optimal preparation process safety characteristic index, the preparation process safety characteristic index is within the preset preparation process threshold range, and the preparation raw material safety characteristic index is within the preset preparation raw material threshold range. Indicates the safe storage time of the preparation. Indicates the storage time of the reference preparation. The safe storage time of the preparation is greater than the storage time of the reference preparation. represents the storage impact factor of the preparation, Indicates the preparation storage environment correction factor, Indicates the light intensity of the preparation storage environment, Indicates the storage environment light intensity threshold range. Indicates the reference storage environment light intensity, Indicates the maximum deviation of the reference ambient light intensity.

[0053] In this embodiment, the safety characteristic index of the raw materials of the preparation to be stored refers to the safety characteristic index of the raw materials of the preparation after the storage safety test of the traditional Chinese medicine uric acid lowering preparation is carried out, and the process safety characteristic index of the preparation to be stored refers to the process safety characteristic index of the preparation after the storage safety test of the traditional Chinese medicine uric acid lowering preparation is carried out. The preparation storage safety time is obtained by a date calculator, and the light intensity of the preparation storage environment is obtained by a light intensity meter deployed in the storage environment of the traditional Chinese medicine uric acid lowering preparation.

[0054] The preparation storage environment correction factor is obtained from a preset database and is used to reflect the degree of influence of preparation storage environment influencing factors (such as preparation storage environment temperature and humidity) on preparation storage influencing factors. The real-time preparation storage environment influencing factors (such as preparation storage environment temperature and humidity) are input into the preset mapping set in the database to obtain the corresponding correction factor.

[0055] The storage environment light intensity threshold range is generally set at 200 lux to 300 lux. The reference storage environment light intensity is represented by summing and averaging the collected historical preparation storage environment light intensities. The maximum absolute value of the difference between the collected historical preparation storage environment light intensities and the reference storage environment light intensity is used to represent the maximum deviation of the reference environment light intensity.

[0056] The reference maximum preparation raw material safety characteristic index is the maximum value of the preset preparation raw material threshold range, the reference optimal preparation raw material safety characteristic index is generally set to the middle value of the preset preparation raw material threshold range, the reference minimum preparation raw material safety characteristic index is the minimum value of the preset preparation raw material threshold range, the reference optimal preparation process safety characteristic index is generally set to the middle value of the preset preparation process threshold range, and the reference preparation storage time is represented by the sum and average of the collected historical preparation storage safety times.

[0057] Specific assumptions: the reference maximum preparation raw material safety characteristic index is 0.8, the reference optimal preparation raw material safety characteristic index is 0.6, the reference minimum preparation raw material safety characteristic index is 0.5, the reference optimal preparation process safety characteristic index is 0.9, the reference preparation storage time is 5 months, the preparation storage environment correction factor is 1.5, the storage environment light intensity threshold range is 200lux to 500lux, the reference storage environment light intensity is 450lux, and the reference environment light intensity maximum deviation is 200lux; the preparation storage safety characteristic index can be calculated by the above method, and the change statistics of the preparation storage safety characteristic index are shown in Table 1: Table 1 Statistics of changes in storage safety characteristics of preparations

[0058] It can be seen from the second and third groups of data in Table 1 that as the degree of deviation between the safety characteristic index of the preparation raw material to be stored and the reference optimal preparation raw material safety characteristic index decreases, the preparation storage safety characteristic index increases accordingly. In addition, as in the first group of data, when the safety characteristic index of the preparation raw material to be stored is less than the reference minimum preparation raw material safety characteristic index, the preparation storage safety characteristic index is zero; at the same time, the process safety characteristic index of the preparation to be stored, the preparation storage safety time and the light intensity of the preparation storage environment also affect the preparation storage safety characteristic index; specifically, as in the third and fourth groups of data, as the process safety characteristic index of the preparation to be stored increases and the preparation storage safety time decreases, the preparation storage safety characteristic index also increases.

[0059] The preparation storage safety characteristic index is used to comprehensively quantify the compliance degree of storage safety testing of traditional Chinese medicine uric acid-lowering preparations. Among them, the preparation storage safety characteristic index includes parameters from multiple aspects, and each parameter is related to each other and does not exist independently. For example, as the safety characteristic index of the preparation raw materials to be stored increases, the process safety characteristic index of the preparation to be stored increases accordingly, and then the preparation storage safety characteristic index also increases accordingly; in addition, changes in light intensity will also affect the chemical stability of the preparation during storage, that is, as the degree of deviation between the storage environment light intensity and the reference storage environment light intensity increases, the degree of deviation between the preparation storage safety time and the reference preparation storage time decreases, and then the preparation storage safety characteristic index decreases accordingly; at the same time, the preparation raw materials to be stored Safety characteristic indicators and process safety characteristic indicators of preparations to be stored also have an impact on the safe storage time of preparations. Specifically, as the safety characteristic indicators of the raw materials of the preparations to be stored and the process safety characteristic indicators of the preparations to be stored decrease, the deviation between the safe storage time of the preparations and the storage time of the reference preparations decreases, which in turn leads to a decrease in the preparation storage safety characteristic indicators. Therefore, through a quantitative approach, the correlation and mutual influence between various factors are taken into account, and a comprehensive analysis is performed to obtain the preparation storage safety characteristic indicators, which realizes a numerical evaluation of the compliance degree of the storage safety test of traditional Chinese medicine uric acid-lowering preparations. The compliance degree of the storage safety test of traditional Chinese medicine uric acid-lowering preparations is judged through numerical evaluation, thereby realizing a more accurate evaluation of the compliance degree of the storage safety test of traditional Chinese medicine uric acid-lowering preparations.

[0060] Furthermore, the specific process for judging whether to implement the storage safety optimization of traditional Chinese medicine uric acid lowering preparations based on the preparation storage safety characteristic index is as follows: compare the preparation storage safety characteristic index with the preset preparation storage threshold range obtained from the preset database; if the preparation storage safety characteristic index is within the preset preparation storage threshold range (including the corresponding upper and lower limits), the storage safety optimization of traditional Chinese medicine uric acid lowering preparations will not be implemented, and at the same time, the preparation safety evaluation data will be uploaded to the preset shared database, and the preparation safety evaluation data includes preparation raw material safety data, preparation raw material safety characteristic indicators, preparation process safety characteristic indicators and preparation storage safety characteristic indicators; if the preparation storage safety characteristic indicators exceed the preset preparation storage threshold range, the storage safety optimization of traditional Chinese medicine uric acid lowering preparations will be implemented.

[0061] In the present embodiment, specifically, the preset preparation storage threshold range is set by professionals according to standards in the field. For example, the safety characteristic index range of the raw materials of the preparation to be stored is set to 0.6 to 0.8, the process safety characteristic index range of the preparation to be stored is set to 0.5 to 1, the preparation storage safety time range is 1 month to 24 months, and the preparation storage environment light intensity range is 50lux to 300lux, thereby determining the preset preparation storage threshold range; by making judgments based on the preset preparation storage threshold range and optimizing the storage safety of the traditional Chinese medicine uric acid lowering preparation, a more accurate judgment of the compliance degree of the storage safety detection of the traditional Chinese medicine uric acid lowering preparation is achieved.

[0062] It should be added that the specific process for optimizing the storage safety of Chinese herbal uric acid-lowering preparations is as follows: A1, optimizing the storage environment monitoring equipment for the storage of Chinese herbal uric acid-lowering preparations. When the storage safety characteristic index of the preparation storage after the optimization of the storage environment monitoring equipment is within the preset preparation storage threshold range, the optimization of the storage safety of the Chinese herbal uric acid-lowering preparations is stopped, otherwise A2 is executed; A2, adaptively optimizing the storage environment for the storage of Chinese herbal uric acid-lowering preparations. When the storage safety characteristic index of the preparation storage after the adaptive optimization of the storage environment is within the preset preparation storage threshold range, the optimization of the storage safety of the Chinese herbal uric acid-lowering preparations is stopped, otherwise A3 is executed; A3, optimizing the storage environment monitoring for the storage of Chinese herbal uric acid-lowering preparations. When the storage safety characteristic index of the preparation storage after the storage environment monitoring optimization is within the preset preparation storage threshold range, the optimization of the storage safety of the Chinese herbal uric acid-lowering preparations is stopped, otherwise, the preset personnel are reminded to change the storage environment of the Chinese herbal uric acid-lowering preparations.

[0063] In this embodiment, the storage environment monitoring equipment is optimized by machine learning algorithms (such as Isolation Forest and DBSCAN). Specifically, for example, data is cleaned by Pandas (specifically, missing values ​​are processed for preparation storage related data by using Pandas) and sensor fault clusters are identified by using DBSCAN clustering algorithm. Adaptive optimization of the storage environment is achieved by reinforcement learning algorithms (such as Deep Q-Learning). Specifically, for example, Deep Q-Network (DQN) is built using TensorFlow or PyTorch and the Q value is updated in real time (after each interaction with the environment and execution of an action, the experience replay buffer is updated and the Deep Q-Network model to update Q value in real time); optimize storage environment monitoring through big data analysis tools (such as ApacheSpark and Pandas). For example, use visualization tools (such as Matplotlib and Grafana) to display changes in the storage environment (configure Grafana to connect to data sources (such as databases or real-time data streams), create dashboards to display real-time data of key indicators (such as temperature, humidity, and pressure) on the dashboard); optimize the storage safety of traditional Chinese medicine for lowering uric acid preparations, and improve the reliability of storage safety detection of traditional Chinese medicine for lowering uric acid preparations under abnormal conditions.

[0064] like Figure 4As shown, it is a structural schematic diagram of a safety evaluation system for a traditional Chinese medicine uric acid-lowering preparation provided in an embodiment of the present application. A safety evaluation system for a traditional Chinese medicine uric acid-lowering preparation provided in an embodiment of the present application comprises: a preparation raw material data acquisition module, a preparation raw material safety judgment module, a preparation process safety judgment module, and a preparation storage safety judgment module; wherein the preparation raw material data acquisition module is used to obtain the preparation raw material safety data of the preset preparation raw materials in the traditional Chinese medicine uric acid-lowering preparation; the preparation raw material safety judgment module is used to evaluate the raw material safety characteristics of the preset preparation raw materials in the traditional Chinese medicine uric acid-lowering preparation according to the preparation raw material safety data to obtain the preparation raw material safety characteristic index, and judge whether to perform the traditional Chinese medicine uric acid-lowering preparation process safety detection based on the preparation raw material safety characteristic index; the preparation raw material safety characteristic index The indicator is used to quantitatively evaluate the degree of compliance with the safety characteristics of preset preparation raw materials in traditional Chinese medicine uric acid-lowering preparations; the preparation process safety judgment module is used to obtain the preparation process safety characteristic indicators after the execution of the process safety test of traditional Chinese medicine uric acid-lowering preparations, and judge whether to execute the storage safety test of traditional Chinese medicine uric acid-lowering preparations based on the preparation process safety characteristic indicators. The preparation process safety characteristic indicators are used to comprehensively quantify the degree of compliance with the process safety test of traditional Chinese medicine uric acid-lowering preparations; the preparation storage safety judgment module is used to obtain the preparation storage safety characteristic indicators after the execution of the storage safety test of traditional Chinese medicine uric acid-lowering preparations, and judge whether to execute the storage safety optimization of traditional Chinese medicine uric acid-lowering preparations based on the preparation storage safety characteristic indicators. The preparation storage safety characteristic indicators are used to comprehensively quantify the degree of compliance with the storage safety test of traditional Chinese medicine uric acid-lowering preparations.

[0065] In this embodiment, by obtaining the raw material safety data of the preset raw materials in the traditional Chinese medicine uric acid lowering preparation, the compliance degree of the preset raw materials in the traditional Chinese medicine uric acid lowering preparation is evaluated, and after the compliance degree of the preset raw materials safety characteristics is evaluated, it is determined whether to perform the process safety testing of the traditional Chinese medicine uric acid lowering preparation, and based on the preparation process safety characteristics indicators after the process safety testing of the traditional Chinese medicine uric acid lowering preparation, it is determined whether to perform the storage safety testing and optimization of the traditional Chinese medicine uric acid lowering preparation, thereby achieving the improvement of the accuracy of the safety evaluation of the traditional Chinese medicine uric acid lowering preparation.

[0066] To summarize, the embodiments of the present application evaluate the raw material safety characteristics of preset raw materials in the traditional Chinese medicine uric acid lowering preparation through the raw material safety data to determine whether to perform the process safety test of the traditional Chinese medicine uric acid lowering preparation, and obtain the preparation process safety characteristic index to determine whether to perform the storage safety test of the traditional Chinese medicine uric acid lowering preparation, and finally determine whether to perform the storage safety optimization of the traditional Chinese medicine uric acid lowering preparation, thereby realizing the evaluation of the raw materials and storage safety compliance of the traditional Chinese medicine uric acid lowering preparation, and then realizing the improvement of the storage safety of the traditional Chinese medicine uric acid lowering preparation, and effectively solving the problem of insufficient correlation between the storage safety evaluation of the traditional Chinese medicine uric acid lowering preparation and the raw materials in the prior art.

[0067] 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.

[0068] 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.

[0069] 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.

[0070] 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. Figure 1 A process or multiple processes and / or boxes Figure 1 The steps for the functions specified in one or more boxes.

[0071] 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.

[0072] 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 evaluating the safety of a traditional Chinese medicine uric acid-lowering preparation, characterized in that: The following steps are involved: S1, obtain the raw material safety data of the preset raw materials in the traditional Chinese medicine uric acid-lowering preparation; S2, evaluating the raw material safety characteristics of the preset raw materials in the traditional Chinese medicine uric acid-lowering preparation according to the raw material safety data to obtain the raw material safety characteristics index, and judging whether to perform the process safety test of the traditional Chinese medicine uric acid-lowering preparation based on the raw material safety characteristics index, wherein the raw material safety characteristics index is used to quantitatively evaluate the compliance degree of the preset raw material safety characteristics in the traditional Chinese medicine uric acid-lowering preparation; S3, obtaining a preparation process safety characteristic index after executing the process safety test of the traditional Chinese medicine uric acid-lowering preparation, and judging whether to execute the storage safety test of the traditional Chinese medicine uric acid-lowering preparation based on the preparation process safety characteristic index, wherein the preparation process safety characteristic index is used to comprehensively quantify the compliance degree of the process safety test of the traditional Chinese medicine uric acid-lowering preparation; S4, obtaining the preparation storage safety characteristic index after executing the storage safety test of the traditional Chinese medicine uric acid lowering preparation, and judging whether to execute the storage safety optimization of the traditional Chinese medicine uric acid lowering preparation based on the preparation storage safety characteristic index, wherein the preparation storage safety characteristic index is used to comprehensively quantify the compliance degree of the storage safety test of the traditional Chinese medicine uric acid lowering preparation.

2. A method for evaluating the safety of a traditional Chinese medicine uric acid-lowering preparation according to claim 1, characterized in that: The specific steps of evaluating the raw material safety characteristics of the preset raw materials in the traditional Chinese medicine uric acid-lowering preparation according to the raw material safety data to obtain the raw material safety characteristic index are as follows: Obtaining physicochemical indicators of the preparation raw materials according to the obtained physicochemical data of the preparation raw materials preset in the traditional Chinese medicine uric acid-lowering preparation and the reference data of physicochemical data of the preparation raw materials obtained from the preset database; The physicochemical data of the preparation raw materials include the water content of the preparation raw materials, the ash content of the preparation raw materials and the particle size of the preparation raw materials, and the physicochemical data reference data of the preparation raw materials include the reference value of the physicochemical data of the preparation raw materials and the reference deviation of the physicochemical data of the preparation raw materials; The reference deviation of the physical and chemical data of the preparation raw materials includes the maximum deviation of the water content of the reference preparation raw materials, the maximum deviation of the ash content of the reference preparation raw materials, and the maximum deviation of the particle size of the reference preparation raw materials; Obtaining a safety characteristic index of the preparation raw material according to the total bacterial count of the preparation raw material, the heavy metal content of the preparation raw material, the physical and chemical indicators of the preparation raw material, and the preparation raw material safety assessment data obtained from a preset database, wherein the preparation raw material safety assessment data includes a preparation raw material safety assessment value and a preparation raw material safety assessment weight; The safety assessment value of the preparation raw material includes a reference maximum preparation raw material colony count and a reference maximum heavy metal content, and the safety assessment weight of the preparation raw material includes a raw material physical and chemical assessment weight, a raw material colony assessment weight, and a raw material heavy metal assessment weight.

3. The method for evaluating the safety of a Chinese medicine uric acid-lowering preparation according to claim 1, characterized in that: The specific process of judging whether to perform the process safety test of the traditional Chinese medicine uric acid-lowering preparation based on the safety characteristic index of the preparation raw materials is as follows: comparing the drug substance safety characteristic index with a preset drug substance threshold range obtained from a preset database; If the safety characteristic index of the preparation raw material is within the preset preparation raw material threshold range, the process safety test of the traditional Chinese medicine uric acid lowering preparation is performed, and the preparation process safety characteristic index after the process safety test of the traditional Chinese medicine uric acid lowering preparation is obtained; If the safety characteristic index of the preparation raw materials exceeds the preset threshold range of the preparation raw materials, the process safety test of the traditional Chinese medicine uric acid-lowering preparation will not be performed, and the preset personnel will be reminded to re-obtain the safety data of the preparation raw materials.

4. A method for evaluating the safety of a traditional Chinese medicine uric acid-lowering preparation as claimed in claim 3, characterized in that: The specific steps of obtaining the preparation process safety characteristic index after the traditional Chinese medicine uric acid-lowering preparation process safety test are as follows: Obtaining the actual measured values ​​of the preparation process at the preset time within the preset time interval, wherein the actual measured values ​​of the preparation process include the safety characteristic index of the preparation raw material to be tested, the actual measured value of the preparation process temperature, the actual measured value of the preparation process pH, and the concentration of the preparation process solvent; Obtaining a formulation process safety characteristic index according to the formulation process measured value combined with the formulation process reference data obtained from a preset database, wherein the formulation process reference data includes a formulation process reference optimal value, a formulation process reference maximum value, and a formulation process reference minimum value; The formulation process reference minimum values ​​include a reference formulation process temperature minimum value, a reference formulation process pH minimum value, and a reference formulation process solvent concentration minimum value.

5. The method for evaluating the safety of a traditional Chinese medicine uric acid-lowering preparation according to claim 1, characterized in that: The specific process of judging whether to perform the storage safety test of the traditional Chinese medicine uric acid-lowering preparation based on the preparation process safety characteristic index is as follows: If the preparation process safety characteristic index is within the preset preparation process threshold range, the storage safety test of the traditional Chinese medicine uric acid lowering preparation is performed, and the preparation storage safety characteristic index after the storage safety test of the traditional Chinese medicine uric acid lowering preparation is obtained; If the preparation process safety characteristic index exceeds the preset preparation process threshold range, the storage safety test of the traditional Chinese medicine uric acid lowering preparation will not be performed, and the preset personnel will be reminded to optimize the process safety of the traditional Chinese medicine uric acid lowering preparation; The process safety optimization of the traditional Chinese medicine uric acid-lowering preparation includes preparation process safety adaptive optimization and preparation process safety monitoring optimization.

6. A method for evaluating the safety of a traditional Chinese medicine uric acid-lowering preparation as claimed in claim 5, characterized in that: The specific steps of obtaining the storage safety characteristic index of the preparation after the storage safety test of the traditional Chinese medicine uric acid-lowering preparation is as follows: Obtaining preparation storage-related data after performing storage safety testing of traditional Chinese medicine uric acid-lowering preparations, wherein the preparation storage-related data includes safety characteristic indicators of raw materials of preparations to be stored, process safety characteristic indicators of preparations to be stored, preparation storage safety time, and light intensity of the preparation storage environment; Obtaining a preparation storage influencing factor according to the obtained preparation storage environment light intensity combined with environment-related reference data obtained from a preset database, wherein the environment-related reference data includes a preparation storage environment correction factor, a storage environment light intensity threshold range, a reference storage environment light intensity, and a reference environment light intensity maximum deviation; Obtaining a preparation storage safety characteristic index based on preparation storage influencing factors, preparation storage related data, and storage related reference data obtained from a preset database; The storage-related reference data includes a reference maximum preparation raw material safety characteristic index, a reference optimal preparation raw material safety characteristic index, a reference minimum preparation raw material safety characteristic index, a reference optimal preparation process safety characteristic index and a reference preparation storage time.

7. A method for evaluating the safety of a traditional Chinese medicine uric acid-lowering preparation according to claim 6, characterized in that: The method for obtaining the preparation storage safety characteristic index is as follows: ； In the formula, Indicates the storage safety characteristics of the preparation. Indicates the reference maximum safety characteristic index of the preparation raw material, Indicates the safety characteristics of the raw materials of the preparation to be stored. Indicates the reference to the optimal safety characteristics index of the preparation raw material. Indicates the reference minimum safety characteristic index of the raw material of the preparation, Indicates the process safety characteristic index of the preparation to be stored. Indicates the reference to the optimal formulation process safety characteristic index, Indicates the safe storage time of the preparation. Indicates the storage time of the reference preparation, Represents the storage impact factor of the preparation.

8. The method for evaluating the safety of a traditional Chinese medicine uric acid-lowering preparation according to claim 1, characterized in that: The specific process of judging whether to perform the storage safety optimization of the traditional Chinese medicine uric acid-lowering preparation based on the preparation storage safety characteristic index is as follows: If the preparation storage safety characteristic index is within the preset preparation storage threshold range, the storage safety optimization of the traditional Chinese medicine uric acid-lowering preparation will not be performed, and the preparation safety evaluation data will be uploaded to the preset shared database, and the preparation safety evaluation data includes preparation raw material safety data, preparation raw material safety characteristic index, preparation process safety characteristic index and preparation storage safety characteristic index; If the preparation storage safety characteristic index exceeds the preset preparation storage threshold range, the storage safety optimization of the traditional Chinese medicine uric acid-lowering preparation will be implemented.

9. A method for evaluating the safety of a traditional Chinese medicine uric acid-lowering preparation according to claim 8, characterized in that: The specific process for optimizing the storage safety of the traditional Chinese medicine uric acid-lowering preparation is as follows: A1, optimize the storage environment monitoring equipment for the storage of traditional Chinese medicine uric acid lowering preparations. When the storage safety characteristic index of the preparation after the storage environment monitoring equipment is optimized is within the preset preparation storage threshold range, stop the storage safety optimization of traditional Chinese medicine uric acid lowering preparations, otherwise execute A2; A2, perform adaptive optimization of the storage environment for the storage of traditional Chinese medicine uric acid-lowering preparations. When the storage safety characteristic index of the preparation after adaptive optimization of the storage environment is within the preset preparation storage threshold range, stop the optimization of the storage safety of the traditional Chinese medicine uric acid-lowering preparations, otherwise execute A3; A3, optimize the storage environment monitoring of the storage of traditional Chinese medicine uric acid lowering preparations. When the preparation storage safety characteristic index after storage environment monitoring optimization is within the preset preparation storage threshold range, stop the optimization of storage safety of traditional Chinese medicine uric acid lowering preparations. Otherwise, remind the preset personnel to change the storage environment of traditional Chinese medicine uric acid lowering preparations.

10. A safety evaluation system for a traditional Chinese medicine uric acid-lowering preparation, characterized in that: include: Preparation raw material data acquisition module, preparation raw material safety judgment module, preparation process safety judgment module, preparation storage safety judgment module; Among them, the preparation raw material data acquisition module is used to obtain the preparation raw material safety data of the preset preparation raw materials in the traditional Chinese medicine uric acid-lowering preparation; The preparation raw material safety judgment module is used to evaluate the raw material safety characteristics of the preset preparation raw materials in the traditional Chinese medicine uric acid lowering preparation according to the preparation raw material safety data to obtain the preparation raw material safety characteristic index, and judge whether to perform the traditional Chinese medicine uric acid lowering preparation process safety detection based on the preparation raw material safety characteristic index, and the preparation raw material safety characteristic index is used to quantitatively evaluate the compliance degree of the preset preparation raw material safety characteristics in the traditional Chinese medicine uric acid lowering preparation; The preparation process safety judgment module is used to obtain the preparation process safety characteristic index after the traditional Chinese medicine uric acid-lowering preparation process safety test is performed, and judge whether to perform the traditional Chinese medicine uric acid-lowering preparation storage safety test based on the preparation process safety characteristic index. The preparation process safety characteristic index is used to comprehensively quantify the compliance degree of the traditional Chinese medicine uric acid-lowering preparation process safety test; The preparation storage safety judgment module is used to obtain the preparation storage safety characteristic index after executing the storage safety test of the traditional Chinese medicine uric acid lowering preparation, and judge whether to execute the storage safety optimization of the traditional Chinese medicine uric acid lowering preparation based on the preparation storage safety characteristic index. The preparation storage safety characteristic index is used to comprehensively quantify the compliance degree of the storage safety test of the traditional Chinese medicine uric acid lowering preparation.

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