Intelligent supervision system and method based on cyclocarya paliurus and poria cocos pharmaceutical composition production

Abstract

The invention discloses an intelligent supervision system and method based on cyclocarya paliurus and poria cocos pharmaceutical composition production, and relates to the technical field of traditional Chinese medicine analysis. The intelligent supervision system based on cyclocarya paliurus and poria cocos pharmaceutical composition production comprises a formula proportion control module, an ingredient standardization module and an auxiliary material additive detection module. According to the invention, proportioning and shunting treatment is carried out on the to-be-produced batch of medicines through the formula proportion control index, then standardized shunting treatment is carried out on the to-be-produced batch of medicines through the medicine standardization evaluation index, and finally auxiliary material shunting treatment is carried out on the to-be-produced batch of medicines through the auxiliary material adding accuracy index. The effect of improving the processing supervision accuracy of the cyclocarya paliurus and poria cocos pharmaceutical composition is achieved, and the problem of inaccurate processing supervision of the cyclocarya paliurus and poria cocos pharmaceutical composition in the prior art is solved.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine analysis, and in particular to an intelligent monitoring system and method based on the production of a Qingqianfuling drug composition. Background Art

[0002] With the rapid development of modernization and intelligent technology of traditional Chinese medicine, the production and supervision of traditional Chinese medicine have gradually integrated advanced scientific and technological means to achieve digital management of the entire process. As an important Chinese medicinal material, Qingqian Fuling has attracted much attention in clinical practice for its medicinal value. It is often used to regulate the spleen and stomach, promote diuresis and eliminate dampness. In order to improve the production efficiency and quality safety of drug compositions, an intelligent supervision system based on Qingqian Fuling came into being. Through big data, the Internet of Things, artificial intelligence and other technologies, it realizes intelligent monitoring of the entire chain from raw material planting, production and processing to market circulation, and promotes the high-quality development of the Chinese medicine industry.

[0003] Existing Chinese medicine production supervision technology mainly relies on traditional manual management and experience accumulation, and has problems such as low degree of informatization, incomplete data collection, and difficult to accurately control quality. In the production process of Qingqian Fuling drug composition, there is a lack of real-time monitoring methods for the source of medicinal materials, processing and product circulation, which easily leads to uneven quality and increased difficulty in supervision. Although some companies have introduced basic digital equipment in recent years, such as quality testing instruments and simple traceability systems, the overall situation is still limited to the improvement of a single link, and has failed to achieve intelligent management of the entire process and a systematic quality traceability mechanism.

[0004] For example, the invention patent with announcement number: CN103134883B announces a method for detecting a pharmaceutical composition and its preparation, including: identification and / or content determination method, wherein the identification method is one or more of microscopic identification, identification of Astragalus, identification of Phellodendron, identification of Atractylodes, identification of Atractylodes, identification of Codonopsis, and identification of Poria, and the content determination method is a method for determining the content of astragaloside I.

[0005] For example, the invention patent announcement with announcement number: CN105301127B discloses a ribavirin pharmaceutical composition and a method for detecting related substances thereof, including: Parts of ribavirin by weight, 10 parts of water by weight. The present invention comprises the following steps: a. adding ribavirin and water for injection into a preparation tank, stirring and dissolving; b. adjusting the pH value of the solution to 4.0-6.0, stirring the liquid medicine for 15 minutes; c. filtering the liquid medicine through a 0.45um filter and a 0.22um ultrafilter in sequence, and circulating the liquid medicine for more than 15 minutes; d. pumping the ultrafiltrate into a dilution tank, and maintaining the temperature of the dilution tank at 0-20°C; e. sterilizing the intermediate product after potting; f. packaging the sterilized product.

[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: In the prior art, due to the complex processing procedures of Qingqian and Poria, different extraction processes (such as solvent selection, extraction temperature, time, etc.) have a great influence on the extraction efficiency of active ingredients during formula preparation and ingredient standardization, and the preparation and testing of the pharmaceutical composition may not be accurate enough, resulting in inaccurate processing supervision of the Qingqian and Poria pharmaceutical composition. Summary of the invention

[0007] The embodiments of the present application solve the problem of inaccurate processing supervision of the Qingqian Fuling pharmaceutical composition in the prior art by providing an intelligent supervision system and method based on the production of the Qingqian Fuling pharmaceutical composition, thereby improving the accuracy of processing supervision of the Qingqian Fuling pharmaceutical composition.

[0008] An embodiment of the present application provides an intelligent supervision system based on the production of Qingqian Fuling drug composition, including: a formula proportion control module, a component standardization module and an excipient additive detection module: wherein the formula proportion control module is used to obtain the formula proportion control index by acquiring the ratio data of the batch of drugs to be produced, and perform ratio diversion processing on the batch of drugs to be produced based on the formula proportion control index, and the formula proportion control index is used to reflect the degree of standardization of the raw material ratio of the Qingqian Fuling drug; the component standardization module is used to obtain the drug standardization evaluation index by acquiring the component detection data of the batch of drugs to be produced and perform standardized diversion processing on the batch of drugs to be produced, and the drug standardization evaluation index is used to reflect the degree of standardization of the extract of the Qingqian Fuling drug; the excipient additive detection module is used to obtain the excipient addition accuracy index by acquiring the excipient data of the batch of drugs to be produced and perform excipient diversion processing on the batch of drugs to be produced, and the excipient addition accuracy index is used to evaluate the accuracy of the injection amount of excipients and additives.

[0009] Furthermore, the ratio data include the total flavonoids content of Qingqian, the polysaccharide content extracted from Poria, the feeding ratio and batch component differences; the component detection data include the monomer flavonoids content of Qingqian, the total polysaccharide content of Poria, the triterpenoid content of Poria and the impurity content data; the impurity content data include the residual solvent content, the heavy metal content and the pesticide residue content; the auxiliary material data include the auxiliary material pH value, the change rate of the active ingredient content, the heavy metal content of the auxiliary material, the microbial content and the active ingredient retention rate.

[0010] Furthermore, the specific steps of the formula ratio control index are as follows: A1, numbering the batches of drugs to be produced; A2, obtaining reference ratio data from a preset database, the reference ratio data including a flavonoid content reference range, a polysaccharide content reference range and a standard feed ratio; A3, comparing the total flavonoid content of Qingqian with the flavonoid content reference range, and obtaining a corresponding flavonoid content deviation according to the comparison result, the flavonoid content deviation represents the absolute value of the difference between the total flavonoid content of Qingqian and the flavonoid content reference range, and the flavonoid content reference range represents the range corresponding to the flavonoid content reference minimum value and the flavonoid content reference maximum value; A4, comparing the Poria polysaccharide content with the polysaccharide content reference range, and obtaining a corresponding polysaccharide content deviation according to the comparison result, the polysaccharide content deviation represents the absolute value of the difference between the Poria polysaccharide content and the polysaccharide content reference range, and the polysaccharide content reference range represents the range corresponding to the polysaccharide content reference minimum value and the polysaccharide content reference maximum value; A5, obtaining the formula ratio control index according to the flavonoid content deviation, the polysaccharide content deviation, the standard feed ratio and the ratio data.

[0011] Furthermore, the specific limiting expression of the formula ratio control index is as follows: In the formula, n represents the number of the batch of drugs to be produced, , represents the total number of batches of drug to be produced, represents the flavonoid content deviation of the nth batch of drugs to be produced, represents the polysaccharide content deviation of the nth batch of drug to be produced, It represents the feed ratio of the nth batch of drugs to be produced. represents the batch composition difference of the nth batch of drugs to be produced, Indicates the standard feed ratio, Represents the formula ratio control index of the nth batch of drugs to be produced.

[0012] Furthermore, the specific process of proportioning and diverting the batch of drugs to be produced based on the formula ratio control index is as follows: if the formula ratio control index is less than the ratio threshold value obtained from the preset database, the ratio deviation is obtained from the preset database, and the difference between the formula ratio control index and the ratio threshold value is recorded as the ratio control deviation value; the ratio control deviation value is compared with the ratio deviation, if the ratio control deviation value is less than the ratio deviation, the batch of drugs to be produced is diverted to the proportioning rework line, otherwise the batch of drugs to be produced is diverted to the isolation line; the proportioning rework line is used to re-transmit the batch of drugs to be produced for ratio adjustment; the isolation line is used to transport the production batch of drugs to the drug isolation container.

[0013] Furthermore, the specific acquisition process of the drug standardization evaluation index is as follows: obtain reference ingredient data from a preset database, the reference ingredient data including reference indicators and reference deviations, the reference indicators including monomer flavonoid content indicators, Poria cocos total polysaccharide content indicators and Poria cocos triterpenoid content indicators, and the reference deviations including monomer flavonoid content deviations, Poria cocos total polysaccharide content deviations and Poria cocos triterpenoid content deviations; perform data preprocessing on impurity content data, and the data preprocessing is used to unify the dimensions of impurity content data; obtain standardized analysis weights from a preset database, and the standardized analysis weights include effective ingredient content weights and impurity content weights; obtain an indicator evaluation index based on the reference indicators and ingredient detection data, and the indicator evaluation index is used to quantify the effective ingredient content of a batch of drugs to be produced; obtain the drug standardization evaluation index based on the indicator evaluation index, impurity content data, reference deviations and standardized analysis weights.

[0014] Furthermore, the specific process of the standardized diversion processing of the batch of drugs to be produced is as follows: if the drug standardization evaluation index is less than the standardized threshold value obtained from the preset database, the standardized deviation is obtained from the preset database, and the difference between the drug standardization evaluation index and the standardized threshold value is recorded as the standardized deviation value; the standardized deviation value is compared with the standardized deviation, if the standardized deviation value is less than the standardized deviation, the batch of drugs to be produced is diverted to the standardized rework line, otherwise the batch of drugs to be produced is diverted to the destruction line; the standardized rework line is used to re-transmit the batch of drugs to be produced for standardized adjustment; the destruction line is used to transport the production batch of drugs to the drug destruction machine.

[0015] Furthermore, the specific acquisition process of the auxiliary material addition accuracy index is as follows: obtain the minimum pH value of the reference auxiliary material and the maximum pH value of the reference auxiliary material from a preset database; obtain the auxiliary material pH value index according to the auxiliary material pH value, the minimum pH value of the reference auxiliary material and the maximum pH value of the reference auxiliary material; respectively process the auxiliary material pH value index and the change rate of the effective ingredient content, the auxiliary material heavy metal content, the sum of the microbial content and the effective ingredient retention rate to obtain the auxiliary material addition accuracy index.

[0016] Furthermore, the specific process of excipient diversion processing for the batch of drugs to be produced is as follows; if the excipient addition accuracy index is less than the excipient threshold value obtained from the preset database, the excipient deviation is obtained from the preset database, and the difference between the excipient addition accuracy index and the excipient threshold value is recorded as the excipient deviation value; the excipient deviation value is compared with the excipient deviation, if the excipient deviation value is less than the excipient deviation, the batch of drugs to be produced is diverted to the excipient rework line, otherwise the batch of drugs to be produced is diverted to the destruction line; the excipient rework line is used to re-transmit the batch of drugs to be produced for excipient addition adjustment.

[0017] An embodiment of the present application provides an intelligent supervision method based on the production of Qingqian Fuling drug composition, comprising the following steps: obtaining a formula proportion control index by acquiring the ratio data of the drug batch to be produced, and performing a ratio diversion process on the drug batch to be produced based on the formula proportion control index, wherein the formula proportion control index is used to reflect the degree of standardization of the raw material ratio of the Qingqian Fuling drug; obtaining a drug standardization evaluation index by acquiring the component detection data of the drug batch to be produced and performing a standardization diversion process on the drug batch to be produced, wherein the drug standardization evaluation index is used to reflect the degree of standardization of the extract of the Qingqian Fuling drug; obtaining an excipient addition accuracy index by acquiring the excipient data of the drug batch to be produced and performing an excipient diversion process on the drug batch to be produced, wherein the excipient addition accuracy index is used to evaluate the accuracy of the injection amount of excipients and additives.

[0018] One or more technical solutions provided in the embodiments of the present application have at least the following technical effects or advantages: 1. The drug batches to be produced are processed for proportioning and diversion through the formula proportion control index, and then the drug batches to be produced are processed for standardization and diversion through the drug standardization evaluation index. Finally, the excipient addition accuracy index is used to perform excipient diversion processing on the drugs batches to be produced, thereby improving the preparation quality of the drugs batches to be produced, thereby achieving the improvement of the accuracy of the processing supervision of the Qingqian Fuling drug composition, and effectively solving the problem of inaccurate processing supervision of the Qingqian Fuling drug composition in the prior art.

[0019] 2. By obtaining reference ingredient data from a preset database and performing data preprocessing on the impurity content data, then obtaining the standardized analysis weight from the preset database, and then obtaining the indicator evaluation index based on the reference indicator and ingredient detection data, and finally obtaining the drug standardization evaluation index based on the indicator evaluation index, impurity content data, reference deviation and standardized analysis weight, the degree of standardization of the drug composition can be more accurately evaluated, thereby achieving more accurate supervision of the drug composition.

[0020] 3. By obtaining the minimum pH value and the maximum pH value of the reference excipient from the preset database, and obtaining the excipient pH index according to the excipient pH value, the minimum pH value and the maximum pH value of the reference excipient, and then processing the excipient pH index with the change rate of the active ingredient content, the excipient heavy metal content, the sum of the microbial content and the active ingredient retention rate, respectively, to obtain the excipient addition accuracy index, thereby more accurately evaluating the degree of standardization of drug excipient addition, and thus achieving more accurate supervision of drug compositions. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 A schematic diagram of the structure of an intelligent monitoring system for the production of a Qingqianfuling pharmaceutical composition provided in an embodiment of the present application; Figure 2 A schematic diagram showing the variation of the auxiliary material addition accuracy index with the auxiliary material pH value provided in the embodiment of the present application; Figure 3 A schematic diagram showing the variation of the excipient addition accuracy index with the change rate of the active ingredient content provided in the examples of the present application; Figure 4 A schematic diagram showing the variation of the auxiliary material addition accuracy index with the heavy metal content of the auxiliary material provided in the embodiments of the present application; Figure 5 A schematic diagram showing the variation of the accuracy index of auxiliary material addition with the microbial content provided in the embodiments of the present application; Figure 6 This is a schematic diagram of the variation of the excipient addition accuracy index with the active ingredient retention rate provided in the examples of the present application. DETAILED DESCRIPTION

[0022] The embodiment of the present application solves the problem of inaccurate processing supervision of Qingqian Poria cocos pharmaceutical compositions in the prior art by providing an intelligent supervision system and method based on the production of Qingqian Poria cocos pharmaceutical compositions, performs a proportioning and diversion process on the drugs to be produced by a formula ratio control index, then obtains reference component data from a preset database, and performs data preprocessing on the impurity content data, then obtains the standardized analysis weight from the preset database, and then obtains the index evaluation index according to the reference index and the component detection data, and then obtains the drug standardized evaluation index based on the index evaluation index, the impurity content data, the reference deviation and the standardized analysis weight, and performs standardized diversion process on the drugs to be produced, and finally obtains the minimum pH value of the reference excipient and the maximum pH value of the reference excipient from the preset database, and obtains the excipient pH index according to the excipient pH value, the minimum pH value of the reference excipient and the maximum pH value of the reference excipient, and then respectively processes the excipient pH index and the effective ingredient content change rate, the excipient heavy metal content, the sum of the microbial content and the effective ingredient retention rate to obtain the excipient addition accuracy index, and performs excipient diversion process on the drugs to be produced, thereby improving the accuracy of processing supervision of Qingqian Poria cocos pharmaceutical compositions.

[0023] The technical solution in the embodiment of the present application is to solve the problem of inaccurate processing supervision of the above-mentioned Qingqian Fuling drug composition, and the overall idea is as follows: The production batches of drugs are processed for proportioning and diversion through the formula proportion control index, and then the production batches of drugs are processed for standardization and diversion through the drug standardization assessment index. Finally, the production batches of drugs are processed for excipient diversion through the excipient addition accuracy index, thereby achieving the effect of improving the accuracy of processing supervision of the Qingqian Fuling drug composition.

[0024] 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.

[0025] like Figure 1 As shown, it is a structural schematic diagram of the intelligent supervision system for the production of Qingqian Poria drug composition provided in an embodiment of the present application. The intelligent supervision system for the production of Qingqian Poria drug composition provided in an embodiment of the present application includes: a formula proportion control module, a component standardization module and an excipient additive detection module: wherein the formula proportion control module is used to obtain the formula proportion control index by acquiring the ratio data of the batch of drugs to be produced, and perform ratio diversion processing on the batch of drugs to be produced based on the formula proportion control index, and the formula proportion control index is used to reflect the degree of standardization of the raw material ratio of the Qingqian Poria drug; the component standardization module is used to obtain the drug standardization evaluation index by acquiring the component detection data of the batch of drugs to be produced and perform standardized diversion processing on the batch of drugs to be produced, and the drug standardization evaluation index is used to reflect the degree of standardization of the extract of the Qingqian Poria drug; the excipient additive detection module is used to obtain the excipient addition accuracy index by acquiring the excipient data of the batch of drugs to be produced and perform excipient diversion processing on the batch of drugs to be produced, and the excipient addition accuracy index is used to evaluate the accuracy of the injection amount of excipients and additives.

[0026] In the present embodiment, the batches of drugs to be produced are numbered according to specific production rules, such as numbering according to the production time; and there is a sequential connection between the formula proportion control module, the ingredient standardization module and the excipient additive detection module. If after executing the formula proportion control module, the batch of drugs to be produced does not need to be proportioned and diverted, the ingredient standardization module is executed. Similarly, if after executing the ingredient standardization module, the batch of drugs to be produced does not need to be standardized and diverted, the excipient additive detection module is executed; based on the synergistic effect of the formula proportion control module, the ingredient standardization module and the excipient additive detection module of the present embodiment, the intelligence of the entire production process of the Qingqian Fuling drug composition is realized, and the accuracy of the processing supervision of the Qingqian Fuling drug composition is also improved.

[0027] It should be supplemented that the ratio data include the total flavonoids content of Qingqian, the polysaccharide content extracted from Poria, the feed ratio and batch composition differences; the ingredient detection data include the monomer flavonoids content of Qingqian, the total polysaccharide content of Poria, the triterpenoid content of Poria and the impurity content data; the impurity content data include the residual solvent content, the heavy metal content and the pesticide residue content; the auxiliary material data include the auxiliary material pH value, the change rate of the active ingredient content, the heavy metal content of the auxiliary material, the microbial content and the active ingredient retention rate.

[0028] Among them, the total flavonoids content and the monomer flavonoids content of Qingqian were detected by UV-visible spectrophotometry, the polysaccharide extract content of Poria cocos and the total polysaccharide content of Poria cocos were detected by gel permeation chromatography, and the feeding ratio was obtained by weighing the ratio of Qingqian and flavonoids; the triterpenoid content, residual solvent content and pesticide residue content of Poria cocos were obtained by gas chromatography-mass spectrometry, and the heavy metal content and heavy metal content of auxiliary materials were obtained by atomic absorption spectrometry; the pH value of the auxiliary material was determined by a pH meter, and the change rate of the effective ingredient content was calculated after measurement by high performance liquid chromatography (that is, the ratio of the absolute value of the difference between the effective ingredient content before adding the auxiliary material and the effective ingredient content after adding the auxiliary material to the effective ingredient content before adding the auxiliary material), and the microbial content was measured and obtained by plate counting method; the acquisition of the above data laid a data foundation for subsequent analysis.

[0029] Furthermore, the specific steps of the formula ratio control index are as follows: A1, numbering the batches of drugs to be produced; A2, obtaining reference ratio data from a preset database, the reference ratio data including a reference range of flavonoid content, a reference range of polysaccharide content and a standard feed ratio; A3, comparing the total flavonoid content of green money with the reference range of flavonoid content, and obtaining the corresponding flavonoid content deviation (i.e. ), when the total flavonoid content of Qingqian is within the reference range of flavonoid content, the flavonoid content deviation is 0, when the total flavonoid content of Qingqian is less than the reference minimum value of flavonoid content, the flavonoid content deviation is the absolute value of the difference between the total flavonoid content of Qingqian and the reference minimum value of flavonoid content, when the total flavonoid content of Qingqian is greater than the reference maximum value of flavonoid content, the flavonoid content deviation is the absolute value of the difference between the total flavonoid content of Qingqian and the reference maximum value of flavonoid content, and the flavonoid content reference range represents the range corresponding to the reference minimum value of flavonoid content and the reference maximum value of flavonoid content; A4, compare the Poria cocos polysaccharide content with the polysaccharide content reference range, and obtain the corresponding polysaccharide content deviation according to the comparison result (i.e. ), the polysaccharide content deviation represents the absolute value of the difference between the Poria polysaccharide content and the polysaccharide content reference range. When the Poria polysaccharide content is within the polysaccharide content reference range, the polysaccharide content deviation is 0. When the Poria polysaccharide content is less than the polysaccharide content reference minimum value, the polysaccharide content deviation is the absolute value of the difference between the Poria polysaccharide content and the polysaccharide content reference minimum value. When the Poria polysaccharide content is greater than the polysaccharide content reference maximum value, the polysaccharide content deviation is the absolute value of the difference between the Poria polysaccharide content and the polysaccharide content reference maximum value. The polysaccharide content reference range represents the range corresponding to the polysaccharide content reference minimum value and the polysaccharide content reference maximum value. A5, the formula proportion control index is obtained according to the flavonoid content deviation, polysaccharide content deviation, standard feed ratio and ratio data.

[0030] The specific limiting expression of the recipe ratio control index is as follows: In the formula, n represents the number of the batch of drugs to be produced, , represents the total number of batches of drug to be produced, represents the flavonoid content deviation of the nth batch of drugs to be produced, represents the polysaccharide content deviation of the nth batch of drug to be produced, It represents the feed ratio of the nth batch of drugs to be produced. represents the batch composition difference of the nth batch of drugs to be produced, Indicates the standard feed ratio, represents the total flavonoids content of the nth batch of drugs to be produced. Indicates the content of tuckahoe polysaccharide in the nth batch of drugs to be produced, Indicates the total flavonoids content of the n-1th batch of drugs to be produced. Indicates the content of tuckahoe polysaccharide in the n-1th batch of drugs to be produced, Indicates the minimum reference value of flavonoid content, Indicates the maximum reference value of flavonoid content, Indicates the minimum reference value of polysaccharide content, Indicates the maximum value of polysaccharide content. Represents the formula ratio control index of the nth batch of drugs to be produced.

[0031] In this embodiment, the algorithm combines the flavonoid content deviation, polysaccharide content deviation, standard feed ratio and ratio data for comprehensive analysis to obtain the formula ratio control index, wherein the flavonoid content deviation is classified and analyzed according to the total flavonoid content of Qingqian and the corresponding flavonoid content reference range to obtain the flavonoid content deviation corresponding to different situations, and the polysaccharide content deviation is analyzed in the same way; with the increase of flavonoid content deviation, polysaccharide content deviation, feed ratio and batch component difference, the corresponding formula ratio control index decreases, indicating that the accuracy of formula ratio control is reduced; through the analysis of the formula ratio control index, it is helpful to more accurately monitor the formula ratio of the Qingqian Poria cocos pharmaceutical composition, and through the design and analysis of the formula ratio control index, the system realizes the scientific and standardized management of the production process of the Qingqian Poria cocos pharmaceutical composition, more accurately controls the flavonoid and polysaccharide content, ensures that the quality of the main active ingredients in the medicine meets the standards, thereby ensuring the accuracy of the formula ratio control of the Qingqian Poria cocos pharmaceutical composition.

[0032] Specifically, assuming that the standard feed ratio is 1.0, the data change table of the formula ratio control index can be obtained, as shown in Table 1: Table 1 Data change table of the formula ratio control index

[0033] It can be seen from Table 1 that with the increase of flavonoid content deviation, polysaccharide content deviation, feed ratio and batch component difference, the corresponding formula ratio control index decreases. For example, when the flavonoid content deviation increases from 0.00 in the first row to 0.50 in the fifth row, the polysaccharide content deviation increases from 0.00 in the first row to 0.50 in the fifth row, the feed ratio increases from 0.80 in the first row to 1.16 in the fifth row, and the batch component difference increases from 0.20 in the first row to 0.30 in the fifth row, the corresponding formula ratio control index decreases from 0.73 in the first row to 0.66 in the fifth row, indicating that the flavonoid content deviation, polysaccharide content deviation, feed ratio and batch component difference are negatively correlated with the formula ratio control index. The larger the formula ratio control index, the more accurate the formula ratio control. Otherwise, corresponding adjustment measures may need to be taken to improve the accuracy of the formula ratio control of the Qingqian Fuling pharmaceutical composition, which also helps to reduce the drug rework rate and improve the production efficiency of the Qingqian Fuling pharmaceutical composition.

[0034] Specifically, the parameters involved in the processing of the formula ratio control index in this algorithm are interrelated and do not exist independently. Among them, the feed ratio directly determines the input amount of the two raw materials, Qingqian and Poria, in the production. If the feed ratio is inaccurate, the key components (total flavonoids content of Qingqian and polysaccharide content extracted from Poria) will deviate from the corresponding reference range. Under ideal circumstances, the total flavonoids content of Qingqian is proportional to the feed amount of Qingqian, and the polysaccharide content of Poria is proportional to the feed amount of Poria. Different initial contents of total flavonoids of Qingqian and Poria polysaccharides in different batches of raw materials may cause batch composition differences. The composition differences of different batches of drugs may also come from the deviation of the feed ratio. The error in the feed ratio may lead to changes in the composition content.

[0035] Specifically, the reference ratio data (i.e., the reference range of flavonoid content, the reference range of polysaccharide content, and the standard feed ratio) are obtained from a preset database. In a specific embodiment, the reference ratio data are specifically set by professional drug preparation personnel according to the actual production requirements of the Qingqian Fuling drug composition.

[0036] Furthermore, the specific process of proportioning and diverting the drugs in the production batch based on the formula ratio control index is as follows: the ratio threshold is obtained from the preset database. If the formula ratio control index is not less than the ratio threshold, no measures are taken for the drugs in the production batch; if the formula ratio control index is less than the ratio threshold obtained from the preset database, the ratio deviation is obtained from the preset database, and the difference between the formula ratio control index and the ratio threshold is recorded as the ratio control deviation value; the ratio control deviation value is compared with the ratio deviation. If the ratio control deviation value is less than the ratio deviation, the drugs in the production batch are diverted to the ratio rework line, otherwise the drugs in the production batch are diverted to the isolation line; the ratio rework line is used to re-transmit the drugs in the production batch for ratio adjustment; the isolation line is used to transport the production batch drugs to the drug isolation container.

[0037] In this embodiment, the ratio rework line transmits the batch of drugs to be produced to the ratio adjustment port for ratio adjustment. The ratio adjustment means that the professional drug preparation personnel will make adjustments according to the actual ratio so that the batch of drugs to be produced can meet the production requirements of the drug composition again, thereby reducing cost losses; the isolation line means that the batch of drugs to be produced that cannot be adjusted in the ratio will be isolated to prevent confusion with other batches of drugs to be produced, and will be specifically handled by professional drug preparation personnel; through the preset ratio threshold and ratio deviation, it is possible to automatically determine whether the formula ratio of the batch of drugs to be produced is qualified, avoiding the errors and subjectivity of manual judgment, and at the same time, the diversion processing process records the processing status of each batch of drugs to be produced, including whether to divert, which line to divert to, and subsequent processing results; these records are helpful for quality traceability and data analysis, providing strong support for the continuous improvement and optimization of drug production.

[0038] Specifically, the ratio threshold is obtained from a preset database. In a specific embodiment, the ratio data corresponding to the situation where the formula ratio in the historical data does not meet the production requirements is substituted into the specific restriction expression of the formula ratio control index to obtain the corresponding data set, and the result of the mean operation of the data set is recorded as the ratio threshold.

[0039] Specifically, the ratio deviation is obtained from a preset database. In a specific embodiment, the ratio deviation is specifically set by a professional drug preparation personnel according to the production requirements of the Qingqian Fuling drug composition.

[0040] Furthermore, the specific process of obtaining the drug standardization evaluation index is as follows: obtaining reference ingredient data from a preset database, the reference ingredient data including reference indicators and reference deviations, the reference indicators including monomer flavonoid content indicators, Poria cocos total polysaccharide content indicators and Poria cocos triterpenoid content indicators, and the reference deviations including monomer flavonoid content deviations, Poria cocos total polysaccharide content deviations and Poria cocos triterpenoid content deviations; performing data preprocessing on the impurity content data, the data preprocessing is used to unify the dimensions of the impurity content data; obtaining standardized analysis weights from a preset database, the standardized analysis weights including effective ingredient content weights and impurity content weights; obtaining the index evaluation index (i.e., ), the indicator evaluation index is used to quantify the content of the active ingredient in the batch of drugs to be produced; the drug standardization evaluation index is obtained based on the indicator evaluation index, impurity content data, reference deviation and standardized analysis weight. The specific restricted expression of the drug standardization evaluation index is as follows:

[0041] In the formula, n represents the number of the batch of drugs to be produced, , represents the total number of batches of drug to be produced, represents the content of flavonoids in the nth batch of drugs to be produced. Indicates the total polysaccharide content of Poria cocos in the nth batch of drugs to be produced, Indicates the content of Poria triterpenoids in the nth batch of drugs to be produced, represents the residual solvent content of the nth batch of drug to be produced, Indicates the heavy metal content of the nth batch of drugs to be produced, Indicates the pesticide residue content of the nth batch of drugs to be produced, represents the indicator evaluation index of the nth batch of drugs to be produced, Indicates the content of monomer flavonoids. Indicates the total polysaccharide content of Poria cocos. Indicates the content index of Poria triterpenoids, Indicates the deviation of monomer flavonoid content, Indicates the deviation of total polysaccharide content of Poria cocos, Indicates that the content of Poria triterpenes is biased. Indicates the weight of the active ingredient content, represents the impurity content weight, represents the drug standardization evaluation index of the nth batch of drugs to be produced, and e represents a natural constant.

[0042] In this embodiment, the algorithm combines the index evaluation index, impurity content data, reference deviation and standardized analysis weight for comprehensive analysis to obtain the drug standardization evaluation index, wherein the index evaluation index increases with the relative deviation of the monomer flavonoid content of the green coin and the monomer flavonoid content index (i.e. ), the relative deviation of the total polysaccharide content of Poria cocos and the index of total polysaccharide content of Poria cocos (i.e. ) and the relative deviation of the content of Poria cocos triterpenoids and the index of the content of Poria cocos triterpenoids (i.e. ), the smaller the index evaluation index, the more standardized the drug standardization; and when the reference deviations are not less than the corresponding absolute deviations of the monomer flavonoid content of Qingqian and the monomer flavonoid content index, the absolute deviations of the total polysaccharide content of Poria cocos and the total polysaccharide content of Poria cocos, and the absolute deviations of the triterpenoid content of Poria cocos and the triterpenoid content of Poria cocos, as the index evaluation index and impurity content data increase, the corresponding drug standardization evaluation index decreases, indicating that the standardization degree of the Qingqian Poria cocos pharmaceutical composition is lower, and when the reference deviations are less than the corresponding absolute deviations of the monomer flavonoid content of Qingqian and the monomer flavonoid content index, the absolute deviations of the total polysaccharide content of Poria cocos and the total polysaccharide content of Poria cocos, and the absolute deviations of the triterpenoid content of Poria cocos and the triterpenoid content of Poria cocos, then as the impurity content data increases, the corresponding drug standardization evaluation index decreases, indicating that the standardization degree of the Qingqian Poria cocos pharmaceutical composition is lower. The analysis of the drug standardization evaluation index can help to better understand the standardization of the Qingqian Poria cocos drug mixture, so as to take corresponding adjustment measures in time to improve the accuracy of the supervision of the Qingqian Poria cocos drug mixture.

[0043] Specifically, the parameters involved in the processing of the drug standardization evaluation index in this algorithm are interrelated and do not exist independently. Among them, if the content of Cyclocarya paliurus flavonoids is too high and the content of Poria cocos triterpenoids is insufficient, it may affect the overall balance of drug efficacy, and the ratio of Cyclocarya paliurus and Poria cocos in the formula directly affects the balance of flavonoids and polysaccharides, which ultimately determines the efficacy of the drug; and the higher the impurity content, the more likely the impurities are to be mixed with monomeric flavonoids, reducing the purity of flavonoids, and some impurities may also be similar to polysaccharides in structure, increasing the deviation of polysaccharide detection data, and at the same time, impurities may compete with Poria cocos triterpenoid compounds for dissolution or precipitation, affecting the extraction efficiency.

[0044] Specifically, the weights of the active ingredient content of the drug are directly obtained from the preset database. These weights correspond to key active ingredients of the drug, such as flavonoids, polysaccharides and triterpenes, and they reflect the degree of influence of these ingredients in the drug standardization evaluation index. In practical applications, there is a pre-set mapping relationship to determine the correspondence between the active ingredients of the batch of drugs to be produced and the corresponding weights of the drug standardization evaluation index in the preset database. This mapping relationship is one-to-one, which means that each active ingredient can find its corresponding weight value. In this example, the weight range is set to between 0 and 1. By inputting the real-time active ingredients of the drug into this mapping relationship, their corresponding weight values ​​can be obtained.

[0045] Specifically, the sum of the effective ingredient content weight and the impurity content weight is 1.

[0046] Specifically, the reference index and the reference deviation are obtained from a preset database. In a specific embodiment, the reference index and the reference deviation are specifically set by professional drug preparation personnel according to the production requirements of the Qingqian Fuling drug composition.

[0047] Furthermore, the specific process of standardized diversion of the production batch drugs is as follows: obtain the standardized threshold from the preset database, if the drug standardized evaluation index is not less than the standardized threshold, do not take any measures for the production batch drugs; if the drug standardized evaluation index is less than the standardized threshold obtained from the preset database, obtain the standardized deviation from the preset database, and record the difference between the drug standardized evaluation index and the standardized threshold as the standardized deviation value; compare the standardized deviation value with the standardized deviation, if the standardized deviation value is less than the standardized deviation, divert the production batch drugs to the standardized rework line, otherwise divert the production batch drugs to the destruction line; the standardized rework line is used to re-transmit the production batch drugs for standardized adjustment; the destruction line is used to transport the production batch drugs to the drug destruction machine.

[0048] In this embodiment, the standardized rework line transfers the batch of drugs to be produced to the standardized adjustment port for standardized adjustment. Standardized adjustment means that professional drug preparation personnel perform standardized adjustment of the ingredients according to the actual standardization situation so that the batch of drugs to be produced can meet the standardized production requirements of the drug composition again; the isolation line means that the batch of drugs to be produced that cannot be standardized will be destroyed to prevent confusion with other batches of drugs to be produced; through precise control of standardized thresholds, standardized deviations and standardized deviations, efficient diversion processing of batches of drugs to be produced is achieved, effectively ensuring the quality, safety and efficacy of the drugs, while reducing production costs and risks; and the division of labor between standardized rework and destruction lines is clear, which improves production efficiency.

[0049] Specifically, the standardized threshold is obtained from a preset database. In a specific embodiment, the ratio data corresponding to the situation in which the drug does not meet the production requirements due to standardization in the historical data is substituted into the specific restriction expression of the drug standardization evaluation index to obtain the corresponding data set, and the result of the mean operation on the data set is recorded as the standardized threshold.

[0050] Specifically, the standardized deviation is obtained from a preset database. In a specific embodiment, the standardized deviation is specifically set by a professional drug preparation personnel according to the production requirements of the Qingqian Fuling drug composition.

[0051] Furthermore, the specific process of obtaining the excipient addition accuracy index is as follows: obtaining the minimum pH value of the reference excipient and the maximum pH value of the reference excipient from a preset database; obtaining the excipient pH value index (i.e., ); The auxiliary material pH value index and the change rate of the active ingredient content, the auxiliary material heavy metal content, the sum of the microbial content and the active ingredient retention rate were processed respectively to obtain the auxiliary material addition accuracy index.

[0052] The method for obtaining the accuracy index of excipient addition is as follows: In the formula, n represents the number of the batch of drugs to be produced, , represents the total number of batches of drug to be produced, represents the pH value of the excipients of the nth batch of drug to be produced, It represents the change rate of the active ingredient content of the nth batch of drugs to be produced, Indicates the heavy metal content of the excipients of the nth batch of drugs to be produced, represents the microbial content of the nth batch of drug to be produced, represents the active ingredient retention rate of the nth batch of drugs to be produced, represents the pH index of the excipients of the nth batch of drug to be produced, Represents the excipient addition accuracy index of the nth batch of drugs to be produced.

[0053] In this embodiment, the algorithm combines the excipient pH index, the change rate of the active ingredient content, the excipient heavy metal content, the microbial content and the active ingredient retention rate to comprehensively analyze and obtain the excipient addition accuracy index, wherein, when the excipient pH value is within the range corresponding to the minimum pH value of the reference excipient and the maximum pH value of the reference excipient, the excipient pH index reaches the maximum, and as the excipient pH value deviates more from the minimum pH value of the reference excipient or the maximum pH value of the reference excipient, the excipient pH index is smaller, indicating that the accuracy of the excipient pH control gradually decreases; and as the change rate of the active ingredient content, the excipient heavy metal content, and the microbial content increase, the excipient addition accuracy index decreases, indicating that the greater the change rate of the active ingredient content, the excipient heavy metal content, and the microbial content, the less accurate the excipient addition control; and the greater the active ingredient retention rate means that the more stable the addition control of the excipient addition is, the smaller the impact on the active ingredient of the pharmaceutical composition; through the excipient addition accuracy index, the degree of influence of the excipient on the Qingqian Fuling pharmaceutical composition can be detected in time, so that corresponding measures can be taken in time to reduce the loss of drug raw materials and extracts, and also improve the production quality of the Qingqian Fuling pharmaceutical composition.

[0054] Specifically, the parameters involved in the processing of the excipient addition accuracy index in this algorithm are interrelated and do not exist independently. Among them, the pH value of the excipient directly affects the chemical stability of the active ingredient during production and storage. For example, acidic or alkaline excipients may promote hydrolysis, oxidation or polymerization of the active ingredient, thereby causing an increase in the content change rate. A neutral pH (6.5-7.5) is prone to breeding microorganisms, while an acidic or alkaline environment has a certain inhibitory effect. In addition, heavy metals (such as lead, cadmium, mercury, etc.) may catalyze the degradation reaction of the active ingredient. For example, triterpenoid components may accelerate oxidation under the action of heavy metals, and flavonoid compounds may undergo isomerization or polymerization under the catalysis of heavy metals. At the same time, the higher the heavy metal content, the lower the retention rate of the active ingredient may be.

[0055] Specifically, Figure 2 As shown in FIG. 1 , it is a schematic diagram of the variation of the excipient addition accuracy index with the excipient pH value provided in the embodiment of the present application, wherein it is assumed that the minimum pH value of the reference excipient is 6, the maximum pH value of the reference excipient is 8, the change rate of the active ingredient content is 0.05, the excipient heavy metal content is 0.05, the microbial content is 0.05, and the active ingredient retention rate is 0.8. Figure 2 As shown in the figure, when the pH value of the auxiliary material is within the range corresponding to the minimum pH value of 6 and the maximum pH value of 8 of the reference auxiliary material, the auxiliary material addition accuracy index reaches the maximum, indicating that the auxiliary material pH value is most accurately controlled at this time. As the auxiliary material pH value deviates more from the minimum pH value of the reference auxiliary material or the maximum pH value of the reference auxiliary material, Figure 2 It shows a downward trend, indicating that the accuracy of controlling the pH value of the auxiliary materials is gradually decreasing.

[0056] like Figure 3 As shown in FIG. 1 , it is a schematic diagram of the variation of the excipient addition accuracy index with the change rate of the active ingredient content provided in the embodiment of the present application, wherein it is assumed that the excipient pH value is 7, the excipient heavy metal content is 0.05, the microbial content is 0.05, and the active ingredient retention rate is 0.8. Figure 3 It can be seen that with the increase of the change rate of the effective ingredient content, Figure 3 It shows a downward trend, and the accuracy index of auxiliary material addition gradually decreases, indicating that the changes in the content of active ingredients are not stable, and the addition of auxiliary material additives causes fluctuations in the content of active ingredients.

[0057] like Figure 4 As shown in FIG. 1 , it is a schematic diagram of the variation of the auxiliary material addition accuracy index with the heavy metal content of the auxiliary material provided in the embodiment of the present application, wherein it is assumed that the auxiliary material pH value is 7, the effective ingredient content change rate is 0.05, the microbial content is 0.05, and the effective ingredient retention rate is 0.8. Figure 4 It can be seen that with the increase of heavy metal content in auxiliary materials, Figure 4 It shows a downward trend, and the accuracy index of excipient addition gradually decreases, indicating that the increase in the heavy metal content of the excipients affects the proportion of the effective ingredients. The increase in the heavy metal content of the excipients has a greater impact on the effect of the drug composition.

[0058] like Figure 5 As shown in FIG. 1 , it is a schematic diagram of the variation of the accuracy index of the auxiliary material addition with the microbial content provided in the embodiment of the present application, wherein it is assumed that the pH value of the auxiliary material is 7, the change rate of the active ingredient content is 0.05, the heavy metal content of the auxiliary material is 0.05, and the active ingredient retention rate is 0.8. Figure 5 It can be seen that as the microbial content increases, Figure 5 It shows a downward trend, and the accuracy index of excipient addition gradually decreases, indicating that the increase in microbial content affects the proportion of effective ingredients, and the increase in microbial content has a greater impact on the effect of the pharmaceutical composition.

[0059] like Figure 6 As shown, it is a schematic diagram of the variation of the excipient addition accuracy index with the effective ingredient retention rate provided in the embodiment of the present application, wherein it is assumed that the excipient pH value is 7, the effective ingredient content change rate is 0.05, the excipient heavy metal content is 0.05, and the microbial content is 0.05. As the effective ingredient retention rate increases, Figure 6 It shows an upward trend, and the corresponding excipient addition accuracy index gradually increases. The greater the active ingredient retention rate, the smaller the influence of the excipient on the active ingredients of the pharmaceutical composition. It also reflects the accuracy of the control of excipient additives. The excipient addition accuracy index helps to more accurately analyze the influence of excipient addition on the pharmaceutical composition, thereby improving the accuracy of production supervision of Qingqian Fuling pharmaceutical composition.

[0060] Specifically, the minimum pH value of the reference excipient and the maximum pH value of the reference excipient are obtained from a preset database. In a specific embodiment, the minimum pH value of the reference excipient and the maximum pH value of the reference excipient are specifically set by professional drug preparation personnel according to the production requirements of the Qingqian Fuling drug composition.

[0061] Furthermore, the specific process of excipient diversion processing for the batch of drugs to be produced is as follows: the excipient threshold is obtained from the preset database, and if the excipient addition accuracy index is not less than the excipient threshold, no measures are taken for the batch of drugs to be produced; if the excipient addition accuracy index is less than the excipient threshold obtained from the preset database, the excipient deviation is obtained from the preset database, and the difference between the excipient addition accuracy index and the excipient threshold is recorded as the excipient deviation value; the excipient deviation value is compared with the excipient deviation, and if the excipient deviation value is less than the excipient deviation, the batch of drugs to be produced is diverted to the excipient rework line, otherwise the batch of drugs to be produced is diverted to the destruction line; the excipient rework line is used to re-transmit the batch of drugs to be produced for excipient addition adjustment.

[0062] In this embodiment, the excipient rework line transfers the batch of drugs to be produced to the excipient addition adjustment port for excipient addition adjustment. The excipient addition adjustment means that professional drug preparation personnel make excipient addition adjustments according to the actual excipient addition situation so that the batch of drugs to be produced can meet the excipient addition production requirements of the drug composition again; the destruction line means that the batch of drugs to be produced that cannot be adjusted for excipient addition will be destroyed to prevent confusion with other batches of drugs to be produced; the excipient diversion processing mechanism realizes scientific and standardized management of the production process through precise control of the excipient addition accuracy index, excipient threshold, deviation value and bias; and its excipient rework and destruction processes are clear and unambiguous, which not only improves resource utilization, but also ensures drug quality and safety.

[0063] Specifically, the auxiliary material threshold is obtained from a preset database. In a specific embodiment, the auxiliary material data corresponding to the situation in which the auxiliary material addition does not meet the production requirements in the historical data is substituted into the specific restriction expression of the auxiliary material addition accuracy index to obtain the corresponding data set, and the result of the mean operation of the data set is recorded as the auxiliary material threshold.

[0064] Specifically, the standardized deviation is obtained from a preset database. In a specific embodiment, the standardized deviation is specifically set by a professional drug preparation personnel according to the production requirements of the Qingqian Fuling drug composition.

[0065] An embodiment of the present application provides an intelligent supervision method based on the production of Qingqian Poria drug composition, comprising the following steps: obtaining a formula proportion control index by acquiring the ratio data of the drug batch to be produced, and performing a ratio diversion process on the drug batch to be produced based on the formula proportion control index, wherein the formula proportion control index is used to reflect the degree of standardization of the raw material ratio of the Qingqian Poria drug; obtaining a drug standardization evaluation index by acquiring the component detection data of the drug batch to be produced and performing a standardization diversion process on the drug batch to be produced, wherein the drug standardization evaluation index is used to reflect the degree of standardization of the extract of the Qingqian Poria drug; obtaining an excipient addition accuracy index by acquiring the excipient data of the drug batch to be produced and performing an excipient diversion process on the drug batch to be produced, wherein the excipient addition accuracy index is used to evaluate the accuracy of the injection amount of excipients and additives.

[0066] In this embodiment, by controlling and diverting the three major indicators of the formula ratio, ingredient standardization and auxiliary material addition of the Qingqian Fuling pharmaceutical composition, the production efficiency, drug quality and the intelligence level of the production process are effectively improved, and the accuracy of the processing supervision of the Qingqian Fuling pharmaceutical composition is also improved.

[0067] To summarize, the embodiment of the present application performs a proportioning and diversion process on the drugs to be produced batches through a formula proportion control index, then performs a standardization and diversion process on the drugs to be produced batches through a drug standardization evaluation index, and finally performs an excipient addition accuracy index and an excipient diversion process on the drugs to be produced batches, thereby improving the preparation quality of the drugs to be produced batches, thereby achieving the improvement of the accuracy of the processing supervision of the Qingqian Fuling drug composition, and effectively solving the problem of inaccurate processing supervision of the Qingqian Fuling drug composition in the prior art.

[0068] 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.

[0069] The present invention is described with reference to flowcharts and / or block diagrams of systems, 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.

[0070] 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.

[0071] 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.

[0072] 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.

[0073] 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. An intelligent supervision system based on the production of Qingqian Poria cocos drug composition, characterized in that: include: Formula ratio control module, ingredient standardization module and auxiliary material additive detection module: Among them, the formula ratio control module is used to obtain the ratio data of the batch of drugs to be produced to obtain the formula ratio control index, and perform ratio diversion processing on the batch of drugs to be produced based on the formula ratio control index. The formula ratio control index is used to reflect the standardization degree of the raw material ratio of the Qingqian Fuling drug; The component standardization module is used to obtain the component detection data of the batch of drugs to be produced to obtain the drug standardization evaluation index and perform standardized diversion processing on the batch of drugs to be produced, and the drug standardization evaluation index is used to reflect the standardization degree of the extract of the Qingqian Fuling drug; The excipient additive detection module is used to obtain the excipient data of the batch of drugs to be produced to obtain the excipient addition accuracy index and perform excipient diversion processing on the batch of drugs to be produced. The excipient addition accuracy index is used to evaluate the accuracy of the injection amount of excipients and additives.

2. The intelligent monitoring system based on the production of the Qingqian Poria cocos drug composition according to claim 1, characterized in that: The ratio data include the total flavonoids content of green money, the polysaccharide content extracted from Poria cocos, the feed ratio and the batch composition difference; The component detection data include the content of flavonoids in green money, the content of total polysaccharides in Poria cocos, the content of triterpenes in Poria cocos and the content of impurities; The impurity content data include residual solvent content, heavy metal content and pesticide residue content; The excipient data include excipient pH value, active ingredient content change rate, excipient heavy metal content, microbial content and active ingredient retention rate.

3. The intelligent monitoring system based on the production of the Qingqian Poria cocos drug composition according to claim 2, characterized in that: The specific steps of the formula ratio control index are as follows: A1, number the batches of drugs to be produced; A2, obtaining reference ratio data from a preset database, wherein the reference ratio data includes a reference range of flavonoid content, a reference range of polysaccharide content and a standard feed ratio; A3, comparing the total flavonoid content of the green pine nuts with the reference range of the flavonoid content, and obtaining a corresponding flavonoid content deviation according to the comparison result, wherein the flavonoid content deviation represents the absolute value of the difference between the total flavonoid content of the green pine nuts and the reference range of the flavonoid content, and the reference range of the flavonoid content represents the range corresponding to the reference minimum value of the flavonoid content and the reference maximum value of the flavonoid content; A4, comparing the content of Poria cocos polysaccharide with the reference range of polysaccharide content, and obtaining a corresponding polysaccharide content deviation according to the comparison result, wherein the polysaccharide content deviation represents the absolute value of the difference between the content of Poria cocos polysaccharide and the reference range of polysaccharide content, and the reference range of polysaccharide content represents the range corresponding to the reference minimum value of the polysaccharide content and the reference maximum value of the polysaccharide content; A5, the formula ratio control index is obtained according to the flavonoid content deviation, polysaccharide content deviation, standard feed ratio and ratio data.

4. The intelligent monitoring system based on the production of the Qingqian Poria cocos drug composition as claimed in claim 3, characterized in that: The specific limiting expression of the formula ratio control index is as follows: In the formula, n represents the number of the batch of drugs to be produced, , represents the total number of batches of drug to be produced, represents the flavonoid content deviation of the nth batch of drugs to be produced, represents the polysaccharide content deviation of the nth batch of drug to be produced, It represents the feed ratio of the nth batch of drugs to be produced. represents the batch composition difference of the nth batch of drugs to be produced, Indicates the standard feed ratio, Represents the formula ratio control index of the nth batch of drugs to be produced.

5. The intelligent monitoring system based on the production of the Qingqian Poria cocos drug composition according to claim 1, characterized in that: The specific process of performing the proportion diversion process on the production batch of drugs based on the formula proportion control index is as follows: If the formula ratio control index is less than the ratio threshold value obtained from the preset database, the ratio deviation is obtained from the preset database, and the difference between the formula ratio control index and the ratio threshold value is recorded as the ratio control deviation value; Compare the ratio control deviation value with the ratio deviation. If the ratio control deviation value is less than the ratio deviation, the drug batch to be produced is diverted to the ratio rework line; otherwise, the drug batch to be produced is diverted to the isolation line; The proportioning rework line is used to retransmit the batch of drugs to be produced for proportioning adjustment; The isolation line is used to transfer production batches of drugs to drug isolation containers.

6. The intelligent monitoring system based on the production of the Qingqian Poria cocos drug composition according to claim 2, characterized in that: The specific process of obtaining the drug standardization evaluation index is as follows: Acquire reference component data from a preset database, wherein the reference component data includes reference indicators and reference deviations, wherein the reference indicators include monomer flavonoid content indicators, Poria cocos total polysaccharide content indicators, and Poria cocos triterpenoid content indicators, and the reference deviations include monomer flavonoid content deviations, Poria cocos total polysaccharide content deviations, and Poria cocos triterpenoid content deviations; Performing data preprocessing on the impurity content data, wherein the data preprocessing is used to unify the dimensions of the impurity content data; Obtaining standardized analysis weights from a preset database, wherein the standardized analysis weights include effective ingredient content weights and impurity content weights; Obtaining an indicator evaluation index based on the reference indicator and the component detection data, wherein the indicator evaluation index is used to quantify the content of the active ingredient in the batch of drugs to be produced; The drug standardization evaluation index was obtained based on the indicator evaluation index, impurity content data, reference deviation and standardized analysis weight.

7. The intelligent monitoring system based on the production of the Qingqian Poria cocos drug composition according to claim 6, characterized in that: The specific process of the standardized diversion process for the production batch of drugs is as follows: If the drug standardization evaluation index is less than the standardization threshold value obtained from the preset database, a standardization deviation is obtained from the preset database, and the difference between the drug standardization evaluation index and the standardization threshold value is recorded as a standardization deviation value; Compare the standardized deviation with the standardized deviation. If the standardized deviation is less than the standardized deviation, the drug batch to be produced is diverted to the standardized rework line; otherwise, the drug batch to be produced is diverted to the destruction line; The standardized rework line is used to retransmit the batches of drugs to be produced for standardized adjustment; The destruction line is used to convey the production batch of drugs to the drug destruction machine.

8. The intelligent monitoring system based on the production of the Qingqian Poria cocos drug composition as claimed in claim 2, characterized in that: The specific process of obtaining the auxiliary material addition accuracy index is as follows: Obtain the minimum pH value of the reference auxiliary material and the maximum pH value of the reference auxiliary material from a preset database; The excipient pH value index is obtained according to the excipient pH value, the minimum reference excipient pH value and the maximum reference excipient pH value; The auxiliary material pH index and the change rate of the active ingredient content, the sum of the auxiliary material heavy metal content and microbial content, and the active ingredient retention rate were processed respectively to obtain the auxiliary material addition accuracy index.

9. The intelligent monitoring system based on the production of the Qingqian Poria cocos drug composition according to claim 8, characterized in that: The specific process of the auxiliary material diversion process for the production batch of drugs is as follows: If the auxiliary material addition accuracy index is less than the auxiliary material threshold value obtained from the preset database, the auxiliary material deviation is obtained from the preset database, and the difference between the auxiliary material addition accuracy index and the auxiliary material threshold value is recorded as the auxiliary material deviation value; Compare the excipient deviation value with the excipient deviation. If the excipient deviation value is less than the excipient deviation, the drug batch to be produced is diverted to the excipient rework line; otherwise, the drug batch to be produced is diverted to the destruction line; The excipient rework line is used to retransmit the batch of drugs to be produced for excipient addition and adjustment.

10. An intelligent supervision method based on the production of Qingqian Poria cocos drug composition, characterized in that: The following steps are involved: The formula ratio control index is obtained by obtaining the ratio data of the batch of drugs to be produced, and the batch of drugs to be produced is subjected to ratio diversion processing based on the formula ratio control index, wherein the formula ratio control index is used to reflect the standardization degree of the raw material ratio of the Qingqian Fuling drug; Obtaining the drug standardization evaluation index by obtaining the component detection data of the batch of drugs to be produced and performing standardized diversion processing on the batch of drugs to be produced, wherein the drug standardization evaluation index is used to reflect the degree of standardization of the extract of the Qingqian Fuling drug; The excipient addition accuracy index is obtained by acquiring the excipient data of the batch of drugs to be produced and performing excipient diversion processing on the batch of drugs to be produced. The excipient addition accuracy index is used to evaluate the accuracy of the injection amount of excipients and additives.

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