Drug quality traceability method and system based on blockchain

Abstract

The present invention belongs to the technical field of drug quality supervision, and specifically relates to a drug quality traceability method and system based on blockchain. The method includes authenticating the identity of drug quality traceability participants, obtaining a blockchain drug traceability data set and judging whether the blockchain drug traceability data set is complete, judging whether the drug storage process quality, drug packaging process quality, and drug production process quality are qualified. The present invention solves the problem that the traditional drug traceability system often relies on information transmission and recording between various links, data islands are ubiquitous, it is difficult to form a complete traceability system throughout the entire life cycle of drugs, and the integrity of data is insufficiently considered, and the storage, packaging and production processes are gradually analyzed and judged. The present invention realizes the tracing of the drug life cycle, ensures that the quality of each link meets the standards, significantly improves the overall quality of drugs, reduces the risk of unqualified products, and protects the health and safety of consumers.

Description

Technical Field

[0001] The present invention relates to the technical field of drug quality supervision, and specifically to a drug quality traceability method and system based on blockchain. Background Art

[0002] The supply chain of drugs from production to sales involves multiple links, including raw material procurement, production and processing, warehousing and transportation, and distribution and sales, and problems may occur in each link.

[0003] However, due to the complexity of the supply chain, it is difficult to fully track drugs. Blockchain technology, with its decentralized, tamper-proof and transparent characteristics, provides new ideas for the drug traceability system. However, the traditional drug traceability system often relies on information transmission and recording between various links. Data islands are common, making it difficult to form a complete traceability system throughout the entire life cycle of drugs, and insufficient consideration of data integrity. Due to the data island phenomenon, the data between various links cannot be seamlessly connected, resulting in the inability to form a complete traceability system throughout the entire life cycle of drugs, which means that when problems arise, the root cause of the problem cannot be accurately and quickly traced, thereby delaying the resolution of the problem, which may lead to the continued circulation of inferior drugs and increase consumer health risks. Although blockchain technology can ensure the immutability of data on the chain, if the data is incomplete or tampered with before data entry, the credibility of the entire traceability system will be greatly reduced. Summary of the invention

[0004] In view of the shortcomings of the existing technology, the present invention provides a blockchain-based drug quality traceability method and system, which realizes the traceability of the drug life cycle, ensures that the quality of each link meets the standards, and significantly improves the overall quality of the drug.

[0005] To achieve the above objectives, the present invention is implemented through the following technical solutions: 1. A drug quality traceability method based on blockchain, comprising the following steps:

[0006] Perform identity verification on drug quality traceability participants to determine whether the identity verification of drug quality traceability participants has been passed;

[0007] Drug quality traceability participants who have passed identity authentication obtain blockchain drug traceability data sets, which specifically include drug storage traceability data sets, drug packaging traceability data sets, and drug production traceability data sets;

[0008] Determine whether the blockchain drug traceability data set is complete;

[0009] Based on the complete blockchain drug traceability data set, the drug storage traceability data set is analyzed to determine whether the quality of the drug storage process is qualified;

[0010] Analyze the drug packaging traceability data set with qualified drug storage process quality to determine whether the drug packaging process quality is qualified;

[0011] Analyze the drug production traceability data set with qualified drug packaging process quality to determine whether the drug production process quality is qualified.

[0012] Preferably, the process of determining whether the identity verification of the drug quality traceability participant is passed is as follows:

[0013] Obtaining a participant identity authentication status data set, the participant identity authentication status data set specifically includes the total duration of a single identity authentication of the participant, the total number of single identity authentication failures of the participant, and the total number of single biometric identity authentication failures of the participant;

[0014] The total duration of a participant's single identity authentication, the total number of failed single identity authentication attempts, and the total number of failed single biometric identity authentication attempts of the participant are stored as a designated tag, and the designated tag is compared with each set tag stored in the database to determine the set tag corresponding to the designated tag, and obtain the identity authentication status evaluation value corresponding to the set tag;

[0015] comparing the authentication status evaluation value with an authentication status reference evaluation value stored in a database;

[0016] If the identity verification status evaluation value is not lower than the identity verification status reference evaluation value, the identity verification of the drug quality traceability participant corresponding to the identity verification status evaluation value is passed;

[0017] If the identity authentication status evaluation value is lower than the identity authentication status reference evaluation value, the identity authentication of the drug quality traceability participant corresponding to the identity authentication status evaluation value fails, and an alarm is issued for the identity authentication process of the drug quality traceability participant who fails the identity authentication.

[0018] Preferably, the drug warehouse traceability data set specifically includes the absolute value of the difference between the drug warehouse temperature and the reference temperature, the absolute value of the difference between the drug warehouse humidity and the reference humidity, and the absolute value of the difference between the drug warehouse light intensity and the reference light intensity.

[0019] Preferably, the drug packaging traceability data set specifically includes the absolute value of the difference between the drug packaging temperature and the reference temperature, the absolute value of the difference between the drug packaging pressure and the reference pressure, and the absolute value of the difference between the drug packaging gas permeability and the reference gas permeability.

[0020] Preferably, the drug production traceability data set specifically includes the absolute value of the difference between the drug production temperature and the reference temperature, the absolute value of the difference between the mixing speed of each drug component and the reference mixing speed, and the absolute value of the difference between the reaction time of each drug production component and the reference reaction time.

[0021] Preferably, the process of determining whether the blockchain drug traceability data set is complete is as follows:

[0022] Obtain the complete status data set of the drug traceability data set, which specifically includes the absolute value of the difference between the total number of drug traceability data and the total number of reference data, the absolute value of the difference between the actual update number of drug traceability data and the reference update number, and the number of abnormal storage times of drug traceability data;

[0023] Based on the obtained complete status data set of the drug traceability data set, a comprehensive analysis is performed to obtain the complete status evaluation value of the data set, which is used as the analysis basis for judging whether the blockchain drug traceability data set is complete;

[0024] comparing the data set integrity status assessment value with the data set integrity status delimitation assessment value stored in the database;

[0025] If the complete status assessment value of the data set is not lower than the complete status delimitation assessment value of the data set, then the blockchain drug traceability data set corresponding to the complete status assessment value of the data set is complete;

[0026] If the complete status assessment value of the data set is lower than the complete status definition assessment value of the data set, the blockchain drug traceability data set corresponding to the complete status assessment value of the data set is incomplete, and an incomplete prompt is issued for the incomplete blockchain drug traceability data set.

[0027] Preferably, the process of judging whether the quality of the drug storage process is qualified is as follows:

[0028] Based on the obtained drug storage traceability data set, a comprehensive analysis is performed to obtain the drug storage quality assessment value, which is used as the analysis basis for judging whether the quality of the drug storage process is qualified;

[0029] The specific calculation formula for the drug storage quality assessment value is:

[0030] ;

[0031] In the formula, α is the evaluation value of drug storage quality, cw is the absolute value of the difference between drug storage temperature and reference temperature, cs is the absolute value of the difference between drug storage humidity and reference humidity, and cg is the absolute value of the difference between drug storage light intensity and reference light intensity. is the compensation factor of the set cw, is the compensation factor of the set cs, is the compensation factor of the set cg;

[0032] The drug storage quality assessment value will be compared with the drug storage quality definition assessment value stored in the database;

[0033] If the drug storage quality assessment value is not lower than the drug storage quality definition assessment value, the drug storage process quality corresponding to the drug storage quality assessment value is qualified;

[0034] If the drug storage quality assessment value is lower than the drug storage quality definition assessment value, the drug storage process quality corresponding to the drug storage quality assessment value is unqualified, and a storage process quality unqualified prompt will be issued for the drugs with unqualified storage process quality.

[0035] Preferably, the process of judging whether the quality of the drug packaging process is qualified is as follows:

[0036] Based on the obtained drug packaging traceability data set, a comprehensive analysis is performed to obtain a drug packaging quality assessment value, which is used as an analysis basis for judging whether the quality of the drug packaging process is qualified;

[0037] The specific calculation formula for the drug packaging quality assessment value is:

[0038] ;

[0039] Where, β is the drug packaging quality assessment value, fw is the absolute value of the difference between the drug packaging temperature and the reference temperature, fy is the absolute value of the difference between the drug packaging pressure and the reference pressure, ft is the absolute value of the difference between the drug packaging gas permeability and the reference gas permeability, is the compensation factor of the set fw, is the compensation factor of the set fy, is the compensation factor of the set ft, and e is a natural constant;

[0040] The drug packaging quality assessment value will be compared with the drug packaging quality definition assessment value stored in the database;

[0041] If the drug packaging quality assessment value is not lower than the drug packaging quality definition assessment value, the drug packaging process quality corresponding to the drug packaging quality assessment value is qualified;

[0042] If the drug packaging quality assessment value is lower than the drug packaging quality definition assessment value, the drug packaging process quality corresponding to the drug packaging quality assessment value is unqualified, and a packaging process quality unqualified prompt is issued for the drug with unqualified packaging process quality.

[0043] Preferably, the process of judging whether the quality of the drug production process is qualified is as follows:

[0044] Based on the obtained drug production traceability data set, a comprehensive analysis is performed to obtain the drug production quality assessment value, which is used as the analytical basis for judging whether the quality of the drug production process is qualified;

[0045] The specific calculation formula for the drug production quality assessment value is:

[0046] ;

[0047] In the formula, γ is the drug production quality assessment value, sw is the absolute value of the difference between the drug production temperature and the reference temperature, sh is the absolute value of the difference between the mixing speed of each component of the drug and the reference mixing speed, sf is the absolute value of the difference between the reaction time of each component of the drug production and the reference reaction time, is the compensation factor of the set sw, is the compensation factor of the set sh, is the compensation factor of the set sf;

[0048] The drug manufacturing quality assessment value will be compared with the drug manufacturing quality qualification assessment value stored in the database;

[0049] If the drug production quality assessment value is not lower than the drug production quality definition assessment value, the drug production process quality corresponding to the drug production quality assessment value is qualified;

[0050] If the drug production quality assessment value is lower than the drug production quality definition assessment value, the drug production process quality corresponding to the drug production quality assessment value is unqualified, and a production process quality unqualified prompt will be issued for the drug with unqualified production process quality.

[0051] The drug quality traceability system based on blockchain is used to implement the above-mentioned drug quality traceability method based on blockchain, including an identity authentication judgment module, a traceability data set acquisition module, a data set completeness judgment module, a storage quality qualified judgment module, a packaging quality qualified judgment module and a production quality qualified judgment module, wherein:

[0052] The identity authentication judgment module is used to authenticate the identity of the drug quality traceability participant and determine whether the identity authentication of the drug quality traceability participant has been passed;

[0053] The traceability data set acquisition module is used by drug quality traceability participants who have passed identity authentication to obtain blockchain drug traceability data sets. The blockchain drug traceability data sets specifically include drug storage traceability data sets, drug packaging traceability data sets, and drug production traceability data sets.

[0054] The data set integrity judgment module is used to determine whether the blockchain drug traceability data set is complete;

[0055] The storage quality judgment module is used to analyze the drug storage traceability data set based on the complete blockchain drug traceability data set to determine whether the quality of the drug storage process is qualified;

[0056] The packaging quality judgment module is used to analyze the drug packaging traceability data set with qualified drug storage process quality to determine whether the drug packaging process quality is qualified;

[0057] The production quality qualification judgment module is used to analyze the drug production traceability data set with qualified drug packaging process quality to determine whether the drug production process quality is qualified.

[0058] The present invention has the following advantages:

[0059] The present invention authenticates the participants of drug quality traceability to ensure that only authorized personnel or institutions can access the drug traceability data on the blockchain, which helps prevent unauthorized access and ensures data security. Before any analysis, it first determines whether the blockchain drug traceability data set is complete to ensure that data from all key links have been recorded and available. Data integrity is a prerequisite for reliable analysis and decision-making, and prevents misjudgments due to missing data. The gradual analysis and judgment of the warehousing, packaging and production processes realizes the traceability of the drug life cycle, ensuring that the quality of each link meets the standards. Strict quality control can significantly improve the overall quality of drugs and reduce the risk of product failures.

[0060] The present invention performs identity verification on drug quality traceability participants to determine whether the identity verification of drug quality traceability participants has been passed. Identity verification can effectively prevent unauthorized individuals or organizations from accessing the drug quality traceability system. Only verified legitimate participants can view or submit traceability data, thereby protecting data security in the system. Through identity verification, the traceability system can ensure that all participants are legally authorized, which provides a basis for the overall credibility of the system.

[0061] The present invention determines whether the blockchain drug traceability data set is complete and confirms the integrity of the data set, ensuring that all data recorded on the blockchain are accurately recorded and saved without omissions or damage. A complete data set is a prerequisite for correct analysis and decision-making. In the blockchain drug traceability system, any missing or inconsistent data will affect the traceability and supervision of drug quality. Judging whether the data set is complete can timely discover and correct these problems and ensure the accuracy of traceability information. When conducting drug quality analysis, only complete data can provide a comprehensive perspective to help companies accurately identify problems and take corresponding improvement measures. Missing data may lead to deviations in analysis results, thereby affecting decision-making. BRIEF DESCRIPTION OF THE DRAWINGS

[0062] Figure 1 It is a schematic diagram of the method steps of the present invention;

[0063] Figure 2 It is a schematic diagram of system module connection of the present invention;

[0064] Figure 3 is the drug storage quality assessment value α along with cw and Changing three-dimensional images;

[0065] Figure 4 This is an image of the drug storage quality assessment value α changing with cw. DETAILED DESCRIPTION

[0066] The technical solutions in the embodiments of the present invention are clearly and completely described below in conjunction with the accompanying drawings.

[0067] Example 1: Figure 1 As shown, the drug quality traceability method based on blockchain includes: authenticating the identities of drug quality traceability participants, and determining whether the identity authentication of drug quality traceability participants is passed.

[0068] The specific analysis process is as follows: obtaining a data set of participant identity authentication status, which specifically includes the total duration of a single identity authentication of the participant, the total number of single identity authentication failures of the participant, and the total number of single biometric identity authentication failures of the participant; storing the total duration of a single identity authentication of the participant, the total number of single identity authentication failures of the participant, and the total number of single biometric identity authentication failures of the participant as a designated tag, comparing the designated tag with each set tag stored in a database, determining a set tag corresponding to the designated tag, and obtaining an identity authentication status evaluation value corresponding to the set tag;

[0069] The identity authentication status evaluation value is compared with the identity authentication status reference evaluation value stored in the database; if the identity authentication status evaluation value is not lower than the identity authentication status reference evaluation value, the identity authentication of the drug quality traceability participant corresponding to the identity authentication status evaluation value passes; if the identity authentication status evaluation value is lower than the identity authentication status reference evaluation value, the identity authentication of the drug quality traceability participant corresponding to the identity authentication status evaluation value fails, and an alarm prompt is issued for the identity authentication process of the drug quality traceability participant who fails the identity authentication.

[0070] The total duration of a participant's single identity authentication refers to the total time from the start of the participant's identity authentication process to the end of the successful or failed authentication, including the entire process of the participant inputting information, waiting for the system response, and performing the authentication operation. The starting and ending points of the authentication process are automatically marked by the system through a timer or software log record connected to the authentication system, and these timestamps are extracted through the background log or API to calculate the total duration; the total number of single identity authentication failures of participants refers to the total number of identity authentication failures caused by incorrect password input and biometric verification errors during a verification attempt, which can be counted through the failure log of the authentication system; the total number of single biometric identity authentication failures of participants refers to the number of times the participant fails to authenticate through biometrics (such as fingerprints, irises, facial recognition, etc.) during a single identity authentication process, such as fingerprint recognition mismatch, facial recognition failure, etc., which are obtained through the verification system connected to the biometric device.

[0071] A higher total number of authentication failures usually results in a longer total authentication time. Each failure may require the participant to re-authenticate, which increases the total time. If a password or biometric verification fails, the system will require the user to re-enter or perform other verification steps, which will extend the verification time. The total number of biometric authentication failures is part of the total number of authentication failures. If a user uses biometrics for authentication (such as fingerprint or facial recognition), each biometric failure will be recorded as a failure and included in the total number of authentication failures. If biometric authentication fails multiple times, it will also lead to an increase in the total authentication time. Especially after biometric failure, the user may need to choose other verification methods (such as password entry), which will further increase the time required for verification.

[0072] The evaluation of the identity authentication status of participants can ensure that only participants who have passed the verification can participate in the drug traceability process, avoid the participation of unauthorized or suspicious persons, and ensure the safety and reliability of the drug circulation process. When the participant's identity authentication status evaluation value is lower than the reference evaluation value, an alarm will be automatically issued, which can immediately discover and respond to potential safety hazards and reduce reliance on manual intervention; evaluating multiple indicators of a single identity authentication, including verification time, number of failures, etc., can more comprehensively judge the reliability of the verification process, reduce operational risks in identity authentication, and prevent malicious access. By analyzing the verification status of each participant, the strictness of the verification process can be adjusted according to the specific situation, further optimizing the identity authentication steps in the drug quality traceability process.

[0073] Drug quality traceability participants who have passed identity authentication will obtain the blockchain drug traceability data set, which specifically includes the drug storage traceability data set, drug packaging traceability data set, and drug production traceability data set.

[0074] The drug warehouse traceability data set includes the absolute value of the difference between the drug warehouse temperature and the reference temperature, the absolute value of the difference between the drug warehouse humidity and the reference humidity, and the absolute value of the difference between the drug warehouse light intensity and the reference light intensity.

[0075] The absolute value of the difference between the drug storage temperature and the reference temperature refers to the absolute value of the difference between the actual temperature in the storage environment and the preset reference temperature (or standard storage temperature), which reflects the degree of deviation of the storage temperature from the reference temperature. Temperature control has a key impact on the quality of drugs, especially for those drugs that need to be refrigerated or stored at a constant temperature. The real-time temperature of the storage environment is obtained through a temperature sensor; the absolute value of the difference between the drug storage humidity and the reference humidity refers to the absolute value of the difference between the actual humidity and the reference humidity in the storage environment. Humidity has a great impact on the storage of drugs, especially for drugs that are easy to absorb moisture. The deviation of humidity may cause quality problems of drugs. The humidity data in the storage environment is obtained through a humidity sensor; the absolute value of the difference between the drug storage light intensity and the reference light intensity refers to the absolute value of the difference between the actual light intensity in the storage environment and the set reference light intensity. Light has an impact on the stability of certain drugs. Excessive light may accelerate the degradation of drugs. Therefore, it is necessary to strictly control the light conditions and obtain the light intensity of the storage environment through a light sensor or a light meter.

[0076] Temperature, humidity and light are important environmental parameters that affect the stability of drugs. Any deviation of any parameter from the reference value will affect the quality and shelf life of the drug, and jointly determine whether the drug is stored in a suitable environment. If the difference of one or more parameters is too large, the drug may undergo chemical changes, degradation or failure. Temperature, humidity and light intensity often affect each other. The humidity in the air may decrease in a high temperature environment, causing the drug to lose water or deteriorate. The increase in temperature may also affect the effect of light, making the light more destructive to the drug. There is a certain coupling effect between these parameters. The absolute value of the three differences reflects the deviation between the storage environment and the ideal storage conditions. The larger the difference means that the environmental conditions deviate further from the reference standard, the higher the storage risk of the drug. The risk of drug quality is not determined by a single parameter, but by multiple parameters. When multiple parameters deviate from the reference value at the same time, the deterioration rate of the drug will accelerate, and the possibility of drug quality problems will increase.

[0077] The drug packaging traceability data set includes the absolute value of the difference between the drug packaging temperature and the reference temperature, the absolute value of the difference between the drug packaging pressure and the reference pressure, and the absolute value of the difference between the drug packaging gas permeability and the reference gas permeability.

[0078] The absolute value of the difference between the drug packaging temperature and the reference temperature refers to the absolute value of the difference between the actual packaging temperature and the preset reference temperature (or standard temperature) when packaging the drug. The packaging temperature usually has an important impact on the stability of the drug and the sealing effect of the packaging material. In particular, for heat sealing or cold sealing technology, the temperature data during packaging is obtained through a temperature sensor or a temperature control module of the heat sealing equipment; the absolute value of the difference between the drug packaging pressure and the reference pressure refers to the absolute value of the difference between the actual pressure (such as the pressure applied during packaging and sealing) and the set reference pressure during the packaging process. The packaging pressure directly affects the sealing effect of the packaging. If the pressure is insufficient, it may cause loose packaging and affect the shelf life of the drug. If the pressure is too high, it may damage the packaging material or the drug. The actual pressure applied during packaging is obtained through a pressure sensor or a pressure control module on the packaging equipment; the absolute value of the difference between the drug packaging gas permeability and the reference gas permeability The absolute value of the difference between the actual gas permeability of the drug packaging material and the reference gas permeability. The gas permeability refers to the ability of the packaging material to allow air to pass through. A higher gas permeability may cause the drug to be exposed to an adverse gas environment, thereby affecting the quality and stability of the drug. The actual gas permeability of the packaging material is obtained through a gas permeability tester.

[0079] Packaging temperature and packaging pressure are mutually influential factors in many packaging processes. Especially in the heat sealing process, the appropriate combination of temperature and pressure can ensure the sealing and integrity of the pharmaceutical packaging. If the temperature is insufficient, the packaging material may not achieve the expected bonding effect. If the pressure is too low, the packaging may not be firm. On the contrary, too high temperature or too high pressure may damage the packaging material. The packaging temperature affects the sealing of the packaging material, which in turn affects the gas permeability of the packaging. A higher packaging temperature can usually better seal the package and reduce the gas permeability; however, too high a temperature may also damage the material, resulting in increased gas permeability. The size of the packaging pressure directly affects the degree of adhesion of the packaging material and also affects the airtightness of the packaging. A higher pressure can ensure that the packaging material is more tightly bonded and reduce the gas permeability, but too high a pressure may cause excessive deformation or rupture of the material, which will increase the gas permeability.

[0080] The drug production traceability data set includes the absolute value of the difference between the drug production temperature and the reference temperature, the absolute value of the difference between the mixing speed of each drug component and the reference mixing speed, and the absolute value of the difference between the reaction time of each drug component and the reference reaction time.

[0081] The absolute value of the difference between the drug production temperature and the reference temperature refers to the absolute value of the difference between the actual production temperature and the reference temperature (standard or set production temperature) during the drug production process. Temperature control is crucial in drug production, especially in chemical reactions, drying, sterilization and other links. Too high or too low temperature will affect the chemical properties, stability and quality of the drug. Temperature monitoring is performed through temperature sensors or temperature control equipment; the absolute value of the difference between the mixing speed of each component of the drug and the reference mixing speed refers to the absolute value of the difference between the actual mixing speed of each component and the reference mixing speed (preset or standard mixing speed) during the production process. The mixing speed has an impact on the uniformity of the drug formula and the distribution of components. The mixing speed is obtained by the speed sensor on the mixing equipment. The absolute value of the difference between the reaction time of each component in drug production and the reference reaction time refers to the absolute value of the difference between the actual reaction time of each component and the reference reaction time (preset or standard reaction time) in the drug production process. The reaction time determines whether the chemical reaction is complete. Too long or too short will affect the effectiveness and purity of the product. Insufficient reaction may cause residual impurities or insufficient active ingredients in the drug, affecting the efficacy. It is recorded by the time control system or the reaction monitoring system.

[0082] Temperature and mixing speed are closely related in chemical reactions and physical mixing processes. Increased temperature usually speeds up the reaction rate and the diffusion rate of the components. Therefore, at high temperatures, the mixing speed may need to be adjusted to ensure that the components are evenly distributed. Too high a mixing speed may cause local temperature rise, thus affecting the equilibrium of the reaction. Temperature directly affects the reaction rate, which increases with increasing temperature. Therefore, at high temperatures, the reaction time may need to be shortened to avoid overreaction or side reactions. At low temperatures, the reaction may take longer to achieve the desired chemical conversion or output. The mixing speed affects the distribution and contact time of the reactants, which in turn affects the progress of the reaction. A faster mixing speed can accelerate the contact between the components, thereby shortening the reaction time. Too high a mixing speed may also cause excessive mechanical stress, affecting the normal progress of the reaction. Insufficient mixing or too low a speed may prolong the reaction time and result in incomplete reaction.

[0083] Determine whether the blockchain drug traceability data set is complete. The specific analysis process is: obtain the complete state data set of the drug traceability data set, which specifically includes the absolute value of the difference between the total number of drug traceability data and the total number of reference data, the absolute value of the difference between the actual number of updates of drug traceability data and the reference number of updates, and the number of abnormal storage of drug traceability data; based on the obtained complete state data set of the drug traceability data set, a comprehensive analysis is performed to obtain the complete state evaluation value of the data set, which is used as the analysis basis for determining whether the blockchain drug traceability data set is complete; compare the complete state evaluation value of the data set with the complete state definition evaluation value of the data set stored in the database; if the complete state evaluation value of the data set is not lower than the complete state definition evaluation value of the data set, then the blockchain drug traceability data set corresponding to the complete state evaluation value of the data set is complete; if the complete state evaluation value of the data set is lower than the complete state definition evaluation value of the data set, then the blockchain drug traceability data set corresponding to the complete state evaluation value of the data set is incomplete, and an incomplete prompt is issued for the incomplete blockchain drug traceability data set.

[0084] The absolute value of the difference between the total amount of drug traceability data and the total amount of reference data refers to the absolute value of the difference between the total amount of drug data recorded in the current drug traceability system and the total amount of preset reference standard data. It is used to evaluate whether the data in the system is complete, whether there is data omission or duplication, and the number of drug batches and logistics information that should be recorded in the system should be consistent with the total amount of standard records in the reference database. The total amount of data is compared through the blockchain node or database query system;

[0085] The absolute value of the difference between the actual update times and the reference update times of drug traceability data refers to the absolute value of the difference between the actual record update times in the drug traceability system and the preset reference standard update times. It reflects whether the data update frequency in the system meets expectations and ensures that the traceability data is updated in a timely and accurate manner. If the update times are too low, it may mean that the data in certain links are not correctly recorded or uploaded. The update times are tracked through the blockchain recording system or data monitoring tools. The number of abnormal drug traceability data saves refers to the number of abnormalities that occur during the drug traceability data preservation process, such as data preservation failure, incorrect format, failure to submit on time, etc. It is used to evaluate the stability and reliability of data preservation, ensure that each piece of data can be correctly stored in the blockchain or database, and count abnormal situations through the blockchain system's log records or data storage monitoring system.

[0086] There is a direct connection between the total number of drug traceability data and the number of updates. The larger the difference in the number of updates, the more likely it is that some data has not been updated on time or as needed, which in turn leads to abnormal deviations in the total number of data. If the data in some links are not updated or recorded in a timely manner, it may affect the integrity of the entire data set, resulting in an increase in the difference between the total number of data and the reference data. The increase in the number of abnormal saves usually directly affects the accuracy of the total number of data. When data save anomalies occur, some data may not be successfully saved, resulting in the total number of data being inconsistent with the expected value. If there are many save anomalies, the system may miss important records, resulting in a low total amount of data, or repeatedly save wrong data, resulting in a high total amount of data. The abnormal number of updates and the abnormal number of saves are interrelated. The increase in the number of abnormal saves may cause the data to not be updated correctly, thereby affecting the number of updates. Whenever a save anomaly occurs, the update record of the data may not be completed, resulting in the actual number of updates being lower than the reference standard.

[0087] By checking whether the data set is complete and issuing incomplete prompts, you can promptly discover missing data or abnormal updates, and ensure the integrity and accuracy of drug traceability data. Incomplete traceability data may make it impossible to accurately track the source and circulation of drugs, thereby increasing drug quality risks. Timely issuance of incomplete prompts can help prevent these risks and ensure that key information is not missed during the drug circulation and supervision process. Drug traceability systems usually need to comply with strict laws and industry regulations, such as GMP (Good Manufacturing Practice), etc. Through incomplete prompts, it can ensure that drug data complies with relevant regulatory requirements and reduce compliance risks. Drug production, distribution, sales and other links rely on complete traceability data to make decisions. If the data is incomplete, it may lead to wrong decisions, which in turn affects the market supply or regulatory review of drugs. Through incomplete prompts, relevant parties can avoid relying on erroneous or incomplete data to make decisions.

[0088] The complete status evaluation value of the data set. The specific analysis process is as follows:

[0089] ;

[0090] In the formula, is the complete status evaluation value of the data set, zs is the absolute value of the difference between the total number of drug traceability data and the total number of reference data, gx is the absolute value of the difference between the actual update times of drug traceability data and the reference update times, yc is the number of abnormal storage times of drug traceability data, is the compensation factor of the set zs, is the compensation factor of the set gx, is the compensation factor of the set yc.

[0091] When calculating each formula, normalization is performed as needed.

[0092] Analyzing the difference between the total number of drug traceability data and the total number of reference data, and the actual number of updates and the reference number of updates can timely discover problems with missing data or untimely updates, and ensure the integrity of drug traceability data, which is crucial to ensuring the transparency of drug production, packaging, warehousing and other links. The number of abnormal storage times can reflect whether there are abnormalities or errors in the data during the storage process. Evaluating these anomalies can help timely discover the source of data anomalies, avoid error propagation, and ensure data accuracy. When the evaluation value of the complete status of the data set is low, an alarm can be automatically issued to indicate that there are potential problems with the data, and timely measures can be taken to prevent drug quality traceability errors or regulatory loopholes caused by incomplete data.

[0093] The compensation factors of zs, gx, and yc are obtained from the database. Based on the historical data, the absolute value of the difference between the total number of historically measured drug traceability data and the total number of reference data, the absolute value of the difference between the actual number of updates of drug traceability data and the reference number of updates, the number of abnormal drug traceability data saves and the compensation factors of zs, gx, and yc are established to obtain the compensation factors of zs, gx, and yc corresponding to the current zs, gx, and yc. The compensation factors in the remaining formulas are obtained in the same way.

[0094] Based on the complete blockchain drug traceability data set, the drug storage traceability data set is analyzed to determine whether the quality of the drug storage process is qualified. The specific analysis process is: based on the acquired drug storage traceability data set, a comprehensive analysis is performed to obtain the drug storage quality assessment value, which is used as the analysis basis for determining whether the quality of the drug storage process is qualified;

[0095] The specific calculation formula for the drug storage quality assessment value is:

[0096] ;

[0097] In the formula, α is the evaluation value of drug storage quality, cw is the absolute value of the difference between drug storage temperature and reference temperature, cs is the absolute value of the difference between drug storage humidity and reference humidity, and cg is the absolute value of the difference between drug storage light intensity and reference light intensity. is the compensation factor of the set cw, is the compensation factor of the set cs, is the compensation factor of the set cg;

[0098] like Figure 3 , Figure 4As shown in the figure, the drug storage quality assessment value α decreases with the increase of cw. The larger the drug storage quality assessment value, the better the drug storage quality. Changes in drug storage temperature, humidity and light intensity directly affect the quality and shelf life of drugs. Monitoring the difference between these parameters and the reference values ​​can ensure that the storage environment meets the standard requirements for drug storage and avoid drug quality degradation or failure due to improper environment. Continuous monitoring and calculation of assessment values ​​can issue unqualified prompts when storage environment conditions deviate, and take corrective measures in time to prevent environmental conditions from having irreversible effects on drugs. This is of great significance to avoid large quantities of drugs being scrapped due to improper storage. Automated data evaluation can reduce the need for manual testing and supervision, making storage environment monitoring more efficient. Data-based evaluation can also help discover hidden dangers and trends in long-term storage management and improve storage management levels.

[0099] The drug storage quality assessment value will be compared with the drug storage quality definition assessment value stored in the database; if the drug storage quality assessment value is not lower than the drug storage quality definition assessment value, the drug storage process quality corresponding to the drug storage quality assessment value is qualified; if the drug storage quality assessment value is lower than the drug storage quality definition assessment value, the drug storage process quality corresponding to the drug storage quality assessment value is unqualified, and a storage process quality unqualified prompt will be issued for the drugs with unqualified storage process quality.

[0100] Monitoring of warehouse quality assessment values ​​can timely discover possible problems in the storage process, such as deviations in parameters such as temperature, humidity or light. After issuing an unqualified prompt, warehouse management personnel can quickly take measures to avoid further damage to drug quality. The storage environment of drugs directly affects their quality. Unqualified storage conditions may cause drugs to become invalid or deteriorate. Through unqualified prompts, it can ensure that drugs meet specifications during storage and maximize the effectiveness and safety of drugs. If drugs are prompted with unqualified quality during the storage process, managers can promptly prevent unqualified drugs from entering the market and reduce the risk of drug recalls. Real-time monitoring of the storage process and issuing unqualified prompts can ensure transparent management of the storage process. Through unqualified prompts, warehouse management personnel can analyze the causes of unqualified, optimize the storage environment and processes, thereby improving the overall management level and reducing the occurrence of unqualified events in the future.

[0101] Analyze the drug packaging traceability data set with qualified drug storage process quality to determine whether the drug packaging process quality is qualified. The specific analysis process is: Based on the obtained drug packaging traceability data set, a comprehensive analysis is performed to obtain the drug packaging quality evaluation value, which is used as the analysis basis for determining whether the drug packaging process quality is qualified;

[0102] The specific calculation formula for the drug packaging quality assessment value is:

[0103] ;

[0104] Where, β is the drug packaging quality assessment value, fw is the absolute value of the difference between the drug packaging temperature and the reference temperature, fy is the absolute value of the difference between the drug packaging pressure and the reference pressure, ft is the absolute value of the difference between the drug packaging gas permeability and the reference gas permeability, is the compensation factor of the set fw, is the compensation factor of the set fy, is the compensation factor of the set ft, and e is a natural constant;

[0105] The difference in drug packaging temperature, pressure and gas permeability directly affects the sealing and protective properties of the packaging. Monitoring the difference between these parameters and the reference values ​​can ensure that the packaging process meets the standards and avoid problems such as moisture, oxidation and deterioration of drugs due to improper packaging, thereby ensuring the quality of drugs during circulation. Deviations in packaging temperature and pressure will affect the performance and sealing of packaging materials. Deviations in gas permeability may cause changes in the gas environment inside the package, thereby affecting the shelf life of the drugs. Evaluating these differences can ensure that the packaging provides suitable storage conditions for the drugs and extend their shelf life. The drug packaging quality assessment value provides important data support for the traceability system. If a drug has quality problems after packaging, it can be quickly traced back to the packaging link by analyzing the differences in temperature, pressure and gas permeability during the packaging process, locate the source of the problem and reduce unnecessary losses.

[0106] The drug packaging quality assessment value will be compared with the drug packaging quality definition assessment value stored in the database; if the drug packaging quality assessment value is not lower than the drug packaging quality definition assessment value, the drug packaging process quality corresponding to the drug packaging quality assessment value is qualified; if the drug packaging quality assessment value is lower than the drug packaging quality definition assessment value, the drug packaging process quality corresponding to the drug packaging quality assessment value is unqualified, and a packaging process quality unqualified prompt will be issued for the drugs with unqualified packaging process quality.

[0107] Packaging quality directly affects the stability and protection of drugs. Unqualified packaging may cause drugs to be exposed to adverse environments, affecting their shelf life and safety. Unqualified prompts can ensure that packaging quality meets requirements and protect the stability and effectiveness of drugs. Unqualified prompts can promote the standardization and consistency of packaging processes. By analyzing the reasons for unqualified products, companies can improve packaging processes to ensure that each batch of products meets the same high quality standards. Packaging quality monitoring and unqualified prompts can optimize the management of the entire supply chain. Every link from packaging material procurement to finished product packaging is effectively controlled to ensure the quality of the final product. Unqualified prompts are based on data analysis and can help companies establish a more scientific and accurate quality control system, reduce human judgment errors, and improve the efficiency and accuracy of quality management.

[0108] Analyze the drug production traceability data set with qualified drug packaging process quality to determine whether the drug production process quality is qualified. The specific analysis process is: based on the obtained drug production traceability data set, a comprehensive analysis is performed to obtain the drug production quality assessment value, which is used as the analysis basis for determining whether the drug production process quality is qualified;

[0109] The specific calculation formula for the drug production quality assessment value is:

[0110] ;

[0111] In the formula, γ is the drug production quality assessment value, sw is the absolute value of the difference between the drug production temperature and the reference temperature, sh is the absolute value of the difference between the mixing speed of each component of the drug and the reference mixing speed, sf is the absolute value of the difference between the reaction time of each component of the drug production and the reference reaction time, is the compensation factor of the set sw, is the compensation factor of the set sh, is the compensation factor of the set sf;

[0112] The difference in drug production temperature, ingredient mixing speed and reaction time reflects the difference between the actual implementation of the production process and the standard process. Evaluating these differences can ensure the stability and consistency of the drug production process and avoid product quality fluctuations caused by deviations of production parameters from the standard. Drug production temperature, mixing speed and reaction time are crucial to the effectiveness and stability of drugs. By strictly controlling the difference between these parameters and reference values, problems such as uneven drug ingredients, insufficient or excessive reaction of active substances can be reduced, ensuring that the drugs have the expected efficacy and safety. The temperature, mixing speed and reaction time are evaluated digitally. When a parameter exceeds the set range, the system can issue an unqualified prompt to determine the source of the problem.

[0113] The drug production quality assessment value will be compared with the drug production quality definition assessment value stored in the database; if the drug production quality assessment value is not lower than the drug production quality definition assessment value, the drug production process quality corresponding to the drug production quality assessment value is qualified; if the drug production quality assessment value is lower than the drug production quality definition assessment value, the drug production process quality corresponding to the drug production quality assessment value is unqualified, and a production process quality unqualified prompt will be issued for the drugs with unqualified production process quality.

[0114] The quality of drug production directly affects the efficacy and safety of drugs. Unqualified production processes may result in substandard drug ingredients or insufficient efficacy. Through unqualified prompts, companies can ensure that only drugs that meet the standards enter the market and protect the health of users. Unqualified prompts can help companies identify problems in the production process in a timely manner, such as equipment failure, raw material quality problems or improper operation. Timely discovery and correction of these problems can avoid further expansion of errors in the production process and reduce scrap rates and losses. If unqualified drugs enter the market, it may trigger large-scale recalls, causing economic losses and brand damage. Through unqualified prompts, problems can be discovered before drugs enter the market, thereby reducing the risk and cost of recalls. By analyzing the frequency and causes of unqualified prompts, companies can identify and optimize bottlenecks or inefficient links in the production process, thereby improving production efficiency and resource utilization.

[0115] Traceability is the process of tracking the production and distribution of drugs from storage, packaging, and production. The purpose is to trace the problem back to its source to determine the quality problem or responsibility and find the root cause of the problem.

[0116] Example 2: Figure 2 As shown, the blockchain-based drug quality traceability system is used to implement the method of Example 1, including an identity authentication judgment module, a traceability data set acquisition module, a data set completeness judgment module, a storage quality qualified judgment module, a packaging quality qualified judgment module and a production quality qualified judgment module.

[0117] The identity authentication judgment module is used to authenticate the identity of the drug quality traceability participants and determine whether the identity authentication of the drug quality traceability participants has been passed.

[0118] The traceability data set acquisition module is used for drug quality traceability participants who have passed identity authentication to obtain blockchain drug traceability data sets. The blockchain drug traceability data sets specifically include drug storage traceability data sets, drug packaging traceability data sets, and drug production traceability data sets.

[0119] The data set integrity judgment module is used to determine whether the blockchain drug traceability data set is complete.

[0120] The storage quality judgment module is used to analyze the drug storage traceability data set based on the complete blockchain drug traceability data set to determine whether the quality of the drug storage process is qualified.

[0121] The packaging quality judgment module is used to analyze the drug packaging traceability data set with qualified quality in the drug storage process to determine whether the quality of the drug packaging process is qualified.

[0122] The production quality qualification judgment module is used to analyze the drug production traceability data set with qualified drug packaging process quality to determine whether the drug production process quality is qualified.

Claims

1. The drug quality traceability method based on blockchain is characterized by: The following steps are involved: Perform identity verification on drug quality traceability participants to determine whether the identity verification of drug quality traceability participants has been passed; Obtaining a participant identity authentication status data set, the participant identity authentication status data set specifically includes the total duration of a single identity authentication of the participant, the total number of single identity authentication failures of the participant, and the total number of single biometric identity authentication failures of the participant; The total duration of a participant's single identity authentication, the total number of failed single identity authentication attempts, and the total number of failed single biometric identity authentication attempts of the participant are stored as a designated tag, and the designated tag is compared with each set tag stored in the database to determine the set tag corresponding to the designated tag, and obtain the identity authentication status evaluation value corresponding to the set tag; comparing the authentication status evaluation value with an authentication status reference evaluation value stored in a database; If the identity verification status evaluation value is not lower than the identity verification status reference evaluation value, the identity verification of the drug quality traceability participant corresponding to the identity verification status evaluation value is passed; If the identity authentication status evaluation value is lower than the identity authentication status reference evaluation value, the identity authentication of the drug quality traceability participant corresponding to the identity authentication status evaluation value fails, and an alarm is issued for the identity authentication process of the drug quality traceability participant who fails the identity authentication; Drug quality traceability participants who have passed identity authentication obtain blockchain drug traceability data sets, which specifically include drug storage traceability data sets, drug packaging traceability data sets, and drug production traceability data sets; Determine whether the blockchain drug traceability data set is complete; Obtain the complete status data set of the drug traceability data set, which specifically includes the absolute value of the difference between the total number of drug traceability data and the total number of reference data, the absolute value of the difference between the actual update number of drug traceability data and the reference update number, and the number of abnormal storage times of drug traceability data; Based on the obtained complete status data set of the drug traceability data set, a comprehensive analysis is performed to obtain the complete status evaluation value of the data set, which is used as the analysis basis for judging whether the blockchain drug traceability data set is complete; The complete status evaluation value of the data set. The specific analysis process is as follows: Where, δ is the complete status evaluation value of the data set, zs is the absolute value of the difference between the total number of drug traceability data and the total number of reference data, gx is the absolute value of the difference between the actual update times of drug traceability data and the reference update times, yc is the number of abnormal storage times of drug traceability data, μ1 is the compensation factor of zs, μ2 is the compensation factor of gx, and μ3 is the compensation factor of yc. comparing the data set integrity status assessment value with the data set integrity status delimitation assessment value stored in the database; If the complete status assessment value of the data set is not lower than the complete status delimitation assessment value of the data set, then the blockchain drug traceability data set corresponding to the complete status assessment value of the data set is complete; If the complete status assessment value of the data set is lower than the complete status definition assessment value of the data set, the blockchain drug traceability data set corresponding to the complete status assessment value of the data set is incomplete, and an incomplete prompt is issued for the incomplete blockchain drug traceability data set; Based on the complete blockchain drug traceability data set, the drug storage traceability data set is analyzed to determine whether the quality of the drug storage process is qualified; The drug storage traceability data set specifically includes the absolute value of the difference between the drug storage temperature and the reference temperature, the absolute value of the difference between the drug storage humidity and the reference humidity, and the absolute value of the difference between the drug storage light intensity and the reference light intensity; Based on the obtained drug storage traceability data set, a comprehensive analysis is performed to obtain the drug storage quality assessment value, which is used as the analysis basis for judging whether the quality of the drug storage process is qualified; The specific calculation formula for the drug storage quality assessment value is: In the formula, α is the evaluation value of drug storage quality, cw is the absolute value of the difference between the drug storage temperature and the reference temperature, cs is the absolute value of the difference between the drug storage humidity and the reference humidity, cg is the absolute value of the difference between the drug storage light intensity and the reference light intensity, ε1 is the compensation factor of the set cw, ε2 is the compensation factor of the set cs, and ε3 is the compensation factor of the set cg; The drug storage quality assessment value will be compared with the drug storage quality definition assessment value stored in the database; If the drug storage quality assessment value is not lower than the drug storage quality definition assessment value, the drug storage process quality corresponding to the drug storage quality assessment value is qualified; If the drug storage quality assessment value is lower than the drug storage quality definition assessment value, the drug storage process quality corresponding to the drug storage quality assessment value is unqualified, and a storage process quality unqualified reminder is issued for the drug with unqualified storage process quality; Analyze the drug packaging traceability data set with qualified drug storage process quality to determine whether the drug packaging process quality is qualified; The drug packaging traceability data set specifically includes the absolute value of the difference between the drug packaging temperature and the reference temperature, the absolute value of the difference between the drug packaging pressure and the reference pressure, and the absolute value of the difference between the drug packaging gas permeability and the reference gas permeability; To judge whether the quality of drug packaging process is qualified, the process is as follows: Based on the obtained drug packaging traceability data set, a comprehensive analysis is performed to obtain a drug packaging quality assessment value, which is used as an analysis basis for judging whether the quality of the drug packaging process is qualified; The specific calculation formula for the drug packaging quality assessment value is: Wherein, β is the drug packaging quality assessment value, fw is the absolute value of the difference between the drug packaging temperature and the reference temperature, fy is the absolute value of the difference between the drug packaging pressure and the reference pressure, ft is the absolute value of the difference between the drug packaging gas permeability and the reference gas permeability, σ1 is the compensation factor of the set fw, σ2 is the compensation factor of the set fy, σ3 is the compensation factor of the set ft, and e is a natural constant; The drug packaging quality assessment value will be compared with the drug packaging quality definition assessment value stored in the database; If the drug packaging quality assessment value is not lower than the drug packaging quality definition assessment value, the drug packaging process quality corresponding to the drug packaging quality assessment value is qualified; If the drug packaging quality assessment value is lower than the drug packaging quality definition assessment value, the drug packaging process quality corresponding to the drug packaging quality assessment value is unqualified, and a packaging process quality unqualified reminder is issued for the drug with unqualified packaging process quality; Analyze the drug production traceability data set with qualified drug packaging process quality to determine whether the drug production process quality is qualified; The drug production traceability data set specifically includes the absolute value of the difference between the drug production temperature and the reference temperature, the absolute value of the difference between the mixing speed of each drug component and the reference mixing speed, and the absolute value of the difference between the reaction time of each drug production component and the reference reaction time; To judge whether the quality of the drug production process is qualified, the process is as follows: Based on the obtained drug production traceability data set, a comprehensive analysis is performed to obtain the drug production quality assessment value, which is used as the analytical basis for judging whether the quality of the drug production process is qualified; The specific calculation formula for the drug production quality assessment value is: In the formula, γ is the drug production quality assessment value, sw is the absolute value of the difference between the drug production temperature and the reference temperature, sh is the absolute value of the difference between the mixing speed of each component of the drug and the reference mixing speed, sf is the absolute value of the difference between the reaction time of each component of the drug production and the reference reaction time, τ1 is the compensation factor of the set sw, τ2 is the compensation factor of the set sh, and τ3 is the compensation factor of the set sf; The drug manufacturing quality assessment value will be compared with the drug manufacturing quality qualification assessment value stored in the database; If the drug production quality assessment value is not lower than the drug production quality definition assessment value, the drug production process quality corresponding to the drug production quality assessment value is qualified; If the drug production quality assessment value is lower than the drug production quality definition assessment value, the drug production process quality corresponding to the drug production quality assessment value is unqualified, and a production process quality unqualified prompt will be issued for the drug with unqualified production process quality.

2. A drug quality traceability system based on blockchain, used to implement the drug quality traceability method based on blockchain as claimed in claim 1, characterized in that: It includes identity authentication judgment module, traceability data set acquisition module, data set integrity judgment module, storage quality judgment module, packaging quality judgment module and production quality judgment module, among which: The identity authentication judgment module is used to authenticate the identity of the drug quality traceability participant and determine whether the identity authentication of the drug quality traceability participant has been passed; The traceability data set acquisition module is used by drug quality traceability participants who have passed identity authentication to obtain blockchain drug traceability data sets. The blockchain drug traceability data sets specifically include drug storage traceability data sets, drug packaging traceability data sets, and drug production traceability data sets. The data set integrity judgment module is used to determine whether the blockchain drug traceability data set is complete; The storage quality judgment module is used to analyze the drug storage traceability data set based on the complete blockchain drug traceability data set to determine whether the quality of the drug storage process is qualified; The packaging quality judgment module is used to analyze the drug packaging traceability data set with qualified drug storage process quality to determine whether the drug packaging process quality is qualified; The production quality qualification judgment module is used to analyze the drug production traceability data set with qualified drug packaging process quality to determine whether the drug production process quality is qualified.

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