CN110084626B - Vaccine production supervision method based on block chain - Google Patents

Abstract

The invention belongs to the field of computer science, and discloses a block chain-based vaccine production supervision method, which is used for storing relevant parameters and results of culture, harvesting, ultrafiltration, inactivation and purification processes of vaccine production, corresponding sterility inspection, virus titration experiments, inactivation verification experiments and stock solution verification through data acquisition in the vaccine production process, and simultaneously storing hash results of corresponding information in a block chain transaction form and sending the hash results to a supervision mechanism. When the production of the vaccine is completed and the batch issuance is applied, the transaction information of the batch of the vaccine is packaged into a block and is sent to a monitoring mechanism after being written into the information of a production enterprise, the monitoring mechanism completes the verification of the vaccine and simultaneously checks the stored production information of the vaccine, compares the hash result of the production information with the hash information of each transaction in the block, and writes the block into a chain after checking the hash information is correct.

Description

A Blockchain-Based Approach to Vaccine Production Supervision

technical field

The invention relates to a blockchain-based vaccine production supervision method, which belongs to the field of computer science.

Background technique

Vaccines are the most economical and effective public health interventions to prevent and control infectious diseases. For families, they are also an effective means to reduce the incidence of diseases among members and reduce medical expenses. The fatality rate of many diseases can reach 100%, and vaccination is a very effective means to protect life, health and safety. Many nasty diseases have been eradicated and countless lives saved through vaccination.

At present, the safety of our vaccine production cannot be well protected. In the past decade or so, there have been many vaccine safety accidents, including vaccine falsification, quality problems caused by unauthorized changes in vaccine production processes, and so on. In view of this, it is necessary to use a new technology that can not only protect the privacy of vaccine manufacturers, but also effectively supervise the vaccine production process, and then supervise the production of vaccines.

Contents of the invention

In view of the above problems, the present invention provides a blockchain-based vaccine production supervision method.

In order to achieve the above object, the solution of the present invention is:

A blockchain-based vaccine production supervision method, comprising the following steps:

The first step is to start preparing the vaccine; when the bioreactor is turned on, the production staff records the equipment parameter information and enters it into the data processing equipment; the data processing equipment automatically uses the hash function to calculate the hash value of the data, and the hash value is used as a transaction Output and save the timestamp information, save it as a block chain transaction and send it to the drug regulatory agency through the network; the drug regulatory agency receives the transaction information, verifies that it is not a dual-use transaction and is not in the transaction pool, if the verification is passed, then Join your own trading pool.

In the second step, each time the virus liquid is harvested, samples are taken for sterility inspection and virus titration experiments. The production staff records the amount of venom harvest and the experimental results and enters them into the data processing equipment; the data processing equipment automatically uses the hash function to calculate the hash value of the data, and uses the hash value generated in the previous step as the transaction input, and the generated this time The hash value is output as a transaction, and the timestamp information is saved, saved as a blockchain transaction and sent to the drug regulatory agency through the network; the drug regulatory agency receives the transaction information and verifies that it is not a dual-use transaction and is not in the transaction pool. The transaction input of this transaction is the output of a certain transaction in the transaction pool. If the verification is passed, it will be added to its own transaction pool;

The third step is to perform ultrafiltration on the virus liquid; the production staff records the ultrafiltration parameter information, measures the venom protein content through experiments and records the content value, and inputs the recorded data into the data processing equipment and saves it; the data processing equipment automatically uses Ha The Hash function calculates the hash value of the data, takes the hash value generated in the previous step as the transaction input, and takes the hash value generated this time as the transaction output, and saves the timestamp information, saves it as a blockchain transaction and passes it through the network Sent to the drug regulatory agency; the drug regulatory agency receives the transaction information and verifies that it is not a dual-use transaction and is not in the transaction pool. The transaction input of this transaction is the output of a certain transaction in the transaction pool. If the verification passes, it will be added to its own transaction pool;

The fourth step is to inactivate the venom, and then carry out the inactivation verification experiment; the production staff reads the parameter information on the centrifuge panel and records these parameter information, and records the information of the inactivator and the inactivator during the inactivation process. Verify the experimental result information, input the recorded data into the data processing device and save it; the data processing device automatically uses the hash function to calculate the hash value of the data, and uses the hash value generated in the previous step as the transaction input, and transfers the generated The hash value is output as a transaction, and the time stamp information is saved, saved as a blockchain transaction and sent to the drug regulatory agency through the network; the drug regulatory agency receives the transaction information and verifies that it is not a dual-use transaction and is not in the transaction pool , the transaction input of this transaction is the output of a certain transaction in the transaction pool, if the verification is passed, it will be added to its own transaction pool;

The fifth step is to use the chromatographic column to purify the venom and test the original solution; the production staff records the parameter information in the purification process, and records the original solution test result information, and inputs the recorded data into the data processing equipment and saves it; the data processing equipment Automatically use the hash function to calculate the hash value of the data, use the hash value generated in the previous step as the transaction input, and use the hash value generated this time as the transaction output, and save the timestamp information as a blockchain transaction And send it to the drug regulatory agency through the network; the drug regulatory agency receives the transaction information and verifies that it is not a dual-use transaction and is not in the transaction pool. The transaction input of this transaction is the output of a certain transaction in the transaction pool. If the verification is passed, then Join its own trading pool;

Step 6: The venom is diluted, freeze-dried, and packaged to make a finished vaccine; the production staff records the vaccine protective agent, excipient and related ratio information, and inputs the recorded data into the data processing equipment and saves it. The data processing equipment automatically uses the hash function to calculate the hash value of the data, takes the hash value generated in the previous step as the transaction input, and takes the hash value generated this time as the transaction output, and saves the timestamp information as a block The chain transaction is saved and sent to the drug regulatory agency through the network; the drug regulatory agency receives the transaction information and verifies that it is not a dual-use transaction and is not in the transaction pool. The transaction input of this transaction is the output of a certain transaction in the transaction pool. If passed, join its own trading pool;

The seventh step is to apply for batch issuance; the production staff chooses to start submitting the application operation in the data processing equipment, and the data processing equipment packages all transactions into a block and adds timestamp information, and writes the name and address of the production company in the block header The hash information of the block is sent to the drug regulatory agency through the network and an application for batch release is submitted;

Step 8: After the drug regulatory agency receives the block and the application, it conducts a sampling inspection of the batch of vaccine samples; the inspector checks whether the transaction information in the received block is consistent with the transaction information stored in the transaction pool, and the district Whether the enterprise information of the block header is correct, and whether the hash value generated by the production record information is consistent with the hash value of each transaction; The batch vaccine production block is broadcast to all enterprise nodes in the whole network;

Step 9. Each enterprise node verifies the received block, confirms whether the signature of the block is signed by the drug regulatory agency, and confirms whether the transaction input and output in the block correspond one-to-one. For blocks with the same hash value of the company name and address written in the block header of the block, check the time stamp of each block, and confirm whether the company is suspected of falsifying production records according to the production time. If normal production is confirmed, the block information Add to the blockchain saved by itself, otherwise report to the drug regulatory agency.

The beneficial effects of the present invention are: a blockchain-based vaccine production supervision method is provided, through the data collection in the vaccine production process, the relevant parameters and experimental detection results in the vaccine production process are saved, and at the same time, the blockchain The form of the transaction saves the hash result of the corresponding information and sends it to the drug regulatory agency. When a batch of vaccines is produced, the transactions are packaged into blocks, and the drug regulatory department verifies that the production information of the batch of vaccines is correct and then puts the blocks on the chain. It realizes the supervision of the vaccine production process, ensures the quality and safety of vaccine production, and protects the commercial privacy data of vaccine production enterprises.

Description of drawings

Fig. 1 is the overall block chain network structural diagram of the present invention;

Fig. 2 is a block chain network structure diagram within an enterprise node in the present invention.

Detailed ways

The present invention will be further described below in conjunction with the accompanying drawings and embodiments.

As shown in Figure 1, the blockchain network includes a supervisory node and multiple enterprise nodes.

as shown in picture 2:

The present invention provides a blockchain-based vaccine production supervision method, which can supervise the vaccine production behavior of enterprises. The steps of the method will be described in detail in conjunction with an example below:

The first step is to start preparing the vaccine. The production enterprise puts the corresponding production cells in the microcarrier bioreactor to amplify, adds the treatment solution to the microcarrier bioreactor, then adjusts the microcarrier bioreactor, sets its perfusion speed to zero, and cleans the surface of the production cells. Finally, virus-immobilized strains are inoculated on the washed producer cells. At this time, the production staff records the equipment parameter information and enters it into the data processing equipment. The data processing equipment automatically uses the hash function to calculate the hash value of the data, outputs the hash value as a transaction, and saves the time stamp information, saves it as a block chain transaction and sends it to the drug regulatory agency through the network. The drug regulatory agency receives the transaction information and verifies that it is not a dual-use transaction and is not in the transaction pool. If the verification passes, it will join its own transaction pool.

The second step is to cultivate for about 5 days, and harvest the first virus liquid. According to the growth of the cells, re-add the newly prepared virus maintenance solution, about 500-600ml, and harvest the second virus solution 4 days later. According to the growth of the cells, re-add the newly prepared virus maintenance solution, about 400-600ml, harvest the third virus solution after 3 days, and carry out the virus titration experiment and sterility inspection on the harvested venom every time the venom is harvested. Every time the venom is harvested, the production staff records the amount of venom harvested and the experimental results, and enters them into the data processing equipment. The data processing equipment automatically uses the hash function to calculate the hash value of the data, takes the hash value generated in the previous step as the transaction input, and takes the hash value generated this time as the transaction output, and saves the timestamp information as a block On-chain transactions are saved and sent across the network to drug regulators. The drug regulatory agency receives the transaction information and verifies that it is not a dual-use transaction and is not in the transaction pool. The transaction input of this transaction is the output of a certain transaction in the transaction pool. If the verification passes, it will be added to its own transaction pool.

The third step is to combine multiple bottles of virus harvest liquids that have passed the test under strict aseptic operation, use 300,000 molecular weight ultrafiltration membrane ultrafiltration, wash with PBS, and concentrate to a suitable protein content range. The production staff records the ultrafiltration parameter information, measures the venom protein content through experiments and records the content value, and inputs the recorded data into the data processing equipment and saves it. The data processing equipment automatically uses the hash function to calculate the hash value of the data, takes the hash value generated in the previous step as the transaction input, and takes the hash value generated this time as the transaction output, and saves the timestamp information as a block On-chain transactions are saved and sent across the network to drug regulators. The drug regulatory agency receives the transaction information and verifies that it is not a dual-use transaction and is not in the transaction pool. The transaction input of this transaction is the output of a certain transaction in the transaction pool. If the verification passes, it will be added to its own transaction pool.

The fourth step is to add 2.5ml of 10% β-propiolactone solution to each 1000ml of the ultrafiltration concentrate according to the final concentration of 1/4000, shake it with a centrifuge, and place it in a freezing environment at 4°C for 24 hours. Then it was placed in an environment of 37°C for 2 hours, hydrolyzed, and the inactivation verification experiment was completed. The production staff read the output information of the centrifuge to obtain and record the parameter information, and at the same time record the inactivation agent information and the inactivation verification experiment result information during the inactivation process, and input the recorded data into the data processing equipment and save it. The data processing equipment automatically uses the hash function to calculate the hash value of the data, takes the hash value generated in the previous step as the transaction input, and takes the hash value generated this time as the transaction output, and saves the timestamp information as a block On-chain transactions are saved and sent across the network to drug regulators. The drug regulatory agency receives the transaction information and verifies that it is not a dual-use transaction and is not in the transaction pool. The transaction input of this transaction is the output of a certain transaction in the transaction pool. If the verification passes, it will be added to its own transaction pool.

The fifth step is to use Sepharose4FF agarose gel column to purify the virus inactivation solution by chromatography, and the loading volume is about 800-1500ml each time. According to the peak shape of ultraviolet monitoring, the target peak was collected in time, the removal rate of impurity protein was not less than 99%, human serum albumin with a final concentration of 1% was added as a stabilizer, the stock solution was harvested, and the test of the stock solution was carried out. The production staff records the parameter information during the purification process, and records the raw liquid test result information, and inputs the recorded data into the data processing equipment and saves it. The data processing equipment automatically uses the hash function to calculate the hash value of the data, takes the hash value generated in the previous step as the transaction input, and takes the hash value generated this time as the transaction output, and saves the timestamp information as a block On-chain transactions are saved and sent across the network to drug regulators. The drug regulatory agency receives the transaction information and verifies that it is not a dual-use transaction and is not in the transaction pool. The transaction input of this transaction is the output of a certain transaction in the transaction pool. If the verification passes, it will be added to its own transaction pool.

The sixth step is to subpackage the semi-finished vaccine, add the protective agent and then half-press it into the freeze dryer chassis for freeze-drying operation. The production staff records the vaccine protective agent, excipient and related ratio information, and inputs the recorded data into the data processing equipment and saves it. The data processing equipment automatically uses the hash function to calculate the hash value of the data, takes the hash value generated in the previous step as the transaction input, and takes the hash value generated this time as the transaction output, and saves the timestamp information as a block On-chain transactions are saved and sent across the network to drug regulators. The drug regulatory agency receives the transaction information and verifies that it is not a dual-use transaction and is not in the transaction pool. The transaction input of this transaction is the output of a certain transaction in the transaction pool. If the verification passes, it will be added to its own transaction pool.

In the seventh step, after the freeze-drying is completed, the required vaccine is prepared. The production staff chooses to submit the application for vaccine batch release through the data processing equipment. The data processing equipment packs all transactions into a block and adds time stamp information. Regulators send the block information and apply for batch issuance.

Step 8: After receiving the block and the application, the drug regulatory agency will sample and inspect the batch of vaccine samples. The inspector checks whether the transaction information in the received block is consistent with the transaction information stored in the transaction pool, whether the enterprise information in the block header is correct, and whether the hash value generated by the production record information is consistent with the hash value of each transaction. After the inspection is correct, the drug regulatory agency passes the application, signs the corresponding block with a private key, and broadcasts the batch of vaccine production blocks to all enterprise nodes on the entire network through the network.

Step 9. Each enterprise node verifies the received block, confirms whether the signature of the block is signed by the drug regulatory agency, and confirms that the transaction input and output in the block correspond one-to-one, and searches for the block in its own block chain. Blocks with the same hash value of the company name and address written in the block header, check the timestamps of each block, and confirm whether the company is suspected of falsifying production records according to the production time. If normal production is confirmed, add the block information to itself Saved on the blockchain, otherwise it will be reported to the drug regulatory agency.

Finally, it should be noted that the above examples are only used to illustrate the technical solutions of the present invention, rather than to limit the protection scope of the present invention. Referring to the description of this embodiment, those skilled in the art should be able to understand and make relevant modifications or replacements to the technical solutions of the present invention without departing from the essence and scope of the present invention.

Claims (1)

1. A block chain-based vaccine production supervision method is characterized by comprising the following steps:

firstly, preparing a vaccine; when the bioreactor is started, production workers record equipment parameter information and input the equipment parameter information into data processing equipment; the data processing equipment automatically calculates the hash value of the data by using a hash function, outputs the hash value as a transaction, stores the timestamp information as a block chain transaction, and sends the timestamp information to a drug monitoring mechanism through a network; the drug supervision agency receives the transaction information, verifies that the drug supervision agency is not a double-use transaction and is not in the transaction pool, and if the drug supervision agency passes the verification, the drug supervision agency is added into the transaction pool;

secondly, sampling to perform sterility test and virus titration experiment each time the virus liquid is harvested; production staff record the venom yield and experimental result information and input the information into data processing equipment; the data processing equipment automatically calculates the hash value of the data by using a hash function, takes the hash value generated in the last step as transaction input, takes the hash value generated this time as transaction output, saves the timestamp information as a block chain transaction, and sends the timestamp information to a drug monitoring mechanism through a network; the drug supervision agency receives the transaction information, verifies that the drug supervision agency is not a dual-use transaction and is not in the transaction pool, the transaction input of the transaction is the output of a certain transaction in the transaction pool, and if the transaction passes the verification, the drug supervision agency is added into the transaction pool;

step three, performing ultrafiltration on the virus liquid; production staff record ultrafiltration parameter information, measure venom protein content through experiments and record content values, and input recorded data into data processing equipment and store the data; the data processing equipment automatically calculates the hash value of the data by using a hash function, takes the hash value generated in the last step as transaction input, takes the hash value generated this time as transaction output, saves the timestamp information as a block chain transaction, and sends the block chain transaction to a drug monitoring mechanism through a network; the drug supervision agency receives the transaction information, verifies that the drug supervision agency is not a dual-use transaction and is not in the transaction pool, the transaction input of the transaction is the output of a certain transaction in the transaction pool, and if the transaction passes the verification, the drug supervision agency is added into the transaction pool;

fourthly, inactivating the venom, and then performing an inactivation verification experiment; production staff read parameter information on a centrifuge panel and record the parameter information, meanwhile record the information of an inactivating agent and the information of an inactivation verification experiment result in the inactivation process, and input the recorded data into data processing equipment for storage; the data processing equipment automatically calculates the hash value of the data by using a hash function, takes the hash value generated in the last step as transaction input, takes the hash value generated this time as transaction output, saves the timestamp information as a block chain transaction, and sends the timestamp information to a drug monitoring mechanism through a network; the drug supervision mechanism receives the transaction information, verifies that the drug supervision mechanism is not a dual-use transaction and is not in the transaction pool, the transaction input of the transaction is the output of a certain transaction in the transaction pool, and if the verification is passed, the drug supervision mechanism is added into the transaction pool;

fifthly, purifying the venom by using a chromatographic column and detecting the stock solution; production workers record parameter information in the purification process, record the information of the verification result of the stock solution, and input the recorded data into data processing equipment for storage; the data processing equipment automatically calculates the hash value of the data by using a hash function, takes the hash value generated in the last step as transaction input, takes the hash value generated this time as transaction output, saves the timestamp information as a block chain transaction, and sends the timestamp information to a drug monitoring mechanism through a network; the drug supervision agency receives the transaction information, verifies that the drug supervision agency is not a dual-use transaction and is not in the transaction pool, the transaction input of the transaction is the output of a certain transaction in the transaction pool, and if the transaction passes the verification, the drug supervision agency is added into the transaction pool;

sixthly, diluting the venom, freeze-drying and subpackaging to prepare a finished vaccine; production staff record vaccine protective agent, excipient and relevant proportion information, and input the recorded data into data processing equipment for storage; the data processing equipment automatically calculates the hash value of the data by using a hash function, takes the hash value generated in the last step as transaction input, takes the hash value generated this time as transaction output, saves the timestamp information as a block chain transaction, and sends the timestamp information to a drug monitoring mechanism through a network; the drug supervision mechanism receives the transaction information, verifies that the drug supervision mechanism is not a dual-use transaction and is not in the transaction pool, the transaction input of the transaction is the output of a certain transaction in the transaction pool, and if the verification is passed, the drug supervision mechanism is added into the transaction pool;

seventhly, proposing a wholesale application; production staff select to start submitting application operation in data processing equipment, the data processing equipment packages all transactions into a block and adds timestamp information, hash information of name and address of a production enterprise is written in the head of the block, the block information is sent to a drug supervision mechanism through a network, and a wholesale application is proposed;

eighthly, after receiving the block and the application, the drug supervision mechanism samples the vaccine samples of the batch for inspection; the checker checks whether the received transaction information in the block is consistent with the transaction information stored in the transaction pool, whether the enterprise information at the block head is correct, and whether the hash value generated by the production record information is consistent with the hash value of each transaction; after the check is correct, the drug supervision organization signs the corresponding blocks by using the private key through application, and broadcasts the batch of vaccine production blocks to all enterprise nodes of the whole network through the network;

and ninthly, verifying the received block by each enterprise node, confirming whether the block signature is a signature of a drug supervision mechanism, confirming whether the transaction input and output in the block are in one-to-one correspondence, searching the block consistent with the hash value of the enterprise name and address written by the block head of the block in a block chain of the enterprise, checking a timestamp of each block, confirming whether the enterprise is suspected of forging production records according to production time, adding the block information into the block chain stored by the enterprise if normal production is confirmed, and otherwise, reporting the block information to the drug supervision mechanism.

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