CN110084626B - Vaccine production supervision method based on block chain - Google Patents
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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
Technical Field
The invention relates to a vaccine production supervision method based on a block chain, and belongs to the field of computer science.
Background
The vaccine is the most economic and effective public health intervention measure for preventing and controlling infectious diseases, and is an effective means for reducing the occurrence of member diseases and reducing medical expenses for families. The fatality rate of many diseases can reach one hundred percent, and vaccination is a very effective means for protecting life health and safety. By vaccination, many of the severe diseases are eliminated and countless lives are saved.
At present, the safety of our vaccine production is not well protected. Over the past decade, many vaccine safety incidents have occurred, including vaccine counterfeiting, quality problems resulting from unauthorized changes to the vaccine manufacturing process, and the like. In view of the above, there is a need for a new technology that can protect the production privacy of vaccine manufacturers and effectively supervise the vaccine production process, so as to supervise the production of vaccines.
Disclosure of Invention
Aiming at the problems, the invention provides a block chain-based vaccine production supervision method.
In order to achieve the above object, the solution of the present invention is:
a block chain-based vaccine production supervision method comprises 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; and 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.
And 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 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;
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 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;
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 verifying 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 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;
sixthly, diluting the venom, freeze-drying and subpackaging to prepare a finished vaccine; production staff records vaccine protective agent, excipient and relevant proportion information, and inputs 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 application submitting operation in the data processing equipment, the data processing equipment packages all transactions into a block and adds timestamp information, hash information of a name address of a production enterprise is written in the block head, and the block information is sent to a drug supervision mechanism through a network and a batch issuing application is proposed;
eighthly, after receiving the block and the application, the drug supervision mechanism performs sampling inspection on the vaccine samples of the batch; 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.
The invention has the beneficial effects that: the block chain based vaccine production supervision method is characterized in that relevant parameters and experimental detection results in the vaccine production process are stored through data acquisition in the vaccine production process, and meanwhile, hash results of corresponding information are stored in a block chain transaction mode and sent to a drug supervision organization. After a batch of vaccine is produced, the transaction is packaged into blocks, and the blocks are linked after the medicine supervision department verifies that the production information of the batch of vaccine is correct. The supervision on the vaccine production process is realized, the safety of the vaccine production quality is ensured, and the commercial privacy data of vaccine production enterprises is protected.
Drawings
FIG. 1 is a block diagram of an entire blockchain network according to the present invention;
fig. 2 is a block chain network structure diagram in an enterprise node according to the present invention.
Detailed Description
The invention is further illustrated by the following examples in conjunction with the drawings.
As shown in fig. 1, the blockchain network includes one supervisory node and a plurality of enterprise nodes.
As shown in fig. 2:
the invention provides a block chain-based vaccine production supervision method, which can supervise vaccine production behaviors of enterprises, and the steps of the method are specifically described by combining an embodiment as follows:
in the first step, the vaccine preparation is started. The production enterprise puts the corresponding production cell in the microcarrier bioreactor to expand, adds the treating fluid into the microcarrier bioreactor, then adjusts the microcarrier bioreactor, sets the perfusion speed to be zero, and cleans the surface of the production cell. Finally, the washed producer cells are inoculated with a virus-immobilized strain. At this time, production staff records equipment parameter information and inputs the equipment parameter information 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, saves the timestamp information as a block chain transaction, and sends the timestamp information to a drug supervision agency through a network. And 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.
And step two, culturing for about 5 days, and harvesting the first virus liquid. Newly prepared virus maintenance solution is added again according to the growth condition of the cells, and the second virus solution is harvested after about 500-600ml and 4 days. And (3) adding the newly prepared virus maintenance solution again according to the growth condition of the cells, harvesting the virus solution for the third time after about 400-600ml after 3 days, and performing virus titration experiment and sterility check on the harvested virus solution each time the virus solution is harvested. And (3) when the venom is harvested each time, recording the venom harvesting amount and the experimental result by production workers, and recording the results into data processing equipment. The data processing equipment automatically uses a hash function to calculate the hash value of the data, 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. And 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 drug supervision mechanism passes the verification, the drug supervision mechanism is added into the transaction pool.
And thirdly, combining multiple bottles of qualified virus harvest liquid under strict aseptic operation, performing ultrafiltration by using an ultrafiltration membrane with the molecular weight of 30 ten thousand, washing by using PBS (phosphate buffer solution), and concentrating to a proper protein content range. Production staff record ultrafiltration parameter information, measure venom protein content and record content values through experiments, and input recorded data into data processing equipment and store the data. The data processing equipment automatically uses a hash function to calculate the hash value of the data, 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 verification is passed, the drug supervision agency is added into the transaction pool.
And fourthly, adding 2.5ml of 10 percent beta-propiolactone solution into every 1000ml of ultrafiltration concentrated solution according to the final concentration of 1/4000, shaking up by using a centrifugal machine, placing in a freezing environment at 4 ℃ for 24 hours, then placing in an environment at 37 ℃ for 2 hours, hydrolyzing, and finishing the inactivation verification experiment. Production staff reads centrifuge output information to obtain and record parameter information, records inactivator information and inactivation verification experiment result information in an inactivation process, and inputs and stores recorded data into 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 last step as transaction input, takes the hash value generated this time as transaction output, saves the timestamp information, saves as a block chain transaction and sends the block chain transaction to a drug monitoring and managing organization through a network. And 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 drug supervision mechanism passes the verification, the drug supervision mechanism is added into the transaction pool.
And step five, purifying the virus inactivation liquid by using a Sepharose4FF Sepharose column, wherein the sample loading amount is about 800-1500 ml each time. Monitoring the peak shape according to ultraviolet, collecting the target peak in time, removing the impurity protein with a rate not lower than 99%, adding human serum albumin with a final concentration of 1% as a stabilizer, collecting the stock solution, and performing a stock solution detection experiment. And 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 uses a hash function to calculate the hash value of the data, 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 verification is passed, the drug supervision agency is added into the transaction pool.
And sixthly, subpackaging the vaccine semi-finished product, adding the protective agent, and then filling the protective agent into a freeze dryer case for freeze drying operation. Production staff records vaccine protective agents, excipients and related proportioning information, and inputs the recorded data into data processing equipment for storage. The data processing equipment automatically uses a hash function to calculate the hash value of the data, 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 verification is passed, the drug supervision agency is added into the transaction pool.
And seventhly, preparing the required vaccine after the freeze-drying is finished. Production staff select to submit a vaccine batch issuance application through data processing equipment, the data processing equipment packages all transactions into a block and adds timestamp information, hash information of a production enterprise name address is written in the block head, and the block information is sent to a drug supervision mechanism through a network and the batch issuance application is provided.
And step eight, after the block and the application are received by the drug supervision mechanism, sampling 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. And 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 agency, confirming one-to-one correspondence of transaction input and output in the block, searching the block consistent with the hash value of the enterprise name address written by the block head of the block in the block chain of the enterprise, checking the timestamp of each block, confirming whether the enterprise is suspected of forging production records according to production time, adding the block information to the block chain stored by the enterprise if normal production is confirmed, and otherwise, reporting the block information to the drug supervision agency.
Finally, it should be noted that the above embodiments are only used for illustrating the technical solutions of the present invention, and do not limit the protection scope of the present invention. With reference to the description of the embodiment, those skilled in the art will understand and make modifications or substitutions related to the technical solution of the present invention without departing from the spirit 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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| CN110599180B (en) * | 2019-09-26 | 2023-06-27 | 腾讯科技（深圳）有限公司 | Vaccine circulation management method and device based on blockchain |
| CN111031036B (en) * | 2019-12-12 | 2020-11-27 | 深圳大学 | Block chain-based vaccine information monitoring method and device and computer equipment |
| CN110992068B (en) * | 2019-12-17 | 2023-06-06 | 浙江大学 | Vaccine full life cycle management method and system based on block chain |
| CN112347504A (en) * | 2020-10-16 | 2021-02-09 | 杭州甘道智能科技有限公司 | Block chain based vaccination monitoring device and method |
| CN112308489A (en) * | 2020-11-02 | 2021-02-02 | 杭州甘道智能科技有限公司 | Vaccine circulation supervision device and method based on block chain |
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