CN110084626A - A kind of production of vaccine monitoring and managing method based on block chain - Google Patents
A kind of production of vaccine monitoring and managing method based on block chain Download PDFInfo
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Abstract
The invention belongs to computer sciences, disclose a kind of production of vaccine monitoring and managing method based on block chain, by being acquired to the data in vaccine production process, the culture of production of vaccine, harvest, ultrafiltration, inactivation, purification process and corresponding sterility test, titration of virus experiment, inactivation confirmatory experiment, the relevant parameter of stoste calibrating and result are saved, while saving the Hash result of corresponding informance in the form of block chain transaction and being sent to regulatory agency.Complete production of vaccine; each Transaction Information of this batch vaccine is packaged as a block when application approval and sign hair; and regulatory agency is sent to after manufacturing enterprise's information is written; regulatory agency completes the production of vaccine information that vaccine assay checks preservation simultaneously; and compare the Hash information respectively traded in production information Hash result and block; check it is errorless after by block broadcast write-in chain in; the present invention realizes the supervision to vaccine production process and protects the business privacy of manufacturing enterprise, has highly important application value.
Description
Technical field
The present invention relates to a kind of production of vaccine monitoring and managing methods based on block chain, belong to computer science.
Background technique
Vaccine is prevention and control infectious disease is most economical, effective public health intervening measure, is also for family
Reduce the effective means that member's disease occurs, reduces medical expense.The lethality of many diseases is up to a hundred percent, vaccine inoculation
It is protection life and health highly effective means safely.By vaccine inoculation, many severe diseases are destroyed, and countless life obtain
To rescue.
Current, our production of vaccine can't be protected safely well.For over ten years, many occurred for the past
Vaccine safety accident is played, including vaccine fakes, changes quality problems caused by production of vaccine flow process etc. without authorization.In view of
This, it is necessary to production of vaccine producer production privacy can be protected using one kind and effectively supervises the new skill of vaccine production process
Art, and then the production of vaccine is supervised.
Summary of the invention
In view of the above-mentioned problems, the present invention provides a kind of production of vaccine monitoring and managing method based on block chain.
To achieve the goals above, solution of the invention is:
A kind of production of vaccine monitoring and managing method based on block chain, includes the following steps:
The first step starts to prepare vaccine；When opening bioreactor, production work personnel record's device parameter information is simultaneously
It is entered into data processing equipment；Data processing equipment use automatically hash function calculate data cryptographic Hash, using cryptographic Hash as
Transaction output, and the holding time stabs information, saves as a block chain transaction and is sent to Drug Administration mechanism by network；
Drug Administration mechanism receives Transaction Information, verifies it not and be the dual transaction used and not in trading pit, if being verified,
Itself trading pit is added.
When second step, each harvest virus liquid, sampling carries out sterility test and titration of virus experiment.Production work personnel note
Record venom harvest yield and test result information are simultaneously entered into data processing equipment；Data processing equipment uses hash function meter automatically
The cryptographic Hash for the evidence that counts, the cryptographic Hash that previous step is generated are inputted as transaction, and the cryptographic Hash that this is generated is defeated as trading
Out, and the holding time stabs information, saves as a block chain transaction and is sent to Drug Administration mechanism by network；Drug prison
Pipe mechanism receives Transaction Information, verifies it not and be the dual transaction used and not in trading pit, and the transaction of the transaction inputs
Itself trading pit is added if being verified for the output of transaction a certain in trading pit；
Third step carries out ultrafiltration to virus liquid；Production work personnel record's ultrafiltration parameter information measures venom by experiment
Protein content simultaneously records content value, and the data of record are input in data processing equipment and are saved；Data processing equipment is automatic
The cryptographic Hash that data are calculated using hash function, the cryptographic Hash that previous step is generated are inputted as transaction, the Kazakhstan that this is generated
Uncommon value is as transaction output, and the holding time stabs information, saves as a block chain transaction and is sent to drug by network
Regulatory agency；Drug Administration mechanism receives Transaction Information, verifies it not and be the dual transaction used and not in trading pit, the pen
The transaction input of transaction is that itself trading pit is added if being verified in the output of a certain transaction in trading pit；
4th step carries out inactivation treatment to venom, carries out inactivation confirmatory experiment after the completion；Production work personnel read centrifugation
Parameter information on machine side plate simultaneously records these parameter informations, while recording the inactivator information in inactivation process and inactivation verifying
The data of record are input in data processing equipment and are saved by test result information；Data processing equipment uses Hash automatically
Function calculate data cryptographic Hash, using previous step generate cryptographic Hash as transaction input, using this generation cryptographic Hash as
Transaction output, and the holding time stabs information, saves as a block chain transaction and is sent to Drug Administration mechanism by network；
Drug Administration mechanism receives Transaction Information, verifies it not and be the dual transaction used and not in trading pit, the friendship of the transaction
Easily input is that itself trading pit is added if being verified in the output of a certain transaction in trading pit；
5th step purify simultaneously stoste calibrating to venom using chromatographic column；In production work personnel record's purification process
Parameter information, and record stoste verification result information, the data of record be input in data processing equipment and saved；Data
Processing equipment uses hash function to calculate the cryptographic Hash of data automatically, and the cryptographic Hash that previous step is generated, will as transaction input
This cryptographic Hash generated is as transaction output, and the holding time stabs information, saves as a block chain transaction and passes through net
Network is sent to Drug Administration mechanism；Drug Administration mechanism receives Transaction Information, and verifying it not is the dual transaction used and does not exist
In trading pit, the transaction input of the transaction is the output of a certain transaction in trading pit, if being verified, itself is added and hands over
Yi Chi；
Venom is diluted, is lyophilized, dispensing finished product vaccine is made by the 6th step；The protection of production work personnel record's vaccine
Agent, excipients and related proportion information, the data of record are input in data processing equipment and are saved.Data processing equipment is certainly
The dynamic cryptographic Hash that data are calculated using hash function, the cryptographic Hash that previous step is generated are inputted as transaction, this is generated
Cryptographic Hash is as transaction output, and the holding time stabs information, saves as a block chain transaction and is sent to medicine by network
Product regulatory agency；Drug Administration mechanism receives Transaction Information, verifies it not and be the dual transaction used and not in trading pit, should
The transaction input of transaction is that itself trading pit is added if being verified in the output of a certain transaction in trading pit；
7th step proposes approval and sign hair application；Production work personnel select starting to submit application behaviour in the data processing apparatus
Make, All Activity is packaged as a block and timestamp information is added by data processing equipment, the write-in production enterprise in block head
The Hash information of industry title address sends the block information to Drug Administration mechanism by network and proposes approval and sign hair application；
After 8th step, Drug Administration mechanism receive block and application, inspection is sampled to the vaccine sample of the batch；Inspection
Whether the Transaction Information looked into the block that personnel inspection receives is consistent with the Transaction Information saved in trading pit, the enterprise of block head
Whether information is correct, and whether the cryptographic Hash that record of production information generates is consistent with the cryptographic Hash traded every time；Check it is errorless after, medicine
Product regulatory agency by application, signed to respective block using private key, by network by the batch production of vaccine block to
All enterprise's nodes of the whole network are broadcasted；
9th step, each enterprise's node verify the block received, confirm whether block signature is Drug Administration machine
Structure signature, while confirming that whether transaction input and output correspond in block, search the area with the block in itself block chain
The consistent block of enterprise name Address-Hash value written by build, checks each block timestamp, confirms the enterprise according to the production time
Whether industry has the suspicion for forging the record of production, if the block information, is added the block chain of itself preservation by the normal production of confirmation
On, otherwise then reported to Drug Administration mechanism.
The beneficial effects of the present invention are: a kind of production of vaccine monitoring and managing method based on block chain is provided, by vaccine
Data acquisition in production process, by vaccine production process relevant parameter and laboratory test results save, while with block
The form of chain transaction saves the Hash result of corresponding informance and is sent to Drug Administration mechanism.After a collection of production of vaccine,
Transaction is packaged as block, by Drug Administration department verify the batch production of vaccine information it is errorless after by block cochain.It realizes
Supervision to vaccine production process guarantees production of vaccine quality safety, and protects the business private data of production of vaccine enterprise.
Detailed description of the invention
Fig. 1 is the whole block chain network structure chart of the present invention；
Fig. 2 is enterprise's node intra block chain network structure chart of the present invention.
Specific embodiment
Present invention will be further explained below with reference to the attached drawings and examples.
As shown in Figure 1, block chain network includes a supervisory node and multiple enterprise's nodes.
It is as shown in Figure 2:
The present invention provides a kind of production of vaccine monitoring and managing method based on block chain, can supervise the production of vaccine row of enterprise
For the step of illustrating this method below with reference to one embodiment:
The first step starts to prepare vaccine.Corresponding production cell is placed in microcarrier bioreactor by manufacturing enterprise to be expanded
Increase, treatment fluid is added into microcarrier bioreactor, then adjusts microcarrier bioreactor, its perfusion rate, which is arranged, is
Zero, cleaning production cell surface.Finally, virus inoculation fixed virus on production cell after cleaning.At this point, production work people
Member's recording equipment parameter information is simultaneously entered into data processing equipment.Data processing equipment uses hash function to calculate data automatically
Cryptographic Hash is exported cryptographic Hash as transaction, and the holding time stabs information, is saved as a block chain transaction and is passed through network
It is sent to Drug Administration mechanism.Drug Administration mechanism receives Transaction Information, and verifying it not is the dual transaction used and is not handing over
In Yi Chi, if being verified, itself trading pit is added.
Second step, about 5 days or so time of culture, harvest first time virus liquid.According to cell growth status, rejoin new
The viral maintaining liquid of preparation, about 500-600ml harvest second of virus liquid after 4 days.According to cell growth status, rejoin
The viral maintaining liquid newly prepared, about 400-600ml harvests third time virus liquid after 3 days, to the poison of harvest when harvesting venom every time
Liquid carries out titration of virus experiment and sterility test.Every time when harvest venom, production work personnel record's venom harvest yield and experiment
As a result, and being entered into data processing equipment.Data processing equipment uses the cryptographic Hash of hash function calculating data automatically, will be upper
The cryptographic Hash that one step generates exports the cryptographic Hash that this is generated as transaction as transaction input, and the holding time stabs information,
It is saved as a block chain transaction and Drug Administration mechanism is sent to by network.Drug Administration mechanism receives Transaction Information,
Verify it not and be the dual transaction used and not in trading pit, the transaction input of the transaction is a certain transaction in trading pit
Output itself trading pit is added if being verified.
Third step merges more bottles of assay approval multiple virus harvest liquids under strict aseptic technique, sub very much with 30
Ultrafiltration membrane ultrafiltration, the PBS cleaning of amount, are concentrated into suitable protein content range.Production work personnel record's ultrafiltration parameter letter
Breath by experiment measurement venom protein content and records content value, the data of record is input in data processing equipment and is protected
It deposits.Data processing equipment uses hash function to calculate the cryptographic Hash of data automatically, and the cryptographic Hash that previous step is generated is as transaction
Input exports the cryptographic Hash that this is generated as transaction, and the holding time stabs information, saves simultaneously as a block chain transaction
Drug Administration mechanism is sent to by network.Drug Administration mechanism receives Transaction Information, and verifying it not is the dual transaction used
And not in trading pit, the transaction input of the transaction is that the output of a certain transaction in trading pit is added if being verified
Itself trading pit.
4th step, by the ultrafiltration concentration liquid of every 1000ml according to ultimate density 1/4000, be added 10% beta-propiolactone it is molten
Liquid 2.5ml, is shaken up using centrifuge instrument, is placed in 4 DEG C of freezing environment 24 hours, 2 is small in the environment of being subsequently placed in 37 DEG C
When, inactivation confirmatory experiment is completed in hydrolysis.Production work personnel read centrifuge output information and obtain simultaneously recording parameters information, together
The data of record are input to data processing by inactivator information and inactivation confirmatory experiment result information in Shi Jilu inactivation process
In equipment and save.Data processing equipment uses the cryptographic Hash of hash function calculating data, the Hash that previous step is generated automatically
Value exports the cryptographic Hash that this is generated as transaction as transaction input, and the holding time stabs information, as a block chain
Transaction saves and is sent to Drug Administration mechanism by network.Drug Administration mechanism receives Transaction Information, and it is dual for verifying it not
The transaction that uses and not in trading pit, the transaction input of the transaction is the output of a certain transaction in trading pit, if verifying
Pass through, then itself trading pit is added.
5th step purifies the analysis of inactivation of virus liquid layer using Sepharose4FF agarose Gel column, each loading
Measure about 800~1500ml.According to ultraviolet monitoring peak shape, purpose peak is collected in time, and removal rate of impure protein is not less than 99%, is added eventually
The human serum albumin that concentration is 1% makees stabilizer, harvests stoste, carries out stoste calibrating experiment.Production work personnel record purifying
Parameter information in the process, and stoste verification result information is recorded, the data of record are input in data processing equipment and are protected
It deposits.Data processing equipment uses hash function to calculate the cryptographic Hash of data automatically, and the cryptographic Hash that previous step is generated is as transaction
Input exports the cryptographic Hash that this is generated as transaction, and the holding time stabs information, saves simultaneously as a block chain transaction
Drug Administration mechanism is sent to by network.Drug Administration mechanism receives Transaction Information, and verifying it not is the dual transaction used
And not in trading pit, the transaction input of the transaction is that the output of a certain transaction in trading pit is added if being verified
Itself trading pit.
6th step, packing vaccine semi-finished product, are added the later half tamponade of protective agent and enter to carry out freeze-drying operation in freeze dryer cabinet.It is raw
It produces staff and records vaccine protectant, excipients and related proportion information, the data of record are input to data processing equipment
In and save.Data processing equipment uses hash function to calculate the cryptographic Hash of data automatically, and the cryptographic Hash of previous step generation is made
For transaction input, the cryptographic Hash that this is generated is exported, and the holding time stabs information as transaction, is traded as a block chain
It saves and passes through network and be sent to Drug Administration mechanism.Drug Administration mechanism receives Transaction Information, and verifying it not is dual use
Transaction and not in trading pit, the transaction transaction input be trading pit in a certain transaction output, if being verified,
Itself trading pit is then added.
After 7th step, freeze-drying, the vaccine needed is made.Production work personnel select to submit by data processing equipment
Vaccine approval and sign hair application, All Activity is packaged as a block and timestamp information is added by data processing equipment, in block head
The Hash information of middle write-in manufacturing enterprise's title address sends the block information to Drug Administration mechanism by network and proposes to criticize
Sign and issue application.
After 8th step, Drug Administration mechanism receive block and application, the vaccine sample sampling of the batch is checked.Inspection
Whether the Transaction Information looked into the block that personnel inspection receives is consistent with the Transaction Information saved in trading pit, the enterprise of block head
Whether information is correct, and whether the cryptographic Hash that record of production information generates is consistent with the cryptographic Hash traded every time.Check it is errorless after, medicine
Product regulatory agency by application, signed to respective block using private key, by network by the batch production of vaccine block to
All enterprise's nodes of the whole network are broadcasted.
9th step, each enterprise's node verify the block received, confirm whether block signature is Drug Administration machine
Structure signature, while confirming that transaction input and output correspond in block, search and the block block head institute in itself block chain
The consistent block of enterprise name Address-Hash value write, checks each block timestamp, whether confirms the enterprise according to the production time
There is the suspicion for forging the record of production, if the normal production of confirmation, which is added on the block chain of itself preservation, otherwise
Then reported to Drug Administration mechanism.
Finally it should be noted that the above embodiments are merely illustrative of the technical solutions of the present invention, rather than the present invention is protected
Protect the limitation of range.Referring to the explanation of the embodiment, those skilled in the art are to be understood that and to of the invention
Technical solution carries out relevant modifications or substitutions, without departing from the spirit and scope of the invention.
Claims (1)
1. a kind of production of vaccine monitoring and managing method based on block chain, which comprises the following steps:
The first step starts to prepare vaccine；When opening bioreactor, production work personnel record's device parameter information and typing
To data processing equipment；Data processing equipment uses the cryptographic Hash of hash function calculating data automatically, using cryptographic Hash as transaction
Output, and the holding time stabs information, saves as a block chain transaction and is sent to Drug Administration mechanism by network；Drug
Regulatory agency receives Transaction Information, verifies it not and be the dual transaction used and not in trading pit, if being verified, is added
Itself trading pit；
When second step, each harvest virus liquid, sampling carries out sterility test and titration of virus experiment；Production work personnel record's poison
Liquid harvest yield and test result information are simultaneously entered into data processing equipment；Data processing equipment uses hash function to calculate number automatically
According to cryptographic Hash, using previous step generate cryptographic Hash as transaction input, using this generate cryptographic Hash as trade output, and
Holding time stabs information, saves as a block chain transaction and is sent to Drug Administration mechanism by network；Drug Administration machine
Structure receives Transaction Information, verifies it not and be the dual transaction used and not in trading pit, and the transaction input of the transaction is hands over
Itself trading pit is added if being verified in the output of a certain transaction in Yi Chi；
Third step carries out ultrafiltration to virus liquid；Production work personnel record's ultrafiltration parameter information measures venom protein by experiment
Content simultaneously records content value, and the data of record are input in data processing equipment and are saved；Data processing equipment uses automatically
Hash function calculates the cryptographic Hash of data, and the cryptographic Hash that previous step is generated is inputted as transaction, the cryptographic Hash that this is generated
It is exported as transaction, and the holding time stabs information, saved as a block chain transaction and Drug Administration is sent to by network
Mechanism；Drug Administration mechanism receives Transaction Information, verifies it not and be the dual transaction used and not in trading pit, the transaction
Transaction input be that itself trading pit is added if being verified in the output of a certain transaction in trading pit；
4th step carries out inactivation treatment to venom, carries out inactivation confirmatory experiment after the completion；Production work personnel read centrifugation machine side
Parameter information on plate simultaneously records these parameter informations, while recording the inactivator information in inactivation process and inactivation confirmatory experiment
The data of record are input in data processing equipment and are saved by result information；Data processing equipment uses hash function automatically
The cryptographic Hash for calculating data, the cryptographic Hash that previous step is generated are inputted as transaction, and the cryptographic Hash that this is generated is as transaction
Output, and the holding time stabs information, saves as a block chain transaction and is sent to Drug Administration mechanism by network；Drug
Regulatory agency receives Transaction Information, verifies it not and be the dual transaction used and not in trading pit, and the transaction of the transaction is defeated
Enter the output for transaction a certain in trading pit, if being verified, itself trading pit is added；
5th step purify simultaneously stoste calibrating to venom using chromatographic column；Ginseng in production work personnel record's purification process
Number information, and stoste verification result information is recorded, the data of record are input in data processing equipment and are saved；Data processing
Equipment uses hash function to calculate the cryptographic Hash of data automatically, and the cryptographic Hash that previous step is generated is inputted as transaction, by this
The cryptographic Hash of generation is as transaction output, and the holding time stabs information, saves as a block chain transaction and is sent out by network
It is sent to Drug Administration mechanism；Drug Administration mechanism receives Transaction Information, and verifying it not is the dual transaction used and is not trading
In pond, the transaction input of the transaction is the output of a certain transaction in trading pit, if being verified, itself transaction is added
Pond；
Venom is diluted, is lyophilized, dispensing finished product vaccine is made by the 6th step；Production work personnel record vaccine protectant is assigned
Type agent and related proportion information, the data of record are input in data processing equipment and are saved；Data processing equipment makes automatically
The cryptographic Hash that data are calculated with hash function, the cryptographic Hash that previous step is generated are inputted as transaction, the Hash that this is generated
Value is as transaction output, and the holding time stabs information, saves as a block chain transaction and is sent to drug prison by network
Pipe mechanism；Drug Administration mechanism receives Transaction Information, verifies it not and be the dual transaction used and not in trading pit, which hands over
Easy transaction input is that itself trading pit is added if being verified in the output of a certain transaction in trading pit；
7th step proposes approval and sign hair application；Production work personnel select starting to submit application operation, number in the data processing apparatus
All Activity is packaged as a block according to processing equipment and timestamp information is added, manufacturing enterprise's title is written in block head
The Hash information of address sends the block information to Drug Administration mechanism by network and proposes approval and sign hair application；
After 8th step, Drug Administration mechanism receive block and application, the vaccine sample sampling of the batch is checked；Scrutineer
Member checks whether the Transaction Information in the block received is consistent with the Transaction Information saved in trading pit, the company information of block head
Whether correct, whether the cryptographic Hash that record of production information generates is consistent with the cryptographic Hash traded every time；Check it is errorless after, drug prison
Pipe mechanism is signed to respective block using private key by application, by network by the batch production of vaccine block to the whole network
All enterprise's nodes are broadcasted；
9th step, each enterprise's node verify the block received, confirm whether block signature is Drug Administration mechanism label
Name, while confirming that whether transaction input and output correspond in block, search the block head with the block in itself block chain
The written consistent block of enterprise name Address-Hash value, checks each block timestamp, confirms that the enterprise is according to the production time
It is no to have the suspicion for forging the record of production, it is no if the normal production of confirmation, which is added on the block chain of itself preservation
Then reported to Drug Administration mechanism.
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| CN201910381347.8A CN110084626B (en) | 2019-05-08 | 2019-05-08 | Vaccine production supervision method based on block chain |
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| CN201910381347.8A CN110084626B (en) | 2019-05-08 | 2019-05-08 | Vaccine production supervision method based on block chain |
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| CN110084626B CN110084626B (en) | 2023-04-18 |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN110599180A (en) * | 2019-09-26 | 2019-12-20 | 腾讯科技（深圳）有限公司 | Block chain-based vaccine circulation management method and device |
| CN110992068A (en) * | 2019-12-17 | 2020-04-10 | 浙江大学 | Vaccine full life cycle management method and system based on block chain |
| CN111031036A (en) * | 2019-12-12 | 2020-04-17 | 深圳大学 | Block chain-based vaccine information monitoring method and device and computer equipment |
| 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 |
| 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 |
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