CN101380471A - Preparation method of absorption diphtheria tetanus combined vaccine without formaldehyde and merthiolate - Google Patents
Preparation method of absorption diphtheria tetanus combined vaccine without formaldehyde and merthiolate Download PDFInfo
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- CN101380471A CN101380471A CNA200810166061XA CN200810166061A CN101380471A CN 101380471 A CN101380471 A CN 101380471A CN A200810166061X A CNA200810166061X A CN A200810166061XA CN 200810166061 A CN200810166061 A CN 200810166061A CN 101380471 A CN101380471 A CN 101380471A
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Abstract
The invention discloses a method for preparing adsorbent diphtheria-tetanus vaccine without formaldehyde and Merthiolate. The preparation method comprises preparation of purified dipheria toxoid stock solution without the formaldehyde and the Merthiolate, and preparation, compounding and split charging of purified tetanus toxoid stock solution without the formaldehyde and the Merthiolate. By adopting human dosage specification, the vaccine is charged in a split way per time. When inoculation is carried out, the residence time contacting with air of the vaccine from unsealing to the inoculation is reduced to the maximum, thereby corrosion protection that is carried out by using the Merthiolate in the process of producing the purified dipheria toxoid stock solution and the purified tetanus toxoid stock solution is cancelled. The adsorbent diphtheria-tetanus vaccine without the formaldehyde and the Merthiolate is prepared by the preparation method provided by the technical proposal that formaldehyde is removed by dialysis or ultrafiltration, thereby the purpose that an inoculator suffers no potential mercury harzard risk from the Merthiolate and strong local pains of the inoculator is reduced is achieved.
Description
Technical field
The present invention relates to the preparation method of biological preparation vaccine, specifically be meant and produce a kind of adsorbed diphtheria,tetanus toxoid and pertussis vaccine tetanus combined vaccine compound method that does not contain formaldehyde and thimerosal of preventing and treating diphtheria and tetanus disease combined vaccine.
Background technology
2005 editions three ones of the Pharmacopoeias of the People's Republic of China are seen in the preparation of the adsorbed diphtheria,tetanus toxoid and pertussis vaccine tetanus combined vaccine of prior art, the 70th～71 page, " adsorbed diphtheria,tetanus toxoid and pertussis vaccine tetanus combined vaccine ".The domestic adsorbed diphtheria,tetanus toxoid and pertussis vaccine tetanus combined vaccine of now being produced all contains formaldehyde and thimerosal according to the pharmacopeia standard.Thimerosal plays antiseptic in vaccine, wherein hydrargyrum is heavy metal, the inoculator is had the risk of potential hydrargyrum harm; The effect of the existing antiseptic of formaldehyde has the effect that prevents the toxoid Poison Reverse again; Owing to contain formaldehyde in the vaccine, can produce intensive local pain sense behind human vaccination's vaccine.
Summary of the invention
Using the thimerosal antiseptic in adsorbed diphtheria,tetanus toxoid and pertussis vaccine tetanus combined vaccine is to consider, the inoculation of vaccine, mostly being the groupment queuing carries out in turn, often there is a group of people group's inoculation to finish, wait for the neutral gear gap of a group of people group's inoculation down, when the vaccine of big specification packing finishes from the inoculation that breaks a seal, have one period time of staying that contacts with air when waiting for down a group of people, therefore, just there is requirement for anticorrosion to vaccine.
Problems and shortcomings at above-mentioned prior art existence, the present invention adopts the vaccine of human dosage specification packing each time, when inoculation, reduce vaccine to greatest extent and inoculate the time of staying that contacts with air from breaking a seal to, in the process of producing Toxoidum Diphthericum Purificatum stock solution and tetanus toxoid purified stock solution, use thimerosal to carry out anticorrosion thereby just can cancel, and remove the technical scheme of formaldehyde by dialysis or ultrafiltration, a kind of adsorbed diphtheria,tetanus toxoid and pertussis vaccine tetanus combined vaccine compound method that does not contain formaldehyde and thimerosal is provided, be mixed with the adsorbed diphtheria,tetanus toxoid and pertussis vaccine tetanus combined vaccine that does not contain formaldehyde and thimerosal, reach no thimerosal to the potential hydrargyrum harm of inoculator risk, alleviate the purpose of the intensive local pain sense of inoculator.
The object of the present invention is achieved like this: the adsorbed diphtheria,tetanus toxoid and pertussis vaccine tetanus combined vaccine compound method that does not contain formaldehyde and thimerosal comprises the preparation of the Toxoidum Diphthericum Purificatum stock solution that does not contain formaldehyde and thimerosal, does not contain preparation, preparation, the packing of the tetanus toxoid purified stock solution of formaldehyde and thimerosal, wherein:
Being prepared as of the described Toxoidum Diphthericum Purificatum stock solution that does not contain formaldehyde and thimerosal, the following change that the production link of " adsorbed diphtheria Vaccine " standard in the pharmacopeia is made: " making with extra care " of pharmacopeia standard, " detoxification ", production link in do not add the thimerosal antiseptic, in " detoxification " link, increase dark detoxification process process and suppress to prevent the toxoid Poison Reverse, and increase ultrafiltration technology process is removed the formaldehyde in the goods, wherein, dark detoxification is for adjusting to 0.06%～0.08% to the total nitrogen of refining diphtheria toxin, diphtherotoxin, add 0.2% formaldehyde and 0.18% lysine, put 20～25 ℃ of detoxifications 4～5 days, adjust temperature to 35～36 ℃ detoxification 35 days, adjust temperature to 39 ℃ intensification detoxification 10 days, obtain dark detoxification Toxoidum Diphthericum Purificatum stock solution, ultrafiltration is for dialysing dark detoxification Toxoidum Diphthericum Purificatum stock solution or ultrafiltration removal formaldehyde, with 0.22 μ m filter membrane microporous filter, obtain not contain the dark detoxification Toxoidum Diphthericum Purificatum stock solution of formaldehyde and thimerosal, other not marked all production processes, project, calibrating subject and measurement unit thereof are all carried out in accordance with pharmacopeia " adsorbed diphtheria Vaccine " code requirement;
Being prepared as of the described tetanus toxoid purified stock solution that does not contain formaldehyde and thimerosal, the following change that the production link of " adsorbed Tetanus Vaccine " standard in the pharmacopeia is made: the dark detoxification process process that increases in " detoxification " link in the pharmacopeia standard suppresses to prevent the toxoid Poison Reverse, in the production link of " making with extra care ", do not add the thimerosal antiseptic, and increase ultrafiltration technology process is removed the formaldehyde in the goods, wherein, dark detoxification is for adjusting to 0.03%～0.04% to the total nitrogen of refining tetanus toxin, add 0.06% formaldehyde and 0.09% lysine, put 20～25 ℃ of detoxifications 4～5 days, adjust temperature to 34～35 ℃ detoxification 18 days, adjust temperature to 37～38 ℃ intensification detoxification 10 days, obtain dark detoxification tetanus toxoid purified stock solution, ultrafiltration is for dialysing dark detoxification tetanus toxoid purified stock solution or ultrafiltration removal formaldehyde, with 0.22 μ m filter membrane microporous filter, obtain not contain the dark detoxification tetanus toxoid purified stock solution of formaldehyde and thimerosal, other not marked all production processes, project, calibrating subject and measurement unit thereof are all carried out in accordance with pharmacopeia " adsorbed Tetanus Vaccine " code requirement;
Described being formulated as, the dark detoxification Toxoidum Diphthericum Purificatum stock solution of formaldehyde and thimerosal will do not contained, with the tetanus toxoid purified stock solution that does not contain formaldehyde and thimerosal, add and contain the aluminum adsorbent and be mixed with the combined vaccine semi-finished product that do not contain formaldehyde and thimerosal, prescription is: the dark detoxification Toxoidum Diphthericum Purificatum stock solution 20lf/ml that does not contain formaldehyde and thimerosal, the dark detoxification tetanus toxoid purified stock solution 3lf/ml that does not contain formaldehyde and thimerosal, aluminium hydroxide 2.3mg/ml, sodium chloride 8.5mg/ml, acquisition does not contain the combined vaccine semi-finished product of formaldehyde and thimerosal;
Described being packed as will not contain the combined vaccine semi-finished product of formaldehyde and thimerosal, by the cillin bottle of human dosage specification packing each time, and every bottle of 0.5ml of single agent.
Technical process:
By the described preparation that does not contain the Toxoidum Diphthericum Purificatum stock solution of formaldehyde and thimerosal, obtain not contain the dark detoxification Toxoidum Diphthericum Purificatum stock solution of formaldehyde and thimerosal; By the described preparation that does not contain the tetanus toxoid purified stock solution of formaldehyde and thimerosal, obtain not contain the dark detoxification tetanus toxoid purified stock solution of formaldehyde and thimerosal; In " preparation " link of pharmacopeia " adsorbed diphtheria,tetanus toxoid and pertussis vaccine tetanus combined vaccine " specification procedure, by described preparation, do not add the thimerosal antiseptic, obtain not contain the adsorbed diphtheria,tetanus toxoid and pertussis vaccine tetanus combined vaccine semi-finished product of formaldehyde and thimerosal; " finished product " link in pharmacopeia " adsorbed diphtheria,tetanus toxoid and pertussis vaccine tetanus combined vaccine " specification procedure, by described packing, obtain not contain the adsorbed diphtheria,tetanus toxoid and pertussis vaccine tetanus combined vaccine finished product of formaldehyde and thimerosal, other not marked all processes, project, calibrating subject and measurement unit thereof are all carried out in accordance with pharmacopeia " adsorbed diphtheria,tetanus toxoid and pertussis vaccine tetanus combined vaccine " code requirement.
Of particular note, the adsorbed diphtheria,tetanus toxoid and pertussis vaccine tetanus combined vaccine compound method that does not contain formaldehyde and thimerosal of the present invention, the prepared adsorbed diphtheria,tetanus toxoid and pertussis vaccine tetanus combined vaccine that does not contain formaldehyde and thimerosal, by the every calibrating section purpose calibrating of pharmacopeia standard, do not pollute, inefficacy and Poison Reverse phenomenon.
In sum, the present invention adopts the vaccine of human dosage specification packing each time, when inoculation, reduce vaccine to greatest extent and inoculate the time of staying that contacts with air from breaking a seal to, in the process of producing Toxoidum Diphthericum Purificatum stock solution and tetanus toxoid purified stock solution, use thimerosal to carry out anticorrosion thereby cancelled, and by the technical scheme of dialysing or formaldehyde is removed in ultrafiltration, a kind of adsorbed diphtheria,tetanus toxoid and pertussis vaccine tetanus combined vaccine compound method that does not contain formaldehyde and thimerosal that is provided, be mixed with the adsorbed diphtheria,tetanus toxoid and pertussis vaccine tetanus combined vaccine that does not contain formaldehyde and thimerosal, reach no thimerosal to the potential hydrargyrum harm of inoculator risk, alleviated the purpose of the intensive local pain sense of inoculator.
The embodiment explanation
Below by specific embodiment the adsorbed diphtheria,tetanus toxoid and pertussis vaccine tetanus combined vaccine compound method that does not contain formaldehyde and thimerosal of the present invention is described in further detail.
The specific embodiment
Goods name: the adsorbed diphtheria,tetanus toxoid and pertussis vaccine tetanus combined vaccine that does not contain formaldehyde and thimerosal
Step 1, do not contain the preparation of the Toxoidum Diphthericum Purificatum stock solution of formaldehyde and thimerosal:
The following change that the production link of " adsorbed diphtheria Vaccine " standard in the pharmacopeia is made: " making with extra care " of pharmacopeia standard, " detoxification ", production link in do not add the thimerosal antiseptic, in " detoxification " link, increase dark detoxification process process and suppress to prevent the toxoid Poison Reverse, and increase ultrafiltration technology process is removed the formaldehyde in the goods, wherein, dark detoxification is for adjusting to 0.06%～0.08% to the total nitrogen of refining diphtheria toxin, diphtherotoxin, add 0.2% formaldehyde and 0.18% lysine, put 20～25 ℃ of detoxifications 4～5 days, adjust temperature to 35～36 ℃ detoxification 35 days, adjust temperature to 39 ℃ intensification detoxification 10 days, obtain dark detoxification Toxoidum Diphthericum Purificatum stock solution, ultrafiltration is for dialysing dark detoxification Toxoidum Diphthericum Purificatum stock solution or ultrafiltration removal formaldehyde, with 0.22 μ m filter membrane microporous filter, obtain not contain the dark detoxification Toxoidum Diphthericum Purificatum stock solution of formaldehyde and thimerosal, other not marked all production processes, project, calibrating subject and measurement unit thereof are all carried out in accordance with pharmacopeia " adsorbed diphtheria Vaccine " code requirement;
Step 2, do not contain the preparation of the tetanus toxoid purified stock solution of formaldehyde and thimerosal:
The following change that the production link of " adsorbed Tetanus Vaccine " standard in the pharmacopeia is made: the dark detoxification process process that increases in " detoxification " link in the pharmacopeia standard suppresses to prevent the toxoid Poison Reverse, in the production link of " making with extra care ", do not add the thimerosal antiseptic, and increase ultrafiltration technology process is removed the formaldehyde in the goods, wherein, dark detoxification is for adjusting to 0.03%～0.04% to the total nitrogen of refining tetanus toxin, add 0.06% formaldehyde and 0.09% lysine, put 20～25 ℃ of detoxifications 4～5 days, adjust temperature to 34～35 ℃ detoxification 18 days, adjust temperature to 37～38 ℃ intensification detoxification 10 days, obtain dark detoxification tetanus toxoid purified stock solution, ultrafiltration is for dialysing dark detoxification tetanus toxoid purified stock solution or ultrafiltration removal formaldehyde, with 0.22 μ m filter membrane microporous filter, obtain not contain the dark detoxification tetanus toxoid purified stock solution of formaldehyde and thimerosal, other not marked all production processes, project, calibrating subject and measurement unit thereof are all carried out in accordance with pharmacopeia " adsorbed Tetanus Vaccine " code requirement;
Step 3, preparation:
The dark detoxification Toxoidum Diphthericum Purificatum stock solution that does not contain formaldehyde and thimerosal with the step 1 acquisition, the tetanus toxoid purified stock solution that does not contain formaldehyde and thimerosal with the step 2 acquisition, add and contain the aluminum adsorbent and be mixed with the combined vaccine semi-finished product that do not contain formaldehyde and thimerosal, prescription is: the dark detoxification Toxoidum Diphthericum Purificatum stock solution 20lf/ml that does not contain formaldehyde and thimerosal, the dark detoxification tetanus toxoid purified stock solution 3lf/ml that does not contain formaldehyde and thimerosal, aluminium hydroxide 2.3mg/ml, sodium chloride 8.5mg/ml, acquisition does not contain the adsorbed diphtheria,tetanus toxoid and pertussis vaccine tetanus combined vaccine semi-finished product of formaldehyde and thimerosal;
Step 4, packing:
With the adsorbed diphtheria,tetanus toxoid and pertussis vaccine tetanus combined vaccine semi-finished product that do not contain formaldehyde and thimerosal that step 3 obtains, press the cillin bottle of human dosage specification packing each time, every bottle of 0.5ml of single agent, acquisition does not contain the adsorbed diphtheria,tetanus toxoid and pertussis vaccine tetanus combined vaccine finished product of formaldehyde and thimerosal.
Other not marked all processes, project, calibrating subject and measurement unit thereof are all carried out in accordance with pharmacopeia " adsorbed diphtheria,tetanus toxoid and pertussis vaccine tetanus combined vaccine " code requirement.
Claims (2)
1, the adsorbed diphtheria,tetanus toxoid and pertussis vaccine tetanus combined vaccine compound method that does not contain formaldehyde and thimerosal comprises the preparation of the Toxoidum Diphthericum Purificatum stock solution that does not contain formaldehyde and thimerosal, do not contain the preparation of the tetanus toxoid purified stock solution of formaldehyde and thimerosal, preparation, packing, it is characterized in that: being prepared as of the described Toxoidum Diphthericum Purificatum stock solution that does not contain formaldehyde and thimerosal, the following change that the production link of " adsorbed diphtheria Vaccine " standard in the pharmacopeia is made: " making with extra care " of pharmacopeia standard, " detoxification ", production link in do not add the thimerosal antiseptic, in " detoxification " link, increase dark detoxification process process and suppress to prevent the toxoid Poison Reverse, and increase ultrafiltration technology process is removed the formaldehyde in the goods, wherein, dark detoxification is for adjusting to 0.06%～0.08% to the total nitrogen of refining diphtheria toxin, diphtherotoxin, add 0.2% formaldehyde and 0.18% lysine, put 20～25 ℃ of detoxifications 4～5 days, adjust temperature to 35～36 ℃ detoxification 35 days, adjust temperature to 39 ℃ intensification detoxification 10 days, obtain dark detoxification Toxoidum Diphthericum Purificatum stock solution, ultrafiltration is for dialysing dark detoxification Toxoidum Diphthericum Purificatum stock solution or ultrafiltration removal formaldehyde, with 0.22 μ m filter membrane microporous filter, obtain not contain the dark detoxification Toxoidum Diphthericum Purificatum stock solution of formaldehyde and thimerosal;
Being prepared as of the described tetanus toxoid purified stock solution that does not contain formaldehyde and thimerosal, the following change that the production link of " adsorbed Tetanus Vaccine " standard in the pharmacopeia is made: the dark detoxification process process that increases in " detoxification " link in the pharmacopeia standard suppresses to prevent the toxoid Poison Reverse, in the production link of " making with extra care ", do not add the thimerosal antiseptic, and increase ultrafiltration technology process is removed the formaldehyde in the goods, wherein, dark detoxification is for adjusting to 0.03%～0.04% to the total nitrogen of refining tetanus toxin, add 0.06% formaldehyde and 0.09% lysine, put 20～25 ℃ of detoxifications 4～5 days, adjust temperature to 34～35 ℃ detoxification 18 days, adjust temperature to 37～38 ℃ intensification detoxification 10 days, obtain dark detoxification tetanus toxoid purified stock solution, ultrafiltration is for dialysing dark detoxification tetanus toxoid purified stock solution or ultrafiltration removal formaldehyde, with 0.22 μ m filter membrane microporous filter, obtain not contain the dark detoxification tetanus toxoid purified stock solution of formaldehyde and thimerosal;
Described being formulated as, the dark detoxification Toxoidum Diphthericum Purificatum stock solution of formaldehyde and thimerosal will do not contained, with the tetanus toxoid purified stock solution that does not contain formaldehyde and thimerosal, add and contain the aluminum adsorbent and be mixed with the combined vaccine semi-finished product that do not contain formaldehyde and thimerosal, prescription is: the dark detoxification Toxoidum Diphthericum Purificatum stock solution 201f/ml that does not contain formaldehyde and thimerosal, the dark detoxification tetanus toxoid purified stock solution 31f/ml that does not contain formaldehyde and thimerosal, aluminium hydroxide 2.3mg/ml, sodium chloride 8.5mg/ml, acquisition does not contain the combined vaccine semi-finished product of formaldehyde and thimerosal;
Described being packed as will not contain the combined vaccine semi-finished product of formaldehyde and thimerosal, by the cillin bottle of human dosage specification packing each time, and every bottle of 0.5ml of single agent.
2, the adsorbed diphtheria,tetanus toxoid and pertussis vaccine tetanus combined vaccine compound method that does not contain formaldehyde and thimerosal according to claim 1, it is characterized in that: described technical process is, by the described preparation that does not contain the Toxoidum Diphthericum Purificatum stock solution of formaldehyde and thimerosal, obtain not contain the dark detoxification Toxoidum Diphthericum Purificatum stock solution of formaldehyde and thimerosal; By the described preparation that does not contain the tetanus toxoid purified stock solution of formaldehyde and thimerosal, obtain not contain the dark detoxification tetanus toxoid purified stock solution of formaldehyde and thimerosal; In " preparation " link of pharmacopeia " adsorbed diphtheria,tetanus toxoid and pertussis vaccine tetanus combined vaccine " specification procedure, by described preparation, do not add the thimerosal antiseptic, obtain not contain the adsorbed diphtheria,tetanus toxoid and pertussis vaccine tetanus combined vaccine semi-finished product of formaldehyde and thimerosal; In " finished product " link of pharmacopeia " adsorbed diphtheria,tetanus toxoid and pertussis vaccine tetanus combined vaccine " specification procedure,, obtain not contain the adsorbed diphtheria,tetanus toxoid and pertussis vaccine tetanus combined vaccine finished product of formaldehyde and thimerosal by described packing.
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| CNA200810166061XA CN101380471A (en) | 2008-10-15 | 2008-10-15 | Preparation method of absorption diphtheria tetanus combined vaccine without formaldehyde and merthiolate |
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| CNA200810166061XA CN101380471A (en) | 2008-10-15 | 2008-10-15 | Preparation method of absorption diphtheria tetanus combined vaccine without formaldehyde and merthiolate |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102363041A (en) * | 2011-11-17 | 2012-02-29 | 成都欧林生物科技股份有限公司 | Method for preparing preservative-free vaccine |
| CN101503725B (en) * | 2009-03-19 | 2012-06-06 | 浙江天元生物药业有限公司 | Technique for improving purity of diphtheria toxoid |
| GB2495341A (en) * | 2011-11-11 | 2013-04-10 | Novartis Ag | Fermentation medium for increased yield of Corynebacterium diphtheriae toxin, and uses of the toxin. |
| GB2498112A (en) * | 2011-11-11 | 2013-07-03 | Novartis Ag | Preparation of a diphtheria toxoid by incubating toxin concentrate with an amino acid and formaldehyde |
| CN115448981A (en) * | 2022-10-20 | 2022-12-09 | 北京智飞绿竹生物制药有限公司 | Preparation method of adsorbed tetanus vaccine |
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2008
- 2008-10-15 CN CNA200810166061XA patent/CN101380471A/en active Pending
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101503725B (en) * | 2009-03-19 | 2012-06-06 | 浙江天元生物药业有限公司 | Technique for improving purity of diphtheria toxoid |
| GB2495341A (en) * | 2011-11-11 | 2013-04-10 | Novartis Ag | Fermentation medium for increased yield of Corynebacterium diphtheriae toxin, and uses of the toxin. |
| GB2498112A (en) * | 2011-11-11 | 2013-07-03 | Novartis Ag | Preparation of a diphtheria toxoid by incubating toxin concentrate with an amino acid and formaldehyde |
| GB2495341B (en) * | 2011-11-11 | 2013-09-18 | Novartis Ag | Fermentation methods and their products |
| US9040058B2 (en) | 2011-11-11 | 2015-05-26 | Glaxosmithkline Biologicals Sa | Fermentation media free of animal-derived components for production of diphtheria toxoids suitable for human vaccine use |
| CN102363041A (en) * | 2011-11-17 | 2012-02-29 | 成都欧林生物科技股份有限公司 | Method for preparing preservative-free vaccine |
| CN115448981A (en) * | 2022-10-20 | 2022-12-09 | 北京智飞绿竹生物制药有限公司 | Preparation method of adsorbed tetanus vaccine |
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Open date: 20090311 |