CN101366945A - Formulation method for adsorption diphtheria vaccine not containing methanal and thimerosal - Google Patents
Formulation method for adsorption diphtheria vaccine not containing methanal and thimerosal Download PDFInfo
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- CN101366945A CN101366945A CNA2008102136922A CN200810213692A CN101366945A CN 101366945 A CN101366945 A CN 101366945A CN A2008102136922 A CNA2008102136922 A CN A2008102136922A CN 200810213692 A CN200810213692 A CN 200810213692A CN 101366945 A CN101366945 A CN 101366945A
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Abstract
The invention discloses a method for preparing an adsorption diphtheria vaccine without formaldehyde and merthiolate, which comprises deepdetoxification, ultrafiltration, preparation and subpackaging. The invention overcomes the defects in prior art that the adsorption diphtheria vaccine contains the formaldehyde and the merthiolate, and the children inoculating the vaccine have potential mercury risk and can feel intense local pain, and adopts the technical proposal of subpackaging vaccine according to the one-time human dosage, eliminates the use of the merthiolate for corrosion resistance in the process of preparing the refined diphtheria toxoid raw liquor and removes the formaldehyde by dialysis or ultrafiltration to prepare the adsorption diphtheria vaccine wothout the formaldehyde and the merthiolate, thereby achieving the aims that the children inoculating the vaccine have not potential mercury risk and can alleviate the intense local pain.
Description
Technical field
The present invention relates to the preparation method of biological preparation vaccine, specifically be meant a kind of compound method that does not contain the adsorbed diphtheria Vaccine of formaldehyde and thimerosal of the adsorbed diphtheria Vaccine of producing prevention diphtheria disease.
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 Vaccine of prior art, the 65th～66 page, " adsorbed diphtheria Vaccine ".The domestic adsorbed diphtheria 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 inoculation child 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 Vaccine is to consider, the inoculation of vaccine mostly is the groupment queuing and 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 than big specification packing finishes from the inoculation that breaks a seal, have the time of staying of one section ingress of air, therefore, just have requirement for anticorrosion 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, use thimerosal to carry out anticorrosion thereby just can cancel, and remove the technical scheme of formaldehyde by dialysis or ultrafiltration, a kind of compound method that does not contain the adsorbed diphtheria Vaccine of formaldehyde and thimerosal is provided, be mixed with the adsorbed diphtheria Vaccine that does not contain formaldehyde and thimerosal, reach the worry and the purpose that alleviate inoculation child intensive local pain sense of no thimerosal the potential hydrargyrum harm of inoculation child risk.
The object of the present invention is achieved like this: a kind of compound method that does not contain the adsorbed diphtheria Vaccine of formaldehyde and thimerosal comprises method, dark detoxification, ultrafiltration, preparation, packing, wherein:
Described method is 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 ", do not add the thimerosal antiseptic in the production link of " preparation of adsorbed toxoid ", 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, in " finished product " link, adopt the vaccine of human dosage specification packing each time, 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;
Described 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;
Described ultrafiltration obtains not contain the dark detoxification Toxoidum Diphthericum Purificatum stock solution of formaldehyde and thimerosal for dark detoxification Toxoidum Diphthericum Purificatum stock solution being dialysed or ultrafiltration removal formaldehyde with 0.22 μ m filter membrane microporous filter;
Described being formulated as will not contain the dark detoxification Toxoidum Diphthericum Purificatum stock solution of formaldehyde and thimerosal, add and contain the aluminum adsorbent and be mixed with the vaccine semi-finished product that do not contain formaldehyde and thimerosal, prescription is diphtheria toxoid 401f/ml, aluminium hydroxide 2.8mg/ml, sodium chloride 8.5mg/ml;
Described being packed as will not contain the 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: obtain diphtheria toxoid by officinal " adsorbed diphtheria Vaccine " specification procedure, in " making with extra care " link of pharmacopeia specification procedure, do not add the thimerosal antiseptic; " detoxification " link in the pharmacopeia specification procedure, increase described dark detoxification process, suppress to prevent Poison Reverse, obtain the dark detoxification Toxoidum Diphthericum Purificatum stock solution of no thimerosal, and increase described ultra-filtration process, remove the formaldehyde in the dark detoxification Toxoidum Diphthericum Purificatum stock solution of no thimerosal, obtain not contain the dark detoxification Toxoidum Diphthericum Purificatum stock solution of formaldehyde and thimerosal; In " preparation of adsorbed toxoid " link of pharmacopeia specification procedure, by described preparation preparation, do not add the thimerosal antiseptic, obtain not contain the adsorbed diphtheria Vaccine semi-finished product of formaldehyde and thimerosal; " finished product " link in the pharmacopeia specification procedure, obtain not contain the adsorbed diphtheria Vaccine finished product of formaldehyde and thimerosal by described packing, other other not marked all processes, project, calibrating subject and measurement unit thereof are all carried out in accordance with pharmacopeia " adsorbed diphtheria Vaccine " code requirement.
Of particular note, the prepared adsorbed diphtheria Vaccine that does not contain formaldehyde and thimerosal of compound method that does not contain the adsorbed diphtheria Vaccine of formaldehyde and thimerosal of the present invention, 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, use thimerosal to carry out anticorrosion thereby cancelled, and by the technical scheme of dialysing or formaldehyde is removed in ultrafiltration, a kind of compound method that does not contain the adsorbed diphtheria Vaccine of formaldehyde and thimerosal that is provided, be mixed with the adsorbed diphtheria Vaccine that does not contain formaldehyde and thimerosal, reached the worry and the purpose that alleviate inoculation child intensive local pain sense of no thimerosal the potential hydrargyrum harm of inoculation child risk.
The embodiment explanation
Below by specific embodiment the compound method that does not contain the adsorbed diphtheria Vaccine of formaldehyde and thimerosal of the present utility model is described in further detail.
The specific embodiment
Goods name: the adsorbed diphtheria Vaccine that does not contain formaldehyde and thimerosal
Technical process: obtain diphtheria toxoid by pharmacopeia " adsorbed diphtheria Vaccine " specification procedure, in " making with extra care " link of pharmacopeia specification procedure, do not add the thimerosal antiseptic; " detoxification " link in the pharmacopeia specification procedure, increase described dark detoxification process, obtain the dark detoxification Toxoidum Diphthericum Purificatum stock solution of no thimerosal, and increase described ultra-filtration process, remove the formaldehyde in the dark detoxification Toxoidum Diphthericum Purificatum stock solution of no thimerosal, obtain not contain the dark detoxification Toxoidum Diphthericum Purificatum stock solution of formaldehyde and thimerosal; In " preparation of adsorbed toxoid " link of pharmacopeia specification procedure, by described preparation preparation, do not add the thimerosal antiseptic, obtain not contain the adsorbed diphtheria Vaccine semi-finished product of formaldehyde and thimerosal; " finished product " link in the pharmacopeia specification procedure, obtain not contain the adsorbed diphtheria Vaccine finished product of formaldehyde and thimerosal by described packing, other other not marked all processes, project, calibrating subject and measurement unit thereof are all carried out in accordance with pharmacopeia " adsorbed diphtheria Vaccine " code requirement.
The adsorbed diphtheria Vaccine that does not contain formaldehyde and thimerosal that the compound method of the adsorbed diphtheria Vaccine that does not contain formaldehyde and thimerosal of the invention described above is prepared by the every calibrating section purpose calibrating of pharmacopeia standard, does not pollute, inefficacy and Poison Reverse phenomenon.
Claims (2)
1. the compound method that does not contain the adsorbed diphtheria Vaccine of formaldehyde and thimerosal comprises method, dark detoxification, ultrafiltration, preparation, packing, it is characterized in that: described method is 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 ", do not add the thimerosal antiseptic in the production link of " preparation of adsorbed toxoid ", 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, in " finished product " link, adopt the vaccine of human dosage specification packing each time, other other not marked all processes, project, calibrating subject and measurement unit thereof are all carried out in accordance with pharmacopeia " adsorbed diphtheria Vaccine " code requirement; Described 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; Described ultrafiltration obtains not contain the dark detoxification Toxoidum Diphthericum Purificatum stock solution of formaldehyde and thimerosal for dark detoxification Toxoidum Diphthericum Purificatum stock solution being dialysed or ultrafiltration removal formaldehyde with 0.22 μ m filter membrane microporous filter; Described being formulated as will not contain the dark detoxification Toxoidum Diphthericum Purificatum stock solution of formaldehyde and thimerosal, add and contain the aluminum adsorbent and be mixed with the vaccine semi-finished product that do not contain formaldehyde and thimerosal, prescription is diphtheria toxoid 40lf/ml, aluminium hydroxide 2.8mg/ml, sodium chloride 8.5mg/ml; Described being packed as will not contain the 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 compound method that does not contain the adsorbed diphtheria Vaccine of formaldehyde and thimerosal according to claim 1, it is characterized in that: described technical process is, obtain diphtheria toxoid by officinal " adsorbed diphtheria Vaccine " specification procedure, in " making with extra care " link of pharmacopeia specification procedure, do not add the thimerosal antiseptic; " detoxification " link in the pharmacopeia specification procedure, increase described dark detoxification process, suppress to prevent Poison Reverse, obtain the dark detoxification Toxoidum Diphthericum Purificatum stock solution of no thimerosal, and increase described ultra-filtration process, remove the formaldehyde in the dark detoxification Toxoidum Diphthericum Purificatum stock solution of no thimerosal, obtain not contain the dark detoxification Toxoidum Diphthericum Purificatum stock solution of formaldehyde and thimerosal; In " preparation of adsorbed toxoid " link of pharmacopeia specification procedure, by described preparation preparation, do not add the thimerosal antiseptic, obtain not contain the adsorbed diphtheria Vaccine semi-finished product of formaldehyde and thimerosal; In " finished product " link of pharmacopeia specification procedure, obtain not contain the adsorbed diphtheria Vaccine finished product of formaldehyde and thimerosal by described packing.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2008102136922A CN101366945A (en) | 2008-08-21 | 2008-08-21 | Formulation method for adsorption diphtheria vaccine not containing methanal and thimerosal |
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| Application Number | Priority Date | Filing Date | Title |
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| CNA2008102136922A CN101366945A (en) | 2008-08-21 | 2008-08-21 | Formulation method for adsorption diphtheria vaccine not containing methanal and thimerosal |
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| CN101366945A true CN101366945A (en) | 2009-02-18 |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN109310776A (en) * | 2016-04-14 | 2019-02-05 | 梅里亚股份有限公司 | Multidose composition containing antimicrobial polyamide or Octenidine preservative |
-
2008
- 2008-08-21 CN CNA2008102136922A patent/CN101366945A/en active Pending
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN109310776A (en) * | 2016-04-14 | 2019-02-05 | 梅里亚股份有限公司 | Multidose composition containing antimicrobial polyamide or Octenidine preservative |
| CN109310776B (en) * | 2016-04-14 | 2022-02-11 | 勃林格殷格翰动物保健美国公司 | Multi-dose compositions containing antimicrobial polyamide or octenidine preservatives |
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