CN102389570A - Antiseptic-free vaccine - Google Patents
Antiseptic-free vaccine Download PDFInfo
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- CN102389570A CN102389570A CN201110365656XA CN201110365656A CN102389570A CN 102389570 A CN102389570 A CN 102389570A CN 201110365656X A CN201110365656X A CN 201110365656XA CN 201110365656 A CN201110365656 A CN 201110365656A CN 102389570 A CN102389570 A CN 102389570A
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- vaccine
- antiseptic
- contain
- toxoid
- free
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Abstract
The invention discloses an antiseptic-free vaccine, which is made from the following components of: by weight, 7-9Lf/ml of an antiseptic-free vaccine stock solution, 1.0-3.0g/L of an adsorbent, 0.05-0.07g/L of Na2HPO4, 0.005-0.015g/L of KH2PO4, and 7-9g/L of NaCl. The antiseptic-free vaccine provided by the invention can be used to solve the problem that traditional vaccine products contain antiseptics. According to the invention, the whole process of the vaccine preparation is aseptic and the vaccine finished product is aseptic during the storage, transportation and preservation process within the period of validity, thus raising the vaccine security. The antiseptic-free vaccine is suitable for a plurality of bacterial toxins and has a wide application range.
Description
Technical field
The present invention relates to a kind of antiseptic vaccine that do not contain.
Background technology
Mostly the inoculation of vaccine is that groupment queuing carries out in turn, has a group of people crowd's inoculation to finish often, waits for the neutral gear gap of a group of people crowd'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, and the storage and transportation process of vaccine product after production touches germ contamination easily; Therefore, just have the requirement for anticorrosion to vaccine, a lot of vaccine products prepare at finished product and add the antiseptic thimerosal in the process with bacteria growing inhibiting; But be to use thimerosal to cause potential safety hazard to human body, can produce intensive local pain sense behind the human vaccination, have document to point out: high-load hydrargyrum is a kind of never poison in the period of development of key; And research shows that the vaccine that contains thimerosal can make the intravital mercury content of neonate increase (referring to " biological product news flash "; 2000 the 3rd phases, select from Vaccine Weekly, 2000; May24, p10); Also have document to point out: heavy dose of thimerosal can cause nerve and Toxicity of Kidney; The level of security that EPA (U.S. environment protection management board) and WHO (World Health Organization (WHO)) make respectively about hydrargyrum was defined as for 0.7 μ g/ kg body weight/week and 3.3 μ g/kg body weight/weeks, according to statistics, and in the U.S.; The broken vaccine (being equivalent to contain 75 μ g ethyl mercuries) of 3 doses of one hundred days of baby due 14 week inoculation, Hepatitis B virus vaccine (being equivalent to contain 37.5 μ g ethyl mercuries), Hib (Type B haemophilus) vaccine (being equivalent to contain 75 μ g ethyl mercuries); The ethyl mercury total content has surpassed the high limit that each mechanism defines (referring to " foreign medical science, the biological product fascicle is used in prevention, diagnosis, treatment " up to 187.5 μ g; 2000; 23 (3), pp105-107 is translated from Wkly Epidem Rec 2000; 75 (2): 12-16), the meeting of the relevant thimerosal of international vaccine consultative committee tissue in 1999 thinks that the baby lacks the ability of removing hydrargyrum, and 2002 the 3rd phase 128-130 pages or leaves are translated from Wkly Epidem Rec 2002; 77 (47): 389-394).
Summary of the invention
The object of the invention promptly is to overcome the deficiency of prior art; A kind of various bacteria toxoid that is applicable to is provided; The scope of application is wider, and has solved the problem that the traditional vaccine goods contain antiseptic, and the vaccine production overall process is aseptic; Vaccine finished product accumulating and preservation process in its effect duration is aseptic, and that improves vaccine safety does not contain the antiseptic vaccine.
The objective of the invention is to realize through following technical scheme: do not contain the antiseptic vaccine, it is made up of following component and weight: do not contain antiseptic vaccinogen liquid 7 ~ 9Lf/ml, adsorbent 1.0 ~ 3.0g/L, Na
2HPO
40.05 ~ 0.07g/L, KH
2PO
40.005 ~ 0.015g/L, NaCl 7 ~ 9g/L.
Described adsorbent is Al (OH)
3The described antiseptic vaccine that do not contain comprises bacillary toxoid vaccine; Described bacillary toxoid vaccine comprises tetanus vaccine, diphtheria vaccine, pertussis vaccine at least.
The invention has the beneficial effects as follows: the present invention provides a kind of antiseptic vaccine that do not contain; Be applicable to the various bacteria toxoid, the scope of application is wider, adopts unique sterile production equipment and technology and pharmaceutical formulation; Has the problem that traditional vaccine goods contain antiseptic that solved; Aseptic in the vaccine production overall process, vaccine finished product accumulating and preservation process in its effect duration is aseptic, improves advantages such as vaccine safety.
The specific embodiment
Below in conjunction with embodiment the present invention is done further description, but protection scope of the present invention is not limited to the following stated.
Embodiment 1:
Do not contain the antiseptic vaccine, it is made up of following component and weight: do not contain antiseptic vaccinogen liquid 7Lf/ml, Al (OH)
31.0g/L, Na
2HPO
40.05g/L, KH
2PO
40.015g/L, NaCl 7g/L, the described antiseptic vaccine that do not contain comprises bacillary toxoid vaccine; Described bacillary toxoid vaccine comprises tetanus vaccine, diphtheria vaccine, pertussis vaccine at least.
Embodiment 2:
Do not contain the antiseptic vaccine, it is made up of following component and weight: do not contain antiseptic vaccinogen liquid 9Lf/ml, Al (OH)
33.0g/L, Na
2HPO
40.07g/L, KH
2PO
40.005g/L, NaCl 9g/L, the described antiseptic vaccine that do not contain comprises bacillary toxoid vaccine; Described bacillary toxoid vaccine comprises tetanus vaccine, diphtheria vaccine, pertussis vaccine at least.
Embodiment 3:
Do not contain the antiseptic vaccine, it is made up of following component and weight: do not contain antiseptic vaccinogen liquid 8Lf/ml, Al (OH)
32.0g/L, Na
2HPO
40.06g/L, KH
2PO
40.01g/L, NaCl 8g/L, the described antiseptic vaccine that do not contain comprises bacillary toxoid vaccine; Described bacillary toxoid vaccine comprises tetanus vaccine, diphtheria vaccine, pertussis vaccine at least.
Processing technology of the present invention may further comprise the steps:
(1) refining: as to adopt the plate and frame filter press technique to remove thalline; Collect filtrating; It is that the ultrafiltration system of 28～32KD concentrates that the filtrating of collecting is used molecular weight, concentrates to accomplish the back and add ammonium sulfate and saltout centrifugal collecting precipitation after; Treat to carry out the ultrafiltration desalination behind the resolution of precipitate, obtain refining toxoid;
(2) detoxification: add formalin by 0.1～0.3% of refining toxoid solution, 36～40 ℃ of following detoxifications 30～50 days;
(3) detoxification inspection: detoxification is taken a sample to every bottle of refining toxoid after accomplishing, and chooses body weight and be at least 2 of the Cavia porcelluss of 300～400g; Every subcutaneous injection 400～600 Lf are diluted to 90～110Lf/ml with 0.8～1.0% aseptic sodium chloride solution, every subcutaneous injection 4～6ml with every bottle of refining toxoid detoxification sample; Observed in the 5th～9 day, the 12nd～16 day, the 19th～23 day in the injection back; Animal does not have bad symptom, and body weight does not have before the injection and do not alleviate, and strong deposit the used toxoid of animal be qualified; The person of losing weight should increase injection volume and carry out the retrial judgement, continues detoxification with the used toxoid of ill symptoms animal takes place;
(4) aseptic filtration: the stock solution of detoxification passed examination is carried out aseptic filtration, make and do not contain the antiseptic vaccinogen liquid;
(5) preparation: prepare by following component and weight: do not contain antiseptic vaccinogen liquid 7～9lf/ml, Al (OH)
31.0 ~ 3.0g/L, Na
2HPO
40.05 ~ 0.07g/L, KH
2PO
40.005 ~ 0.015g/L, NaCl 7 ~ 9 g/L make after preparation is accomplished and do not contain antiseptic vaccine semi-finished product;
(6) packing: will not contain antiseptic vaccine semi-finished product by human dosage specification packing each time, and preserve in 2～8 ℃ of shadings.
Claims (4)
1. do not contain the antiseptic vaccine, it is characterized in that: it is made up of following component and weight: do not contain antiseptic vaccinogen liquid 7 ~ 9Lf/ml, adsorbent 1.0 ~ 3.0g/L, Na
2HPO
40.05 ~ 0.07g/L, KH
2PO
40.005 ~ 0.015g/L, NaCl 7 ~ 9g/L.
2. the antiseptic vaccine that do not contain according to claim 1 is characterized in that: described adsorbent is Al (OH)
3
3. the antiseptic vaccine that do not contain according to claim 1 is characterized in that: the described antiseptic vaccine that do not contain comprises bacillary toxoid vaccine.
4. the antiseptic vaccine that do not contain according to claim 3 is characterized in that: described bacillary toxoid vaccine comprises tetanus vaccine, diphtheria vaccine, pertussis vaccine at least.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201110365656XA CN102389570A (en) | 2011-11-17 | 2011-11-17 | Antiseptic-free vaccine |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201110365656XA CN102389570A (en) | 2011-11-17 | 2011-11-17 | Antiseptic-free vaccine |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN102389570A true CN102389570A (en) | 2012-03-28 |
Family
ID=45857034
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201110365656XA Pending CN102389570A (en) | 2011-11-17 | 2011-11-17 | Antiseptic-free vaccine |
Country Status (1)
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| CN (1) | CN102389570A (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102961741A (en) * | 2012-12-10 | 2013-03-13 | 武汉生物制品研究所有限责任公司 | Method for preparing tetanus toxoid vaccine |
| CN102961740A (en) * | 2012-12-10 | 2013-03-13 | 武汉生物制品研究所有限责任公司 | Preparation method of diphtheria toxoid vaccine |
| CN106039308A (en) * | 2016-06-29 | 2016-10-26 | 玉溪九洲生物技术有限责任公司 | Preservative-free horse tetanus immune globulin preparation for injection and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101971030A (en) * | 2007-12-24 | 2011-02-09 | 诺华有限公司 | Assays for adsorbed influenza vaccines |
-
2011
- 2011-11-17 CN CN201110365656XA patent/CN102389570A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101971030A (en) * | 2007-12-24 | 2011-02-09 | 诺华有限公司 | Assays for adsorbed influenza vaccines |
Non-Patent Citations (2)
| Title |
|---|
| 《Human Vaccines》 20090831 Jan Jezek et al. "A heat-stable hepatitis B vaccine formulation" 第529－535页 1-4 第5卷, 第8期 * |
| JAN JEZEK ET AL.: ""A heat-stable hepatitis B vaccine formulation"", 《HUMAN VACCINES》 * |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102961741A (en) * | 2012-12-10 | 2013-03-13 | 武汉生物制品研究所有限责任公司 | Method for preparing tetanus toxoid vaccine |
| CN102961740A (en) * | 2012-12-10 | 2013-03-13 | 武汉生物制品研究所有限责任公司 | Preparation method of diphtheria toxoid vaccine |
| CN102961741B (en) * | 2012-12-10 | 2014-12-03 | 武汉生物制品研究所有限责任公司 | Method for preparing tetanus toxoid vaccine |
| CN106039308A (en) * | 2016-06-29 | 2016-10-26 | 玉溪九洲生物技术有限责任公司 | Preservative-free horse tetanus immune globulin preparation for injection and preparation method thereof |
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Application publication date: 20120328 |