CN105267960A - Recombinant adenovirus vaccine preparation and preparation method thereof - Google Patents
Recombinant adenovirus vaccine preparation and preparation method thereof Download PDFInfo
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- CN105267960A CN105267960A CN201410261625.3A CN201410261625A CN105267960A CN 105267960 A CN105267960 A CN 105267960A CN 201410261625 A CN201410261625 A CN 201410261625A CN 105267960 A CN105267960 A CN 105267960A
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- recombinant adenovirus
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- adenovirus vaccine
- vaccine preparation
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Abstract
The invention relates to a preparation method of a recombinant adenovirus vaccine preparation in the field of biotechnology. The invention aims to provide a recombinant adenovirus vaccine preparation. According to the technical scheme, the recombinant adenovirus vaccine preparation contains a recombinant adenovirus stock solution and a preparation prescription. The method for producing the above recombinant adenovirus vaccine preparation comprises the following steps: (1) preparing a buffer solution according to the preparation prescription, finally adding the virus stock solution, uniformly mixing, carrying out aseptic filtration, and subpackaging in penicillin bottles; filling nitrogen and tamponing and capping; and (2) carrying out light inspection on the subpackaged recombinant adenovirus vaccine preparation, and preserving the recombinant adenovirus vaccine preparation at minus 20 DEG C. The recombinant adenovirus vaccine preparation can be preserved for at least 24 months.
Description
Technical field
The present invention relates to a kind of recombinant adenovirus vaccine preparation and preparation method thereof in biological technical field.
Background technology
Adenovirus is extensive in distributed in nature, all finds that it exists in numerous mammal and birds; Because it is pathogenic little and do not induce canceration to people, struck capacity is large, and host cell is wide, and reproductive titer is high, becomes viral vector study hotspot in recent years.Even but liquid recombinant adenovirus toxin preparation containing stabilizing agent is also comparatively responsive to temperature, and give transport, preserve and bring larger difficulty, which greatly limits its application clinically.Up to the present, the long-term recombinant adenovirus toxin preparation preserved is be kept at-20 DEG C substantially.
Summary of the invention
Recombinant adenovirus vaccine preparation that the object of the present invention is to provide a kind of safety, good stability, effect duration long and preparation method thereof.
A kind of recombinant adenovirus vaccine preparation, comprises the composition of cryoprotective agent, sucrose, L-Histidine; In order to better protect recombinant adenovirus stock solution active, also containing Basionic, magnesium chloride, sodium chloride, tween 80, ethylenediaminetetraacetic acid, dehydrated alcohol in described cryoprotective agent.The w/v of each component of described cryoprotective agent is:
| Basionic | 0.05～0.15％ |
| Sodium chloride | 0.1～1％ |
| Sucrose | 1～20％ |
| Magnesium chloride | 0.01～0.1％ |
| Tween 80 | 0.001～0.1％ |
| Ethylenediaminetetraacetic acid | 0.001～0.05％ |
| L-Histidine | 0.1～0.5％ |
| Dehydrated alcohol | 0.1～3％ |
The ratio of described recombinant adenovirus toxin preparation stock solution and described cryoprotective agent is recombinant adenovirus toxin preparation stock solution: cryoprotective agent=1: (0.5 ~ 2).
A preparation method for recombinant adenovirus vaccine preparation, comprises the steps:
Recombinant adenovirus toxin preparation stock solution is pressed gland-containing virus amount 1.0*10
12the concentration cryoprotective agent of VP/ml dilutes, aseptic filtration after mixing, injects cillin bottle, fills that nitrogen is jumped a queue, Zha Gai;-20 DEG C of preservations are put into after lamp inspection.Wherein cryoprotective agent is made up of sucrose, L-Histidine; Its finished product is by the described method calibrating of " Chinese Pharmacopoeia " (2010 editions) three, qualified.
The recombinant adenovirus vaccine preparation prepared with formula of the present invention and method, proves through TCID50 titre test experience, preparation maintains the original activity of recombinant adenovirus; And prove to have good stability through the stability experiment of 36 months.Compared with prior art, present invention process is reasonable, safety, good stability, and effect duration is long, provides good application prospect for adopting recombinant adenovirus as the clinical trial of the gene therapy of carrier.
Detailed description of the invention
Embodiment 1
Cryoprotection agent prescription: three hydroxyl methylamino methane: 1.5g, sodium chloride 9.1g, sucrose 75g, magnesium chloride 0.15g, tween 80 0.2g, ethylenediaminetetraacetic acid 0.02g, L-Histidine 1.3g, dehydrated alcohol 1g.
Preparation:
By formula, each component is mixed, add be cooled to 4 DEG C water for injection to 200ml, stirring and dissolving, mix homogeneously, then by recombinant adenovirus stock solution 2*10
14vP amount adds, and mix homogeneously is mended and injected water to 1000ml, is uniformly mixed, aseptic filtration, fill, fills nitrogen tamponade, Zha Gai, after lamp inspection, put into-20 DEG C of freezen protective.
Embodiment 2
Cryoprotection agent prescription: three hydroxyl methylamino methane: 1.0g, sodium chloride 5.6g, sucrose 10g, magnesium chloride 0.2g, tween 80 0.3g, ethylenediaminetetraacetic acid 0.04g, L-Histidine 4.5g, dehydrated alcohol 5g.
Preparation:
By formula, each component is mixed, add be cooled to 4 DEG C water for injection to 200ml, stirring and dissolving, mix homogeneously, then by recombinant adenovirus stock solution 2*10
14vP amount adds, and mix homogeneously is mended and injected water to 1000ml, is uniformly mixed, aseptic filtration, fill, fills nitrogen tamponade, Zha Gai, after lamp inspection, put into-20 DEG C of freezen protective.
Embodiment 3
Cryoprotection agent prescription: three hydroxyl methylamino methane: 1.3g, sodium chloride 4.5g, sucrose 50g, magnesium chloride 0.1g, tween 80 0.1g, ethylenediaminetetraacetic acid 0.015g, L-Histidine 3g, dehydrated alcohol 7.5g.
Preparation:
By formula, each component is mixed, add be cooled to 4 DEG C water for injection to 200ml, stirring and dissolving, mix homogeneously, then by recombinant adenovirus stock solution 2*10
14vP amount adds, and mix homogeneously is mended and injected water to 1000ml, is uniformly mixed, aseptic filtration, fill, fills nitrogen tamponade, Zha Gai, after lamp inspection, put into-20 DEG C of freezen protective.
Claims (6)
1. a recombinant adenovirus vaccine preparation, is characterized in that preparation prescription comprises the composition of cryoprotective agent, sucrose, L-Histidine.
2. recombinant adenovirus vaccine preparation as claimed in claim 1, is characterized in that also comprising Basionic, magnesium chloride, sodium chloride, tween 80, ethylenediaminetetraacetic acid, dehydrated alcohol in described protective agent.
3. recombinant adenovirus vaccine preparation as claimed in claim 2, is characterized in that each constituent mass volume ratio of described preparation prescription is:
4. recombinant adenovirus vaccine preparation as claimed in claim 1, is characterized in that: the ratio of described recombinant adenovirus toxin preparation stock solution and described cryoprotective agent is recombinant adenovirus toxin preparation stock solution: cryoprotective agent=1: (0.5 ~ 2).
5. a preparation method for recombinant adenovirus vaccine preparation, is characterized in that the method comprises the steps:
Recombinant adenovirus toxin preparation stock solution is pressed gland-containing virus amount 1.0*10
12the concentration cryoprotective agent of VP/ml dilutes, aseptic filtration after mixing, injects cillin bottle, fills that nitrogen is jumped a queue, Zha Gai;-20 DEG C of preservations are put into after lamp inspection; Wherein cryoprotective agent is made up of sucrose, L-Histidine.
6. method as claimed in claim 5, is characterized in that also having Basionic, magnesium chloride, sodium chloride, tween 80, ethylenediaminetetraacetic acid, dehydrated alcohol in described Cryoprotectant; The each constituent mass volume ratio of described cryoprotective agent is:
The ratio of described recombinant adenovirus toxin preparation stock solution and described cryoprotective agent is recombinant adenovirus toxin preparation stock solution: cryoprotective agent=1: (0.5 ~ 2).
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410261625.3A CN105267960A (en) | 2014-06-13 | 2014-06-13 | Recombinant adenovirus vaccine preparation and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410261625.3A CN105267960A (en) | 2014-06-13 | 2014-06-13 | Recombinant adenovirus vaccine preparation and preparation method thereof |
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| Publication Number | Publication Date |
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| CN105267960A true CN105267960A (en) | 2016-01-27 |
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| CN201410261625.3A Pending CN105267960A (en) | 2014-06-13 | 2014-06-13 | Recombinant adenovirus vaccine preparation and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2021244120A1 (en) * | 2020-06-01 | 2021-12-09 | 康希诺生物股份公司 | Sars-cov-2 vaccine |
| WO2022121917A1 (en) * | 2020-12-11 | 2022-06-16 | 康希诺生物股份公司 | Pharmaceutical composition and use thereof |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2001066137A1 (en) * | 2000-03-07 | 2001-09-13 | Merck & Co., Inc. | Adenovirus formulations |
| CN101234088A (en) * | 2008-03-05 | 2008-08-06 | 北京诚创康韵医药科技有限公司 | Micronizing medicaments injection and preparation thereof |
| CN102271707A (en) * | 2008-10-29 | 2011-12-07 | 惠氏有限责任公司 | Formulations of single domain antigen binding molecules |
| CN102911967A (en) * | 2011-08-02 | 2013-02-06 | 天津泽世德生物医药有限公司 | Preparation method of recombinant adenovirus preparation |
-
2014
- 2014-06-13 CN CN201410261625.3A patent/CN105267960A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2001066137A1 (en) * | 2000-03-07 | 2001-09-13 | Merck & Co., Inc. | Adenovirus formulations |
| CN101234088A (en) * | 2008-03-05 | 2008-08-06 | 北京诚创康韵医药科技有限公司 | Micronizing medicaments injection and preparation thereof |
| CN102271707A (en) * | 2008-10-29 | 2011-12-07 | 惠氏有限责任公司 | Formulations of single domain antigen binding molecules |
| CN102911967A (en) * | 2011-08-02 | 2013-02-06 | 天津泽世德生物医药有限公司 | Preparation method of recombinant adenovirus preparation |
Non-Patent Citations (1)
| Title |
|---|
| ROBERT K. EVANS ET AL.: "Development of Stable Liquid Formulations for Adenovirus-Based Vaccines", 《JOURNAL OF PHARMACEUTICAL SCIENCES》 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2021244120A1 (en) * | 2020-06-01 | 2021-12-09 | 康希诺生物股份公司 | Sars-cov-2 vaccine |
| WO2022121917A1 (en) * | 2020-12-11 | 2022-06-16 | 康希诺生物股份公司 | Pharmaceutical composition and use thereof |
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Application publication date: 20160127 |
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| RJ01 | Rejection of invention patent application after publication |