CN104491854A - 一种无佐剂b型流感嗜血杆菌结合疫苗冻干剂的制备方法 - Google Patents
一种无佐剂b型流感嗜血杆菌结合疫苗冻干剂的制备方法 Download PDFInfo
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- CN104491854A CN104491854A CN201410817576.7A CN201410817576A CN104491854A CN 104491854 A CN104491854 A CN 104491854A CN 201410817576 A CN201410817576 A CN 201410817576A CN 104491854 A CN104491854 A CN 104491854A
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- 238000000034 method Methods 0.000 title abstract description 13
- 108010060123 Conjugate Vaccines Proteins 0.000 title abstract 4
- 241000606768 Haemophilus influenzae Species 0.000 title abstract 4
- 229940031670 conjugate vaccine Drugs 0.000 title abstract 4
- 238000001035 drying Methods 0.000 claims abstract description 27
- 239000002671 adjuvant Substances 0.000 claims abstract description 26
- 238000004108 freeze drying Methods 0.000 claims abstract description 15
- 239000000463 material Substances 0.000 claims abstract description 15
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 13
- 239000000203 mixture Substances 0.000 claims abstract description 10
- 238000002360 preparation method Methods 0.000 claims description 40
- 229960005486 vaccine Drugs 0.000 claims description 32
- 206010022000 influenza Diseases 0.000 claims description 27
- 238000011068 loading method Methods 0.000 claims description 15
- 238000000859 sublimation Methods 0.000 claims description 15
- 230000008022 sublimation Effects 0.000 claims description 15
- 150000001875 compounds Chemical class 0.000 claims description 12
- 239000003085 diluting agent Substances 0.000 claims description 12
- 238000001179 sorption measurement Methods 0.000 claims description 11
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims description 9
- 229930006000 Sucrose Natural products 0.000 claims description 9
- 239000002994 raw material Substances 0.000 claims description 9
- 239000005720 sucrose Substances 0.000 claims description 9
- ZOXJGFHDIHLPTG-UHFFFAOYSA-N Boron Chemical compound [B] ZOXJGFHDIHLPTG-UHFFFAOYSA-N 0.000 claims description 8
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 8
- 229910052796 boron Inorganic materials 0.000 claims description 8
- 230000007935 neutral effect Effects 0.000 claims description 8
- 108090000623 proteins and genes Proteins 0.000 claims description 6
- 102000004169 proteins and genes Human genes 0.000 claims description 6
- 239000002904 solvent Substances 0.000 claims description 6
- 238000002347 injection Methods 0.000 claims description 4
- 239000007924 injection Substances 0.000 claims description 4
- 238000001816 cooling Methods 0.000 claims description 3
- 238000003756 stirring Methods 0.000 claims description 3
- 239000008215 water for injection Substances 0.000 claims description 3
- 230000015556 catabolic process Effects 0.000 abstract description 10
- 238000006731 degradation reaction Methods 0.000 abstract description 10
- 230000004845 protein aggregation Effects 0.000 abstract description 7
- 108010071134 CRM197 (non-toxic variant of diphtheria toxin) Proteins 0.000 abstract description 6
- 239000003795 chemical substances by application Substances 0.000 abstract 3
- 230000002776 aggregation Effects 0.000 abstract 1
- 238000004220 aggregation Methods 0.000 abstract 1
- 239000002775 capsule Substances 0.000 abstract 1
- 230000007547 defect Effects 0.000 abstract 1
- 238000003795 desorption Methods 0.000 abstract 1
- 230000005496 eutectics Effects 0.000 abstract 1
- 238000010438 heat treatment Methods 0.000 abstract 1
- 238000002061 vacuum sublimation Methods 0.000 abstract 1
- 238000010521 absorption reaction Methods 0.000 description 8
- 239000006096 absorbing agent Substances 0.000 description 6
- 150000004676 glycans Chemical class 0.000 description 4
- 229920001282 polysaccharide Polymers 0.000 description 4
- 239000005017 polysaccharide Substances 0.000 description 4
- 238000009472 formulation Methods 0.000 description 3
- 239000012528 membrane Substances 0.000 description 3
- 239000002552 dosage form Substances 0.000 description 2
- 238000009777 vacuum freeze-drying Methods 0.000 description 2
- 125000000824 D-ribofuranosyl group Chemical group [H]OC([H])([H])[C@@]1([H])OC([H])(*)[C@]([H])(O[H])[C@]1([H])O[H] 0.000 description 1
- 239000000370 acceptor Substances 0.000 description 1
- 230000002421 anti-septic effect Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000004071 biological effect Effects 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 230000036039 immunity Effects 0.000 description 1
- 230000003993 interaction Effects 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 239000012669 liquid formulation Substances 0.000 description 1
- 229920001542 oligosaccharide Polymers 0.000 description 1
- 150000002482 oligosaccharides Chemical class 0.000 description 1
- 229920001523 phosphate polymer Polymers 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 239000012646 vaccine adjuvant Substances 0.000 description 1
- 229940124931 vaccine adjuvant Drugs 0.000 description 1
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- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
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CN201410817576.7A CN104491854B (zh) | 2014-12-17 | 2014-12-17 | 一种无佐剂b型流感嗜血杆菌结合疫苗冻干剂的制备方法 |
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CN201410817576.7A CN104491854B (zh) | 2014-12-17 | 2014-12-17 | 一种无佐剂b型流感嗜血杆菌结合疫苗冻干剂的制备方法 |
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CN104491854A true CN104491854A (zh) | 2015-04-08 |
CN104491854B CN104491854B (zh) | 2017-10-31 |
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Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN105462840A (zh) * | 2015-12-10 | 2016-04-06 | 浙江卫信生物药业有限公司 | 一种口腔支原体的活体冻干体的制备方法 |
CN109337095A (zh) * | 2018-09-21 | 2019-02-15 | 杭州协合医疗用品有限公司 | 一种交联透明质酸凝胶的制备方法及所制备的交联透明质酸凝胶 |
CN112057603A (zh) * | 2020-07-25 | 2020-12-11 | 艾美卫信生物药业(浙江)有限公司 | 一种白喉毒素无毒突变体crm197蛋白的冻干方法 |
CN113930356A (zh) * | 2021-09-23 | 2022-01-14 | 艾美卫信生物药业(浙江)有限公司 | 一种发酵生产白喉毒素无毒形式crm197蛋白菌种的冻干方法 |
Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102600086A (zh) * | 2012-04-01 | 2012-07-25 | 成都欧林生物科技股份有限公司 | 冻干b型流感嗜血杆菌结合疫苗的制备方法 |
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2014
- 2014-12-17 CN CN201410817576.7A patent/CN104491854B/zh active Active
Patent Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102600086A (zh) * | 2012-04-01 | 2012-07-25 | 成都欧林生物科技股份有限公司 | 冻干b型流感嗜血杆菌结合疫苗的制备方法 |
Non-Patent Citations (2)
Title |
---|
MAILA J MATJILA ET AL.: "Safety and immunogenicity of two Haemophilus influenzae type b conjugate vaccines", 《S AFR MED J》 * |
宋航: "《制药分离工程》", 31 August 2011 * |
Cited By (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN105462840A (zh) * | 2015-12-10 | 2016-04-06 | 浙江卫信生物药业有限公司 | 一种口腔支原体的活体冻干体的制备方法 |
CN109337095A (zh) * | 2018-09-21 | 2019-02-15 | 杭州协合医疗用品有限公司 | 一种交联透明质酸凝胶的制备方法及所制备的交联透明质酸凝胶 |
US11098168B2 (en) * | 2018-09-21 | 2021-08-24 | Hangzhou Singclean Medical Products Co., Ltd. | Method for preparing cross-linked hyaluronic acid gel and cross-linked hyaluronic acid gel prepared by the same |
CN112057603A (zh) * | 2020-07-25 | 2020-12-11 | 艾美卫信生物药业(浙江)有限公司 | 一种白喉毒素无毒突变体crm197蛋白的冻干方法 |
CN112057603B (zh) * | 2020-07-25 | 2023-07-14 | 艾美卫信生物药业(浙江)有限公司 | 一种白喉毒素无毒突变体crm197蛋白的冻干方法 |
CN113930356A (zh) * | 2021-09-23 | 2022-01-14 | 艾美卫信生物药业(浙江)有限公司 | 一种发酵生产白喉毒素无毒形式crm197蛋白菌种的冻干方法 |
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Address after: 315600 Zhejiang Weixin Biopharmaceutical Co., Ltd. No. 29 Zhuquan Road, Ninghai County Science and Technology Industrial Park Patentee after: AIMEI WEIXIN BIOPHARMACEUTICAL (ZHEJIANG) Co.,Ltd. Address before: 315600 Zhejiang Weixin Biopharmaceutical Co., Ltd. No. 29 Zhuquan Road, Ninghai Science and Technology Industrial Park, Ningbo City, Zhejiang Province Patentee before: ZHEJIANG VACIN BIO-PHARMACEUTICAL Ltd. |
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Address after: No. 29 Zhuquan Road, Science and Technology Industrial Park, Ninghai County, Ningbo City, Zhejiang Province, 315615 Patentee after: Aimei Persist Biopharmaceutical Co.,Ltd. Address before: 315600 Zhejiang County of Ninghai province science and Technology Industrial Park Road No. 29 Zhejiang bamboo Wilson Biological Pharmaceutical Co Ltd Patentee before: AIMEI WEIXIN BIOPHARMACEUTICAL (ZHEJIANG) Co.,Ltd. |