CN1073447C - 冻干的甲型肝炎减毒活疫苗 - Google Patents

冻干的甲型肝炎减毒活疫苗 Download PDF

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CN1073447C
CN1073447C CN98117802A CN98117802A CN1073447C CN 1073447 C CN1073447 C CN 1073447C CN 98117802 A CN98117802 A CN 98117802A CN 98117802 A CN98117802 A CN 98117802A CN 1073447 C CN1073447 C CN 1073447C
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hepatitis
vaccine
virus
freeze
liquid
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CN1243752A (zh
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张晶
周妍
王寿江
高俊芳
魏巍
董秀华
郭丽姝
赵克俭
王德贤
贾国富
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Changchun Changsheng Life Sciences Limited
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CHANGCHUN CHANGSHENG INDUSTRY Co Ltd
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    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
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Abstract

甲型肝炎是由甲型肝炎病毒引起的传染疾病，为有效控制甲型肝炎的流行与暴发，保护人类健康，我们通过人胚肺2BS细胞传代培养后感染甲肝病毒，洗换、收获病毒液，制成甲型肝炎减毒活疫苗。本专利为在液体剂型甲基肝炎减毒活疫苗中加入由蔗糖、明胶、味精、尿素、L-精氨酸、海藻糖等配比而成的保护剂，混匀，在适宜的冻干条件下制成冻干剂型。甲型肝炎病毒在冻干状态下得到更好的保护，疫苗稳定性能好，2-8℃有效期为18个月，室温运输过程中病毒滴度不受影响，方便使用，提高免疫效果。冻干后疫苗无需冰冻保存，一改液体疫苗低温冻结保存及运输过程中严格冷链，2-8℃有效期短(仅为6个月)的缺点。

Description

冻干的甲型肝炎减毒活疫苗
本发明公开一种冻干的甲型肝炎减毒活疫苗，涉及甲型肝炎疫苗剂型的生产技术领域。
目前，国内的甲型肝炎减毒活疫苗系为液体剂型，2～8℃保存有效期仅为半年，-20℃以下冰冻保存有效期仅为12个月，从出厂地到使用现场均要求疫苗严格的冷链运输，如保存和运输不能严格冷链，致使疫苗的病毒滴度下降，影响接种效果，且增加了生产及使用部门的费用。
本发明专利冻干的甲型肝炎减毒活疫苗从根本上解决了疫苗冷链运输问题，实现了常温(22℃)运输，不影响疫苗的病毒滴度，在2～8℃条件下可实现18个月的有效期。
本发明的技术解决方案是由蔗糖、味素、尿素、L-精氨酸、海藻糖配制成冻干保护剂。
基本工艺如下：传代后的人胚肺二倍体细胞培养长成单层后，感染LA-1株甲型肝炎病毒，37℃吸附4小时，补加维持液置35℃培养4周，每周换液一次，洗换加疫苗液，冻化，超声去除细胞碎片，合并疫苗液，加入冻干保护液，保护剂在疫苗最终浓度分别为：明胶0.5～0.7％、蔗糖3～6％、味精0.5～2％、尿素0.3～0.8％、L-精氨酸0.1～0.4％、海藻糖3％。制品入箱后冻结，-40℃保持4小时，开始干燥，冷凝器真空度进入正常状态后保持1小时后开始加温，隔板温度第一小时加温至-20℃，第四小时加温至-10℃，制品保持在-20℃以下，升华，待制品完全成型后，逐渐加温至28℃，控制6～8小时，干燥结束，冻干后的样品应为淡黄色疏松体，水分≤3％(g/g)。
专有设备有转瓶机，医用低温冷冻干燥机等。
本发明积极效果在于：冻干的甲型肝炎减毒活疫苗易于保存，稳定性好，彻底解决了液体剂型甲型肝炎减毒活疫苗的冷链运输及稳定性差等问题，2～8℃制品有效期可从液体剂型的6个月延长至冻干剂型的18个月。
冻干后的甲型肝炎减毒活疫苗加速热稳定性试验结果：
37℃ 7天，前后滴度下降不超过0.5LogTCID50/mL
37℃ 14天，前后滴度下降不超过0.5LogTCID50/mL
2～8℃ 18个月，病毒滴度下降不超过1.0LogTCID50/mL。

Claims (3)

1、一种冻干的甲型肝炎减毒活疫苗，其特征在于由减毒的甲型肝炎病毒和病毒疫苗保护剂组成，所述的病毒疫苗保护剂由海藻糖、明胶、蔗糖、味精、尿素、L-精氨酸组成。
2、根据权利要求1所述的甲型肝炎减毒活疫苗，其特征在于：所述的保护剂在疫苗中的最终浓度为：海藻糖3～6％、明胶0.5～0.7％、蔗糖3～6％、味精0.5～2％、尿素0.3～0.8％、L-精氨酸0.1～0.4％。
3、制备权利要求1、2中的任一项冻干的甲型肝炎减毒活疫苗的工艺如下：
传代后的人胚肺二倍体细胞经培养长成单层后，感染LA-1株甲型肝炎病毒，将感染后的甲型肝炎病毒37℃吸附4小时，补加维持液置35℃培养4周，每周换液一次，洗换加疫苗液，冻化、超声去除细胞碎片，合并疫苗液，加入病毒疫苗保护剂混合均匀，冷冻干燥，将上述制品预冷-20℃以下入箱冻结，-40℃保持4小时，开始干燥，冷凝器真空度进入正常状态后保持1小时后开始加温，隔板温度第一小时加温至-20℃，第四小时加温至-10℃，制品保持在-20℃以下，升华，待制品完全成型后，逐渐加温至28℃，控制6～8小时，干燥结束。
CN98117802A 1998-08-27 1998-08-27 冻干的甲型肝炎减毒活疫苗 Expired - Lifetime CN1073447C (zh)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005066333A1 (en) * 2003-12-30 2005-07-21 Aventis Pasteur, Inc. Stabilizing compositions for recombinant viruses

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101537186B (zh) * 2009-04-30 2011-04-06 长春百克生物科技股份公司 一种不含明胶的疫苗冻干保护剂
CN101816786B (zh) * 2010-04-30 2012-09-05 长春生物制品研究所有限责任公司 一种甲型肝炎灭活疫苗及其制备方法
CN103387958B (zh) * 2013-08-16 2016-04-06 北京科兴中维生物技术有限公司 人胚肺成纤维细胞sv-7在病毒培养中的应用

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005066333A1 (en) * 2003-12-30 2005-07-21 Aventis Pasteur, Inc. Stabilizing compositions for recombinant viruses

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