CN1073858C - 含有稳定剂的甲型肝炎减毒活疫苗及制备方法 - Google Patents

含有稳定剂的甲型肝炎减毒活疫苗及制备方法 Download PDF

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CN1073858C
CN1073858C CN98123772A CN98123772A CN1073858C CN 1073858 C CN1073858 C CN 1073858C CN 98123772 A CN98123772 A CN 98123772A CN 98123772 A CN98123772 A CN 98123772A CN 1073858 C CN1073858 C CN 1073858C
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hepatitis
stabilizing agent
gram
vaccine
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毛江森
陈念良
柴少爱
张峰
王平
谢汝瑛
高丽美
余哲
黄海鹰
毛子安
吴海光
陈卓
黄伟新
钱汶
刘春江
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ZHEJIANG PUKANJG BIOTECHNOLOGY CO Ltd
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Abstract

一种含有稳定剂的甲型肝炎减毒活疫苗及制备方法，其疫苗包含有高浓度的氯化镁和硫酸镁，以及明胶、乳糖组成的甲型肝炎病毒稳定剂。将甲肝病毒浓缩液按每人份接种病毒量比例加入到上述含有甲型肝炎病毒稳定剂的基础氨基酸培养基(MEM)平衡盐溶液中，即制成含有稳定剂的甲肝减毒活疫苗。本发明工艺合理，疫苗安全性和稳定性好，有效期长，预防甲型肝炎效果好，具有重大社会经济效益和实施价值。

Description

含有稳定剂的甲型肝炎减毒活疫苗及制备方法
本发明属于甲型肝炎减毒活疫苗及制备方法，尤其是含有稳定剂的甲型肝炎减毒活疫苗及制备方法，适用于预防人体甲型肝炎的减毒活疫苗及制备的场合。
病毒性肝炎是我国最主要的传染病，而甲型肝炎占已知六种病毒性肝炎发病率的首位。自1992年以来，全国已有近一亿人接种液体剂型的甲型肝炎减毒活疫苗，获得了非常满意的流行病学保护效果。甲肝的年发病率平均每年以20％左右的速度下降。但是，由于我国处于发展中国家，许多边远地区交通仍然不便，而一般的液体剂型甲型肝炎减毒活疫苗在4-8℃条件保存有效期只有3个月。
根据我国国情，为控制甲型肝炎的流行，接种甲型肝炎减毒活疫苗是一种行之有效的方法。因此，须使广大的人群，特别是农村人群都能接种到安全的、高效的甲型肝炎减毒活疫苗。
本发明的目的就在于提供一种安全、高效、稳定性好、有效期长的甲型肝炎减毒活疫苗新剂型-即含有稳定剂的甲型肝炎减毒活疫苗及制备方法。
本发明为含有稳定剂的甲型肝炎减毒活疫苗，疫苗中包含有高浓度的氯化镁和硫酸镁，以及明胶、乳糖组成的甲型肝炎病毒稳定剂。
甲型肝炎病毒稳定剂的组成为：氯化镁，疫苗中终浓度为0.3-0.45克％、硫酸镁，疫苗中终浓度为0.1-0.25克％、明胶，疫苗中终浓度为0.10-0.50克％、乳糖，疫苗中终浓度为3.0-3.5克％。
含有稳定剂的甲型肝炎减毒活疫苗的制备方法，每100毫升去离子蒸馏水中加入可耐高温灭菌的基础氨基酸培养基(MEM)平衡盐0.94克，待溶解后加入明胶0.1-0.50克，将该溶液温热，待明胶充分溶解后再加入乳糖3.0-3.5克，然后加入用去离子蒸馏水溶解好的氯化镁0.3-0.45克和硫酸镁0.1-0.25克。过滤，分装，蒸气高压灭菌。再将甲肝病毒浓缩液按每人份接种病毒量6.5-7.0log10TCID50比例加入到上述含有甲型肝炎减毒活疫苗稳定剂的基础氨基酸培养基(MEM)平衡盐溶液中进行灌装、封口，基础氨基酸培养基(MEM)平衡盐溶液为可耐高温灭菌的基础氨基酸培养基(MEM)平衡盐溶液，基础氨基酸培养基(MEM)平衡盐溶液的PH值为7.0-7.4。
本发明的含有稳定剂的甲型肝炎减毒活疫苗及制备方法，与现有技术相比，工艺合理、安全性和稳定性好，有效期长，通常4-8℃保存有效期可达6个月或以上，预防甲肝效果好，具有重大社会经济效益和实施价值。
本发明的含有稳定剂的甲型肝炎减毒活疫苗及制备方法，其实施方案为：疫苗中包含有高浓度的氯化镁和硫酸镁，以及明胶、乳糖、组成的甲型肝炎病毒稳定剂。
甲型肝炎病毒稳定剂的组成为：氯化镁，疫苗中终浓度为0.3-0.45克％、硫酸镁，疫苗中终浓度为0.1-0.25克％、明胶，疫苗中终浓度为0.10-0.50克％、乳糖，疫苗中终浓度为3.0-3.5克％。
含有稳定剂的甲型肝炎减毒活疫苗的制备方法，每100毫升去离子蒸馏水中加入可耐高温灭菌的基础氨基酸培养基(MEM)平衡盐0.94克，待溶解后加入明胶0.1-0.50克，将该溶液温热，待明胶充分溶解后再加入乳糖3.0-3.5克，然后加入用去离子蒸馏水溶解好的氯化镁0.3-0.45克和硫酸镁0.1-0.25克。过滤，分装，蒸气高压灭菌。再将甲肝病毒浓缩液按每人份接种病毒量比例6.5-7.0log10TCID50加入到上述含有甲型肝炎减毒活疫苗稳定剂的基础氨基酸培养基(MEM)平衡盐溶液中进行过滤、灌封，即制得含有稳定剂的甲型肝炎减毒活疫苗，其中基础氨基酸培养基(MEM)平衡盐溶液为可耐高温灭菌的基础氨基酸培养基(MEM)平衡盐溶液，基础氨基酸培养基(MEM)平衡盐溶液的PH值为7.0-7.4。
用于制备含有稳定剂的甲型肝炎减毒活疫苗是采用经低温减毒的、用组织培养法繁殖的、经纯化的、对人体接种不发生肝炎、也不产生其他反应的甲型活病毒液。
实施例1：
含有稳定剂的甲肝减毒活疫苗4-8℃存放24周，疫苗感染滴度下降0.33log10TCID50/ml，而不含有稳定剂的甲肝减毒活疫苗4-8℃保存24周，疫苗感染性滴度则下降0.76log10TCID50/ml。两者有明显差异。(见表1)
表1．H2株甲肝减毒活疫苗加稳定剂和未加稳定剂保存后滴度比较
批号                       4-8℃保存(周)疫苗log10TCID50/ml
 原始滴度   6  12  18  21  24  27  32  34
 950509     7.00  6.83  6.83  6.73 6.17  6.17  ND  ND  ND
 950510加稳定剂     7.1  7.17  7.17  7.00 7.00  6.83  6.50  6.00  ND
 950829     6.83  6.13  6.33  6.13 5.88  6.13  6.13  ND  5.0
 950829加稳定剂     7.13  7.0  7.0  7.13 6.88  6.82  6.83  ND  5.88
实施例2：
将加有稳定剂的甲肝减毒活疫苗与未加有稳定剂的甲肝减毒活疫苗进行热稳定性试验，结果证明，分别在25℃和37.0℃条件下保存15天，加有稳定剂的甲肝减毒活疫苗对热的稳定性明显比未加有稳定剂的甲肝减毒活疫苗好。
表2．稳定剂对不同温度保存甲肝减毒活疫苗滴度的影响
疫苗批号 稳定剂 原始滴度             疫苗log10TCID50/ml
       25℃     37℃
  7天  15天     15天
 9501     -    6.50  6.50  6.50     4.00
 9502     -    6.83  6.50  6.17     4.00
 9701-1     +    6.75  6.31  6.31     4.50
 9701-2     +    6.80  6.57  6.57     4.33

Claims (3)

1、含有稳定剂的甲型肝炎减毒活疫苗，由甲肝病毒和稳定剂组成，其特征是所述的稳定剂是由氯化镁、硫酸镁，明胶、乳糖组成的。
2、如权利要求1所述的疫苗，其特征是甲型肝炎病毒稳定剂组成为：每100毫升疫苗溶液中含有0.3-0.45克的氯化镁、0.1-0.25克的硫酸镁、0.1-0.5克的明胶和3.0-3.5克的乳糖。
3、根据权利要求1所述的含有稳定剂的甲型肝炎减毒活疫苗的制备方法，其特征是100毫升去离子蒸馏水中加入基础氨基酸培养基(MEM)平衡盐0.94克，待溶解后加入明胶0.1-0.56克、乳糖3.0-3.5克，然后加入事先用去离子蒸馏水溶解好的硫酸镁0.1-0.25克和氯化镁0.3-0.45克，再将甲肝病毒按每人份接种病毒量6.5-7.0log10TCID50比例，加入到上述含有甲肝病毒活疫苗稳定剂的基础氨基酸培养基(MEM)平衡盐溶液中进行安装灌装、封口，即制得含有稳定剂的甲型肝炎减毒活疫苗。
CN98123772A 1998-10-28 1998-10-28 含有稳定剂的甲型肝炎减毒活疫苗及制备方法 Expired - Lifetime CN1073858C (zh)

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