CN106405090A - 一种用于鉴定每品种变应原制剂批间差异的方法 - Google Patents

一种用于鉴定每品种变应原制剂批间差异的方法 Download PDF

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CN106405090A
CN106405090A CN201510494852.5A CN201510494852A CN106405090A CN 106405090 A CN106405090 A CN 106405090A CN 201510494852 A CN201510494852 A CN 201510494852A CN 106405090 A CN106405090 A CN 106405090A
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翁晖
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Abstract

本发明公开了一种用于鉴定每品种变应原制剂批间差异的方法，本发明提供一种用于鉴定每品种变应原制剂批间差异的方法，为自主研发并生产出WHO所认可的标准化特异性诊断及免疫治疗过敏性疾病的变应原体内诊断及脱敏制剂，并用于产业化，满足国内广大过敏性疾患的特异性诊疗需求。

Description

一种用于鉴定每品种变应原制剂批间差异的方法
技术领域
本发明涉及一种变应原制剂批间差异的方法，尤其涉及一种用于鉴定每品种变应原制剂批间差异的方法。
背景技术
1998年世界卫生组织(WHO)发表规范文件正式肯定检测致敏原并进行特异性免疫治疗为唯一可以影响过敏性疾病自然进程的病因治疗方法，并可防止新的过敏发生。同时发布指导文件，认为变应原提取物的质量对临床特异性诊断的准确性和治疗的有效性都是至关重要的。
目前世界上在变应原的治疗方面主要有德国默克集团的阿罗格标准化变应原注射液，及丹麦爱尔开一阿贝优公司的安脱达标准化变应原制剂；国内主要有北京协和医院制作变应原粗提液，但与WHO所认可的标准化变应原相比仍有一定距离，不能满足国内广大过敏性疾患的特异性诊疗需求。
发明内容
本发明的目的就在于为了解决上述问题而提供一种用于鉴定每品种变应原制剂批间差异的方法。
本发明通过以下技术方案来实现上述目的：
本发明包括以下步骤：
a、进行变应原的标准化饲养；
b、将其提炼制成变应原粗提液；
c、进行变应原致敏蛋白成分的分离纯化；
d、制备抗变应原的McAb杂交瘤细胞株，获得单克隆抗体；
e、用纯化抗原筛选抗体；
f、通过McAb抗体对抗原进行检测方法筛选；
g、筛选并确定化学发光法(CLIA)用于鉴定每品种变应原批间差异；
h、建立检测变应原的标准化方法。
本发明的有益效果在于：
本发明提供一种用于鉴定每品种变应原制剂批间差异的方法，为自主研发并生产出WHO所认可的标准化特异性诊断及免疫治疗过敏性疾病的变应原体内诊断及脱敏制剂，并用于产业化，满足国内广大过敏性疾患的特异性诊疗需求。
具体实施方式
下面对本发明作进一步说明：
本发明本发明包括以下步骤：
a、进行变应原的标准化饲养；
b、将其提炼制成变应原粗提液；
c、进行变应原致敏蛋白成分的分离纯化；
d、制备抗变应原的McAb杂交瘤细胞株，获得单克隆抗体；
e、用纯化抗原筛选抗体；
f、通过McAb抗体对抗原进行检测方法筛选；
g、筛选并确定化学发光法(CLIA)用于鉴定每品种变应原批间差异；
h、建立检测变应原的标准化方法。
实施例一：
a、针对粉尘螨变应原进行标准化饲养；
b、将粉尘螨收集、粉碎和净化，用CoCa’s液提取浸出其有效成份，制作出粉尘螨变应原粗提液；
c、通过SDS-PAGE电泳技术，将粉尘螨变应原粗提液进行蛋白测定及蛋白分离纯化；
d、将纯化所得致敏蛋白进行体外试验，确定Der f11，分子量81KD，为粉尘螨变应原的致敏组分之一；
e、制备针对抗Der f11的McAb杂交瘤细胞株，获得单克隆抗体；
f、将纯化的粉尘螨Der f11致敏组分与获得的单克隆抗体进行反应，筛选出针对Der f11的抗体；
g、通过免疫学检测的不同标记方法，将抗Der f11的单克隆抗体与Der f11抗原进性反应；
h、筛选并确定化学发光法(CLIA)用于定量检测Der f11变应原的批间差异。
本领域技术人员不脱离本发明的实质和精神，可以有多种变形方案实现本发明，以上所述仅为本发明较佳可行的实施例而已，并非因此局限本发明的权利范围，凡运用本发明说明书内容所作的等效结构变化，均包含于本发明的权利范围之内。

Claims (1)

1.一种用于鉴定每品种变应原制剂批间差异的方法，其特征在于：包括以下步骤：
a、进行变应原的标准化饲养；
b、将其提炼制成变应原粗提液；
c、进行变应原致敏蛋白成分的分离纯化；
d、制备抗变应原的McAb杂交瘤细胞株，获得单克隆抗体；
e、用纯化抗原筛选抗体；
f、通过McAb抗体对抗原进行检测方法筛选；
g、筛选并确定化学发光法，用于鉴定每品种变应原批间差异；
h、建立检测变应原的标准化方法。
CN201510494852.5A 2015-08-14 2015-08-14 一种用于鉴定每品种变应原制剂批间差异的方法 Pending CN106405090A (zh)

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CN103645328A (zh) * 2013-12-17 2014-03-19 中国计量学院 一种花生致敏蛋白Arah2标准品的制备方法
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JP2008249458A (ja) * 2007-03-30 2008-10-16 Osaka Gas Co Ltd 熱変性スギ花粉アレルゲンを検出および定量するためのｅｌｉｓａ法
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