WO2022127135A1 - 一种化学发光免疫试剂、冻干微球及冻干微球的制备方法 - Google Patents

一种化学发光免疫试剂、冻干微球及冻干微球的制备方法 Download PDF

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WO2022127135A1
WO2022127135A1 PCT/CN2021/110438 CN2021110438W WO2022127135A1 WO 2022127135 A1 WO2022127135 A1 WO 2022127135A1 CN 2021110438 W CN2021110438 W CN 2021110438W WO 2022127135 A1 WO2022127135 A1 WO 2022127135A1
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freeze
chemiluminescence
immunoreagent
dried
reagent
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陈珠金
程涛
张捷李
张林华
胡啸
雷洋
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安邦（厦门）生物科技有限公司
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Priority to EP21905068.9A priority Critical patent/EP4124863A4/en
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Priority to US17/965,761 priority patent/US20230048869A1/en

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    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54313—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals the carrier being characterised by its particulate form
    • G01N33/54326—Magnetic particles
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    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
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    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
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    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54393—Improving reaction conditions or stability, e.g. by coating or irradiation of surface, by reduction of non-specific binding, by promotion of specific binding
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    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6887—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids from muscle, cartilage or connective tissue
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    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/74—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors

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  • the present invention relates to the technical field of chemiluminescence immune reagents, in particular to a chemiluminescence immune reagent, freeze-dried microspheres and a preparation method of the freeze-dried microspheres.
  • luminescent immunoreagents have been widely used in food detection, pathogen detection and cancer gene diagnosis.
  • luminescent immunoreagents are demanding in terms of storage and transportation conditions, generally need to be stored at 2-8°C, and require cold chain transportation. If these conditions are not met, the performance of the luminescent immunoreagent will be greatly affected, and even lead to the failure of the reagent.
  • the purpose of the present invention is to provide a chemiluminescent immunoreagent and a preparation method thereof for freeze-dried microspheres, so as to solve the problem in the prior art that the luminescent immunoreagent is not easy to separate and detect the detection substance.
  • a preparation method of chemiluminescence immunoreagent freeze-dried microspheres further comprising a reagent storage agent, which reduces the reagents from being damaged by various stresses during the freeze-drying process, and protects the reagent from denaturation and inactivation, thereby protecting the stability of the reagent.
  • Reagent storage agents include lyoprotectants, PEG20000, and antioxidants.
  • the lyoprotectant includes: mannitol, trehalose, casein, surfactant, gelatin, preservative, and buffer TBS.
  • freeze-drying protective agent is calculated according to the sum of the mass percentages as 100%, and the mass percentages of each component are: mannitol 2%-10%, trehalose 5%-20%, casein 0.5%-2% %, surfactant 0.05%-0.5%, gelatin 0.05%-1%, and preservative 0.1%-1%, and buffer TBS 65.5%-92.3%.
  • the surfactant is Tween 20, Tween 80 or triton x 100.
  • the antioxidant is a mixture of sodium thiosulfate and EDTA-2Na at 1:1.
  • a preparation method of chemiluminescence immunoreagent freeze-dried microspheres is as follows:
  • S1 configure chemiluminescence immunoreagent: use magnetic particle coating material and acridine ester labeling material to prepare, wherein magnetic particle is used as solid phase carrier, and acridine ester is used as luminescent signal marker;
  • the reagent is protected under the environment of temperature, humidity and pH value, which is convenient for lyophilization of the prepared luminescent immunoreagent to form lyophilized beads, and the samples are separated and frozen to form a frozen microsphere. ball, to realize the single-person packaging test mode;
  • a chemiluminescence immune reagent disclosed in the present invention includes:
  • the magnetic particles are coated with raw materials, and the magnetic particles are solid-phase carriers, which are coupled with antigen-antibody and other raw materials;
  • Acridine-labeled raw materials, acridine esters are luminescent signal markers, labeled antigens or antibodies and other raw materials;
  • a chemiluminescence immunoreagent freeze-dried microsphere comprising: a magnetic particle coating raw material, acridine-labeled raw material, and a reagent storage agent, the reagent storage agent is used to reduce various stress damages received by the reagent during the freeze-drying process, and to protect the reagent Not easy to denature and inactivate, protect the stability of reagents.
  • Reagent storage agents include lyoprotectants, PEG20000, and antioxidants.
  • Mannitol As a freeze-dried filler, it has no hygroscopicity, and freeze-drying is fast. The freeze-drying process can prevent the active components from subliming with water vapor and make the active components form;
  • Trehalose in the freezing process, it plays the role of low temperature protection, and it plays the role of dehydration protection agent in the drying and dehydration process;
  • the surfactant is Tween 20, Tween 80 or triton x 100: the freeze-drying process reduces the freezing and dehydration deformation caused by the ice-water interfacial tension, and acts as a wetting agent and a heavy-wrinkling agent for the active components during the rehydration process. effect. At the same time reduce non-specific reactions in the process of immune response;
  • Gelatin freeze-dried filler, at the same time, it can block the site in the immune reaction, enhance the stability of the protein, and eliminate the non-specific reaction;
  • Antioxidant sodium thiosulfate and EDTA-2Na prevent oxidative deterioration of reagents during freeze-drying and storage.
  • a preparation method of chemiluminescence immunoreagent freeze-dried microspheres is as follows:
  • S1 configure chemiluminescence immunoreagent: use magnetic particle coating material and acridine ester labeling material to prepare, wherein magnetic particle is used as solid phase carrier, and acridine ester is used as luminescent signal marker;

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Abstract

一种化学发光免疫试剂，包括：磁微粒包被原料，磁微粒为固相载体，偶联抗原或抗体等原料；吖啶酯标记原料，吖啶酯为发光信号标记物，标记抗原或抗体等原料。一种化学发光免疫试剂冻干微球，还包括试剂储存剂，保护试剂的稳定性以及提供免疫反应所需环境，试剂存储剂包括冻干保护剂、PEG20000、以及抗氧化剂。一种化学发光免疫试剂冻干微球的制备步骤如下：用磁微粒包被原料和吖啶酯标记原料配制化学发光免疫试剂；添加试剂储存剂，保护试剂稳定性；液氮冻干化学发光免疫试剂，形成冷冻微球；将冷冻微球转入冻干机，冷冻干燥后充保护气体分装保存。解决化学发光免疫试剂不能常温保存与运输的问题。

Description

[根据细则37.2由ISA制定的发明名称]一种化学发光免疫试剂、冻干微球及冻干微球的制备方法 技术领域
本发明涉及化学发光免疫试剂的技术领域，尤其是涉及一种化学发光免疫试剂、冻干微球及其冻干微球的制备方法。
 背景技术
近年来，发光免疫试剂广泛应用在食品检测、病原体检测和癌基因诊断等方面。但发光免疫试剂在保存和运输条件上要求苛刻，一般需要保存在2-8℃，需要冷链运输。这些条件如果得不到满足，会对发光免疫试剂的性能造成很大的影响，甚至导致试剂失效。
 技术问题
目前已有不少即时检测产品投入中国市场。现有的发光免疫试剂不易对检测物进行分离和检测。
 技术解决方案
本发明的目的是提供一种化学发光免疫试剂及其冻干微球的制备方法，解决现有技术中，发光免疫试剂不易对检测物进行分离和检测的问题。
本发明的上述发明目的是通过以下技术方案得以实现的：
一种试剂，包括：
磁微粒包被原料，磁微粒为固相载体，偶联抗原抗体等原料；
吖啶标记原料，吖啶酯为发光信号标记物，标记抗原或抗体等原料；。
一种化学发光免疫试剂冻干微球的制备方法，还包括试剂储存剂，减少试剂在冻干过程中受到多种应力损伤，保护试剂不易变性和失活，从而保护试剂的稳定性，所述试剂存储剂包括冻干保护剂、PEG20000、以及抗氧化剂。
进一步设置为：所述冻干保护剂包括：甘露醇、海藻糖、酪蛋白、表面活性剂、明胶、防腐剂、以及缓冲液TBS。
进一步设置为：所述冻干保护剂按质量百分数之和为100%计，各组分占质量百分数为：甘露醇2%-10%，海藻糖5%-20%，酪蛋白0.5%-2%，表面活性剂0.05%-0.5%、明胶0.05%-1%，以及防腐剂0.1%-1%、以及缓冲液TBS 65.5%-92.3%。
进一步设置为：所述缓冲液TBS由10-50mm TRIS-HCL和0.85%NaCL制成,使缓冲液的pH7.0-7.4的中性环境下。
进一步设置为：所述表面活性剂为吐温20、吐温80或triton x 100。
进一步设置为：所述抗氧化剂为硫代硫酸钠与EDTA-2Na 按1：1混合使用。
一种化学发光免疫试剂冻干微球的制备方法如下：
S1:配置化学发光免疫试剂：采用磁微粒包被原料和吖啶酯标记原料配制，其中磁微粒作为固相载体，吖啶酯作为发光信号标记物；
S2：在配制好的化学发光免疫试剂中，添加试剂储存剂，保护试剂稳定性；
S3:利用液氮冻干化学发光免疫试剂，形成冻干的珠点小球，分液冷冻样品，形成冷冻微球，实现单人份包装测试模式；
S4：将冷冻微球转入冻干机，冷冻干燥后充保护气体分装保存，解决现有化学发光试剂不能常温储存与运输的问题。
 有益效果
1.通过利用磁微粒包被原料和吖啶酯标记原料配制化学发光免疫试剂，以磁微粒作为固相载体，吖啶酯作为发光信号标记物，试剂与样本反应形成磁微粒偶联原料与待测物、吖啶酯标记原料的免疫复合物，在施加磁场作用下，通过洗涤分离出免疫复合物，复合物在激发液的作用下发光，实现对待测物的检测；
2.通过加入试剂储存剂，对试剂进行温度、湿度、PH值环境下的保护，便于制备完成的发光免疫试剂进行冻干，形成冻干的珠点小球，分液冷冻样品，形成冷冻微球，实现单人份包装测试模式；
3.通过利用液氮冻干的珠点小球，分液冷冻样品，形成冷冻微球，再将冻干微球转入冻干机，冷冻干燥后充保护气体分装保存，解决现有化学发光试剂不能常温储存与运输的问题。
 本发明的实施方式
为了使本发明所要解决的技术问题、 技术方案及有益效果更加清楚、明白，以下结合实施例，对本发明进行进一步详细说明。应当理解，此处所描述的具体实施例仅用以解释本发明，并不用于限定本发明。
本发明公开的一种化学发光免疫试剂，包括：
磁微粒包被原料，磁微粒为固相载体，偶联抗原抗体等原料；
吖啶标记原料，吖啶酯为发光信号标记物，标记抗原或抗体等原料；
一种化学发光免疫试剂冻干微球，包括：磁微粒包被原料、吖啶标记原料、以及试剂储存剂，试剂储存剂用以减少试剂在冻干过程中收到多种应力损伤，保护试剂不易变性和失活，保护试剂的稳定性。
试剂储存剂包括冻干保护剂、PEG20000、以及抗氧化剂。
冻干保护剂包括：甘露醇、海藻糖、酪蛋白、表面活性剂、明胶、防腐剂、以及缓冲液TBS。
其中，
甘露醇：作为冻干填充剂，无吸湿性，冻干快，冻干过程可防止有效组分随水蒸气一起升华，并使有效组分成形；
海藻糖：冻结过程，起到低温保护的作用，干燥脱水过程中起到脱水保护剂的作用；
酪蛋白:蛋白保护的作用，脱水干燥过程中填充剂的作用，同时在免疫试剂中可以起到控制本底，消除假阳的作用；
表面活性剂为吐温20、吐温80或triton x 100：冻干过程降低冰水界面张力所引起的冻结和脱水变形，复水过程中对活性组分起到润湿剂和重褶皱剂的作用。同时降低免疫反应过程中非特异性反应；
明胶：冻干填充剂，同时免疫反应中可以封闭点位，增强蛋白质的的稳定性，消除非特异性反应；
防腐剂采用Proclin 300:广泛抑菌，生物相容性好。
PEG20000：低温保护剂和脱水保护剂的作用，同时免疫反应中可起到加速反应，提高试剂灵敏度的作用；
抗氧化剂硫代硫酸钠和EDTA-2Na：防止试剂在冻干过程及贮藏过程中发生氧化变质。
一种化学发光免疫试剂冻干微球的制备方法如下：
S1:配置化学发光免疫试剂：采用磁微粒包被原料和吖啶酯标记原料配制，其中磁微粒作为固相载体，吖啶酯作为发光信号标记物；
S2：在配制好的化学发光免疫试剂中，添加试剂储存剂，保护试剂的稳定性；
S3:利用液氮冻干化学发光免疫试剂，形成冻干的珠点小球，分液冷冻样品，形成冷冻微球，实现单人份包装测试模式；
S4：将冷冻微球转入冻干机，冷冻干燥后冲保护气体分装保存，解决现有化学发光试剂不能常温储存与运输的问题。
显然本发明具体实现并不受上述方式的限制，只要采用了本发明的方法构思和技术方案进行的各种非实质性的改进，或未经改进将本发明的构思和技术方案直接应用于其它场合的，均在本发明的保护范围之内。
 

Claims (8)

  1. 一种化学发光免疫试剂，其特征在于：包括：
    磁微粒包被原料，磁微粒为固相载体，偶联抗原抗体等原料；
    吖啶酯标记原料，吖啶酯为发光信号标记物，标记抗原或抗体等原料；
  2. 一种冻干微球，包括权利要求1所述的一种化学发光免疫试剂，其特征在于：还包括试剂储存剂，减少试剂在冻干过程中收到多种应力损伤，保护试剂不易变性和失活，从而保护试剂的稳定性，所述试剂存储剂包括冻干保护剂、PEG20000、以及抗氧化剂。
  3. 根据权利要求2所述的一种冻干微球，其特征在于：所述冻干保护剂包括：甘露醇、海藻糖、酪蛋白、表面活性剂、明胶、防腐剂、以及缓冲液TBS。
  4. 根据权利要求2所述的一种冻干微球，其特征在于：所述冻干保护剂按质量百分数之和为100%计，各组分占质量百分数为：甘露醇2%-10%，海藻糖5%-20%，酪蛋白0.5%-2%，表面活性剂0.05%-0.5%、明胶0.05%-1%，以及防腐剂0.1%-1%、以及缓冲液TBS 65.5%-92.3%。
  5. 根据权利要求3或4所述的一种冻干微球，其特征在于：所述缓冲液TBS由10-50mm TRIS-HCL和0.85%NaCL制成,使缓冲液的pH7.0-7.4的中性环境下。
  6. 根据权利要求2所述的一种冻干微球，其特征在于：所述表面活性剂为吐温20、吐温80或triton x 100。
  7. 根据权利要求2所述的一种冻干微球，其特征在于：所述抗氧化剂为硫代硫酸钠与EDTA-2Na 按1：1混合使用。
  8. 根据权利要求2-7任意一项所述的一种化冻干微球，其特征在于：一种化学发光免疫试剂冻干微球的制备方法如下：
    S1:配置化学发光免疫试剂：采用磁微粒包被原料和吖啶酯标记原料配制，其中磁微粒作为固相载体，吖啶酯作为发光信号标记物；
    S2：在配制好的化学发光免疫试剂中，添加试剂储存剂，保护试剂的稳定性；
    S3:利用液氮冻干化学发光免疫试剂，形成冻干的珠点小球，分液冷冻样品，形成冷冻微球，实现单人份包装测试模式；
    S4：将冷冻微球转入冻干机，冷冻干燥后充保护气体分装保存，解决现有化学发光试剂不能常温储存与运输的问题。
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