CN106282308A - 一种体外诊断生化试剂稳定剂 - Google Patents

一种体外诊断生化试剂稳定剂 Download PDF

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CN106282308A
CN106282308A CN201610750868.2A CN201610750868A CN106282308A CN 106282308 A CN106282308 A CN 106282308A CN 201610750868 A CN201610750868 A CN 201610750868A CN 106282308 A CN106282308 A CN 106282308A
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stabilizer
biochemical reagents
vitro diagnosis
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200mmol
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姜志华
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Hunan Hy Biopoct Technology Co Ltd
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Hunan Hy Biopoct Technology Co Ltd
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    • C12Q1/25—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving enzymes not classifiable in groups C12Q1/26 - C12Q1/66

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Abstract

本发明公开了一种体外诊断生化试剂稳定剂及其使用方法。该稳定剂组成成份为：10mmol/L‑200mmol/L的氯化钠、0.1％‑2％(体积)的Triton X‑100、0.1％‑2％(体积)的Tween20、1％‑10％(体积)甘油、50mmol/L‑200mmol/L甘露醇、50mmol/L‑200mmol/L山梨醇、10mmol/L‑200mmol/L葡萄糖、10mmol/L‑250mmol/L蔗糖、20mmol/L‑300mmol/L甜菜碱、0.005％‑0.05％(体积)Proclin 300。使用时，本稳定剂按照20％的体积百分比添加到体外诊断生化试剂中即可。本稳定剂稳定作用明显，并且能基本覆盖生化试剂中的酶类项目。

Description

一种体外诊断生化试剂稳定剂
技术领域
本发明涉及II类医疗器械中的体外诊断生化试剂，特别涉及一种体外诊断生化试剂稳定剂。
背景技术
目前体外诊断生化试剂的酶类项目因其中含有诊断用酶，而大部分酶类在工作浓度及试剂储存温度(2-8℃)下稳定性较差，导致该类诊断试剂有效期缩短并且需要频繁定标，大幅增加临床检测的工作量并带来潜在的误诊风险。目前市场上同类产品主要采用BSA、明胶、海藻糖和甘油等作为稳定剂。BSA和明胶为动物源性提取物，可能混杂有未完全清除的目标酶类，会对检测结果带来干扰。而海藻糖或甘油的单一组分只对少数几种酶有稳定作用，适用范围不大。
发明内容
本发明所要解决的技术问题是，针对现有体外诊断生化试剂稳定剂为动物源性提取物，易对检测结果造成干扰，适用范围小的状况，提供一种采用非动物源性原料，且对试剂稳定效果好，适用范围广的体外诊断生化试剂稳定剂。
为解决上述技术问题，本发明采用的技术方案是：一种体外诊断生化试剂稳定剂，其组成成份为：
本发明稳定剂以无机盐(氯化钠)、非离子型表面活性剂(Triton X-100,Tween20)、多元醇(甘露醇，山梨醇，甘油)、糖类(葡萄糖、蔗糖)、生物碱(甜菜碱)、防腐剂(Proclin300)等成份组合成复方即得。使用时按照20％的体积百分比添加到体外诊断生化试剂中，并混匀即可。
与现有技术相比，本发明所具有的有益效果为：
本发明稳定剂的稳定作用明显，同时避免了引入潜在干扰物质，并且能基本覆盖生化试剂中的酶类项目。
具体实施方式
实施例1:
氯化钠 10mmol/L
Triton X-100 0.5％(体积)
Tween 20 0.2％(体积)
甘油 8％(体积)
甘露醇 50mmol/L
山梨醇 50mmol/L
葡萄糖 50mmol/L
蔗糖 30mmol/L
甜菜碱 50mmol/L
Proclin 300 0.01％(体积)
选取如下项目试剂，按照20％的体积百分比添加实施例1的稳定剂做全效期稳定性试验，并设置未添加稳定剂的对照组(添加和未添加稳定剂的试剂都置于2-8℃保存12个月后对比测试)。按试剂说明书操作，比较检测数据与质控品靶值之间的偏差。
质控品：朗道HN1530(1046UN),朗道HE1532(791UE)
检测数据如下：
由上述试验可知，实施例1制备的稳定剂的稳定作用明显，并且能基本覆盖生化试剂中的酶类项目。
实施例2:
氯化钠 50mmol/L
Triton X-100 1％(体积)
Tween 20 0.5％(体积)
甘油 5％(体积)
甘露醇 100mmol/L
山梨醇 50mmol/L
葡萄糖 100mmol/L
蔗糖 100mmol/L
甜菜碱 150mmol/L
Proclin 300 0.02％(体积)
选取如下项目试剂，按照20％的体积百分比添加实施例2的稳定剂做全效期稳定性试验，并设置未添加稳定剂的对照组做全效期稳定性试验(添加和未添加稳定剂的试剂都置于2-8℃保存12个月后对比测试)。按试剂说明书操作，比较检测数据与质控品靶值之间的偏差。
质控品：朗道HN1530(1046UN),朗道HE1532(791UE)
检测数据如下：
由上述试验可知，实施例2制备的稳定剂的稳定作用明显，并且能基本覆盖生化试剂中的酶类项目。
实施例3:
选取如下项目试剂，按照20％的体积百分比添加实施例3的稳定剂做全效期稳定性试验，并设置未添加稳定剂的对照组做全效期稳定性试验(添加和未添加稳定剂的试剂都置于2-8℃保存12个月后对比测试)。按试剂说明书操作，比较检测数据与质控品靶值之间的偏差。
质控品：朗道HN1530(1046UN),朗道HE1532(791UE)
检测数据如下：
由上述试验可知，实施例3制备的稳定剂的稳定作用明显，并且能基本覆盖生化试剂中的酶类项目。

Claims (2)

1.一种体外诊断生化试剂稳定剂，其组成成份为：
2.一种权利要求1所述体外诊断生化试剂稳定剂的使用方法，其特征在于，按照20％的体积百分比添加到体外诊断生化试剂中，并混匀即可。
CN201610750868.2A 2016-08-29 2016-08-29 一种体外诊断生化试剂稳定剂 Pending CN106282308A (zh)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109856383A (zh) * 2019-03-05 2019-06-07 湖北泰康医疗设备有限公司 一种用于宫颈癌辅助诊断的免疫化学染色试剂盒
CN110954581A (zh) * 2019-12-19 2020-04-03 湖南海源医疗科技股份有限公司 一种快速检测同型半胱氨酸的电化学方法

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CN1986785A (zh) * 2005-12-23 2007-06-27 上海复星长征医学科学有限公司 酶复合稳定剂
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CN104390925A (zh) * 2014-10-20 2015-03-04 苏州康铭诚业医用科技有限公司 一种用于天冬氨酸氨基转移酶测定试剂盒的复合稳定剂
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CN105603049A (zh) * 2016-01-18 2016-05-25 沈阳百创特生物科技有限公司 一种用于体外诊断试剂的复合稳定剂及试剂盒

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CN104195221A (zh) * 2014-08-18 2014-12-10 苏州康铭诚业医用科技有限公司 一种用于葡萄糖测定试剂盒的复合稳定剂
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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109856383A (zh) * 2019-03-05 2019-06-07 湖北泰康医疗设备有限公司 一种用于宫颈癌辅助诊断的免疫化学染色试剂盒
CN110954581A (zh) * 2019-12-19 2020-04-03 湖南海源医疗科技股份有限公司 一种快速检测同型半胱氨酸的电化学方法

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