CN110726833A - 一种血糖质控液配置方法 - Google Patents
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Abstract
本发明提供的血糖质控液配置方法,包括如下步骤:(1)装3000ml磷酸盐稀释剂于5000ml烧杯中,把烧杯置于磁力搅拌器上,让搅拌转子匀速转动起来,并且用蒸馏水或纯化水做溶剂;(2)然后在磁力搅拌器缓慢搅拌的情况下,往5000ml烧杯中匀速加入52.3g(葡萄糖质控液水平2:122.51g)β‑D(+)无水葡萄糖,不断搅拌约30min。本发明提供的配制方法精准度高,且可以作为多种品牌的POCT血糖仪的质量控制,能够满足临床室内、室间质量控制应用的需要,同时节省总体试剂的使用成本。
Description
技术领域
本发明涉及医疗器械体外诊断试剂领域。
背景技术
葡萄糖质控液的主要成分为磷酸盐稀释剂和β-D(+)无水葡萄糖。其中磷酸盐是生物化学研究中使用最广泛的一种缓冲剂,由于它们是二级解离,有二个pKa值,所以用它们配制的缓冲液,pH范围最宽。β-D(+)无水葡萄糖是经过提纯、结晶的D-葡萄糖系无水物,或含有一分子结晶水。白色无臭结晶性颗粒或晶粒状粉末。易溶于水,极易溶于沸水,微溶于乙醇。储存条件为2~8℃。D-葡萄糖溶于水时,其旋光度随时间发生变化,逐渐接近+57.2°。这是因为此时的溶液形成了一个含1/3的α-D-葡萄糖和2/3的β-D-葡萄糖的稳定体系。
市售血糖仪的葡萄糖质控液一般采用溶剂为注射用水作为溶剂,注射用水的pH值为5.0-7.0,电导率为1.3us/cm,该方法生产的质控液由于电导率的偏大,在临床上不良反应较多,并且稳定性不好,而我们配制的质控液所用的水质的技术指标pH值6.0-7.0,水质更靠近中性,电导率为0.65us/cm,避免了微生物影响质控液的质量。同时市售质控品开瓶后置于一定温度下保存可稳定8小时、7天不等,其中朗道质控在-20℃冷冻时可保存较长的时间,但用户使用较为繁琐。我们配制的质控液所用到的稀释剂中含有Parmetol K40,既保证了质控液的长期稳定性,密封保存置于2~8℃保存有效期9个月,又确保其在开瓶使用后置2~8℃保存可稳定一个月,长于一般质控液的开瓶有效期,且用于仪器上测试血液的结果相当乐观。
作为体外诊断试剂所用葡萄糖质控液,其技术指标主要涉及的是准确度和精密度,再根据相关技术,发现准确度在±11wt%、精密度 CV≤8.00wt%范围的质控液符合市面多种款型的POCT血糖分析仪使用,并且测试效果优于一些血糖仪配套的试剂。
发明内容
本发明提供的葡萄糖质控液水平1(葡萄糖质控液水平2)配制方法,包括如下步骤:
1.1装3000ml磷酸盐稀释剂于5L烧杯中,把烧杯置于磁力搅拌器上,让搅拌转子匀速转动起来,其中,所述磷酸盐稀释剂包含:磷酸二氢钾添加量0.055wt%,二水合磷酸氢二钠添加量浓度0.237wt%—0.238wt%,氯化钾添加量0.15wt%,硝酸钠添加量浓度为0.019wt%—0.020wt%,二水合依地酸二钠添加量浓度为0.038wt%—0.040wt%,TritonX-100的添加量为0.005wt%—0.0055wt%,Parmetol K40的添加量为0.05wt%—0.06wt%,并且用蒸馏水或纯化水做溶剂;
1.2然后缓慢往5L烧杯中加入52.3g(葡萄糖质控液水平2:122.51g)β-D(+)无水葡萄糖,放于磁力搅拌器上不断搅拌约30min;
1.3等上述化学品完全溶解后,用磷酸盐稀释剂定容至5L;
1.4移取步骤1.3的混合溶液500ml于另一5L烧杯中,然后用磷酸盐稀释剂定容至5L,放于磁力搅拌器上不断搅拌30min,静置 30min;
1.5溶解均匀后,即得灌装前溶液,在过滤器中放入三蒸水中浸泡过的0.22um的醋酸纤维滤膜,过滤三次,即为需要的5.80mmol/L的葡萄糖质控液水平1(13.6mmol/L的葡萄糖质控液水平2);
1.6若溶液是澄清透明状,则取样检测,连做三批,开始测试其准确性,若有沉淀和浑浊现象则祛除,重新配制;
1.7测试合格后,再用上述5.80mmol/L的葡萄糖质控液水平1 (13.6mmol/L的葡萄糖质控液水平2)进行上机验证试验。
2.本发明的配制方法具备以下优点:
2.1使用符合一定标准的纯化水作为磷酸盐缓冲稀释液的溶剂,提高了质控液的准确性和精密性。
2.2磷酸盐稀释剂中加入的Parmetol K40可令质控液在开瓶后置 2~8℃保存稳定一个月,符合广大用户需求;
2.3 Parmetol K40的含量应为0.05wt%~0.06wt%,配制出的校准液稳定性更加良好,同时测试出的结果更加准确;
2.4对于有机物Parmetol K40和TritonX-100,一个是起杀菌、灭菌的作用,一个是离散血样中的细胞使之分散,便于仪器检测,同时降低稀释液的表面张力从而减少气泡的产生,消除气泡给对测量带来的干扰,该物质同时还具有鞘液的作用;添加顺序是先添加TritonX-100后添加Parmetol K40;
2.5本发明采用低转速搅拌溶解法,避免高转速导致泡沫和气泡的产生且低转速节能,更适合工业生产要求,其原材料价格低廉,操作步骤简洁明了,有利于工业化生产;
具体实施方式
下面通过具体实施方式来进一步说明本发明的技术方案。可以理解的是,此处所描述的具体实施例仅仅用于解释本发明,而非对本发明的限定。
制备实施例
本发明的阶段目标:
第一阶段设计含有Parmetol K40杀菌剂的磷酸盐稀释液技术配方;
第二阶段配制5.80mmol/L的葡萄糖质控液水平1(13.6mmol/L的葡萄糖质控液水平2);
第三阶段依据配方建立成熟的工艺流程;
第四阶段利用血糖仪等仪器进行准确性测试,精密度测试,重复试验及临床校准一致性试验,并正式投入生产。
最终目的:制备一种血糖样本检测用的5.80mmol/L的葡萄糖质控液水平1(13.6mmol/L的葡萄糖质控液水平2)的方法。
1.本发明研究的溶液所需的附加条件如下:
1.1分析天平(0.0001g)
1.2磁力搅拌器;
1.3数字温控器;
1.4 pH计;
1.5电导率仪;
1.6烧杯;
1.7配制的磷酸盐稀释剂需测其pH和电导率,具体步骤如下:
1.7.1取少量磷酸盐稀释剂于一个100ml的小烧杯中;
1.7.2先后将校准过的pH计和电导率仪的电极插入溶液中;
1.7.3分别按下pH计和电导率仪的“读数”按钮;
1.7.4等待1min-2min,记录下pH计上的读数和电导率上的读数;
2.关键技术要领:
2.1溶解原材料的溶剂体积应为目标体积的60wt%,方可避免泡沫的产生;
2.2对于有机物Parmetol K40和TritonX-100,一个是起杀菌、灭菌的作用,一个是离散血样中的细胞使之分散,便于仪器检测,同时降低稀释液的表面张力从而减少气泡的产生,消除气泡给对测量带来的干扰,该物质同时还具有鞘液的作用;添加顺序是先添加TritonX-100后添加Parmetol K40;
2.3质控液的配制过程为先配一定浓度的浓溶液,随后进行稀释,保证溶液均一性;
2.4配制完的葡萄糖质控液需静置;
2.5本发明采用低转速搅拌溶解法,配制后需搅拌30min。
2.6 Parmetol K40的含量应为0.05wt%~0.06wt%,配制出的校准液稳定性更加良好,同时测试出的结果更加准确;
2.7水质最好是三级蒸水或纯化水且符合一定标准。
3.葡萄糖质控水平1(葡萄糖质控水平2)具体制备方法:
3.1制备一定体积的磷酸盐稀释剂,其中该稀释剂包含:磷酸二氢钾添加量0.055wt%,二水合磷酸氢二钠添加量浓度0.237wt%— 0.238wt%,氯化钾添加量0.15wt%,硝酸钠添加量浓度为0.019wt%—0.020wt%,二水合依地酸二钠添加量浓度为0.038wt%—0.040wt%, TritonX-100的添加量为0.005wt%—0.0055wt%,Parmetol K40的添加量为0.05wt%—0.06wt%,并且用符合一定标准的蒸馏水或纯化水做溶剂;
3.2装3000ml磷酸盐稀释剂于5000ml烧杯中,把烧杯置于磁力搅拌器上,让搅拌转子匀速转动起来;
3.3然后缓慢往5000ml烧杯中加入52.3g(葡萄糖质控液水平2: 122.51g)β-D(+)无水葡萄糖,放于磁力搅拌器上不断搅拌约30min;
3.4等上述化学品完全溶解后,然后再往5L烧杯中加磷酸盐稀释剂定容至5L;
3.5移取步骤3.4的混合溶液500ml于另一5L烧杯中,然后用磷酸盐稀释剂定容至5L,放于磁力搅拌器上不断搅拌30min,静置30min
3.6溶解均匀后,即得灌装前溶液,在过滤器中放入三蒸水中浸泡过的0.22um的醋酸纤维滤膜,过滤三次,即为需要的5.80mmol/L的葡萄糖质控液水平1(13.6mmol/L的葡萄糖质控液水平2)
3.7若溶液是澄清透明状,则取样检测,连做三批,开始测试其准确性,若有沉淀和浑浊现象则祛除,重新配制;
3.8测试合格后,再用上述5.80mmol/L的葡萄糖质控液水平1 (13.6mmol/L的葡萄糖质控液水平2)进行上机验证试验
引证:YYT 0456.1-2014血液分析仪用试剂第1部分:清洗液; YYT 0456.3-2014血液分析仪用试剂第3部分:稀释剂;ISO18113-2 第2部分:专业用体外诊断试剂;GBT 26124-2011临床化学体外诊断试剂盒标准(GB)YYT 0701-2008血细胞分析仪用校准物(品)GBT1.1-2009标准化工作导则第1部分:标准的结构和编写
效果实施例
各物质组分含量说明
对比例1中加入基准范围之外的无机盐,其电导率为40.23ms/cm,在电导率标准范围5.00~6.00ms/cm之外。
对比例2中加入过量的TritonX-100,产生的泡沫极难消去,需静置30min以上。
对比例3中加入过量的Parmetol K40,溶液稳定性较差,无法达到预期贮存日期。
按照实例1所述比例加入各物质,其电导率为5.3ms/cm,在规定的电导率标准范围之内,产生的泡沫极易消去。实例2的电导率为 5.4ms/cm。
本发明还可有其它多种实施例,在不背离本发明精神及其实质的情况下,熟悉本领域的技术人员当可根据本发明作出各种相应的改变和变形,但这些相应的改变和变形都应属于本发明所附的权利要求的保护范围。
以上仅为本发明的较佳实施例,并不用以限制本发明,凡在本发明的精神和原则之内,所作的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。
Claims (1)
1.一种血糖质控液配置方法,其特征在于,包含如下步骤:
1.1溶解原材料的溶剂体积需为目标体积的60wt%;
1.2先配制成浓溶液再进一步稀释;
1.3添加顺序为先添加TritonX-100后添加Parmetol K40;
还包括:
2.1装3000ml磷酸盐稀释剂于5L烧杯中,把烧杯置于磁力搅拌器上,让搅拌转子匀速转动起来,其中,所述磷酸盐稀释剂包含:磷酸二氢钾添加量0.055wt%,二水合磷酸氢二钠添加量浓度0.237wt%—0.238wt%,氯化钾添加量0.15wt%,硝酸钠添加量浓度为0.019wt%—0.020wt%,二水合依地酸二钠添加量浓度为0.038wt%—0.040wt%,TritonX-100即曲拉通-100,分子式:C14H22O(C2H4O)n,添加量为0.005wt%—0.0055wt%,Parmetol K40添加量为0.05wt%—0.06wt%,,用蒸馏水或纯化水做溶剂;
2.2然后缓慢往5L烧杯中加入52.3gβ-D(+)无水葡萄糖,放于磁力搅拌器上不断搅拌约30min;
2.3等上述化学品完全溶解后,用磷酸盐稀释剂定容至5L;
2.4移取所述步骤2.3的混合溶液500ml于另一5L烧杯中,用磷酸盐稀释剂定容至5L,放于磁力搅拌器上不断搅拌30min,静置30min;
2.5溶解均匀后,即得灌装前溶液,在过滤器中放入三蒸水中浸泡过的0.22um的醋酸纤维滤膜,过滤三次,即为需要的5.80mmol/L的葡萄糖质控液;
2.6若溶液是澄清透明状,则取样检测,连做三批,开始测试其准确性,若有沉淀和浑浊现象则祛除,重新配制;
2.7测试合格后,再用所述的5.80mmol/L的葡萄糖质控液进行上机验证试验。
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