CN114839240A - 一种不含甲醛的电极法临床电解质测量试剂 - Google Patents
一种不含甲醛的电极法临床电解质测量试剂 Download PDFInfo
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Abstract
本发明涉及一种电极法临床电解质测量用配套试剂,包括稀释液及内标液。其特点在于避免使用甲醛,使用特定缓冲体系及防腐剂,并使用表面活性剂,彻底消除生产及使用过程中甲醛对空气的污染。稀释液组分及含量为:硼酸1‑20g/L,丙酸0‑15g/L,苯甲酸0‑5g/L,缓血酸铵2‑30g/L,Mg(NO3)2 5‑20mmol/L,尼泊金乙酯0.01‑1g/L,尼泊金丁酯1‑100mg/L,IPBC 0‑30mg/L,Pluronic 0.1‑1g/L;内标液组分及含量为:硼酸1‑20g/L,丙酸0‑15g/L,苯甲酸0‑5g/L,缓血酸铵2‑30g/L,Mg(NO3)2 5‑20mmol/L,氯化钠1‑30mmol/L,KH2PO4 0.02‑4mmol/L、Na2HPO4 0‑10mmol/L,尼泊金乙酯0.01‑1g/L,尼泊金丁酯1‑100mg/L,IPBC 0‑30mg/L,普兰尼克0.1‑1g/L。试剂配制简单,测量结果准确、稳定,试剂有效期长。
Description
技术领域
本发明涉及体外诊断试剂,尤其涉及间接电极法临床电解质测量用配套试剂。
背景技术
钾、钠、氯等是人体血液中最主要电解质,对于维持体液平衡及正常生理机能有重要意义。人体电解质浓度过高或过低,严重时会危及生命。临床医生需要及时监控患者体液中各项电解质浓度,以帮助诊断和制定治疗措施。因此,临床电解质分析是必不可少的。
离子选择性电极(ion selective electrodes,ISE)法由于其测量速度快、结果可靠而在临床电解质测量中受到广泛应用。其中间接电极法是将标本自动稀释后进行测量,相对于直接电极法(标本不经稀释直接测量)而言,具有所需标本量更小、测量速度更快、对电极及测量通道污染更小因而故障率低等优点,因而广泛应用在全自动生化分析仪上。
全自动生化分析仪配置的间接电极法测量模块,由电极(包括测量电极如钾电极、钠电极、氯电极等及参比电极)、试剂及机械和控制部分组成。其中试剂包括稀释液(也称缓冲液或样本稀释液)、内标液(也称内部标准液、参比液、MID液等)。仪器用定标品定标后,自动吸取稀释液对标本进行定量稀释,稀释后的标本吸入电极室读取各电极的电压值,用内标液冲洗电极室后读取内标液的电压值,经比较计算得到标本中各离子浓度。
传统上,上述电解质试剂中稀释液主要成份是酸碱缓冲剂及惰性无机盐;内标液主要成分为酸碱缓冲液、惰性无机盐及待测离子无机盐等。
上述电解质试剂很容易滋生微生物产生絮状物,在电极膜表面产生微生物膜,导致故障增多、电极寿命降低、测量结果不稳或出现错误结果,因此传统上都会添加甲醛(又名福尔马林)抑制微生物。一些公司产品通常会在标签或其它资料中标注这些试剂含甲醛,例如西门子的电解质缓冲液标签上标明含甲醛0.5%,JEOL的电解质缓冲液、内标液在中国的公开注册资料中也都载明含甲醛<1.0%。甲醛虽然能有效延长试剂有效期,降低微生物膜对电极膜的伤害,但一方面在生产环节会污染车间空气,对生产工人健康产生很大危害。如果试剂按含甲醛0.5%计算,每吨试剂需加37%甲醛大约13.5kg,这将对仓储、分装特别是配制环节产生很大危害。同时,在临床实验室使用环节,这些试剂中的甲醛还会挥发到实验室空气中,造成实验室空气甲醛超标,长年累月对检验医师的健康造成危害。而且上述含甲醛的电解质试剂室温下有效期通常只有一年,开盖装机后通常只能稳定2周左右,如果因为标本较少而更长时间没有用完时,容易发生测量结果不稳的现象。
发明内容
针对现有技术的上述不足,本发明旨在提供一种不含甲醛或其它挥发性有害物质的间接电极法临床电解质测量试剂,从而避免在生产、使用等环节对空气及人员造成危害,并且这些试剂不干扰电极测量,试剂存放有效期不低于2年、开封装机后的有效期不低于1个月,并且对电极膜友好,测量结果稳定。
上述电解质试剂的酸碱缓冲剂至少包括一种酸性物质和一种碱性物质,构成pH缓冲对。传统上酸性物质多采用MOPS、HEPES或乙酸,这些缓冲剂都很容易滋生微生物,并且MOPS、HEPES成本很高。本发明对传统配方进行试验改进,优选除盐酸之外的无机酸HNO3、H3PO4、H2SO4、H3BO3,及有机酸丙酸、苯甲酸,进一步优选硼酸、丙酸或苯甲酸。巧合的是硼酸、丙酸或苯甲酸本身就是一种防腐剂,并且在后面试验中发现它们还有意外的好处,对所有电极都友好,不干扰电极测量。传统上碱性物质多采用缓血酸胺、双-羟乙基三羟甲基甲胺、乙醇胺、二乙醇胺、三乙醇胺,优选缓血酸铵。本发明不使用甲醛或其它挥发性有害添加剂,从食品或化妆品允许添加的防腐剂中经过大量试验筛选,优选尼泊金酯、5-溴-5-硝基-1,3-二恶烷(Bronidox)、碘丙炔醇丁基氨甲酸酯(IPBC)、苯甲酸、对羟基苯甲酸做为防腐剂,进一步优选其中两种或两种以上的防腐剂复配使用。本发明为了使试剂更快速润湿电极膜,减轻标本中蛋白质、脂肪在电极膜的沉积,从而进一步防止电极上产生微生物膜,改善测量结果稳定性,在试剂中添加表面活性剂。优选非离子型表面活性剂,进一步优选环氧乙烷-环氧丙烷嵌段类共聚物,进一步优选添加普兰尼克(Pluronic), 意外发现,它还能促进上述优选防腐剂的溶解,增强上述防腐剂的效果。
优选的其中稀释液组分及含量为:硼酸0-50g/L, 丙酸0-50g/L,苯甲酸0-20g/L,缓血酸铵0-50g/L,Mg(NO3)2 0-40mmol/L,尼泊金乙酯0-5g/L,尼泊金丁酯1-500mg/L,IPBC0-100mg/L, Pluronic 0.01-10g/L,进一步优选为:硼酸1-20g/L,丙酸 0-15g/L,苯甲酸0-5g/L,缓血酸铵2-30g/L,Mg(NO3)2 5-20mmol/L,尼泊金乙酯0.01-1g/L,尼泊金丁酯1-100mg/L,IPBC 0-30mg/L,Pluronic 0.1-1g/L。
优选的其中内标液组分及含量为:硼酸0-50g/L,丙酸0-50g/L,苯甲酸0-20g/L,缓血酸铵0-50g/L,Mg(NO3)2 0-40mmol/L,NaCl 0.1-100mmol/L,KH2PO4 0.01-10mmol/L,Na2HPO4 0-50mmol/L,尼泊金乙酯0-5g/L,尼泊金丁酯1-500mg/L,IPBC 0-100mg/L,Pluronic 0.01-10g/L,进一步优选为:硼酸1-20g/L,丙酸 0-15g/L,苯甲酸0-5g/L,缓血酸铵2-30g/L,Mg(NO3)2 5-20mmol/L,NaCl 1-30mmol/L,KH2PO4 0.02-4mmol/L、Na2HPO4 0-10mmol/L,尼泊金乙酯0.01-1g/L,尼泊金丁酯1-100mg/L,IPBC 0-30mg/L,Pluronic 0.1-1g/L。
上述电解质试剂制备方法,将酸性物质(丙酸、硼酸、苯甲酸)称量后加入适量去离子水溶解,加入碱性物质缓血酸铵,调节pH至5-9, 更优选的pH6-8,再分别加入其它组分,摇匀,放置全部溶解,用去离子水定容后即可。
具体实施方式:
下面通过具体实施例对本发明进行详细说明,应当理解,此处所描述的具体实施例仅仅用以解释本发明,并非对本发明的实际保护范围构成任何形式的任何限定,更非将本发明的保护范围局限于此。
实施例1
A 稀释液的组分与制备 硼酸 10.2g/L 苯甲酸 1.2g/L 加适量去离子水溶解后,用缓血酸铵调节pH至6-8 硝酸镁 10mmol/L 尼泊金乙酯 0.08g/L 尼泊金丁酯 50mg/LIPBC 5mg/L Pluronic 25R2 0.2g/L 搅拌溶解后定容即得 B 内标液的组分及制备 硼酸9.7g/L 苯甲酸 1.2g/L 加适量去离子水溶解后,用缓血酸铵调节pH至6-8 硝酸镁11mmol/L 尼泊金乙酯 0.08g/L 尼泊金丁酯 50mg/L IPBC 5mg/L Pluronic 25R2 0.2g/L氯化钾 0.05mmol/L 氯化钠 0.95mmol/L 磷酸氢二钠 0.025mmol/L 搅拌溶解后定容即得
实施例2
A 稀释液的组分与制备 硼酸 1.6g/L 丙酸 8.2g/L 加适量去离子水溶解后,用缓血酸铵调节pH至6-8 硝酸镁 15mmol/L 尼泊金乙酯 0.08g/L 尼泊金丁酯 30mg/LPluronic F88 0.2g/L 搅拌溶解后转入容量瓶定容即得 B 内标液的组分及制备 硼酸1.5g/L 丙酸 7.8g/L 加适量去离子水溶解后,用缓血酸铵调节pH至6-8 硝酸镁 15mmol/L尼泊金乙酯 0.08g/L 尼泊金丁酯 30mg/L Pluronic F88 0.2g/L 氯化钾 0.13mmol/L 氯化钠 3.10mmol/L 磷酸氢二钠 0.605mmol/L 搅拌溶解后转入容量瓶定容即得
实施例3 一 将实施例1、实施例2所配制的试剂与进口原装对照试剂(明示含有甲醛),分别装机定标后做120份标本,将结果分别进行线性回归,相关系数均大于具统计意义的0.975,显示一致性良好。
K<sup>+</sup>回归方程及相关系数 | Na<sup>+</sup>回归方程及相关系数 | Cl<sup>-</sup>回归方程及相关系数 | |
实施例1试剂 | Y=1.013x-0.087 r=0.999 | Y=0.995x+0.429 r=0.997 | Y=0.989x+1.199 r=0.998 |
实施例2试剂 | Y=1.011x-0.120 r=0.996 | Y=1.004x-0.208 r=0.995 | Y=0.991x+1.012 r=0.992 |
二 分别测量高低质控品各5次,结果(均值±SD)显示一致性均良好
K<sup>+</sup>(mmol/L) | Na<sup>+</sup>(mmol/L) | Cl<sup>-</sup>(mmol/L) | |
进口对照试剂(含甲醛) | 2.81±0.12 6.54±0.23 | 126.5±0.8 156.2±1.4 | 92.8±0.5 116.3±0.8 |
实施例1试剂 | 2.79±0.09 6.52±0.18 | 126.2±0.6 156.5±1.1 | 92.8±0.6 116.4±0.7 |
实施例2试剂 | 2.82±0.15 6.51±0.19 | 126.7±0.9 156.3±1.3 | 92.4±0.6 116.1±0.7 |
实施例4 分别用胰酪大豆胨液体培养基(TSB)及硫乙醇酸盐流体培养基(FTM)对进口对照试剂及实施例1、实施例2试剂进行72小时微生物培养,结果显示菌落数均未检出。
待检样品 | TSB菌落数(cfu) | FTM菌落数(cfu) |
进口对照试剂稀释液(含甲醛) | 未检出 | 未检出 |
进口对照试剂内标液液(含甲醛) | 未检出 | 未检出 |
实施例1稀释液 | 未检出 | 未检出 |
实施例1内标液 | 未检出 | 未检出 |
实施例2稀释液 | 未检出 | 未检出 |
实施例2内标液 | 未检出 | 未检出 |
实施例5 一 实施例1、2试剂装机后持续使用一个月,日常做质控,结果均在控,显示开盖稳定性能持续至少一个月。
二 使用实施例1、2试剂的仪器的电极寿命都在一年以上,与使用对照试剂的电极寿命无显著性差异,提示本发明试剂对电极寿命无不良影响。
三 实施例1、2试剂室温下存放满2年后,观察外观无变化,仍无色透明,未发现浑浊、絮状物或沉淀。装机测量高低值质控品均在给定范围内。提示试剂储存期限至少两年。
Claims (5)
1.一种电极法临床电解质分析配套试剂,包括稀释液和内标液,其中稀释液组分至少包含酸碱缓冲剂、防腐剂;内标液组分至少包含酸碱缓冲剂、待测无机盐离子、防腐剂。
2.如权利要求1所述的电解质分析配套试剂,其特征在于稀释液组分为:酸、碱、惰性无机盐、防腐剂及表面活性剂;内标液组分为:酸、碱、惰性无机盐、含待测离子的无机盐、防腐剂及表面活性剂。
3.如权利要求2所述的电解质分析配套试剂,其特征在于酸为丙酸、硼酸、磷酸或苯甲酸中的一种或两种,防腐剂不使用甲醛或其它挥发性有害物质,采用尼泊金酯、5-溴-5-硝基-1,3-二恶烷、碘丙炔醇丁基氨甲酸酯、苯甲酸、对羟基苯甲酸的一种或几种复配,并添加普兰尼克表面活性剂。
4.如权利要求3所述的电解质配套试剂,其特征在于稀释液组分及含量为:硼酸0-50g/L, 丙酸0-50g/L,苯甲酸0-20g/L,缓血酸铵0-50g/L,Mg(NO3)2 0-40mmol/L,尼泊金乙酯0-5g/L,尼泊金丁酯1-500mg/L,IPBC 0-100mg/L, 普兰尼克0.01-10g/L;内标液组分及含量为:硼酸0-50g/L,丙酸0-50g/L,苯甲酸0-20g/L,缓血酸铵0-50g/L,Mg(NO3)2 0-40mmol/L,氯化钠 0.1-100mmol/L,KH2PO4 0.01-10mmol/L,Na2HPO4 0-50mmol/L,尼泊金乙酯0-5g/L,尼泊金丁酯1-500mg/L,IPBC 0-100mg/L, 普兰尼克 0.01-10g/L。
5.如权利要求4所述的电解质配套试剂,其特征在于稀释液组分及含量为:硼酸1-20g/L,丙酸 0-15g/L,苯甲酸0-5g/L,缓血酸铵2-30g/L,Mg(NO3)2 5-20mmol/L,尼泊金乙酯0.01-1g/L,尼泊金丁酯1-100mg/L,IPBC 0-30mg/L,Pluronic 0.1-1g/L;内标液组分及含量为:硼酸1-20g/L,丙酸 0-15g/L,苯甲酸0-5g/L,缓血酸铵2-30g/L,Mg(NO3)2 5-20mmol/L,氯化钠 1-30mmol/L,KH2PO4 0.02-4mmol/L、Na2HPO4 0-10mmol/L,尼泊金乙酯0.01-1g/L,尼泊金丁酯1-100mg/L,IPBC 0-30mg/L,普兰尼克 0.1-1g/L。
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