CN115530154A - 一种异噻唑啉酮的新用途 - Google Patents
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- YIXJRHPUWRPCBB-UHFFFAOYSA-N magnesium nitrate Chemical compound [Mg+2].[O-][N+]([O-])=O.[O-][N+]([O-])=O YIXJRHPUWRPCBB-UHFFFAOYSA-N 0.000 claims abstract description 8
- 229940100484 5-chloro-2-methyl-4-isothiazolin-3-one Drugs 0.000 claims abstract description 7
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- BEGLCMHJXHIJLR-UHFFFAOYSA-N methylisothiazolinone Chemical compound CN1SC=CC1=O BEGLCMHJXHIJLR-UHFFFAOYSA-N 0.000 claims description 8
- 238000004321 preservation Methods 0.000 claims description 8
- UEFCKYIRXORTFI-UHFFFAOYSA-N 1,2-thiazolidin-3-one Chemical compound O=C1CCSN1 UEFCKYIRXORTFI-UHFFFAOYSA-N 0.000 claims description 7
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Classifications
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- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N1/00—Preservation of bodies of humans or animals, or parts thereof
- A01N1/02—Preservation of living parts
- A01N1/0205—Chemical aspects
- A01N1/021—Preservation or perfusion media, liquids, solids or gases used in the preservation of cells, tissue, organs or bodily fluids
-
- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N1/00—Preservation of bodies of humans or animals, or parts thereof
- A01N1/02—Preservation of living parts
- A01N1/0205—Chemical aspects
- A01N1/021—Preservation or perfusion media, liquids, solids or gases used in the preservation of cells, tissue, organs or bodily fluids
- A01N1/0215—Disinfecting agents, e.g. antimicrobials for preserving living parts
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
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- Zoology (AREA)
- Environmental Sciences (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Abstract
本发明公开了一种生物医药技术领域,涉及异噻唑啉酮的新用途,具体的说是涉及异噻唑啉酮作为全天尿液样本保存剂的应用。其中,所述样本保存剂中的主要成分包括5‑氯‑2‑甲基‑4异噻唑啉‑3‑酮、2‑甲基‑4异噻唑啉‑3‑酮、氯化镁、硝酸镁、水。本发明中的样本保存剂在确保尿液样本中物质结构不被破坏、分解、变质、污染等情况下样本保存剂杀菌效果显著,抑菌能力强,同时不会干扰检测结果,不与蛋白和尿酸反应,不影响各种离子的检查,从而为临床尿液检测提供相对准确的参考结果。
Description
技术领域
本发明公开了一种生物医药技术领域,涉及异噻唑啉酮的新用途,具体的说是涉及异噻唑啉-3-酮作为全天尿液样本保存剂的新用途。
背景技术
蛋白尿的检测对指导慢性肾脏病治疗、评价治疗效果和判断预后都具有重要意义,但是全天尿液标本的留取过程会显得比较“漫长”,在这“漫长”的24小时中有的物质会分解、变质、污染等,为能将尿液中的物质稳定下来,因此需要在被检测的全天尿液中加入样本保存剂以保证样本的质量。异噻唑啉酮是目前性价比最具优势的样本保存剂之一,对常见细菌、真菌、藻类等具有很强的抑制和杀灭作用,所以异噻唑啉酮类的样本保存剂在全天尿液中抑制细菌的滋生和保持全天尿液标本中物质的含量方面效果显著。
现目前,很多样本保存剂也有对尿液标本实现杀菌防腐的效果,比如:甲苯、浓盐酸、麝香草酚、甲醛等,但以上这些防腐大多都属于易挥发、易燃易爆的危险化学品,长期接触对人体会造成很大伤害,抑菌效果虽可以但是不通用,因为对于不同的检测项目是需要使用不同的样本防腐保存处理剂,这些都不利于临床上的处理操作和选择,所以,大部分临床上24小时尿的样本的防腐处理存在着不规范,这样间接地导致了24小时尿检测开展困难和滞后。因此,异噻唑啉酮作为全天尿液中的样本保存剂被设计出来,此类防腐剂用量少且效果明显,无毒无污染,极易混合在各类配方中,稀释使用浓度后,很容易被生物降解为无毒无污染物质。
因此,采用异噻唑啉酮作为全天尿液的样本保存剂,通过更为简单的化学元素组合得到功能可控且效果较佳的样本保存剂,最终达到温度在1~55℃的环境中抑制全天尿液里细菌滋生并保持待检尿液中原有物质的含量。
发明内容
本发明的目的在于拓展异噻唑啉酮的新用途。
本发明第一方面提供异噻唑啉酮在制备用于检验样本防腐保存方面的用途;
所述异噻唑啉酮为异噻唑啉-3-酮混合物;
进一步地,所述异噻唑啉-3-酮混合物包括5-氯-2-甲基-4异噻唑啉-3-酮、2-甲基-4异噻唑啉-3-酮;
进一步地,所述异噻唑啉-3-酮混合物中,5-氯-2-甲基-4异噻唑啉-3-酮与2-甲基-4异噻唑啉-3-酮的摩尔比为2:1~4:1;优选为2.8:1~3.2:1。
进一步地,所述检验样本包括尿液、血液、分泌物;
进一步地,所述尿液包括24小时尿液、全天尿液、12小时尿液;
本发明另一方面还提供噻唑啉酮在制备样本保存剂用于全天尿液中杀菌防腐方面的用途;
进一步地,所述样本保存剂,为异噻唑啉-3酮混合物与医药学上可接受的载体、稳定剂、添加剂中一种或多种配合制备成用于全天尿液的样本保存剂;
进一步地,所述样本保存剂,具体组合成及重量占比分别为:5-氯-2-甲基-4异噻唑啉-3-酮和2-甲基-4异噻唑啉-3-酮混合物占比2%~3%,氯化镁占比0.5%~1.0%,硝酸镁占比21.0%~22.0%;
进一步地,所述杀菌防腐,菌包括葡萄球菌、大肠杆菌、链球菌、变形杆菌;
在本发明优选实施方式中,所述样本保存剂中的5-氯-2-甲基-4异噻唑啉-3-酮与2-甲基-4异噻唑啉-3-酮的摩尔比为3:1;
在本发明优选实施方式中,所述样本保存剂中的5-氯-2-甲基-4异噻唑啉-3-酮和2-甲基-4异噻唑啉-3-酮混合物占比2.5%;
在本发明具体实施方式中,所述由异噻唑啉酮组合成的样本保存剂的储存温度在1~55℃;
在本发明具体实施方式中,所述异噻唑啉酮的样本保存剂,为其制备成的粉末、片剂或者液体;
与现有技术相比,本发明的有益效果为:
1.异噻唑啉酮的新用途作为一种环保型的杀菌样本保存剂,在尿液防腐方面解决了现有防腐方法在尿液防腐中的不稳定性和各种危害。作为尿液检测使用的样本保存剂能在保持原有尿液样本物质的含量的前提下,抑制尿液标本中细菌的滋生和繁殖,维持待检尿液中物质的稳定性。
2.本发明的一种异噻唑啉酮的新用途,操作安全、杀生效率高、稳定性强、防腐效果好,使用成本低。
具体实施方式
下面结合实施例对本发明作进一步的说明,但不以任何方式对本发明加以限制,基于发明导致所做的任何改变或替换,均属于本发明的保护范围。
发明人用了大量的实验,发现异噻唑啉酮对尿液中的细菌具有较好的抑制作用,这从以下的生物实验可以清楚看出。
实施例1、
样本保存剂的制备成分、重量比例及方法:将5-氯-2-甲基-4异噻唑啉-3-酮和2-甲基-4异噻唑啉-3-酮混合物占比2%~3%、氯化镁占比0.5%~1.0%、硝酸镁占比21.0%~22.0%、水占比74.0%~77.5%的原料混匀制成液体的抗菌样本保存剂。
将上述制备得到的样本保存剂用于对细菌的杀菌实验,具体为:
实验菌种:大肠杆菌
设备和材料:一次性无菌培养皿、无菌试管、无菌吸管、无菌洗耳球、无菌锥形瓶、天平、恒温培养箱、高压蒸汽灭菌锅。
培养基和试剂:结晶紫中性红胆盐琼脂培养基(VRBA)、0.9%无菌生理盐水。
具体实验操作:
样品制作:无菌操作制作一定浓度的大肠杆菌悬液并充分混合均匀。提前在无菌培养皿上做好标记,将相对应的大肠杆菌菌悬液用无菌吸管吸取1ml大肠杆菌菌悬液匀液于无菌平皿内,每个浓度对应两个平皿。同时,分别吸取1ml制作大肠杆菌菌悬液的稀释液加入无菌平皿内做空白对照。
样本保存剂与培养基比例,结果见下表1:
表1
按照表1的比例依次将样本保存剂加入温度为46℃左右的培养基中充分混合后及时将15-20ml的培养基倾注所对应的平皿中,并转动平皿使其混合均匀。同时,倾注两个空白培养基平板做空白对照。
待培养基凝固以后,将平板翻转,36℃±1℃培养48h±2h,然后检查菌生长情况。
实验结果,见下表2:
表2
由表1和表2数据可知:未加入本发明所述样本保存剂的菌悬液样品内进行大肠杆菌培养结果为有菌生长;加入本发明所述样本保存剂的菌悬液样品进行大肠杆菌培养结果为比例1/10000以上的情况下无菌生长;样本保存剂与培养基的比例在1/100000时,检测结果为有菌生长;
表明本发明所述样本保存剂对大肠杆菌在防腐剂比例达到1/10000以上时具有对大肠杆菌较好的抑制效果。
实施例2、
取按照实施例1组分比例制备得到液体的样本保存剂三份,每份 2 mL,分别加入24小时尿液收集容器A、B、C中;取24小时尿液收集容器K未加入实施例1制备得到的24小时尿液样本保存剂,作为空白样品对照;然后向A、B、C、K尿液收集容器中分别收集四人的24小时时间段的尿液;将收集的尿液取样检测;
检测方法操作:
将A、B、C、K尿液收集容器中尿液分别取待测尿液样品1 mL,加入30mL的培养基混合均匀后转移至培养皿中,36℃±1℃培养48h±2h,然后检查菌生长情况;
检测结果表3所示;
表3
葡萄球菌 | 大肠杆菌 | 链球菌 | 变形杆菌 | |
K | 有菌生长(菌落计数大于1000) | 有菌生长(菌落计数大于1000) | 有菌生长(菌落计数大于1000) | 有菌生长(菌落计数大于1000) |
A | 无菌生长 | 无菌生长 | 无菌生长 | 无菌生长 |
B | 无菌生长 | 无菌生长 | 无菌生长 | 无菌生长 |
C | 无菌生长 | 无菌生长 | 无菌生长 | 无菌生长 |
从表3数据可知,编号为A、B、C的尿液收集容器中尿液样品中,葡萄球菌、大肠杆菌、链球菌、变形杆菌均未见生长;编号为K尿液收集容器中尿液样品中,葡萄球菌、大肠杆菌、链球菌、变形杆菌的菌落计数大于1000;
表明,未使用本发明实施例的样本保存剂的空白尿液样品K 中,细菌快速繁殖,菌落计数大于正常的计数参考值;添加了本发明实施例1制备得到的样本保存剂的24小时尿液样品,葡萄球菌、大肠杆菌、链球菌、变形杆菌均未见生长,具有明显防腐抗菌效果;
试验例3、
取新鲜得到的正常人尿液样本三份,每份50mL;一份作为对照样品编号为D;另外一份中加入实施例1得到的24小时尿液样本保存剂0.5mL,搅拌均匀编号为M;第三份尿液样品中加入按照现有公开的CN110074099的配比样本保存剂0.5mg,搅拌均匀编号为N;
将M、N和D样品中分别各取待测尿液样品1 mL,进行常规尿液的成分检测,检测项目包括pH、尿蛋白、隐血、比重、葡萄糖、酮体。尿胆原、白细胞,维生素C,尿结晶的尿酸晶型盐(钠、钾或钙),碱性磷酸盐、碳酸钙等结晶盐;
检测结果为样品M和D之间各检测成分指标数据误差不超过1%,符合检验样本检测仪器允许的误差范围内;样品N和D之间检测成分指标数据中,样品N 中尿酸晶型盐数据与D相比高25~30%,其中以钠盐异常高含量为主;
表明:
添加了本发明实施例1的24小时尿液样本保存剂的M尿液样品中,与正常未添加样本保存剂的空白尿液样品D相比,各组分成分检测结果基本相同,本发明实施例1的24小时尿液样本保存剂对尿液各组分、成分检测均无影响;
添加了本发明实施例1的24小时尿液样本保存剂的M尿液样品中,与添加了现有技术公开的样本保存剂的尿液样品N相比,尿酸晶型盐数据,尤其是钠盐成分检测更与空百样品相近,本发明实施例1的24小时尿液样本保存剂对尿液离子成分检测无影响;
综上,本发明实施例1得到的24小时尿液样本保存剂在用于24小时尿液收集抗菌防腐过程中,不与尿蛋白和尿酸起反应干扰检测结果,也不影响各种离子的检查,与现有的样本保存剂相比,更有利于减少检测误差,提供更准确、更优异的检测结果数据,有利于疾病的精准判断,降低误诊几率。
经实际使用,本发明的新用途在抑制全天尿液细菌滋生中效果明显,同时保持待检测尿液标本中原有物质的含量,防止待检测尿液样出现变质、污染而影响检测结果,最终能提高尿液标本的检测质量,具有良好的防腐杀菌效果。
以上详细描述了本发明的新用途较佳具体实施方式。应当理解,本领域涉及的发明范围并不限于上述技术特征的特定组合而形成的技术方案,因此,凡本技术领域中技术人员依据本发明的构思在现有技术的基础上通过逻辑分析、推理或者有限的实验可以得到的方案,皆应在由权利要求书所确定的保护范围。
Claims (10)
1.一种异噻唑啉酮的新用途,其特征在于,
所述异噻唑啉酮在制备用于检验样本防腐保存方面的用途;其中,所述异噻唑啉酮为异噻唑啉-3-酮混合物。
2.如权要求1所述异噻唑啉酮的新用途,其特征在于,
所述异噻唑啉-3-酮混合物包括:5-氯-2-甲基-4异噻唑啉-3-酮和2-甲基-4异噻唑啉-3-酮,其中所述5-氯-2-甲基-4异噻唑啉-3-酮与2-甲基-4异噻唑啉-3-酮的摩尔比为2:1~4:1。
3.如权要求1所述异噻唑啉酮的新用途,其特征在于,
所述异噻唑啉-3-酮混合物中,5-氯-2-甲基-4异噻唑啉-3-酮与2-甲基-4异噻唑啉-3-酮的摩尔比为2.8:1~3.2:1。
4.如权要求1所述异噻唑啉酮的新用途,其特征在于,所述噻唑啉-3-酮混合物在制备样本保存剂用于全天尿液中杀菌防腐方面的用途。
5.如权要求4所述异噻唑啉酮的新用途,其特征在于,所述样本保存剂为异噻唑啉-3酮混合物与医药学上可接受的载体、稳定剂、添加剂中一种或多种配合制备而成。
6.如权要求5所述异噻唑啉酮的新用途,其特征在于,所述异噻唑啉-3-酮混合物与其他多个成分配制得到对全天尿液中细菌的样本保存剂,具体组合成及重量占比分别为:5-氯-2-甲基-4异噻唑啉-3-酮和2-甲基-4异噻唑啉-3-酮的混合物1.5%~4%,氯化镁占比0.5%~1.0%,硝酸镁占比21.0%~22.0%。
7.如权要求6所述异噻唑啉酮的新用途,其特征在于,所述异噻唑啉-3-酮混合物的占比为2%~3%。
8.如权利要求6所述的异噻唑啉酮的新用途,其特征在于,所述细菌包括葡萄球菌、大肠杆菌、链球菌、变形杆菌。
9.如权要求6中所述异噻唑啉酮的新用途,其特征在于:所述样本保存剂的储存温度为1~55℃。
10.如权要求6 中所述异噻唑啉酮的新用途,其特征在于:所述样本保存剂为制备成粉末、片剂或者液体的样本保存剂在全天尿液中杀菌防腐的用途。
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