CN115109293A - 一种血沉试验管及其制备方法 - Google Patents
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Abstract
本发明提供一种血沉试验管及其制备方法,涉及医疗器械技术领域。该血沉试验管,包括管身,所述管身为聚合树脂注塑管件;所述管身的内壁设有抗血凝层;所述抗血凝层由抗血凝涂料喷涂获得;以重量份数计,所述抗血凝涂料的原料组成包括:含抗血凝金属离子的盐0.05‑1份、螯合剂10‑13份、玻尿酸钠2‑5份、交联剂4‑6份、润滑聚合物5‑6份、抗感染药物1.2‑2份和水70‑90份。本发明通过在管身内壁喷涂抗血凝涂料制得抗血凝层的血沉试验管,有效改善血沉试验管的抗血凝效果。
Description
技术领域
本发明涉及医疗器械技术领域,特别涉及一种血沉试验管及其制备方法。
背景技术
血沉的全称是红细胞沉降率,简称为血沉,是指身体中的红细胞,在一定条件下的沉降速度。在临床上测定血沉,可以了解疾病、观察疾病的发展和变化的情况以及病情活动度。魏氏法(Westergren法)是常见的血沉测试方法之一,其方法将离体抗血凝液置于特制刻度测定管内,垂直立于室温中,1h准红细胞层下沉距离,用毫米(mm)数值报告。
血沉移液管和血沉试验管是魏氏法测试常用实验器材,通常的操作方法为:打开内含柠檬酸三钠的血沉试验管,加入0.8mL血液样本,充分混匀后水平放置在管架上,将血沉移液管缓缓插入血沉试验管底部,在负压的作用下血沉试验管里的样本溶液会沿着血沉移液管缓缓上升到“0”刻度处,停止操作,静置1小时后观察血沉移液管内血浆高度,以红细胞下沉的毫米数据报告血沉值。
由于血沉试验长达1个小时,为了避免实验过程中血凝导致试验数据的不准确,因此血沉试验管中都含有抗凝剂(柠檬酸三钠等)与血样混合。这样的抗血凝处理方法比较单一,因此如何进一步提高血沉试验管的抗血凝效果,已成为本行业的研究课题。
发明内容
为解决背景技术提到的目前大多数血沉试验管的抗血凝处理方法单一的问题。本发明提供一种在管身内壁喷涂抗血凝涂料制得抗血凝层的血沉试验管,有效改善血沉试验管的抗血凝效果。
具体方案为:
一种血沉试验管,包括管身,所述管身为聚合树脂注塑管件;所述管身的内壁设有抗血凝层;所述抗血凝层由抗血凝涂料喷涂获得;
以重量份数计,所述抗血凝涂料的原料组成包括:含抗血凝金属离子的盐0.05-1份、螯合剂10-13份、玻尿酸钠2-5份、交联剂4-6份、润滑聚合物5-6份、抗感染药物1.2-2份和水70-90份。
在实施上述实施例时,优选地,所述聚合树脂为聚乙烯、聚丙烯、聚苯乙烯和聚烯烃弹性体中的至少一种。
在实施上述实施例时,优选地,所述含抗血凝金属离子的盐为氯化铜。
在实施上述实施例时,优选地,所述螯合剂为乙二胺四乙酸。
在实施上述实施例时,优选地,所述交联剂为N,N-亚甲基双丙烯酰胺。
在实施上述实施例时,优选地,所述螯合剂和所述交联剂的重量比例为2:1。
在实施上述实施例时,优选地,所述抗感染药物为磺胺嘧啶、氯己定、三氯生、利福平、盐酸米诺环素中的一种或几种的混合物。
在实施上述实施例时,优选地,所述润滑聚合物为聚乙烯吡咯烷酮、聚氧乙烯亲水聚合物中的一种或几种的混合物。
在实施上述实施例时,优选地,所述抗血凝涂料的制备步骤包括:
S1、将玻尿酸钠加入到MES缓冲溶液,调节pH在4-7之间,充分溶解制得第一溶液
S2、将抗血凝金属离子的盐和螯合剂溶于MES缓冲溶液中,调节pH在4-7之间,得到第二溶液;
S3、将第一溶液和第二溶液混合,加入交联剂,获得第三溶液;
S4、往第三溶液加入润滑聚合物、抗感染药物和水,混合均匀获得抗血凝涂料。
另一方面,本发明还提供一种血沉试验管的制备方法,包括如下步骤:
步骤一、将聚合树脂加入注塑机,挤出注塑,获得管件;
步骤二、清洗管件;
步骤三、管件干燥;
步骤四、将抗血凝涂料均匀喷在管件中,于35-45℃进行烘干;
步骤五、向管件内添加柠檬酸三钠;
步骤六、将管件按预置真空容量抽真空、盖胶塞,即获得血沉试验管。
与现有技术相比,本发明的有益效果为:
1、本发明的血沉试验管通过在内壁喷涂抗血凝涂料形成抗血凝层,可以有效减缓血液与血沉试验管内壁接触的界面的血凝速度,相较于传统的只在血沉试验管内添加抗血凝剂,本发明的血沉试验管不止保证混合有看血凝剂的区域血凝速度减缓,影响血沉试验的主要因素即血液与血沉试验管内壁接触界面的血凝速度同样能够有效减缓。
2、本发明的抗血凝涂料,将具有抗血凝效果的金属离子与螯合剂熬合,并将其与玻尿酸钠交联,由于玻尿酸钠具有粘性较强的交联呈网状结构,与具有抗血凝效果的螯合产物形成稳定的凝胶网络,可持续长久的发挥抗血凝功效。
3、本发明的抗血凝涂料,其原料组分中添加有抗感染药物,抗菌物质保证留血液试验管具有抗血流感染的性。
具体实施方式
为使本发明实施例的目的、技术方案和优点更加清楚,下面将结合本发明实施例,对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
本发明实施例及其对比例采用的实验药品与试剂说明如下:
聚合树脂:聚苯乙烯;
含抗血凝金属离子的盐:氯化铜;
螯合剂:乙二胺四乙酸;
交联剂:N,N-亚甲基双丙烯酰胺;
润滑聚合物:聚乙烯吡咯烷酮;
抗感染药物:磺胺嘧啶;
2-(N-吗啡啉)乙磺酸(MES)缓冲溶液(0.1mol/L,pH=6.4)。
需要说明的是,实施例中未注明具体技术或条件者,按照本领域内的文献所描述的技术或条件或者按照产品说明书进行,所用试剂或仪器未注明生产厂商者,均为可以通过市购获得的常规产品。上述用品均采用医用级。
实施例1
一种血沉试验管,其制备方法为:
步骤一、将聚合树脂加入注塑机,挤出注塑,获得管件;
步骤二、将管件放置于超声装置中,进行超声波清洗;
步骤三、将清洗好的管件放置于烘干设备中,50℃真空干燥,60min;
步骤四、向干燥后的管件内壁均匀喷涂抗血凝涂料,于45℃进行烘干;
步骤五、向烘干后的管件内添加柠檬酸三钠;
步骤六、将管件按预置真空容量抽真空、盖胶塞,即可。
其中,所述抗血凝涂料,以重量份数计,其原料组成包括:含抗血凝金属离子的盐0.05份、螯合剂13份、玻尿酸钠5份、交联剂6份、润滑聚合物6份、抗感染药物2份和水90份。
其制备步骤包括如下:
S1、将玻尿酸钠加入到MES缓冲溶液,调节pH在4-7之间,充分溶解制得第一溶液
S2、将抗血凝金属离子的盐和螯合剂溶于MES缓冲溶液中,调节pH在4-7之间,得到第二溶液;
S3、将第一溶液和第二溶液混合,加入交联剂,获得第三溶液;
S4、往第三溶液加入润滑聚合物、抗感染药物和水,混合均匀获得抗血凝涂料。
实施例2
一种血沉试验管,其制备方法为:
步骤一、将聚合树脂加入注塑机,挤出注塑,获得管件;
步骤二、将管件放置于超声装置中,进行超声波清洗;
步骤三、将清洗好的管件放置于烘干设备中,50℃真空干燥,60min;
步骤四、向干燥后的管件内壁均匀喷涂抗血凝涂料,于45℃进行烘干;
步骤五、向烘干后的管件内添加柠檬酸三钠;
步骤六、将管件按预置真空容量抽真空、盖胶塞,即可。
其中,所述抗血凝涂料,以重量份数计,其原料组成包括:含抗血凝金属离子的盐1份、螯合剂10份、玻尿酸钠5份、交联剂6份、润滑聚合物6份、抗感染药物2份和水90份。
其制备步骤包括如下:
S1、将玻尿酸钠加入到MES缓冲溶液,调节pH在4-7之间,充分溶解制得第一溶液
S2、将抗血凝金属离子的盐和螯合剂溶于MES缓冲溶液中,调节pH在4-7之间,得到第二溶液;
S3、将第一溶液和第二溶液混合,加入交联剂,获得第三溶液;
S4、往第三溶液加入润滑聚合物、抗感染药物和水,混合均匀获得抗血凝涂料。
实施例3
一种血沉试验管,其制备方法为:
步骤一、将聚合树脂加入注塑机,挤出注塑,获得管件;
步骤二、将管件放置于超声装置中,进行超声波清洗;
步骤三、将清洗好的管件放置于烘干设备中,50℃真空干燥,60min;
步骤四、向干燥后的管件内壁均匀喷涂抗血凝涂料,于45℃进行烘干;
步骤五、向烘干后的管件内添加柠檬酸三钠;
步骤六、将管件按预置真空容量抽真空、盖胶塞,即可。
其中,所述抗血凝涂料,以重量份数计,其原料组成包括:含抗血凝金属离子的盐1份、螯合剂13份、玻尿酸钠2份、交联剂6份、润滑聚合物6份、抗感染药物2份和水90份。
其制备步骤包括如下:
S1、将玻尿酸钠加入到MES缓冲溶液,调节pH在4-7之间,充分溶解制得第一溶液
S2、将抗血凝金属离子的盐和螯合剂溶于MES缓冲溶液中,调节pH在4-7之间,得到第二溶液;
S3、将第一溶液和第二溶液混合,加入交联剂,获得第三溶液;
S4、往第三溶液加入润滑聚合物、抗感染药物和水,混合均匀获得抗血凝涂料。
实施例4
一种血沉试验管,其制备方法为:
步骤一、将聚合树脂加入注塑机,挤出注塑,获得管件;
步骤二、将管件放置于超声装置中,进行超声波清洗;
步骤三、将清洗好的管件放置于烘干设备中,50℃真空干燥,60min;
步骤四、向干燥后的管件内壁均匀喷涂抗血凝涂料,于45℃进行烘干;
步骤五、向烘干后的管件内添加柠檬酸三钠;
步骤六、将管件按预置真空容量抽真空、盖胶塞,即可。
其中,所述抗血凝涂料,以重量份数计,其原料组成包括:含抗血凝金属离子的盐1份、螯合剂13份、玻尿酸钠5份、交联剂4份、润滑聚合物6份、抗感染药物2份和水90份。
其制备步骤包括如下:
S1、将玻尿酸钠加入到MES缓冲溶液,调节pH在4-7之间,充分溶解制得第一溶液
S2、将抗血凝金属离子的盐和螯合剂溶于MES缓冲溶液中,调节pH在4-7之间,得到第二溶液;
S3、将第一溶液和第二溶液混合,加入交联剂,获得第三溶液;
S4、往第三溶液加入润滑聚合物、抗感染药物和水,混合均匀获得抗血凝涂料。
实施例5
一种血沉试验管,其制备方法为:
步骤一、将聚合树脂加入注塑机,挤出注塑,获得管件;
步骤二、将管件放置于超声装置中,进行超声波清洗;
步骤三、将清洗好的管件放置于烘干设备中,50℃真空干燥,60min;
步骤四、向干燥后的管件内壁均匀喷涂抗血凝涂料,于45℃进行烘干;
步骤五、向烘干后的管件内添加柠檬酸三钠;
步骤六、将管件按预置真空容量抽真空、盖胶塞,即可。
其中,所述抗血凝涂料,以重量份数计,其原料组成包括:含抗血凝金属离子的盐1份、螯合剂13份、玻尿酸钠5份、交联剂6份、润滑聚合物5份、抗感染药物2份和水90份。
其制备步骤包括如下:
S1、将玻尿酸钠加入到MES缓冲溶液,调节pH在4-7之间,充分溶解制得第一溶液
S2、将抗血凝金属离子的盐和螯合剂溶于MES缓冲溶液中,调节pH在4-7之间,得到第二溶液;
S3、将第一溶液和第二溶液混合,加入交联剂,获得第三溶液;
S4、往第三溶液加入润滑聚合物、抗感染药物和水,混合均匀获得抗血凝涂料。
实施例6
一种血沉试验管,其制备方法为:
步骤一、将聚合树脂加入注塑机,挤出注塑,获得管件;
步骤二、将管件放置于超声装置中,进行超声波清洗;
步骤三、将清洗好的管件放置于烘干设备中,50℃真空干燥,60min;
步骤四、向干燥后的管件内壁均匀喷涂抗血凝涂料,于45℃进行烘干;
步骤五、向烘干后的管件内添加柠檬酸三钠;
步骤六、将管件按预置真空容量抽真空、盖胶塞,即可。
其中,所述抗血凝涂料,以重量份数计,其原料组成包括:含抗血凝金属离子的盐1份、螯合剂13份、玻尿酸钠5份、交联剂6份、润滑聚合物6份、抗感染药物1.2份和水70份。
其制备步骤包括如下:
S1、将玻尿酸钠加入到MES缓冲溶液,调节pH在4-7之间,充分溶解制得第一溶液
S2、将抗血凝金属离子的盐和螯合剂溶于MES缓冲溶液中,调节pH在4-7之间,得到第二溶液;
S3、将第一溶液和第二溶液混合,加入交联剂,获得第三溶液;
S4、往第三溶液加入润滑聚合物、抗感染药物和水,混合均匀获得抗血凝涂料。
为了验证本发明的抗血凝涂料具有抗血凝效果,本发明涉及抗血凝测试进行验证,具体如下:
抗血凝测试:实施例1-6的抗血凝涂料分别喷涂在聚苯乙烯样条上,所得样品分别裁剪成0.5*0.5cm2,浸泡在1mLPBS(PH=7.4)缓冲液1h,然后加入0.5mL的全血,37℃孵育1h,吸出全血,进行测试。TEG实验可以动态监测全血血凝的全过程,被广泛用于临床以及血液相关的基础研究。TEG检测包括四个参数:
(1)R,指从加入氯化钙到初始纤维蛋白形成所需时间;
(2)K,表明动态血栓形成时间;
(3)α角,表示纤维蛋白交联成凝块的速率或速度;
(4)MA,代表凝块强度。
通过TEG检测结果可综合反映血液从血凝因子的激活到牢固的血小板-纤维蛋白凝块形成再到纤维蛋白溶解过程,展示血液与样品薄膜接触后发生的血凝状况的全貌和血凝块形成的速率、血凝块的强度,血凝块的纤溶水平。其结果如表1所示:
表1
R(min) | K(min) | α(deg) | MA(mm) | |
正常值 | 5-10 | 1-3 | 53-72 | 50-70 |
实施例1 | 5.8 | 3.3 | 51.4 | 47.6 |
实施例2 | 5.2 | 3.1 | 52.6 | 49.1 |
实施例3 | 5.7 | 3.6 | 52.2 | 49.5 |
实施例4 | 5.4 | 3.3 | 50.7 | 48.2 |
实施例5 | 5.7 | 3.2 | 51.1 | 49.3 |
实施例6 | 5.8 | 3.4 | 52.1 | 48.9 |
如表1所示,本实施例1-6的抗血凝涂料制作的样品的TEG凝血参数与正常血浆样品相比,表现为K值升高、α值降低以及MA值降低,这些不仅意味着血液凝血变慢,而且血块加固的速度变低,血块的最大强度也变低,表现为抗凝血的特性。由此证明了,本发明的抗血凝涂料具有减缓血凝速度的效果,能够改善血沉试验管的抗血凝效果。
最后应说明的是:以上各实施例仅用以说明本发明的技术方案,而非对其限制;尽管参照前述各实施例对本发明进行了详细的说明,本领域的普通技术人员应当理解:其依然可以对前述各实施例所记载的技术方案进行修改,或者对其中部分或者全部技术特征进行等同替换;而这些修改或者替换,并不使相应技术方案的本质脱离本发明各实施例技术方案的范围。
Claims (10)
1.一种血沉试验管,其特征在于,包括管身,所述管身为聚合树脂注塑管件;所述管身的内壁设有抗血凝层;所述抗血凝层由抗血凝涂料喷涂获得;
以重量份数计,所述抗血凝涂料的原料组成包括:含抗血凝金属离子的盐0.05-1份、螯合剂10-13份、玻尿酸钠2-5份、交联剂4-6份、润滑聚合物5-6份、抗感染药物1.2-2份和水70-90份。
2.根据权利要求1所述的血沉试验管,其特征在于,所述聚合树脂为聚乙烯、聚丙烯、聚苯乙烯和聚烯烃弹性体中的至少一种。
3.根据权利要求1所述的血沉试验管,其特征在于,所述含抗血凝金属离子的盐为氯化铜。
4.根据权利要求1所述的血沉试验管,其特征在于,所述螯合剂为乙二胺四乙酸。
5.根据权利要求1所述的血沉试验管,其特征在于,所述交联剂为N,N-亚甲基双丙烯酰胺。
6.根据权利要求1所述的血沉试验管,其特征在于,所述螯合剂和所述交联剂的重量比例为2:1。
7.根据权利要求1所述的血沉试验管,其特征在于,所述抗感染药物为磺胺嘧啶、氯己定、三氯生、利福平、盐酸米诺环素中的一种或几种的混合物。
8.根据权利要求1所述的血沉试验管,其特征在于,所述润滑聚合物为聚乙烯吡咯烷酮、聚氧乙烯亲水聚合物中的一种或几种的混合物。
9. 根据权利要求1所述的血沉试验管,其特征在于,所述抗血凝涂料的制备步骤包括:
S1、将玻尿酸钠加入到MES缓冲溶液,调节pH在4-7之间,充分溶解制得第一溶液
S2、将抗血凝金属离子的盐和螯合剂溶于MES缓冲溶液中,调节pH在4-7之间,得到第二溶液;
S3、将第一溶液和第二溶液混合,加入交联剂,获得第三溶液;
S4、往第三溶液加入润滑聚合物、抗感染药物和水,混合均匀获得抗血凝涂料。
10.一种如权利要求1~9任一项所述的血沉试验管的制备方法,其特征在于,包括如下步骤:
步骤一、将聚合树脂加入注塑机,挤出注塑,获得管件;
步骤二、清洗管件;
步骤三、管件干燥;
步骤四、将抗血凝涂料均匀喷在管件中,于35-45℃进行烘干;
步骤五、向管件内添加柠檬酸三钠;
步骤六、将管件按预置真空容量抽真空、盖胶塞,即获得血沉试验管。
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