CN101744798A - 一种含钙枸橼酸盐浓缩抗凝血液透析液 - Google Patents
一种含钙枸橼酸盐浓缩抗凝血液透析液 Download PDFInfo
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Abstract
体外充分抗凝是保证血液净化技术顺利进行的前提条件。综合国内外研究，对于有透析指征的高危出血患者，目前还没有一种理想的抗凝方法。近年来，枸橼酸抗凝显示了一定的优越性，体外抗凝效果确切，系统凝血功能不受影响。从局部枸橼酸抗凝到枸橼酸抗凝置换液、透析液，仍存在补钙量不确定等不足。根据电离平衡、配位平衡、质子平衡以及配位价键理论和总钙不变的规律，提出含钙枸橼酸盐浓缩抗凝血液透析液的设想，即在新型枸橼酸盐浓缩抗凝血液透析液基础上加入钙、镁离子，不需要外源性补钙，使临床上枸橼酸抗凝方法进一步简化，使其能更好的应用于临床，同时也为临床上高危出血患者尝试性探索一种新的抗凝思路、方法。
Description
技术领域
近几十年来，血液净化技术的不断发展不仅挽救了许多急性肾衰竭患者的生命，也提高了慢性肾衰竭患者的生存质量，同时为临床多脏器功能衰竭的抢救提供治疗平台，其范围已经涉及临床各个领域。
体外充分抗凝是保证血液净化技术顺利进行的前提条件。没有抗凝剂，血液在透析器和透析管路中因生物不相容性，而激活内源性或外源性凝血系统会导致凝血、缩短滤器的寿命、加重患者血液的浪费，造成透析失败，而给患者带来很多不良的影响。目前，临床上体外循环的抗凝剂主要是肝素，但其具有抑制血小板聚集、抑制平滑肌血小板衍生生长因子、增加血管渗透性等作用，同时因为它的全身抗凝性，致使高危出血患者在透析后出现继发出血。继发出血的发生率高达10-30％。综合国内外研究，对于有透析指征的高危出血患者，目前还没有一种理想的抗凝方法。如何选用合适的抗凝剂用于有高危出血倾向患者的血液净化治疗，一直是临床上的一大难题。为此，研究工作者进行了许多抗凝方法的探索和研究。常用的替代方法有低分子肝素透析、无肝素透析、小剂量肝素透析、鱼精蛋白中和肝素的局部抗凝透析、前列环素抗凝透析、重组水蛭素抗凝透析、丝氨酸蛋白酶抑制剂抗凝透析等，但这些方法都存在不足
背景技术
近年来，枸橼酸抗凝显示了很多优越性，可用于高危出血患者。枸橼酸抗凝从1961年Morita最早应用，到2002年Evenepoel等报道了203例次局部枸橼酸抗凝(RCA)血液透析(hemodialysis，HD)，同时与肝素抗凝组进行比较，可以看出RCA在HD中的应用已比较成熟，并经历了从无钙透析液到含钙透析液的发展；Plasson等在1999年最早将含枸橼酸钠的抗凝置换液应用于连续性肾脏替代治疗(continuous renal replacementtherapy，CRRT)，2002年我国季大玺等将其广泛应用于临床；桂保松等以枸橼酸钠作为碱基配成抗凝血液透析液并应用于临床。RCA具体原理为：枸橼酸钠通过动脉端输入，枸橼酸根离子与血液中游离钙离子结合成难以解离的可溶性复合物枸橼酸钙，使血液中有活性的钙离子明显减少，阻止凝血酶原转化为凝血酶以及凝血过程的其它很多环节，从而达到充分的体外抗凝作用，保证良好的透析效果。血中的枸橼酸根或部分被透析器清除，或部分被透析液中的钙离子或其它含钙注射液所螯合，或因输入量本身较小，在体内(肝脏、骨骼肌和肾皮质)通过三羧酸循环迅速被代谢为碳酸氢根，与枸橼酸根结合的钙离子解离重新释放，就能够使体内钙离子浓度保持在正常范围，故无体内抗凝作用，不会因RCA加重或诱发出血。抗凝枸橼酸根浓度不同(2％～46.7％)，但无论何种浓度，只要血液进入滤器时浓度保持在2.5～5mmol/L，即可在体外达到充分的抗凝效果；另外，通过监测体外循环静脉端离子钙水平，也可反映抗凝效果，认为离子钙水平的理想范围是0.25～0.35mmol/L。其独特的优势在于：体外抗凝效果确切，系统凝血功能不受影响，能安全地应用于高危出血病人，尿毒症毒素清除效果与肝素抗凝无异，不良反应少；另外生物相容性也优于肝素抗凝，能够避免引起白细胞、血小板下降，抑制黏附因子的表达。Hofbauer用电镜观察发现RCA时透析膜上的细胞黏附和血栓形成比普通肝素和低分子肝素抗凝时明显减少。
无论是局部枸橼酸抗凝、枸橼酸抗凝置换液还是枸橼酸抗凝透析液，都是利用枸橼酸根螯合血液中的钙离子，使游离钙离子减少，从而抑制凝血，产生抗凝作用。文献报道，体内枸橼酸浓度＜1.44mmol/L是安全的，出现低钙血症的最低血清浓度为2.5mmol/L以及输入速度超过0.04mmol·kg-1/min。枸橼酸在体内代谢迅速，进入体内后，主要在肝脏、肌肉组织及肾皮质参加三羧酸循环，很快被代谢为碳酸氢根，而无任何残留，当停止输入枸橼酸半小时后，机体能将之完全代谢，使体内离子钙和枸橼酸浓度恢复正常。桂保松等将枸橼酸盐作为碱基加入透析液研制的新型枸橼酸盐浓缩抗凝血液透析液通过动物实验和临床应用，显示了一定的优越性，但补钙量较大，补钙量不能精确确定直接影响抗凝效果和安全性。
发明内容
鉴于枸橼酸在溶液中存在三步电离平衡，提供不等量电子以及在浓缩A、B液中与钙离子存在不同的配位平衡和质子平衡。根据配位价键理论，枸橼酸钙存在不同的空间结构，同时枸橼酸钙在溶液中存在一定的可逆配位平衡，另外根据总钙不变的规律，我们提出了含钙枸橼酸盐浓缩抗凝血液透析液配方即在新型枸橼酸盐浓缩抗凝血液透析液基础上进行改良加入钙、镁离子，既有枸橼酸抗凝的共同优点，同时利用枸橼酸盐的四大特点：含钠、代谢成碱基、螯合钙和通过透析膜，透析液中含钙，不需要外源性补钙，使临床上枸橼酸抗凝方法进一步简化，使其能更好的应用于临床，同时也为临床上高危出血患者尝试性探索一种新的抗凝思路、方法。
具体实施方式
1)将洁净的6L塑料桶以反渗水冲洗3次，用75％的乙醇消毒，再用注射用水冲洗3次备用。
2)按精确计算好的处方和限菌操作规则，称取氯化钠、氯化钾、氯化钙、氯化镁、碳酸氢钠、枸橼酸钠粉末，溶于适量注射用水完全溶解过滤后，加称好的葡萄糖溶解、过滤后，再加注射用水至全量，搅匀。
3)用枸橼酸调节pH值，使得稀释34倍后透析液pH值在7.1-7.4之间。最后盛装在消毒好的塑料桶中。
4)B液现用现配。
Claims (2)
1.一种应用枸橼酸盐抗凝的含钙抗凝透析液，其特征在于在新型枸橼酸盐浓缩抗凝血液透析液基础上将枸橼酸盐加入透析液中，利用其含有钠盐、代谢成碱基、螯合钙、通过透析膜，同时在浓缩的透析液中加入钙离子，按照血液透析液标准配成的含钙枸橼酸盐浓缩抗凝血液透析液。
2.按照权利要求1的方法制备含钙枸橼酸盐浓缩抗凝血液透析液配方。
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102579333A (zh) * | 2012-03-28 | 2012-07-18 | 成都青山利康药业有限公司 | 一种血液置换基础液及其制备方法 |
| CN107684558A (zh) * | 2017-10-27 | 2018-02-13 | 宋宏婷 | 一种血液透析液 |
| CN107854481A (zh) * | 2017-10-27 | 2018-03-30 | 宋宏婷 | 一种血液透析液的配置方法 |
| CN107890471A (zh) * | 2017-10-27 | 2018-04-10 | 宋宏婷 | 一种抗凝血液透析液 |
| JP2023519359A (ja) * | 2020-03-23 | 2023-05-10 | ケレシス アクチェンゲゼルシャフト | 抗微生物溶液および感染の治療または予防におけるその使用方法 |
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2008
- 2008-12-03 CN CN200810232579A patent/CN101744798A/zh active Pending
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102579333A (zh) * | 2012-03-28 | 2012-07-18 | 成都青山利康药业有限公司 | 一种血液置换基础液及其制备方法 |
| WO2013143462A1 (zh) * | 2012-03-28 | 2013-10-03 | 成都青山利康药业有限公司 | 一种血液置换基础液及其制备方法 |
| CN102579333B (zh) * | 2012-03-28 | 2015-08-19 | 成都青山利康药业有限公司 | 一种血液置换基础液及其制备方法 |
| CN107684558A (zh) * | 2017-10-27 | 2018-02-13 | 宋宏婷 | 一种血液透析液 |
| CN107854481A (zh) * | 2017-10-27 | 2018-03-30 | 宋宏婷 | 一种血液透析液的配置方法 |
| CN107890471A (zh) * | 2017-10-27 | 2018-04-10 | 宋宏婷 | 一种抗凝血液透析液 |
| JP2023519359A (ja) * | 2020-03-23 | 2023-05-10 | ケレシス アクチェンゲゼルシャフト | 抗微生物溶液および感染の治療または予防におけるその使用方法 |
| JP7518185B2 (ja) | 2020-03-23 | 2024-07-17 | ケレシス アクチェンゲゼルシャフト | 抗微生物溶液および感染の治療または予防におけるその使用方法 |
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