CN107854426A - 一种新型氨基酸腹膜透析液 - Google Patents
一种新型氨基酸腹膜透析液 Download PDFInfo
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- CN107854426A CN107854426A CN201711045040.8A CN201711045040A CN107854426A CN 107854426 A CN107854426 A CN 107854426A CN 201711045040 A CN201711045040 A CN 201711045040A CN 107854426 A CN107854426 A CN 107854426A
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- Medicinal Preparation (AREA)
Abstract
本发明提供一种新型氨基酸腹膜透析液，涉及腹膜透析技术领域，包括N‑乙酰基‑L‑半胱氨酸，L‑组氨酸，L‑异亮氨酸，L‑亮氨酸，L‑赖氨酸，L‑苯丙氨酸等多种氨基酸，包括缓冲碱，电解质等；缓冲碱是乳酸盐、柠檬酸盐、异柠檬酸盐、丙酮酸盐、琥珀酸盐、延胡索酸盐、苹果酸盐，草酰乙酸盐中任意一种；电解质包括钠离子、钙离子、镁离子、氯离子。本发明具有更好的超滤药效，预防心血管并发症，较强的抗氧化应激能力等有益效果。
Description
技术领域
本发明提供了一种新型氨基酸腹膜透析液，涉及医药技术领域。
背景技术
目前，腹膜透析是一种常用的终末期肾脏替代治疗方式。与血液透析相比，其优势表现为治疗费用相对低廉、操作简单、不依赖于大型透析仪器，可以实现居家治疗，对患者的生活自由限制较少。因此，推广腹膜透析疗法尤其符合我国现阶段的国情。故接受腹膜透析的患者人数逐年增多。但是，我国最常用的乳酸盐腹膜透析液以高浓度的葡萄糖为主要渗透剂。患者长期使用会导致大量葡萄糖经腹膜吸收进入体内，从而影响食欲、减少蛋白质类营养吸收。同时，腹膜透析时经腹膜丢失的蛋白质明显高于血透，平均每日丢失约5～15g。因此以上因素决定了腹膜透析患者普遍存在蛋白质能量营养不良。考虑到蛋白质能量营养不良是导致透析病人死亡和出现并发症的主要诱因之一，向腹膜透析患者补充氨基酸、维持正氮平衡具有重要的治疗意义。
1.1％的氨基酸腹膜透析液是目前唯一一种应用于临床可以补充氨基酸的腹透液。不仅可产生超滤作用，还可直接补充人体所缺乏的营养物质，适用于糖尿病腹膜透析患者，尤其是合并有营养不良的透析患者，但其具有潜在的诱导超滤减少、可能增加心血管并发症的发生率，无法有效减少尿毒症患者的氧化应激损伤，易导致各类氧化损伤。
发明内容
本发明提供了一种新型氨基酸腹膜透析液，解决了现有氨基酸腹透液缺少抗氧化应激损伤，增加透析患者心血管疾病发病率，透析药效低下，部分氨基酸浓度不足等技术问题。
为了解决上述问题，本发明的技术方案是这样实现的：
包括N-乙酰-L-半胱氨酸，浓度范围是10～25mmol/L，所述透析液PH值为5.5-7.0。
本发明提供的新型氨基酸腹膜透析液，加入N-乙酰-L-半胱氨酸，可以阻止同型半胱氨酸的合成，同时实现抗氧化应激作用。
作为进一步地优选，所述N-乙酰-L-半胱氨酸的浓度是20～25mmol/L，所述透析液PH 值为6.4～6.8。
作为进一步地优选，所述透析液包括以下组分及各组分的浓度：L-组氨酸5.6～8.2mmol/L， L-异亮氨酸6.47mmol/L，L-亮氨酸7.77mmol/L，L-赖氨酸5.23mmol/L，L-苯丙氨酸3.45 mmol/L，L-苏氨酸5.41mmol/L，L-色氨酸1.32mmol/L，L-缬氨酸11.89mmol/L，L-丙氨酸10.67mmol/L，甘氨酸6.78mmol/L，L-脯氨酸5.17mmol/L，L-丝氨酸4.84mmol/L，L-酪氨酸3.2～5.4mmol/L。
与传统的氨基酸腹膜透析液相比较，本发明提供的腹膜透析液去除精氨酸，实现透析液的超滤药效提高，同时去除了蛋氨酸成分，利于减少同型半胱氨酸的合成。
作为进一步地优选，所述组氨酸的浓度是6.5～8.0mmol/L，所述酪氨酸的浓度是4.5～5.0mmol/L。
作为进一步地优选，包括缓冲碱，电解质，包括血管扩张剂、利尿剂、激素、维生素、抗氧化剂中至少一种。
作为进一步地优选，所述缓冲碱可以是乳酸盐、柠檬酸盐、异柠檬酸盐、丙酮酸盐、琥珀酸盐、延胡索酸盐、苹果酸盐，草酰乙酸盐中至少一种。
作为进一步地优选，所述缓冲碱为乳酸盐，所述乳酸盐浓度是40mmol/L。
作为进一步地优选，所述电解质为CaCl2·2H2O 1.25mmol/L，MgCl2·6H2O0.25mmol/L， NaCl 92mmol/L。
本发明的有益效果：经大量文献研究证实，同型半胱氨酸是导致心血管疾病的独立危险因素，经研究传统氨基酸腹膜透析液汇总的蛋氨酸可促进同型半胱氨酸合成，或增加心血管并发症的发生率，在氨基酸腹膜透析液中添加N-乙酰-L-半胱氨酸，可以阻止同型半胱氨酸的合成，预防透析者心血管并发症，同时实现抗氧化应激作用；为了进一步避免同型半胱氨酸对人体的影响，本发明在不影响氨基酸腹膜透析液对透析患者的氨基酸营养物质补充的基础上，去掉了组氨酸成分；同时去掉精氨酸，实现更好的超滤药效。
附图说明
图1是各组丙二醛含量结果图；
图2是各组同型半胱氨酸含量结果。
具体实施例
为了更好地描述本发明的内容，下面结合具体实施例，对本发明所述的一种新型氨基酸腹膜透析液进行进一步阐述。但不应将此理解为本发明上述主题的范围仅限于以下的实例，凡基于本发明上述内容所实现的技术均属于本发明的范围。
实施例一
一种新型氨基酸腹膜透析液，组分及组分浓度为：N-乙酰-L-半胱氨酸25mmol/L，L- 组氨酸5.6mmol/L，L-异亮氨酸6.47mmol/L，L-亮氨酸7.77mmol/L，L-赖氨酸5.23mmol/L， L-苯丙氨酸3.45mmol/L，L-苏氨酸5.41mmol/L，L-色氨酸1.32mmol/L，L-缬氨酸11.89mmol/L，L-丙氨酸10.67mmol/L，甘氨酸6.78mmol/L，L-脯氨酸5.17mmol/L，L-丝氨酸4.84mmol/L，L-酪氨酸5.4mmol/L，PH值为6.4。
还包括缓冲碱、电解质，缓冲碱可以是乳酸盐、柠檬酸盐、异柠檬酸盐、丙酮酸盐、琥珀酸盐、延胡索酸盐、苹果酸盐，草酰乙酸盐中至少一种，本本实施例选择乳酸钠，乳酸钠的浓度为42mmol/L；电解质种类及各浓度为CaCl2·2H2O 1.25mmol/L，MgCl2·6H2O0.25mmol/L，NaCl 92mmol/L。
当然，可根据病人需要，向氨基酸酸腹膜透析液中添加血管扩张剂、利尿剂、激素、维生素、抗氧化剂中至少一种。
实施例二
一种新型氨基酸腹膜透析液，组分及组分浓度为：N-乙酰-L-半胱氨酸20mmol/L，L-组氨酸6.5mmol/L，L-异亮氨酸6.47mmol/L，L-亮氨酸7.77mmol/L，L-赖氨酸5.23mmol/L，L-苯丙氨酸3.45mmol/L，L-苏氨酸5.41mmol/L，L-色氨酸1.32mmol/L，L-缬氨酸11.89mmol/L，L-丙氨酸10.67mmol/L，甘氨酸6.78mmol/L，L-脯氨酸5.17mmol/L，L-丝氨酸4.84mmol/L，L-酪氨酸4.8mmol/L，PH值为6.8。
还包括缓冲碱、电解质，缓冲碱可以是乳酸盐、柠檬酸盐、异柠檬酸盐、丙酮酸盐、琥珀酸盐、延胡索酸盐、苹果酸盐，草酰乙酸盐中至少一种，本实施例选择乳酸钠，乳酸钠的浓度为42mmol/L；电解质种类及各浓度为CaCl2·2H2O 1.25mmol/L，MgCl2·6H2O0.25mmol/L，NaCl 92mmol/L。
当然，可根据病人需要，向氨基酸酸腹膜透析液中添加血管扩张剂、利尿剂、激素、维生素、抗氧化剂中至少一种。
实施例三
一种新型氨基酸腹膜透析液，组分及组分浓度为：N-乙酰-L-半胱氨酸15mmol/L，L-组氨酸7.4mmol/L，L-异亮氨酸6.47mmol/L，L-亮氨酸7.77mmol/L，L-赖氨酸5.23mmol/L，L-苯丙氨酸3.45mmol/L，L-苏氨酸5.41mmol/L，L-色氨酸1.32mmol/L，L-缬氨酸11.89mmol/L，L-丙氨酸10.67mmol/L，甘氨酸6.78mmol/L，L-脯氨酸5.17mmol/L，L-丝氨酸4.84mmol/L，L-酪氨酸4.0mmol/L，PH值为5.5。
还包括缓冲碱、电解质，缓冲碱可以是乳酸盐、柠檬酸盐、异柠檬酸盐、丙酮酸盐、琥珀酸盐、延胡索酸盐、苹果酸盐，草酰乙酸盐中至少一种，本实施例选择乳酸钠，乳酸钠的浓度为42mmol/L；电解质种类及各浓度为CaCl2·2H2O 1.25mmol/L，MgCl2·6H2O0.25mmol/L，NaCl 92mmol/L。
可根据病人需要，向氨基酸酸腹膜透析液中添加血管扩张剂、利尿剂、激素、维生素、抗氧化剂中至少一种。
实施例四
一种新型氨基酸腹膜透析液，组分及组分浓度为：N-乙酰-L-半胱氨酸10mmol/L，L-组氨酸8.2mmol/L，L-异亮氨酸6.47mmol/L，L-亮氨酸7.77mmol/L，L-赖氨酸5.23mmol/L，L-苯丙氨酸3.45mmol/L，L-苏氨酸5.41mmol/L，L-色氨酸1.32mmol/L，L-缬氨酸11.89mmol/L，L-丙氨酸10.67mmol/L，L-甘氨酸6.78mmol/L，L-脯氨酸5.17mmol/L，L-丝氨酸4.84mmol/L，L-酪氨酸3.2mmol/L，PH值为6.0。
还包括缓冲碱、电解质，缓冲碱可以是乳酸盐、柠檬酸盐、异柠檬酸盐、丙酮酸盐、琥珀酸盐、延胡索酸盐、苹果酸盐，草酰乙酸盐中任意一种，本实施例选择乳酸钠，乳酸钠的浓度为42mmol/L；电解质种类及各浓度为CaCl2·2H2O 1.25mmol/L，MgCl2·6H2O0.25mmol/L，NaCl 92mmol/L。
可根据病人需要，向氨基酸酸腹膜透析液中添加血管扩张剂、利尿剂、激素、维生素、抗氧化剂中至少一种，本实施例添加的是利尿剂。
本发明的有益效果是去除了精氨酸成分，可实现良好的超滤作用，利于代谢废物的清除。去除了蛋氨酸并加入了N-乙酰基-L-半胱氨酸成分，可有效减少同型半胱氨酸的形成，减少氧化应激损伤，避免相关的不良反应。同时对组氨酸和酪氨酸进行了成分优化，使其更适合腹膜透析患者补充氨基酸使用。本本发明的新型氨基酸腹膜透析液可实现良好超滤、抗氧化应激、减少同型半胱氨酸，对预防心血管事件具有更好的治疗作用。
实施例1至实施例4的制备方法是：首先制备三层输液用共挤膜袋。在配制罐中加入表2中处方量的各种氨基酸成分、N-乙酰基-L-半胱氨酸、CaCl2·2H2O、MgCl2·6H2O、氯化钠及乳酸钠，使其充分溶解。加入适量HCl使其pH值为5.7～6.8，最终定容。微孔滤膜滤过后，灌入输液袋中，使其体积为2000ml。制备好的各实例腹透液进行湿热灭菌，灭菌温度115℃，灭菌时间30min。灭菌后得到成品。
氨基酸腹膜透析液的药效学实验
将具体实施例一至实施例四所述的氨基酸腹膜透析液，与市面上购买到的NUTRINEAL 腹透液(1.1％的氨基酸腹膜透析液)进行药效学实验。
1、兔尿毒症透析模型制备
本实验选择健康的新西兰白兔80只，雌雄各半，体重大约1.5～2kg。给予正常饮食、饮水，适应性饲养一周。其中随机选择10只作正常组，其余70只均作5/6肾切除尿毒症模型，麻醉，待固定新西兰白兔后，行左侧腹切开，剥离肾囊部，游离左肾，切除左肾上下极各1/3处并称取重量，其结果等于预先根据体重计算的单肾2/3重量，青霉素抗感染3天。1周后结扎切除右肾，青霉素抗感染3天。4周后检测肾功能，确诊为尿毒症后，开始第二步腹透模型制备：进行麻醉，于腹腔中置入腹透管，手术后休息7-10天至伤口愈合完全。完全随机分为7组，即空白对照组(健康组)、尿毒症无透析对照组、NUTRINEAL 腹透液对照组以及每个实例作为一组。每组8只动物。进行每日1次的腹透治疗，注入 30ml/kg的各组腹透液，于透析240min时结束。连续腹膜透析治疗8周，于末次透析结束时收集血液和透析流出液样本。
2、超滤实验及结果
于末次透析置腹240min时，收集透析流出液，并测量体积。计算透析各组动物的平均净超滤量。结果如下：
表3.各实例净超滤量试验结果
| 分组 | 净超滤量(ml) |
| NUTRINEAL(n＝8) | 20±3 |
| 实例1(n＝8) | 26±4 |
| 实例2(n＝8) | 28±3 |
| 实例3(n＝8) | 27±5 |
| 实例4(n＝8) | 26±3 |
从上表可以看出，4个实例的净超滤量均大于NUTRINEAL腹透液组，提示本发明实例的超滤药效优于传统的氨基酸腹透液。
3、血浆游离氨基酸含量检测及结果
于末次透析透析后，抽取新西兰兔耳静脉血，以肝素抗凝，3000转/分钟离心分离出血浆。向血浆样品中加入磺基水杨酸以去除蛋白质成分，并高速低温离心(12000 转/分钟，离心30分钟)，收集上清液，经0.22μm滤膜过滤后，进样氨基酸自动分析仪，检测各种氨基酸的含量。结果如下所示：
表4.各组新西兰兔血浆游离氨基酸含量测定结果(浓度：μmol/L，)
由于各实例处方中去除了蛋氨酸和精氨酸成分，因此，腹膜透析治疗后新西兰兔血浆中游离的蛋氨酸和精氨酸浓度未见升高，浓度水平相比NUTRINEAL组显著降低。各实例相比NUTRINEAL，在处方中加强了组氨酸和酪氨酸的成分配比，因此透析后血浆游离的组氨酸、酪氨酸的浓度高于NUTRINEAL组。
4、血浆中丙二醛(MDA)浓度检测
于末次腹膜透析后，抽取新西兰兔耳静脉血，以肝素抗凝，3000转/分钟离心分离出血浆。采用硫代巴比妥酸比色法测定血浆中的MDA含量，结果如下所示：
表5.各组新西兰兔血浆丙二醛含量测定结果(浓度：μmol/L，)
| 分组 | 血浆MDA含量 |
| 正常对照组(n＝8) | 2.30±0.38 |
| 尿毒症无透析组(n＝8) | 5.12±1.31 |
| NUTRINEAL(n＝8) | 5.08±1.44 |
| 实例1(n＝8) | 2.57±0.59 |
| 实例2(n＝8) | 3.02±0.82 |
| 实例3(n＝8) | 3.28±1.03 |
| 实例4(n＝8) | 3.75±0.87 |
由以上结果得知，各实例组新西兰兔血浆中的丙二醛含量明显低于尿毒症无透析组和NUTRINEAL透析组。说明各实例添加了N-乙酰基-L-半胱氨酸后具有良好的抗氧化作用，其降低MDA的作用具有一定的剂量依赖性。
5、血浆中同型半胱氨酸浓度检测
于末次透析透析后，抽取新西兰兔耳静脉血，以肝素抗凝，3000转/分钟离心分离出血浆。采用高效液相法测定血浆中的同型半胱氨酸的浓度，结果如下所示：
表6.各组新西兰兔血浆同型半胱氨酸含量测定结果(浓度：μmol/L，)
| 分组 | 血浆Hcy含量 |
| 正常对照组(n＝8) | 10.22±0.78 |
| 尿毒症无透析组(n＝8) | 44.23±12.57 |
| NUTRINEAL(n＝8) | 67.08±18.14 |
| 实例1(n＝8) | 25.47±6.79 |
| 实例2(n＝8) | 23.15±5.17 |
| 实例3(n＝8) | 23.80±6.52 |
| 实例4(n＝8) | 26.35±7.33 |
由以上结果得知，各实例组新西兰兔血浆中的同型半胱氨酸的含量明显低于尿毒症无透析组和NUTRINEAL透析组。说明各实例去掉了蛋氨酸成分，明显减少了同型半胱氨酸的生成。此外，新加入了N-乙酰基-L-半胱氨酸也具有抑制同型半胱氨酸的作用。
与现有技术的NUTRINEAL相比，本发明提供的新型氨基酸腹膜透析液可实现良好超滤、抗氧化应激、减少同型半胱氨酸，对预防心血管事件具有更好的治疗作用。
本发明的有益效果：经大量文献研究证实，同型半胱氨酸是导致心血管疾病的独立危险因素，经研究传统氨基酸腹膜透析液中的蛋氨酸可促进同型半胱氨酸合成，或增加心血管并发症的发生率，在氨基酸腹膜透析液中添加N-乙酰-L-半胱氨酸，可以阻止同型半胱氨酸的合成，预防透析者心血管并发症，同时实现抗氧化应激作用；为了进一步避免同型半胱氨酸对人体的影响，本发明在不影响氨基酸腹膜透析液对透析患者的氨基酸营养物质补充的基础上，去掉了组氨酸成分；同时去掉精氨酸，实现更好的超滤药效。
当然，上述说明并非是对本发明的限制，本发明也并不限于上述举例，本技术领域的普通技术人员，在本发明的实质范围内作出的变化、添加或替换，也应属于本发明的保护范围。
Claims (8)
1.一种新型氨基酸腹膜透析液，其特征在于，包括N-乙酰-L-半胱氨酸，浓度范围是10～25mmol/L，所述透析液PH值为5.5-7.0。
2.根据权利要求1所述的一种新型氨基酸腹膜透析液，其特征在于，所述N-乙酰-L-半胱氨酸的浓度是20～25mmol/L，所述透析液PH值为6.4～6,8。
3.根据权利要求1或2所述的一种新型氨基酸腹膜透析液，其特征在于，所述透析液包括以下组分及各组分的浓度：L-组氨酸5.6～8.2mmol/L，L-异亮氨酸6.47mmol/L，L-亮氨酸7.77mmol/L，L-赖氨酸5.23mmol/L，L-苯丙氨酸3.45mmol/L，L-苏氨酸5.41mmol/L，L-色氨酸1.32mmol/L，L-缬氨酸11.89mmol/L，L-丙氨酸10.67mmol/L，甘氨酸6.78mmol/L，L-脯氨酸5.17mmol/L，L-丝氨酸4.84mmol/L，L-酪氨酸3.2～5.4mmol/L。
4.根据权利要求3所述的一种新型氨基酸腹膜透析液，其特征在于，所述L-组氨酸的浓度是6.5～8.0mmol/L，所述L-酪氨酸的浓度是4.5～5.0mmol/L。
5.根据权利要求4所述的一种新型氨基酸腹膜透析液，其特征在于，包括缓冲碱，电解质，包括血管扩张剂、利尿剂、激素、维生素、抗氧化剂中至少一种。
6.根据权利要求5所述的一种新型氨基酸腹膜透析液，其特征在于，所述缓冲碱可以是乳酸盐、柠檬酸盐、异柠檬酸盐、丙酮酸盐、琥珀酸盐、延胡索酸盐、苹果酸盐，草酰乙酸盐中至少一种。
7.根据权利要求6所述的一种新型氨基酸腹膜透析液，其特征在于，所述缓冲碱为乳酸盐，所述乳酸盐浓度是40mmol/L。
8.根据权利要求7所述的新型氨基酸腹膜透析液，其特征在于，所述电解质包括CaCl2·2H2O 1.25mmol/L，MgCl2·6H2O 0.25mmol/L，NaCl 92mmol/L。
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