CN115414383A - 血液透析浓缩液及其制备方法 - Google Patents
血液透析浓缩液及其制备方法 Download PDFInfo
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- 230000000322 hemodialysis Effects 0.000 title claims abstract description 82
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- OVBPIULPVIDEAO-LBPRGKRZSA-N folic acid Chemical compound C=1N=C2NC(N)=NC(=O)C2=NC=1CNC1=CC=C(C(=O)N[C@@H](CCC(O)=O)C(O)=O)C=C1 OVBPIULPVIDEAO-LBPRGKRZSA-N 0.000 claims abstract description 20
- PHIQHXFUZVPYII-ZCFIWIBFSA-N (R)-carnitine Chemical compound C[N+](C)(C)C[C@H](O)CC([O-])=O PHIQHXFUZVPYII-ZCFIWIBFSA-N 0.000 claims abstract description 13
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Abstract
本发明涉及一种血液透析浓缩液及其制备方法，属于血液净化产品领域。所述血液透析浓缩液包括钠离子、钙离子、镁离子、钾离子、氯离子、pH调节剂、葡萄糖、左旋肉碱、硫辛酸、叶酸和维生素C。本发明的血液透析浓缩液能够有效改善慢性肾衰病人因血液透析所致的左旋肉碱缺乏，减轻患者透析过程中的氧化应激反应，使其在不明显增加患者经济负担的前提下增加对透析患者的营养支持，提高透析患者的生活质量。
Description
技术领域
本发明属于血液净化产品领域，具体涉及一种血液透析浓缩液及其制备方法。
背景技术
血液透析是急慢性肾功能衰竭患者肾脏替代治疗的方式之一，通过将体内血液引流至体外，经一个由无数根空心纤维组成的透析器中，血液与含机体浓度相似的透析液在一根根空心纤维内外，通过弥散或对流的原理，清除血液中代谢废物、有害物质和过多的水分。
血液透析的关键之一是血液透析液，目前常用的血液透析液成分为钠、钾、钙、镁、氯和葡萄糖。钠是决定细胞外液的主要阳离子，维持晶体渗透压的主要成分，很容易通过透析膜，故而透析液中钠浓度对血液透析患者血压稳定性起着重要作用；钾是维持心脏电活动的重要离子，透析对钾的清除非常快速；钙可平衡维持性血透病人的血钙水平，使其达到正常或轻度症；镁浓度略低于正常血浆镁，常用高镁血症透析液用于慢性肾功能衰竭；因钠、钾、钙、镁常以氯化物形式存在于浓缩液中，透析液中的氯浓度决定于总阴离子电荷，相应于阳离子电荷的电化学关系，调整钠浓度时，氯浓度也随之变化，由于氯离子浓度过高不利于纠正酸中毒，必要时透析液钠离子的增加可用少量醋酸钠或碳酸氢盐代替；葡萄糖主要为了提高透析液渗透压，增加超滤。中国专利CN202111244994.8公开了一种血液透析浓缩液及其制备方法，其中记载了包括上述几种成分的血液透析液。这类血液透析液虽然能完成基础的血液透析功能，但透析过程中不可忽视的常存在透析患者体内营养流失、营养不良的情况，极大增加了患者感染的风险，提高了患者的住院率和死亡率。
发明内容
本发明要解决的技术问题是，提供一种新型血液透析浓缩液，在保证血液透析功能的基础上，增加对透析患者的营养支持，提高透析患者的生活质量。
本发明所述的血液透析浓缩液，包括血液透析浓缩液A液和血液透析浓缩液B液，血液透析浓缩液A液包括氯化钠、氯化钾、氯化钙、氯化镁、葡萄糖、pH调节剂、左旋肉碱、硫辛酸、叶酸、维生素C，血液透析浓缩液B液包括碳酸氢钠或碳酸氢钠和氯化钠的组合。
所述血液透析浓缩液A液以水为溶剂各组分添加量：左旋肉碱226～395mg/L，硫辛酸2.6～8.8g/L，叶酸122.5～525mg/L，维生素C 2.2～8.8g/L，氯化钠150～220g/L，氯化钾4～7g/L，氯化钙5～13g/L，氯化镁1.5～7g/L，葡萄糖0～40g/L，pH调节剂4～9g/L，pH调节剂优选冰醋酸、枸橼酸、乳酸。
所述血液透析浓缩液B液以水为溶剂各组分添加量：碳酸氢钠50～90g/L，或碳酸氢钠40～60g/L和氯化钠20～40g/L的组合。
所述血液透析浓缩液的制备方法包括以下步骤：
(1)制备血液透析浓缩液A液：按照限菌操作规则，将浓缩液A液各组分原料按配比混合均匀后加入注射用水溶解，经三级精细过滤，灌装、封口、包装，获得血液透析浓缩液A液；
(2)制备血液透析浓缩液B液：按照限菌操作规则，将浓缩液B液各组分原料按配比混合均匀后加入注射用水溶解，经三级精细过滤，灌装、封口、包装，获得血液透析浓缩液B液。
优选三级精细过滤的滤膜规格依次为0.45μm、0.2μm、0.2μm。
在实际使用时，将血液透析浓缩液A液、B液和透析用水根据所使用的透析机型号按相应比例混合，获得血液透析液，保证血液透析液的pH为7.0～7.8。
与现有技术相比，本发明的有益效果在于：
(1)本发明血液透析浓缩液在保证血液透析功能的基础上，增加了对透析患者的营养支持，降低了患者感染的风险，降低了住院率和死亡率，进而提高了透析患者的生活质量。
(2)本发明血液透析浓缩液各有效成分协同作用，改善了患者身体健康状况，添加左旋肉碱补充了患者因透析造成的左旋肉碱的丢失，缓解其因体内缺乏左旋肉碱引起的脂肪代谢紊乱、骨骼肌和心肌等组织的功能障碍；添加硫辛酸和维生素C，具有抗氧化作用，减轻患者透析过程中的氧化应激反应，有效增强体内免疫系统，并缓和体内因发炎所引起的过敏、关节炎及气喘等；添加叶酸，促进人体充分利用糖分和氨基酸，促进机体细胞的生长发育。
(3)本发明血液透析浓缩液性价比较高，其效果显著，而成本提高较少，对患者的经济负担小。
具体实施方式
下面结合实施例对本发明作进一步描述。实施例中用到的所有原料除特殊说明外，均为市购。
实施例1
本发明所述血液透析浓缩液的制备方法包括以下步骤：
(1)制备血液透析浓缩液A液：按照限菌操作规则，将浓缩液A液各组分原料按配比混合均匀后加入注射用水溶解，其各组分配比为：氯化钠210.68g/L、氯化钾5.22g/L、氯化钙7.72g/L、氯化镁3.56g/L、葡萄糖35g/L、pH调节剂6.99g/L、左旋肉碱235mg/L、叶酸350mg/L，维生素C7g/L，经三级精细过滤，灌装、封口、包装，获得血液透析浓缩液A液；
(2)制备血液透析浓缩液B液：按照限菌操作规则，将碳酸氢钠加入注射用水溶解，其配比为84.01g/L，经三级精细过滤，灌装、封口、包装，获得血液透析浓缩液B液。
实施例2
本发明所述血液透析浓缩液的制备方法包括以下步骤：
(1)制备血液透析浓缩液A液：按照限菌操作规则，将浓缩液A液各组分原料按配比混合均匀后加入注射用水溶解，其各组分配比为：氯化钠210.68g/L、氯化钾5.22g/L、氯化钙7.72g/L、氯化镁3.56g/L、葡萄糖35g/L、pH调节剂6.99g/L、左旋肉碱339mg/L、叶酸425mg/L，维生素C7g/L，经三级精细过滤，灌装、封口、包装，获得血液透析浓缩液A液；
(2)制备血液透析浓缩液B液：按照限菌操作规则，将碳酸氢钠加入注射用水溶解，其配比为84.01g/L，经三级精细过滤，灌装、封口、包装，获得血液透析浓缩液B液。
实施例3
本发明所述血液透析浓缩液的制备方法包括以下步骤：
(1)制备血液透析浓缩液A液：按照限菌操作规则，将浓缩液A液各组分原料按配比混合均匀后加入注射用水溶解，其各组分配比为：氯化钠166.80g/L、氯化钾5.49g/L、氯化钙8.12g/L、氯化镁3.74g/L、pH调节剂6.64g/L、左旋肉碱282mg/L、叶酸263mg/L，硫辛酸6.13g/L，经三级精细过滤，灌装、封口、包装，获得血液透析浓缩液A液；
(2)制备血液透析浓缩液B液：按照限菌操作规则，浓缩液B液各组分原料按配比混合均匀后加入注射用水溶解，其各组分配比为：氯化钠30g/L、碳酸氢钠59.18g/L，经三级精细过滤，灌装、封口、包装，获得血液透析浓缩液B液。
实施例4
本发明所述血液透析浓缩液的制备方法包括以下步骤：
(1)制备血液透析浓缩液A液：按照限菌操作规则，将浓缩液A液各组分原料按配比混合均匀后加入注射用水溶解，其各组分配比为：氯化钠166.80g/L、氯化钾5.49g/L、氯化钙8.12g/L、氯化镁3.74g/L、pH调节剂6.64g/L、左旋肉碱282mg/L、叶酸187mg/L，硫辛酸4.2g/L，经三级精细过滤，灌装、封口、包装，获得血液透析浓缩液A液；
(2)制备血液透析浓缩液B液：按照限菌操作规则，浓缩液B液各组分原料按配比混合均匀后加入注射用水溶解，其各组分配比为：氯化钠30g/L、碳酸氢钠59.18g/L，经三级精细过滤，灌装、封口、包装，获得血液透析浓缩液B液。
对比例1
血液透析浓缩液的制备方法包括以下步骤：
(1)制备血液透析浓缩液A液：按照限菌操作规则，将浓缩液A液各组分原料按配比混合均匀后加入注射用水溶解，其各组分配比为：氯化钠210.68g/L、氯化钾5.22g/L、氯化钙7.72g/L、氯化镁3.56g/L、pH调节剂6.99g/L，经三级精细过滤，灌装、封口、包装，获得血液透析浓缩液A液；
(2)制备血液透析浓缩液B液：按照限菌操作规则，浓缩液B液各组分原料按配比混合均匀后加入注射用水溶解，其各组分配比为：碳酸氢钠84.01g/L，经三级精细过滤，灌装、封口、包装，获得血液透析浓缩液B液。
将上述实施例和对比例得到的血液透析液进行血液透析治疗有效率对比试验
将258名血液透析患者随机分成6组，为实验组4组和对照组2组，每组43人，4组实验组分别采用实施例1-实施例4的血液透析液，2组对照组分别采用对比例1血液透析液和市售血液透析液产品；根据患者透析后观察其精神状态、血压、体重、食欲、透析耐受性变化予以评价。
结果见表1，其中，显效：所有指标均有较大改善，有效：所有指标有所缓解，无效：所有指标无明显变化；治疗有效率＝(显效+有效)/总例数×100％。
表1血液透析液治疗效果数据表
试验结果表明：本发明提供实验例在血液透析过程中有效率为90％以上，而对比例1及市售组有效率分别为62.79％、69.77％，使用本发明血液透析浓缩液的患者精神状态、体重、食欲、透析耐受性均有显著改善，在缓解透析患者不良症状上明显优于市售产品。
以上所述仅为本发明的较佳实验例而已，并不用以限制本发明，凡在本发明的精神和原则之内所作的任何修改、等同替换和改进等，均应包含在本发明的保护范围之内。
Claims (7)
1.一种血液透析浓缩液，包括血液透析浓缩液A液和血液透析浓缩液B液，血液透析浓缩液A液包括氯化钠、氯化钾、氯化钙、氯化镁、葡萄糖、pH调节剂，血液透析浓缩液B液包括碳酸氢钠或碳酸氢钠和氯化钠的组合，其特征在于：血液透析浓缩液A液还包括左旋肉碱、硫辛酸、叶酸、维生素C。
2.根据权利要求1所述的血液透析浓缩液，其特征在于：血液透析浓缩液A液以水为溶剂各组分添加量为：左旋肉碱226～395mg/L，硫辛酸2.6～8.8g/L，叶酸122.5～525mg/L，维生素C 2.2～8.8g/L。
3.根据权利要求2所述的血液透析浓缩液，其特征在于：血液透析浓缩液A液以水为溶剂其他组分添加量为：氯化钠150～220g/L，氯化钾4～7g/L，氯化钙5～13g/L，氯化镁1.5～7g/L，葡萄糖0～40g/L，pH调节剂4～9g/L。
4.根据权利要求3所述的血液透析浓缩液，其特征在于：pH调节剂为冰醋酸、枸橼酸或乳酸。
5.根据权利要求1所述的血液透析浓缩液，其特征在于：血液透析浓缩液B液以水为溶剂各组分添加量：碳酸氢钠50～90g/L或碳酸氢钠40～60g/L和氯化钠20～40g/L的组合。
6.一种权利要求1-5任一所述的血液透析浓缩液的制备方法，其特征在于：包括以下步骤：将各组分原料按配比混合后加入注射用水溶解，经三级精细过滤，灌装、封口、包装，分别制备得到血液透析浓缩液A液和血液透析浓缩液B液。
7.根据权利要求6所述的血液透析浓缩液的制备方法，其特征在于：三级精细过滤的滤膜规格依次为0.45μm、0.2μm、0.2μm。
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