环硅酸锆钠:一种新型钾离子结合剂的研究进展

杨世婕, 庄杰, 刘倩, 牛剑钊

中国新药杂志 ›› 2026, Vol. 35 ›› Issue (14) : 1502 -1509.

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中国新药杂志 ›› 2026, Vol. 35 ›› Issue (14) : 1502 -1509. DOI: 10.20251/j.cnki.1003-3734.2026.14.008
综述

环硅酸锆钠:一种新型钾离子结合剂的研究进展

    杨世婕, 庄杰, 刘倩, 牛剑钊*
作者信息 +

Sodium zirconium cyclosilicate:research progress on a novel potassium binder

    YANG Shi-jie, ZHUANG Jie, LIU Qian, NIU Jian-zhao*
Author information +
文章历史 +
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摘要

本文综述了新型钾离子结合剂环硅酸铅钠的研究进展。环硅酸铅钠是一种不吸收不溶解的非聚合物无机结晶性粉末,具有均匀的微孔结构,是一种高选择性的无机阳离子交换剂。其经口服,在人体肠道中捕获钾离子后经粪便排出体外,因而可以通过减少钾离子吸收,减少人体血液中钾离子的含量,治疗高钾血症。环硅酸铅钠对钾离子具有高度亲和力,不受其他阳离子的影响,与现有高钾血症治疗方案相比,提高了捕获过量钾离子选择性和速度的能力,为高钾血症长期治疗提供了安全有效的治疗选择。本文详细介绍了环硅酸铅钠的化学结构、作用机制、药动学特性、临床研究进展以及药学研究进展。研究表明,环硅酸铅钠在治疗高钾血症方面表现出良好的疗效和安全性,为临床治疗高钾血症提供了新选择。

Abstract

This paper reviews the research progress of sodium zirconium cyclosilicate,a novel potassium binder.Sodium zirconium cyclosilicate is a non-absorbed,insoluble,non-polymer inorganic crystalline powder with a uniform microporous structure,and functions as a highly selective inorganic cation exchanger.When taken orally, it captures potassium ions in the human intestinal tract,which are then excreted in the feces.By reducing potassium ion absorption,it lowers the potassium ion level in the blood,thereby treating hyperkalemia.Sodium zirconium cyclosilicate has a high affinity for potassium ions that is unaffected by other cations.Compared with existing treatments for hyperkalemia,it offers improved selectivity and speed in capturing excess potassium ions,providing a safe and effective option for the long-term management of hyperkalemia.This article describes in detail the chemical structure, mechanism of action,pharmacokinetic characteristics,clinical research progress and pharmaceutical research progress of sodium zirconium cyclosilicate.Studies have shown that sodium zirconium cyclosilicate demonstrates favorable efficacy and safety in the treatment of hyperkalemia,offering a new option for clinical practice.

关键词

环硅酸锆钠 / 钾离子结合剂 / 高钾血症 / 晶体结构 / 药动学

Key words

sodium zirconium cyclosilicate / potassium ion binder / hyperkalemia / crystal structure / phar-macokinetics

引用本文

引用格式 ▾
杨世婕, 庄杰, 刘倩, 牛剑钊. 环硅酸锆钠:一种新型钾离子结合剂的研究进展[J]. 中国新药杂志, 2026, 35(14): 1502-1509 DOI:10.20251/j.cnki.1003-3734.2026.14.008

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参考文献

[1] ELLIOTT MJ,RONKSLEY PE,CLASE CM,et al.Management of patients with acute hyperkalemia[J].Can Med Assoc J,2010, 182(15):1631-1635.
[2] BEN SALEM C,BADREDDINE A,FATHALLAH N,et al.Drug-induced hyperkalemia[J].Drug Saf,2014,37(9): 677-692.
[3] TAMIRISA KP,AARONSON KD,KOELLING TM.Spironolac-tone-induced renal insufficiency and hyperkalemia in patients with heart failure[J].Am Heart J,2004,148(6):971-978.
[4] LEHNHARDT A,KEMPER MJ.Pathogenesis,diagnosis and management of hyperkalemia[J].Pediatr Nephrol,2011,26(3): 377-384.
[5] DUNLAY RW,STEVENS MS.Hyperkalemia in hospitalized pa-tients[J].Int Urol Nephrol,2000,32(2):177-180.
[6] STAVROS F,LEON A,YANG A,et al.In vitro comparison of water absorption by hyperkalemia therapies:sodium zirxonium cy-closilicate(ZS-9)vs organic polymer resin[J].Am J Kidney Dis,2015,65(4):A81.
[7] PACKHAM DK,KOSIBOROD M.Pharmacodynamics and phar-macokinetics of sodium zirconium cyclosilicate[ZS-9] in the treatment of hyperkalemia[J].Expert Opin Drug Metab Toxicol, 2016,12(5):567-573.
[8] BATTERINK J,LIN J,AU-YEUNG SHM,et al.Effectiveness of sodium polystyrene sulfonate for short-term treatment of hy-perkalemia[J].Can J Hosp Pharm,2015,68(4):296-303.
[9] STEVENS MS,DUNLAY RW.Hyperkalemia in hospitalized pa-tients[J].Int Urol Nephrol,2000,32(2):177-180.
[10] BECCARI MV,MEANEY CJ.Clinical utility of patiromer,sodi-um zirconium cyclosilicate,and sodium polystyrene sulfonate for the treatment of hyperkalemia:an evidence-based review[J]. Core Evid,2017,12:11-24.
[11] JADOUL M,KARABOYAS A,GOODKIN DA,et al.Potassi-um-binding resins:Associations with serum chemistries and inter-dialytic weight gain in hemodialysis patients[J].Am J Nephrol, 2014,39(3):252-259.
[12] NASIR K,AHMAD A.Treatment of hyperkalemia in patients with chronic kidney disease:a comparison of calcium polystyrene sulphonate and sodium polystyrene sulphonate[J].J Ayub Med Coll Abbottabad,2014,26(4):455-458.
[13] BLAIR HA.Patiromer:a review in hyperkalaemia[J].Clin Drug Investig,2018,38(8):785-794.
[14] 贾蓓,姜苗,张馨予,等.消食药在肿瘤治疗中的运用规律[J].世界中医药,2024,19(17):2704-2708.
[15] BOUNTHAVONG M,BUTLER J,DOLAN CM,et al.Cost-ef-fectiveness analysis of patiromer and spironolactone therapy in heart failure patients with hyperkalemia[J].Pharmacoeconom-ics,2018,36(12):1463-1473.
[16] RASTOGI A,HANNA RM,MKRTTCHYAN A,et al.Sodium zirconium cyclosilicate for the management of chronic hyperkale-mia in kidney disease,a novel agent[J].Expert Rev Clin Phar-macol,2021,14(9):1055-1064.
[17] MORALES E,CRAVEDI P,MANRIQUE J.Management of chronic hyperkalemia in patients with chronic kidney disease:an old problem with news options[J].Front Med(Lausanne), 2021,8: 653634.
[18] CHEN X,et al.(2024,November).WS016 rapidly lowers ser-um potassium in hyperkalemia patients:Results from a phase II, randomized,double-blind,placebo-controlled trial[Oral presen-tation].American Society of Nephrology Kidney Week 2024, San Diego,CA,United States.Abstract TH-OR03.
[19] STAVROS F,LEON A,YANG A,et al.In vitro comparison of water absorption by hyperkalemia therapies:sodium zirconium cy-closilicate(ZS-9)vs organic polymer resin[J].Am J Kidney Dis,2015,65(4):A81.
[20] PACKHAM DK,KOSIBOROD M.Pharmacodynamics and phar-macokinetics of sodium zirconium cyclosilicate[ZS-9] in the treatment of hyperkalemia[J].Expert Opin Drug Metab Toxicol,2016,12(5):567-573.
[21] SCHROEDER HA,BALASSA JJ.Abnormal trace metals in man: zirconium[J].J Chronic Dis,1966,19(5):573-586.
[22] BEM DS,SHERMAN JD,NAPOLITANO A,et al.Zirconium silicate molecular sieves and process using the same:US5888472[P].1998-03-30.
[23] BEM DS,SHERMAN JD,NAPOLITANO A,et al.Zirconium silicate and zirconium germanate molecular sieves and process u-sing the same:US6096282[P].2000-08-01.
[24] BEM DS,SHERMAN JD,ASH SR,et al.Ammonium removal with a novel zirconium silicate[J].ASAIO J,47(2): 151.
[25] KOSIBOROD M,RASMUSSEN HS,LAVIN P,et al.Effect of sodium zirconium cyclosilicate on potassium lowering for 28 days among outpatients with hyperkalemia:the HARMONIZE random-ized clinical trial[J].JAMA,2014,312(21):2223-2233.
[26] ASH SR,SINGH B,LAVIN PT,et al.A phase 2 study on the treatment of hyperkalemia in patients with chronic kidney disease suggests that the selective potassium trap,ZS-9,is safe and effi-cient[J].Kidney Int,2015,88(2):404-411.
[27] STAVROS F,YANG A,LEON A,et al.Characterization of structure and function of ZS-9,a K+ selective ion trap[J].PLoS One,2014,9(12):e114686.
[28] ROSANO GMC,SPOLETINI I,AGEWALL S.Pharmacology of new treatments for hyperkalaemia:patiromer and sodium zirconi-um cyclosilicate[J].Eur Heart J Suppl,2019,21(Suppl A): A28-A33.
[29] Food and Drug Administration.Draft Guidance on Sodium Zirco-nium Cyclosilicate[EB/OL].(2021-08-20)[2025-04-20].https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207078.pdf.
[30] 杭州国瑞生物科技有限公司.一种环硅酸锆钠 ZS-9 的制备方法及其应用:中国,CN117776193 A[P].2024.03.29.
[31] 南京百泽医药科技有限公司.一种环硅酸锆钠 ZS-9 晶体及其制备方法:中国,CN119038567A[P].2024.11.29.
[32] 杭州国瑞生物科技有限公司.一种环硅酸锆钠的 A 晶型及其制备方法:中国,CN117342570 A[P].2024.01.05.
[33] 杭州国瑞生物科技有限公司.一种环硅酸锆钠的 B 晶型及其制备方法与应用:中国,CN 117735564A[P].2024.03.22
[34] 朱俐,赵瑜,姚尚辰,等.药物中元素杂质检测技术研究最新进展[J].分析测试学报,2020,39(4):547
[35] 孙佳敏,杨美玲,杜颖,等.药品质量标准中杂质的限度确定方式探讨[J].中国新药杂志,2023,32(21): 2129
[36] ICH.Q3D(R2):Guideline for Elemental Impurities[S]. 2022.
[37] 李智明,卢日刚,邓鸣,等.电感耦合等离子体质谱法检测药品中重金属及其他元素的研究进展[J].理化检验-化学分册,2022,58(12):1477
[38] 张更宇,崔世荣.ICP-MS 最新应用及未来发展[J].科技资讯,2016,14(10):1-4.
[39] 徐冬梅,陈晋,张敏.WDXRF 法测定污染土壤和沉积物中金属元素[J].环境监测管理与技术,2022,34(6):52-55, 68.
[40] STAVROS F,YANG A,LEON A,et al.Characterization of structure and function of ZS-9,a K+ selective ion trap[J].PLoS One,2014,9(12):e114686.
[41] 张慧杰,陈晓旭,王芳宇,等.钾离子结合药物研究进展[J].中国药学杂志,2023,58(8):658-667.

基金资助

中检院学科建设课题(2025HYZX06);中检院学科建设课题(2026HYZX01)

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