WO2021223732A1 - Blood purification concentrate - Google Patents

Blood purification concentrate Download PDF

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WO2021223732A1
WO2021223732A1 PCT/CN2021/092064 CN2021092064W WO2021223732A1 WO 2021223732 A1 WO2021223732 A1 WO 2021223732A1 CN 2021092064 W CN2021092064 W CN 2021092064W WO 2021223732 A1 WO2021223732 A1 WO 2021223732A1
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acid
blood purification
preparation
purification concentrate
concentrate according
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PCT/CN2021/092064
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French (fr)
Chinese (zh)
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夏永彪
冯克民
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Xia Yongbiao
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Priority to CN202180032037.0A priority Critical patent/CN116056715A/en
Publication of WO2021223732A1 publication Critical patent/WO2021223732A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/194—Carboxylic acids, e.g. valproic acid having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7004—Monosaccharides having only carbon, hydrogen and oxygen atoms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/14—Alkali metal chlorides; Alkaline earth metal chlorides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/08—Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock

Definitions

  • the invention relates to a preparation and a preparation method and application thereof, and is a blood purification concentrate, a preparation method and application thereof, and belongs to the technical field of medical devices.
  • Blood purification is to take the patient's blood out of the body and pass it through a purification device to remove pathogenic substances or wastes in the blood to purify the blood to achieve the purpose of curing diseases.
  • Blood purification includes treatment technologies such as hemodialysis, hemofiltration, hemodiafiltration and peritoneal dialysis.
  • the application of blood purification technology is not only used to treat acute and chronic renal failure and uremia, but blood purification technology has become a subject.
  • An important multi-disciplinary life science it can treat a variety of cross-disciplinary diseases such as nephropathy, hematopathy, hyperlipidemia, drug poisoning, continuous renal replacement therapy and so on.
  • Acetic acid also affects the phosphorus metabolism of dialysis patients and is one of the causes of chronic hyperphosphatemia. At the same time, acetic acid is metabolized in the liver, increasing the burden on the liver, irritating the liver, and bringing other clinical pathological manifestations. Therefore, the replacement of acetic acid by a certain acid has become an urgent problem to be solved in dialysis, and the emergence of acetic acid-free blood purification concentrates has also become inevitable.
  • the technical problem to be solved by the present invention is to overcome the shortcomings of the prior art and provide a new concept hemodialysis concentrate.
  • the blood purification concentrate solves the shortcomings of acid-base regulators in the current commonly used dialysis concentrates.
  • the acid-base used in the invention The regulator is a physiological organic acid, or physiologically essential acid, and it exists in foods such as beef, fungi, etc., and has a wide range of applications in food additives and medicine.
  • the present invention further provides a preparation method and application of the blood purification concentrate.
  • the blood purification concentrate is a preparation in a solid state or a liquid state, and the blood purification concentrate contains an acid-base regulator; the acid-base regulator is fumaric acid, maleic acid, or succinic acid One or two, and a mixture of three with citric acid.
  • the above-mentioned blood purification concentrate is a preparation for hemodialysis, hemofiltration, hemodiafiltration or peritoneal dialysis.
  • the clinical application concentration of the liquid preparation is: Na+100.0-145.0mmol/L, K+0.0 ⁇ 4.5mmol/L, Ca2+0.5 ⁇ 2.5mmol/L, Mg2+0.20 ⁇ 1.5mmol/L, Cl—90.0 ⁇ 120.0mmol/L, fumaric acid 0.1 ⁇ 10.0mmol/L, citric acid 0.1 ⁇ 10.0mmol/L, maleic acid 0.1 ⁇ 10.0mmol/L, succinic acid 0.1 ⁇ 10.0mmol/L L. Citrate 0.1-10.0mmol/L, HCO3-25.0-40.0mmol/L, glucose 0.0-15.0mmol/L.
  • Preparation method of solid preparation mainly composed of sodium chloride, potassium chloride, calcium chloride, magnesium chloride, fumaric acid, citric acid, sodium bicarbonate, glucose, sieved, and sealed in a packaging container after mixing
  • use purified water or dialysis water to dissolve and dilute to make the above concentration In use, use purified water or dialysis water to dissolve and dilute to make the above concentration;
  • Preparation method of solid preparation mainly composed of sodium chloride, potassium chloride, calcium chloride, magnesium chloride, succinic acid, citric acid, sodium bicarbonate, glucose, sieved, mixed and sealed in a packaging container , When used, dissolve and dilute with purified water or dialysis water to make the above concentration;
  • Preparation method of preparations in liquid state mainly composed of sodium chloride, potassium chloride, calcium chloride, magnesium chloride, fumaric acid, citric acid, sodium bicarbonate, glucose, purified water or dialysis water, after dissolving and filtering It is then filled in a packaging container, and diluted with purified water or dialysis water to make the above-mentioned concentration during use.
  • Preparation method of liquid preparations mainly composed of sodium chloride, potassium chloride, calcium chloride, magnesium chloride, maleic acid, citric acid, sodium bicarbonate, glucose, sieved, and sealed in a packaging container after mixing
  • use purified water or dialysis water to dissolve and dilute to make the above concentration In use, use purified water or dialysis water to dissolve and dilute to make the above concentration;
  • fumaric acid, maleic acid, succinic acid and citric acid are used together as the acid-base regulator of bicarbonate blood purification concentrate, which can well adjust the pH, reach a stable PH value, interact and be effective It prevents calcium and magnesium ions from combining with carbonate ions to produce precipitation.
  • a stable dialysis solution is formed. Prevent blood clotting and achieve safe treatment
  • the present invention is an acetic acid-free blood purification concentrate. Compared with traditional blood purification concentrates containing acetate, it completely overcomes the complications caused by acetate during the treatment process.
  • the fumaric acid, maleic acid, succinic acid and citric acid used in the present invention are important substances in the tricarboxylic acid cycle and important intermediates of human metabolism. They are not metabolized in the liver. They have been used in the fields of medicine and food. It has a wide range of applications and plays an important role in preventing acidosis.

Abstract

An acetic acid-free blood purification concentrate, which is a solid or liquid preparation, and an acid-base regulator contained in the blood purification concentrate is a mixture of citric acid and one, two or three of fumaric acid, maleic acid or succinic acid.

Description

血液净化浓缩物Blood purification concentrate 技术领域Technical field
本发明涉及一种制剂及其制备方法与应用，是一种血液净化浓缩物及其制备方法与应用，属医疗器械技术领域。The invention relates to a preparation and a preparation method and application thereof, and is a blood purification concentrate, a preparation method and application thereof, and belongs to the technical field of medical devices.
背景技术Background technique
血液净化就是将患者血液引出体外并通过一种净化装置，除去血液中的致病物质或废物而净化血液，达到治疗疾病的目的。血液净化包括血液透析、血液滤过、血液透析滤过和腹膜透析等治疗技术，目前，血液净化技术的应用己不仅用于治疗急、慢性肾衰和尿毒症，血液净化技术己成为一门涉及多学科的重要生命科学，它可以治疗肾病、血液病、高血脂症、药物中毒、连续性肾替代疗法等多种跨科别的疾病。Blood purification is to take the patient's blood out of the body and pass it through a purification device to remove pathogenic substances or wastes in the blood to purify the blood to achieve the purpose of curing diseases. Blood purification includes treatment technologies such as hemodialysis, hemofiltration, hemodiafiltration and peritoneal dialysis. At present, the application of blood purification technology is not only used to treat acute and chronic renal failure and uremia, but blood purification technology has become a subject. An important multi-disciplinary life science, it can treat a variety of cross-disciplinary diseases such as nephropathy, hematopathy, hyperlipidemia, drug poisoning, continuous renal replacement therapy and so on.
目前，血液净化技术己得到广泛的应用，但碳酸氢盐血液净化浓缩物为了调整酸碱度，使透析液达到合适的PH范围，防止钙、镁离子与碳酸根离子结合产生沉淀，需加入一定量的醋酸或冰醋酸，而醋酸或冰醋酸在透析溶液中产生的醋酸根离子与透析中和透析后患者的许多并发症有关，由于醋酸根本身能够刺激机体释放多种活性细胞因子，如PNF/PGE2、IL-1等，这些活性因子在许多透析并发症的病理方面起着重要作用，醋酸还影响透析患者的磷代谢，是慢性高磷血症的发病原因之一。同时，醋酸在肝脏代谢，加重肝脏负担，剌激肝脏，带来其他临床病理表现，因此，由某种酸替代醋酸成为透析急需要解决的问题，无醋酸血液净化浓缩物的出现也成为必然。At present, blood purification technology has been widely used, but in order to adjust the pH of the bicarbonate blood purification concentrate, make the dialysate reach the appropriate pH range, and prevent calcium and magnesium ions from combining with carbonate ions to produce precipitation, it is necessary to add a certain amount of Acetic acid or glacial acetic acid, and the acetate ion produced by acetic acid or glacial acetic acid in the dialysis solution is related to many complications of dialysis and post-dialysis patients, because acetate itself can stimulate the body to release a variety of active cytokines, such as PNF/PGE2 These active factors play an important role in the pathology of many dialysis complications. Acetic acid also affects the phosphorus metabolism of dialysis patients and is one of the causes of chronic hyperphosphatemia. At the same time, acetic acid is metabolized in the liver, increasing the burden on the liver, irritating the liver, and bringing other clinical pathological manifestations. Therefore, the replacement of acetic acid by a certain acid has become an urgent problem to be solved in dialysis, and the emergence of acetic acid-free blood purification concentrates has also become inevitable.
发明内容Summary of the invention
本发明所要解决的技术问题是克服现有技术之缺陷提供一种全新概念的血液透析浓缩物，该血液净化浓缩物解决了目前常用透析浓缩物中酸碱调节剂的缺点，发明中所用酸碱调节剂为生理有机酸，或者说生理必需酸，而且其存在于牛肉、及菌类等食物中，在食品添加与医学上有广泛的应用。The technical problem to be solved by the present invention is to overcome the shortcomings of the prior art and provide a new concept hemodialysis concentrate. The blood purification concentrate solves the shortcomings of acid-base regulators in the current commonly used dialysis concentrates. The acid-base used in the invention The regulator is a physiological organic acid, or physiologically essential acid, and it exists in foods such as beef, fungi, etc., and has a wide range of applications in food additives and medicine.
本发明进一步提供该血液净化浓缩物的制备方法与应用。The present invention further provides a preparation method and application of the blood purification concentrate.
本发明所述技术问题是由以下技术方案实现的。The technical problem of the present invention is achieved by the following technical solutions.
该种血液净化浓缩物，其为固体状态的制剂或液体状态的制剂，该血液净化浓缩物中含有酸碱调节剂；所述酸碱调节剂为富马酸或马来酸、琥珀酸中的一种或两种、及三种与柠檬酸的混合物。The blood purification concentrate is a preparation in a solid state or a liquid state, and the blood purification concentrate contains an acid-base regulator; the acid-base regulator is fumaric acid, maleic acid, or succinic acid One or two, and a mixture of three with citric acid.
上述血液净化浓缩物为血液透析、血液滤过、血液透析滤过或腹膜透析用制剂。The above-mentioned blood purification concentrate is a preparation for hemodialysis, hemofiltration, hemodiafiltration or peritoneal dialysis.
上述血液净化浓缩物，所述液体状态的制剂其临床应用的浓度为：Na+100.0～145.0mmol/L、K+0.0～4.5mmol/L、Ca2+0.5～2.5mmol/L、Mg2+0.20～1.5mmol/L、Cl—90.0～120.0mmol/L、富马酸0.1～10.0mmol/L、柠檬酸0.1～10.0mmol/L、马来酸0.1～10.0mmol/L、琥珀酸0.1～10.0mmol/L、柠檬酸盐0.1～10.0mmol/L、HCO3-25.0～40.0mmol/L、 葡萄糖0.0～15.0mmol/L。For the above blood purification concentrate, the clinical application concentration of the liquid preparation is: Na+100.0-145.0mmol/L, K+0.0～4.5mmol/L, Ca2+0.5～2.5mmol/L, Mg2+0.20～ 1.5mmol/L, Cl—90.0～120.0mmol/L, fumaric acid 0.1～10.0mmol/L, citric acid 0.1～10.0mmol/L, maleic acid 0.1～10.0mmol/L, succinic acid 0.1～10.0mmol/L L. Citrate 0.1-10.0mmol/L, HCO3-25.0-40.0mmol/L, glucose 0.0-15.0mmol/L.
制备上述血液净化浓缩物的方法，步骤如下：The method for preparing the above blood purification concentrate, the steps are as follows:
(1)固体状态的制剂的制备方法：主要由氯化钠、氯化钾、氯化钙、氯化镁、富马酸、柠檬酸、碳酸氢钠、葡萄糖组成，过筛，混合后封存于包装容器中，使用时用纯化水或透析用水溶解并稀释制成上述浓度；(1) Preparation method of solid preparation: mainly composed of sodium chloride, potassium chloride, calcium chloride, magnesium chloride, fumaric acid, citric acid, sodium bicarbonate, glucose, sieved, and sealed in a packaging container after mixing In use, use purified water or dialysis water to dissolve and dilute to make the above concentration;
(2)固体状态的制剂的制备方法：主要由氯化钠、氯化钾、氯化钙、氯化镁、马来酸、柠檬酸、碳酸氢钠、葡萄糖组成，过筛，混合后封存于包装容器中，使用时用纯化水或透析用水溶解并稀释制成上述浓度；(2) Preparation method of solid preparation: mainly composed of sodium chloride, potassium chloride, calcium chloride, magnesium chloride, maleic acid, citric acid, sodium bicarbonate, glucose, sieved, and sealed in a packaging container after mixing In use, use purified water or dialysis water to dissolve and dilute to make the above concentration;
(3)固体状态的制剂的制备方法：主要由氯化钠、氯化钾、氯化钙、氯化镁、琥珀酸、柠檬酸、碳酸氢钠、葡萄糖组成，过筛，混合后封存于包装容器中，使用时用纯化水或透析用水溶解并稀释制成上述浓度；(3) Preparation method of solid preparation: mainly composed of sodium chloride, potassium chloride, calcium chloride, magnesium chloride, succinic acid, citric acid, sodium bicarbonate, glucose, sieved, mixed and sealed in a packaging container , When used, dissolve and dilute with purified water or dialysis water to make the above concentration;
(4)液体状态的制剂的制备方法：主要由氯化钠、氯化钾、氯化钙、氯化镁、富马酸、柠檬酸、碳酸氢钠、葡萄糖、纯化水或透析用水组成，经溶解过滤后灌装于包装容器中，使用时用纯化水或透析用水稀释制成上述浓度。(4) Preparation method of preparations in liquid state: mainly composed of sodium chloride, potassium chloride, calcium chloride, magnesium chloride, fumaric acid, citric acid, sodium bicarbonate, glucose, purified water or dialysis water, after dissolving and filtering It is then filled in a packaging container, and diluted with purified water or dialysis water to make the above-mentioned concentration during use.
(5)液体状态的制剂的制备方法：主要由氯化钠、氯化钾、氯化钙、氯化镁、马来酸、柠檬酸、碳酸氢钠、葡萄糖组成，过筛，混合后封存于包装容器中，使用时用纯化水或透析用水溶解并稀释制成上述浓度；(5) Preparation method of liquid preparations: mainly composed of sodium chloride, potassium chloride, calcium chloride, magnesium chloride, maleic acid, citric acid, sodium bicarbonate, glucose, sieved, and sealed in a packaging container after mixing In use, use purified water or dialysis water to dissolve and dilute to make the above concentration;
(6)液体状态的制剂的制备方法：主要由氯化钠、氯化钾、氯化钙、氯化镁、琥珀酸、柠檬酸、碳酸氢钠、葡萄糖组成，过筛，混合后封存于包装容器中，使用时用纯化水或透析用水溶解并稀释制成上述浓度；(6) Preparation method of liquid preparations: mainly composed of sodium chloride, potassium chloride, calcium chloride, magnesium chloride, succinic acid, citric acid, sodium bicarbonate, glucose, sieved, mixed and sealed in a packaging container , When used, dissolve and dilute with purified water or dialysis water to make the above concentration;
上述血液净化浓缩物在用于制备血液净化治疗器械中的应用Application of the above-mentioned blood purification concentrate in the preparation of blood purification treatment devices
本发明的优点Advantages of the invention
1、本发明用富马酸、马来酸、琥珀酸与柠檬酸共同作为碳酸氢盐血液净化浓缩物的酸碱调节剂，能很好的调节酸碱度，达到稳定的PH值，相互作用，有效的防止了钙、镁离子与碳酸根离子结合产生沉淀。形成稳定的透析溶液。预防凝血，达到安全的治疗作用1. In the present invention, fumaric acid, maleic acid, succinic acid and citric acid are used together as the acid-base regulator of bicarbonate blood purification concentrate, which can well adjust the pH, reach a stable PH value, interact and be effective It prevents calcium and magnesium ions from combining with carbonate ions to produce precipitation. A stable dialysis solution is formed. Prevent blood clotting and achieve safe treatment
2、本发明是一种无醋酸血液净化浓缩物，与传统的含有醋酸根血液净化浓缩物相比，完全克服了在治疗过程中由醋酸根引起的并发症。2. The present invention is an acetic acid-free blood purification concentrate. Compared with traditional blood purification concentrates containing acetate, it completely overcomes the complications caused by acetate during the treatment process.
3、本发明中使用的富马酸、马来酸、琥珀酸和柠檬酸，是三羧酸循环中的重要物质，是人体代谢的重要中间体，不在肝脏内代谢，在医药和食品领域己有广泛的应用，防止酸中毒的起着重要缓冲作用。3. The fumaric acid, maleic acid, succinic acid and citric acid used in the present invention are important substances in the tricarboxylic acid cycle and important intermediates of human metabolism. They are not metabolized in the liver. They have been used in the fields of medicine and food. It has a wide range of applications and plays an important role in preventing acidosis.
凡是属于本发明的技术方案所引伸出的显而易见的变化或变动仍处于本发明的保护范围之列。Any obvious changes or changes derived from the technical solutions of the present invention are still within the protection scope of the present invention.

Claims (9)

  1. 一种血液净化浓缩物，其为固体状态的制剂或液体状态的制剂，其特征在于，该血液净化浓缩物中含有酸碱调节剂；所述酸碱调节剂为富马酸或马来酸、琥珀酸中的一种或两种、及三种与柠檬酸的混合物。A blood purification concentrate, which is a solid preparation or a liquid preparation, characterized in that the blood purification concentrate contains an acid-base regulator; the acid-base regulator is fumaric acid or maleic acid, One or two of succinic acid, and a mixture of three and citric acid.
  2. 根据权利要求1所述的血液净化浓缩物，其特征在于，所述酸碱调节剂为富马酸与柠檬酸的混合物。The blood purification concentrate according to claim 1, wherein the acid-base regulator is a mixture of fumaric acid and citric acid.
  3. 根据权利要求1所述的血液净化浓缩物，其特征在于，所述酸碱调节剂为马来酸与柠檬酸的混合物。The blood purification concentrate according to claim 1, wherein the acid-base regulator is a mixture of maleic acid and citric acid.
  4. 根据权利要求1所述的血液净化浓缩物，其特征在于，所述酸碱调节剂为琥珀酸与柠檬酸的混合物。The blood purification concentrate according to claim 1, wherein the acid-base regulator is a mixture of succinic acid and citric acid.
  5. 根据权利要求5所述的血液净化浓缩物，其特征在于，该血液净化浓缩物为血液透析、血液滤过、血液透析滤过或腹膜透析用制剂。The blood purification concentrate according to claim 5, wherein the blood purification concentrate is a preparation for hemodialysis, hemofiltration, hemodiafiltration or peritoneal dialysis.
  6. 根据权利要求1-5所述的血液净化浓缩物，其特征在于，所述液体状态和固体状态的制剂，其临床应用的浓度为：Na+100.0～145.0mmol/L、K+0.0～4.5mmol/L、Ca2+0.5～2.5mmol/L、Mg2+0.20～1.5mmol/L、Cl—90.0～120.0mmol/L、富马酸0.1～10.0mmol/L、柠檬酸0.1～10.0mmol/L、马来酸0.1～10.0mmol/L、琥珀酸0.1～10.0mmol/L、HCO3-25.0～40.0mmol/L、葡萄糖0.0～15.0mmol/L。The blood purification concentrate according to claims 1-5, wherein the liquid state and solid state preparations have a clinical application concentration of: Na+100.0-145.0mmol/L, K+0.0-4.5mmol /L, Ca2+0.5～2.5mmol/L, Mg2+0.20～1.5mmol/L, Cl-90.0～120.0mmol/L, fumaric acid 0.1～10.0mmol/L, citric acid 0.1～10.0mmol/L, horse Lyric acid 0.1-10.0mmol/L, succinic acid 0.1-10.0mmol/L, HCO3-25.0-40.0mmol/L, glucose 0.0-15.0mmol/L.
  7. 根据权利要求1-5所述的血液净化浓缩物，其特征在于，所述液体状态和固体状态的制剂，其临床应用的浓度为：Na+100.0～145.0mmol/L、K+0.0～4.5mmol/L、Ca2+0.5～2.5mmol/L、Mg2+0.20～1.5mmol/L、Cl—90.0～120.0mmol/L、富马酸0.1～10.0mmol/L、柠檬酸0.1～10.0mmol/L、马来酸0.1～10.0mmol/L、琥珀酸0.1～10.0mmol/L、HCO3-25.0～40.0mmol/L、葡萄糖0.0～15.0mmol/L。The blood purification concentrate according to claims 1-5, wherein the liquid state and solid state preparations have a clinical application concentration of: Na+100.0-145.0mmol/L, K+0.0-4.5mmol /L, Ca2+0.5～2.5mmol/L, Mg2+0.20～1.5mmol/L, Cl-90.0～120.0mmol/L, fumaric acid 0.1～10.0mmol/L, citric acid 0.1～10.0mmol/L, horse Lyric acid 0.1-10.0mmol/L, succinic acid 0.1-10.0mmol/L, HCO3-25.0-40.0mmol/L, glucose 0.0-15.0mmol/L.
  8. 一种制备如权利要求1至7任一权利要求所述的血液净化浓缩物的方法，其特征在于，包括如下步骤：A method for preparing the blood purification concentrate according to any one of claims 1 to 7, characterized in that it comprises the following steps:
    (1)固体状态的制剂的制备方法：主要由氯化钠、氯化钾、氯化钙、氯化镁、富马酸或马来酸或琥珀酸、柠檬酸、碳酸氢钠、葡萄糖组成，经过筛，混合后封存于包装容器中，使用时用纯化水或透析用水溶解并稀释制成上述浓度；(1) Preparation method of solid state preparations: mainly composed of sodium chloride, potassium chloride, calcium chloride, magnesium chloride, fumaric acid or maleic acid or succinic acid, citric acid, sodium bicarbonate, and glucose. , Sealed in a packaging container after mixing, dissolved and diluted with purified water or dialysis water to make the above concentration;
    (2)液体状态的制剂的制备方法：主要由氯化钠、氯化钾、氯化钙、氯化镁、富马酸或马来酸或琥珀酸、柠檬酸、碳酸氢钠、葡萄糖、纯化水或透析用水组成，经溶解过滤后灌装于包装容器中，使用时用纯化水或透析用水稀释制成上述浓度。(2) Preparation method of liquid preparations: mainly composed of sodium chloride, potassium chloride, calcium chloride, magnesium chloride, fumaric acid or maleic acid or succinic acid, citric acid, sodium bicarbonate, glucose, purified water or It is composed of water for dialysis, which is filled in a packaging container after dissolution and filtration, and diluted with purified water or water for dialysis to make the above concentration during use.
  9. 权利要求1至9任一权利要求所述的血液净化浓缩物在用于制备血液净化治疗器械中的应用。The use of the blood purification concentrate according to any one of claims 1 to 9 in the preparation of blood purification treatment devices.
PCT/CN2021/092064 2020-05-08 2021-05-07 Blood purification concentrate WO2021223732A1 (en)

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1938058A (en) * 2004-03-30 2007-03-28 尼普洛株式会社 Solid pharmaceutical preparation for dialysis
CN101084878A (en) * 2006-06-09 2007-12-12 桂保松 Blood dialysate dry powder containing citrate
CN101366710A (en) * 2007-08-16 2009-02-18 北京信东联创生物技术有限公司 Medicinal composition for haemofiltration or hemodialysis
CN108066356A (en) * 2018-02-05 2018-05-25 济泰（上海）生物科技有限公司 A kind of haemodialysis concentrate
CN111603479A (en) * 2020-05-08 2020-09-01 夏永彪 Blood purification concentrate

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1938058A (en) * 2004-03-30 2007-03-28 尼普洛株式会社 Solid pharmaceutical preparation for dialysis
CN101084878A (en) * 2006-06-09 2007-12-12 桂保松 Blood dialysate dry powder containing citrate
CN101366710A (en) * 2007-08-16 2009-02-18 北京信东联创生物技术有限公司 Medicinal composition for haemofiltration or hemodialysis
CN108066356A (en) * 2018-02-05 2018-05-25 济泰（上海）生物科技有限公司 A kind of haemodialysis concentrate
CN111603479A (en) * 2020-05-08 2020-09-01 夏永彪 Blood purification concentrate

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