WO2021233432A1 - 一种血液净化分子浓缩物及其制备方法与应用 - Google Patents

一种血液净化分子浓缩物及其制备方法与应用 Download PDF

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WO2021233432A1
WO2021233432A1 PCT/CN2021/095226 CN2021095226W WO2021233432A1 WO 2021233432 A1 WO2021233432 A1 WO 2021233432A1 CN 2021095226 W CN2021095226 W CN 2021095226W WO 2021233432 A1 WO2021233432 A1 WO 2021233432A1
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acid
citrate
blood purification
chloride
preparation
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夏永彪
冯克民
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夏永彪
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    • 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
    • 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
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • 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

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  • the invention relates to a preparation and a preparation method and application thereof, in particular to a blood purification molecular 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 metabolizes the liver, increases the burden on the liver, stimulates the liver, and brings other clinical pathological manifestations. Molecular substances play an important role in the prevention of dialysis complications, which can prevent dialysis hyperparathyroidism and prevent the occurrence of metastatic calcification. Therefore, the replacement of acetic acid by a certain acid has become an urgent problem in dialysis, and the emergence of acetic acid-free blood purification molecular 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 of hemodialysis non-acetic acid molecular concentrate.
  • the blood purification molecular concentrate solves the shortcoming of no molecular substances in the current commonly used dialysis concentrates.
  • the invention is The acid-base regulator used is a physiological organic acid, or physiologically essential acid, and it exists in most fruits and foods in nature, 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 molecular concentrate.
  • the blood purification molecular concentrate which is a solid preparation or a liquid preparation, is characterized in that the blood purification molecular concentrate contains an acid-base regulator and a substance in molecular form; the acid-base regulator One or two of L-malic acid, DL-malic acid, maleic acid, fumaric acid, succinic acid, calcium citrate or sodium citrate, magnesium citrate, potassium citrate, and A variety of mixtures.
  • the above-mentioned blood purification molecular concentrate is a preparation for hemodialysis, hemofiltration, hemodiafiltration or peritoneal dialysis.
  • the above-mentioned blood purification molecular concentrate, the preparations in the liquid state and the solid state, the weight of the clinical application is: sodium chloride 55%-92%, potassium chloride 0-3%, magnesium chloride 0.1%-2%, chlorinated Calcium 0.1%-5%, L-malic acid 0.1%-15%, DL-malic acid 0.1%-10%, maleic acid 0.1%-15%, fumaric acid 0.1%-15%, succinic acid 0.1%-15 %, calcium citrate 0.1-10%, sodium citrate 0.1-20%, potassium citrate 0.1-20%, magnesium citrate 0.1-20%, glucose 1%-25%.
  • the above blood purification molecular concentrate, the liquid state and solid state preparations, the clinical application concentration 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, L-malic acid 0.1 ⁇ 10.0mmol/L, DL-malic acid 0.1 ⁇ 10.0mmol/L, maleic acid 0.1 ⁇ 10.0mmol/L , Fumaric acid 0.1 ⁇ 10.0mmol/L, Succinic acid 0.1 ⁇ 10.0mmol/L, Calcium citrate 0.1 ⁇ 10.0mmol/L, Sodium citrate 0.1 ⁇ 10.0mmol/L, Potassium citrate 0.1 ⁇ 10.0mmol /L, magnesium citrate 0.1-10.0mmol/L, HCO3-25.0-40.0mmol/L, glucose 0.0-15.0mmol/L.
  • Preparation method of solid state preparation mainly composed of sodium chloride, potassium chloride, calcium chloride, magnesium chloride, L-malic acid, DL-malic acid, maleic acid, fumaric acid, succinic acid, citric acid It is composed of calcium, sodium citrate, magnesium citrate, potassium citrate, sodium bicarbonate, and glucose. It is sieved, mixed and sealed in a packaging container. When used, it is dissolved and diluted with purified water or dialysis water to make the above concentration ;
  • Preparation method of liquid preparations mainly composed of sodium chloride, potassium chloride, calcium chloride, magnesium chloride, L-malic acid, DL-malic acid, maleic acid, fumaric acid, succinic acid, citric acid It is composed of calcium, sodium citrate, magnesium citrate, potassium citrate, sodium bicarbonate, glucose, purified water or dialysis water. After dissolving and filtering, it is filled in a packaging container and used with purified water or dialysis water Dilute to make the above concentration.
  • the present invention uses L-malic acid, DL-malic acid, maleic acid, fumaric acid, succinic acid, calcium citrate, sodium citrate, magnesium citrate, potassium citrate, sodium bicarbonate, As the acid-base regulator and molecular substance of bicarbonate blood purification molecular concentrate, it can well adjust the pH, reach a stable pH value, maintain osmotic pressure and solution balance, interact, prevent dialysis hyperparathyroidism and metastasis The occurrence of calcification effectively prevents calcium and magnesium ions from combining with carbonate ions to produce precipitation, forming a stable dialysis solution. Prevent blood clotting and achieve safe treatment
  • the present invention is a molecular concentrate for blood purification without acetic acid. Compared with the traditional hemodialysis solution containing acetate and molecular-free, it completely overcomes the complications caused by acetate and the pathology of molecular-free substances in the treatment process. Performance.

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Abstract

一种血液净化分子浓缩物，其为固体状态的制剂或液体状态的制剂，含有酸碱调节剂和以分子形式存在的物质，所述酸碱调节剂为L-苹果酸、DL--苹果酸、马来酸、富马酸、琥珀酸与枸橼酸钙、枸橼酸钠、枸橼酸镁、枸橼酸钾的一种或两种或多种混合物。

Description

一种血液净化分子浓缩物及其制备方法与应用 技术领域
本发明涉及一种制剂及其制备方法与应用，尤其涉及一种血液净化分子浓缩物及其制备方法与应用，属医疗器械技术领域。
背景技术
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。
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分子浓缩物中分子物质和酸碱调节剂在透析中没有得到重视，分子物质和酸碱调节剂是溶液平衡的重要组成部分，对调节渗透压、预防凝血，维持酸碱度，调节PH值、预防转移性钙化及钙结晶起着非常重要的作用，而目前透析普遍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，分子物质在透析并发症的预防方面起着重要作用，可以预防透析性甲旁亢和预防转移性钙化的发生，因此，由某种酸替代醋酸成为透析急需要解决的问题，无醋酸血液净化分子浓缩物的出现也成为必然。
发明内容
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无醋酸分子浓缩物，该血液净化分子浓缩物解决了目前常用透析浓缩物中没有分子物质的缺点，发明中所用酸碱调节剂为生理有机酸，或者说生理必需酸，而且其存在于自然界的大部分果食中，在食品添加与医学上有广泛的应用。
本发明进一步提供该血液净化分子浓缩物的制备方法与应用。
本发明所述技术问题是由以下技术方案实现的。
该种血液净化分子浓缩物，其为固体状态的制剂或液体状态的制剂，其特征在于，该血液净化分子浓缩物中含有酸碱调节剂和以分子形式存在的物质；所述酸碱调节剂为L-苹果酸、DL-苹果酸、马来酸、富马酸、琥珀酸与枸橼酸钙或枸橼酸钠、枸橼酸镁、枸橼酸钾的的一种或两种、及多种混合物。
上述血液净化分子浓缩物为血液透析、血液滤过、血液透析滤过或腹膜透析用制剂。
上述血液净化分子浓缩物，所述液体状态和固体状态的制剂，其临床应用的重量为：氯化钠55％-92％、氯化钾0-3％、氯化镁0.1％-2％、氯化钙0.1％-5％、L-苹果酸0.1％-15％、 DL-苹果酸0.1～10％、马来酸0.1％-15％、富马酸0.1％-15％、琥珀酸0.1％-15％、枸橼酸钙0.1～10％、枸橼酸钠0.1～20％、枸橼酸钾0.1～20％、枸橼酸镁0.1～20％、葡萄糖1％-25％。
上述血液净化分子浓缩物，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、L-苹果酸0.1～10.0mmol/L、DL-苹果酸0.1～10.0mmol/L、马来酸0.1～10.0mmol/L、富马酸0.1～10.0mmol/L、琥珀酸0.1～10.0mmol/L、枸橼酸钙0.1～10.0mmol/L、枸橼酸钠0.1～10.0mmol/L、枸橼酸钾0.1～10.0mmol/L、枸橼酸镁0.1～10.0mmol/L、HCO3-25.0～40.0mmol/L、葡萄糖0.0～15.0mmol/L。
制备上述血液净化分子浓缩物的方法，步骤如下：
(1)固体状态制剂的制备方法：主要由氯化钠、氯化钾、氯化钙、氯化镁、L-苹果酸、DL-苹果酸、马来酸、富马酸、琥珀酸、枸橼酸钙、枸橼酸钠、枸橼酸镁、枸橼酸钾、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；
(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、L-苹果酸、DL-苹果酸、马来酸、富马酸、琥珀酸、枸橼酸钙、枸橼酸钠、枸橼酸镁、枸橼酸钾、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。
上述血液净化分子浓缩物在用于制备血液净化治疗器械中的应用
本发明的优点
1、本发明用L-苹果酸、DL-苹果酸、马来酸、富马酸、琥珀酸、枸橼酸钙、枸橼酸钠、枸橼酸镁、枸橼酸钾、碳酸氢钠、作为碳酸氢盐血液净化分子浓缩物的酸碱调节剂和分子物质，能很好的调节酸碱度，达到稳定的PH值，维持渗透压和溶液平衡，相互作用，预防透析性甲旁亢和转移性钙化的发生，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
2、本发明是一种无醋酸血液净化分子浓缩物，与传统的含有醋酸根和无分子血液透析液相比，完全克服了在治疗过程中由醋酸根引起的并发症和无分子物质的病理表现。
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。

Claims (6)

  1. 一种血液净化分子浓缩物，其为固体状态的制剂或液体状态的制剂，其特征在于，该血液净化分子浓缩物中含有酸碱调节剂和以分子形式存在的物质；所述酸碱调节剂为L-苹果酸、DL--苹果酸、马来酸、富马酸、琥珀酸与枸橼酸钙、枸橼酸钠、枸橼酸镁、枸橼酸钾的一种或两种或多种混合物。
  2. 根据权利要求1所述的血液净化分子浓缩物，其特征在于，该血液净化分子浓缩物为血液透析、血液滤过、血液透析滤过或腹膜透析用制剂。
  3. 根据权利要求1-2所述的血液净化分子浓缩物，其特征在于，所述液体状态和固体状态的制剂，其临床应用的重量为：氯化钠55％-92％、氯化钾0-3％、氯化镁0.1％-2％、氯化钙0.1％-5％、L-苹果酸0.1％-15％、DL-苹果酸0.1％-15％、马来酸0.1％-15％、富马酸0.1％-15％、琥珀酸0.1％-15％、枸橼酸钙0.1～10％、枸橼酸钠0.1～20％、枸橼酸钾0.1～20％、枸橼酸镁0.1～20％、葡萄糖1％-25％。
  4. 根据权利要求1-2所述的血液净化分子浓缩物，其特征在于，所述液体状态和固体状态的制剂，其临床应用的溶质浓度为：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、L-苹果酸0.1～10.0mmol/L、DL-苹果酸0.1～10.0mmol/L、马来酸0.1～10.0mmol/L、富马酸0.1～10.0mmol/L、琥珀酸0.1～10.0mmol/L枸橼酸钙0.1～10.0mmol/L、枸橼酸钠0.1～10.0mmol/L、枸橼酸钾0.1～10.0mmol/L、枸橼酸镁0.1～10.0mmol/L、HCO3-25.0～40.0mmol/L、葡萄糖0.0～15.0mmol/L。
  5. 一种制备如权利要求1至4任一权利要求所述的血液净化分子浓缩物的方法，其特征在于，包括如下步骤：
    (1)固体状态制剂的制备方法：主要由氯化钠、氯化钾、氯化钙、氯化镁、L-苹果酸、DL-苹果酸、马来酸、富马酸、琥珀酸、枸橼酸钙、枸橼酸钠、枸橼酸镁、枸橼酸钾、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；
    (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、L-苹果酸、DL-苹果酸、马来酸、富马酸、琥珀酸、枸橼酸钙、枸橼酸钠、枸橼酸镁、枸橼酸钾、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。
  6. 权利要求1至5任一权利要求所述的血液净化分子浓缩物在用于制备血液净化治疗器械中的应用。
PCT/CN2021/095226 2020-05-22 2021-05-21 一种血液净化分子浓缩物及其制备方法与应用 WO2021233432A1 (zh)

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