CN111714515A

CN111714515A - Blood purification molecule concentrate and preparation method and application thereof

Info

Publication number: CN111714515A
Application number: CN202010446821.3A
Authority: CN
Inventors: 冯克民; 夏永彪
Original assignee: Individual
Current assignee: Individual
Priority date: 2020-05-22
Filing date: 2020-05-22
Publication date: 2020-09-29
Also published as: CN115811988A; WO2021233432A1

Abstract

A blood purification molecule concentrate, a preparation method and application thereof, belonging to the technical field of medical instruments. The invention relates to a blood purification molecule concentrate, which is a molecular substance-free acetic acid-free concentrate with a brand-new concept, is used for overcoming the defects of the prior art, and solves the defect that no molecular substance exists in the conventional dialysis concentrate. The invention has the technical characteristics that: the concentrate is a solid or liquid preparation, and contains pH regulator and molecular substances selected from one or two or more of L-malic acid, DL-malic acid, maleic acid, fumaric acid, succinic acid, and calcium citrate or sodium citrate, magnesium citrate, and potassium citrate.

Description

Blood purification molecule concentrate and preparation method and application thereof

Technical Field

The invention relates to a preparation, 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 instruments.

Background

Blood purification is to draw the patient's blood out of the body and pass through a purification device to remove pathogenic substances or waste in the blood and purify the blood to achieve the purpose of treating diseases. The blood purification includes treatment technologies such as hemodialysis, hemofiltration, hemodiafiltration and peritoneal dialysis, at present, the application of the blood purification technology is not only used for treating acute and chronic renal failure and uremia, but also becomes an important life science relating to multiple disciplines, and the blood purification technology can be used for treating various cross-discipline diseases such as nephropathy, hematopathy, hyperlipidemia, drug poisoning, continuous renal replacement therapy and the like.

At present, blood purification technology is widely applied, but molecular substances and acid-base regulators in bicarbonate blood purification molecular concentrates are not taken into consideration in dialysis, the molecular substances and the acid-base regulators are important components of solution balance and play very important roles in regulating osmotic pressure, preventing blood coagulation, maintaining pH value, regulating pH value and preventing metastatic calcification and calcium crystallization, a certain amount of acetic acid or glacial acetic acid is generally added in dialysis at present, acetate ions generated in the dialysis solution by the acetic acid or the glacial acetic acid are related to a plurality of complications of patients in and after dialysis, and as the acetate can stimulate the organism to release a plurality of active cytokines, such as PNF/PGE2, IL-1 and the like, the active factors play an important role in the pathology aspect of a plurality of dialysis complications, the acetic acid also influences the phosphorus metabolism of the dialysis patients, is one of the causes of chronic hyperphosphatemia. Meanwhile, acetic acid is metabolized in the liver, the burden of the liver is increased, the liver is stimulated, other clinical pathological manifestations are brought, molecular substances play an important role in the prevention of dialysis complications, dialysis hyperthyroidism can be prevented, and occurrence of metastatic calcification can be prevented, so that the problem that the dialysis needs to be solved urgently is solved by replacing acetic acid with certain acid, and the occurrence of acetic acid-free blood purification molecular concentrates is inevitable.

Disclosure of Invention

The invention aims to solve the technical problem of overcoming the defects of the prior art and providing a novel concept of hemodialysis acetic acid-free molecular concentrate, the blood purification molecular concentrate overcomes the defect that no molecular substance exists in the conventional dialysis concentrate, and the acid-base regulator used in the invention is a physiological organic acid or a physiologically necessary acid, exists in most fruit foods in the nature and has wide application in food addition and medicine.

The invention further provides a preparation method and application of the blood purification molecule concentrate.

The technical problem of the invention is realized by the following technical scheme.

The blood purification molecule concentrate is a solid preparation or a liquid preparation, and is characterized in that the blood purification molecule concentrate contains an acid-base regulator and a substance existing in a molecular form; the acid-base regulator is one or two or a mixture of L-malic acid, DL-malic acid, maleic acid, fumaric acid, succinic acid and calcium citrate or sodium citrate, magnesium citrate and potassium citrate.

The blood purification molecule concentrate is used for hemodialysis, hemofiltration, hemodiafiltration or peritoneal dialysis.

The blood purification molecule concentrate, the liquid state preparation and the solid state preparation have the following clinical application weights: 55-92% of sodium chloride, 0-3% of potassium chloride, 0.1-2% of magnesium chloride, 0.1-5% of calcium chloride, 0.1-15% of L-malic acid, 0.1-10% of DL-malic acid, 0.1-15% of maleic acid, 0.1-15% of fumaric acid, 0.1-15% of succinic acid, 0.1-10% of calcium citrate, 0.1-20% of sodium citrate, 0.1-20% of potassium citrate, 0.1-20% of magnesium citrate and 1-25% of glucose.

The blood purification molecule concentrate, the liquid state preparation and the solid state preparation have the clinically applied concentrations as follows: 100.0-145.0 mmol/L, K + 0.0-4.5 mmol/L, Ca2+ 0.5-2.5 mmol/L, Mg2+ 0.20-1.5 mmol/L, Cl-90.0-120.0 mmol/L, L-0.1-10.0 mmol/L, DL-0.1-10.0 mmol/L malic acid, 0.1-10.0 mmol/L maleic acid, 0.1-10.0 mmol/L fumaric acid, 0.1-10.0 mmol/L succinic acid, 0.1-10.0 mmol/L calcium citrate, 0.1-10.0 mmol/L sodium citrate, 0.1-10.0 mmol/L potassium citrate, 0.1-10.0 mmol/L magnesium citrate, 0.1-10.0 mmol/L, HCO 3-25.0-40.0 mmol/L glucose, 0-15.0 mmol/L glucose.

The method for preparing the blood purification molecule concentrate comprises the following steps:

(1) the preparation method of the solid preparation comprises the following steps: mainly comprises sodium chloride, potassium chloride, calcium chloride, magnesium chloride, L-malic acid, DL-malic acid, maleic acid, fumaric acid, succinic acid, calcium citrate, sodium citrate, magnesium citrate, potassium citrate, sodium bicarbonate and glucose, is screened, mixed and sealed in a packaging container, and is dissolved and diluted by purified water or dialysis water when in use to prepare the concentration;

(2) the preparation method of the liquid preparation comprises the following steps: mainly comprises sodium chloride, potassium chloride, calcium chloride, magnesium chloride, L-malic acid, DL-malic acid, maleic acid, fumaric acid, succinic acid, calcium citrate, sodium citrate, magnesium citrate, potassium citrate, sodium bicarbonate, glucose, purified water or dialysis water, is filled into a packaging container after being dissolved and filtered, and is diluted by purified water or dialysis water when in use to prepare the concentration.

Application of blood purification molecular concentrate in preparation of blood purification therapeutic apparatus

THE ADVANTAGES OF THE PRESENT INVENTION

1. The invention uses L-malic acid, DL-malic acid, maleic acid, fumaric acid, succinic acid, calcium citrate, sodium citrate, magnesium citrate, potassium citrate, sodium bicarbonate, acid-base regulator and molecular substance as bicarbonate blood purification molecular concentrate, can well regulate the pH value, reach stable pH value, maintain osmotic pressure and solution balance, interact, prevent dialysis hyperthyroidism and metastatic calcification, effectively prevent calcium, magnesium ions and carbonate ions from combining to produce precipitation, form stable dialysis solution. Preventing blood coagulation and achieving safe treatment effect

2. The invention relates to an acetic acid-free blood purification molecule concentrate, which completely overcomes the complications caused by acetic acid radicals and the pathological manifestations of molecular-free substances in the treatment process compared with the traditional acetic acid radical-containing and molecular-free hemodialysis liquid.

All obvious changes and modifications which are obvious to the technical scheme of the invention are covered by the protection scope of the invention.

Claims

1. A blood purification molecule concentrate, which is a solid state preparation or a liquid state preparation, and is characterized in that the blood purification molecule concentrate contains an acid-base regulator and a substance existing in a molecular form; the acid-base regulator is one or the mixture of two or more of L-malic acid, DL-malic acid, maleic acid, fumaric acid, succinic acid, calcium citrate, sodium citrate, magnesium citrate and potassium citrate.

2. The blood purification molecule concentrate of claim 1, wherein the blood purification molecule concentrate is a preparation for hemodialysis, hemofiltration, hemodiafiltration, or peritoneal dialysis.

3. A blood purification molecule concentrate according to claims 1-2, wherein the liquid and solid formulations are in clinical use in the weight ratios: 55-92% of sodium chloride, 0-3% of potassium chloride, 0.1-2% of magnesium chloride, 0.1-5% of calcium chloride, 0.1-15% of L-malic acid, 0.1-15% of DL-malic acid, 0.1-15% of maleic acid, 0.1-15% of fumaric acid, 0.1-15% of succinic acid, 0.1-10% of calcium citrate, 0.1-20% of sodium citrate, 0.1-20% of potassium citrate, 0.1-20% of magnesium citrate and 1-25% of glucose.

4. A blood purification molecule concentrate according to claims 1-2, wherein the liquid and solid state formulations have clinically applied solute concentrations of: 100.0-145.0 mmol/L, K + 0.0-4.5 mmol/L, Ca2+ 0.5-2.5 mmol/L, Mg2+ 0.20-1.5 mmol/L, Cl-90.0-120.0 mmol/L, L-0.1-10.0 mmol/L, DL-0.1-10.0 mmol/L malic acid, 0.1-10.0 mmol/L maleic acid, 0.1-10.0 mmol/L fumaric acid, 0.1-10.0 mmol/L succinic acid, 0.1-10.0 mmol/L calcium citrate, 0.1-10.0 mmol/L sodium citrate, 0.1-10.0 mmol/L potassium citrate, 0.1-10.0 mmol/L magnesium citrate, 0.1-10.0 mmol/L, HCO 3-25.0-40.0 mmol/L citrate, and 0-15.0 mmol/L glucose.

5. A method of preparing a blood purification molecule concentrate according to any one of claims 1 to 4, comprising the steps of:

6. Use of the blood purification molecule concentrate of any one of claims 1 to 5 for the preparation of a blood purification therapeutic device.