CN116056715A

CN116056715A - Blood purification concentrate

Info

Publication number: CN116056715A
Application number: CN202180032037.0A
Authority: CN
Inventors: 冯克民; 夏永彪
Original assignee: Individual
Current assignee: Individual
Priority date: 2020-05-08
Filing date: 2021-05-07
Publication date: 2023-05-02
Also published as: WO2021223732A1; CN111603479A

Abstract

A non-acetic acid blood purification concentrate is solid or liquid preparation, wherein the acid-base regulator is one or two or three of fumaric acid, maleic acid and succinic acid and citric acid.

Description

Blood purification concentrate

Technical Field

The invention relates to a preparation, a preparation method and application thereof, in particular to a blood purification concentrate, a preparation method and application thereof, and belongs to the technical field of medical appliances.

Background

The blood purification is to draw the blood of the patient out of the body and remove pathogenic substances or wastes in the blood by a purification device so as to purify the blood and achieve the purpose of treating diseases. The blood purification comprises treatment technologies such as hemodialysis, hemofiltration, hemodiafiltration and peritoneal dialysis, and 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 related to multiple subjects, and can be used for treating various cross-subject diseases such as nephropathy, hematopathy, hyperlipidemia, drug poisoning, continuous renal replacement therapy and the like.

Currently, blood purification technology is widely used, but bicarbonate blood purification concentrate is used for regulating the pH value to enable dialysate to reach a proper pH range, a certain amount of acetic acid or glacial acetic acid is needed to be added to prevent calcium ions and magnesium ions from being combined with carbonate ions to generate precipitation, acetate ions generated by the acetic acid or glacial acetic acid in dialysis solution are related to a plurality of complications of dialysis and post-dialysis patients, and as acetate can stimulate the body 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 of a plurality of dialysis complications, and acetic acid also affects phosphorus metabolism of dialysis patients and is one of the pathogenesis causes of chronic hyperphosphatemia. Meanwhile, acetic acid is metabolized in the liver, the burden of the liver is increased, the liver is stimulated, and other clinical pathological manifestations are brought, so that the substitution of certain acid for acetic acid becomes a problem to be solved in urgent dialysis, and the appearance of an acetic acid-free blood purification concentrate becomes necessary.

Disclosure of Invention

The invention aims to overcome the defects of the prior art and provide a hemodialysis concentrate with a brand new concept, which solves the defects of acid-base regulators in the conventional hemodialysis concentrate, wherein the acid-base regulator is a physiological organic acid or a physiological essential acid, is in foods such as beef, fungus and the like, and has wide application in food addition and medicine.

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

The technical problems are realized by the following technical scheme.

The blood purification concentrate is a preparation in a solid state or a preparation in a liquid state, and contains an acid-base regulator; the acid-base modifier is one or two of fumaric acid, maleic acid and succinic acid, and the mixture of the three acids and citric acid.

The blood purification concentrate is a preparation for hemodialysis, hemofiltration, hemodiafiltration or peritoneal dialysis.

The blood purification concentrate, the liquid state preparation has the following clinical application concentration: na+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, fumaric acid 0.1-10.0 mmol/L, citric acid 0.1-10.0 mmol/L, maleic acid 0.1-10.0 mmol/L, succinic acid 0.1-10.0 mmol/L, citric acid 0.1-10.0 mmol/L, HCO 3-25.0-40.0 mmol/L, and glucose 0.0-15.0 mmol/L.

The preparation method of the blood purification concentrate comprises the following steps:

(1) The preparation method of the solid state preparation comprises the following steps: the preparation method mainly comprises the steps of sieving sodium chloride, potassium chloride, calcium chloride, magnesium chloride, fumaric acid, citric acid, sodium bicarbonate and glucose, mixing, sealing in a packaging container, dissolving with purified water or dialysis water and diluting to obtain the concentration;

(2) The preparation method of the solid state preparation comprises the following steps: the preparation method mainly comprises the steps of sieving sodium chloride, potassium chloride, calcium chloride, magnesium chloride, maleic acid, citric acid, sodium bicarbonate and glucose, mixing, sealing in a packaging container, dissolving with purified water or dialysis water and diluting to obtain the concentration;

(3) The preparation method of the solid state preparation comprises the following steps: mainly comprises sodium chloride, potassium chloride, calcium chloride, magnesium chloride, succinic acid, citric acid, sodium bicarbonate and glucose, and is prepared by sieving, mixing, sealing in a packaging container, dissolving with purified water or dialysis water, and diluting to obtain the above concentration;

(4) The preparation method of the liquid state preparation comprises the following steps: the concentration is mainly composed of sodium chloride, potassium chloride, calcium chloride, magnesium chloride, fumaric acid, citric acid, sodium bicarbonate, glucose, purified water or dialysis water, and is prepared by dissolving, filtering, filling into a packaging container, and diluting with purified water or dialysis water when in use.

(5) The preparation method of the liquid state preparation comprises the following steps: the preparation method mainly comprises the steps of sieving sodium chloride, potassium chloride, calcium chloride, magnesium chloride, maleic acid, citric acid, sodium bicarbonate and glucose, mixing, sealing in a packaging container, dissolving with purified water or dialysis water and diluting to obtain the concentration;

(6) The preparation method of the liquid state preparation comprises the following steps: mainly comprises sodium chloride, potassium chloride, calcium chloride, magnesium chloride, succinic acid, citric acid, sodium bicarbonate and glucose, and is prepared by sieving, mixing, sealing in a packaging container, dissolving with purified water or dialysis water, and diluting to obtain the above concentration;

application of blood purification concentrate in preparing blood purification therapeutic equipment

THE ADVANTAGES OF THE PRESENT INVENTION

1. The invention uses fumaric acid, maleic acid, succinic acid and citric acid as the acid-base regulator of the bicarbonate blood purification concentrate, can well regulate the pH value, achieves stable pH value, and effectively prevents the combination of calcium ions, magnesium ions and carbonate ions from generating precipitation. A stable dialysis solution is formed. Preventing coagulation and achieving safe treatment effect

2. Compared with the traditional blood purification concentrate containing acetate, the acetic acid-free blood purification concentrate completely overcomes the complications caused by acetate in the treatment process.

3. The fumaric acid, the maleic acid, the succinic acid and the citric acid used in the invention are important substances in tricarboxylic acid circulation, are important intermediates for metabolism of human bodies, are not metabolized in livers, have wide application in the fields of medicines and foods, and play an important role in buffering for preventing acidosis.

All obvious changes or modifications which come within the spirit of the invention are desired to be protected.

Claims

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 modifier is one or two of fumaric acid, maleic acid and succinic acid, and the mixture of the three acids and citric acid.
The blood purification concentrate of claim 1, wherein the acid-base modifier is a mixture of fumaric acid and citric acid.
The blood purification concentrate of claim 1, wherein the acid-base modifier is a mixture of maleic acid and citric acid.
The blood purification concentrate of claim 1, wherein the acid-base modifier is a mixture of succinic acid and citric acid.
The blood purification concentrate of claim 5, wherein the blood purification concentrate is a hemodialysis, hemofiltration, hemodiafiltration or peritoneal dialysis preparation.
The blood purification concentrate of claims 1-5, wherein the liquid and solid state formulations are used in a clinical concentration of: na+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, fumaric acid 0.1-10.0 mmol/L, citric acid 0.1-10.0 mmol/L, maleic acid 0.1-10.0 mmol/L, succinic acid 0.1-10.0 mmol/L, HCO 3-25.0-40.0 mmol/L, glucose 0.0-15.0 mmol/L.
The blood purification concentrate of claims 1-5, wherein the liquid and solid state formulations are used in a clinical concentration of: na+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, fumaric acid 0.1-10.0 mmol/L, citric acid 0.1-10.0 mmol/L, maleic acid 0.1-10.0 mmol/L, succinic acid 0.1-10.0 mmol/L, HCO 3-25.0-40.0 mmol/L, glucose 0.0-15.0 mmol/L.
A method of preparing a blood purification concentrate according to any one of claims 1 to 7, comprising the steps of:

(1) The preparation method of the solid state preparation comprises the following steps: the preparation method mainly comprises the steps of sieving sodium chloride, potassium chloride, calcium chloride, magnesium chloride, fumaric acid or maleic acid or succinic acid, citric acid, sodium bicarbonate and glucose, mixing, sealing in a packaging container, dissolving with purified water or dialysis water and diluting to obtain the concentration;

(2) The preparation method of the liquid state preparation comprises the following steps: the concentration is 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 dialysis water, and is prepared by dissolving, filtering, filling into a packaging container, and diluting with purified water or dialysis water when in use.
Use of a blood purification concentrate according to any one of claims 1 to 9 for the preparation of a blood purification therapeutic apparatus.