CN117919274A - Hemodialysis concentrate - Google Patents

Hemodialysis concentrate Download PDF

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Publication number
CN117919274A
CN117919274A CN202410024290.7A CN202410024290A CN117919274A CN 117919274 A CN117919274 A CN 117919274A CN 202410024290 A CN202410024290 A CN 202410024290A CN 117919274 A CN117919274 A CN 117919274A
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hemodialysis
solution
concentration
supplement
hemodialysis concentrate
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张志伟
魏金金
邱国良
张伦宁
曹新民
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Rongjia Medical Technology Group Co ltd
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Rongjia Medical Technology Group Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/14Alkali metal chlorides; Alkaline earth metal chlorides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/194Carboxylic acids, e.g. valproic acid having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/4965Non-condensed pyrazines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7004Monosaccharides having only carbon, hydrogen and oxygen atoms
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/06Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/24Heavy metals; Compounds thereof
    • A61K33/26Iron; Compounds thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/06Antianaemics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/08Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system

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  • Life Sciences & Earth Sciences (AREA)
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  • Veterinary Medicine (AREA)
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  • Inorganic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
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  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Diabetes (AREA)
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  • Heart & Thoracic Surgery (AREA)
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  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The invention discloses a hemodialysis concentrate, which relates to the technical field of hemodialysis and comprises the following components: fluid a, fluid B and supplements; the solution A comprises: sodium chloride, potassium chloride, calcium chloride, magnesium chloride, and pH adjuster; the solution B comprises: sodium bicarbonate; the supplement comprises iron, ligustrazine, ketoglutaric acid, and glucose. The hemodialysis concentrate provided by the invention can be suitable for hemodialysis treatment of patients suffering from acute and chronic renal failure and drug poisoning, and has an excellent market prospect. The iron ions are supplemented into the hemodialysis concentrate by adding the components rich in the iron ions, so that the iron ions enter a human body to relieve anemia symptoms caused by blood loss caused by long-term ventilation treatment, and meanwhile, the hemodialysis concentrate can supplement nutrition, required elements, energy and the like for patients subjected to long-term dialysis, so that the effect of dialysis treatment is improved, and discomfort of the patients is relieved.

Description

Hemodialysis concentrate
Technical Field
The invention relates to the technical field of hemodialysis, in particular to a hemodialysis concentrate.
Background
Hemodialysis is a treatment form in which blood in a patient is led out of the body and then purified, pathogenic substances in the blood are removed to achieve the aim of purification, and then the blood is returned, and is commonly used for treating diseases such as aging, uremia, nephropathy, hyperlipidemia, drug poisoning and the like, and is a long-term treatment means for certain diseases.
The existing hemodialysis concentrate can filter and purify harmful substances, has certain gain, is difficult to avoid blood loss in the long-term hemodialysis process, and can cause problems once the transfusion quantity of blood is reduced, for example, when beneficial substances such as iron ions, nutrient substances and the like contained in the blood are reduced, the corresponding patients can suffer from anemia, malnutrition and other complications after multiple times of dialysis, and the pain of the patients is increased.
Disclosure of Invention
The present invention aims to solve at least one of the technical problems of the prior art and to provide a hemodialysis concentrate.
The technical scheme of the invention is as follows:
a hemodialysis concentrate comprising the following components: fluid a, fluid B and supplements;
The solution A comprises: sodium chloride, potassium chloride, calcium chloride, magnesium chloride, and pH adjuster;
the solution B comprises: sodium bicarbonate;
the supplement comprises iron, ligustrazine, ketoglutaric acid, and glucose.
Preferably, in the solution A, the concentration of sodium chloride is 210.70g/1000ml,
The concentration of the potassium chloride is 5.22g/1000ml;
the concentration of the calcium chloride is 7.72g/1000ml;
The concentration of magnesium chloride is 3.56g/1000ml;
The concentration of the pH regulator was 8.41g/1000ml.
Further, the pH regulator is one or more of glacial acetic acid, citric acid, lactic acid, malic acid and amino acid.
Preferably, in the solution B, the concentration of sodium bicarbonate is 84.00g/1000ml.
Preferably, in the supplement, the iron agent comprises one or more of ferrous fumarate, ferric sucrose and ferric citrate, and the total content of iron in the supplement is 0.127-0.232g/1000ml.
Preferably, the content of ligustrazine in the supplement is 0.113-0.235g/1000ml.
Preferably, the content of ketoglutaric acid in the supplement is 0.0009-0.0042g/1000ml.
Preferably, the glucose content in the supplement is 0.0021-0.0113g/1000ml.
The invention discloses a preparation method of hemodialysis concentrate, which comprises the steps of weighing the contents of the components of solution A, solution B and replenisher respectively, adding dialysis water respectively, fully dissolving to reach acceptable concentration, and uniformly mixing.
The beneficial effects of the invention are as follows:
(1) The hemodialysis concentrate provided by the invention can be suitable for hemodialysis treatment of patients suffering from acute and chronic renal failure and drug poisoning, and has an excellent market prospect.
(2) According to the hemodialysis concentrate, the iron ions are supplemented in the hemodialysis concentrate by adding the component rich in the iron ions, so that the iron ions enter a human body to relieve the anemia symptoms caused by blood loss due to long-term ventilation treatment.
(3) The hemodialysis concentrate is prepared according to a certain formula by using the supplement, and glucose and ketoglutaric acid are added at the same time, so that the hemodialysis concentrate can supplement nutrition, required elements, energy and the like to patients subjected to long-term dialysis, and the effect of dialysis treatment is improved, and discomfort of the patients is relieved.
(4) The hemodialysis concentrate of the invention can effectively improve hyperglycemia of patients, increase blood flow and improve renal microcirculation by adding the ligustrazine, and the ligustrazine can inhibit platelet aggregation to a certain extent so as to expand arterioles, thereby playing a role in improving microcirculation and cerebral blood flow.
Detailed Description
A hemodialysis concentrate comprising the following components: fluid a, fluid B and supplements;
The solution A comprises: sodium chloride, potassium chloride, calcium chloride, magnesium chloride, and pH adjuster;
the solution B comprises: sodium bicarbonate;
the supplement comprises iron, ligustrazine, ketoglutaric acid, and glucose.
Specifically, in the solution A, the concentration of sodium chloride is 210.70g/1000ml,
The concentration of the potassium chloride is 5.22g/1000ml;
the concentration of the calcium chloride is 7.72g/1000ml;
The concentration of magnesium chloride is 3.56g/1000ml;
pH regulator 8.41g/1000ml.
Further, the pH regulator is one or more of glacial acetic acid, citric acid, lactic acid, malic acid and amino acid.
Preferably, in the solution B, the concentration of sodium bicarbonate is 84.00g/1000ml.
Preferably, in the supplement, the iron agent comprises one or more of ferrous fumarate, ferric sucrose and ferric citrate, and the total content of iron in the supplement is 0.127-0.232g/1000ml. The concrete composition comprises the following components in percentage by weight:
ferrous fumarate is 0.392-0.589g/1000ml;
Iron sucrose is 0.303-0.854g/1000ml;
ferric citrate is 0.536-0.801g/1000ml;
Preferably, the content of ligustrazine in the supplement is 0.113-0.235g/1000ml.
Preferably, the content of ketoglutaric acid in the supplement is 0.0009-0.0042g/1000ml.
Preferably, the glucose content in the supplement is 0.0021-0.0113g/1000ml.
Ferrous fumarate is one of the pharmaceutical ingredients for treating anemia, and can improve the anti-stress capability and the disease resistance capability, so that the ferrous fumarate has good compatibility with various nutrient substances and antibiotics; iron sucrose and iron citrate are commonly used iron supplementing components, wherein iron citrate is commonly used as food iron fortifier and nutritional supplement in actual use, so that one or more of ferrous fumarate, iron sucrose and iron citrate can be used for supplementing iron for patients after being combined, and anemia is a common complication of hemodialysis in the process of dialysis treatment, so that the anemia is one of the key points of dialysis treatment, namely iron is absent in the body, and 1g of iron ions can be lost in dialysis patients each year due to the fact that the patients have to have certain blood loss in dialysis, and the invention can slowly supplement iron lost in the process of dialysis by adding 0.127-0.232g/1000ml of iron into hemodialysis concentrate, and can be combined with transferrin and transported into bone marrow to form hematopoiesis after entering blood of patients in the process of dialysis, so that the prescription can help weaken anemia of dialysis patients.
The ligustrazine can effectively improve hyperglycemia of patients, increase blood flow and improve renal microcirculation, inhibit platelet aggregation to a certain extent so as to expand arterioles, and has the effects of improving microcirculation and cerebral blood flow, and the ligustrazine is added into the solution A due to acidity.
The ketoglutaric acid, in particular a-ketoglutaric acid, is a tricarboxylic acid, and the addition of a-ketoglutaric acid to hemodialysis concentrate provides an additional source of energy which helps to correct post-dialysis debilitating symptoms and thus improve the nutritional status of the patient.
Because the patient loses a large amount of nutrient substances during long-time dialysis treatment, glucose is further added into the hemodialysis concentrate, so that the nutrient substances can be slowly infused to supplement the lost amount during the dialysis process during the hemodialysis, thereby ensuring the nutrition requirements of the dialysis patient.
The method for preparing hemodialysis concentrate comprises respectively weighing the solution A, the solution B and the components of the supplement, respectively adding dialysis water, fully dissolving to reach acceptable concentration, and uniformly mixing.
More specifically, the hemodialysis concentrate may be specifically a dry powder or concentrate.
Embodiments of the present invention are described in detail below. The following examples are illustrative only and are not to be construed as limiting the invention. The examples are not to be construed as limiting the specific techniques or conditions described in the literature in this field or as per the specifications of the product. The reagents or apparatus used were conventional products commercially available without the manufacturer's attention.
Example 1
A hemodialysis concentrate comprising the following components: fluid a, fluid B and supplements;
in the solution A, the concentration of sodium chloride is 210.70g/1000ml,
The concentration of the potassium chloride is 5.22g/1000ml;
the concentration of the calcium chloride is 7.72g/1000ml;
The concentration of magnesium chloride is 3.56g/1000ml;
the concentration of the pH regulator (glacial acetic acid) is 8.41g/1000ml;
in the solution B, the concentration of sodium bicarbonate is 84.00g/1000ml;
the supplement comprises iron, ligustrazine, ketoglutaric acid, and glucose.
Ferrous fumarate at 0.392g/1000ml;
iron sucrose is 0.0.854g/1000ml;
Ferric citrate is 0.536g/1000ml;
the content of ligustrazine is 0.113g/1000ml;
the content of ketoglutaric acid is 0.0009g/1000ml;
the glucose content is 0.0021g/1000ml;
the ratio of solution A, solution B and water per liter of hemodialysis concentrate was 1:1.23:32.77.
Example 2
A hemodialysis concentrate comprising the following components: fluid a, fluid B and supplements;
in the solution A, the concentration of sodium chloride is 210.70g/1000ml,
The concentration of the potassium chloride is 5.22g/1000ml;
the concentration of the calcium chloride is 7.72g/1000ml;
The concentration of magnesium chloride is 3.56g/1000ml;
the concentration of the pH regulator (citric acid) is 8.41g/1000ml;
in the solution B, the concentration of sodium bicarbonate is 84.00g/1000ml;
the supplement comprises iron, ligustrazine, ketoglutaric acid, and glucose.
Ferrous fumarate at 0.512g/1000ml;
Iron sucrose is 0.516g/1000ml;
ferric citrate is 0.601g/1000ml;
The content of ligustrazine is 0.152g/1000ml;
the content of ketoglutaric acid is 0.0021g/1000ml;
Glucose content was 0.0089g/1000ml;
the ratio of solution A, solution B and water per liter of hemodialysis concentrate was 1:1.23:32.77.
Example 3
A hemodialysis concentrate comprising the following components: fluid a, fluid B and supplements; in the solution A, the concentration of sodium chloride is 210.70g/1000ml,
The concentration of the potassium chloride is 5.22g/1000ml;
the concentration of the calcium chloride is 7.72g/1000ml;
The concentration of magnesium chloride is 3.56g/1000ml;
the concentration of the pH regulator (amino acid) was 8.41g/1000ml;
in the solution B, the concentration of sodium bicarbonate is 84.00g/1000ml;
the supplement comprises iron, ligustrazine, ketoglutaric acid, and glucose.
Ferrous fumarate is 0.589g/1000ml;
iron sucrose is 0.854g/1000ml;
the ferric citrate is 0.801g/1000ml;
The content of ligustrazine is 0.235g/1000ml;
The content of ketoglutaric acid is 0.0042g/1000ml;
Glucose content is 0.0113g/1000ml;
the ratio of solution A, solution B and water per liter of hemodialysis concentrate was 1:1.23:32.77.
Comparative example 1 (no supplement added)
The present example was modified on the basis of example 1 without supplements.
The test method comprises the following steps: the arterial ends of a 500mL disinfection bottle and a dialysis pipeline are tightly connected by a soft rubber tube, physiological saline (containing 5mmol/L of iron ions) is used for carrying out extracorporeal circulation hemodialysis instead of blood, the content of the added iron ions in the physiological saline is equal to that of the iron ions in human serum, the flow rate is 200mL/min, the flow rate of the dialyzate is 500mL/min, the ultrafiltration amounts are 0.3kg/h, the model of a dialyzer is Below LO15, and the dialyzate is designed according to the content of the iron ions in the physiological saline which is 1 times, 1.5 times and 2 times respectively and the content of the iron ions in the dialyzate which is not added. After dialysis for 4 hours, the rate of change of the iron ion content in the physiological saline and dialysate side before and after dialysis was detected by an automatic biochemical analyzer. The results are shown in Table 1.
Table 1 results of the tests of examples and comparative examples
Sample preparation Example 1 Example 2 Example 3 Comparative example 1
Rate of change of iron ions 0.11% 0.13% 0.12% Detection of iron ions
Rate of change of ligustrazine 0.08% 0.10% 0.09% -
Rate of change of ketoglutaric acid 0.11% 0.15% 0.13% -
Rate of change of glucose 0.05% 0.08% 0.07% -
The concentrates of example 1 and comparative example above were simultaneously subjected to dialysis treatment on dialysis patients.
Treatment group (example 1): of 30 dialysis patients, 18 men and 12 women had an average age of 45.6 years (20 to 70 years), and the average value of pre-treatment hemoglobin (Hb) was 83.5g/L;
general group (comparative example 1): of 30 dialysis patients, 17 men and 13 women had an average age of 42.7 years (20 to 70 years), and the average value of pre-treatment hemoglobin (Hb) was 83.2g/L;
the hemoglobin (Hb) index before and after hemodialysis was observed for both groups of dialysis patients, and the results are shown in table 2.
TABLE 2 hemoglobin (Hb) index before and after hemodialysis for two groups of dialysis patients
Group of Mean value of hemoglobin (Hb, g/L) Other symptoms of
Treatment group 115.8 Good quality
Common group 81.3 Part of the total nutrient solution has the symptoms of hypoglycemia and malnutrition
It can be seen from tables 1 and 2 that the iron ions in the examples of table 1 are not greatly changed, but the iron ions are detected in the dialysate without the iron additive, and most likely the normal saline water is lost into the dialysate, so that the iron ions are supplemented in the hemodialysis concentrate by adding the component rich in the iron ions, and the anemia symptoms caused by blood loss due to long-term ventilation treatment are relieved after the iron ions enter the human body. Meanwhile, the use of the supplement is found to be carried out according to a certain formula, and glucose and ketoglutaric acid are added at the same time, so that the hemodialysis concentrate can supplement nutrition, required elements, energy and the like for patients subjected to long-term dialysis, thereby improving the effect of dialysis treatment and relieving discomfort of the patients; furthermore, by adding the ligustrazine, the hyperglycemia condition of a patient can be effectively improved, the blood flow is increased, the renal microcirculation is improved, and the ligustrazine can inhibit platelet aggregation to a certain extent so as to expand arterioles, thereby playing a role in improving microcirculation and cerebral blood flow.
The foregoing examples have shown only the preferred embodiments of the invention, which are described in more detail and are not to be construed as limiting the scope of the invention. It should be pointed out that various other corresponding changes and modifications can be made by those skilled in the art in light of the above description of the technical solution and the idea, and all such changes and modifications are intended to be within the scope of the invention as defined in the appended claims.

Claims (9)

1. A hemodialysis concentrate comprising the following components: fluid a, fluid B and supplements;
The solution A comprises: sodium chloride, potassium chloride, calcium chloride, magnesium chloride, and pH adjuster;
the solution B comprises: sodium bicarbonate;
the supplement comprises iron, ligustrazine, ketoglutaric acid, and glucose.
2. A hemodialysis concentrate according to claim 1, wherein the concentration of sodium chloride in the solution A is 210.70g/1000ml,
The concentration of the potassium chloride is 5.22g/1000ml;
the concentration of the calcium chloride is 7.72g/1000ml;
The concentration of magnesium chloride is 3.56g/1000ml;
The concentration of the pH regulator was 8.41g/1000ml.
3. The hemodialysis concentrate of claim 1, wherein the pH adjuster in the solution B is one or more of glacial acetic acid, citric acid, lactic acid, malic acid, and amino acids.
4. A hemodialysis concentrate according to claim 1, wherein the concentration of sodium bicarbonate in the solution B is 84.00g/1000ml.
5. A hemodialysis concentrate according to claim 1, wherein the iron agent in the supplement comprises one or more of ferrous fumarate, ferric saccharate, ferric citrate, and the total iron content in the supplement is 0.127-0.232g/1000ml.
6. The hemodialysis concentrate of claim 1, wherein the supplement contains ligustrazine in an amount of 0.113-0.235g/1000ml.
7. A hemodialysis concentrate according to claim 1, wherein the content of ketoglutaric acid in the supplement is 0.0009-0.0042g/1000ml.
8. A hemodialysis concentrate according to claim 1, wherein the glucose content of the supplement is 0.0021-0.0113g/1000ml.
9. A process for the preparation of a hemodialysis concentrate according to any one of claims 1-8, characterized in that
Respectively weighing the contents of the components of the solution A, the solution B and the replenisher, respectively adding dialysis water,
Fully dissolving to the qualified concentration, and then uniformly mixing to obtain the product.
CN202410024290.7A 2024-01-08 2024-01-08 Hemodialysis concentrate Pending CN117919274A (en)

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Application Number Priority Date Filing Date Title
CN202410024290.7A CN117919274A (en) 2024-01-08 2024-01-08 Hemodialysis concentrate

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