CN109106724A - A kind of malic acid bicarbonate external hemodialysis agent - Google Patents
A kind of malic acid bicarbonate external hemodialysis agent Download PDFInfo
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- CN109106724A CN109106724A CN201710483054.1A CN201710483054A CN109106724A CN 109106724 A CN109106724 A CN 109106724A CN 201710483054 A CN201710483054 A CN 201710483054A CN 109106724 A CN109106724 A CN 109106724A
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- chloride
- malic acid
- sodium
- bicarbonate
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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
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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
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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
- A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
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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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
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- Pharmacology & Pharmacy (AREA)
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- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
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Abstract
A kind of malic acid bicarbonate external hemodialysis agent, its main feature is that being made of component A and component B, component A: sodium chloride, potassium chloride, calcium chloride, magnesium chloride, levo form malic acid；Component B: sodium bicarbonate, sodium chloride；Weight ratio of constituents are as follows: component A: sodium chloride 77%-95%, potassium chloride 0-4%, calcium chloride 2%-6%, magnesium chloride 1%-3%, L MALIC ACID 2%-10%；Component B: sodium bicarbonate 60%-100%, sodium chloride 0-40%.Final ion concentration is (mmol/L): Na when use+ 133‑145、K+ 0‑4.0、Ca2+ 1.0‑2.0、Mg2+ 0.3‑1.0、Cl‑ 100‑130、HCO3 ‑25-45,H2MA 2-8.It solves acetate adverse reaction caused by patient in traditional dialyzing agent, is adjustable pH value in suitable range, protects patient's heart, liver function, residual renal function and normal cell, is adapted to blood-cleansing dialysis treatment and uses.
Description
Technical field
The present invention relates to medical blood purification treatment field, the bicarbonate body of specifically a kind of malic acid containing levo form
Outer haemodialysis preparation.
Background technique
The bicarbonate extracorporeal blood dialyzing agent that medical industry generally uses at present, mainly by sodium chloride (NaCl), chlorination
Potassium (KCl), calcium chloride (CaCl2), magnesium chloride (MgCl2), acetic acid (HAc), sodium bicarbonate (NaHCO3) or sodium chloride (NaCl) group
At.Due to containing HCO simultaneously3 -With Ca2+And Mg2+Plasma, it is anti-that in pH value, calcium easy to form, magnesium salts, which were not precipitated, at that time
Precipitating is only generated, conventional formulation is to add the acetic acid of 3-8mmol/L, acetate (Ac-) become after human liver is metabolized
HCO3 -, it usually needs it could complete within 3-5 hours, headache, dizziness, Nausea and vomiting, twitch, low blood pressure occurs in the patient during which having
Etc. symptoms, i.e. " acetic acid does not tolerate phenomenon ", while acetate and its mesostate, it is also possible to cause in chronic metabolic acid
Hyperphosphatemia, peritoneal fibrosiss, promotion inflammatory factor generation etc. after poison, dialysis.
Summary of the invention
The present invention is to solve many adverse reactions caused by acetic acid in tradition dialysis preparation, invents a kind of apple containing levo form
The bicarbonate extracorporal dialysis preparation of acid.
The technical scheme is that a kind of malic acid bicarbonate external hemodialysis agent, including component A and component B；
Component A: sodium chloride, potassium chloride, calcium chloride, magnesium chloride, levo form malic acid (also known as " L MALIC ACID ")；Component B: carbonic acid
Hydrogen sodium, sodium chloride；
Component ratio are as follows: component A: sodium chloride 77%-95%
Potassium chloride 0-4%
Calcium chloride 2%-6%
Magnesium chloride 1%-3%
Levo form malic acid 2%-10%
Component B: sodium bicarbonate 60%-100%
Sodium chloride 0-40%
Calcium chloride in mentioned component, magnesium chloride point are containing the crystallization water and without the compound of the crystallization water, and dosage is to be free of in prescription
Hydrate is crystallized to calculate.
Preparation method:
It weighs sodium chloride, potassium chloride, calcium chloride, magnesium chloride, levo form malic acid respectively in proportion, is uniformly mixed, that is, be made solid
The component A of body preparation；
It is different by dialysis machine dosage form, it weighs sodium bicarbonate, sodium chloride respectively in proportion, is uniformly mixed, that is, solid dosage forms is made
Component B；
Use dissolved in purified water at defined volume respectively component A, the component B of solid pharmaceutical preparation, the component A of liquid dosage form and
Component B.
In use, requiring according to the different use ratios of different brands, different model dialysis machine, liquid dosage form is drawn respectively
Component A, component B and pure water, be diluted in dialysis machine internal mix using dialyzate, then in dialyzer with patient blood
Carry out ion exchange, the final ion concentration (mmol/L) when use are as follows:
Na+ 133-145、K+ 0-4.0、 Ca2+ 1.0-2.0、Mg2+ 0.3-1.0、Cl- 100-130、HCO3 -25-45、H2MA
2-8, pH value 7.0-7.5
Malic acid also known as 2- hydroxysuccinic acid, contraction: H2MA, structural formula: HOOCCHOHCH2COOH, molecular formula:
C4H6O5, molecular weight: 134.09, it is intermediate product important in body tricarboxylic acid cycle, belongs to small-molecule substance, it can be freely
Blood side is entered by the micropore of dialyzer.Malic acid has two kinds of isomers of D, L, and the present invention selects levo form malic acid (L-
Malic acid), it is one of compound amino acid infusion component, can improve the absorptivity of amino acid for treating uremia, hypertension
Deng and reduce infringement of the anticancer drug to normal cell, it is widely present in organism, body metabolism can be directly participated in, by people
Body directly absorbs, if lacked, to can lead to tricarboxylic acid cycle abnormal and cause metabolism disorder.Since malic acid is in metabolism
Locating specific position in approach, is able to achieve in the short time and provides energy to body, eliminates fatigue, regains one's strength, can play shield
Liver protects kidney, the effect of cardioprotection.It can ionize out 2 hydrogen ions, be a kind of acidic organic compound, it can make component A molten
Solution is maintained at the acid state of 2-4 at the pH value after concentrate；Component B main component is sodium bicarbonate, pH value 7.7-7.9 it
Between.Component A and component B inside dialysis machine plus after pure water mixing stablize between 7.1-7.3 by final pH value, both adapts to people
Body physiological requirements can prevent calcium ion and magnesium ion from precipitating again, meet requirement of the extracorporal dialysis to dialyzate pH value.
Technical effect
The solution have the advantages that using the above scheme, may be implemented a kind of containing the organic acid with physiological activity ---
The bicarbonate extracorporeal blood dialyzing agent of levo form malic acid can efficiently solve acetate in traditional dialyzing agent and cause to patient
Adverse reaction, eliminate headache, dizziness, Nausea and vomiting, twitch, the symptoms, i.e. " acetic acid does not tolerate phenomenon " such as low blood pressure, elimination
Acetate and its mesostate lead to hyperphosphatemia, peritoneal fibrosiss, promotion inflammatory after chronic metabolic acidosis, dialysis
Phenomena such as factor generates.
Specific embodiment
According to dialysis machine different type of machines, different dialyzing agents is prepared:
Embodiment 1 weighs sodium chloride (NaCl) 1192.4g, potassium chloride (KCl) 43.1g, calcium chloride (CaCl2·2H2O)
42.5g, magnesium chloride (MgCl2·6H2O) 18.7g, levo form apple (C4H6O5) 54.2g are uniformly mixed, that is, solid dosage forms are made
Component A；Weigh sodium bicarbonate (NaHCO3) 385.0g, solid dosage forms component B(the present embodiment component B not chloride containing
Sodium)；Dissolved in purified water is added to be diluted to 5500 milliliters the component A of solid dosage forms, component B adds dissolved in purified water to be diluted to 7000 millis
It rises, that is, the component A and component B of liquid dosage form is made.By A:B: water=1:1.26:32.74 ratio is sucked with dialysis machine
Component A, component B and pure water, the final ion concentration of mixed liquor (mmol/L) are as follows: Na+ 135、K+ 2.5、Ca2+ 1.5、Mg2+
0.5 、Cl- 112.2、MA 2.8、HCO3 -32, PH7.2.
Embodiment 2 weighs sodium chloride (NaCl) 885.5g, potassium chloride (KCl) 22.7g, calcium chloride (CaCl2·2H2O)
53.4g, magnesium chloride (MgCl2·6H2O) 30.3g, levo form malic acid (C4H6O5) 102.2g are uniformly mixed, that is, solid are made
The component A of dosage form；Weigh sodium bicarbonate (NaHCO3) 363.0g, sodium chloride (NaCl) 167.7g, be uniformly mixed solid formulation
The component B of type；Dissolved in purified water is added to be diluted to 5500 milliliters the component A of solid dosage forms, component B adds dissolved in purified water to be diluted to
7000 milliliters, that is, the component A and component B of liquid dosage form is made.By A:B: water=1:1.83:34 ratio is inhaled with dialysis machine
Enter component A, component B and pure water, the final ion concentration of mixed liquor (mmol/L) are as follows: Na+ 138、K+ 2.0、Ca2+ 2.0、Mg2 + 0.75 、Cl- 110.5、MA 4.5、HCO3 - 30,PH 7.3。
Embodiment 3 weighs sodium chloride (NaCl) 1159.3g, potassium chloride (KCl) 41.9g, calcium chloride (CaCl2·2H2O)
41.3g, magnesium chloride (MgCl2·6H2O) 15.3g, levo form malic acid (C4H6O5) 52.7g are uniformly mixed, that is, solid are made
The component A of dosage form；Weigh sodium bicarbonate (NaHCO3) 394.3, solid dosage forms component B(the present embodiment component B be free of chlorine
Change sodium)；Dissolved in purified water is added to be diluted to 5500 milliliters the component A of solid dosage forms, component B adds dissolved in purified water to be diluted to 7000
Milliliter, that is, be made the component A and component B of liquid dosage form.By A:B: water=1:1.225:32.775 ratio uses dialysis machine
Suck component A, component B and pure water, the final ion concentration of mixed liquor (mmol/L) are as follows: Na+ 138、K+ 2.0、Ca2+
1.75、Mg2+ 0. 5 、Cl- 109、MA 2.8、HCO3 - 35,PH 7.25。
Claims (2)
1. a kind of malic acid bicarbonate external hemodialysis agent, it is characterized in that being made of component A and component B, component A includes:
Sodium chloride, potassium chloride, calcium chloride, magnesium chloride, levo form malic acid (also known as " L MALIC ACID ")；Component B include: sodium bicarbonate,
Sodium chloride.
2. malic acid bicarbonate external hemodialysis agent according to claim 1, it is characterised in that: components by weight
Are as follows: component A: sodium chloride 77%-95%, potassium chloride 0-4%, calcium chloride 2%-6%, magnesium chloride 1%-3%, L MALIC ACID 2%-10%；Group
Divide B: sodium bicarbonate 60%-100%, sodium chloride 0-40%.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710483054.1A CN109106724A (en) | 2017-06-23 | 2017-06-23 | A kind of malic acid bicarbonate external hemodialysis agent |
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| CN201710483054.1A CN109106724A (en) | 2017-06-23 | 2017-06-23 | A kind of malic acid bicarbonate external hemodialysis agent |
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| CN109106724A true CN109106724A (en) | 2019-01-01 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2021233432A1 (en) * | 2020-05-22 | 2021-11-25 | 夏永彪 | Blood-purification molecular concentrate, preparation method therefor, and application thereof |
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- 2017-06-23 CN CN201710483054.1A patent/CN109106724A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2021233432A1 (en) * | 2020-05-22 | 2021-11-25 | 夏永彪 | Blood-purification molecular concentrate, preparation method therefor, and application thereof |
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