CN108653299A - A kind of preparation method of dialyzate - Google Patents

A kind of preparation method of dialyzate Download PDF

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Publication number
CN108653299A
CN108653299A CN201810625629.3A CN201810625629A CN108653299A CN 108653299 A CN108653299 A CN 108653299A CN 201810625629 A CN201810625629 A CN 201810625629A CN 108653299 A CN108653299 A CN 108653299A
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parts
dialyzate
preparation
distilled water
sterile distilled
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CN201810625629.3A
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CN108653299B (en
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不公告发明人
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JIANGSU NAHAI BIOLOGICAL TECHNOLOGY Co.,Ltd.
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Beijing Dianyu Technology Co Ltd
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    • 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
    • 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
    • A61K31/191Carboxylic acids, e.g. valproic acid having two or more hydroxy groups, e.g. gluconic 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
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/44221,4-Dihydropyridines, e.g. nifedipine, nicardipine
    • 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
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/42Phosphorus; 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
    • A61P7/08Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock

Abstract

The invention belongs to medical material technical fields, and in particular to a kind of preparation method of dialyzate.The preparation method of the dialyzate is, mass fraction is passed through the mixed liquor that is prepared in 45 parts of modified polyvinylalcohol, 20 25 parts of electrolyte solution, 0.1 0.2 nifedipine, 24 parts of mineral ion solution, 100 120 parts of sterile distilled water;It by the modification to polyvinyl alcohol, and adds it in the preparation of dialyzate, it is larger that its molecular weight is utilized, therefore its grain size is larger, does not pass through translucent principle, avoids the occurrence of backflow phenomenon, the dialyzate property is relatively stable simultaneously, is not easy to be aoxidized, the shelf-life is longer.

Description

A kind of preparation method of dialyzate
Technical field
The invention belongs to medical material technical fields, and in particular to a kind of preparation method of dialyzate.
Background technology
Peritoneal dialysis is the characteristic using peritonaeum as semipermeable membrane, is advised prepared dialyzate by gravity Rule periodically pours into the cavum peritoneale of patient through conduit, due in peritonaeum both sides there are the concentration gradient of solute is poor, high concentration side Solute moves (dispersion) to low concentration side;Moisture then moves (osmosis) from a hypotonic side to hypertonic side.Pass through Abdominal dialysis liquid is constantly replaced, and interior metabolism product, toxicant are removed and to correct water, electrolyte balance disorderly to reach Purpose.This method has become one of most effective treatment means of Renal Failure Patients at present, therefore seems particularly to the research and development of dialyzate It is important.
106265726 A of Chinese patent application CN disclose a kind of Astragaloside IV peritoneal dialysis solution preparation prescription and its system Preparation Method.It is characterized in that being necessary component by the effective monomer-Astragaloside IV extracted in Radix Astragali, with glucose, sodium chloride, chlorine It is helper component to change calcium, magnesium chloride, sodium lactate, is dissolved in suitable water for injection, Astragaloside IV peritoneal dialysis solution is made, specially It is treated for renal prostration disease.
Chinese patent application CN 107281196A disclose a kind of low calcium lactate peritoneal dialysat composition, contain Portugal Grape sugar, calcium chloride, magnesium chloride, alkali, sulfonic acid difficult to understand and salt or ester in terms of sulfonic acid difficult to understand and water, can make peritoneal dialysis solution to peritonaeum not Good influence declines.
Invention content
In order to achieve the purpose that in background technology, a kind of preparation method of dialyzate proposed by the present invention;By to poly- second The modification of enol, and adding it in the preparation of dialyzate, it is larger to be utilized its molecular weight, therefore its grain size is larger, will not Across translucent principle, backflow phenomenon is avoided the occurrence of, while the dialyzate property is relatively stable, be not easy to be aoxidized, the shelf-life It is longer.
What the present invention realized by the following technical solutions
A kind of preparation method of dialyzate, which is characterized in that the preparation method of the dialyzate is that mass fraction exists 4-5 parts of modified polyvinylalcohol, 20-25 parts of electrolyte solution, the nifedipine of 0.1-0.2,2-4 parts of mineral ion are molten Liquid, 100-120 parts of sterile distilled water passes through the mixed liquor that is prepared.
Further, the preparation method is, in desinfection chamber, by mass fraction be 4-5 part modified polyvinylalcohol with 80-100 parts of sterile distilled water is mixed, and high-speed stirred is carried out in mixed process 1-2 hours, obtains solution after mixing A;Again the nifedipine of 0.1-0.2,2-4 parts of mineral ion solution, 10-20 parts of sterile distilled water mix It arrives, obtains mixed liquid B after mixing, then obtained A and B solution are mixed, add 20-25 after mixing Then the electrolyte solution of part carried out high-speed stirred after 1-2 hours, taking-up is sealed preservation, this substance is exactly a kind of dialyzate.
Further, the modified polyvinylalcohol is that reaction kettle is added in the polyvinyl alcohol that mass fraction is 10-20 parts In, then be added 100-120 parts solvent, 1-2 parts to styryl benzoic acid, 1-2 parts of the concentrated sulfuric acid, be then turned on stirring After device carries out reaction 1-2 hours, which is subjected to revolving and removes solvent, after obtained substance is dried, weighs 10-20 parts The substance be put into reaction kettle, be then added 0.1-0.2 part the concentrated sulfuric acid, 1-2 parts of concentrated phosphoric acids, progress sulfonating reaction 1-2 is small Shi Hou is added 100-200 parts of sterile distilled water and is washed, then obtained object is dried, obtained solid powder It is exactly modified polyvinylalcohol.
Further, the electrolyte solution is β-D- glucofuranoses, 3-4 parts of α-by mass fraction for 1-2 parts D- glucopyranoses, 6-8 parts of β-D- glucopyranoses, 10-20 parts of sterile distilled water carry out mixture prepared substance.
Further, the mineral ion solution is, by 1-2 parts of sodium chloride, 0.1-0.2 parts of potassium chloride, 1-2 parts Rare Elements Preparations, 0.2-0.3 parts of calcium chloride, 0.2-0.4 parts of dibastic sodium phosphate, 1-2 parts of malic acid, 10-40 parts Sterile distilled water carries out mixture prepared substance.
Further, the sterile distilled water is that after mineral water is carried out high temperature distillation in an aseptic environment, then will obtain Water by translucent, remove the water that microorganism that may be present etc. obtains.
Further, the preparation condition is the speed control of temperature control blender at 30-40 DEG C, high-speed stirred In 500-600rpm.
Further, the solvent is that ether and acetone are according to 1:3 mixed liquors being mixed to get.
Beneficial to benefit
1, the present invention increases osmotic pressure by the way that modified polyvinyl alcohol, the concentration that can have effectively passed through solution is added While, additionally it is possible to ensure in process of osmosis Material recirculation phenomenon occur since water suction can excessively cause concentration to reduce, profit With this substance, its molecular weight is larger, therefore its grain size is larger, does not pass through translucent principle;
2, the polyvinyl alcohol for the modification that the present invention is added, it is soluble easily in water, but because its amount of substance is larger, property is more Stablize, while also oxidation resistant group on its strand, makes it that the same of the problem of denaturation etc. influences dialyzate quality will not occur When increase time of shelf-life;
3, dialyzate its effect that the present invention is prepared through the invention is preferable, can be effectively accomplished dialysis-effect.
Specific implementation mode
In order to keep the purpose of the present invention, technical solution and advantageous effect clearer, below in conjunction with experimental data, to this The preferred embodiment of invention is described in detail, to facilitate the technical staff to understand.
Embodiment 1
A kind of preparation method of dialyzate includes the following steps:
(1) polyvinyl alcohol that mass fraction is 15 parts is added in reaction kettle, be then added 120 parts solvent, 1.5 parts To styryl benzoic acid, 1.5 parts of the concentrated sulfuric acid, it is then turned on blender and carries out after reacting 2 hours, which is revolved Solvent is evaporated off, after obtained substance is dried, weighs the 15 parts substance and is put into reaction kettle, is then added 0.15 part The concentrated sulfuric acid, 1.5 parts of concentrated phosphoric acids carried out sulfonating reaction after 2 hours, and 150 parts of sterile distilled water is added and is washed, and then will Obtained object is dried, and obtained solid powder is exactly modified polyvinylalcohol;
(2) β-D- glucofuranoses, 3.5 parts of α-D- glucopyranoses, 7 parts of β-D- for being 1.5 parts by mass fraction Glucopyranose, the mixing of 15 parts of sterile distilled water, are prepared electrolyte solution;
(3) by 1.5 parts of sodium chloride, 0.15 part of potassium chloride, 1.5 parts of Rare Elements Preparations, 0.25 part of chlorination Calcium, 0.3 part of dibastic sodium phosphate, 1.5 parts of malic acid, the mixing of 20 parts of sterile distilled water, the mineral ion being prepared are molten Liquid;
(4) in desinfection chamber, mass fraction is carried out for 4.5 parts of modified polyvinylalcohol and 100 parts of sterile distilled water It mixes, high-speed stirred is carried out in mixed process 2 hours, obtain solution A after mixing;Again by 0.15 nifedipine, 3 parts Mineral ion solution, 15 parts of sterile distilled water are mixed to get, and obtain mixed liquid B after mixing, then will be obtained A and B solution mixed, add 25 parts of electrolyte solution after mixing, then carry out high-speed stirred after 1 hour, take Go out and be sealed preservation, this substance is exactly a kind of dialyzate.
Embodiment 2
A kind of preparation method of dialyzate includes the following steps:
(1) polyvinyl alcohol that mass fraction is 15 parts is added in reaction kettle, 120 parts of solvent, 2 parts of pair is then added Styryl benzoic acid, 1 part of the concentrated sulfuric acid are then turned on blender and carry out after reacting 2 hours, which is carried out revolving removing Solvent after obtained substance is dried, weighs the 18 parts substance and is put into reaction kettle, and 0.15 part of dense sulphur is then added Acid, 2 parts of concentrated phosphoric acids carried out sulfonating reaction after 2 hours, and 120 parts of sterile distilled water is added and is washed, the object that then will be obtained It is dried, obtained solid powder is exactly modified polyvinylalcohol;
(2) it is 1 part of β-D- glucofuranoses, 4 parts of α-D- glucopyranoses, 8 parts of β-D- pyrans by mass fraction Glucose, the mixing of 20 parts of sterile distilled water, are prepared electrolyte solution;
(3) by 2 parts of sodium chloride, 0.1 part of potassium chloride, 1 part of Rare Elements Preparations, 0.3 part of calcium chloride, 0.2 part Dibastic sodium phosphate, 2 parts of malic acid, 20 parts sterile distilled water mixing, the mineral ion solution being prepared;
(4) it is that 5 parts of modified polyvinylalcohol and 100 parts of sterile distilled water mix by mass fraction in desinfection chamber It closes, high-speed stirred is carried out in mixed process 2 hours, obtain solution A after mixing;Again by 0.1 nifedipine, 4 parts of mine Substance solion, 20 parts of sterile distilled water are mixed to get, and obtain mixed liquid B after mixing, the A that then will be obtained It is mixed with B solution, adds 22 parts of electrolyte solution after mixing, then carried out high-speed stirred after 2 hours, take out It is sealed preservation, this substance is exactly a kind of dialyzate.
Embodiment 3
A kind of preparation method of dialyzate includes the following steps:
(1) polyvinyl alcohol that mass fraction is 12 parts is added in reaction kettle, 120 parts of solvent, 2 parts of pair is then added Styryl benzoic acid, 2 parts of the concentrated sulfuric acid, are then turned on blender and carry out after reacting 1-2 hours, which, which is carried out revolving, removes Solvent is removed, after obtained substance is dried, the 10-20 parts substance is weighed and is put into reaction kettle, then 0.2 part of addition is dense Sulfuric acid, 2 parts of concentrated phosphoric acids carried out sulfonating reaction after 2 hours, and 200 parts of sterile distilled water is added and is washed, then will obtain Object be dried, obtained solid powder is exactly modified polyvinylalcohol;
(2) it is 2 parts of β-D- glucofuranoses, 4 parts of α-D- glucopyranoses, 8 parts of β-D- pyrans by mass fraction Glucose, the mixing of 20 parts of sterile distilled water, are prepared electrolyte solution;
(3) by 2 parts of sodium chloride, 0.2 part of potassium chloride, 2 parts of Rare Elements Preparations, 0.3 part of calcium chloride, 0.4 part Dibastic sodium phosphate, 2 parts of malic acid, 40 parts sterile distilled water mixing, the mineral ion solution being prepared;
(4) it is that 5 parts of modified polyvinylalcohol and 100 parts of sterile distilled water mix by mass fraction in desinfection chamber It closes, high-speed stirred is carried out in mixed process 2 hours, obtain solution A after mixing;Again by 0.2 nifedipine, 4 parts of mine Substance solion, 20 parts of sterile distilled water are mixed to get, and obtain mixed liquid B after mixing, the A that then will be obtained It is mixed with B solution, adds 25 parts of electrolyte solution after mixing, then carried out high-speed stirred after 2 hours, take out It is sealed preservation, this substance is exactly a kind of dialyzate.
Embodiment 4
A kind of preparation method of dialyzate includes the following steps:
(1) polyvinyl alcohol that mass fraction is 10 parts is added in reaction kettle, 100 parts of solvent, 1 part of pair is then added Styryl benzoic acid, 1 part of the concentrated sulfuric acid are then turned on blender and carry out after reacting 2 hours, which is carried out revolving removing Solvent after obtained substance is dried, weighs the 10 parts substance and is put into reaction kettle, then be added 0.1 part the concentrated sulfuric acid, 1 part of concentrated phosphoric acid carries out sulfonating reaction after 1 hour, and 100 parts of sterile distilled water is added and is washed, then by obtained object into Row drying, obtained solid powder are exactly modified polyvinylalcohol;
(2) it is 1 part of β-D- glucofuranoses, 3 parts of α-D- glucopyranoses, 6 parts of β-D- pyrans by mass fraction Glucose, the mixing of 10 parts of sterile distilled water, are prepared electrolyte solution;
(3) by 1 part of sodium chloride, 0.15 part of potassium chloride, 1.2 parts of Rare Elements Preparations, 0.25 part of calcium chloride, 0.3 part of dibastic sodium phosphate, 1.2 parts of malic acid, the mixing of 25 parts of sterile distilled water, the mineral ion solution being prepared;
(4) in desinfection chamber, mass fraction is carried out for 4.5 parts of modified polyvinylalcohol and 100 parts of sterile distilled water It mixes, high-speed stirred is carried out in mixed process 2 hours, obtain solution A after mixing;Again by 0.12 nifedipine, 3 parts Mineral ion solution, 20 parts of sterile distilled water be mixed to get, obtain mixed liquid B after mixing, then will To A and B solution mixed, add 25 parts of electrolyte solution after mixing, then carry out high-speed stirred after 2 hours, Taking-up is sealed preservation, this substance is exactly a kind of dialyzate.
Experimental analysis:
1, permeance property is tested
The dialyzate that 1-4 of the embodiment of the present invention dialyzates prepared and market are bought, carries out osmotic pressure experiment, tests it After 4 hours, the decline percentage of the concentration of water in blood, by test, result is as follows:
The dialyzate that it can be seen from above-mentioned table prepared by the present invention, osmotic pressure ability is very strong, is sold than market Dialyzate penetrating power it is high by 10% or more, effect is very outstanding.
2, the dialyzate shelf-life tests
The dialyzate that 1-4 of the embodiment of the present invention dialyzates prepared and market are bought, carries out shelf-life experiment, tests it Its deteriorating time in a natural environment, by test, result is as follows:
By table it can be seen that its shelf-life of dialyzate for preparing of the present invention is longer, the service life used is comparatively longer.
3, the reverse osmosis test of dialyzate
The dialyzate that 1-4 of the embodiment of the present invention dialyzates prepared and market are bought, reverse osmosis test, test method For that the dialyzate of dialyzate and market purchase prepared by 1-4 of the embodiment of the present invention will be respectively placed in the bottle in left side, and The higher solution of concentration is added in the bottle of right side, it is then intermediate to be connected with pipe, be added inside pipe it is translucent, by two A solution separates, wherein the liquid level in two bottles is identical, and the variation of its liquid level, liquid are observed after a period of time Face is got higher, and illustrates that its penetrating power is strong, and by test, result is as follows:
By experimental result it can be seen that dialyzate its reverse osmosis ability for preparing of the present invention is stronger, illustrate its dialysis ability compared with By force, it can effectively ensure that dialysis-effect.
Finally illustrate, preferred embodiment above is only used to illustrate the technical scheme of the present invention and unrestricted, although logical It crosses above preferred embodiment the present invention is described in detail, however, those skilled in the art should understand that, can be Various changes are made to it in form and in details, defined by claims of the present invention.

Claims (8)

1. a kind of preparation method of dialyzate, which is characterized in that the preparation method of the dialyzate is, by mass fraction in 4- 5 parts of modified polyvinylalcohol, 20-25 parts of electrolyte solution, the nifedipine of 0.1-0.2,2-4 parts of mineral ion solution, 100-120 parts of sterile distilled water passes through the mixed liquor that is prepared.
2. a kind of preparation method of dialyzate according to claim 1, which is characterized in that the preparation method is, In desinfection chamber, it is that 4-5 parts of modified polyvinylalcohol and 80-100 parts of sterile distilled water mix by mass fraction, mixed High-speed stirred is carried out in journey 1-2 hours, obtain solution A after mixing;Again by the nifedipine of 0.1-0.2,2-4 parts of mineral Matter solion, 10-20 parts of sterile distilled water is mixed to get, obtain mixed liquid B after mixing, then will be obtained A and B solution are mixed, and add 20-25 parts of electrolyte solution after mixing, then carry out high-speed stirred after 1-2 hours, Taking-up is sealed preservation, this substance is exactly a kind of dialyzate.
3. a kind of preparation method of dialyzate according to claim 1, which is characterized in that the modified polyvinylalcohol For, the polyvinyl alcohol that mass fraction is 10-20 part is added in reaction kettle, then the solvent of 100-120 parts of addition, 1-2 parts To styryl benzoic acid, 1-2 parts of the concentrated sulfuric acid, it is then turned on blender and carries out after reacting 1-2 hours, which is revolved Solvent is evaporated off, after obtained substance is dried, weighs the 10-20 parts substance and is put into reaction kettle, 0.1- is then added 0.2 part of the concentrated sulfuric acid, 1-2 parts of concentrated phosphoric acids carried out sulfonating reaction after 1-2 hours, and 100-200 parts of sterile distilled water is added and carries out Washing, then obtained object is dried, obtained solid powder is exactly modified polyvinylalcohol.
4. a kind of preparation method of dialyzate according to claim 1, which is characterized in that the electrolyte solution is to incite somebody to action Mass fraction be 1-2 parts of β-D- glucofuranoses, 3-4 parts of α-D- glucopyranoses, 6-8 parts of β-D- glucopyranoses, 10-20 parts of sterile distilled water carries out mixture prepared substance.
5. a kind of preparation method of dialyzate according to claim 1, which is characterized in that the mineral ion is molten Liquid is, by 1-2 parts of sodium chloride, 0.1-0.2 parts of potassium chloride, 1-2 parts of Rare Elements Preparations, 0.2-0.3 parts of calcium chloride, 0.2-0.4 parts of dibastic sodium phosphate, 1-2 parts of malic acid, 10-40 parts of sterile distilled water carries out mixture prepared substance.
6. a kind of preparation method of dialyzate according to claim 1, which is characterized in that the sterile distilled water is, After mineral water is carried out high temperature distillation in an aseptic environment, then by obtained water by translucent, removing micro- life that may be present The water that object etc. obtains.
7. a kind of preparation method of dialyzate according to claim 2, which is characterized in that the preparation condition is temperature The speed control of degree control blender at 30-40 DEG C, high-speed stirred is in 500-600rpm.
8. a kind of preparation method of dialyzate according to claim 3, which is characterized in that the solvent is, ether and Acetone is according to 1:3 mixed liquors being mixed to get.
CN201810625629.3A 2018-06-18 2018-06-18 Preparation method of dialysate Active CN108653299B (en)

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Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010141949A2 (en) * 2009-06-05 2010-12-09 Fresenius Medical Care Holdings, Inc. Urea sorbent

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010141949A2 (en) * 2009-06-05 2010-12-09 Fresenius Medical Care Holdings, Inc. Urea sorbent

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
MITSURU HIGA 等: "New Hemodialysis Method Using Positively Charged Membrane Dialyzer and/or Polycation Dialysate", 《IND. ENG. CHEM. RES.》 *
江莹雯 等: "两亲性聚乙烯醇-b-聚苯乙烯嵌段共聚物的合成及表征", 《合成技术及应用》 *
王占仁: "血液灌流器的研究与临床应用新进展", 《血液净化透析膜与透析液研究进展及质量控制学习班》 *

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