CN104434959A - Dialysis concentrate containing vitamins - Google Patents

Dialysis concentrate containing vitamins Download PDF

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Publication number
CN104434959A
CN104434959A CN201310434028.1A CN201310434028A CN104434959A CN 104434959 A CN104434959 A CN 104434959A CN 201310434028 A CN201310434028 A CN 201310434028A CN 104434959 A CN104434959 A CN 104434959A
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CN
China
Prior art keywords
vitamin
dialysis
concentration
dialysate concentrate
water soluble
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN201310434028.1A
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Chinese (zh)
Inventor
李波
曹慕真
李�杰
刘娟琴
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TIANJIN SHENYOUDA MEDICAL INSTRUMENTS TECHNOLOGY DEVELOPMENT Co Ltd
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TIANJIN SHENYOUDA MEDICAL INSTRUMENTS TECHNOLOGY DEVELOPMENT Co Ltd
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Priority to CN201310434028.1A priority Critical patent/CN104434959A/en
Publication of CN104434959A publication Critical patent/CN104434959A/en
Pending legal-status Critical Current

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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
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365Lactones
    • A61K31/375Ascorbic acid, i.e. vitamin C; Salts thereof
    • 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
    • A61K33/14Alkali metal chlorides; Alkaline earth metal chlorides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Inorganic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • External Artificial Organs (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The invention provides a dialysis concentrate containing vitamins, and the dialysis concentrate comprises water soluble vitamins, wherein the water soluble vitamins comprise one or two of vitamin C and vitamin B. The water soluble vitamins comprise vitamin C with concentration of 0.5-2.4 g/10L, or comprise vitamin B with concentration of 3-16 g/10L, or comprise vitamin C with concentration of 0.5-2.4 g/10L and vitamin B with concentration of 3-16 g/10L. By adopting the dialysis concentrate provided by the invention, the loss of vitamins B and C in a dialysis process is greatly reduced, and the vitamins B and C are controlled within a reasonable concentration range of a human body, in order to reduce the metabolism burden of patients and improve the dialysis comfort to ensure the living quality of the patients.

Description

Dialysate concentrate containing vitamin
Technical field
The invention belongs to dialysate concentrate technical field, especially relate to a kind of dialysate concentrate containing vitamin.
Background technology
In existing technology, dialysate concentrate generally includes A preparation and B preparation two kinds of components, and wherein A preparation is sodium chloride, potassium chloride, calcium chloride, magnesium chloride and acid adjustment thing etc., and B preparation is sodium bicarbonate, or adds sodium chloride again by sodium bicarbonate and form.Its form can be dry powder or concentrated solution.
During use, dialysis dry powder needs to dissolve, dilute for concentrated solution, and dialysis concentrated solution directly can be connected with dialysis machine and be used for hemodialysis.
Regardless of the formula of A, B preparation, also regardless of the dilution ratio of dialysis machine, in the dialysis solution after dialysis machine dilution, leading ion content must meet treatment requirement, i.e. the regulation of table 1.
Table 1: leading ion content and pH value thereof in the dialysis solution after dialysis machine dilution
In dialysis procedure, dialysis solution carries out ion exchange by the blood of dialyser and patient, removes part small molecular toxin, to reach the object for the treatment of.
But because human blood in dialyzer membrane is different from the composition of the dialysis solution outside film, the vitamin in human blood can cause part to run off due to Concentraton gradient difference.
Summary of the invention
The problem to be solved in the present invention is to provide a kind of using water-soluble (vitamin) B and C as the dialysate concentrate of additive, is particularly suitable for the use of conventional hemodialysis (CHD).
For solving the problems of the technologies described above, the technical solution used in the present invention is: a kind of dialysate concentrate containing vitamin, comprises water soluble vitamins, described water soluble vitamins comprise in vitamin C and vitamin B one or both.
Further, described water soluble vitamins comprises the vitamin C that concentration is 0.5-2.4g/10L.
Described water soluble vitamins comprises the vitamin B that concentration is 3-16g/10L.
Described water soluble vitamins comprises vitamin C that concentration is 0.5-2.4g/10L and concentration is the vitamin B of 3-16g/10L.
Further, comprising concentration in described dialysate concentrate is the vitamin C of 0.5-2g/10L and the vitamin B of 3-12g/10L, also comprises the PH adjusting agent of sodium chloride that concentration is 2000-2300g/10L, the potassium chloride of 0-220g/10L, the calcium chloride of 50-250g/10L, the magnesium chloride of 30-75g/10L and 50-150g/10L in described dialysate concentrate.
The sodium bicarbonate that concentration is 385-700g/10L is also comprised in described dialysate concentrate.
Further, the vitamin C that concentration is 0.55-2.2g/10L is comprised in described dialysate concentrate, the vitamin B of 3.5-14g/10L, also comprises the PH adjusting agent of sodium chloride that concentration is 1600-1800g/10L, the potassium chloride of 0-240g/10L, the calcium chloride of 50-280g/10L, the magnesium chloride of 30-80g/10L and 50-350g/10L in described dialysate concentrate.
Also comprising concentration in described dialysate concentrate is the sodium chloride of 200-350g/10L and the sodium bicarbonate of 600-900g/10L.
Further, comprising concentration in described dialysate concentrate is the vitamin C of 0.6-2.4g/10L and the vitamin B of 4-16g/10L, also comprises the PH adjusting agent of sodium chloride that concentration is 2000-2300g/10L, the potassium chloride of 0-220g/10L, the calcium chloride of 50-250g/10L, the magnesium chloride of 30-75g/10L and 50-180g/10L in described dialysate concentrate.
The sodium bicarbonate that concentration is 385-900g/10L is also comprised in described dialysate concentrate.
The advantage that the present invention has and good effect are: owing to adopting technique scheme, high degree decreases the loss of vitamin B and C, is controlled, in reasonable concentration range, to reduce the burden of patient's metabolism, improve the comfort level of dialysis, and then ensure that the life quality of patient.
Detailed description of the invention
Embodiment:
Vitamin B group maintains the indispensable water soluble vitamins of human normal function and metabolic activity, and human body cannot manufacture synthesis voluntarily, must be extra supplementary.It is supplementary that vitamin B group is also that dialysis patient needs most, and main cause is in dialysis procedure, have a large amount of losses.
Vitamin B complex has more than 12 kinds, and that is unanimously generally acknowledged by the world has nine kinds, and be water soluble vitamins entirely, the time of being detained in vivo only has a few hours, must supplement every day.Vitamin B group is the requisite nutrient of everyone soma, is the key that food releases energy.Be coenzyme entirely, participate in the metabolism of sugar, protein and fat in body, be therefore listed in of the same clan.All vitamin Bs must play a role simultaneously, are called the fusion of VB.
Vitamin C is wound repair, the necessary material of building up resistance, also easily a large amount of loss in dialysis procedure, therefore should supplement every day.
The technical scheme of the embodiment of the present invention adds water-soluble (vitamin) B and C in existing dialysate concentrate, to reduce vitamin loss during dialysis.Dialysate concentrate can be dialysis concentrated solution also can be dialysis dry powder, if dialysis dry powder, then needs dilution for concentrated solution in use." g/10L " this unit representation in the present embodiment: for dialysis concentrated solution, just refer to the content of material in 10L concentrated solution; For dialysis dry powder, after just referring to that dialysis dry powder is diluted to 10L, content of material wherein.
Existing dialysate concentrate formula, is generally the content of table 2, but is not limited only to table 2.
Table 2: in prior art, the formula of dialysate concentrate
Show the measurement result of health volunteer, in healthy human body, vitamin C plasma concentration is 26.7nmol/ml(4.7 μ g/ml), vitamin B plasma concentration is 96.8nmol/ml(29 μ g/ml).Vitamin B in the present invention's foundation healthy human body and the plasma concentration component design of C, the formula of the embodiment of the present invention is as shown in table 3.During each dialysis, need according to patient profiles, use of following the doctor's advice.
Table 3: the formula of the embodiment of the present invention
With 706 plasma substitute simulation blood of human body, the vitamin B wherein added, C and body burden are suitable.Be below three simulation dialysis experiments: in dialysis solution, the content of vitamin B, C is respectively and measures with the content equivalent of the vitamin B in 706 plasma substitutes, C, half and do not add vitamin B, C in dialysis solution.
The experiment condition of three simulation dialysis experiments is: dialysate temperature is 36.5 ± 0.5 DEG C; 706 plasma substitute temperature are 36.5 ± 0.5 DEG C; Dialysate flow is 500ml/min; 706 plasma substitute flows are 200ml/min; Dialyser model is Nipro130G; Dialysis time is 4 hours; The method of inspection is high-efficient liquid phase technique.
Experiment 1:
Blood side: 706 plasma substitute 5L, adds vitamin C 0.0235g, vitamin B 0.145g.
Dialysis fluid side: dialysate concentrate formula selects formula in embodiment 1, each component content is as shown in table 4.
Table 4: dialysate concentrate formula in experiment 1
Dialysate concentrate is according to A:B: after water=1:1.6:32.4 dilution, dialysis solution ion concentration is as shown in table 5.
Table 5: after dialysate concentrate dilution, dialysis solution ion concentration and pH value thereof
After simulation dialysis experiment terminates, high-efficient liquid phase technique is utilized to detect the content obtaining vitamin B, C in 706 plasma substitutes and dialysis solution as shown in table 6.
Table 6: after simulation dialysis experiment, the content (nmol/ml) of vitamin B, C in 706 plasma substitutes and dialysis solution
Experiment 2:
Blood side: 706 plasma substitute 5L, adds vitamin C 0.0235g, vitamin B 0.145g.
Dialysis fluid side: dialysate concentrate selects formula in embodiment 2, each component content is as shown in table 7.
Table 7: dialysate concentrate formula in experiment 2
Dialysate concentrate is according to A:B: after water=1:1.6:32.4 dilution, dialysis solution ion concentration is as shown in table 8.
Table 8: after dialysate concentrate dilution, dialysis solution ion concentration and pH value thereof
After simulation dialysis experiment terminates, high-efficient liquid phase technique is utilized to detect the content obtaining vitamin B, C in 706 plasma substitutes and dialysis solution as shown in table 9.
Table 9: after simulation dialysis experiment, the content (nmol/ml) of vitamin B, C in 706 plasma substitutes and dialysis solution
Experiment 3:
Blood side: 706 plasma substitute 5L, adds vitamin C 0.0235g, vitamin B 0.145g.Dialysis fluid side: dialysate concentrate does not add vitamin C and B, and content is as shown in table 10.
Table 10: dialysate concentrate formula in experiment 3
Dialysate concentrate is according to A:B: after water=1:1.6:32.4 dilution, dialysis solution ion concentration is as shown in table 11.
Table 11: after dialysate concentrate dilution, dialysis solution ion concentration and pH value thereof
After simulation dialysis experiment terminates, high-efficient liquid phase technique is utilized to detect the content obtaining vitamin B, C in 706 plasma substitutes and dialysis solution as shown in table 12.
Table 12: after simulation dialysis experiment, the content (nmol/ml) of vitamin B, C in 706 plasma substitutes and dialysis solution
Data in experiment 1,2,3 show:
In experiment 1, what dialysis solution added is and vitamin B, the C of simulation blood of human body equivalent, and after dialysis, the vitamin B in 706 plasma substitutes and dialysis solution, the content of C do not have significant change at Before and after dialysis.For testing the optimum formula in 1,2,3.
In experiment 2, that dialysis solution adds is vitamin B, the C that simulation blood of human body half is measured, after dialysis, vitamin B in 706 plasma substitutes and dialysis solution, the content of C there occurs change at Before and after dialysis, in 706 plasma substitutes, vitamin B, C content reduce, and vitamin B, C content raise in dialysis solution, illustrate that some vitamin B, C are run off in dialysis solution by dialyser in dialysis procedure.
In experiment 3, vitamin B, C is not added in dialysis solution, after dialysis, vitamin B in 706 plasma substitutes and dialysis solution, the content of C there occurs change at Before and after dialysis, in 706 plasma substitutes, vitamin B, C content reduce, and vitamin B, C content raise in dialysis solution, and content is about the half of content in 706 plasma substitutes, has illustrated that some vitamin B, C are run off in dialysis solution by dialyser in dialysis procedure.
Therefore, in dialysis solution, add vitamin B, C, effectively can stop the loss of vitamin B in human body, C.Improve the comfort level that improve dialysis of patient, and then ensure that the life quality of patient.
Above embodiments of the invention and the experiment relevant to embodiment have been described in detail, but described content being only preferred embodiment of the present invention, can not being considered to for limiting practical range of the present invention.All equalizations done according to the present patent application scope change and improve, and all should still belong within patent covering scope of the present invention.

Claims (10)

1., containing the dialysate concentrate of vitamin, it is characterized in that: comprise water soluble vitamins, described water soluble vitamins comprise in vitamin C and vitamin B one or both.
2. dialysate concentrate according to claim 1, is characterized in that: described water soluble vitamins comprises the vitamin C that concentration is 0.5-2.4g/10L.
3. dialysate concentrate according to claim 1, is characterized in that: described water soluble vitamins comprises the vitamin B that concentration is 3-16g/10L.
4. dialysate concentrate according to claim 1, is characterized in that: described water soluble vitamins comprises vitamin C that concentration is 0.5-2.4g/10L and concentration is the vitamin B of 3-16g/10L.
5. dialysate concentrate according to claim 4, it is characterized in that: comprising concentration in described dialysate concentrate is the vitamin C of 0.5-2g/10L and the vitamin B of 3-12g/10L, in described dialysate concentrate, also comprise the PH adjusting agent of sodium chloride that concentration is 2000-2300g/10L, the potassium chloride of 0-220g/10L, the calcium chloride of 50-250g/10L, the magnesium chloride of 30-75g/10L and 50-150g/10L.
6. dialysate concentrate according to claim 5, is characterized in that: also comprise the sodium bicarbonate that concentration is 385-700g/10L in described dialysate concentrate.
7. dialysate concentrate according to claim 4, it is characterized in that: in described dialysate concentrate, comprise the vitamin C that concentration is 0.55-2.2g/10L, the vitamin B of 3.5-14g/10L, also comprises the PH adjusting agent of sodium chloride that concentration is 1600-1800g/10L, the potassium chloride of 0-240g/10L, the calcium chloride of 50-280g/10L, the magnesium chloride of 30-80g/10L and 50-350g/10L in described dialysate concentrate.
8. dialysate concentrate according to claim 7, is characterized in that: also comprising concentration in described dialysate concentrate is the sodium chloride of 200-350g/10L and the sodium bicarbonate of 600-900g/10L.
9. dialysate concentrate according to claim 4, it is characterized in that: comprising concentration in described dialysate concentrate is the vitamin C of 0.6-2.4g/10L and the vitamin B of 4-16g/10L, in described dialysate concentrate, also comprise the PH adjusting agent of sodium chloride that concentration is 2000-2300g/10L, the potassium chloride of 0-220g/10L, the calcium chloride of 50-250g/10L, the magnesium chloride of 30-75g/10L and 50-180g/10L.
10. dialysate concentrate according to claim 9, is characterized in that: also comprise the sodium bicarbonate that concentration is 385-900g/10L in described dialysate concentrate.
CN201310434028.1A 2013-09-22 2013-09-22 Dialysis concentrate containing vitamins Pending CN104434959A (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111481570A (en) * 2020-05-29 2020-08-04 甘肃锦东医疗器械有限公司 Citric acid hemodialysis concentrate for supplementing vitamin K
CN111544449A (en) * 2020-05-29 2020-08-18 甘肃锦东医疗器械有限公司 Citric acid hemodialysis concentrate for supplementing vitamin D

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1561967A (en) * 2004-03-23 2005-01-12 毛一鹏 Nano-scale vitamin microemulsion and preparation method thereof
CN101366781A (en) * 2008-09-22 2009-02-18 北京冠五洲生物科学研究院 Medicament composition for preventing birth defection and improving memory
CN102370990A (en) * 2010-08-09 2012-03-14 俞黎黎 Blood purification preparation using malic acid as pH conditioning agent, and preparation method and application thereof

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1561967A (en) * 2004-03-23 2005-01-12 毛一鹏 Nano-scale vitamin microemulsion and preparation method thereof
CN101366781A (en) * 2008-09-22 2009-02-18 北京冠五洲生物科学研究院 Medicament composition for preventing birth defection and improving memory
CN102370990A (en) * 2010-08-09 2012-03-14 俞黎黎 Blood purification preparation using malic acid as pH conditioning agent, and preparation method and application thereof

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111481570A (en) * 2020-05-29 2020-08-04 甘肃锦东医疗器械有限公司 Citric acid hemodialysis concentrate for supplementing vitamin K
CN111544449A (en) * 2020-05-29 2020-08-18 甘肃锦东医疗器械有限公司 Citric acid hemodialysis concentrate for supplementing vitamin D

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Application publication date: 20150325

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