GR1009074B - A sodium bicarbonate-containing cartridge with added anhydrous citric acid as ph stabiliser - Google Patents
A sodium bicarbonate-containing cartridge with added anhydrous citric acid as ph stabiliser Download PDFInfo
- Publication number
- GR1009074B GR1009074B GR20160100172A GR20160100172A GR1009074B GR 1009074 B GR1009074 B GR 1009074B GR 20160100172 A GR20160100172 A GR 20160100172A GR 20160100172 A GR20160100172 A GR 20160100172A GR 1009074 B GR1009074 B GR 1009074B
- Authority
- GR
- Greece
- Prior art keywords
- sodium bicarbonate
- citric acid
- anhydrous citric
- cartridge
- solution
- Prior art date
Links
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 title claims abstract description 38
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 title claims abstract description 35
- 229910000030 sodium bicarbonate Inorganic materials 0.000 title claims abstract description 19
- 235000017557 sodium bicarbonate Nutrition 0.000 title claims abstract description 19
- 229960004543 anhydrous citric acid Drugs 0.000 title claims abstract description 14
- 239000003381 stabilizer Substances 0.000 title abstract description 5
- 238000001631 haemodialysis Methods 0.000 claims abstract description 6
- 230000000322 hemodialysis Effects 0.000 claims abstract description 6
- 239000000203 mixture Substances 0.000 claims abstract 2
- 239000003708 ampul Substances 0.000 claims description 5
- 239000000843 powder Substances 0.000 claims description 5
- CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 claims description 4
- 235000015165 citric acid Nutrition 0.000 claims description 4
- 239000000004 hemodialysis solution Substances 0.000 claims description 4
- -1 Polypropylene Polymers 0.000 claims description 2
- 239000001569 carbon dioxide Substances 0.000 claims description 2
- 229910002092 carbon dioxide Inorganic materials 0.000 claims description 2
- 238000000034 method Methods 0.000 claims description 2
- 239000004743 Polypropylene Substances 0.000 claims 1
- 229920001155 polypropylene Polymers 0.000 claims 1
- 239000001509 sodium citrate Substances 0.000 claims 1
- 239000007787 solid Substances 0.000 claims 1
- 235000019263 trisodium citrate Nutrition 0.000 claims 1
- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 abstract description 12
- 229910000029 sodium carbonate Inorganic materials 0.000 abstract description 6
- UIIMBOGNXHQVGW-DEQYMQKBSA-M Sodium bicarbonate-14C Chemical compound [Na+].O[14C]([O-])=O UIIMBOGNXHQVGW-DEQYMQKBSA-M 0.000 abstract description 2
- 239000000243 solution Substances 0.000 description 9
- 239000000047 product Substances 0.000 description 3
- 239000002253 acid Substances 0.000 description 2
- 229960004106 citric acid Drugs 0.000 description 2
- 210000003734 kidney Anatomy 0.000 description 2
- 230000003472 neutralizing effect Effects 0.000 description 2
- 239000002994 raw material Substances 0.000 description 2
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 description 1
- BVKZGUZCCUSVTD-UHFFFAOYSA-M Bicarbonate Chemical compound OC([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-M 0.000 description 1
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 1
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 description 1
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 description 1
- 239000003929 acidic solution Substances 0.000 description 1
- 239000000872 buffer Substances 0.000 description 1
- 239000011575 calcium Substances 0.000 description 1
- 229910052791 calcium Inorganic materials 0.000 description 1
- 238000005202 decontamination Methods 0.000 description 1
- 230000003588 decontaminative effect Effects 0.000 description 1
- 239000008367 deionised water Substances 0.000 description 1
- 229910021641 deionized water Inorganic materials 0.000 description 1
- 239000008121 dextrose Substances 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 239000012467 final product Substances 0.000 description 1
- 230000001965 increasing effect Effects 0.000 description 1
- 239000011777 magnesium Substances 0.000 description 1
- 229910052749 magnesium Inorganic materials 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- 239000011591 potassium Substances 0.000 description 1
- 229910052700 potassium Inorganic materials 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- CLJTZNIHUYFUMR-UHFFFAOYSA-M sodium;hydrogen carbonate;2-hydroxypropane-1,2,3-tricarboxylic acid Chemical compound [Na+].OC([O-])=O.OC(=O)CC(O)(C(O)=O)CC(O)=O CLJTZNIHUYFUMR-UHFFFAOYSA-M 0.000 description 1
- 230000001052 transient effect Effects 0.000 description 1
- 238000012384 transportation and delivery Methods 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1654—Dialysates therefor
-
- 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
- A61K33/10—Carbonates; Bicarbonates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1654—Dialysates therefor
- A61M1/1656—Apparatus for preparing dialysates
- A61M1/1666—Apparatus for preparing dialysates by dissolving solids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1654—Dialysates therefor
- A61M1/1656—Apparatus for preparing dialysates
- A61M1/1668—Details of containers
- A61M1/167—Flexible packaging for solid concentrates
Landscapes
- Health & Medical Sciences (AREA)
- Urology & Nephrology (AREA)
- Heart & Thoracic Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Hematology (AREA)
- Biomedical Technology (AREA)
- Anesthesiology (AREA)
- Vascular Medicine (AREA)
- Emergency Medicine (AREA)
- Inorganic Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- External Artificial Organs (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
Description
ΦΥΣΙΓΓΑ ΔΙΤΤΑΝΑΝΘΡΑΚΙΚΟΥ ΝΑΤΡΙΟΥ ΜΕ ΑΝΥΔΡΟ ΚΙΤΡΙΚΟ ΟΞΥ ΩΣ ΣΤΑΘΕΡΟΠΟΙΗΤΗ ΤΟΥ ΡΗ SODIUM BICARBONATE CARTRIDGE WITH ANHYDROUS CITRIC ACID AS PH STABILIZER
ΠΕΡΙΓΡΑΦΗ ΤΗΣ ΕΦΕΥΡΕΣΗΣ DESCRIPTION OF THE INVENTION
Σκοπός Purpose
Ο σκοπός της χρήσης της φύσιγγας διττανθρακικού νατρίου (όξινου ανθρακικού νατρίου) με άνυδρο κιτρικό οξύ ως σταθεροποιητή του pH είναι η παραγωγή υγρού αιμοκάθαρσης. Η φύσιγγα συνδέεται στο μηχάνημα του τεχνητού νεφρού τύπου GAMBRO και πληρώνεται με απιονισμένο ύδωρ όπου η περιεχόμενη σκόνη του διττανθρακικού νατρίου και κιτρικού οξέος διαλύεται σταδιακά έτσι ώστε να παρέχει το διάλυμα. Το διάλυμα αυτό διέρχεται από το μηχάνημα όπου αναμιγνύεται με κατάλληλο όξινο διάλυμα το οποίο περιέχει ιόντα Νατρίου, Καλιού, Ασβεστίου, Μαγνησίου, Οξικών & Δεξτρόζης. Η μίξη διττανθρακικού νατρίου- κιτρικού οξέος και όξινου διαλύματος γίνεται σε προκαθορισμένες αναλογίες από το ίδιο το μηχάνημα αιμοκάθαρσης χωρίς ανθρώπινη παρέμβαση. Η εφαρμογή της φύσιγγας στο μηχάνημα αιμοκάθαρσης, καθώς και του όξινου διαλύματος γίνεται από ειδικευμένο και εκπαιδευμένο προσωπικό κατά την έναρξη της συνεδρίας αιμοκάθαρσης σε μονάδα τεχνητού νεφρού. The purpose of using sodium bicarbonate (sodium bicarbonate) ampoule with anhydrous citric acid as a pH stabilizer is to produce hemodialysis fluid. The cartridge is connected to the GAMBRO type artificial kidney machine and filled with deionized water where the contained sodium bicarbonate and citric acid powder is gradually dissolved to provide the solution. This solution passes through the machine where it is mixed with a suitable acidic solution containing Sodium, Potassium, Calcium, Magnesium, Acetate & Dextrose ions. The mixing of sodium bicarbonate-citric acid and acid solution is done in predetermined proportions by the hemodialysis machine itself without human intervention. The application of the cartridge to the hemodialysis machine, as well as the acid solution, is done by qualified and trained personnel at the start of the hemodialysis session in an artificial kidney unit.
ΒΙΒΛΙΟΓΡΑΦΙΑ BIBLIOGRAPHY
1) Indian journal of Nephrology. 1) Indian journal of Nephrology.
Basics of base in haemodialysis solution. Basics of base in hemodialysis solution.
Dialysate buffer production, delivery and decontamination. Dialysate buffer production, delivery and decontamination.
N. Desai N. Desai
2) Sodium Bicarbonate Chemistry. Integrated Biomedical Technology, Inc (IBT) 2) Sodium Bicarbonate Chemistry. Integrated Biomedical Technology, Inc (IBT)
Προσφορά του προϊόντος στην κλινική πράξη Offering the product in clinical practice
Το τελικώς προκύπτον διάλυμα αιμοκάθαρσης ελέγχεται από το μηχάνημα αιμοκάθαρσης ως προς την αγωγιμότητα και το ΡΗ. Εχει παρατηρηθεί πως στα πρώτα 20 λεπτά της συνεδρίας η τιμή ΡΗ του διαλύματος μπορεί να ξεπεράσει τα προκαθορισμένα όρια του 6, 8-7, 9. The resulting hemodialysis solution is checked by the hemodialysis machine for conductivity and pH. It has been observed that in the first 20 minutes of the session the pH value of the solution can exceed the predetermined limits of 6.8-7.9.
Μετά την πάροδο αυτή το ΡΗ σταθεροποιείται εντός των αποδεκτών τιμών. Η παροδική αυτή αύξηση του ΡΗ εκτιμάται πως οφείλεται στην παρουσία ανθρακικού νατρίου στο χρησιμοποιούμενο διττανθρακικό νάτριο της φύσιγγας. Το ανθρακικό νάτριο είναι περισσότερο διαλυτό από το διττανθρακικό νάτριο, οπότε στα αρχικά λεπτά της συνεδρίας παρατηρείται αύξηση του ΡΗ του διαλύματος λόγω της διαλυτοποίησης του ανθρακικού νατρίου. Μόλις το ανθρακικό νάτριο διαλυτοποιηθεί το ΡΗ σταθεροποιείται. After this period the pH stabilizes within acceptable values. This transient increase in pH is estimated to be due to the presence of sodium carbonate in the sodium bicarbonate used in the cartridge. Sodium carbonate is more soluble than sodium bicarbonate, so in the initial minutes of the session an increase in the pH of the solution is observed due to the dissolution of sodium carbonate. Once the sodium carbonate dissolves the pH stabilizes.
Για την αντιμετώπιση της παροδικής αύξησης του ΡΗ του διαλύματος έχει προστεθεί στη φύσιγγα Διττανθρακικού Νατρίου άνυδρο κιτρικό οξύ ικανό να εξουδετερώσει αυτήν την αύξηση του ΡΗ. To deal with the temporary increase in the pH of the solution, anhydrous citric acid has been added to the Sodium Bicarbonate ampoule capable of neutralizing this increase in pH.
Η ποσότητα αυτή του κιτρικού οξέος κατά τα πρώτα λεπτά χρήσης του προϊόντος δρα ως ρυθμιστής οξύτητας του περιεχομένου διττανθρακικού διαλύματος εξουδετερώνοντας την αυξητική δράση του ανθρακικού νατρίου στο ΡΗ του διαλύματος. This amount of citric acid during the first minutes of use of the product acts as an acidity regulator of the content of bicarbonate solution, neutralizing the increasing effect of sodium carbonate on the pH of the solution.
ΤΡΟΠΟΣ ΠΑΡΑΣΚΕΥΗΣ: ΦΥΣΙΓΓΑΣ ΔΙΤΤΑΝΘΡΑΚΙΚΟΥ ΝΑΤΡΙΟΥ ΜΕ ΑΝΥΔΡΟ ΚΙΤΡΙΚΟ ΟΞΥ ΩΣ ΣΤΑΘΕΡΟΠΟΙΗΤΗ TOY pH . METHOD OF PREPARATION: SODIUM BICARBONATE CARTRIDGE WITH ANHYDROUS CITRIC ACID AS A PH STABILIZER.
Οι πρώτες ύλες παρασκευής είναι : The raw materials are:
1) Διττανθρακικό Νάτριο . 1) Sodium bicarbonate.
2) Άνυδρο κιτρικό οξύ . 2) Anhydrous citric acid.
Οι πρώτες ύλες πρέπει να ανταποκρίνονται στις προδιανραφές της ισχύουσας έκδοσης της Ευρωπαϊκής φαρμακοποιίας 2014. The raw materials must meet the specifications of the current edition of the European Pharmacopoeia 2014.
i. Ζυγίζονται οι ποσότητες διττανθρακικού νατρίου και κιτρικού οξέος ii. OL ποσότητες φέρονται στον αναμικτήρα κόνεων και αναμιγνύονται για 30 min i. Weigh the amounts of sodium bicarbonate and citric acid ii. OL quantities are brought to the powder mixer and mixed for 30 min
iii. Μετά την ολοκλήρωση της ανάμιξης ελέγχεται η ομοιογένεια της προκΰπτουσας σκόνης με ποσοτικό προσδιορισμό των συστατικών τους. iii. After the mixing is complete, the homogeneity of the resulting powder is checked by quantitative determination of their components.
iv. Το προϊόν της ανάμιξης, πριν την πλήρωση του, παραμένει επί μια εβδομάδα σε σάκο μέχρι να ολοκληρωθεί η αντίδραση της σκόνης του άνυδρου κιτρικού οξέος με την σκόνη του διττανθρακικού νατρίου και να απομακρυνθεί το παραγόμενο διοξείδιο του άνθρακα το οποίο εάν παραμείνει μπορεί να προκαλέσει παραμόρφωση της φύσιγγας στο τελικό προϊόν. iv. The mixing product, before filling, remains for a week in a bag until the reaction of the anhydrous citric acid powder with the sodium bicarbonate powder is completed and the carbon dioxide produced is removed which, if it remains, can cause distortion of the cartridge in the final product.
C6H8O7+ 3NaHC03→ Na3C6HsO7+ 3Η2O 3CO2^ C6H8O7+ 3NaHC03→ Na3C6HsO7+ 3H2O 3CO2^
ν. Μετά την ολοκλήρωση της αντίδρασης η αναμειχθείσα ποσότητα φέρεται στον κάδο του μηχανήματος συσκευασίας όπου γίνεται πλήρωση των φυσίγγων . n. After the completion of the reaction, the mixed quantity is brought to the bucket of the packaging machine where the cartridges are filled.
Claims (5)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GR20160100172A GR1009074B (en) | 2016-04-20 | 2016-04-20 | A sodium bicarbonate-containing cartridge with added anhydrous citric acid as ph stabiliser |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GR20160100172A GR1009074B (en) | 2016-04-20 | 2016-04-20 | A sodium bicarbonate-containing cartridge with added anhydrous citric acid as ph stabiliser |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| GR1009074B true GR1009074B (en) | 2017-07-07 |
Family
ID=60162963
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| GR20160100172A GR1009074B (en) | 2016-04-20 | 2016-04-20 | A sodium bicarbonate-containing cartridge with added anhydrous citric acid as ph stabiliser |
Country Status (1)
| Country | Link |
|---|---|
| GR (1) | GR1009074B (en) |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1994025084A1 (en) * | 1993-04-23 | 1994-11-10 | Baxter International Inc. | Method for manufacturing and storing stable bicarbonate solutions |
| WO2000044418A1 (en) * | 1999-01-29 | 2000-08-03 | Baxter Biotech Technology S.A.R.L. | Cartridge for dialysis containing sodium bicarbonate |
-
2016
- 2016-04-20 GR GR20160100172A patent/GR1009074B/en active IP Right Grant
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1994025084A1 (en) * | 1993-04-23 | 1994-11-10 | Baxter International Inc. | Method for manufacturing and storing stable bicarbonate solutions |
| WO2000044418A1 (en) * | 1999-01-29 | 2000-08-03 | Baxter Biotech Technology S.A.R.L. | Cartridge for dialysis containing sodium bicarbonate |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PG | Patent granted |
Effective date: 20171023 |