DE2851037C2 - Process for the stabilization of sodium thiosulphate solutions intended for medical purposes - Google Patents
Process for the stabilization of sodium thiosulphate solutions intended for medical purposesInfo
- Publication number
- DE2851037C2 DE2851037C2 DE19782851037 DE2851037A DE2851037C2 DE 2851037 C2 DE2851037 C2 DE 2851037C2 DE 19782851037 DE19782851037 DE 19782851037 DE 2851037 A DE2851037 A DE 2851037A DE 2851037 C2 DE2851037 C2 DE 2851037C2
- Authority
- DE
- Germany
- Prior art keywords
- sodium
- solutions
- stabilization
- sodium thiosulphate
- alkali metal
- Prior art date
- 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.)
- Expired
Links
- AKHNMLFCWUSKQB-UHFFFAOYSA-L sodium thiosulfate Chemical compound [Na+].[Na+].[O-]S([O-])(=O)=S AKHNMLFCWUSKQB-UHFFFAOYSA-L 0.000 title claims description 13
- 235000019345 sodium thiosulphate Nutrition 0.000 title claims description 13
- 238000000034 method Methods 0.000 title claims description 4
- 239000004133 Sodium thiosulphate Substances 0.000 title description 10
- 230000006641 stabilisation Effects 0.000 title description 3
- 238000011105 stabilization Methods 0.000 title description 3
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 12
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims description 8
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 7
- 239000004471 Glycine Substances 0.000 claims description 4
- 239000003638 chemical reducing agent Substances 0.000 claims description 4
- CDBYLPFSWZWCQE-UHFFFAOYSA-L sodium carbonate Substances [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 claims description 4
- GEHJYWRUCIMESM-UHFFFAOYSA-L sodium sulfite Chemical compound [Na+].[Na+].[O-]S([O-])=O GEHJYWRUCIMESM-UHFFFAOYSA-L 0.000 claims description 4
- 150000001370 alpha-amino acid derivatives Chemical class 0.000 claims description 3
- 235000008206 alpha-amino acids Nutrition 0.000 claims description 3
- 235000001014 amino acid Nutrition 0.000 claims description 3
- 239000011780 sodium chloride Substances 0.000 claims description 3
- GZLGNNHEHXBCBI-UHFFFAOYSA-L [Na+].[Na+].OC(=O)C(O)C(O)C(O)=O.[O-]C(=O)C(O)C(O)C([O-])=O Chemical compound [Na+].[Na+].OC(=O)C(O)C(O)C(O)=O.[O-]C(=O)C(O)C(O)C([O-])=O GZLGNNHEHXBCBI-UHFFFAOYSA-L 0.000 claims description 2
- 229910000029 sodium carbonate Inorganic materials 0.000 claims description 2
- 235000010265 sodium sulphite Nutrition 0.000 claims description 2
- 230000000087 stabilizing effect Effects 0.000 claims description 2
- 229910001514 alkali metal chloride Inorganic materials 0.000 claims 2
- 229910052936 alkali metal sulfate Inorganic materials 0.000 claims 2
- 239000000243 solution Substances 0.000 description 18
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 6
- 239000003513 alkali Substances 0.000 description 5
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 description 4
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 4
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 description 3
- 239000007789 gas Substances 0.000 description 3
- 238000001802 infusion Methods 0.000 description 3
- MWUXSHHQAYIFBG-UHFFFAOYSA-N nitrogen oxide Inorganic materials O=[N] MWUXSHHQAYIFBG-UHFFFAOYSA-N 0.000 description 3
- DHCDFWKWKRSZHF-UHFFFAOYSA-L thiosulfate(2-) Chemical compound [O-]S([S-])(=O)=O DHCDFWKWKRSZHF-UHFFFAOYSA-L 0.000 description 3
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 2
- 208000005374 Poisoning Diseases 0.000 description 2
- NINIDFKCEFEMDL-UHFFFAOYSA-N Sulfur Chemical compound [S] NINIDFKCEFEMDL-UHFFFAOYSA-N 0.000 description 2
- LSNNMFCWUKXFEE-UHFFFAOYSA-N Sulfurous acid Chemical compound OS(O)=O LSNNMFCWUKXFEE-UHFFFAOYSA-N 0.000 description 2
- 150000001413 amino acids Chemical class 0.000 description 2
- KGBXLFKZBHKPEV-UHFFFAOYSA-N boric acid Chemical compound OB(O)O KGBXLFKZBHKPEV-UHFFFAOYSA-N 0.000 description 2
- 239000004327 boric acid Substances 0.000 description 2
- 239000000872 buffer Substances 0.000 description 2
- 230000003139 buffering effect Effects 0.000 description 2
- 239000012153 distilled water Substances 0.000 description 2
- 238000001914 filtration Methods 0.000 description 2
- -1 for example Chemical class 0.000 description 2
- LELOWRISYMNNSU-UHFFFAOYSA-N hydrogen cyanide Chemical compound N#C LELOWRISYMNNSU-UHFFFAOYSA-N 0.000 description 2
- 150000002825 nitriles Chemical class 0.000 description 2
- 231100000572 poisoning Toxicity 0.000 description 2
- 230000000607 poisoning effect Effects 0.000 description 2
- 229910000030 sodium bicarbonate Inorganic materials 0.000 description 2
- 235000017557 sodium bicarbonate Nutrition 0.000 description 2
- 229910001220 stainless steel Inorganic materials 0.000 description 2
- 239000010935 stainless steel Substances 0.000 description 2
- 229910052717 sulfur Inorganic materials 0.000 description 2
- 239000011593 sulfur Substances 0.000 description 2
- UEUXEKPTXMALOB-UHFFFAOYSA-J tetrasodium;2-[2-[bis(carboxylatomethyl)amino]ethyl-(carboxylatomethyl)amino]acetate Chemical compound [Na+].[Na+].[Na+].[Na+].[O-]C(=O)CN(CC([O-])=O)CCN(CC([O-])=O)CC([O-])=O UEUXEKPTXMALOB-UHFFFAOYSA-J 0.000 description 2
- QWCKQJZIFLGMSD-UHFFFAOYSA-N 2-Aminobutanoic acid Natural products CCC(N)C(O)=O QWCKQJZIFLGMSD-UHFFFAOYSA-N 0.000 description 1
- 235000003351 Brassica cretica Nutrition 0.000 description 1
- 235000003343 Brassica rupestris Nutrition 0.000 description 1
- 241000219193 Brassicaceae Species 0.000 description 1
- QNAYBMKLOCPYGJ-UHFFFAOYSA-N D-alpha-Ala Natural products CC([NH3+])C([O-])=O QNAYBMKLOCPYGJ-UHFFFAOYSA-N 0.000 description 1
- QWCKQJZIFLGMSD-GSVOUGTGSA-N D-alpha-aminobutyric acid Chemical compound CC[C@@H](N)C(O)=O QWCKQJZIFLGMSD-GSVOUGTGSA-N 0.000 description 1
- QNAYBMKLOCPYGJ-REOHCLBHSA-N L-alanine Chemical compound C[C@H](N)C(O)=O QNAYBMKLOCPYGJ-REOHCLBHSA-N 0.000 description 1
- 229910052783 alkali metal Inorganic materials 0.000 description 1
- 239000000729 antidote Substances 0.000 description 1
- 150000004982 aromatic amines Chemical class 0.000 description 1
- 229910021538 borax Inorganic materials 0.000 description 1
- 239000000571 coke Substances 0.000 description 1
- 239000000824 cytostatic agent Substances 0.000 description 1
- 230000001085 cytostatic effect Effects 0.000 description 1
- 230000007717 exclusion Effects 0.000 description 1
- 229910052736 halogen Inorganic materials 0.000 description 1
- 150000002367 halogens Chemical class 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 235000010460 mustard Nutrition 0.000 description 1
- 150000002826 nitrites Chemical class 0.000 description 1
- 229910052757 nitrogen Inorganic materials 0.000 description 1
- 238000010979 pH adjustment Methods 0.000 description 1
- 239000002244 precipitate Substances 0.000 description 1
- 238000001556 precipitation Methods 0.000 description 1
- 239000000779 smoke Substances 0.000 description 1
- SRRKNRDXURUMPP-UHFFFAOYSA-N sodium disulfide Chemical compound [Na+].[Na+].[S-][S-] SRRKNRDXURUMPP-UHFFFAOYSA-N 0.000 description 1
- HRZFUMHJMZEROT-UHFFFAOYSA-L sodium disulfite Chemical compound [Na+].[Na+].[O-]S(=O)S([O-])(=O)=O HRZFUMHJMZEROT-UHFFFAOYSA-L 0.000 description 1
- 235000010262 sodium metabisulphite Nutrition 0.000 description 1
- 235000010339 sodium tetraborate Nutrition 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 238000004659 sterilization and disinfection Methods 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- DPUZPWAFXJXHBN-UHFFFAOYSA-N tetrasodium dioxidoboranyloxy(dioxido)borane Chemical compound [Na+].[Na+].[Na+].[Na+].[O-]B([O-])OB([O-])[O-] DPUZPWAFXJXHBN-UHFFFAOYSA-N 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
- BSVBQGMMJUBVOD-UHFFFAOYSA-N trisodium borate Chemical compound [Na+].[Na+].[Na+].[O-]B([O-])[O-] BSVBQGMMJUBVOD-UHFFFAOYSA-N 0.000 description 1
Classifications
-
- C—CHEMISTRY; METALLURGY
- C01—INORGANIC CHEMISTRY
- C01B—NON-METALLIC ELEMENTS; COMPOUNDS THEREOF; METALLOIDS OR COMPOUNDS THEREOF NOT COVERED BY SUBCLASS C01C
- C01B17/00—Sulfur; Compounds thereof
- C01B17/64—Thiosulfates; Dithionites; Polythionates
Landscapes
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Inorganic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Description
Die vorliegende Erfindung betrifft ein Verfahren zur Stabilisierung insbesondere von Natriumthiosulfat-Lösungen, welche für Injektionen und Infusionen bestimmt sind.The present invention relates to a method for stabilizing, in particular, sodium thiosulphate solutions, which are intended for injections and infusions.
Natriumthiosulfat dient als Antidot zur Behandlung von Vergiftungen mit Cyaniden, Nitrilen, Blausäure, Nitriten, aromatischen Aminen, Rauchgasen, Auspuffgasen, Kokerei- und Gichtgasen, sowie von Vergiftungen mt Halogenen, Stickoxiden, S-Lost, N-Lost und zytostatischen Alkylantien.Sodium thiosulphate is used as an antidote for the treatment of poisoning with cyanides, nitriles, hydrocyanic acid, Nitrites, aromatic amines, smoke gases, exhaust gases, coke oven and blast furnace gases, as well as poisoning with halogens, nitrogen oxides, sulfur mustards, nitrogen mustards and cytostatic alkylants.
In diesem Zusammenhang verweisen wir beispielsweise auf Weger; Wehrmedizinische Monatsschrift 19 (1) f» bis 11 (1975).In this context we refer, for example, to Weger; Military Medical Monthly 19 (1) f » to 11 (1975).
Es ist sehr bekannt, daß Natriumthiosulfat-Lösungen beim Sterilisieren und/oder beim Lagern eine ungenügende Stabilität aufweisen, weshalb es erforderlich ist, durch geeignete Maßnahmen die Haltbarkeit von 10 bis 25% wässerigen Thiosulfat-Lösungen zu stabilisieren. Es wurde beispielsweise vorgeschlagen, Natriumthiosulfat-Lösungen durch Zusatz wechselnder Mengen von Natriumhydrogencarbonat und von Zitronensäure oder aber durch Zusatz von Di-natrium-hydrogenphosphat oder durch Zusatz von Borsäure und Natrium-di-borat auf pH-Werte 7,2 bis 7,5 zu puffern und dadurch zu stabilisieren. Es hat sich gezeigt, daß durch Zusatz von Natriumhydrogencarbonat und Zitronensäure oder durch Zusatz von Dinatriumhydrogenphosphat keine genügende Stabilisierungerzielt wird. Bessere Ergebnisse wurden durch Pufferung von Thiosulfat-Lösungen mit Borsäure und Natrium-di-borat erzielt. Leider sind derartige Lösungen wegen ihres Gehaltes an toxischen Stabilisatoren für medizinische Zwecke unbrauchbar. Es wurde nun überraschend gefunden, daß sich wässerig«-. Thiosulfat-Lösungen ausgezeichnet stabilisieren lassen, wenn man die Lösungen mit einer α-Aminosäure und Alkalichlorid puffert, zur weiteren Stabilisierung ein Reduktionsmittel bestehend aus Alkalisulfit zufügt und schließlich die Lösungen durch Zusatz von Di-natrium-hydrogentartrat und Natriumhydroxid oder von Natriumcarbonat auf einen pH-Wert von 9,0 bis 9,5It is very well known that sodium thiosulphate solutions are insufficient during sterilization and / or storage Have stability, which is why it is necessary to take appropriate measures to extend the shelf life to stabilize 10 to 25% aqueous thiosulphate solutions. For example, it has been suggested Sodium thiosulphate solutions by adding varying amounts of sodium hydrogen carbonate and of Citric acid or by adding disodium hydrogen phosphate or by adding boric acid and to buffer sodium borate to pH values 7.2 to 7.5 and thereby stabilize it. It has shown that by adding sodium hydrogen carbonate and citric acid or by adding disodium hydrogen phosphate insufficient stabilization is achieved. Better results have been achieved through Buffering of thiosulphate solutions with boric acid and sodium diborate is achieved. Unfortunately, such solutions are unsuitable for medical purposes because of their content of toxic stabilizers. It was now surprisingly found that watery «-. Thiosulfate solutions Can be stabilized excellently if the solutions with an α-amino acid and Alkali chloride buffers, for further stabilization a reducing agent consisting of alkali sulfite is added and finally the solutions by adding disodium hydrogen tartrate and sodium hydroxide or sodium carbonate to a pH of 9.0 to 9.5
einstellt.adjusts.
Als α-Aminosäure wird dazu vorzugsweise Glycin oder eine andere leicht zugängliche Aminosäure wie beispielsweise α-Aminopropionsäure oder a-Aminobuttersäure verwendet. Als Alkalichlorid wird vorzugsweise Natriumchlorid und als Alkalisulfit ein Natriumsulfit als Reduktionsmittel zugesetzt.The α-amino acid used for this purpose is preferably glycine or another easily accessible amino acid such as for example, α-aminopropionic acid or α-aminobutyric acid is used. The preferred alkali chloride is Sodium chloride and, as alkali metal sulfite, a sodium sulfite added as reducing agent.
Durch die Pufferung mit einer Aminosäure und Alkalichlorid, den Zusatz eines Reduktionsmittels bein stehend aus Alkalisulfit und der pH-Einstellung von 9,0 bis 9,5 gelingt es, die Stabilität von wässerigen Natriumthiosulfat-Lösungen in den Konzentrationen von 10 bis 25% langfristig, d. h. für mehrere Jahre, sicherzustellen.By buffering with an amino acid and alkali chloride, the addition of a reducing agent Standing out from alkali sulfite and the pH adjustment from 9.0 to 9.5 it manages the stability of aqueous Sodium thiosulphate solutions in concentrations of 10 to 25% long-term, d. H. for several years, to ensure.
Γι Die erfindungsgemäß hergestellten wässerigen Natriumthiosulfat-Lösungen bleiben beim Lagern unter den üblichen Bedingungen, d. h. bei 15 bis 25° C und unter Lichtausschluß frei von Niederschläge.! oder Ausfällungen, bei denen es sich in der Regel um kol-JMi loidalen Schwefel oder dessen Agglomerate handelt. Die so stabilisierten Natriumthiosulfat-Lösungen lassen sich sogar sterilisieren.Γι The aqueous sodium thiosulfate solutions prepared according to the invention remain under the usual conditions during storage, d. H. at 15 to 25 ° C and free of precipitation with exclusion of light.! or precipitates, which are usually kol-JMi loidal sulfur or its agglomerates. Leave the sodium thiosulphate solutions stabilized in this way even sterilize themselves.
2Ί 1. In einem Rührkessel aus Edelstahl werden nach Vorlage von 2Ί 1. In a stirred tank made of stainless steel, after presentation of
50 1 frisch destilliertem Wasser
85 g Natriumhydroxid
100 g Di-natrium-hydrogenphosphat
yi 380 g Natriumchlorid50 1 freshly distilled water
85 g sodium hydroxide
100 g disodium hydrogen phosphate
yi 380 g sodium chloride
560 g Glycin
10 g Natriumdisulfid und
10 g Natrium-EDTA560 grams of glycine
10 g sodium disulfide and
10 g sodium EDTA
eingetragen und gelöst. Zu dieser Lösung werden π 25 kg Natriumthiosulfat portionsweise zugesetzt,registered and solved. 25 kg of sodium thiosulfate are added in portions to this solution,
worauf der Kesselinhalt mit Wasser ad iniectabilia auf 100 I aufgefüllt wird.
Nach Filtration dieser Lösung wird in Ampullen oder Infusionsflaschen abgefüllt und lege artis
in bei 1200C, während 20 Minuten, sterilisiert.whereupon the contents of the kettle are made up to 100 l with water ad iniectabilia.
After filtration of this solution it is filled into ampoules or infusion bottles and sterilized at 120 ° C. for 20 minutes.
Die so hergestellte 25%ige Natriumthiosulfat-Lösung zeichnet sich durch eine sehr hohe Stabilität aus.The 25% sodium thiosulphate solution produced in this way is characterized by a very high level of stability the end.
2. In einem Rührkcssel aus Edelstahl werden nach ι > Vorlage von2. In a stirring bowl made of stainless steel, according to ι> template of
50 I frisch destilliertem Wasser
85 g Natriumhydroxid
100 g Di-natrium-hydrogenphosphat
380 g Natriumchlorid
-■ι) 560 g Glycin50 l of freshly distilled water
85 g sodium hydroxide
100 g disodium hydrogen phosphate
380 g sodium chloride
- ■ ι) 560 g of glycine
10 g Natriumdisulfit und
l')g Natrium-EDTA10 g sodium disulfite and
l ') g of sodium EDTA
eingetragen und gelöst. Zu dieser Lösung werden 10 kg Natriumthiosulfat portionsweise zugesetzt, V) worauf der Kesselinhalt mit Wasser ad inicetabi-registered and solved. Become this solution 10 kg of sodium thiosulphate added in portions, V) whereupon the boiler contents with water ad inicetabi-
Nach Filtration dieser Lösung wird in Ampullen oder Infusionsflaschen abgefüllt und lege artis bei ho 120° C, während 20 Minuten, sterilisiert.After filtering this solution, it is filled into ampoules or infusion bottles and enclosed with artis ho 120 ° C, for 20 minutes, sterilized.
Die so hergestellte lOfrige Natriumthiosulfat-l.ösung ist von sehr guter Stabilitiit.The sodium thiosulphate solution prepared in this way is of very good stability.
Claims (2)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE19782851037 DE2851037C2 (en) | 1978-11-25 | 1978-11-25 | Process for the stabilization of sodium thiosulphate solutions intended for medical purposes |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE19782851037 DE2851037C2 (en) | 1978-11-25 | 1978-11-25 | Process for the stabilization of sodium thiosulphate solutions intended for medical purposes |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| DE2851037B1 DE2851037B1 (en) | 1980-02-14 |
| DE2851037C2 true DE2851037C2 (en) | 1980-10-02 |
Family
ID=6055524
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DE19782851037 Expired DE2851037C2 (en) | 1978-11-25 | 1978-11-25 | Process for the stabilization of sodium thiosulphate solutions intended for medical purposes |
Country Status (1)
| Country | Link |
|---|---|
| DE (1) | DE2851037C2 (en) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE3048211A1 (en) * | 1980-12-20 | 1982-07-08 | Volker Dr.med. 5000 Köln Schulz | SODIUM NITROPRUSSIDE SODIUM THIOSULFATE PERFUSOR KIT |
| CN112805238A (en) | 2018-07-03 | 2021-05-14 | 芬内克制药股份有限公司 | Anhydrous sodium thiosulfate and formulations thereof |
-
1978
- 1978-11-25 DE DE19782851037 patent/DE2851037C2/en not_active Expired
Also Published As
| Publication number | Publication date |
|---|---|
| DE2851037B1 (en) | 1980-02-14 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| 8327 | Change in the person/name/address of the patent owner |
Owner name: DR. FRANZ KOEHLER CHEMIE GMBH, 6146 ALSBACH, DE |
|
| 8339 | Ceased/non-payment of the annual fee |