AT165549B - A process for the preparation of hemostatic plug acting and associations - Google Patents

A process for the preparation of hemostatic plug acting and associations

Info

Publication number
AT165549B
AT165549B AT165549DA AT165549B AT 165549 B AT165549 B AT 165549B AT 165549D A AT165549D A AT 165549DA AT 165549 B AT165549 B AT 165549B
Authority
AT
Austria
Prior art keywords
september
thrombin
associations
solution
gelatin
Prior art date
Application number
Other languages
German (de)
Original Assignee
Hoffmann La Roche
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Priority to CH2350347A priority Critical patent/CH264752A/en
Application filed by Hoffmann La Roche filed Critical Hoffmann La Roche
Application granted granted Critical
Publication of AT165549B publication Critical patent/AT165549B/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/32Proteins, polypeptides; Degradation products or derivatives thereof, e.g. albumin, collagen, fibrin, gelatin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42Use of materials characterised by their function or physical properties
    • A61L15/425Porous materials, e.g. foams or sponges
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42Use of materials characterised by their function or physical properties
    • A61L15/64Use of materials characterised by their function or physical properties specially adapted to be resorbable inside the body
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08JWORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G
    • C08J9/00Working-up of macromolecular substances to porous or cellular articles or materials; After-treatment thereof
    • C08J9/28Working-up of macromolecular substances to porous or cellular articles or materials; After-treatment thereof by elimination of a liquid phase from a macromolecular composition or article, e.g. drying of coagulum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
    • A61L2400/00Materials characterised by their function or physical properties
    • A61L2400/04Materials for stopping bleeding
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08JWORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G
    • C08J2389/00Characterised by the use of proteins; Derivatives thereof
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S514/00Drug, bio-affecting and body treating compositions
    • Y10S514/802Fibrinopeptides, blood-coagulation factors or derivatives

Description


    <Desc/Clms Page number 1> <Desc / CLMS Page number 1> 
 



   Verfahren zur Herstellung von hämostatisch wirkenden Pfropfen und Verbänden A process for the preparation of hemostatic plug acting and associations 
 In der Chirurgie werden bereits hämostatisch wirkende, aus Fibrin-und CellulosederivatSchwämmen bestehende Pfropfen und Verbände benützt, die eine Thrombinlösung enthalten. In surgery are already hemostatically acting used consisting of fibrin, and cellulose derivative sponges grafting and associations, which contain a thrombin solution.  Diese Pfropfen und Verbände werden so gebrauchsfertig gemacht, dass man sie unmittelbar vor der Verwendung in die Thrombinlösung eintaucht. These plugs and associations to be made ready for use so that they are immersed immediately before use in the thrombin solution.  Diese Verwendung macht es notwendig, dass die Schwämme aus wasserunlöslichem Material hergestellt werden, da sie sonst bei der Benetzung mit der Thrombinlösung zusammenfallen würden. This use makes it necessary that the sponges are made of water-insoluble material, or they would collapse during wetting with the thrombin solution.  Solche Schwämme haben den grossen Nachteil, dass sie vom Organismus bedeutend schlechter resorbiert werden als lösliche Substanzen. Such sponges have the great disadvantage that they are absorbed by the organism significantly worse than soluble substances. 



    Um diesem Nachteil zu begegnen, verwenden verschiedene Autoren statt diese Schwämme lösliche Gelatine-Gelee, die sie kurz vor Gebrauch in eine Thrombinlösung eintauchen. To this disadvantage to face, using different authors soluble take these sponges gelatin jelly which they are immersed shortly before use, a thrombin.  Die Durchtränkung eines solchen Gelees mit der Thrombinlösung ist aber schwierig und verläuft sehr langsam ; The impregnation of such a jelly with the thrombin solution is, however, difficult and is very slow;  ferner können die Pfropfen und Verbände, wenn sie mit der Thrombinlösung vollgesogen sind, nicht lange aufbewahrt werden, da das Thrombin in Gegenwart von Wasser nicht stabil ist und sehr rasch an Wirksamkeit verliert. Furthermore, the plugs and associations, when they are soaked with the thrombin, can not be kept long, as the thrombin in the presence of water is not stable and very rapidly loses its effectiveness.  Ausserdem wurde festgestellt, dass das Thrombin eine Verminderung des Geliervermögens der Gelatine bewirkt. It was also found that the thrombin causes a reduction of the gelling capacity of the gelatin. 



    Es wurde nun gefunden, dass man hämostatisch wirkende Pfropfen und Verbände aus löslicher It has now been found that grafting hemostatic acting and associations of soluble
 Gelatine dadurch herstellen kann, dass man einer Gelatin can be prepared by allowing a
 Gelatinelösung Thrombin zusetzt, die erhaltene Gelatin solution thrombin is added, the resulting
 Lösung in Schaum vei wandelt, diesen Schaum bei tiefer Temperatur im Vakuum trocknet und den erhaltenen thrombinhaltigen Gelatine- schwamm in geeignete Form bringt. Vei solution converts into foam, this foam is dried at low temperature in vacuo and the obtained thrombin gelatin sponge in suitable form brings.  Gemäss diesem Verfahren werden hämostatisch wirkende According to this method are hemostatically acting
 Pfropfen und Verbände erhalten, die aus einer leicht löslichen Gelatinethrombinmasse von watte- ähnlichem Aussehen bestehen. Grafting and associations obtained, consisting of a readily soluble Gelatinethrombinmasse of cotton wool-like appearance.  Diese Pfropfen und Verbände brauchen vorher nicht in Thrombin- lösung getaucht zu werden, sie können unmittelbar auf die Wunde, wo sie eine sehr rasche Hämostase bewirken, gelegt werden. These plugs and associations do not need advance in thrombin solution to become immersed, they can be on the wound, where they cause a very rapid hemostasis down immediately.

    Das aus der Wunde ausfliessende Blut wird in die schwammige Masse aufgesogen und löst den Gelatinebestandteil auf ; The effluent from the wound, blood is absorbed into the spongy mass and dissolves the gelatin component on;  das dabei freiwerdende Thrombin bewirkt sofort die Verwandlung des Fibrinogens in Fibrin. The thrombin thereby released immediately causes the transformation of the fibrinogen into fibrin.  Auf der Wunde bildet sich auf diese Weise ein Fibrin- film, welcher den Verschluss der Wunde bewirkt und den Blutfluss hemmt. On the wound, a fibrin film formed in this manner, which causes the closure of the wound and inhibits blood flow.  Dieser Film haftet so stark auf der Oberfläche der Wunde, dass ein zusätzlicher Verband nicht notwendig ist. This film adheres so strongly to the surface of the wound that an additional association is not necessary. 



    In vitro wird die Wirksamkeit der Pfropfen folgendermassen gezeigt. In vitro, the effectiveness of the plug is shown as follows. 



    In einem Reagensglas (Durchmesser zirka 1 cm) werden einige Pfropfen zu einer Kolonne von ungefähr 5 cm Höhe lose eingestampft. In a test tube (diameter approximately 1 cm) some grafting to be pulped to a column of about 5 cm height loose.  Darauf werden 5 ccm 37 C warmes Plasma gegossen. Then 5 cc of 37 C hot plasma to be cast.  Das Plasma wird in die schwammartige Masse eingesogen und gerinnt so schnell, dass das Reagensglas unmittelbar nach dem Eingiessen umgekehrt werden kann, ohne dass das Plasma abfliesst. The plasma is drawn into the sponge-like mass and coagulates so fast that the test tube can be reversed immediately after pouring, without flowing off the plasma. 



    Der Gelatine-Thrombinmasse können verschiedene Antiseptica zugesetzt werden, ohne dass die Wirksamkeit der Verbände und Pfropfen dadurch leiden würde : Thymol, ein Gemisch von p-Oxy-benzoesäuremethyl-und-propylester, Sulfanilamide, wie 5-Sulfanilamido-3,4-dimethyl-isoxazol und vemarbungsbeschleunigende Sub- The gelatin Thrombinmasse various antiseptics may be added without reducing the effectiveness of the associations and grafting would suffer characterized: thymol, a mixture of p-oxy-benzoesäuremethyl-and-propyl, Sulfanilamide, such as 5-sulfanilamido-3,4-dimethyl- isoxazole and vemarbungsbeschleunigende sub- 
  EMI1.1 EMI1.1 
 



    Die Gelatine übt auf das in Lösung befindliche Thrombin eine deutliche Schutzwirkung aus. The gelatin exerts on the in solution thrombin from a significant protective effect.  So verliert eine wässerige, 50" Gelatine enthaltende Thrombinlösung langsamer an Wirksamkeit als eine gleiche Lösung ohne Gelatine. Thus an aqueous, 50 "gelatin containing thrombin loses its effectiveness slower than an equal solution without gelatin. 
  EMI1.2 EMI1.2 
 
 <tb> <Tb> 
 <tb> <Tb> 



   Wässerige aqueous
 <tb> Wässerige <SEP> Thrombin- <SEP> und <Tb> Aqueous <SEP> thrombin <SEP> and
 <tb> Thrombinlosung <SEP> Gelantinelosung <Tb> Thrombinlosung <September> Gelantinelosung
 <tb> 5 <SEP> 500 <SEP> Th. <SEP> E <SEP> ccm <SEP> 7 <SEP> 500 <SEP> Th <SEP> E <SEP> ccm <Tb> 5 <September> 500 <September> Th. <September> E <September> cc <September> 7 <September> 500 <September> Th <September> E <September> cc
 <tb> nach <SEP> 24 <SEP> Stunden <SEP> 4.000 <SEP> 7.500 <Tb> after <September> 24 <September> hours <September> 4000 <September> 7500
 <tb> # <SEP> 48 <SEP> # <SEP> 2.500 <SEP> 5.500 <Tb> # <September> 48 <September> # <September> 2500 <September> 5500
 <tb> # <SEP> 72 <SEP> # <SEP> 350 <SEP> 4.000 <Tb> # <September> 72 <September> # <September> 350 <September> 4000
 <tb> <Tb> 
    Beispiel 1 : Zu l00ccm destilliertem Wasser werden 5 g Blattgelatine zugesetzt, worauf auf 80 C erwärmt wird. Example 1: 5 g of leaf gelatin are added to l00ccm distilled water, whereupon heated to 80 C.  Die erhaltene etwas trübe Lösung wird warm durch ein Seitz-Filter filtriert und, wenn notwendig, auf einen pH-Wert von 6, 6 gestellt. The slightly turbid solution obtained is hot-filtered through a Seitz filter and, if necessary, adjusted to a pH of 6. 6 



    Nun werden zu 50 ccm der erhaltenen, auf 20 C abgekühlten Lösung 10 ccm einer Thrombinlösung mit einem Thrombingehalt von 10.000 Einheiten pro Kubikzentimeter zugesetzt. Now, to 50 cc of the obtained solution, cooled to 20 C 10 cc of a thrombin solution having a thrombin content of 10,000 units per cubic centimeter added.  Diese Thrombinlösung Wird mit Hilfe eines Thrombinpräparates hergestellt, dessen Gehalt titrimetrisch zu 100 Th. E bestimmt wurde. This thrombin solution is prepared by a Thrombinpräparates whose content was determined titrimetrically to 100 Th. E.  Es bildet sich eine It forms a 

  <Desc/Clms Page number 2> <Desc / CLMS Page number 2> 

    lochte Trübung) die durch Sterilisierung mittels eines Seitz-Filters entfernt wird. punched turbidity is removed by sterilization by means of a Seitz filter) the. 



     Die Hare Lösung wird durch Einblasen von steriler Luft mittels einer Sinterglasplatte und durch Schlagen mit Hilfe eines Schlagbesens in einem voluminösen Schaum verwandelt. The Hare solution is transformed by blowing sterile air by means of a sintered glass plate and by hitting by means of a whisk in a voluminous foam.  Dieser wird dann auf ein- Blatt ausgebreitet, bei tiefer Temperatur eingefroren und im Hochvakuum bei-5"C entwässert. This is then spread on one sheet, frozen at low temperature and dehydrated "C in a high vacuum at 5-.   



    Beispiel 2 : In 100 ccm warmem destilliertem Wasser werden 70 mg Thymol gelöst, der Lösung werden 5 Gelatine zugesetzt und das Ganze auf 80 C erwärmt. Example 2: In 100 cc of warm distilled water 70 mg thymol are dissolved, the solution is 5 gelatin was added and the whole was heated to 80 C.  Im übrigen wird wie im Beispiel 1 weiter gearbeitet. Incidentally, as work continues in the example first 



      Beispiel 3 : In 100 ccm destilliertem Wasser werden 20 mg p-Oxy-benzoesäuremethylester und Example 3: In 100 cc of distilled water 20 mg of p-oxy-benzoic acid methyl ester and
 80 mg p-Oxybenzoesäurepropylester gelöst. 80 mg p-Oxybenzoesäurepropylester dissolved.  Die The
 Lösung wird mit 5 g Gelatine versetzt, auf 80 C erwärmt und im übrigen wie im Beispiel 1 weiter- verarbeitet. Solution is mixed with 5 g of gelatin, heated to 80 C and further processed as in Example 1 for the rest. 



    Beispiel 4 : 5g Gelatine werden mit 90ccm destilliertem Wasser auf 800 C erwärmt. Example 4: 5 g of gelatin are heated with distilled water to 800 90ccm C.  In der warmen Lösung werden 2 fein pulverisierte In the warm solution 2 are finely pulverized
 5-Sulfanilamido-3, 4-dimethyl-isoxazol suspen- diert. 5-sulfanilamido-3, 4-dimethyl-isoxazol suspensions diert.  Das PH wird durch Zusatz von 5 bis 10 ccm normaler Natronlauge auf 6, 6 gestellt, worauf sich das SuKanilamid auflöst. The PH is provided by addition of 5 to 10 cc of sodium hydroxide solution to 6, 6, whereupon the SuKanilamid dissolves.  Man erwärmt auf 80 QC und verfährt im übrigen wie im Beispiel 1. The mixture is heated to 80 QC and the procedure is otherwise as described in Example. 1 



    Beispiel 5 : In 100 ccm destilliertem Wasser werden 0, 28 g Panthenol, [d (+)--Dioxy-ss, ss- dimethylbutyryl-Y'-oxypropylamid] gelöst. Example 5: In 100 cc of distilled water are 0, 28 g panthenol, [d (+) - dioxy-ss, ss- dimethylbutyryl-Y'-oxypropylamid] solved.  Man setzt 5 Gelatine zu, erwärmt das Ganze auf 800 C und verfährt im übrigen wie im Beispiel 1. 5 are employed to gelatin, the whole heated to 800 C and the procedure is otherwise as in Example. 1 



    PATENTANSPRÜCHE : CLAIMS: 
 1. Verfahren zur Herstellung von hämostatisch wirkenden Pfropfen und Verbänden, dadurch gekennzeichnet, dass man einer Gelatinelösung Thrombin zusetzt, die erhaltene Lösung in 1. A process for the preparation of hemostatic plug acting and associations, characterized in that is added to a gelatin solution of thrombin, the solution obtained in
 Schaum verwandelt, diesen Schaum bei tiefer Temperatur im Vakuum trocknet und den so erhaltenen thrombinhaltigen Gelatineschwamm in geeignete Form bringt. Foam transforms, this foam brings dried at low temperature in vacuo and the thus obtained thrombin gelatin sponge in suitable form. 

Claims (1)

  1. 2. Verfahren nach Anspruch 1, dadurch gekenn- zeichnet, dass man der Gelatinelösung Antiseptica zusetzt. 2. The method of claim 1, marked thereby distinguished, that is added to the gelatin solution antiseptics.
    3. Verfahren nach Anspruch l, dadurch gekenn- zeichnet, dass man der Gelatinelösung ver- narbungsbeschleunigende Stoffe zusetzt. 3. The method according to claim l, characterized marked by the fact that the gelatin solution is added narbungsbeschleunigende comparable substances.
AT165549D 1947-06-03 1948-05-12 A process for the preparation of hemostatic plug acting and associations AT165549B (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CH2350347A CH264752A (en) 1947-06-03 1947-06-03 A process for producing carriers for drugs.

Publications (1)

Publication Number Publication Date
AT165549B true AT165549B (en) 1950-03-15

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Family Applications (1)

Application Number Title Priority Date Filing Date
AT165549D AT165549B (en) 1947-06-03 1948-05-12 A process for the preparation of hemostatic plug acting and associations

Country Status (6)

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US (1) US2558395A (en)
AT (1) AT165549B (en)
CH (1) CH264752A (en)
DE (1) DE915973C (en)
DK (1) DK73956C (en)
ES (1) ES183694A1 (en)

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DE915973C (en) 1954-08-02
US2558395A (en) 1951-06-26
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ES183694A1 (en) 1948-07-04
DK73956C (en) 1952-03-31

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