DD294959A5 - PROCESS FOR PRODUCING RUBBER ARTICLES WITH FIBRINOLYTIC DEPOT EFFECT - Google Patents

Abstract

The invention relates to a process for the vulcanization of rubber mixtures at vulcanization temperatures between 40 and 80 ° C in which rubber articles with fibrinolytic properties are produced. The fibrinolytic properties are achieved through the use of phyllosilicates loaded with appropriate drugs.

Description

Field of application of the invention

The invention relates to a process for the production of rubber articles with fibrinolytic depot effect on the basis of natural and / or synthetic silica, which can be used for prostheses and implantable biomaterials.

Characteristic of the known state of the art

It is known that after artificial replacement of organs in the animal and human body fibrinolytic drugs are used by intramuscular injections.

A major disadvantage of this procedure is that must be injected several times to maintain the limit for the Ungerinnbarkeit the blood under a steady control. The formation of thrombi or emboli is a common cause of death.

Object of the invention

The object of the invention relates to the development of a process for the production of rubber articles with fibrinolytic properties, which ensures a continuous dosage of fibrinolytic drugs after artificial replacement of organs in animal and human body and thus exclude the formation of thrombi or emboli.

Explanation of the essence of the invention

It has been found that in the thermal vulcanization of rubber blends based on natural and / or synthetic rubber, various fillers, plasticizers, accelerators, sulfur and other blend ingredients by the use of fibrinolytic drug loaded sheet silicates, rubber articles can be made which are fibrinolytic Possess properties and can prevent the formation of thrombi. The phyllosilicate-fibrinolytic adduct is added to the rubber mixture before vulcanization and then vulcanized the entire mixture at temperatures between 40 ⁰ C and 8O ⁰ C.

The proportion of phyllosilicate-fibrinolytic adduct is 2 to 10% by mass, based on the total mixture, while the fibrinolytic proportion in the phyllosilicate-fibrinolytic adduct should be 10 to 50% by mass. Streptokinase, urokinase and / or plasmin can be used according to the invention as fibrinolytic agents.

As layered silicate, sodium magadiite is preferably used. It has been found that the fibrinolytic properties of the rubber articles are sufficient to induce fibrinolysis in the flowing blood and thus the development of thrombosis following artificial replacement of the organ, e.g. As heart, vessels, endoprostheses, in the animal and human body can prevent.

The extraordinary advantage of the solution according to the invention is that for the first time a rubber material is available that a thrombosis directly on the foreign material d. H. on the prosthesis or an implanted biomaterial. On the other hand, the bioactive rubber material has an excellent depot effect of at least 6 days. In the following, an example explains the solution according to the invention, without restricting it.

embodiment

The rubber mixtures were prepared in a laboratory mixer of the type GK4 N according to a uniform mixing procedure. The volcanic rheological behavior of the mixtures was determined by recording cross-linking isotherms on the rheometer and the physical-mechanical characteristics of the vulcanizates were determined in accordance with valid TGL test specifications.

Rubber material WS 01/20 NR elastomer: Silica ΚβΟ S: stearic acid: tetramethylthiuram:

Sulfur:

diphenylguanidine: Zinc N-ethylphenyldithiocarbamat:

2,6-di-tert-butyl-4-methylphenol:

Special Paraffin:

Zinc oxide:

Titanium dioxide: Phyllosilicate / Awelysln adduct:

(Degree of loading: 60Ma .-%)

10 000 Mass Parts 1BP0 Mass Parts 3PO Mass Parts 2P0 Mass Parts 2P0 Mass Parts 1PO Mass Parts 1.50 Mass Parts 2ßO Mass Parts 2po Mass Parts 5pO Mass Parts 5po Mass Parts 400 Mass Parts

test results The demonstration of the biological activity of substances incorporated into materials (streptokinase) to the external medium becomes

methodically guided as follows:

Defined rubber discs (10 mm 2, 280 mg) are placed on fibrin agar plates and stored at 37 ° C. for five days. The extent of lysis is in square millimeters (of two perpendicular diameters of the lysis zones)

expelled.

Table: Fibrinolytic activity after contact of rubber WS 01/20 with fibrin agar plates

incubation period Fibrinolytic activity d mm ² 1 194 2 241 3 307 4 372 5 441 6 512

The rubber material WS01 shows a contact time-dependent increase in fibrinolytic activity.

Claims (5)

1. A process for the preparation of rubber articles with fibrinolytic depot effect, which natural and / or synthetic rubber, vulcanizing agents, fillers, dyes, medicinal agents and other Mischungsingredienzien may contain, characterized in that the rubber mixtures before vulcanization, a layered silicate fibrinolytic adduct added and the entire mixture is cured at temperatures between 4O ⁰ C and 80 ⁰ C. 2. The method according to claim 1, characterized in that the proportion of phyllosilicate Fib.rinolytikum adduct2-10Ma .-%, based on the total mixture. 3. Process according to claims 1 to 2, characterized in that the proportion of antithrombotics in the layered silicate-fibrinolytic adduct 10 to 50Ma .-%. 4. Process according to claims 1 to 3, characterized in that streptokinase, urokinase or plasmin are used as fibrinolytic agents. 5. Process according to claims 1 to 4, characterized in that are used as layered silicate Natriummagadiit.