DD294866A5 - PROCESS FOR PREPARING LATEX DENTAL ARTICLES WITH FIBRINOLYTIC DEPOT EFFECT - Google Patents

Abstract

The invention relates to a process for the preparation and vulcanization of latex mixtures, preferably NK-Zentrifugenlatex or precrosslinked latexes which have fibrinolytic properties and are vulcanized at temperatures between 40C and 80C. The fibrinolytic properties are achieved through the use of drug-loaded molecular sieves.

Description

Application of the invention

The invention relates to a method for producing medical dipping articles made of NK latex or pre-vulcanized latex types with fibrinolytic depot effect, which can be used for prostheses, catheters and implantable biomaterials.

Characteristic of the known technical solutions

It is known that after artificial replacement of organs in the animal and human body fibrinolytic drugs are used by intramuscular injections. A drawback of this method is that in order to maintain the limit for blood coagulability it is necessary to inject several times under a steady control. Thrombi or emboli are a common cause of death.

Object of the invention

The aim of the invention is the development of a process for the production of latex dipped articles with fibrinolytic properties, which ensures a continuous dosage of fibrinolytic drugs after artificial replacement of organs in the animal and human body and thus exclude the threat of thrombi or emboli.

Explanation of the essence of the invention

It is an object of the present invention to provide a process for the preparation and vulcanization of latex dicutaries based on NK latex, preferably centrifuge latex or pre-vulcanized latex types, various fillers, plasticizers, accelerators, sulfur and other compounding ingredients through the use of fibrinolytic drug loaded molecular sieves. To develop fibrinolytic adducts. These articles have fibrinolytic properties and prevent the development of thrombi or emboli.

The zeolite / fibrinolytic adducts are added to the latex mixture in the form of dispersion prior to vulcanization. The subsequent vulcanization takes place at temperatures of 40 ° C to 80 ° C.

The proportion of zeolite-fibrinolytic adduct is 0.5-1 OMa .-%, based on the total mixture and the Fibrinolytika share in the zeolite / Fibrinolytikum adduct should be 5-50Ma .-%.

Streptokinase urokinase and / or plasmin can be used according to the invention as fibrinolytic agents.

The zeolites used are preferably synthetic crystalline aluminosilicates of types A, X, Y or mixtures thereof.

It was found that the fibrinolytic properties of the latex diving articles are sufficient to trigger thrombolysis in the flowing blood and thus the formation of thrombosis or embolism after an artificial organ replacement, such. As heart, vessels, endoprostheses, in the animal and human body can prevent.

The advantage of the solution according to the invention is that for the first time a made of latex, flexible elastomeric material is available that a thrombosis directly on the foreign material, d. H. on the prosthesis, catheter or implanted biomaterial.

On the other hand, the bioactive, flexible elastomer 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 latex mixtures were produced and processed in a laboratory. All solid components were added to the latex in the form of B0Ma .-% aqueous dispersions. The dispersions were prepared in laboratory ball mills, meal 2 days. The dispersant used is a nonionic surfactant. The physico-mechanical characteristics of the vulcanizates were determined according to valid TGL test specifications.

recipe

component NK latex type LA-TZ weight point 60% sulfur dispersion 167 50% KOEH solution 3.6 20% Zinkdiethylphenyldithiocarbamat-Disp. 1.0 50% Zinc oxide dispersion 1.8 50% Zeolite 13X / Awnlysine adduct dispersion 2.0 50% (Degree of loading: 50Ma .-%) 4.0

test results

The proof of the biological activity of substances incorporated into materials (streptokinase) to the external medium is carried out methodically as follows:

From the o.g. Recipe prepared mixture were poured plates (0 50mm, wall thickness 5 mm). Subsequently

these plates were vulcanized at 70 ° C.

From the plates defined rubber discs (10mm 0,250mg) were placed on fibrin-agar plates and stored at 37 ⁰ C for 5 days. The extent of lysis is measured in millimeter squared (of 2 perpendicular diameters of the

Lysis zones).

Table: Fibrinolytic activity after contact of the prepared latex article with fibrin agar plates

incubation period Fibrinolytic activity H mm ² 24 150 48 236 72 289 96 376 120 420 144 462

There is a noticeable increase in fibrinolytic activity as a function of the contact time.

Claims (5)

1. A process for the preparation of latex dipped articles with fibrinolytic depot effect, characterized in that the NK-latex, preferably centrifuge latex or precrosslinked latexes, in addition to vulcanizing agents, fillers and other Gemischungsingredenzien before vulcanization, a zeolite / fibrinolytic adduct is added and latex mixture at temperatures between 4O ⁰ C and 80 ⁰ C is vulcanized. 2. The method according to claim 1, characterized in that the proportion of zeolite / Fibrinolytikum adduct 0.5-10Ma .-% based on the total mixture, is. 3. Process according to claims 1 and 2, characterized in that the proportion of antithrombotics in the zeolite / fibrinolytic adduct 5-10Ma .-%. 4. Process according to claims 1 to 3, characterized in that are used as fibrinolytic streptokinase, urokinase, plasmin. 5. Process according to claims 1 to 4, characterized in that are used as zeolites synthetic crystalline aluminosilicates of the types A, X, Y, mordenite or mixtures thereof.