DD294867A5 - 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 centrifuge latex 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 phyllosilicates loaded with appropriate drugs.

Description

Application by 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 embryos 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 formation of thrombi or embryos.

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 phyllosilicates. To develop fibrinolytic adduct. These articles have fibrinolytic properties and prevent the formation of thrombi or embryos.

The layered silicate / fibrinolytic adducts are added to the latex mixture in the form of dispersions prior to vulcanization.

The subsequent vulcanization is conducted at temperatures from 4O ⁰ C to 80 ⁰ C.

The fraction of phyllosilicate / fibrinolytic agent is 0.5-10% by mass, based on the total mixture and fibrinolytic fraction in the phyllosilicate / fibrinolytic adduct, should be 5-50% by mass.

As fibrinolytic agents, streptokinase, urokinase and / or plannin can be used according to the invention.

The phyllosilicates are polysilicates of the general formula M ₂ O.ySiO ₂ .zH ₂ O having a layer structure, where M is an alkali metal ion or proton, y is a number between 4 and 48 and ζ is a number between 5 and 25. The synthesis of the phyllosilicates takes place by crystallization in the ternary system. Thereafter, the separation of the water-insoluble phyllosilicates from the suspension takes place by mechanical means. For example, sodium magadiite has the formula Na ₂ O. 14SiO ₂ .9H ₂ O and is dewatered by drying.

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 artificial replacement of organs, such. As heart, vessels, endoprostheses, in the animal and human body can vethindern.

The advantage of the solution according to the invention is that, for the first time, a flexible elastomeric material made of latex is available, that a thrombosis directly on the foreign material, i. 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 illustrates the solution according to the invention without limiting it.

embodiment

The latex mixtures were produced and processed in a laboratory. All solids were added to the latex in the form of 50% by weight 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 adjustment 60% sulfur dispersion 167 50% "KOH solution 3.6 20% Zinkdiethylphenyldithiocarbamat-Disp. 1.0 50% Zinc oxide dispersion 1.8 50% Phyllosilicate / Awelysin 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 methodically carried out as follows.

Of the mixtures prepared according to the above recipe plates (0 50 mm, wall thickness 5 mm) were poured. Subsequently, these plates were vulcanized at 70 ° C. From the plates, defined rubber discs (10 mm, 0.280 mg) were placed on fibrin agar plates and stored at 37 ^° C. for 5 days. The extent of lysis is reported in square millimeters (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 an increase in fibrinolytic activity as a function of the contact time.

Claims (5)

1. A process for the production of latex dipped goods having fibrinolytic depot effect, characterized in that a layered silicate / fibrinolytic adduct is added to the NK-latex, preferably Centrifuge latex or pre-crosslinked latices next vulcanizing agents, fillers and other Mischungsingredenzien before vulcanization and latex mixture at temperatures between 4O ⁰ C and 8O ⁰ C is vulcanized. 2. The method according to claim 1, characterized in that the proportion of phyllosilicate / Fibrinolytikum adduct 0.5-10 Ma .-% based on the total mixture, is. 3. Process according to claims 1 and 2, characterized in that the proportion of antithrombotics in the layered silicate / Fibrinolytikum adduct & 50Ma .-%. 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 z as layer silicate. As sodium magadiite (Na ₂ O · 14SiO ₂ · 9H ₂ O) can be used.