The material for the manufacture of extra - ocular transplant

 

(57) Abstract:

The invention relates to ophthalmology and is intended for the manufacture of out - and intraocular grafts used for UV protection of the retina afakii. The material on the basis of polymethylmethacrylate containing as Sitophilus additive N,N'-ethylenebis-(1.1.1.2.2. 3.3.4.4-nomatter-7-aminoach-6-EN-5-one)-at copper, Nickel or palladium. The graft material provides protection from UV radiation to 480 nm is similar to the natural lens of the eye. 1 Il., table 1.

The invention relates to ophthalmology and is intended for the manufacture of extra - ocular graft, in particular glasses, contact lenses and intraocular lens (IOL), which are able to protect the retina from ultraviolet radiation, like the natural lens of the eye.

Known materials for the manufacture of eye transplants: glass, synthetic sapphire, polymethylmethacrylate (PMMA), polycarbonate, collagen and other (Rosenblum Y. Z. Actual problems of optical correction. Vestnik of ophthalmology, 1992, No. 1, S. 3-9). The disadvantage of these materials is that they do not protect the retina from harmful spectrum of UV radiation in ex the config spectrum of ultraviolet and blue radiation in the range from 320 to 480 nm. Afakii (absence of the natural lens) this radiation enters the eye and causes irreversible changes of the retina (Ostrovsky M. A. Clinical physiology of vision. 1993, S. 27 - 56. Zueva M. C. Damaging effect of visible light on the retina. Abstract. ... candles. dis. M., 1980).

The closest analogues (prototype) is the material of the intraocular lens "Range", which has UV protection due to the presence in its composition of organic filters. As the base material contains polymethylmethacrylate, and the filter - ortho-oxybenzone and dye yellow "W" (Linnik L. F., Ostrovsky M. A. Artificial lens, absorbing UV rays: safety, efficacy and long term use in ophthalmic surgery. Ophthalmic surgery. 1991, No. 4, p. 3-7).

The lack of material IOL "Spectrum", is that it absorbs UV radiation to 420 nm, leaving open the most harmful to the retina blue spectrum. Another disadvantage of the prototype is also relatively high toxicity, due to the chemical structure and the presence of chemically active functional groups in the molecule used in organic light high acidity, increasing the irradiation of molecules by ultraviolet light. Furthermore, formed over time, the decay products of filter cause significant and in most cases unpredictable toxic reaction.

The objective of the invention is to provide a material that absorbs UV light at 480 nm is similar to the natural lens of the eye and having a lower toxicity compared to the prototype.

The task is solved in that the material for the manufacture of extra - ocular graft containing polymethylmethacrylate and Sitophilus additive according to the invention as Sitophilus additive contains a compound of General formula (1):

< / BR>
where M=Ni, Cu or Pd in the following ratio, wt. share:

polymethylmethacrylate - 99,80 - 99,99

connection (1) - 0,01 - 0,20

The compound (1) is a fluorine-containing N,N'-ethylenebis--aminophenylacetate copper, Nickel or palladium. This chelate compound, Sitophilus properties which is based on the effect of "Heavy atom". Under UV irradiation, the structure of this compound is not changed, and redistribution of relationships is not. This leads to the absence of toxic properties in contrast to proto receiving first described in the application for the grant of a patent of the Russian Federation for invention "Performancemanagement N,N'-ethylenebis--aminovinyl ketumati Nickel, palladium and copper, and the method of their production" the decision to grant a patent on the application N 96105049/44 from 17.01.97, the applicant Institute of physics and applied mathematics at the Ural state University, authors A. I. Aizikovich, V. M. Popov).

The compound (1) is produced by the interaction of the fluorinated benzene diketone with Ethylenediamine in the presence of epirate boron TRIFLUORIDE at boiling of the reaction mixture with simultaneous azeotropic distillation of the reaction water for 4 to 8 hours, followed by addition of the corresponding metal salt and boiling the reaction mixture for 1.5 - 4 hours with simultaneous azeotropic distillation of the water.

Compounds are crystalline substances, soluble in organic solvents and stable during storage.

The inventive material is obtained by introducing the compound (1) in poly (methyl methacrylate) by one of the known technology of polymer processing, for example, during injection molding, extrusion, process block and emulsion polymerization, and gigaplane technology.

Example 1. 200 g of granulated PMMA injected N,N-ethylenebis--aminophenylacetate Nickel in the amount of 0.2 g (0.01 wt. share), mechanically mixed and loaded into individual product.

Example 2. To a solution of 50 g of PMMA in 200 ml of dichloroethane add 0.05 g (0.01 wt.fraction) N,N-ethylenebis--aminophenylacetate copper in ethylene dichloride, poured onto a glass substrate and incubated until complete evaporation of the solvent. Get this film, which is used for the manufacture of IOLs.

Example 3. 200 g of granulated PMMA injected with 0.2 g (0.01 wt. fraction) N, N-ethylenebis--aminophenylacetate palladium, mechanically mixed and loaded into a molding machine "Quasi get the product in the form of a disk, which is made of the optical part of the intraocular lens.

Other examples of using the complexes of copper, Nickel or palladium were conducted similarly.

By varying the concentration of the compound (1) in the polymethylmethacrylate is possible to obtain a material with a given UV permeability. The spectral characteristics of the proposed material were investigated on the spectrophotometer SF-26, Specord UV - Vis (Germany) along with the characteristics of different materials used for the correction of apachi. The data presented in the table (see the end of the description and the drawing.

The drawing shows absorption spectra of a standard lens company "Hoja" and absorption spectra of samples containing compounds 1a (Ni), 1B (Cu) and 1B (Pd) in Concerto radiation, necessary to protect the retina, the inventive material has already when the content of compound (1) in concentrations of 0.01 wt.share.

Therefore, the introduction of compounds of General formula (1) specified in the claims concentrations allows to obtain materials on the basis of polymethylmethacrylate, fully absorbing the radiation to 420 - 480 nm.

Research conducted in the Sverdlovsk regional center of sanitary-epidemiological surveillance, toxicity, progenote and sanitary chemistry showed that the material presented devices for the correction of apachi meets the requirements for polymeric materials and medical products.

The claimed material was tested in Ekaterinburg research Institute of viral infections. Received opinion that the sample preparation sterile, non-toxic and biocompatible with cell cultures.

The biological tests on the basis of the Central research laboratory at the Ural state medical Academy. Research was conducted on a group of animals - 24 rabbit breed Korolinsky weight from 2.3 to 3.5 kg, which is implanted in the anterior chamber of the eye samudaya and histological examination.

The results showed good tolerance of the experimental material, the absence of inflammation, low toxicity, minimal changes to the tissue on histological examination.

The material for the manufacture of extra - ocular graft containing polymethylmethacrylate and Sitophilus additive, characterized in that as Sitophilus additives it contains a compound of General formula I

< / BR>
where M = Ni, Cu or Pd,

in the following ratio, wt.%:

Polymethylmethacrylate - 99,80 - 99,99

The compound of General formula I - 0,01 - 0,20 p

 

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6 dwg

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