Eye film

 

(57) Abstract:

The invention relates to medicine, in particular to ophthalmology, and can be used in the treatment of traumatic burn and dystrophic lesions of the cornea and conjunctiva. Eye film contains crushed native cornea of the eye of cattle 0.25 g of polyvinyl alcohol 99,25 g, gamma-globulin 0.25 g, gentamicin 0.25 was Applying eye films enhances wound healing activity, reduces the time of treatment of patients, easy to use, have a prolonged, antimicrobial, antiviral and anti-adhesive properties.

The invention relates to medicine, in particular to ophthalmology, and can be used in the treatment of trauma, burns and trophic lesions of the cornea and conjunctiva.

Currently widely used ophthalmic drug films based on collagen, APRACA and other biological means of stimulating reparative regeneration processes (A. F. Week, Y. F., Michuk, V. P. Solov'ev, V. I. the Week "Ocular drug films with applicom in treatment of eye burns", in the book of abstracts. Dokl. Symposium "New trends in the treatment of burns of the eye. M. , 1989, avici", ibid, S. 38-39).

A common disadvantage of the above films is their heterogeneity with corneal tissue, i.e., the absence of transpacificus, which significantly reduces their therapeutic effect. Due to the lack of specific glycosaminoglycans (GAGS), namely createsurface, decreases the probability transparent recovery of the defect of the cornea.

Also known collagen coating on the basis of the sclera pigs, obtained by alkaline-saline treatment, neutralization, washing, dissolution of collagen, drying with simultaneous formation of a thin transparent specific coverage (ed. mon. USSR N 1321420, class A 61 K 37/12, 1987). The said coating has good transparency and better bio-stimulating properties in comparison with the named equivalents.

However, with all its positive properties of this film has a number of disadvantages: the technological process of obtaining them is time-consuming, costly.

The closest in technical essence is eye film from native cornea cattle, rosehip and polyacrylamide (decision on granting of the patent of the Russian Federation from 21.12.95 on request N 94037745/14 from 04.10.94), which stimu, their action is directed only to the stimulation of regeneration. For prevention of bacterial and viral infections, it is additionally necessary to instillation of the drops. Flushing these drops of tears in patients with severe inflammatory process, the need for frequent instillation more difficult to attain the desired concentration of drugs in the conjunctival cavity.

We have been tasked to reduce the treatment time of patients by enhancing wound healing, antimicrobial and antiviral properties of the drug, enhance adhesive properties of films.

To achieve the objectives of the proposed eye film containing crushed native cornea of the eye of cattle, characterized in that it further comprises a gamma-globulin, gentamicin and polyvinyl alcohol in the following ratio, wt. %:

crushed the native cornea of the eye of cattle (cattle) - 0,25

gamma globulin - 0,25

gentamicin - 0,25

polyvinyl alcohol - 99,25

The proposed film is rounded white d = 15,0 0,03 mm Parameters of the film are determined by the micrometer in average sample. On the cornea under the action of the tear film rehydrations and fall in radlogin method for quantitative determination of crushed native cornea cattle in the film by grinding the total optical density of the resulting solution on a spectrophotometer at a wavelength of 265 nm in a cell with a layer thickness of 10 mm (the rat. proposal N 381 from 27.06.1991 year). Technology of preparation of medicinal film is as follows:

- preparation of suspension gel of crushed native cornea cattle (VFS 42-1895-89) with gamma globulin and gentamicin at selected concentrations, mixing with PVA;

- preparation of a film by freeze drying;

- sterilization of the film.

Example 1. The method of preparation of the eye film.

To 99,25 grams of polyvinyl alcohol added 0.75 g suspension - gel, consisting of crushed native cornea cattle (0.25 g), gamma globulin (0.25 g) and gentamicin (0.25 g). The resulting mixture is applied to the surface layer of molds for the casting of films of PTFE. In the process of freeze drying is the formation of films within 84 hours, the film is placed in a special packaging 2 PCs and sterilized with radiation at a dose of 25 RTG.

Method of application: under local anesthesia (Sol Dicaini 0,25% - epibulbar) eye film placed on the surface of the cornea (like contact lenses) 2-3 times a day. The experiment proves that ocular drug film prepared from the following components, per 100 weight parts:

crushed native who BR>
meets all the requirements of Pharmacopoeia XI.

Example 2. The experiment was made on the eyes of 10 rabbits breed "Chinchilla" weighing 2.5 to 3.0 kg In the right eye (10 eyes) after applying the non-dosed defect of the cornea 3 times a day lay eye film (experimental group). The left eye (10 eyes) serves as a control: buried 30% solution sulfatsila sodium - 3 times a day.

On the first day, changes in both eyes identical (vascular injection of the sclera, the defect of epithelial and anterior stromal layers). However, in the conjunctival cavity during the first days in the experienced eyes of defined fragments eye films in the stage of resorption. On the 3rd day in the experienced eyes of rabbits defect of the cornea was reduced almost by half, significantly reduced inflammation. On day 7 in patients with marked complete epithelialization of the defect of the cornea in all experimental eyes. 14 days - full transparent healing of the cornea. Two eyes in the control group inflammation kept up to 5-8 days in the form of manifestation of purulent iridocyclitis with positive fluorescein test. In the control eyes transparent healing in 80% of cases. In 1 case (control) was formed blackvideo opacity, 1 - Ani proved that eye film with the proposed composition accelerates the regeneration of the cornea, prevents secondary infectious complications. It is easy to use, has a long action and adhesive properties, reduces treatment time on average 3-4 days and improves functional outcomes.

Eye film containing crushed native cornea of the eye of cattle, characterized in that it further contains polyvinyl alcohol, gamma-globulin and gentamicin in the following ratio, wt.%:

Crushed the native cornea of the eye of cattle - 0,25

Gamma globulin - 0,25

Gentamicin - 0,25

Polyvinyl alcohol - 99,25

 

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