RU2288702C1 - Irrigation solution for ophthalmology - Google Patents

Abstract

FIELD: medicine, ophthalmology, pharmacy.

SUBSTANCE: invention relates to irrigation solution used in ophthalmology. Irrigation solution used in ophthalmology surgery operations comprises sodium chloride, sodium hydrogen phosphate and sodium dihydrogen phosphate, L-carnosine, glycoseaminoglycans and water wherein glycoseaminoglycans are represented by as a solution of keratan sulfate and chondroitin sulfate sodium salts taken in the definite ratio of components. Invention provides preparing the balanced saline solution for irrigation and anti-exudative effect in using. Invention can be used for washing out lens masses in cataract extraction and filling chamber eye space in different ophthalmic surgery operations.

EFFECT: valuable medicinal properties of solution.

3 ex

Description

The invention relates to medicine, namely to ophthalmology, and can be used in eye surgery to wash out the lens masses during cataract extraction, when washing the anterior chamber, and to protect surrounding tissues during other surgical interventions, replacing moisture in the anterior chamber during surgery.

In ophthalmology during surgical interventions: cataract extraction, anti-glaucomatous and other operations - to irrigate the crystalline masses, rinse the anterior chamber and fill the chamber space into the anterior chamber of the eye, irrigation moisture-substituting solutions are introduced. The disadvantage of all known solutions used for irrigation during ophthalmic surgery is the inadequate protection of the corneal endothelium, iris and lens epithelium during prolonged irrigation and, as a result, damage to the corneal and iris endothelium as a result of prolonged irrigation.

Known irrigation solutions, which are a physiological solution, 1% solution of carnosine (patent N 2012297). The disadvantage of using these solutions is that in some cases, they can cause damage to surrounding tissues with the presence of exudation, corneal edema, and other postoperative complications.

Known irrigation solution (RF patent 2071316), including sodium chloride, mono- and disubstituted sodium phosphate, L-carnosine in the following ratios of components in g / l: monosubstituted sodium phosphate - 0.018-0.072, disubstituted sodium phosphate - 0.079-0.141, sodium chloride - 8.5-9.50, L-carnosine - 0.5-20.0, purified water - the rest. An essential distinguishing feature of this irrigation solution is the presence of carnosine, since the latter is an antioxidant, stabilizes cell membranes, has a fairly strong anti-inflammatory effect, which makes it possible to use it immediately after traumatic eye damage in physiological saline buffered saline. However, the use of this irrigation solution often leads to desquamation of the corneal endothelium and edema of its stroma, which is fraught with the development of postoperative keratopathy, and ultimately endothelial-epithelial corneal dystrophy.

The task of the invention is to reduce postoperative complications consisting in the loss of endothelial cells, corneal edema, the presence of exudate in the anterior chamber of the eye.

The closest in technical essence to the claimed technical solution is an irrigation solution (patent 2121324), which includes sodium chloride, mono- and disubstituted sodium phosphate, L-carnosine with the following ratios of components in g / l: monosubstituted sodium phosphate - 0.001-0.01, disubstituted sodium phosphate - 0.01-0.09, sodium chloride - 8.5-9.50, L-carnosine - 0.002-0.02 and additionally glycosaminoglycans - 0.001-0.03, purified water - the rest. The disadvantage of this irrigation solution is that it does not have a sufficiently specific effect on reparative processes in the cornea, since it does not contain specific biological stimulants separately, and also, apparently, because it contains a mixture of different glycosaminoglycans taken in an ineffective amount rather than the metered dosage combination of keratan sulfate sodium salt and chondroitin sulfate sodium salt.

The technical result of the invention is to obtain a balanced saline solution for irrigation, with more stable pH and more pronounced protective properties on the surrounding tissue of the eye.

It is known that from the point of view of physiology, the process of maintaining equilibrium is the exchange of water molecules of salts between the cornea, lacrimal and intraocular fluids. The optimal equilibrium ratio is achieved when the tear film contains 0.9% salts (tonicity). This is why most irrigation solutions have the same tonicity. When the concentration of salts in the tear film exceeds 0.9%, a hypertonic state develops. In this case, water flows from the cornea into the lacrimal fluid and dehydration and / or eventually corneal wrinkling can occur. The epithelium acts mainly as a semipermeable membrane and does not affect the passive diffusion of water. When the salt concentration in the tear film is below 0.9%, a hypotonic state occurs and water enters the cornea, which swells. The main function of the endothelial layer is to maintain the transparency of the cornea. The ion "pump" controls the flow of water and ions from and into the cornea so that the water content remains at 78%. Sulfated glycosaminoglycans enter the corneal stroma in the form of sodium salts of chondroitin sulfate and keratan sulfate. The main function of these salts is to maintain a normal water-salt balance between the cornea, lacrimal and intraocular fluids. During surgical interventions, the loss of endothelial cells occurs, due to which the work of the "ion pump" is disrupted. Normal operation can be restored by artificially introducing a solution of sodium salts of keratan sulfate and chondroitin sulfate into the chamber cavity. In addition, the sodium salts of keratansulfate and chondroitin sulfate in the amount we proposed stimulate the mobility of the damaged endothelium and thereby accelerate the restoration of the integrity of the endothelial layer of the cornea.

The technical result according to the invention is achieved in that an irrigation solution comprising sodium chloride, mono- and disubstituted sodium phosphate, L-carnosine, glycosaminoglycans and water, characterized in that the glycosaminoglycans are present in the solution as sodium salts of keratan sulfate and chondroitin sulfate in the following ratios of components g / l:

Monosubstituted Sodium Phosphate 0.018-0.072; Disubstituted Sodium Phosphate 0.079-0.141; Sodium chloride 8.5-9.5; L-carnosine 0.5-20.0; Keratan Sulfate Sodium 0.002-0.2; Chondroitin Sulfate Sodium 0.006-0.1; Purified water rest

Glycosaminoglycans are one of the main components of connective tissue. A number of well-studied diseases (hyperglycosaminoglycanuria, mucopolysaccharidoses) are associated with increased excretion of various glycosaminoglycans attached to peptides. The glycosoaminoglycans themselves, with the exception of keratan sulfate, are constructed from alternating residues of hexuronic acids and 2-amino-2-deoxyhexoses, the latter being N-acetylated, often O-sulfonated and sometimes N-sulfonated. Glycosaminoglycans include hyaluronic acid, chondroitin sulfate, dermatan sulfate, heparin, keratan sulfate, heparan sulfate. Keratan sulfate, unlike other glycosaminoglycans, does not contain hexuronic acid residues. Its molecule consists of repeating disaccharide units, which include the remainder of D-galactose and 2-acetamido-D-glucose-6-sulfate. Keratan sulfates containing other neutral sugars are known, for example, D-mannose, L-fucose, sialic acid.

Sulfated glycosaminoglycans stimulate repair processes and normalize metabolism in the cornea of the human eye, have the property of reducing the inflammatory and exudative reaction.

Keratan sulfate, chondroitin sulfate, heparan sulfate, heparin belong to sulfated glycosaminoglycans (sGAG) of the corneal stroma. Sulfated glycosaminoglycans stimulate the regeneration of keratitis stroma of the cornea in case of damage, normalize water-salt metabolism and contribute to the restoration of the transparent stroma of the cornea, which leads to their use in drugs.

To reduce postoperative complications in the process of ophthalmic surgery, it is necessary to use balanced solutions that are closest in composition to chamber moisture and have protective properties. The most physiologically acceptable and balanced salt composition is an isotonic solution with a pH of 6.8-7.8.

The proposed balanced saline solution for ophthalmology is obtained by known technology, for which exact weights of the components are dissolved in deionized pyrogen-free water in any sequence, the solution is mixed, filtered through a 0.22 μm filter, packaged in bottles, sealed and autoclaved.

The following components are used to prepare an irrigation solution of the claimed composition:

Monosubstituted sodium phosphate;

Disubstituted sodium phosphate;

L-carnosine;

Keratan sulfate sodium salt;

Chondroitin Sulfate Sodium;

Purified water.

All the starting components used to obtain the irrigation solution comply with the requirements of the Pharmacopoeia.

Example 1

According to the above method, an irrigation solution of the following composition is prepared, g / l:

Monosubstituted Sodium Phosphate 0.018; Disubstituted Sodium Phosphate 0.079; Sodium chloride 8.5; L-carnosine 0.5; Keratan Sulfate Sodium 0.002; Chondroitin Sulfate Sodium 0.006; Purified water rest

The ready-made solution was used during extracapsular senile cataract extraction with IOL implantation in patient N. 65 years old on OS. During the operation, 100 ml of solution was used. In the postoperative period, minor inflammation was stopped within three days. Corneal transparency has fully recovered. There was no exudate in the anterior chamber. 0.5 years after surgery, the loss of endothelial cells was 5.1%.

Example 2

According to the above method, an irrigation solution of the following composition is prepared, g / l:

Monosubstituted Sodium Phosphate 0.025; Disubstituted Sodium Phosphate 0.085; Sodium chloride 8.7; L-carnosine 19.5; Keratan Sulfate Sodium 0.02; Chondroitin Sulfate Sodium 0.005; Purified water rest

The prepared solution was used in the operation of extracapsular extraction of traumatic cataract by phacoemulsification with IOL implantation in patient C., 35 years old, on OD. During the operation, 90 ml of solution was used. In the postoperative period, a mild inflammatory reaction was stopped within four days. Corneal transparency has fully recovered. There was no exudate in the anterior chamber. 0.5 years after surgery, the loss of endothelial cells was 8.5%.

Example 3

According to the above method, an irrigation solution of the following composition is prepared, g / l:

Monosubstituted Sodium Phosphate 0.05; Disubstituted Sodium Phosphate 0.140; Sodium chloride 9.1; L-carnosine 3.2; Keratan Sulfate Sodium 0.2 Chondroitin Sulfate Sodium 0.1; Purified water rest.

The prepared solution was used during extracapsular extraction of complicated cataract with IOL implantation in patient N, 52 years old, on OD. During the operation, 120 ml of solution was used. In the postoperative period, a minor inflammatory reaction was stopped within three days. Corneal transparency has fully recovered. There was no exudate in the anterior chamber. 0.5 years after surgery, the loss of endothelial cells was 7.4%.

Claims (1)

An irrigation solution including sodium chloride, mono- and disubstituted sodium phosphate, L-carnosine, glycosaminoglycans and water, characterized in that the glycosaminoglycans are present in the solution as sodium salts of keratan sulfate and chondroitin sulfate in the following ratios of components, g / l: Monosubstituted Sodium Phosphate 0.018-0.072 Disubstituted Sodium Phosphate 0,079-0,141 Sodium chloride 8.5-9.5 L-carnosine 0.5-20.0 Keratan Sulfate Sodium 0.002-0.2 Chondroitin Sulfate Sodium 0.006-0.1 Purified water Rest