RU2529787C1 - Ophthalmic irrigation solution - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention represents an irrigation solution containing sodium chloride, mono- and dibasic sodium phosphate, glycosaminoglycans, glucose or its derivatives, water-soluble cellulose or its derivatives, neuraminic acid, an antihypertensive agent and water.

EFFECT: irrigation solution is balanced; it possesses the anti-inflammatory, anti-oedemic and antihypertensive properties.

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Description

The invention relates to medicine, namely to ophthalmology, and can be used when performing abdominal operations in ophthalmology, phacoemulsification in particular.

A known irrigation solution for ophthalmology, the closest in technical solution, consisting of sodium chloride, mono- and disubstituted sodium phosphate, glycosaminoglycans, glucose or its derivatives, water-soluble cellulose or its derivatives and water (RF patent No. 2234309) in the following ratio of components, wt. .%:

Sodium chloride 0.8-0.85 Monosubstituted Sodium Phosphate 0.01-0.8 Disubstituted Sodium Phosphate 0.001-0.8 Glycosaminoglycans 0.0001-4 Glucose or its derivatives 0.5-5 Water-soluble cellulose or its derivatives 0.01-0.2 Purified water rest

However, this solution has a number of disadvantages, such as defective protection of the eye structures during prolonged irrigation, as well as instability of the hydrodynamics of the eye and, as a result, the appearance of a transient increase in intraocular pressure during the operation and in the early postoperative period, the development of an inflammatory reaction (descemetitis, corneal edema).

The technical result of the invention is to obtain a balanced saline solution for irrigation, which has more pronounced protective properties on the eye structures, such as anti-inflammatory, decongestant, as well as moderate hypotensive. The technical result according to the invention is achieved in that an irrigation solution comprising sodium chloride, mono- and disubstituted sodium phosphate, glycosaminoglycans, glucose or its derivatives, water-soluble cellulose or its derivatives and water, according to the invention additionally contains neuraminic acid and a hypotensive agent in the following ratio of components , wt.%:

Sodium chloride 0.8-0.85 Monosubstituted Sodium Phosphate 0.01-0.8 Disubstituted Sodium Phosphate 0.001-0.8 Glycosaminoglycans 0.0001-4 Glucose or its derivatives 0.5-5 Water-soluble cellulose or its derivatives 0.01-0.2 Neuraminic acid 0.01-1 Antihypertensive agent 0.01-0.1 Purified water rest

Sodium chloride, mono- and disubstituted sodium phosphate are used to create isotonic solution.

Sulfated glycosaminoglycans (sGAGs) are naturally occurring polysaccharides present in all body tissues. Numerous studies have proven the leading role of sGAG in the initiation and nature of the inflammatory process. Sulfated GAGs released after damage (function like pathogen-associated molecular models) serve as a signal of damage to the body in the absence of microbial invasion. They are most fully integrated into the framework synthesized by inflammatory cells, which allows the most rapid formation of an ordered matrix in the lesion area and, accordingly, eliminates inflammatory mediators (N. Volpi. Current Medicinal Chemistry, 2006, 13, 1799-1810; J.Wever, Mechanisms of Ageing and Development, 14 (1980) 89-99), on the one hand, suppressing the synthesis of inflammatory mediators, giving a signal for migration to the zone of damage of neutrophils, macrophages, fibroblasts, on the other hand, does not interfere with the migration of fibroblast cells, thus stimulating proliferative process in damaged tissues. As glycosaminoglycans, keratan sulfate, chondroitin sulfates can be used.

Glucose is a high-energy material for eye tissues. The cornea, lens and iris utilize glucose at a high speed, metabolize glucose with the release of lactic acid into chamber moisture. In stressful situations and with various pathological conditions of the eye tissue, for example, with cataracts, the level of this metabolite decreases (A. Peary and R. van Heiningen. Eye Biochemistry. M .: Medicine 1968, pp. 266-300). When glucose is added to cultured corneal cells, ATP synthesis is redistributed and their mitochondrial metabolic activity decreases, which makes the cell state more resistant to stressful effects (R. A. Howkins et al, Biochem. J., 122, 13, 1971). Adding glucose to the proposed solution leads to stabilization of cell membranes and the pH of the medium, in addition, the osmolarity of the solution rises, which prevents swelling of cells and tissues. Glucose or its derivatives are introduced into the solution in a concentration of from 0.5 to 5%. A concentration below 0.5% can lead to hypoosmolarity of the solution, and at a concentration above 5%, the effect of hyperosmolarity can occur, which is undesirable and can lead to cell death. As glucose derivatives, dextrose, anhydrous glucose, can be used.

Water-soluble cellulose or its derivatives, such as methyl cellulose, hydroxyethyl cellulose, hyaroxypropyl cellulose, carboxyethyl cellulose, are introduced into the solution to give it protective viscoelastic properties. Water-soluble cellulose is an inert material that prevents damage to endothelial cells and the iris during surgical procedures to remove the crystalline masses by phacoemulsification. The boundary values of water-soluble cellulose derivatives are determined by the time of irrigation and the volume of surgical intervention. When the concentration of water-soluble derivatives of cellulose is less than 0.01%, the effect is absent. At a concentration above 0.2%, the viscosity characteristics of the solution increase, which prevents aspiration of both the solution itself and the lens masses.

Neuraminic acid is part of various carbohydrate-containing substances, such as glycoproteins, glycolipids (gangliosides), oligosaccharides. Occupying an end position in the molecules of these substances, sialic acids determine the negative charge of glycoprotein molecules, have a significant effect on their physicochemical properties and biological activity. Being part of the carbohydrate portion of glycoproteins, sialic acids mask the remnants of sugars, which are antigenic determinants, and thus play an important role in immune responses, reducing the immunogenic properties of normal and damaged cells. Intraocularly introduced glycosaminoglycans have protein residues in their structure, which are bound by neuraminic acid added to the composition of the irrigation solution in an amount of from 0.01 to 1 wt.%. The concentration of neuraminic acid in an amount of <0.01% does not provide the desired effect. A concentration> 1% can lead to the effect of hyperosmolarity, which is undesirable, because can cause cell death (Metzler D.E. Biochemistry, trans. from English, vol. 1, p. 1111, 118, M .: 1980).

One of the serious postoperative complications after phacoemulsification is reactive hypertension. The frequency of reactive hypertension after cataract phacoemulsification is 7.2%. A feature of its course is a decrease in visual acuity below 0.1 in 92.5% of cases with an increase in IOP to 34.3 ± 2.54 mm Hg. on the first day after surgery against inflammatory edematous changes in the anterior segment (cornea, ciliary body). The use of small amounts of antihypertensive agents in the composition of the irrigation solution during surgery will avoid the development of hypertension in the early postoperative period, as well as prevent transient IOP rises during the operation. A concentration of antihypertensive agent <0.01% will not provide the necessary hypotensive effect, and a concentration of> 0.1% may lead to an undesirable effect, causing severe hypotension. As a hypotensive agent, timolol, arutimol, azopt can be used.

The proposed irrigation solution for ophthalmology is obtained according to the following technology: exact weights of the components are dissolved in water for injection and thermostated at 37 ° C for 2 hours. Then filtered through a filter with a pore size of 0.22 μm.

For a better understanding of the invention it is illustrated by examples of specific performance.

Example 1

Patient V., 69 years old.

Diagnosis: mature cataract of the right eye. The patient underwent cataract extraction by phacoemulsification using the described irrigation solution of the following composition, wt.%:

Sodium chloride 0.8 Monosubstituted Sodium Phosphate 0.01 Disubstituted Sodium Phosphate 0.001 Keratan sulfate + chondroitin sulfate 0.0001 Anhydrous glucose 0.5 Cellulose 0.01 Neuraminic acid 0.01 Timolol 0.01 Purified water rest

The volume of the irrigation solution is 200 ml, the postoperative period without complications, biomicroscopically: the eye is calm, the cornea is transparent, chamber moisture is transparent, the anterior chamber is medium depth, the iris is subatrophic, the IOL in the capsule bag, the posterior segment is calm. Endothelial loss of 3.5%, intraocular pressure (IOP) on the first day after surgery 15 mm Hg

Example 2

Patient Sh., 73 years old.

Diagnosis: mature cataract of the left eye. The patient was extracted cataract by phacoemulsification using the described solution of the following composition of components, wt.%:

Sodium chloride 0.83 Monosubstituted Sodium Phosphate 0.1 Disubstituted Sodium Phosphate 0.05 Keratan sulfate + chondroitin sulfate 0.002 Dextrose 1,0 Hydroxyethyl cellulose 0.1 Neuraminic acid 0.8 Arutimol 0.08 Purified water rest

The volume of irrigation solution is 200 ml, the postoperative period without complications. Biomicroscopic: the eye is calm, the cornea is transparent, chamber moisture is transparent, the anterior chamber is of medium depth, the iris is subatrophic, the IOL in the capsular bag, the posterior segment is calm. Endothelial loss 5%, IOP on the first day after surgery 17 mm Hg

Example 3

Patient W., 67 years old.

Diagnosis: mature cataract of the right eye, cataract extraction was performed by phacoemulsification using the described solution of the following composition of components, wt.%:

Sodium chloride 0.85 Monosubstituted Sodium Phosphate 0.8 Disubstituted Sodium Phosphate 0.8 Glycosaminoglycans four Dextrose 5 Hydroxyethyl cellulose 0.2 Neuraminic acid one Azopt 0.1 Purified water rest

The volume of irrigation solution is 150 ml, the postoperative period without complications. Biomicroscopic: the eye is calm, the cornea is transparent, chamber moisture is transparent, the anterior chamber is of medium depth, the iris is subatrophic, the IOL in the capsular bag, the posterior segment is calm. Endothelial loss of 4.5%, IOP on the first day after surgery 14 mm Hg

Claims (1)

An irrigation solution including sodium chloride, mono- and disubstituted sodium phosphate, glycosaminoglycans, glucose or its derivatives, water-soluble cellulose or its derivatives and water, characterized in that it additionally contains neuraminic acid and antihypertensive agent in the following ratio of components, wt.%:
Sodium chloride 0.8-0.85 Monosubstituted Sodium Phosphate 0.01-0.8 Disubstituted Sodium Phosphate 0.001-0.8 Glycosaminoglycans 0.0001-4 Glucose or its derivatives 0.5-5 Water-soluble cellulose or its derivatives 0.01-0.2 Neuraminic acid 0.01-1 Antihypertensive agent 0.01-0.1 Purified water rest