Pharmaceutical composition for treatment of cornea injury

FIELD: medicine, ophthalmology, pharmacy.

SUBSTANCE: invention proposes a pharmaceutical composition used in treatment of cornea injuries that comprises, mas.p.p.: sodium deoxyribonucleate, 14-15; sodium chloride, 0.8-0.9; lyophilized blood plasma, 74-75, and distilled water, the balance. Components are mixed in aseptic conditions and packaged. Invention provides anti-inflammatory, antiviral, antibacterial, reparative and regenerative effect, decreasing treatment period and declining post-operative complications.

EFFECT: improved, enhanced and valuable medicinal properties of pharmaceutical composition.

2 tbl, 5 ex

 

The technical field to which the invention relates.

The invention relates to medicine, in particular to ophthalmology, and can be used for the treatment of lesions of the cornea.

The level of technology

Known composition for the treatment of burns of the cornea by removing necrotic masses then close the resulting defect biological substrate, with the resulting defect diseased cornea is applied repeatedly until epithelialization freeze-dried blood plasma, dissolved in physiological solution (see autospid. The USSR №1344354, CL 61F 9/00, publ. 15.10.1987 year).

The disadvantage of this composition and method of treatment is a low effect, since the dried blood plasma itself is insufficient pronounced stimulant regenerative processes of the cornea, as well as long term treatment.

Renowned pharmaceutical composition for the treatment of inflammatory processes of viral etiology in the eyeball that contains the antiviral drug, while it additionally contains vegetable and/or animal phospholipids, sodium chloride one-deputizing, sodium phosphate disubstituted and water purified in the following ratio, wt.%:

Antiviral medicationof 0.001-5
Vegetable and/or animal phospholipids0,001-2
Sodium chloride0,8-0,9
Sodium phosphate one-deputizingof 0.001 to 0.2
Sodium phosphate disubstitutedof 0.001 to 0.2
Purified waterrest

(see U.S. Pat. Of the Russian Federation No. 2245137, CL AC 31/00, 61F 9/00, F61P 27/02).

The disadvantage of this composition is a low efficiency and a prolonged effect in the treatment of lesions of the cornea.

The closest in technical essence and the achieved positive effect and adopted by the authors for the prototype is Derinat, including deoxyribonuclease, sodium chloride, distilled water (see the Handbook, VIDAL, drugs in Russia", B-402, 2005).

The disadvantage of this drug is a long term treatment, and he does not have a sufficiently strong antiviral, antimicrobial, reparative and regenerative action.

Disclosure of inventions

Object of the present invention to provide pharmaceutical compositions for the treatment of lesions of the cornea, which has anti-inflammatory, antiviral, antimicrobial, as well as reparative and regenerative action, the ability to normalize the condition of the tissue at distroficescimi in the cornea, the reduction of treatment time and reduce postoperative complications.

The technical result that can be achieved using the present invention is an anti-inflammatory, antiviral, antimicrobial, as well as reparative and regenerative action, the normalization condition of the tissues in degenerative changes, reducing treatment time and reduce postoperative complications.

The technical result is achieved by using a pharmaceutical composition for the treatment of lesions of the cornea, including deoxyribonuclease, sodium chloride and distilled water, it additionally contains freeze-dried blood plasma in the following ratio, wt.%:

Deoxyribonuclease sodium14-15
Sodium chloride0,8-0,9
Freeze-dried blood plasma74-75
Distilled waterrest

The essence of a pharmaceutical composition for the treatment of lesions of the cornea is as follows: the initial substance in wt.%, namely, deoxyribonuclease sodium 14-15, sodium chloride 0,8-0,9, freeze-dried blood plasma 74-75, the rest distilled water, mix in ASEP is practical conditions, and Packed.

Pharmacological action Derinat, namely, deoxyribonuclease, sodium chloride and distilled water is that it is an immunomodulator that affects cellular and humoral immunity, stimulates reparative processes and disorders (normalizes the number of granulocytes, lymphocytes, platelets), has anti-inflammatory, antiviral, antimicrobial, and reparative and regenerative action, normalizes the tissues in degenerative changes, has a poorly marked anticoagulant effect.

Freeze-dried blood plasma, biological dressing, improves the processes of regeneration, trophic corneal, restore osmotic equilibrium, at the same time having good adhesive properties, plasma provides biological isolation, performs a protective function: inhibits the growth of newly formed blood vessels, protects it from the tear fluid and pathogenic microflora, at the same time, lyophilized blood plasma by itself alone is not enough pronounced stimulant regenerative processes of the cornea.

The implementation of the invention

Examples of specific performance of the receipt and testing of pharmaceutical compositions for the treatment of lesions of the cornea.

Example 1. Pharmaceutical composition (FC) th is ovat by mixing the components and dissolved in distilled water in the following ratio of components, wt.%:

Deoxyribonuclease sodium10
Sodium chloride0,5
Freeze-dried blood plasma65
Distilled waterrest

followed by the package.

The obtained composition was too liquid, as follows from the palpebral fissure, not acting as a biological dressing.

Example 2. Carried out analogously to example 1, but the composition is taken in the following ratio, wt.%:

Deoxyribonuclease sodium14
Sodium chloride0,8
Freeze-dried blood plasma74
Distilled waterrest

The resulting composition turned out to be consistency in the form of eye ointments, which are evenly located on the eyeball, performing the function of a biological dressing.

Example 3. Carried out analogously to example 1, but the composition is taken in the following ratio, wt.%:

Deoxyribonuclease sodium15
Sodium chloride0,9
Leofiles the automated blood plasma 75
Distilled waterrest

The resulting composition is also turned consistency in the form of eye ointments, which are evenly located on the eyeball, performing the function of a biological dressing.

Example 4. Carried out analogously to example 1, but the composition is taken in the following ratio, wt.%:

Deoxyribonuclease sodium15,5
Sodium chloride0,95
Freeze-dried blood plasma80
Distilled waterrest

The resulting composition has a very thick consistency, which do not cover the affected area of the cornea.

Thus, the best was the composition according to examples 2 and 3.

Clinical studies using the proposed FC was performed in 70 patients (40 men and 30 women) aged from 18 to 73 years, among them, 21 patients with keratopathy, 22 patients with keratitis of various etiologies, 11 patients with AAD, 9 patients with burns, 7 patients with corneal opacities varying degrees. Assessment of corneal they had a way of ceratopogonidae, altimetry, refractometry, biomicroscopic activeassistant recovery of corneal transparency. All patients received treatment with 20% solution of Derinat, consisting of deoxyribonuclease, sodium chloride and distilled water, with dissolved lyophilized blood plasma. The control group consisted of 20 people receiving conventional treatment and holistic therapy (vitamins, antioxidants, detoxification and desensibiliziruyuschee therapy).

Example 5. The patient takes a horizontal position. Ever bred by wikopedia. On the affected cornea without anaesthetic, using eye glass sticks aplitsiruetsya pharmaceutical composition. Velodyne removed after 3-5 minutes. Impose monocular bandage on for 20-30 minutes, during which the patient remains in a horizontal position. This procedure is carried out 2 times a day. The best course of treatment was 5-6 days, when traditional methods of treatment, usually 10-12 days.

As a result of the treatment it is shown that the inflammatory process was alloreactive, after the start of treatment eyes became calm. In all cases, there is a strong link regenerated epithelium from underlying tissue of the cornea, which contributes to the conservation and restoration of transparency in affected areas, increased visual acuity, the average rose to 0.30+0.03 in (P<0.001) statistical and reliably, restored the sensitivity of the cornea statistically significantly (P<0,001).

Allergic reactions were not observed. Given the pronounced positive effect of therapy, this pharmaceutical composition may be recommended in treatment of lesions of the cornea doctors-ophthalmologists practical health care.

Assessment for each of the indicators in dystrophic diseases of the cornea are shown in tables 1 and 2.

Table 1
DayPachymetry before the treatmentPachymetry Derinat + plasmaPachymetry cent. the treatment
1stThe thickness of the cornea in the Central zone ranged from 1000 to 1200 microns1100-12001000-1200
3600-7501000-1100
7th500-600800-900
15th450-500800-700
remote450-500550-600
Table 2
DiseasesPachymetry is Einat + plasma Pachymetry traditional treatment
AED700-800800-900
Burns 1-2 degrees600-650650-700
Postoperative keratopathy450-500550

Visual acuity before treatment from 0,01-0,09 increased to 0.1 and 0.35 in the treatment of complex - Derinat + plasma, 0,05-0,1 traditional treatment.

The present invention in comparison with the prototype and other known technical solution has the following advantages:

- anti-inflammatory, antiviral, antimicrobial, as well as reparative and regenerative actions;

the normalization condition of the tissues in degenerative changes;

- reduction of treatment time and reducing postoperative complications;

the exception of allergic reactions.

Pharmaceutical composition for the treatment of lesions of the cornea, including deoxyribonuclease, sodium chloride and distilled water, characterized in that it further comprises a freeze-dried plasma in the following ratio, wt.%:

Deoxyribonuclease sodium14-15
Sodium chloride0,8-0,9
Freeze-dried blood plasma74-75
Distilled waterrest



 

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