Eye drops

 

The invention relates to medicine. Eye drops as active substance contains a mixture of glycosaminoglycans 0.1 wt.%, isolated from human placenta, polyvinylpyrrolidone 2 wt.%, saline - rest. Eye drops provide effective healing and reducing treatment time. table 1.

The invention relates to medicine, in particular to ophthalmology, and can be used in the treatment of traumatic injuries, trophic disorders and chemical burns of the conjunctiva, cornea and skin.

There are several drugs that promote tissue regeneration, the eye in different lesions. For example, "Vitreous body", the drug from the vitreous body of the eye of cattle. "Caracol" - from the dried and crushed cornea cattle, effective with keratitis, ulcers and burns of the cornea and other eye lesions (M. D. Mashkovsky. Medicinal product. 1997, part 2, 113 S.) "Solcoseryl" - depotentiating extract the blood in the form of a 20% eye gel, also used in the treatment of corneal diseases, enter it into the conjunctival SAC (M. D. Mashkovsky. Pharmaceutical shredstation), selected from petuhsinyh scallops, or get microbiologically "Healon" and "Provise" in the form of 1% solution is prepared to replace the liquid media of the eye during cataract extraction. These drugs also have reparative properties and promote tissue regeneration eyes.

The closest to the essence of the present invention is a drug - 0,1-1% Eye drops containing a water-soluble mixture of glycosaminoglycans isolated from the cornea of the eye of cattle (EN 2062079, a 61 F 9/00, a 61 K 9/06, 1996). The use of eye drops enhances wound healing activity and reduces the treatment time.

All of these drugs are derived from different organs of animals, i.e. they are not homologous to the human body. The instillation of the drops is carried out in the conjunctival cavity 6-8 times a day, i.e., they do not have a prolonging effect.

We have been tasked to develop a drug on the basis of glycosaminoglycans (GAG), obtained from homogeneous tissue of the human body, with a higher regenerative effect, prolonged action and reduces the time of treatment.

To achieve the objectives of the proposed eye drops containing water is installed from human placenta mixture of glycosaminoglycans and polymer polyvinylpyrrolidone in the following ratio of components, wt.%: A mixture of glycosaminoglycans - 0.1 Polyvinylpyrrolidone - 2 saline - Else GAG from human placenta is a mixture consisting of hyaluronic acid (46-57%) and heparin with heparansulfate (2-7%). High degree of purification (95%) GAG is achieved through a multi-stage process of liberation alkaline placenta extract. The residual content of proteins and nucleic acids of not more than 3%.

Polyvinylpyrrolidone (Pvp) are obtained by radical polymerization of monomers, most commonly in water. Pitr - colorless and transparent thermoplastic, amorphous hygroscopic polymer with a molecular weight 10000-1000000. Very soluble in water (A. I. ANCOVA, MT Alushin. Polymers in pharmacy. M.: Medicine, 1985, 61 S.).

The human placenta is subjected to testing for infection with HIV, hepatitis and syphilis.

The method of obtaining eye drops.

Under aseptic conditions in a sterile stand dissolved glycosaminoglycans and polyvinylpyrrolidone, were sterilized with gamma rays in physiological solution. The solution is filtered through sterile glass filter with a pore size 10-16 μm in sterile cylinder, through the same filter filter remaining saline and Dolny rubber plugs, the solution is looking at the naked eye lit on white and black background. The vials are sealed with metal caps under running".

For experimental verification of the claimed eye drops were prepared recipe, containing various amounts of GAG placental and polyvinylpyrrolidone. The best results were obtained at concentrations of a mixture of glycosaminoglycans 0.1% and 2.0 polyvinylpyrrolidone with three times instillation in the day in the eyes of experimental animals.

When less than 0.1 GAG placental eye drops will not possess a proper therapeutic effect, when more than 0.1 GAG placental enhance therapeutic effect is not observed. With the introduction of a drop of 1.5 g Pvp not observed prolonged action, and with the introduction of 2.5 g Pvp, eye drops turn into a gel-like form.

Example 1. The method of preparation.

Under aseptic conditions in a sterile stand dissolve 0.05 g placental glycosaminoglycans and 1.5 g of polyvinylpyrrolidone past sterilization with gamma rays in 50 ml of physiological solution. The solution is filtered through a special filter with a pore size 10-16 μm in sterile cylinder, through the same filter the rest fiziologicheskii. Vials with solution packaged sterile rubber stoppers, the solution is looking at the naked eye lit on white and black background. The vials are sealed with metal caps "running". The components are taken in the ratio, wt.%: GAG placental - 0.05 g Pitr - 1.5 grams of saline solution Up to 100 ml When given ratio will produce a solution with prolonged action.

Example 2. The preparation method similar to example 1. Eye drops with components taken in the following ratio, wt.%:
GAG placental - 0.1 g
Pitr - 2.0 g
Saline solution Up to 100 ml
Cooked drops in the specified ratio of the components meet the requirements of the global Fund XI edition: a sterile, stable, no mechanical impurities, isotonic and have a prolonged action. Prepared eye drops odorless, clear, colorless.

Example 3. The preparation method similar to example 1. Eye drops with components taken in the following ratio, wt.%:
GAG placental - 0.5 g
Pitr - 2.5 g
Saline solution Up to 100 ml
When taken ratio is obtained a viscous solution.

How to use: installation drops in the conjunctival cavity apiwat 30% solution sulfatsila sodium 6 times a day, 1% solution of atropine sulfate 1 time a day and offer eye drops 3 times a day.

On the first day of weak injection of the vessels of the conjunctiva of the eyeball, the defect of the cornea 4x6 mm, colored fluorescein.

On the third day the defect of the cornea is reduced by half, the front camera is of medium depth, the reaction of the pupil to light alive, iris calm.

On the sixth day epithelization of the wound defect, as evidenced by the absence of staining fluorescein, gentle abrocomidae corneal opacity in the center.

On the 12th day and in subsequent periods - complete epithelialization of the cornea, the cornea is transparent.

Histological, electromicroscopic studies highlight that complete epithelialization of the cornea occurs on the sixth day.

Example 5. (the control group).

After receiving the non-through defect of the cornea in the right eye of the rabbit breed "Chinchilla" buried 30% solution sulfatsila sodium 6 times a day, 1% solution of atropine sulfate 1 times a day, and a mixture of glycosaminoglycans 0.1% solution 6 times a day.

On the first day was low vascular injection of the conjunctiva of the eyeball, the defect of the cornea 5x5 mm, colored fluorescein.

On the third day the defect of the cornea mind the days epithelization of the wound defect, as evidenced by the absence of staining fluorescein, gentle abrocomidae corneal opacity in the center.

On the 14th day and in subsequent periods - complete epithelialization of the cornea, the cornea is transparent.

Thus, compared to the prototype (the control group) epithelization of the cornea in the treatment offered eye drops occurred in 1-2 days faster, prolonging the action has reduced the number of instillations 2 times and get a high functional effect.


Claims

Eye drops containing a water-soluble mixture of glycosaminoglycans and saline solution, characterized in that they contain isolated from human placenta mixture of glycosaminoglycans and polymer polyvinylpyrrolidone in the following ratio, wt. %:
A mixture of glycosaminoglycans - 0,1
Polyvinylpyrrolidone - 2
Saline - Rest

 

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