RU2519010C1 - Composition for treating cystitis - Google Patents

Abstract

FIELD: chemistry, pharmacology.

SUBSTANCE: composition contains 0.8-2.0 wt % of sodium hyaluronate, 1-3 wt % of sodium alginate and distilled water to 100 wt %. Composition possesses prolonged adhesion to glycosamine-glycan urothelium layer and creates barrier for adhesion of bacteria to affected tissues by covering urothelium with biopolymer film.

EFFECT: composition ensures expressed therapeutic effect, considerably reduces edema of urinary bladder walls, stops or considerably reduces pain syndrome, considerably reduces number of cystitis recurrences.

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Description

The invention relates to medicine, namely to medicinal compositions, and can be used in the treatment of cystitis of various etiologies.

A gel oxybutylene gel is known for topical application, in particular for the treatment of cystitis, containing synthetic polymers and polysaccharides (RF Patent No. 2290929, IPC АКК 31/439, publ. 2007).

The disadvantage of this gel agent is the poor adhesion of the agent to urothelium, which can lead to a short-term effect of the drug, reducing the effectiveness of the treatment.

The closest is a therapeutic composition for the treatment of cystitis based on sodium hyaluronate diluted with saline (P.V. Glybochko, Yu.G. Alyaev, Z.K. Gadzhieva, Mirkin Ya.B. Use of hyaluronic acid in the treatment of chronic cystitis. EF. Urology. 5/2011, p.30-35).

The disadvantage of this composition is the short-term adhesion to urothelium of the bladder, which reduces the possibility of evacuation of pathogenic microorganisms that cause cystitis, requires frequent administration of the drug and does not provide a long-term effect.

The objective of the invention is to eliminate these drawbacks, the creation of a new drug with pronounced pharmacological activity for the treatment of cystitis, with high therapeutic activity, allowing to reduce unwanted side effects by providing prolonged adhesion of the created composition to the glycosaminoglycan layer of urothelium, as well as creating obstacles to the adhesion of bacteria to damaged tissues by covering urothelium with a biopolymer film.

The problem is solved in that the known medicinal composition containing sodium hyaluronate, a diluent, additionally contains sodium alginate in the following wt.%:

sodium hyaluronate - 0.8-2.0

sodium alginate - 1-3

distilled water - the rest

A method of obtaining a composition for the treatment of cystitis can be carried out with the implementation of this task as follows.

Preparing a solution of sodium hyaluronate 0.8-2.0% of the mass. with 1-3% of the mass. sodium alginate, respectively.

For this, 1 g of sodium hyaluronate (1%) is poured into a 150 ml container, 99 ml of distilled water is added (up to 100%) and mixed thoroughly, left for 60 minutes. Then, 1.5 g (1.5%) of sodium alginate is added with stirring and allowed to swell for 60 minutes. Then mix, pack in syringes and carry out gamma sterilization.

To confirm the best adhesion to urothelium of the proposed polymer composition for drug delivery in the treatment of cystitis, the following studies were carried out.

To determine the adhesion of the polymer composition to biological tissues by a specially developed technique, thin collagen-elastin films (collagen and elastin - the basis of connective tissue) were cast. The films were dried under pressure at 25-35 ° C, after which a composition of sodium alginate and hyaluronic acid (in the ratio indicated in the formula) was applied to the outer side of the 1 film and, in parallel, for comparison, with the Urogial preparation at the same concentration of hyaluronic acid in both cases . Then the film with a layer of polymer composition coated with a second collagen film, kept under pressure for 10, 20, 30, 40, 50, 60 minutes (6 samples for each composition). Then, the films joined by the composition were installed between the fixed lower clamp and the movable upper and the work of separation of the films from each other was determined. Tests were performed on a Brookfield CT3 texture analysis instrument. The experiments showed that the proposed composition based on sodium alginate and sodium hyaluronate adhesion compared with the drug Urogial higher 6-8 times.

To determine the degree of protection of urothelium from the aggressive effects of the bladder medium, a seven-layer membrane was assembled from pre-cast collagen films, a composition of sodium alginate and sodium hyaluronate was applied to it, held for 15 to 60 minutes, exposed to alkali solutions, and the degree of membrane destruction was observed. In parallel, an experiment was conducted with the Urogial drug for comparison.

The experiments showed that the created composition based on sodium alginate and sodium hyaluronate provides protection of urothelium to the aggressive environment of the bladder by 60% compared with the drug Urogial.

The possibility of carrying out the invention is confirmed by the following examples.

Example 1

Patient A., 34 years old, suffers from recurrent bacterial cystitis, the frequency of relapses 10-12 relapses per year. I received treatment with the composition: sodium hyaluronate solution 1%, sodium alginate 1.5%, diluent distilled water up to 100%. A course of intravesical instillations for 2 months once a week. After a course of therapy with this composition, no relapse was observed for 1 year.

Example 2

Patient D., 48 years old, received radiation therapy for cervical cancer, after the end of the course of treatment she began to notice symptoms of cystitis, up to 20 urination per day. I received treatment with the composition: sodium hyaluronate solution 1.5%, sodium alginate 1.8%, diluent distilled water up to 100%. The course of intravesical instillations was 12 weeks, the first 2 weeks 2 instillations per week, from 3 weeks to 1 instillation once a week. Starting from 2 weeks, the frequency of urination decreased to 15-12 times a day, from 3 weeks to 10-7 times a day.

Example 3

Patient P., 41 years old, diagnosed with interstitial cystitis, pain, urination up to 18 times a day. He received treatment with the composition of a solution of sodium hyaluronate 1.5%, sodium alginate 1.5%, diluent distilled water to 100%. The course of treatment was 10 weeks, the first week of 2 instillations per week. Then 1 instillation once a week. By the end of the 5th week of the course, the urination frequency is 7-10.

All patients included in our study had a fairly large experience of treatment for their disease in the form of standard conservative treatment, but without a satisfactory effect.

The use of the proposed composition significantly reduces the severity of the reaction of edema of the walls of the bladder, the bladder capacity increases by an average of 47 ml, after treatment there is a pronounced positive dynamics: in some patients the pain stopped completely, the remaining patients noted a significant decrease in pain. The indicator of the number of cystitis relapses decreased significantly - more than 2 times, which had a positive effect on the quality of life of patients, the psychoemotional state improved.

Claims (1)

Composition for the treatment of cystitis containing sodium hyaluronate, a diluent, characterized in that the composition further comprises sodium alginate, in the following wt.%:
sodium hyaluronate - 0.8-2.0
sodium alginate - 1-3
distilled water - the rest is up to 100