UA139724U - NOSAL SPRAY BASED ON A SOLUTION OF COLLOIDAL SILVER WITH ICELANDIC CETRARIA EXTRACT - Google Patents

Abstract

Nasal spray based on a solution of colloidal silver with Iceland cetraria extract contains as an active ingredient a solution of colloidal silver with an activity of 45-55 ppm, obtained by the physical method of electrolysis. Additionally, the spray contains cetraria extract (Extractum Cetraria fluidum), vitamin A, vitamin E, D-Panthenol, thymol, as excipients contains PEG-40 hydrogenated castor oil, glycerin pharmaceutical, sodium hyaluronate, propylene glycol, potassium soror.

Description

The utility model belongs to the pharmaceutical industry and refers to medical devices that are used as an adjunct to relieve the course of rhinitis, rhinosinusitis, adenoiditis, as an adjunct to relieve the course of ARVI (acute respiratory infections) and colds, accompanied by significant nasal congestion and the formation of thick secretions.

Deterioration of the environmental situation, an increase in the number of respiratory viral infections and allergens contribute to the growth of rhinitis and sinusitis - inflammatory diseases of the mucous membrane of the nose and paranasal sinuses.

The development of new highly effective medical products for adjunctive therapy in nasal infectious diseases remains an urgent problem due to the wide spread of infectious diseases of the nose among the population of Ukraine and the world, as well as the appearance of frequent complications and limitations of both domestic and foreign combined medical products that would act as to stop the development of infection in the nose, as well as to remove unwanted symptoms at the same time. Today, viruses and bacteria pose a threat to medicine and society, and are one of the main causes of morbidity and mortality in the population. Despite the successes in the development of drugs for antiviral, fungicidal and antibacterial therapy, modern treatment regimens are not able to fully control the course of infections. Therefore, there is a need to create new effective drugs.

Nanoparticles of metals and metal oxides are of particular interest in this aspect, because such nanostructures exhibit unique physicochemical, biological, and pharmacological properties, and have pronounced bactericidal, fungicidal, and viricidal potential.

Today, among metal nanostructures with pronounced biocidal properties, the most studied are silver nanoparticles, which are actively used in the development of new medicines, as well as in the creation of medical products, synthetic fabrics and packaging materials with antimicrobial activity, and water disinfection devices.

Silver is also widely used as an antiseptic in the treatment of open wounds and burns.

Nowadays, thanks to the development of nanotechnology, compounds of this metal are returning to medicine as new highly effective antimicrobial agents.

A wide spectrum of antimicrobial action of silver, lack of resistance to it in most pathogenic microorganisms, low toxicity, as well as good tolerability contributed

Due to the increased interest of doctors around the world in preparations of this metal.

This is due to the growth of allergic complications of antibacterial therapy, the toxic effect of antibiotics on internal organs and suppression of immunity, the occurrence of fungal lesions of the respiratory tract and dysbacteriosis after long-term antibacterial therapy, as well as the appearance of resistant strains of pathogens to the antibiotics used.

The well-known preparation "PectolvanF phyto Icelandic moss" (about /Laptak.tsa/dgydv/rekioimap iliOo iviapab5-Kiu toyp/), containing an alcoholic extract of the root of the delusion (Ehigasisht Ipshaye Janpidit) (an alcoholic extract of cetraria Iceland (Ehigasisht Seigagia

TPiidit) (1:20), soapwort root tincture (Tipsishiga Zaropagiae) (1:5), hyssop herb tincture (Tipsimga Nuzzori) (1:5), thyme herb tincture (Tipsiiga Tpute) (1:5).

But the agent in the form of a spray is used for coughs and colds as an expectorant.

The well-known remedy "Protargol" in 2 95 solution (producer Istok-Plus Ukraine), drop form pNrz/Lymlu.oroghemaiei.sot/peaiLekKagzima/rgoiagdo!.pitiyaapisie-itekhi klussheShe--1) contains silver proteinate (agdepiy rgoieipaekh) 2 g and auxiliary substances - sodium phosphate, potassium dihydrogen phosphate, imidourea, purified water.

The well-known drug "Collargol" (pErv:/Lumly.oroghemaiieI.sot/peinLekKagvima/koPagdo!. pit) contains in its composition up to 70 95 colloidal silver and approximately 30 95 protein albumin, which connects silver molecules together and supports them in active state, available in the following dosage forms: solution for external use 0.2 95, 1 95, 2 90; powder (for preparing a solution); ointment 15 90; eye drops 2 95, Z 95, 5 o.

However, these drugs contain many by-products, impurities, protein stabilizers and have a caustic effect that dries and injures the mucous membrane, and in a normal state it should be moist.

The basis of a useful model is the task of developing a nasal spray based on a solution of colloidal silver with an extract of cetraria icelandia obtained by electrolysis with the addition of an extract of cetraria icelandia (Icelandic moss) as an active ingredient.

The task is solved by the fact that the nasal spray based on a solution of colloidal silver with an extract of cetraria icelandia contains as an active pharmaceutical ingredient a colloidal silver solution, as well as auxiliary substances, according to a useful model, it contains a solution of colloidal silver with an activity of 45-55 ppt, obtained by a physical method electrolysis,

additionally contains cetraria extract (Ehigasisht Seigagia Piidit), vitamin A, vitamin E, D-

Panthenol, thymol, as auxiliary substances contains PEG-40 hydrogenated castor oil, pharmaceutical glycerin, sodium hyaluronate, potassium sorbate, with the following ratio of components, (wt. b): castor oil o moss) Mo mouth

According to the utility model, the nasal spray is made in the form of a brown plastic bottle equipped with a spray pump.

Icelandic moss has an anti-inflammatory effect, its use is indicated for infectious diseases, for medicinal purposes the whole lichen slush (Hispep isiapaiisiv) is used, which contains more than 7095 carbohydrates, among which the largest specific weight is lichen starch (lichenin), as well as crystalline bitter substances - centrarin, fumaric and other acids, gum, sugar, quite a lot of iodine and boron, antibiotics - protolyesteric and usnic acids, which kill tuberculosis bacteria.

Thymol (systematic name: 2-isopropyl-5--methylphenol) is a natural monoterpene phenol, a derivative of cymol, STONE140, an isomer of carvacrol, which was found in thyme oil, which was extracted from TPputiv ucidagis, the most common species of thyme, although many other plant species also contain thymol. It is a white crystalline substance with a pleasant aromatic smell and strong antiseptic properties.

Colloidal silver - a product consisting of microscopic silver particles that form a suspension in demineralized and deionized water, is obtained by the electrolytic method. Colloidal silver has antiviral and antibacterial properties. Able to suppress the growth or cause the death of a wide range of bacteria, it has a virulicidal effect on the influenza virus and other viruses.

The bactericidal effect on eiarpuosossi5 acygeiz was noted at a concentration of colloidal silver nanoparticles of 45-50 ppm. Silver doses of 50-250 μg/l with long-term use are physiological and do not have a harmful effect on the body.

On Staphylococcus aureus, protea vulgaris, silver ions have a different antimicrobial effect - from bactericidal (the ability to kill microbes) to bacteriostatic (the ability to prevent

With the reproduction of microbes).

The mechanism of action of silver on viruses, bacteria, and fungi consists in inhibiting enzymes that control their energy metabolism.

Silver obtained by electrolysis is the purest substance, which minimizes the presence of foreign impurities in the finished medical product. A wide spectrum of antimicrobial action of silver, the lack of resistance to it in most pathogenic microorganisms, low toxicity, contributes to its introduction into formulations as an antimicrobial antiseptic agent. Nanotechnology makes it possible to reduce the price of silver-based drugs and make them available for the treatment of many infectious diseases.

D-Panthenol is used for moisturizing and accelerating the regeneration of various skin lesions as part of pharmaceutical and cosmetic products.

Sodium hyaluronate is found naturally in the vitreous body of the eye, serum, chicken combs, shark skin and whale cartilage. It is used as an adjuvant for the delivery of substances, a lubricant, a solution stabilizer.

Vitamin A has many biochemically important functions in the human and animal body. Retinal is a component of rhodopsin - the main visual pigment. In the form of retinoic acid, it stimulates growth and development. Retinol is a structural component of cell membranes. Provides antioxidant protection of the body.

Vitamin E is a key factor in strong immunity and cell protection.

Potassium sorbate, a potassium salt of sorbic acid, is a natural preservative.

Example 1. Research to determine the optimal concentration of colloidal silver solution

Table 1 shows a comparison of the solution of colloidal silver, obtained by the electrolysis method, which is used in the invention, with the above-mentioned preparations "Protargol" and "Collargol".

Table 1

Differences between colloidal silver and traditional silver preparations

M Components | 95 silver. with. method

Name) Chemical name Composition for water!| ppt, g/l of production From production! bottles 10,000 ppt/l (1Og/l), in

Chemical Nitrate conversion of silver, to pure protein per 10 ml of silver. Silver hydrolyzate |0.1-2 g, which is 75-0.85 g/l

Protargol Grogeinat 7.5-8.5 Fo, casein, is | -200,000

P protein to 100 95 gelatin, 1-20 95 ppt/l egg sequence |respectively| (200g/l), oxidizing protein in reductive calculations of reactions for pure silver 17g/l 20000 рrt/l. per 10 ml (2o g/l),

Nitrate 02-03 g in

Silver 70 95, Chemical silver, " o " Hypercalculation hydroxide is pure

Sodium silver and sodium salt silver (caustic soda), 14 g/l,

Copargop lysalbin and protein

P protalbin hydrolyzate 30,000 casein acids, ppt/l g. . . gelatin, (ZOg/l),), sodium salts | sequence

I: p. egg in lysalbin and oxidation 2-3 90. and The formula for converting protalbinic reducing agents into pure acid reactions - silver 21 g/l 50 ppt/l

Colloidal on 10 ml - M per solution of silver. Physical - 0.0005 g, ' r

Silver Z Nanoparticles. . account 50 rrt. electrolysis silver 999.9 the same as silver water" pure water (according to the invention) 0.005 96 silver" is 0.05 g/l

In order to determine the optimal concentration of the colloidal silver solution, studies of the effect of silver preparations with an activity of 20 ppt, 30 ppt, 40 ppt, 45 ppt, 50 ppt on test cultures were conducted:

Rzendotopaz ayegidipoz ATOSS 27/99 earnuiosossiv aigei5 ATOS 25923

Based on the research results, graphs were drawn (Fig. 1-4).

Extrapolation of the obtained results of the effectiveness of silver against staphylococcus and Pseudomonas aeruginosa allows to determine an approximate "lethal dose" for them. It is 45-50 for ziarpuiosossi5 aigei5 ATSS 25923 and 55-60 ppt for Rheidotopavh aegidiposa ATSS 27/99.

The same samples of colloidal silver solution with an activity of 20 ppt, 30 ppt, 40 ppt, 45 ppt, 50 ppt were also tested on the test culture: Sapaida aiIrisapz (Fig. 4). The yeast fungus Sapdida aibisap5 completely stopped growing already at 20 ppt of colloidal silver.

That is, on the basis of the received empirical data, it is possible to determine the optimal activity of the colloidal silver solution, which should be used in the original formulation of the nasal spray based on the colloidal silver solution - 45-55 ppm.

Example 2

The claimed medicinal product can be obtained using standard equipment.

The process of preparing a medical product consists of the following stages: production preparation, during which the required amount of components is measured by weighing; preparation of the solution, in which the required amount of active substances is placed in the reactor according to the prescription; filling of the solution into the required container, labeling and packaging, laboratory tests of each batch of the product.

The medical product is presented in the form of a spray in a dark plastic bottle with a sprayer pump, the status of which is determined by the Company as an invasive non-sterile medical product

First class.

According to organoleptic and physico-chemical indicators, the medical product must meet the standards and requirements listed in Table 2

Table 2 6. Colloid stability Stable:/7/7/7/7/7/7/7/:(«/./:/.:/: K6oS Z

According to microbiological indicators, the medical product must meet the norms and requirements,

Co.) given in table Z

Table C of facultatively anaerobic microorganisms

According to the toxicological and hygienic, according to the received protocols, safety indicators, the medical product meets the standards and requirements listed in Table 4.

Table 4 p/p documentation 1 Index of acute toxicity when applied to the skin.d///|77777777777011сСс1С

C Index of sensitizing action 77777710 4 Index of skin-irritating action 77111101 (| 5 | Index of irritating action of the mucous membrane.d | 0

The total score of severity of irritation of the mucous membrane of the oral cavity and the mucous membrane in the area of the lip junction on the 1st-7th day of observation is 0 points.

The irritation factor is 0 points.

The severity of the irritating effect: absent. The index of irritant action on the mucous membrane of the oral cavity is 0 points.

The indicated indications for use of the drug are a medical product that is used as an adjunct in the case of a runny nose accompanying adenoiditis, rhinitis, and rhinosinusitis.

The medical product, which is claimed as an aid for colds, is intended to facilitate nasal breathing, thanks to the anti-edematous, antiseptic, astringent effect of the components of the medical product; to restore the mucous membrane of the nose in chronic rhinosinusitis; as an adjunct to ease the course of acute bacterial rhinosinusitis, in combination with antibiotic therapy; as an adjunct to relieve the course of SARS (acute respiratory infections) and colds, which are accompanied by significant nasal congestion and the formation of thick secretions.

Example. WITH

Variants of the pharmaceutical composition are presented in Table 5.

Table 5 of skedteayut 0000000

The composition of the drug

Cetraria extract (Ehigasisht Semapa ytsasht) 17/70 | 30 | 80

Pharmaceutical glycerin.//-/-/:/7sssssgg111111111111o 130 | 80

The composition according to option 1 with a reduced amount of active substances has unsatisfactory pharmacological activity.

The composition according to option 2 corresponds to the qualitative and quantitative content of the components of the composition and has satisfactory pharmacological, physicochemical and technological characteristics.

The composition according to option 3 has unsatisfactory technological, physicochemical and pharmacological characteristics of the dosage form.

Thus, the new domestic drug, which is being claimed, is an effective medical product, which is used as an adjuvant for a runny nose accompanying adenoiditis,

From rhinitis, rhinosinusitis. Contributes to the relief of the course of the common cold due to the main expected effect on the nasal mucosa, without the help of pharmacological, immunological and metabolic means, but with the possibility of promoting their functioning.

Claims (2)

USEFUL MODEL FORMULA 1. Nasal spray based on a solution of colloidal silver with an extract of cetraria icelandia, containing as an active ingredient a colloidal silver solution, as well as auxiliary substances, which is distinguished by the fact that it contains a solution of colloidal silver with an activity of 45-55 ppt, obtained by the physical method of electrolysis, additionally contains cetraria extract (Ehigasisht Seigagia Yapidit), vitamin A, vitamin E, D-Panthenol, thymol, as auxiliary substances contains PEG-40 hydrogenated castor oil, pharmaceutical glycerin, sodium hyaluronate, propylene glycol, potassium sorbate, with the following ratio of components, weight. 90: PEG-40 hydrogenated castor oil, 0 oil, 0-5.0 cetraria extract (Icelandic, 0.50 Mohs), pharmaceutical glycerin 1.0-5.0, propylene glycol 1.0-5.0, D-Panthenol 0.1-1, 0 thymol 0.025-0.5 sodium hyaluronate 0.025-0.5 potassium sorbate 0.025-0.5 vitamin E 0.025-0.5 vitamin A 0.025-0.5 colloidal silver solution 45-55 ppt the rest. 2. The spray according to claim 1, which differs in that it is packaged in a brown plastic bottle equipped with a spray pump. Suppression of the rhizome, the test is cultured for B hour of growth after bO-min. contact more s g o ivbyakshva " WIN INN UN INNY XX inpnnnnnnn nin wnvnnnnnn y y in s... MY Ks NOOO MO o schu BI R KY KO PK EK Me: KE t ke OH PAH PAH PAH ZH y y - 1 "OD AH route: o vrach cha rumvAh prp a Z Fig (c) Bactericidal dose of silver in relation to "arpuyusossuv atsvyv iza-20 min. of contact)" between I and the gate 80 E Z TI I OA rr VNS can I I SIDE oon Mrii g g I N EV h cy Y00000000000000000000000000011110011....... F 20101011111........... .................................1 wok in o NO; 20 Ko to 5 because what Concentration of swibpa, dat "is the tekaznik of the root of Fig. Bactericidal dose of srizpa in relation to Gzeoiotopaz avgdtova (for 20 ha. contact) - between Zb and 60 or ФОво роя nn VE g Favtay I in C, pom mm pn pom vv pom uchi netptnnttyat renya yantedttnnttayaannntnyaya WHAT, 79 o For 4 BO 50 7 8 Concentration of silver, Vrya; he indicator of roots Fig Sapa zvisape KO V V V I MO and EH i di kn BUT not shk DGFV FDZDAD DH BJ Yani BAN i- NNNNNNNNNNNNNN NN nn 00000000 yuka EN 0 nn B shi NN NM, ih y y nn gu nu BEN t U 75 Z KZ Bremv, tea "Vigo Ya