UA122473C2 - THROAT SPRAY BASED ON COLLOID SILVER SOLUTION WITH EXTRACTS AND ESSENTIAL OILS - Google Patents

Abstract

The invention relates to a throat spray based on a solution of colloidal silver with extracts and essential oils, which contains as active pharmaceutical ingredients a solution of colloidal silver with an activity of 45-55 ppm, obtained by physical electrolysis, Iceland moss extract (Extractum Cetraria mixtures, fluidum) sage, essential oils of eucalyptus and mint, menthol, thymol, camphor, vitamin E; as excipients contains PEG-40 hydrogenated castor oil, pharmaceutical glycerin, D-Panthenol, sodium saccharin, potassium sorbate, lysozyme and sodium hyaluronate.

Description

(57) Abstract:

The invention relates to a throat spray based on a solution of colloidal silver with extracts and essential oils, which contains as active pharmaceutical ingredients a solution of colloidal silver with an activity of 45-55 ppt, obtained by the physical method of electrolysis, an extract of Icelandic moss (Ehigassht Seigagia mixture, Yapidit), extracts of eucalyptus and sage, essential oils of eucalyptus and mint, menthol, thymol, camphor, vitamin E; as auxiliary substances contains PEG-40 hydrogenated castor oil, pharmaceutical glycerin, D-Panthenol, sodium saccharinate, potassium sorbate, lysozyme and sodium hyaluronate.

The invention belongs to pharmacy and relates to medical products that are used as an adjuvant to relieve symptoms in acute and chronic lesions of the throat and oral cavity accompanying tonsillitis, pharyngitis, laryngitis, stomatitis.

Deterioration of the environmental situation, an increase in the number of respiratory viral infections contribute to the growth of acute and chronic lesions of the throat, pharyngitis and laryngitis. Oral lesions - stomatitis - are also common.

The development of new highly effective medical products for adjunctive therapy for 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 a suspension the development of an infection in the nose, as well as the removal of unwanted symptoms at the same time. Today, viruses and bacteria pose a serious 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.

The wide spectrum of antimicrobial action of silver, the lack of resistance to it in most pathogenic microorganisms, low toxicity, as well as good tolerability contributed to the increased interest of doctors of 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 remedy "Protargol" in 2 95 solution (producer Istok-Plyus Ukraine), droplet release form pNrz/Lymlu.oroghemaiei.sot/peaiLekKagzima/rgoiagdo!.pitiyaapisie-itekhi klushshe--1) contains silver proteinate (agdepiy rgoieipa5).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 o, 1 Uyu, 2 90; - powder (for preparing a solution); - ointment 15 9o; - eye drops 2 95, Z 90, 5 c.

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 invention is based on the task of developing a composition of a throat spray based on a solution of colloidal silver, obtained by the electrolysis method, with plant extracts and essential oils.

The task is solved in such a way that a throat spray based on a colloidal silver solution with extracts and essential oils contains as an active pharmaceutical ingredient a colloidal silver solution, as well as auxiliary substances, according to the invention, a colloidal silver solution with an activity of 45-55 ppt obtained by the physical method of electrolysis , also as active active substances additionally contains an extract of Icelandic moss (Ehigasisht Seigagia mixture,

TPidit), eucalyptus extract, sage extract, essential oils of eucalyptus and mint, menthol, thymol, camphor, vitamin E; as auxiliary substances it contains PEG-40 hydrogenated castor oil, pharmaceutical glycerin, D-Panthenol, sodium saccharinate, potassium sorbate, lysozyme, sodium hyaluronate, with the following ratio of components (wt. 9Ub):

PEG-40 hydrogenated castor oil 0.5-5.0 Icelandic moss extract 0.5-5.0 glycerin 0.5-5.0

D-Panthenol 0.5-5.0 menthol 0.1-1.0 eucalyptus extract 0.1-1.0 sage extract 0.1-1.0 eucalyptus essential oil 0.1-1.0 essential oil m' yati 0.1-1.0 sodium saccharinate 0.1-1.0 thymol 0.1-1.0 camphor 0.1-1.0 potassium sorbate 0.005-0.25 lysozyme 0.005-0.25 vitamin E 0.005- 0.25 sodium hyaluronate 0.005-0.25 colloidal silver solution 45-55 ppt the rest.

According to the invention, the product is made in the form of a spray in a bottle made of dark plastic with a PomPoy atomizer.

Essential oils are complex mixtures consisting of simple components. Each of the components has a beneficial effect on the body. According to the World Health Organization, most of the world's population at the first stage of treatment prefers folk remedies due to their sufficiently high antimicrobial activity and lack of side effects. Numerous scientific studies have proven the presence of antibacterial, antifungal, antiviral, and antioxidant activity in essential oils.

When developing the new product, essential oil plants that have antimicrobial properties, namely mint and eucalyptus essential oils, were studied and analyzed. Also, the latest research on the use of a plant extract of Icelandic moss was used.

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 Z(arpuyusossy5 acygei5) 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 different antimicrobial effects - from bactericidal (ability to kill microbes) to bacteriostatic (ability to prevent 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

They make it possible to make silver-based drugs cheaper and make them available for the treatment of many infectious diseases.

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

Eucalyptus extract has pronounced antimicrobial, antibacterial and anti-inflammatory effects, as well as hemostatic and astringent effects. It is active against bacteria, fungi, and protozoa, has a pain-relieving effect, and promotes rapid healing of oral mucosal wounds.

Mint essential oil - has antispasmodic, anti-inflammatory, antimicrobial, soothing, wound-healing, tonic, refreshing effect.

PEG-40 hydrogenated castor oil is a solubilizer (solvent) and stabilizer, viscosity modifier, restores the skin's natural moisture level, has a soothing effect on the skin, and is quickly absorbed.

Pharmaceutical glycerin is a moisturizing and softening agent for increasing adhesion, adjusting the rheological parameters of viscous systems and their moisture-retaining properties. Helps improve skin permeability.

D-Panthenol - is used to moisturize and accelerate the regeneration of various skin injuries as part of pharmaceutical and cosmetic products.

Menthol is the main component of essential oil, widely distributed in nature, obtained from

Meppia riregya and Meppia agmepzi5. Menthol is obtained mainly by extraction from essential oils. Menthol gives a cooling and refreshing effect, thanks to which it is used in many products for external use.

Sodium saccharinate is used as an intensive sweetener in beverages, food products and pharmaceutical preparations, such as tablets, powders, medicated confectionery, gels, suspensions, liquids, including mouthwash.

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.

Camphor - when used locally, has an antiseptic, local irritant, analgesic and anti-inflammatory effect. Exciting the sensitive nerve endings of the skin, it reflexively improves the trophism of organs and tissues.

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

Lysozyme is an antibacterial agent, an enzyme of the hydrolase class, a protein that is an enzyme that destroys the cell wall of bacteria. Lysozyme is found in large quantities in many animal secretions, such as tears, saliva and mucus. Lysozyme is also found in cytoplasmic granules of polymorphonuclear neutrophils. This enzyme is also present in large quantities in egg whites.

It is also used as a preservative in the food industry.

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

Sodium paluronate - 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.

Silver, obtained by the method of electrolysis, is the purest substance, which minimizes the presence

From extraneous 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.

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

Method /IS Components for t silver in

Name) Chemical name Composition per ppm, g/l of production and production. bottle 10000ppm/l (1Og/l), in re-

Chemical. expense accounts for pure and 10 ml of silver. fir n. Silver: and 0.1-2 g, which) 0.75-0.85 g/l roteinate o hydrolyzate

Protargol silver 7.5-8.5 95, casein is -

P protein up to 100 95' 1 95-20 U5 | 200000ppm/l

Followed by gelatin, respectively) (200g/l). egg white's oxidation-reduction ratio of pure silver 17g/l 20000ppm/l (20g/l),

Nitrate per 10 ml per

Silver 7096, | Chemical- | silver, 270) accounts for the hydroxide that in m

Sodium silver (caustic makes up 14 g/l, sodium salts of sodium),

Kolargol | lysalbinic and protein protalbinic hydrolyzate, l of acids. and casein, sodium salts The consistency of the per-lysalbinic content of oxidized gelatin, 2 Cho-3 Cho accounts. . egg white protalbino- | silver 21 g/l 5 Orrt/l of reducing reactions on pure acids

Colloidal per 10 ml - (ooo) solution of silver: Physical - 0.0005g and

Silver Nanoparticles and . account 5 Orrt. electrolysis silver 999.9 what is silver water" pure water (according to the invention) 0.005 95 silver" is 0.O5g/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

B test cultures:

Rzendotopaz ayegidipoz ATOSS 27/99 earnuiosossiv aigei5 ATOS 25923

Based on the research results, graphs were drawn (Fig. 1-5).

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 effectiveness of products for the throat and nose against Staphylococcus aureus and the degree of inhibition of the growth of test cultures is presented in Fig. 4.

The same samples of colloidal silver solution were also tested for activity

20ppm, 30ppm, 40ppm, 45ppm, 50ppm per test culture: Sapaida aibisapvz (Fig. 5). The rain mushroom Sapaiida aibisape5 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 ppt.

The negative aspects of the use of antibiotic therapy listed above are an incentive to study alternative possibilities, one of which is phytotherapy.

Example 2

The claimed medical product can be produced 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 of 30 ml with a spray pump in a brown plastic bottle, the status of which is determined by the Company as an invasive non-sterile medical product of the I class.

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

Table 2 6. Colloid stability 0000 |Stable.//7//777/////:/33///://:(К3ЯЯ./:-( !/ her

According to microbiological indicators, the medical product must comply with the norms and requirements listed in Table C

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 of documentation 1 (Index of acute toxicity when applied to the skin.dG | 7.077777 2 |Index of chronic toxicity when applied to the skin.dD | 7.077772

C (Index of sensitizing action /-/-:77711Ї111111111111101111111сС1С 4 |Index of skin irritating action /-:/Ї110111сС1С

Coo)

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 irritation on the mucous membrane of the oral cavity is 0 points.

The indicated indications for use of the drug are a medical product, which is used as an auxiliary means to relieve symptoms in acute and chronic lesions of the throat and oral cavity accompanying tonsillitis, pharyngitis, laryngitis, stomatitis.

Example C

Variants of the pharmaceutical composition are presented in Table 5.

Table 5 0000000 Composition of the drug 000 - annual salary

The composition of the drug

Extraxevkallite 77777711 11111011 1111106 110

Extra cashews 77777711 11110111 1111108 |10

Lymol//////7771111111111111111111111Ї1111171041171111108 | 0

Camphor.i/////777777777711111111111111111111111110m11 11111106 110

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 C has unsatisfactory technological, physicochemical and pharmacological characteristics of the dosage form.

Thus, the new domestic drug that is being applied for is an effective medical product that is used as an adjuvant for a runny nose accompanying adenoiditis, rhinitis, rhinosinusitis. metabolic means, but with the possibility of facilitating their functioning.

Claims (2)

FORMULA OF THE INVENTION 1. Throat spray based on a colloidal silver solution with extracts and essential oils, containing colloidal silver solution as an active pharmaceutical ingredient, as well as auxiliary substances, which is characterized by the fact that the colloidal silver solution with an activity of 45-55 ppt is obtained by the physical method of electrolysis, also as active ingredients it additionally contains Icelandic moss extract (Ehigasisht Seigagia mixture, Janpidit), eucalyptus extract, sage extract, essential oils of eucalyptus and mint, menthol, thymol, camphor, vitamin E; as auxiliary substances it contains PEG-40 hydrogenated castor oil, pharmaceutical glycerin, D-Panthenol, sodium saccharinate, potassium sorbate, lysozyme, sodium hyaluronate, with the following ratio of components (wt.9o): PEG-40 hydrogenated castor oil 0.5-5.0 Icelandic moss extract 0.5-5.0 glycerin 0.5-5.0 D-panthenol 0.5-5.0 menthol 0.1-1.0 extract eucalyptus 0.1-1.0 sage extract 0.1-1.0 eucalyptus essential oil 0.1-1.0 mint essential oil 0.1-1.0 sodium saccharinate 0.1-1.0 thymol 0 ,1-1.0 camphor 0.1-1.0 potassium sorbate 0.005-0.25 lysozyme 0.005-0.25 vitamin E 0.005-0.25 sodium hyaluronate 0.005-0.25 colloidal silver solution 45-55 ppt the rest. 2. The spray according to claim 1, which is distinguished by the fact that it is packed in a bottle made of brown plastic, equipped with a spray pump. Suppression of the development of the test-cultivate for B hour the rest of the 20-hV forest. contact - Ghyshi OO Pe Avlyuvova; shi psh rrmchAV zha ba roitav Feta u shcha Fig. i Bactericidal dose of silver in relation to harpoon sucker (in 20 minutes of contact) - between 45 and 50 ppt VO. dd nn Ne PO ЧИ t МНН Fe Z v VO nn nin 503 e i Za ! ; ! in ШОЕ пн х Ж: Е PAK, п, VU lation of rennia tn rnnnnnnnnnniatnnnnnnnnnnniai 0 to 2 50 40 5 5O to o concentration of srp, pt "-indicator of corapation Bacticidal dose of sriila in relation to Reindutotase of aeloid cells (for 20 minutes of contact! - between 55 and 0 rrt I ren nt BV ad. I. 30 2-0 ZO "o BO o to 80 Silver concentration, pp. there are hvokaznyh correpatio fi. Effectiveness of the products against Staphylococcus aureus that EttttTttTtTtchtchtchtntsht't''tzhnshchttpshn in i t. sho shk sh shk . p. o yamlzeoyu pbhviy Babhzhozn V-MHV3v Riy VYAH3y 0 RYAHIIv 0 RLOHVV Variants of the experiment: TP egalenn -bbret 2RN throat spray; ZE - nasal spray. Time would pour over the goadivyad 1; 28 od ryad Z Fa Sapikia ayvisanv 12 PO V V V V V V V V von un 5 ov ev V shi ENN shchi: omanu Ya ya 81100 zho EM y En 15 z z Z Za Vrema, chae Fir. 5