UA139927U - NOSAL INSTALLATION IN THE FORM OF SPRAY BASED ON A SOLUTION OF COLLOID SILVER WITH ALOE VERA GEL - Google Patents

Abstract

Nasal agent in the form of a spray based on a solution of colloidal silver with Aloe Vera gel contains as an active pharmaceutical ingredient a colloidal solution of silver, as well as excipients. The colloidal silver solution is obtained by physical electrolysis, in addition as active ingredients contains Aloe Vera gel, D-Panthenol, extracts of eucalyptus and Kalanchoe, vitamin A, vitamin E, thymol, as excipients contains glycerin, PEG-40 hydrogenated castor oil, sodium , potassium sorbate.

Description

The utility model belongs to the pharmaceutical industry and relates to medical devices that are used as an adjunct for the relief of rhinitis, rhinosinusitis, adenoiditis, as an adjunct for the relief 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 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.

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 drug in the form of a spray "for the acute prevention of acute respiratory viral infections (pat. RF Mo 2665959 publ. contains sodium chloride and sodium hypochlorite solution with a pH of 8.0-10.0, a concentration of active chlorine of 0.30-0, 60 mg/l and droplet size 90-110 μm".

The well-known agent "Protargol" 2 95 solution (producer Istok-Plus Ukraine), drop form pErv/Lymly.orogtemaisei.sot/peinLekKagvima/rgoiagoo!.pitiyaapisiye-itekhi zMYiBiShe--1) contains silver proteinate (agdepiy rgoivipav) - 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.

Well-known folk remedies are often used for diseases of the ENT organs, including aloe vera or aloe Barbados, which have gained wide popularity. Its juice has good medicinal properties that can be used for sinusitis. Preparation of drops - dilute aloe juice with water in a ratio of 1: 1, 1: 2 or 1: 3.

But in some cases, the use of aloe in this form can cause allergic reactions and bowel disorders, sometimes a rash may appear.

Known drops of aloe, if they are mixed with peach oil. This will help to soften the mucous membrane, if the secretions are too frequent, they may additionally contain chlorhexidine or miramistin. as an option, it can be combined with kalanchoe (1:1) and sea salt.

Some use aloe, honey and celandine. However, you need to be careful here, because plants and honey can cause allergies.

The useful model is based on the task of developing a nasal spray based on a solution of colloidal silver with aloe vera gel based on a solution of colloidal silver obtained by the electrolysis method with the addition of aloe vera gel as an active ingredient.

The task is solved in such a way that a nasal spray based on a solution of colloidal silver with aloe vera gel contains as an active pharmaceutical ingredient a colloidal silver solution, as well as auxiliary substances, according to a useful model, a solution of colloidal silver obtained by the physical method of electrolysis, additionally as active agents contains substances

Aloe Vera gel, extracts of eucalyptus and Kalanchoe, D-panthenol, vitamin A, vitamin E, thymol, as auxiliary substances contains glycerin, PEG-40 hydrogenated castor oil, sodium hyaluronate, potassium sorbate, with the following ratio of components, weight. Fo: Aloe Vera gel (10:1) 3.0-10.0 Eucalyptus extract 0.5-5.0 Kalanchoe extract 0.25-3.0

D-panthenol 0.25-3.0 vitamin E 0.1-1.0 vitamin A 0.01-0.1 thymol 0.01-0.1 glycerin 0.5-5.0

PEG-40 hydrogenated castor oil 0.5-5.0 sodium hyaluronate 0.25-3.0 potassium sorbate 0.1-1.0 colloidal silver solution 45-55 ppt the rest.

According to the useful model, the tool is made in the form of a spray in a dark plastic bottle with a spray pump.

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 inhibit growth or

It causes the death of a wide range of bacteria, has a virucidal 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 exert different antimicrobial effects - from bactericidal (the ability to kill microbes) to bacteriostatic (the 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 the method of electrolysis minimizes accompanying impurities and has a mild effect on the skin and mucous membranes. That is, silver obtained by electrolysis, the purest substance, which minimizes the presence of foreign impurities in the finished medical product.

Aloe Vera gel (10:1) (AIoe Vagradepviv I eai dtsise) is a powerful biogenic stimulator that has a complex, anti-inflammatory, regenerating, moisturizing, photoprotective and antimicrobial effect on the skin.

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.

Kalanchoe extract has bactericidal properties, is widely used for the prevention and treatment of various ENT diseases - sore throat, otitis, sinusitis, SARS, flu.

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.

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

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.

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

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

Table 1

Differences between colloidal silver and traditional silver preparations

Name- Chemical Method Ingredients for silver in the name Composition of production | production per ppt, g/l bottle

Protar - Proteinate | Silver Chemical Nitrate per 10 ml | 10000 gol of silver 7.5-8.5 95, silver, 0.1-2 g, which | ppt/l protein to protein is (10 g/l), in 100 Fo hydrolyzate 1 U6-20 Fo of percasein, respectively | amount of gelatin, per pure egg white silver 0.75-0.85 g/l consistency -200000 ppt/l oxidation (200 g/l), reducible in reactions amount per pure silver 17 g/l

Continuation of table 1

Kolargol Silver same | Silver Chemical-Nitrate per 10 ml | 20000 sodium 70 ob, silver, 0.2-0.3 g,| ppt/l of salt hydroxide that (20 g/l), lysalbi- sodium (caustic | consists in renova and sodium), counts pro- protein on the pure silver hydrolyzate of casein acids, 14 g/l, gelatin, sodium sequence egg white | 2 95-3 95 30000 salinity ppt/l lysalbi-oxidic- (30 g/l), new and | restorative in re-protalbi- | of new reactions on pure acid silver 21 g/l

Colloid | Silver Nano - Physical - silver 999.9 per 10 ml - | 50 rrit/l solution water electrolysis particles 0.0005 g, (0.05g/l), in silver 50 silver that perrrit water is calculated (according to 0.005 96 per pure useful silver model) is 0.05 g/l

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 carried out:

Rzendotopaz ayegidipoz ATOSS 27/99 earnuiosossiv aigei5 ATOS 25923

Based on the research results, graphs were drawn (Fig. 1-Fig. 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 earnuiosossiv aigei5 ATOSS 25923 and 55-60 ppt for Rheidotopavh aegidipoz ATOS 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 aibisapz (Fig. 4). Yeast mushroom Sapaiida aibisapo 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 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 release form is introduced for the first time, because preparations based on silver and cyclamen were not produced before, the spray is presented as a medical product in the form of a nasal spray in

From a bottle made of dark plastic with a pump sprayer, the status of which is determined by the Company as an invasive non-sterile medical product of the first class.

According to organoleptic and physicochemical indicators, the medical product must meet the standards and requirements listed in Table 2.

Table 2 p/p shade 6. | Colloid stability Stable.:/:47/7/7/7/:/(/: o: С: С: 7. Mass fraction of water and volatile substances, | 65.0-98.0 to

According to microbiological indicators, the medical product must meet the standards and requirements listed in Table 3.

Table Z of facultatively anaerobic microorganisms of fungi

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. | 0 8 2 | Index of chronic toxicity when applied to the skin -:/ 0777777

With | Index of sensibilities of action ///Ї7777777777777710111 4 | index of skin-irritating action /-:/ HER 6 | Acute gastric toxicity index./-./ | //:/ 07777:

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 expression of the irritating effect: absent. Indkeks irritant action on the mucous membrane of the oral cavity 0 points.

Indications for use of the claimed drug - a medical product that is used as an adjuvant for a runny nose accompanying adenoiditis, rhinitis, rhinosinusitis.

Example. WITH

Variants of the pharmaceutical composition are presented in Table 5.

Table 5

The composition of the preparation AloeVeragel (0O) -:/ 77777771 111350 1. 60 | 100

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)

USEFUL MODEL FORMULA 1. Nasal agent in the form of a spray based on a solution of colloidal silver with Aloe Vera gel, containing as an active pharmaceutical ingredient a colloidal silver solution, as well as auxiliary substances, which is characterized by the fact that the colloidal silver solution is obtained by the physical method of electrolysis, additionally as active agents contains Aloe Vera gel, D-Panthenol, extracts of eucalyptus and Kalanchoe, vitamin A, vitamin E, thymol, as auxiliary substances contains glycerin, PEG-40 hydrogenated castor oil, sodium hyaluronate, potassium sorbate, with the following ratio of components, weight. 9o: Aloe Vera gel (1:10) 3.0-10.0 PEG-40 hydrogenated castor oil 0.5-5.0 eucalyptus extract 0.5-5.0 kalanchoe extract 0.25-3.0 D- Panthenol 0.25-3.0 Ko) glycerin 0.5-5.0 sodium hyaluronate 0.25-3.0 potassium sorbate 0.1-1.0 vitamin E 0.1-1.0 thymol 0.01- 0.1 vitamin A 0.01-0.1 colloidal solution of silver 45-55 ppt the rest. 2. Nasal agent according to claim 1, which differs in that it is made in the form of a spray in a dark plastic bottle with a spray pump. Suppression of the development of test cultures During the hour of growth, after 20 minutes. Contact information: seeding 1 s vegetable br ota osrotAv 0 Gate Fig. The bactericidal dose of silver in relation to EUarpuyusossiv ashetsv (for 20 min. of contact! - between 45 and 5Orrg I in 1 m: - pi 0 10 o kyu B. 50 VO what Silver concentration, ort "index of correpation Fig. The bactericidal dose of silver in relation to Rheiyutopaz vegidtova (per 20 ha. of contact) is between 55 and 80 mouth ETO VA PON p also: sti NI a, i. : I'm eating and E is also Z. и и шк Ок ни ко и Е в 5 0 4 В и В т т и В ! o yu 20 KV 40 sh BO 7 vo Concentration of silver, mouth "herelation index Fig. Sazoyua zibisate them ZM MM MVV M M M M M M M M M M M M vni Es Zhan 1 "V y V selen non Zh az Y. Ziplyusa y 5 KEy yii 88 that ZO KIV Binchav i, cha Fig