RU2637438C1 - Means for nasal cavity, nasopharynx and oral cavity rinsing - Google Patents

Abstract

FIELD: pharmacology.

SUBSTANCE: invention is a means for nasal cavity, nasopharynx and oral cavity rinsing on the basis of natural raw materials, including sodium (Na⁺), potassium (K⁺), calcium (Ca²⁺), magnesium (Mg²), chlorine (Cl^-) and bromine (Br^-) ions, characterized by containing an aqueous solution of a dry concentrate of salt lake brine with concentration ranging from 0.5 to 10%, with pH ranging from 7.2 to 8.3, osmolarity of 276-278 mOsm/l, with a certain ionic composition in terms of mg/ml as the natural raw material.

EFFECT: improved overall health of children and adults and provision of an opportunity to reduce the incidence of influenza during the epidemic.

2 cl, 10 ex

Description

The invention relates to personal hygiene products and medical devices, namely to isotonic and hypertonic solutions for washing and irrigation of the throat and nose and is intended for the prevention and comprehensive treatment of acute and chronic inflammatory diseases.

Known means for the prevention of diseases of the oral cavity and nasopharynx based on salt (pure sodium chloride) using preservatives and stabilizers or based on seawater freed from the decay products of organic impurities (bacteria, particles of plant and animal origin). However, they are either difficult to prepare or have limited functionality. The use of sodium chloride solutions has limitations due to the presence of preservatives, and obtaining funds based on sea water is a technologically complex process due to the need for water purification.

A known method of rehabilitation of children with chronic tonsillitis, which consists in exposing the tonsils with low-frequency phonophoresis, characterized in that the focus is first sanitized with a 1% brine solution, followed by phonophoresis with 1-2% brine ointment on the tonsils, contact, in for 20 s for each tonsil, a course of 8-10 daily procedures. Application RU No. 95114335/14, 08/10/1995. However, this method has a limited scope, since it is used only in the rehabilitation of children with chronic tonsillitis.

It is known that the agent used in the method of preventing complications from the common cold or flu-like syndrome according to the patent RU 2519671 is known as the closest analogue. The method for preventing complications from the common cold or flu-like syndrome is that an isosmotic ionic solution based on sea water having an osmolarity of 250- 350 mOsm / kg, is administered daily to each nostril for patients suffering from a runny nose or flu-like syndrome, from 2 to 9 times, preferably from 3 to 8 times, and more preferably from 4 to 6 times during the manifestation of the common cold or flu-like syndrome and at the stage of remission, they are administered from 1 to 3 times daily in the form of a spray for at least two weeks, while the dose decreases with the onset of remission.

In this method, the term "isosmotic ionic solution or composition based on sea water" refers to any solution based on sea water, namely a solution or composition containing more than 30% by weight of sea water, preferably more than 75% by weight of sea water, which have an osmolarity of 250-350 mOsm / kg, preferably 305-315 Osm / kg. This definition does not cover the so-called physiological saline solutions. The tool is obtained as follows:

- seawater with a salt content equal to or greater than 32 g / l, samples of which are taken mainly at a depth of 5 to 10 m in a zone with a strong current, is used as the starting material,

- the specified water is analyzed and defended,

- sodium is removed from the settled water by electrodialysis until the osmolarity becomes 250-350 mOsm / kg, preferably 305-315 mOsm / kg,

- regulate the concentration of ions using selective electrodialysis,

- the resulting product is filtered off and stored under sterile conditions.

The application of this method makes it possible to control the concentration of ions of the main components while maintaining the quantitative and qualitative composition of all other ingredients contained in sea water.

The above tool has several disadvantages.

Firstly, the manufacture of the above-described products is a complicated and expensive process, since it involves the use of natural sea water, which has a limited shelf life and requires immediate purification from decomposition products of organic impurities (bacteria, particles of plant and animal origin).

Secondly, the provision of preset osmolarity values is associated with the removal of sodium by electrodialysis and further concentration for other salts, which also complicates the manufacturing process of the product.

Thirdly, the wide variation in the content of basic ions in sea water with a dry residue of 1 to 2% in the three examples cited indicates the difficulty in obtaining the concentration of sea water with the present salt content.

Fourth, the disadvantage of the known composition based on sea water is the limitation of its functional capabilities, since the composition does not have a pronounced emollient and sedative effect, since it does not contain bicarbonate anions, which also play an important role along with sulfates in maintaining the specified parameters of isotonic and osmolar solutions.

The problem is solved in that the means for washing the nasal cavity, nasopharynx and oral cavity based on natural raw materials, including sodium ions (Na ⁺ ); potassium (K ^+); calcium (Ca ²⁺ ); magnesium (Mg ² ), chlorine (Сl ^- ) and bromine (Br ^- ), as a natural raw material contains an aqueous solution of dry brine concentrate in salt lakes with a concentration in the range from 0.5 to 10%, with a pH in the range from 7.2 up to 8.3, osmolarity 276-278, with the ionic composition:

- 1,5-30,0 mg / mL of sodium (Na ^+);

- 0.015-0.3 mg / ml potassium (K ⁺ );

- 0.025-0.5 mg / ml calcium (Ca ²⁺ );

- 0.01-2.0 mg / ml magnesium (Mg ²⁺ );

- 2.7-54 mg / ml of chlorine ions (Cl ^- );

- 0.7-14 mg / ml of bicarbonate ions (HCO ₃ ^- );

- 0.55-10.0 mg / ml sulfate ions (SO ₄ ^2- );

- 0.001-0.02 mg / ml of bromine ions (Br ^- ).

The means for washing the nasal cavity, nasopharynx and oral cavity may additionally contain aqueous extracts of medicinal plants of chamomile, calendula, sage, eucalyptus, mint and yarrow, taken individually or in various combinations.

In addition to the above ions, the solution based on brine concentrate contains in the range of 5.0 mg / l: iron (Fe), silicon (Si) and less than 5 mg / l: aluminum (Al), nickel (Ni), manganese (Mn), zinc (Zn) and other trace elements.

The tool is used for the prevention and complex treatment of acute and chronic inflammatory diseases of the oral cavity, throat and nasal cavity, paranasal sinuses, nasopharynx in the form of drops, solutions, spray and aerosol for children and adults.

The tool helps to thin the mucus and normalize its production in the goblet cells of the mucous membrane, improves the function of the ciliated epithelium, which increases the resistance of the mucous membrane to pathogenic bacteria and viruses. The tool helps rinse and remove street and room dust, allergens and haptens from the nasal mucosa, and reduces the local inflammatory process.

The tool also flushes viruses and bacteria from the surface of the mucous membrane of the oral cavity, throat, tonsils, reducing microbial contamination, reduces swelling and hyperemia of the mucous membrane of the oral cavity and throat, removes purulent deposits, and accelerates the regeneration of the mucous membrane after infections.

The tool increases the therapeutic effectiveness of drugs applied to the mucous membrane of the nose, mouth and throat.

The mineral composition of dry brine concentrates extracted from salt lakes in Russia was studied using a ThermoiCAP-6500 Duo atomic emission spectrometer, and the pH of the solutions was determined using the Anion-4100 ionomer.

Microbiological purity according to the methods given in GFHIII, OFS.1.2.4.0002.15.

The complex of natural mineral salts is distinguished by microbiological purity, the absence of contamination by various microorganisms, which compares favorably with its use in comparison with seawater, saturated with waste products of living organisms of the ocean, and the need to clean them.

Thus, this invention relates to the use of isotonic and hypertonic solutions with a concentration of 0.5; 0.9; 1.5; 2 and 10% containing dry brine concentrate. The solutions can be used in the form of drops for the nose, spray or aerosol to rinse and irrigate the nasal cavity and throat. 10% solution is used only for gargling by diluting 1-2 tablespoons in a glass of water. Sprays and aerosols are intended for use by adults and children using various nozzles and solutions of various concentrations.

Solutions, regardless of the concentration of dry brine, have the same pH (7.2-8.3), osmolality in the range of 276-298 mOsm / l and differ in the quantitative content of the mineral composition depending on the prepared concentration of the solution. The composition of the ionic composition of the solutions used according to the invention is in the range of:

- 1.5-30.0 mg / ml sodium (Na ⁺ );

- 0,015-0,3 mg / ml of potassium (K ^+);

- 0.0025-0.05 mg / ml calcium (Ca ²⁺ );

- 0.15-3.0 mg / ml magnesium (Mg ²⁺ );

- 2.3-46 mg / ml of chlorine ions (Cl ^- );

- 0,7-14 mg / ml of bicarbonate ions (HCO ₃ ^-);

- 0.55-11.0 mg / ml sulfate ions (SO ₄ ^2- );

- 0.001-0.02 mg / ml of bromine ions (Br ^- ).

In addition to these ions, the solution based on brine concentrate contains in the range of 5.0 mg / l: iron (Fe), silicon (Si) and less than 5 mg / l: aluminum (Al), nickel (Ni), manganese (Mn), zinc (Zn) and other trace elements.

We also obtained solutions of dry brine with the addition of extracts of medicinal plants with anti-inflammatory activity: chamomile, calendula, peppermint, yarrow, sage and eucalyptus.

In accordance with one preferred embodiment of the invention, the agent based on dry brine concentrate can be used for the prevention and care of the nasal cavity and throat and for the complex treatment of acute and chronic inflammatory diseases of the nasal cavity, throat and oral cavity.

The applied tool provides an improvement in the overall health status of children and adults and makes it possible to reduce the incidence of influenza during the epidemic.

Example No. 1.

Structure:

Dry brine concentrate 0.5 g Water purified before 100 ml

Product Option: nose drops, 30 ml

- pH of 7.2-8.4;

- osmolarity - 276-298.

The composition of the ionic composition of the solution:

- at least 1.5 mg / ml sodium (Na ⁺ );

- at least 0.015 mg / ml of potassium (K ^+);

- not less than 0.0025 mg / ml calcium (CA ²⁺ );

- not less than 0.15 mg / ml magnesium (Mg ²⁺ );

- not less than 2.30 mg / ml of the chlorine ions (Cl ^-);

- not less than 0.70 mg / ml of bicarbonate ions (HCO ₃ ^- );

- not less than 0.55 mg / ml of sulfate ions (SO ₄ ^2- );

- not less than 0.001 mg / ml of bromine ions (Br ^- ).

Example No. 2 .

Structure:

Dry brine concentrate 0.9 g Purified water up to 100 ml

- pH of 7.2-8.4;

- osmolarity - 276-298.

The composition of the ionic composition of the solution:

- not less than 2.7 mg / ml sodium (Na ⁺ );

- not less than 0.027 mg / ml potassium (K ⁺ );

- not less than 0.0045 mg / ml calcium (Ca ²⁺ );

- not less than 0.27 mg / ml of magnesium (Mg ²⁺ );

- not less than 4.1 mg / ml of the chlorine ions (Cl ^-);

- at least 1.3 mg / ml of bicarbonate ions (HCO ₃ ^- );

- not less than 0.9 mg / ml of sulfate ions (SO ₄ ^2- );

- not less than 0.002 mg / ml of bromine ions (Br ^- ).

Example No. 3.

Structure:

Dry brine concentrate 1.5 g Purified water up to 100 ml

Sterile!

- pH of 7.2-8.4;

- osmolarity - 276-298.

The composition of the ionic composition of the solution:

- not less than 4.5 mg / ml sodium (Na ^+);

- not less than 0.045 mg / ml potassium (K ⁺ );

- not less than 0.007 mg / ml calcium (Ca ²⁺ );

- not less than 0.45 mg / ml magnesium (Mg ²⁺ );

- not less than 6.9 mg / ml of chlorine ions (Cl ^- );

- at least 2.1 mg / ml of bicarbonate ions (HCO ₃ ^- );

- at least 1.65 mg / ml of sulfate ions (SO ₄ ^2- );

- at least 0.003 mg / ml of bromine ions (Br ^-).

Example No. 4.

Structure:

Dry brine concentrate 2.0 g Purified water up to 100 ml

- pH of 7.2-8.4;

- osmolarity - 276-298.

The composition of the ionic composition of the solution:

- not less than 6.0 mg / ml sodium (Na ^+);

- not less than 0.06 mg / ml potassium (K ^+);

- not less than 0.01 mg / ml calcium (Ca ²⁺ );

- not less than 0.6 mg / ml magnesium (Mg ²⁺ );

- not less than 10.0 mg / ml of chlorine ions (Cl ^- );

- not less than 2.8 mg / ml of bicarbonate ions (HCO ₃ ^- );

- not less than 2.2 mg / ml of sulfate ions (SO ₄ ^2- );

- not less than 0.004 mg / ml of bromine ions (Br ^- ).

EXAMPLE №5.

Structure:

Dry brine concentrate 10 g Purified water up to 100 ml

Sterile!

Product option: rinse solution by diluting 1-2 tablespoons of the solution in a glass of water.

- pH of 7.2-8.4;

- osmolarity - 276-298.

The composition of the ionic composition of the solution:

- not less than 30.0 mg / ml sodium (Na ⁺ );

- not less than 0.3 mg / ml potassium (K ^+);

- not less than 0.05 mg / ml calcium (Ca ²⁺ );

- not less than 3.0 mg / ml magnesium (Mg ²⁺ );

- not less than 46.0 mg / ml of chlorine ions (Cl ^- );

- not less than 14.0 mg / ml of bicarbonate ions (HCO ₃ ^-);

- not less than 11.0 mg / ml of sulfate ions (SO ₄ ^2- );

- not less than 0.02 mg / ml of bromine ions (Br ^- ).

Example No. 6.

Structure:

Dry brine concentrate 2.0 g Calendula Liquid Extract 5.0 ml Purified water up to 100 ml

- pH of 7.2-8.4;

- osmolarity - 276-298.

The composition of the ionic composition of the solution:

- not less than 6.0 mg / ml sodium (Na ⁺ );

- not less than 0.06 mg / ml potassium (K ^+);

- not less than 0.01 mg / ml calcium (Ca ²⁺ );

- not less than 0.6 mg / ml magnesium (Mg ²⁺ );

- not less than 10.0 mg / ml of the chlorine ions (Cl ^-);

- not less than 2.8 mg / ml of bicarbonate ions (HCO ₃ ^- );

- not less than 2.2 mg / ml of sulfate ions (SO ₄ ²⁺ );

- at least 0.004 mg / ml of bromine ions (Br ^-).

Example No. 7.

Structure:

Dry brine concentrate 2.0 g Yarrow liquid extract (aqueous) 5.0 ml Purified water up to 100 ml

- pH of 7.2-8.4;

- osmolarity - 276-298.

The composition of the ionic composition of the solution:

- not less than 6.0 mg / ml sodium (Na ^+);

- not less than 0.06 mg / ml potassium (K ⁺ );

- not less than 0.01 mg / ml calcium (Ca ²⁺ );

- not less than 0.6 mg / ml of magnesium (Mg ^2+);

- not less than 10.0 mg / ml of the chlorine ions (Cl ^-);

- not less than 2.8 mg / ml of bicarbonate ions (HCO ₃ ^- );

- not less than 2.2 mg / ml of sulfate ions (SO ₄ ^2- );

- not less than 0.004 mg / ml of bromine ions (Br ^- ).

Example No. 8.

Structure:

Dry brine concentrate 2.0 g Sage Liquid Extract (water) 5.0 ml Purified water up to 100 ml

- pH of 7.2-8.4;

- osmolarity - 276-298.

The composition of the ionic composition of the solution:

- not less than 6.0 mg / ml sodium (Na ^+);

- not less than 0.06 mg / ml potassium (K ⁺ );

- not less than 0.01 mg / ml calcium (Ca ²⁺ );

- not less than 0.6 mg / ml of magnesium (Mg ^2+);

- not less than 10.0 mg / ml of chlorine ions (Cl ^- );

- not less than 2.8 mg / ml of bicarbonate ions (HCO ₃ ^- );

- not less than 2.2 mg / ml of sulfate ions (SO ₄ ^2- );

- not less than 0.004 mg / ml of bromine ions (Br ^- ).

Example No. 9.

Structure:

Dry brine concentrate 2.0 g Chamomile Liquid Extract 5.0 ml Purified water up to 100 ml

Sterile!

- pH of 7.2-8.4;

- osmolarity - 276-298.

The composition of the ionic composition of the solution:

- not less than 6.0 mg / ml sodium (Na ^+);

- not less than 0.06 mg / ml potassium (K ⁺ );

- not less than 0.01 mg / ml calcium (Ca ²⁺ );

- not less than 0.6 mg / ml magnesium (Mg ²⁺ );

- not less than 10.0 mg / ml of chlorine ions (Cl ^- );

- not less than 2.8 mg / ml of bicarbonate ions (HCO ₃ ^- );

- not less than 2.2 mg / ml of sulfate ions (SO ₄ ^2- );

- not less than 0.004 mg / ml of bromine ions (Br ^- ).

Example No. 10.

Structure:

Dry brine concentrate 10.0 g Calendula Liquid Extract (water) 5.0 ml Purified water up to 100 ml

Sterile!

-pH equal to 7.2-8.4;

- osmolarity - 276-298.

The composition of the ionic composition of the solution:

- not less than 30.0 mg / ml sodium (Na ⁺ );

- not less than 0.3 mg / ml potassium (K ⁺ );

- not less than 0.05 mg / ml calcium (Ca ²⁺ );

- not less than 3.0 mg / ml magnesium (Mg ²⁺ );

- not less than 46.0 mg / ml of chlorine ions (Cl ^- );

- at least 14.0 mg / ml of bicarbonate ions (HCO ₃ ^- );

- not less than 11.0 mg / ml of sulfate ions (SO ₄ ^2- );

- not less than 0.02 mg / ml of bromine ions (Br ^- ).

The composition is consumed at room temperature.

The need for regular use of this composition is determined by the following. Inhaled air in an urban environment or industrial zone contains a significant amount of harmful components and pathogens. When inhaling, some of them are deposited in the nasal cavity and may subsequently cause illness. Therefore, the nasal cavity should be washed regularly.

This procedure is especially important when the air temperature drops below + 10 ° C and the frequency of respiratory diseases increases. As you know, the incubation period for the development of these diseases is 2-3 days. It is during this period that it is easiest to eliminate the consequences of infection, without leading to the disease. The supply of the composition to the nasal cavity can be accomplished by directly retracting it during inspiration or using a special supply agent. Then, the composition along with the impurities is removed during exhalation, partially through the nasal cavity, partially orally.

The mechanism of action of the composition is as follows. Salt dissolved in water removes the unpleasant sensations that occur when clean water enters the nasal cavity. Bicarbonate helps cleanse and soften.

Regular use of this composition before bedtime showed that a cold-like illness is practically eliminated and the risk of a catarrhal illness of the upper respiratory tract is significantly reduced. Perhaps the use of the composition in the morning with the so-called "clogged nose" effect.

This composition is not therapeutic. It relates to preventative hygiene products.

Claims (10)

1. Means for washing the nasal cavity, nasopharynx and oral cavity based on natural raw materials, including sodium ions (Na ⁺ ); potassium (K ⁺ ); calcium (Ca ²⁺ ); magnesium (Mg ² ), chlorine (Cl ^- ) and bromine (Br ^- ), characterized in that as a natural raw material it contains an aqueous solution of dry brine concentrate in salt lakes with a concentration in the range from 0.5 to 10%, with a pH in the range from 7.2 to 8.3, osmolarity 276-278, with the ionic composition: - 1.5-30.0 mg / ml sodium (Na ⁺ ); - 0,015-0,3 mg / ml of potassium (K ^+); - 0.025-0.5 mg / ml calcium (Ca ²⁺ ); - 0.01-2.0 mg / ml magnesium (Mg ²⁺ ); - 2,7-54 mg / ml of the chlorine ions (Cl ^-); - 0.7-14 mg / ml of bicarbonate ions (HCO ₃ ^- ); - 0.55-10.0 mg / ml sulfate ions (SO ₄ ^2- ); - 0.001-0.02 mg / ml of bromine ions (Br ^- ). 2. Means for washing the nasal cavity, nasopharynx and oral cavity according to claim 1, characterized in that it further comprises aqueous extracts of medicinal plants of chamomile, calendula, sage, eucalyptus, mint and yarrow, taken individually or in various combinations.