RU2369397C2 - Nasal medicine morenazal - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: according to the invention there is provided a spray-type nasal medicine containing active and additive agents, natural minerals and microelements, wherein natural sea-salt is used as active agent, water for injection is used as additive agent where osmolality of isotonic sterile solution makes 220 to 350 mmole/kg of water and pH from 6.0 to 9.5 and contains ions of natrium, magnesium, calcium, kalium and hydrocarbonates. The medicine is intended for active irrigation, rhinenchysis and cleansing nasal cavity, free nasal breathing management, prevention and treatment for infection of upper air passages.

EFFECT: components forming part of active agent complement and potentiate each other.

2 cl, 2 ex, 1 tbl

Description

The invention relates to the field of pharmaceutical industry, namely to pharmacology, in particular to the creation of medicines intended for the treatment and prevention of diseases of the nose.

A flavored bath agent “LEFMA” is known that contains natural salt, natural essential coniferous oils, a dye that additionally contains water from Florentine fir or Florentine pine-cedar, as a natural salt, a mixture of sea and edible table salt, and Far Eastern fir as natural essential coniferous oils and natural cedar-volcanic essential oil (RF Patent No. 2290917. Publ. 2007.01.10).

However, the known agent has a biostimulating, anti-inflammatory, antimicrobial and restorative effect on the activity of the whole organism, improving the cardiovascular system, but is not intended to treat nasal diseases.

Known cardioplegic solution "INFUZOL" containing sodium chloride, potassium chloride, calcium chloride, magnesium chloride, trisamine and water for injection, characterized in that it additionally contains potassium asparaginate, magnesium asparaginate and mannitol in the following ratio of ingredients, wt.%:

Sodium chloride 0.63-0.77

Potassium chloride 0.027-0.033

Magnesium chloride hexahydrate 0.18-0.22

Calcium chloride hexahydrate 0.009-0.011

Potassium asparaginate semi-aquatic 0.20-0.24

Four-water magnesium asparaginate 0.17-0.19

Mannitol 0.32-0.38

Trisamine 0.05-0.07

Water for injection - the rest,

while at 22 ° C the pH of the solution is 7.6 ± 0.1, the osmolarity is 350 ± 5 m Osm (RF Patent No. 2226093. Publ. 2004.04.27).

However, the known cardioplegic solution "INFUZOL" is not intended for the treatment of diseases of the nose.

Known solutions for organ transplants and an organ transplant method, including, per liter of solution, a balanced isotonic solution of sodium, potassium, calcium, magnesium and bicarbonate ions in a physiologically acceptable amount of at least 0.5 μM containing amiloride compounds and sufficient water for preparation liters of solution, and preservative solutions include, per liter of solution, a balanced isotonic solution of sodium, potassium, calcium, magnesium and bicarbonate ions in a physiologically acceptable amount, from approximately from 1.0 μM to about 5.0 μM, containing amiloride compounds and sufficient water to prepare a liter of solution, in addition, the preservation solution may contain EDTA, a small amount of adenosine and at least one antioxidant (RF Patent No. 2151405, publ. 2001.01 .10).

However, the known solutions relate to cardioleptic solutions, which are designed to suppress ion exchange, prolong organ viability and reduce cell damage during organ preservation and transplantation, but their use for the treatment of nasal diseases is not provided.

A known strain of Phyllobacterium myrsinacearum DKS-1 for the destruction of petroleum hydrocarbons of brackish water ecosystems isolated from the sea waters of the North Caspian in the area of exploratory drilling of oil wells. The strain is grown on standard environments and environments with the addition of sea salt. The destructive activity of the drug based on the strain against hydrocarbons of oil and oil products is 54.5-96% in the range of salinity of sea water 0.05-20% (RF Patent No. 2268934. Publ. 2005.04.20).

However, the known strain is intended for the purification of brackish-water ecosystems from contamination with oil and oil products and is not intended for the treatment of diseases of the nose.

Known drops of Petrosyan No. 1B (2B-7B, their options) for the treatment of allergic and neotopic diseases of the eyes and nose, including: Petrosyan drops 1B - cromolyn or nedocromil sodium or cromoglicic acid, dexamethasone-21-phosphate sodium salt, boric acid and sterile buffer solution; drops of Petrosyan 3B instead of dexamethasone-21-phosphate of sodium salt - diphenhydramine, and drops of Petrosyan 7B - ephedrine hydrochloride (RF Patent №2123839. Publ. 1998.12.27).

However, the known drops are not intended for active irrigation, washing and cleansing of the nasal cavities, restoration of free nasal breathing, prevention and treatment of infections of the upper respiratory tract, as they have limited contraindications, can cause short-term burning.

The present invention is the creation of a medicinal product intended for active irrigation, rinsing and cleansing of the nasal cavities, restoration of free nasal breathing, prevention and treatment of upper respiratory tract infections.

The problem is solved in that the nasal drug containing the active and auxiliary substances is made in the form of an isotonic sterile solution having an osmolality of 220 to 350 mmol / kg of water and a pH of 6.0 to 9.5, containing natural minerals and trace elements, in which natural sea salt is used as the active substance, water for injection is used as an auxiliary substance, with the following ratio w / v%:

sea salt 0.3-3.0

water for injection - the rest,

in addition, the isotonic sterile solution contains ions:

Sodium 0.01-1.0

Magnesium 0.001-0.72

Calcium 0.00002-0.00027

Potassium 0.0036-0.0036

Hydrocarbonates 0.002-0.003.

It is advisable for ease of use in children up to a year to use the form of release in the form of drops.

In an embodiment, for use in children over one year of age and in adults, the agent may be in the form of a spray.

The present invention is illustrated by a detailed description, examples of manufacture and use.

The nasal drug "Morenazal" is prepared as follows.

For the preparation of the nasal drug "Morenazal" use an auxiliary substance - water for injection. In 50 l of water for injection, 1.08 kg of the active substance is dissolved with stirring, using natural sea salt. Then the resulting volume of the solution was adjusted with water for injection to 100 l. After that, the resulting solution containing the active and auxiliary substances, which include natural minerals and trace elements, is subjected to sterilizing filtration, turning it into an isotonic sterile solution having an osmolality of 220 to 350 mmol / kg of water and a pH of 6.0 to 9, 5.

Moreover, in an isotonic sterile solution, the active and auxiliary substances have the following ratio wt./vol.%:

sea salt 0.3-3.0

water for injection - the rest.

In addition, an isotonic sterile solution contains ions:

Sodium 0.01-1.0

Magnesium 0.001-0.72

Calcium 0.00002-0.00027

Potassium 0.0036-0.0036

Hydrocarbonates 0.002-0.003.

The nasal drug "Morenazal" is made in the form of drops, for ease of use in children up to a year, and for use in children over one year of age and adults, the drug is made in the form of a spray.

The nasal medicinal product "Morenazal" in the form of drops is packaged in 5 or 10 ml in polymer bottles with dropper caps and screw caps (polymer dropper bottle) from Bunder Glas GmbH Plastoform, Germany.

Morenazal nasal drug in the form of a spray is packaged in 20, 50,100 ml bottles in polymer bottles of Bunder Glas GmbH Plastoform (Germany) or other polymer bottles with a spray nozzle from AERO Pump GmbH (Germany) or another approved for use by the Ministry of Health of the Russian Federation.

Each bottle with instructions for use is packed in a pack of cardboard.

An example of the implementation of the nasal drug "Morenazal".

For its preparation, take the active - sea salt - and auxiliary - water for injection - substances in the following amount wt./vol.%:

sea salt 0.3-3.0

water for injection - the rest.

While stirring, 1.08 kg of natural sea salt was dissolved in 50 L of water for injection. The resulting volume of the isotonic solution was adjusted with water for injection to 100 l.

The resulting isotonic solution was subjected to sterilizing filtration.

Convenient use of a sterile isotonic solution was achieved by packaging it, after manufacture, in bottles with a nozzle spray (spray form) - for children over 1 year old and adults, or in bottles with stoppers - droppers (drop form) - for children up to a year.

The sterile isotonic solution has a transparent or slightly opalescent colorless appearance.

An example of the use of the nasal drug "Morenazal" in the form of drops.

For therapeutic purposes, the nasal drug "Morenazal" is prescribed: for children under 1 year old - 4 times a day, 2 drops in each nasal passage; children from 1 year to 7 years - 4 times a day, 2 drops in each nasal passage; children from 7 to 16 years old - 4-6 times a day, 2 drops in each nasal passage; adults - 4-8 times a day, 2-3 drops in each nasal passage.

The course of treatment is 2-4 weeks. It is recommended to repeat the course of treatment after a month.

With a hygienic purpose.

To soften and remove secretions from the nose, drops are instilled into each nasal passage in the required amount, removing the remaining fluid flowing from the nose with a handkerchief or using cotton wool.

The procedure can be repeated many times until the discharge accumulated in the nasal passage is softened and removed.

In children under 1 year of age, it is recommended to carry out a toilet of the mucous membrane of the nasal cavity to preserve its physiological characteristics in the form of instillation of drops 2-3 times a day, 1-2 drops in each nasal passage.

To soften and remove contaminating accumulations and nasal secretions, the drug is used as needed.

An example of the use of the nasal drug "Morenazal" in the form of a spray.

A child from 1 year old to 2 years old is in a supine position, head turned to one side. A nasal drug is injected into the nostril located on top.

Have the baby sit down to clean the nose.

Then similarly repeat the procedure from the other nostril.

Adults and children over 2 years old when using the nasal drug "Morenazal" tilt their heads to the side. With the help of others, or independently enter the nasal drug in the form of a spray or drops into the nostril located on top. After 2-3 minutes, it is necessary to clean the nose by blowing. Then similarly repeat the procedure from the other nostril.

Recommended single doses of the drug (the number of injections in each nostril) and the frequency of use per day are shown in the table.

Age of patients Medicinal use Hygienic use Children from 1 year to 2 years old 1 injection into each nostril 2-4 times / day 1 injection into each nostril 1-2 times / day Children aged 2 years to 7 years 2 injections in each nostril 4 times / day 1-2 injections into each nostril 1-3 times / day Children and adolescents aged 7 to 16 years 2 injections into each nostril 4-6 times / day 2 injections into each nostril 2-4 times / day Adults and teenagers over 16 2-3 injections into each nostril 4-8 times / day 2-3 injections into each nostril 3-6 times / day

The proposed nasal drug "Morenazal" is intended for active irrigation, rinsing and purification of the nasal cavities, restoration of free nasal breathing, prevention and treatment of upper respiratory tract infections.

"Morenazal" helps to maintain the normal physiological state of the mucous membrane of the nasal cavity, thinning the mucus and normalizing its formation in the goblet cells of the mucous membrane.

Natural minerals and trace elements that make up the drug have an anti-inflammatory effect, stimulate recovery processes, improve the function of the ciliated epithelium, which increases the resistance of the nasal mucosa to pathogenic bacteria and viruses.

The nasal drug is designed so that the active and excipient, trace elements and natural minerals complement and enhance each other's action.

The proposed nasal drug "Morenazole" is produced by the Joint Stock Company Kurgan Society of Medicines and Products "Synthesis" (OJSC "Synthesis").

Claims (2)

1. Nasal drug, made in the form of a spray and containing the active and excipients, natural minerals and trace elements, in which natural sea salt is used as the active substance, water for injection is used as the excipient, and the isotonic sterile solution contains sodium ions, magnesium, calcium, potassium, characterized in that the isotonic sterile solution has an osmolality of 220 to 350 mmol / kg of water, a pH of 6.0 to 9.5 and contains bicarbonate ions in the following ratio, wt. /about.%:
Natural sea salt 0.3-3.0 Water for injections Rest,
in addition, the isotonic sterile solution contains ions
sodium 0.01-1.0 magnesium 0.001-0.72 calcium 0.00002-0.00027 potassium 0.0036-0.0036 bicarbonates 0.002-0.003. 2. The drug according to claim 1, characterized in that it is made in the form of drops.