RU2393871C1 - Therapeutic composition - Google Patents

Abstract

FIELD: medicine, pharmaceutics. ^ SUBSTANCE: invention refers to pharmaceutical industry, particularly to a composition for treatment and prevention of acute respiratory viral infections. A therapeutic soluble composition for treatment and prevention of acute respiratory viral infections, containing dry extracts of sea-buckthorn leaves, liquorice root, willow barks, Uncaria Tomentosa bark, ascorbic acid, an aromatiser, a flavour additive and an excipient in a certain ratio. ^ EFFECT: composition is effective for treatment and prevention of acute respiratory viral infections, exhibits joint antiviral and symptomatic action. ^ 3 tbl

Description

The invention relates to medicine and pharmaceuticals, and in particular to medicines based on medicinal plants with therapeutic effect in acute respiratory viral infections (ARVI).

Acute respiratory viral infections are currently the most common and socially significant diseases. Various respiratory viruses cause the disease: rhinoviruses, coronoviruses, respiratory syncytial viruses, parainfluenza viruses, adenoviruses, enteroviruses.

For the treatment of acute respiratory viral infections, hundreds of drugs from various pharmacological groups are used, but the problem of the treatment and prevention of these diseases has not been fully resolved.

The list of clinical manifestations of acute respiratory viral infections is diverse and can manifest itself as a general toxic syndrome, and catarrhal with damage to various levels of the respiratory tract. To stop the symptoms of the disease, several classes of drugs can rightly be used. Such a wide range of funds needed for treatment is simply inconvenient for the patient, especially an active lifestyle. The solution to this problem was the creation of combined / multisymptomatic agents that can affect the main symptoms of a viral infection. In the vast majority of cases, the combination formulations are standard, containing an antipyretic component - NSAIDs, systemic decongestant, antihistamine, ascorbic acid. The main disadvantage of these combination drugs is their lack of antiviral action.

In addition to combined symptomatic agents, etiotropic antiviral drugs exist that block the reproduction of the virus at various stages of the replicative cycle. However, during treatment with etiotropic drugs, unfortunately, the symptoms of the disease associated with intoxication and catarrhal phenomena do not immediately disappear, therefore, other drugs have to be connected to treatment.

In the period of a seasonal rise in acute respiratory viral infections, they are most often recommended by doctors recently and combined symptomatic agents in the form of soluble powders, for example, Coldrex, Fervex, Teraflu.

A common drawback of these synthetic agents, despite their effectiveness, is the lack of antiviral action and a large number of side effects, and therefore they are not recommended for a long time and are not used prophylactically.

The only drug capable of exerting both an etiotropic (with respect to influenza A virus) and symptomatic effect is Antigrippin Maximum. The antiviral effect of this combination is due to the presence of rimantadine, and the symptomatic effect is due to the presence of paracetamol, ascorbic acid, calcium gluconate, rutoside and loratadine.

The disadvantage of this medication is the presence of side effects, a large number of contraindications and the inability to use the drug for more than five days, which indicates the impossibility of its prophylactic use in the season of rise in colds.

According to the patent of the Russian Federation No. 2068701, a collection for treating acute respiratory viral infections is known, including black elderberry flowers, Elecampane root, Calamus swamp root, Eucalyptus leaf, ball or black poplar buds, large celandine grass.

RF patent No. 2245157 describes a biologically active additive for the prevention and treatment of influenza containing tinctures of propolis and calendula, ascorbic acid, calcium gluconate, diphenhydramine, rutin and excipients such as starch, calcium stearate, talc.

Famous herbal preparations for colds produced by PARAFARM: Kan-Yang, which includes one of the most popular cold-fighting plants in China, andrographis and adaptogen Eleutherococcus; Gerbasprin, which includes: extract of white willow bark, extract of rose hips of May, extract of paniculiforum grass, extract of the roots of Rhodiola rosea.

Known complex herbal preparation Fitogor as a means of combating a variety of viruses, including flu and herpes infection, which includes 7 herbs: wrinkled polygon, peppermint, lemon balm, calendula, catnip, corn stigmas, sage.

Known biologically active additives produced by Fora Pharm - syrups on sorbitol and sugar "Sophia. In case of influenza, ”containing dry extracts of cranberry, raspberry and red mountain ash fruits as an active ingredient, as well as dry extract of peppermint grass.

In addition to the above, herbal remedies for flu and colds are known: Hyporamine and Viruksin based on sea buckthorn leaves, preparations and fees containing echinacea, Rhodiola rosea, Eleutherococcus, ginseng. It is known to use linden flowers, fruits and leaves of raspberries, oregano, rosehips, garlic, onions, etc. (V.V. Telyatyev "Healing Treasures", 1991).

Common shortcomings of all known herbal remedies is their symptomatic effect, in connection with which with acute respiratory viral infections it is necessary to take several classes of drugs at once. Although medicine has accumulated large resources of effective herbal preparations and compositions that help with colds, there are still no combined soluble herbal remedies, similar to synthetic ones, combining antiviral, pathogenetic and symptomatic effects. The closest analogue from the prior art is not revealed. The absence on the market of soluble herbal compositions exhibiting the stated activity suggests a number of reasons that impede the achievement of the desired result, in particular, the complexity and variety of biochemical and physiological mechanisms affecting the processes of immunological protection, as well as technological problems and poor solubility of dry extracts in water, etc.

The objective of the invention is to expand the arsenal of soluble combination agents for the treatment and prevention of acute respiratory viral infections and the replacement of synthetic drugs by creating a soluble herbal composition that has a combined antiviral and symptomatic effect. The technical result is the implementation of the declared purpose.

The problem is solved by the proposed therapeutic and prophylactic soluble composition containing dry extracts of sea buckthorn leaf, licorice root, willow bark, Uncaria Tomentosa bark, ascorbic acid, flavor, flavoring and filler, wt.%:

sea buckthorn leaf extract 1-4 licorice root extract 1-3 willow bark extract 1-3 Uncaria tomentosa bark extract 0.5-2 vitamin C 3-6 flavoring 0.33-0.4 flavoring 1,6 filler rest

The claimed composition contains, as active components, dry water-soluble extracts of sea buckthorn leaf, licorice root, willow bark, Uncaria Tomentosa bark and ascorbic acid, and as auxiliary components, a fragrance in the form of essential oil, a flavoring agent, for example dry lemon juice, and a filler, for example fructose.

Buckthorn buckthorn (Hippophae rhamnoides L.) of the sucker family (Elaeegnaceae) is a dioecious shrub or tree. The use of sea buckthorn oil in medicine is widely known. The antiviral effect of sea buckthorn leaves was detected relatively recently and the hyporamine preparation was created on their basis (EA Zamkova, Hyporamine as a means of preventing acute respiratory viral infections. // Russian Medical Journal. - 2003. - T.11, No. 4).

Sea buckthorn leaves contain hydrolyzable tannins, flavonoids, as well as essential amino acids, a large number of vitamins, minerals, organic acids. Hydrolyzable tannins have antiviral activity, increase the production of interferon, increase its content in the blood, which increases the body's resistance to various viral infections. Flavonoids contained in sea buckthorn leaves (up to 2.5%) have anti-inflammatory, antioxidant, tonic and diuretic properties.

Licorice (Glycyrrhiza) of the legume family (Fabaceae) has been known in folk medicine since ancient times. The most used part of the plant - the roots and rhizomes contain up to 23% glycyrrhizin - potassium and calcium salts of glycyrrhizic acid (Biologically active substances of plant origin. In three volumes. M .: Nauka, 2001). Also found are 27 different flavonoids (liquiquirithin, isoliquirithin, lacriside, etc.), ascorbic acid (up to 30 mg%), a small amount of essential oil, gum, gum, asparagine. An increase in the secretory function of the respiratory tract epithelium, a change in the surface-active properties of pulmonary surfactant, and a stimulating effect on the function of the cilia of the epithelium are associated with glycyrrhizin and licorice root saponins. Under the influence of licorice preparations, sputum liquefies, and its coughing becomes easier. Licorice preparations also have an antiviral effect, with the greatest antiviral activity inherent in saponins.

White willow (Salix alba) of the willow family (Salicaceae) is a deciduous shrub or tree. For medical purposes, willow bark is used as an antipyretic for febrile diseases of various etiologies. Willow bark contains the substance salicin (salicylates) - a natural precursor to aspirin, which has practically the same healing properties as it (Sokolov S.Ya. Phytotherapy and pharmacology: a guide for doctors. M: Medical Information Agency, 2000, p. 906).

The feline claw (Uncaria Tomentosa) of the madder family (Rubiaceae) is a multi-year climbing liana, so called because of the structural features and the nature of attachment to the support (spine in the form of a feline claw). For medical purposes, bark is used as an immunomodulatory, antioxidant, anti-inflammatory, antiviral, general tonic (Altern Med Rev. 2001 Dec; 6 (6); 567-79). Uncaria tomentosa contains oxindolalkaloids: isorinchophyllin and rinhofillin, isomitrafillin and mitrafillin, isopterotopin and pteropodin. In addition to alkaloids, the cortex includes catechins, ellagic and gallic acids (hydrolyzable tannins), sterols and sitosterols (beta-cystosterol, stigmasterol, campesterol), proanthocyanidins (water-soluble bioflavonoids), which provide a wide range of biological effects of this plant, namely anti-inflammatory, antispasmodic, antiseptic, hypotensive, hepatoprotective, choleretic, diuretic, detoxifying effect.

Ascorbic acid, which is part of the composition, makes up for the increased need for vitamin C for colds and flu. The amount of ascorbic acid is selected so that when taking a course it will fill this need. Vitamin C strengthens blood vessels, plays an important role in providing oxygen supply to cells. In our composition, it is also important that vitamin C improves taste and increases shelf life.

As a flavoring additive, for example, lemon juice in an amount of about 1.6 wt.% Can be used. When dissolved in water, it has a pleasant taste and aroma. Lemon juice improves the organoleptic of the finished drink and at the same time has a multivitamin, tonic effect.

As a flavoring in the proposed technical solution, essential oil is used, for example, sage or peppermint, or grapefruit, or eucalyptus in an amount of 0.33-0.4 wt.%.

As a filler in the proposed technical solution use fructose or oligofructose, or inulin. These carbohydrates are approved for use in all countries of the world and are widely used in the food and pharmaceutical industries.

The herbal composition, which has a prophylactic and therapeutic effect in acute respiratory viral infections and contains all of these components, has not been identified in the prior art, therefore, the invention meets the criterion of "novelty."

The mechanism of action of the drug is based on its antiviral (sea buckthorn leaf, cat's claw, licorice), interferon-inducing (licorice, cat's claw), antipyretic and anti-inflammatory (willow, vitamin C) activities. The action of the plant components included in the claimed composition occurs according to different biological mechanisms, therefore, the combined therapeutic effect is manifested, that is, it was possible to overcome to a certain extent the above difficulties in creating soluble herbal remedies.

The extracts included in the composition may be aqueous and / or hydroalcoholic, preferably aqueous. These extracts are obtained by known methods (Ponomarev VD Extraction of medicinal raw materials, M .: "Medicine, 1976) according to the manufacturer's specifications.

The idea of combining a multifunctional medicinal plant extracts such as licorice root, cat's claw bark, willow bark, sea buckthorn leaf directly from the prior art in the indicated number of extracts does not follow directly from the prior art. The authors conducted research on a large number of compositions and unexpectedly found a composition that meets the task: good solubility in water and the presence of active active substances that have the desired effect. The herbs included in the composition are not antagonists, their ratios in the composition are selected so that they complement each other to the necessary extent.

A significant advantage of the claimed composition is the amount of each active component identified by the authors, since it is the claimed quantitative composition that affects the achievement of the specified technical result - a combined antiviral and symptomatic effect. It should also be noted that the claimed technical result is manifested only at the intervals of the content of active components defined in this technical solution. Reducing the quantitative content of components below the declared limits does not have a therapeutic and prophylactic effect, and exceeding the content of components above the stated limits can cause undesirable side effects.

The results of clinical testing, below, convincingly show that the claimed composition fulfills the declared purpose.

In favor of the patentability of the technical solution is the fact that the proposed tool can replace known synthetic imported products used in the form of hot drinks for colds.

The above allows us to conclude that the technical solution meets the inventive step,

The composition has no contraindications, except for individual intolerance to the constituent components, has no side effects and can be used prophylactically for a long time. The advantage of the claimed drug is its conformity to the multivalence of the pathogenesis of the disease, the effect on the patient’s body as a corrective system; it prevents the development of complications, reduces the frequency of exacerbation of chronic diseases, normalizes immunological parameters.

The composition is made by mixing dry water and / or water-alcohol extracts: sea buckthorn leaf, licorice root, white willow bark, Uncaria Tomentosa bark (cat's claw), as well as dry lemon juice, ascorbic acid, fructose or inulin, or oligofructose, with the addition of an essential oil selected from the series: sage essential oil, peppermint essential oil, grapefruit essential oil, eucalyptus essential oil. The product is packaged in a 3 g sachet or in jars of 50, 100, 250, 500 g. The composition is administered orally by adding the necessary amount of solvent, for example water.

The invention is illustrated by non-limiting examples of the industrial implementation of the composition in the form of a dry soluble powder, packaged in a sachet weighing 3 g.

Table 1 Examples of industrial implementation, sachets weighing 3 g name of raw materials Content, g Example 1 Example 2 Example 3 Sea buckthorn leaf extract 0,03 0,048 0.12 Licorice Root Extract 0,03 0,048 0.09 Willow Bark Extract 0,03 0,048 0.09 Uncaria Tomentosa Bark Extract (Feline Claw) 0.015 0.024 0.06 Vitamin C 0.09 0.17 0.18 Sage or peppermint essential oil, or grapefruit, or eucalyptus 0.012 0.010 0.012 Lemon juice 0,048 0,048 0,048 Fructose or inulin or oligofructose 2,745 2,604 2.40

According to physicochemical parameters, the composition is a powder from light brown to dark brown, with small patches of lighter and darker color, with a moisture content of not more than 8.0%, the content of tannins (in terms of tannin) is not less 0.047 g / sachet, the content of ascorbic acid is not less than 0.09 g / sachet. The smell of the composition is specific, depending on the essential oils used, the taste is bitter-sweet, with a lemon aftertaste.

To assess the effectiveness of the claimed composition in the prevention and treatment of patients with acute respiratory diseases, a study was conducted of the drug in the conditions of the Municipal Health Center “Central City Hospital”.

The study was conducted in a hospital for 60 patients with a traumatological pathology and an acute respiratory viral infection, of which two groups of 30 people each were formed.

The first group (main, 30 people) - trauma patients with acute respiratory viral infections who received a therapeutic and prophylactic composition.

The second group (control, 30 people) - trauma patients with acute respiratory viral infections who did not receive the claimed therapeutic and prophylactic composition.

The product was taken orally, 1 sachet (3 g), dissolving the contents in 200 ml of warm boiled water, 4 times a day. The main indicators are given in table 2.

Table 2. The dynamics of clinical symptoms in patients with acute respiratory viral infections Clinical indicators Main group Control group At the beginning of observation On the 5th day On the 21st day At the beginning of observation On the 5th day On the 21st day t, ° C 37.5 ± 1.2 36.6 ± 1.7 36.5 ± 1.6 37.3 ± 1.3 36.9 ± 1.4 36.6 ± 1.7 Respiratory Rate (min) 20.0 ± 3.4 19.0 ± 3.2 19.0 ± 3.2 20.1 ± 0.6 19.6 ± 2.9 19.5 ± 2.8 Heart Rate (in min) 68.0 ± 2.8 70.1 ± 2.6 70.2 ± 2.6 69.9 ± 2.5 73.3 ± 3.9 73.2 ± 3.8 HELL (mmHg) 126/80 126/80 120/80 140/90 136/84 136/84 Breathing system Respiration (ausc.) In the number of patients,% vesicular 43.3 ± 5.3 83.4 ± 3.7 * 93.4 ± 4.5 46.7 ± 5.2 40.0 ± 4.9 83.6 ± 4.5 tough 36.4 ± 4.5 10.0 ± 2.8 * 6.6 ± 1.7 33.3 ± 4.4 36.7 ± 4.5 13.3 ± 3.1 weakened 16.6 ± 3.0 6.6 ± 1.6 0,0 20.0 ± 3.5 23.3 ± 3.9 3.3 ± 1.6 fragmented 3.3 ± 1.6. 0,0 0,0 0,0 0,0 0,0 Wheezing (ausc.) In the number of patients,% dry 23.3 ± 3.8 0,0 * 0,0 26.6 ± 3.7 20.0 ± 3.5 0,0 wet 6.6 ± 1.8 0,0 * 0,0 9.3 ± 2.9 16.6 ± 3.0 0,0 combined 6.6 ± 1.8 0,0 * 0,0 3.3 ± 1.9 0,0 0,0 Cough% rude barking 53.3 ± 5.3 3.3 ± 3.1 * 0,0 50.0 ± 5.2 26.6 ± 3.7 0,0 The presence of the mucous membrane separated from the nasal passages,% 100.0 6.6 ± 1.8 * 0,0 100.0 26.6 ± 3.8 0,0 Hoarseness of voice,% 53.3 ± 5.3 0,0 * 0,0 50.0 ± 5.2 26.6 ± 3.7 3.3 ± 1.6 General weakness,% 86.6 ± 2.8 10.0 ± 2.8 * 0,0 83.3 ± 2.9 53.3 ± 5.2 0,0 Headache, % 90.0 ± 3.6 0,0 * 0,0 90.0 ± 3.1 20.0 ± 3.5 0,0 Conjunctivitis,% 46.6 ± 5.1 0,0 * 0,0 53.3 ± 5.4 16.6 ± 3.0 0,0 Note: * - significance of differences in means (p <0.05)

In the main group, against the background of using the composition on the third day of therapy, there was a significant, significant decrease in the severity of symptoms such as chills, runny nose, headache, general weakness and malaise. The phenomena of conjunctivitis (photophobia, lacrimation, redness of the mucosa) were stopped in all patients on the third or fourth day of therapy.

The average duration of treatment in the group of patients with acute respiratory viral infections who received a therapeutic and prophylactic composition was 5.0 ± 0.4 days. In the group of ARVI patients who did not receive the treatment and prophylactic composition, symptoms of intoxication, catarrhal phenomena, changes in the respiratory tract were reliably stopped much later. The average duration of treatment in this group of patients was 8.6 ± 0.3 days.

A clinical study of the composition confirmed safety, good tolerance and showed therapeutic efficacy in the treatment of acute respiratory viral infections.

To study the prophylactic effect of the treatment and prophylactic composition, a group of 10 people from the staff of the trauma unit was created, which belong to the high-risk group by contact. He conducted the course: taking 1 sachet (3 g), previously dissolved in 200 ml of warm boiled water, 4 times a day for 21 days. The control group included 10 employees who did not receive preventive treatment. The results are presented in the table.

Table 3. The results of the use of the composition for the prevention of acute respiratory viral infections among adults at risk (medical workers). Indicators The main group (10 people) Control group (10 people) abs. % abs. % 1. The number of acute respiratory viral infections 2 20,0 four 40,0 2. The presence of complications one 10.0 3 30,0 3. The presence of repeated cases of SARS 0 0 four 40,0 4. The number of days of disability 10 days 100 days per 100 employees 32 days 320 days per 100 employees

As can be seen from the table, the incidence of SARS against the background of the prevention of the invented composition was lower than in the control group both in cases and in days per 100 employees.

Thus, the claimed composition has the claimed therapeutic and prophylactic effect, which makes it expedient to include it in the treatment and rehabilitation of patients with acute respiratory diseases, and also to use it as a prophylactic. The recommended course of admission is 3 weeks.

The proposed composition acts on viruses, on symptoms and enhances immunity, it also has no contraindications and does not cause side effects, with the exception of allergies to medicinal plants contained in the composition.

Claims (1)

Therapeutic prophylactic soluble composition for the treatment and prevention of acute respiratory viral infections, containing dry extracts of sea buckthorn leaf, licorice root, willow bark, Uncaria Tomentosa bark, ascorbic acid, flavor, flavoring and filler in the following ratio, wt.%:
sea buckthorn leaf extract fourteen licorice root extract 1-3 willow bark extract 1-3 Uncaria tomentosa bark extract 0.5-2 vitamin C 3-6 flavor 0.33-0.4 flavoring additive not less 1,6 filler rest