RU2377010C1 - Biologically active additive - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to production of biologically active additives for prevention and assisted treatment of gastritis, duodenitis and colitis of various aetiologies, and peptic ulcer disease. The composition of the herbal biologically active additive for prevention and assisted therapy of gastrointestinal diseases contains the following components, wt fractions: liquid linseed extract 7000-8000; shelf fungus extract 130-170; camomile extract 40-50; licorice extract 20-25; calcium carbonate 400-600; magnesium carbonate 280-360; magnesium oxide 245-250; sodium hydrocarbonate 50-100; sorbite 1300-1700; starch 130-170; carboxymethyl cellulose 110-160; potassium sorbate 12-17; nisin 1-2; an aromatiser 5-15; water up to 15000.

EFFECT: composition expresses antacidic action, improves condition of upper digestive mucosa and differs for good tolerance.

3 tbl

Description

The invention relates to compositions of biologically active additives for the prevention and auxiliary treatment of gastritis, duodenitis and colitis of various etiologies, peptic ulcer disease.

From the patent RU 2223780 a dietary supplement composition is known containing the following components per tablet weighing 0.55 g, g:

Dry leaf infusion concentrate yarrow 0.00001-0.00008 Dry concentrate of infusion of chamomile flowers 0.00001-0.00008 Dry Concentrate of Peppermint Tincture 0.0002-0.0016 Dry Sea Buckthorn Syrup Concentrate 0.0003-0.0024 Dry Nettle Leaf Extract Concentrate 0.0002-0.0016 St. John's wort herb tincture dry concentrate 0.0002-0.0016 Starch 0.0200-0.1000 Wheat bran 0.0150-0.0800 Calcium stearate 0.0025-0.0200 Sugar Rest

The supplement has a general strengthening effect on the function of the gastrointestinal tract.

Closest to the proposed is known from patent RU 2205656 composition of a biologically active additive for the prevention and maintenance therapy of diseases of the gastrointestinal tract, containing the following components per tablet weighing 0.55 g, g:

Dry licorice root extract 0.0030-0.0150 Dry water elecampane decoction root concentrate 0.00001-0.00012 St. John's wort herb tincture dry concentrate 0.000175-0.00175 Propolis tincture dry concentrate 0.000175-0.0014 Dry Carrot Juice Concentrate 0.0018-0.0090 pollen 0.0100-0.0500 Vitamin E 0.0025-0.0100 Zinc sulphate 0.0025-0.0100 Aluminum hydroxide 0,0500-0,2000 Chopped oats 0.0200-0.1000 Starch 0.0360-0.1000 Calcium stearate 0.0055 Talc 0.0055 Sugar Rest

This composition of dietary supplements has an anti-inflammatory antimicrobial, analgesic, enveloping, soothing effect. Improves digestion processes, promotes the regeneration of damaged tissues, reduces dyspeptic phenomena.

Known additives are in tablet form, take time to dissolve, and do not act gently enough.

Gel antacids are also known (for example, RU 2002117333, RU 2211039), but they do not have a complex therapeutic effect on the gastrointestinal tract.

The technical result of the proposed invention is the provision of rapid dissolution of dietary supplements in the stomach and its mild action while providing a comprehensive therapeutic effect on the gastrointestinal tract.

The technical result is achieved by the composition of a biologically active additive for the prevention and maintenance therapy of diseases of the gastrointestinal tract based on medicinal plants, containing licorice extract, acid neutralizing components, starch, which according to the invention additionally contains liquid flax seed extract, chaga extract, chamomile extract, licorice extract, sorbitol carboxymethyl cellulose, potassium sorbate, nisin, flavor and water, and the additive contains calcium as acid-neutralizing components Oia carbonate, magnesium carbonate, magnesium oxide and sodium bicarbonate in the following ratio, wt. parts:

Liquid Flax Seed Extract 7000-8000 Chaga extract 130-170 Chamomile extract 40-50 Licorice extract 20-25 Calcium carbonate 400-600 Magnesium carbonate 280-360 Magnesium oxide 245-250 Sodium bicarbonate 50-100 Sorbitol 1300-1700 Starch 130-170 Carboxymethyl cellulose 110-160 Potassium sorbate 12-17 Lowlands 1-2 Flavoring 5-15 Water Up to 15000

The invention consists in the following.

The composition of dietary supplements includes components that have antacid, enveloping, antispasmodic action, as well as ulcer regeneration stimulants and agents that increase the protective effect of mucus and inhibit the secretion of hydrochloric acid.

This dietary supplement, called Acidneutral, is used to prevent hypersecretory gastritis and as a tool used in the complex treatment of chronic gastritis with increased acidity of the stomach, gastric ulcer and duodenal ulcer. Supplement "Acidneutral", as an antacid, can be used as an ambulance for heartburn, acid burping and epigastric pain, which are the result of increased acidity of gastric juice and smooth muscle spasms.

Acid neutralizing activity (KNA) of antacids is expressed in milliequivalents (meq), which is equivalent to the amount of IN hydrochloric acid, which is titrated to pH 3.5 with a certain dose of the drug for a specified time.

It has been clinically proven that the use of antacids with an average KNA for stomach ulcers allows scarring of 75% of ulcers to be achieved after 4 weeks of antacid use.

KNA dietary supplement “Acidneutral” is determined by its constituent components and, if used correctly, amounts to at least 25 ml IN hydrochloric acid per 15 g of gel (single dose). Acidneutral gel can be classified as a dietary supplement with a high acid-neutralizing activity. Supplement "Acidneutral" contains a small amount of calcium, therefore, does not cause secondary hypersecretion and burping.

Thus, under the action of this dietary supplement, an increase in pH in the stomach occurs, accompanied by a decrease in the formation of a number of proteolytic enzymes and a decrease in the action of aggressive factors. Moreover, alkalization of the gastric contents increases the tone of the lower esophageal sphincter, which may be important, for example, with gastroesophagic reflux.

Acidneutral gel contains acid-neutralizing components in the form of a suspension, therefore it dissolves faster than tablets or powders and acts softer. Pronounced neutralization of gastric acid begins after about 15 minutes. The duration of antacid action depends on how long the drug remains in the stomach. When taken on an empty stomach, a rapid evacuation of antacids occurs and their duration does not exceed 20-40 minutes. If the stomach contains food, evacuation from it significantly slows down, therefore, the antacid taken 1 hour after eating retains its acid-neutralizing effect for about three hours.

"Acidneutral" is a magnesium-containing dietary supplement. It is able to increase the protective properties of the gastric mucosa. Under the influence of magnesium, there is a slight increase in the synthesis of cytoprotective and vasoactive prostaglandins, as well as the binding of the epithelial growth factor to its fixation in the area of the ulcer defect. As a result, this stimulates the proliferation and normal differentiation of cells, the development of vascular collaterals and tissue regeneration, which, of course, affects the quality of the forming scar at the site of the ulcer defect. Magnesium-containing drugs are able to increase the formation of mucus and fucoglycoproteins, which further increases the resistance of the gastric mucosa to the action of aggression factors and can slightly reduce the severity of inflammatory processes in the mucosa.

Chaga extract (birch chaga - Inonotus obliquus Fr.), which is part of the Acidneutral dietary supplement, contains water-soluble chromogens - derivatives of phenolic aldehydes, polyphenols, hydroxyphenol carboxylic acids and their quinones, as well as humic-like chagic acid, lysinides, polysaccharides and triterpenic acids. Chaga extract has antispasmodic, diuretic, antimicrobial, reparative properties. It normalizes the activity of the gastrointestinal tract and intestinal microflora, promotes scarring of gastric and duodenal ulcers, and exhibits pronounced gastroprotective properties.

The gastroprotective properties of the chaga dry extract have been experimentally confirmed in acute and chronic models of the ulcerative process in mice and rats, superior to that of drugs of a similar effect.

The gastroprotective effect of licorice extract (naked licorice - Glycyrrhiza glabra L.) is due to the presence of triterpene compounds, which are close both in structure and action to steroid hormones, which are produced by the cortical layer of the adrenal glands and have extremely strong anti-inflammatory properties. Of particular interest are glycyrrhizic and glycyretic acids contained in the underground parts of the plant and acting similarly to the chemical mediators of protection (prostaglandins) described above, which increase the protective effect of gastric mucus and inhibit the secretion of hydrochloric acid. In addition, licorice extract has antispasmodic (flavonoids), anticholinergic, antihistamine, enveloping effect and reduces capillary fragility.

Chamomile extract is one of the components of Acidneutral dietary supplement.

The composition of chamomile extract includes an antispasmodic glycoside that relaxes smooth muscles and anesthetizes with intestinal cramps, apigenin, apiin, herniarin, matricin.

Supplements from chamomile extract have a pronounced anti-inflammatory, anti-allergic, local anesthetic effect, enhances regenerative processes. Chamomile extract is used in the treatment of asthma, rheumatism, allergic gastritis and colitis. Chamomile extract is used orally for intestinal cramps, gastritis, stomach and duodenal ulcers, enteritis, flatulence, inflammation of the liver and gall bladder, kidneys, bladder, dysmenorrhea and neurosis.

Supplement "Acidneutral" contains mucus of flax seed. Flax Seed (Seminis Lini) is a well-known and widely recognized source of mucous substances. Seeds contain 12% mucus, organic acids and enzymes. The mucus of the seeds has an enveloping and softening effect, prevents the manifestation of local irritating effects of aggression factors.

The gel-like filler may contain the following components: starch, sodium bicarbonate, sorbitol, carboxymethyl cellulose, potassium sorbate, nisin, food flavor “mint”, food flavor “lemon”.

Starch obtained from potato tubers has an emollient, enveloping and anti-inflammatory effect and is used internally as a starch paste and mucus to protect sensitive nerve endings from irritating substances and to slow the absorption of certain drugs. Starch mucus is used internally for diseases such as gastric and duodenal ulcers, gastritis with high acidity and painful heartburn.

As a result, Acidneutral dietary supplement reduces inflammatory processes in the gastric mucosa and increases its resistance to the effects of bacterial aggression factors, including Helicobacter pylori.

A dietary supplement in gel form was prepared as follows.

To prepare the gel form, four groups of components were used in the following amounts per 1 packet of gel, the first two groups were the main substances, and the rest were substances that form the gel filler:

1 group Liquid Flax Seed Extract (1:30) 6074.7 mg Magnesium oxide 221 mg Magnesium carbonate basic 267 mg Calcium carbonate 468.3 mg Chaga extract 150 mg Chamomile extract 45 mg Sorbitol 1500 mg Licorice extract 22.5 mg Sodium bicarbonate 75 mg Total group 1 8823.5 mg 2 group Starch (X-Amyl Acetate) 150 mg Liquid Flax Seed Extract (1:30) 1500 mg Total group 2 1650 mg 3 group Carboxymethyl cellulose 135 m Water 4365 Total group 3 4500 Group 4 Mint flavoring (dry) 23244 / PWD 5 mg Flavoring lemon (dry) 5 mg Potassium sorbate 15 mg Lowlands 1.5 mg Total part 4 26.5 mg TOTAL 15,000 mg

A flax seed liquid extract was prepared in a flax seed: water ratio of 1:30. To do this, the required amount of water was heated in a food kettle to a temperature of 90 ° C and the calculated amount of crushed flax seed was added with stirring, then it was kept for 55 minutes at a given temperature (90 ° C) and with constant stirring. After that, the mixture was filtered through a nylon filter with a hole diameter of 0.315 mm.

The dry components of the first group were crushed and sieved on a sieve with a mesh size of 1 mm The screenings were subjected to re-grinding in a hammer mill and re-sieving.

Then, the components of the first group — dry components and most of the liquid extract of flax seed — were thoroughly mixed together in a homogenizing reactor until a homogeneous mixture was obtained (approximately 1 hour).

The components of the second group — the remainder of the obtained flaxseed liquid extract and starch — were mixed and mixed to prevent starch particles from settling.

Then, a solution of carboxymethyl cellulose (blanose) was prepared from the components of the third group.

For this, carboxymethyl cellulose was mixed with water in a container and left for 8-10 hours with periodic stirring for swelling.

The components of the first and second groups located in the homogenizing reactor were heated to 90 ° C and a solution of carboxymethyl cellulose was added to them. Then the heating was turned off and mixed until a uniform gel was obtained.

The components of the fourth group were introduced separately: first, preservatives of potassium sorbate and nisin were added at a temperature of no higher than 60 ° C and mixed until dissolved, then flavorings were added at a temperature of no higher than 50 ° C and mixed until dissolved.

Then carried out the packing and packaging of dietary supplements in disposable bags.

Table 1 shows the compositions of the claimed dietary supplement.

The drug was prescribed for 28 patients with acid-dependent diseases of the esophagus and stomach in the acute phase, as well as functional heartburn. The trial involved 16 men and 12 women aged 19 to 67 years.

According to nosological forms, patients were divided as follows: gastroesophageal reflux disease in the form of distal erosive esophagitis in 9 people, functional periodic heartburn without organic lesions of the stomach and esophagus (NERD) in 10 people, gastric ulcer or duodenal ulcer in four, and erosive gastritis in 5 examined. 7 patients received Acidneutral dietary supplement in the conditions of the General Surgery Clinic of the Siberian State Medical University; The course of treatment for the main diseases ranged from 7 to 24 days in conjunction with the basic therapy (proton pump blockers Omeprazole, Nexium in recommended dosages, antibiotics according to the Maastricht Agreement on H. pylori eradication therapy). With NERD, the drug was taken sporadically, in the form of monotherapy "on demand". BAA "Acidneutral" was used in a dose of 15 g 2 times a day.

All patients underwent a general blood test, FGDS, ECG, Clinical control of effectiveness was carried out on the 7th, 14th and 21st day of supplement intake.

Heartburn as the main sign of a hyperacid state was evaluated by the point system on days 1, 7, 14, 21 of Acidneutral supplement,

- heartburn (0 - no, 1 - little expressed with high physical exertion, 2 - in the evening and at night in a horizontal position, 3 - with low physical exertion, 4 - after each meal).

The results of the study are displayed in table.2-3.

Table 2 investigated the dynamics of heartburn, expressed in points, in patients on the background of the Acidneutral dietary supplement.

Table 3 shows the dynamics of the frequency of detection of heartburn in patients treated with Acidneutral dietary supplement.

According to the results of a general blood test and ECG, there were no significant differences in the dynamics before and after taking Acidneutral dietary supplement. This fact indicates the absence of the influence of the studied dietary supplement on the main indicators of homeostasis and good tolerance of dietary supplements by volunteers.

The monitoring of FGDS was performed in patients with peptic ulcer after 18-20 days from the start of treatment. By this time, ulcerative defects were in the “red scar” stage, which indicated a good reparative effect of the main therapy in combination with the Acidneutral dietary supplement. In other pathological processes, control FGDS may be indicated at a later date if the conservative treatment is unsuccessful, therefore, it was not performed for the patients participating in this study.

27 patients noted good tolerance to the drug. In one patient treating distal erosive esophagitis on day 4, the course of atopic dermatitis worsened. With a more thorough collection of anamnesis, pronounced sensitization to weeds was revealed. Apparently, the chamomile extract contained in the Acidneutral dietary supplement gave a cross-allergic reaction. This patient was excluded from further research. Two patients noted constipation when taking basic therapy in combination with Acidneutral dietary supplement for 10-14 days. This effect can have both proton pump blockers and antacid drugs.

Most patients - 21 (75%) - rated the organoleptic properties of the drug as excellent and good, the remaining 7 (25%) - as satisfactory. Almost half of the patients - 13 - were previously familiar with other antacid preparations and noted a more pleasant and “natural” taste of Acidneutral dietary supplement compared with the classical representatives of this group.

25 patients had a good effect: already on the 2nd – 3rd day of taking Acidneutral dietary supplement, all patients noted that heartburn significantly decreased, its manifestations became less pronounced (Tables 1, 2).

The results indicate the effectiveness of Acidneutral dietary supplement in the treatment of gastroesophageal reflux disease, functional periodic heartburn without organic lesions of the stomach and esophagus, stomach ulcers and duodenum, as well as with erosive gastritis.

BAA "Acidneutral" has a pronounced antacid effect, improves the condition of the mucosa of the upper digestive tract and is well tolerated.

The use of Acidneutral dietary supplement is shown to patients in the complex therapy of acid-dependent diseases of the esophagus and stomach, as well as in the form of monotherapy for functional heartburn.

Table 1 No. Name of components Content mg Composition 1 Composition 2 Composition 3 one Liquid Flax Seed Extract (1:30) 7574.7 7000 8000 2 Chaga extract 150 170 130 3 Chamomile extract 45 40 fifty four Licorice extract 22.5 25 twenty 5 Calcium carbonate 468.3 600 400 6 Magnesium carbonate basic 267 360 280 7 Magnesium oxide 221 245 250 8 Sodium bicarbonate 75 fifty one hundred 9 Sorbitol 1500 1700 1200 10 Starch 150 170 130 eleven Carboxymethyl cellulose 135 110 160 12 Potassium sorbate fifteen 17 12 13 Lowlands 1,5 1,0 2.0 fourteen Dry Mint Flavor 5 5 5 fifteen Dry lemon flavoring 5 0 10 16 Water 4365 4507 4251

table 2 The severity of heartburn in points, depending on the timing Duration of observation 1 day 7 days 14 days 21 days Severity 2.51 ± 0.13 1.24 ± 0.14 1.02 ± 0.11 0.56 ± 0.12

Table 3 Heartburn The severity of symptoms in points Reliability of differences in indicators Before treatment, n = 28 After treatment, n = 27 n % n % Absent 3 10.7 25 one hundred <0.001 Not very pronounced at high physical exertion 5 17.9 one four 0.12 In horizontal position 10 35.7 one four 0.005 With low physical activity 6 21,4 0 0 0.016 After each meal four 14.3 0 0 0,07

Claims (1)

Dietary supplement for the prevention and maintenance therapy of diseases of the gastrointestinal tract based on medicinal plants, containing licorice extract, acid neutralizing components, starch, characterized in that it additionally contains liquid flax seed extract, chaga extract, chamomile extract, sorbitol, carboxymethyl cellulose, potassium sorbate, nisin, flavor and water, as an acid-neutralizing component, the additive contains calcium carbonate, magnesium carbonate, magnesium oxide and sodium bicarbonate, etc. and the following ratio of components, in parts by weight:
Liquid Flax Seed Extract 7000-8000 Chaga extract 130-170 Chamomile extract 40-50 Licorice extract 20-25 Calcium carbonate 400-600 Magnesium carbonate 280-360 Magnesium oxide 245-250 Sodium bicarbonate 50-100 Sorbitol 1300-1700 Starch 130-170 Carboxymethyl cellulose 110-160 Potassium sorbate 12-17 Lowlands 1-2 Flavoring 5-15 Water Up to 15000