RU2207144C1 - Biologically active supplement "sustavnye travy" for prophylaxis and maintenance drug therapy in inflammatory diseases of locomotor system - Google Patents

Abstract

FIELD: medicine, phytotherapy, parapharmaceutical industry. SUBSTANCE: biologically active supplement comprises dry concentrate of burdock roots infusion, dry concentrate of knotgrass herb infusion, dry concentrate birch leaves infusion, dry concentrate barberry fruits infusion, laurel leaves dry concentrate, dry concentrate of propolis tincture, nicotinic, ascorbic acids, starch, oat, calcium stearate and sugar being components are taken in the definite quantitative ratio, Biologically active supplement reduces risk of exacerbations of locomotor system chronic inflammation diseases, relieves articulate pain and eliminates constraints in morning. EFFECT: enhanced effectiveness and valuable medicinal properties of supplement. 2 tbl, 4 ex

Description

 The invention relates to medicine, in particular to the parapharmaceutical industry, producing drugs for therapeutic and prophylactic purposes, and can be used as an auxiliary tonic for hypothermia, to reduce the risk of exacerbations of chronic inflammatory diseases of the musculoskeletal system.

 Known biologically active food supplement - "The Wise Dragon" / Pilate T. L. (ed.) Federal Register of biologically active food additives ", M., Kogelet, 2000, S. 347 /, which includes the root of fluffy angelica, Ledeburyella gill root, Milkflower peony root, Cinnamon bark, Poria, Stalker stalks, Azaricum grass, Wallic ligustum rhizome, Achiranzis root, Ural licorice root, Buckwheat root, Chinese angelica root, Remani root, Campendo root, Campendo root. guide and auxiliary agents in the treatment of inflammatory diseases of the musculoskeletal system.

 Contraindications: individual intolerance to the components of the drug.

 Known biologically active food supplement - "Reukom-mix" / Pilate T. L. (ed.) Federal Register of biologically active food additives ", M., Kogelet, 2000, S. 347 /, which includes ash leaves, Willow bark, nettle leaves, birch leaves, horsetail bark, elm bark, buckthorn bark, wheatgrass rhizomes, juniper fruits, elderberry flowers, linden flowers. Recommended for use as a general strengthening and adjuvant in chronic inflammatory diseases of the musculoskeletal system.

 Contraindications: individual intolerance to the components of the drug.

 Known biologically active food supplement "Antiartrol" / Pilate T.L. (ed.) Federal Register of Biologically Active Food Supplements ", M., Kogelet, 2000, p. 345 /, which includes field horsetail grass, chicory roots, dandelion roots, burdock roots, juniper fruits, buckthorn bark, elderberry flowers black, primrose leaves, kidney tea grass, calendula grass, birch leaves, bearberry leaves, knotweed, fennel fruits, flax seeds. It is produced in the form of a liquid extract of these active substances, packaged in capsules. Recommended for use as a restorative, mild anti-inflammatory and recall gatelnogo analgesic for diseases of the joints.

 A disadvantage of the known drugs is the lack of a balanced complex of vitamins and minerals, as well as individual intolerance to certain components of the drug observed in individual patients.

 The objective of the invention is to develop a new available biologically active additives in tablet form, convenient for use and having a balanced complex of vitamins and minerals.

 The invention is aimed at expanding the range of alternative restorative agents to maintain the function of the musculoskeletal system to compensate for individual intolerance to certain components of known drugs.

This is achieved by the fact that the proposed biologically active additive contains a dry concentrate of infusion of burdock roots, a dry concentrate of infusion of grass knotweed, a dry concentrate of infusion of leaves of birch, a dry concentrate of infusion of barberry fruits, a dry concentrate of infusion of leaf laurel, a dry concentrate of tincture of propolis, nicotinic acid, ascorbic acid , starch, oats, calcium stearate and sugar in the following ratio of components per tablet weighing 0.55 g, in g:
dry concentrate of infusion of burdock roots - 0.0000075-0.000075
dry concentrate of infusion of knotweed grass - 0.0000075-0.000075
dry concentrate of infusion of birch leaves - 0.0000075-0.000075
dry concentrate of barberry fruit infusion - 0.0000075-0.000075
dry concentrate of infusion of laurel leaf - 0.0000075-0.000075
dry concentrate of propolis tincture - 0.000175-0.00175
nicotinic acid - 0.0010-0.0050
ascorbic acid - 0.0050-0.0300
oats - 0,0100-0,0600
starch - 0.0250-0.0750
calcium stearate - 0.0055
sugar - the rest
The remedy is called - dietary supplement "Joint herbs."

 Supplement "Joint herbs" has an anti-inflammatory, analgesic, decongestant effect, improves the metabolism of cartilage, helps to improve the functional state of the joints. Recommended for use as a prophylactic and adjuvant in the treatment of inflammatory diseases of the joints and metabolic nature: arthritis, rheumatism, gout, osteochondrosis, arthrosis, with increased loads on the musculoskeletal system.

Mechanism of action
The invention is illustrated by the following example.

 Dietary supplement "Joint herbs" in the form of tablets is prepared as follows.

 Sugar in the amount of 84.0 kg is weighed on a balance, visually checked for mechanical impurities, then, in the absence of impurities, crushed in a mill. To do this, sugar from the bag is loaded in portions into the loading hopper. Crushed sugar through the lower nozzle of the mill is collected in a plastic bag, the ends of which are previously fixed on the nozzle. The bag is placed in the receiver.

 The yield of crushed sugar is 83.0 kg.

 Oats in the amount of 5.7 kg are weighed on a scale, visually checked for mechanical impurities, then, in the absence of impurities, crushed in a mill. To do this, oats are loaded in portions into the loading hopper. The crushed oats through the lower nozzle of the mill are collected in a plastic bag, the ends of which are previously fixed on the nozzle. The bag is placed in the receiver.

 The yield of crushed oats is 5.6 kg.

 The roots of burdock in the amount of 0.37 kg are weighed on the scales, visually checked for mechanical impurities. They are placed in an enameled container of 15-20 liters. Pre-crushed barberry fruits in the amount of 0.185 kg are weighed on a scale, visually checked for mechanical impurities. They are placed in an enameled container of 15-20 liters containing burdock roots. Pour 11 kg of water at room temperature, insist on a boiling water bath with frequent stirring for 25 minutes. Then add 0.185 kg of birch leaves, laurel leaves and knotweed grass and insist for another 20 minutes with frequent stirring. Cool at room temperature for 45 minutes, after which the infusion is filtered, squeezing the plant material. If necessary, add water to the desired volume. Then filtered through four layers of gauze.

 The output of the finished infusion is 9.25 kg.

 The crushed sugar, oats, starch, ascorbic acid, nicotinic acid in a powder are sieved on a vibrating unit through a sieve with a hole diameter of 1 mm, calcium stearate is sieved through a sieve with a hole diameter of 0.5 mm. Propolis tincture is filtered through four layers of gauze.

 In an enameled container of 10 l, 8.25 kg of the ready-made infusion of herbs is weighed on a scale, brought to a boil. Separately, starch in the amount of 0.7 kg is weighed on the scales, placed in an enameled container of 3 l, add 1.0 kg of herbal infusion. The prepared suspension of starch is introduced into a boiling infusion with constant stirring, brought to a boil.

Starch paste yield - 9.9 kg
With the lid open, load 83.0 kg of ground sugar, 5.6 kg of oats, 9.5 kg of starch, mix for 10 minutes, then moisten with tincture of propolis in the amount of 1.85 kg, mix for 10 minutes and add starch paste in the amount of 9 , 9 kg, stirred for 10 minutes

 The yield of the product is 109.85 kg.

Moistened tablet mass in the amount of 109.85 kg is laid out on paper in trays with a layer thickness of 1.5-2 cm. The trays are installed in an oven. Turn on the hot air supply system in the switchgear of the drying cabinet. Set the drying temperature of 40-45 ^o C, with an increase in which the flow of hot air is automatically turned off. The drying process is carried out for 10 hours to constant weight with periodic stirring (at least 3 times). Drying control is carried out in the laboratory by weighing product samples from trays to a constant weight. Product humidity - no more than 2%. The dry tablet mass is sent to dry granulation.

 The yield of dry tablet mass is 98.10 kg.

 The dried mixture in the amount of 98.10 kg is loaded in portions into the installation to obtain granulate from dry tablets. Turn on the screw device, with which the mixture is rubbed through a mesh with holes with a diameter of 1.5 mm. Dry granulate is collected in a receiver. From the receiver, dry granulate is loaded with a scoop with the lid open into the mixer. To the dry granular tablet mixture, pre-mixed nicotinic acid in the amount of 0.37 kg and ascorbic acid in the amount of 1.85 kg are added to the mixers, stirred for 10 minutes, then sieved calcium stearate in the amount of 1.02 kg is added. Turn on the stirrer and mix for another 5 minutes. The finished granulate is transferred to tableting.

 The yield of finished granulate is 101.34 kg.

 From the mixer, the dry granulate is sent for tabletting to the loading hopper of the tabletting machine. Turn on the engine. Pre-set engine speed in accordance with the bulk density, the pressing zone and the height of the tablet. When the machine starts, the vacuum cleaner turns on.

The diameter of the tablet is 12.0 ± 0.3 mm;
tablet height 3.8 ± 0.3 mm;
the average tablet weight is 0.55 ± 0.02 g.

 During tabletting, they monitor the operation of the machine and the quality of the tablets. Every 30 minutes, the disintegration, strength and average weight of the tablets are checked. Inadequate tablets are discarded and sent for recycling. At the end of the process, the machine is turned off in the reverse order. The tablets are collected in a receiver and sent for dust removal.

 The product yield is 100.33 kg.

 Finished tablets are sieved on a vibrating screen through an opening with a diameter of 8 mm, weighed on an 8 kg scale and loaded into clean, dry plastic buckets. Samples of the finished tablets are transferred to the control and analytical laboratory for analysis. When the tablets comply with the technical documentation standards, the finished tablets are transferred to the packaging stage.

 The yield of finished tablets is 99.32 kg.

 The sequence of operations is the same regardless of the number of prepared composition.

 The “Joint Herbs” dietary supplement contains well-known medicinal products approved for use in medical practice, which in the indicated combination (see Table 1. Examples 1-4) provide for the reduction or disappearance of symptoms of exacerbations of chronic inflammatory diseases of the musculoskeletal system.

 Starch, oats, sugar were used as auxiliary components ensuring the reliability of maintaining the shape of the pressed tablets in a dry form and their short disintegration time in a humid environment, and calcium stearate and talc were used to improve the fluidity of the granulate.

 The tablet form is convenient for use, has a long shelf life (2 years).

 Clinical trials were conducted on volunteers.

 In clinical trials, dietary supplements "Joint herbs" was prescribed for rheumatoid arthritis.

 A more pronounced improvement in clinical indicators was obtained in patients with stage 1-2, mild and moderate severity, with impaired joint function of at least 2 degrees, a moderately pronounced degree of activity, joint pain, stiffness in the morning decreased. It is necessary to note the parallel positive dynamics of common symptoms - increased mood, a decrease in the frequency of headaches.

 It should be noted that the appointment of dietary supplements led to a more rapid positive dynamics of the main clinical symptoms, starting from the 30th day of therapy. Moreover, by the 60th day of observation, a 2-fold decrease in the severity of clinical and laboratory symptoms was observed in 80% of patients, whereas in the control group it was 60%.

 Side effects of dietary supplements in patients of all groups were not observed.

 Patients with a "mild" form of the disease who received the drug on an outpatient basis, in 100% of cases noted a decrease in pain and the elimination of morning stiffness.

 Against the background of dietary supplement monotherapy, positive dynamics was observed in all patients of this group. Clinical improvement was obtained in patients with stage 1, mild severity, joint dysfunction of the 1st degree, a moderate degree of activity. A marked decrease in joint pain was noted, stiffness in the morning disappeared.

 Positive dynamics were observed in assessing the quality of life: mood increased, the incidence of headaches decreased, general weakness disappeared, patients began to better tolerate household and workloads (Table 2).

 Dynamometry data showed that the press of the affected hand increased from 15.7 to 21.2 kg.

 The reason for the appointment of the “Joint Herbs” dietary supplement to patients taking specific anti-tuberculosis drugs was the administration of pyrazinamide, which causes pain in large and small joints in patients, which gives the patient significant inconvenience and requires the appointment of analgesics. In the observed patients, when examining the objective criteria for damage to the osteoarticular system was not found. The skin above the joints was not hyperemic, the shape remained the same. Restrictions in movements were not noted, however, aching pains intensified at night were felt almost constantly in the small joints of the hands, knees, and hips.

 The observations showed that by the end of the month the treatment results were the same in both groups. In patients of the first group, joint pain disappeared as a result of the abolition of pyrazinamide, and in patients of the second group - as a result of the action of the drug "Joint herbs". This gives reason to recommend the drug "Joint Herbs" to eliminate side effects from the use of specific anti-tuberculosis therapy.

Claims (1)

Dietary supplement for the prevention and adjunctive therapy for inflammatory diseases of the musculoskeletal system based on plant materials, characterized in that it contains a dry concentrate of infusion of burdock roots, a dry concentrate of infusion of grass knotweed, a dry concentrate of infusion of birch leaves, a dry concentrate of infusion of barberry fruits, dry concentrate of tincture of laurel leaf, dry concentrate of tincture of propolis, nicotinic acid, ascorbic acid, starch, oats, calcium stearate and sugar in the following ratio Elenia components per tablet weighing 0.55 g, g:
Dry concentrate of infusion of burdock roots - 0.0000075-0.000075
Dry concentrate of infusion of knotweed herb - 0.0000075-0.000075
Dry concentrate of infusion of birch leaves - 0.0000075-0.000075
Dry concentrate of barberry fruit infusion - 0.0000075-0.000075
Dry Laurel Leaf Infusion Concentrate - 0.0000075-0.000075
Propolis tincture dry concentrate - 0.000175-0.00175
Niacin - 0.0010-0.0050
Ascorbic acid - 0.0050-0.0300
Starch - 0.0250-0.0750
Oats - 0.0100-0.0600
Calcium Stearate - 0.0055
Sugar - The Rest

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