Biologically active additive "sleepy", possessing tonic and soothing effect

 

The invention relates to medicine, in particular to the pharmaceutical industry for the production of drugs therapeutic and prophylactic purposes, and can be used as an auxiliary tonic and mild sedative. The proposed biologically active additive "Sleepy", containing dry concentrates infusions of herbs lemon balm, chamomile flowers, stems hops, dry concentrate tincture of motherwort, cinnamon, sodium bromide, crushed oats, starch, calcium stearate and sugar, at a certain ratio of components a tablet weight of 0.55 g, in grams. The invention extends the range of alternative restorative and soothing means to compensate for individual intolerance to some of the components of known drugs. table 1.

The invention relates to medicine, in particular to the pharmaceutical industry for the production of drugs therapeutic and prophylactic purposes, and can be used as an auxiliary tonic and mild sedative.

Known biologically active additive to food (BAD) - "Night sleep" / Pilate T. L. (editor). Fe the roots of Valerian, an extract of the herb lemon balm, extract of hops, vitamin B1. Recommended for use as a mild sedative.

Known biologically active food Supplement - tea "Night dreams" / Pilate T. L. (editor). Federal register biologically active additives to food), Kohelet, 2000, S. 67/, which includes chamomile flowers, foliage and fruit blueberries, chicory root, stevia leaf, mint green, passion fruit, berries of hawthorn, Valerian root, flowers (cones) hops, skullcap. Recommended for use as a General tonic and mild sedative with high psycho-emotional stress.

Known biologically active food Supplement - tea "Ivan Kuzmich 2" / Pilate T. L. (ed.. Federal register biologically active additives to food), Kohelet, 2000, S. 65/, which includes Valerian root, hawthorn flowers, balm leaves, inflorescences hops, peppermint leaves, chamomile flowers. Recommended for use as a General tonic and mild sedatives.

A disadvantage of the known drugs is observed in individual patients, individual intolerance to some of the components of the drug.

The task of the invention assetstore, easy to use and has a balanced complex of vitamins and minerals.

The invention is aimed at expanding the range of alternative restorative and soothing means to compensate for individual intolerance to some of the components of known drugs.

This is achieved by the fact that the proposed dietary Supplement contains dry concentrates infusions of herbs lemon balm, chamomile flowers, stems hops, dry concentrate tincture of motherwort, cinnamon, sodium bromide, crushed oats, starch, calcium stearate and sugar, in the following ratio of components a tablet weight of 0.55 g, g: Dry concentrate of the extract of the herb Melissa 0,000015-0,00012 Dry concentrate of the extract of camomile flowers - 0,0000075-of 0.00006 Dry concentrate of the extract of stems of hop - 0,000015-0,00012 Dry concentrate tincture of motherwort - 0,000175-0,0014 Cinnamon - 0,0025-0,0200 Sodium bromide - 0,0050-0,0400 Crushed oats - 0,0100-0,1000 Starch - 0,0200-0,1000 calcium Stearate - 0,0020-0,0100
Sugar - Rest
Dietary Supplement named "Sleepy."

BAD "Sleepy" is recommended for use as a General tonic, tonic, sedative, vegetational, sleeping, eliminating Prasangika and Intracom the prevention and adjuvant therapy of sleep disorders secondary to somatic pathology, increased irritability in menopause.

The invention is illustrated by the following example.

Biologically active Supplement "Sleeping" in the form of tablets obtained as follows.

The sugar in the number of 84.3 kg weighed, visually check for the presence of mechanical impurities, then, in the absence of impurities, crushed in the mill. For this sugar load portions in the hopper. Powdered sugar through the bottom fitting of the mill gathering into a polyethylene bag, the ends of which are pre-fixed to the fitting. The bag is placed in the receiver.

The output of crushed sugar of 83.4 kg

Oats in the amount of 4.8 kg weighed, visually check for the presence of mechanical impurities, then, in the absence of impurities, crushed in the mill. For this purpose, oats load portions in the hopper. Crushed oats through the bottom fitting of the mill gathering into a polyethylene bag, the ends of which are pre-fixed to the fitting. The bag is placed in the receiver.

The output of crushed oats - 4,7 kg

Stems hops in the number 0,37 kg weighed, visually check for the presence of mechanical impurities. Placed in an enamel container for 15-20 liters. P is and scales visually check for the presence of mechanical impurities. Placed in an enamel container for 15-20 l containing compound fruit hops. Pour 11 l of water at room temperature, insist on a boiling water bath with frequent stirring for 15 minutes, Cooled at room temperature for 45 min, after which the infusion is filtered, pressing plant material. If necessary, add water to the desired volume. Then filtered through four layers of gauze.

The yield of extract (1.5% of dry) - 9,25 kg

Sodium bromide in an amount of 1.85 kg weighed in a glass flask, add 3 kg infusion of herbs, mix until dissolved.

Output - 4,85 kg

Powdered sugar, oats, starch, cinnamon powder sieved by the shaker through a sieve with the hole diameter of 1 mm calcium stearate is sifted through a sieve with the hole diameter of 0.5 mm Solution of sodium bromide, pharmacopeial tincture (3,5% of dry) motherwort filtered through four layers of gauze.

In an enamelled vessel 10 l weighed 5,0 kg of prepared infusion of herbs, bring to a boil, add 10 kg of sugar, mix, boil for 5 min to Separate the starch in the amount of 1.2 kg weighed, placed in an enamel container h is mesheanii, bring to a boil.

The output of the starch paste was 17.4 kg

In a mixer with the cover open load 73.4 kg powdered sugar, 4.7 kg of crushed oats, 9,0 kg of starch, and then separately mixed 0,94 kg of cinnamon powder and 10 kg mass from the mixer, mix, then re-loaded into the mixer, mix for 5 minutes, then moisturize pharmacopeias tincture (3,5% of dry) motherwort in the number of 1.85 kg, add a solution of sodium bromide in the amount of 4,85 kg, mix 10 min and add starch paste in the amount of 17.4 kg, stirred for 10 minutes

Yield - 112,14 kg

Hydrated tablets weight in the number 112,14 kg laid out on paper in the trays, the layer thickness of 1,5-2 see Trays install in a drying Cabinet.

Include hot air distribution device of the drying Cabinet. Set the drying temperature 40-45oWith the increase of which the flow of hot air is automatically disabled. The drying process is carried out for 10 h to a constant weight at periodic stirring (not less than 3 times). The control end of the drying conduct in the laboratory by weighing samples of the product from the trays to a constant weight. The humidity of the product - not more than 2%. Dry tnou mixture in an amount of 105,24 kg load portions in the device for producing granules from dry tablespace. Include a screw device, in which the mixture is forced through the mesh holes with a diameter of 1.5 mm, the Dry granulate is collected in the receiver. From the receiver the dry granulate load when the cover is open in the mixer. To the dry granulated pellet mixture in a mixer add the sifted calcium stearate in the amount of 1.02 kg Include a mixer and stirred for 5 minutes the Finished granulate is passed on tableting.

The output of the finished granulate - 104,04 kg

From the mixer, the dry granulate is directed to tableting in the hopper tablet press machine. Turn on the engine. Pre-set engine speed in accordance with a bulk weight of the pressing zone and the height of the tablet. When you start the machine turn on a vacuum cleaner.

The diameter of the tablets to 12.00.3 mm;
the height of the tablet 3,80.3 mm;
the average weight of a tablet is 0.55of 0.02,

During tabletting apparatchik and master monitor machine operation and quality tablets. Every 30 min check raspadaemost, the strength and the average weight of the tablets. Tablets that do not meet the requirements, the operator rejects and sends for reprocessing. On okoncane>/p>Yield - 101,96 kg

The finished tablets are sieved by the vibrating screen through a hole diameter of 8 mm, weighed 8 kg and load in a clean dry plastic bucket. Samples of finished tablets passed into the analytical laboratory for analysis. In accordance tablets norms technical documentation prepared tablets passed the stage of packing.

The output of finished tablets to 99.9 kg

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

BAD "Sleepy" contains the famous authorized for use in the practice of medicine medicines that said combination (see table, examples 1-4) can be used as an auxiliary tonic and mild sedative.

As auxiliary components, ensuring reliability maintain the shape of the pressed pellets in a dry form and a short time raspadaemosti them in a humid environment, used starch, oats, sugar, and to improve the fluidity of the granulated calcium stearate.

Tablet form is easy to use and has a long shelf life (2 years).

Clinical trials were carried out on volunteers.

Por the dynamics in relieving precariously and intraamniotic disorders. By the 5th day of therapy significantly decreased the number of patients with complaints of difficulty falling asleep (from 100% to 27-36%) and insufficient depth of sleep (83-86% to 57-45%). Patients treated BAD "Sleepy", circadian rhythms are fully recovered within the first 5 days. After sleeping they felt alert and awake. While patients in the control group (treated with standard therapy) remained inversion of circadian rhythms in the form of daytime sleepiness, 63 % of patients remained fatigue and other adverse events after sleep.

When using BAA "Sleepy" in patients with sleep disorders showed positive dynamics of General symptoms, which was a distinct reduction of symptoms such as fatigue, irritability, meteosensitivity on average 2 times (conditional-point scale). According to EEG studies registered objective shortening time falling asleep, fewer motives night, sleep becomes deeper, disappears fatigue upon awakening, increased efficiency, disappears daytime sleepiness.

When assigning BAD "Sleepy" patients with preconnecting sleep disorders on the background of organic lesions of the Central nervous system reported subjective xt-align:center; margin-top:2mm;">
Claims

Biologically active additive, which has a tonic and calming effect on the basis of vegetative raw material, characterized in that it contains dry concentrates infusions of herbs lemon balm, chamomile flowers, stems hops, dry concentrate tincture of motherwort, cinnamon, sodium bromide, crushed oats, starch, calcium stearate and sugar in the following ratio of components in the tablet weight of 0.55 g, g:
Dry concentrate of the extract of the herb Melissa 0,000015-0,00012
Dry concentrate of the extract of camomile flowers - 0,0000075-of 0.00006
Dry concentrate of the extract of stems of hop - 0,000015-0,00012
Dry concentrate tincture of motherwort - 0,000175-0,0014
Cinnamon - 0,0025-0,0200
Sodium bromide - 0,0050-0,0400
Crushed oats - 0,0100-0,1000
Starch - 0,0200-0,1000
Calcium stearate - 0,0020-0,0100
Sugar - Ostalnoe

 

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