RU2185844C2 - Biologically active food additive "pechenochnyye" - Google Patents

Abstract

FIELD: parapharmaceutical industry. SUBSTANCE: biologically active food additive for prophylaxis and auxiliary treatment of liver diseases on base of immortelle contains ascorbic acid, citric acid and auxiliary substances including sugar. The food additive additionally contains extract of maize stigmas, oat, decoction of burdock roots. Immortelle is used in the form of flowers infusion. The additive contains the following ratio of components, g: infusion of immortelle flowers, 0.002; extract of maize stigmas, 0.01; decoction of burdock roots, 0.002; ascorbic acid, 0.025; citric acid, 0.005; oat, 0.1; auxiliary substances including sugar, the balance up to 0.55. EFFECT: increased therapeutical activity and storage life of product. 2 cl, 2 tbl

Description

 The invention relates to the parapharmaceutical industry, producing drugs for therapeutic and prophylactic purposes, and can be used for prophylaxis and auxiliary treatment for liver diseases.

 Known drug "Flamin", which has a choleretic effect, based on immortelle flowers [M.D. Mashkovsky. Medicines Kharkov: Torsing, in 2 volumes, 1998, volume 1, p. 510]. It is available in the form of granules (18.4 g) containing dry immortelle concentrate (0.18 g), pectin (1 g), citric acid (0.1 g), ascorbic acid and sugar (up to 18.4 g).

 The disadvantage of this drug is the use in the form of a suspension, insufficient therapeutic activity, short shelf life.

 It is known to use the extract of corn stigmas as a choleretic agent for cholecystitis, dysfunction of the gastrointestinal tract. Liquid extract includes corn stigmas, water, alcohol. [M.D. Mashkovsky. Medicines Kharkov: Torsing, in 2 volumes, 1998, volume 1, p. 511].

 The disadvantage of these drugs is the liquid form, insufficient therapeutic activity, short shelf life.

 These drugs have a limited preventive effect.

 The objective of the invention is to develop a new affordable food supplement with a wide prophylactic spectrum of action and improving the functional state in the treatment of chronic liver diseases, convenient for oral use and with a long shelf life.

This result is achieved by the fact that in a biologically active food supplement for prevention and adjunctive treatment for diseases of the liver based on Helichrysum, used as an infusion of flowers, containing ascorbic acid, citric acid and excipients, including sugar, additionally introduced corn extract stigmas, oats, decoction of burdock roots in the following ratio of components, g:
Infusion of immortelle flowers - 0.002
Corn stigma extract - 0.01
A decoction of the roots of burdock - 0.002
Ascorbic acid - 0.025
Citric acid - 0.005
Oats - 0.1
Excipients, including sugar - The rest is up to 0.55
As auxiliary substances, it contains starch, water, sugar and calcium stearate.

 Burdock root is used as a diuretic and diaphoretic, as well as a means of improving metabolism.

 The use of a combination of previously used substances for this purpose became possible as a result of more pronounced qualities established by the authors, having a choleretic, diaphoretic, diuretic, antispasmodic effect, which leads to an increase in bile secretion, promotes the passage of small stones from the gall bladder.

 Optimally obtained amounts of components were obtained experimentally.

 And although the effect of these drugs on the human body is known, their use in new quality and in small doses gives a new effect, which allows the use of a new pharmacological agent as a biological additive.

 The drug is prepared as follows.

 Prepare in a water bath with frequent stirring a decoction of burdock root. An infusion of immortelle flowers is prepared. Sugar, oatmeal are crushed in a mill. Starch paste is separately prepared.

 The crushed sugar, oats, ascorbic acid are sieved through a sieve with a hole diameter of 1 mm, calcium stearate - through a sieve with a hole diameter of 0.5 mm. A decoction of burdock root, an infusion of immortelle flowers, a solution of citric acid is filtered through 4 layers of gauze.

 The mixer is loaded with crushed oatmeal, crushed sugar, starch paste, include a mixing device and mix thoroughly for 3 minutes.

 To the resulting mixture add burdock broth, immortelle infusion, citric acid solution, corn stigma extract and mix for 10 minutes. The finished tablet mass is transferred to wet granulation.

 The wet mass is loaded into the installation to obtain granulate from wet tablets. Turn on a screw device, with which the mixture is rubbed through a mesh with holes with a diameter of 4-5 mm. Wet granulate is collected in a receiver. Wet granulate is transferred from the receiver to the dryer. The drying process is carried out for 10 hours to constant weight, with periodic stirring. Product humidity not more than 4%.

 The dry tablet mass is sent to dry granulation. The dried mixture is loaded into the installation to obtain granulate from dry tablets. Dry granulate is collected in a receiver. From the receiver, dry granulate is loaded into the mixer, ascorbic acid and sieved calcium stearate are added. Turn on the stirrer and mix for 10 minutes. Dry granulate is sent for tableting. At the end of the process, the tablets are collected in a receiver and sent to dedusting. Finished tablets are sieved on a vibrating screen through a hole with a diameter of 10 mm, weighed on the scales and packaged.

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

 Dietary supplement “Hepatic” contains well-known medicinal products approved for use in medical practice, which, in the indicated combination (see Table 1), ensure the reduction or disappearance of the symptoms of biliary tract and liver diseases.

 With the introduction of these components in amounts lower than the indicated doses, a prophylactic effect is not observed.

 With an increase in dose, there is no increase in the prophylactic effect of the drug, and with an increase in doses more than twice the physiological rejection reaction begins.

 Calcium stearate was used as auxiliary components providing reliability of disintegration and pressing times to improve the fluidity of the granulate and increase the compressive strength, sugar and distilled water.

 Available in the form of tablets, which is convenient for use, has a long shelf life (2 years).

 Clinical trials of biologically active food additives were carried out in the city consultative and territorial clinic of Moscow.

 Under observation were 22 children with biliary dyskinesia (6 boys and 16 girls) aged 5 to 8 years.

 During the clinical trial for a month against a background of fractional nutrition with the restriction of mechanical and chemical food irritants and fats, patients of the experimental group were additionally prescribed a test biologically active supplement (BAA) 1-3 tablets 3-4 times a day. 10 children in the control group received the same diet without the inclusion of dietary supplements at the same time.

 Starting from 2-3 days after the start of the study, the number of patients in the experimental group with symptoms of diseases of the gallbladder and biliary tract, such as dyspeptic symptoms, abdominal pain, or discomfort in the abdomen, decreased. In the control group, certain dynamics of the number of clinical signs of diseases could not be detected.

 Table 2 presents the number of cases of improvement in the indicators of the second portion of bile in%.

 As a result of the studies, it can be concluded that the use of dietary supplements contributed to the normalization of bile parameters in patients. So in patients with chronic stoneless cholecystitis, the amount of bile increased, which became transparent with an alkaline reaction. In patients with biliary dyskinesia, discontinuous bile secretion disappeared or became less pronounced, and its density decreased.

 The proposed biologically active food supplement “Hepatic” is a new affordable drug with a wide prophylactic spectrum of action and improving the functional state in the treatment of chronic liver diseases, convenient for oral use and with a long shelf life.

Claims (1)

1. Biologically active food supplement for the prevention and adjunctive treatment of immortelle-based liver diseases, containing ascorbic acid, citric acid and excipients, including sugar, characterized in that it additionally contains an extract of corn stigmas, oats, a decoction of burdock roots , and the immortelle is used as an infusion of flowers in the following ratio of components, in g:
Infusion of immortelle flowers - 0.002
Corn stigma extract - 0.01
A decoction of the roots of burdock - 0.002
Ascorbic acid - 0.025
Citric acid - 0.005
Oats - 0.1
Excipients, including sugar - The rest is up to 0.55
2. The additive according to claim 1, characterized in that it contains starch, water and calcium stearate as auxiliary substances.

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