CZ282012B6 - Mumio-containing food - Google Patents

Abstract

This foodstuff containing mummy contains 0.1 to 25% by weight of mummy, 10 to 20% by weight of swelling agents and the remaining part is filling. The most suitable form of the foodstuff containing mummy according to the invention is a tablet or/and a film coated tablet weighing 600.0 mg containing 1 to 130 mg of mummy, preferably 100 mg of mummy.

Description

Technical field

The invention relates to a mumio-containing edible foodstuff with a description of a process for its manufacture.

Food supplements, also called parapharmaceuticals, are preparations intended for healthy individuals of different age and occupational groups. These preparations are not intended for the treatment, prevention or diagnosis of a particular disease, but are intended to improve the general condition of the body, to support certain physiological processes and also to improve the overall resistance of the body.

BACKGROUND OF THE INVENTION

Whether food supplements contain chemically uniform active substances (vitamins, trace elements, amino acids, etc.) or non-uniform substances (eg medicinal plant extracts), these substances must be formulated for their own use. This treatment is the result of technological processing of active, auxiliary and technical auxiliaries in the selected process on suitable production facilities.

Conversion into a dosage form is intended to provide the possibility of use for a given purpose (eg, to control skin or mucous membranes, inhalation, swallowing, dissolution in the mouth). In the case of oral preparations, the dosage form should additionally ensure a uniform distribution of the prescribed doses of active components, easy swallowability, acceptable taste, while ensuring the stability of the preparation.

The subject of our interest is a biologically active product of natural origin - mumio and a method of its transformation into an oral dosage form meeting the above requirements.

The origin of mummies are mountain voles of the genus Alticola, which feed on a number of medicinal plants with a predominance of wormwood, and their dry mumio excrements arise under certain climatic and physical conditions. The occurrence of mummies is thus closely related to the Alticol habitat in the Asian mountains.

Mumio contains 26 different inorganic and organic ingredients: water 14-20%, mineral substances 17.6-20.8%, proteins 6.6-13.7%, fats 3.8-4.4%, nitrogen-free organic substances 18.7 to 22.9%. From macroelements sodium, potassium, calcium, magnesium, iron and phosphorus, from microelements cobalt, molybdenum, zinc, copper, cadmium, manganese, vanadium, lead, aluminum, chromium, bismuth, tin, silicon, titanium, mercury.

Mumio promotes physiological functions, affects metabolism and has non-specific stimulatory effects. In Eastern folk medicine, mumio was widely used hundreds of years ago because it was attributed to almost universal therapeutic properties. Currently, its use can be linked to serious pharmacological and clinical trials that have been conducted since the 1950s, especially in the USSR.

The raw mumio exists in two forms. The so-called old mumio, dating back several thousand years, has a dark-brown color, a compact asphalt consistency and a characteristic beeswax odor. The young or fresh mumio, estimated to be tens to hundreds of years old, has a brown color and a grainy texture. , caused by the sintering of droppings rollers, and a less pleasant odor. Both forms have a bitter taste and are readily soluble in water. The aqueous solutions obtained from both forms are thickened and the mass thus obtained reaches the market (Pauliš, P .: Mumio - Legend and Reality. Our Medicinal Plants 26, 6, 169-171, 1989, Gregáň, F .: Some Properties and occurrence of mummy (Farm. Obzor 60, pp. 509-510, 1991).

- 1 GB 282012 B6

For use in application forms in human practice (parapharmaceuticals, cosmetics), the National Institute of Public Health permits the use of only three qualitative types of imported mummies, which have the same infrared spectrum with standards.

Mumium-containing dosage forms for external use include aqueous solutions used to combat skin and mucous membranes, or for lining or irrigation of cavities, ointments, creams and gels for application to the skin, scalp or gum massage.

Dosage forms for oral use herein include, for the most part, mumio itself, shaped by slicing, chopping or punching tablets in the form of thin sheets of dried dense mummia extract (94-072651 / 09 / WPIDS, Bamienko, BG, Prepn. Of extract from rocks) intended for the preparation of solutions in water, tea, milk or honey, respectively. directly to swallow.

The mumio itself is sticky when touched, has a bitter taste and, for some, an unpleasant odor. These properties are also transferred to solutions prepared therefrom and intended for oral administration. The taste and odor correction is only possible to some extent and is successful depending on the concentration of the mummy and the solution.

Another important disadvantage of these dosage forms is their limited durability, in addition to their inaccurate dosage. Aqueous solutions may be stored at 4-6 ° C in a refrigerator for a maximum of 10 days. There is a certain limitation here for the individual user, both the need to prepare the solution at the time of need, as well as the eventual transport of the stock of the solution and its gentle storage for a longer period of use.

A certain solution is to apply mummia in the form of a chewing gum, which, however, only holds 0.5 to 2% of the active substance of mummia (93-212756 / 26 / WPIDS, Aronbaev, DM, Krivoruchko, VI, Tkeshashvili, ΜE. prodn.).

A more qualitatively effective solution to the problem of oral mummial dosage forms appears to be the consumable according to the invention and its method of manufacture in the form of tablets and / or coated tablets.

SUMMARY OF THE INVENTION

The present invention provides a solid-state eatable containing from 0.1 to 25 wt. 10 to 20 wt. swelling agent and the rest being fillers.

Preferably, the edible solid contains 16.7 wt. mummia, 64 wt.%, fillers, 18.3 wt. % swell and 1 wt. glidants.

A preferred embodiment is an eatable in the form of a tablet and / or a lacquered tablet containing 1 to 130 mg of the active substance mummia in a 600 mg tablet and / or in a lacquered tablet with a total weight increased by the weight of the coating layer.

The mumio-containing edible product is produced by mixing a dust mixture of 20 to 45 wt. % of soluble fillers and 30 to 50 wt. % of insoluble fillers and 10 to 20 wt. the swelling agent is admixed with a 0.2 to 35% mummium solution, dried, sieved and optionally further blended with glidants and swelling agents such that the swelling agent does not generally exceed 20% by weight, and is compressed.

Mum containing tablets in the form of a tablet are produced by compressing a mixture of granulate formed by saturating a homogeneous mixture of dusty soluble and insoluble and swellable excipients with an aqueous solution of mummia, in admixture with a swelling and glidant. The weight of the excipients together with the chosen concentration of the aqueous mummium solution used for saturation determines the final one

The content of the active substance mumium in the tablet.

In the above process, the mumio is converted into a 0.2 to 35% aqueous solution at ordinary temperature and the solution impregnates a mixture of dusty excipients (fillers, swelling agents) in a special granulating machine to form an evenly sintered granulate. Preferably, the dusty excipient mixture is saturated with a 25% aqueous mummy solution.

According to the invention, excipients (fillers) are lactose, mannitol, microcrystalline cellulose, colloidal silicon dioxide, magnesium trisilicate. These are present in a proportion of 20 to 45 wt. % soluble and 30 to 50 wt. insoluble components. Also included in the dust composition saturated with mummium solution are swellable substances, facilitating rapid disintegration of the tablet and / or the lacquered tablet and consequently the disintegration of the granules in contact with the gastric fluid. Of this group of excipients (disintegrants) constituting a total of 10 to 20% by weight of the tablet and / or the coated tablet, starches, sodium starch carboxymethyl ether, cross-linked polyvinylpyrrolidone, formaldehyde caseinate are suitable according to the invention.

In the production process, the wet granulate is dried in a suitable fluid or chamber dryer at a drying air inlet temperature of 40 to 60 ° C for a period which guarantees a maximum drying loss of up to 3-4% by dry granulate, determined by weight after 30 minutes. drying with an infrared lamp at 105 ° C.

In the dry granulate, the particle size is adjusted by sieving on a suitable machine through a sieve having a mesh side size of 1 to 1.2 mm. The granulate thus treated is further admixed with excipients (disintegrants) to aid the disintegration of the tablet and / or the lacquered tablet in an amount of 5 to 10% by weight. The adjuvant from the group of anti-adhering resp. glidants in an amount of 0.5 to 5 wt. Here, talc, stearic acid salts, polyethylene glycol 6000 finely ground may be used.

The mixture of granulate and excipients is homogenized in a suitable machine and further used for preparing tablets and / or cores by compression on a suitable tabletting machine in a conventional manner using a suitable shape and size of flat and / or lenticular punches.

The appearance, taste and smell of the lens-shaped tablet is corrected by the coating applied to the cores in the form of an aqueous lacquer dispersion composed of a film-forming substance, a plasticizer, a pigment, an anti-sticking agent, an antifoaming agent and a nonionic surfactant surfactant.

In the case of subsequent coring of the cores, i.e. lenticular-shaped tablets, according to the invention, the aqueous lacquer dispersion is applied to the cores by means of a two-way nozzle or a set of nozzles in a suitable device. The coating layer of the coated tablets constitutes 3 to 5% of the total weight of the uncoated tablet and is constituted by a film-forming substance, preferably represented here by cellulose derivatives constituting 80% by weight, of the coating dispersion solids. Of the other components, it is a plasticizer, preferably represented by polyethylene glycol 6000 in an amount of 5-7% by weight, a pigment, preferably represented by a mixture of ferric iron oxides in an amount of 3-5% by weight, an anti-sticking component, preferably represented by talc in an amount 3 to 5 wt.%, Antifoam, preferably represented here by a silicone emulsion in an amount of 0.3 to 0.5 wt. and a non-ionic O / W emulsifier, preferably represented here by a sorbitan monooleate polyoxyethylether in an amount of 3 to 4.5 wt. from the solids of the lacquer dispersion.

The mummy-containing edible tablets and / or lacquered tablets produced according to the present invention are based on our experiments. Experiments have shown that the process of choice permits the saturation of the powder mixture of excipients with an aqueous solution of mummy to a concentration such that the resulting granulate and the tablets and / or lacquered tablets prepared therefrom contain 1 to 130 mg of mumium per tablet. This then allows the user to receive a suitable amount of the active mummy substance in the range of 100 to 130 mg over one to three application cycles.

-3GB 282012 B6

An advantage of an eatable composition according to the invention is that it contains up to 25% mummium by weight. This product is free of unpleasant taste and odor, accurate dosing is possible and convenient application is possible. The product has satisfactory stability and thus a sufficiently long shelf life.

The invention is illustrated by the following non-limiting examples.

DETAILED DESCRIPTION OF THE INVENTION

Example 1

Preparation of the granulate

Microcrystalline cellulose Lactose monohydrate Sodium starch carboxymethyl ether Colloidal silicon dioxide Corn starch 2,000.0 g 1,600.0 g 600.0 g 240.0 g 200.0 g

The raw materials are sieved together through a sieve with a mesh side size of 0.34 mm and transferred to a working container of a suitable granulating apparatus. Here the mixture is homogenized. A mummy solution is prepared with stirring. 1000.0 g of mummy is gradually dissolved in 3,000 g of distilled water in small fragments. The solution is poured into a rotating homogeneous dust mixture and after a given time the finished granulate is discharged. This is dried in a suitable drying device at an inlet drying air temperature of 40 to 50 ° C until the dry granulate shows a loss on drying of more than 3-4% (determined by weight drying under an infrared lamp for 30 minutes at 105 ° C). The dried granulate is screened through a sieve with a mesh side size of 1 to 1.2 mm. Furthermore, 5,640.0 g of the granulate are mixed with 300.0 g of sodium starch carboxymethyl ether and 60.0 g of magnesium stearate.

Preparation of tablets

The homogeneous mixture of granulate and tabletting ingredients is further processed on a suitable tableting machine using 12 mm diameter flat punches to form tablets of 600.0 mg, a radial strength of 60-90 N (Pharma Test) and a disintegration time of up to 15 minutes (Cs14). .

Example 2

Using the procedure described in Example 1, the granulate and subsequently the tablets are prepared except that the granular mixture of the powdery excipients has the following composition:

Microcrystalline cellulose Lactose monohydrate Cross-linked polyvinylpyrrolidone Magnesium trisilicate Colloidal silicon dioxide Corn starch 1,600.0 g 1,600.0 g 600.0 g 400.0 g 240.0 g 200.0 g

and 300.0 g of cross-linked polyvinylpyrrolidone and 60.0 g of calcium stearate are added to 5,640.0 g of dry sieved granulate.

-4GB 282012 B6

Example 3

The granules and tablets are prepared as described in Example 1, except that the granular mixture of the powdery excipients has the following composition:

Microcrystalline cellulose 2000.0 g

Lactose monohydrate 1,600.0 g

Formaldehyde caseinate 600.0g

Colloidal silica 240,0g

Corn starch 200.0g and 300.0 g of formaldehyde caseinate 60.0 g of aluminum stearate are added to 5640.0 g of dry sieved granulate.

Example 4

The granules and tablets are prepared as described in Examples 1 to 3, except that a granulating solution of the active mummy substance is prepared by dissolving 1300 g of mummy in 3000 g of distilled water and used to granulate a mixture of powdery excipients of the composition:

Microcrystalline cellulose 2000.0 g

Lactose monohydrate 1300.0 g

Cross-linked polyvinylpyrrolidone 600.0g

Colloidal silica 240,0g

Corn starch 200.0g and 300.0 g of cross-linked polyvinylpyrrolidone and 60.0 g of calcium stearate were added to 5640.0 g of dry sieved granulate.

An equal amount of mannitol may be used instead of lactose. Instead of 60.0 g of calcium stearate, 30.0 g of calcium stearate and 30.0 g of talc may be used.

Example 5

The granules and tablets are prepared as described in Examples 1-4, except that the granulation solution is prepared by dissolving 10 g of the active substance mummia in 3,659 g of distilled water and used to granulate a mixture of powdery excipients of the composition:

Microcrystalline cellulose 2,830.0 g

Lactose monohydrate 2,290.0 g

Colloidal silica 240,0g

Corn starch 200.0g

Sodium starch carboxymethyl ether 100.0 g and to 5 660.0 g dry sieved granulate are added 300.0 g sodium starch carboxymethyl ether and 30.0 g magnesium stearate.

Example 6

The granules and tablets are prepared as described in Examples 1-5, except that a granulating solution of the active substance mummia is prepared by dissolving 1,300 g of mummia in 2,760 g

-5EN 282012 B6 distilled water and used to granulate a mixture of powdery excipients of the following composition:

Microcrystalline cellulose

Lactose monohydrate

Sodium starch carboxymethyl ether

Colloidal silicon dioxide

Corn starch

850.0 g

110.0 g

600.0 g

240.0 g

200.0 g and 400.0 g of dry sieved granulate were added with 400.0 g of sodium starch carboxymethyl ether and 300.0 g of finely divided polyethylene glycol 6000.

Example 7

The granules and subsequently the tablets are prepared as described in Examples 1 to 6 except that the tablets have a lens shape, a radial strength of 60-90 N (Pharma Test) and a disintegration time of up to 15 minutes (Cs14). Their appearance, taste and smell are corrected by a coating which is applied to the cores by means of a two-way nozzle in a suitable equipment and the aqueous lacquer dispersion has the following composition:

Methyhydroxypropyr Ice lu losa 178.5 g Polyethylene glycol 6000 14.7 g Mixture of ferric iron oxides 8,4 g Talc 8,4 g Polyoxyethylether of sorbitan monooleate 9.4 g Silicone emulsion 1.1 g Distilled water 3,000.0 g

The coated tablets have a weight of 621.0 mg, a smooth, compact and glossy coating in a color corresponding to the selected pigment from ocher yellow through reddish brown to dark brown. They are odorless and easy to swallow.

Claims (7)

PATENT CLAIMS A mumio-containing foodstuff comprising from 0.1 to 25 wt. 10 to 20 wt. swelling agent and the rest being fillers. The eatable according to claim 1, wherein the filler is selected from the group consisting of lactose, mannitol, microcrystalline cellulose, colloidal silica and magnesium trisilicate. The eatable according to claim 1 or 2, wherein the swelling agent is selected from the group consisting of starch, sodium starch carboxymethyl ether, cross-linked polyvinylpyrrolidone and formaldehyde caseinate. Foodstuff according to at least one of Claims 1 to 3, characterized in that it contains 0.5 to 5 wt. glidants, based on the total weight of the eatable, wherein the glidant is selected from the group consisting of talc, stearic acid salt and polyethylene glycol 6000. Foodstuff according to at least one of Claims 1 to 4, characterized in that it contains 16.7 wt. mummia, 64 wt.%, fillers, 18.3 wt. % swell and 1 wt. glidants. 5 Foodstuff according to at least one of Claims 1 to 5, characterized in that the foodstuff in the form of a tablet having a weight of 600.0 mg contains 1 to 130 mg of mummy, preferably 100 mg of mummy. 7. The foodstuff according to claim 6, characterized in that it is coated with a coating layer of 3 to 5% by weight. the total weight of the uncoated tablet, which comprises a film-forming agent, a plasticizer, a pigment, an anti-sticking agent, an antifoaming agent, and a surfactant.