CZ280795A3 - Mumium containing comestible - 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

(57)

The mumio-containing edible contains 0.1 to 25 wt. 10 to 20 wt. swelling agent and the rest being fillers. According to the invention, a preferred form of the mumio-containing eatable is a 600.0 mg tablet and / or a lacquered tablet containing 1 to 130 mg of mummia, preferably 100 mg of mummia.

CZ 2807-95 A3

AND

Foodstuff containing t

- 1 - ! 22 1 - ^s; (i) i f j _. · - - ί> · ť -:>'> 2 ^σ i CD X it 0 0 CD Tf = 5i <j J Οϊ · i her? 'r * * mumio and and - No! cn -. *

BACKGROUND OF THE INVENTION [0002]

BACKGROUND OF THE INVENTION The present invention relates to an eatable composition comprising a mummole / 3 process for its manufacture.

Food supplements, also called parapharmaceuticals, are formulations intended for healthy individuals of different age and professional 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, support certain physiological processes and also contribute to improving the overall resistance of the body.

BACKGROUND OF THE INVENTION

Whether dietary 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 should ensure the possibility of use for a given purpose (e.g., skin or mucosal application, inhalation, swallowing, dissolution in the mouth). In the case of oral preparations, the dosage form should, moreover, ensure a uniform distribution of the prescribed doses of the 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 the method of its transformation into an oral dosage form meeting the above mentioned requirements. under certain climatic and physical conditions. The occurrence of mummies is thus closely linked to the Alticol habitat in the Asian mountains.

Mumio contains 26 different components of inorganic and organic character: water 14-20%, mineral substances 17,6-20,8%, proteins

6.6-13.7 , fats 3,8-4,4 'o, bezdus íkaté organic substances 18.7 22.9%. OF makroe1emen tů sodium, potassium , calcium. magnesium, iron and phosphorus of microelements cobalt, i 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 and 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, which has 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 bee wax odor. The young or fresh mumio, estimated to be tens to hundreds of years old, has a brown color and a grainy texture. , resulting from 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 (Paulis, P.: Mumio - Legend and Reality. Our Medicinal Plants 26,6,169-171,1989, Gregáň, F. Farm 60 (pp. 509-510, 1991).

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. V <

Mumium-containing dosage forms for external use include aqueous solutions used to combat skin and mucous membranes, or for siding or irrigation of sinuses, 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 thick mummy extract (94-072651 / 09 / WPIDS, Barnienko, B.G.,

Switch of extract from rocks) intended for the preparation of solutions in water, tea, milk or honey, respectively. directly to swallow.

- 3 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 a certain 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 necessity of preparing the solution at the time of need, as well as the eventual transport of a stock of the solution and its gentle storage for a longer period of use.

A certain solution is the application of mummia in the form of chewing gum, which, however, only holds 0.5 2% of the active substance of mummies (93-212756 / 26 / WPIDS, Aronbaev, D.Μ., Krivoruchko, VI, Tkeshashvili, ME, Prophylactic chewing gum .).

A qualitatively more effective solution to the problem of oral and mummial dosage forms of the present invention appears to be an eatable 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 comprising 0.1 to 25 wt. 10 to 20 wt. swelling agent and the rest being fillers.

Preferably, the edible solid contains 16.7 wt. mummy, 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 comprising 1 to 130 mg of the active substance mummia in a tablet weighing 600 mg 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 admixed with glidants and swelling agents such that the swelling agent does not generally exceed 20% by weight, and is compressed.

The mumium-containing edible tablet is produced by compressing a granulate mixture formed by saturating a homogeneous mixture of dusty soluble and insoluble and swellable excipients with an aqueous solution of mumium, in admixture with a swelling and glidant. The weight of the excipients, together with the selected concentration of the aqueous mummium solution used for saturation, determines the final content of the active mummium substance 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. The dust composition saturated with mummium solution also contains swellable substances, which facilitate the 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 (swelling disintegrants) constituting a total of 10-20% by weight of the tablet and / or the lacquered tablets, starches, sodium starch carboxymethyl ether, cross-linked polyvinylpyrrolidone, formaldehyde cachetate 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.

For dry granules, the particle size is adjusted by sieving to

- in ** suitable equipment, through a sieve with a mesh side size of 1 2 2 i, 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 5-10% by weight. The adjuvant from the group of anti-adhering resp. glidants in an amount of 0.5 - 5 wt. Here it can be used advantageously

6,

talc, stearic acid salts, polyethylene glycol 6000 finely ground.

The mixture of granulate and excipients is homogenized in a suitable machine and further used to prepare 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 agent, 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, the present invention is carried out by applying the aqueous lacquer dispersion 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 represents 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. solids of lacquer dispersion. Of the other components, it is a plasticizer, here preferably represented by polyethylene glycol 6000 in an amount of 5 to 7% by weight of pigment, here preferably represented by a mixture of iron-iron oxides in an amount of 3 to 5% by weight. antiadhesive component, preferably represented by talc in an amount of 3 to 5% by weight, antifoam, preferably represented by a silicone emulsion in an amount of 0.3 to 0.5% by weight, and non-ionic emulsifier of the O / W types, preferably represented here % polyoxyethylether of sorbitan monooleate in an amount of 3 to 4.5 wt.% of the dry weight of the lacquer dispersion.

The edible mummified tablet and / or lacquered tablet produced according to the present invention is 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 mummies at 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 100-130 mg over one to three application cycles.

An advantage of an eatable according to the invention is that it contains

ΗΗβΧΝ.

up to 25% Rome. 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 granulate

Microcrystalline cellulose 2 000.0 g

Lactose monohydrate 1,600.0 g

Carboxymethyl ether starch 600.0 g

Colloidal silica 240.0 g

Corn starch 200.0 g

The raw materials are stitched together through a sieve with a mesh side size of 0.34 mm and transferred to a working container of a suitable granulating machine. 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 apparatus 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 having a mesh side size of 1 - 1.2 mm. Furthermore, 5,640.0 g of the granulate are mixed with 300.0 g of sodium carboxymethyl ether starch and 60.0 g of magnesium stearate.

Preparation of tablets

The homogeneous mixture of granulate and tablet additives is further processed on a suitable tablet 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 (CGs14).

Example 2

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

Microcrystalline cellulose Lactose monohydrate Cross-linked polyvinylpyrrolidone Magnesium trisilicate Colloidal silicon dioxide Corn starch

600.0 g 1 600.0 g

600.0 g 400.0 g 240.0 g 200.0 g and 30040 polyvinylpyrrolidone and 60.0 g calcium stearate are added to 5640.0 g cross-linked g of dry sieved granulate.

Example 3

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

Microcrystalline cellulose 20.0 g

Lactose monohydrate 1,600.0 g

Formaldehyde caseinate 600.0 g

Colloidal silica 240.0 g

Corn starch 200.0 g 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 are prepared as described in Examples 1 to 3, followed by tablets, except that a granulating solution of the active substance Raumium is prepared by dissolving 1300 g of Mum in 3000 g of distilled water and used to granulate the mixture. dusty excipients with the following composition:

Microcrystalline cellulose Lactose monohydrate Cross-linked polyvinylpyrrolidone Colloidal silicon dioxide Corn starch and to 5 640,0 g dry cross-linked cross-linked pdfyvinyl pyrrolidone and 60,0

The same 60.0 g calcium stearate and 30.0 g talc may be used instead of lactose.

Example 5

000.0 g 1 300.0 g

600.0 g 240.0 g 200.0 g granules 300 g of calcium stearate are added.

amount of mannitol. Instead of 30.0 g of calcium stearate

Using the procedure described above, the tablets are prepared by dissolving g of distilled water and using the following ingredients:

in the examples with the difference, active

1-4 is prepared granulate that granulating solution with substance mummia in 3,659 to granulate the mixture of powdery

Microcrystalline cellulose 2,830.0 g Lactose monohydrate 2,290.0 g Colloidal silicon dioxide 240.0 g Starch-maize 200.0 g Sodium starch carboxymethyl ether 100.0 g and 5 660.0 g dry sieved granulate 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 mummy substance is prepared by dissolving 1,300 g of mummium in 2,760 g of distilled water and used to granulate a mixture of powdery excipients of the composition:

Microcrystalline cellulose

Lactose monohydrate

Sodium sfll carboxymethylene starch Colloidal silicon dioxide Corn starch

850.0 g 1,110.0 g

600.0 g 240.0 g 200.0 g and to 5.290.0 g dry sieved granulate were added 400.0 sodium carboxymethyl ether starch and 300.0 g finely ground 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-like shape, a radial strength of 60-90 (CPharma Test) and a disintegration time of up to 15 minutes. 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 air-handling device and the aqueous lacquer dispersion has the following composition:

í i,

Λ

Methylhydroxypropylcellulose 178.5 g Polyethylene glycol 6000 14.7 g Iron-iron oxide mixture - 8.4 g Talc 8.4 g Sorbitan monooleate polyoxyethylether 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 color corresponding to the selected pigment from ocher yellow through reddish brown to dark brown. They are odorless and easy to swallow.

Claims (7)

Claims denoting PATENTOVÉ A muirtio-containing foodstuff comprising 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. The edible 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. , _{f (} . mummy, 64 wt. % fillers, 18.3 _w wt. % swell and 1 wt. glidants. / _ ._____________ ____. _ Foodstuff according to at least one of Claims 1 to 5, characterized by: The composition according to claim 1, characterized in that the eatable in the form of a tablet weighing 600.0 mg contains 1 to 130 mg of mummy, preferably 100 mg of mummy. 7. A foodstuff according to claim 6, characterized in that it is coated with a coating layer which comprises 3 to 5 wt. the total weight of the uncoated tablet, which consists of a film former, a plasticizer, a pigment, an anti-sticking agent, an antifoaming agent, and a surfactant.