Composition with hepatoprotective and metabolism normalizing activity

FIELD: pharmaceutical industry, in particular phospholipid-based pharmaceutical composition hawing hepatoprotective and metabolism normalizing activity in form of tablets, pellets, capsules, injection solutions, etc.

SUBSTANCE: claimed composition contains both plant and animal origin phospholipid, essential amino acid such as methionine and threonine, and filler at total phospholipid and amino acid content of 15-80 % in mass ratio of 2:1.

EFFECT: effective pharmaceutical composition having excellent hepatoprotective and lipid, protein, and carbohydrate metabolism normalizing activity.

12 cl, 26 tbl, 98 ex

 

The present invention relates to the field of medicine and for the creation of a pharmaceutical composition based on phospholipid having hepatoprotective activity and normalizes metabolic processes, and can be used in the manufacture of a medicinal product in the form of tablets, granules, pellets, capsules, solutions for injection, syrup, suspensions.

According to the world health organization, over the last 20 years all over the world has been a trend to increase the number of liver diseases. Only in the CIS countries annually from 500 thousand to 1 million people suffering from one or other liver pathology. In this regard, an important problem is the search for new highly efficient and at the same time safe means of hepatoprotective action.

Among the most promising are the products of natural origin, such as phospholipids.

Known drug "Essentiale® H" ["drugs in Russia, directory Vidal, Izd. - M.: Attraversare, 2002, strb-733], which contains essential phospholipids. The drug is available in form of capsules and injections, in its application improves liver function and enzyme activity of the liver cells.

However, he does not normalize metabolic processes in the body sufficiently.

Known drug "e the sliver® Forte" ["drugs in Russia, directory Vidal, Izd. - M.: Attraversare, 2002, strb-733], which contains essential phospholipids and vitamins.

However, vitamins can lead to the deterioration of essential phospholipids, which reduces the effectiveness of the drug.

Closest to the claimed composition to the technical essence and the achieved result is a pharmaceutical composition that is protected by RF patent No. 2133122 ["Composition with the properties to repairbot biological membranes", class. And 61 To 31/685, a 61 K 35/78, publ. 20.07.1999, patentee: Institute of biomedical chemistry of Russian Academy of medical Sciences], which is chosen as the prototype for both independent claims.

Known composition contains phospholipids, glycyrrhizinic acid or its salts and excipients when the total content of phospholipids and glycyrrhizic acid or its salts 2-80 wt.% and the mass ratio of phospholipids and glycyrrhizic acid or its salt is not more than 4:1.

The pharmaceutical composition described in the patent, has hepatoprotective activity and normalizes fat metabolism, so it is used for treatment and prevention of acute and chronic liver diseases, the recovery of liver intoxication.

However, the tool has insufficient hepatoprotector the activity and as a consequence, affects the normalization only fat metabolism, while not affecting the protein and carbohydrate metabolism in the body.

The problem solved by the invention, the creation of an effective pharmaceutical compositions on the basis of phospholipid, with pronounced hepatoprotective activity and normalizes fat, protein and carbohydrate exchanges and expanding the Arsenal of drugs for treatment of liver diseases, in the form of various dosage forms.

The technical result from the use of the invention is to improve therapeutic efficacy of a drug by increasing its hepatoprotective activity and the ability to normalize as fat and protein and carbohydrate metabolism in the body.

The specified technical result is achieved by the proposed pharmaceutical composition having hepatoprotective activity and normalizes metabolic processes and containing a phospholipid, both vegetable and animal origin, essential amino acid and a filler, the total content of phospholipid and amino acids 15-80 wt.% and their mass ratio of 2:1, the filler - rest.

It is preferable that, as an essential amino acid pharmaceutical composition contains ± -amino-γ-methylthiophenol acid (methionine) or α-aminoβ-hydroxybutyric acid (threonine).

It is preferable that, as a phospholipid, a pharmaceutical composition comprises a phospholipid of vegetable origin, obtained, for example, from soybeans.

It is preferable that, as a phospholipid, a pharmaceutical composition comprises a phospholipid of animal origin, obtained, for example, from egg yolk.

It is preferable that, as a phospholipid of plant or animal origin, a pharmaceutical composition comprises a phospholipid content of phosphatidylcholine 73-79 wt.%.

It is preferable that the compositions may be in the form of tablets, granules, or pellets.

It is preferable that the tablets or granules, or pellets can be coated on the base polymer.

It is preferable that a certain amount of pellets or granules may be placed in a pharmaceutically acceptable capsule for oral administration.

Preferably, the capsule can be filled with pellets or granules in such a quantity that the concentration of active ingredient equivalent to therapeutic dose.

It is preferable that the filler pharmaceutical composition comprises a vegetable oil, such as soy.

Predpochtitel is but the pharmaceutical composition containing as filler vegetable oil, may be placed in a capsule for oral administration in such a quantity that the content of active substances equivalent to therapeutic dose.

It is preferable that the compositions may be in the form of solution for injection, syrup, suspension.

The introduction of the proposed pharmaceutical composition simultaneously phospholipid and essential amino acids when the total content of phospholipid and amino acids 15-80% and the mass ratio of 2:1 gives composition, with pronounced hepatoprotective activity and allows you to simultaneously stabilize both fat and protein and carbohydrate metabolism in the body.

Pharmacological action of essential amino acids is based on their role in metabolic processes of the organism, in particular protein metabolism.

The phospholipid being one of the main components of cell membranes, has hepatoprotective activity. This is due to its role in maintaining and restoring normal part of the cell membranes.

Pronounced hepatoprotective activity proposed composition ensured the achievement of a synergistic effect, which is due to the fact that an essential amino acid, in particular methionine and renin, produces endogenous synthesis of choline in the body, which in turn is involved in the biosynthesis of endogenous phospholipids and increase efficiency in maintaining and restoring normal part of the cell membranes of the liver introduce exogenous phospholipids.

Along with the fact that the amino acid normalizes protein metabolism, normalization of liver function entails additional stabilization of protein metabolism, as well as the stabilization of lipid metabolism for the production of bile and stabilization of carbohydrate metabolism by regulating the total concentration of glucose in the blood.

The ratio of the components in the proposed composition is chosen experimentally and is optimal, which allows to obtain a technical result that is appropriate to the task.

Pharmaceutically acceptable filler to obtain tablets or granules, or pellets may consist of, for example, starch, talc, calcium stearate, lactose, polyvinylpyrrolidone.

Pharmaceutically acceptable filler to obtain injection solutions may consist of, for example, from water and polyvinylpyrrolidone.

Pharmaceutically acceptable filler to obtain a syrup may contain, for example, from a carbohydrate thickener and fruit food extract.

As carbohydrate can be used for the Vanir, for example, sugar or sweeteners suitable for diabetics.

As a sugar substitute can be used, for example, sorbitol.

As a thickener may be used, for example, sodium alginate.

As fruit food extract can be used, for example, the extract from the fruit of apples.

Pharmaceutically acceptable filler to obtain a suspension may consist of, for example, water, preservative and fruit food extract

As preservative can be used, for example, sodium metabisulfite.

The method of obtaining the proposed composition in the form of tablets. The estimated amount of the phospholipid and amino acids, when the total content of 15-80 wt.% and their mass ratio of 2:1, mix, add up to 100 wt.% pharmaceutically acceptable filler to obtain a tablet mass, containing, for example, starch, talc, calcium stearate, lactose, polyvinylpyrrolidone, and mix. The resulting mass is formed into the kernel in the form of tablets. At the core of the tablets may be coated shell component of 5-10 wt.% from the mass of the nucleus.

The method of obtaining the proposed composition in the form of granules or pellets.

The estimated amount of the phospholipid and amino acids when the total content of 15-80 wt.% and their mass ratio of 2:1, mix, add up to 100 wt.% pharmaceutically PR is integral filler, containing, for example, starch, talc, calcium stearate, lactose, and the resulting mixture is moistened, for example, polyvinylpyrrolidone. The resulting mass is get the pellets or granules obtained kernel calibrated and dried. At the core of the pellets or granules may be applied to the shell, for example, based on the polymer component of 12-20 wt.% by weight of the core pellets and 30-45 wt.% by weight of the core granules. The obtained pellets or granules can be placed in the gastro-soluble capsules, for example made of gelatin, in such a quantity that the concentration of active ingredients equivalent to therapeutic dose.

The method of obtaining the proposed composition in the form of a mixture for encapsulation.

The estimated amount of the prepared powders phospholipid and amino acids when the total content of 15-80 wt.% and their mass ratio of 2:1 mix, add up to 100 wt.% pharmaceutically acceptable filler, such as soybean oil, and mix. The resulting mixture was placed in a gastric-soluble capsules, for example made of gelatin, in such quantity that the content of active substances equivalent to therapeutic dose.

The method of obtaining the proposed composition in the form of a solution for injection.

The estimated amount of the powders phospholipid and amino acids when the total content of 15-80 wt.% and their mass aspect] is to 2:1 mix, add up to 100 wt.% pharmaceutically acceptable filler, consisting, for example, from water and polyvinylpyrrolidone, and mix. The resulting solution is filtered, Packed in ampoules and sterilized.

The method of obtaining the proposed composition in the form of syrup. Estimated number of powders phospholipid and amino acids when the total content of 15-80 wt.% and their mass ratio of 2:1 add up to 100 wt.% pre-cooked pharmaceutically acceptable filler, consisting, for example, from sugar syrup, thickener and fruit food additives. The resulting mixture is stirred and Packed in bottles.

The method of obtaining the proposed composition in suspension.

The estimated amount of the powders phospholipid and amino acids when the total content of 15-80 wt.% and their mass ratio of 2:1 mix, add up to 100 wt.% pharmaceutically acceptable filler, consisting, for example, water, sodium metabisulfite, fruit supplements, mixed and Packed in bottles.

In the described ways of obtaining the proposed composition as phospholipid used a phospholipid that meets the requirements of USP; as amino acids - α-aminoγ-meticiously acid (methionine), meeting the requirements of FS 42-2787-99, and α-aminoβ-hydroxybutyric acid (threonine), corresponding to Tr the ments USP27-NF22.

The following are specific examples of the manufacture of the proposed composition in tablet form.

Example 1.

10.0 g (10%) of phospholipid from soybean and 5.0 g (5%) methionine mix, add to 26.8 g (26.8 per cent) of starch, 1.0 g (1%) of talc, 0.5 g (0.5%) calcium stearate, of 53.7 g (53.7%) lactose and 3.0 g (3%) polyvinylpyrrolidone. The result is a tablet with a total phospholipid content and methionine 15% of their mass ratio of 2:1.

Example 2.

53,3 g (53.3%) phospholipid from soybean and 26.7 g (26,7%) methionine mix, added to 5.2 g (5.2%) of starch, 1.0 g (1%) of talc, 0.5 g (0.5%) calcium stearate, 10.3 g (10,3%) and lactose 3.0 g (3%) polyvinylpyrrolidone. The resulting mixture tabletirujut. The result is a tablet with a total phospholipid content and methionine 80% when the mass ratio of 2:1.

Example 3.

Carried out as example 1, except that as the phospholipid composition contains phospholipids from egg yolk.

Example 4.

Carried out as example 2, only as phospholipid composition contains phospholipids from egg yolk.

Example 5.

Carried out as example 1, except that as amino acid composition contains a threonine.

Example 6.

Carried out as example 2, only the amino acid composition contains a threonine.

Example 7.

Carried out as example 3 except that as the amino acid composition contains a threonine.

When is EP 8.

Carried out as example 4, only as amino acid composition contains a threonine.

Example 9.

Is carried out as example 1, except that the tablet weighing 1 g is covered by a polymeric shell. The mass of the shell is 0.05 g (5%) by weight of the kernel.

Example 10.

Is carried out as example 1, except that the tablet weighing 1 g is covered by a polymeric shell. The mass of the shell is 0.1 g (10%) by weight of the kernel.

Example 11.

Is carried out as example 2, only the tablet weighing 1 g is covered by a polymeric shell. The mass of the shell is 0.05 g (5%) by weight of the kernel.

Example 12.

Is carried out as example 2, only the tablet weighing 1 g is covered by a polymeric shell. The mass of the shell is 0.1 g (10%) by weight of the kernel.

Example 13.

Is carried out as example 3, only the tablet weighing 1 g is covered by a polymeric shell. The mass of the shell is 0.05 g (5%) by weight of the kernel.

Example 14.

Is carried out as example 3, only the tablet weighing 1 g is covered by a polymeric shell. The mass of the shell is 0.1 g (10%) by weight of the kernel.

Example 15.

Is carried out as example 4, only the tablet weighing 1 g is covered by a polymeric shell. The mass of the shell is 0.05 g (5%) by weight of the kernel.

Example 16.

Is carried out as example 4, only the tablet weighing 1 g Pokrywa the t polymer shell. The mass of the shell is 0.1 g (10%) by weight of the kernel.

Example 17.

Is carried out as example 5, only the tablet weighing 1 g is covered by a polymeric shell. The mass of the shell is 0.05 g (5%) by weight of the kernel.

Example 18.

Is carried out as example 5, only the tablet weighing 1 g is covered by a polymeric shell. The mass of the shell is 0.1 g (10%) by weight of the kernel.

Example 19.

Is carried out as example 6, only the tablet weighing 1 g is covered by a polymeric shell. The mass of the shell is 0.05 g (5%) by weight of the kernel.

Example 20.

Is carried out as example 6, only the tablet weighing 1 g is covered by a polymeric shell. The mass of the shell is 0.1 g (10%) by weight of the kernel.

Example 21.

Is carried out as example 7, only the tablet weighing 1 g is covered by a polymeric shell. The mass of the shell is 0.05 g (5%) by weight of the kernel.

Example 22.

Is carried out as example 7, only the tablet weighing 1 g is covered by a polymeric shell. The mass of the shell is 0.1 g (10%) by weight of the kernel.

Example 23.

Is carried out as example 8, only the tablet weighing 1 g is covered by a polymeric shell. The mass of the shell is 0.05 g (5%) by weight of the kernel.

Example 24.

Is carried out as example 8, only the tablet weighing 1 g is covered by a polymeric shell. While the ACCA shell is 0.1 g (10%) by weight of the kernel.

The following are specific examples of the manufacture of the proposed composition in the form of granules and pellets.

Example 25.

10.0 g (10%) of phospholipid from soybean and 5.0 g (5%) methionine mix, add to 26.8 g (26.8 per cent) of starch, 1.0 g (1%) of talc, 0.5 g (0.5%) calcium stearate and 53.7 g (53.7%) lactose. The resulting mixture is moistened 3.0 g (3%) polyvinylpyrrolidone. The resulting mass is obtained masses get pellets or granules, which are calibrated and dried. As a result, granules or pellets with a total phospholipid content and methionine 15% of their mass ratio of 2:1.

Example 26.

53,3 g (53.3%) phospholipid from soybean and 26.7 g (26,7%) methionine mix, added to 5.2 g (5.2%) of starch, 1.0 g (1%) of talc, 0.5 g (0.5%) calcium stearate, 10.3 g (10,3%) lactose. The resulting mixture is moistened 3.0 g (3%) polyvinylpyrrolidone. The resulting mass is obtained masses get pellets or granules, which are calibrated and dried. The result is a tablet with a total phospholipid content and methionine 80% when the mass ratio of 2:1.

Example 27.

Carry, as an example 25, just as the phospholipid composition contains phospholipids from egg yolk.

Example 28.

Carried out as example 26, just as the phospholipid composition contains phospholipids from egg yolk.

Example 29.

Carry, as an example 25, only as amino acids to the position contains threonine.

Example 30.

Carry, as an example of the 26, only as amino acid composition contains a threonine.

Example 31.

Carry, as an example of the 27, only as amino acid composition contains a threonine.

Example 32.

Carry, as an example of the 28, only as amino acid composition contains a threonine.

Example 33.

Is, as the example 25, the granule mass of 0.75 mm is covered by a polymeric shell. The mass of the shell is 0,225 g (30%) by weight of the kernel.

Example 34.

Is, as the example 25, the granule mass of 0.75 mm is covered by a polymeric shell. The mass of the shell is 0,338 g (45%) by weight of the kernel.

Example 35.

Is carried out as example 26, only the pellet weight of 0.75 mm is covered by a polymeric shell. The mass of the shell is 0,225 g (30%) by weight of the kernel.

Example 36.

Is carried out as example 26, only the pellet weight of 0.75 mm is covered by a polymeric shell. The mass of the shell is 0,338 g (45%) by weight of the kernel.

Example 37.

Is carried out as example 27, the granule mass of 0.75 mm is covered by a polymeric shell. The mass of the shell is 0,225 g (30%) by weight of the kernel.

Example 38.

Is carried out as example 27, the granule mass of 0.75 mm is covered by a polymeric shell. The mass of the shell is 0,338 g (45%) of the mass of the poison is and.

Example 39.

Is carried out as example 28, the granule mass of 0.75 mm is covered by a polymeric shell. The mass of the shell is 0,225 g (30%) by weight of the kernel.

Example 40.

Is carried out as example 28, the granule mass of 0.75 mm is covered by a polymeric shell. The mass of the shell is 0,338 g (45%) by weight of the kernel.

Example 41.

Is carried out as example 29, the granule mass of 0.75 mm is covered by a polymeric shell. The mass of the shell is 0,225 g (30%) by weight of the kernel.

Example 42.

Is carried out as example 29, the granule mass of 0.75 mm is covered by a polymeric shell. The mass of the shell is 0,338 g (45%) by weight of the kernel.

Example 43.

Is carried out as example 30, only the pellet weight of 0.75 mm is covered by a polymeric shell. The mass of the shell is 0,225 g (30%) by weight of the kernel.

Example 44.

Is carried out as example 30, only the pellet weight of 0.75 mm is covered by a polymeric shell. The mass of the shell is 0,338 g (45%) by weight of the kernel.

Example 45.

Is carried out as example 31, the granule mass of 0.75 mm is covered by a polymeric shell. The mass of the shell is 0,225 g (30%) by weight of the kernel.

Example 46.

Is carried out as example 31, the granule mass of 0.75 mm is covered by a polymeric shell. The mass of the shell is 0,338 g (45) from the mass of the nucleus.

Example 47.

Is carried out as example 32, only the pellet weight of 0.75 mm is covered by a polymeric shell. The mass of the shell is 0,225 g (30%) by weight of the kernel.

Example 48.

Is carried out as example 32, only the pellet weight of 0.75 mm is covered by a polymeric shell. The mass of the shell is 0,338 g (45%) by weight of the kernel.

Example 49.

Is, as the example 25 except that the pellets weighing 1.5 mm covered by a polymeric shell. The mass of the shell is 0.18 g (12%) by weight of the kernel.

Example 50.

Is, as the example 25 except that the pellets weighing 1.5 mm covered by a polymeric shell. The mass of the shell is 0.3 g (20%) by weight of the kernel.

Example 51.

Is carried out as example 26 except that the pellets weighing 1.5 mm covered by a polymeric shell. The mass of the shell is 0.18 g (12%) by weight of the kernel.

Example 52.

Is carried out as example 26 except that the pellets weighing 1.5 mm covered by a polymeric shell. The mass of the shell is 0.3 g (20%) by weight of the kernel.

Example 53.

Is carried out as example 27 except that the pellets weighing 1.5 mm covered by a polymeric shell. The mass of the shell is 0.18 g (12%) by weight of the kernel.

Example 54.

Is carried out as example 27 except that the pellets weighing 1.5 mm covered by a polymeric shell. The mass of the shell is 0.3 g (20%) by weight of the s kernel.

Example 55.

Is carried out as example 28 except that the pellets weighing 1.5 mm covered by a polymeric shell. The mass of the shell is 0.18 g (12%) by weight of the kernel.

Example 56.

Is carried out as example 28 except that the pellets weighing 1.5 mm covered by a polymeric shell. The mass of the shell is 0.3 g (20%) by weight of the kernel.

Example 57.

Is carried out as example 29 except that the pellets weighing 1.5 mm covered by a polymeric shell. The mass of the shell is 0.18 g (12%) by weight of the kernel.

Example 58.

Is carried out as example 29 except that the pellets weighing 1.5 mm covered by a polymeric shell. The mass of the shell is 0.3 g (20%) by weight of the kernel.

Example 59.

Is carried out as example 30 except that the pellets weighing 1.5 mm covered by a polymeric shell. The mass of the shell is 0.18 g (12%) by weight of the kernel.

Example 60.

Is carried out as example 30 except that the pellets weighing 1.5 mm covered by a polymeric shell. The mass of the shell is 0.3 g (20%) by weight of the kernel.

Example 61.

Is carried out as example 31 except that the pellets weighing 1.5 mm covered by a polymeric shell. The mass of the shell is 0.18 g (12%) by weight of the kernel.

Example 62.

Is carried out as example 31 except that the pellets weighing 1.5 mm covered by a polymeric shell. The mass of the shell is 0.3 g (20%) of the mass of the DRA.

Example 63.

Is carried out as example 32 except that the pellets weighing 1.5 mm covered by a polymeric shell. The mass of the shell is 0.18 g (12%) by weight of the kernel.

Example 64.

Is carried out as example 32 except that the pellets weighing 1.5 mm covered by a polymeric shell. The mass of the shell is 0.3 g (20%) by weight of the kernel.

Examples of the manufacture of the proposed composition for encapsulation.

Example 65.

10.0 g (10%) of phospholipid from soybean and 5.0 g (5%) methionine mix 85.0 g (85%) of soybean oil. The result is a mixture with a total phospholipid content and methionine 15% of their mass ratio of 2:1. The mixture capsulebuy.

Example 66.

53,3 g (53.3%) phospholipid from soybean, 26.7 g (26,7%) methionine, mixed with 20,0 g (20%) of soybean oil. The result is a mixture with a total phospholipid content and methionine 80% when the mass ratio of 2:1. The mixture capsulebuy.

Example 67.

Carry, as an example 65, only as phospholipid composition contains phospholipids from egg yolk.

Example 68.

Carry, as an example 66, only as phospholipid composition contains phospholipids from egg yolk.

Example 69.

Carry, as an example 65, only as amino acid composition contains a threonine.

Example 70.

Carry, as an example 66, only as amino acids the composition which contains threonine.

Example 71.

Carried out as example 67, only as amino acid composition contains a threonine.

Example 72.

Carry, as an example 68, only as amino acid composition contains a threonine.

Examples of the manufacture of the proposed composition in the form of a solution for injection.

Example 73.

Take 10.0 g (10%) of phospholipid from soybean, 5.0 g (5%) methionine, 3 g (3%) polyvinylpyrrolidone and 72,0 g (72%) of water for injection. You get a solution with the total phospholipid content and methionine 15% of their mass ratio of 2:1.

Example 74.

Take 53,3 g (53.3%) phospholipid from soybean, 26.7 g (26,7%) methionine, 3 g (3%) polyvinylpyrrolidone and 17.0 g (17%) of water for injection. You get a solution with the total phospholipid content and methionine 80% when the mass ratio of 2:1.

Example 75.

Carry, as an example 73, only as phospholipid composition contains phospholipids from egg yolk.

Example 76.

Carry, as an example 74, only as phospholipid composition contains phospholipids from egg yolk.

Example 77.

Carry, as an example 73, only as amino acid composition contains a threonine.

Example 78.

Carry, as an example 74, only as amino acid composition contains a threonine.

Example 79.

Carry, as an example 75, just as amino acids are the components of ice contains threonine.

Example 80.

Carried out as example 76, and only as amino acid composition contains a threonine.

Examples of the manufacture of the proposed composition in the form of syrup.

Example 81.

Take 10.0 g (10%) of phospholipid from soybean, 5.0 g (5%) methionine, 1.0 g (1%) fruit food additives, and 71.4 g (71,4%) sugar syrup and 12.6 g (12.6 per cent) of sodium alginate. The resulting mixture is stirred and Packed. You get a syrup with a total phospholipid content and methionine 15% of their mass ratio of 2:1.

Example 82.

Take 53,3 g (53.3%) phospholipid from soybean, 26.7 g (26,7%) methionine, 1.0 g (1%) fruit food additives, 16,15 g (16,15%) sugar syrup and 2.85 g (2.85 percent) of sodium alginate. The resulting mixture is stirred and Packed. You get a syrup with a total phospholipid content and methionine 80% when the mass ratio of 2:1.

Example 83.

Carry, as an example 81, only as phospholipid composition contains phospholipids from egg yolk.

Example 84.

Carry, as an example, 82, only as phospholipid composition contains phospholipids from egg yolk.

Example 85.

Carry, as an example 81, only as amino acid composition contains a threonine.

Example 86.

Carry, as an example, 82, only as amino acid composition contains a threonine.

Example 87.

Carry, as an example 83, just as the e amino acid composition contains a threonine.

Example 88.

Carry, as an example 84, only as amino acid composition contains a threonine.

Example 89.

Carry, as an example 81, only as carbohydrate composition contains sorbitol syrup.

Example 90.

Carry, as an example, 82, only as carbohydrate composition contains sorbitol syrup.

Examples of the manufacture of the proposed composition in suspension.

Example 91.

Take 10.0 g (10%) of phospholipid from soybean, 5.0 g (5%) methionine, 0.5 g (0,5%) fruit food additives, 0.1 g (0.1%) of sodium metabisulfite and 84.4 g (84.4 per cent) of water. The resulting mixture is stirred and Packed. You get a suspension with a total phospholipid content and methionine 15% of their mass ratio of 2:1.

Example 92.

Take 53,3 g (53.3%) phospholipid from soybean, 26.7 g (26,7%) methionine, 0.5 g (0,5%) fruit food additives, 0.1 g (0.1%) of sodium metabisulfite and of 19.4 g (19.4%) of water. The resulting mixture is stirred and Packed. You get a suspension with a total phospholipid content and methionine 80% when the mass ratio of 2:1.

Example 93.

Carry, as an example of 91, just as phospholipid composition contains phospholipids from egg yolk.

Example 94.

Carry, as an example 92, only as phospholipid composition contains phospholipids from egg yolk.

Example 95.

Carry, as an example of 91, just as the e amino acid composition contains a threonine.

Example 96.

Carry, as an example 92, only as amino acid composition contains a threonine.

Example 97.

Carry, as an example 93, only as amino acid composition contains a threonine.

Example 98.

Carry, as an example 94, only as amino acid composition contains a threonine.

Determination of phospholipid in the proposed compositions are performed by the spectrophotometric method, essential amino acids, in particular methionine, - by direct titration.

Tests for microbiological purity of tablets, granules, pellets and mass for encapsulation obtained in examples 1-72, syrup obtained in examples 81-88, and slurries obtained in examples 89-96, conducted in accordance with the requirements of the global Fund XI and Changes No. 3, category 3B. The obtained results are in line with regulatory requirements.

Test for sterility of the solution for injection, obtained in example 73-80, conducted in accordance with the requirements of the global Fund XI. The obtained results are in line with regulatory requirements.

Studies have been conducted to study the influence of physical factors such as temperature and light, in the pharmaceutical compositions described in the examples 1-96.

After research it was found that the best storage conditions: in dry place at temperature is ur not exceeding 25° C.

To determine the General toxic action and evidence of the effectiveness of the proposed pharmaceuticals were conducted its pre-clinical trials.

These tests were conducted at the Central research laboratory of the Nizhny Novgorod state medical Academy in December 2004.

To test the proposed pharmaceutical composition was presented as hard gelatin capsules (HGC). Component content in mg per capsule are presented in tables (a, B). When you do this:

- in table And the total content of phospholipid and amino acids is of 54.5 wt.% when the mass ratio of 2:1;

in table B the percentage of total phospholipid and amino acids is 15 wt.% when the mass ratio of 2:1.

Table

The composition of the proposed pharmaceutical composition per capsule:
A)
Phospholipids200 mg
Methionine100 mg
Soybean oilTo 550 mg
B)
Phospholipids55 mg
Methionine27,5 mg
Soybean oilTo 550 mg

Experiment the performance communications studies were conducted in accordance with the requirements of the normative document "Guidance on experimental (preclinical) study of new pharmacological substances". - M.: JJA "Remedium". 2000 and the Order of the Ministry of health of Russia from 19.06.03 No. 267 "On approval of rules of good laboratory practice in the Russian Federation".

In experiments were used Mature white outbred rats (kennel "High" SE NTS BMT RAMS). Experimental groups of animals were formed by random sampling taking into account body mass as a defining parameter.

To assess the efficacy of the proposed pharmaceutical composition she was administered intragastrically in 2% starch gel through the probe.

Based on the projected course of the drug in humans, the duration of administration of the composition to the animals during the experiment was 30 days.

When calculating doses proceeded from a daily dose of hard gelatin capsules: 6 capsules (2 capsules 2-3 times a day) with a total content of essential phospholipids 1800 mg per person weighing 70 kg and taking into account the conversion factor on rat 5,9 on essential phospholipids: 25,7·5,9=152 mg/kg

Determination of acute toxicity was carried out on randombred white mice-males weighing 20-22, Studied composition was injected into mice once intraperitoneally at doses of 3000, 5000, and 6000 mg/kg observation of the animals was carried out for 14 days.

Introduction composition intraperitoneal injection at doses of 3000, 5000, and 6000 mg/kg caused in mice minor edit the unintended behavioral responses, manifested in the form of increased frequency of breathing, group of animals, reduction of motor activity. This condition of the animals was maintained for 30-40 minutes, after which behavioral responses gradually normalized. The death of animals was not observed (table 1). The large doses is technically impossible, it is not possible to determine the median lethal dose.

The increase of body weight, daily intake of dry, wet food and water animals when exposed to the proposed composition did not show a statistically significant difference with the control (table 2, 3, 4, 5) Behavioral responses of experimental animals did not differ significantly from control animals.

When the impact of the proposed composition for 30 days in the peripheral blood of rats of all experimental groups was not significantly different from the control side of investigated parameters (erythrocytes, leukocytes, hemoglobin, reticulocytes, platelets, WBC). The data presented in tables 6, 7.

The proposed composition within 30 days of the experiment did not affect the state of the coagulation system of the blood of experimental animals according to the parameters of coagulation (table 8).

The study of the functional state of liver and pancreas showed that the proposed composition - TFA for 30 days not able to provide the lo impact on excretory, absorption and velocimeters liver function in all animals tested (table, 10).

Lipid liver function and glucose in the blood in all experimental groups did not differ from control (table, 12)

The concentration of total cholesterol in the serum of animals of all experimental groups, the compositions - TFA had no significant effect (table 13).

When studying the functional state of the kidneys was found that under the impact of the proposed composition - TFA functional state of the kidneys in all experimental animals was almost unchanged (table 14-20).

When studying the functional state of the cardiovascular system, it was found that after 30 days the introduction of the proposed composition TFA does not cause statistically significant changes in studied parameters of the electrocardiogram in experimental animals (table 21, 22).

The study of the nervous system have shown that 30 days after the beginning of the introduction of the proposed composition - TFA parameters conditional and unconditional reflexes were not significantly different from control (table, 24).

After 1 month on a proposed composition - TFA indicators of General motor activity and emotional state were not significantly different from control (table).

After 30 days of administration offer composers the AI visual and histological studies in either group was not detected local irritant effect.

During the experiment, mortality was not observed.

Examination of the animals revealed that all of them are normally well-fed, have the correct shape, neat hair and natural orifice clean.

By visual examination during autopsy from internal organs significant differences in experimental and control rats were not identified. The bodies are correctly positioned, free fluid in the thoracic and abdominal cavities no. Visual signs of pathology of organs and tissues was not found.

The heart muscle and valves unchanged. The Lumina of the trachea and large bronchi free. The light fabric of the air, pink color, with no signs of edema. The mucous membrane of the stomach, duodenum 12, small and large intestines and Appendix without ulcerations and hemorrhages. The capsule of the kidney is removed easily, in the context of cortical and brain chemistry is distinct. Thymus gray-pink color, not increased. The thyroid gland is pink in color with distinct parathyroid gland. The adrenal glands intact. Shell brain is not strained, gyrus is well expressed. Genitals without any deviations.

For pathomorphological studies were taken from experimental animals of all groups of the following organs: brain, heart, lymph nodes, spleen, thyroid and parasite is a prominent gland, thymus, adrenal glands, pituitary gland, stomach, intestine, pancreas, liver, lungs, kidneys, testes.

The determination of the relative masses of the bodies of experimental animals revealed no significant differences from control at the impact of the proposed composition in the studied doses (table).

Histological studies have shown that the morphological structure of the internal organs of the control animals corresponds to the norm. In the introduction pathological changes could not be found.

According to the results of the experiment proposed composition - TFA in tested doses did not cause significant changes in the integral indices in experimental animals (weight gain, behavioral response, food intake, water), cell structure and parameters of coagulation peripheral blood, excretion, absorption, protein-synthesizing, carbohydrate liver, the level of cholesterol in the serum of functional excretory, cardiovascular and nervous systems. The proposed composition - TFA had no local irritating effect.

Composition in the studied doses did not cause structural abnormalities in organs and tissues. Under the influence of the proposed composition at a dose of 700 mg/kg noted the plethora in the liver and weakly expressed degeneration of hepatocytes.

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Thus, the choice of active substances - phospholipids and amino acids, the choice of the quantitative value of the composition in the form of tablets or pellets, or granules, or capsules or injection, or syrup, or suspension, allows to obtain a new technical result - the creation of an effective pharmaceutical composition having hepatopathic the priori activity and normalizing lipid, protein and carbohydrate metabolism.

1. Pharmaceutical composition having hepatoprotective activity and normalizes metabolic processes and containing a phospholipid, both vegetable and animal origin, organic acid, and a filler, characterized in that as organic acids it contains the essential amino acid when the total content of phospholipid and amino acids 15-80 wt.% and their mass ratio of 2:1.

2. The pharmaceutical composition according to claim 1, characterized in that it is as essential amino acids contains α-aminoγ-methylthiophenol acid (methionine) or α-aminoβ-hydroxybutyric acid (threonine).

3. The pharmaceutical composition according to claim 1, characterized in that it as a phospholipid of plant origin contain a phospholipid from soybean.

4. The pharmaceutical composition according to claim 1, characterized in that it as a phospholipid of animal origin contains phospholipids from egg yolk.

5. The pharmaceutical composition according PP and 4, characterized in that included in its membership a phospholipid contains 73-79 wt.% phosphatidylcholine.

6. The pharmaceutical composition according to claim 1, characterized in that it can be made in the form of tablets, granules or pellets.

7. The pharmaceutical composition according to claim 6, characterized in that the tablet or granules or pellets can be coated on the base polymer.

8. The pharmaceutical composition according PP and 7, characterized in that a number of pellets or granules may be placed in a pharmaceutically acceptable capsule for oral administration.

9. The pharmaceutical composition of claim 8, characterized in that the capsule can be filled with pellets or granules in such a quantity that the concentration of active ingredients equivalent to therapeutic dose.

10. The pharmaceutical composition according to claim 1, characterized in that it as filler contains vegetable oil is soybean.

11. The pharmaceutical composition of claim 10, characterized in that it can be placed in a capsule for oral administration in such a quantity that the content of active substances equivalent to therapeutic dose.

12. The pharmaceutical composition according to claim 1, characterized in that it can be made in the form of solution for injection, syrup, suspension.



 

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47 cl, 11 dwg, 16 tbl, 18 ex

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7 cl, 10 dwg, 4 tbl, 3 ex

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6 cl, 3 tbl, 9 dwg

FIELD: pharmacy.

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EFFECT: improved and valuable pharmaceutical properties of agent.

10 cl, 11 tbl, 32 ex

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