Pharmaceutical composition 'myceslavine' with anti-shock and anti-allergic action (variants)

FIELD: medicine.

SUBSTANCE: the invention relates to medicine and pharmaceutics, in particular, to creation of pharmaceutical composition in the form of suspension with anti-shock and anti-allergic action. The pharmaceutical composition with said actions contains dexamethasone sodium phosphate and “Micellate of calcium carbonate and magnesium”. The pharmaceutical compositions also contain sodium hyalurate, alcohol, Nipagin, fructose and water. A variant of the invention is a suspension which additionally contains sodium fluoride and ascorbic acid. Research was carried out and it proved that the offered pharmaceutical compositions have expressed specific pharmacological effect, they express anti-shock action, and have no toxic effect with various doses and various routes for experimental animals. The compositions have no irritant effect, sensibilizing action was not expressed.

EFFECT: the offered pharmaceutical compositions are effective and safe medication and can be used to treat state of shock, suitable for treatment of patients additionally suffering from diabetes mellitus.

2 cl, 2 ex, 1 tbl, 3 dwg

 

The invention relates to the field of medicine and pharmacy, namely the creation of a pharmaceutical composition in the form of a suspension, with anti-shock and anti-allergic action.

Glucocorticosteroids (GCS) actively influence carbohydrate, fat and protein metabolism (have a catabolic effect) and, to a lesser extent, water and salt.

The main effects of corticosteroids include the following:

- accumulation of glycogen in the liver;

- reduction of glucose utilization in peripheral tissues;

- increased breakdown of proteins and fats;

- the increase of glucose in the blood;

- the ions of potassium and calcium in the urine;

- delay of sodium ions and water;

stimulate secretion of parathormone;

the creation of conditions for eosino-, lympho - and neutropenia;

- decrease absorption of calcium ions.

Corticosteroids have anti-inflammatory, desensitizing, anti-allergic, immunosuppressive and anti-shock properties.

From the register of medicines of Russia 2008 issue known a number of drugs, showing glucocorticosteroid properties. In particular, these drugs Dexamethasone (tablets 500 microgram No. 10) company KRKA (Slovenia), Dexamethasone-Darnitsa (pill 0.0005 g No. 50) of closed joint stock company "Pharmaceutical company "Darnitsa" (Ukraine), Dexamethasone (tablets 500 microgram No. 50) of the company JSC "Himfor the plant "Akrikhin" (Russia), Daxin (tablets 500 microgram No. 100) of the firm Wave International (India), Dexason (tablets 500 microgram No. 10 and 50) company ICN Galenika (Yugoslavia), Dexamethasone (tablets 500 microgram No. 50) company Orion Pharma International (Finland), Dexamethasone (tablets 500 microgram No. 20 and 1000 firms Sanavita (Germany), Fortecortin (tablets 500 microgram No. 20, 1.5 mg n 50, 4 mg, 50 and 100) Merck (Germany) and others, However, the composition excipients in oral forms are not disclosed.

Renowned pharmaceutical composition [Mashkovsky PPM Medicines, 15th ed. - M.: RIA "New wave": the Publisher Merenkov, 2008. - 572 S.], containing corticosteroids in the form of dexamethasone sodium phosphate used for the treatment of rheumatoid arthritis, dermatoses, nephrotic syndrome, allergic diseases (bronchial asthma and other); lymphogranulomatosis, shock, brain edema, Addison disease, eczema, ulcerative colitis, etc.

However, the composition is a liquid preparation (0.4% solution for injection in ampoules of 1, 2 and 5 ml), which creates a number of problems with its application, in particular the increase in such side effects as increased excretion of calcium, leading to osteoporosis, slow process of regeneration, exacerbation of peptic ulcer and duodenal ulcer, ulceration of the digestive tract, the unrecognized perforation of ulcers, gemorragicheskii the pancreatitis and other

The closest analogue to the present invention is a pharmaceutical composition (patent RF №2381790, publ. 2010), which may be in the form of a tablet form and contains as active substances of the corticosteroid drug, including dimefest and excipients identified in the patent as a filler, from the class of disaccharide (sugar milk) and polysaccharide (starch).

The disadvantage of this structure is the large number of side effects, such as increased excretion of calcium, leading to osteoporosis, slow process of regeneration, exacerbation of peptic ulcer and duodenal ulcer, ulceration of the digestive tract, the unrecognized perforation of the ulcer, hemorrhagic pancreatitis, etc. in Addition, the use in the composition of sugar exclude from the circle of consumers with diabetes.

The present invention is to develop a pharmaceutical composition in suppository form for expanding Arsenal glucocorti-costeroids medicines, shown in patients with shock, allergic diseases.

The technical result is that when using the claimed composition does not occur allocation of calcium, followed by osteoporosis and other disorders of KOs is Noah fabric, not to injure the gastrointestinal tract, as well as the composition acceptable for diabetics.

The problem is solved by a group of inventions by creating a pharmaceutical composition exhibiting anti-shock and anti-allergic action.

The 1st variant, the composition, wt.%:

Dexamethasone sodium phosphate0,01-0,20
Substance "Micellar carbon dioxide
calcium and magnesium"1,0-30,0
Sodium hyaluronate0.3 to 1.0
Alcohol1.5 to 2.5
Nipagin0,15-0,24
Fructose5,0-15,0
Waterrest

The 2nd variant, the composition, wt.%:

Dexamethasone sodium phosphate0,01-0,20
Substance "Micellar carbon dioxide
calcium and magnesium the 1,0-30,0
Sodium hyaluronate0.3 to 1.0
Sodium fluoride0,008-0,015
Ascorbic acid0,10-0,25
Alcohol1.5 to 2.5
Nipagin0,15-0,24
Fructose5,0-15,0
Waterrest

The composition is conventionally called the "Mecaslin".

Carbonates of calcium and magnesium are used in the form of substance "Micellar of calcium carbonate and magnesium when the mass ratio of the carbonates of calcium and magnesium in a negatively charged suspension from 99:1 to 95:5.

Substance "Micellar of calcium carbonate and magnesium" is a complex negatively charged suspension containing carbonates of calcium and magnesium in micellar form, and micelles have a variable composition:

In addition, the suspension contains trace amounts of manganese, copper and iron (TU 5743-001-43646913-2006).

The unique ability of calcium to be absorbed by the body from the "Michellina plek logo calcium and magnesium due to the negative charge of the particles, micelles, generated ions HCO3-and CO32-. Such particles easily penetrate through the skin and the intestine directly into the bloodstream, where they actively participate in the processes of human activity. Impact negatively charged particles "Michellina of calcium carbonate and magnesium next. First, stabilization of the pH of the blood and blood cleansing, removal from the body of waste cells, toxins, regulation of blood clotting, stabilize cardiovascular activity, which is extremely important in shock. Secondly, the known positive effect of calcium on fat cells in allergic diseases (serum sickness, urticaria, angioneurotic edema, hay fever and other) and allergic complications associated with medication as well as skin diseases (itching, eczema, psoriasis, and others).

For long-term preservation of the contents of Michellina of calcium carbonate and magnesium", which is based on a negative particle charge of the micelles, in the form of pharmaceutical compositions entered the polysaccharide from the class of glycosaminoglycans and salt endogenous hyaluronic acid

Sodium hyaluronate is able to adsorb on the particle micelles without changing its charge. In General, the micelle is always electroneutrality, the particle charge is determined by the adsorbed ions are strongly related to the particle micelles. Figure tightly bound ions, in this case, negativeanddepicted in the form of a minus sign inside the particles, and counterions - CA2+and Mg2+in the form of a plus sign.

Brief description of drawings

In the initial suspension "Micellar of calcium carbonate and magnesium" total charge and Zeta-potential of the micelles is equal to zero (figure). In the pharmaceutical composition in the absence of polysaccharide "protection" may change the charge of the particle, because the other components can either be adsorbed on the particle surface, or to react with counterions (risb).

It is assumed that the hyaluronic acid has a double helix mesh structure inside cells which may get negatively charged ions and colloidal particles [D. Metzler Biochemistry. Chemical reactions in a living cell / Dresler; TRANS. from English. edited Ajebota, Limpinuntana, Essively. - Volume 1. - M.: Mir, 1980. - 121 C.]. Link glucuronic acid, existing in the form of sodium salt, and N-acetylglucosamine link in hyaluronic acid as a whole electrically neutral and contribute to the capture of negatively charged particles of suspension "Micellar carbonate of calcium and magnesium, preventing and wsimages the view with other components of the composition (a) : figure b).

On the other hand, hyaluronic acid structures suspension and manifests enveloping and regenerating effect, thereby protecting the gastrointestinal tract [Goa K.L., Benfield P. Hyaluronic acid. A review of its pharmacology and use as a surgical aid in ophtalmology and its therapeutic potential in joint disease and wound healing // Drugs. - 1994. - V.47. - N3. - P.536-566].

In addition, a protective effect of hyaluronic acid is evident in the fact that it eliminates the inhibitory effect of corticosteroids on the synthesis of endogenous hyaluronic acid in the human body.

In one of the pharmaceutical compositions is administered fluoride ions to reduce bone resorption by stimulating osteoblasts. To prevent adverse effects of fluoride in the composition additionally injected ascorbic acid.

Fructose as an excipient acts as a sweetener, and therefore the pharmaceutical composition may be recommended for patients with diabetes mellitus.

As preservative chose alcohol solution nipagina. It is known that nipagin, which represents a methyl ester parahydroxybenzoic acid (paraben), at the expense of low toxicity, it is recommended for the conservation of medicinal products intended for internal use, in particular hormonal means. In addition, this representative param the new best combined with glycosaminoglycans (hyaluronic acid).

Selected qualitative and quantitative composition makes it possible to achieve the desired therapeutic effect and to eliminate the side effects of active components.

Examples of obtaining a composition

Example 1.

In the reactor with stirring to 30 ml of water to make from 0.3 to 1.0 g of sodium hyaluronate, add with stirring 1.0 to 30.0 g of the substance "Micellar carbonate of calcium and magnesium, and then from 5 to 15 g of fructose. Then add from 0.01 to 0.2 g of dexamethasone sodium phosphate, 1.5 to 2.5 g of the alcohol from 0.15 to 0.24 g nipagina. The mixture to bring the water up to 100 g

The composition of the following composition, wt.%:

Dexamethasone sodium phosphate0,01-0,20
Substance "Micellar carbon dioxide
calcium and magnesium"1,0-30,0
Sodium hyaluronate0.3 to 1.0
Alcohol1.5 to 2.5
Nipagin0,15-0,24
Fructose5,0-15,0
Water100

Example 2.

In the reaction the op with stirring to 30 ml of water to make from 0.3 to 1.0 g of sodium hyaluronate, add while stirring from 1 to 30 g of substance "Micellar carbonate of calcium and magnesium, and then from 5 to 15 g of fructose. Then add from 0.01 to 0.2 g of dexamethasone sodium phosphate from 0,0008 to 0.015 g of sodium fluoride, 0.1 to 0.25 g of ascorbic acid, from 1.5 to 2.5 g of the alcohol from 0.15 to 0.24 g nipagina. The mixture to bring the water up to 100 g

The composition of the following composition, wt.%:

Dexamethasone sodium phosphate0,01-0,20
Substance "Micellar carbon dioxide
calcium and magnesium"1,0-30,0
Sodium hyaluronate0.3 to 1.0
Sodium fluoride0,008-0,015
Ascorbic acid0,10-0,25
Alcohol1.5 to 2.5
Nipagin0,15-0,24
Fructose5,0-15,0
Water100

Compositions represent a suspension.

Formulations of the compositions are given in the table

Example No. 5 is preferred.

Preclinical study of the effectiveness of pharmacological activity and safety of the proposed composition were conducted at the Central research laboratory of SEI HPE "Nizhny Novgorod state medical Academy Ministry of health of Russia" (bmrc GOU VPO "Nigga University") in accordance with the requirements of the order of Ministry of health of Russia from 19.06.03 No. 267 "On approval of rules of good laboratory practice in the Russian Federation", and also according to the Guidance on experimental (preclinical) study of new pharmacological substances. - M.: Medicine, 2005. - 832 C. the Maintenance and care of animals was in accordance with the international rules for the content and use of laboratory animals, Guide for care and use of laboratory animals. ILAR publication, 1996, NationalAcademy Press.

Specific pharmacological effect is studied in the simulation of allergic contact dermatitis in Guinea pigs, obtained from the kennel "High" SE NTS BMT RAMS.

Research has shown that the proposed pharmaceutical compositions have expressed specific pharmacological action, showing antishock action, and not have expressed General toxic effect at different doses and routes of entry into the body of an experimental animal is H. The compositions do not possess irritant, sensitizing effects were not identified.

The proposed pharmaceutical composition is an effective and safe tool and can be used with the brutal conditions, including diabetes mellitus.

1. Pharmaceutical composition having anti-shock and anti-allergic effect, characterized in that it contains dexamethasone sodium phosphate, a substance "Micellar carbonate of calcium and magnesium, sodium hyaluronate, alcohol, nipagin, fructose and water in the following ratio, wt.%:

Dexamethasone sodium phosphate0,01-0,20
Substance "Micellar carbon dioxide
calcium and magnesium"1,0-30,0
Sodium hyaluronate0.3 to 1.0
Alcohol1.5 to 2.5
Nipagin0,15-0,24
Fructose5,0-15,0
WaterRest

2. Pharmaceutical composition having p is oteosemuem and antiallergic effect, characterized in that it contains dexamethasone sodium phosphate, a substance "Micellar carbonate of calcium and magnesium, sodium hyaluronate, alcohol, nipagin, fructose, sodium fluoride, ascorbic acid and water in the following ratio, wt.%:

Dexamethasone sodium phosphate0,01-0,20
Substance "Micellar carbon dioxide
calcium and magnesium"1,0-30,0
Sodium hyaluronate0.3 to 1.0
Sodium fluoride0,008-0,015
Ascorbic acid0,10-0,25
Alcohol1.5 to 2.5
Nipagin0,15-0,24
Fructose5,0-15,0
WaterRest



 

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