Pharmaceutical formulation of antibiotics and prebiotics (versions) applied for prevention and medical treatment of disbioses caused by antibacterial therapy

FIELD: medicine; pharmacy.

SUBSTANCE: first version implies that pharmaceutical formulation contains antibiotic and prebiotic - oligosaccharide selected from: fructooligosaccharides, galactooligosaccharides, xylooligosaccharides, maltooligosaccharides and isomaltooligosaccharides by degree of polymerization from 2 to 10, and particles sizes up to 0.3 mm and purity not less than 95%, and antibiotic with particles sizes from 20 to 200 mcm; antibiotic and oligosaccharide are included in mass proportion from 1:1 to 1:100 respectively. Second version implies that pharmaceutical formulation contains powder antibiotic with particles from 20 to 200 mcm selected from: beta-lactamase, including combinations of beta-lactams and bacterial beta-lactamases inhibitors; azalides, fluoroquinolones, amphenicoles, glycopeptides, ansamicynes, nitrofurans, phosphonic acid derivatives, cycloserine, trimetoprym, and as a prebiotic - powder oligosaccharide by degree of polymerization from 2 to 10, particles sizes up to 0.3 mm and purity not less than 95%; antibiotic and oligosaccharide are included in mass proportion from 1:1 to 1:100 respectively; mentioned compositions are intended for oral introduction and applied for bowel disbios prevention caused by antibiotic therapy.

EFFECT: stimulates lactobacilli and bifidus bacteria action.

4 cl, 9 ex

 

The invention relates to medicine, namely to the pharmaceutical industry and the creation of compositions of pharmaceutical preparations containing antibiotics and probiotics, to adjust the composition of the intestinal microflora during antibiotic therapy.

Therapeutic effect of broad-spectrum antibiotics, usually accompanied by disorders of the gastro-intestinal tract, associated with the negative impact of antibiotics on the microflora of the colon. While antibiotics are strongly and negatively affect the permeability of biological membranes to ions of ammonia in the colon. As a result, the antibiotics suppress not only pathogenic but also the microflora of the digestive tract, leading to disruption of homeostasis and contribute to the development of dysbiosis and allergies.

Imbalance in the microbiocenosis of intestines in some cases leads to violations on the part of the immune system and active reproduction of single-celled fungi that colonise the intestine. The normal intestinal microflora is essential to the digestion and assimilation of nutrients, as well as a barrier to exogenous infection is involved in the toxic metabolites, restricting the proliferation of pathogenic and conditionally-pathogenic strains of microorganisms entering the intestine.

Most wealth is pleasant conditions for vital activity of microflora occurs in the distal small intestine, where you do not get the secrets of the stomach and pancreatic protease, as well as components of bile, bacteriostatic and bactericidal effects which weaken as it approaches a thick intestine.

On the background of dysbiosis trapped in the body of pathogenic causative agents of intestinal infections or opportunistic pathogens quickly colonise the mucous membrane of the intestine and colon, destroying epithelial cells and showing a pronounced antagonism to the indigenous microflora.

Develop inflammation, which leads to decreased production short-chain fatty acids, inhibiting the growth of pathogenic microorganisms. This occurs during antibiotic therapy with drugs with a broad spectrum of action. Even a partial loss of their own intestinal microflora leads to serious consequences for the organism and requires self-treatment.

Such treatment may be carried out, in particular, by assigning a variety of probiotics, which are not always compatible with representatives normoflora and in a few days can eliminate from the intestines.

With regard to the development of adverse effects when using these drugs, they relate primarily to the ability of probiotics to modulate immune inflammation. For example, it is known that 10% of workers on p is izvodstvu bacterial and immunobiological products (probiotics) after a few years of work developing allergic diseases.

A more physiological way of maintaining the active state of the normal intestinal flora is the administration of prebiotics. To prebiotics are nevereverever ingredients of food, contributing to improved health due to selective stimulation of growth and/or metabolic activity of one or more groups of bacteria living in the colon.

Prebiotics unlike probiotics in the stomach is not digested and reach the large intestine intact, as they have in the structure of beta-glycosidic bonds, which in humans is not hydrolyzed due to the lack of beta-field of glycosidase inhibition. Prebiotics are able to selectively stimulate the growth and reproduction of lactobacilli and bifidobacteria, i.e. species that dominate the composition normoflora of the human intestine.

The purpose of complex therapy with the inclusion of prebiotics aimed at the elimination of atrophic processes in the mucous membrane of the colon and degenerative changes in the epithelium with the restoration of functional abilities.

However, separated in time to take antibiotics and probiotics at least half of the cases may not exclude destruction of the intestinal microflora by antibiotics.

Most of the probiotics use after the onset of symptoms of dysbiosis in the form of diarrhea and flatulence. In d is the query result to start taking probiotics after antibiotic therapy useful microflora falters or practically viable.

In this regard, it is advisable to provide selective advantages useful microflora in front of pathogenic or opportunistic bacteria during antibiotic treatment. Therefore, attempts are being made to protect the indigenous microflora of the intestine due to simultaneous reception of antibiotics and prebiotic in the form of a single pharmaceutical composition.

Renowned pharmaceutical composition, its preparation and method of application that contains the prebiotic lactulose and antibiotics from the group of penicillins, cephalosporins, tetracyclines, lincosamides, macrolides (EN 2284832 from 10.10.2006; prototype).

The disadvantage of this composition is that lactulose contains a significant amount of impurities (lactose, galactose, fructose), which stimulate the growth of pathogenic and conditionally pathogenic microorganisms, parasites in the intestines.

Negative is the laxative effect of lactulose, which shortens the time of passage of chyme and reduces the absorption and assimilation of nutrients, and in addition, the purgative effect of lactulose in combination with antibiotics may clinically be regarded as a sign of a dysbacteriosis.

In addition, it is known that dry lactulose is extremely hygroscopic, and this creates serious technical difficulties in the production of compositions, packaging, storage and the ready attachment of drugs, containing lactulose.

Known dosage form is a pharmaceutical composition, its preparation and method of application, containing an antibiotic and a prebiotic fructan, which in addition to the antibacterial action and to some, more slowly evolving maintain intestinal flora increases the absorption of calcium and mineralization of bones (EP 1166800 from 2002, prototype)

The disadvantages of this arrangement are narrow application range, low specificity stimulating action on the main types of indigenous microflora, optimal mass ratio (unbalanced) antibiotic and fructan, non-optimal dispersion (particle size), the optimal degree of polymerization of prebiotic, which reduces the fermentation of sugars and antibacterial product. This reduces therapeutic effect of receiving the composition, and the absorption of calcium and bone mineralization. In addition, the above composition is distinguished by the complexity of the process of preparation and lack of effectiveness of the application.

The disadvantages of this composition is largely due to the high polymerizate and low purity of fructan, which complicates the process of fermentation of polysaccharide lactobacilli and bifidobacteria and requires an increase in the number of preby the tick in the composition.

Negative is the presence of lactulose most domestic producers of impurities (up to 40%), stimulating the growth of pathogenic and conditionally pathogenic enteric bacteria, the presence of side effects on the blood clotting system (mainly elongation partial prothrombin time and decreased levels of fibrinogen), a significant frequency of allergic reactions.

The technical task of the group of inventions so linked as to form a single inventive concept is to provide effective pharmaceutical compositions and method of prevention of dysbiosis and expanding Arsenal of pharmaceutical compositions and methods of prevention of dysbiosis.

Technical result, which provides the solution of the problem, is that a broader range of compositions of prebiotics and antibiotics due to the inclusion in the composition of the most effective antibacterial preparations (fluoroquinolones and ansamycins were) and eliminate side effects.

In addition, effective utilization of prebiotic component of the composition in the intestine due to the introduction of oligosaccharides optimal degree of polymerization and the optimum ratio of components necessary defernatly (particle size).

Summary of the invention in the part of pharmaceutical compositions for p is moralnego use in the first embodiment is the pharmaceutical composition comprises an antibiotic and a prebiotic, and as a prebiotic - oligosaccharide with a degree of polymerization of from 2 to 10 from the group of natural or synthetic is not digestible oligosaccharide selected from the group: fructo-oligosaccharides, galactooligosaccharides, xylooligosaccharides, maltooligosaccharides and isomaltooligosaccharides, the antibiotic and the oligosaccharide in a fixed composition taken in a weight ratio of from 1:1 to 1:100.

The claimed composition comprises the oligosaccharide in the form of powder with particle size up to 0.3 mm, with a purity not less than 95%, and the antibiotic is in the form of a powder with a particle size of 20-200 μm, and pharmaceutically acceptable amounts of auxiliary substances, improves sensory and consumer properties, selected from the group of fillers, correctors of taste, flavors, fragrances.

The claimed pharmaceutical composition can be made in a dosage form suitable for oral administration selected from the group: capsules, tablets, powders, pills, pills, granules, sachets, gels, pastes, syrups, emulsions, suspensions, solutions.

The invention is in part a pharmaceutical composition for oral administration according to the second variant consists in that the pharmaceutical composition contains an antibiotic and a prebiotic, and it contains Antibes is Otik, selected from the group of beta-lactams, including combinations of beta-lactam inhibitors bacterial betalactams, macrolides, azalides, fluoroquinolones, amphenicols, lincosamides, glycopeptides, ansamycins, nitrofuranov, derivatives of phosphonic acid, cycloserine, and sulfonamides (trimethoprim), and as a prebiotic - oligosaccharide with a degree of polymerization of from 2 to 10, with the antibiotic and the oligosaccharide contained in the composition of fixed composition in a weight ratio of from 1:1 to 1:100, respectively.

The claimed composition comprises the oligosaccharide in the form of powder with particle size up to 0.3 mm, with a purity not less than 95%, and the antibiotic is in the form of a powder with a particle size of from 20 to 200 μm, and pharmaceutically acceptable amounts of auxiliary substances, improves sensory and consumer properties, selected from the group of fillers, correctors of taste, flavors, fragrances.

The claimed pharmaceutical composition can be made in a dosage form suitable for oral administration selected from the group: capsules, tablets, powders, pills, pills, granules, sachets, gels, pastes, syrups, emulsions, suspensions, solutions.

The invention is in part a way to prevent is that the method of prevention of dysbiosis in antibacterial therapy with antibiotics and/or sulfanilamidnymi drugs involves receiving a prebiotic with antibiotic or sulfa drug (respectively) within a single pharmaceutical composition, containing as a prebiotic oligosaccharide with a degree of polymerization of from 2 to 10, when the mass ratio of the content of the antibiotic and the oligosaccharide from 1:1 to 1:100, respectively.

The claimed composition comprises the oligosaccharide in the form of powder with particle size up to 0.3 mm, with a purity not less than 95%, and the antibiotic is in the form of a powder with a particle size of from 20 to 200 μm, and pharmaceutically acceptable amounts of auxiliary substances, improves sensory and consumer properties, selected from the group of fillers, correctors of taste, flavors, fragrances.

The pharmaceutical composition may be in a dosage form suitable for oral administration, from the group of capsules, tablets, powders, pills, pills, granules, sachets, gels, pastes, syrups, emulsions, suspensions, solutions.

The claimed composition of the antibiotic and the oligosaccharide, among other things, significantly increases the absorption of calcium and enhances bone mineralization patients.

In turn, the oligosaccharides used in the claimed compositions: fructo-oligosaccharides, galactooligosaccharides, xylooligosaccharides, maltooligosaccharide and isomaltooligosaccharide not only create conditions for the growth of beneficial bacteria, but also effectively improve the blood, the cardiovascular and immune systems.

This takes into account that the PR is aNISM person is a multiorgan system, cellular elements which are specialized to perform different functions.

The interaction inside the body is a complex regulating, coordinating and correlating mechanisms with the participation of neurohumoral and other factors. Many individual mechanisms regulating intra - and intercellular interactions, perform multi-directional functions, balancing each other.

This leads to the establishment of a body rolling physiological balance and allows the whole system to maintain the relative dynamic balance, despite changes in the environment and the shifts that occur during the life of the organism.

Violation of physiological balance, including those associated with imbalance in the microbiocenosis, may manifest as diseases of various organs.

The inventive composition and method of treatment aimed at prevention or effective reduction of the variance of the physiological balance of the intestinal under the influence of "disturbing" factor in the form of antibiotics.

Oligosaccharides, carbohydrates whose molecules have formed no more than 10 residues of monosaccharides. Accordingly, there are disaccharides, trisaccharide etc.

In organisms oligosaccharides are formed by enzymatic cleavage is polisaharidov. The microorganisms of the intestinal disposed of oligosaccharides using field of glycosidase inhibition, and the introduction of oligosaccharides leads to increased production and increased sacharolytica activity of these enzymes.

As a prebiotic - oligosaccharide, in the form prescribed in accordance with the present invention comes in the claimed composition simultaneously with the antibiotic and the required mass ratio, when the antibiotic suppression of pathogenic bacteria native microflora of the colon does not die, and synchronously with the receipt of oligosaccharide hydrolyzes (brivet) the latter with the formation of effective amounts of acids: lactic, partially formic and acetic.

While in the colon increases the osmotic pressure to 6.6-8.0 ATM and decreases the value of the measure of the acidity below pH 5.0, i.e. in the direction of increasing acidity that leads to a reliable maintenance of normal selective permeability of biological membranes of the intestine and retention therein of ammonium ions, removing ammonia from the blood into the intestine and its ionization and thereby creates in the lumen of the large intestine completely unfavorable conditions for the development of other bacteria, such as Salmonella.

The resulting acidic products and other metabolites inhibit the development of a wide range of putrefactive microflora. As a result, the clearance key is ecnica decreases the number of pathogenic bacteria and toxic metabolites (ammonia, of skatole, indole, etc).

On the background of effective maintenance of homeostasis freely provided sufficient reproduction and growth stimulation maintain a natural healthy intestinal flora.

When increasing the acidity of the acid reacts with the amine groups of the protein and thus, by subtracting the HE-ions contributes to electropolishing protein that suppresses inflammatory processes that could occur in the intestine because of external reasons and as a complication of the underlying disease.

Any nonliving and living matter: the body system, organ, tissue, cell, cell organelles and substrates, etc. has its own spectrum of electromagnetic oscillations in a wide range from a few hundredths of Hertz (Hz) to kilo-, megahertz and more complex harmonics.

Normally, these oscillations are called harmonic (or physiological), in pathology - disharmoniously fluctuations (or pathological).

Oligosaccharides as plant components have energy components, initiating ultra-weak electromagnetic oscillations, which are superimposed on disharmonies fluctuations introduced by the antibiotics, and if the selected mass ratio of ingredients is as if "erase" this potentially pathological information.

This action oligosaccharides, obviously due the ANO with an immunostimulating effect, which increases the nonspecific resistance of the body to infections and keeps the "biological balance".

When this occurs, the recovery processes of self-regulation and amplification of harmonic oscillations, stimulating the regeneration of the mucous membrane of the intestine.

The process of preparing the inventive composition provides for the preparation of specified quantities of powdered antibiotic and prebiotic with a guaranteed supplier of purity not less than 95%, the drying up 2-3% humidity and mixing ratio provided by the present invention. In the mix also impose anti-caking, flavors, taste correctors and removing static electrical charges.

Further, in accordance with the dosage and dosage form produces a packing of the finished product.

There were prepared compositions with the following combination of ingredients:

1. FOS with one amphenicols, and FOS in the form of a powder with a particle size of from 0.1 to 0.3 mm and with degree of polymerization from 2 to 6, and the antibiotic is in the form of a powder with a particle size of from 130 to 200 μm, the antibiotic and FOS taken in the mass ratio 1:1.5, respectively.

2. FOS with one of the fluoroquinolones, and FOS in the form of a powder with a particle size of from 0.1 to 0.3 mm and with degree of polymerization from 2 to 6, and the antibiotic is in the form of powder is and with a particle size of from 30 to 120 μm, when this antibiotic and FOS taken in a mass ratio of 1:2 respectively.

3. FOS with one of glycopeptides, and FOS in the form of a powder with a particle size of from 0.1 to 0.3 mm and with degree of polymerization from 2 to 6, and the antibiotic is in the form of a powder with a particle size of from 20 to 90 μm, the antibiotic and FOS taken in a mass ratio of 1:4, respectively.

4. FOS with one ansamycins, and FOS in the form of a powder with a particle size of from 0.1 to 0.3 mm and with degree of polymerization from 4 to 10, and the antibiotic is in the form of a powder with a particle size of from 20 to 140 μm, the antibiotic and FOS taken in a mass ratio of 1:15, respectively.

5. FOS with one amphenicols, and FOS in the form of a powder with a particle size of from 0.1 to 0.3 mm and with degree of polymerization from 2 to 6, and the antibiotic is in the form of a powder with a particle size of from 20 to 90 μm, the antibiotic and FOS taken in a mass ratio of 1:30, respectively.

6. FOS with one of nitrofuranov, and FOS in the form of a powder with a particle size of from 0.1 to 0.3 mm and with degree of polymerization from 2 to 8, antibiotic in powder form with a particle size of from 20 to 120 μm, the antibiotic and FOS taken in a mass ratio of 1:70, respectively.

7. FOS with one of the sulfa drugs (Biseptol), and FOS in the form of a powder with a particle size of from 0.2 to 0.3 mm and with degree of polymerization from 2 to 6, and the antibiotic is in the form of a powder with a size of the portion is from 20 to 120 μm, when this antibiotic and FOS taken in a mass ratio of 1:100, respectively.

8. Galactooligosaccharide (GOS) with one amphenicols, and the STATE in the form of a powder with a particle size of from 0.1 to 0.3 mm and with degree of polymerization from 5 to 15, and the antibiotic is in the form of a powder with a particle size of from 50 to 150 μm, the antibiotic and the STATE taken in a mass ratio of 1:2 respectively.

9. The STATE with one of the fluoroquinolones, and the STATE in the form of a powder with a particle size of from 0.1 to 0.3 mm and with degree of polymerization from 4 to 12, and the antibiotic is in the form of a powder with a particle size of from 20 to 90 μm, the antibiotic and the STATE taken in a mass ratio of 1:3, respectively.

10. The STATE with one of the glycopeptides, and the STATE in the form of a powder with a particle size of from 0.1 to 0.3 mm and with degree of polymerization from 5 to 15, and the antibiotic is in the form of a powder with a particle size of from 30 to 100 μm, the antibiotic and the STATE taken in a mass ratio of 1:40, respectively.

11. The STATE with one of ansamycins, and the STATE in the form of a powder with a particle size of from 0.1 to 0.3 mm and with degree of polymerization from 3 to 10, and the antibiotic is in the form of a powder with a particle size of from 20 to 110 μm, the antibiotic and the STATE taken in a mass ratio of 1:60, respectively.

12. The STATE with one of the derivatives of phosphonic acid (fosfomicin), and the STATE in the form of a powder with a particle size of from 0.1 to 0.3 mm and with degree of polymerization from 4 to 12, and antibioti is - in powder form with a particle size of from 20 to 90 μm, the antibiotic and the STATE taken in a mass ratio of 1:90, respectively.

13. The STATE with one of the nitrofuranov, and the STATE in the form of a powder with a particle size of from 0.1 to 0.3 mm and with degree of polymerization from 3 to 10, and the antibiotic is in the form of a powder with a particle size of from 90 to 200 μm, the antibiotic and the STATE taken in a mass ratio of 1:55, respectively.

14. The STATE with one of the sulfa drugs (streptocid), and the STATE in the form of a powder with a particle size of from 0.2 to 0.3 mm and with degree of polymerization from 2 to 6, and the antibiotic is in the form of a powder with a particle size of from 40 to 150 μm, the antibiotic and the STATE taken in a mass ratio of 1:45, respectively.

15. Xylooligosaccharide (KOS) with one amphenicols, and KOS in the form of a powder with a particle size of from 0.2 to 0.3 mm and with degree of polymerization from 2 to 6, and the antibiotic is in the form of a powder with a particle size of from 20 to 120 μm, the antibiotic and KOS taken in a mass ratio of 1:45, respectively.

16. KOS is one of the fluoroquinolones, and KOS powder form with a particle size of from 0.1 to 0.3 mm and with degree of polymerization from 2 to 8, antibiotic in powder form with a particle size of from 20 to 120 μm; the antibiotic and KOS taken in a mass ratio of 1:80, respectively.

17. KOS is one of the glycopeptides, and KOS in the form of a powder with a particle size of from 0.2 to 0.3 mm and with degree is the group of polymerization of from 4 to 10, and the antibiotic in powder form with a particle size of from 160 to 200 microns; the antibiotic and KOS taken in a mass ratio of 1:100, respectively.

18. KOS with one ansamycins, and KOS in the form of a powder with a particle size of from 0.1 to 0.3 mm and with degree of polymerization from 2 to 8, antibiotic in powder form with a particle size of from 20 to 100 μm; the antibiotic and KOS taken in a mass ratio of 1:65, respectively.

19. KOS with one of the derivatives of phosphonic acid (fosfomicin), and KOS in the form of a powder with a particle size of from 0.2 to 0.3 mm and with degree of polymerization from 4 to 10, and the antibiotic is in the form of a powder with a particle size of from 20 to 100 μm; the antibiotic and KOS taken in the mass ratio 1:5,5, respectively.

20. KOS is one of nitrofuranov, and KOS in the form of a powder with a particle size of from 0.1 to 0.3 mm and with degree of polymerization from 2 to 6, and the antibiotic is in the form of a powder with a particle size of from 30 to 120 μm, the antibiotic and KOS taken in a mass ratio of 1:3.5, respectively.

21. KOS is one of the sulfa drugs, and KOS in the form of a powder with a particle size of from 0.1 to 0.3 mm and with degree of polymerization from 2 to 6, and the antibiotic is in the form of a powder with a particle size of from 20 to 90 μm, the antibiotic and KOS taken in a mass ratio of 1:2 respectively.

22. Maltooligosaccharides (MOS) with one amphenicols, and MOS in powder form with R is Merom particles from 0.1 to 0.3 mm and with degree of polymerization from 2 to 6, and the antibiotic in powder form with a particle size of from 120 to 180 μm, the antibiotic and MOS are taken in a mass ratio of 1:1, respectively.

23. MOS with one of the fluoroquinolones, and MOS in the form of a powder with a particle size of from 0.2 to 0.3 mm and with degree of polymerization from 2 to 6, and the antibiotic is in the form of a powder with a particle size of from 20 to 120 μm, the antibiotic and MOS are taken in a mass ratio of 1:6, respectively.

24. MOS with one of glycopeptides, and MOS in the form of a powder with a particle size of from 0.1 to 0.3 mm and with degree of polymerization from 2 to 6, and the antibiotic is in the form of a powder with a particle size of from 20 to 90 μm, the antibiotic and MOS are taken in a mass ratio of 1:25, respectively.

25. MOS with one of the derivatives of phosphonic acid (fosfomicin), and MOS in the form of a powder with a particle size of from 0.1 to 0.3 mm and with degree of polymerization from 2 to 8, antibiotic in powder form with a particle size of from 20 to 120 μm, the antibiotic and MOS are taken in a mass ratio of 1:60, respectively.

26. MOS with one ansamycins, and MOS in the form of a powder with a particle size of from 0.1 to 0.3 mm and with degree of polymerization from 5 to 15, and the antibiotic is in the form of a powder with a particle size of from 20 to 90 μm, the antibiotic and MOS are taken in a mass ratio of 1:70, respectively.

27. MOS with one of the carbapenems, and MOS in the form of a powder with a particle size of from 0.1 to 0.3 mm with frame is Yu polymerization of from 4 to 12, and the antibiotic in powder form with a particle size of from 40 to 140 μm, the antibiotic and the oligosaccharide taken in a mass ratio of 1:100, respectively.

28. MOS with one of the sulfa drugs, and MOS in the form of a powder with a particle size of from 0.1 to 0.3 mm and with degree of polymerization from 2 to 8, antibiotic in powder form with a particle size of from 20 to 120 μm, the antibiotic and MOS are taken in a mass ratio of 1:6, respectively.

The claimed pharmaceutical composition is presented in the pharmaceutical forms suitable for oral administration, in particular in the form of capsules, tablets, powders, pills, pills, granules, sachets, gel, paste, syrup, emulsion, suspension, solution.

The compositions are introduced pharmaceutically acceptable amount of auxiliary substances, improve sensory and consumer properties, in particular fillers, correctors of taste, flavors.

The possibility of carrying out the invention can be illustrated by the following examples:

Example 1.
Gelatine capsule (contents) (1100 mg):
Azithromycin500.0 mg
Foz5000,0 mg
Example 2.
Pill and weight 1300 mg)
Moxifloxacin400,0 mg
MOSof 800.0 mg
Excipients:
Microcrystalline cellulose50.0 mg
Crosspovidone20.0 mg
Crosscarmellose sodium20.0 mg
Talc5.0 mg
Magnesium stearate5.0 mg
Example 3.
Powder (for the preparation of a suspension of 5.0 ml)
Amoxicillin125,0 mg
Clavulanic acidof 31.25 mg
Foz200.0 mg

The powder was dissolved in 5.0 ml) cooled to room temperature boiled water immediately before use.

Example 4.
Syrup:
Nifuroxazide200.0 mg
STATE300,0 mg
Excipients:
Sucrose30.0 mg
Citric acid monohydrate1000,0 mg
Glycine (flavor enhancer)14,5 mg
Quinoline yellow (dye)5.0 mg
Sodium tetraborate (preservative)5.0 mg
Orange 526 (flavouring)4,56 mg
Distilled water100,0 ml
Example 5.
Gel:
Moxifloxacin400,0 mg
Fozof 800.0 mg
Basis:
Polyvinylpyrrolidone12000,0 mg
Example 6.
Pellets (in bags):
Nifuratel500.0 mg
KOS400,0 mg
Example 7.
Pasta:
Amoxicillin125,0 mg
Clavulanic acidof 31.25 mg
Foz200.0 mg
Basis:
Vaseline oil712,5 mg
Example 8.
Ointment:
Azithromycin500.0 mg
STATEof 600.0 mg
Basis:
The vase is new oil 11000,0 mg

Example 9.

To study the action of the drugs and confirm their suitability as a preventive and therapeutic medicines conducted studies of their influence on the organism of patients with various infectious diseases.

What was to assess the effect of drugs on overall health, physical activity, sleep, appetite, progression of atherosclerosis, neurological status and somatic chronic diseases (diabetes).

As part of the experimental group were observed 157 patients aged 19 to 70 years, men and 67 women) 82.

Among them: with a diagnosis of peptic ulcer - 48 patients diagnosed with chronic bronchitis and bronchiectasis - 45 patients with a diagnosis of acute or chronic pneumonia - 40 people, with gynaecological diagnoses - 24 women.

Diagnosis in outpatient examination on the basis of the General medical examination and, in particular, colposcopy, additional survey data, including, in particular, laboratory, biochemical, cytological study, the instrumental methods (ECG, echocardiography, fluoroscopy, esophagogastroduodenoscopy (EGD)).

All patients were divided by nosa is Ogii into three groups: I (48 people) - with diseases of the gastrointestinal tract: gastric ulcer; II (85) - lower respiratory disease: chronic bronchitis, bronchiectasis, acute and chronic pneumonia; III (24 persons) diseases of the reproductive system: cervical erosion, vaginal dysbiosis.

Almost all patients (as history) for a long time had symptoms of disorders of the gastrointestinal tract, colitis, enterocolitis, intestinal dysbiosis, irritable bowel syndrome (IBS), due to the use of (previous treatment) antibiotics from the group of penicillins, cephalosporins, tetracyclines, lincosamides, macrolides, which are practically not had the desired effect and, as a rule, caused allergic reactions.

All patients prior to receiving the claimed compositions investigated the blood: a General analysis, biochemical parameters: ACT, ALT, creatinine, glucose, calcium, total bilirubin, albumin, serum iron, TIBC, sodium, potassium, cholesterol, uric acid, urea, albumin, alkaline phosphatase, GGT, triglycerides, βlipoproteins; urine: General analysis; the contents of the intestine: mikrobiologicheskii analysis of the gut contents and coprogram; patients with diseases of the gastrointestinal tract additionally performed the SDS, and women, before and after treatment, underwent diagnostic procedures: colposcopy and subsequent biopsy of the mucosa of the cervix for cytological study and took a swab of the cervical canal and vagina for microbiological examination content.

In each nosological group were selected: one experimental and two control groups.

Thus, patients of group I were separated as follows:

Group 1 patients (experienced) - 6 people took the pharmaceutical composition in the form of granules, including nifuratel and KOS, 2-3 times a day after meals, for 7-10 days.

The 2nd group of patients (control) - 18 people took nifuratel at a dose of 500.0 mg and KOS dose 400,0 mg separately, within 7-10 days.

Group 3 (control) - 24 people took nifuratel at a dose of 500.0 mg and placebo in the dose 400,0 mg (instead KOS) for 7-10 days.

Control studies were performed within 2 months every 10-14 days.

Summary: improvement of the General condition were recorded in most of the patients of the experimental group (5 people) after 5-6 days of receiving the claimed composition. Patients with gastric ulcer and duodenal ulcer (DU) noted the disappearance of pain in the stomach, duodenum and intestines, and in the analysis of intestinal contents showed an increase in sod is Rania lactobacilli and bifidobacteria; 14 days after the start of treatment (during the control EGDS) they noted a significant reduction of hyperemia and edema of the mucous membrane of the stomach and duodenum and the first signs of epithelialization of ulcers.

In 6-9 days after the start of treatment status of the patients in the control group also improved, but in the first group (9 patients - 50%), while the second group (18 patients - 75%) was clearly manifested symptoms of the effects of antibiotics on the intestinal microflora in the form of discomfort in the abdomen, weak pain along the large intestine, flatulence and diarrhea (intestinal dysbiosis).

In 2 patients of these two groups of intestinal dysbiosis has led to decreased appetite and insomnia.

Patients of group II (with lower respiratory disease) were also divided into three groups:

Group 1 patients (experienced) - 12 people took the claimed composition in pill form azithromycin with MOS, 1 time a day, during or after meals for 3 days; dose rate of azithromycin corresponded to the number specified by the instruction on the use of azithromycin in standard treatment regimens for specific diseases of the lower respiratory tract and, as a rule, did not exceed 1.5 grams;

The 2nd group of patients (control) is 36 persons, took azithromycin at a dose of 500.0 mg and MOS dose 1500,0 mg p is zdolno, 1 times a day with an interval of 2-2,5 hours, within 3 days;

Group 3 patients (control) 37 people took azithromycin at a dose of 500.0 mg and placebo in the dose 1500,0 mg (instead MOS) 1 times a day with an interval of 2 - 2, 5 hours, within 3 days.

In each group of patients were comparable in age, duration and severity of illness, and comorbidity.

Control studies were performed within 2 months after every 8-10 days.

Summary: improvement of the General condition were recorded in all 6 patients of the experimental group after 3 days of receiving the composition. During x-ray of the lungs marked reduction peribronchiolar and intrabronchial inflammation, increase transparency of the lungs, increasing the mobility of the diaphragm, the improvement of the drainage function of bronchi.

Patients in both control groups in the first days of receiving the composition, the condition has been evaluated as unsatisfactory: there was an increase in body temperature, weakness, depression, flatulence, constipation or diarrhea. 5 days after the start of treatment, the condition of patients in the control group also improved, but in the first group, 9 (50%) in the second group of 28 (75%) patients clearly showed symptoms negative effects of antibiotics on the intestinal microflora in the form of discomfort in the abdomen, weak pain during Tolstov the intestines, flatulence and diarrhea.

Patients in group III were divided into 3 groups:

Group 1 patients (experienced) - 6 people took the claimed pharmaceutical composition in the form of capsules containing moxifloxacin dose 400.0Hz in units of mg and FOS dose of 800.0 mg, 2 times a day, during or after a meal within 7-10 days;

The 2nd group of patients (control) - 9 people took moxifloxacin dose 400.0Hz in units of mg and FOS dose of 800.0 mg separately, twice, with an interval in 2 - 2.5 hours for 7-10 days;

Group 3 patients (control), 9 people took moxifloxacin dose 400.0Hz in units of mg and placebo in the dose of 800.0 (instead FOS) twice, after delivery within 7-10 days.

Summary: improvement in General condition was recorded in 9 patients of the experimental group after 5-8 days of receiving the composition. During the colposcopy after 21 days from the start of treatment was marked by the appearance of the first signs of epithelialization erosion and the occurrence of vaginal microbiocenosis of lactobacilli and bifidobacteria; significantly decreased allocation and completely pain disappeared. Data cytological study after administration of the drug testified to the almost complete replacement of columnar epithelium squamous epithelium and strokes was evidence of decreased inflammation phenomena.

Patients of all control gr the PP in the first days of receiving the composition, the condition has been evaluated as unsatisfactory: there was an increase in body temperature, weakness, depression, flatulence, constipation or diarrhea. In 6-9 days after the start of treatment the patients of the control groups improved, but in the first group, 5 in the second group, 6 patients clearly showed symptoms negative effects of antibiotics on the intestinal microflora in the form of discomfort in the abdomen, weak pain along the large intestine, flatulence and diarrhea.

Almost all patients experienced groups (taking into account the division by nosology) the functional status of the gastrointestinal tract is normalized, the number of muscle fibers, fat, fatty acids, is not digested fiber in the coprogram was within normal limits. Analysis of the dynamics of some biochemical parameters showed that there is a significant decrease in bilirubin, β-lipoproteins, triglycerides, ALT, ACT. Structural and functional changes in the plasma proteins show increased binding capacity of albumin, increase in the activity of antibodies and proteins of the complement system. The results of biochemical studies and the cellular composition of peripheral blood also indicate the positive dynamics of the process.

At the same time increased the number of synthesized urea, which indicates the improvement of processes of transamination and transamination of amino acids in the liver, i.e. the normalization of metabolic Deux is ntoxication processes in the liver.

Almost all patients experienced groups reported improvement in quality of life through increased physical activity, improved mood and sleep, normalize appetite and bowel function. Negative side effects of taking songs with antibiotics did not manifest either during treatment or during follow-up.

In the control groups in patients receiving the antibiotic and the oligosaccharide separately, indicators of intestinal homeostasis approached the performance of the experimental group only in 53% of cases.

In the control groups in patients receiving antibiotic with placebo, regardless of decreasing the intensity of symptoms under the influence of antibiotic indicators of intestinal homeostasis in 87% of cases had no clear trend of improvement.

Monitoring the condition of most patients in experimental groups treated with the claimed preparation (based on the severity of the underlying disease), continued in the next 18 months and confirmed the reduction of the incidence of acute respiratory viral diseases, increase efficiency, normalization of sleep, reduce the frequency of relapse of the underlying disease and steady improvement in the quality of life, in particular the evacuation activity of the intestine.

When compared to the average age and morbidity in patients of the experimental group has also reduced the incidence of cancer, cardiovascular diseases, diseases of the musculoskeletal system, as well as reducing recovery times for minor injuries of the ligaments, bones and joints.

Considering all the above, it can be reasoned conclusion that the claimed composition is an effective and safe method for the treatment of diseases caused by infectious agents, and the composition has a stimulating effect on lactobacilli and bifidobacteria, inhibiting the growth and reproduction of extraneous microflora, thereby providing a stronger preventive action.

Thus, the result set of options effective pharmaceutical compositions and effective method of prevention of dysbiosis, expanded arsenals pharmaceutical compositions and methods of prevention of dysbiosis.

This extended the range of application of the composition of prebiotics and antibiotics due to the inclusion in the composition of the most effective antibacterial preparations (e.g., fluoroquinolones and ansamycins were) and eliminate side effects.

In addition, effective utilization of prebiotic component of the composition in the intestine due to the introduction of oligosaccharides optimal degree of polymerization and the optimum ratio of components necessary defernatly (the size of the ditch particles).

1. Pharmaceutical composition for the prevention of intestinal dysbiosis in the process of antibiotic intended for oral administration containing an antibiotic and a prebiotic, characterized in that the antibiotic and the prebiotic included in powder form, included as a prebiotic oligosaccharide selected from the group: fructo-oligosaccharides, galactooligosaccharides, xylooligosaccharides, maltooligosaccharide and isomaltooligosaccharide with degree of polymerization from 2 to 10, with a particle size up to 0.3 mm and a purity of at least 95%, and antibiotic - with particle sizes from 20 to 200 μm; the antibiotic and the oligosaccharide is included in a mass ratio of from 1:1 to 1:100, respectively.

2. Pharmaceutical composition for the prevention of intestinal dysbiosis in the process of antibiotic intended for oral administration containing an antibiotic and a prebiotic, characterized in that the antibiotic and the prebiotic, is included in the form of a powder, while the antibiotic is selected from the group: beta-lactams, including combinations of beta-lactam inhibitors bacterial betalactamase; azalides, fluoroquinolones, amphenicol, glycopeptides, ansamycins were, nitrofurans, derivatives of phosphonic acid, cycloserine, trimethoprim, included with particle sizes from 20 to 200 μm, and included as a prebiotic oligosaccharide with a degree of polymerization of from 2 to 10 times the leader of particles up to 0.3 mm, purity not less than 95%, the antibiotic and the oligosaccharide is included in the composition in a weight ratio of from 1:1 to 1:100, respectively.

3. The pharmaceutical composition according to any one of claims 1 and 2, characterized in that it contains a pharmaceutically acceptable amount of auxiliary substances, improve sensory and consumer properties, selected from the group of fillers, correctors of taste, flavors, fragrances.

4. The pharmaceutical composition according to any one of claims 1 and 2, characterized in that it is made in a dosage form suitable for oral administration selected from the group: capsules, tablets, powders, pills, pills, granules, sachets, gels, pastes, syrups, emulsions, suspensions, solutions.

5. Method of prevention of intestinal dysbiosis during antibiotic therapy, providing for the reception of the pharmaceutical composition according to claim 1 or 2, which is administered orally.



 

Same patents:

FIELD: medicine.

SUBSTANCE: method involves introducing ozonized physiologic saline once a day during 30 min in addition to traditionally applied drugs. The ozonized solution has ozone in concentration of 100-150 mcg/l in the amount of 100-150 ml when treating children younger than 3 years. Children being elder then 3 years, ozone concentration is 200-250 mcg/l, its amount is 200-250 ml. The total therapy course is 5 days long. The traditionally applied drugs are not to be used within 30 min before and after ozonized physiologic saline application.

EFFECT: accelerated treatment course; no antibiotics being used; reduced risk of adverse side effects.

1 tbl

FIELD: medicine, biochemistry, pharmacy.

SUBSTANCE: invention relates to drugs used in treatment and prophylaxis of diseases associated with deficiency or absence of enzyme lactase in human body. Agent comprises enzyme lactase isolated from cultural fluid of microscopic fungus Penicillium canescens with activity 10000 U/g, not less, and shows stability in the pH range from 2.5 to 7.0 and temperatures from 4°C to 60°C. Agent provides effective cleavage of lactose in milk and dairy foodstuffs to a mixture of easily assimilable monosuccharides: glucose and galactose that results to availability of dairy foodstuffs for their using by humans suffering from lactose intolerance. Enzyme is stable that allows its using both for dosing orally with simultaneous using dairy foodstuffs and for their preliminary treatment.

EFFECT: valuable medicinal and nutrient properties of agent.

2 cl, 2 tbl, 2 dwg, 2 ex

FIELD: medicine.

SUBSTANCE: method involves applying dietotherapy containing nutrient fibers at a dose of 10-20 g/day. De-nol is additionally introduced at a dose of 120 mg 3-4 times 30 min before taking meals and Mezyme forte at a dose of 1 tablet 3 times a day while eating.

EFFECT: enhanced effectiveness in normalizing intestinal flora; reduced number of adverse side effects; excluded disease recurrence.

FIELD: medicine, pharmacology, biochemistry, enzymes.

SUBSTANCE: invention relates to an enzyme-containing medicinal agent wherein enzymes are chosen from a group consisting of hydrolases, lipases, amylases, glycosidases, phospholipases, phosphodiesterases, phosphatases prepared from infusoria. Also, invention relates to a method for using indicated enzymes in improving digestion or in treatment of digestion disorders. Invention enhances resistance to stomach acid media and preparing from safety microorganism.

EFFECT: valuable medicinal properties of enzymes.

7 cl, 2 tbl, 7 dwg, 2 ex

FIELD: medicine, surgical oncoproctology.

SUBSTANCE: one should introduce laevomycetin and furasolidon or bactrim and furasolidon 5 d before operation. Then, on the 3d d after operation it is necessary to perorally introduce 300 ml low-methoxylated 1%-pectin extract (LPE) - per 100 ml thrice daily, and then 600 ml - per 200 ml thrice daily, 10 d totally. Starting since the 4th d after operation one should fulfill peroral introduction of sorbed probiotic (SP) per 10 dosages thrice daily for 10 d. Moreover, 1 dosage of SP corresponds to 1·107 bifidobacterial CFU. In 21 d SP introduction mentioned should be repeated. Due to matched dosages and the mode of introduction of medicinal preparations the present innovation provides complex reconstruction of motor-evacuator function of gastrointestinal tract and microecological balance of large intestine and, thus, the prophylaxis of purulent-septic complications in this particular category of patients.

EFFECT: higher efficiency of correction.

2 ex, 3 tbl

FIELD: veterinary, in particular agents for prophylaxis and treatment of gastric diseases in calves.

SUBSTANCE: the fist foremilk of calved in summer cows is collected, filtered, bottled in sterile 1 l vessels and frozen in freezing apparatus at 20-22°C. In winter-spring period foremilk is defrosted and conserved with potassium sorbate in ratio of 2.5 ml of 40 % potassium sorbate solution per 1 l of foremilk.

EFFECT: environment friendly method for stimulation of calves immunity.

3 tbl

FIELD: medicine.

SUBSTANCE: method involves treating gastrointestinal tract without drugs, cleaning organism with enema and lavage procedure, per os introducing a set of nutrient substrates and proper microflora metabolism regulators as a complex of bran and vegetable additives being carriers of micro- and macroelements in the following ingredient proportion taken in weight parts. Bran - 72-86, microelements carriers like green tea, sea kale, shelf fungus, agar-agar, wartwort - 2-3, macroelements carriers like sedge grass, nettle, balm - 1.5-2.5; microbiologic fermentation regulators like cardamom, chili, black pepper, red pepper, nutmeg - 1.0-2.0, fermentation initiator (pastry texturizing agent) - 0.2-0.5. Single lavage procedure with appropriate preparation or cleaning vegetable protein enema of 1.5-2 l is applied before introducing nutrient substrates. A course of own microflora cultivation in gastrointestinal tract is carried out by introducing nutrient substrates set and daily volume of liquid in the amount of not less than 30 ml/kg of body weight and 10-20 mg of lactulose.

EFFECT: enhanced effectiveness of treatment; minimized enema-mediated treatment.

3 cl, 3 dwg

FIELD: veterinary medicine.

SUBSTANCE: method involves introducing alcohol-honey extract of milky-wax ripe walnut with farina and glycine added to unit dose liquid twice a day during 6 days at a dose of 0.5 ml per 1 kg of animal weight.

EFFECT: enhanced effectiveness of treatment; accelerated treatment course.

1 tbl

FIELD: medicine, pharmacology, pharmacy.

SUBSTANCE: invention relates to the development of a new medicinal agent representing the complex enzyme preparation with the digestive effect. Agent comprises enzyme pectate lyase providing effective cleavage of vegetable food intercellular substances, in particular, pectin and protopectin that results to formation of the homogenous and easily digestible mass, and promotes to assimilation vegetable food that is not assimilated by human organism that results to the more complete digestion of food, its cleavage and assimilation of nutrient substances. The optimal content of enzyme pectate lyase and pancreatin in a tablet covered by the enterosoluble envelope promotes to the more rapid and complete digestion of food in intestine and shows significant advantages as compared with the known digestive preparations.

EFFECT: improved and valuable properties of agent.

5 cl, 11 tbl

FIELD: veterinary obstetrics.

SUBSTANCE: the method deals with subcutaneous injection of bioglobin (placenta denaturated suspended - PDS) at the quantity of 20 mg/animal/d not earlier that 10 d before calving. The innovation enables to increase quality in preventing the onset of functional dyspepsia in newborn calves and level of total body resistance.

EFFECT: higher efficiency.

20 dwg, 1 ex, 2 tbl

FIELD: medicine; pharmacy.

SUBSTANCE: gastrointestinal tea contains natural cardamon (seed), pomegranate (grains), long red pepper (foeti), physocarpous siberian (roots), berry apple (foeti), red bartsia (herb) of specified proportions.

EFFECT: anti-inflammatory action; enzyme normalization of gastrointestinal tract; improvement of gastric juice enzymatic activity; antispasmodic and analgesic action.

3 ex

FIELD: medicine; gastroenterology.

SUBSTANCE: invention concerns selection of eradication therapy for ulcer patients associated with Helicobacter pylori. Invention implies that patients with exacerbation rates more than two times per year are initially prescribed four-component therapy, and patients with two and less exacerbation annually are initially prescribed with three-component therapy.

EFFECT: method provides registration of established dependence between therapeutic effect and annual exacerbation rate, simplification of eradication therapy regardless severity of clinical semiotics.

1 tbl, 4 ex

FIELD: medicine; veterinary.

SUBSTANCE: antagonists of metabotropic glutamate receptor 5 (MGLUR5) are suggested to inhibit the transit relaxation of the inferior esophageal sphincter, as well as the corresponding method of treatment and/or prevention of related disorders. Particularly, such disorders include gastroesophageal reflux, gastroesophageal reflux disease, regurgitation, pulmonary disease, hypoplasia of organism, and asthma. The following antagonists of metabotropic glutamate receptor 5 are preferable: 2-methyl-6-(fenyl-etynyl) pyridine, hydrochloride 2- methyl-6-(fenyl-etynyl) pyridine, 3-[3-(5- fluoropyridine -2-il)-1,2,4-oxadiazol-5-il]-5-(metoxymethyl) benzonitrile, 3-fluor-5-[3-(5- fluoropyridine -2-il)-1,2,4- oxadiazol-5-il] benzonitrile.

EFFECT: compounds inhibited the pressure of inferior esophageal sphincter decreased by infusion pomp, in dogs.

26 cl, 4 tbl, 3 ex

FIELD: agriculture.

SUBSTANCE: specimen consists of polyzones and thiamine bromide at a following relation of components (in mass fraction): polyzones - 80...60, thiamine bromide - 20...40.

EFFECT: specimen has a hyperactivity growth-stimulating effect and raises resistance of animals to sicknesses of a gastrointestinal tract.

5 tbl

FIELD: medicine, angiocardiosurgery, gastroenterology.

SUBSTANCE: the present innovation deals with endoscopic treatment of gastroduodenal ulcers in angiocardiosurgical patients. One should endoscopically apply gel containing 3%-aqueous solution of sodium carboxymethyl cellulose and 5%-oxymethyl uracil upon the ulcer. Single dosage corresponds 5-10 ml, the course - about 3-4 seances every 1-2 d. The innovation provides polycomponent impact of the mentioned medicinal preparation and, thus, shortened terms of pre-surgical preparatory procedures in angiocardiosurgical patients upon the main disease, the prevention of the development of its complicated forms.

EFFECT: higher efficiency of therapy.

3 ex

FIELD: medicine.

SUBSTANCE: method involves detecting duodenum wall integrity disorders in performing endoscopic examination of duodenal ulcer after removing necrotic detritus from ulcer bottom. Available wall defect is subjected to endoscopic probing with catheter introducing water-soluble radiopaque solution through the probe and followed with fistulographic examination. The radiopaque solution being observed outside of duodenum, duodenal fistula or perforated ulcer are diagnosed.

EFFECT: high reliability of early stage diagnosis.

3 dwg

FIELD: medicine.

SUBSTANCE: method involves giving magnesium-sodium-hydrocarbonate mineral water of moderate mineralization degree at room temperature in the amount of 150-200 ml. 20-30 min later alternating electromagnetic field operating in low frequency bandwidth of 0.022 Hz-270 kHz is administered in scanning mode of 43 produced by Rematherp apparatus. The total treatment course is 8-10 procedures long.

EFFECT: enhanced effectiveness of treatment; stimulated reparative processes in esophageal mucous membrane.

FIELD: medicine.

SUBSTANCE: method involves introducing Omeprasol at a dose of 20 mg twice a day before taking meals 10 days long, Amoxycillin at a dose of 1000 mg twice a day after breakfast and supper 7 days long, Clarithromycin at a dose of 500 mg twice a day before taking meals and Imudon as local immunomodulating factor at a dose of 8 pills a day making 2-3 h long pauses for resolving drug in oral cavity within 10 days.

EFFECT: enhanced effectiveness of treatment; reduced reinfection risk.

2 tbl

FIELD: medicine, gastroenterology, pediatrics.

SUBSTANCE: method involves using drugs directed on eradication of microorganism Helicobacter pylori that comprises the preparation "Vetoron" additionally. The preparation "Vetoron" is prescribed in the dose 6-8 drops to children of age 7-12 years and in the dose 8-10 drops to children of age 13-17 years for 7-10 days. Invention provides decreasing the mutagenic effect in carrying out the anti-helicobacter therapy in children. Invention can be used in treatment of children suffering from diseases of upper regions of digestive tract associated with infection with Helicobacter pylori.

EFFECT: improved method of treatment.

3 tbl, 2 ex

FIELD: medicine, pharmaceutical.

SUBSTANCE: invention relates to solid composition for treatment of reflux esophagitis, gastritis, or ulcers, method for production thereof and uses in therapy. Claimed composition contains alginate, bicarbonate and/or carbonate, and poly(C1-C5-alkylene glycol) hawing molecular mass of at least 6000 in amount of 1-50 %.

EFFECT: composition of decreased foam-forming properties and improved organoleptic characteristics.

12 cl, 18 ex

FIELD: medicine; pharmacology.

SUBSTANCE: present method of bacteria outer membrane vesicle preparation of Neisseria bacteria implies destruction of bacteria shell and gathering of outer membrane vesicles at deoxycholate solution < 0.05%. Bacteria express surplus NspA. Invention allows to keep significant bacterial immunogenic components, specifically (i) protective surface protein NspA, (ii) protein '287' and (iii) protein '741'.

EFFECT: significant immunogenic components keeping.

17 cl, 2 tbl, 2 dwg

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