Cream for medicinal purposes, made with application of framycetin sulfate and chitosan

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention relates to pharmaceutical industry and represents dermatological cream, intended for local treatment of bacterial skin infections and for healing wounds associated with them, which contains framycetin sulfate and biopolymer, included into cream base, which contains at least one substance from each of the following groups: preservative, primary and secondary emulsifier, selected from the group which contains ketostearyl alcohol, ketomacrogol 1000, polysorbate-80 and Span-80; paraffin as wax-like product, cosolvent, selected from the group, including propylene glycol, hexylene glycol and polyethylene glycol-400; nitric acid or lactic acid and water, with said biopolymer preferably being chitosan.

EFFECT: invention provides higher therapeutic effect.

8 cl, 10 tbl, 2 dwg

 

The technical field

This invention relates to compositions for treatment of bacterial infections of the skin simultaneously with the rejuvenation of the skin. More specifically, this invention relates to a pharmaceutical cream containing the biopolymer and the active antibacterial agent in the form of framycetin sulfate.

Background of invention

Skin disease can broadly be divided into those that are caused by bacteria, and those caused by fungi. Antifungal and antibacterial compositions are traditionally applied in the form of lotions, creams or ointments. In addition, in many cases it is difficult to establish whether this is due to the condition of the skin bacterial agent, or fungus.

One approach to the treatment of skin diseases is the method of trial and error. Antibacterial or antifungal composition is applied in turn, monitor the response and modify the treatment. A significant drawback of this approach is that the treatment should be carried out many times a day during the whole time of treatment. It's extremely not comfortable, and also has the lowest "cost-effectiveness" for the majority of the population, particularly in countries with low levels of economic development.

There are several types of therapy for the treatment of skin diseases caused by bacteria is whether fungi. In typical cases of such compositions use steroids, antibacterial or Antifungal agents (or combination of them in a certain dose) and the greatest attention is paid to these pharmaceutical active ingredients. Composition with a similar composition aims to improve their profile, physico-chemical and biological release.

Many skin diseases are caused by inflammation and bacteria, leading to itching and subsequent scratching, which, among other reasons, may in turn lead to serious and complicated by secondary infections. The existing traditional methods of treatment do not pay enough attention to the healing of the skin or rejuvenation; it is generally assumed that these two processes will take place in a natural way.

The word "healing" in relation to skin condition with injuries (cuts, wounds, infection, inflammation, abrasions, etc.) involves not only the prevention, control and elimination of the main causes, such as bacteria or fungi, but also restores the skin to its state prior to infection.

Modern approaches to the treatment of skin can in General be divided into two stages: a) healing and recovery skin before illness. Stage of healing involves eliminating as far as possible the main cause of the disease. what then can be the elimination of bacteria or fungi, caused the infection, using appropriate treatment, antibacterial or antifungal agents or reducing inflammation by treatment with steroids. During this treatment the skin lesions continues to be in the same condition and remains susceptible to secondary infections, which can be quite serious. In case of scratches or wounds of the skin, it is important that coagulation occurred quickly, because it reduces the likelihood of secondary infections. The focus in these kinds of treatment which is carried out with the help of creams, lotions, ointments, refers to the action of active pharmaceutical ingredients. Bases for creams and ointments are considered only as carriers of active substances to the site of an injury.

However, the aspect restore skin to its state before the disease is almost entirely left to the forces of nature. Therefore, one of the main drawbacks of the existing approaches to the treatment of the skin is that they leave the risk of secondary infections due to slow blood clotting and slow the healing process.

In addition, the study of the prior art become apparent disadvantages of the existing prescription dermatological products used for local treatment is Iya skin diseases. This is evident in the underestimation of the possible therapeutic benefits enclosed in the matrix of the cream and ointment base. In particular, none of the known solutions does not imply that:

Compositions for topical treatment of skin can spread the healing and recovery of the skin over the effects of the main active substances in such a way that they reinforce therapeutic result from the effects of the main active substances.

- Add a biologically active polymers (so-called biopolymers) is a complex process, which may affect the stability of the composition, if not properly consider and not to optimize the choice of the right biopolymer or natural way of interacting with each other excipients in the composition or process parameters in order to strengthen and complement therapeutic effects already at the stage of drug development.

- The inclusion of excipients in the form of a functionally bioactive polymer in the matrix of cream while maintaining functional stability of the active substance in the format of one drug in the form of a dermatological cream involves solving the problems of determining the physical stability of the matrix of cream.

Review some of the existing patents proil ustrinum disclosed above paragraphs.

In the patent GB 987010 disclosed water, water-permeable composition is essentially devoid of bacterial action, which contain one or more antibiotics, active against gram-negative bacteria, and methyl or ethyl alcohol. The invention uses a mixture of antibiotics, such as neomycin sulphate, catamites, polymyxin B, streptomycin, colistin or framycetin. It declares the presence of inventive step on the basis that it was discovered that when added to the antibiotic, active against gram-negative bacteria, together with a small amount of methyl or ethyl alcohol to water protein colloid, in particular, to a gelatin composition, gram-negative bacteria are destroyed, and the presence of antibiotics in dry layers made of them, suppress them in the growth of bacteria, even in conditions of high humidity. The resulting water-permeable colloid composition is essentially devoid of bacterial action.

In GB 1090421 disclosed surgical dressing, which contains, inter alia, the textile material treated with a basic antibiotic and/or the main antibacterial substance. Compounds that may be present in the emulsions used in this product include neomycin, neomycin sulfate is whether framycetin and the like. In the document GB 1090421 claims about the benefits compared to the prototypes because of the obvious opportunities to apply the dressings on burns and wounds and lack of adhesion to the raw wound surfaces for easy removal without damage to delicate healing tissue. In addition, it is assumed that antibiotic or antibacterial effect created by these bands is their advantage.

In GB 1218978 disclosed polyvinylpyrrolidone basis, which may include antibiotics, such as sulfates of framycetin, paromomycin, kanamycin, gentamicin, and neomycin. It clearly States that this composition may be made in the form of a dosage form for internal use, for example, as protivodiareynoe tool, or for external use, for example as a remedy for ulcers. In GB 1218978 declares the presence of inventive step on the basis that the pharmaceutical composition in accordance with this invention possess valuable pharmacological properties, in particular anti-diarrhoeal activity for domestic use and antiulcer activity when applied externally.

In U.S. patent US 6428800 disclosed is a method of treatment of wounds, including contact with RAS effective wound healing amount of bioactive glass and is of tibiotic for local use, and the composition is intended to accelerate the healing of burns and comprising particles of bioactive glass, and at least one antibiotic for topical use. According to patent US 6428800, it has been unexpectedly discovered that the combination of bioactive glass particles and antibiotic for topical application forms composition, which can significantly reduce the time required for wound healing. Applicants have discovered that the combination proposed in this invention speeds up the natural healing process. The effect of the application of the combination proposed in this invention is most clearly illustrated by the example of a patient with a weakened immune system, which reduced the ability to heal wounds.

None of the above patent applications are not offered simultaneously:

- Use matrix cream base as a functional element of the cream, and not just media the main active substances.

- Using known biopolymer as a functional filler together with framycetin sulfate.

- Achieving a much superior healing effects, since education microfilms, coagulation, promoting growth of the epidermis, the electrostatic immobilization of microbes occur simultaneously, not one after the other, that meetmest in the case of traditional therapy with one drug.

- Improvement of General medical properties of the cream that complements active substance used in the matrix of cream.

Therefore, there is a need in the local treatment of one medicinal product containing the active substance which is in a cream base, this cream Foundation should have additional therapeutic value in relation to the main active substance and be used for purposes beyond simple media or transport.

The objectives and other advantages of the present invention

Thus, there is a need to develop a formulation of a composition for the local treatment of one product containing framycetin sulfate, which would ensure the effective treatment of bacterial infections, and contributed actively to heal and rejuvenate the skin.

Further objectives of this invention are to develop a formulation of a composition for the local treatment of the skin, which is:

- Can extend the action of framycetin sulfate for healing or regeneration of the skin in such a way as to enhance therapeutic effect of the main active substances.

Contains biologically active polymers (so-called biopolymers), without compromising the stability of the composition, which may be affected by improper selection of the biopolymer.

Includes functionally bioactive polymer - auxiliary substance in the matrix of the cream, while maintaining functional stability of the substance in the format of a single drug.

Brief description of drawings

Fig.1 - inhomogeneous nature of creams containing chitosan with incompatible auxiliary substance, such as carbomer.

Fig.2 - film formation using chitosan.

Summary of the invention.

The purpose of this invention is a composition intended for the treatment of bacterial infections of the skin simultaneously with the rejuvenation of the skin and contains:

a) a biopolymer in the form of chitosan,

b) an active pharmaceutical substance (AB) framycetin sulfate is used to treat bacterial infections of the skin

c) a cream base containing primary and secondary emulsifiers, waxy materials, co solvents, acids, preservatives, buffering agents, antioxidants, chelating additives and hygroscopic means,

d) water.

Active ingredients, namely chitosan and framycetin sulfate incorporated in cream base for the treatment of bacterial infections of the skin, accompanied by allergies, itching and sores on the skin that involves the contact of human skin with the above-described composition.

Detailed description of the invention

In all cases, not related to work ol the measures or when specified otherwise, all numbers expressing quantities of ingredients, should be considered as modified by the word "approximately".

The present invention features a composition containing a homogeneous dose framycetin sulfate and intended for local treatment of the skin, which refers to medicines, prescription. Medicines, prescription, differ significantly in their use of the so-called cosmetics. Cosmetic products aimed at improving the condition and appearance of more or less intact skin or skin that is not suffering from a serious illness. On the other hand, prescription dermatological compositions directed to the treatment of serious skin diseases resulting from infections and wounds.

In the study of the prior art become apparent several weaknesses in existing compositions for the topical treatment related to prescription medicines. In the known technical solutions are not approved or not proposed that:

- Composition for the local treatment of skin can extend the basic AB by healing or regeneration of the skin in such a way as to enhance therapeutic effect of the basic AB.

- Add a biologically is active polymers (so-called biopolymers) is a complex process, which may be degraded stability of the composition, if the biopolymer is selected correctly.

- The inclusion of functionally bioactive polymer excipients in matrix cream while maintaining functional stability of AVI format is one of the medicinal product in the form of a dermatological cream includes solving the problems of determining the physical stability of the matrix of cream.

Active connection framycetin sulfate, which can be used in this invention, is well known in the treatment of bacterial infections, as well as a biopolymer for the treatment of wounds and rejuvenate the skin of the person, and they involve the contact of human skin with the above composition.

Examples of suitable biopolymer that can be used include chitosan and the like, but are not limited to.

Examples of suitable antibacterial agents for topical applications that can be used include fusidate sodium, mupirocin calcium, gentamicin, neomycin, sulfadiazine, ciprofloxacin, framycetin sulfate, hindocha, povidone-iodine, sizomitsin, nitrofural and the like, but are not limited to.

Active connection framycetin sulfate requires the use of a pharmaceutical composition comprising this compound, component framework, because the connection with the MoE on its own cannot be applied directly to human skin due to its krupnodernytsi.

Component framework usually contains the primary and secondary emulsifiers, waxy products, compatible solvents, acids, preservatives, buffering agents, antioxidants, chelating additives, hygroscopic tools and the like.

Chitosan

Chitosan is a linear polysaccharide consisting of distributed randomly β-(1-4)-linked D-glucosamine (dezazetilirovanie molecule) and N-acetyl-D-glucosamine (acetylated molecule). It is known that he has wide application in agriculture and horticulture for water treatment, chemical industry, pharmaceuticals and Biomedicine.

Its known properties include acceleration of blood clotting. However, experts in this area is unknown, that it should be handled with caution and take into account the behavior of chitosan in its impact with a pharmaceutically active ingredient, such as an antibacterial or antifungal agent.

It is known to possess properties to form a film, to increase the viscosity and has mucoadhesive, and that it is used as a binding and grinding substances in tablets.

In General, chitosan absorbs moisture from the atmosphere/environment, and the number of absorbing moisture depends on the initial moisture content, temperature, and classifies the school of humidity.

It is considered to be non-toxic and does not cause irritation substance. It is biologically compatible with both healthy and infected skin, and it was shown that it is biodegradable because it is derived from shrimp, squid and crab.

Chitosan due to its unique properties, accelerates wound healing and regeneration. It has a positive charge and is soluble in solutions of from acidic to neutral. Chitosan has bioadhesive and readily binds to negatively charged surfaces, such as mucous membranes. Chitosan increases the migration of polar drugs across epithelial surfaces. Properties of chitosan allows him to quickly collapse the blood, and he recently received approval in the USA for use in bandages and other hemostatic materials.

Chitosan does not cause allergies and has natural antibacterial properties, even more conducive to its use. As biomaterial forming microfilm, chitosan helps to reduce the width of the wound, control the penetration of oxygen to this place, absorbs secretion from the wound and is decomposed by enzymes in the tissues, which are used to accelerate healing. It also reduces itching, creating a calming effect. He also acts as a hygroscopic agent. He also is kazyvaetsya useful in the treatment of the usual minor cuts and wounds, burns, keloids, diabetic and venous ulcers. The chitosan used in this invention comes with different molecular weight in the range from 1 kdal to 5000 kdal.

Chitosan is discussed on the forum USP with respect to the ability to qualify it as functional excipients. Since the chitosan-based polymer is, there are several varieties of it, differing in molecular weight. Different varieties include chitosan chitosan long chain, chitosan chain of medium length and chitosan with a short chain. Varieties with long, medium and short circuits correspond to the molecular weight of chitosan.

In the General case, the sort of long-chain has a molecular weight in the range from 500000 to 5000000 Da, grade with average chain length has a molecular weight in the range of from 100000 to 2000000 Da, and sort of short-chain has a molecular weight of 50,000 to 1,000,000 Da.

The molecular weight of chitosan plays an important role in this composition. Chitosan with a higher molecular weight gives the system a higher viscosity and chitosan with low molecular weight gives the system a lower viscosity.

However, the grade of chitosan with chains of medium length gave the song an optimum level of viscosity. Since the dosage form is a cream, appropriate levels of viscosity is necessary in order to achieve a good distribution to the E.

The authors have made a final choice in favor of chitosan with an average chain length for the present invention because it gave the necessary rheological properties of the cream, without reducing therapeutic activity as active ingredients, and chitosan. The concentration of chitosan with chains of medium length has been carefully selected on the basis of several laboratory tests and preclinical efficacy studies in animals.

Antibacterial drugs for local application

Antibacterial drugs for local application are intended to be applied on the skin in cases of bacterial infections caused by Staphylococcus aureus, Staphylococcus epidermidis resistant to meticillin Staphylococcus aureus (MRSA), etc.

Antibacterial agents act by inhibiting the synthesis of cell walls due to the connection with the ribosomes of bacteria and inhibiting combination of ribosomes mPHK.

According to another hypothesis believe that Antibacterials force ribosomes to produce chains of peptides with the wrong amino acids that completely destroys the bacterial cell.

Antimicrobial agent for topical use include the following substances, but are not limited to: fusidate sodium, mupirocin calcium, gentamicin, neomycin, sulfadiazine, ciprofloxacin, framycetin sulfate, hindocha, povidone-iodine, PPE is CIN, the nitrofural and the like.

Framycetin sulfate

Framycetin sulfate belongs to a group of medicines known as antibiotics. Framycetin sulfate is an antibiotic with bactericidal activity with broad spectrum antibacterial and belongs to the group of aminoglycosides and sulfate salt of neomycin C. It is used for treatment of bacterial infections due to its ability to kill bacteria that cause infection, or stop their growth.

Molecular formula Framycetin sulfate C23H46N6O13×H2SO4and molecular weight 614.64374. Its chemical name (2R,3S,4R,5R,6R)-5-amino-2-(aminomethyl)-6-[(1R,2R,3S,4S,68)-4,6-diamino-2-[(2R,3R,4S,5R)-4-[(2S,3S,4S,5R,6R)-3-amino-6-(aminomethyl)-4,5-dihydroxy-oxan-2-yl]hydroxy-3-hydroxy-5-(hydroxymethyl)oxolan-2-yl]oxy-3-hydroxy-cyclohexyl]oxy-oxan-3,4-diol sulfate. It is a white or yellowish-white, hygroscopic powder, soluble in water.

Pharmacology and mechanism of action

Framycetin is active against Staphylococcus spp., including coagulase-negative Susceptible Escherichia coli, Klebsiella spp., Salmonella, Shigella, Enterobacter spp., Proteus spp., Serratia marcescens, Pasteurella spp., Vibrio spp., Borellia and Leptospira spp.and Mycobacterium tuberculosis, also including strains resistant to streptomycin. Promicin shows relatively high activity from which Oseni some strains of Pseudomonas aeruginosa, which are pathogenic microorganisms that cause the biggest problems. Resistance to framycetin hardly achieved even after frequent and very long-lasting use. To avoid resistance emergence or expansion of therapeutic action in dosage forms containing framycetin usually include other antibacterial substances, as well as steroidal anti-inflammatory agents.

In dermatological practice framycetin prescribed for the treatment of wounds, ulcers, burns and other skin defects, infected by susceptible microorganisms. This is the preferred antibiotic treatment for bacterial dermatitis and pyoderma, such as impetigo, furunculosis, etc.,

In ophthalmology, this antibiotic has been used successfully for the treatment of conjunctivitis, blepharitis, and infections of the anterior segment of the eye. Forms for topical application, containing framycetin, show high efficiency in the treatment of corneal ulcers. Despite the possible manifestation of ototoxicity, framycetin sulfate alone or in combination with other antibacterial or anti-inflammatory drugs are also used to make ear drops. Given the wide use of framycetin in otorhinolaryngology and occur only separate the cases, it is believed that the growth of ototoxicity is insignificant after local application. Dosage forms for topical application, containing framycetin been used successfully in the treatment of rhinitis caused by Staphylococcus.

Perhaps the mechanism of action of framycetin associated with the suppression of protein synthesis in bacteria by binding of the ribosomal subunits.

Indications for use

Framycetin sulfate active against a wide range of both gram-positive and gram-negative bacteria commonly found in superficial infections: Staphylococcus (including strains resistant to other antibiotics), Pseudomonas aeruginosa, Escherichia bacteria and pneumococci. He is tolerated by the tissues exceptionally well.

Most of the products for local use have the form of either creams or ointments. The cream is a preparation for local application used for applying on the skin. Creams are semi-solid emulsions are mixtures of oil and water, in which the active pharmaceutical substance (AB). They are divided into two types: creams of type oil-in-water (M/V), which consist of small droplets of oil dispersed in a continuous aqueous phase, and creams of the type water-in-oil (W/M), which consist of small droplets of water dispersed in a continuous oil phase is. Creams of the type water-in-oil easy to use and therefore cosmetically acceptable because they are less greasy and lighter washed with water. An ointment is a viscous semisolid preparation containing active substances which are applied topically on a variety of body surfaces. Binder ointment known as the basis for ointments. The choice of basis ointments depends on the clinical application of the ointment, and are typically used bases ointments of the following types:

- Hydrocarbon bases, such as solid paraffin, soft paraffin.

- Absorbing bases such as lanolin, beeswax.

Both of the above bases are oily and fatty in nature, and this leads to undesirable consequences such as difficulties applying to the skin and remove the skin. In addition, this also leads to the appearance of stains on clothing. Most of the products for local use comes in the form of creams due to the greater cosmetic appeal.

The pH for acidic ranges from 1 to 7, and pH for alkaline environment is from 7 to 14. The pH of human skin is approximately between 4.5 and 6. The pH value of the skin of a newborn baby is closer to neutral (pH=7), but quickly turns sour. Apparently, this natural mechanism is formed in order to protect the skin of small children, because of the acid which kills bacteria. As people get older, their skin becomes more and more neutral and can't kill as much bacteria as before. This is why the skin becomes weak, and the problems begin. When the pH falls below 6, patients will have real problems with the skin or skin diseases. This suggests that it is necessary to choose drugs for local use where the value of the pH close to the pH at a young age.

A slight shift of the pH towards alkalinity will create an environment conducive to the rapid multiplication of microorganisms. Most of the products for local use comes in the form of creams. The active ingredients in the cream are available in the ionized state. In General, formulations of creams are the first choice of pharmacists in the design and development of dosage forms for local use, because of the formulation of creams cosmetically attractive, but also because the active component is available in the ionized state and medication can quickly penetrate into the skin layer, which makes this structure is favorable for the patient.

The pH of the cream as proposed in the present invention, with a functional biopolymer such as chitosan, framycetin sulfate ranged from approximately 3 to 6. On the other hand industrially produced ointments are the two who are greasy and cosmetically unappealing. Moreover, because the active ingredient in the ointment is located in the UN-ionized form, he slowly penetrates the skin.

It is important that the active drug into the skin and provide the skin with optimal biological performance. Here the important role played by the particle size of the active drug. It is necessary that the active drug was available in the state and / or molecular dispersion, so that the product had a high efficiency. You will also need to achieve in an environment that is safe compatible with the skin on the value of pH (4.0-6.0). In order to achieve this, it is important to choose the appropriate media or co-solvents for dissolving or dispersing the drug. The product proposed in this invention has a very high efficiency due to the pronounced activity of framycetin sulfate as antibacterial and wound healing agent, which is available in colloidal form with ultra-fine particulate matter that contributes to its penetration into the skin.

The rationale for using a combination of framycetin sulfate and chitosan

Currently used numerous types of local treatment for the treatment of bacterial infections. However, there is no effective therapy for one drug to protect the s skin, control of surface bleeding, heal wounds and burns. In order to meet this need and to provide affordable and safe therapy for the population spread across the countries/communities, offers therapy using a unique combination of chitosan, a biopolymer, has anti-aging properties, and framycetin in the form of a new cream.

Framycetin sulfate in the case of local application has high efficacy against primary and secondary bacterial skin infections of various etiologies due to its antibacterial properties. The disadvantage alone one local antibacterial agent is relatively slow onset of effect.

Using the composition of framycetin sulfate and chitosan, it is possible to optimize the properties of antibacterial drug and chitosan. Since chitosan is a product of forming a film of biocompatible and non-allergenic, it helps to protect the skin, acting as a barrier. It also reduces surface bleeding caused by combing, and stops the mobility of pathogenic microorganisms due to their cationic charge.

Properties framycetin sulfate and chitosan in relation to the regeneration of the skin are widely used in this invention, and as they provide the provide therapeutic benefit to the patient, promoting rapid healing. This provides a beneficial effect on the patient in the treatment of wounds and skin burns, accompanied by bacterial infections.

The inclusion of chitosan in the composition provides the appearance of many of the properties that are considered extremely important in the treatment of skin diseases. The combination of chitosan with framycetin sulfate is a unique and new because it is not available anywhere else in the world on an industrial scale.

The idea of such a combination is justified by consideration of the physical, chemical and therapeutic properties of chitosan, which is used in conjunction with framycetin sulfate.

Inventive aspects of the present invention

Another inventive aspect of the present invention is that adding in a cream base functional excipients is not a direct process of simple addition. The inventor has found that the compatibility of the functional filler, such as chitosan, with other substances in the cream is critical. This is because the incompatibility affects the stability of the final product. For example, the inventors have found that a well-known excipients, such as xanthan gum and carbopol used in a variety of the cases as stabilizers, cannot be used in conjunction with functional biopolymers, such as chitosan.

Excipients in dosage forms local applications include polymers, surfactants, emulsifiers, etc., the Polymers are used as gelling substances, suspendida agents, thickeners, release modifiers, diluents, etc., Surfactants are used as moisturizers, emulsifiers, solvents, amplifiers, release, etc.

In General, polymers and surfactants can have or not to have an ionic charge. They are, by their nature, can be anionic, cationogenic or nonionic. If anionic filler included in the composition, they interact with cationogenic fillers of the composition and form due to incompatibility products that are not homogeneous and aesthetically attractive, and create unwanted side products, it is possible allergens, pollutants, toxic substances, etc.,

Since the dosage form is suitable for the treatment of sick people, the incompatibility of the products should not be allowed, and this creates additional difficulties for patients.

The inventors have carefully checked all auxiliary substances is TBA, including polymers and surfactants, before the development of the composition. In-depth study was conducted after he was selected a short list of excipients. Special attention was paid to possible interactions between excipients, and were conducted detailed experiments.

To make it possible to give a few examples of the anionic-cationic interaction in the cream, the inventors have produced several songs, including framycetin sulfate (see Tables 1-5) containing xanthan gum and chitosan, polyacrylate and chitosan, sodium lauryl sulphate and chitosan, sodium docusinate and chitosan, as well as the Arabian gum and chitosan. The results clearly indicate the presence of interaction, which could well be seen as separate pieces in the entire system. The final product was also devoid of aesthetic appeal and uniformity. The Attached Fig.1 clearly explains the interaction between chitosan and inappropriate anionic auxiliaries. On the basis of these observations and in-depth knowledge of auxiliary substances inventors have come to a reasonable formula without any possible interactions.

Table 1
A cream composition containing framycetin sulfate, chitosan and xanthan gum
№ p/pIngredients% (in weight ratio)
1Framycetin sulfate1,00
2Xanthan gum1,00
3Cetosteatil alcohol8,25
4White soft paraffin8,25
5Polyoxyl 20 cetosteatil ether (Macrogol cetostearyl-1000)2,50
6Propylene glycol5,00
7Methyl parahydroxybenzoate0,2
8Sodium propyl parahydroxybenzoate0,02
9Light liquid paraffin5,00
10The disodium salt of EDTA 0,1
11Anhydrous dvuhkamernyi orthophosphoric acid sodium0,5
12Chitosan0,25
13Lactic acid0,10
14Purified water68,00

Table 2
A cream composition containing framycetin sulfate, chitosan and polyacrylate
№ p/pIngredients% (in weight ratio)
1Framycetin sulfate1,00
2Polyacrylate0,75
3Cetosteatil alcohol8,25
4White soft paraffin8,25
5Polyoxyl 20 cetostearyl the ether (Macrogol cetostearyl-1000) 2,50
6Propylene glycol5,00
7Methyl parahydroxybenzoate0,2
8Sodium propyl parahydroxybenzoate0,02
9Light liquid paraffin5,00
10The disodium salt of EDTA0,1
11Anhydrous dvuhkamernyi orthophosphoric acid sodium0,5
12Chitosan0,25
13Lactic acid0,10
14Purified water68,00

Table 3
A cream composition containing framycetin sulfate, chitosan and sodium lauryl
№ p/p Ingredients% (in weight ratio)
1Framycetin sulfate1,00
2Sodium lauryl sulfate1,00
3Cetosteatil alcohol8,25
4White soft paraffin8,25
5Polyoxyl 20 cetosteatil ether (Macrogol cetostearyl-1000)2,50
6Propylene glycol5,00
7Methyl parahydroxybenzoate0,2
8Sodium propyl parahydroxybenzoate0,02
9Light liquid paraffin5,00
10The disodium salt of EDTA0,1
11Anhydrous dvuhkamernyi orthophosphoric acid sodium 0,5
12Chitosan0,25
13Lactic acid0,10
14Purified water68,00

Table 4
A cream composition containing framycetin sulfate, chitosan and sodium docusinate
№ p/pIngredients% (in weight ratio)
1Framycetin sulfate1,00
2The sodium docusinate1,00
3Cetosteatil alcohol8,25
4White soft paraffin8,25
5Polyoxyl 20 cetosteatil ether (Macrogol cetostearyl-1000)2,50
6Propylene glycol 5,00
7Methyl parahydroxybenzoate0,2
8Sodium propyl parahydroxybenzoate0,02
9Light liquid paraffin5,00
10The disodium salt of EDTA0,1
11Anhydrous dvuhkamernyi orthophosphoric acid sodium0,5
12Chitosan0,25
13Lactic acid0,10
14Purified water68,00

Framycetin sulfate
Table 5
A cream composition containing framycetin sulfate, chitosan and the Arabian gum
№ p/pIngredients% (in weight ratio)
11,00
2Arabian gum1,00
3Cetosteatil alcohol8,25
4White soft paraffin8,25
5Polyoxyl 20 cetosteatil ether (Macrogol cetostearyl-1000)2,50
6Propylene glycol5,00
7Methyl parahydroxybenzoate0,2
8Sodium propyl parahydroxybenzoate0,02
9Light liquid paraffin5,00
10The disodium salt of EDTA0,1
11Anhydrous dvuhkamernyi orthophosphoric acid sodium0,5
12Chitosan0,25
13Lactic acid0,10
14Purified water68,00

The above products (Tables 1-5) are examples of products that do not form a homogeneous creams, but form inhomogeneous creams such as the one shown in Fig.1. However, the proportions specified in these examples, are what may make use of a specialist in this field, based on currently available information. Only after deep and numerous trials and errors, you will come to the correct types and proportions of the excipients.

As mentioned earlier, when therapy using framycetin sulfate is improvement in bacterial infections. However, treatment with one drug was not decided until the present time such issues as protection of the skin, bleeding in this place, the mobility of pathogenic microorganisms and their movement from one place to another and so on

This invention, giving the opportunity to use one drug, fills this gap by incorporating chitosan and obtain the desired effect of protecting the skin (due to the ability to form a film), stop Cavotec the deposits (due to the ability to collapse the blood) and immobilization of pathogenic microorganisms (thanks nationalincome electrostatic property).

Therapeutic value increases due to the inclusion of functional excipients in the form of chitosan, which is a biopolymer matrix of the cream. Increasing value is a combination of the following functional characteristics of biopolymer:

- education microfilms on the surface of the skin;

- accelerated blood coagulation compared to creams that do not contain linkoeping biopolymers;

- electrostatic surface immobilization of microbes due to the cationic charge of the biopolymer;

- significant acceleration of epithelialization or regeneration of the skin.

It took the following inventive efforts in the development of technology, including the introduction of a functional biopolymer in dermatological products prescription:

- identify additional therapeutic value, which gives this introduction;

- identify the problems associated with the physico-chemical stability of the product resulting from the introduction of the biopolymer;

- creation of the drug in the format of a single dosage form for those cases when it was revealed bacterial infection.

The importance of treatment in the format of one of the medicinal product, in particular in countries with low levels of economic development cannot be overemphasized. In the absence of access to doctors is the General practice in most parts of South Asia or Africa, not to mention the dermatologists, the composition is in the format of one drug increases the opportunity to resolve the root cause of skin diseases and, at the same time to allow the skin to recover.

When used for dermatological disorders currently available treatments do not solve problems such as the protection of the skin, stop bleeding, etc., Unique innovative composition proposed in this invention, improves the condition of skin, restoring it simultaneously with the suppression of surface bleeding in this place. It is well known that if the surface bleeding left untreated, it will lead to secondary microbial infections. The present invention successfully address this unmet need.

In addition, as increasing pressure on health services and failure/high cost of personnel, around the world there was an urgent need to solve the following problems in such cases:

- Patients waiting for treatment for too long;

When they enter the hospital, you stay there too long;

- They have to go back more often than required.

Reducing the residence time is a key problem that must be solved in most cases. This invention, in which th is presumed to therapy with one drug, significantly reduces the total time of treatment of serious skin diseases.

The preferred embodiment of No. 1

A new dermatological cream for topical treatment of bacterial skin infections and wound healing associated RAS, and the indicated cream contains framycetin sulfate and biopolymer included in a cream base, and the said cream base contains at least one substance from each of the following group: a preservative, a primary and a secondary emulsifier, a waxy product, joint solvent, an acid and water, preferably purified water.

Option run No. 1

A new dermatological cream, as he revealed in a preferred embodiment of No. 1, with the indicated cream, in addition, contains any substance from the group comprising a buffering agent, antioxidant, chelating additive, hygroscopic agent, or any combination thereof.

Option run No. 2

A new dermatological cream, as he revealed in a preferred embodiment of No. 1, in which:

- the specified substance of framycetin sulfate is added in an amount of from approximately 0.5% in weight ratio to approximately 15% in weight ratio, preferably from 0.5% to 5.0% in weight ratio, and more preferably

- approximately 1.0% in weight ratio; and

- the specified biopolymer PR is dstable in the form of chitosan, added in an amount of from approximately 0.01% to approximately 1% in weight ratio, preferably from about 0.01% to about 0.5% in weight ratio, and in the preferred embodiment, approximately 0.25% in weight ratio, with the specified chitosan presents the relevant Pharmacopoeia of the United States with regard to its category as functional excipients and is selected from chitosan of any kind, such as chitosan long chain, chain of medium length and short circuit, and has a molecular weight in the range from 50 to 5000 kDa kDa,

- specified primary and secondary emulsifiers are selected from the group comprising cetostearyl alcohol, cetomacrogol-1000, cetyl alcohol, stearyl alcohol, Polysorbate-80, Span-80 and the like, and are added in amounts of from approximately 1% in weight ratio to 20% in weight ratio; these waxy products are selected from a group comprising white soft paraffin, liquid paraffin, hard paraffin and the like or any combination thereof, and added in an amount of from about 5% in weight ratio to 50% in weight ratio; this collaborative solvent is selected from a group comprising propylene glycol, hexyleneglycol, polyethylene glycol-400 and the like or any combination thereof, and added in an amount of from about 5% in weight is ω with respect to 50% in weight ratio; this acid is selected from a group comprising HCl, H2SO4, HNO3and lactic acid, and the like or any combination thereof, and added in an amount of from about 0,005% in weight ratio to 0.5% in weight ratio; the specified preservative is selected from the group comprising methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, chlorocresol, potassium sorbate, benzoic acid, 2-Phenoxyethanol, benzyl alcohol and the like or any combination thereof, and added in an amount of from about 0.05% in weight ratio to 2.5% in weight ratio; the specified water is added in the range of from 20% in weight ratio to 85% in weight ratio, preferably from 40% in weight ratio to 80% in terms of weight, more preferably from 65% in weight ratio to 75% in weight ratio, preferably purified water.

Option run No. 3

New cream, as it has been disclosed in preferred embodiment 1 and embodiment No. 2, containing, in addition, a buffering agent which is selected from the group comprising dvuhkamernyi orthophosphoric acid sodium, phosphoric acid sodium, calcium lactate and the like or any combination thereof, and added in an amount of from about 0.05% in weight ratio to 1.00% in terms of weight.

Option run No. 4

New cream, as it is escrit in a preferred embodiment of No. 1 and versions of the No. 2 and No. 3, including, in addition, the antioxidant is selected from the group including butylhydroxyanisole, butylhydroxytoluene and the like or any combination thereof, and added in an amount of from about 0,001% in weight with respect to 1% in weight ratio.

Option run No. 5

New cream, as he revealed in a preferred embodiment of No. 1 and variants of execution No. 2-4, includes, in addition, chelating additive, which is selected from a group comprising disodium salt of EDTA and the like or any combination thereof, and added in an amount of from about 0.05% in weight with respect to 1% in weight ratio.

Option run No. 6

New cream, as he revealed in a preferred embodiment of No. 1 and variants of execution No. 2-4, includes, in addition, hygroscopic agent, which is selected from a group comprising glycerin, sorbitol, propylene glycol and the like or any combination thereof, and added in an amount of from about 5% in weight ratio to 50% in weight ratio.

Option run No. 7

Disclosed a method of manufacturing cream, with the specified method includes the steps of introducing framycetin sulfate and a biopolymer in a cream base containing at least one substance from each group: a preservative, a primary and a secondary emulsifier, a waxy product is t, joint solvent, an acid and water, preferably purified water, and mixing all of the ingredients to the formation of homogeneous cream.

Option run No. 8

The method of preparation of the cream, as he revealed in option # 7, in which the ingredients are, in addition, include any substance from the group comprising a buffering agent, antioxidant, chelating additive, hygroscopic agent, stabilizer or any combination of them.

Option run No. 9

New cream, as he revealed in any of the above variants, in which the chitosan has a molecular weight in the range from 1 kdal to 5000 kdal.

Hereinafter the invention will be explained with reference to the accompanying examples, containing data on the composition and stability studies, which, however, have no purpose in any way limit the invention.

Example I

Table 6
Cream containing 1% of framycetin sulfate+chitosan
№ p/pIngredients% (in weight ratio)
1Framycetin sulfate1
2Ke is sterilely alcohol 8,25
3White soft paraffin8,25
4Polyoxyl 20 cetostearyl ether (Cetomacrogol-1000)2,50
5Propylene glycol5,00
6Methylparaben0,2
7Propylparaben0,02
8Light liquid paraffin5,00
9The disodium salt of EDTA0,1
10Dvuhkamernyi orthophosphoric acid sodium0,5
11Chitosan0,25
12Lactic acid0,10
13Purified water69,00

Comparing Table 6 with Table 1-5 illustrates the difference in products is Oh, due to the traditional composition of the medicinal product and the new approach adopted in this invention.

Experiments to study the stability of the active substance was conducted (see Tables 7-9) using the product proposed in this invention. The tests were carried out with the aim to observe (or measure, if possible) the appearance of the product, the pH value and quantitative analysis of active substances over a certain period of time. Each gram of the product proposed in this invention and used in the test contained an appropriate amount of an antibacterial agent. The product used in the tests for stability studies, contained approximately 10% excess of the active substance (excess). He was Packed in soft aluminum tube.

Presents the detailed results of the testing of the product of this invention. The percentage of framycetin sulfate used in all examples was measured in terms of weight in relation to the final product.

Product: Cream containing framycetin sulfate

Packing: Soft aluminum tuba

Composition: Each gram contains: i) Framycetin sulphate IP 1% in weight ratio

Table 7
Descriptive test. Party No. FSC-13
Measured parameter: appearance
The best value of measured parameter: Homogeneous viscous cream white to cream-coloured
Method of measurement: Observation by naked eye
ConditionsThe initial value1thmonth2thmonth3rdmonth
40°C 75% relates. RH-tHomogeneous viscous cream white to cream-colouredHomogeneous viscous cream white to cream-colouredHomogeneous viscous cream white to cream-colouredHomogeneous viscous cream white to cream-coloured
30°C 65% relates. RH-tthe same thingthe same thingthe same thing
25°C 60% relates. RH-tthe same thingthe same is Amoy the same thing
thermal Cyclingthe same thing--
freeze-thawthe same thing--

25°C 60% relates. RH-t
Table 8
The pH study. Party No. FSC-13
Measuring parameter: pH; Limits of measured parameter: 3-6
Method of measurement: Digital pH meter
ConditionsThe initial value1thmonth2thmonth3rdmonth
40°C 75% relates. RH-tto 4.524,514,504,50
30°C 65% relates. RH-t-to 4.524,514,50
-to 4.52to 4.524,51
thermal Cycling-4,49--
freeze-thaw-4,50--

Table 9
Quantitative analysis (%), Batch No. FSC-13
Measured parameter: Quantitative analysis
The limits of measured parameter: 90-110 (%);
Method of measurement: HPLC (liquid chromatography high pressure)
ConditionsThe initial value1thmonth2thmonth3rdmonth
40°C 75% relates. RH-t108,57108,46108,16 108,02
30°C 65% relates. RH-t-108,53average 108.41108,36
25°C 60% relates. RH-t-108,54108,42108,40
thermal Cycling-108,20--
freeze-thaw-108,22--

How to apply cream

The cream is applied after thoroughly cleaning and drying the affected area. Apply enough cream to cover the affected skin and surrounding area. The cream should be applied 2-4 times a day depending on the condition of the skin throughout the treatment period, even in case of improvement of symptoms.

Experiments

The experiments were carried out with the cream in the laboratory, as well as using suitable animal, which was applied to the wound by cutting. We investigated four aspects of reduction of the area of wound epithelialization, the clotting time of blood and clicks the education of the film. A joint study of these aspects suggest that the microbes were immobilized, and this led to effective wound healing.

A. a Reduction in the area of RAS:

The activity of the cream, in the present invention, in the healing of cut wounds was determined by testing on animals. Cut the wound with a diameter of 2.5 cm was applied by cutting the skin to its full thickness. The value of reduction of area of the wound, observed over a certain period of time, pointed to the fact that the cream is proposed in this invention, showed significantly better results in terms of reduction of the area of the wound compared to those that were achieved when applying traditional cream.

Century Time epithelialization:

When using the cream, proposed in this invention, the epithelization of the wound occurs in fewer days compared to the time required for epithelialization using traditional cream. Therefore, one of the advantages of the cream is proposed in this invention is that it promotes more rapid epithelialization of the skin than when using traditional creams.

C. the Coagulation of blood:

Observed clotting time of blood in both groups of animals: not receiving treatment control group and the test group of animals receiving treatment p is Toktom of the present invention. A statistically significant reduction in the clotting time of blood in the treated group of animals was noted compared with the control group animals. Average decrease in the clotting time of blood, comprising from 35 to 60%, was observed when using the product of this invention.

The ability to form a film:

It Is Evident From Fig.1 it is evident that chitosan does not lose its properties to form a film in the presence of excipients used in the formulation of the cream is proposed in this invention.

Results and discussion:

Obviously, the property of chitosan in the case when it is used in formulations containing excipients used in this invention does not deteriorate. This was achieved by careful selection of excipients. For example, our experiments show that such a widely used excipients as xanthan gum or carbopol, in combination with chitosan to form a precipitate due to cationic, anionic interactions.

As shown by tests on animals, therapeutic effect due to the addition of chitosan to framycetin sulfate, shown in the following table when considering various aspects of therapeutic treatment to the poor condition of the skin:

Table 10
therapeutic aspectExisting creamsThe product of this invention
1. The clotting timeclearly not declaredA statistically significant reduction in clotting time, as evidenced by pre-clinical animal testing
2. Immobilization of microbesclearly not declaredIt is expected the surface immobilization of microbes due to the cationic charge of chitosan
3. Promoting the growth of the epidermisclearly not declaredIt is well known that chitosan possesses properties that make a significant favorable effect on the growth of the epidermis. This functional aspect of chitosan is stored in the product of this invention
4. Education microfilmsclearly not declaredYes (see Fig.2)
5. The full effect of drugs on wound healingThe standard, as the La of existing products Has better healing properties

It is obvious that the ability to form a film of chitosan included in the cream provides the best access framycetin sulfate to the infected area and leads to better effect of this active substance.

Therapeutic efficacy of the local application of cream, proposed in this invention, due to the pronounced antibacterial activity of framycetin sulfate against organisms that cause skin infections, the unique ability of active substances to penetrate the intact skin and properties of chitosan to heal and soothe.

From the above discussion it becomes apparent that this invention offers the following advantages and unique aspects compared to currently available dermatological compositions for the treatment of bacterial infections:

1. The cream is proposed in this invention, includes a positive current to the skin of the biopolymer in the form of chitosan, which enhances therapeutic effect. This is evident from the reduction of the clotting time of blood, increases the effect of epithelization and faster getting rid of the infection.

2. The cream is proposed in this invention, includes a biopolymer, without sacrificing stabiles the d matrix of the cream and without negative effects on the properties of a known active pharmaceutical ingredients. This was achieved by careful selection of functional excipients that will avoid undesirable aspects of physico-chemical compatibility/stability and biological release.

3. Cream, this invention provides an integrated treatment with a single drug, which so far has not been achieved in dermatological compositions prescription.

4. New cream, proposed in the present invention, stores the corresponding stability/efficiency in environmental conditions and does not require temperature control during transport/storage, therefore, he will advance very far in achieving these social goals.

According to another variant implementation of the present invention also proposes a method of treatment of bacterial skin infections and wound healing, comprising contacting human skin with the disclosed above composition.

Although the above description contains much specificity, this should not be construed as limiting the scope of the invention, but only as an illustrated example of the preferred option it is running. You need to understand that based on the above disclosure, it is possible to make various modifications and variations which will not go beyond the nature and scope of this invention. Follow the consequently, the scope of this invention should be determined not illustrated variants of execution, but the accompanying paragraphs patent claims and their legal equivalents.

1. Dermatological cream intended for the local treatment of bacterial infections of the skin and for healing associated RAS containing framycetin sulfate and biopolymer included in a creamy base, which contains at least one substance from each of the following group: a preservative, a primary and a secondary emulsifier selected from the group consisting of cetostearyl alcohol, cetomacrogol-1000, Polysorbate-80, Span-80; paraffin wax as a wax-like product; joint solvent selected from the group comprising propylene glycol, hexyleneglycol and polyethylene glycol-400; nitric acid or lactic acid and water, and the biopolymer is preferably chitosan.

2. Dermatological cream under item 1, in which:
specified framycetin sulfate is added in an amount of from 0.5% in weight ratio to 15% in weight ratio, preferably between 0.5% and 5% in weight ratio, and more preferably approximately 1.0% in weight ratio; and
this biopolymer is presented in the form of chitosan, added in an amount of from 0.01% to 1% in weight ratio, preferably from 0.01% to 0.5% in weight ratio, and the pre is reverent version of 0.25% in weight ratio,
- specified primary and secondary emulsifiers are added in an amount of from 1% in weight ratio to 20% in terms of weight;
- these waxy products are selected from a group comprising white soft paraffin, liquid paraffin, paraffin wax, or combination thereof, and added in an amount of from 5% in weight ratio to 50% in terms of weight;
-the specified joint solvent is added in an amount of from 5% in weight ratio to 50% in terms of weight;
- this acid is added in amounts of 0.005% in weight ratio to 0.5% in weight ratio;
- the specified preservative is selected from the group comprising methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, chlorocresol, potassium sorbate, benzoic acid, 2-Phenoxyethanol, benzyl alcohol, or a combination thereof, and added in quantities of from 0.05% in weight ratio to 2.5% in terms of weight;
- this water is added in the range of from 20% in weight ratio to 85% in weight ratio, preferably from 40% in weight ratio to 80% in terms of weight, more preferably from 65% in weight ratio to 75% in weight ratio, preferably purified water.

3. Dermatological cream on PP.1 and 2, containing, in addition, a buffering agent which is selected from the group comprising dvuhkamernyi orthophosphoric acid sodium, phosphoric acid is th sodium, calcium lactate or a combination thereof, and added in quantities of from 0.05% in weight ratio to 1.00% in terms of weight.

4. Dermatological cream on PP.1 and 2, containing, in addition, the antioxidant is selected from the group including butylhydroxyanisole, butylhydroxytoluene or combination thereof, and added in quantities of from 0.001% by weight with respect to 1% in weight ratio.

5. Dermatological cream on PP.1 and 2, containing, in addition, chelating additive, which is selected from a group comprising disodium salt of EDTA, which is added in amounts of from 0.05% in weight with respect to 1% in weight ratio.

6. Dermatological cream on PP.1 and 2, containing, in addition, hygroscopic agent, which is selected from a group comprising glycerin, sorbitol, propylene glycol or a combination thereof, and added in an amount of from 5% in weight ratio to 50% in weight ratio.

7. A method of manufacturing a cream under item 1, which includes the steps of introducing framycetin sulfate and a biopolymer in a cream base, and mixing all of the ingredients to the formation of homogeneous cream.

8. A method of manufacturing a cream under item 7, in which the ingredients are, in addition, include a substance from the group comprising a buffering agent, antioxidant, chelating additive, hygroscopic agent, a stabilizer or a combination of both.



 

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11 cl, 1 dwg, 18 tbl, 88 ex

FIELD: biotechnology.

SUBSTANCE: wound-healing agent is a concentrate of the culture liquid of strain Trichoderma harzianum Rifai deposited in the Russian National Collection of Industrial Microorganisms under the number of RNCIM: F-180, as a producer of L-lysine of alpha-oxidase, and can be applied as a wound-healing agent for skin lesions.

EFFECT: invention enables to expand the range of means that provide wound healing of skin lesions.

1 tbl, 2 ex

FIELD: medicine.

SUBSTANCE: invention relates to medicine. Described is method of treating infection of human or animal body surface, in particular, contamination with fungi, including application of water liquid on infected body surface, for instance, nail area, with further application of bandage, which includes hydrogen peroxide source. Combinations of bandage liquid for application in method are also provided.

EFFECT: combination makes it possible to considerably reduce or eliminate infection in nail area.

16 cl, 1 tbl, 2 dwg, 2 ex

FIELD: medicine.

SUBSTANCE: ointment consists of emulsion base and pharmacologically active substance. The pharmacologically active substance of the ointment is presented by a fraction having a boiling temperature of 170-215°C (5-6 mm Hg) prepared by yolk pyrolysis on montmorillonite clay at 250-280°C for 20-30 min. The ointment also contains Carbomer, monoglycerides, hydrogenated coconut oil, glycerol, stearic acid, liquid paraffin, ethanol, myristyl myristate, hydrogenated lanolin, butylene glycol, polydimethyl siloxane, dimethicone, Nipagin, Nipasol, and a flavouring agent in certain proportions.

EFFECT: improving wound-healing action.

1 dwg, 1 tbl, 3 ex

FIELD: medicine.

SUBSTANCE: what is described is hydrogel composition containing sodium acrylate, a linking agent, biologically active substances, polyvinyl pyrrolidone, glycerol, propanediol, water, a catalyst agent and a radical polymerisation indicator in the following proportions, wt %: sodium acrylate 2.0-10.0, catalyst agent 0.045-0.48, linking agent 0.195-0.21, radical polymerisation indicator 0.045-0.06, glycerol 4.5-7.5, propanediol 3.0-10.5, biologically active substances 0-1.5, polyvinyl pyrrolidone 0.3-1.5, water - the rest. What is described is a surgical dressing containing a carrier with the hydrogel composition applied thereon.

EFFECT: higher efficacy of the hydrogel composition and surgical dressing thereof, lower labour intensity of the method for preparing the above composition.

10 cl, 1 tbl, 2 ex

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to pharmaceutical industry, namely to an immunomodulatory composition for injection into a mammal. The immunomodulatory composition for injection into a mammal containing a hydrolysate prepared by acid and/or enzymatic hydrolysis of one or more bioresources specified in a group consisting of bivalve molluscs, annelids, leeches, and water taken in certain proportions. A method for preparing the immunomodulatory composition for injection into a mammal. A method of treating a pathological condition in a mammal in need thereof involving the injections of the immunomodulatory composition into the above mammal. Using the composition for normalising metabolism into the mammal in need thereof.

EFFECT: composition enables extending the range of products with immunomodulatory activity for injections.

19 cl, 7 tbl, 7 ex

FIELD: medicine, pharmaceutics.

SUBSTANCE: present invention refers to pharmaceutics and represents a pharmaceutical composition for parenteral administration containing sub-micron particles of dosocahexaenoic acid ester dispersed in a water phase with the use of mixture of at least two surfactants specified in a) at least one fatty acid polyoxyethylene ester and b) at least one phospholipide derivative, as well as a method for preparing the above pharmaceutical composition.

EFFECT: invention provides higher pharmacological activity.

14 cl, 3 dwg, 3 tbl, 2 ex

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