Agent for superficial mycoses treatment

FIELD: medicine.

SUBSTANCE: agent for superficial mycoses treatment contains antimycotic Ketoconazole; emulsion carrier including emulsifiers, castor oil, water; end additives stabiliser and preserving agent. Agent is aerosol liniment additionally containing antioxidant Dibunolum or butylhydroxytoluene. As emulsifier agent contains emulsifiers of the first and second type that are distilled monoglycerides, emulsion wax, Tvin 80; as stabiliser it contains oxymethylpropylcellulose (OMPC), and preserving agent is mixture of Nipaginum and Nipazole.

EFFECT: provided lasting contact medicinal substance with affected region and its environmental protection; lowered risk of mycosis transfer from infected person to other people and higher sedimentation stability of agent.

3 tbl, 4 ex

 

The present invention relates to the field of medicine, namely pharmaceuticals, and can be used in the pharmaceutical industry for the production of the drug used in the treatment of superficial mycoses.

Fungal infections are fairly common diseases. Of particular relevance to their treatment gains in connection with the rapid growth of immunodeficiency, as weakening of the immune protection activated many fungi, with which the body peacefully coexisted before. In addition, fungal infections can occur in cases of violation of the microbial flora of man.

In this regard, the important is the problem of finding new reliable and at the same time safe antifungal agents.

Well-known antifungal agents with broad spectrum of activity, representing a composition, containing a pharmacologically active agent, terbinafine (RF Patent 2093152 invention "ANTIMYCOTIC PHARMACEUTICAL COMPOSITION (OPTIONS)", CL AC 31/135, publ. 1997.10.20). Terbinafine is an effective antifungal agent in oral and local application. It is effective against a wide spectrum of fungal diseases. In Russia there are several dosage forms terbinafine hydrochloride for external use: - terbinafine (Lamisil) cream 1% (t the BA 15 g), Novartis Pharma, Switzerland; Activin (Exifine) cream 1% (dose 10 g), Dr. Reddy's Laboratories, India; terbinafine (Lamisil) is a topical solution 1%, vial, 30 ml, Novartis Pharma, Switzerland; terbinafine (Lamisil) spray for topical application of 1%, bottle of spray 30 ml, Novartis Pharma, Switzerland. Famous cream terbinafine 1% of the company Novartis Pharma, Switzerland, contains terbinafine hydrochloride 1%, benzyl alcohol, isopropyl myristate, monostearate, sorbitan, sodium hydroxide, Polysorbate 60, stearyl alcohol, cetyl alcohol, cetylpalmitate, demineralized water. (Reference VIDAL. Drugs in Russia, M., Attraversare, 2001, strb-305). However, the application of terbinafine may cause adverse reactions : headaches, gastrointestinal symptoms, anomalies detected during the study of the liver, dermatological symptoms such as itching, hives and rash, and taste disorders, such as loss of taste.

The most effective and low-toxic antifungal agents are clotrimazole and ketoconazole. On the basis of the known number of pharmaceutical compounds: ointments, creams, vaginal gels, emulsions, etc. Known composition in the form of a gel, containing (wt.%): as the active component - clotrimazole - 0.5-3; as a gelling agent carboxyvinyl polymer is 0.1-3; as solvent - 1,3-butyleneglycol - 5-90 and predpochtitel is about, additionally ethanol - 30; as the pH regulator is an organic amine and water [patent EP 0186055, IPC AC 31/415, 1986]. A disadvantage of the known compositions is that the solvent used is not physiologically indifferent. Alcohol has a defatting to the skin effect, leading to exacerbation of the pathological process, additional drying with the skin. In addition, the solvent does not provide prolonged contact of medicinal substances from the affected area, has tanning and irritant effect on skin and mucous membranes. Tanning action of ethyl alcohol leads to strengthening and thickening of the walls of the spores of the fungus, and thereby reduces therapeutic effect of the drug.

Known for a number of pharmaceutical antifungal compounds: ointments, creams, emulsions, etc., lipophilic-hydrophilic basis, providing a high drug release and not having irritating to the skin. Thus, in the Federal Republic of Germany patent N3243544 (IPC AC 31/415; AC 47/10; publ. 30.05.1984) proposed composition with clotrimazolum on lipophilic-hydrophilic base containing: clotrimazole - 10%, span (arbitarily ether fatty acids) - 2% (emulsifier), twins (polyoxyethylenesorbitan ether fatty acids) - 1.5 (emulsifier), synthetic spermaceti - 3% (lipophilic base), cetylstearyl alcohol - 3,5% (stabilizat is p), isopropylmyristate - 13,5% (lipophilic base), benzyl alcohol 1% (preservative), water up to 100% (hydrophilic base). Also known emulsion compositions suitable for use in the form of ointments, gels, creams. In the United Kingdom patent N2187956 (IPC AC 31/41; AC 31/415; AC 33/38; AC 31/41, publ. 23.09.1987) described ingredients: clotrimazole is 1%, a silver salt sulfapyridine - 1%, vaseline oil - 6%, cetosteatil alcohol was 7.2%, Atamanova of 1.8%, paraffin white - 15,0%, glycerin 5%, and water to 100%. In the Federal Republic of Germany patent N3600947 (IPC AC 31/415; AC 47/10; AC 47/26, publ. 16.07.1987) described emulsion and lipophilic-hydrophilic compounds clotrimazolum used in the form of a cream: clotrimazole - 1%, span 60 (arbitarily ether fatty acids) - 2%, the twin 60 - 1,5%, cetylpalmitate - 3%. Lannete (a mixture of primary hexadecenoic and octadecenoic alcohols) - 10%, ethylene glycol monotropy ether - 31,25%, water - 41,25%. The disadvantage of these compositions is the use of hydrocarbon bases (vaseline, vaseline oil, paraffin), which is slowly and incompletely release of medicinal substance, can cause disorders in the physiological functions of the skin, to provide alligatoroidea and sensitizing effect.

Closest to the proposed invention, the essential features and the achieved therapeutic effect is a pharmaceutical composition with p is olivegrove activity containing clotrimazole or ketoconazole; emulsion liofilizirovannuu basis, including castor oil and emulsifier, which contains a derivative of methylcellulose; target additive is a stabilizer and a preservative; sodium benzoate and succinic acid in the following ratios, wt.%: clotrimazole or ketoconazole is 0.5 - 10; derived methylcellulose - 1-5; castor oil - 8-20; sodium benzoate (0.01 to 7; succinic acid is 0.01-5; target additives up to 100 (patent RF №2120305 to the invention PHARMACEUTICAL COMPOSITION HAVING anti-fungal ACTIVITY, AND METHOD thereof", IPC AC 47/38, AK 47/44, AK 31/415, publ. 20.10.1998). Known pharmaceutical composition does not cause allergic and sensibilise action, does not form a solid film when dry. The presence of castor oil in the composition provides high bioavailability of the composition. The disadvantage of the pharmaceutical composition is a low sedimentation stability and lack of hygiene when using. Ointment form of known composition requires special conditions of use, can contaminate clothing and impede the natural breathing of the skin. In addition, the use of funds will not protect against infection with other people

The task to be solved by the invention is the creation of a new headlight is aseptically composition for the treatment of superficial mycoses, having a high therapeutic effect and improved characteristics that remain stable over a long time - at least two years.

The technical result that can be obtained by carrying out the claimed invention is:

- improving therapeutic effect by providing prolonged contact of medicinal substances from the affected area and protect it from external influences;

- reducing the risk of transmission of infections from an infected person to other people;

improving hygienic use;

- improved sedimentation stability.

This technical result is achieved in that the means for the treatment of superficial mycoses contains antifungal substance - namely ketoconazole; emulsion media, including emulsifiers, castor oil, water, additives target stabilizer and preservative. The tool is made in the form of aerosol liniment, further comprises an antioxidant, which used BHT or equivalent. As emulsifier declare that the product contains emulsifiers first or second kind, distilled monoglycerides, emulsion wax, tween 80; as a stabilizer contains oxymethylphenyl (OPMC), and as a preservative mixture, SOS is ojasuu of nipagina and nipazola, when the following ratios, wt%:

Ketoconazole1,0-5,0
Of distilled monoglycerides0,5-5,0
Emulsion wax0,1-1,0
Castor oil1,0-10,0
Tween-800,5-5,0
Dibunola or butylhydroxytoluene0,01-0,5
Nipagina0,05-0,5
Nipazolaof 0.01-0.1
OPMC0,5-5,0
Purified waterto 100 g

In all cases, implementation of the proposed remedy for the treatment of superficial mycosis is different from the above known closest to him means:

- implementation in the form of aerosol liniment;

- additional content of antioxidant, which used BHT or butylhydroxytoluene;

- content as an emulsifier emulsifier of the first and second kind - distilled monoglycerides, emulsion wax, tween 80;

- content oxymethylphenyl (OPMC) as a stabilizer;

- content of the mixture consisting of nipagina and nipazola, as a preservative

- the following ratio of components, wt.%:

Ketoconazole1,0-5,0Of distilled monoglycerides0,5-5,0Emulsion wax0,1-1,0Castor oil1,0-10,0Tween-800,5-5,0Dibunola or butylhydroxytoluene0,01-0,5Nipagina0,05-0,5Nipazolaof 0.01-0.1OPMC0,5-5,0Purified waterto 100 g

The proposed ratio of operating, auxiliary substances and bases is optimal in terms of quality and quantity, found experimentally, is the original, unknown in the prior art.

The proposed composition is an aerosol liniment used in the form of a spray, dosed by a pump and spray push button type, which has high bioavailability; do not dry the skin; this does not affect the natural breathing of XI; washes off easily with water and will not stain clothes; has a prolonged action; hygienic to use.

Ketoconazole is an antifungal drug from the group of imidazole derivatives. Important features of ketoconazole are its effectiveness when administered, as well as its impact spacecraft is on the surface, and systemic mycoses. Linked to the drug-impaired biosynthesis of ergosterol, triglycerides, and phospholipids necessary for the formation of cell mambrane mushrooms. Assign ketoconazole in superficial and systemic mycoses: dermatomycosis and onychomycosis caused by blastomycete; avium scalp; vaginal mycosis; blastomycetes the oral cavity and gastrointestinal tract, genitourinary tract and other fungal infections of internal organs.

The preservatives used in the proposed structure can be represented by the following components: mixture of nipagin and nipazola. The introduction of the preservative in the composition ensures the stability of the drug in relation to antimicrobial action. Nipagin inhibits the growth of fungi; nipazol yeast. These preservatives are used, for example, FS No. 42-1460-89; FS No. 42-2079-91.

As an antioxidant in the proposed composition is used equivalent, which is used as an antioxidant in medicines for external use. As a stabilizer of the dispersed phase (ketoconazole), the proposed composition is used oxymethylphenyl (OPMC)providing sedimentation stability. For suspension must have a uniform distribution of the dispersed phase in the liquid with the food when drinking (GF XI) - resuspendable maintained throughout the shelf life. The results of the evaluation of the sedimentation stability are presented in table 1.

Table 1

Comparative evaluation of the effect of the dispersion medium on the sedimentation stability of suspensions of ketoconazole (n=5)
The dispersion mediumShelf life
1 day2 days5 days1 month12 months24 months36 months
Emulsion without OPMCUniform distribution on volumeResuspendable satisfy your high.Not resuspendedNot resuspendedNot resuspendedNot resuspendedNot resuspended
An aqueous solution OPMC without emulsionUniform distribution on volumeUniform distribution on volumeResuspendable satisfy your high.Not resuspendedNot resuspendedNot resuspendedNot resuspended
Emulsion with the addition of OPMCUniform distribution on the volume of the mu Uniform distribution on volumeUniform distribution on volumeResuspendable with saved him a uniform distribution for 5 daysResuspendable preserving a uniform distribution for 5 daysResuspendable preserving a uniform distribution for 5 daysResuspendable preserving a uniform distribution for 5 days

In addition, UPMC forms on the skin is thin, breathable film, which after being committed on the skin, provides long contact of medicinal substances from the affected area, protects it from external influences and reduces the likelihood of transmission of infections to other people. Oxymethylphenyl used, for example, on THE 2231-107-0574-2755-96.

As the carrier in the proposed composition is used, the emulsion composition which can be represented by a mixture of emulsifiers, dispersion medium and dispersed phase (castor oil).

As emulsifiers can be used emulsifiers of the first and second kind, for example, distilled monoglycerides on THE 10-1197-95; emulsion wax on THE 915411-012-20820231-01 and tween-80 (imported), which are widely used in pharmaceutical and cosmetic production quality is ve emulsifying components.

As the dispersion medium use water purified by FC 42-2619-97.

As the dispersed phase in the emulsion is used castor oil with penetrating power due to ricinoleic acids. The presence in the composition of castor oil provides high bioavailability of the proposed structure. In addition, the oil softens dry skin, which is especially important when hyperkeratosis treatment.

The proposed set of media components provides a uniform dosing and stability of the dosage form.

When the concentration of ketoconazole in the composition is less than 1% of the drug is pharmacologically ineffective concentration of more than 5% technologically feasible.

The concentration of castor oil (from 1 to 10%) due to the pharmacological efficiency and expediency.

Concentration OPMS (from 0.5 to 5.0%) due to technological efficiency. Less than 0.5%, it does not ensure the stability of the dispersed phase, more than 5% over the long-term storage in the system is the formation that is accompanied by the impossibility of dispensing.

The proposed ratio of preservatives in the composition provides for the preservation of biological activity and the absence of contamination of the medicinal product putrefactive bacteria and fungi during storage, as well as maintain the pH level.

When reducing the number of any component creates an opportunity for the growth of pathogenic organisms, if the increase is not excluded allergic reactions when using the composition.

Antioxidant exerts its action with concentrations of 0.05%, its content in the composition of more than 0.5% is inappropriate.

Examples of the composition of the proposed pharmaceutical composition is shown below.

Example 1

Ketoconazole2.0 g
Of distilled monoglycerides1.2 g
Emulsion wax (import)1.0 g
Castor oil FS 42-1906-955.0 g
Tween-80 (import)2.0 g
Dibunola VFS 42-457-750.1 g
Nipagina FS 42-1460-890,15
Nipazola THE 18-16-387-810,05
OPMC (TU 2231-107-0574-2755-96 or imported)1.6 g
Purified water (FS 42-2619-97)to 100 g

Example 2

Ketoconazole1,0
Of distilled monoglycerides0,5
Emulsion wax0,1
Castor oil1,0
Tween-800,5
Dibunola or botiller is kitawala 0,01
Nipagina0,05
Nipazola0,01
OPMC0,5
Purified waterto 100 g

Example 3

Ketoconazole5,0
Of distilled monoglycerides5,0
Emulsion wax0,1-1,0
Castor oil10,0
Tween-805,0
Dibunola or butylhydroxytoluene0,5
Nipagina0,5
Nipazola0,1
OPMC5,0
Purified waterto 100 g

Example 4

td align="left"> Purified water
Ketoconazole2,5
Of distilled monoglycerides2,5
Emulsion wax0,5
Castor oil5,0
Tween-802,5
Dibunola or butylhydroxytoluene0,25
Nipagina0,25
Nipazola0,05
OPMC 2,5
to 100 g

Examples with specified ratios of ingredients provide a pharmaceutical composition that meets the requirements of the global Fund XI (in appearance, microbiological purity and other parameters), stable during storage. Offered as an invention composition is an effective drug in superficial mycoses: dermatomycosis and onychomycosis caused by blastomycete.

Preclinical study of the effect of spray with ketoconazole was conducted on the basis of the clinical laboratory. Antimicrobial activity of the claimed medicinal preparation was studied in accordance with the "Manual on experimental (preclinical) study of new pharmacological substances" (2005).

Test the fungicidal activity of the dosage form was evaluated in relation to cultures of fungi in the yeast and mycelial forms. As the test microorganisms used strains of Candida albicans and Aspergillus niger recommended GF-X1 for testing antimicrobial activity. The cultures were grown on solid medium Saburo. From yeast cells were preparing the suspension according to the turbidity standard of 10 U and diluted in sterile saline to a concentration of 107cells/ml Conidia of Aspergillus niger suspended in a solution of Tween-80, 0.5% and counting the number of PR is led in the camera Goryaeva. The content of conidia was 108/ml.

The determination of minimum fungicidal activity was performed by the method of serial dilutions in liquid nutrient medium Saburo in increments of 2 times. The initial concentration of the test dosage form of the drug was 1 mg/ml in terms of substance. The test drug was compared with a known drug, selected as a prototype. After dilution in all test tubes number made the same microbial load in a volume of 0.1 ml, incubated for 24 hours at a temperature of 24°C. In connection with the fact that the mixture of the drug with a nutrient medium are not transparent, the sowing was made from all tubes. To check the viability of used agar medium Saburo, seeding bar method. After incubation for 48 hours fungicidal effect was assessed by the absence of crop growth. Control was the growth of the test strain in a nutrient medium without drug. The results are presented in tables 2 and 3.

Table 2

Fungicidal activity against Aspergillus niger
MedicationThe content of active substance, mg/ml
1,00,50,250,1250,0630,0315of) 0.157 0,0079
Trial medication-----+++
The placeholder----4-+++
"+" is growth; "-" - no growth.

The data show that the fungicidal action of the test drug is at a concentration of 63 mg/ml, and prototype completely inhibited the mycelial growth of the fungus when the content of 125 µg/ml Thus, the activity of the test drug against Aspergillus niger in 2 times higher than that of the prototype.

Table 3

Fungicidal activity against Candida albicans
MedicationThe content of active substance, mg/ml
1000-15,67,8a 3.91,90,80,40,20,10,05
Trial medication-------++
The placeholder- ------++
"+" is growth; "-" - no growth.

For ease of presentation, results of concentration in the first 8 tubes of the row, where there is a complete inactivation of yeast cells, indicated as a range. The results show that the cells of the yeast Candida much more sensitive to the action of the substance in the checked dosage form than filamentous fungus. For the manifestation of fungicide enough of 0.2 µg/ml of the active substance in the test preparation and the prototype comparable.

The remedy for the treatment of superficial mycoses, containing antifungal substance - namely, ketoconazole, emulsion media, including castor oil, emulsifiers and water, additives target stabilizer and preservative, characterized in that it is made in the form of aerosol liniment, further comprises an antioxidant, which used BHT or equivalent, as an emulsifier contains emulsifiers of the first and second kind, distilled monoglycerides, emulsion wax, tween 80 as a stabilizer contains oxymethylphenyl (OPMC), and the preservative is a mixture consisting of nip is Gina and nipazola in the following proportions, wt.%:

Ketoconazole1,0-5,0
Of distilled monoglycerides0,5-5,0
Emulsion wax0,1 -1,0
Castor oil1,0-10,0
Tween-800,5-5,0
Dibunola or butylhydroxytoluene0,01-0,5
Nipagina0,05-0,5
Nipazolaof 0.01-0.1
OPMC0,5-5,0
Purified waterto 100 g



 

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1 ex, 2 tbl, 3 dwg

FIELD: medicine; surgery.

SUBSTANCE: method involves injections, in area of Achilles tendon, of a medicinal admixture consisting of 4 ml of 10% solution of anecaine, 25 mg of chymopsine, 80 mg of actovegin, 0.5 ml of neostigmine methylsulfate. The medicinal admixture is injected in periphery of Achilles tendon into projections of peripheric nerves n.tibialis and n.suralis on anticnemion.

EFFECT: intensifying local restorative processes and reduction of for time treatment.

1 ex

FIELD: medicine, surgery.

SUBSTANCE: invention can be applied to septic wounds, cavities, and fistulas sanitation. The means comprise aqueous antiseptic solution, including 2.7-3.3% hydrogen peroxide, 0.9-10.0% sodium chloride, and carbon dioxide giving positive pressure 0.2 atm at +8°C.

EFFECT: invention provides safe and effective sanitation conditions, facilitates biological masses elimination, renders expressed geyser-like, dehydrating and antiseptic action.

1 ex

FIELD: medicine.

SUBSTANCE: in case of extreme affections or pathological conditions accompanied by stem cells mobilisation, or in case of exposure of stem cell functional activity modifiers causing stem cells mobilisation, hyaluronidase is injected intraperitoneally in dose 500-1500 CU/kg within 2 days once a day.

EFFECT: increased level of stem cells mobilisation.

11 ex, 11 tbl

FIELD: medicine.

SUBSTANCE: general diabetes-corrigent therapy and low-intensity laser radiation are performed. Surgical processing of purulent-necrotic centre, hydromechanical wound clearing, ozone-therapy are followed with magnetic-infrared-laser radiation initially of trophic ulcer area within 2 minutes, then - of left infraclavicular region and inguinal vascular beams within 2 mines per zone, of thymus gland projection area within 1 mines, of pancreas projection area with scanning within 2 minutes. Frequency is 50 Hz. Infra-red radiation power of light-emitting diodes is 60 mW. Procedures are performed every second day, totally 10 - 16 procedures.

EFFECT: decreased dosage of sugar-lowering medicinal agents; reduced terms of wound surface clearance from purulent-necrotic tissues; pain syndrome reduction; inflammatory processes reduction; activated regenerative process; reduction of operative intervention volume and restoration of limb support function.

7 dwg, 1 tbl, 2 ex

FIELD: medicine.

SUBSTANCE: medicinal product contains carrier and dry mineral medicinal agent, particles of which are homogeneously distributed within volume and/or on the carrier surface. As dry mineral medicinal agent it contains powder with particles sized not more than 10 mcm of sterile mechanochemical activated natural zeolite with saline addition in ratio not less than 5:1. As saline addition product contains marine or lacustrine salt, or bischofite, and as natural zeolite product contains clinoptillolyte or chabazite, or heulandites, or phillipsyte. As carrier product contains material made as hydrophilic absorber and gas-permeable material of woven or non-woven material containing natural filaments or fibres. Carrier can be designed as bandage, or tissue, or plaster and is furnished with fixing elements on the surface. Carrier can be designed as capacity with netting dispenser in filler and cover. Content of zeolite powder and mixed zeolite with saline addition on carrier as bandage, tissue, or plaster does not exceed amount enough to form particle monolayer on one side of specified carrier.

EFFECT: high haemostatic, wound healing and anti-inflammatory properties of product.

7 cl, 1 tbl, 3 dwg, 4 ex

FIELD: medicine; pharmacology.

SUBSTANCE: invention concerns medicinal agent applied for various dermal diseases, injuries, stab, cut and septic wounds, burns and frostbites. Stated medicinal agent is antiseptic ointment containing iodophor as reactant, and polyethylene glycol as ointment base. As iodophor stated ointment contains pharmaiodine, and as ointment base - mixed polyethylene oxide-1500, polyethylene oxide-400 and glycerine taken in proportions as follows, (mass.%): pharmaiodine 5.0-20.0 (0.5-2.0 by active iodine); polyethylene oxide -1500 35-40; glycerine 15-17; polyethylene oxide-400 and other components to 100.

EFFECT: ointment is characterised by antiseptic, anti-inflammatory and wound healing action.

9 ex

FIELD: medicine.

SUBSTANCE: invention concerns biopharmacology and medicine area. The antitumor agent representing a immunoliposome biological structure, including a liposome containing the therapeutic agent, sewed with a vector of peptide nature, thus for treatment of CNS tumors is declared, the liposome contains the therapeutic agent in a water phase, as a vector contains monoclonal antibodies to CD34+, and a linking represents 2-iminotiolan (IT) in 0.1% concentration. As a therapeutic agent, immunoliposome contains the substance chosen from the group: Daunomycin, Carminomycinum, Melphtalan, Methotrexatum, Cytarabinum, Doxorubicinum, Ricine. The method of obtaining of an antitumoral agent and way of inhibition of a tumor of the brain, consisting in agent administering due to item 1 in a pharmaceutically suitable carrier in effective quantity is declared also. Thus preliminary administer parenterally a preparation of hematological stem cells CD34+.

EFFECT: provision of highly effective delivery of an antitumor agent to a CNS tumor.

4 cl, 7 ex, 4 dwg

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