Antibacterial and regenerative agent presented in form of topical oily gel

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to pharmaceutics and medicine, namely to a soft dosage form in the form of a topical oily gel used in treating purulent skin infections and containing sodium fusidine, methyluracil (dioxomethyl tetrahydropyrimidine), an oily gel base (mineral oil and polyethylene) and additionally hydroxymethyl quinoxaline dioxide.

EFFECT: developing the preparation for treating purulent wounds, degrees 3-4 burns, decubituses and ulcers, possessing the improved antibacterial effect and regenerative action.

2 cl, 8 ex, 2 tbl

 

The invention relates to the field of pharmaceutical industry and relates to creating an effective treatment for purulent skin infections.

The technical result of the present invention is an expanding Arsenal of medicinal antibacterial and regenerating means topical application for the treatment of purulent infections of open wounds, burns, ulcers, bedsores.

The treatment of painful disorders of the skin of man (wounds, burns, ulcers, bedsores, eczema and other manifestations) is one of the most difficult for modern medicine problems. Local medicinal product for the treatment of wounds must perform several functions:

to prevent wound infection by pathogenic organisms

- to promote the drainage of wounds from infiltration,

to prevent drying of tissues (tissue dehydration on the periphery of the burn, which slows down the processes of regeneration),

- to reduce inflammation and improve blood microcirculation.

Currently known drugs for the local treatment of bacterial skin infections, containing guideway acid or its derivatives (patent RF №2418806, No. 2180216).

The tool described in patent No. 2418806, contains along with fusidic acid, corticosteroids, anti-inflammatory effect which is generally quite good, but can the t to be extremely dangerous when there is an active infectious agents. When topically applied corticosteroids can have side effects, which are manifestations of local and systemic adverse action, including a possible increase of the existing bacterial infection. In addition, side effects such as suppression of adrenal function, can be marked by excessive and prolonged local application of corticosteroids, particularly in pediatric patients.

Closest to the claimed composition of the drug "Futime ointment for external application"described in the patent of Russian Federation №2180216. The prototype containing fuzidin sodium, methyluracil, PVP, sodium preservatory and fat petrolatum lanolin base, successfully established itself on the Russian pharmaceutical market. It combines antimicrobial activity of fuzidinu sodium and regenerating effect methyluracil. However, a comprehensive clinical and laboratory study of the effectiveness of the drug "Futime ointment for external use showed that it is necessary to strengthen its antibacterial and regenerative activity. According to the laboratory of bacteriology, epidemiology and antibiotic therapy NII swap them. Nevskogo, detachable burn wounds most often contains staphylococci (almost 75% of cases), somewhat less Pseudomonas aeruginosa (about 50%) and significantly less likely one is e microorganisms. Formation in wounds associations of microorganisms with different sensitivity or resistance to antibiotics that causes the need for a comprehensive treatment of burn wounds.

Fuzidin sodium is an antibiotic having a high specific antimicrobial activity against staphylococci, meningococci, gonococci. It has a high antimicrobial activity against Staphilococcus epidermidis (methicillin resistant and methicillin sensitive). Sredneterapevticheskih doses has on microorganisms bacteriostatic action due to the ability of a drug to disrupt protein synthesis in the microbial cell. Resistance is rare. Fuzidin sodium low toxicity.

Plastic surgery is a stimulator of cell regeneration, has anabolic and anti-catabolic activity, reduces the healing time of wounds.

When deciding on the application of a local external tool takes into account not only the sensitivity of microflora to antimicrobial component of the drug, but also the nature of the foundations. Ointments are oil-based't have osmotic activity, is not able to drain the wound, but instead can create a so-called "greenhouse effect". Based prototype as an auxiliary agent used La the Olin-vaseline base. The based ointment With antibiotics provide only short-term effect, because it violates the outflow of wound, does not provide sufficient release of the active component of the composition, is not conducive to the penetration of the antibiotic into deeper tissues, where are the germs that can lead to the transition of acute inflammatory diseases chronic. Lanolin is an organic substance capable of interacting with oxides and basic salts of heavy metals, as well as to sensitize the skin against various substances causing allergic reactions, especially in dermatological patients. Lanolin is also easily oxidized (rancid). To prevent oxidation of lanolin in the prototype use antioxidant (sodium preservatory - preservative E223), can also cause an allergic reaction in sensitive patients.

Known gels in water-glycerol-based in the application form on the skin thin film, which has a protective effect for minor wounds, but painfully pulls tissue impedes the outflow of pus in the case of serious skin lesions, increasing the duration of treatment.

The present invention is to develop an effective drug for the treatment of purulent wounds, burns 3-4 degree, Strait is sung, ulcers with power regenerating and anti-bacterial action with the best combination of excipients.

The problem is solved in that the proposed drug is oily gel and contains fuzidin sodium, dioxotetrahydrofuran (methyluracil), mineral oil and polyethylene, and optionally an antimicrobial substance hydroxymethanesulfinic in the following ratio of components, g:

Fuzidin sodium1,0-5,0
Methyluracil (dioxotetrahydrofuran)0.5 to 10.0
Hydroxymethanesulfinic0,5-5,0
Gel base (blend of mineral oil and
polyethylene)100

Oily gel-based when applied to the skin forms an elastic film, providing a protective effect and do not cause dryness of the skin. Thanks to its properties, such as low sensitivity to changing pH environment, the stability of physico-chemical parameters during storage, non-susceptibility to microbial spoilage, no peculiar is th smell, allows you to exclude from the drug stabilizers. The advantage of the oily gel bases is also easy method of producing a pharmaceutical composition by direct cold mixing the components, excluding energy-intensive stage of fusion of foundations, as well as prevent thermal inactivation of active substances, which increases, in turn, pharmacological efficacy of the drug.

Hydroxymethanesulfinic - antimicrobial agent with a wide spectrum of action. Active against Proteus vulgaris, Pseudomonas aeruqinosa, Escherichia coli, Staphylococcus spp., Streptococcus spp., Shigella, sticks Rindler, pathogenic fungi (Clostridium perfringens). There are strains of bacteria that are resistant to other chemotherapeutic drugs, including antibiotics. Additional inclusion of hydroxymethylhinoxilindioxide promotes more rapid cleansing of the wound surface, stimulates reparative regeneration, regional apitalization, favorably influences the course of the wound process.

The method of obtaining the pharmaceutical composition comprises the following stages: preparation of suspension No. 1 fuzidinu sodium, preparation of suspension No. 2 methyluracil, additionally as a variant of the preparation of the suspension No. 3 hydroxymethylhinoxilindioxide, obtaining gel introduction of said suspensions in the canvas.

Example 1.

the Estimated amount of the gel base (mineral oil and polyethylene), 97,7 1.1 g of fuzidinu sodium is mixed with part of the gel base in a ratio of 1:3, homogenize to obtain a suspension No. 1 with a particle size of not more than 90 μm. Methyluracil 0.6 g mixed with part a gel base in a ratio of 1:3, homogenize to obtain a suspension No. 2 with a particle size of not more than 90 μm. Hydroxymethanesulfinic 0.6 g mixed with part a gel base in a ratio of 1:3, homogenize to obtain a suspension No. 3 with a particle size of not more than 90 μm. In the remainder of estimated part of the gel foundations contribute with stirring suspension No. 1, 2, 3, homogenize the resulting mass until smooth, Packed in tubes.

Example 2.

The estimated amount of the gel base (mineral oil and polyethylene) 80,0,

5.0 g of fuzidinu sodium is mixed with part of the gel base in a ratio of 1:3, homogenize to obtain a suspension No. 1 with a particle size of not more than 90 μm. Methyluracil 10.0 g mixed with part a gel base in a ratio of 1:3, homogenize to obtain a suspension No. 2 with a particle size of not more than 90 μm. Hydroxymethanesulfinic 5.0 g mixed with part a gel base in a ratio of 1:3, homogenize to obtain a suspension No. 3 with a particle size of not more than 90 μm. In the remainder of estimated part of the gel foundations contribute with stirring suspension No. 1, 2, 3, homogenize the resulting mass to which narodnosti, Packed in tubes.

Received the drug is stable during storage, meets the requirements of Pharmacopoeia and has a shelf life of 2 years (table 1).

Example 3.

The estimated amount of the gel base (mineral oil and polyethylene) 96,4,

1.8 g of fuzidinu sodium is mixed with part of the gel base in a ratio of 1:3, homogenize to obtain a suspension No. 1 with a particle size of not more than 90 μm. Methyluracil 0.8 g mixed with part a gel base in a ratio of 1:3, homogenize to obtain a suspension No. 2 with a particle size of not more than 90 μm. Hydroxymethanesulfinic 0.8 g mixed with part a gel base in a ratio of 1:3, homogenize to obtain a suspension No. 3 with a particle size of not more than 90 μm. In the remainder of estimated part of the gel foundations contribute with stirring suspension No. 1, 2, 3, homogenize the resulting mass until smooth, Packed in tubes.

Received the drug is stable during storage, meets the requirements of Pharmacopoeia and has a shelf life of 2 years (table 1).

Example 4.

2.0 g of fuzidinu sodium mixed with 5.0 g of mineral oil, homogenize to obtain a suspension No. 1 with a particle size of not more than 90 μm. 1.0 g methyluracil mixed with 5.0 g of mineral oil, homogenize to obtain a suspension No. 2 with a particle size of not more than 90 μm. 1.0 g of hydroxymethyl is nonclinical mixed with 5.0 g of mineral oil, homogenize to obtain a suspension No. 3 with a particle size of not more than 90 μm. 81,0 g gel base portion is mixed with the suspension No. 1, suspension, No. 2, suspension, No. 3, obtained masses are combined, homogenized until smooth, Packed in tubes.

Received the drug is stable during storage, meets the requirements of Pharmacopoeia and has a shelf life of 2 years (table 1).

Example 5.

The estimated amount of the gel base (mineral oil and polyethylene), 97,0

2.0 g of fuzidinu sodium mixed with gel basis in the ratio of 1:3, homogenize to obtain a suspension with a particle size of not more than 90 μm. 1.0 g methyluracil mixed with gel basis in the ratio of 1:3, homogenize to obtain a suspension with a particle size of not more than 90 μm.In the remainder of estimated part of the gel foundations contribute with stirring suspension of fuzidinu sodium and suspension methyluracil, homogenize the resulting mass until smooth, Packed in tubes.

Received the drug is stable during storage, meets the requirements of Pharmacopoeia and has a shelf life of 2 years (table 2).

Example 6.

The estimated amount of the gel base (mineral oil and polyethylene) 96,7,

2.2 g of fuzidinu sodium mixed with gel basis in the ratio of 1:3, homogenize to obtain a suspension with the size of ASTEC not more than 90 μm. 1.2 g methyluracil mixed with gel basis in the ratio of 1:3, homogenize to obtain a suspension with a particle size of not more than 90 μm. In the remainder of estimated part of the gel foundations contribute with stirring suspension of fuzidinu sodium and suspension methyluracil, homogenize the resulting mass until smooth, Packed in tubes.

Received the drug is stable during storage, meets the requirements of Pharmacopoeia and has a shelf life of 2 years (table 2).

Example 7.

The estimated amount of the gel base (mineral oil and polyethylene) 97,3,

1.8 g of fuzidinu sodium mixed with gel basis in the ratio of 1:3, homogenize to obtain a suspension with a particle size of not more than 90 μm. 0.8 g methyluracil mixed with gel basis in the ratio of 1:3, homogenize to obtain a suspension with a particle size of not more than 90 μm. In the remainder of estimated part of the gel foundations contribute with stirring suspension of fuzidinu sodium and suspension methyluracil, homogenize the resulting mass until smooth, Packed in tubes.

Received the drug is stable during storage, meets the requirements of Pharmacopoeia and has a shelf life of 2 years (table 2).

Example 8.

2.0 g of fuzidinu sodium mixed with 7.5 g of mineral oil, homogenize to obtain a suspension with RA who Merom particles is not more than 90 μm. 1.0 g methyluracil mixed with 7.5 g of mineral oil, homogenize to obtain a suspension with a particle size of not more than 90 μm. 82,0 g gel base portion is mixed with a suspension of fuzidinu sodium and suspension methyluracil obtained masses are combined, homogenized until smooth, Packed in tubes.

Received the drug is stable during storage, meets the requirements of Pharmacopoeia and has a shelf life of 2 years (table 2).

Sources of information

1. Patent RU 2180216.

2. Patent RU 2418806.

3. Nmiau, Maistrova, Ipomea, Smelaxin. "Fuzidin and its properties. Antibiotics, No. 6, 1967, s-454.

4. Smelaxin, Ipomea. Reference antibiotics. Medicine, 1974.

5. The state register of medicines,.

Table 1
Table of analytical data on the quality and stability of the medicinal product
DescriptionMicrobiological purityParticle sizepHQuantitative determination
The gel is white with elevatum shade <10/<10/UTS.Not more than 90 μmfrom 6.0 to 8.0fuzidin sodiummethyluracilhydroxymethanesulfinic
at the time of manufacture
App.1Respectively.Respectively.82,87,21,100,520,54
PRRespectively.Respectively.81,47,84,929,854,95
PRRespectively.Respectively.82,57,51,81 0,880,91
PRRespectively.Respectively.81,87,41,981,020,99
after 2 years of storage at the end of the shelf life
App.1Respectively.Respectively.82,07,31,000,550,51
PRRespectively.Respectively.82,27,74,899,924,90
PRsRespectively.Respectively.of 83.47,7 1,800,890,91
PRRespectively.Respectively.82,97,62,001,020,99

Table 2
Table of analytical data on the quality and stability of the medicinal product
DescriptionMicrobiological purityParticle sizepHQuantitative determination
Gel white<10/<10/UTS.Not more than 90 μmfrom 6.0 to 8.0fuzidin sodiummethyluracil
at the time of manufacture
PRRespectively. Respectively.81,97,52,021,03
PRRespectively.Respectively.82,37,5of 2.211,08
PRRespectively.Respectively.82,07,71,820,91
PRRespectively.Respectively.81,87,62,001,02
after 2 years of storage at the end of the shelf life
PRRespectively.Respectively.82,47,72,011,01
PRRespectively.Respectively.83,07,7,18 1,1
PRRespectively.Respectively.82,87,61,810,89
PRRespectively.Respectively.83,17,52,000,99

1. Antibacterial regenerating agent for external use containing fuzidin sodium, methyluracil and oily gel base, wherein the base is a mixture of mineral oil and polyethylene, in the following ratio of components, g:

fuzidin sodium1,0-5,0
methyluracil (dioxotetrahydrofuran)0.5 to 10.0
gel-based (mineral oil and polyethylene)100

2. The tool according to claim 1, characterized in that it further contains antibacterial broad-spectrum action hydroxymethanesulfinic in an amount of from 0.5 g to 5.0 g per 100 g of the funds is.



 

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8 cl, 2 dwg, 3 ex

FIELD: chemistry.

SUBSTANCE: invention relates to a method for synthesis of chelator-targeting ligand conjugates, which can be used to treat and diagnose diseases, e.g., by imaging tumours or myocardial ischaemia. The method includes step (a) for conjugating, in an organic medium, a chelator of formula with at least one unprotected targeting ligand, which is glucosamine, where each of A and D is a protected thiol, each of B and C is a protected secondary amine; each of E and F is a -COOH group; each of R1, R2, R3 and R4 is H; X denotes -CH2-CH2-; and where conjugation occurs through formation of an amide bond between E or F of the chelator and the amino group of the glucosamine. The organic medium used is usually a polar or nonpolar solvent or a mixture thereof. The method can further include (b) purifying the conjugate of the chelator-targeting ligand; step (c) of chelating a metal ion with the conjugate of the chelator-targeting ligand to form a metal ion-labelled chelator-targeting ligand conjugate. Step (c) includes a step (d) of removing at least one protective group from the metal ion-labelled chelator-targeting ligand conjugate or additionally a step (e) of adding a reducing agent. The preferred conjugates are 99mTc- ethylenedicysteine (EC)-glucosamine, 188Re-EC-glucosamine or 187Re-EC-glucosamine.

EFFECT: method enables to products of high purity.

10 cl, 13 dwg, 4 tbl, 18 ex

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