Pharmaceutical composition for treatment of skin lesions

FIELD: medicine.

SUBSTANCE: invention relates to pharmaceutical composition preferably in ointment form for treatment of skin lesions containing as active ingredient dexpanthenol and target additives such as fatty additives, namely solid, soft and liquid additives, emulsifier and water. As emulsifier cetostearyl alcohol is used. Composition of present invention has storage time not less than 2 years.

EFFECT: composition of improved quality and prolonged storage time.

8 cl, 2 tbl, 6 ex

 

The invention relates to the field of medicine and relates to pharmaceutical agents for the treatment of wounds, fractures, burns, trophic ulcers, dermatitis, itching and allergic dermatoses, etc.

In the basis of preparation is dexpanthenol - R-2,4-dihydroxy-N-(3-hydroxypropyl)-3,3-dimethylbutyramide. Dexpanthenol is a synthetic derivative of Pantothenic acid, optically active isomer panthenol, fills, as panthenol, deficiency of Pantothenic acid, has anti-inflammatory properties, stimulates regeneration processes and peristalsis. In the body forms an active metabolite of Pantothenic acid.

Due to their biochemical and pharmacological properties dexpanthenol has found application in the cosmetic and medical practice.

Thus, in U.S. patent 4268526, 1981, 6231837, 2001, application France 2700954, 1994, the patent of Russia 2128504, 1999, provides cosmetic compositions containing various amounts of dexpanthenol (or panthenol), characterized by complexity and labor-intensive production technology.

Known aerosol dexpanthenol, which is used for the treatment of lesions of the skin (Mashkovsky PPM, "Drugs", M, LLC "New Wave", 2004, Vol.2, s).

In the patent of Russia 2117479, 1998 proposed pharmaceutical composition for the treatment and mitigation of the symptoms is alvita and candidiasis in accordance with the invention contains, wt%: 0,005-0,5 folic acid, 0.25 to 2.5 panthenol and/or 0.15-1.5 allantoin, 0.75 to 7.5 hydrolyzed protein or hydrolyzed casein, 3-15 lactose or dextrose, 0,25-2,5 lactic acid, 0.25 to 2.5 magnesium sulfate and 0.75-7.5 sodium chloride or ammonium chloride, allowing for quick absorption. The disadvantage of this composition is its use for the treatment of one type of disease.

In recent years there have been other dosage forms that contain panthenol. Thus, in the patent of Russia 2166963, 2001, describes a method of closing and treatment of wound surfaces and floor for its implementation. On the wound healing place means representing beeswax and/or waxy raw materials in the form of particles, or plates, or grids. Particles can be blended with panthenol (spray) in equal amounts, providing acceleration of the healing process, protection against the occurrence of infection and the appearance of scars. The disadvantage of this method admittedly quite complicated production technology of medicinal forms and the need to use panthenol in the form of spray.

The objective of this invention is to provide a new pharmaceutical composition for external use on the basis of dexpanthenol, which would meet the requirements of Gosfarmakapei XI edition and who ate a shelf life of 2 years.

The problem is solved by a pharmaceutical composition comprising as active ingredient dexpanthenol, fat additive, emulsifier and water in the following ratio, wt.%:

Dexpanthenol4,0-6,0
Fat Supplement60,0-74,0
Emulsifier2,5-3,5
Waterthe rest is up to 100%

As a fat Supplement use hard, soft and liquid fat supplements in the following ratio, wt.%:

Dexpanthenol4,0-6,0
Solid fat Supplement39,3-48,7
Soft fat Supplement2,7-3,3
Liquid fat Supplement18,0-22,0
Waterthe rest is up to 100%

As a solid fat supplements are used, mainly, petrolatum and/or lanolin, and/or alcohols wool wax. As a mild fat Supplement use beeswax white. As liquid fatty additives used vaseline oil and/or almond oil. As the emulsifier used alcohol cetosteatil, a mixture of the latter with cetostearyl sulfate intothree is or matricariifolium, emulsifying wax, emulsifiers brand "Lanette", mainly alcohol cetosteatil. All components included in the inventive composition, possess a pharmaceutically acceptable properties and quality.

A new pharmaceutical composition is made in the form of soft medicinal forms, preferably in the form of ointment.

The proposed ratio of the active substance and the target additives found experimentally and is optimal, providing the pharmaceutical compositions according to the requirements of Gosfarmakapei XI ed. and the shelf life of not less than 2 years (see table 2).

The following examples illustrate the invention (table 1).

A typical example. In a round bottom flask equipped with a stirrer and a thermometer, load consistently vaseline and/or lanolin, and/or alcohols, wool wax, vaseline oil and/or almond oil, beeswax white and cetosteatil alcohol. The mass is heated to 70-75°C and stirred at this temperature until a homogeneous mass, and then gradually cooled to 60°s Dexpanthenol placed in chemical beaker, add pre-heated to 60°With water and stirred at 60-65°until complete dissolution of the substance. A fat basis, in the flask, with stirring and at a temperature of 60-65°gradually poured an aqueous solution of expandin the La. The mass is stirred at 55-60°C to obtain a homogeneous ointment. Ointment gradually cooled to 25-30°and Packed in tubes.

Specific examples of carrying out the invention is presented in table 1.

The resulting ointment on the basis of dexpanthenol meets all regulatory requirements and has a shelf life of at least 2 years (see table 2).

td align="center"> 100
Table 1
ComponentsExamples
123
Dexpanthenol, wt.%5,24,15,8
Solid fat additive, wt.%44,2 (vaseline, lanolin alcohols, wool wax)48,4 (alcohols, wool wax, petrolatum)39,6 (alcohols, wool wax, lanolin)
Soft fat additive, wt.%

(beeswax white)
3,13,32,7
The liquid fat additive, wt.%20,1 (vaseline oil, almond oil)22,0 (vaseline oil)18,0 (almond oil)
Emulsifier, wt.% (cetosteatil alcohol)3,12,73,3
Water, wt.%100100

Table 2
№№ p/pName quality scoreStandards of quality requirementsThe actual indicators
Example 1Example 2Example 3
1.DescriptionOintment light yellowOintment light yellowOintment light yellowOintment light yellow
2.pHFrom 6.0 to 7.56,66,37,2
3.UniformityThe ointment should be homogeneousUniformUniformUniform
4.Microbiological purityOn GF XI ed., 2), s and Edit. No. 3, cat
5.Quantitative determinationThe content of Dexpanthenol 1 g drug g from 0,0475 to 0,05250,05040,04910,0514
6.Shelf life2 years2 years2,5 the ode 2 years

1. Pharmaceutical composition for treating skin lesions comprising as active ingredient dexpanthenol, characterized in that it further comprises a fat Supplement, emulsifier and water in the following ratio, wt.%:

Dexpanthenol4,0-6,0
Fat Supplement60,0-74,0
Emulsifier2,5-3,5
WaterThe rest is up to 100%

2. The pharmaceutical composition according to claim 1, characterized in that as a fat Supplement it contains solid fat Supplement, soft fat additive and the liquid fat Supplement in the following ratio, wt.%:

Dexpanthenol4,0-6,0
Solid fat Supplement39,3-48,7
Soft fat Supplement2,7-3,3
Liquid fat Supplement18,0-22,0
Emulsifier2,5-3,5
WaterThe rest is up to 100%

3. The pharmaceutical composition according to claim 2, characterized in that the solid fat additives it contains mostly vaseline, and/or lanolin, and/or the alcohols wool wax.

4. The pharmaceutical composition according to claim 2, characterized in that as a mild fat additives it contains beeswax white.

5. The pharmaceutical composition according to claim 2, characterized in that the liquid fatty additives it contains mostly vaseline oil and/or almond oil.

6. The pharmaceutical composition according to claim 1, characterized in that as an emulsifier it contains mostly alcohol cetosteatil.

7. The pharmaceutical composition according to any one of claims 1 to 6, characterized in that it is made in the form of soft medicinal forms.

8. The pharmaceutical composition according to claim 7, characterized in that it is made mostly in the form of ointment.



 

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