RU2128990C1 - Anti-inflammatory and wound-healing ointment "vundehil" - Google Patents

Abstract

FIELD: medicine, pharmacology, pharmacy. SUBSTANCE: ointment has the following components taken at definite amounts: anhydrous lanolin, inner fat, bee wax, carophylene, cinquefoil rhizomes an aqueous-spirituous extract, Sophora japonica an aqueous-spirituous extract, milfoil herb an aqueous-spirituous extract, propolis spirituous extract, vegetable oil. Ointment provides wound-healing, anti-inflammatory, bactericidal and antiallergic effect and can be used for skin sicknesses treatment and in gynecology and proctology also. Ointment shows the enhanced penetrating capacity into biotissues and tissue healing and retains biologically active properties for 2 years, not less. EFFECT: enhanced effectiveness of an ointment, prolonged effect, broadened pattern of effect. 1 tbl, 7 ex

Description

 The invention relates to pharmacology and for the creation of a therapeutic ointment.

Known ointment for the treatment of trophic ulcers (AS USSR N 305549, class A 61 K 9/06, bull. N 36, 1979), containing components in the following ratio, wt.%:
right-handed camphor - 2.0 - 4.0
ethyl ether - 8.0 - 10.0
basic bismuth nitrate - 4.0 - 6.0
salicylic acid - 1.0 - 3.0
amidochloride mercury - 2.0 - 6.0
liquid paraffin - 8.0 - 10.0
medical vaseline - 43.0 - 35.0
water lanolin - 24.0 - 26.0
The ointment is stored in a glass or porcelain dish at a temperature of 8 - 10 ^o C; the ointment retains its properties for 6 months, has a good smear and adhesion to the integumentary tissues and is difficult to wash off with soap and water.

 At the same time, the presence of bismuth nitrate and amidochloride mercury in the composition can cause a negative effect on skin regeneration, and various people with prolonged use can manifest not only an allergic reaction, but also poisoning of the body. As a result, the healing process itself can be ineffective.

Known drug (US Pat. RF N 2007164, class A 61 K 9/06, bull. N 3, 1994), containing components in the following ratio, wt.%:
apricot oil - 20.0 - 82.0
dibenzoyl (DB) - 1.0 - 7.0
dibenzoyl peroxide (PB) - 1.0 - 7.0
lanolin - 63.9 - 62.0
urortropine - 0.05 - 0.1
ethanol - 1.0 - 9.5
The known tool is used in the treatment of skin diseases, burns, in oncology and proctology and has antitumor, antifungal and antiviral activity and retains it for 1 year.

 However, like the above analogue, this ointment in its composition contains a large number of chemical components that can cause an allergic reaction of the body as a whole and irritation of the wound surface.

Known antiseptic ointment (US Pat. USSR N 1805952, class A 61 K 9/06, bull. N 12, 1993), containing components in the following ratio, wt.%:
beeswax - 12.0 - 13.0
15% rivanol solution - 1.2 - 1.3
vegetable oil - the rest
Unlike the given analogues, this ointment contains chemical components in a smaller amount and, due to the content of a wax-oil mixture in its basis, provides increased penetration into biological tissues and tissue healing. The ointment is used for external use in purulent wounds and frostbite. The prepared ointment is suitable for more than 90 days when stored in the dark at room temperature.

 However, the combination of vegetable oil and beeswax does not provide a sufficiently active regenerative effect, and the presence of rivanol, although in small quantities, does not exclude the occurrence of an allergic reaction and, on the contrary, with prolonged (more than 14 days) use can cause irritation of the wound surface.

 The basis of the invention is the task of creating an ointment that would have an increased healing, bactericidal, anti-inflammatory, anti-allergic effect, would have biologically active and regenerating properties, could be used both for the treatment of skin diseases and mucous membranes (in gynecology, proctology) and preserved their biologically active properties for at least 2 years at room temperature due to the presence in the composition of exclusively components of natural origin, and among them to components that exclude the decomposition of the structure of the ointment.

The solution to this problem is provided by the fact that the ointment anti-inflammatory and wound healing "VUNDEKHIL" containing beeswax and vegetable oil, according to the invention additionally contains anhydrous lanolin, interior fat, carophilen, water-alcohol extracts of the roots of the cinquefoil erecta, Japanese sophora and yarrow grass, as well as alcohol extract of propolis in the following ratio, wt.%:
anhydrous lanolin - 15 - 17.0
body fat - 22.0 - 24.0
beeswax - 8.0 - 10.0
karofilen - 1.0 - 3.0
water-alcohol extract of the rhizomes of the cinquefoil erect - 1.0 - 3.0
water-alcohol extract of Japanese sophora - 2.0 - 4.0
water-alcohol extract of yarrow grass - 1.0 - 3.0
propolis alcohol extract - 4.0 - 6.0
vegetable oil - the rest
As an ointment base, this preparation includes: anhydrous lanolin, internal fat and vegetable oil.

Lanolin (Lanolinum) - a natural product that is obtained by cleaning wool wax, which is isolated from the water remaining after washing the wool of the sheep. Due to the content of the mixture of esters of cholesterol, isocholesterol and higher fatty acids with C ₁₈ -C ₂₄ , as well as up to 10% of free stearins, lanolin provides nutrition and metabolism not only in the surface layers of the skin, but also in deeper subcutaneous layers, which stimulates more active regeneration of damaged tissues.

 Interior fat (pork) is a natural product isolated from adipose tissue of pigs. The main component is triacylglycerols of monobasic higher fatty acids. It also contains cholesterol, phosphatides, vitamins A, D, E, G, which stimulate the human immune system, contribute to the rapid regeneration and epithelization of tissues.

 Vegetable oil is a natural product obtained from annual sunflower seeds (Helianthus annuus L). The oil contains glycerides of palmitic, stearic, arachidonic, lignoceric, oleic and linoleic acids, up to 19% protein, 26.5% carbohydrates, about 2% phytin and 1.5% tannins.

 The above fatty components that form the ointment base of the drug "VUNDEHIL" in combination provide excellent contact with the affected areas of the skin and mucous membrane due to its natural origin. They also have the ability, along with direct exposure, to stimulate the action of biologically active principles of the ingredients of plant origin of this formulation and to provide a healing, anti-inflammatory, bactericidal and anti-allergic effect.

 As a structure-forming and film-forming component, beeswax was introduced into the composition of VUNDEKHIL ointment, which has valuable medicinal properties due to the content of meliesil alcohol and palmitic acid in it, as well as free acids - neocerotinic, cerotinic, montanic, melies and others.

 Beeswax in the presence of triglycerides contained in vegetable oil is capable of releasing oxidative oxygen into the wound, which contributes to the bactericidal gentle action of the ointment and the active healing of tissues.

 Karofilen - a dense extract of the sum of carotenoids and other lipophilic substances isolated from the flowers of medicinal marigolds (Calendulas Officinali), a family of Asteraceae (Asteraceac). Calendula preparations have a wide spectrum of pharmacological activity, which is due to the rich content of biologically active compounds such as carotenoids (carotene, rubixanthin, lycopene, citroxanthin, violoxanthin, flavochrom, flavoxanthin, etc.) in the flowers of the plant, flavonoids - possessing capillary-strengthening activity, resins and vitamins. The main properties of galenic forms and herbal remedies from calendula officinalis are anti-inflammatory, wound healing, bactericidal, antispasmodic and choleretic. The clinical use of calendula is mainly due to its antiseptic, anti-inflammatory and wound healing effects both for external and internal use.

 The aqueous-alcoholic extract of the rhizome rhizomes erect is part of the VUNDEHIL ointment due to the pronounced anti-inflammatory and hemostatic effect. The action of the rhizome rhizomes erect is based on the rich content of tannins (up to 30%), in which condensed catechins and catechin phlobaphenes (tormentil red) predominate, the presence of tormentilin glycoside, quinic and elagic acids, resins, essential oil, etc.

 The fruits of Japanese sophora (Sophora Japonica L) contain a large amount of rutin (vitamin P) - 12 - 20%, which has the property of lowering the permeability and fragility of capillaries. Sophora has a hemostatic, bactericidal, anti-inflammatory, decongestant and wound healing effect.

 Yarrow grass (Achillea millefolium L) has multilateral pharmacological properties due to the presence of various biologically active compounds in the medicinal raw material.

 The leaves of the plant contain alkaloid achillein, an essential oil that contains chamazulene, esters, camphor, thujone, borneol, cineole, glycosides - apigenin and luteolin, tannins, resins, amino acids, organic acids, carotene, vitamin K, ascorbic acid, bitter substances.

 The content of tannins, essential oil and chamazulene in the plant determines the anti-inflammatory, bactericidal, anti-allergic and wound healing properties of yarrow.

Propolis is included in the formulation of VUNDEHIL ointment due to its pronounced antimicrobial, antibiotic effect. It contains about 55% of resins and balms, benzoic acid, volatile, about 10% of essential oils, about 30% of wax and 5% of pollen. Propolis balm contains cinnamon (CgH ₁₀ O), cinnamic acid (CgH ₈ O) and tannins. Due to pollen, propolis is rich in minerals, vitamins, trace elements and antibiotic substances. Propolis has a detrimental effect on a number of bacteria (streptococci, staphylococci, salmonella, etc.), has a well-defined local analgesic effect. By force of action, it surpasses well-known local anesthetics - cocaine by 3.5 and novocaine by 5.2 times.

 The introduction of propolis in the formulation of VUNDEKHIL ointment significantly enhances its therapeutic effect and, in addition, propolis is a strong natural preservative, which is very important for long-term storage of the ointment.

 When the content of laniline anhydrous, body fat and beeswax is not less than 15, 22 and 8 wt.%, Respectively, a structure-forming effect will not be provided, the ointment will be excessively liquid.

 When the content of these components is more than 17, 24 and 10 wt.%, Respectively, the structure of the ointment will be excessively rigid.

 When the content of carophilene is less than 1.0 wt.%, The healing, anti-inflammatory and bactericidal effects will be reduced (and in some people not provided).

 When the content of carophilen is more than 3.0 wt.%, Excessive biological activity will appear that is ahead of the physiological need of the wound for healing.

 When the content of water-alcohol extracts of the rhizome rhizomes is erect, Japanese Sophora and yarrow herbs is less than 1, 2 and 1 wt.%, The healing, anti-inflammatory, bactericidal and capillary-strengthening effects will be correspondingly reduced due to the insufficient activity of the components to suppress the action of a number of microorganisms that interfere with the skin regeneration and mucous membranes.

 When the content of these components is more than 3, 4 and 3 wt.%, Respectively, the structure of the ointment will be violated and its separation will occur due to the large amount of water, which anhydrous lanolin cannot compensate for. This will affect the shelf life of the ointment.

 When the content of propolis alcohol extract is less than 4 wt.%, The activity of the ointment to pathogenic bacteria that interfere with the tissue regeneration process will be reduced, and in addition, the role of propolis as a natural preservative will be reduced, which will affect the shelf life of the ointment.

 A content of this component of more than 6 wt.% Can cause an allergic reaction to the ointment.

 The content of vegetable oil is determined by the total content of all components and is added in the amount necessary to obtain 100 wt.% The composition of the ointment, and ranges from 36 to 38 wt.%.

 The technology for the preparation of VUNDEHIL ointment is as follows.

A prescription amount of anhydrous lanolin (80 kg), pre-treated interior fat (115 kg), vegetable oil (185 kg), and beeswax (45 kg) are loaded into the auxiliary reactor No. 1 with a steam jacket and a mixer with a capacity of 1 m ³ . With stirring, the mixture is heated to the boiling stage and boiled with constant stirring for 1 hour.

After that, the finished fat (ointment) base from the auxiliary reactor is pumped into the main cooking pot with a capacity of 1 m ³ and the prescription amount of carophilene (10 kg), water-alcohol extract of the rhizomes of the cinquefoil erect (10 l), water-alcohol extract of the fruits of Japanese Sophora are added ( 15 l), a water-alcohol extract of yarrow grass (10 l) and an alcohol extract of propolis (25 l).

The resulting mixture is stirred for 1 hour (the alcohol evaporates), then the temperature is reduced to 20 - 25 ^o C with constant stirring with a frame stirrer at 3000 rpm After this, the ointment is supplied for packaging.

 The table shows examples of obtaining ointments "VUNDEHIL" with different contents of the components that make up its composition.

 As studies have shown, when exceeding the limit values of the claimed values of the components (examples 4-7), there is a significant decrease in the pharmacological activity of the ointment and its shelf life is halved.

 Pharmacological studies conducted on animals and humans have shown that VUNDEKHIL ointment does not have a general toxic, irritating and sensitizing effect. The effect of the ointment on damaged skin was characterized by an improvement in reparative processes.

 The combination of biologically active substances of the drug "VUNDEHIL" provides anti-inflammatory, bactericidal, anti-allergic and healing effects on the affected skin, contributes to the normalization of metabolic processes and rapid tissue regeneration. All components of the ointment are biologically combined with each other and ensure the safety of the ointment for at least 2 years.

 Ointment "VUNDEHIL" has been tested on animals and humans and is recommended for clinical trials and implementation.

 Example 1. Patient M., 49 years old. Serious damage to the skin of the left hand, head, and right lower leg as a result of an accident. After suturing the damaged skin areas, VUNDEHIL ointment was used. The ointment was applied to a gauze swab and applied to the wounds, then the wounds were bandaged. After 1 hour the pain passed. The wounds healed in 6 days. Not observed intoxication, swelling, inflammation. Scars at the site of damage are hardly noticeable.

 Dressings were painless, because dressings with VUNDEKHIL ointment do not stick to the wound surface and are freely removed.

 Example 2. Patient C., 70 years old. Diagnosis: 25% of the back surface is damaged by pressure sores as a result of a long lie down due to disability (not healing for a long time, despite prolonged treatment).

 Used ointment "VUNDEHIL." On gauze swabs, the ointment was applied to the affected areas. The pain was quickly relieved, after 3 days the necrotic tissues were removed and after 10 days, tender skin appeared on the site of the pressure sores.

 Example 3. Patient R., 37 flax. Diagnosis: extensive trophic ulcers of the right lower leg, not healing for a long time, despite prolonged treatment.

 After applying VUNDEKHIL ointment, recovery came on the 14th day.

 Example 4. Patient S., 41 years old. Diagnosis: weeping eczema on the fingers of the right hand.

 After the first application of VUNDEHIL ointment on the affected fingers, a strong effect of "pulling" pustules from under the skin was observed. With the further use of VUNDEHIL ointment, complete cleansing and healing of the affected fingers was observed. Recovery occurred on the 10th day.

 Example 5. Patient Yu., 35 years old. Diagnosis: hemorrhoids (long non-healing, despite prolonged treatment).

 After applying VUNDEKHIL ointment, recovery came on the 12th day.

 Example 6. Patient S., 29 years old. Diagnosis: cervical erosion, not healing for a long time, despite prolonged treatment.

 Ointment "VUNDEHIL" was introduced on a gauze swab (applied in a thick layer) deep into the vagina at night. In the morning, the tampon was removed. Recovery occurred on the 10th day.

 Example 7. Patient K., 53 years old. Diagnosis: varicose veins of the lower leg of both legs with a large number of small non-healing wet ulcers.

 Ointment "VUNDEKHIL" was applied to the lower legs, then the lower legs were covered with compress paper and bandaged. This procedure was done at night every day. Recovery came on the 15th day.

 Ointment "VUNDEHIL" has a high pharmacological activity. It has a healing anti-inflammatory, bactericidal effect. Quickly relieves pain, swelling, intensively removes necrotic tissue, stimulates the rapid healing of wounds, trophic ulcers, pressure sores, erosion, and cracks in the skin. It is also used to treat varicose veins, hemorrhoids and a number of skin diseases (eczema, dermatoses, furunculosis, allergic manifestations). Dressings with this ointment do not stick to the wound surface and are freely removed.

Claims (1)

An anti-inflammatory and wound healing ointment containing beeswax and vegetable oil, characterized in that it additionally contains anhydrous lanolin, interior fat, carophilene, water-alcohol extracts of the upright rhizomes, Japanese sophora and yarrow grass, as well as an alcohol extract of propolis in the following ratio of components , wt.%:
Anhydrous lanolin - 15.0 - 17.0
Interior Fat - 22.0 - 24.0
Beeswax - 8.0 - 10.0
Karofilen - 1.0 - 3.0
Water-alcohol extract of the rhizomes of the cinquefoil erect - 1.0 - 3.0
Water-alcohol extract of Japanese Sophora - 2.0 - 4.0
Hydroalcoholic extract of yarrow grass - 1.0 - 3.0
Propolis alcohol extract - 4.0 - 6.0
Vegetable Oil - Else

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