A wound healing agent for local use

 

(57) Abstract:

Scope: the invention relates to medicine, namely to facilities for the treatment of wounds and injuries. Objective: improvement activity funds. The inventive tool contains polysulfate-aluminum compound of the disaccharide in an amount of 0.1 - 50 wt.% and pharmaceutically acceptable carrier. 2 C.p. f-crystals, 1 table.

The invention relates to a method and pharmaceutical composition for treatment of wounds and injuries, it also relates to a method and pharmaceutical composition for the treatment of symptoms of anorectal diseases and hemorrhoids.

Anorectal disease is irritating and causes the feeling of nekomfortno disorder. Hemorrhoids is a common ailment anorectal region and can be both internal and external in nature. Anorectal disorders are characterized by signs and symptoms of itching, burning, pain, bleeding, leakage, protrusion, inflammation, irritation, swelling, and General discomfort and changes in the structure intestine, or any combination of these signs. Have been proposed a variety of remedies and attempt to mitigate tacky, widespread in humans. A person not immune. A significant portion of adults suffer from one or more anorectal symptoms for some period of their lives. Anorectal disease is the cause of countless lost hours of work annually.

Previously proposed compositions which facilitate or itching, or inflammation, but there was little achievements, which would be reduced or completely eliminated both. Thus, the effectiveness of such a composition for the relief or treatment of symptoms of such diseases is questionable.

Some of the songs suggested for the treatment of hemorrhoids, include a powder mixture of alum, sulphate of quinine, and aspirin mixed with jelly-based oil, a mixture of enzymes oxidase, the mixture is crushed into powder or flakes branches or roots of a Bush Celastrus scandens, a mixture of polyglycerol and products Mature berries of Solanum plants carolinese, which was added sublimated sulfur, ammonium alum and oil of turpentine. Examples of products (they have not exhausted the entire list) with different composition are anusol, balneol, Lanakane, Nupercainal, Preparation H and Vaseline.

There have been many attempts to solve the problem of how to treat hemorrhoids, but so far, this problem has no satisfactory solution. There is currently a real need in a safe and effective product in the treatment with the aim of calming and healing of anorectal diseases.

The purpose of the invention is to provide preparation for use for the treatment of anorectal diseases and irritation, which reduces swelling, inflammation and pain caused by or characteristic of anorectal disease, which instead is accordance with the invention features a method of treating symptoms of anorectal disease with the help of a local application to the perianal area of the human body in number, which is effective to suppress or relieve symptoms such composition, which is safe and effective and includes as the active ingredient polysulfate-aluminum compound of the disaccharide.

In accordance with the invention features a composition and method for treatment of skin wounds or injuries that do not are called conditions of high acidity or chemotherapie.

The composition in accordance with the invention contains polysulfate-aluminum compound disaccharide such as sukralfat in combination with acceptable from a pharmaceutical point of view of the media. The song in General is dispersed in the local environment as a carrier.

Shared connections are polysulfate-aluminum compounds sucrose polysulfate-aluminum compound and lactose polysulfate-aluminum compounds maltose. The sulfur and aluminum in General use in the field 7-13 and 11-24%, respectively, and, therefore, generally contain 1-4 atom of aluminum per atom of sulfur.

The symptoms of rectal diseases that can be treated by the proposed method and using the compositions, include itching, burning, causing pain, inflammation, ratmono to reduce the size of hemorrhoids.

Compositions used local way to the anorectal area to obtain relief from the above symptoms. Depending on the specific symptoms the use of exercise to any area or all areas of the anorectal region, including the perianal region or part of the skin and buttocks immediately surrounding the anus, a modified anal skin of the anal canal and mucous membrane of the rectum.

Compositions used local way to the field as long until relief of symptoms. The composition is applied one or more times during the day. Application continue for as many days as needed to improve disease undergoing treatment.

The number of sukralfat, which is used in accordance with the invention, is important. In particular, it should be noted that in accordance with the invention, compositions that are the subject of the present invention to form a visible set of white sukralfat with inflamed and affected area. Thus, the proposed compositions provide long treatment.

In the composition of the invention sukralfat when it is 0.1%, or more than 25 to 50%.

Used a single dose of from 0.01 to 0.1 g per dose, but does not exceed approximately 5 g over a time period of 24 h In a preferred embodiment, the unit dose is from about 0.05 to 0.5 g per dose, although a single dose can be adjusted up or down, which is dictated by the size of the area to be treated.

If the ointment containing 5% of sukralfat, use a local method to the rectal area of a patient suffering from hemorrhoids, directly or immediately after the cleansing of the stomach, the patient will immediately feel the soothing of pain. In addition, after 5 days reduced bleeding and the size of the hemorrhoids.

It was noted that white ointment containing sukralfat remains stuck to the hemorrhoids even after cleaning the stomach. This effect was not observed when using the same ointment, but without the sukralfat. Thus, it was visual proof that a complex is formed between sukralfat and inflamed and damaged area. Unexpectedly it was found that the complex formation takes place in acid-free environment.

In accordance with another implementation of the invention sukralfat applied to the patient with the symptoms is critical to the treatment of anorectal diseases. Examples of the countless products that can be applied together with sucralfate, are (but not limited to the entire list):-Cain, American, Anusol, Balneol, Bilzen, blue-gray, Calmol 4, ointment Cortef against rectal itching, Ditan, Epidemically ointment, rubbing Hentzi, Gamorrean, Ointment UTR, Colorless utrs, Lanakane, MediaNet, the non-Steroidal Proctofoam, ointment Nupercainal, suppositories, Nupercainal, Tongue, Pyrifoam, ointment Peterson, Pontocaine, exposure of N, cleansing swabs Spooling N, Protogon, Runtex, Rectal Suppositories Medicon, Rectal Unguent Medicon, Anikanova ointment Anikanova suppositories, Tronolane, Cream and ointment Dachshund, tampons Dachshund, jelly on the basis of vaseline and refined petroleum product, Vianocne ointment and Vianocne suppositories (Federal Register, 45 33576, may 22, 1980).

The main pharmacological agents, which include the mentioned products include local anesthetic agents, agents, narrowing the blood vessels, protecting tools, agents, anti-irritant agents that cause contraction of the tissues, the agents used for wound healing, antiseptic funds (Federal Register 45 35576, may 27, 1980). In the area covered by the invention, sod is Osada agents, known as local anesthetics, protective equipment, agents that reduce blood vessels and agents for wound healing.

Local or local anesthetic agents temporarily relieves pain, burning sensation, itching, discomfort and irritation help prevent the transmission of nerve impulses. Examples of local anesthetic agents (they have not exhausted the entire list) include benzocaine, hydrochloride pramoxine, benzyl alcohol, dibucaine hydrochloride, hydrochloride dicyanin, lidocaine, tetracaine and hydrochloride tetracaine (Federal Register, 45 35576, may 27, 1980 ). In a preferred embodiment, use benzocaine and hydrochloride pramoxine, which in General is known as a safe and effective products.

Protecting agents act in order to prevent irritation of the rectal area and water loss in the skin layer during the formation of a physical barrier on the skin. There is little absorption or even a complete absence of a protective agent. Examples of such agents (they have not exhausted the full list) include gel, hydrate, aluminum oxide, calamine, cocoa butter, cod liver oil, glycerin, kaolin, lanolin, minerals, fish oil, starch, white VA is used to reduce inflammation, irritation and swelling, listening symptomatic, abnormally large nodes of blood vessels. Non-limiting examples include ephedrine and epinephrine (Federal register 45 so, 35576, may 27, 1980).

Among nonspecific anorectal products, it was found that several of the ingredients are effective in accelerating wound healing or repair tissue in anorectal disease. Non-limiting examples of agents of wound healing are the factors of breath skin (FDC), water-soluble yeast extract of Brever, referred to as derived cells of living yeast, butter, cod liver, vitamin a and vitamin D (Peerally the registry, so 45, 35576, may 27, 1980).

Within the scope of the invention also includes the fact that sukralfat applied to the patient having the symptoms of anorectal disease, in separate compositions, which are used along with the use of known composition for the treatment of anorectal diseases. Thus, in accordance with one embodiments the composition comprising sukralfat, apply to the patient immediately before or immediately after application of anorectal product. In accordance with another variant of the wasp is the label of the second composition.

In accordance with another embodiment of the invention sukralfat and other pharmacological agents used for the treatment of anorectal symptoms of the disease include a form of the same composition, for example, with the agent for wound healing, protecting agent, agent, narrowing blood vessels, or a local anesthetic agent, or with several of these agents.

In yet another embodiment of the invention, which is also contained in the area covered by the invention, sukralfat mixed with the currently available product for the treatment of anorectal diseases. For example, sukralfat mixed with preparation H in order to obtain a composition of the invention.

In the area covered by the invention also provides a pharmaceutical composition comprising sukralfat used local way to wounds or lesions, which are different from anorectal. It should be known that the wound or lesion should be treated the local way.

These wounds or lesions can be caused by infections, such as fungal infection. An example is the damage caused by athlete's foot. In addition, sores or lesions m the sumac poisoning, or can be caused by infection or exacerbation of another disorder that is characterized by the formation of acne. The wound may also be formed as a result of physical injury with formation in the wound cracks, scratches or abrasions.

In accordance with another embodiment of the invention, topical application of a composition containing sukralfat, used to accelerate healing of abrasions, such that in the General case are formed as a result of physical trauma to joints such as the knee, elbow, fingers, shoulder, hip, foot, etc.

For example, abrasions on the knees of the players in the basketball, which were caused by falls while playing basketball, was treated with an ointment containing 5% of sukralfat. Applied white ointment could still be observed on the affected area after 24 h after the first application. The ointment was applied repeatedly every day. The bleeding stopped within twenty-four hours, and a good healing took place three days later.

It was noted that each local application in wound ointments containing sukralfat, or rectal area, or to something else sukralfat formed visible set with cloth, okruzhayuscyem, as the supporting arrangements for additional pharmaceutical compounds or compounds. Complexes of sukralfat with the damaged area while carry additional pharmaceutical compound in the immediate proximity of the wound. In this way, for example, antibiotics, steroids, antifungal agent, biocidally agent, local anesthetic or protivougrevoe agent, or combination thereof used by a local way to the injury or damage in the composition containing sukralfat, and remains at the application site as a result of formation of the complex of sukralfat with the tissue in the wound or area damage.

For the local treatment of anorectal or neuroretinal wounds compositions are in the form of ointments, creams, gels, pastes, suppositories, tampons, liquids, foams or sprays, or other types of compositions suitable for topical application.

In accordance with other aspects of the invention proposed composition may contain known materials and ingredients and they can be considered acceptable from a pharmacological point of view of the form.

To the media, which can be entered active ingredients to obtain a satisfactory composition, against rmaceuticals drugs. Such carriers or solvents include lotions, ointments, aerosols, solutions in water, creams (in a preferred variant of the type oil-in-water), the powder mixture, the gel-like adhesive mass, etc., depending on the physical nature of the used solvent or carrier, the proposed method can be implemented by using such compositions local way any known way according to the specific type of media.

Upon receipt of the target pharmaceutical form of the proposed compositions can be used various additives, diluents and additives. To them as illustrations include fragrances, essential oils, surface-active agents, bases type ointments, higher fatty acids, expanding agents, thickening agents, moisturizers, liquid and solid diluents type silicone, known in this technical field.

The examples should not be construed as limiting the invention, but only as his illustrations. Every expert in this field of technology it is obvious that can be done in various substitutions, changes in the proportions, you can make other modifications, remaining in the field, HC is Imanov.

P R I m e R 1. The ointment.

The ointment was obtained by offsetting the following ingredients, wt.%: Stearic acid 7 Cetyl alcohol 2 Mineral oil 20 Glycerin 10 Triethanolamine 2 Purified water to 100

This ointment was added sukralfat to get 5% final concentration.

P R I m m e R 2. The gel.

The gel composition was obtained by mixing the following ingredients, wt.%: Samuel of 0.3 Purified water to 100

To this gel was added sukralfat to get 5% of the final filtering.

P R I m e R 3. Cream.

The cream was obtained by mixing the following ingredients: 5% of sukralfat, hydrophilic ointment was added to balance.

P R I m e R 4. Suppository.

The suppository was obtained by mixing the following ingredients, wt.% : Polyethylene glycol 400 10 Polyethylene glycol 1500 30 Polyethylene glycol 6000 60

In this form was added sukralfat to the final 5% concentration and the resulting form gave the desired configuration.

P R I m e R 5. The ointment.

The ointment was obtained by mixing the following ingredients, wt.%: Exposure of the N 95 Sukralfat 5

P R I m e R 6. The ointment.

The ointment was obtained by mixing sledujushshei 6 Sukralfat 5 Purified water 48

P R I m e R 7. Ointment of example 1 containing 5% of sukralfat, were compared for efficacy in the treatment of hemorrhoids with the same ointment, but without the sukralfat.

The total number of patients was 6. All patients were from 55 to 70 years and they all had external hemorrhoids. As symptoms all patients experienced pain and bleeding during cleansing of the stomach. In addition, each suffering from hemorrhoids was quite fat, so they could easily observe.

Three patients were treated with ointment without sukralfat, and the other three were treated with an ointment containing 5% of sukralfat. The ointment was applied immediately before and immediately after the cleansing of the stomach in an amount sufficient to cover the perianal region and the anal canal with a thin layer.

After 5 days of the three patients who were treated only with the ointment only one felt some solace, which was that there was some decrease in pain and a decrease bleeding during cleansing of the stomach. The other two patients did not feel relief of symptoms and three days later demanded changes in treatment due to the lack of improvement.

Three patients who were treated with ointment 5% of sukralfat, all felt the tion of the stomach. Visually noted a significant reduction in size of the external hemorrhoids to almost normal. The results are shown in the table.

P R I m e R 8. Ointment of example 5 was used before and after the cleansing of the stomach to the patient suffering from external hemorrhoids, as described in example 7. Symptomatic relief of pain and reduce bleeding during cleansing of the stomach received along with the reduction of external hemorrhoids.

P R I m e R 9. Ointment of example 6 was applied before and after the cleansing of the stomach to the patient suffering from external hemorrhoids, as described in example 7. Received symptomatic relief of pain and reduce bleeding during the cleansing of the stomach and reducing the size of the external hemorrhoids.

P R I m e R 10. Abrasions on his knees three adult men aged 19-21 years resulting basketball, was treated with ointment 5% of sukralfat of example 1 as follows.

The wound was cleansed by washing and put ointment 5% of sukralfat. In each case, the flow was stopped the next day. The ointment was applied daily. A good healing received within three days. Sukralfat could be observed on the wound after 24 h after a single application.

In accordance with the invention features a composition that is relatively simple in manufacture and use and which, as shown, is effective to achieve the target results.

Although there have been described particular pharmaceutical forms, they allow various modifications.

1. WOUND-healing AGENT FOR topical APPLICATION containing an active ingredient and a pharmaceutically acceptable carrier, characterized in that, with the aim of increasing activity, it contains as active substance polysulfate-aluminum compound of the disaccharide in the following ratio, wt.%:

Polysulfate - aluminum compound disaccharide 0,1 - 5,0

The media and the Rest

2. Means under item 1, characterized in that polysulfate-aluminum compound of the disaccharide is contained in an amount of 0.1 - 5%.

3. Means under item 1, characterized in that polysulfate-aluminum compound disaccharide selected from the group polysulfate-aluminum compounds sucrose polysulfate-aluminum compounds maltose or lactose, containing

 

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