LT3018B - Preparation for treating local burns in an open way - Google Patents

Abstract

Preparation applies to the field of medicine and is intended for the treatment of burned skin and mucous surfaces. The following composition is created with (in %): soap-stock 26-27; 96 degrees ethyl alcohol 55.3-55.6; distilled water 17.4-18.7 and glycerol up to 100 percent of the total weight.

Description

The invention relates to medicine, in particular to the treatment of burns, and may be used in medical emergency rooms, outpatient clinics, medical centers, hospital hospitals and in the open-air local treatment of burns.

As we know, burns are very painful. ' We also know from experience that burnt surfaces become red, heat up and swell. Without the pain and other mentioned 'inflammatory signs of burns' it is impossible, just as it is impossible to reliably cure the burn without timely elimination of these symptoms. Therefore, the ability to eliminate these signs of inflammation in a timely manner must be a prerequisite for a burn treatment concept.

However, it is clear that the signs of inflammation in burns - pain, redness, heat and swelling - are the same. Signs of inflammation that are at the root of the inflammation problem and cannot be eliminated - because the inflammation problem is still unresolved.

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Various ointments, creams, powders, balms, aerosols (eg, Festin ointment, Demazin ointment, Terrilitin powder, Shostakovsky balm) are known for the local treatment of burns. The most sought after and progressive in the field of topical burn treatment are aerosols such as Oxyciclazol, Olazol, Livian, Legrazole, Levovinizol, '' Tegralizel,

Vinizol, Pantenol and its synonyms (Bepanthen, Cozyme, Doxpanthenol,. Ilopan, Intra-Pan, Motilyn, B30 Panthene, D-Panthenolum, Panthoderm, Panthothenol, Pantothenyl alcohol, Tonestat).

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The therapeutic efficacy of the said analogues lies in their quest to protect the burned surface from infection, intoxication, reduce pain, stimulate the development of granulating tissues and regenerate. Therefore, the main active ingredients of all the most progressive analogs are antibiotics, antiseptics, analgesics and various nutrients, mainly vitamins and vitamins.

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The most closely resolved .aerosol is the closest analogue to the effect achieved and of the number of other aerosols Olazol as claimed

10 · Its active ingredients are sea buckthorn oil, anesthetic, levomycin and boric acid. The above preparation is used to treat burns and long-term wounds by applying it daily or every other day to the burned surface from an aerosol dispenser, and in the open, 1-4 times a day. Contraindicates without compromising the ingredients in its composition.

An essential feature of the closest analogue, as an 'and' claimed subject, is the ability to be used in the treatment of open burns.

This analogue is recognized by the Moscow Pharmacology Committee (Registration No. 81/610/4).

A major disadvantage of this analogue is the use of antibiotics to treat burns. Burns are the most prominent example of inflammation, with signs of pain,

- Redness, heat and swelling all over the body, particularly fast, vivid and visually accessible. The inflammatory agent of inflammation in the burn is not the bacteria, but the burns, and therefore antibiotics cannot be used to eliminate the signs of inflammation.

Anesthetic used to relieve pain is also present

- an inadequate component of burn treatment.

Stable pain relief by treating burns can only be achieved by actually healing the burned surface, i.e.

timely 'to eliminate signs of inflammation. The use of anesthetic only causes temporary pain relief and does not help the skin to recover.

The stated shortcomings of the nearest analogue are remedied by the claimed therapeutic agent, since the timely removal of signs of inflammation assures the healing of burned surfaces.

. The ability to use the invented product for this stated purpose has / has been tested. ' under experimental conditions. Because the invented burn treatment is unique in its versatility as it can be used to treat not only skin surfaces, but also mucous surfaces (such as the respiratory tract, oral cavity, stomach, etc.), acute and chronic toxicity has also been investigated. For all kinds of experiments, including the main one, i.e. for the treatment efficacy experiment, 180 animals were used: 103 white rats, 72 white mice and. 5 rabbits.

Biological Research ·,

Acute toxicity

Acute toxicity was assayed by the 'Lichtfield method (Lichtfield J. T., Wilcoxon F. J.' J. Pharmacol.

Therap. 1949 Vol. 106, pp. 99-113), using white mice weighing 28 g and white non-breeding rats, mean weight 132 g, by parenteral (subcutaneous) injection () in mice 10; 12; 13.5; 15; 17.5 and 25 g / kg, and in rats at doses of 20, 25, 30 and 35 g / kg.

The following confidence limits have been set:

When researching the mouse ^.

ED ₅ q = 15.5 (14.09-17.05) g / kg at P - 0.0 * 5

V .5

In rats:

. ED _S0 = 23 (19.41-27.37) g / kg at P = 0.05

High confidence limits in mice and even higher in rats indicate the acute non-toxicity of the test product.

Chronic toxicity

Rabbit and white non-breeding rats of both sexes were used in the chronic toxicity study. For the latter, the test preparation was applied to the surface of the skin, and at drip to the surface of the eye mucosa.

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In preparation for experimentation with dermal toxicity, two groups of rats were formed: one group (rats # 1-7) had scissors. the dorsal and dorsal surfaces were cut off, whereas the other 25 (rat no. 8-12) differed only in that the entire docked area was divided into two parts of approximately equal size, leaving a narrow strip of untrimmed surface between them. The right side of the cut surface was used for topical application, the left side was non-invasive and should be used as a control to explain any difference with the experimental part.

The use of the preparation on the skin surface has facilitated the development of chronic toxicity testing.

• First of all, because the test surfaces were carefully prepared for the experiment. This is also because the test areas were large, ranging from 18.9% to 37% of the total skin surface (see Table 4). These values were determined at the completion of the experiment, when all 12 rats were sacrificed. This allowed them to accurately calculate the total skin surface of each rat used for the experiment and the part that was used for the experiment by removing their 5 fur and using millimeter paper. Yes. in addition, the rat's rat fur, when viewed through the light, made it possible to see * how healthy the experimental skin surface and the entire circulatory system remained. In a chronic toxicity experiment. reliability was also guaranteed by the circumstance that the preparation was repeatedly administered at various doses. The attached table (see Table # 1) shows that each rat received twelve different doses of the test product over different time periods (19 to 30 days). · From the total amount of 336.5 ml used for chronic toxicity testing. rats with full experimental surface (rats

20; No. 1-7) averaged 33.8 ml each and 20 ml each in rats with an experimental half surface.

In addition, in addition to the aforementioned twelve, seven rats were used as controls to investigate the effects of topical application of the leukocyte formulation on the blood to enhance the reliability of the experimental data. This study showed (see Table 3) that both the topical application date and the significantly later date (two weeks later) showed percentages of major leukocyte groups. ratios in experimental rats remained within the normal and control rat leukocyte level.

No signs of toxicity were observed either during the duration of the experiment or throughout the month. On the contrary, it was noted that the topical application of the preparation had a positive soothing and gentle effect: the skin surface became pale and soft, and the hair was clipped. the surface quickly renewed. Experimented rats had a good sense of appetite, 'good appetite. The absence of chronic toxicity and the well-being of rats were confirmed by their breeding.

. All seven females in the group of twelve rats produced abundant growth, producing 55 rats (see Table 2). All gains, despite continued expertism ,. normal breastfeeding milk, developed well and successfully complemented the experimental rats. This one

The fact of high-quality growth also suggests that the topical application of this preparation does not cause teratogenic effects in childbirth.

All this is a reliable indication that there is no chronic toxicity with topical application of this preparation.

Rabbits · were used in the experiment for the toxicity of the preparation to the mucosal surface of the eye. ,

Human and animal eyes are highly complex and sensitive organs, and therefore each eye, even the slightest one, responds with a variety of innate safety features. Therefore, the methodology for ocular toxicity is particularly variable in dosage. One drop is enough for this purpose.

The test product was applied to the eye, the mucous membrane just below the right eyelid, and left the left eye untreated and left in the control.

The sharp clamping of the instillation caused the rabbits to close their eyes for about 3 minutes and then close their eyes for about 2 minutes, and then close again, • only about 5 minutes after instillation, watching the rabbits with both eyes. During this time, the eye underwent profuse tears from the beginning of the instillation, and the cornea was markedly red. However, tears and redness gradually subsided. By the end of the hour, the corneal flushing had disappeared, the eye was greasy, and it was no different from the left control eye.

Observations in experimental rabbits have shown that the use of the preparation in the eye does not result in any subsequent effects

- and therefore leads to the conclusion that it is not toxic to the eyes.

-F.

Toxicity of oral (pe.r os) application

The studies were performed on CBVA consecutive white mice weighing 19-45 g and both sexes. Rats weighing 103-309 g.

Of the 36 units used in the study, white mice in six identical groups were administered various test preparations. at doses of 10, 15, 20, 25, · 30 and 35 g / kg, 7 units were killed at 25 g / kg, one at 30 g / kg - two, at 35 g / kg - four . There were no fatalities at doses of 10, 15, 20 g / kg. The highest dose used also did not cause 100% death, although it was limited to white mice, i.e. should not exceed 1 ml (in the Laboratory of the animal razvedenij, soderžanije, ispolzovanije v experiment., J.P. Zapodniuk, V.J. Zapodniuk, E.A. Zachariah, B.V. Zapodniuk, tertiary edition Kiev - 1985; p. 282),.

The results of an oral toxicity study using white mice were determined according to the Lichtfield method (Belenkij M.L. Elemehty coli Stevennoj ocenki pharmacological effect. Gos.

ed. medic. L-ry L. 1963).

The confidence limits are as follows:

ED ₅₀ = 30.5 (26, 75 7 34.77) g / kg at P = 0.05

A starting dose of 10 g / kg was also used in the toxicology study in white rats. The toxicity in rats at this dose was apparently negligible, as no single rat was killed. Mild toxicity was also demonstrated at the higher dose (12.5 'g / kg) as only two rats died. Since the volume of liquid administered to white rats should not exceed 1.5 IU and the average dose is 10% / day at a dose of 10 g / kg, it is not possible to determine the toxicity of this product in rats, nor can the Lichtfield method be used.

High. the margin of confidence in mice suggests that the test preparation used topically for local treatment of burns is classified as a non-toxic substance for oral use according to the Toxicity Classification of Substances (according to K.K. Sidorov, 1973).

This conclusion can also be drawn from the toxicity profile of the preparation in rats, even at doses well in excess of the tolerable limits.

Treatment Effectiveness Experiment

The main criterion for the evaluation of any medicinal product should be its therapeutic reliability.

Three treatment options were selected for the experiment:

I. By steaming the animals' back using steam pressurized household steam hose with a fixed hose to release steam. Exposure time is 10 seconds. Seven · rats were used for this variant, three of which will be control.

II. Burning the hind paws by immersing them in boiling water for one to one and a half seconds. Nine rats were used for this variant, five of which would be control animals. 5

III. Burning larger surfaces of the skin, which would be immersed in boiling water for one to two seconds, and burning on those surfaces, would cause a three-second t-flame on gasoline.

44 white rats were used for this variant, of which <nineteen controls and five were treated with the prototype and analogue Oxycyclazole.

To fulfill these treatment options in 1984 in Vilnius

A unique experiment in the treatment of burned animals was carried out at the State University, and its results confirmed the viability of the concept of burn treatment for reliable burn treatment, i. y. the ability of the claimed invention to timely eliminate the signs of inflammation and thereby legitimized the initial resolution of the inflammation problem. ·.

From the experimental report data presented, we can see that the signs of inflammation were removed in the shortest possible time. Yes, for example, after burning the animals' backs with pressurized steam, the signs of inflammation were removed on the same day (see Table V, cont. V). (see Table V, cont. V). Burned

- Wide surfaces of the animals' skin with boiling water and a gasoline flame took approximately one hour to remove the signs of inflammation (see Table 5, Continued VI).

When the signs of inflammation disappeared, the pathological condition of the burned animals suddenly intervened. and in the subsequent days of recovery it was little different from the condition of the untried animals. All experimental animals treated with the invented product recovered without any complications and deformation of the burned surfaces.

Example of specific fulfillment *

Here is an example of how the preparation works. 11.5% by weight (400 g) of crude soap was mixed with 23.3% by weight (810 g) of ethyl alcohol in 96 ° and 7.2% by weight (250 g) of distilled water. After dissolving the soap, the solution was filtered. Obtained clear filtrate - 42% · Total weight (1390 ¹ g) Addition of this amount 58% by weight of glycerin gave 3400 g of a clear pale yellow liquid with a characteristic odor ^x (Annex 6.1).

Claims (1)

Preparation 5 wherein the local mucous comprising distilled rakes green soap · ethyl alcohol 96 ° distilled water, glycerin nudegiiP ^'1 is in that the surface treatment of raw soap, water and glycerin,% by weight: open-label treatment, sunburned skin or composition, and, with ethyl alcohol,>