The composition of the antiseptic, reparative and analgesic properties

 

(57) Abstract:

The invention relates to the field of medicine, veterinary medicine and for the composition with antiseptic, reparative and analgesic properties. The invention lies in the fact that the composition on the hydrophilic base contains trimekain, antiseptic Miramistin, calcium pentatonic (D-panthenol). The invention provides the possibility of using the proposed composition for the treatment and prevention of suppurative complications of burns, traumatic, post-surgical wounds, bedsores and ulcers. 1 C.p. f-crystals, 8 PL.

The invention relates to the field of medicine, veterinary medicine and can be used for the prevention and treatment of wounds of different origin and localization, venous ulcers and pressure sores. Among the known dosage forms, which are used in medicine as drugs for the local treatment of wounds in period 1 and 2 phases of wound healing, the most widely multicomponent hydrophilic ointments on the basis of. These drugs should include the ointment the vegetable "levomekol, composition (wt.%): chloramphenicol - 0,75; methyluracil - 4,0; polyethylene oxide 1500 - 19,05; polyethylene oxide 400 - 76,2 (In kN.: Theory and practice of local treatment of purulent wounds (edited by Raziel - 4,0; trimekain - 3,0; polyethylene oxide 1500 - 17,6; polyethylene oxide 400 - 70,4 (ibid, S. 240), ointment "Toxicol ", composition (wt.%): dioxidine - 1,0; trimekain - 4,0; methyluracil - 4,0; polyethylene oxide 1500 - 18,2; polyethylene oxide 400 - 72,8 (ibid, S. 241), ointment "Iometrix", composition (wt.%): yodopiron - 15,0; trimekain - 5,0; methyluracil - 5,0; polyethylene oxide 1500 - 15,0; polyethylene oxide 400 - 60,0 (ibid, S. 243), the ointment "Solfanelli", composition (wt.%): mafenide acetate - 10,0; methyluracil - 4,0; trimekain - 5,0; polyethylene oxide 1500 - 16,2; polyethylene oxide 400 - 64,8 (ibid, S. 245), ointment "Marocain", composition (wt.%): metronidazole - 2,0; chloramphenicol - 1,0; trimekain - 4,0; polyethylene oxide 1500 to 18.6; polyethylene oxide 400 - 74,4 (ibid, S. 247), ointment "Streptonitol, composition (wt.%): nitazol - 2,0; streptocid - 5,0; vaseline oil - 20,0; propylene glycol - 30,0; fatty alcohols fractions of C16- C21- 6,8; drug 0C20- 1,2; distilled water - 35,0 (ibid, S. 248), ointment "Netacad", composition (wt. %): nitazol - 2,5; streptocid - 5,0; proxanol is chosen 268 - 20,0; polyethylene oxide 400 - 29,0; 1,2-propylene glycol - 43,5 (ibid., 250 C.), etc.

Included in their ingredients to provide them with a comprehensive therapeutic effect to the wound: antimicrobial, dehydraters, anti-inflammatory, analgesic.

However, these lekagul include:

1) allergic reactions (skin rash) in the case of individual hypersensitivity to chloramphenicol (the vegetable"levomekol, "Levein");

2) the occurrence of toxic reactions in the case of individual intolerance to the dioksidin and sulfa drugs and nitazol ("Toxicol", "Streptonitol, "Netacad");

3) reinfection RAS due to the narrow (directional) spectrum of antibacterial action (the vegetable"levomekol, "Levein", "Marocain", "Solfanelli");

4) dehydration and impaired granulation tissue, due to the high osmotic action polietilenoksidnoy basis (the vegetable"levomekol, "Levein", "Toxicol"), resulting in the application of ointments with pure polietilenoksidnoy basis in the 2nd phase of wound healing is little reasonable, although they contain in its composition substance (methyluracil), stimulating reparative tissue regeneration;

5) listed ointments are ineffective in the treatment of wounds infected by pathogenic fungi.

Closest to the claimed solution component composition is an ointment "Levocin", which we took as a reference product (PS).

The basis of the invention is the task: the search for whom is tibacterial, fungicidal, reparative and anaesthetic activity.

This objective is achieved in that the composition on a hydrophilic base containing trimekain and antiseptic, as an antiseptic enter Miramistin and impose additional D-panthenol and/or calcium Pantothenate in the following ratio of components (wt.%):

Miramistin - 0,3 - 0,7

D-panthenol and/or calcium Pantothenate - 4,0 - 5,0

Trimekain - 4,0 - 10,0

Hydrophilic base - 100

As the hydrophilic base water use mixtures of various oxides, propylene glycol and other geleobrazovanie, for example proxanol is chosen - 268 and/or the modified pulp.

The claimed composition (CS) is a emulhel with a slight characteristic odor. Get emulhel mixing at a temperature of 40-60oC industrial and permitted for use in health care components.

Miramistin (VFS 42-2098-91) is known and is used as a means of prevention of sexually transmitted diseases (A. C. USSR N 1832496). Its application in this technical solution has led to an unexpected result, as manifested in the synergistic action of the main components in wound healing and obezbolivajuschem action, as well as in poaul in tissues D-panthenol (BAW 1991, band III) or calcium Pantothenate (FS 42-2530-88) was the literary evidence that pantothenatecide compounds (derivatives of Pantothenic acid - precursor and fragment universal coenzyme of atsilirovaniya - To-A) participate in the regulation of intracellular metabolic processes.

Locally irritating properties of CS was studied by applying it once at a dose of 500 mg/kg body weight (density plotted CS 200-250 mg/cm2) on pre-prodefilirovala, scarification fine needle skin of rabbits. Skin condition was evaluated after 20 min, 24, 72 and 120 h after application of CS. This registered General condition of the animals, the presence and degree of erythema, swelling.

The results showed that the claimed ointment is not only indifferent to local irritation, but also has a pronounced anti-inflammatory effect.

While studying allergic action of CS found that statistically significant differences between the indices of active cutaneous anaphylaxis in Guinea pigs sensitized intact and was not detected, indicating the absence of allergenic properties of CS.

Allergizing applications of CS in pre prodefilirovala skin area up to 10% of the total body surface of animals. Sensitization was performed with doses of 5 mg/kg body weight for 14 days. 21 days from the start of the sensitization introduced allowing the dose of CS, which was 50 mg/kg of body weight. Simultaneously with the application of the resolving dose ointment animal was injected intravenously with 1.0 ml of 1% solution of Evans blue.

As a result of the research showed that the differences between the color of the skin of sensitized and intact animals were not identified. The skin is sensitized animals was smooth, smooth, swelling of skin and mucous membranes of the skin were observed, there was no rash, desquamation, and other signs of allergies.

Thus, we can conclude that the AP has no properties.

The specific activity of CS was assessed by its ability to provide a wound healing effect under different way of playing wounds.

1. The chemical method of playing Russian Academy of Sciences. The experiments were carried out on white rats weighing 20010, Wounds caused by intraperitoneal administration to animals 6% dextran solution and subcutaneous administration 9% acetic acid. During the emergence of necrotic ulcers on the injection of acetic acid was applied CS.

CS and PS appliciable on time for the effects of CS were the time of occurrence of the dividing line between healthy skin and necrotic area, start and complete rejection of the scab, the General condition of the animals and the condition of the skin at the wound site after exclusion of scab. The results are presented in table. 1.

As can be seen from the data table. 1, statically significant differences between treated and untreated animals are observed after 7 days of starting treatment, and the complete rejection scab notes to 22-27 days. In untreated animals, a similar effect is observed only 40-49 day.

Significant differences were observed between animals treated with CS and PS. It was noted a more rapid emergence of the demarcation line, the beginning and the exclusion of scab on the wound, faster (5-7 days) wound healing.

Thus, the results indicate a pronounced healing effect of CS wounds, reproduced with the help of chemical substances, and its advantage over PS.

2. Acute local thermal damage of the skin and underlying tissue. Wound healing and anasthesiologie properties of CS was studied on the model of local thermal damage to the skin of animals. For studies used a model of contact thermal burn, which was put under ether Rausch-anesthesia mice on nepilirovanny dorsal on top of the m //Century Century Minuchin, Century, Shamrai, T. N. Gubina et al. //Honey.Ref.magazine, 1985. Section 3, N 12. Publ. N 3621, S. 66).

Treatment of animals was started 24 hours after application of the burn. Take into account the area of the burn surface and painful reactions in animals during handling on the wound and surrounding tissues.

In each group there were 18 animals.

The results of the experiments by planimetry of burn surface in animals experimental and control groups are presented in table. 2.

Analysis of the data shows that mice treated with CS, reduction of the area of burn wounds occurs significantly earlier and more rapidly than in animals treated with PS.

When the manipulation in the area of burn damage to the skin of animals, untreated and treated with PS, there was an increased sensitivity to pain, which was reflected in increased motor reacci. At the same time, in the group of animals that have to treat burns were applied CS, pain sensitivity is not marked.

In the control group 6 animals died in the group that used the AP, fell 2 mouse, and among the animals treated with PS - 4 mouse.

Thus, the CS compared to the PS has a more pronounced wound svoistvami wounds were simulated in rats Guinea pigs and rabbits according to the standard technique and containerbase their 0.2 ml daily culture of S. aureus 209 P at a concentration of 9.0 CFU/ml dose sufficient for the development of the inflammatory process, that is, Afinogenov, N. P. Elin. Antiseptics in surgery, 1987). The wounds inflicted in the back and limbs ischemia of the limb. Purulent wounds were formed after 3 days after the operational period, in animals with experimental ischemia limb wounds were formed by the end of 2 days.

The treatment of animals in all groups were started on day 3 after modeling wound healing process and was carried out by applying gauze bandages with CS once a day.

To control the dynamics of wound healing were executed wound surface, the state of microbial contamination were recorded healing of wounds.

The results of observation of the dynamics of wound healing in experimental animals are presented in table. 3.

The data in the table. 3 suggests that the most effective way to treat experimental purulent wounds was using CS. The healing time of wounds, as well as other indicators of a favorable course of the wound process in group 1 of icesta the difference in the positive indicators of the course of wound process in the group, where was used the AP was in 5-6 days.

Determination of microbial contamination of the wound showed that this figure was most pronounced in the group of animals with wounds limb subjected to ischemia (P<0,05), indicating that most microbial invasion in conditions of impaired peripheral perfusion wounds.

Reducing bacterial contamination of wounds to a critical level (5,0 CFU/ml(log)before just arrived (4 days) in groups of animals treated with CS, while in animals treated with PS, this figure was reached at 7 days after treatment, and in animals, where treatment was conducted under the traditional scheme, on the 14th day (P<0,01).

When the test took into account the General condition of the patient, the dynamics of local changes in the wound, bacteriological control of wound content.

Treatment postamputation RAS conducted armbands with the stakeholders once a day on the background of standard therapy.

The results of clinical trials are presented in table. 4.

The analysis of the presented data shows that the most effective treatment results observed in the group of patients with the Aulnay, receiving substation, the figure was 17,31,3 (P<0.05), and in the group with conventional treatment 29,11,2 (P<0,01).

In patients with postamputation wounds treated with CS, decreased pain symptoms in the area of the wound surface.

Thus, on the basis of the conducted research and analysis of the array data we can conclude that CS has pronounced wound healing and anesthetic properties.

Study of the effect of CS on the intact skin of animals and humans has shown its complete harmlessness, as no adverse reactions were identified (see table. 5-8).

1. The composition of the antiseptic, reparative and analgesic properties, containing trimekain and antiseptic in the hydrophilic base, characterized in that as an antiseptic contains Miramistin and additionally contains D-panthenol and/or calcium Pantothenate in the following ratio, wt.%:

Miramistin - 0,3 - 0,7

D-Panthenol and/or the decomposing those as the hydrophilic base contains a mixture of the following components, wt%:

Proxanol is chosen-268 - 6,5 - 20

1,2-Propylene glycol - 13 - 44

The polyethylene oxide-400 - 13th - 29

Purified water Up to 100C

 

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