UA64801C2 - Composition possessing antiseptic, reparative and analgesic activities - Google Patents

Abstract

The invention relates to the medicine and the veterinary, in particular to the composition possessing the antiseptic, reparative and analgesic activities. The composition comprises Miramystin, D-Pantenol (calcium pantotenate), Trimecain, and the hydrophilic base. The composition may be used for treating and preventing the purulent complications of the wounds developed upon the burns, the injury, and the surgery, the neurepathic eschar, and the decubitus.

Description

total body surface of animals. Sensitization was carried out with doses of 5 mg/kg of body weight for 14 days. On the 21st day from the beginning of sensitization, a permissive dose of ZS was introduced, which was 50 mg/kg of body weight. Simultaneously with the application of the permissible dose of ointment, 1.0 ml of 195 solution of Evans blue was administered intravenously to the animals.

As a result of the research, it was established that there was no difference between the color of the skin of sensitized and intact animals. The skin of the sensitized animals was even, smooth, swelling of the skin and mucous membranes was not observed, rashes, desquamation and other signs of allergy were absent.

Thus, it can be concluded that ZS does not have allergic properties.

The specific activity of ZS was assessed by its ability to exert a wound-healing effect in different ways of reproducing wounds. 1. With the chemical method of reproduction of wounds. Experiments were carried out on white rats weighing 200-210 g. Wounds were caused by intraperitoneal injection of dextran solution and subcutaneous injection of 995 acetic acid. During the period of appearance of necrotic ulcers, ZS was applied at the site of acetic acid injection.

ZS and PP were applied to the affected area in a dose of ZOOmg/kg of animal body weight.

The moment of the appearance of a dividing line between healthy skin and the necrotic area, the beginning and complete rejection of the scab, the general condition of the animals and the condition of the skin at the wound site after the rejection of the scab served as criteria for the specific wound-healing effect of ZS. The results are given in table. 1.

Table 1

Wound-healing effect of the declared ointment in conditions of chemical damage to the skin of rats

Symptoms that Time of observation Static n 8 8 8

The size of the wounds, OE initial M 57 55.9 60.7 ! that 2.7 3.55 2.14

P - »0.05 »0.05 p (5) (5) (5)

M 52.5 39.2 45.2 7 you 2.2 1.7 11

P -0.05 -0.05

Ri - -0.05 - p (5) (5) (5)

M 42.4 20.7 34.0 14 th 2.55 1.5 1.3

P -0.05 -0.05

Ri - -0.05 - p (5) (5) (5)

M 39.2 10.0 21.4 21 te 2.7 0.8 0.9

P - 0.05 -0.05

Ri - -0.05 - p (5) (5) (5)

M 20.4 (9) 10.2 28 te 1.4 (0) 0.68

P - - -0.05

Ri - -0.05 - p b

M 15.7 and 0.9

R -

Ri - p b. M 8.8

The size of the wounds (OEE) is 42 t 12

R - p b

M 1.5 49 te 02

R - p b (5) 610.5

Time of appearance of M 14.7 7.2 0.8 demarcation strip te 1 0.9 -0.05 (days) P - -0.05 -

Ri - -0.05 p (5) (5) (5)

Beginning of rejection of M 24.8 12.8 179 scab ori te 1.6 1.0 14

P - -0.05 -0.05 r! - -0.05 - p (5) (5) (5)

Complete rejection of M 16.5 23.2 23.8 scab (days) te 21 1.7 21

P - -0.05 -0.05

R! - -0.05 -

Note:

P - the degree of reliability in comparison with the control group of animals

R! - the degree of reliability of the difference between the drugs being compared.

As can be seen from the data in the table. 1 statistically significant differences between treated and untreated animals were noted already after 7 days from the start of treatment, and complete rejection of the scab was noted on 22-27 days. In animals that were not treated, a similar effect was observed only on 40-49 days.

Significant withdrawals were also observed between animals treated with ZS and PP. At the same time, a faster appearance of the demarcation line, the beginning and rejection of the scab at the wound site, and a faster (5-7 day) healing of the wound were noted.

Thus, the obtained results testify to the pronounced wound-healing effect of ZS in wounds reproduced with the help of chemical substances, and to its superiority over PP. 2. With acute local thermal damage to the skin and subcutaneous tissue. The wound-healing and anesthetic properties of ZS were studied on the model of local thermal damage to the skin of animals. For the study, a model of contact thermal burn was used, which was applied to mice under ether anesthesia on the depilated dorsal surface of the back with the help of a standard applicator (Device for applying a dosed burn to small animals / V.V. Mynukhin, V.G. Shamrai,

T.N. Gubyna et al. / Med. Ref. Journal, 1985. Section 3, Me12, Publ. Mo3621, p. 667).

Treatment of animals was started after 24 hours. after applying a burn. The area of the burn surface and pain reactions in animals during manipulation of the wound and surrounding tissues were taken into account.

There were 18 animals in each group.

The results of experiments on planometry of the burn surface in animals of the experimental and control groups are given in Table 2.

Periods of observations 77771776... | ..yuYyurovyahoov | 086:007 | 0895008 ..-ЮКК 7777778 ..юЮюЮюЮЮЮД177777111110п69о3008.7777777. | 0803006 | 0875007

Analysis of the obtained data shows that in mice treated with ZS, the reduction of the area of burn wounds occurs significantly earlier and at a faster rate than in animals treated with PP.

When manipulations were performed on the areas of protective skin lesions in animals that were not treated and that were treated with PP, increased pain sensitivity was observed, which was manifested in increased motor reactions.

At the same time, pain sensitivity was not noted in the group of animals in which ZS was used for the treatment of burns.

In the control group, 6 animals died, in the group where ZS was used, 2 mice died, and among the animals treated with PP - 4 mice.

Thus, in comparison with PP, ZS has more pronounced wound-healing properties, and also causes an anesthetic effect.

Z. In experimental purulent wounds. Experimental wounds were modeled in rats, guinea pigs and rabbits according to the generally accepted method and they were contaminated with 0.2 ml of daily culture 5. ashgeiz 209R at a concentration of 9.0 CFU/ml, a dose sufficient for the development of a purulent-inflammatory process (T.E. Afinogenov,

N.P. Edynov. Antiseptics in surgery, 1987"). Wounds were applied to the back and limbs in conditions of limb ischemia. Purulent wounds were formed 3 days after the operative period, in animals with experimental limb ischemia, wounds were formed at the end of 2 days.

Treatment of animals in all groups began on the 3rd day after simulation of the wound process and was carried out by applying gauze bandages with a wound dressing once a day.

To control the dynamics of the wound process, planometry of the wound surface, the state of microbial contamination, and wound healing were recorded.

The results of observations of the dynamics of the wound process in experimental animals are given in Table 3.

Table C

Clinical changes of the wound surface in rats depending on the method of treatment (in days) and the beginning of cleaning - the beginning of the duration of epidelization of the wound treated by Grula2lP. 7 | 777771717457777 77771767 7777111 8.9,..Yuyu | 1383035 ren ve ee Seam even treatment)

The data shown in Table 3 indicate that the most effective method of treatment of experimental purulent wounds was when using ZS. Wound healing times, as well as other indicators of a favorable course of the wound process in 1 group of animals occurred 2-4 days earlier than in other groups.

In animals with wounds in conditions of ischemia of the limbs, the difference in positive indicators of the course of the wound process in the group where ZS was used was 5-6 days.

The determination of microbial contamination of the wound showed that this indicator was most evident in the group of animals with limb wounds subjected to ischemia (Р«0.05), which indicates greater microbial invasion in conditions of damaged peripheral blood supply to the wound.

The decrease in the degree of bacterial insemination of wounds to a critical level (5.0 CFU/ml)) occurred earlier (4 days) in groups of animals treated with ZS, while in animals treated with PP, this indicator was reached on the 7th day after treatment , and in animals treated according to the traditional scheme - on the 14th day (P<0.01). 4. In the treatment of post-amputation wounds in patients with obliterating limb diseases.

The test took into account the general condition of the patient, the dynamics of local changes in the wound, and bacteriological control of the contents of the wound.

Treatment of post-amputation wounds should be carried out with the help of bandages with a wound dressing once a day against the background of conventional therapy.

The results of clinical trials are given in Table 4.

The analysis of the provided data shows that the most effective treatment results were noted in the group of patients with the use of ZS. Thus, the average duration of treatment in this group of patients was 12,151.3 days. While in the group of patients receiving PP, this indicator was 17.3541.3 (P<0.05), and in the group with traditional treatment - 29.121.2 (P<0.01).

In patients who received ZS, purulent wounds were cleared 1-2 days sooner than in the other groups. A faster appearance of pink juicy granulations, islands of epithelization, activation of reparative processes at the edges of wounds was also noted.

In patients with post-amputation wounds who received ZS, a decrease in pain symptoms in the area of the wound surface was noted.

Table 4

Duration of treatment (days) of post-amputation wounds in patients with obliterating diseases of the limbs depending on the treatment method and clinical manifestation of the disease p-19 p-28 p-Z0 gangrene p-26 p-43 p-46

Gangrene on the ground 15.0 41.0 19.8-2.0 49.6-2.5 obliterating p-Z p-Z p-5 endoarteritis

M-203 m-48 M-74 M-81

Thus, on the basis of the conducted research and analysis of the obtained data array, it can be concluded that ZS has revealed wound-healing and anesthetic properties.

The study of the effect of ZS on the intact skin of animals and humans showed its complete harmlessness, as no adverse reactions were detected.