Wound healing suppositories

 

Wound healing suppositories as an active ingredient contain thiotriazoline - morpholine 3-methyl-1,2,4-triazolyl-5-thioacetate, as a fatty basis - solid fat such as hydrogenated sunflower oil. The suppository mass 2,28-2,52 g contains 0,18-0,22 g thiotriazoline and fat - the rest. Suppositories is used to treat erosive-ulcerative lesions of the mucous membranes of the rectum and vagina, as well as hepatitis a different etymology. The use of suppositories with thiotriazoline improves efficiency and reduces the duration of treatment due to the wide spectrum of biological activity thiotriazoline and its high biological availability. 1 C.p. f-crystals, 2 tab.

The invention relates to medicine, in particular to medicines used to treat erosive-ulcerative lesions of the mucous membranes of the rectum and vagina, as well as hepatitis a different etymology, you Know the "zelibor" (tablets) with antioxidant, hepatoprotective, immunomodulatory properties and produce FF "Darnitsa", Ukraine.

As the active component of celebra are flavonoids fruits of milk Thistle batistatou least as it has a narrow spectrum of pharmacological activity, but also because of the low (16,9%) biological availability of the active basis for the use of the tablets. In addition, tablets are not applicable for the treatment of erosive-ulcerative lesions of the mucous membranes.

Known cardioprotective, hepatoprotective, antioxidative, anti-inflammatory, immunomodulatory, antiviral, anti-ischemic, a stabilizing agent "thiotriazoline", chemical name - morpholine 3-methyl-1,2,4-triazolyl-5-thioacetal, patent of Ukraine 1988, class a 61 K 31/41.

"Thiotriazoline" as an active Foundation and its dosage forms in the form of solutions for injection and tablets registered with the Ministry of health of Ukraine of 31 may 1994, registration certificate 94/85/1, 94/85/2, 94/85/3 and 94/85/4.

The disadvantage of these dosage forms with thiotriazoline is the lack of availability of active fundamentals of using tablets in the treatment of hepatitis in the elderly and the impossibility of their use for the treatment of erosive and ulcerative diseases of the mucous membranes.

Known wound healing suppositories, in which the active component is used methyluracil, and as the basis - fat (M. D. Mash is active when used as a wound healing agent, but don't possess hepatoprotective properties and accordingly are not used for the treatment of hepatitis.

This form of the medicinal product taken as a prototype, as the most similar in shape and main pharmacological characteristics.

The basis of the invention is the task of the development of dosage forms for the treatment of hepatitis and erosive-ulcerative lesions of the mucous membranes, providing a high therapeutic efficacy and shorter duration of treatment.

The solution of this problem provides wound healing suppositories containing active ingredient and a fat basis, due to the fact that as the active component contains thiotriazoline, and as fat fundamentals - solid fat such as hydrogenated sunflower oil, in the following ratio of components; g one suppository: thiotriazoline - 0,18-0,22; fat - the rest to get the suppository mass 2,28-2,52,

The clinical effect of the use of the invention.

Suppositories thiotriazoline in rectal and vaginal introduction to 3.5 times increase bioavailability (60%) in comparison with tablets and present analogues and extend the range of the proposed use with the deposits, easily tolerated and non-toxic.

The invention is illustrated below by the description and examples of its clinical trials.

For the manufacture of suppositories according to the invention in quantities of 1000 candles weighed 0.2 kg thiotriazoline and 2.2 kg of solid fat such as hydrogenated sunflower oil.

In the initial position thiotriazoline has the form of a colorless crystalline powder, and for the preparation of suppositories according to the invention the powder is milled in a ball mill. The fat is heated until complete melting (55-60oC) bring back the obtained powder thiotriazoline, thoroughly mix until a homogeneous mass at a temperature above.

The resulting mass produced candles weighing 2.4 g method of pouring or pressing. The finished candle is placed in a contour of a package of 5 pieces.

Examples of clinical trials suppositories according to the invention.

According to the decision of the State Pharmacological center MOH Ukraine, clinical research suppositories 0.2 g thiotriazoline carried out at the Department of gastroenterology and nutrition, KMAPE them. P. education in the treatment of patients with chronic hepatitis and in the Department of obstetrics and gynecologists who spymania was conducted in two groups of patients with chronic hepatitis. Results were examined in 45 patients aged 20 to 65 years.

The main group consisted of 30 people, including 24 men and 6 women. The control group consisted of 15 people, including 10 men and 5 women.

Patients of the main group received the suppositories according to the invention with a content of 0.2 g thiotriazoline, which was introduced in the rectum and one candle twice a day every 12 hours for 21 days.

Patients in the control group gave zelibor 2 tablets 0.04 g 2 times a day during 21 days.

The duration of the disease in the examined patients ranged from 2 to 11 years. Patients of the main group and the control group were adequate in terms of age, duration and severity of the disease. Before treatment, all 45 patients surveyed noted the manifestation astenovegetativeh syndrome. All patients complained of General weakness, fatigue, decreased performance, dryness and bitterness in the mouth, nausea, belching, loss of appetite, bloating, impaired defecation, feeling of heaviness and pain in the right hypochondrium and epigastrium.

Analysis of biochemical parameters of liver function showed increased levels of aminotransferases and glutamyltransferase serum that caused by the development of softany and bilirubin level, suggests that patients with cholestatic syndrome (PL. 1).

Ultrasonography of the abdominal cavity in all patients revealed an enlarged liver and increased echogenicity of its structure.

The results of the dynamics of clinical manifestations in patients of both groups on the background of treatment is shown in table. 2.

Analysis of the results showed that under the influence of treatment by suppositories with thiotriazoline was observed pronounced positive dynamics of clinical symptoms compared with the control group. So, after taking the suppositories according to the invention symptoms asthenia (weakness, fatigue) were preserved in 5 days from the start of treatment in 17 patients (56.6 per cent), and after the course of treatment in 5 patients (16.7 per cent).

In the control group, patients receiving celebra, after 5 days from the start of treatment, General weakness and fatigue persisted in 13 patients (86.7 per cent), and after the end of treatment, 9 patients (60%).

Welcome suppositories according to the invention also contributed to reduced severity and frequency of such manifestations dispersionnogo syndrome, as a feeling of bitterness in the mouth, bloating, impaired defecation (table. 2) that obukov the Aulnay main group taking the suppositories according to the invention showed reduction of pain in the right hypochondrium and size of the liver. Stabilized pigmentocracy liver function, which manifested itself in the form of a statistically significant reduction in levels of total, direct, and indirect bilirubin, decreased enzymatic activity of alkaline phosphatase.

Patients of the main group was also marked by a more marked reduction in the activity gammaglutamyltransferase, aminotransferases.

The use of suppositories according to the invention also contributed to the increase in the concentration of albumin in serum and decrease thymol turbidity samples (table. 1).

Ultrasound examination of abdominal cavity organs also showed a more pronounced positive dynamics of the main group of patients that were manifested in the reduction of liver size 1-2 cm and fall of its echogenicity.

Evaluation of the effectiveness of the influence of the suppositories according to the invention on the dynamics of clinical manifestations of chronic hepatitis.

1. Significant improvement in 20 patients.

2. Minor improvement in 9 patients.

3. Unchanged in one patient.

4. Deterioration is not marked.

The analysis of the conducted research allowed us to draw the following conclusions researchers estimate and patients.

1. Suppositories according to the invention are effective environments is of suppositories on patients was accompanied by clinical improvement, a significant reduction of the manifestations of asthenic syndrome.

3. Suppositories according to the invention contribute to the normalization of pigment metabolism and reduce laboratory parameters cytolytic syndrome.

4. Suppositories according to the invention are characterized by good tolerability and lack of side effects.

II. Clinical trials were conducted in two groups of patients with nonspecific erosive-ulcerative lesions of the mucous membrane of the vagina and cervix.

The sample of 45 people aged 18 to 60 years with the presence of nonspecific erosive-ulcerative forms. The main group consisted of 30 women, a control group of 15 women. On the nosology of patients of the main group were distributed as follows: - with atrophic colpitis - 12 people with acute viral vulvovaginitis - 6 people - nonspecific colpitis - 3 person - endocervicitis - 3 person - postpartum ulcer vaginal - 4 of human cervical erosion, vaginitis 2 people.

The average age of patients was 50 years, including: - 20-30 years - 9 31-40 years 3 persons
- 41-50 years 3 persons
- 51-60 years 9 people
- over 60 years - 6 people.

Equivalent clinical and age pokazala:
the burning and itching of the vagina,
- the presence of vaginal discharge,
- the character of discharge.

Upon examination of the vaginal part of the cervix, vaginal walls and vulva were evaluated by color and relief of the mucous membrane, the size and depth of the ulcer, the condition of the surrounding tissue, the presence and character of discharge, the degree of epithelialization of the mucosal defect.

When examining patients before treatment in women with atrophic vaginitis revealed atrophy of the vaginal mucosa, focal hyperemia of the cervix, mild trauma to the mucous membrane in the study with the help of mirrors, the defects of the mucous of the vagina.

Subjectively, patients reported dryness of the vagina, itching, burning, four patients were diagnosed with purulent colpitis with purulent discharge from the vagina.

Patients in the control group were treated according to the standard technique with the use of estrogen drugs.

Patients of the main group was introduced into the vagina suppositories with thiotriazoline within 14 days. In the case of complete epithelization of defects treatment was stopped.

Before the introduction of drugs to the patients of both groups were vaginal cleansing with antiseptics (atani, furatsilin, KMPO4, herbal teas).

High effektivnost the seventh plague of the vagina.

In the process of treatment by suppositories according to the invention has disappeared subjective feelings on the 3rd day from the start of treatment, complete epithelialization of ulcers was observed to 7-10 days of treatment.

In the control group (use estrogensoderzhaschih drugs) duration of treatment was 11 days.

In the group of women with postpartum sores of the vagina as a result of application of suppositories according to the invention is marked by the disappearance of the swelling of the tissue, epithelialization of the wound surface at 5-6 days, which significantly reduces the time of their hospital stay.

On the basis of subjective symptoms and sensations, as well as on the basis of objective data obtained during clinical trials, was well tolerated suppositories according to the invention and no side effect.

As can be seen from the examples above clinical trials, suppositories according to the invention have a wider range of applications, improve treatment efficiency and reduce the duration of treatment in comparison with known drugs of the same purpose.


Claims

1. Wound healing suppository, containing the active ingredient and giovagnoli - solid fat such as hydrogenated sunflower oil, in the following ratio of components, g on one suppository:
Thiotriazoline - 0,18-0,22
Fat - Rest
2. Suppository under item 1, characterized in that it contains the specified fatty base in a quantity sufficient to obtain the suppository mass 2,28-2,52,

 

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