Liniment methyluracil

 

(57) Abstract:

The invention relates to medicine and pharmaceutical industry and for the creation of new dosage forms. Proposed liniment-shaped methyluracil, consisting of a medicinal substance, Aerosil and castor oil. Liniment has a high wound-healing activity and bioavailability. It can be recommended for widespread use in medical practice. 5 table.

The invention relates to medicine and pharmaceutical industry and for the creation of new dosage forms of drugs, namely bio-stimulating liniment drugs, derivatives of uracil.

Methyluracil comes in the form of powders, tablets (0.5), candles (0,5), as well as in the form of solution for injection (0.7% ) and 5-10% ointment.

Known newly acquired form 2,4-dioxo-6-methyl-1,2,3,4-tetrahydropyrido - Medina (methyluracil), which is assigned to N state of registration 7382186 September 12, 1986

Known application-form 2,4-dioxo-6-methyl-1,2,3,4-tetrahydropyrimido (methyluracil) as a wound healing agent.

Known ointment-shaped methyluracil used to accelerate healing in radonov interferes with the normal gas exchange, that reduces healing activity methyluracil, especially when slow processes. On the skin lanolin, vaseline basis can cause allergies. This ointment in connection with the above may not be used to treat extensive ulcers.

The purpose of the invention is the creation of a new dosage form methyluracil for outdoor applications with high wound-healing activity and bioavailability in the absence of side effects, expanding the scope of use.

The essence of the invention is that the first suspension liniment methyluracil, containing the wt. % : -form methyluracil 4,0-6,0 Aerosil 2,0-4,0 Oil castor Else

Because the proposed dosage form is a form methyluracil previously was not known, you should consider this solution as a pioneer.

Preparation of liniment is carried out in accordance with the standards of the global Fund X. For this form methyluracil mixed with Aerosil add parts castor oil and thoroughly mix until smooth.

The essential features that characterize the invention, are: the choice of ingredients of the composition and their quantitative values, enabling only GF X and possessing new properties - high wound healing, and regenerative activity (when lesions, reaching more than 80% of the surface) and bioavailability, in the absence of side effects typical of other Lek. forms for external use.

During preliminary biopharmaceutical research as the beginning of the current liniment was selected form methyluracil, because the use of pharmacopoeial methyluracil) leads to delamination of liniment and does not allow to obtain a stable dosage form.

Special studies were conducted on the selection of ingredients liniment and their mass quantities.

A comparative determination of the dispersion, the external specific surface area, solubility and dissolution rate-shape methyluracil in comparison with standard drug.

Using the technique of dialysis methyluracil of liniment identified optimal content-form methyluracil in the composition is 5.0% (4,0-6,0).

When selecting excipients were guided by the recommendations of the State Pharmacopoeia XI ed. , availability of auxiliary substances and their possible impact on the physico-chemical, structural-makasete fundamentals of composition used castor oil, the purpose of thickening liniment presented.

Bioavailability methyluracil of liniment was determined by equilibrium dialysis in the dialysis apparatus. Sampling of dialysis cups was performed on 5 ml and then adding the same amount of solvent. 1 ml of dialysate was transferred into a tube containing 9 ml of distilled water, and determined the density in the spectrophotometer SF-4 at a wavelength of 260 nm. Studies have shown that the basis has an impact on the release of drugs from the liniment.

Most fast release of the drug from the liniment of sunflower and castor oil. However, the use of castor oil, unlike sunflower, gives the required viscosity of the liniment and stability during storage. When using sunflower oil received liniment liquid with high flow and unstable. In this regard, as a pharmaceutical diluent selected castor oil.

Survey data are given in table. 1.

To select the optimal number of Aerosil in the composition studied its effect on the release of methyluracil of liniment using static methods and is of lorella grows, and with a further increase to 4% - is reduced.

The influence of the content data on the release of methyluracil of liniment illustrates a table. 2.

Studies to determine thermal stability of the claimed liniment showed that liniment containing Aerosil, under the influence of temperature is almost not divided into solid and liquid phases. At the same time, liniment containing form methyluracil without Aerosil were stratified in 1.5 h, and 8 h was observed stratification liniment containing pharmacopoeial methyluracil and Aerosil.

Rheological studies liniment showed that for liniment, not containing Aerosil, dynamic viscosity amounted to 285 DN/cm2and for liniment containing 4% Aerosil, this feature was 1455,0 DN/cm2. Effective viscosity, respectively, was equal to 5,8642 JV and 29,9338 SP. The results of the research illustrates the table. 3.

Thus, a biopharmaceutical research has shown that the claimed liniment-shaped methyluracil requirements GF's and proved the optimality of the selected values of the ingredients in liniment.

Determination of the bioavailability of the claimed liniment methyluracil and% : -form methyluracil 5; Aerosil 3; castor oil 92.

The comparative increase in the release of methyluracil showed that the speed and completeness release methyluracil of liniment surpass those of the official ointments on average 30 times.

These data are given in table. 4

Thus, a biopharmaceutical studies have shown increased bioavailability of the claimed liniment-shaped methyluracil, in accordance with the requirements of the GF's and proved the optimality of the selected values of the ingredients in liniment.

Evaluation of therapeutic efficacy of the liniment was conducted on rats.

Aseptic inflammation of the vaginal mucosa of rats (ulcers) were obtained by processing the vagina 7% solution of silver nitrate with an exposure time of 3 minutes

Evaluation of the effectiveness of the treatment were carried out according to the visual and histological studies. To this end, the tissue of the vagina were fixed in 10% neutral formalin, followed by pouring in the wax. Sections were stained with hematoxylin-eosin.

Set 3 a series of experiments on 24 animals in each series: 1 series - intact control. In this group, after applying the burn and the formation of large ulcers - (80% bath water.

2 series - comparative control - a day after the burn, when formed, the ulcer, daily for 20 days the vagina of rats was treated with a swab moistened with sea buckthorn oil. Sea buckthorn oil was selected as a comparative control, because it is one of the most effective means wound healing effects in the treatment of slow processes, for example, trophic ulcers.

3 series - experience.

A day after the burn, when education was extensive ulcer, daily for 20 days the vagina of rats treated swab dipped the claimed liniment.

P R I m e R 1 (intact control). Aseptic inflammation in the rat caused by the described method. A day after applying burn daily for 20 days the vagina of rats was treated with a swab moistened with distilled water. At 5,10,15 and 20 days were scored in 6 animals of groups and a study of the condition of the vaginal mucosa by visual inspection with the use of painting the affected areas of the mucosa with a solution of methylene blue. The results were evaluated according to the system:

"+++" - total burn (inflammation) of the entire surface or large areas of deep lesions with symptoms NCR is the ATA and necrosis, occupying about 50% of the mucosal surface;

"+" - mild inflammatory response in areas occupying less than 50% of the surface;

"0" - normal mucosa intact rats.

According to the results of visual studies at 24 h after treatment of the mucous nitrate of silver, the surface of the burn reached 80% of the total surface of the mucous membrane with deep pockets lesions in the form of pitting, peeling of the epithelium, necrosis. On the 5th day the nature of the lesion did not change significantly. 10-15 day was a decrease areas of deep lesions, the area was reduced to 60% . At 20 days the condition of the mucous membrane close to the norm, the surface of staining did not exceed 20% , the deep pockets of lesions in small quantities.

Pathomorphological study showed that after 24 h after application of the burn was determined histologically extensive necrosis of the epithelium and underlying connective tissue. The zone of necrosis surrounded by inflammatory leukocyte shaft, which is a zone of extensive edema, razvlechenie connective tissue with stasis of blood vessels and hemorrhage. After 5 days the depth of the lesion increased leukocyte shaft extended. Increased the number of blood SOS is I the same. On the 15th day marked the growth of epithelium at the wound surface, decreases leukocyte shaft, which increases the number of blood vessels. 20 days is not observed foci of necrosis, square reepithelization minor foci. Leukocyte reaction is practically absent. Sterowanie vessels and swelling of surrounding tissue is missing.

P R I m m e R 2 (comparative control). Aseptic inflammation in the rat caused by the described method. A day after applying burn daily for 20 days the vagina of rats treated swab with sea buckthorn oil.

At 5,10,15 and 20 days were scored in 6 animals of the study group and the study of inflammatory reaction of the mucosa of the vagina visually and with pathological method.

According to the results of visual observations, already for 5 days significantly decreased the area of staining. To 15 days, the mucous membrane is almost completely restored.

According to the pathological study, after 5 days there are extensive foci of necrosis with potent leukocyte shaft, extensive oedema of the surrounding tissues, stasis of blood vessels.

After 15 days, a significant decrease of the area is within the wound surface. Leukocyte infiltration is negligible. Swelling persists, the vessels are dilated.

P R I m e R (claimed). Aseptic inflammation in the rat caused by the described method. A day after applying burn daily for 20 days the vagina of rats was treated with the composition stated. Used the liniment to the minimum and maximum contents of the ingredients, % :

I composition II composition

-form the stands - racila 4,0 6,0 Aerosil 2,0 4,0

Castor oil 90,0 94,0

According to visual observations, already at 5 days after burn practically not observed deep lesions and significantly reduced (up to 20-30% ) area of staining. To 10 days, the mucous membrane of the vagina is almost fully recovered.

According to pathological studies after 10 days of necrosis is not detected, the epithelialization of the wound surface on the background of a slight leukocyte infiltration. 20 days showed complete regeneration of epithelial tissue. Comparative dynamics of reparative regeneration is presented in table. 5.

The table shows that the claimed liniment has the greatest regenerative activity. Already on the 5th day of defeat is reduced to 30% of the area of the ptx2">

Thus, it should be emphasized that the proposed liniment, including form methyluracil, Aerosil and castor oil in the stated proportions, has a high regenerative activity. And regenerating the activity is for burns of III-IV degree, when due to the lack of epithelial elements delayed maturation of granulation tissue, formed granulation shaft, preventing the manifestation of the regenerative capacity of the epithelium.

In General, presents the results of biomedical research indicate a high regenerating, anti-inflammatory and wound healing activity of liniment. Selection of appropriate oil-free, allows you to avoid the side effects inherent in the ointments on lanolin-based and contributes to the activation of endogenous factors of regeneration, especially lipolytic enzymes. In General, the composition also reduces exudative-alternative changes in the source of the damage, prevents excessive education, the growth of connective tissue and the appearance of scars.

At the same time biopharmaceutical research has demonstrated full compliance liniment GF's and high bio is in the practice of medicine new dosage form allows you to expand the range of drugs.

LINIMENT METHYLURACIL, characterized in that the active substance contains a methyluracil, and as a pharmaceutical diluent Aerosil and castor oil in the following ratio, wt. % :

form methyluracil 4 - 6

Aerosil 2 - 4

Castor oil Else

 

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