Improved dosage form of human interferon-candle

 

(57) Abstract:

The invention relates to the pharmacy, the pharmaceutical form of human recombinant interferon Alfa-2 - rectal and vaginal suppositories. Candles contain a specified interferon, antioxidants - vitamin C, tocopherol (E), vitamin a, hyaluronic acid, base, cocoa butter at a certain ratio of components. The invention avoids the inconvenience and hazards associated with the introduction of interferon in the form of injection solutions.

The invention relates to the pharmacy, particularly to the dosage form is a suppository containing recombinant (genetically engineered) human interferon alpha-2, and may find application in the treatment of diseases of viral etiology or due to impaired natural immunity.

From the patent of Russian Federation N 2024253, class A 61 K 9/02 known rectal suppositories with recombinant interferon alpha-2 (250-500 thousand units ), -tocopherol (0,25-0,30 g), vitamin C (0,015-0,025 g) and base (up to 1.0-1.5 g), which can be used to cure patients with various nosological forms of chlamydial infections, meningitis and other diseases. However, these candles have certain defects which, jedco and even macropodidae (cracks) of the mucous membrane, capable of secondarily infected;

famous candles are deprived of the dosed release of the components of the antioxidants (a-tocopherol and vitamin C), which is confirmed emphasize the author of the need to vary the content of these components in a very hard boundaries (respectively 0.25 to 0.30 0,016 0,025 grams): if the amount of-tocopherol greater than 0.30 g, and vitamin C, 0.25 g is a Pro-oxidant effect, which will entail in the limiting case of violation of the membrane permeability and the destruction of the hepatocytes of the liver; on the contrary, if the amount of the antioxidant is less than the lower limits (respectively 0.25 and 0.015 g), the synergy of their actions with interferon disappears.

The aim of the present invention is to provide dosage forms-candles of recombinant human interferon alpha-2, which would be devoid of the above disadvantages or, having appeared, they were eliminated by themselves, without intervention of a doctor.

This goal is achieved thanks to the fact that the candle is a pharmaceutical form of human recombinant interferon alpha-2, including, in addition to the interferon, the antioxidants a-tocopherol and vitamin C and the base (cocoa butter), fill the>/BR>Recombinant human interferon alpha-2 - (7,0-17,5)106IU

-tocopherol - 3,5-7

Vitamin C - 0,7-1,4

Vitamin A - 0,7-1,4

Hyaluronic acid is 1.0 to 2.0

Base (cocoa butter) - Up to 100

Hyaluronic acid is mucopolysaccharide (glycosaminoglycan), built from repeating units of D-glucuronic acid and N-acetylglucosamine-2-ndimethylacetamide-2-deoxy-D-glucose with glucosidase links 1 ---> 3 - 1 ---> 4-type and allocated from such natural sources as the umbilical cord of newborns, synovial fluid, combs chickens, etc. As the main structural element of connective tissues, hyaluronic acid provides optimal distribution of interferon in the candle and thereby on the surface of mucous membranes, and his uniform penetration into the bloodstream. In addition, this acid has a beneficial effect on the mucous membrane of the rectum and the vagina, stimulating the processes of tissue regeneration.

Supplementation of vitamin A, which molecule has a long side and Deputy thereby detect structural similarities with a-tocopherol (vitamin E), leads to potenzirovania activity of antioxidants, probably due to abrashi interferon-shaped candles

- eliminates the risk of iatrogenic infection patients through syringes and instruments - risk, especially formidable in terms of clinics and in areas with a high incidence;

- provides slow absorption and decreases the rate of biotransformation of interferon, which allows you to have distinct biological effects at low doses of the active substance;

- there are practically no side effects typically observed with parenteral therapy with interferon;

- do not form antibodies to recombinant interferon.

We offer candle has proven its effectiveness as a pre-and post-operative tool, and in the case of immunodeficiency caused by long courses of antibiotic-, radiation and hormonal therapy.

The antiviral effect of interferon alpha-2 when combined with hyaluronic acid and offer natural antioxidants-vitamins A, C, E increases by 5-10 times.

Accumulated clinical experience proves the high efficiency of the proposed candles in the treatment of herpes infections, including genital herpes, chlamydia, papillomatosis, other diseases of bacterial etiology, outside of AK, in the treatment of infections caused by herpes simplex virus types 1 and 2, clinical effect, according to the observations of the authors, was achieved in 17 patients out of 20, with a marked reduction in the duration of recurrent disease, reduce the severity of the disease, the increase in relapse-free period, which is illustrated by the following examples.

Example 1. Patient S. , 46 years old. Regarding recurrent herpetic infections were treated in the outpatient Department of the hospital drugs "Zovirax" and "Oksolina", but to no avail. For this reason, was transferred for treatment candles (one suppository into the rectum 2 times a day for 10 days, then 2 times a day a day for 2 months) of the following composition, g:

Recombinant human interferon alpha-2 - 250,000 IU

Hyaluronic acid - 0,03

-tocopherol - 0,1

Vitamin A - 0,01

Vitamin C - 0.02

Cocoa butter - 1.5

5 days after the start of treatment indicated the disappearance of clinical symptoms, later registered an increase of 2.5 times of recurrence-free period (observation period is 2 years).

Example 2. Patient C., 27 years. Entered in the gynecological Department with urogenital chlamydiosis and complaints svechi, containing, g:

Recombinant human interferon alpha-2 - 250,000 IU

Hyaluronic acid - 0.02

-tocopherol - 0,05

Vitamin A - 0.02

Vitamin C - 0,01

Cocoa butter - 1.5

The treatment consisted in vnutrivlagalischno the introduction of one candle 2 times a day every day for 2 weeks and then 2 times a day every day for 3 months. Upon completion of the course of treatment established clinical cure, confirmed by laboratory studies. Subsequently the patient became pregnant and gave birth to a healthy child.

Example 3. Patient K. , age 9. Was in the hospital with a diagnosis of chronic active hepatitis C. the State of moderate severity, with symptoms of intoxication. Treatment by suppositories of the following composition, g:

Recombinant human interferon alpha-2 - 150000 IU

Hyaluronic acid - 0.02

-tocopherol - 0,1

Vitamin A - 0.02

Vitamin C - 0,01

Cocoa butter - 1.5

After 20 days of treatment (one candle 2 times a day) the patient's condition has improved, the phenomenon disappeared intoxication decreased the size and density of the liver. The child was discharged in a satisfactory condition for continued treatment candles in the outpatient setting for 6 mesjacem therapeutic possibilities of candles, containing interferon, pediatric, gynecological and General practice.

Candles with human recombinant interferon alpha-2, containing the specified interferon, antioxidants - a-tocopherol and vitamin C Foundation - cocoa butter, characterized in that they additionally contain hyaluronic acid and vitamin a in the following ratio of components, g:

Recombinant human interferon alpha-2 - (7,0 - 17,5) 106IU

-tocopherol - 3,5 - 7,0

Vitamin C - 0,7 - 1,4

Vitamin a - 0,7 - 1,4

Hyaluronic acid - 1,0 - 2,0

Cocoa butter - Up to 100.0

 

Same patents:

The invention relates to medicine, namely to Virology, immunology, gynecology and pharmacology
The invention relates to medicine
The invention relates to chemical-pharmaceutical industry, medicine and relates to integrated natural drug "Postopen and method of its production

The invention relates to the formulation of new drugs and methods of treatment of bacterial and viral infections and can be used in pharmacology and medicine

The invention relates to the pharmaceutical industry, concerns the creation of suppositories, having a laxative effect, and can be used for constipation of various etiology
The invention relates to medicine, namely to methods for obtaining concentrated virionyx Antiherpes virus effect of vaccines

The invention relates to medicine, in particular drugs for the treatment of inflammatory and degenerative processes of the mucous membranes

The invention relates to medicine, to pharmaceutical compositions based on natural substances

The invention relates to pharmaceutical production and can be used in the manufacture of rectal and vaginal suppositories for the prevention and treatment of diseases caused by yeast-like fungi of the genus Candida, treatment for candidatesa mucous membranes of the lower bowel and vagina, as well as with obesity and vulvovaginitis
The invention relates to medicine
The invention relates to medicine, namely to pulmonology, and for the treatment of lung acute pneumonia
The invention relates to medicine and can be used for the treatment of infectious diseases
The invention relates to medicine, in particular to the treatment of infectious diseases

The invention relates to medicine, namely to methods for treating infectious diseases, including diphtheria

The invention relates to the field of medicine and is intended for treatment of hepatitis
The invention relates to medicine, in particular to Pediatrics, and for the treatment of stenosing laryngotracheitis

The invention relates to medicine, the pharmaceutical industry and applies ointment with human leukocyte interferon

The invention relates to medicine, namely to Oncology, and for the treatment of metastatic liver lesions
The invention relates to pharmacology, specifically to the preparation interferonsource compositions, which can find application in ophthalmology

FIELD: medicine, anesthesiology-resuscitation, infectology, detoxication.

SUBSTANCE: the innovation suggested interrupts infectious-toxic shock, moreover, after that it is necessary to prescribe peroral intake of Reaferon-EC-Lipint at the dosage of 10000 - 15000 U/kg. Then one should sample patient's blood to obtain leukocytes to be washed and diluted in 0.9%-NaCl solution, activated due to incubation with immunophan and intravenously injected for a patient. Then comes peroral intake of Reaferon-EC-Lipint at the dosage of 10000 - 15000 U/kg once daily for 5 d. The innovation enables to decrease the number of complications and lethality due to decreasing immunodeficiency.

EFFECT: higher efficiency of therapy.

3 ex, 1 tbl

Up!