Agent possessing antitumor activity

FIELD: medicine, oncology, pharmacy.

SUBSTANCE: invention relates to agents used in treatment of tumors and can be used in treatment of different tumor neoplasms. The proposed agent possessing an antitumor activity comprises methylene glycol as an active component and a saline solution as an inert solvent in the following ratio of components, wt.-%: calcium chloride (CaCl2), 0.018-0.021; potassium chloride (KCl), 0.018-0.021; methylene glycol, 0.1-1.0, and water, the balance. The optimal curative daily dose is 20-40 mcl/1 kg of body weight. Invention provides achievement of the stable clinical effect, reducing treatment time and decreasing the toxic effect.

EFFECT: valuable medicinal property of agent.

2 cl, 5 ex

 

The invention relates to medicine, more precisely to pharmacology, and can be used for the manufacture of drugs used for the prevention and treatment of cancer.

In the study of cells of healthy people and patients with leukemia results, showing that there is a correlation between the number of generated etilenglikola, folate levels and proliferative potential of cells. It was found that the higher proliferative potential, the more the enzyme system of folic acid, the more is produced by etilenglikola. Suggested that the regulation of endogenous etilenglikola folic acid. It was concluded that the formation of etilenglikola in the cell is backed by the withdrawal of folate from the zone of active metabolism, and the introduction of aldehyde in the body can contribute to the depletion depot folate and reduce their impact on the enabled processes for the synthesis of nucleic acids and amino acids (Lapkina GI "Influence of formaldehyde on the metabolism of ischemic organs" Dessert. Kida. M., 1982). Thus, it is shown that etilenglikol affects several parts of a metabolism that are involved in the mechanism of development and inhibition of ecoprocess.

It is also known that aldehydes, to cat the eye is etilenglikol, both natural and synthetic, are applicable beginning in many medicines used in the treatment of tumors, infectious diseases and diseases of the nervous system. What are the properties of the data connection that allows them to become components of many drugs? First and foremost is the ability of aldehydes contact with many cellular receptors, including covalently, even with non-specific receptors, which is especially important in Oncology, where such well-known drug as topotecan, and a lot of other drugs whose action is based on the ability to bind to DNA of tumor cells and inhibit the development of tumors. The second important property of aldehydes is the ability to be as prooxidants and antioxidants, making them a versatile anti-inflammatory drugs. A huge role in this process plays etilenglikol able to inhibit the activity proteasome complex (MG132, lactacystin), to destroy short-lived proteins, including Senigallia (regulatory)-53, P-53.

The development of cancer (carcinogenesis) is a process consisting of several stages in the progression of cells from the normal state to transformed. A variety of tumors contributes to the existence teroperability tumors, various reaction is and medicines. The main objective of chemotherapy is the destruction of tumors without the effects of medicinal substances on healthy tissue (see Aterballoon, Averros, Not "Modern medicines, 2003, 745-774). However, at present, to achieve therapeutic effect of the conduct of monochemotherapy not enough. There are many side effects of chemotherapy, which often determines the cessation of therapy.

The technical result of the claimed invention is to provide a tool for the prevention and treatment of cancer, which would ensure the achievement of a stable clinical effect, reducing treatment time and reduced toxic effect.

The technical result is achieved by known means, with protivoopujolevoe activity containing inert solvent and the active principle, the solvent contains water, salt solution, and acting as a start it contains etilenglikol in the following ratio, wt.%:

CaCl20,018-0,021
KCl20,018-0,021
Etilenglikol0,1-1,0
WaterRest

Optimal therapeutic daily dose is 20-40 µl per 1 kg of body weight.

The tool is prepared as follows.

Sample CaCl2and KCl2the number 0,018-0,021 g dissolve at careful hashing in a small amount (e.g., 50 ml) of distilled water, then in the resulting solution add etilenglikol in an amount of 0.1-1.0 g and again mix thoroughly. Bring the solution volume to 100 ml, re-mix.

Thus prepared medium of the following composition, g:

CaCl20,018
KCl20,018
Etilenglikol0,25
WaterThe rest is up to 100

was tested for antitumor activity in animals.

Antitumor activity of the proposed tools were investigated during chemical carcinogenesis model of tumor in the bladder.

Example 1

On the model of the tumor process bladder conducted 15 series of experiments. 10 groups, each of which consisted of 5 outbred rats of either sex weighing 200 to 250 grams, caused bladder cancer phenoloxidase compounds (phenobarbital, estrogenic steroids with the addition of nicotine) by injection into the submucosal membrane of the bladder. A day in the field of introduction of said the and hyperemia tissue and collateral edema. On the 3rd day was determined by the limited infiltration. In animals there came a sharp violation of urination. 7-10 day on the surface of the infiltration was formed by the erosion saped edges. Marked enlargement of the regional lymph nodes Through the month histological examination diagnosed with bladder cancer in the stage of malignancy. Initiated the introduction of a 0.25 % solution of etilenglikola in the amount of 2 μl per 100 g weight of the animal in the inferior caval vein once daily for 7-10 days. On the 3rd day marked reduction of infiltration and epithelialization of the wound surface. For 7-10 days found a significant reduction of infiltration and regional lymph nodes. Through the month noted the resolution of the pathological process.

Similar results were obtained when using etilenglikola in the treatment of leukoplakia. Leukoplakia along with the other is a tumorous disease, which is easily subjected to malignancy (see RF patent №2101045).

Known potential malignant degeneration of leukoplakia.

The use of cryosurgery and laser therapy is not always possible due to contraindications. In addition, according to our experience, these treatments give a high percentage of relapses. Usually, after 5 years of treatment there has been a relapse of the disease.

We used to treat leukoplakia 7 b is selected (4 women and 3 men) aged from 46 to 52 years with disease duration of 5 to 7 years canned in etilenglikole allograft. It should be noted that in all these patients in the past was conservative and surgical treatment, which did not give a positive result. Potential malignancy of leukoplakia of the mucous membranes of the oral cavity (ocan) and the red portion of the lips requires timely and adequate treatment of this pathology. Excision of the lesion is not always possible because of contraindications to surgery with the use of cryo - or lasertechnologie. On the above methodology, we have applied the graft mucosa, preserved in the solution of the following composition, g:

CaCl20,02
KCl20,02
Etilenglikol0,25
WaterThe rest is up to 100

7 patients (4 women, 3 men) aged from 46 to 52 years, with a given disease from 5 to 7 years. When the observations have all delivered the diagnosis of leukoplakia, the previous conservative and surgical treatment did not give a positive result.

Example 2

Sick Am 52 years old with a diagnosis of leukoplakia erosive-ulcerous form localized in the mucosa of the cheeks and the roof of the jaw in the molar region, suffered from pain in the area of a lesion in the tissue. After provoding the conservative and surgical treatment remission was not observed. The stress RESISTANCE of canned 0.25% solution of etilenglikola in the field refreshed the surface of the damaged tissue, for 7-10 days, was noted in the resolution process, i.e. full or partial epithelialization tissue. Relapse was not within 5 years.

Example 3

Patient X. 65 years old, came with a diagnosis of KPL, erosive-ulcerous form localized in the mucosa of the cheeks and retromolar region, periodontitis generalized moderate. Suffers KPL for 15 years. Comorbidities: hypertension II century, the form of diabetes mellitus insulin dependent. The patient receives insulin. The patient produced the sanitation of the oral cavity. Further, under local anesthesia using a cutter with a small notch conducted abrasion of the surface of leukoplakia. Next on the shape and size of the wound surface formed allogeneic transplant mucous membranes of the oral cavity, preserved in the above 0.25% solution etilenglikola, which is sutured to the edges of the wound surface with catgut. On the 2nd day started epithelialization, which ended on the 6th day. After 6 years of relapse is not marked.

It should be noted that in the process of treatment postoperative period is not accompanied by necrosis of the lesion and surrounding tissues.

The proposed model for the treatment of PLCs can be used in lacenaire any part of the gastrointestinal tract at an early stage of its development.

This has allowed us to formulate a new promising approach for the prevention and treatment of cancer.

Allogeneic transplant mucous membrane is prepared as follows:

1. Make preparation material from allogeneic transplant mucous membranes of the oral cavity.

2. Then it is placed in a solution containing 0.02% of CaCl2, 0,02% KCl2and 0.25% etilenglikola.

3. Maintained at a temperature-3-0°C for 14 days.

4. Before using allogenic the graft is washed with saline solution.

Creating high background etilenglikola at a given time level in the field of blastomycosis process contributes to a positive resolution of the pathological process in tissues and organs.

Example 4

We studied the impact of the proposed funds for the inhibition of tumor growth of sarcoma-45.

To obtain tumor suspension of tumor cells of sarcoma-45 were injected with under the skin of the back in white rats weighing 200-220 g "Treatment" of animals was started after reaching the tumor volume of at least 1 cm3. To do this 1 time per 3 days produced the introduction of a solution containing 0.02% of CaCl2, 0,02% KCl2and 0.1% etilenglikola, directly into the tumor at the rate of 2 µg per 100 g of body weight of the animal.

The control group consisted of 20 rats carriers of tumour, which centuries the Dili saline without etilenglikola.

30 days after inoculation, the size of tumors in the experimental group of animals was 3 times less than in the control group.

Example 5

The proposed tool is also tested for cytotoxic activity in cultures of epithelial cells. Used cell breast carcinoma (McF7).

Cytotoxic activity was studied on the effect of different concentrations money on cell growth compared to control cells. For this purpose cells were cultured in medium RPMI-1640 with 10%fetal calf serum. After growing the cells were removed from the glass with 0.5%trypsin solution containing 5.3 mm EDTA, centrifuged, resuspendable and bred to the content of 25,000-50,000 cells per ml, the Cells were sown in the daily culture contributed a different drug concentrations, cytotoxicity was determined by the presence of protein in experimental and control samples. Found that the proposed remedy containing 0,021% CaCl2, 0,021% KCl2and etilenglikol in an amount of 0.1% or 1.0%, inhibits the growth of cell cultures by 50% or more.

As a result of the research presents new properties etilenglikola as antitumor agents.

Set the dose of formaldehyde required for the prevention and treatment of cancer. Such dose is 20-40 mg/kg form is elegida or 20 ml of 0.2-1.0% solution per 1 kg of weight.

1. The agent with antitumor activity, containing inert solvent and the active principle, characterized in that the solvent it contains aqueous salt solution, and as an active start - etilenglikol in the following ratio, wt.%:

CaCl20,018-0,021
KCl20,018-0,021
Etilenglikol0,1-1,0
WaterRest

2. The tool according to claim 1, wherein the optimal therapeutic daily dose is 20-40 µl per 1 kg of body weight.



 

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1 tbl, 4 ex

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15 cl, 5 tbl, 6 ex

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1 ex

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1 tbl

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47 cl, 11 dwg, 16 tbl, 18 ex

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4 cl, 2 tbl

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3 ex, 4 tbl

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