RU2238751C1 - Vegetable-base raw rehabilitating agent - Google Patents

Abstract

FIELD: medicine, phytotherapy.

SUBSTANCE: invention relates to the development of vegetable-base raw rehabilitating agents. Vegetable-base raw rehabilitating agent comprises three complexes. The first complex is made as dragee, tablet, granule, powder; the second complex is made as a tincture; the third complex is made as an oily solution and capsule. The balanced application of components in agent provides maximally possible therapeutic effect in stress states of body.

EFFECT: valuable medicinal properties of agent.

2 cl, 10 tbl

Description

The invention relates to medicine, namely to rehabilitation means based on plant materials, and can be used to restore body functions after undergoing surgical operations, for the prevention and correction of functional diseases and disorders associated with exposure to the body of adverse environmental factors, as well as for improving the quality of life and rehabilitation of cancer patients.

Currently, there are a large number of adaptogenic, biostimulating, radioprotective and general strengthening agents used to correct the body's immune status when exposed to adverse factors (stressful situations, ionizing radiation, etc.), for the prevention, treatment of chronic fatigue syndrome and the rehabilitation of cancer patients.

Herbal preparations and herbal preparations in combination with various minerals and vitamins occupy an increasing place in the series of such products. So, one of the tools used to improve the quality of life of cancer patients is chaga or birch mushroom. The use of chaga preparations in inoperable stage IV patients with different localization of the tumor (stomach, lungs, esophagus, mammary gland, intestines, etc.) contributed to the improvement of general condition and well-being, the disappearance of pain symptoms and, in the absence of cachexia, prolonging life from several months to several years ("Chaga and its therapeutic use", 1959, Moscow).

Known biostimulating agent containing wheat and rye bran, oats, Japanese kelp, madder, Chaga (birch mushroom), zeolite and healing clay. The tool has an immunomodulating and restorative effect, it is used for diseases of the gastrointestinal tract, atherosclerosis, urolithiasis (Patent RU 2125460, 1997).

In the application RU 98104282, 1998, the drug Savitam is described having a general strengthening effect. The tool is a mixture of equal amounts of alcohol tinctures of biologically active components of plant and animal origin, a total of 83 components; the drug is used for cardiovascular diseases, tuberculosis and in gerontology.

Known collection of medicinal herbs with a restorative effect; the collection contains nettle, yarrow, a watch, a golden rod, ivan tea, cat's paws, plantain and chaga and normalizes the gastrointestinal tract and liver (Patent RU 2119344, 1996).

Known composition "LAN" for the treatment of chronic fatigue syndrome, containing alcohol tinctures of St. John's wort, hops, valerian, motherwort and chaga, stimulin and table salt; used in the form of a bath (Patent RU 2110252, 1996).

Known means for the prevention and treatment of malignant neoplasms, containing tincture of 21 plants; the drug also has a general strengthening effect, positively affects the blood composition, stimulates the immune system and body tone (Patent RU 2044547, 1993).

Known phytocomplex with antitumor activity, including three collections of medicinal plants that are used in combination therapy with fruit bodies of red fly agaric, tinctures of aconite root and hemlock herb, echinacea, milk powder, propolis tincture with honey and chaga tincture all day (Patent RU 2074731, 1994).

Known means for the prevention and postoperative treatment of malignant neoplasms, containing two tinctures, each of several plants and chaga decoction (Patent RU 2027441, 1993).

The patent RU 2152794, 2000 describes the radioprotective effect of a dry aqueous extract from St. John's wort herb.

The closest analogue to the claimed technical solution is a rehabilitation product based on plant materials containing Rhodiola rosea, licorice, peony, nettle and chaga. The tool is made in the form of tablets as morning and evening doses (Patent RU 2164146, 1999). A known tool improves the peripheral blood of the body in the treatment of cytostatics, and therefore is used for the rehabilitation of cancer patients. However, the vitamin composition and the amount of vitamins in plant materials are subject to significant fluctuations depending on natural factors, processing method and degree of extraction of biologically active substances. As a result, in the finished preparation - tablets, - the content of vitamins is minimally low and varies within wide limits, which cannot satisfy the body's need for them to normalize metabolism. It is known that in cancer patients, as well as in patients of a different profile, metabolic disorders, a decrease in enzymatic activity due to a deficiency of coenzyme structures, which include vitamins, metal ions, etc., are observed.

The objective of the present invention is to provide a means based on plant materials with a wide spectrum of action with increased rehabilitative effect. The problem is solved by the fact that the proposed remedy based on plant materials, including three complexes, the first of which contains chaga, ascorbic acid, riboflavin, thiamine hydrochloride, folic acid, rutin, succinic acid nicotinamide and calcium pantothenate with the following components, in g:

Chaga 5.0-10.0

ascorbic acid 2.5-5.0

riboflavin 0.05-0.1

thiamine hydrochloride 0.05-0.1

pyridoxine hydrochloride 0.05-0.1

folic acid 0.01-0.02

routine 1.5-3.0

succinic acid 2.0-5.0

nicotinamide 0.5-2.5

calcium pantothenate 0.5-2.5

excipients up to 100.0

The second complex contains tinctures of calamus, chaga, hawthorn, motherwort, calendula, yarrow, plantain, echinacea, licorice, propolis and honey with the following components, in g:

tincture calamus 1-5

tincture of chaga 1-5

tincture of hawthorn 1-5

motherwort tincture 1-5

calendula tincture 1-5

yarrow tincture 0.5-2

plantain tincture 1-5

Echinacea tincture 0.5-2

licorice tincture 1-5

propolis 1-5

honey 20-25

The third complex contains chaga in linseed oil 1: 10-20, grape seed oil, milk thistle, pumpkin, wheat germ, amaranth, dog rose, sea buckthorn in equal proportions.

The technical result obtained by using the present invention is to expand the arsenal of rehabilitation means based on plant materials and increase the rehabilitation effect.

The invention is illustrated by the following examples.

Example 1

I complex, in g:

chaga 5.0

ascorbic acid 3.0

riboflavin 0.05

thiamine hydrochloride 0.07

pyridoxine hydrochloride 0.07

folic acid 0.01

routine 2.0

succinic acid 2.5

nicotinamide 0.5

calcium pantothenate 1.0

excipients up to 100.0

II complex, in parts:

tincture calamus 1

tincture of chaga 2

tincture of hawthorn 3

motherwort tincture 2

calendula tincture 4

yarrow tincture 0,5

plantain tincture 3

Echinacea tincture 0.7

licorice tincture 2

propolis 1

honey 20

III complex, in parts:

Chaga in linseed oil 1:10, grape seed oil, milk thistle, pumpkin, wheat germ, amaranth, rose hip, sea buckthorn in equal proportions.

Example 2

I complex, in g:

chaga 10.0

ascorbic acid 4.0

riboflavin 0.1

thiamine hydrochloride 0.1

pyridoxine hydrochloride 0.1

folic acid 0.02

routine 3.0

succinic acid 5.0

nicotinamide 2.0

calcium pantothenate 2.0

excipients up to 100.0

II complex, in parts:

tincture calamus 3

Chaga tincture 5

tincture of hawthorn 2

motherwort tincture 5

calendula tincture 1

yarrow tincture 2

plantain tincture 1

Echinacea tincture 2

licorice tincture 5

propolis 5

honey 25

III complex, in parts:

Chaga in linseed oil 1:20, grape seed oil, milk thistle, pumpkin, wheat germ, amaranth, rose hip, sea buckthorn in equal proportions.

I complex: made in the form of dragees, capsules, tablets, granules or powder.

II complex - tinctures in banks (bottles).

Complex III - a mixture of oils in jars, capsules.

The claimed tool is obtained as follows.

To obtain the first complex, the plant material is extracted in a conventional manner, the extracts are subjected to vacuum evaporation, followed by drying. Vitamins are micronized, mixed in the stated proportions and combined with extracts in mixers. The compositions are obtained in the form of a powder or dragee, which, if necessary, is granulated in the usual manner. Powder and granules are packaged in jars or hard gelatine capsules or tabletted in a known manner.

The second complex is obtained by conventional mixing of these tinctures with propolis and honey in the stated proportions

The third complex is obtained by conventional mixing of the components, followed by dosing into capsules or vials.

It has been experimentally confirmed that it is the claimed qualitative and quantitative composition of the composition that ensures the achievement of the claimed technical result.

In the process of research, work was carried out to study the specific effect of the claimed drug, its harmlessness and subacute toxicity. The specific effect was studied experimentally on various models, and also tested on volunteers in a clinical setting.

The effect of the claimed funds on physical performance in the experiment

The experiment was carried out on outbred rats weighing 170-190 g. Animals were divided into 3 groups of 12 rats in each group. The animals of the experimental and control groups were subcutaneously injected with a 50% oily solution of CCl ₄ (carbon tetrachloride) at a rate of 0.3 ml per 100 g of body weight daily for five days. Starting from the 3rd day, the rats of the experimental group received the claimed product with food in a dose exceeding the therapeutic dose for humans by 2 times for 8 days. The animals were kept on a normal vivar diet with free access to water. The physical performance of rats was determined by the duration of the run on a treadmill to complete fatigue. The data are presented in table 1. From the data presented in table 1, it is seen that under the influence of carbon tetrachloride, the physical performance of rats (control group) is sharply reduced compared with the intact group. The claimed rehabilitation means increases the running time of rats on a treadmill by 68.5% in relation to the control.

Radioprotective activity of the claimed funds.

The study was performed on outbred male rats with a body weight of 300-360 g. Animals of the experimental group for the two weeks preceding the experiment received, in addition to the vivar diet, the claimed drug in a dose equivalent to its therapeutic dose for humans. On the next day after the last feeding, the animals were subjected to a total single gamma irradiation in a sublethal dose of 850 r (dose rate 140 r '/ min, t = 6'07 "). After irradiation, the animals were monitored for 30 days. funds were evaluated according to the results of animal survival for 30 days after a single gamma irradiation in a sublethal dose.The results are presented in table 2.

As follows from the data presented in table 2, the survival of rats when using the claimed means increases by 4.5 times compared with the group of irradiated rats not receiving the claimed means.

Immunomodulating properties of the claimed funds

The immunopharmacology of the claimed drug was studied on various models of the body's immune response. To assess the effect of the agent on proliferative activity, we used the BALB / c mouse splenocyte blast transformation reaction model in response to the polyclonal mitogen concanavalin A and alloantigens in a mixed lymphocyte culture (SCR) of the spleen of allogeneic mice.

The claimed tool was administered to three groups of mice with food daily at doses of 10, 25 and 75 mg / kg body weight for 8 weeks. The results are presented in tables 3 and 4.

As follows from the data presented in tables 3 and 4, an increase in the proliferative activity of BALB / c mouse splenocytes occurs starting from the 4th week of the experiment and reaches a maximum by 6-8 weeks. An increased proliferative response persists for two weeks after cessation of administration of the claimed drug.

To study the effect of the claimed agent on the cytolytic activity of T-killers in a mixed culture of BALB / c mouse spleen lymphocytes, the agent was administered to animals according to the previously described scheme. The results are presented in table 5.

As follows from the data presented in table 5, prolonged administration to mice of the claimed drug causes a 1.5-2-fold increase in the formation of T-killers in a mixed culture of lymphocytes, starting from the 4th week of the experiment, and the maximum increase in T-killer activity occurs 6-8 weeks of drug administration.

Thus, the claimed agent exhibits immunomodulatory activity in a wide range of doses on various models of the body's immune response.

Antitumor and antimetastatic activity of the claimed funds

The study of the antitumor and antimetastatic effects of the claimed funds was carried out on mice of the line With 57 In 1/6. Mice were divided into 4 groups of 10 animals in each group; the anticancer drug cyclophosphamide was administered at a rate of 100 mg / kg weight with an interval of 96 hours, starting from 10 days after tumor inoculation, the administration of the claimed drug (at a dose of 25 mg / kg) orally daily for 25 days, starting from 2- x days after inoculation, on the 27th day the animals were killed, the antitumor activity of the claimed drug was evaluated by inhibition of tumor growth, the frequency of metastasis, tumor mass and the number of metastases per mouse. The results are presented in table 6.

As follows from the data presented in table 6, the administration of the claimed agent increased the inhibition of tumor growth in mice by 2 times compared with the introduction of cyclophosphamide, the number of metastases per mouse and tumor mass decreased 2 times, the frequency of metastasis also decreased from 49 to 8 % From the data of table 6 it can be seen that the claimed agent increases the antitumor effect of cyclophosphamide.

Clinical testing of the claimed funds

For a clinical study of the claimed funds, a group of volunteers was selected with a diagnosis of Chronic pneumonia of stage I. The number of volunteers in the group was 15 people aged 40 to 50 years. All patients underwent treatment in a hospital, 12 of them - for acute pneumonia. After being discharged from the hospital for two months, they received supportive care at the place of residence. In the majority of patients (12 out of 15 patients), the factors that caused chronic pneumonia were the treatment that was started late or stopped early in acute pneumonia, as well as chronic bronchitis (1 person) and influenza (2 people). Over the past two months, the health status of patients has not improved.

The condition before starting to receive the declared funds:

- subjectively - complaints of weakness, sweating, periodic rises in temperature, cough with a small amount of sputum mucosa;

- objectively - during the examination, hard breathing, shortening of percussion sound is determined; X-ray detected enhanced pulmonary pattern; in 12 patients for whom chronic pneumonia was the result of acute pneumonia, infiltration changes were seen on radiographs. In all patients, ESR is increased and amounts to 25-32 mm / hour, the content of C-reactive protein in serum is more than 5 mg / l.

The treatment with the claimed agent has begun, oral administration according to the scheme. The first complex is 1 g 2 times a day in the morning and evening, the second complex is 15-20 drops 2 times a day in the afternoon and evening, and the third complex is 25-30 drops 3 times a day in the morning, afternoon and evening before meals. The course of treatment was 1 month. At the end of the course of treatment, the condition of all 15 people improved significantly. Complaints about constant weakness ceased, cough decreased, body temperature was in the range of 36.6-36.9 ° С. Infiltrative changes were not detected on radiographs, breathing became deep and even. Patients began to perform feasible physical exercises. The value of ESR is from 10 to 14 mm / hour, the content of C-reactive protein in the blood serum is less than 5 mg / l.

Subacute toxicity studies

Experimental studies were carried out in accordance with the Recommendations of the Pharmacological Committee of the Ministry of Health of the Russian Federation and the rules of preclinical safety assessment of pharmacological agents (Moscow, 1992).

Subacute toxicity was studied on the basis of a study of the dynamics of changes in body weight, general clinical and clinical studies of urine, and biochemical parameters of rat serum.

The body weight of rats with the introduction of the claimed funds was not significantly different from the control during the study period (table 7). All groups of animals took food and water well, physiological administration proceeded normally, the stool had the usual consistency. The weekly recorded body weight of the animals is presented in table 7. Observation of the respiratory rate did not reveal abnormalities. The number of respiratory movements in animals of all groups ranged from 114.8 ± 2.3 to 120.9 ± 3.0 (p <0.05).

As follows from the data presented in table 7, the body weight of female and male rats treated with the claimed drug did not statistically significantly differ from the control group treated with saline. Thus, the claimed tool does not affect the body weight of animals.

Clinical and biochemical examination of urine and blood

At the end of the experiment, urine and blood tests were performed. For analysis, blood was collected by decapitation of animals. Hematological analyzes were performed by conventional methods. Erythrocytes and leukocytes were counted in the Goryaev’s chamber. The hemoglobin content was determined by the hemoglobin cyanide method, ESR by the Panchenkov method, the osmotic resistance of erythrocytes was determined by the Godelson method, and the platelet count by smear was determined by Fonio. The effect of the claimed drug on metabolism was evaluated by the content of serum protein, urea, glucose, and total cholesterol. The functional state of the liver and heart was evaluated by the activity of alanine and aspartate aminotransferases (ALT and ACT). A thymol test was performed. Protein, ketones, glucose, bile and blood pigments, nitrates, urine pH were determined visually with test strips Osmofan and Pentafan.

The results of clinical and biochemical studies of urine and blood

No sugar, bilirubin, ketone bodies, hemoglobin were found in the urine of the experimental and control groups of animals. The urine reaction in the experimental groups was slightly alkaline, and in the control - neutral, and did not significantly differ from the normal range. The amount of protein in all groups was found in trace amounts, which does not go beyond the norm (table 8).

A clinical blood test indicates that there were no significant changes in the main indicators with the introduction of the claimed funds compared with the control (table 9).

The course introduction of the claimed drug did not cause statistically significant changes in the serum content of protein and protein fractions, urea, glucose, total cholesterol, colloidal stability of the protein, thymol test, as well as the activity of transaminases and alkaline phosphatase (table 10).

Based on the foregoing, we can conclude that the introduction of the claimed funds within 28 days did not have a noticeable effect on the main indicators of homeostasis in comparison with the control.

Thus, the proposed tool has a high rehabilitation ability in stressful situations for the body, with chronic and oncological diseases, it is harmless, convenient to use, which allows it to take its rightful place in wide medical practice.

Claims (2)

1. A rehabilitation product based on plant materials, characterized in that it includes three complexes, the first of which contains chaga, ascorbic acid, riboflavin, thiamine hydrochloride, pyridoxine hydrochloride, folic acid, rutin, succinic acid, nicotinamide, calcium pantothenate and excipients in the following ratio of components, g: Chaga 5.0-10.0 Ascorbic acid 2.5-5.0 Riboflavin 0.05-0.1 Thiamine hydrochloride 0.05-0.1 Pyridoxine hydrochloride 0.05-0.1 Folic Acid 0.01-0.02 Rutin 1.5-3.0 Succinic acid 2.0-5.0 Nicotinamide 0.5-2.5 Calcium pantothenate 0.5-2.5 Excipients Up to 100 the second complex contains tinctures of calamus, chaga, hawthorn, motherwort, calendula, yarrow, plantain, echinacea, licorice, propolis and honey with the following components, parts: Calamus tincture 1-5 Chaga tincture 1-5 Hawthorn tincture 1-5 Motherwort tincture 1-5 Calendula tincture 1-5 Yarrow tincture 0.5-2 Plantain Tincture 1-5 Echinacea tincture 0.5-2 Licorice tincture 1-5 Propolis 1-5 Honey 20-25 the third complex contains chaga in linseed oil 1: 10-20, grape seed oil, milk thistle, pumpkin, wheat germ, amaranth, dogrose, sea buckthorn in equal proportions. 2. The tool according to claim 1, characterized in that it is intended for oral use, while the first complex is taken 2 times a day, morning and afternoon, the second complex is taken 2 times a day, day and evening, and the third complex is taken 3 times day, morning, afternoon and evening before meals.