RU2061491C1 - Method of preparing agent increasing organism resistance - Google Patents

Abstract

FIELD: medicine, pharmacy. SUBSTANCE: agent is prepared by wood greens steaming for 1.5-2 hr at 100-110 C, under pressure 0.2-0.3 atm followed by removal and cooling steam-gas mixture and separation of an aqueous extract from oil. Agent prepared from coniferous species wood greens enhances organism resistance to catarrhal diseases, stimulates hemopoiesis and immune system, shows positive effect on the central nervous system and at radiation disease. Also, agent can be used in cattle breeding as biostimulating agent and for organism sanitation. EFFECT: simplified method, enlarged raw source, high effectiveness of preparation.

Description

 The invention relates to the production of drugs from plant materials. The drug obtained by the proposed method can be used in medicine to increase the body's resistance to colds, to stimulate reparative processes during surgical interventions. It stimulates the activity of the hematopoietic system and the immune system, has a beneficial effect on the central nervous system, and reduces fatigue. Effective in diseases of the upper respiratory tract, gastrointestinal tract, radiation sickness. It can be used in animal husbandry as a biostimulant and for sanitation of the body.

 In medicine, it is known to use preparations prepared from plant materials, for example ginseng, eleutorococcus, which are used as biostimulants (Dardymov I.V. Ginseng, eleutorococcus. M. Nauka. 1976). However, these drugs are used in the form of alcohol tinctures and extracts, which reduces their biological activity. At the same time, these plants have a limited mass in natural conditions, low renewability. The introduction of these drugs is laborious and not widespread. Overdosing instead of biostimulating action leads to pathological changes in the functional systems of the body.

Known tool with immunomodulatory activity, taken as a prototype and prepared from plant materials of leuzea, ledum, celandine. The tool is used in the form of an aqueous extract. The extraction is carried out by treating the raw materials with water vapor at a temperature of 100 ^o C for 20 minutes, after filtering, bee honey is added. The mixture is electrolyzed for 20 minutes and the alkaline fraction is taken (ed. St. USSR N 1731225, class A 61 K 35/76).

 However, these drugs cannot be widely used because of the narrow spectrum of biological action and weak raw material base.

 The problem to which the invention is directed, is to obtain a highly effective agent that increases the body's resistance, prepared on the basis of available plant materials. The drug should not have negative side effects, and the method of its preparation should be quite simple.

 In the invention, it is proposed to use woody greens of coniferous species as plant raw materials, in particular a fir foot of Siberian fir (Abies sibirica). In folk medicine, the use of drugs from these tree species for angina pectoris, atherosclerosis, bronchial asthma, etc. is known. The defining feature of these drugs is anti-inflammatory and bactericidal action. Their active substance is coniferous oil, obtained by distillation of green wood with steam, followed by separation of the oil from the aqueous extract. Moreover, the latter was a waste of production. It was found that if oil is distilled off under certain conditions, then the aqueous extract acquires a number of valuable healing properties. It is saturated with biologically active substances, includes multivitamin complexes C, P, B, K, carotenoids, polyphenolic complexes, sugars, chlorophyllin, phytoncides and various trace elements. Thus obtained extract has a wide range of therapeutic effects that exceed the spectrum of the oil.

To obtain an aqueous extract according to the proposed method, the plant material is steamed with water vapor for 1.5 to 2 hours at a temperature of 100 - 110 ^o C, and the pressure is maintained within 0.2 0.3 atm. Then, under the same conditions, the vapor-gas mixture is removed, cooled, condensed, and the oil separated from the aqueous extract.

 The resulting extract is subjected to an input control, sterilizing filtration and poured into sterile vials.

 Temperature conditions are maximally gentle, in which the destruction of vitamin complexes and other biologically active substances does not occur.

When the temperature rises above 110 ^° C, the biological activity of the obtained extract sharply decreases due to the destruction of whole groups of biologically active substances, and when the temperature drops below 100 ^° C, the biological activity also decreases, probably due to incomplete extraction of the biologically active substances in the needles.

 Pressure at the level of 0.2 0.3 atm. also provides optimal extraction of biologically active substances. If the ratio of the values of these parameters (temperature, pressure) is violated, the quality of the obtained extract sharply decreases (biological quality is the quality criterion).

 Currently, the proposed method is implemented at the enterprises of JSC "Association Delta", Tomsk. The preparation obtained in this way from the woody greens of Siberian fir (Abies sibirica) has the registered trademark ABISIB.

 The method is as follows. A distillation vat stainless steel extractor having a sealing lid and a steam pipe is loaded with a pre-ground fir foot and steam is supplied into it from a steam generator for pre-steaming. The fir foot is periodically added and tamped. After the foot ceases to sit under the action of steam, the download is considered complete. The extractor is then sealed with a seal cap.

The process of obtaining ABISIB lead with a uniform supply of steam to the extractor and a continuous supply of water to the steam generator. In this case, the steam temperature is maintained within 100 110 ^o C, and the pressure in the steam generator is 0.2 0.3 atm. In this state, the fir foot is steamed for 1.5 to 2 hours.

 After steaming, the steam vent valve is opened 1/4 of a turn and the vapor-gas mixture formed in the vat enters the refrigerator, where it is cooled and condensed. Then the water-oil mixture enters a single collection of Florentine, where it is divided into 2 components (due to different specific gravity: oil 0.9, extract 1.0). Multilevel conclusions of the collection valves allow a clean separation into separate containers of oil and aqueous extract.

Throughout the process, it is also necessary to monitor the temperature of the condensate leaving the refrigerator, which should not be higher than 25 - 30 ^o С, since the condensation of the incoming steam will not be complete and some of the biologically active substances do not get into the extract.

 The process is considered completed when a condensate sample from the refrigerator (to Florentine), taken in a 0.25 liter bottle, forms a layer of oil of no more than 1 mm in the neck. This sample is taken every hour.

 The removal of oil and ABISIB goes most intensively in the first 5 hours and ends after about 10 hours. After the distillation, the vats are freed from the fir foot and other waste generated at the bottom, thoroughly cleaned, after which the installation is ready for re-loading.

 When loading 1000 kg of fir foot, 150 170 kg of ABISIB and 12 to 14 kg of fir oil are obtained.

 Table 1 shows the dependence of the quality of ABISIB on the technological conditions for its production. The extracts obtained from these examples are subjected to biological activity studies by the criterion of action on the hematopoietic system of the body. Studies were conducted on rats. The control group of animals received distilled water, an experimental aqueous extract of ABISIB fir paws. The research results are shown in table 2.

 As you can see from the tables, the extract obtained in examples 1 and 3, the biological activity does not have significant differences compared with the data of the control group of animals. And the extract obtained in example 2 stimulates the hematopoietic system, both white and red blood sprouts.

The aqueous extract of fir paws obtained by the proposed method is a clear liquid color with a fir smell. The authenticity of the drug is determined by:
a) according to the wave absorption spectrum in the UV region with an absorption maximum of 196,200 nm, 215,218 nm, 276,279 nm. The drug is diluted with water in a ratio of 1 to 9 and the absorption spectrum is recorded on a spectrophotometer;
b) the chloroform extract should have 2 zones of maximum absorption: at a wavelength of 270 276 nm and a second, small peak, in the zone of 410 420 nm. The extract is obtained from 5 ml of the drug three times, in small portions (approximately 3 ml of chloroform), extraction is carried out in a separatory funnel. The resulting portions of the chloroform extract are filtered through absorbent dry cotton, combined and the total volume is adjusted to 10 or 15 ml. The absorption spectrum is recorded on a spectrophotometer. The solution of the drug should be transparent (State Pharmacopoeia, Volume XI, p. 194), the pH is in the range 4.5 6.0 (GF, volume XI, p. 113), the refractive index is 1.333 (GF, volume XI, p. 29 ), density 0.9980 ± 0.0005 (GF, Volume XI, p. 24), solids content of 0.012 0.016
To prepare for the introduction of the drug ABISIB in clinical practice, studies were conducted on acute and chronic toxicity. 40 animals were used to determine acute toxicity. Oral animals (white rats) were injected with 1 ml of various dilutions of ABISIB (1 2, 1 4, 1 8, 1 16). No lethal effect was observed. Therefore, rats were administered the native drug from 1 ml to 4 ml once. At the same time, no fatal outcome was observed. Within a month from the date of administration of the drug, no changes in the general clinical condition and behavior of the animals occurred. Based on the experiments, it was concluded that the drug does not have an acute toxicity threshold.

 The possibility of side effects with prolonged use of the drug (chronic toxicity) was determined in 60 animals. Daily for 6 months, animals were orally administered with 1 ml of ABISIB. The control animals were injected with the same amount of water. Monthly blood was taken from the tail vein, animals were weighed. For 6 months of the experiment, the gain in animals of the experimental group was 12 more than in the control group. None of the rats in the experimental group died, with the death of 4 rats in the control group. After 6 months, the animals were sacrificed and pathological and anatomical and histological studies were performed. The following organs were taken: stomach, pancreas, small intestine, liver, spleen, heart, adrenal gland. Surveying microscopic studies did not reveal any pathological changes at the level of cells, tissues.

Studies of the drug for all types of pharmacological action (acute and chronic toxicity, cumulative effect, embryotoxic, allergenic, carcinogenic effect) showed that this drug does not have these types of action, which allows testing of this drug on volunteers. Tests conducted on more than 100 volunteers. Every day for a month, each of them took 45 ml of the drug (1 tbsp.spoon 3 times a day, 15 20 minutes before meals, and every 2 weeks they examined the blood and recorded the general condition. A generalization of the materials showed:
1. The absence of any side effects.

2. In all volunteers, hemoglobin increased by 2 3 mg
3. In volunteers with an initial white blood cell count of more than 10 thousand, their number decreased to 6 7 thousand.

 4. With peptic ulcer of the stomach and duodenum, the drug relieved pain, leukocytosis decreased from 16 18 thousand to 8 9 thousand in 1 μl of blood.

 5. With inflammatory phenomena from the upper respiratory tract (laryngitis, bronchitis, tonsillitis), they disappeared 3 4 days after the start of the drug. The drug had a pronounced stopping effect in bronchial asthma.

 Clinical testing of the drug for various diseases was carried out, in particular in the rehabilitation center for children affected by the Chernobyl accident, in the regional surgical clinic in Tomsk.

 In the case of using ABISIB for the treatment of people affected by the Chernobyl accident (32 patients with increased fatigue syndrome and a decrease in the activity of natural killers) 15 ml 3 times a day before meals, for a month the condition of all patients improved significantly, the increased fatigue, headache disappeared , subfibril temperature, drowsiness, increased working capacity The number of red blood cells, hemoglobin in the blood increased significantly. The number of leukocytes at a low initial level (3 4 thousand in 1 μl) increased to 5 7 thousand and vice versa, at a high level it decreased to 7 9 thousand in 1 μl of peripheral blood. In 18 out of 32 patients, the activity of natural killer cells increased, and the content of immunoglobulins J, A, M in the peripheral blood returned to normal. The drug did not cause side effects, it is well dosed.

 In the proctology department of the regional clinical hospital in Tomsk, ABISIB was used to treat 21 people with the following diseases: rectal fistula, epithelial coccygeal passages, acute paraproctitis, proctitis, sigmoiditis. The drug was administered enterally in 1 tbsp. spoon 3 times a day, as well as in microclysters of 100 ml, dressings for wounds, as well as in the form of turund. A similar effect is exerted by methyluracil ointment, levasin ointment, but ABISIB, in contrast to them, helps to shorten the time for purulent wounds cleansing, active granulation epithelization. The drug is most effective for the treatment of purulent sluggish wounds, inflammatory processes of the mucous membranes.

 In addition, the drug was tested on animals in the farms of the Tomsk and Kemerovo regions. ABISIB sanitizes the body of animals, prevents the development of infectious diseases. Animals receiving ABISIB gained 15–20 more weight than control animals for the same period of time.

 The drug ABISIB increases the body's resistance to colds and intestinal diseases. So, in the experiment there were 40 piglets, which were divided into 2 groups (20 in each). The first group was on a normal diet and served as a control, the second group of animals was added daily to 40 40 ml of the drug to the usual diet (experimental group). The condition of animals was judged by a general blood test (red blood cells, white blood cells, hemoglobin, ESR, white blood cell count), as well as by weight gain of animals. In the initial stage, the animals showed an increased content of leukocytes, which could indicate the presence of inflammatory processes. 40 days after the start of taking the drug, repeated studies were carried out: the leukocyte count in the blood of the control group of animals did not change and amounted to 23, 2 ± 2.4 thousand in 1 μl, in the experimental group it was 17.3 ± 1.3 thousand These significant differences indicate the reorganization of the animal organism. The use of the drug in the form of a dietary supplement led to an increase in animal gain.

 Testing the drug on 10 weakened calves (diarrhea, anorexia, coughing animals are doomed to death) showed that the use of ABISIB at the rate of 0.7 1.0 ml / kg of animal weight daily led to the fact that after three days the clinical condition of the animals improved: animals began to rise, motor activity increased, pathological symptoms from the gastrointestinal tract disappeared, appetite increased. After 1 month, all animals returned to the herd. Further observations (3 months) revealed no pathologies.

 Thus, the proposed method allows to obtain an effective drug that increases the resistance of the body and has a wide range of therapeutic effects. The method is quite simple to implement and allows you to solve the problem of a comprehensive, waste-free technology for processing Siberian forests. TTT1

Claims (1)

A method of obtaining a tool that increases the resistance of the body, including the processing of raw materials with hot steam and the separation of the aqueous extract, characterized in that the plant raw materials use woody Siberian fir (Abics sibirica), steam treatment is carried out for 1.5-2 hours at a steam temperature 100-110 ^o C and a pressure of 0.2-0.3 atm, the resulting vapor-gas mixture is removed and the aqueous extract is separated from the oil.

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