RU2695324C1 - Method of producing agent possessing adaptogenic activity - Google Patents

Abstract

FIELD: chemistry; pharmaceutics.SUBSTANCE: invention refers to chemical-pharmaceutical industry, namely to a method for preparing an agent possessing adaptogenic activity. Method for preparing a medicament having adaptogenic activity is a dry extract obtained from the following herbal raw materials in ratio: Solomon's seal rootstock 20 g, Morrison's hornstock roots 20 g, anomalous peony roots 20 g, asparagus medicinal roots 20 g, Tribulus terrestris roots 20 g, crushed to particle size 1 mm in diameter and extracted with 50 % ethyl alcohol in ratio of raw material: extractant equal to 1:(14–16), at temperature of 60 °C and continuous stirring, the process is repeated three times and the combined extractions are evaporated to 1/3 of the initial volume and purified by separation, after which the purified extract is additionalized to 1/5 of the initial volume, dried in a vacuum drier at temperature of 60 °C for 8 hours and milled in a propeller type mill.EFFECT: method described above enables to obtain an agent with high output of active substances, including flavonoids, which has pronounced adaptogenic properties.1 cl, 10 tbl, 1 ex

Description

The invention relates to the field of pharmacy and relates to a method for producing funds from plant materials with adaptogenic activity.

In the last decade, due to increasing environmental and social pressure, there has been a significant decrease in overall resistance associated with depression of adaptive-compensatory mechanisms. Under these conditions, preventive measures aimed at increasing the nonspecific resistance of the body are of particular importance. One of the methods to achieve this condition is the use of pharmacological agents with adaptogenic activity and increasing resistance to a wide range of stress factors. The most promising direction is the development of new drugs based on raw materials of natural origin, a growing interest in which is noted throughout the world.

This is due to the fact that preparations obtained from raw materials of plant and animal origin, seafood and beekeeping, have several advantages compared to synthetic products: they contain a wide range of biologically active substances; have several types of pharmacological activity; characterized by a smooth increase in the pharmacological effect. In addition, drugs of natural origin are characterized by low toxicity and the absence of adverse reactions with prolonged use [3].

A promising direction in the search and development of new adaptogenic drugs of natural origin is the study of nonspecific drugs from the arsenal of Tibetan medicine, recommended for the weakened, as well as people of advanced age, as tonic, “giving longevity and health” [11,12].

Based on the prescription “five roots” [11], a dry extract was developed from rhizomes purchased from odoriferous (Polygonatum odoratum (Mill) Druce), the roots of the mountain goat Morison (Peucedanum morisonii Bess.), The roots of the evasive peony (Paeonia anomala L.), the roots of the medicinal asparagus (Asparagus officinalis L.), the fruits of the Tribulus terrestris L.), tentatively called "Pentafiton".

The components of this tool contain a wide range of biologically active substances belonging to different classes of chemical compounds: steroids (dioscin, daucosterol, diosgenin, stigmasterol), flavonoids (rutin, astragaline, quercetin, campferol, isoramnetin and their glycosides), phenol carboxylic acid (coffee , gallic, benzoic), alkaloids (harmol, harmalin), phenols (peonol, peonolide), etc. [7, 8, 9].

The pharmacological activity of these species is known, so extracts of evading peonies exhibit antioxidant and immunomodelling activity; Tribulus terrestris - androgenic and immunostimulating; gorinik Morison - antibacterial; medicinal asparagus - antioxidant and immunomodulating; bought fragrant - cardiotonic [7, 8, 9].

Thus, according to the data of folk and scientific medicine, preparations from peony, mustard, anchor, asparagus and purchased have a pronounced antioxidant and immunomodulating effect, which indicates the advisability of using this composition as an adaptogenic agent.

The aim of the invention is to increase the adaptogenic activity of the drug due to the higher content of active substances (steroids, flavonoids, alkaloids, hydroxycinnamic acids, phenols).

To achieve this goal, the plant material (raw materials) - rhizomes bought fragrant (200 g), the roots of the mountain goat Morison (200 g), the roots of the evading peony (200 g), the roots of the asparagus officinalis (200 g), the fruits of the Tribulus creeping (200 g) are extracted 50% ethyl alcohol in the ratio of raw materials: extractant equal to 1: (14-16) (taking into account the coefficient of water absorption), at a temperature of 60 ° C and constant stirring. The process is repeated three times. The extraction time at the 1st and 2nd phase contacts is 60 minutes, at the 3rd phase contact - 30 minutes. The combined extracts are evaporated to 1/3 of the original volume and purified by separation. The purified extract is doubled to 1/5 of the original volume, dried in a vacuum dryer at a temperature of 60 ° C for 8 hours and ground in a propeller-type mill. Get 270.0 g of the finished product, which is 27.0 ± 0.5% by weight of air-dry raw materials.

The proposed method allows to obtain the final product, a dry extract (under the code name "Pentafiton"), which is a fine brown powder with a pleasant smell and sweet taste, with a moisture content of not more than 5%.

The method is illustrated by the following examples.

Example 1

To achieve this goal, plant material (raw materials) - rhizomes bought fragrant (200 g), the roots of gorinik Morison (200 g), the roots of peony evading (200 g), the roots of asparagus officinalis (200 g), the fruits of the Tribulus creeping (200 g) are crushed in the mill to a particle size of 1 mm in diameter (sieve No. 10 GOST 214-83). The crushed raw materials are loaded into an extraction apparatus with a stirrer and external steam heating. Pour 14 liters of 50% ethyl alcohol in a ratio of raw materials-extractant equal to 1:14, taking into account the coefficient of water absorption of the raw materials. Extracted at a temperature of 60 ° C with constant stirring for 60 minutes The extract is filtered through a tin cloth in the collection. Two more extractions are carried out for 60 and 30 minutes, feeding 50% alcohol each time to the extractor in an amount equal to the volume of the drained extract (1st discharge - 10.85 L, 2nd discharge - 9.80 L, 3rd discharge - 9.60 L) . The combined extracts are evaporated to 1/3 of the original volume and purified by separation. The purified extract is doubled to 1/5 of the original volume, dried in a vacuum dryer at a temperature of 60 ° C for 8 hours and ground in a propeller-type mill. Get 270.3 g of the finished product, which is 27.06% by weight of air-dried raw materials. Pentafiton dry extract is a fine brown powder with a pleasant odor and a sweet taste; crumbles, the moisture content is 4.05%.

The acute toxicity of the Pentafiton dry extract was determined on white outbred male mice with an initial weight of 20.0 ± 1.0 g with intraperitoneal and intragastric administrations of the extract dissolved in water. Each dose of Pentafiton extract was tested in 10 animals. Observation of the animals was carried out for 14 days. Observed signs of intoxication were recorded, autopsy and examination of dead animals was performed. The research results showed that with intraperitoneal administration of large doses of dry Pentafiton extract to white mice, signs of intoxication are observed, which are expressed in a slowdown of the orientational reaction, sudden movements, the appearance of tonic and then tonic-clonic seizures. Animals died in cases of cardiovascular insufficiency mainly during the day from the introduction of the dry Pentafiton extract. Kerber LD50 with intraperitoneal administration of the Pentafiton dry extract 1960 1960 ± 60.76 mg / kg. With the intragastric administration of this drug at the maximum possible dose, the death of animals was not recorded, and there were no obvious signs of intoxication. These data allow us to classify the tested dry Pentafiton extract as a group of low toxic substances according to Sidorov’s classification [10].

Subsequently, the effect of the Pentafiton dry extract on the main phases of the inflammatory process was investigated.

The effect of dry Pentafiton extract on physical endurance and resistance to hypoxia.

Studies were conducted on 55 white Wistar rats of both sexes with an initial weight of 160-180 g contained in the standard diet of vivarium.

To determine the total physical endurance, the generally accepted swimming technique with a load of 5% of body weight was used [5]. An aqueous solution of "Pentafiton" was administered intragastrically in a volume of 1.0 ml / 100 g, containing 0.5; 1.0; A 3.0% Pentafiton solution once for 1 hour before testing, and also repeatedly for 7 days in a volume of 1.0 ml / 100 g, containing 3.0 ml of water infusion 1 time per day before meals. The animals of the control group were intragastrically injected with a similar volume of distilled water. A comparison solution used was a dealkolized solution of Eleutherococcus liquid extract in a volume of 1 ml / 100 g. The swimming time of the animals until complete fatigue was evaluated, the criterion of which was a 10-second immersion in water. The data obtained are shown in table 1.

As follows from the data. Listed in table 1, a single injection of Pentafiton in the volume of 0.5 and 1.0 ml / kg did not significantly affect the duration of swimming of animals, while when using it in the volume of 3.0 ml / kg, an increase in overall physical endurance by 20% was noted compared with the data animals of the control group. Based on this, in further experiments, the volume of Pentafiton corresponding to 3.0 ml / kg was used as an experimental therapeutic.

Seven-day preventive administration of “Pentafiton” in the volume of 3.0 ml / kg was accompanied by a more significant increase in overall physical endurance, as evidenced by an increase in the duration of swimming of animals of the experimental group by an average of 30% compared with the control group.

Thus, the data obtained indicate that Pentafiton has a stimulating effect on general physical endurance, characterized by the predominance of aerobic processes of tissue energy supply. It was found that the test agent possesses the most pronounced actoprotective activity when administered in a volume of 3.0 ml / kg containing 3.0 ml of aqueous infusion; effectiveness increases with repeated administration. Example 2

To achieve this goal, plant material (raw materials) - rhizomes bought fragrant (200 g), the roots of gorinik Morison (200 g), the roots of peony evading (200 g), the roots of asparagus officinalis (200 g), the fruits of the Tribulus creeping (200 g) are crushed in the mill to a particle size of 1 mm in diameter (sieve No. 10 GOST 214-83). The crushed raw materials are loaded into an extraction apparatus with a stirrer and external steam heating. Pour 15 l of 50% ethyl alcohol in a ratio of raw materials-extractant equal to 1:15, taking into account the coefficient of water absorption of raw materials. Extracted at a temperature of 60 ° C with constant stirring for 60 minutes The extract is filtered through a tin cloth in the collection. Two more extractions are carried out for 60 and 30 minutes, each time supplying 50% alcohol to the extractor in an amount equal to the volume of the drained extract (1st discharge - 11.05 L, 2nd discharge - 9.85 L, 3rd discharge - 9.65 L) . The combined extracts are evaporated to 1/3 of the original volume and purified by separation. The purified extract is doubled to 1/5 of the original volume, dried in a vacuum dryer at a temperature of 60 ° C for 8 hours and ground in a propeller-type mill. Get 270.8 g of the finished product, which is 27.10% by weight of air-dried raw materials. Pentafiton dry extract is a fine brown powder with a pleasant odor and a sweet taste; crumbles, the moisture content is -4.05%.

Studies were conducted on 55 white Wistar rats of both sexes with an initial weight of 160-180 g contained in the standard diet of vivarium.

To determine the speed of physical endurance, we used the generally accepted method of running animals on a 10-track treadmill, pr and a speed of 40 m / min [5]. Acute hypobaric hypoxia was reproduced in a pressure chamber at an atmospheric pressure of 198.8 mm Hg, a partial oxygen pressure of 50 mm Hg, which corresponds to the "rise" of animals to a height of 1000 m above sea level. To reproduce histotoxic hypoxia, the animals were intraperitoneally injected once with sodium nitroprusside at a dose of 20 mg / kg [4]. Resistance to hypoxia was evaluated by the life span of the animals.

Pentafiton aqueous solution was administered intragastrically in a volume of 1.0 ml / 100 g containing 3.0% Pentafiton solution once 1 hour before testing, and also repeatedly for 7 days in a volume of 1.0 ml / 100 g containing 3.0 ml of water infusion 1 once a day before meals. The animals of the control group were intragastrically injected with a similar volume of distilled water. As a comparison drug, a dealcalated solution of Eleutherococcus liquid extract in a volume of 1 ml / 100 g was used. The data obtained are shown in table 2.

As follows from the table, the prophylactic administration of “Pentafiton” is accompanied by an increase in running duration by 26% compared with the data of animals in the control group. It was found that the prophylactic administration of Pentafiton increased the life time of rats with histotoxic and hypobaric hypoxia by 20 and 38%, respectively, in relation to the control. At the same time, the actoprotective and antihypoxic activity of Pentafiton was similar to that of the comparison drug Eleutherococcus extract.

Example 3

To achieve this goal, plant material (raw materials) - rhizomes bought fragrant (200 g), the roots of gorinik Morison (200 g), the roots of peony evading (200 g), the roots of asparagus officinalis (200 g), the fruits of the Tribulus creeping (200 g) are crushed in the mill to a particle size of 1 mm in diameter (sieve No. 10 GOST 214-83). The crushed raw materials are loaded into an extraction apparatus with a stirrer and external steam heating. Pour 16 liters of 50% ethyl alcohol in a ratio of raw materials-extractant equal to 1:16, taking into account the coefficient of water absorption of the raw materials. Extracted at a temperature of 60 ° C with constant stirring for 60 minutes The extract is filtered through a tin cloth in the collection. Two more extractions are carried out for 60 and 30 minutes, each time feeding 50% alcohol to the extractor in an amount equal to the volume of the drained extract (1st discharge - 11.55 L, 2nd discharge - 10.05 L, 3rd discharge - 9.86 L) . The combined extracts are evaporated to 1/3 of the original volume and purified by separation. The purified extract is doubled to 1/5 of the original volume, dried in a vacuum dryer at a temperature of 60 ° C for 8 hours and ground in a propeller-type mill. Get 270.9 g of the finished product, which is 27.05% by weight of air-dried raw materials. Pentafiton dry extract is a fine brown powder with a pleasant odor and a sweet taste; crumbles, the moisture content is -4.05%.

Studies were conducted on 55 white Wistar rats of both sexes with an initial weight of 160-180 g contained in the standard diet of vivarium. Immobilization stress was reproduced by the conventional method by fixing animals on the back for 20 hours. To reproduce emotional stress, animals were immobilized in plastic cases and immersed in water (23 C) along the xiphoid process of the sternum for 2 hours [6]. Statistical processing of the results was carried out using the Mann-Whitney U-test.

As can be seen from table 3, as a result of immobilization and emotional stress, animals develop a complex of degenerative changes in the internal organs characteristic of the stess reaction: involution of the lymphoid organs, adrenal hypertrophy, the appearance of destructive lesions of the gastric mucosa. More pronounced changes in the internal organs were noted during immobilization stress, which is obviously associated with a longer stress exposure. The prophylactic administration of the herbal remedy Pentafiton in the volume of 3.0 ml / 100 g had a pronounced antistress effect, as evidenced by a decrease in the relative mass of the adrenal glands of rats of the experimental group with immobilization and emotional stress by an average of 27.9%; an increase in the relative mass of the thymus — by 30% and the spleen — by 18% compared with the corresponding indices of the animals of the control group. The antistessor activity of the test drug was comparable to that of the comparison drug - Eleutherococcus extract.

Thus, a study of the adaptogenic activity of the Pentafiton herbal remedy showed that its preventive administration in the volume of 3.0 ml / 100 g is accompanied by an increase in the animal organism's resistance to the action of extreme factors of various nature: intense physical exertion (general and speed); hypobaric and tissue hypoxia; immobilization and emotional stress. It can be assumed that the basis of the adaptive reorganization of the body, which develops under the influence of the test agent, is a series of functional and metabolic changes occurring at various levels of biological organization and provided by a wide range of biologically active substances that make up its composition, such as triterpene and steroid saponins, flavonoids , polysaccharides, organic acids. It can be assumed that these biologically active substances stimulate ergotropic and trophotropic processes in cells and thereby form a state of nonspecifically increased body resistance to the action of extreme factors of various nature. In particular, during intense physical exertion, the realization of the actoprotective effect of the test drug is associated with the optimization of energy metabolism in cells, which ensures activation of ATP resynthesis and a decrease in metabolic anide, which is known to be the main limiting factor of physical performance. It has been shown that the activation of ATP resynthesis under the influence of Pentafiton is provided by both an increase in the oxygen transport function of the blood and optimization of the limiting energy metabolism in cells, which is confirmed by the data obtained on the pronounced antihypoxic activity of Pentafiton in oxygen-deficient states of various origins.

Thus, the data obtained indicate that the herbal "Pentafiton" has a wide range of adaptogenic activity, which argues the prospect of its further research and implementation in clinical practice as a means designed to increase the nonspecific resistance of the body, prevent fatigue during physical and mental stress, as well as to improve performance.

Based on the qualitative phytochemical analysis [1, 2, 13], the presence of the following biologically active substances was established in the obtained dry extract.

1. Steroids

The sample was chromatographed on paper in the isooctane - acetic acid - chloroform (100: 1: 4) system, the development was carried out using Sagnier reagent - 1% alcohol solution of vanillin - followed by processing of the chromatogram with a mixture of acetic anhydride and sulfuric acid (9: 12: 1 ) The spots were stained yellow, the Rf value of diosgenin was 0.63.

2. Organic acids. By TLC on Silufol UV254 plates, in a 96% ethanol system — concentrated ammonia-water solution (60: 10: 3) —the chromatogram should contain at least four brown spots corresponding to tartaric, citric, malic, and oxalic acids.

3. Phenolcarboxylic acids. Two-dimensional upward chromatography on paper brand FN-12 in solvent systems:

- n-Butanol - acetic acid - water (4: 1: 2);

- 15% acetic acid.

When viewing the chromatogram in UV light, after treatment with ammonia vapors, identified with standard samples:

- caffeic acid - R _f = 0.80 (A), 0.42 (B);

- ferulic - R _f = 0.67 (A), 0.70 (B).

4. Flavonoids. When using Sorbfil PTSX-AF-A-UV plates (chloroform – methanol – water solvent system, 26: 14: 3), spots of rutin (Rf about 0.6), isoramnetin (Rf about 0.7), kempferol (Rf about 0.8), as well as astragaline.

quantitation

The study was performed by HPLC on an Agilent 1290 chromatograph with a spectrophotometric detector and mass spectrometric (6460) 151 detectors. Chromatography conditions: column: ZorbaxXDB-C18 (Agilent, USA) 150 × 4.6 mm in size, sorbent particle diameter 5 μm; pre-column: Security Guard C18 (4.3 mm; Phenomenex, USA); column temperature: 25 ° C; sample volume injected: 20 μl; the speed of the mobile phase: 1 ml / min; mobile phase in gradient mode: A - deionized water, acidified with trifluoroacetic acid to (pH 3.0); B is acetonitrile. UV detection conditions: wavelength 205 nm with a spectral bandwidth of 4 nm. Conditions for mass spectrometric detection: the mode of the selected ions is m / z 869.5 (M-H) +; nebulizer pressure - 70 psi; dehumidifier gas speed - 12 l / min; its temperature is 350 ° C. Dioscin, the retention time of which is 21.0 minutes, was used as a standard. To develop a quantitative determination technique, a linear relationship graph was constructed.

The study showed that the Pentofiton extract, with a confidence level of 95%, contains 12.7% steroid saponins in terms of dioscin. The error of a single determination does not exceed 5%; the experimental results can be considered satisfactory.

Thus, the developed technique allows us to quantify the content of steroidal saponins in terms of dioscin in the Pentafiton dry extract and to standardize the extract according to this indicator.

A quantitative assessment was carried out according to the yield of extractives [1, 2] and the amount of steroid saponins. Metrological characteristics are presented in table. five.

The proposed production method is quite simple, does not require a complex purification scheme, allows you to get a product of constant composition. The technology can be implemented in enterprises producing drugs.

To identify the optimal technological conditions, we studied the main factors affecting the extraction process of plant materials: the nature of the extractant, its ratio with the raw materials, temperature conditions, the degree of grinding of the raw materials, duration and number of extractions.

Water and ethyl alcohol of various concentrations (20, 30, 40, 50, 60, 70, 80, 90, 96%) were used as extractants.

As can be seen from the table. 6, the optimal extractant is 50% ethyl alcohol, as it allows to achieve maximum yield of the amount of triterpenoids, taking into account the yield of extractive substances.

The optimum degree of grinding was determined for the dry extract as a whole. A quantitative assessment was carried out according to the yield of extractives and the amount of steroid saponins in terms of dioscin. Based on the data obtained (Table 7) and taking into account the fact that too fine grinding of the plant material leads to contamination of the extraction with difficult-to-filter high-molecular compounds, the grinding of raw materials should be carried out together to a particle size of 1 mm.

Due to the fact that the source of plant materials contains thermolabile substances, the influence of temperature on the extraction process was studied in the temperature range from 20 to 60 ° C. The data are presented in table. 8, the optimum extraction temperature is 60 ± 5 ° C.

When studying the influence of the ratio of raw materials: extractant on the extraction process, it was found (Table 9) that with an increase in the amount of extractant, the yield of extractives and the amount of steroid saponins in terms of dioscin increases, but this increase for ratios of 1:16 and higher is insignificant, therefore, to prevent an additional consumption of extractant selected ratio equal to 1: (14-16) (taking into account the coefficient of water absorption).

To determine the duration and the required number of extractions, the time was established for reaching equilibrium concentrations of extractive substances and triterpenoids in the raw material: extractant system during three-time extraction. For this purpose, the crushed raw materials were extracted with 50% ethyl alcohol in a ratio of 1:14 in a water bath at a temperature of 60 ° C with constant stirring in a flask with a reflux condenser. Extracts obtained at certain time intervals (15, 30, 45, 60, 75, 90 min) during three extractions were analyzed for the content of extractives and triterpenoids. It was established that the equilibrium concentrations are established at the 1st and 2nd phase contacts after 60 minutes, at the 3rd phase contact after 30 minutes (Table 10). Threefold extraction provides a fairly complete depletion of raw materials - up to 96% of active substances are extracted.

The proposed method allows to obtain a drug of constant composition with a higher adaptogenicity due to the higher content of active substances (triterpenoids, flavonoids, alkaloids, hydroxycinnamic acids, tannins, anthocyanins, polysaccharides).

It is currently not possible to calculate the economic efficiency of the proposed method, however, the above advantages, combined with a simple production scheme, contribute to the rational use of medicinal plant materials and open up the prospect of introducing this method into the pharmaceutical industry.

Information sources

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Claims (1)

A method of obtaining a medicinal product with adaptogenic activity, which is a dry extract obtained from the following plant materials in the ratio: rhizomes bought fragrant 20 g, Morison roots of gorinika Morisona 20 g, peony roots dodging 20 g, asparagus roots 20 g medicinal, Tribulus creeping 20 g, which are crushed to a particle size of 1 mm in diameter and extracted with 50% ethyl alcohol in the ratio of raw materials: extractant equal to 1: (14-16), at a temperature of 60 ° C and constant stirring, the process is repeated three times and the combined extracts are evaporated to 1/3 of the original volume and purified by separation, after which the purified extract is added to 1/5 of the original volume, dried in a vacuum dryer at a temperature of 60 ° C for 8 hours and ground in a propeller-type mill.