KR20140089502A - Composition for improvement of exercise performance, fatigue recovery and antioxidation activity comprising mixture of Panax species plant leaf extract and processed Panax species plant leaf extract - Google Patents

Abstract

The present invention relates to a composition to improve exercise ability and/or fatigue recovery comprising, as an effective ingredient, a mixture of panax species plant leaf extract and processed panax species plant leaf extract. According to the present invention, when a user takes the composition, the effects of increasing the exercise execution time, suppressing the accumulation of blood fatigue substances, and the effects of antioxidation are gained; and the ability for aerobic exercise in accordance to a maximum oxygen uptake, which is the effect of improving cardiorespiratory exercise endurance are obtained, thereby being useful in increasing stamina and exercise ability.

Description

FIELD OF THE INVENTION The present invention relates to a composition for improving exercise capacity, fatigue recovery and antioxidative activity, comprising a mixture of a leaf extract of Panax ginseng plant and a leaf extract of Panax ginseng plant. extract and processed Panax species plant leaf extract}

This research was carried out by the research funding support (# PF0321204-00) of the Natural Plant Usage Technology Development Project, a 21st Century frontier research and development project.

The present invention relates to a composition for promoting exercise capacity, fatigue recovery, and antioxidant composition containing a mixture of a leaf extract of Panax spp. And a leaf extract of Panax spp. As an active ingredient.

In general, if the muscles are not exercised continuously, the muscular function decreases due to aging, the neuromuscular junction (motor unit) decreases, and fatigue easily occurs. (Dohergy TJ, J Appl. Physiol., 95: 1717-1727, 2003; Eric E, et al., Physiol. Behav., 92 (1-2): 129-135, 2007).

In order to prevent this, it is recommended that proper diet is combined with proper exercise such as resistance training. However, most modern people who are chased by busy daily life want to get help from dietary supplements claiming ginseng and red ginseng effects. To improve the quality of life, regular exercise has become part of life for modern people, and not only athletes but also ordinary people want more energy and endurance in everyday life. Ginseng root extract of various formulations for feeding is one of the candidates that has been studied a lot to demonstrate the efficacy of ginseng in promoting exercise capacity.

Ginseng has long been known as a natural ergogenic aid and has been shown to have a wide variety of effects ranging from a tonic effect, an antioxidant effect, and a hangover effect (Kim SH, et al., J Sports Med. Phys Fitness, 45 (2): 178-82, 2005). Panax ginseng, in particular, has been reported to improve mitochondrial energy metabolism, and ginsenosides Rg1 and Rb1 have been implicated in the promotion of aerobic exercise performance (Wang LC, et al., Planta Med. , 64 (2): 130-133, 1998). In addition, antioxidative effects of ginsenosides, Rg3 and Re, which are known to be effective ingredients of ginseng, have been reported to reduce oxidative stress (Tian J, et al., Neurosci. Lett., 374 (2) : 92-97, 2005; Cho WC, et al., 2006, Eur. J. Pharmacol., 550 (1-3): 173-179, 2006). It has also been reported that during extreme exercise, the release of plasma creatine kinase (CK) is reduced to reduce damage to skeletal muscle cell membranes, thereby preventing muscle damage (Hsu CC, et al., World J. Gastroenterol., 11 (34): 5327-5331, 2005). Ginseng is presumed to have pharmacological effects related to anti-aging, immunity, anticancer, anti-stress, antioxidant and long-term protective effects (Gillis CN, Biochem Pharmacol., 54 (1): 1-8, 1997; Attele AS, et al., Biochem Pharmacol., 58 (11): 1685-93, 1999; Shin HR, et al., Cancer Causes Control., 11 (6): 565-76, 2000).

Ginseng roots have been used as ergogenic aids for endurance exercise and have been consumed by many athletes around the world to promote stamina improvement and rapid recovery from injury. Ginseng roots increase the duration of exercise until exhaustion, reduce malondialdehyde (MDA), and increase CAT (catalase) and SOD (superoxide dismutase). It has been shown that CAT and SOD activities, which are scavenger enzymes, are increased and MDA levels are lowered after administration of ginseng roots (2 g, 3 times a day, to sedentary human) (J. Sports Med Phys Fitness 2005, 45 (2): 178-82).

Panax noto has also been reported to increase exercise duration until exhaustion (J Strength Cond Res., 2005 19 (1): 108-14). Ginseng roots have been reported to improve lung function and improve motor performance in patients with chronic obstructive pulmonary disease (COPD) (Monaldi Arch Chest Dis. 2002, 57 (5-6): 242-6). Red ginseng roots increase the amount of time it takes to run out of treadmill exercise and prevent exercise-induced synthesis of serotonin and increased expression of tryptophan hydroxylase. This suggests that red ginseng root is able to function as an ergogenic mechanism by inhibiting serotonin levels during exercise (J. Pharmacol Sci. 2003, 93 (2): 218-21).

Panax ginseng leaves are known to have antioxidant and hypoglycemic activity and can prevent the rapid increase in blood glucose levels and result in a decrease in TBARS levels in diabetic rats (J Ethnopharmacol. 2005 98 (3): 245 -50). American ginseng leaves have been reported to have anti-hyperglycemic and thermogenic activities (Pharmacol Res., 2004, 49 (2): 113-7).

However, there is little clinical evidence to prove that body endurance is improved by ingesting ginseng products (J Am Coll Nutr 1998, 17 (5); 462-6, Int J Sport Nutr 1996 6 (3): (Eg, Forgo I, and J Strength Cond Res., 2001, 15 (3): 290-5) MMW Munch Med Wochenschr., 125 (38): 822-4, 1983) and sports teachers (Pieralisi G, et al., Clin Ther., 13 (3): 373-82 , 1991). However, ginseng roots have been reported to have no effect on the maximum oxygen uptake (VO ₂ max) and lactate threshold (LDH) of soccer players (Int J Sport Nutr 1999 9 (4): 371-7) (J Med Assoc Thai 2007 90 (6): 1172-9), which suggests that ginseng roots are not associated with a well-fit person's aerobic fitness It does not show an ergogenic effect in the enhancement.

It is also reported that ginseng roots do not promote anabolic hormonal status according to resistance exercise (J Strength Cond Res., 2002 16 (2): 179-83), Iluterococcus , Eleutherococcus) have not been reported to support ergogenic effects on metabolic, behavioral, or psychological parameters associated with submaximal and maximal aerobic exercise tasks (Med Sci Sports Exerc. 1996, 28 (4): 482-9 ). In addition, in order to obtain an athletic performance effect from ginseng, it has been reported that when a standardized ginseng extract is ingested more than 2 g per day for a long period of time, it is possible that the ginseng root extract may increase aerobic exercise performance (Am J Clin Nutr., 2000, 72: 624S-36S).

Thus, there is no specific research result that demonstrates the efficacy of ginseng in relation to improving athletic performance of athletes as well as the general public.

Ginsenosides are a special group of triterpenoid saponins which can be classified into two groups, dammarane type and oleanane type depending on the structure of aglycon. Ginsenosides are found specifically in the genus Panax, and over 150 naturally occurring migratory species are isolated from roots, leaves / stems, fruits or flower heads. Ginsenoside has been the subject of numerous studies because it is considered to be the main active substance showing the efficacy of ginseng. Ginsenoside is an important physiologically active ingredient of ginseng, and glycoside sugar chains are closely related to physiological activity. Fresh saponins (ginsenosides) are extracted from the roots and leaves of ginseng. A number of studies have been conducted focusing on the conversion of major ginsenosides to the more active minor ginsenosides Rg3. Due to difficulties in preparing ginsenosides Rg3 and Rg2 compounds have been prepared by heating, enzymatic and strong acid treatment (Phytochemistry 2004, 65 (3): 337-44, Phytochemistry 2008, 69 (1): 218-24, Chem Pharm Bull 2003 51 (4): 404-8).

On the other hand, supplements containing compounds such as steroids, caffeine, sodium hydrogencarbonate and sodium citrate may significantly increase exercise performance if taken over a certain amount, but such drugs may lead to a risk of ultimately causing health problems with fatal side effects .

Therefore, recently, studies for developing a functional adjuvant using natural substances with safety, such as plant extracts, have been actively conducted. For example, Korean Patent Registration No. 526164 discloses a composition for enhancing exercise performance comprising squalene and plant extract .

Korea Patent No. 526164

Dohergy TJ, J Appl. Physiol., ≪ / RTI > 95: 1717-1727, 2003 Eric E, et al., Physiol. Behav., 92 (1-2): 129-135, 2007 Kim SH, et al., J Sports Med. Phys. Fitness., 45 (2): 178-82, 2005 Wang LC, et al., Planta Med., 64 (2): 130-133, 1998). Tian J, et al., Neurosci. Lett., 374 (2): 92-97, 2005 Cho WC, et al., 2006, Eur. J. Pharmacol., 550 (1-3): 173-179, 2006) Hsu CC, et al., World J. Gastroenterol., 11 (34): 5327-5331, 2005 Gillis CN, Biochem Pharmacol., 54 (1): 1-8, 1997 Attele AS, et al., Biochem Pharmacol., 58 (11): 1685-93, 1999 Shin HR, et al., Cancer Causes Control., 11 (6): 565-76, 2000 J. Sports Med Phys Fitness. 2005, 45 (2): 178-82 J Strength Cond Res., 2005 19 (1): 108-14 Monaldi Arch Chest Dis. 2002, 57 (5-6): 242-6 J. Pharmacol Sci. 2003, 93 (2): 218-21 J Ethnopharmacol. 2005 98 (3): 245-50 Pharmacol Res., 2004, 49 (2): 113-7 J Am Coll Nutr. 1998, 17 (5); 462-6, Int J Sport Nutr. 1996 6 (3): 263-71 J Am Diet Assoc 1997, 97: 1110-5 J Strength Cond Res., 2001, 15 (3): 290-5) Forgo I, MMW Munch Med. Wochenschr., 125 (38): 822-4, 1983 Pieralisi G, et al., Clin Ther., 13 (3): 373-82, 1991 Int J Sport Nutr. 1999 9 (4): 371-7 J Med Assoc Thai 2007 90 (6): 1172-9 J Strength Cond Res., 2002 16 (2): 179-83 Med Sci Sports Exerc. 1996, 28 (4): 482-9 Am J Clin Nutr., 2000, 72: 624S-36S Phytochemistry 2004, 65 (3): 337-44 Phytochemistry 2008, 69 (1): 218-24 Chem Pharm Bull 2003 51 (4): 404-8

DISCLOSURE OF THE INVENTION The present invention has been made in view of the above needs, and the present inventors have intensively studied the adjuvant without adverse effect, which effectively enhances exercise performance and fatigue recovery, has antioxidative effect, The present inventors have completed the present invention by confirming that the exercise performance is increased and the accumulation of blood fatigue elements is suppressed when the composition containing the mixture of the leaf extract composition of the plant is inhibited.

In order to solve the above problems, the present invention provides a composition for promoting exercise capacity, fatigue recovery and an antioxidant composition, which comprises a mixture of leaf extract of Panax spp. And leaf extract of Panax spp. As an active ingredient.

Preferably, the total ginsenoside content in the mixture of the leaf extract of Panax ginseng plant and the leaf extract is at least 30 wt%, preferably at least 40 wt%, and contains at least 90% of saponins.

Preferably, the present invention relates to a composition comprising a leaf extract of Panax spp. And a mixture of the leaf extract thereof, comprising a 3-O-glycoside derivative of protopanaxatriol and a 3-O-glycoside derivative of protopanaxadiol Lt; / RTI >

According to one embodiment of the present invention, the leaf extract of Panax ginseng plant and the mixture of the leaf extract product thereof contains at least one ingredient selected from the group consisting of ginsenosides Rg3, Rg5 and Rk1, Or an antioxidant composition is provided.

In the mixture of the leaf extract of the Panax ginseng plant and the product of the leaf extract thereof according to the present invention, the total content of the Rg3, Rg5 and Rk1 components in the extract is preferably 5 wt% or more, more preferably 10 wt% or more.

In the composition according to the present invention, the leaf extract powder of the Panax ginseng plant and the leaf extract powder thereof may be mixed at a ratio of 1: 0.1 to 10, preferably 1: 0.1 to 5, more preferably 1: 0.1 to 3, and even more preferably 1: 0.5 to 2.

In the present invention, the plant belonging to the genus Panax is called Panax ginseng), Panax party pony Qom (Panax japonicum), Panax kwinkeu poly Stadium (Panax quinquefolium), Noto Panax Ginseng (Panax notoginseng), three yeopsam (Panax trifolium) and Panax pseudo-ginseng (Panax pseudoginseng), Vietnam, three (Panax vietnamensis ), Panax elegatior , Panax wangianus , and Panax bipinratifidus .

The mixture of the leaf extract of the Panax ginseng plant and the leaf extract includes squalene, Saururus chinensis extract, Ogassi water extract, Cordyceps juice extract, Collagen powder or extract, Vitamins, Minerals, Taurine, Phosphatidylcholine, Glutamine, L - arginine, and L-carnitine.

The composition according to the present invention has an effect of enhancing exercise performance time during ingestion, inhibiting the accumulation of blood fatigue substances and antioxidative effect, and improving aerobic exercise ability according to the maximum oxygen uptake, that is, cardiopulmonary exercise endurance It is useful for improving physical fitness and athletic ability, and is safe even if ingested by a person.

FIG. 1 shows the results of measurement of the maximum range of the rat after two weeks of exercise in a mixture of ginseng leaf extract and ginseng leaf extract.
FIG. 2 shows the results of measurement of the maximum travel distance of a rat after 8 weeks of exercise in a mixture of ginseng leaf extract and ginseng leaf extract.
FIG. 3 shows the results of measurement of the maximum travel distance of a rat after 6 weeks in a non-rain group of a mixture of a ginseng leaf extract and a ginseng leaf extract product.
FIG. 4 shows the results of measurement of the maximum distance traveled by the rat after 9 weeks of the non-raising group of the mixture of the ginseng leaf extract and the ginseng leaf extract product.
FIG. 5 shows blood creatine kinase (CK) measurement results of rats after two weeks of exercise in a mixture of ginseng leaf extract and ginseng leaf extract.
FIG. 6 shows blood LDH measurement results of a non-osmotic rat mixture of a ginseng leaf extract and a ginseng leaf extract product.
FIG. 7 shows the results of blood LDH measurement in rats after 8 weeks of exercise in a mixture of ginseng leaf extract and ginseng leaf extract.
FIG. 8 shows the results of LDH measurement in the muscle of the exercise group of the mixture of the ginseng leaf extract and the ginseng leaf extract composition.
FIG. 9 shows the results of blood lactate measurement of non-rabbit rats of a mixture of ginseng leaf extract and ginseng leaf extract.
FIG. 10 shows blood lactic acid measurement results of exercise group rats of a mixture of ginseng leaf extract and ginseng leaf extract.
FIG. 11 shows the blood corticosterone measurement results of non-rabbit rats of a mixture of ginseng leaf extract and ginseng leaf extract.
FIG. 12 shows blood corticosterone measurement results of exercise group rats of a mixture of ginseng leaf extract and ginseng leaf extract.
FIG. 13 shows the results of measurement of CS activity in muscle of non-rabbit rats of a mixture of ginseng leaf extract and ginseng leaf extract.
FIG. 14 shows the results of measurement of CS activity in muscles of exercise group rats of a mixture of ginseng leaf extract and ginseng leaf extract product.
Fig. 15 shows the NO measurement results of non-rabbit rats in a mixture of ginseng leaf extract and ginseng leaf extract product.
FIG. 16 shows the results of NO measurement in muscle of non-rabbit rats of a mixture of ginseng leaf extract and ginseng leaf extract product.
FIG. 17 shows the results of measurement of NO content in the blood collected before exercise 2 in the exercise group rats administered with the mixture of the ginseng leaf extract and the ginseng leaf extract composition.
FIG. 18 shows the results of measurement of NO content in blood collected from exercise group 2 rats in exercise group rats administered with a mixture of ginseng leaf extract and ginseng leaf extract composition.
FIG. 19 shows the results of NO measurement in muscle of exercise group rats of a mixture of ginseng leaf extract and ginseng leaf extract.
FIG. 20 shows the results of SOD inhibition (%) measurement in muscle of exercise group rats of a mixture of ginseng leaf extract and ginseng leaf extract.
FIG. 21 shows the results of GPx measurement in muscle of exercise group rats of a mixture of ginseng leaf extract and ginseng leaf extract.
FIG. 22 shows ATPase test results in a soleus muscle of a mixture of ginseng leaf extract and ginseng leaf extract.
FIG. 23 shows ATPase test results on a red gastrocnemius muscle of a mixture of ginseng leaf extract and ginseng leaf extract product.
24 shows the results of measurement of the change in VO ₂ max in the group administered with the mixture of the ginseng leaf extract and the ginseng leaf extract composition.
25 shows the results of measuring changes in AT values in a group administered with a mixture of ginseng leaf extract and ginseng leaf extract.

In order to achieve the object of the present invention, the present invention provides a composition for promoting exercise capacity, fatigue recovery and an antioxidant composition comprising a mixture of a leaf extract of Panax ginseng plant and a leaf extract composition thereof as an active ingredient.

In the composition according to one embodiment of the present invention, the total ginsenoside content of the leaf extract of the Panax ginseng plant is 30 wt% or more, preferably 40 wt% or more, and 90 wt% or more of saponins. When the total content ratio of ginsenoside is more than the above range, excellent effects can be obtained in terms of exercise capacity, fatigue recovery, and antioxidant efficacy.

According to a preferred embodiment of the present invention, a mixture of the leaf extract of Panax spp. And the extract of the leaf extract comprises 3-O-glycoside derivative of protopaxanthriol and 3-O-glycoside derivative of protopanaxadiol O-glycoside derivative of protopanaxatriol versus a 3-O-glycoside derivative of protopanaxadiol in a mixture of leaf extract of Panax spp. The content ratio is 1: 0.1 to 1.5, more preferably 1: 0.5 to 1.5, still more preferably 1: 0.7 to 1.5. Examples of 3-O-glycoside derivatives of protopanaxatriol include Re, Rg1, and Rg2. Examples of 3-O-glycoside derivatives of protopanaxadiol include Rb1, Rb2, Rb3, Rc, and Rd , Rg3 (R, S), Rg5, Rk1, and the like. When the content ratio of the triol to the diol is within the above range, excellent effects can be obtained in terms of exercise capacity, acceleration of fatigue recovery, and antioxidant efficacy.

In the composition according to an embodiment of the present invention, the leaf extract of Panax spp. And the mixture of the leaf extract thereof contains at least one ingredient selected from the group consisting of ginsenosides Rg3, Rg5 and Rk1.

In a composition according to an embodiment of the present invention, the leaf extract of Panax spp. And the mixture of the leaf extracts thereof contains protopanaxadiols such as Rg3, Rg5 and Rk1 in an amount of not less than 5% . In addition, a mixture of both the leaf extract of Panax sp. And the leaf extract thereof contains protopanaxadiols such as Rg3, Rg5 and Rk1 in an amount of 10% or more of the total extract weight. When the total content ratio of Rg3, Rg5, and Rk1 is within the above range, excellent effects can be obtained in terms of exercise capacity, acceleration of fatigue recovery, and antioxidant efficacy.

Table 1 below shows the results of comparing the ginsenoside content of the mixture of the leaf extract of Panax ginseng plant and the product of the leaf extract thereof (UG0712) with commercially available ginseng products. The leaf extract of Panax ginseng according to the present invention is commercially available The content of ginsenoside is remarkably higher than that of other ginseng products.

Protopanaxadiols, such as Rg3, Rg5 and Rk1, contained in the mixture of both the leaf extract of Panax ginseng plant and the leaf extract thereof according to the present invention have the structural and physicochemical properties as shown in Table 2 below .

The Panax genus plant is Panax ginseng (Panax ginseng), Panax party pony Qom (Panax japonicum), Panax kwinkeu poly Stadium (Panax quinquefolium), Noto Panax Ginseng (Panax notoginseng), three yeopsam (Panax trifolium) and Panax pseudo-ginseng (Panax pseudoginseng), Vietnam, three (Panax vietnamensis ), Panax elegatior , Panax wangianus ) and Panax bifunlatipidus ( Panax bipinratifidus ), and the like.

In the composition according to an embodiment of the present invention, the leaf extract of the Panax ginseng plant and the mixture of the processed products may be in powder form, but are not limited thereto. The powder form of the extract can be prepared by a method such as lyophilization, hot air drying or electromagnetic wave drying of a leaf extract of a plant of the genus Panax.

In the composition according to an embodiment of the present invention, the leaf extract powder of the Panax plant and the leaf extract powder composition of the Panax plant can be mixed at a ratio of 1: 0.1 to 10, preferably 1: 0.1 to 5 , More preferably from 1: 0.1 to 3, and still more preferably from 1: 0.5 to 2.

In a composition according to an embodiment of the present invention, a mixture of leaf extract powder of Panax spp. And leaf extract powder of Panax spp.

(a) adding an extraction solvent to the leaf of a plant of the genus Panax, refluxing the extract, and lyophilizing to obtain a leaf extract powder of a plant of the genus Panax;

(b) adding water and glacial acetic acid to the obtained extract powder, performing a processing reaction at 60 to 100 ° C with stirring, and then drying to obtain a workpiece of a leaf extract powder of Panax ginseng; And

(c) mixing the leaf extract powder of the Panax ginseng plant obtained in the step (a) and the leaf extract powder of the Panax ginseng plant obtained in the step (b)

≪ / RTI >

The extraction solvent may be water, C _{1 -4} alcohol, or a mixture thereof, and the alcohol is preferably ethanol, more preferably 70% ethanol.

The composition of the present invention may further contain one or more active ingredients exhibiting the same or similar functions in the mixture of the leaf extract of the Panax spp. And the leaf extract of Panax spp.

The composition according to one embodiment of the present invention may further comprise at least one selected from the group consisting of squalene, Saururus ricinus extract, Ogassi water extract, Cordyceps juice extract, Collagen powder or extract, Vitamins, Minerals, Taurine, Creatine, Phosphatidylcholine, Glutamine, ≪ RTI ID = 0.0 > and / or < / RTI >

The water extracts of Saururus chinensis, Ogapi and Cordyceps can be prepared and used according to known methods, or the commercially available water extracts can be purchased and used.

Squalene is a polyunsaturated hydrocarbons with six double bonds and is generally prepared by extraction and purification in deep sea shark liver oil. Physiological activities of squalene include oxygen supply action and sterilization action. In particular, it is known that squalene binds hydrogen in water molecules of human body and releases oxygen to release oxygen, which activates cells by supplying oxygen to the cells in the body.

Saururus chinensis is a long-lived grass and its pharmacology is very diverse. That is, it is known that there is a remarkable effect in the prevention and treatment of adult diseases such as constipation, diabetes, liver disease, cancer, hypertension, heart disease, gynecological disease and kidney disease.

Ogapi is a dried plant of Araliaceae and a deciduous shrub of Asteraceae and has been known to prescribe bark, arthritis, back pain, degenerative arthritis syndrome, species, bruises, bruises and swelling.

Cordyceps is a small mushroom belonging to the acanthaceous fungus, most of which is parasitic on insects and produces fruiting bodies on insect bodies that become host. It is known that the Chinese caterpillar fungus has physiological activity to purify the bronchi, remove impurities adhering to the blood vessel, and enhance the contraction force of the heart. It is also known to be effective in cell activation and recovery, immunity enhancement, normalization of blood glucose levels, anemia and obesity.

Amino acids such as taurine, creatine, glutamine, L-arginine and L-carnitine help muscle fatigue after exercise and are also used as direct energy sources.

Phosphatidylcholine is a compound of fat, phosphorus, and nitrogen, and exists in large amounts in egg yolk, soybean oil, liver, and brain. It is one of the important components of cell membrane composition and is known effectively for fatigue recovery.

Collaunut refers to the caffeine-bearing fruit of Cola acuminata and C. nitida belonging to Sterculiaceae. It is the origin of the African tropics and is used as a raw material for beverages and medicines without alcohol, and is used as a medicinal herb to treat drug addiction, hangover and diarrhea. The collagen contained in the composition of the present invention may be in the form of an extract or in powder form.

Examples of the vitamins used in the present invention include vitamin B ₁ , vitamin B ₂ , vitamin B ₆ , nicotinic acid amide and vitamin C, and minerals include MgCl ₂ , KCl, NaCl, Ca-lactate and ammonium citrate These can be used in combination.

The composition of the present invention can be used as a composition for promoting exercise capacity and fatigue recovery and a composition for inhibiting oxidation reaction.

For administration of the composition, in addition to the active ingredient described above, one or more pharmaceutically acceptable carriers may be prepared. The pharmaceutically acceptable carrier may be a mixture of saline, sterilized water, Ringer's solution, buffered saline, dextrose solution, maltodextrin solution, glycerol, ethanol and one or more of these components. If necessary, an antioxidant, , And other conventional additives such as a bacteriostatic agent may be added. In addition, diluents, dispersants, surfactants, binders, and lubricants may be additionally added to formulate into injectable solutions, pills, capsules, granules or tablets such as aqueous solutions, suspensions, emulsions and the like. Further, it can be suitably formulated according to each disease or ingredient, using appropriate methods in the art or by the method disclosed in Remington's Pharmaceutical Science (recent edition), Mack Publishing Company, Easton PA.

The composition of the present invention may be administered orally or parenterally (for example, intravenously, subcutaneously, intraperitoneally or topically) orally, and the dose may be appropriately determined depending on the body weight, age, sex, The range varies depending on diet, administration time, method of administration, excretion rate, and severity of the disease.

In the composition according to an embodiment of the present invention, the leaf extract of the plant of the Panax sp. And the mixture of the leaf extract thereof has the effect of enhancing the exercise capacity, inhibiting accumulation of fatigue substances and antioxidant effect, It is useful for improving physical fitness and athletic ability because it has the ability to improve the CPR endurance.

In more detail, the leaf extract of Panax ginseng plant and the mixture of the leaf extract thereof according to the present invention can be used for improving the exercise ability of an animal and for improving the animal's ability to produce creatine kinase, lactate dehydrogenase (LDH), lactate, corticosterone and the like, increase the exercise performance by inhibiting muscle and / or blood accumulation due to exercise, increase type I muscle or CS (citrate synthase) It has an effect of suppressing the oxidation reaction by inhibiting nitric oxide, increasing the inhibition rate of SOD (syperoxide dismutase) oxidation, increasing the activity of GPx (glutathione peroxidase), increasing the VO ₂ max and increasing the anaerobic threshold (AT) Can be improved.

Hereinafter, the present invention will be described in detail with reference to examples. However, the following examples are illustrative of the present invention, and the present invention is not limited to the following examples.

Example

Experimental Example  1. Preliminary Course

(1) Obtaining, quarantining and purification of experimental animals

Seven-week-old SD rats were obtained and veterinary quarantine was conducted on the general health status of all animals at the time of arrival. Experimental animals were housed at a temperature of 22 ± 2 ° C and a humidity of 50 ± 20% at 12hr / day / night for the selection of healthy animals.

(2) Selection of experimental animals and group separation

 In order to select individuals with a certain motor ability as healthy individuals without exercise, a treadmill exercise was performed on the animals that had undergone the refinement period before the separation, and then the outliers were removed, Were randomly grouped and grouped.

(3) Identification of individual

The breeding box was fitted with an individual identification card containing the test number, sex, group number, individual number, dose, duration of the test, and the name of the investigator. Individual identification was done by tail marking method using oil magic.

(4) Preparation of test materials

1) Preparation of ginseng muscle concentrate powder

One kilogram of ginseng root (Panax ginseng root) was refluxed three times for 7 hours by adding 10 L of 70% ethanol. The 1st, 2nd and 3rd extracts were mixed and filtered using a 5 ㎛ filter housing. The filtrate (28 L) was concentrated to 20 Brix% using a vacuum concentrator. 1 kg of the concentrate was placed in a freeze-drying tray and freeze-dried in a deep freezer at -70 ° C for 48 hours. After the freezing was completed, the concentrate was placed in a freeze dryer and lyophilized for 48 hours to obtain 542 g of a concentrated ginseng powder (yield: 54.2%).

2) Preparation of ginseng leaf extract powder

2.5 kg of Panax ginseng leaf was added with 25 L of 70% ethanol and refluxed for 5 hours. The extract was filtered using a 5 [mu] m filter housing. The filtrate (22L) was concentrated to 15 Brix% using a vacuum concentrator. 1 kg of the concentrate was placed in a freeze-drying tray and frozen for 48 hours in a deep freezer at -70 ° C. After the freezing was completed, the concentrate was placed in a freeze dryer (Ilshin Lab, Korea) and lyophilized for 48 hours to obtain 354 g of ginseng leaf extract powder (yield: 14.16%).

3) Preparation of ginseng leaf extract powder

The ginseng leaf extract powder (100 g) prepared by the above method 2) is put into a round bottom flask (2L). 360 ~ 380 mL of purified water and 20 ~ 40 mL (5 ~ 10%) of glacial acetic acid were added. The mixture was heated at 60 to 100 DEG C for 2 to 6 hours with stirring. The extract (400 ml) was concentrated to 20 Brix% using a vacuum concentrator. The concentrate was placed in a freeze-dried tray and frozen for 48 hours in a -70 ° C deep freezer. The frozen concentrate was placed in a freeze dryer and lyophilized for 48 hours to obtain 92.5 g (92.5%) of ginseng leaf extract.

4) Manufacture of mixture of ginseng leaf extract and ginseng leaf extract

350 g of the ginseng leaf extract prepared by the above method 2) and 650 g of the ginseng leaf extract manufactured by the method 3) were mixed for 20 minutes using a ribbon type mixer to obtain 990 g (yield: 99%) of a mixture.

The dose of each test substance was as shown in Table 3 below, and 0.5% Tween 20 was used as a negative control. The ginseng muscle concentrate powder and ginseng leaf extract obtained in 1) and 4) The mixture of leaf extracts was dissolved in 0.5% Tween 20 using an ultrasonic mill to give a positive control group and a test group, respectively.

(5) Content analysis

The HPLC used for the above-described methods 1) to 4) was a HITACHI (pump: L-7100, detector: L-7455, interface: D-7000, column oven: L- (Acetonitrile) and B solvent (water), and the flow rate was 0.5 mL (0.5 mL), and the flow rate was 0.5 mL / min, the total analysis time was 110 minutes, the temperature of the column oven was set at 40 ° C, the amount of the sample was set at 10 μl, and the sample was detected with a UV detector at 203 nm. The ginsenosides Rb1, Rb2, Rb3, Rc, Rd, Re and Rg1 were isolated in 60 minutes and Rg2, Rg3, Rg5 and Rk1 were separated after 70 minutes. The sample for analysis of the ginseng freeze-dried product prepared according to the method of the present invention was prepared from methanol. A ginsenoside standard sample was prepared at a concentration of 0.2 mg / ml. The results of the analysis are shown in Table 4 below.

(6) Administration

From the next day, the test substance was orally administered to the stomach using zonde once a day for 8 weeks in the exercise group and 9 weeks in the non-exercise group.

(7) Non-army forces and exercise groups

The effect of increasing the exercise performance after the administration of the negative control (solvent, 0.5% Tween 20), the positive control (UG0714) and the test group (UG0712, a mixture of ginseng leaf extract and ginseng leaf extract) To evaluate the effects and antioxidant effects, each test substance was orally administered to the rats for 8 weeks in the exercise group, and the maximum travel distance was measured at 2 weeks and 8 weeks after the start of the administration, in order to increase the adaptability to exercise in the treadmill. On the other hand, non - exercise group analyzed the effect of exercise performance after adaptive exercise for 5 days before the 6 - week and 9 - week maximum distance measurement with oral administration for 9 weeks.

(8) General symptom observation and weight measurement

The general symptoms were observed daily once daily during the test substance administration period and the occurrence of deaths was confirmed once a day during the observation period. The body weights of the test animals used in the test were measured immediately prior to the test substance administration, once a week after the start of the test substance administration, and immediately before the autopsy.

(9) Blood sample and analysis sample collection at autopsy

During the autopsy, the abdominal cavity was opened, whole blood was collected through the abdominal vein, analyzed for anti-fatigue markers, blood lactate, and corticosteroid for 4 hours. Muscle samples were buffered with isopentane and frozen with liquefied nitrogen to minimize muscle damage. The frozen muscle samples were stored in a deep freezer.

Example 1 Effect of Ginseng Leaf Extract and Ginseng Leaf Extract Composition on Exercise Capacity

(1) Experimental process

1) Administration of test substance

(0.5% Tween 20 solvent), UG0714 (ginseng root extract, positive control), and UG0712 (0.5% Tween 20) were added to the rats to evaluate the effect of the energy boosting of the test materials by measuring the exercise effect through a treadmill Mixture of ginseng leaf extract powder and ginseng leaf extract composition, test group) were orally administered.

2) Measurement method

A. General Symptom Observations: The general symptoms were observed daily once daily during the test substance administration period, and the occurrence of deaths was confirmed once a day during the observation period.

B. Body weight measurement: The body weight of the test animals used in the test was measured at the time of separation of the reserve group, immediately before administration of the test substance, and once a week after the start of administration of the test substance.

C. Non-exercise group training and maximal momentum measurement: Ten animals in the non-exercise group were given the test substance for 9 weeks and the maximum exercise was measured at 6 and 9 weeks. The maximum exercise time was measured on the 5th day of training with increasing the slope (0% ~ 15%), the speed (20 ~ 40cm / sec) and the activity period (10 ~ 20min) for 4 days on the running machine. The lower 2 out of 10 animals were removed and the results from the upper 8 were used.

D. Exercise Training and Maximum Momentum Measurement: Nine animals in the exercise group were exercised on a treadmill. At 4 weeks, the slope was 15%, the speed (30 ~ 40cm / sec), the slope (0 ~ 15%) and the speed (20 ~ 30cm / , And activity cycle (30-40 minutes). The animals continued to exercise for 2 days and 2 days for 2 days. At the 2nd and 8th weeks of training, the maximal driving time was measured in the exercise group, the lower 2 measurements of the 9 animals were removed, and the upper 7 measurements were used for the results.

(2) Results

As shown in FIG. 1, the maximum range of the rats after 2 weeks of the exercise group according to the slope of 5%, 30 cm / sec, and the induction of electrical stimulation for 90 minutes was as shown in FIG. 1, in which the mixture of the ginseng leaf extract and the ginseng leaf extract composition (UG0712) The athletic performance of the rats was significantly higher than that of the negative control group (p <0.00001). In addition, the athletic performance of UG0712 was significantly increased (p <0.05) than that of the rat administered with the ginseng muscle concentrate powder (UG0714).

As shown in FIG. 2, the maximum distance traveled by the rats after 8 weeks of the exercise group according to the slope of 15%, 35 cm / sec, and the electric stimulation induction time of 90 minutes showed that the mixture of the ginseng leaf extract and the ginseng leaf extract composition (UG0712) The athletic ability of the rats was significantly increased (p < 0.01) than that of the negative control group. In addition, when UG0712 was administered, the athletic ability was significantly increased (p <0.005) compared with the rats administered with the ginseng muscle concentrate powder (UG0714).

As shown in FIG. 3, the maximum distance traveled by the rat after 6 weeks of the non-raising group at 5% slope, 35 cm / sec and electrical stimulation induced 90 minutes showed that the mixture of the ginseng leaf extract and the ginseng leaf extract composition (UG0712) The athletic performance of the rats was significantly increased (p < 0.05) than that of the negative control group. In addition, when UG0712 was administered, the athletic ability was significantly increased (p <0.05) as compared with the rats administered with the ginseng muscle concentrate powder (UG0714).

As shown in FIG. 4, the maximum distance of travel of the rat after 9 weeks of non-raising group at 10% slope, 35 cm / sec, and electrical stimulation induced 90 minutes showed that the mixture of ginseng leaf extract and ginseng leaf extract (UG0712) The athletic performance of the rats was significantly higher than that of the negative control group (p < 0.001). In addition, when UG0712 was administered, the athletic ability was significantly increased (p <0.05) as compared with the rats administered with the ginseng muscle concentrate powder (UG0714).

Therefore, it can be seen that the mixture of the ginseng leaf extract and the ginseng leaf extract composition of the present invention effectively promotes the exercise capacity of the animal, and it is more effective than the ginseng root extract or the negative control.

Example  2. Anti-fatigue marker  Measure

The anti - fatigue markers were measured before and after the measurement of the maximum exercise distance in both non - exercise group and exercise group in order to search for the antistress effect of the test substance on the exercise stress by long - term exercise and exhaust maximal travel distance measurement. For this purpose, blood was collected from the jugular vein within one day before the maximal exercise test and within 20 minutes after the exercise to separate the serum. Creatine kinase (CK) and lactate dehydrogenase (LDH) were measured using a blood biochemical analyzer (Hitachi 7080, Japan). LDH, which is related to anaerobic oxidizing ability, was measured by a spectrophotometer at 37 ° C, and all measured values were expressed in Umol / min / g.

Lactic acid and corticosteroids (AssayMax Corticosterone ELISA Kit, Gentaur, catalog No. EC3001-1) were analyzed in the blood obtained after 8 weeks of maximum distance measurement in the exercise group and in the blood obtained after 9 weeks of maximum distance measurement in the non-exercise group . The measurement results are shown in Tables 5 to 12 below.

CK (creatine kinase) is one of the enzymes expressed in various tissues and is involved in the conversion of creatine into creatine phosphate and ADP by consuming ATP. Clinically, blood CK is myocardial infarction, rhabdomyolysis, severe muscle breakdown, muscular dystrophy, and acute renal failure. When the muscle is damaged, the blood CK level is increased.

Experimental results showed that CK levels were significantly decreased when UG0712 was administered (FIG. 5), and it was found that UG0712 effectively inhibited muscle damage due to exercise.

LDH is an enzyme present in the cytoplasm that is reflected in the catalytic action between the glycolytic enzyme pyruvate and the lactate. Generally, fatigue after exercise is a long-lasting strong contraction of the muscle, Inadequately supplied, the energy required for muscle activity is generated through the anaerobic energy system pathway, resulting in the accumulation of many lactic acid in the muscle, which is a good marker for the process.

When UG0712 was administered to the non-emptied group, serum LDH activity was significantly lower than that of the negative control group and the positive control group (FIG. 6). When administered to the exercise group, the LDH activity in blood and muscle (Figs. 7 and 8).

Experimental results showed that LDH increased overall in the exercise group compared with non-exercise group. This is due to the increase in the LDH enzyme activity due to the increase in the load applied to the muscle by the regular exercise.

The LDH activity in the exercise group was significantly decreased when UG0712 was administered. This suggests that administration of UG0712 would inhibit lactic acid production in the muscle and reduce fatigue, thereby improving exercise performance in the running machine.

Lactic acid, known as one of the major fatigue factors closely related to exercise intensity and duration, is an endogenous metabolite of an anaerobic reaction produced by the reduction of pyruvate, resulting in an increase in blood concentration due to strong exercise stress. Accumulation leads to acidification of the body and inhibits factors related to multiple glucose neogenesis.

The results of the experiment showed that when UG0712 was administered to the non-exercise group and the exercise group, blood lactate was significantly lower than that of the negative control group (FIGS. 9 and 10), and therefore, when UG0712 was administered, It is possible to improve exercise ability.

Corticosteroids, known as typical stressors, play an important role in the process during exercise, and their blood levels vary with exercise intensity. In both endurance exercise and high intensity exercise, it shows an increase pattern. Unlike catecholamine, it does not decrease immediately after exercise but maintains the increased level for a certain time. If long term corticosteroids are maintained at high concentrations, body proteins may be degraded or damaged, and side effects may be caused by inhibiting nitrogen balance. The results of the experiment showed that the administration of UG0712 to the non-exercise group and the exercise group significantly reduced the blood corticosterone level compared to the negative control group (FIGS. 11 and 12). Thus, it can be seen that lowering the concentration of stress factors through the administration of UG0712 can further enhance exercise capacity.

Example  3. Measurement of exercise capacity improvement effect

In general, in relation to exercise, muscle metabolism changes to increase oxidative capacity and to delay muscle fatigue. This change is reflected in the activity of the mito-oxidative enzyme, Changes appear. Examples of such mitochondria-oxidizing enzymes include citrate synthase, cytochrome C oxidase, succinate dehydrogenase, and the like. Particularly, the citrate synthase has an aerobic oxidizing ability Well known as a good marker. To investigate biochemical markers related to exercise capacity improvement in both non - exercise group and exercise group, muscle activity was measured and the activity of CS (citrate synthase) related to aerobic oxidative capacity was measured.

Into the muscle 2mM MgCl ₂ and 2mM EDTA solution in 50 mL TRIS was homogenized in 4 ℃. Citrate synthase (CS), which is involved in energy production by aerobic oxidation in muscles, was measured by spectrophotometer at 37 ° C. All measurements were expressed in terms of Umol / min / g.

CS activity analysis showed that CS activity was significantly increased when UG0712 was administered to untreated and exercise groups (Figures 13 and 14). In this way, when the UG0712 administration is performed, the maximum activity of oxygen in the exercise performance is increased and the exercise performance is improved by increasing the activity of the enzyme related to energy generation by aerobic oxidation, Compared with the exercise control group and the positive control group.

Example  4. Antioxidant effect measurement

Oxygen free radicals and reactive oxygen species (ROS) are generated not only in human metabolic processes but also in vigorous exercise, damaging biological membranes by modifying proteins and DNA, It has been reported that it causes cancer and adult diseases. Enzymes such as mitochondria, peroxisome, xanthine oxidase, NADPH oxidase and COX (cyclooxygenase) present in cells produce various reactive oxygen species (ROS), which cause oxidative damage, In addition, active nitrogen species are produced in large quantities in the inflammatory reaction, and active oxygen species are also produced at the same time. Long-term exercise and excessive muscle-induced inflammatory responses to exercise will produce inflammatory factors such as NO.

The antioxidant system for the elimination of excess free radicals is composed of antioxidant enzymes such as SOD and GPx (glutathione peroxidase), endogenous non-enzymatic antioxidants such as antioxidant vitamins and glutathione, There is a DNA repair enzyme that recovers the ingredients.

In order to evaluate the antioxidant effect, NO analysis was performed in blood and muscle, and SOD and GPx enzyme activities in hindlimb muscle were analyzed.

The intramuscular SOD (superoxide dismutase) inhibition rate was measured using a commercial SOD kit (superoxide dismutase Assays Designs, Catalog No. 30-023).

The activity of glutathione peroxidase (GPx) in muscle was analyzed using Glutathione Peroxidase Activity Kit (Assays Designs Cat. No. 900-158), which measures the change (decrease) of NADPH and analyzes GPx. The equation was used.

Nitric oxide (NO) is synthesized from arginine by the catalytic action of nitric oxide synthase (NOS), skeletal muscle blood flow is inhibited by NOS inhibitors, and increased skeletal muscle blood flow during exercise increases NO It is known to suggest. Therefore, the amount of NO in the blood and muscle can be predicted as an indirect indicator of various oxidative stress factors in the muscle.

After 8 weeks of the test substance administration, the results of the NO analysis of the exercise group showed a lower tendency in the blood compared with the exercise control group as a whole. The non-exercise test substance UG0712 group showed a significant decrease of 62 ± 15.36 micromol / mL compared to the exercise control group. The results in the muscles showed that the exercise group had higher values than the non - exercise group and the difference was significant as the blood results. The non-exercise group showed a significant decrease of 5 ± 0.44 micromol / mL in the non-exercise UG0712 group compared to the non-exercise control group (p <0.05) and the exercise control group (p <0.01) (FIGS. 15 to 19). This suggests that the administration of UG0712 reduces oxidative stressors.

SOD (superoxide dismutase) is one of the most important enzymes in the antioxidant enzyme system that makes superoxide radicals, the first product of the aerobic exercise process, into hydrogen peroxide and oxygen molecules. It is an antioxidant enzyme that is often used as an index by oxidative stress. That is, SOD prevents the formation of peroxynitrate, which is a strong oxidizing substance caused by reaction of nitrogen oxide and superoxide (O ^2- ), and regular exercise increases SOD activity Therefore, the antioxidative effect can be confirmed by measuring SOD oxidation inhibition rate.

As a result, in the UG0712-treated group, the SOD oxidation inhibition rate (%) in muscle was increased in the exercise group (Fig. 20). Therefore, it can be seen that administration of UG0712 effectively inhibits the production of oxidized products produced by oxidative stress.

GPx (glutathione peroxidase) is an antioxidant enzyme that protects organs from oxidative damage. Antioxidant activity can be measured by analyzing the activity of intramuscular GPx.

Experimental results showed that UG0712-treated group had an increase in muscle GPx in the exercise group compared to the negative control group (Fig. 21). Therefore, it can be seen that administration of UG0712 effectively protects organs from oxidative damage due to exercise.

Example  4. ATPase  Test

In order to observe changes in muscle fiber of the hind leg muscles related to energy utilization, histochemical staining of myosin ATPase (myosin ATPase) was performed and used as an auxiliary index of exercise performance.

1) Experimental method

The left hindlimb muscle was frozen at 20 째 C to 12 쨉 m using a microtome. After cryo-cutting, serial sections were obtained from each block and fixed on a microscope slide, while rapidly staining with Hemtoxylin-eosin to confirm the progress of the fibrin. Myocyte ATPase staining was performed by acid preincubation. At least 200 fibers per muscle were calculated for each animal.

2) Results

The muscles involved in exercise are divided into type I and type II fibers through myosin ATPase staining.

Type Ⅰ fiber is an energy source that uses glucose and fat to aerobically metabolize aerobic energy, which is resistant to fatigue and slows the rate of contraction, and is suitable for long-term endurance exercise. It usually refers to red muscle.

Type Ⅱ fibers are anaerobic anaerobic energy metabolism, weak fatigue and rapid shrinking speed, so it is suitable for short-term short-term exercise, usually white muscle (white muscle) is called.

The results of histochemical staining for myosin ATPase muscle (soleus, red gastro) to observe the changes of type I fibers and type II fibers in the main hindlimb muscles related to exercise are shown in Fig. The ratio of type I fibers (oxidative fibers type I fibers) was higher than that of non - In soleus, the type I fiber ratio of exercise group test substance UG0712 group showed a significant increase (UG0712; P <0.01) compared to the non-exercise control group. The exercise group UG0712 showed a significant increase (P <0.05) in the ratio of red gastrocnemius type I fibers (FIG. 22 and FIG. 23) compared to the exercise control group.

In addition, type I fibers were slightly increased in the exercise group treated with exercise for 8 weeks compared to the non-exercised group. This seems to be due to the increase in type I fibers in the muscle fiber composition due to the continuous action.

Therefore, when UG0712 was administered, the proportion of oxidative fibers type I fibers in the exercise group was higher than that in the non-exercise group, because the metabolic system of muscles increased the oxidative power and the muscle fatigue state was delayed . &Lt; / RTI &gt; In addition, this phenomenon is further increased by administration of UG0712, which is a test substance, and it is considered that the exercise performance in running machine is increased.

Example 5: Evaluation of exercise capacity improvement effect in human body ( VO ₂ max and AT measurements) and safety testing

(1) Test method

Single center, double-blind, random allocation, and placebo control methods were used.

Subjects who were healthy and over 20 years old and who did not exercise regularly within 3 months of the trial were selected as subjects. The total number of subjects was 123, but the number of completed subjects was 82. Subjects were randomly assigned to each of the UG0712 high dose group, the UG0712 low dose group, and the control group, and the test was conducted in a double-blind manner.

The UG0712 high-dose group received a total dose of 500 mg twice daily, 250 mg once, and the UG0712 low-dose group received a total dose of 100 mg twice a day, once at 50 mg. Control group (placebo group) received CMC (carboxymethylcellulose) twice a day, 250 mg once a total dose of 500 mg.

The test drug administration period was 12 weeks, and each subject underwent a prescribed exercise (three times a week, aerobic exercise and strength exercise for 60 to 90 minutes). Aerobic exercise was performed using a treadmill and an ergometer with a 70 to 80% VO ₂ max intensity. The number of exercises was measured periodically every two weeks. Three times a week, it was decided to use the sports center designated by the research institute.

VO ₂ max and AT were assessed on the day, 4, 8, and 12 weeks after ingestion of the test product, and safety tests were performed.

(2) Measurement of VO ₂ max

The VO ₂ max were measured in order to evaluate the exercise capacity improvement.

Referring to VO ₂ max (maximum oxygen uptake) analysis results for the entire study population, the mean value based on the high-dose group (Baseline) compared to the last visit changes (Change3) in (Visit 5) was 5.11 ± 4.81ml / kg / min, (UG0712 group), except for the placebo group, showed a statistically significant increase with visits (RM ANOVA, high dose group, p <0.05) = 0.0002, low dose group 0.0045). The difference in baseline values between visits 3, 4, and 5 was generally higher in the two UG0712 groups than in the placebo group, with a statistically significant difference between the high-dose and placebo groups (RM ANCOVA, p = 0.0292) 24).

1) Change over time: RM ANOVA

2) Difference between treatment groups: RM ANCOVA (Dunnett's multiple comparison)

Change 1: Visit - Baseline value, Change 2: Visit 4 - Baseline value, Change 3: Visit 5 - Baseline value

Individual aerobic capacity means how much oxygen can be used during maximal or exhaustive exercises, which can be determined by VO ₂ max. In other words, VO ₂ max is an individual's functional ability and is an important parameter that allows us to know the ability of the lung to carry oxygen to the blood and the blood pump action of the heart and how the pump blood is fed to the muscle.

Result, aerobic exercise capacity according to the maximum oxygen uptake that is, the VO ₂ max representing the cardiopulmonary exercise endurance was a statistically significant improvement compared with the placebo group in a statistically the UG0712 high dose group _{(RM ANCOVA, VO 2 max p} = 0.0292).

(3) AT (anaerobic threshold)

The AT (anaerobic threshold) was measured to evaluate the effect of improving exercise capacity.

The results of AT (Anaerobic threshold) analysis for the total subjects (ITT group) were as follows: 1.63 ± 4.18 ml / kg / min in the high dose group and 0.19 ± 3.59 ml / kg / min in the placebo group, -0.01 ± 4.74 ml / kg / min in the placebo group, and increased in the UG0712 group. The differences in baseline values between visits 3, 4, and 5 were generally higher in the two UG0712 groups than in the placebo group, with a statistically significant difference in the high dose versus placebo groups (RM ANCOVA, p = 0.0378) 25).

1) Change over time: RM ANOVA

2) Difference between treatment groups: RM ANCOVA (Dunnett's multiple comparison)

Change 1: Visit - Baseline value, Change 2: Visit 4 - Baseline value, Change 3: Visit 5 - Baseline value

AT refers to a specific point in time when the serum lactate concentration starts to increase as the exercise intensity increases. If the AT level is high, it means that the aerobic exercise can be continued for a long time without oxygen metabolism. In other words, it means that you can exercise for a long time at your athletic performance pace.

As a result, there was a statistically significant increase (AT p = 0.0378) in the UG0712 high-dose group compared with the placebo group in the AT showing the aerobic exercise capacity according to the anaerobic threshold value.

VO ₂ max and AT are independent indicators of aerobic exercise capacity, ie, degree of improvement in cardiopulmonary endurance. As a result, the VO ₂ max and AT values were significantly increased in the UG0712 high dose group compared with the control group. Thus, when the UG0712 high dose group (500 mg / day) Exercise capacity and endurance.

(4) Safety test

1) Test method

All 117 randomized subjects were included in the analysis because they were able to ingest UG0712 or placebo and to evaluate at least one safety data sheet.

(a) Adverse reaction

The adverse reactions from the symptoms were evaluated from the time of ingestion until 12 weeks after the ingestion (visit 5) and recorded in the case report when an adverse reaction occurred. In addition to the voluntary reporting of the subjects, they were checked through interviews at each visit. In case of adverse events, the symptoms, timing, duration, severity of adverse events, and causal relationship were recorded in the case report. Other clinically significant abnormal clinical laboratory tests and vital sign results were recorded / reported as adverse events.

(b) General observations

Vital signs, ie, blood pressure (mmHg) and pulse (times / minute) were measured after the subjects had stabilized for at least 5 minutes. Clinical laboratory tests and physical examinations (physical examinations) were conducted at screening visits (visit 1) and visits 3, 4 and 5. If clinically significant abnormal findings were found in the above items, they were treated as adverse events and described in detail.

2) Results

There was no statistically significant difference between the treatment group and the placebo group as a result of comparing the incidence of adverse reactions, and there was no significant change in clinical laboratory tests, vital signs, and physical examinations conducted before and after the clinical trial. Therefore, UG0712 was judged as a safe preparation do.

Claims (21)

A composition for promoting exercise capacity, fatigue recovery or antioxidation activity comprising a mixture of a leaf extract of Panax spp. And a leaf extract of Panax spp. As an active ingredient,
Wherein the total ginsenoside content in the leaf extract of the Panax plant is 30 wt% or more,
Wherein the Rg3, Rg5 and Rk1 content of the leaf extract of the Panax plant is 5 wt% or more. 2. The composition of claim 1, wherein the leaf extract of Panax ginseng plant and a mixture thereof is characterized by comprising a 3-O-glycoside derivative of protopanaxatriol and a 3-O-glycoside derivative of protopanaxadiol / RTI &gt; 3. The method of claim 2, wherein the ratio of the 3-O-glycoside derivative of protopaxanthriol to the 3-O-glycoside derivative of protopanaxadiol in a mixture of the leaf extract of a plant of the genus Panax, &Lt; / RTI &gt; The method according to claim 2, wherein the content ratio of the 3-O-glycoside derivative of protopanaxatriol to the 3-O-glycoside derivative of protopanaxadiol in the mixture of the leaf extract of the plant of Panax ginseng and the product thereof is 1: 0.7 &Lt; / RTI &gt; The composition according to claim 1, wherein the total ginsenoside content in the mixture of the leaf extract of the Panax ginseng plant and the composition is 40 wt% or more. The method according to claim 1, wherein the leaf extract of Panax ginseng plant and the mixture of the products are selected from the group consisting of ginsenosides Rb1, Rb2, Rb3, Rc, Rd, Re, Rg3, Rg5 and Rk1 as active ingredients &Lt; / RTI &gt; The composition according to claim 1, wherein the content of ginsenosides Rg3, Rg5 and Rk1 in the mixture is at least 10 wt%. The method of claim 1, wherein the Panax genus plant is Panax ginseng (Panax ginseng), Panax party pony Qom (Panax japonicum , Panax quinquefolium , Panax notoginseng , Panax trifolium , Panax pseudoginseng , Panax vietnamensis ), Panax elegatior , Panax wangianus) and Panax non pinra typhimurium Douce (composition being selected from the group consisting of Panax bipinratifidus). The composition according to claim 1, wherein the leaf extract of Panax spp. And the leaf extract of Panax spp. Are mixed in a ratio of 1: 0.1 to 10. The composition of claim 1, wherein the leaf extract of Panax spp. And the leaf extract of Panax spp. Are mixed in a ratio of 1: 0.1 to 5. The composition according to claim 1, wherein the leaf extract of Panax spp. And the leaf extract of Panax spp. Are mixed in a ratio of 1: 0.1 to 3. The composition of claim 1, wherein the leaf extract of Panax spp. And the leaf extract of Panax spp. Are mixed in a ratio of 1: 0.5 to 2. The composition according to claim 1, which enhances the exercise performance by enhancing VO ₂ max or anaerobic threshold (AT), or increasing the mileage, type I muscle or citrate synthase activity. . 2. The composition of claim 1, wherein the composition enhances fatigue recovery by reducing the level of one or more of the fatigue factors selected from the group consisting of creatine kinase, lactate dehydrogenase (LDH), lactic acid, and corticosterone. The composition according to claim 1, wherein the oxidation reaction is inhibited by inhibiting nitric oxide (NO) oxidation or superoxide dismutase (SOD) oxidation or enhancing glutathione peroxidase (GPx) activity. The mixture according to claim 1, wherein the leaf extract of Panax spp. And the leaf extract of Panax spp.
(a) Leaf of a plant of the genus Panax is refluxed with an extraction solvent selected from the group consisting of water, C _{1 -4} alcohol and a mixed solvent thereof, followed by lyophilization to obtain a leaf extract of a plant of the genus Panax,
(b) adding water and glacial acetic acid to the obtained extract powder, performing a processing reaction with stirring at 60 to 100 캜, and drying the resultant to obtain a leaf extract of a plant of Panax ginseng,
(c) a composition comprising the leaf extract of the Panax ginseng plant obtained in (a) and the leaf extract of the Panax ginseng plant obtained in (b). 17. The composition of claim 16, wherein the extraction solvent is ethanol. The composition according to claim 1, which is selected from the group consisting of squalene, Saururus chinensis extract, Ogassi water extract, Cordyceps juice extract, Collagen powder or extract, Vitamins, Minerals, Taurine, Creatine, Phosphatidylcholine, Glutamine, L-Arginine and L- &Lt; / RTI &gt; wherein the composition further comprises one or more components selected. The process according to claim 1, wherein the leaf extract of Panax spp. Is produced by refluxing the leaves of Panax spp. With an extraction solvent selected from the group consisting of water, C _{1 -4} alcohol, and a mixed solvent thereof, Wherein the extract is obtained by lyophilizing the extract, adding water and glacial acetic acid to the lyophilized extract, stirring at 60 to 100 DEG C, and drying the processed extract. The leaf extract of a plant of the genus Panax, wherein the leaf of a plant of the genus Panax is refluxed with an extraction solvent selected from the group consisting of water, a C _1-4 alcohol, and a mixed solvent thereof, Which is obtained by lyophilization. 21. The composition of claim 19 or 20, wherein the extraction solvent is ethanol.

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