KR100692175B1 - Health functional food having an energetic and sturdy action - Google Patents

Abstract

Kidney activity and anti-fatigue of the present invention, Kangjeong, tonic, health functional food for improving sexual function silkworm 10-20% by weight, cornus oil 1-10% by weight, casualties 1-5% by weight, earth and sand 1-5% by weight, cheongung 1 ~ 10% by weight, 1-5% by deer antler, 1-5% by weight of raw paper, 1-5% by weight of Schisandra chinensis, 1-10% by weight of cinnamon, 1-5% by weight of dew, 20-30% by weight of Angelica, 5 ~ A composition containing 15% by weight, 1-10% by weight, 1-5% by weight, and 0.1-1.5% by weight of soft water.

Silkworm dry extract, tonic tonic and health functional food for improving sexual function.

Description

Health functional food having an energetic and sturdy action for renal activity and anti-fatigue, gangjeong, tonic, sexual function

The present invention relates to renal activity and anti-fatigue, gangjeong, tonic, health functional food for improving sexual function.

Sex is a reflection of the social culture of the changing times of humanity, and now everyone in the stressful age has the potential to suffer sexual dysfunction.

Sexual dysfunction is a generic term for diseases related to the functions of the male and female genital organs. The most common are erectile dysfunction and premature ejaculation.

In terms of incidence, erectile dysfunction usually occurs in 10% of men in their 40s, 20% in their 50s, 30% in their 60s, 50% in their 70s, and 80% in their 80s. It seems to be troubled.

Erectile dysfunction is a term encompassing the meanings of sexual dysfunction, impotence, etc. It means a state in which the penis is not erected or erected due to various reasons, and maintains the degree of stiffness that cannot be inserted into the vagina to prevent sexual intercourse.

The causes are reported to be very diverse, and largely divided into psychogenic causes and organic causes to treat.

1) The main causes of psychogenicity are exposure to continuous fatigue and stress, overdose of instant foods, and other environmental hormones. This requires psychological sexual treatment, and the success rate of psychotherapy (depression, etc.) is reported to be about 70%. It is becoming.

2) The organic causes include vascular or nervous system abnormalities (diabetes, hypertension, heart disease, arteriosclerosis, etc.), sex hormones, erectile dysfunction, and other causes.

Their treatment is applied by medical or surgical therapy. These treatments include drug therapy, the use of vacuum-induced devices, self-injection techniques, vascular surgery, and penile implants.However, with the exception of drug therapy, they gradually become oral due to the inconvenience and side effects of use. Preferred drugs or coatings are preferred.

In oriental medicine, erectile dysfunction is recognized as a categorical or categorical category, and the history of treatment for this is very long.

)”, “이종불수(弛縱不收)”, “종근종(宗筋縱)” 등으로 기재되었으며, <화제국방, 和劑局方>에서는 양사불거(陽事不擧)라 칭하였으며, <경악전서, 景岳全書>에서는 양위(

)라 칭하였다.Erectile dysfunction is the first in <internal diameter, 內 經 篇>

) ”,“ Heterogeneous immorality (弛 縱 不 收) ”,“ jong jong jong ”, and“ jong jong 종 (宗 筋 縱) ”. In <Amazement, 景 岳 全書>

It was called).

The history of treatment has been very long. Chinese medical treatment is mainly divided into drug therapy and acupuncture. Recent reports have reported that this method of treatment is very effective.

However, the treatment of erectile dysfunction due to vascular, endocrine, and neurological causes is limited, and thus, a new treatment method is required. In addition, as the preference for non-surgical treatment methods is needed, studies on the development of oriental medicine treatment methods and improvement of treatment effects are necessary.

In the case of Viagra, which is recently spotlighted as an erectile dysfunction treatment agent, it is the first oral therapeutic agent, and unlike conventional medicine, it is necessary to have sexual stimulation to have an erection, and it is effective in diabetes, spinal cord injury patients, and elderly men. However, there are side effects such as headache, indigestion, nasal congestion, and visual impairment, and there is a hassle to take 1 hour before sexual activity.

Meanwhile, escrim, which is a treatment for premature ejaculation, which has been developed in Korea, is a topical coating agent made of extracts of ginseng and tangui. However, since ES cream is found to have an erectile dysfunction effect as a local anesthetic effect and a local blood circulation enhancement effect, the fundamental therapeutic effect cannot be expected.

Renal and sexual dysfunction and lethargy are fundamentally restored by normalizing and strengthening the spleen and kidneys and treating them. Otherwise, temporary treatment may be solved immediately due to external drug injections or stimulants, but if the drug effects gradually decrease, it will lead to an unrecoverable condition.

Therefore, the present inventors have researched for decades to develop products that are excellent in minimizing the side effects of social attention and erectile dysfunction drugs and improving sexual function (production of sex hormones), improving prostate, energetic oncogenic and anti-fatigue effects. Medicinal herbs such as antler, schisandra chinensis, hyssop, silkworm powder, cornus, raw paper, earth and sand, and casualties that circulate the blood and make the blood smooth by circulating cheonggi, cinnamon, and kidneys. The present invention has been developed as a product composed of tired, donkeys that help blood circulation, such as seals (also called seals, persimmons or persimmons), training, and softened meat.

Therefore, the present invention is capable of fundamental treatment during sexual dysfunction without adding any synthetic drugs such as stimulants, containing natural herbal ingredients with less side effects, and renal activity and anti-fatigue, gangjeong, which can have a secondary effect on maintaining the health of the body. To provide health functional foods with tonic action and sexual function improving action.

Kidney activity and anti-fatigue of the present invention, Kangjeong, tonic, health functional food for improving sexual function silkworm 10-20% by weight, cornus oil 1-10% by weight, casualties 1-5% by weight, earth and sand 1-5% by weight, cheongung 1 ~ 10% by weight, antler 1-5%, raw paper 1-5%, schizandra 1-10%, cinnamon 1-10%, dew 1-5%, donkey 20-40%, probate 5 ~ 15% by weight, 1-10% by weight of tired, 1-5% by weight of soft gyros, 0.1-1.5% by weight of soft water,

The preparation method is extracted 20 ~ 30% by weight with purified water, 10-20% by weight silkworms are extracted with ethanol, 1-10% by weight of cornus oil, 1-5% by weight of casualties, 1-5% by weight of earth and sand, 1 to 10% by weight, 1 to 5% by weight of raw paper, 1 to 10% by weight of Schisandra chinensis, 1 to 10% by weight of cinnamon, 1 to 5% by weight of dew, 5 to 15% by weight of seal, 1 to 10% by weight of tired person, Extract 1 to 5% by weight of lotus root and 0.1 to 1.5% by weight of soft water with purified water, collect and extract the extracts homogeneously, and add 1 to 5% by weight of deer antler to prepare the extract, or It is characterized by producing a health functional food for improving kidney activity and anti-fatigue, gangjeong, tonic, sexual function by vacuum drying the vacuum drying powder.

When explaining the herbal ingredients used in the present invention in detail.

Silkworm dry extract, the main ingredient used in the present invention, is an animal herbal medicine obtained by pulverizing silkworm (Bombyx mori Linne) pupa and extracted with 60% ethanol and concentrated to dryness (freeze-drying). It is known that there is effect such as enhancement.

Cornus dried extract is an extract and dried extract of fruits removed from Cornus Fructus, a ripe fruit of Cornus officialis siebold et Zuccarini, belonging to the Cornaceae family. And glycosides, etc., is used as a nourishing, tonic, astringent medicine in herbal medicine, and is also used as a herbal medicine for lack of yang.

Casualty dry extract is extract extract and dried extract of Torilis Fructus, a fruit of Torilis japonica tree belonging to Umbelliferae. Its main components include essential oils such as Cadinene and Torilene. It is a plant herb that is known to have whole body and astringent anti-inflammatory effect.

Tosa Drying Extract is an extract and drying extract of Cuscutae Semen of Cucuta chinensis Lamarck belonging to the Convolvulaceae family. It contains glycosides such as resin, and is used in the Chinese medicine as a gangjeong and tonic medicine. It is a herbal medicine.

Cnidium Rhizoma from the root of the Cnidium officinale Makino belonging to the Umbelliferae is extracted or dried root extract with the roots removed.The main components are Cnidiumlactone and Knidium acid. Cnidiumic acid) and Sedanoic acid are included, and herbal medicine is widely used in women's diseases such as hematopoietic tonic, febrile blood donation and analgesic.

Deer antler powder (Cervi cornu pantotrichum powder) is a powder of hairy and unosteophilized young horns (kale) of the Cervus nippon Temminck or Cervus elaphus Linne belonging to the family Cervidae. Is an animal medicine widely used in tonic, boheum, gangjeong, perspective bone, pain.

Dried extract extracted from the root of Polygala tenuifolia Willdenow (Polygalae Radix) belonging to the Polygalaceae family. The dry extract is the main ingredient of saponin, tenuigenin A, and tenuigenin B. ), And other fatty oils, polygalitol, onsicin, resin, etc. It is an expectorant used for bronchitis, asthma, and is used as a tonic, gangjeong, and sedative in Chinese medicine. to be.

Schisandra chinensis extract is an extract and extract of the ripe fruit (Maximowiziae Fructus) of Schisandra chinensis (Maximowiczia chinensis Ruprecht var. Typica Nakai or Schizandra chinensis Baillon) belonging to the Magnoliaceae. Schizandrin is known as an organic acid and lignan compound such as tartaric acid, and is a herb that is rich in sugar, mucus, and used in herbal medicine as astringent, Jinhae, and nourishment tonic.

Dry cinnamon is a dry extract of dried cassia (Cassiae Cortex) by removing the cork layer by peeling stems and branches of Cinnamomum Cassia Blume or C. zeylanicum Nees belonging to the family Lauraceae. Cinnamic aldehyde, cinnamyl acetate, cinnamic acid (cinnamic acid, Cinnamic acid) are essential ingredients, and organic acids, tannins, starches, resins, mucus, mannitol and minerals It is used as a fragrant dry, sweating, antipyretic, astringent medicine, etc., and it is a raw material of cinnamon oil.

Dry dried extract of Achyranthis Radix, the root of Achyranthes japonica Nakai, belonging to the Amarantaceae, contains saponin and, when hydrolyzed, oleanolic acid and glucurin Compounds with a similar action to glucuronic acid have been extracted, and recently, metamorphic hormones have been identified (ecdysterone, incoosterone), and herbal medicines are used for menstruation, diuretics, dysmenorrhea, dysmenorrhea, etc. It is also a plant herb that is also used as a sex stimulant in animals.

Angelica gigantis Radix is an extract dried extract of dried roots before flowering of Angelica gigas Nakai belonging to the family Umbelliferae, decrecin and essential oils such as bergapten, steroidal substance and dode It contains canol, tetradecanol and cumin derivatives, and it is widely used as an anesthetic and gynecological medicine in medicinal herbs. Essential oils act on the cerebrum and the training center, pain relief, sedation. Postpartum herbal medicine (gynecological disease).

仁, Euryale ferox Salisb(seed))엑스는 감실, 검실 또는 감인이라고도 하며, 수련과(Nymphaceae)에 속하는 일년생 수생식물인 가시연(Euryale ferox Salisbury)의 과실의 정제수엑스로, 성분으로는 메틸갈레이트(methyl gallate), 갈린산(gallic acid), 1-0-갈로일-2,3-HHDP-α-D-글루코스(1-O-galloyl-2,3-HHDP-α-D-glucose[상퀴린(Sanqulin)H-4]등이 함유되어 있어, 항산화작용, 항당뇨작용이 있음이 밝혀졌고, 특히 한방에서는 강장, 유정, 통풍 및 신장 기능 저하와 여성의 대하증 등의 치료에 이용하는 식물생약이다.Probate (

Euryale ferox Salisb (seed) extract is also called persimmon, gumsil or persimmon. It is purified water extract of fruit of Euryale ferox Salisbury, an annual aquatic plant belonging to Nymphaceae. methyl gallate, gallic acid, 1-0-galloyl-2,3-HHDP-α-D-glucose (1-O-galloyl-2,3-HHDP-α-D-glucose (Sanqulin) H-4], etc., has been shown to have antioxidant and anti-diabetic effects. Especially in herbal medicine, it is a plant herb that is used for the treatment of tonic, oil well, gout and renal function lowering and women's hypothalamus.

Tribuli fructus, also known as white zirconia, is a purified water extract of Tribulus terrestris Linne, a member of the Zygophyllaceae family, and contains components such as saponins, essential oils, alkaloids, and resins. It is used for medicine, kidney protection and eye disease, and it is a plant herb that has been used for diuresis, headache, and menstrual irregularities.

Nelumbinis Semen (X) is an extract extracted with purified water after drying the seed of the aquatic plant (Nelumbo nucifera Gaertner) belonging to the Nymphaceae or Nelumbiaceae. It contains, herbal medicine is used as a tonic, hemostatic medicine.

Nelumbinis Flowers, also known as soft water, is an X-water extracted from purified water by drying flowers of aquatic plants (Nelumbo nucifera Gaetner) belonging to the Nymphaceae family or Nelumbiaceae. It contains -7-glucoside, quercetin-7-glucoside, camphorol-3-glucosylglycoside, and alkaloids, nelumbine. It is a herbal medicine using.

As described above, the composition of the health functional food having whole body and anti-fatigue, tonic, strengthening action and sexual function improving action is composed of two animal herbal medicines and 13 vegetable herbal medicines. It is considered to be due to the complex action of the active ingredient having several pharmacological activities.

Powders, granules, tablets, capsules, solutions, suspensions or pills belong to the formulations prepared by the conventional method according to the present invention, the solution or suspension is 2 to 4 times a day, once 100-120 ml of the stock solution ( 2 g) is preferably diluted in water or the like, and can be taken up to 4 g once. For powder (powder) preparations, take 1.5 to 2 g 2 to 3 times a day, and for capsules, take 4 capsules of 500 mg / capsules once or twice a day for 2 to 4 times a day. Take 1 to 2 times a day, 15 to 20 pills once.

Hereinafter, formulation examples and experimental examples of the present invention are described.

In the present invention, "%" in the prescription means weight% unless otherwise specified.

Preparation method 1 production of concentrated extract

1-1) According to the following Table 1 prescription, 291 g of Angelica tang in 1000 g of crude medicine was collected, chopped, refluxed for at least 6 hours, cooled to room temperature and filtered, and the filtrate obtained was left for 6 hours, and then the filtrate was obtained. Concentrate to 1/3, add 70% purified water to this concentrate and leave for 10 hours. The filtrate was then concentrated by filtration to give 14.55 g of concentrate.

1-2) Silkworms 140 g were first extracted with 98% ethanol 8 times for 5 hours, secondly 60% ethanol was extracted for 6 hours for 3 hours, concentrated under reduced pressure at 55 ℃ ~ 60 ℃ or less to recover ethanol 20 g silkworm extract Get

1-3) The remaining 12 medicinal herbs (569 g) such as cornus, casualty, earthenware, celestial organ, ground, Schizandra chinensis, cinnamon, hyssop, bitter melon, soft water, soft broth and boredom are added to purified water at 70 ℃ or below. Extract twice for 3 hours and concentrate the low pressure solution with 70% to 75% water to give 70.713 g of concentrate.

1-4) The concentrates of 1-1), 1-2) and 1-3) are uniformly mixed and antler powder is added to obtain X 105.263 g of the present invention. (X 1 g corresponds to 9.5 g of crude medicine. do.)

Table 1 (Prescription) 1000 g of raw medicine and composition ratio

For reference, the protein and amino acid content contained in the present invention (concentrate) according to the formulation of Table 1 were shown in Table 2 by component analysis.

Table 2 Protein and Amino Acid Content in Powders

*: Indicates essential amino acid

Analyzer: Gas Chromatograph

Experimental Example 1 : Stability Experiment (1)

1) Sample: Capsule filling x of Preparation 1

2) Experiment period: Accelerated experiment 2001. 05. 07-2001. 11. 06

                     Room temperature experiment 2001. 05. 07-2004. 05. 06

3) Experimental equipment: HPLC, constant temperature and humidity

4) Experimental materials and conditions

LOT NO: 000706 000708 000710

① Acceleration test: 37 ~ 40 ℃, 75% RH, 6 months

② Room temperature experiment: 36 months

5) Experiment Items and Standards:

               Appearance: Light brown liquid with special smell and taste

Check: Angelica, Silkworm, Cinnamon, Probate, Cornus, Schisandra chinensis, Cheongung, Deer Antler, White Chilli, Yeonjak, Yeonsu, Casualties, Earthenware, Garden, Wool

Moisture: 30% or less

6) Quantification: More than 100% of Cinnamic acid and Schizandrin in X

7) Results: Based on the accelerated and room temperature tests, there was no effect or change in properties or quality even if the product was stored for 6 months under accelerated conditions and 3 years in room condition under sealed condition. (See Table 3 and Table 4)

Table 3 Acceleration Condition Experiment (X)

Table 4 : Room condition test (X)

Preparation method 2 : extract (powder) preparation (vacuum drying)

According to the following Table 5 prescription, two specimens were prepared using 1100 g of herbal medicine.

Table 5

2-1) Firstly, 320.1 g of Angelica gigas were finely chopped, and 5 times of 80% ethanol was added thereto, followed by immersion cooling at room temperature for 6 hours. After filtration, the filtrate was left for 12 hours, and the filtrate was concentrated to 1/3. Purified water was first added to the concentrate, and the mixture was left to stand for 6 hours. Secondly, the mixture was left to stand for 6 hours in cooling water (purified water) and filtered to obtain 15.24 g of Angelica Concentrate.

2-2) 154 g of silkworms were first extracted with 90% ethanol 8 times for 5 hours, 50% ethanol extracted 6 times for 3 hours, and concentrated under reduced pressure at 55 ° C to 60 ° C or lower to remove ethanol to give silkworms 26.10 g Get

2-3) Other 525.5 g of herbs, such as cinnamon, black seal, cornus, schisandra, celery, deer antler, white chile, lotus root, soft water, casualty, earth and sand, raw paper, and dew, etc. Extraction was performed twice and the separation solution was concentrated under low pressure with 70% to 75% water to obtain 75.13 g of concentrate.

2-4) The concentrates of 2-1), 2-2) and 2-3) were uniformly mixed, and 116.47 g of the mixture was vacuum dried to give 69.88 g of powder.

Experimental Example 2 : Stability Experiment (2)

1) Sample: Vacuum-dried powder before capsule filling of Preparation 2

2) Experiment period: Acceleration experiment 2001. 04. 20-2001. 10. 19

              Room temperature experiment 2001. 04. 20-2004. 04. 19

3) Experimental equipment: HPLC, constant temperature and humidity

4) Experimental materials and conditions: Powder before capsule filling of Preparation 2 (vacuum drying)

             LOT NO: 000606, 000608, 000610

        ① Acceleration test: 37 ~ 40 ℃, 75% RH, 6 months

        ② Room temperature experiment: 36 months

5) Experiment Items and Standards:

        Appearance: Dark brown powder with special smell and taste

       Check: Angelica, Silkworm, Cinnamon, Probate, Cornus, Schisandra chinensis, Cheongung, Deer Antler, White Chilli, Yeonjak, Yeonsu, Casualties, Earthenware, Garden, Wool

        Moisture: 10% or less

6) Quantification: More than 100% of Cinnamic acid and Schizandrin in vacuum dried powder

7) Results: Based on the accelerated test and room temperature test, there was no effect or change in properties or quality even if the product was stored for 6 months under accelerated conditions and 3 years at room temperature under sealed conditions. (See Table 6 and Table 7)

Table 6 Accelerated Condition Test Table (Vacuum Dry)

Table 7 : Room temperature condition test table (vacuum dry)

Formulation Example 1 Preparation of Pills

Vacuum drying powder of Preparation 2-120 mg

Corn starch-50 mg

Sterile Distilled Water-Proper

The above ingredients are mixed and refilled at a diameter of 0.4 cm by a conventional pill manufacturing method to prepare.

Formulation Example 2 Preparation of Pills

Vacuum drying powder of Preparation 2-120 mg

Corn starch-50 mg

Red Ginseng Powder-Proper

                Pine Needle Powder-Suitable

              Sterile Distilled Water-Proper

It is manufactured by recirculation by a conventional pill manufacturing method.

Formulation Example 3 Preparation of Tablet

Vacuum drying powder of Preparation 2-200 mg

           Lactose-50 mg

                    Starch-50 mg

     Magnesium Stearate-Correct

The above components are mixed and tableted according to a conventional method for producing tablets to produce tablets.

Formulation Example 4 Preparation of Tablet

Vacuum drying powder of Preparation 2-200 mg

Lactose-50 mg

              Starch-50 mg

                Ginseng Powder-Proper

     Magnesium Stearate-Correct

It is prepared by tableting according to a conventional method for preparing tablets.

Formulation Example 5 Preparation of Capsule

Vacuum drying powder of Preparation 2-100 mg

                    Lactose-30 mg

                    Starch-30 mg

Talc-2 mg

      Magnesium Stearate-Correct

The ingredients are mixed and filled into gelatin capsules according to a conventional capsule manufacturing method to prepare capsules.

Formulation Example 6 Preparation of Capsules

Vacuum drying powder of Preparation 2-100 mg

                    Lactose-30 mg

                    Starch-30 mg

Talc-2 mg

Red Ginseng Powder-Appropriate

Camphor Ginseng Powder-Appropriate

Magnesium Stearate-Correct

It is prepared by filling in gelatin capsules according to a conventional capsule manufacturing method.

Formulation Example 7 Preparation of Liquid

Formulation 1 x-1000 mg

         Sugar-10 mg

     Isomerized Sugar-10 mg

       Lemon Scent-Correct

Purified water was added to adjust the total amount to 60 ml. After mixing the above components in accordance with the conventional method for preparing a liquid, the pouch or brown bottle is filled and sterilized to prepare a liquid.

Formulation Example 8 Preparation of Liquid

  Formulation 1 x-1000 mg

           Sugar-10 mg

       Isomerized Sugar-10 mg

   Situation Mushroom Powder-Correct

         Lemon Scent-Correct

Prepared in the same manner as in Formulation Example 7.

Formulation Example 9 Preparation of Health Food

     Formulation 1 x-1000 mg

Vitamin A Acetate-70 μg

          Vitamin E-1.0 mg

         Vitamin B1-0.14 mg

         Vitamin B2-0.16 mg

         Vitamin B6-0.6 mg

        Vitamin B12-0.3 μg

          Vitamin C-8 mg

            Biotin-12 mg

    Nicotinamide-1.8 mg

              Folic acid-40 μg

      Calcium Pantothenate-0.4 mg

        Ferrous Sulfate-1.85 mg

          Zinc Oxide-0.8 ㎍

      Magnesium carbonate-20.8 mg

       Calcium monophosphate-10 mg

       Dicalcium Phosphate-50 mg

        Calcium Citrate-80 mg

      Magnesium chloride-20 mg

             Pine Needle-Correct

    Agaricus Mushroom-Proper

The mineral vitamin mixed composition ratio is a composition suitable for the health food in the formulation example, but may be optionally modified the mixing ratio, and after mixing the above components in accordance with a conventional health food manufacturing method, to prepare a granule And, can be used according to the health food composition manufacturing method.

Experimental Example 3 ( Experiment on the warm-up force action of the present invention)

1. Experimental Materials

1.1 Experimental Animals: Wistar rats and healthy male mice were used, all of which were provided by the Department of Laboratory Animals, OO University Medical School (Certificate of Experiment Animals 10-1022).

The experimental animals were reared and experimented in the animal breeding room of the functional experimental center.

Animals were allowed to acclimate for one week before the experiment, and supplied with sufficient solid feed and drinking water under room temperature 22 ± 3 ° C, relative humidity 50 ± 10%, ventilation 10 times / day, natural sunlight during the day and fluorescent lamps at night.

1.2 Medicines: The present invention liquid formulation was provided by Korea Kukje Pharmaceutical Co., Ltd. (Preparation 1), Oh Natural Jonghwan (五 子 衍 宗 丸) was also provided by Korea Kukje Pharmaceutical Co., Ltd., hydrocortisone, estradiol ) And progesterone were both purchased from raw materials.

For reference, Oh Natural Jonghwan is described in Dongbobogam and its prescription and efficacy have been known since ancient times, and it is a product that is on sale in China. It is a gangjeongja composed of wolfberry, bokbunja, tea, earthenware, and schisandra.

1.3 Instrument: GB-204 Type Analysis Cheonpyeong

1.4 Statistical Analysis: The SPSS10 software was used to analyze, t-test for quantitative data and X ² -test for counting data.

2. Experimental method and result

2.1 Effect of the present invention solution on the adult reproductive organs and kidney weight.

Take 50 healthy male mice weighing 25-30 g, 10 of which are normal controls, 40 others are regularly sterilized under ether hardness anesthesia, and both testicles are removed. 1, the same as below) divided into four groups, 2.30 g / kg group, 1.15 g / kg group, and 3.9 g / kg positive drug group was divided into 10 groups to each group.

Intragastric administration was started from the next day after surgery and was administered once daily for 15 consecutive days.

One hour after the final dose, the animals were lethal by the cervical spine method and weighed. The weight of the animals was measured immediately after taking the foreskin, prostate-sperm gland, levator ani muscle and kidney. As a result, the positive drug group of the present invention group significantly increased the weight of the prostate-sperm gland of castration mice compared to the model group (P <0.01, P <0.05, P <0.005, respectively), and the 2.30 g / kg administration group was more obvious. The present invention solution group significantly increased the weight of the foreskin, anal muscle and kidney, among which the action of the present invention solution group on the paternal reproductive organs and kidney weight was superior to the positive drug group. It was. (See Table 8)

Table 8 Influence on the adult reproductive organ reproductive organ and kidney weight of the solution of the present invention (Preparation 1).

Comparison with model group * P <0.05, ** P <0.01, *** P <0.001;

Comparison with Positive Drug Group △△ P <0.01

2.2 Effect of Inventive Solution on Young Rat Rat Reproductive Organs and Kidney Weight.

Take 50 healthy rats weighing 50-80 g, 10 of which are normal controls, 40 others are regularly sterilized under Etel hardness anesthesia, and both testicles are removed. Inventive liquid formulations (the same as Production Method 1, hereinafter) were divided into four groups, 1.8 g / kg group, 0.9 g / kg group of the present invention liquid formulation, and 2.7 g / kg positive drug group. Intragastric administration was started from the next day after surgery and was administered once daily for 15 consecutive days.

One hour after the final dose, the animals were lethal by the cervical spine method, and the animals were weighed. The weight of the animals was immediately measured by taking the foreskin, prostate-spermatoid vesicles, anus roots and kidneys. As a result, the 1.8 g / kg group, 0.9 g / kg group, and the positive drug group of the present invention all increased the weight of the prostate-sperm gland of young rats (P <0.001, P, respectively). <0.05, P <0.05), of which 1.8 g / kg group was superior, and the 1.8 g / kg group of the present invention solution and the 0.9 g / kg group of the present invention solution increased the weight of the foreskin, anus muscle and kidney. The effect of the invention solution 1.8 g / kg group was superior. The present invention showed that the action of young giant rats on paternal reproductive organs and kidney weight was significantly superior to the positive drug group (see Table 9).

TABLE 9 Influence on the reproductive organs and renal weights of the young rats of the present invention solution (Preparation 1).

Comparison with model group * P <0.05, ** P <0.01, *** P <0.001;

Comparison with Positive Drug Group △ P <0.05, △△△ P <0.001

2.3 Insufficient vital energy model of hydrocortisone of the present invention solution on mouse immune system, kidney and testicle weight.

Fifty healthy male mice were taken, 10 of which were divided into four groups, 10 of which were normal controls and 10 of each group. Both the model and dosing groups were subcutaneously injected once daily for 10 days with 25 mg / kg of hydrocortisone. At the same time, the normal control group and the model group inject the same amount of drink, and the drug group was 2.3 g / kg, 1.15 g / kg, and OH g ring (positive group) of the present invention liquid formulation (the same as Formula 1). The mice were dosed once daily for 15 days. After one hour of final administration, the animals were lethal by the cervical spine method, and the animals were weighed. After opening, the thymus, adrenal glands, kidneys and testicles were taken and weighed immediately. As a result, both the 2.3 g / kg group and 1.15 g / kg group of the present invention increased the weight of the thymus compared to the model group, among which the effect of the 2.3 g / kg group was more pronounced (P <0.05). The solution increased the weight of the kidneys and testicles, which was superior to the model group and the positive drug group. (See Table 10)

Table 10 Effects of Yang model mouse immune organs, kidneys and testicle weights prepared with hydrocortisone of the solution of the present invention (Preparation 1).

Comparison with model group * P <0.05, ** P <0.01

2.4 Effect of the invention solution on the paternal reproductive organs and kidney weight of normal male rats.

Take 40 healthy male rats (180-200 g) and optionally control group, 1.8 g / kg group of the present invention solution (the same as in Preparation 1, below), 0.9 g / kg group of the present invention solution and 2.7 g of natural spontaneous ring. Each group was divided into 4 groups, 10 animals per kg / kg positive drug group. The dose was administered once daily for 15 days. The body weight was measured 1 hour after the last dose, and the weight was measured immediately by taking the foreskin, prostate-sperm gland, anus muscles, testicles and kidneys.

As a result, the 1.8 g / kg, 0.9 g / kg group of the present invention increased the prostate-sperm gland, foreskin, testicle weight compared to the control group, there was a significant difference than the positive drug group. This result indicates that the liquid formulation of the present invention has a superior effect on the weight of the paternal reproductive organs and testes of rats (see Table 11).

TABLE 11 Influence on the paternal reproductive organs, testis and kidney weight of normal male rats of the inventive solution (Preparation 1).

Comparison with model group * P <0.05, ** P <0.01; Comparison with Positive Drug Group △ P <0.05

2.5 Influence of rat capture behavior and mating capacity of the present invention liquid formulations.

40 male rats (250 to 300 g) were randomly taken, and the control group, 1.8 g / kg group of the present invention solution (the same as Formula 1, below), 0.9 g / kg group of the present invention solution, and OH Jong-hwan 2.7 Each group was divided into four groups, 10 g / kg positive drug group. In each group of rats, gastric administration was performed once daily for 15 consecutive days. On the other hand, 40 adult female rats weighing 250-300 g were taken first, followed by intraperitoneal anesthesia with sodium pentobarbital (0.6%, 9 ml / kg), and an incision of 1.5 cm on both sides of the lumbar spine was performed. Both ovaries were removed, and penicillin 20,000 units / kg was injected once daily for 5 consecutive days. Two weeks after the operation, the female and male rats were mated. 48 hours before the experiment, female rats were injected with estradiol (20 μg / horse) and progesterone (500 μg / horse) was injected intramuscularly 4 hours before mating. In the evening of the final rat injection, each male rat is placed in a 50 × 35 × 25 cm plastic container alone for 5 minutes, and then a female rat is placed in each barrel for 20 minutes. The number of times the rat catches the rat, the number of catches, the latency of the catch (the time from the rat rat to the male rat catches the first female rat), The number of ejaculations and ejaculation latencies (time from the rat rat to the male rat first ejaculation) were observed and recorded. Then, each group, index of each term, capture rate (%) and assessment rate (%) were calculated. Experimental results showed that the 1.8 g / kg group and 0.9 g / kg group of the invention solution had a significantly shorter latencies and increased capture rate (%) than the control group, among which the 1.8 g / kg group was more prominent (each P). <0.05). In addition, the present invention solution 1.8 g / kg group, 0.9 g / kg group and positive drug group all increased the ejaculation rate (%) compared to the control group (P <0.01, P <0.05, P <0.05), respectively, 1.8 g / The kg group was much better than the control group and the positive drug group. This result indicates that the action of the present invention solution is superior to the positive drug group. (See Table 12)

TABLE 12 Influence on the capturing and mating ability of rats of the present invention liquid formulation (Manufacturing 1).

Comparison with Control * P <0.05, ** P <0.01

3. Conclusion

From the above experimental results, (1) the 2.3 g / kg group and 1.15 g / kg group of the solution of the present invention (the same as the manufacturing method 1, below) all increased the weight of the prostate-vesicle of the castration mouse, and the anal of the castration mouse The weight of the big muscles and kidneys was increased, and the weight of the foreskin of castration mice was increased. An increase in the weight of the foreskin in the 2.3 g / kg group of the present invention solution made a very significant difference compared to the positive drug group. (2) The present invention solution 1.8 g / kg group, 0.9 g / kg group and positive drug group increased the weight of the prostate-sperm of the young castrated rats, 1.8 g / kg group increased the weight of the foreskin. In addition, the 1.8 g / kg group, 0.9 g / kg group of the invention solution significantly increased the weight of the kidney, there was a significant difference than the positive drug group.

(3) In the lack of vital energy model mice prepared with hydrocortisone, 2.3 g / kg of the present invention solution increased thymus weight, 2.3 g / kg group, 1.15 g / kg group, All of the positive drug groups increased the kidney weight of the mice, among which 2.3 g / kg group and 1.15 g / kg group had a clear effect, especially the 2.3 g / kg group significantly increased the weight of the testicles.

(4) The 1.8 g / kg group of the present invention solution increased the weight of rat prostate-sperm gland, testicles and the weight of the foreskin gland, which was significantly different than the positive drug group.

(5) In the experiment on the rat mating ability of the inventive liquid formulation, the inventive liquid formulation 1.8 g / kg group and 0.9 g / kg group had shorter capture latency, increased capture rate and ejaculation frequency, and 1.8 g compared to the control group. In the / kg group, the 0.9 g / kg group and the positive drug group, the ejaculation rate of rats was increased, but the ejaculation rate of the 1.8 g / kg group of the present invention solution exceeded the positive drug group.

In general, from the above experimental results, the present invention liquid formulations increased the weight of the paternal reproductive organs and kidneys of castrated animals, and increased the immune organ weights of conceived model mice composed of hydrocortisone. In addition, the present invention enhanced the breeding ability of male rats. Therefore, the present invention can be seen that there is a male hormone-like action, the action was superior to the five natural ring. The present invention recognizes that the new drug is of high R & D value.

Experimental Example 4 ( Experiment on Anti-Fatigue Action of the Invention)

1. Experimental Materials

1.1 Experimental Animals: A healthy male mouse was provided by OO University Medical School's Laboratory Animal Division (Experimental Animal Certificate No. 10-1022). The experimental animals were reared and experimented in the animal breeding room of the functional experimental center. Animals were allowed to acclimate for 1 week, and then kept at room temperature 22 ± 3 ℃, relative humidity 50 ± 10%, ventilation 10 times / day, daylight during daylight, and fluorescent lamps at night.

1.2 Medicine: The present invention liquid formulation (Preparation 1) was provided by Korea National Pharmaceutical Co., Ltd.

1.3 instrument: GB-24 type analytical balance (manufactured in Switzerland); 722 type spectrophotometer

1.4 Statistical Analysis: SPSS10 software was used to analyze the t-tests for quantitative data and X ² -test for counting data.

2. Experimental method and result

2.1 Influence on Oxygen Deficiency Endurance Ability in Mouse Atmospheric Pressure of the Invention.

A total of 60 males of healthy male mice weighing 20 ± 2 g (15 randomly in each group) were treated with three dose groups of 2.30 g / kg, 1.15 g / kg, and 0.575 g / kg of the present invention liquid formulation (the same as Formula 1). It was set in four groups such as (beverage salary). The drug was administered orally once a day for 30 days. One hour after the last dose, each animal was first placed in a 125 ml inlet vial with 20 g of quicklime (absorbed CO ₂ ), closed with a cap, sealed with washerin, and then each animal from death to death. Survival time was measured. As a result of comparing the drug group and the control group, the mouse oxygen deficiency endurance survival time of the 2.30 g / kg group, the 1.15 g / kg group, and the 0.575 g / kg group of the present invention was extended, among which the 2.30 g / kg group, The 1.15 g / kg dose group was more pronounced (each P <0.05) (see Table 13).

Table 13 Effect of oxygen deficiency endurance at normal pressure of the mouse of the present invention (liquid formulation, Preparation 1).

Compared to control, * P <0.05

2.2 Influence on the Mouse Load Sliding Capacity of the Invention.

A total of 60 males of healthy male mice weighing 20 ± 2 g, each of 15 groups, were selected. Three dose groups of 2.30 g / kg, 1.15 g / kg, and 0.575 g / kg of the present invention were prepared. It was set up in 4 groups such as (beverage benefit). The drug was administered orally once a day for 30 days. After 1 hour of final administration, each mouse's tail muscle was loaded with a weight of 10% and placed in a water tank with a water temperature of 26 ± 1 ° C and a depth of 22 cm (Swimming tank; 50 cm × 40 cm × 35 cm). That is, the time from sinking to the bottom of the mouse until it could not rise to the surface again within 6 seconds was recorded. As a result, when comparing the drug group to the control group, the swimming duration of the present invention 2.30 g / kg, 1.15 g / kg, 0.575 g / kg dose group was extended, of which the 2.30 g / kg group was much more pronounced. (P <0.01) (see Table 14)

Table 14 Influence on the load carrying capacity of the mouse of the present invention liquid preparation (method 1).

 Compared to control, ** P <0.01

2.3 Effect on Endurance Capacity at Low Temperature of Mouse of the Invention.

A total of 60 healthy male mice, each weighing 20 ± 2 g, were selected from 15 groups in each group. The solution of the present invention was prepared according to the present invention (preparation 1, the same) 2.30 g / kg, 1.15 g / kg, 0.575 g / kg 3 dose groups and the control group ( Drinking water salary). The drug was administered orally once a day for 30 days. After 1 hour of final administration, each group was placed in a refrigerator at -6 ± 1 ° C for 80 minutes and the survival rate of each group was recorded. As a result, there was no significant difference between the drug group and the control group (see Table 15).

Table 15 Influence on the endurance ability at the mouse low temperature of the solution of this invention (Manufacturing method 1).

2.4 Effect on Serum Lactic Acid Content After 45 Minutes of Mouse Streaming of the Invention.

A total of 45 males of 15 healthy male mice each weighing 20 ± 2 g were selected. Two dose groups of 2.30 g / kg and 1.15 g / kg of the present invention liquid formulation (the same as the manufacturing method 1), and the control group (drinks) Three groups were set up. The drug was administered orally once a day for 30 days. After 1 hour of final administration, each mouse was placed in a water tank (swimming tank; 50 cm × 40 cm × 35 cm) with a water temperature of 30 ± 1 ° C. and a water depth of 22 cm. Serum was isolated at (2000 rpm) and the serum lactic acid content was measured with a 722 spectrophotometer. As a result, the serum lactate content of the 2.30 g / kg and 1.15 g / kg dose group of the present invention was lower than that of the control group, and the serum lactate content of the 2.30 g / kg group was much lower than that of the control group (P <0.001) ( See Table 16).

Table 16 Effect of the invention solution (Preparation 1) on serum lactate content after 45 minutes of mouse swimming.

Compared to control, *** P <0.001

2.5 Effect on Serum Urea Nitrogen Content After 45 Minutes of Mouse Streaming of the Invention.

A total of 45 healthy male mice with a body weight of 20 ± 2 g are selected from 15 groups in each group. 2.30 g / kg, 1.15 g / kg of two dose groups and control group (drinks) Three groups were set. The drug was administered orally once a day for 30 days. After one hour of final administration, each mouse was placed in a water tank (water tank; swimming pool; 50 cm × 40 cm × 35 cm) with a water temperature of 30 ± 1 ° C. and a depth of water of 22 cm for 45 minutes. Serum was isolated at (2000 rpm) and the serum urea nitrogen content was measured with a 722 spectrophotometer. As a result, there was no significant difference between the drug group and the control group (see Table 17).

Table 17 Effect on serum urea nitrogen content after 45 minutes of mouse swimming of the inventive solution (Preparation 1).

2.6 Effect on Glycogen Content of Soy and Muscle after 45 Minutes of Mouse Streaming of the Invention.

A total of 45 healthy male mice each weighing 20 ± 2 g are selected for each group of 15 dogs. The present invention liquid formulation (the same as Formula 1, below) 2.30 g / kg, two dose groups of 1.15 g / kg and the control group (drinking water) Three groups were set up. The drug was administered orally once a day for 30 days. One hour after the last dose, each mouse was placed in a water tank (water tank; 50 cm × 40 cm × 35 cm) with a water temperature of 30 ± 1 ° C and a depth of water of 22 cm. After removal, the tissue was swollen, and then glycogen content of the liver and muscle was measured by an anthrone colorimetric method. As a result, the administration group of the present invention significantly increased the liver and muscle glycogen content of 45 minutes after swimming (P <0.001) and the muscle glycogen content of 45 minutes after swimming was significantly higher than the control. It became. (P <0.001, P <0.01 separately) (See Table 18,19)

TABLE 18 Effect on Soy Glycogen Content After 45 Minutes of Mouse Streaming of Inventive Solution (Preparation 1).

Compared to control, *** P <0.001

Table 19 Effect on muscle glycogen content after 45 minutes of mouse swimming of the inventive solution (Preparation 1) .

Compared with control, ** P <0.01; *** P <0.001

3. Conclusion

In this experiment, the oxygen deficiency endurance, load swimming, endurance to low temperature, and after lactation, serum lactate, serum urea nitrogen, and glycogen content of liver and muscle were measured. In addition, the anti-fatigue effect of mice of the present invention liquid formulation (Sec 1, the same below) was studied. As a result, the mice administered with the present invention for 30 days could significantly prolong the survival time and load swimming time of oxygen deficiency, increased the contents of mouse liver glycogen and muscle glycogen, and serum lactate after swimming Lower the content.

However, there were no significant differences in the results of experiments such as endurance to low temperature and serum urea nitrogen content after swimming.

Oxygen deficiency is a type of stress stimulus that causes animals to produce various stress reactions. Oxygen deficiency compensator impairs the oxidation of substances in the body and accumulates acidic metabolites (such as lactic acid) and CO ₂ , which stimulate the central and peripheral chemical receptors (receptors), or the central nervous system directly, reflexively respiration and cardiac activity. Limiting fever's compensatory response, such as stimulating blood pressure, increasing cardiac output, and regulating blood distribution to maintain blood supply to the heart and brain, but at the end of oxygen deficiency, persistent oxygen deficiency causes severe irreversible cardiac and brain dysfunction and damage. This is the leading cause of animal death. The prolonged survival of the mice in an oxygen deprived environment means that the present invention enhances the animal's stress response ability and produces certain protective actions against the heart and brain.

Swimming fatigue time is closely related to fitness status and exercise control ability. The fact that the present invention (liquid formulation, Process 1, the same below) extended the load swimming duration was that this drug increased the anti-fatigue ability of animals. When an animal performs a vigorous exercise for a long time, a large amount of lactic acid is generated in the body, which is one of the important causes of motor fatigue. If too much lactic acid accumulates in the body, the internal environment of the organism is destroyed and safety and normal metabolism are affected, causing fatigue easily. Lowering the lactate lactate content after exercise is evidence of prolonged swimming duration and enhanced antifatigue ability in animals.

Soy and muscle glycogen are the main sources of energy for the organism. The organism gains energy primarily during the oxidation of glucose, which is consumed by the breakdown of glycogen. Synthesis and degradation of glycogen is a major way to regulate blood sugar levels horizontally. Intense exercise consumes large amounts of glucose, which lowers blood sugar, which is constantly supplemented by the breakdown of glycogen. If you consume enough glycogen (glycogen), blood sugar decreases, and central fatigue comes first as a disorder of brain function, followed by systemic fatigue due to mass consumption of muscle glycogen. The experimental results showed that the present invention increased the accumulation of liver and muscle glycogen (glycogen), so that the load running time of the mouse can be prolonged, thereby prolonging and alleviating fatigue.

As described above, the present invention increases the energy source glycogen (glycogen) in the body and reduces the production of the metabolite lactic acid causing fatigue, thereby delaying or alleviating the occurrence of fatigue or accelerating fatigue removal. Therefore, the present invention is recognized to have a strong anti-fatigue action.

Further research is needed on the precise mechanism of the anti-fatigue action of the present invention (liquid preparation, preparation method 1) and the active ingredient.

Experimental Example 5

Tissue Organ Morphology and Effect of Gonadal Hormone in Rat Hypothalamus-Pituitary-Gonad System of the Invention.

1. Experimental Materials

1.1 Animals: Wistar (200-250 g) Adult rats were provided by the Department of Laboratory Animals, OO Medical College. After adapting the animals to the environment for 1 week, the indoor temperature was 22 ± 3 ℃, relative humidity 50 ± 10%, Ventilation was carried out 10 times / day, during daylight under natural sunlight and at night under fluorescent lamps, and a sufficient amount of solid feed and drink was provided.

1.2 Drugs:

1.2.1 The invention liquid formulation (Preparation 1) was provided by Kukil Pharmaceutical Co., Ltd.

1.2.2 Kits required for RIA (Kit), FSH (Follicle stimulating Hormone), LH (Luteinizing Hormone), T (Testosterone), E ₂ (Estradiol), GH (Growth Hormone) ○○ It was provided by the Institute of Biotechnology.

1.3 Instruments: GB-204 analytical balance (manufactured by Switzerland), 722 centrifuge, 10 DIA-96 type RIAγ-counter.

1.4 Statistical Analysis: Statistical analysis was performed using SPSS10 software.

2. Methods and Results

2.1 Influence on Tissue Organ Weight of Adult Rat Reproductive System of the Invention.

Female and female rats with a body weight of 200-250 g were first acclimated in the laboratory for 1 week, and then the female and male rats were treated with the control group and the experimental group (inventive solution (preparation 1) 1.8 g / kg, 0.9 g / kg). , 0.45 g / kg dose group), and 15 animals in each group. The experimental group was orally administered the solution of the present invention once daily for 60 consecutive days, and the normal control group was administered the same volume of drinking water.

Clinical observations were made 2-3 times daily and weighed once weekly. One hour after the last dose of the drug, anesthetized with 2.6% sodium pentobarbital and lethal, and the pituitary gland, seminal vesicle, testis (ovary) and kidney were rapidly taken and weighed. As a result, the weight of the pituitary, seminal vesicles, testes, ovaries and kidneys of rats was increased to a certain degree in the 1.8 g / kg dose group, and the weight of the pituitary and testicles of the male 1.8 g / kg dose group was significantly increased than that of the control group. (P <0.01, P <0.05). The ovary weight of female rats at 1.8 g / kg dose group showed a significant increase compared to the normal control group (P <0.05) (see Tables 20 and 21).

Table 20 Influence on the Long-term Index Changes of Male Adult Rats of Invention Solution (Preparation 1).

Compared with control, ** P <0.01; * <0.05

Table 21 Influence on the female adult rat long-term index of the solution of the present invention (Preparation 1).

Compared with control, * P <0.05

2.2 Influence on Serum Hormone Concentrations in Adult Rats.

The animal and male rat having a body weight of 200-250 g were first adapted to the environment for 1 week in the laboratory, and then the female and male rats were treated with the control group and the experimental group (inventive solution (preparation 1) 1.8 g / kg, 0.9 g / kg, Four groups, including 0.45 g / kg dose group, were randomly divided into 15 groups. Each experimental group orally administered the invention solution once daily for 60 consecutive days and the normal control group was administered the same dose of beverage. Clinical observations were made 2-3 times daily and weighed once weekly. After 1 hour of drug administration, 2.6% sodium pentobarbital was anesthetized, blood was collected from the heart, and serum standards were taken by centrifuge.FSH and LH were measured by IRMA (Immuno radiometric assay), T, E ₂ And GH were measured by radio-immunoassay (RIA). As a result, the LH and T concentrations of the 1.8 g / kg dose group in male rats were significantly increased (P <0.05), FSH was decreased and there was a significant difference compared to the control group (each P <0.05). In addition, E2 concentration of female rats 1.8 g / kg dose group was significantly increased (P <0.05) (see Table 22, 23).

Table 22 Influence on serum germline hormone concentrations in male rats of the present invention solution (Preparation 1).

Compared to control, * P <0.05

Table 23 Influence on serum germline hormone concentrations in female rats of the inventive solution (Preparation 1).

Compared to control, * P <0.05

2.3 Influence of Tissue Morphology of Adult Rat Germline Organs of the Invention.

The animal and male rat having a body weight of 200-250 g were first acclimated in the laboratory for 1 week, and then the female and male rats were treated with the control group and the experimental group (inventive solution (preparation 1) 1.8 g / kg, 0.9 g / kg, 15 dogs were randomly divided into 4 groups, such as 0.45 g / kg dose group). The experimental group orally administered the solution of the invention once daily for 60 consecutive days, and the normal control group was administered the same dose of beverage. Clinical observations were made 2-3 times daily and weighed once weekly. One hour after the last dose of the drug, anesthetize with 2.6% sodium pentobarbital and lethal. Take the pituitary gland, seminal vesicle, testis (ovary) and kidneys quickly, weigh them, and fix them in Bouinwa seed solution. Paraffin sections were prepared, HE stained, and examined with an oil immersion lens.

2.3.1 Effect on Pituitary Tissue Form of Inventive Solution (Preparation 1).

The FSH and LH cells of the male pituitary gland were round or oval, and the LH cell volume was high and the two cells were distributed in capillary strains. In the control group, cells were elliptical and common to partial cytoplasm. Experimental LH cells were more than control and FSH cells were less.

2.3.2. Influence on the testicular tissue morphology of the solution of the present invention (Preparation 1).

The interstitial cells of the test group were filled with satiety and filled with convoluted tubuies, and the border of the wall was square and the basal membrane was thin. Showed a saw blade shape, tube wall was thinned and the connective tissue was increased between the curved tube.

2.3.3. Influence on the seminal vesicle tissue morphology of the solution of the present invention (Preparation 1)

In the experimental group, the seminal vesicles were irregular in size and secreted in the glandular epithelium. The control group was irregular in luminal size, but there was a relatively large amount of secretory aggregates in the lumen.

2.3.4. Effect on the Ovarian Tissue Form of the Invention Solution (Preparation 1).

In the experimental group, there were many primordial follicles, beginner's follicles, secondary follicles and mature follicles and corpus luteum. The number of mature follicles, corpus luteum, and E2 cells in the epithelial cells and epithelium were greater than in the control group.

2.3.5. Effect on the Kidney Tissue Form of the Invention Solution (Preparation 1).

No microscopic difference was found between the experimental and control groups.

3. Conclusion

3.1 The present invention liquid formulation (the same as Formula 1, below) 1.8 g / kg dose group increased the weight of the seminal gland, testicles, ovary and kidney of the male rat pituitary to a certain degree, The pituitary gland and testicle weights were significantly different compared to normal controls. (P <0.01, P <0.05) Female rats The ovary weight of the 1.8 g / kg dose group of the present invention was significantly increased compared to the normal control group (P <0.05).

Male male rats (Preparation 1) The concentrations of LH and T in the 1.8 g / kg dose group were significantly increased (P <0.05) and the FSH was significantly decreased (P <0.05) compared to the normal control group.

3.3 Inventive solution (Preparation 1) In the 1.8 g / kg administration group, the serum E2 concentration of female rats was significantly increased (P <0.05) compared to the normal control group.

3.4 The present invention solution (Preparation 1) had a certain improvement in the morphology of the pituitary gland, seminal vesicle, testis and ovary.

As described above, the experimental results suggest that the present invention influences the function of the hypothalamus-pituitary-germline system, thus promoting the production and secretion of sex hormones and exerting a visceral or energetic action.

Experimental Example 6 Acute Toxicity Test of the Invention

Acute toxicity test was conducted in accordance with Korea Single Drug Toxicity Test (NITR / SOP / GTX / 601-01).

1. Test Material

1.1 Test Animals:

Healthy mice (18-22 g) were provided by OO University Medical School Laboratory Animal Division (Experimental Animal Pass 10-1022). The experimental animals were reared and experimented in the animal breeding room of the functional experimental center. Animals were housed in room temperature 23 ± 5 ℃, relative humidity 50 ± 10%, ventilation 6 ~ 10 times / day, daylight in daylight and fluorescent lamps at night. Solid feeds and drinks were provided. In general, animals were used for testing after one week of environmental adaptation.

1.2 Drugs:

The product according to Formulation Example 1 of the present invention is provided by Kukil Pharmaceutical Co., Ltd.

1.3 Dosage:

After preliminary testing, the maximum dose of 12,000 mg / kg was given as the highest dose and 2,880 mg / kg as the lowest dose, and five dose groups (12,000, 8,400, 5,900, 4,120, 2,880 mg /) at 0.7 azeotropy. kg) and a control group, and administration was administered orally once administered.

   1.4 Observation Items

1.4.1 General symptoms observation

Abnormal symptoms of all test animals were observed once every hour from 1 hour to 6 hours after administration on the day of administration and twice a day from 1 to 14 days of administration. Careful observation was made for expression, presence of dead animals, and other symptoms likely to be caused by the test substance after administration of the test substance.

1.4.2 Weighing

All experimental animals used in the test were weighed on the day (0 day), 3, 7, 10, 14 days of administration of the test substance.

1.4.3 Necropsy

Survival examples after the end of the test was weighed, anesthetized with ether (ether) and bleeding mortality, and the appearance and internal organ abnormalities were visually observed in detail.

2. Test result

2.1 Observation of dead animals and clinical symptoms

No animals died during the trial in all dose groups. In addition, no symptoms were recognized as toxic by the test substance.

2.2 weight change

There was no significant body weight change in all dose groups compared to the control.

2.3 Visual Autopsy Findings

There were no deaths in the control group and all dose groups, and no gross abnormalities were observed in the surviving individuals.

From the above results, the LD ₅₀ value of the present invention was at least 12,000 mg / kg (approximately 200 times the clinical dose), which is the maximum administrable dose in the rat used in this test, and it is impossible to measure at a higher dose, which can be evaluated as a safe drug. . (See Table 24)

Table 24 Survival rate of bister rats orally administered with the present invention

Experimental Example 7 Effect of the present invention on the body weight, blood normal test, hepatic function, and lipid lipids in normal rats.

1. Experimental Materials

1.1 Animals:

Healthy Wistar rats (180-200 g) were provided by the Department of Laboratory Animals, OO Medical College. After the animals were acclimated for one week, they were kept at room temperature 22 ± 3 ℃, relative humidity 50 ± 10%, ventilation 10 times / day, daylight during the day, under fluorescent light at night, and provided solid feed and drink. .

1.2 Medicine: The present invention liquid formulation (Preparation 1) was provided by Kukil Pharmaceutical Co., Ltd.

1.3 Instrument: GB-204 Cheonpyeong (Swiss), Centrifuge K4500 Fully Blood Flow Analyzer, 7600 Fully Automatic Synthesis Analyzer

1.4 Statistical Analysis: Statistical processing was performed with SPSS10 software.

2. Methods and Results

2.1 Effect of Rat Invention on Weight Change in Rats.

The animal and male rats with a body weight of 180-200 g were first adapted to the environment for 1 week in the laboratory, and then the female and male rats were treated with the control group and the experimental group (inventive solution (the same as the method 1, below)) 1.8 g / kg, 0.9 g / kg, 0.45 g / kg dose group), 15 animals in each group were randomly divided. The experimental group was orally administered the present invention once daily for 60 consecutive days, and the normal control group was administered the same volume of drinking water. Clinical observations were made 2-3 times daily and weighed once weekly. As a result, there was no significant difference in the weight of the rats compared to the control group (see Tables 25 and 26).

Table 25 Influence on the weight of male rats of the invention liquid formulation (Preparation 1).

Table 26 Influence on the weight of female rats of the invention liquid formulation (Manufacturing Method 1).

2.2 Effect on Rat Blood Regularity Test of the Invention.

Female and female rats with a body weight of 180 ~ 200 g were first acclimated for 1 week in the laboratory, and then the female and male rats were treated with the control group and the experimental group (inventive solution (the same as in Formula 1, below)) 1.8 g / kg, 0.9 g / kg, 0.45 g / kg dose group), 15 dogs in each group were randomly divided. The experimental group was orally administered the present invention once daily for 60 consecutive days, and the normal control group was administered the same volume of drinking water. Clinical observations were made 2-3 times daily and weighed once weekly. One hour after the last dose of the drug, anesthesia was performed with 2.6% sodium pentobarbital, blood was collected from the heart, put in a bottle, subjected to anticoagulant treatment, and a red blood cell count (RBC) and white blood cell count (WBC) were used as a K4500 type automatic blood flow analyzer. ), Hemoglobin amount (HGB), erythrocyte volume fraction (HCT), erythrocyte mean volume (MCV), mean erythrocyte hemoglobin (MCH), mean erythrocyte hemoglobin (MCHB), platelet count (PLH) and lymphocyte count (W-SCR) The angular index of blood regular test was measured. As a result, the general blood test index of rats to which the present invention was repeatedly administered for 60 days was not significantly affected (see Tables 27 and 28).

Table 27 Influence on blood regular test of male adult rats of the solution of the present invention (Preparation 1).

Table 28 Influence on blood regular test of female adult rats (Preparation 1).

2.3 Effects of Rats of the Invention on Hepatic, Renal Function and Hemostatic Lipids.

Female and male rats with a body weight of 180-200 g were first adapted to the environment for 1 week in the laboratory, and then the female and male rats were treated with the control group and the experimental group (inventive solution (the same as in Preparation 1, below)) 1.8 g / kg, 0.9 g / kg, 0.45 g / kg dose group), and 15 animals were randomly divided in each group. The experimental group was orally administered the present invention once daily for 60 consecutive days, and the normal control group was administered the same volume of drinking water. Clinical observations were made 2-3 times daily and weighed once weekly. After 1 hour of drug administration, after 2.6% sodium pentobarbital anesthesia, blood was collected from the heart, and after 1 hour, serum was separated by centrifuge, and serum was obtained. ), Total cholesterol (CHO), total protein (TP), carbon dioxide (CO ₂ ), GOT (glutamic-oxaloacetic transaminase), GPT (glutamic-pyruvic transaminase), alkaline phosphatase, creatinine, phosphorous ( P), urea nitrogen, total bilirubin (TBIL), direct bilirubin (DBIL), calcium (Ca), gamma glutamyl transpeptidase (GGT), triglyceride (ALG), and hemoglobin Materials related to were measured. As a result, the various measured values in rats which were repeatedly administered the present invention for 60 days did not have much influence (see Tables 29 and 30).

Table 29 Influences on the hepatic, renal function and hemostatic lipid in male rats of the present invention liquid (Preparation 1).

Table 30 Influence on the hepatic, renal function and hemoglobin of female rats of the present invention solution (Preparation 1).

3. Conclusion

3.1 Rats, which were repeatedly administered the solution (Preparation 1) of the present invention for 60 days, had no significant effect on the change in body weight regardless of cancer or male.

3.2 Rats who repeatedly administered the present invention solution (Preparation 1) for 60 days had no significant effect on blood and rats, as compared to the control group.

3.3 The rats, which were repeatedly administered the solution of the present invention (Preparation 1) for 60 days, had no significant effect on the liver, renal function, and hemoglobin of rats regardless of cancer or male.

As described above, there was no significant effect on the body weight, blood regular test, and various blood biochemical indices of rats repeatedly administered 60 days of the solution of the present invention (Preparation 1). Thus, it can be seen that the present invention is a very safe formulation.

According to the present invention, it is composed of two kinds of animal medicines for tonic, gangjeong, and sexual function improvement and 13 kinds of herbal medicines, and have a stable and safe sexual function enhancement effect with renal activity and anti-fatigue, gangjeong, tonic, sexual function improving effect The functional foods expected to be obtained can be obtained, and the present invention must be an industrially useful invention.

Claims (4)

Silkworms 10-20 wt%, Cornus oil 1-10 wt%, casualty 1-5 wt%, earth and sand 1-5 wt%, Cheongung 1-10 wt%, Deer Antler 1-5 wt%, Base paper 1-5 wt%, Schisandra chinensis 1 to 5% by weight, 1 to 10% by weight cinnamon, 1 to 5% by weight of dew, 20 to 40% by weight, Angelica 5 to 15% by weight, 1 to 10% by weight, 1 to 5% by weight of soft broth and soft water Health functional food for improving kidney activity, anti-fatigue, gangjeong, tonic, sexual function, composed of 0.1 to 1.5% by weight. The dietary supplement of claim 1 wherein the formulation is a powder, granule, tablet, capsule, liquid, suspension or pill. Extract 20-40 wt% of Angelica gigas with purified water, 10-20 wt% of silkworms with ethanol, 1-10 wt% cornus oil, 1-5 wt% casualty, 1-5 wt% earthworm, 1-10 % By weight, 1 to 5% by weight, 1 to 5% by weight of Schisandra chinensis, 1 to 10% by weight of cinnamon, 1 to 5% by weight of dew, 5 to 15% by weight of ginseng, 1 to 10% by weight of gyros, 1 to 5 Extract the weight% and soft water 0.1-1.5% by weight with purified water, collect and extract the extracts, and homogeneously mix the obtained X, add 1 to 5% by weight of antler to prepare the X, or vacuum-dry the X Method for producing a health functional food for improving kidney activity and anti-fatigue, gangjeong, tonic, sexual function, characterized in that the vacuum dried powder is produced. The method of claim 3, wherein the formulation is a powder, granule, tablet, capsule, liquid, or pill.