KR101966983B1 - Compositions for Improving Metabolic Syndrome Containing Pine Leaf Extract a Method for Preparing the Same - Google Patents

Abstract

The present invention relates to a composition for alleviating metabolic syndrome containing a pine leaf extract, capable of alleviating metabolic syndrome. The composition of the present invention comprises: a step S1 of immersing pine leaves in carbonated water to firstly preprocess the same; a step S2 of immersing the pine leaves in a lecithin aqueous solution to secondly preprocess the same; a step S3 of performing how water extraction; a step S4 of filtering the extract; and a step S5 of concentrating the filtrate under reduced pressure.

Description

TECHNICAL FIELD The present invention relates to a composition for improving metabolic syndrome comprising pine needle extract,

The present invention relates to a composition for improving metabolic syndrome, which contains pine needle leaf extract which is capable of improving the metabolic syndrome by extracting active ingredients such as pyrene, germane D, and cryofilene from pine needle leaf.

One of the most important pine leaf ingredients is terpene, a volatile component that blows into the air. At present, more than 40 kinds of terpenes of pine needles are revealed. The most abundant components are alpha-pinene, beta-pinene, beta-pellandrene, beta-chyophyllene, myrcene, camphain, alpha-terpinolene and the like. It is known that when a terpene ingredient of a pine tree is absorbed into the human body, it stimulates the blood vessel wall to circulate blood and activate various functions of the body (Korean Patent Laid-Open No. 10-2009-0038645).

Development of Functional Sausage Using Pine Needle and Pine Leaf Extract and Oxidation Effect of Pine Needle Extract on Fe ion and Active Oxygen Related Fatty Acid Oxidation (Korean Society for Food Science of Animal Resources, 22 (1): 20-29. 2002, Journal of the Korean Society of Food Science and Nutrition, 6 (1): 115-120), Nitrite scavenging effect (enzymatic inhibition activity and nitrite scavenging activity of pine needle leaf extract, Korean Journal of Food Science and Technology, 11 (1): 94-99) .

Studies on the anticancer effect of pine needle have been reported to prevent paralysis by folk therapy and to prevent aging diseases such as neuralgia, arthritis, arteriosclerosis, hypertension and diabetes (Korean Veterinary Journal, 33 (4) ; 701-710, 1993).

The effect of pine needle powder on body fat composition and TBARS content in hypercholesterolemic rats has been reported to inhibit body fat accumulation (Korean Journal of Food Science and Technology, 32 (5) 1186-1190, 2000) .

In particular, terpene, which is the main component of pine leaves, has been reported to contain a large amount of unsaturated fatty acids and to lower the serum concentration of cholesterol in the sensory and mechanical properties of steamed cakes with different amounts of pine leaf powder (Korean Society of Food Science and Technology, 18 (4) 399 -406, 2002).

Korean Patent No. 10-2009-0038645 Korean Patent No. 10-1230388

Effects of Pine Needle Powder on Body Lipid Composition and TBARS Content in High Cholesterol-fed Rats, Korean Journal of Food Science and Technology, 32 (5) 1186-1190, 2000 Anticancer effect of pine needle, Korean Journal of Veterinary Medicine, 33 (4), 701-710, 1993 Enzymatic Inhibitory Activity and Nitrite Scavenging Activity of Pine Needle Fermentation Extract, Hong, Keun - Taek et al. Korean Journal of Food Preservation and Distribution. 11 (1): 94-99  Development of functional sausage using pine needles and green tea extract, Chung, J. et.al. Journal of the Korean Society for Food Science of Animal Resources, 22 (1): 20-29. 2002 Effect of Pine Needle Extract on Skin Health Improvement, Choi Ji Eun et.al. Korean Journal of Food Preservation and Distribution, 6 (1): 115-120 Effect of physiological activity of pine needle hot distillate, Lee Hyo Jin et.al. Journal of the Korean Society of Food Science and Nutrition 2005. 179-183

Therefore, the present inventors evaluated the toxicity and efficacy at the cellular level according to the extraction method of pine leaf extract and examined the effect of the pine leaf extract on the efficacy of metabolic syndrome in adults with metabolic syndrome. And the metabolic syndrome ability was remarkably excellent.

Accordingly, an object of the present invention is to provide an efficacy for improving metabolic syndrome containing pine needle extract.

Another object of the present invention is to provide a method for preparing a composition for improving metabolic syndrome containing pine needle extract.

It is yet another object of the present invention to provide a use for improving metabolic syndrome containing pine needle extract.

The present invention relates to a composition for improving metabolic syndrome containing pine leaf extract and a method for producing the same.

The effect of pine needle extract on cellular efficacy was evaluated by evaluating toxicity and efficacy at the cellular level and the effect of pine needle extract on the metabolic syndrome in adults with metabolic syndrome. .

Hereinafter, the present invention will be described in more detail

One example of the present invention relates to a composition for improving metabolic syndrome containing pine needle extract.

The extract according to the present invention comprises fractional distillation extract, supercritical extract, solvent extract, solvent extract (solvent fraction), and solvent fraction of solvent extract, wherein the pine needle extract is in the form of solution, concentrate or powder .

The pine needle according to the present invention uses a method of separating the active ingredients by hot water extraction, supercritical extraction, fractional distillation and solvent extraction of the raw leaf.

When a mixture of water and alcohol is used as a solvent used for preparing crude extract of pine needle, it is preferable to use a mixture of water and alcohol in an amount of 1% to 100% (v / v), 10% to 100% (V / v), less than 100% (v / v), less than 40% to less than 100% (v / Or a branched or unbranched alcohol aqueous solution of 1 to 4 carbon atoms, which is less than 100% (v / v) or less than 70% and less than 100% (v / v)

The alcohol aqueous solution may be at least one selected from the group consisting of an aqueous methanol solution, an aqueous ethanol solution, an aqueous propanol solution, and an aqueous butanol solution.

The pine needle extract according to the present invention may be a solvent fraction obtained by fractionating a solvent crude extract with an additional solvent. For example, at least one solvent selected from the group consisting of ethyl ether, ethyl acetate and butanol is used as the solvent crude extract Solvent fraction.

For example, the solvent extract obtained by extracting the pine needle with at least one solvent selected from the group consisting of water and a linear or branched alcohol having 1 to 4 carbon atoms is dissolved in at least one solvent selected from the group consisting of ethyl ether, ethyl acetate, and butanol ≪ / RTI >

The content of the pine needle extract as an active ingredient in the composition according to the present invention can be appropriately adjusted depending on the mode and purpose of use, patient condition, symptom type, and the like, and is 0.001 to 99.9% by weight, or 0.1 to 99.9% %, Preferably 0.1 to 50 wt%, or 0.1 to 40 wt%.

The composition according to the present invention may be a pharmaceutical composition, a food or a pharmaceutical composition.

When the composition according to the present invention is a pharmaceutical composition, it can be administered to mammals including human in various routes. The mode of administration may be any mode conventionally used and may be administered, for example, by oral, skin, intravenous, intramuscular, subcutaneous, and the like routes, preferably orally. The composition of the present invention can be administered orally or parenterally in the form of powders, granules, tablets, liquids, pills, flakes, gels, bars, jellies, capsules, ointments, suspensions, emulsions, syrups, Parenteral formulations, suppositories, and parenteral formulations in the form of sterile injectable solutions.

The pharmaceutical composition of the present invention may contain pharmaceutically acceptable and physiologically acceptable carriers, excipients, and diluents in addition to the above-mentioned mixed extracts.

Examples of carriers, excipients and diluents that can be contained in the pharmaceutical composition of the present invention include dextrin, crystalline cellulose, lactose, dextrose, sucrose, sorbitol, mannitol, xylitol, erythritol, maltitol, starch, Gelatin, calcium phosphate, calcium silicate, cellulose, methylcellulose, microcrystalline cellulose, polyvinylpyrrolidone, water, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate and mineral oil.

In the case of formulation, diluents or excipients such as fillers, extenders, binders, humectants, disintegrants, surfactants and the like which are usually used can be used. Solid formulations for oral administration include tablets, pills, powders, granules, capsules and the like, which may contain at least one excipient such as starch, calcium carbonate, sucrose sucrose), lactose, gelatin, and the like. In addition to simple excipients, lubricants such as magnesium stearate talc are also used.

For oral administration, suspensions, solutions, emulsions, syrups, ointments and the like may be used. In addition to water and liquid paraffin which are commonly used simple diluents, various excipients such as wetting agents, sweeteners, have.

Formulations for parenteral administration include sterilized aqueous solutions, non-aqueous solutions, suspensions, emulsions, freeze-dried preparations, suppositories, transdermal preparations and the like. Examples of the suspending agent include propylene glycol, polyethylene glycol, vegetable oil such as olive oil, injectable ester such as ethyl oleate, and the like.

As the suppository preparation, witepsol, macrogol, tween 61, cacao paper, laurin, glycerogelatin and the like can be used.

In an embodiment where the pharmaceutical composition of the present invention is applied to humans, the pharmaceutical composition of the present invention may be administered alone, but is generally administered in a pharmacological manner selected in consideration of the mode of administration and standard phamaceutical practice. May be administered in admixture with a carrier.

For example, the pharmaceutical composition for improving metabolic syndrome containing the pine needle extract of the present invention may be in the form of tablets containing starch or lactose, in the form of capsules containing the active ingredient alone or in an excipient, or in the form of tablets containing flavoring or coloring May be administered orally, buccally or sublingually in the form of an elixir or suspension containing the chemical.

Such liquid preparations may contain suspending agents (e. G., A mixture of a semisynthetic glyceride such as methylcellulose, witepsol or apricot kernel oil and a PEG-6 ester or a mixture of PEG-8 and caprylic / Glyceride mixture such as a mixture of glycerides).

The dosage of the pharmaceutical composition for improving metabolic syndrome containing the pine needle extract of the present invention may vary depending on the patient's age, weight, sex, dosage form, health condition, and disease severity. And may be administered once to several times a day at intervals.

For example, the daily dose may be 0.1 to 500 mg / kg, preferably 0.5 to 300 mg / kg, based on the active ingredient content. The above-mentioned dosage is an average case, and the dose may be high or low depending on individual differences.

If the daily dose of the pharmaceutical composition for improving metabolic syndrome containing the pine needle extract of the present invention is less than the above dose, a significant effect can not be obtained. If the daily dose is more than the above dose, it is not only economical but also out of the commercial dose range It may cause undesirable side effects. Therefore, it is preferable to set the above range.

In particular, when the composition for improving metabolic syndrome containing the pine needle extract of the present invention is administered to the human body, it is considered that there is no worry about side effects in comparison with other synthetic drugs in view of the general characteristics of natural extracts. Actually, Toxicity test for a composition for improving metabolic syndrome which was found to have no effect on the living body.

When the composition according to the present invention is a food composition, the food may be various health functional foods, drinks, food additives, medicines, cosmetics, and the like.

Examples of the health functional foods include, but are not limited to, capsules, tablets, pills, and liquid preparations.

Examples of the above-mentioned general food include, but are not limited to, canned foods, retorted foods, frozen foods, confectionery, bakery products, jam, processed fish products, beverages, beverages, soups, dressings and liquors.

Examples of the food additives described above may be nutritional enhancers, flavor enhancers, flavoring agents, but are not limited thereto.

The content of the pine needle extract and / or the pine needle extract as an active ingredient contained in the health functional food is not particularly limited, depending on the form of the food, the intended use, etc. For example, 0.01 to 15% And the health beverage composition may be added at a ratio of 0.02 to 10 g, preferably 0.3 to 1 g, based on 100 ml.

The health beverage composition of the present invention contains the pine needle leaf extract as an essential ingredient in the indicated ratio, and there is no particular restriction on the liquid ingredient, and it may contain various flavors or natural carbohydrates as an additional ingredient have.

Examples of the above-mentioned natural carbohydrates include monosaccharides such as disaccharides such as glucose and fructose such as maltose, sucrose and the like and polysaccharides such as dextrin, cyclodextrin and the like Sugar, and sugar alcohols such as xylitol, sorbitol, and erythritol.

Natural flavors (tau martin, stevia extracts (e.g., rebaudioside A, glycyrrhizin, etc.) and synthetic flavors (saccharin, aspartame, etc.) can be advantageously used as flavors other than those described above .

The ratio of the natural carbohydrate is generally about 1 to 20 g, preferably about 5 to 12 g per 100 ml of the composition of the present invention.

In addition to the above, the composition for improving metabolic syndrome containing the pine needle extract of the present invention may be used as a nutritional supplement, a vitamin, a mineral (electrolyte), a flavoring agent such as a synthetic flavoring agent and a natural flavoring agent, a coloring agent and a thickening agent (cheese, Organic acids, protective colloid thickening agents, pH adjusting agents, stabilizers, preservatives, glycerin, alcohols, carbonating agents used in carbonated drinks, and the like. In addition, the compositions of the present invention may contain flesh for the production of natural fruit juices and fruit juice drinks and vegetable drinks. These components may be used independently or in combination. The proportion of such additives is not so critical, but is generally selected in the range of 0 to about 20 parts by weight per 100 parts by weight of the composition of the present invention

Another example of the present invention relates to a method for preparing a composition for improving metabolic syndrome containing pine needle extract.

The pine needle extract may be a crude extract obtained by extracting with at least one solvent selected from the group consisting of water and linear or branched alcohols having 1 to 4 carbon atoms.

The process for preparing the pine needle extract according to the present invention will be described in more detail as follows:

The pine needle is washed with water to remove stenosis, dried and then subjected to reflux extraction with an extraction solvent at a weight ratio of about 5 to 20% by weight, preferably 7 to 15% by weight, based on the weight of the pine needle. After extraction, the filtrate is collected by filtration.

The extraction temperature is not particularly limited, but it is preferably 40 to 110 占 폚, preferably 55 to 90 占 폚.

The extraction process may be repeated once or several times. In a preferred example of the present invention, a method of re-extraction after the first extraction may be adopted. In the case of mass production of herbal extracts, The loss is generated due to the high water content, so that the extraction efficiency is lowered only by the first extraction. In addition, the extraction efficiency of each step was verified, and it was found that about 80 to 90% of the total extraction amount was extracted by the second extraction.

In one example of the present invention, when the extraction process is repeated twice, the extractant is subjected to reflux extraction at a weight ratio of about 5 to 15%, preferably 8 to 12%, of the extraction solvent. After the extraction, the filtrate is combined with the filtrate obtained previously and concentrated under reduced pressure to prepare pine leaf extract. The extraction efficiency can be increased by mixing the extraction solution obtained after the second extraction and the filtrate obtained after each extraction, but the extract of the present invention is not limited to the extraction number.

The extraction method used in the present invention may be any method that is commonly used and may be, for example, cold-rolling, hot water extraction, ultrasonic extraction, reflux cooling extraction, supercritical extraction, but is not limited thereto.

The preferred extraction method of the present invention is a method of extracting 100 to 100 parts by weight of a pine needle with 300 to 500 parts by weight of a lecithin aqueous solution, A step S2 of immersing the mixture for 1 to 3 hours and a second pretreatment; mixing 100 parts by weight of the mixture obtained by the second pretreatment with 500 to 100 parts by weight of purified water, followed by S3 A step S4 of cooling the extract extracted with hot water in step S3 and a step S5 of concentrating the filtrate in step S4 to obtain a pine leaf extract.

Here, the pH of the carbonated water is 4.5 to 6, and the aqueous solution of lecithin is composed of 100 parts by weight of purified water and 0.01 to 0.5 parts by weight of lecithin.

Another example of the present invention relates to the use of pine needle extract to improve the metabolic syndrome.

The pine leaf extract is the same as described above.

The present invention relates to a composition for improving metabolic syndrome containing pine needle extract and a method for preparing the same, and the composition for improving metabolic syndrome containing pine needle extract according to the present invention is expected to improve the symptoms of a decreased metabolic syndrome.

1 is a graph showing the LC / UV chromatograms of the hot-water extract (A) and the hot-water extract (B).
2 is a graph showing LC / MS chromatograms and major components of the monoterpene series of hot-water extract (A) and hot-water extract (B).
3 is a graph showing LC / MS chromatograms and major components of the sesquiterpene series of the hot-water extract (A) and hot-water extract (B).
4 is a graph showing the blood pressure (systolic / diastolic blood pressure) results of the placebo group and the test group subjects.
5 is a graph showing the results of blood glucose (fasting blood glucose and glycated hemoglobin) in the placebo group and the test group subjects.
6 is a graph showing blood lipid profiles of the placebo group and test group subjects.
FIG. 7 is a graph showing the results of liver function tests between the placebo group and the test group subjects.
8 is a graph showing the fatigue severity results of the placebo group and the test group subjects.
Figure 9 is a graph showing clinical trial steps.

Hereinafter, the present invention will be described in more detail with reference to the following examples. However, these examples are only for illustrating the present invention, and the scope of the present invention is not limited by these examples.

Hereinafter, the present invention will be described in more detail by way of preferred embodiments of the composition for improving metabolic syndrome.

1-1. Production of pine leaf extract by hot water extraction

100 g of pine needles were immersed in 250 g of carbonated water having a pH of 4.2 for 2 hours to perform primary pretreatment, and the pine needle firstly pretreated was immersed in 350 parts by weight of a 0.1 wt% concentration aqueous solution of lecithin for 2 hours for secondary pretreatment. Then, 500 parts by weight of purified water was mixed with 100 parts by weight of the second pre-treated mixture, followed by hot water extraction at 65 ° C for 4 hours. The hot water extract was cooled for 1 hour and then filtered with a 200 mesh and 300 mesh filter , And the filtrate was concentrated under reduced pressure to obtain pine leaf extract.

1-2. Production of pine needle distillation extract by hydrothermal distillation extraction

1,000 g of purified water was mixed with 500 g of pine leaf, and the mixture was heated to 95 DEG C or higher for 4 hours to distill. When it is cooled, crude distillate and condensate are formed. The crude distillate which is formed in the upper layer is recovered and filtered at 0.2 uM. When the filtrate was aged, a clear liquid essential oil was recovered in the upper layer to obtain a pine needle distillation extract.

2-1. Analysis of pine needle extract according to extraction method

Fig. 1 is an LC / UV chromatogram of the extract (A) of Example 1-1 and the extract (B) of Example 1-2. Fig. 2 is a graph showing the LC / UV chromatogram of the extract (A) 3 is an LC / MS chromatogram of the extract (A) of Example 1-1 and the extract (B) of Example 1-2, showing an LC / MS chromatogram of the monoterpene series of the extract (B) MS chromatogram. Referring to FIGS. 1 to 3, chromatographic results of the pine needle extract according to the extraction methods of Examples 1-1 and 1-2 according to the present invention show that there is a difference in the content of the indicator components according to the extraction method. Separation and analysis of the pine needle extract composition was performed using GC / MS. The yield of Example 1-1 was 1.25 wt%, and the yield of Example 1-2 was 0.75 wt%. The contents (%) of the major components are shown in Table 1 below.

main ingredient Example 1-1 Examples 1-2 monoterpene series
alpha-Pinene 27.12 18.35 Myrcene 4.25 4.98 Beta-Phellandrene 1.42 0.85
sesquiterpene series
Germacrene D 8.92 4.01 Caryophyllene 14.26 8.89 epi-Thunbergol 5.42 3.17

Referring to Table 1, the extraction methods of Examples 1-1 and 1-2 are different, but in Example 1-1, the pine needle surface is modified to be soft by the first pretreatment, resulting in a large difference in yield . In addition, the extract of Example 1-1 and the extract of Example 1-2 have a large difference in the content of the major components. Particularly, the extract of Example 1-1 is alpha-Pinene, Beta-Phellandrene, Germacrene D, Caryophyllene and epi -Thunbergol was significantly higher than that of Example 1-2, indicating that the content of the specific component was increased by the second pretreatment of Example 1-1. In Example 1-1, since the extraction is performed at a relatively low temperature as compared with the conventional hot water extraction, destruction or deformation of the active ingredient can be minimized.

2-2. Preparation of Pine Needle Distillation Extract

Based on the results of the analysis of Table 1 above, the sample to be applied to the experiment of Example 3 was found to have a high content of alpha-Pinene, Beta-Phellandrene, Germacrene D, Caryophyllene and epi-Thunbergol, 1 < / RTI > The pine leaf extract sample was prepared to contain 450 mg of pine leaf extract in one capsule.

3-1. Target person selection and characteristics

The subjects of this study were subjects who were exposed to metabolic syndrome over 20 years of age who wanted to participate voluntarily with a detailed explanation of the purpose and method of the study. A total of 32 patients were randomly assigned to two groups of 16 patients per test group (n = 16 in the test group and n = 16 in the placebo group).

The subjects were selected by screening test and the test pine extract was administered 1 capsule (450mg) three times a day. As shown in FIG. 9, the selected subjects were subjected to the second measurement after taking the test drug for 4 weeks after the first measurement, and then the third measurement was performed for 8 weeks after stopping the test drug consumption. The experiment was carried out with a total of 4 measurements including the screening visit.

3-2. Analysis items and measurement methods

(TG, TC, HDL, LDL), hepatic function tests (AST, ALT, γ-lactamase) were performed on the subjects in the placebo group and the test group. GTP), and fatigue severity scale (mental fatigue, body fatigue, and sensory fatigue).

3-3. Statistical analysis

The mean and standard deviation were calculated by descriptive statistics of the data collected using the SPSS (SPSS 21.0 for window, SPSS Inc., Chicago, IL, USA) statistical program. The two-way ANOVA was used for the interaction effect between pre-ingestion and post-ingestion according to experimental group and control group. Statistical significance was set at p <0.05.

3-4. Clinical trial results

3-4-1. Blood pressure (systolic / diastolic blood pressure)

Table 2 and Figure 4 below show the blood pressure (systolic / diastolic blood pressure) of the test group as a result of the blood pressure (systolic / diastolic blood pressure) of the placebo group and the test group subjects. As a result, Respectively.

variable group visit 1 (n = 17)
mean ± SD visit 2 (n = 19)
mean ± SD difference
mean ± SD time × group
F (p) Systolic blood pressure
(mmHg) Test Products 138.12 ± 12.57 133.47 ± 12.15 -4.65 + 4.47 4.254
(0.047) Placebo 134.47 ± 10.99 133.68 + - 11.94 -0.79 + - 6.44 Diastolic blood pressure
(mmHg) Test Products 87.76 ± 11.50 81.65 ± 8.76 -6.12 ± 7.97 4.860 (0.034) Placebo 87.47 + - 7.27 86.47 + - 6.73 -1.00 5.91

3-4-2. Blood sugar (fasting blood glucose and HbA1c)

As a result of the blood glucose (fasting blood glucose and glycated hemoglobin) of the placebo group and the test group subjects, the blood glucose levels (fasting glucose and glycated hemoglobin) were compared with those of the placebo group and the test group, And the blood glucose level of the test group was significantly lower than that of the placebo group.

variable group visit 1 (n = 17)
mean ± SD visit 2 (n = 19)
mean ± SD difference
mean ± SD time × group
F (p) Fasting blood sugar
(mg / dl) Test Products 107.41 ± 17.13 103.94 ± 12.09 -3.47 ± 12.19 1.060 (0.310) Placebo 106.05 ± 11.17 107.16 + - 16.24 1.11 ± 14.24 Glycosylated hemoglobin
(%) Test Products 5.76 + 0.63 5.69 ± 0.67 -0.06 ± 0.10 4.718 (0.037) Placebo 5.56 ± 0.25 5.58 ± 0.29 0.03 0.14

3-4-3. Blood lipids (TG, TC, HDL, LDL)

As shown in Table 4 and FIG. 6 below, blood lipids (TG) in the test group were significantly lower than those in the placebo group, and blood lipid levels of the test group TG, HDL, and LDL) were lower than those of the placebo group.

variable group visit 1 (n = 17)
mean ± SD visit 2 (n = 19)
mean ± SD difference
mean ± SD time × group
F (p) Triglyceride
(mg / dl) Test Products 280.82 ± 180.49 244.18 +/- 147.75 -36.65 ± 61.86 0.180 (0.674) Placebo 297.68 + - 172.86 288.84 ± 157.57 -8.84 + 263.35 TC
(mg / dl) Test Products 211.71 + - 41.95 188.82 ± 33.91 -22.88 ± 17.46 4.160 (0.049) Placebo 208.26 + - 39.40 204.79 ± 36.84 -3.47 ± 35.55 HDL
(mg / dl) Test Products 48.76 ± 14.31 51.06 + - 12.52 2.29 ± 7.35 1.588 (0.216) Placebo 43.84 + - 7.95 43.32 ± 9.93 -0.53 + - 6.08 LDL
(mg / dl) Test Products 132.53 + - 38.05 120.65 ± 16.09 -11.88 ± 36.88 3.103 (0.087) Placebo 114.89 ± 27.57 122.26 + - 34.02 7.37 ± 28.55

3-4-4. Liver function tests (AST, ALT, γ-GTP)

Table 5 and Figure 7 below show the results of liver function tests between the placebo group and the test group subjects. As a result, liver function tests (AST, ALT, γ-GTP) (ALT, γ-GTP) levels in the test group were lower than those in the placebo group.

variable group visit 1 (n = 17)
mean ± SD visit 2 (n = 19)
mean ± SD difference
mean ± SD time × group
F (p) AST
(lU / l) Test Products 30.82 ± 14.54 26.24 + - 8.42 -4.59 ± 9.80 4.191 (0.047) Placebo 28.26 + - 9.60 29.74 ± 11.19 1.47 7.95 ALT
(lU / l) Test Products 42.53 + - 34.25 40.59 ± 33.41 -1.94 + 16.68 0.048 (0.829) Placebo 40.26 ± 18.33 39.47 ± 13.64 -0.79 ± 15.02 -GTP
(lU / l) Test Products 69.65 ± 36.17 65.41 + - 34.87 -4.24 + - 10.07 2.123 (0.154) Placebo 67.79 + - 34.38 69.00 ± 31.84 1.21 ± 12.11

3-4-5. Fatigue severity scale (mental fatigue, physical fatigue, sensory fatigue)

As shown in Table 6 and 8 below, fatigue severity scale (mental fatigue, fatigue, fatigue, fatigue, fatigue, fatigue, fatigue, fatigue, Body fatigue, and sensory fatigue) were significantly decreased compared to placebo.

variable group visit 1 (n = 17)
mean ± SD visit 2 (n = 19)
mean ± SD difference
mean ± SD time × group
F (p) Mental fatigue Test Products 2.67 ± 0.84 2.12 ± 0.98 -0.55 + 0.84 6.254 (0.017) Placebo 2.51 + - 0.51 2.56 + - 0.76 0.05 ± 0.60 Body fatigue Test Products 2.98 ± 1.03 2.23 ± 0.92 -0.75 ± 0.92 11.417 (0.002) Placebo 2.76 ± 0.63 2.85 ± 0.86 0.09 ± 0.55 Sensory fatigue Test Products 2.71 0.95 2.03 ± 0.80 -0.68 ± 0.61 10.346 (0.003) Placebo 2.63 ± 0.52 2.47 ± 0.44 -0.16 ± 0.34

3-5. Clinical trial conclusions

(TG, TC, HDL, LDL), liver function test (AST, blood pressure), blood glucose (fasting glucose and glycated hemoglobin), blood lipid ALT, γ-GTP), and fatigue severity scale (mental fatigue, physical fatigue, and sensory fatigue), the test group was significantly reduced compared to the placebo group.

It is to be understood that the invention is not limited to the form set forth in the foregoing description. Accordingly, the true scope of the present invention should be determined by the technical idea of the appended claims. It is also to be understood that the invention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims.

Claims (4)

A step S1 of immersing 100 g of pine needles in 250 g of carbonic acid water of pH 4.2 for 2 hours for primary pretreatment;
(S2) of immersing the pine needle firstly pretreated in step S1 in 350 parts by weight of a 0.1 wt% concentration aqueous solution of lecithin for 2 hours, followed by secondary pretreatment;
Mixing 500 parts by weight of purified water based on 100 parts by weight of the second pre-treated mixture in step S2, and then performing hot water extraction at 65 DEG C for 4 hours;
Step S 4 is a step of cooling the extract extracted with hot water in step S 3 for one hour, and then filtering the filtered extract through a filter net;
Wherein the extraction yield of at least one of alpha-Pinene, Beta-Phellandrene, Germacrene D, Caryophyllene, and epi-Thunbergol is improved, A composition for improving metabolic syndrome.
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