KR20150027933A - Compostion for treating acne comprising extracts from Betula platyphylla var. japonica, Punica granatum or Rhus javanica - Google Patents

Abstract

The present invention relates to a composition for treating acne comprising extracts from Betula platyphylla var. japonica, Punica granatum, or Rhus javanica. A composition including extracts of the present invention can be manufactured to have excellent alleviating effects to acne-prone skin. Also, using the composition of the present invention can effectively treat acne compared to the conventional composition.

Description

[0001] The present invention relates to a composition for the treatment of acne, which comprises extracts of Habu, papaya, japonica, Punica granatum or Rhus javanica}

The present invention relates to a composition for the treatment of acne, which comprises an extract of hornblende, pomegranate extract or hundreds of acorn extract.

In addition to hereditary and environmental factors, the onset of acne is caused by active sebum production due to changes in hormone secretion in the body, pore clogging due to abnormal keratinization of the sebaceous follicles, activation of acne bacteria and skin inflammation caused by acne bacteria And the interaction between them. Thus, anti-androgens that inhibit sebum production, non-steroid anti-inflammatory agents that act as anti-inflammatory agents, resorcinol with antimicrobial effect, acne by sulfur and benzoyl peroxide and tetracycline, erythromycin, clindamycin, A method of inhibiting bacterial activity and a method using a vitamin A derivative such as retinoic acid have been used as an acne treatment method. However, these conventional methods for treating acne have various problems in terms of efficacy and skin safety. The use of hormones has been reported to cause adverse effects such as epidermal growth inhibition and hormone abuse. Retinoic acid and benzoyl peroxide have been associated with birth defects, skin irritation, and contact dermatitis, and clindamycin Has been reported to exhibit adverse effects such as the appearance of resistant bacteria, allergic reactions, and photosensitization reactions.

On the other hand, acne treatment is not a short-term treatment but requires continuous and continuous treatment. Therefore, the acne treatment method having the above-mentioned problems can be used only for a short time or within a limited range. In recent years, studies have been actively conducted to search for effective ingredients that can reduce the above-mentioned side effects from natural resources including plants and continuously use them, and have a strong anti-acne effect without harming the human body.

It has been reported that ginseng extract has antibacterial activity against skin cosmetic effects and acne causative bacteria (Korean Patent No. 10-2003-0065703), but the fact that the extracts of hundreds of bark and roots have strong activity against acne bacteria And acne prevention and treatment is not so far reported, and extracts effective for the prevention and treatment of acne from extracts of hundreds of bark, pomegranate or pomegranate are extracted, and acne skin treatment The composition, the food for improvement and the technique for use as a cosmetic have not been disclosed. The present inventors have completed the present invention by isolating and identifying the active ingredient of the extracts of Hwasu, Pansyu, or Hundreds of Blood, and confirming the antimicrobial effect against acne-causing strains and clinical study results.

An object of the present invention is to provide a composition for the treatment of acne, which comprises an extract of Hwanggi, Gramucopulaceae, and Hwangbuk, which exhibits antioxidative and antimicrobial effects and exhibits acne treatment and improvement efficacy.

In one embodiment of the present invention, there is provided a pharmaceutical composition for the treatment of acne or inflammatory skin diseases comprising, as an active ingredient, at least one selected from the group consisting of peel extract, ginseng extract, and hundreds of bamboo extracts. In the above embodiment, when the composition includes both the extract of Hwangbuk, the extract of Ganoderma lucidum and the extract of Hwangbuk, the weight ratio of Hwangpyeom extract: Gwangbukpyu extract: Hwangbukhwa extract is 2: 1: 1. In the above embodiment, the composition is selected from the group consisting of one or more strains selected from the group consisting of Staphylococcus epidermidis, Staphylococcus aureus, and Propionibacterium acnes. Wherein the extract has an antibacterial activity. In the above-mentioned embodiment, the extract is an ethanol extract or a hot-water extract.

In one embodiment of the present invention, there is provided a cosmetic composition for alleviating acne or inflammatory skin diseases comprising, as an active ingredient, at least one member selected from the group consisting of extracts of mushrooms, extracts of ginseng extracts and extracts of hundreds of mushrooms. In the above embodiment, the composition is selected from the group consisting of one or more strains selected from the group consisting of Staphylococcus epidermidis, Staphylococcus aureus, and Propionibacterium acnes. And has an antibacterial activity. In the above embodiment, when the composition includes both the extract of Hwangbuk, the extract of Ganoderma lucidum and the extract of Hwangbuk, the weight ratio of Hwangpyeom extract: Gwangbukpyu extract: Hwangbukhwa extract is 2: 1: 1. In this embodiment, the composition is characterized by reducing skin oil content, reducing skin moisture, reducing skin erythema area, and increasing the number of pores in the skin.

In one embodiment of the present invention, there is provided a food composition for improving acne or inflammatory skin disease comprising, as an active ingredient, at least one member selected from the group consisting of extracts of mushrooms, extracts of ginseng, and extracts of hundreds of mushrooms. In the above embodiment, when the composition includes both the extract of Hwangbuk, the extract of Ganoderma lucidum and the extract of Hwangbuk, the weight ratio of Hwangpyeom extract: Gwangbukpyu extract: Hwangbukhwa extract is 2: 1: 1. In the above embodiments, the composition may comprise at least one selected from the group consisting of Staphylococcus epidermidis, Staphylococcus aureus, and Propionibacterium acnes. Activity. In this embodiment, the extract is an ethanol extract or a hot-water extract.

In the present invention, "acne" refers to sebum secreted from the skin and accumulated in the skin without being able to escape. The acne bacterium, which is the cause of acne, has lipophilic properties and can not grow without sebaceous glands. Therefore, acne bacterium proliferation is limited to many lipids. The major strains causing acne are P. aeruginosa, P. epidermis, S. aureus, P. ovale, and P. acnes. These strains mainly cause skin trouble, body odor and acne, , It has been used as a target strain for evaluating antimicrobial activity of a composition for treating and improving acne and inflammatory skin diseases. Acne caused by the above-mentioned acne bacteria or environmental factors belongs to an inflammatory skin disease. The term "inflammatory skin disease" refers to an itch, swelling, erythema or peeling due to various stimulating factors causing a series of inflammatory reactions in the skin epithelium Inflammatory skin diseases such as acne, acne rash, atopic dermatitis and seborrheic dermatitis are known as inflammatory skin diseases.

In the present invention, "fuji" is firstly recorded in the Song Dynasty of the Song Dynasty, which is a deciduous tree belonging to the Fifth Tree and Manchuria birch, and is also called Fifth Tree. The epidermis has the efficacy of chewing gum, detoxification, Lisu, leopard, geomorphic, and wrinkle, and it has the effect such as open fever, jaundice, eugen, lung poison, syphilis, skin rash, acute tonsillitis, pneumonia, It is widely used for inflammatory diseases and skin diseases mainly because it treats symptoms such as chronic bronchitis, enteritis, dysentery, hepatitis, cystitis, diarrhea, eczema, eczema, Among the prescriptions containing the epidermis recorded in "Dong medicine 寶 鑑", the epidermis and the epidermis are used in the reed and the footwear, suggesting that the epidermis is mainly involved in the inflammation treatment of the skin.

In the present invention, "ginseng leaf" is a dried pomegranate root, stem or branch of pomegranate belonging to the genus Pomegranate, and has the effect of collecting and harvesting the intestines and causing diarrhea, diarrhea, bleeding, Treats abdominal pain, treats bacterial diarrhea and various infectious inflammations. Pelletierin, isopelletriene, and prosudopelletieryin, which are alkaloids in the composition of pomegranate, exhibit a controlling action, and exhibit an inhibitory action against a microorganism such as a microorganism such as a fungus.

In the present invention, "Hundreds of Waters" is a bark from which the cork layer of the lacquer tree is removed, and is used to wash the wounds with the same origin as the bark of Rhus javanica, and is used for treating hemorrhage, poisoning,

The composition comprising the extract of the present invention, pomegranate extract or hundreds of pound extracts can be used to effectively prevent and treat acne. In addition, it is possible to produce a composition for improving acne skin which has no side effects, can be continuously used, and has excellent stability compared to conventional acne remedies.

1 is a graph showing the antimicrobial activity of a composition containing the natural extract of the present invention against acne-causing bacteria.
Figure 2 shows the results showing the minimal inhibitory concentration of a composition comprising the natural extract of the present invention.
FIG. 3 shows the results of measurement of cytotoxicity against CaCo-2 (human gut epithelial cell) cell line of the cosmetic composition for improving acne comprising the natural extract of the present invention.
FIG. 4 shows the cytotoxicity of HC11 (mouse breast epithelial cell) of the cosmetic composition for acne improvement containing the natural extract of the present invention.

Manufacture of natural extract

1.1 Materials

Samples of Korean domestic products such as Korean peony, Chinese peony, Korean peony and Korean peony were purchased from Han Kook Lee (Korea).

1.2 Preparation of extract

In the present invention, the extracts of the husks, pomegranate seeds and hundreds of saltings were extracted using alcohol or water.

1) Ethanol extract

The dried medicinal herb was disrupted, and 70% ethanol of 10 times the dry weight was added thereto, followed by extraction at room temperature for 24 hours. The extract was recovered after being filtered through a screen, and this process was repeated twice to obtain a primary filtered extract. The 70% ethanol extracts that had been primarily filtered were further filtered using a 5 μm filter paper (Advantec, No. 2), and then concentrated under reduced pressure at 40 ° C. five times. The concentrated extract was lyophilized at -80 ° C for 12 hours to 24 hours to obtain a powder, which was stored at -20 ° C while being frozen.

2) Hot water extract

The hot - water extracts were prepared using the commonly used hot water extraction method. First, the medicinal herb was crushed and distilled water 10 times the weight of the medicinal herb was added and extracted at 100 ° C for 2 hours. The extracted liquid was filtered through a sieve and recovered. Such a process was repeated twice to obtain a primary filtered hot water extract. The primary filtered hot-water extract was filtered using a 5 μm filter paper (Advantec, No. 2), and then concentrated under reduced pressure at 40 ° C five times. The concentrated extract was lyophilized at -80 ° C for 12 hours to 24 hours to obtain a powder, which was stored at -20 ° C while being frozen.

1.3 Extract Classification

(BKE: Betula platyphylla var. Japonica in Korea-70% EtOH extract), Betula platyphylla var.japonica in Korea-hot water extract, Chinese herbal extracts of ethanol BCE: Betula platyphylla var. Japonica inChina-70% EtOH extract), Betula platyphylla var. Japonica in China-hot water extract, PGE: Punica granatum in Korea 70% EtOH extract (RJE: Rhus javanica in Korea-70% EtOH extract) and HJS (Rhus javanica in Korea-hot water extract) were investigated.

Extract classification Extract classification sign Ethanol extract (domestic) BKE Hot water extract (domestic) BKW Ethanol extract (from China) BCE Chinese herbal extract (hot water extract) BCW Ganoderma lucidum (domestic) ethanol extract PGE Ganoderma lucidum (domestic) hot water extract PGW Hundreds of pear (domestic) ethanol extract RJE Hundreds of pine (domestic) hot water extract RJW

Antimicrobial activity measurement

2.1 Culture of strains

Staphylococcus epidermidis (KCTC 1917), Staphylococcus aureus (KCTC 1927), Escherichia coli (KCTC 2571), Staphylococcus aureus Pseudomonas aeruginosa (KCTC 1637) in an aerobic state at 25 ° C in NB / NA medium, Candida albicans (KCTC 7965) in an aerobic state at 37 ° C in NB / NA medium, YMB / YMA medium And Propionibacterium acnes (KCTC 3314) were cultured in an anaerobic state at 37 ° C in RCMB / RCM medium, respectively.

2.2 Antimicrobial activity measurement

Disc diffusion assay was used to examine the antimicrobial activity of each extract. Each strain suspension (106 CFU / ml) was prepared at the best time of activity and 100 ul of each strain was dispensed into the solid medium of each strain. The sterilized triangle rod was used for smearing. After drying, the sterilized 8 mm paper disc (ADVANTEC, Japan) was placed on the dried medium and the extracts were dispensed and cultured according to the culture conditions of each strain. Thereafter, the presence or absence of the formation of a growth zone around the disk and the size thereof were measured.

As a result, all of the extracts were active against S. epidermidis , S. aureus , P, acnes , and particularly, the extracts of pomegranate ethanol and hundreds of pearl ethanol showed remarkably excellent activity (see FIG. 1).

2.3 Evaluation of Minimum Inhibitory Concentration (MIC)

The minimum inhibitory concentration of each extract was determined by the modified Andrew 's method. The concentration of each bacterial strain was adjusted to 106 CFU / ml, and 50 μl of each was added to the tube. The extract was treated with 50 μl of each concentration and 900 μl of the liquid medium, cultured in each culture condition, The turbidity of the culture was measured to analyze the inhibitory activity.

The extracts of S. epidermidis, S. aureus, P. acnes, and E. coli, which can induce inflammation according to skin condition or skin condition, Respectively. In addition, the extract of Korean peony showed lower inhibitory concentration than that of peony Chinese extract, showing similar results as the disk diffusion method. MIC analysis of S. epidermidis, S. aureus, P. acnes and E. coli showed excellent MIC concentration. Particularly, hundreds of ethanol extracts and ethanol extracts of pomegranate showed low MIC concentrations (see FIG. 2).

Cytotoxicity of cosmetics containing natural extracts

We have confirmed the toxicity of skin, serum and cleansing foams developed by cosmetics with improving efficacy against acne to epithelial cells.

2 × 10 4 cells per well and 1 × 10 4 cells per well were inoculated into the 96 well plate of CaCo-2 (human intestinal epithelial cell) and HC11 (mouse mammary epithelial cell) And cultured under CO 2 conditions. On the next day, the drug was treated and incubated again overnight, then the MTS solution was added at 20ul per well. After incubation at 37 ° C and 5% CO 2 for 4 hours, the absorbance was measured at 490 nm.

As a result, both skin and serum were not toxic to epithelial cells. In the case of cleansing foams, toxicity was shown at a high concentration of 1000 ug / ml (CaCo-2: see FIG. 3, HC 11: see FIG. 4), but this result was due to the detergent component contained in the cleansing foam Can be estimated.

Husk  Clinical efficacy of acne extract in combination cosmetic products

4.1 Study subjects

From October, 2012 to March, 2013, he was admitted to Suncheon Oriental Medicine Clinic, Sunchon Herbang Hospital, and was admitted to the dermatology clinic. He was diagnosed with facial acne after treatment with a dermatologist and a professional practitioner. The study was conducted in a 35-year-old acne patient who met all the criteria and did not meet the exclusion criteria. In addition, before entering clinical studies, subjects were given detailed descriptions of the purpose and contents of the clinical study, and only those patients who signed the patient consent were included in the study. Among the 67 participants, the test subjects except for 7 screening subjects were 12 (40.0%) and 18 (60.0%) in the control group and 9 (30.0%) in the test group and 21 (70.0%). The mean age was not significantly different between the control group (21.17 years) and the test group (21.8 years) (p = 0.466). In addition, there were no statistically significant differences in educational attainment, marital status, dietary habits, exercise habits, smoking status, drinking habits, medication use, and morbidity. Of the 60 patients who participated in the study, 49 except for 11 patients who had dropped out of the study terminated the clinical study according to the 8 - week clinical trial plan.

4.2 Study Method

The products used in the clinical trials were the prototypes manufactured by MEDI-PLAN Co., Ltd. The subjects were randomly assigned to one of the test extract group and the control group to receive the subject number. In order to maintain double blindness, the subjects were packed in the same shape and the subjects were randomly assigned to one of the two groups from the lowest number in order of first visit.

4.2.1 Test products

① Name: Cosmetics including extract complex (Hwangbyeol extract: Ginseng extract: Hwangbuk Hundred Blood extract = 2: 1: 1)

② Formulation: Foam cleansing 170ml, lotion 100ml, ampule 30ml and three kinds

(3) The amount of the raw material product is as shown in Tables 2 to 4 below.

Composition of Foam Cleanser division ingredient Content (% by weight) Group 1 Lauric Acid
Myristic Acid
Palmitic Acid
Stearic Acid
Honeycomb Wax (Bees Wax)
Sorbitan Olivate 3.5
3.8
6.6
5.4
1.5
2.0 Group 2 Aqua
Medi Plan Extract
Lauraide diethanolamine (Lauramide DEA)
EDTA
1,2-pentanediol / gold extract /
Mulberry extract
1,3-butylene glycol (Butylene Glycol)
Glyoerin 23.1
3.0
1.8
0.1
2.0

3.5
8.0 Group 3 Aqua
Potassium Hydroxide 15.0
4.4 Group 4 Ash (Cheju Island scoria)
Yellow Ocher 2.0
1.0 Group 5 Olive oil PEG-7 Esters
Sodium PEG-7 Oil Carboxylate
Sodium cocoyl apple amino acid
(Sodium Cocoyl Apple Aminoacids)
Grapefruit Seed Oil
Lavender Oil 3.0
5.0
5.0

0.2
0.1 Total amount 100

Composition of Toner division ingredient Content (% by weight) Group 1 ethanol
PEG-60 Hydrogenated Castor Oil
Glyoeryl Caprate < RTI ID = 0.0 >
Triethyl citrate (Triethyl citrate) 2.0
1.0
1.0
1.0 Group 2 Aqua
Xanthan Gum
D-Panthenol (D-Panthenol)
1,3-Butylene Glycol (1,3-Butylene Glycol)
Allantoine
Sodium hyaluronate
Horsetail extract
Medi Plan Extract
1,2-pentanediol / gold extract /
Mulberry extract 78.98
0.02
1.0
2.0
0.1
0.9
3.0
7.0
2.0 Total amount 100

Composition of ampule division ingredient Content (% by weight) Group 1 ethanol
Glyoeryl Caprate < RTI ID = 0.0 >
4-Terpineol < / RTI >
PEG-60 Hydrogenated Castor Oil 3.0
1.0
0.5
1.0 Group 2 Aqua
Xanthan Gum
Aloe Vera Gel
Carbomer
1,3-Butylene Glycol (1,3-Butylene Glycol)
Betaine
D-Panthenol (D-Panthenol)
Sodium hyaluronate
EDTA-2NA 54.24
0.05
10.0
0.01
2.0
3.0
3.0
3.0
0.1 Group 3 Triethanolamine 0.1 Group 4 Copper Tripeptide-1
White tea fermentation extract
Medi Plan Extract
1,2-Pentanediol / Golden extract / Root extract 2.0
5.0
10.0
2.0 Total amount 100

4.2.2 Control Products

① Name: Control

② Formulation: Foam cleansing 170ml, lotion 100ml, ampule 30ml and three kinds

③ Amount of raw materials: Does not contain peanut extract compound.

4.2.3 Usage and Usage

1) Usage

170 ml of foam cleansing for 8 weeks, 200 ml of lotion and 60 ml of ampoule were used.

2) How to use

Foam cleansing was used for cleansing twice a day morning and evening. After cleansing, an appropriate amount of toner was applied to the face, and the ampoule was applied only to the acne area.

4.3 Evaluation Items

4.3.1 Validity Evaluation

1) Primary effectiveness evaluation

A) Acne Severity System (GAGS, Global Acne Grading System)

The acne severity system (GAGS) is divided into 6 sections according to the surface area distribution and density of the pilosebaceous units in the facial region, chest and back region, and each factor is given a unique factor, Local scoring was applied to each part to reflect the score on the global score and graded. The dermatologists and professional practitioners were evaluated at 0, 4, and 8 weeks for 3 times. The intrinsic factors and overall score of each section are as follows (Table 5 and Table 6).

Acne Severity System (GAGS) Location Factor Ⅰ. Forehead 2 Ⅱ. Right cheek 2 Ⅲ. Left cheek 2 IV. Nose One Ⅴ. Chin One VI. Chest and upper back, 3

Local score = Location factor x Grade (0-4) ^*

* Grade ^* : 0 (No lesions), 1 (≥ one comedone), 2 (≥ one papule)

3 (≥ one pustule), 4 (≥ one nodule)

GAGS's Global Score 0 None 1 to 18 Low (Mild) 19 to 30 Moderate 31 ~ 38 Severe > 39 Very Severe

B) Results of evaluation

There was no statistically significant difference (p = 0.935) between the two groups, with 28.37 in the control group and 28.23 in the test group before the global score of the subjects. The global scores after 4 weeks of use were 28.17 in the control group and 20.93 in the test group, respectively, which showed a decrease of 0.20 and 7.30, respectively, compared to the baseline values. There was a significant difference between the two groups (p = 0.000) Comparisons were made between the groups before and after the use of the product, with a significant decrease only in the test group (p = 0.541, p = 0.000, respectively).

An ANCOVA analysis of adjusted baseline differences showed a significant difference in the mean of both groups for the 4 week change (p = 0.000). After 8 weeks of use, the control group showed a decrease of 26.57 and the test group showed a decrease of 1.80 and 12.30, respectively (p = 0.001, p = 0.000, respectively). However, the decrease in the test group was statistically significantly greater than that of the control group (p = 0.000). ANCOVA analysis of adjusted baseline values showed statistically significant changes in the mean values for the 8-week period in both groups (p = 0.000) (Table 7).

Average distribution of global scores Measurement variable
(Evaluation variable)

Control group Test group p-value ^a
p-number ^b
Mean ± SD Global Score (ITT set)
(n = 30 vs. 30)






Baseline 28.37 + - 6.043 28.23 + - 6.64 0.935 After 4 weeks 28.17 + - 6.00 20.93 + - 6.539 0.000 0.000

Difference ^c -0.20 ± 1.77 -7.30 ± 5.53 0.000 p-number ^d 0.541 0.000 8 weeks 26.57 + - 5.61 15.93 + - 7.71 0.000 0.000

Differences ^e -1.80 + 2.66 -12.30 ± 6.15 0.000 p-number ^d 0.001 0.000

a: comparison between control and test group: p-value by Student's t-test

b: comparison of control and test groups: p-value by ANCOVA (adjustment with baseline)

c: After 4 weeks - baseline

d: comparison within each group: p-value by paired t-test

Crossover analysis was used to compare the percentage of global and non-declining global scores after 8 weeks compared to baseline. As a result, the ratio of the reducer was 66.7% in the control group and 93.3% in the test group, indicating that the decrease ratio in the test group was significantly higher than that of the control group (p = 0.024) (Table 8).

Analysis of Global Score Decreaser Ratio division Reduction body ^a Non-reducer
(Non-Decreaser) p-value ITT set Control group 20 (66.7) 10 (33.3) 0.024 Test group 28 (93.3) 2 (6.7)

2) Secondary effectiveness evaluation

A) Skin oil and moisture measurement (Skin-O-Met)

Subjects underwent skin stabilization at a point where the test site was rinsed with flowing water and maintained at constant temperature and humidity (temperature 22 ± 2 ° C, humidity 40-60%) for at least 30 minutes. The area of 1 cm from the forehead was measured and analyzed by a dedicated program (MPA5, CK electronics, Germany) using Skin-O-Mat (SM815, CK electronics, Germany). In order to minimize the error of measurement, two measurements were taken at one time, and three measurements were taken at 0, 4, and 8 weeks.

B) Test of changes in oil level

The baseline values of the subjects were 81.53 in the control group and 86.32 in the test group. There was no statistically significant difference between the two groups (p = 0.627). There was a statistically significant decrease (p = 0.000 in both groups) in both groups, as the oil level at 4 weeks after using the product was 53.65 in the control group and 52.65 in the test group, which was 27.88 and 33.67, respectively. However, there was no statistically significant difference between the two groups (p = 0.493). The ANCOVA analysis of adjusted baseline values did not show a significant difference between the two groups (p = 0.626). After 8 weeks of use, the control group showed 49.37 and 47.15, respectively, which was 32.17 and 40.37 lower than the basal value, respectively. The changes in both groups were statistically significant (p = 0.000 in both groups) There was no significant difference between the two groups (p = 0.441). The ANCOVA analysis of baseline corrected ANOVA showed no statistical significance at 8 weeks (p = 0.532) (Table 9).

Average distribution of oil level changes Measurement variable Control group Test group p-value ^a p-number ^b Mean ± SD Global Score
(ITT set)
(n = 30 vs. 30)
Baseline 81.53 ± 30.82 86.32 + - 43.84 0.627 After 4 weeks 53.65 ± 25.34 52.65 ± 36.46 0.902 0.626 Difference ^c -27.88 ± 33.58 -33.67 ± 31.24 0.493 p-number ^d 0.000 0.000 After 8 weeks 49.37 ± 21.05 47.15 ± 11.49 0.607 0.532 Differences ^e -32.17 ± 33.40 -40.37 + 47.35 0.441 p-number ^d 0.001 0.000

C) Test of changes in the water level

The baseline values for the subjects' water levels were 50.16 for the control group and 48.69 for the test group, and there was no statistically significant difference between the two groups (p = 0.592). Moisture level after 4 weeks of use was 51.09 in the control group, 41.55 in the test group, 0.93 in the control group, and 7.14 in the test group, showing a significant difference between the two groups = 0.022), and statistical significance was observed only in the test group (p = 0.011). An ANCOVA analysis of differences in baseline values showed a significant difference in the mean of both groups for the 4 week change (p = 0.002). After 8 weeks of use, the control group showed a decrease of 0.43 and 1.54, respectively, compared to the baseline value of 49.73 and 47.15, respectively, but no statistical significance was observed (p = 0.848, p = 0.573, respectively). ANCOVA analysis of baseline corrected ANOVA showed no statistical significance at 8 weeks (p = 0.400) (Table 10).

Average distribution of moisture level changes Measurement variable Control group Test group p-value ^a p-number ^b Mean ± SD Global Score
(ITT set)
(n = 30 vs. 30) Baseline 50.16 ± 10.52 48.69 ± 10.60 0.592 After 4 weeks 51.09 + - 10.01 41.55 + 12.03 0.001 0.002 Difference ^c 0.93 + - 11.97 -7.14 ± 14.45 0.022 p-number ^d 0.672 0.011 After 8 weeks 49.73 ± 9.69 47.15 ± 11.49 0.350 0.400 Differences ^e -0.43 ± 12.08 -1.54 + 14.84 0.750 p-number ^d 0.848 0.573

D) Skin erythema and pore measurement

Subjects underwent skin stabilization at a point where the test site was rinsed with flowing water and maintained at constant temperature and humidity (temperature 22 ± 2 ° C, humidity 40-60%) for at least 30 minutes. Dermavision, a skin measuring device, consists of cross polarized light, parallel polarized light and UV image. The measurement method is to put the chin of the experimenter on the chin support, attach the forehead, align the vertical line on the monitor with the center of the face, and shoot. 0, 4, and 8 weeks.

(E) Verification of changes in the erythemal normal area

The baseline values for the erythematous normal area of the subjects were 72.99 in the control group and 75.53 in the test group, and there was no statistically significant difference between the two groups (p = 0.604). The mean area of erythematous plaque after 4 weeks of use was 72.67 in both groups, which was 0.32 and 2.86 lower than basal values, respectively. There was statistical significance at the border only in the test group (p = 0.077). However, in the ANCOVA analysis of adjusted baseline differences, there was no significant difference between the two groups (p = 0.371). There was no statistical significance (p = 0.971 and p = 0.361) after 8 weeks of use, in the control group, 72.92 and 73.68, respectively, showing a decrease of 0.07 and 1.85, respectively. The ANCOVA analysis of adjusted baseline values showed no statistical significance at 8 weeks (p = 0.551) (Table 11).

Average distribution of erythematous normal area changes Measurement variable Control group Test group p-value ^a p-number ^b Mean ± SD Global Score
(ITT set)
(n = 30 vs. 30) Baseline 72.99 ± 20.15 75.53 + - 17.45 0.604 After 4 weeks 72.67 ± 20.04 72.67 ± 15.72 0.999 0.371 Difference ^c -0.32 + -10.36 -2.86 + - 8.55 0.305 p-number ^d 0.866 0.077 After 8 weeks 72.92 + - 22.49 73.68 + - 18.24 0.887 0.551 Differences ^e -0.07 ± 9.93 -1.85 +/- 10.93 0.511 p-number ^d 0.971 0.361

F) Verification of changes in the number of pores

The baseline values for the number of pores in the subjects were 4648.27 in the control group and 4672.33 in the test group, and there was no statistically significant difference between the two groups (p = 0.834). The number of pores after 4 weeks of use was 4826.63 in the control group and 4793.47 in the test group, which was increased by 178.37 and 121.13, respectively, compared with the baseline value, and a statistically significant increase was observed in both groups (p = 0.001 and p = 0.034, respectively) ). However, no statistically significant difference was observed between the two groups (p = 0.445), and ANCOVA analysis of baseline differences showed no significant difference between the two groups (p = 0.465 ). After 8 weeks of use, the control group showed 4906.73 and the test group had 4801.37, which showed an increase of 258.47 and 129.03, respectively. There was statistically significant difference in both groups (p = 0.000 and p = 0.017, respectively). In the ANCOVA analysis with baseline corrected values, mean changes over 8 weeks were statistically significant at the border (p = 0.070) (Table 12).

Average distribution of changes in the number of pores Measurement variable Control group Test group p-value ^a p-number ^b Mean ± SD Global Score (ITT set)
(n = 30 vs. 30) Baseline 4648.27 ± 451.08 4672.33 + - 436.12 0.834 After 4 weeks 4826.63 + - 495.02 4793.47 + - 466.80 0.790 0.465 Difference ^c 178.37 ± 278.25 121.13 + - 297.92 0.445 p-number ^d 0.001 0.034 After 8 weeks 4906.73 + - 459.04 4801.37 + - 443.94 0.370 0.070 Differences ^e 258.47 ± 261.20 129.03 ± 279.99 0.069 p-number ^d 0.000 0.017

G) Skindex 29

A total of three evaluations were performed at 0, 4, and 8 weeks using the Korean version of Skindex 29.

A) Skindex 29 Test of numerical change

The baseline values for the Skindex29 values of the subjects were 59.37 in the control group and 59.53 in the test group, and there was no statistically significant difference between the two groups (p = 0.976). Skindex29 values at the 4 weeks after the product use were 55.50 in the control group and 54.70 in the test group, respectively, which showed a 3.87 and 4.83 decrease compared with the baseline, respectively. In the control group, the borderline significance was shown (p = 0.082) (P = 0.003), respectively. However, the difference between the two groups did not reach statistical significance (p = 0.714). In the ANCOVA analysis of adjusted baseline values, there was no significant difference between the two groups (p = 0.714). After 8 weeks of use, the control group showed 50.73 and the test group showed 52.70, showing a decrease of 8.63 and 6.83, respectively, and statistical significance was observed in both groups (p = 0.000 and p = 0.002, respectively). However, ANCOVA analysis of adjusted baseline values did not show statistical significance between the two groups (p = 0.570) (Table 13).

Measurement variable Control group Test group p-value ^a p-number ^b Mean ± SD Global Score
(ITT set)
(n = 30 vs. 30) Baseline 59.37 ± 20.32 59.53 + - 22.26 0.976 After 4 weeks 55.50 ± 20.11 54.70 ± 22.86 0.886 0.714 Difference ^c -3.87 ± 11.76 -4.83 + - 8.25 0.714 p-number ^d 0.082 0.003 After 8 weeks 50.73 + - 19.91 52.70 ± 21.55 0.715 0.507 Differences ^e -8.63 ± 11.37 -6.83 ± 10.74 0.531 p-number ^d 0.000 0.002

4.3.2 Stability assessment

In order to evaluate the stability of the product used in the present invention, vitality signs and hematological tests were performed before the product was used and after 8 weeks of use, and side effects and adverse reactions were evaluated throughout the study period as described in Table 14 below.

Clinical trial schedule term Screening Treatment period visit -14 1 ± 7 28 ± 7 56 ± 7 Primary Secondary Third Fourth Subject agreement O Basic examination O Physical examination O O Vital sign O O O O Examination of disease / drug history O Decision of inclusion / exclusion criteria O Criteria for discontinuance / drop out O O Clinical pathology examination O O Visual evaluation O O O Photograph facial picture O O O Measure of skin Sebum O O O Measure of skin moisture O O O Measure of skin erythema O O O Measure of skin pores O O O Prescription of experimental / control cosmetics O Examination of concurrent medication history O O Examination of adverse event O O Product compliance test O O Questionnaire assessment O O

During the 8 - week study period, there were no clinically significant changes in vital signs and hematologic tests in both the test and control groups, and no side effects or adverse reactions were observed. Therefore, the test product and the comparative product were judged to be safe for human body.

4.4 Statistical Analysis

For the analysis of the result of the third embodiment, an Excel program and a statistical program SPSS Window, version 19.0 were used. For statistical significance, a significance level of 0.05 was set. The statistical methods used in the analysis were compared and analyzed by applying the Paired t-test to the changes before and after the use of the prototype, and the comparison between the test group and the control group was performed by applying ANCOVA and Student's t-test.

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

The composition of the present invention may be administered to humans or animals by various routes including parenteral, intraarterial, intradermal, transdermal, intramuscular, intraperitoneal, intravenous, subcutaneous, The dosage varies depending on the patient's body weight, age, sex, health condition, diet, administration time, administration method, excretion rate, and disease severity. The daily dose of the composition is about 10 ng / kg to 10 mg / kg, preferably about 80 to 400 ng / kg, and it is more preferable to administer the composition once a day or several times a day.

When the composition of the present invention is manufactured from a pharmaceutical composition, the pharmaceutical composition of the present invention includes a pharmaceutically acceptable carrier. The pharmaceutically acceptable carriers to be contained in the pharmaceutical composition of the present invention are those conventionally used in the present invention and include lactose, dextrose, sucrose, sorbitol, mannitol, starch, acacia rubber, calcium phosphate, alginate, gelatin, But are not limited to, calcium silicate, microcrystalline cellulose, polyvinylpyrrolidone, cellulose, water, syrups, methylcellulose, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate and mineral oil. It is not. The pharmaceutical composition of the present invention may further contain a lubricant, a wetting agent, a sweetening agent, a flavoring agent, an emulsifying agent, a suspending agent, a preservative, etc. in addition to the above components. Suitable pharmaceutically acceptable carriers and formulations are described in detail in Remington ' s Pharmaceutical Sciences (19th ed., 1995).

The pharmaceutical composition of the present invention can be administered orally or parenterally, and is preferably administered orally.

The appropriate dosage of the pharmaceutical composition of the present invention may vary depending on factors such as the formulation method, administration method, age, body weight, sex, pathological condition, food, administration time, administration route, excretion rate, . A preferred dosage of the pharmaceutical composition of the present invention is within the range of 0.001-100 mg / kg on an adult basis.

The pharmaceutical composition of the present invention may be formulated into a unit dose form by formulating it using a pharmaceutically acceptable carrier and / or excipient according to a method which can be easily carried out by a person having ordinary skill in the art to which the present invention belongs. Or by intrusion into a multi-dose container. The formulations may be in the form of solutions, suspensions, syrups or emulsions in oils or aqueous media, or in the form of excipients, powders, powders, granules, tablets or capsules, and may additionally contain dispersing or stabilizing agents.

The present invention provides a health functional food comprising a composition comprising a mushroom extract, a mushroom extract, and a few hundred parts of a mushroom extract, which are natural products showing an acne improvement effect, and a pharmaceutically acceptable food supplementary additive. Foods to which the composition of the present invention can be added include, for example, various foods, beverages, gums, tea, vitamin complexes, and health functional foods. It can also be added to foods or beverages for the purpose of preventing allergic diseases. At this time, the amount of the composition of the present invention in the food or beverage may be 0.01 to 5% by weight of the total food, and the health beverage composition may be added in a proportion of 0.02 to 2 g or 0.3 to 1 g based on 100 ml .

The health functional beverage composition of the present invention is not particularly limited as long as it contains the composition of the present invention as an essential ingredient in the indicated ratios and may contain various ingredients such as various flavors or natural carbohydrates such as ordinary beverages . Examples of the above-mentioned natural carbohydrates include monosaccharides such as glucose and fructose; Disaccharides such as maltose, sucrose and the like; And polysaccharides such as dextrin, cyclodextrin and the like, and sugar alcohols such as xylitol, sorbitol and erythritol. As other flavors other than those mentioned above, natural flavors such as tau martin, stevia extract such as rebaudioside A, glycyrrhizin and the like; And synthetic flavors such as saccharin, aspartame and the like can be advantageously used. The ratio of the natural carbohydrate is generally about 1 to 10 g, preferably about 5 to 6 g per 100 ml of the composition of the present invention.

In addition to the above, the composition of the present invention can be applied to various foods such as various nutrients, vitamins, minerals (electrolytes), synthetic and natural flavors, coloring agents and heavy stabilizers (cheese, chocolate etc.), pectic acid and its salts, alginic acid and its salts, Colloid thickening agents, pH adjusting agents, stabilizers, preservatives, glycerin, alcohols, carbonating agents used in carbonated drinks, and the like. These components may be used independently or in combination. At this time, although the ratio of the additive is not so important, it is generally selected from the range of 0 to about 10 parts by weight per 100 parts by weight of the extracts of hornblende, pomegranate and several hundred parts of salt of the present invention.

Examples of formulations for the composition of the present invention are illustrated below. However, the following formulation examples are merely illustrative of the present invention, and the content of the present invention is not limited by the following formulation examples.

[Formulation Example 1]

Manufacture of flexible lotion (skin)

Composition of the present invention 1.0 wt%

1,3-butylene glycol 5.2 wt%

Oleyl alcohol 1.5% by weight < tb >

Ethanol .......................................... 3.2 wt%

Polysorbate 20 3.2% by weight < tb >

Benzophenone-9 2.0% by weight < tb >

Carboxyl vinyl polymer: 1.0 wt%

Glycerin ........................................ 3.5 wt%

Incense .............................................. Trace

Preservative .......................................... Trace

Purified Water .......................................... Trace

[Formulation Example 2]

Production of milk lotions

The composition of the present invention. 1.0 wt%

Glycerin ......................................... 5.1 wt%

Propylene glycol 4.2 wt%

Tocopheryl acetate 3.0 wt%

Liquid paraffin ....................................... 4.6 wt%

Triethanolamine ................................... 1.0 wt%

Squalane .......................................... 3.1 wt%

Macadamia nut oil ............................... 2.5%

Polysorbate 60 ................................. 1.6 wt%

Sorbitan sesquercrolate 1.6 wt%

Propyl paraben ...................................... 0.6 wt%

Carboxyl vinyl polymer: 1.5 wt%

Incense ............................................... Trace

Preservative ....................................... Trace

Purified Water ........................................... Trace

[Formulation Example 3]

Manufacture of nutrition cream

Composition of the present invention 2.0 wt%

Glycerin ......................................... 4.0 wt%

Vaseline ............................................... 3.5%

Triethanolamine ................................... 2.1 wt%

Liquid paraffin 5.3%

Squalane ......................................... 3.0 wt%

Wax .............................................. 2.6 wt%

Tocopheryl acetate ............................... 5.4 wt%

* 110 Polysorbate 60 .............................. 3.2 wt%

Carboxyl vinyl polymer: 1.5 wt%

Sorbitan sesquioleate 3.1 wt%

Incense ............................................... Trace

Preservative ....................................... Trace

Purified Water ........................................... Trace

While the present invention has been described with reference to exemplary embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of the invention. It will be possible. In addition, many modifications may be made to adapt a particular situation and material to the teachings of the invention without departing from the essential scope thereof. Accordingly, it is intended that the invention not be limited to the particular embodiment disclosed as the best mode contemplated for carrying out this invention, but that the invention will include all embodiments falling within the scope of the appended claims.

Claims (15)

Wherein the extract comprises at least one member selected from the group consisting of peel extracts, ginseng extract, and hundreds of bamboo extracts as an active ingredient.
The method according to claim 1,
The composition according to claim 1 or 2, wherein the composition comprises at least one selected from the group consisting of mushroom extract, ginseng extract, and hundreds of mushroom extracts, wherein the weight ratio of mushroom extract to ginseng extract is from 2: 1: A pharmaceutical composition.
The method according to claim 1,
Wherein said composition has antimicrobial activity against at least one strain selected from the group consisting of Staphylococcus epidermidis, Staphylococcus aureus and Propionibacterium acnes Or a pharmaceutically acceptable salt thereof, for the treatment of acne or inflammatory skin diseases.
The method according to claim 1,
The pharmaceutical composition for treating acne or inflammatory skin disease, wherein the extract is an ethanol extract or a hot water extract.
Wherein the composition comprises at least one member selected from the group consisting of peel extracts, gourd extracts, and hundreds of bamboo extracts as an active ingredient.
6. The method of claim 5,
Wherein said composition has antimicrobial activity against at least one strain selected from the group consisting of Staphylococcus epidermidis, Staphylococcus aureus and Propionibacterium acnes Wherein the composition is a cosmetic composition for alleviating acne or inflammatory skin diseases.
6. The method of claim 5,
The composition of the present invention is characterized in that when the composition contains both the extract of Hwangbuk, the extract of Ganoderma lucidum and the extract of Hwangbuk, the weight ratio of Hwangpyeom extract: Gwangbukpyu extract: Hwangbu hundreds extract is 2: 1: 1. Cosmetic composition.
6. The method of claim 5,
The cosmetic composition for alleviating acne or inflammatory skin diseases, wherein the composition reduces skin oiliness.
6. The method of claim 5,
The cosmetic composition for alleviating acne or inflammatory skin diseases, wherein the composition reduces skin moisture.
6. The method of claim 5,
The cosmetic composition for relieving acne or inflammatory skin disease, wherein the composition reduces skin erythema area.
6. The method of claim 5,
Wherein the composition increases the number of pores in the skin.
Wherein the composition comprises at least one member selected from the group consisting of mulberry extract, ginseng extract, and hundreds of bamboo extracts as an active ingredient.
13. The method of claim 12,
The composition according to claim 1, wherein the composition comprises at least one of a mushroom extract, a mushroom extract and a mushroom extract, wherein the weight ratio of mushroom extract to ginseng extract is at least 2: 1: 1. Food composition.
13. The method of claim 12,
Wherein said composition has antimicrobial activity against at least one strain selected from the group consisting of Staphylococcus epidermidis, Staphylococcus aureus and Propionibacterium acnes Wherein the composition is used for improving acne or inflammatory skin diseases.
13. The method of claim 12,
The composition for improving acne or inflammatory skin diseases according to claim 1, wherein the extract is an ethanol extract or a hot-water extract.

Images