KR20230136529A - Composition for improving, preventing or treating scar - Google Patents

Abstract

The present invention relates to a composition for improving, preventing or treating scars, and the composition of the present invention contains 70 to 99.8% by weight of organic silicon, 0.1 to 10% by weight of onion extract, 0.05 to 10% by weight of Centella asiatica extract, and 0.05 to 10% by weight of mulberry extract. Includes %.

Description

Composition for improving, preventing or treating scar {Composition for improving, preventing or treating scar}

The present invention relates to a composition for improving, preventing or treating scars. More specifically, it relates to a composition that can effectively improve, prevent or treat scars based on a combination of organic silicone and plant extract.

Large wounds to the skin caused by surgery or injury can leave scars. These scars can cause problems such as dulled sense of touch and reduced range of motion, and can also cause cosmetic problems.

Conventionally, medical devices and pharmaceuticals for improving, preventing or treating scars have been disclosed. For example, gel sheets (e.g., CicaCare) and gel ointments (e.g., Dermatix Ultra) made of silicone components, which are classified as medical devices, and active ingredients effective against scars, which are classified as medicines, For example, ointments containing onion extract (eg, Contratuvex) are known. However, there is a need to develop products that can provide improved effects beyond the effects of existing medical devices or drugs.

Techniques for including specific compounds as active ingredients to improve scar improvement, prevention, or treatment effects are also known. However, rather than using purified compounds as active ingredients, it is necessary to expect ease of manufacture or cost reduction by using relatively easily obtainable substances such as plant extracts as active ingredients.

Accordingly, the present inventors attempted to develop a product that could show excellent scar improvement, prevention, or treatment effects while using relatively easily obtained substances such as plant extracts along with silicon as active ingredients.

Korean Patent No. 10-1921727

The main purpose of the present invention is to provide a composition that contains plant extracts as active ingredients along with silicone and exhibits excellent scar improvement, prevention, or treatment effects.

According to one aspect of the present invention, the present invention provides a scar improvement, prevention or treatment comprising 70 to 99.8% by weight of organic silicon, 0.1 to 10% by weight of onion extract, 0.05 to 10% by weight of Centella asiatica extract, and 0.05 to 10% by weight of mulberry extract. A therapeutic composition is provided.

In one embodiment, the onion extract is obtained by extracting the onion with C1 to C4 lower alcohol to obtain a primary onion extract and separating the oil-soluble component from the primary onion extract into an oil phase, and the centella asiatica extract is The primary Centella asiatica extract was obtained by extraction with lower alcohol of C1 to C4, and the oil-soluble component was separated from the primary Centella asiatica extract into an oil phase. The mulberry extract was extracted from mulberry with lower alcohol of C1 to C4. A primary mulberry extract was obtained, and fat-soluble components were separated into an oil phase from the primary mulberry extract.

The composition of the present invention can effectively improve, prevent and/or treat scars based on a combination of organic silicon, onion extract, centella asiatica extract and mulberry extract.

Figure 1 shows the manufacturing process of a composition according to an embodiment of the present invention.
Figure 2 shows the results of testing the scar improvement and treatment effects of a composition according to an embodiment of the present invention on a 2-year-old male patient with a hot burn on the foot. A, photo of scar before application of composition; B, Photograph of the scar during the period of application of the composition; C, Photograph of scar after application of the composition for approximately 6 months.
Figure 3 shows the results of testing the scar improvement and treatment effects of a composition according to an embodiment of the present invention on a 22-year-old female patient with a hot burn on the thigh. A, photo of scar before application of composition; B, Photograph of the scar after applying the composition for approximately 3 months.
Figure 4 shows the results of testing the scar improvement and treatment effects of a composition according to an embodiment of the present invention on a 55-year-old female patient with a hot burn on the thigh. A, photo of scar before application of composition; B, Photograph of the scar during the period of application of the composition; C, Photograph of the scar after applying the composition for approximately 3 months.

The present invention relates to a composition for improving, preventing or treating scars comprising organic silicon, onion extract, centella asiatica extract and mulberry extract.

In one embodiment of the present invention, the organic silicone is an organic silicone applicable to human skin. The organic silicone may be, for example, an organic silicone used in existing silicone products for improving, preventing or treating scars or wounds, such as existing silicone gel sheets or silicone-containing ointment-type wound dressings. The organic silicone is, for example, dimethicone, polysilicone-11, polysilicone-15, polysilicone-8, and polysilicone-17. -17), hydrogen dimethicone, lauryl dimethicone, methylcyclopentasiloxane, methylcyclohexasiloxane, methyltrimethicone, phenyldimethicone ( phenyldimethicone), dimethicone copolyol, dimethicone copolyol acetate, silicone glycol copolyol, dimethiconol, methylpolysiloxane, methylphenylpolysiloxane, dimethicone copolyol methyl ether, methylcyclopolysiloxane, dimethylpolysiloxane, hexamethyldi It may be selected from the group consisting of siloxane and caprylylmethylpolysiloxane, but is not limited thereto. In certain embodiments of the invention, the organosilicone is methylcyclopentasiloxane. In another specific embodiment of the invention, the organic silicone is polydimethylsiloxane.

In the present invention, the extracts, namely onion extract, centella asiatica extract, and mulberry extract, can be prepared from the corresponding extraction raw materials by extraction methods commonly used in this field, such as boiling water extraction, ultrasonic extraction, and reflux extraction. In the present invention, the extract is, for example, a liquid component obtained by immersing the extraction raw material in a solvent and then extracting it at room temperature or at a heated state for a certain period of time, and a solid content obtained by removing the solvent from the liquid component. It can mean. In addition, it may refer to the result produced by crushing or compressing the extraction raw material, for example, juice. And it can be comprehensively interpreted to include all dilutions, concentrates, fractions, crude products, purified products, etc. of the above results.

In one embodiment of the present invention, the extraction raw material for the onion extract is the scale stem part (a part generally used for food) of an onion (eg, Allium cepa ).

In one embodiment of the present invention, the extraction raw material for the Centella asiatica extract is the sentinel part excluding the roots of Centella asiatica .

In one embodiment of the present invention, the extraction raw material of the mulberry extract is the bark part of the mulberry tree (eg, Broussonetia kazinoki ).

Using extracts from such areas as described above can enhance the scar improvement, prevention and/or treatment effects of the composition.

In one embodiment, the extract of the present invention is extracted using a polar solvent or a non-polar solvent. At this time, the polar solvent may be, for example, a solvent selected from the group consisting of C1 to C4 lower alcohols, water, and combinations thereof, and the nonpolar solvent may be, for example, chloroform, petroleum ether, ether, butanol, hexane, toluene, and these. It may be a solvent selected from the group consisting of a combination of.

During solvent extraction, for example, a solvent having a weight of 1 to 20 times the weight of the dried product of the extraction raw material can be used, and preferably, a solvent having a weight of 5 to 15 times the weight of the dried material of the extraction raw material is used.

The extraction temperature can be set to, for example, 0 to 200°C, and is preferably set to 10 to 100°C rather than 5 to 150°C.

The extraction time can be set to, for example, 10 minutes to 10 days, preferably 30 minutes to 5 days, and more preferably 1 hour to 2 days.

According to the above extraction conditions, an extract for the effect intended in the present invention can be efficiently prepared from the extraction raw material.

In addition, the extract can be obtained by repeating the solvent extraction, for example, by separating the extract after extraction from the residue, recovering it, adding a new solvent to the residue, and re-extracting it to obtain the extract again.

To prepare an extract in the form of a dried product, a drying process such as concentration under reduced pressure, freeze drying, etc. may be performed after extraction.

In a specific embodiment of the present invention, the onion extract is extracted with a C1 to C4 lower alcohol to obtain a primary onion extract, and the fat-soluble component is separated into an oil phase from the primary onion extract. In a specific specific embodiment, the onion extract is prepared by mixing the primary onion extract (e.g., dried product from which the solvent has been removed) with oil at a weight ratio of 1:99 to 10:90, adding water, mixing, and then separating the oil phase. It was obtained by doing so.

In a specific embodiment of the present invention, the Centella asiatica extract is obtained by extracting with C1 to C4 lower alcohol to obtain a primary Centella asiatica extract and separating the oil-soluble component from the primary Centella asiatica extract into an oil phase. In a specific specific embodiment, the Centella asiatica extract is prepared by mixing the primary Centella asiatica extract (e.g., dried product from which the solvent has been removed) with oil at a weight ratio of 1:99 to 10:90, adding water, mixing, and then separating the oil phase. It was obtained by doing so.

In a specific embodiment of the present invention, the mulberry extract is obtained by extracting with C1 to C4 lower alcohol to obtain a primary mulberry extract and separating the oil-soluble component from the primary mulberry extract into an oil phase. In a specific specific embodiment, the mulberry extract is prepared by mixing the primary mulberry extract (e.g., dried material from which the solvent has been removed) with oil at a weight ratio of 1:99 to 10:90, adding water, mixing, and then separating the oil phase. It was obtained by doing so.

Using the above extract can increase the scar improvement, prevention and/or treatment effect of the composition, and also enables even dispersion in the composition due to its high miscibility with organic silicon.

The composition of the present invention contains 70 to 99.8% by weight of organic silicon, 0.1 to 10% by weight of onion extract, 0.05 to 10% by weight of Centella asiatica extract, and 0.05 to 10% by weight of mulberry extract. Includes. According to this content, the scar improvement, prevention and/or treatment effect of the composition can be increased, and side effects such as skin trouble can be reduced. For this purpose, the composition of the present invention more preferably contains 87 to 94% by weight of organic silicon, 3 to 6% by weight of onion extract, and 2 to 4% by weight of Centella asiatica extract, It contains 1 to 3% by weight of mulberry extract.

In one embodiment of the present invention, the composition of the present invention consists only of organic silicon, onion extract, Centella asiatica extract, and mulberry extract. In another embodiment, the composition of the present invention further comprises substances other than organosilicon, onion extract, centella asiatica extract, and paper mulberry extract. At this time, the other substance may be a substance that does not independently substantially affect the improvement, prevention or treatment of scars, or may be a substance whose effect on improving, preventing or treating scars is already known. Additionally, it may be a pharmaceutically acceptable additive.

The composition of the present invention may be a pharmaceutical composition.

The composition of the present invention can be formulated in various forms according to the formulation standards for pharmaceutical preparations presented by the Ministry of Food and Drug Safety. In one embodiment, the composition of the present invention is in an ointment formulation or a gel sheet formulation. If it is an ointment formulation, it can be used by applying it to the skin, and if it is a gel sheet formulation, it can be used by attaching it to the skin.

The composition of the present invention can be used to improve or treat scars that have already occurred, for example, to lighten the color or reduce the size of the scar, ultimately returning it to the same level as normal skin, and also to prevent scars from occurring. It can be used to:

The composition of the present invention can be applied, for example, in the form of an ointment by applying it to the scar area, or, for example, in the form of a gel sheet by attaching it to the scar area. If it is in the form of an ointment, for example, apply about 1 to 100 mg to the skin per 1 cm2 of the skin area of the scar area, or if it is in the form of a gel sheet, for example, about 1 to 100 mg of the gel sheet per 1 cm2 of the skin area of the scar area. It can be applied by attaching it to the skin at the scar area, but it is not limited to this, and the range will vary depending on the situation.

The thickness of the gel sheet may be, for example, 0.5 to 1.5 mm, but is not limited thereto.

Hereinafter, the present invention will be described in more detail through examples. Since these examples are merely for illustrating the present invention, the scope of the present invention is not to be construed as limited by these examples.

[Example]

Examples 1 to 3. Preparation of composition in ointment form

(1) Onion extract production

A primary extract was prepared from onions using ethanol as a solvent. Onion residues and impurities were removed from the obtained primary extract, and after going through a neutralization process and enzyme inactivation process, the extract was filtered to obtain a filtrate. The solvent was recovered from the filtrate using reduced pressure distillation. The extract concentrated by solvent recovery and the oil (MCT (caprylic/capric triglyceride)) were mixed, heated and stirred so that the fat-soluble components of the extract could be extracted in the oil phase. At this time, the concentrated extract and oil were set at a weight ratio of 5:95. Excess water was added and mixed, and then only the oil phase was separated using the difference in specific gravity. Afterwards, water remaining in the oil phase was removed through a heating process (80 to 100°C).

(2) Manufacturing of Centella asiatica extract

The extract was prepared using the same method as (1) above, but using centella asiatica (outplant excluding roots) instead of onion.

(3) Manufacturing of mulberry extract

The extract was prepared using the same method as (1) above, but using paper mulberry (bark) instead of onion.

(4) Preparation of ointment-type composition

Decamethylcyclopentasiloxane was pre-stirred at 500 rpm for 30 minutes at 60°C, then the onion extract of (1), the Centella asiatica extract of (2), and the mulberry extract of (3) were added, 15 Mixed by stirring at 200 rpm for 1 minute. At this time, the ratios of decamethylcyclopentasiloxane, onion extract, centella asiatica extract, and mulberry extract to the total weight of the composition are shown in Table 1.

Decamethylcyclopentasiloxane and the above extracts were mixed, cooled to room temperature, and degassed to prepare the final composition.

Raw material Example 1 Example 2 Example 3 Decamethylcyclopentasiloxane 97 70 90 onion extract One 10 5 Centella asiatica extract One 10 3 Mulberry extract One 10 2 Sum 100 100 100

* Unit: weight%

Examples 4 to 6. Preparation of a composition in the form of a gel sheet

In Part A and Part B of Dow corning®7-9700, Examples 1 to 3, the onion extract of (1), the centella asiatica extract of (2), and the mulberry extract of (3) were stirred, mixed, and cured to form a gel sheet. A composition was prepared. At this time, the respective ratios to the total weight of the composition were as shown in Table 2.

Raw material Example 4 Example 5 Example 6 Dow Corning® 97 70 90 onion extract One 10 5 Centella asiatica extract One 10 3 Mulberry extract One 10 2 Sum 100 100 100

* Unit: weight%

Experimental Example 1. Toxicity test

An acute systemic toxicity test and a cytotoxicity test (test by indirect contact) for the composition of Example 3 were conducted by requesting the Korea Testing and Research Institute.

As a result, the composition of the present invention met the requirements of the acute systemic toxicity test and was judged to be Grade 0 (None) according to the cytotoxicity criteria of ISO 10993-5.

The results of the acute systemic toxicity test are as follows.

To evaluate the acute systemic toxicity test for the eluate of the composition of Example 3, five mice each were used in the polar solvent control and test groups, and the non-polar solvent control and test groups, and the eluate was administered at 50 ml/kg B.W. The dose was administered intraperitoneally. The results of observing mortality, general symptoms, weight change, and autopsy findings for 72 hours after administration of the test substance are as follows.

- No dead animals were observed due to test substance administration during the experiment period.

- As a result of observing general symptoms, no abnormal symptoms were observed due to administration of the test substance.

- As a result of weight measurement, weight loss was observed 24 hours after administration, but there was no weight loss of more than 10%, and considering the general symptoms, it is believed that the weight loss was not caused by the test substance.

- As a result of the autopsy results, no abnormal findings were observed in all treatment groups.

The cytotoxicity test results are as follows.

The test was conducted using mouse fibroblast cells (L-929 mouse fibroblast cells) according to the Agar diffusion test of ISO 10993-5: Biological Evaluation of Medical Devices, Part 5: Tests for in vitro Cytotoxicity.

Agar medium was layered on mouse fibroblast cells (L-929 mouse fibroblast cells) that formed a confluent monolayer. The test substance, negative control, and positive control were placed on a plate aseptically in a layered culture dish.

All cells were cultured in a (37 ± 1)°C (5 ± 1)% CO2 incubator for 48 hours, the sample was removed, and the degree of cell lysis in the area below and around the sample was observed under a microscope. Afterwards, the decrease in stainability was observed using Neutral red.

As a result of the test, under these test conditions, no decolorization zone was observed on the middle layer of cells in response to the test substance, and no toxicity or lysis was observed in the cells.

Experimental Example 2. Skin sensitization and skin irritation test

A skin sensitization test and a skin irritation test for the composition of Example 3 were conducted at the Korea Testing & Research Institute.

As a result, when skin sensitization for guinea pigs was evaluated using the Buehler method, no skin reaction was observed, so it is considered to be a non-sensitizing substance, and in the skin irritation test for rabbits, the reaction category was classified as a “Negligible” substance. The results were obtained to be conclusive.

The results of the skin sensitization test are as follows.

To investigate skin sensitization, sensitization was induced in Dunkin Hartley Guinea pigs by topical application of the test substance over 3 weeks (3 times a week), and mortality, general symptoms, and skin sensitization were evaluated by topical application.

The results of examining the mortality rate, general symptoms, weight change, and skin reaction of the experimental animals after the induction phase during the experiment period are as follows.

- As a result of observing general symptoms during the test period, no unusual clinical symptoms or dead animals were observed.

- As a result of body weight measurement, no changes were observed due to test substance administration in the test group compared to the control group.

- As a result of evaluating skin reactions 24 and 48 hours after sensitization, the sensitization index and sensitization rate of the test group were calculated as 0.1, 0.0% and 0.0, 0.0%.

The results of the skin irritation test are as follows.

To evaluate skin irritation, the test substance was applied to the skin of three rabbits for 4 hours and mortality rate, general symptoms, weight change, and skin irritation were evaluated. The results are as follows.

- Moribund (death) and general symptoms were not observed due to application of test substances during the experiment period.

- As a result of body weight measurement during the experiment period, no change in body weight was observed due to application of the test substance.

- As a result of observing the application site at 1, 24, 48, and 72 hours after application of the test substance, no skin reactions such as erythema, crusting, or edema were observed at the application site, so the primary skin irritation index (P.I.I.) was set at "0.0." calculated.

Experimental Example 3. Scar improvement and treatment test

The scar improvement and treatment effects of the composition of Example 3 were tested on patients with scars.

The patient's guardian or the patient was provided with the composition of Example 3 in ointment form and advised to apply the composition to the scar area at least once a day, and then the condition of the scar was checked after a certain period of time.

Figure 2 shows the results of a 2-year-old male patient with a scalding burn on the foot, and it was found that the scar was significantly improved and treated when the composition of the present invention was applied for about 6 months.

Figure 3 shows the results of a 22-year-old female patient with a hot burn on the thigh, and it was found that the scar was significantly improved and treated when the composition of the present invention was applied for 3 months.

Figure 4 shows the results of a 55-year-old female patient with a hot burn on the thigh, and it was shown that the scar was significantly improved and treated when the composition of the present invention was applied for 3 months.

Claims (2)

A composition for improving, preventing or treating scars, comprising 70 to 99.8% by weight of organic silicon, 0.1 to 10% by weight of onion extract, 0.05 to 10% by weight of Centella asiatica extract, and 0.05 to 10% by weight of mulberry extract. According to paragraph 1,
The onion extract is obtained by extracting the onion with C1 to C4 lower alcohol to obtain a primary onion extract and separating the fat-soluble component from the primary onion extract into an oil phase,
The Centella asiatica extract is obtained by extracting Centella asiatica with C1 to C4 lower alcohol to obtain a primary Centella asiatica extract and separating the oil-soluble component from the primary Centella asiatica extract into an oil phase,
The mulberry extract is obtained by extracting the mulberry tree with C1 to C4 lower alcohol to obtain a primary mulberry extract and separating the oil-soluble component from the primary mulberry extract into an oil phase. A composition for improving, preventing or treating scars.