TW202003587A - Use of collagen peptide for inducing expression of CCT gene, Parkin gene and MRPS5 gene, enhancing mitochondrial activity of cells, promoting skin fibroblast proliferation, and anti-aging - Google Patents

Abstract

The present disclosure provides a use of a collagen peptide for inducing expression of CCT gene, Parkin gene and MRPS5 gene, enhancing the mitochondrial activity of cells, promoting the skin fibroblast proliferation, and anti-aging.

Description

Collagen peptides are used for lifting CCT gene, Parkin gene and The use of MRPS5 gene expression, enhancing cell mitochondrial activity, promoting skin fibroblast proliferation and anti-aging

The present invention relates to the use of a collagen peptide for enhancing the expression of CCT gene, Parkin gene and MRPS5 gene, enhancing the mitochondrial activity of cells, promoting the proliferation of skin fibroblasts and anti-aging.

The skin is the largest barrier to protect human individuals, it has the function to resist water loss, pathogenic bacteria and various environmental damage. Exposure to a large amount of ultraviolet (UV), ionizing radiation, drugs or xenobiotics will cause the skin to generate reactive oxygen species (ROS) and free radicals. When the accumulated amount of reactive oxygen species and free radicals exceeds the antioxidant capacity of the cell or tissue itself, oxidative stress will be formed. Next, the reactive oxygen species and free radicals will react with intracellular components (including DNA, proteins, lipids, etc.), which will undesirably affect the skin.

In recent years, human demand for enhancing skin activity (for example, by promoting the proliferation of skin fibroblasts) has increased day by day, because once skin activity is enhanced, anti-aging effects can be achieved. However, the most common methods currently used to enhance skin activity are the use of cosmetics, skin care products applied to the surface of the skin, or oral health foods that claim to enhance skin activity. However, the conventional cosmetics, skin care products and health foods are mostly made of chemical ingredients. Long-term use is not only harmful to human health, but also these products are often expensive and not affordable for general users.

On the other hand, mitochondria is also known as the power station of the cell, because it is the main site for the synthesis of adenosine triphosphate (ATP) (a molecule that transfers energy) in the cell, providing various activities for the cell. Chemical energy. If the mitochondria are damaged, it will have a huge impact on cells and individual organisms. Mitochondria produce a lot of free radicals in the process of ATP synthesis. The free radicals are extremely active and will undergo a strong oxidation reaction with any substance in the body to destroy their normal functions. Free radicals damage the enzymes and DNA in the mitochondria day by day, gradually reducing their functions and degrading the functions of various organs and tissues. Therefore, how to increase the mitochondrial activity of cells to achieve anti-aging effect has become an important issue in this field.

In order to solve the above-mentioned problems, those skilled in the art urgently need to develop novel medicines, food products or maintenance products with the functions of enhancing the mitochondrial activity of the cells, promoting the proliferation of skin fibroblasts and anti-aging to benefit the people who have this need. Ethnic group.

In view of this, the purpose of the present invention is to provide a collagen peptide for the preparation of a chaperonin containing T-complex protein 1 subunit alpha (TCP1) complex containing a T-complex protein 1 (TCP1) complex , CCT ) gene, Parkin gene and/or mitochondrial ribosomal protein S5 (mitochondrial ribosomal protein S5, MRPS5 ) gene expression component use.

In an embodiment of the present invention, the CCT gene is a chaperonin containing TCP1 subunit 5, CCT5 gene or a chaperonin containing TCP1 subunit 6A, CCT6A gene. .

In an embodiment of the invention, the effective concentration of the collagen peptide is at least 1 mg/mL.

In an embodiment of the invention, the collagen peptide is derived from a fish of the genus Lutjanus sp.

Another object of the present invention is to provide a use of a collagen peptide for preparing a composition that enhances the activity of a cell's mitochondria.

In an embodiment of the invention, the effective concentration of the collagen peptide is at least 1 mg/mL.

In an embodiment of the invention, the collagen peptide is derived from a fish of the genus Lutjanus sp.

In an embodiment of the invention, the cell is a skin fibroblast.

Another object of the present invention is to provide a use of a collagen peptide for preparing a composition that promotes the proliferation and anti-aging of a skin fibroblast.

In an embodiment of the invention, the effective concentration of the collagen peptide is at least 1 mg/mL.

In an embodiment of the invention, the collagen peptide is derived from a fish of the genus Lutjanus sp.

In an embodiment of the invention, the composition is a pharmaceutical product, a food product or a maintenance product.

In summary, the effect of the collagen peptide of the present invention is that it can improve the skin activity by enhancing the expression of the CCT gene, Parkin gene and MRPS5 gene, promoting the proliferation of skin fibroblasts, and enhancing the mitochondrial activity of cells And anti-aging effects. In addition, the collagen peptide of the present invention can be used as a raw material for enhancing the anti-aging potential of cell anti-aging genes.

The embodiments of the present invention will be further described below. The examples listed below are used to clarify the present invention, and are not intended to limit the scope of the present invention. Anyone who is familiar with this art, without departing from the spirit and scope of the present invention, Some changes and retouching can be done, so the scope of protection of the present invention shall be deemed as defined by the scope of the attached patent application.

Figure 1 is a data graph of the effect of the collagen peptide of the present invention on promoting the proliferation of skin fibroblasts after 24 hours of action, where "*" indicates comparison with the control group, p <0.05.

FIG. 2 is a data graph showing the effect of the collagen peptide of the present invention on enhancing the mitochondrial activity of skin fibroblasts after 24 hours of action, where “**” indicates comparison with the control group, p <0.01.

Fig. 3 is a graph showing the efficacy of the collagen peptide of the present invention in enhancing the performance of the CCT5 gene, CCT6A gene, Parkin gene, and MRPS5 gene related to skin anti-aging when acting for 24 hours, where "*" indicates comparison with the control group , P <0.05;"**" means comparison with the control group, p <0.01;"***" means comparison with the control group, p <0.001.

definition

The numerical values used in this article are approximate values, and all experimental data are expressed within a range of 20%, preferably within a range of 10%, and most preferably within a range of 5%.

Use Excel software for statistical analysis. Data mean ± standard deviation (standard deviation, STDEV) represents the difference between the two in this one-tailed Student's t test (single-tailed student's t -test ) analysis.

As used herein, the terms "collagen peptide", "collagen peptide", "collagen peptide" and "collagen peptide" are used interchangeably.

As used herein, the term "anti-aging" means preventing and slowing down the aging phenomenon of the appearance of human skin, such as the generation of wrinkles and loss of elasticity. The degree to which this objective is achieved will be determined based on many factors known to those skilled in the art, such as the consumer’s overall state, age, and gender.

According to the present invention, a pharmaceutical product can be manufactured into a dosage form suitable for parenterally, orally, or topically administration using techniques well known to those skilled in the art, including, But not limited to: injection [for example, sterile aqueous solution (sterile aqueous solution or dispersion)], sterile powder (sterile powder), tablet (tablet), tablet (troche), oral solution Contain lozenge, pill, capsule, dispersible powder or granule, solution, suspension, emulsion, syrup, elixir (elixir), thick slurry (slurry), external preparation (external preparation) and the like.

According to the present invention, the pharmaceutical product may further include a pharmaceutically acceptable carrier widely used in pharmaceutical manufacturing technology. For example, the pharmaceutically acceptable carrier may include one or more agents selected from the group consisting of solvents, buffers, emulsifiers, suspending agents, and decomposers ), disintegrating agent, dispersing agent, binding agent, excipient, stabilizing agent, chelating agent, diluent , Gelling agent, preservative, wetting agent, lubricant, absorption delaying agent, liposome, and the like. The selection and quantity of these reagents fall within the professional qualities and routine techniques of those who are familiar with this technology.

According to the present invention, the pharmaceutically acceptable carrier contains a solvent selected from the group consisting of water, normal saline, phosphate buffered saline (PBS), Aqueous solution containing alcohol and their combination.

According to the present invention, the medicinal product can be administered by parenteral routes selected from the group consisting of intraperitoneal injection, subcutaneous injection, and epidermal injection Injection (intraepidermal injection), intradermal injection (intradermal injection), intramuscular injection (intramuscular injection), intravenous injection (intravenous injection) and intralesional injection (intralesional injection).

According to the present invention, pharmaceutical products can be manufactured into an external preparation suitable for topical application to the skin using techniques well known to those skilled in the art, which include, but are not limited to: emulsion, gel Gel, ointment, cream, patch, liniment, powder, aerosol, spray, lotion, milk Serums, pastes, foams, drops, suspensions, salves and bandages.

According to the present invention, the external preparation is prepared by mixing the pharmaceutical product of the present invention with a base well known to those skilled in the art.

According to the present invention, the substrate may include one or more additives selected from the group consisting of water, alcohols, glycols, hydrocarbons [such as petroleum, jelly, and White petrolatum], wax [such as paraffin and yellow wax], preserving agents, antioxidants, surfactants, absorption enhancers ( absorption enhancers), stabilizers (stabilizing agents), gelling agent (gelling agents) [such as Carbopol ^® 974P (carbopol ^® 974P), microcrystalline cellulose (microcrystalline cellulose) and carboxymethyl cellulose (carboxymethylcellulose)], Active agents, humectants, odor absorbers, fragrances, pH adjusting agents, chelating agents, emulsifiers, occlusive agents (occlusive agents), softeners (emollients), thickeners (thickeners), solubilizing agents (solubilizing agents), penetration enhancers (penetration enhancers), anti-irritants (anti-irritants), colorants (colorants) and propellants (propellants) etc. The selection and quantity of these additives fall within the scope of professional qualities and routine skills of those who are familiar with this technology.

According to the present invention, the maintenance product may further include an acceptable adjuvant widely used in the maintenance product manufacturing technology. For example, the acceptable adjuvant may contain one or more agents selected from the group consisting of solvents, gelling agents, active agents, preservatives, antioxidants, screening agents, chelating agents, surfactants, dyes Coloring agent, thickening agent, filler, fragrance and odor absorber. The selection and quantity of these reagents fall within the professional qualities and routine techniques of those who are familiar with this technology.

According to the present invention, skin care products can be manufactured into a form suitable for skincare or makeup using techniques well known to those skilled in the art. This includes, but is not limited to: aqueous solution (aqueous solution), water -Aqueous-alcohol solution or oily solution, oil-in-water type, water-in-oil type or compound emulsion, gel Glue, ointment, cream, mask, patch, pack, wipe, powder, aerosol, spray, emulsion, emulsion, paste, foam, dispersion, drops, mousse ( mousse, sunblock, tonic water, foundation, foundation remover products, makeup remover products, soap, and other body cleansing products.

According to the present invention, the skin care product can also be used in combination with one or more external use agents of known activity selected from the following: whitening agents [such as tretinoin, catechins (catechin), kojic acid, arbutin, and vitamin C], humectants, anti-inflammatory agents, bactericides, ultraviolet absorbers, plant extracts [plant extracts] [ Such as aloe extract, skin nutrients, anesthetics, anti-acne agents, antipruritics, analgesics, anti-dermatitis agents (antidermatitis agents), antihyperkeratolytic agents (antihyperkeratolytic agents), anti-dry skin agents (anti-dry skin agents), antiperspirants (antipsoriatic agents), anti-aging agents (antiaging agents), anti-wrinkle agents (antiwrinkle agents), Antiseborrheic agents, wound-healing agents, corticosteroids and hormones. The selection and quantity of these external agents fall within the professional qualities and routine technologies of those who are familiar with this technology.

According to the present invention, a food product can be used as a food additive, which is added during the preparation of raw materials by conventional methods, or added during the production of food, and formulated with any edible material for Food products consumed by humans and non-human animals.

According to the present invention, the types of food products include, but are not limited to: beverages, fermented foods, bakery products, health foods, and dietary supplements.

Example 1. Evaluation of the effectiveness of collagen peptides in promoting the proliferation of skin fibroblasts

In this embodiment, the collagen peptide is purchased from NIPPI Corporation, the trade name is NIPPI PEPTIDE, the model is "FCP-G", and it is from a fish of the genus Snapper ( Lutjanus sp.), preferably Red snapper ( Lutjanus sanguineus ).

First, add 0.1mM non-essential amino acids, 1.5g/L sodium bicarbonate, 1mM sodium pyruvate (90%), and 10% fetal bovine serum (FBS) ( Gibco) Minimum Essential Medium (MEM) (Eagle) (Earle's Balanced Salt Solution (Earle's BSS)) (GIBCO, No. 41500-034, United States) to cultivate human skin fibroblasts Cell CCD-966SK (purchased from Taiwan Bioresource Collection and Research Center (BCRC), number BCRC 60153) is in a 6-well dish, and the cell concentration is 1×10 ⁵ cells/well.

After that, the cells were divided into two groups, including a control group and an experimental group. The collagen peptide was diluted with water to a dilution with a concentration of 1 mg/mL, and then the dilution with 1 mg/mL was added to the cells of the experimental group, and the cells of the control group were not subjected to any treatment. Next, the cells were cultured with 10 μM EdU (component A, 5-ethynyl-2′-deoxyuridine) in the medium for 1 to 2 hours, and then the cells were collected. After that, the cells were washed once with 1% bovine serum albumin (BSA) (prepared in phosphate buffered saline (PBS, GIBCO, No. 14200-075, USA)), and then removed. Supernatant. Next, add 100μL of Click-iT ^TM fixative (Click-iT ^TM fixative) (component D, with 4% paraformaldehyde (paraformaldehyde) in PBS) and mixed thoroughly, the role of the dark at room temperature for 15 minutes . After that, the cells were washed once with 1% BSA (in PBS), and then the supernatant was removed. Next, add 100μL of 1X Click-iT ^TM washed with permeabilization reagent ^{(Click-iT TM saponin-based} permeabilization and wash reagent) ( component E) in saponin-based, acts on the dark at room temperature for 15 minutes. After that, the cells were washed once with 1% BSA (in PBS), and then the supernatant was removed. Next, the cells were resuspended in 100 μL of 1X Click-iT ^TM saponin-based permeabilization and washing reagent, and then the Click-iT ^TM reaction was performed.

Click-iT ^TM reaction process is as follows: first prepare 1X Click-iT ^TM EdU buffer additive (component G) (at -20°C with 2 mL of deuterium depleted water (DDW) to dilute 10X buffer solution ). Next, prepare Click-iT ^TM Plus reaction cocktails (reaction cocktails), including PBS (or Dulbecco's phosphate-buffered saline (D-PBS) or Tris-Hcl Buffered buffer solution (Tris-Hcl Buffered Saline, TBS)), copper protectant (component F), fluorescent dye picolyl azide (component B), and reaction buffer additive (prepared within 15 minutes). After that, 0.1 mL of Click-iT ^™ Plus reaction mixture (total volume of 200 μL) was added to each test tube, and then it was allowed to act in a dark environment at room temperature for 30 minutes. Next, the cells were washed with 1X Click-iT ^TM saponin-based permeabilization and washing reagents, and then the supernatant was removed. After that, the cells were resuspended in 500 μL of 1X Click-iT ^TM saponin-based permeabilization and washing reagent. Next, the analysis was performed by flow cytometry, the excitation wavelength was 488 nm, and the emission wavelength was 530/30 nm, which was detected by logarithmic amplification. The results of this example are shown in Figure 1.

FIG. 1 is a graph showing the efficacy of the collagen peptide of the present invention in promoting the proliferation of skin fibroblasts after 24 hours of action. As can be seen from Figure 1, compared with the control group, the relative EdU incorporation ratio of the experimental group has a significant increase. The results of this example show that the collagen peptide of the present invention can promote the proliferation of skin fibroblasts and enhance the activity of skin cells after 24 hours.

Example 2. Evaluation of the effectiveness of collagen peptides in enhancing mitochondrial activity of cells

In this example, human skin fibroblasts were used for skin cell mitochondrial activity analysis, and the flow cytometry Mitochrondrial membrane potential detection kit (BD) was used for experiments. Human skin fibroblasts were purchased from Taiwan Bioresource Collection and Research Center (BCRC), number BCRC 60153. The cells were cultured with the addition of 10% fetal bovine serum (FBS) (GIBCO Corporation, No. 10438-026, United States), 0.1 mM non-essential amino acids, and 1.5 g/L sodium bicarbonate (Sigma Corporation, No. S5761, United States), 1 mM sodium pyruvate (GIBCO, No. 11360-070, United States) minimum essential medium (MEM) (Eagle) (for Earle's Balanced Salt Solution, Earle's BSS)) (GIBCO Corporation, No. 41500-034, United States).

1×10 ⁵ human skin fibroblasts (n=3) were inoculated into each hole in a 6-well culture dish containing 2 mL of the above-mentioned medium. After that, the cells were divided into two groups, including a control group and an experimental group. The collagen peptide was diluted with water to a dilution solution with a concentration of 1 mg/mL, and then the 1 mg/mL dilution solution was added to the cells of the experimental group, and the cells of the control group were added with culture medium. Next, cells of each group were cultured at 37°C for 24 hours, and then preheated 10X analysis buffer at 37°C. After that, prepare 1X analysis buffer with sterile 1X PBS, mix well and place at 37°C, then add 130 μL of dimethyl sulfoxide (DMSO) to the freeze-dried JC-1 mitochondrial stain (BD ^TM MitoScreen (JC-1) reagent kit) to prepare JC-1 stock solution, the stock solution can be stored at -20 ℃ for 6 months. Next, JC-1 mitochondrial stain and 1X analysis buffer were prepared at a ratio of 1:100, and then the medium was removed and rinsed twice with 1XPBS. After adding trypsin/EDTA for 3 minutes, the suspended cells were sucked into a 1.5 mL microcentrifuge tube and centrifuged at 400 g for 5 minutes to collect the precipitated cells.

After removing the supernatant, the cells were resuspended in 1 mL of 1X PBS, then transferred to a 1.5 mL centrifuge tube, and centrifuged at 400 g for 5 minutes. After removing the supernatant, add 100 μL of JC-1 working solution, mix well and act in the dark for 15 minutes. After that, centrifuge at 400 g for 5 minutes, then wash with 1 mL of 1X washing buffer and centrifuge at 400 g for 5 minutes, then wash with 1 mL of 1X washing buffer and centrifuge at 400 g for 5 minutes. In 500μL of 1X PBS containing 2% FBS resuspended cells were then analyzed for mitochondrial membrane potential changes when viewed apoptosis by flow cytometry (a Beckman), and in Excel for t - test (student t -test) Statistics Analyze the statistical significance of differences between sample groups.

Figure 2 is a graph showing the effect of the collagen peptide of the present invention on enhancing the mitochondrial activity of skin fibroblasts after 24 hours of action. It can be seen from FIG. 2 that compared with the control group, the mitochondrial activity of skin fibroblasts in the experimental group (ie, relative JC-1 aggregate) has been significantly improved. The results of this example show that the collagen peptide of the present invention can significantly enhance the activity of mitochondria, maintain cell vitality and normal metabolism after stimulating human skin fibroblasts for 24 hours.

Example 3. Evaluation of the effectiveness of collagen peptides in enhancing the expression of genes related to skin anti-aging

This example discusses whether collagen peptides can achieve anti-aging effects by enhancing the gene expression related to skin anti-aging.

First, human skin fibroblast CCD-966SK (purchased from Taiwan Bioresources Conservation and Research) was cultured in the minimum essential medium (MEM) (Eagle) (with Earl's balanced salt solution) (GIBCO Corporation, No. 41500-034, USA) Center, No. BCRC 60153) In a 6-well plate, the cell concentration of 2 mL medium is 1.5×10 ⁵ cells/well.

After that, the cells were divided into 2 groups, including a control group and an experimental group. Dilute collagen peptide (supplier is NIPPI Corporation, trade name is NIPPI PEPTIDE, model is "FCP-G") with water to a dilution with a concentration of 1 mg/mL, and then add 1 mg/mL to the experimental group Of the cells in the control group, the cells in the control group were not treated. Next, cells of each group were cultured in an incubator for 24 hours, and then cell cultures of each group were collected and used for gene expression analysis.

In this embodiment, the genes used to analyze skin anti-aging include chaperonin containing TCP1 subunit 5 ( CCT5 ) gene, and chaperonin containing TCP1 subunit 6A, TCP1 subunit 6A, CCT6A ), Parkin gene and mitochondrial ribosomal protein S5 (mitochondrial ribosomal protein S5, MRPS5 ) gene.

RNA extraction was performed on the cell cultures of each group obtained above with an RNA extraction kit (Geneaid). Take 2,000 ng of each set of RNA thus obtained and reverse transcribe the extracted RNA into cDNA with SuperScript ^® III reverse transcriptase (Invitrogen). Next, using cDNA as a template and using primer pairs to amplify the target gene, including CCT5 , CCT6A , Parkin , MRPS5, and GAPDH (as an internal control group), their nucleotide sequences are shown in Table 1 below, at StepOne Plus real-time PCR system (ABI) uses KAPA CYBR FAST qPCR kit (2x) (KAPA Biosystems) to perform quantitative real-time PCR to amplify and quantify the target gene. The melting curve of the PCR product is confirmed during the quantitative real-time PCR reaction.

The relative expression of the target gene is derived from Equation 2 ^-△△Ct , and the relative fold change is calculated using the cycle threshold of GAPDH gene (as an internal control group) and the reference gene and the standard deviation, where △Ct=Ct _{target gene / Reference gene-} Ct _GAPDH , △△Ct = △Ct _target gene-△Ct _{reference gene} , fold change = 2- ^△△Ct _average . The target gene expression amount of the control group was used as the comparison criterion of 1. The statistically significant differences between the groups were determined by the one-tailed Stein's t-test. The results of this example are shown in Figure 3.

FIG. 3 is a graph showing the efficacy of the collagen peptide of the present invention in enhancing the performance of CCT5 gene, CCT6A gene, Parkin gene, and MRPS5 gene related to skin anti-aging in 24 hours. As can be seen from Figure 3, whether it is the CCT5 gene, CCT6A gene, Parkin gene, or MRPS5 gene, compared with the control group, the relative expression of the gene in the experimental group has been significantly improved. The results of this example show that the collagen peptide of the present invention can significantly enhance the expression of anti-rejuvenation genes CCT5 and CCT6A mRNA of skin fibroblasts after 24 hours of stimulation of human skin fibroblasts, and can also increase the mitochondrial rejuvenation gene Parkin mRNA expression promotes cells to clear mutant mitochondrial DNA, restore mitochondrial function, and activate NAD ⁺ pathway genes. MRPS5 mRNA expression enhances mitochondrial activity and prolongs the life of skin cells.

In summary, the collagen peptides of the present invention can improve the overall activity of cells and maintain cell vitality by enhancing the expression of CCT gene, Parkin gene and MRPS5 gene, promoting the proliferation of skin fibroblasts, and enhancing the mitochondrial activity of cells. And normal metabolism, to enhance skin activity and anti-aging effects. In addition, the collagen peptide of the present invention can be used as a raw material for enhancing the anti-aging potential of cell anti-aging genes.

The above is only exemplary, and not restrictive. Any equivalent modifications or changes made without departing from the spirit and scope of the present invention shall be included in the scope of the attached patent application.

<110> Dajiang Biomedical Co., Ltd.

<120> Collagen peptide is used to enhance the expression of CCT gene, Parkin gene and MRPS5 gene, enhance the mitochondrial activity of cells, promote the proliferation of skin fibroblasts and anti-aging

<130> 108B0141-I1

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Claims (12)

A collagen peptide is used to prepare chaperonin containing T-complex protein 1 subunit alpha (TCP1) complex ( CCT ) gene, Parkin gene and/or containing T-complex protein 1 (TCP1) complex The use of the composition of the expression level of the mitochondrial ribosomal protein S5 ( MRPS5 ) gene. The use as described in item 1 of the patent application, wherein the CCT gene is a chaperonin containing TCP1 subunit 5 ( CCT5 ) gene or a chaperonin containing TCP1 subunit 6A chaperonin containing TCP1 subunit 6A, CCT6A ) gene. The use as described in item 1 of the patent application range, wherein the effective concentration of the collagen peptide is at least 1 mg/mL. The use as described in item 1 of the patent application scope, wherein the collagen peptide is from a fish of the genus Lutjanus sp. A collagen peptide is used to prepare a composition that enhances the mitochondrial activity of a cell. The use as described in item 5 of the patent application range, wherein the effective concentration of the collagen peptide is at least 1 mg/mL. The use as described in Item 5 of the patent application scope, wherein the collagen peptide is from a fish of the genus Lutjanus sp. The use as described in item 5 of the patent application, wherein the cell is a skin fibroblast. A collagen peptide is used to prepare a composition that promotes the proliferation and anti-aging of a skin fibroblast. The use as described in item 9 of the patent application range, wherein the effective concentration of the collagen peptide is at least 1 mg/mL. The use as described in item 9 of the patent application range, wherein the collagen peptide is from a fish of the genus Lutjanus sp. The use as described in item 1, item 5 or item 9 of the patent application scope, wherein the composition is a pharmaceutical product, a food product or a maintenance product.

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