Composition with whitening and spot-fading effects and application of composition in oral preparation

Abstract

The invention relates to the technical field of medicine processing, in particular to a composition with whitening and spot-fading effects and application of an oral preparation of the composition in medicines. The functional component of the composition is prepared from the following raw materials in parts by weight: 25 to 60 parts of fructus crataegi, 4 to 12 parts of folium mori, 1 to 6 parts of fructus phyllanthi, 0.1 to 1.2 parts of flos chrysanthemi, 0.5 to 5 parts of radix puerariae, 3 to 12 parts of rhizoma dioscoreae, 1 to 8 parts of poria cocos, 0.1 to 1 part of radix ginseng, 0.05 to 0.9 part of colla corii asini, 0.1 to 1 part of mangosteen and 40 to 100 parts of collagen peptide. The oral pharmaceutical preparation prepared from the composition disclosed by the invention has the effects of whitening and fading spots, is safe and convenient, and has a wide market prospect.

Description

[0001] This application is based on the parent application CN202211153996.0. The parent application CN202211153996.0 has the following invention title: A composition with cosmetic effects and its use in oral preparations. The application date is September 21, 2022. Technical Field

[0002] The present invention relates to the technical field of pharmaceutical processing, in particular to a composition with whitening and spot-lightening effects and application of an oral preparation thereof in pharmaceuticals. Background Art

[0003] Everyone loves beauty, and the pursuit of external beauty is a modern human need. Healthy skin is clear, radiant, elastic, and free of wrinkles, spots, and acne. Relying solely on external cosmetics and makeup merely covers up and disguises the skin. Targeted internal conditioning, treating the symptoms, can address the root cause and achieve twice the result with half the effort. Many factors can contribute to skin problems, including irregular work and rest, stress, an unbalanced diet, illness, immune system disorders, and aging. Furthermore, women with dysmenorrhea often experience imbalances in their Qi and blood, leading to facial pigmentation, dull complexion, and lack of elasticity. Poor digestion and malnutrition can also contribute to dry, opaque skin.

[0004] As people increasingly appreciate the efficacy and use of plant and animal nutritional supplements, numerous products using these ingredients have been launched. However, these products often suffer from limited functionality and poor results. Therefore, developing oral beauty solutions with multiple functions has become a hot topic in market research and development. Summary of the Invention

[0005] The present invention aims to provide a composition containing hawthorn, mulberry leaf, emblica fruit, chrysanthemum, kudzu root, yam, poria, ginseng, mangosteen, collagen peptide and donkey-hide gelatin, which has a synergistic effect and has significant whitening and spot-removing effects.

[0006] In order to achieve the above-mentioned object of the present invention, the present invention provides the following technical solutions:

[0007] The composition is composed of the following raw materials in parts by weight: 25-60 parts of hawthorn, 4-12 parts of mulberry leaves, 1-6 parts of emblica fruit, 0.1-1.2 parts of chrysanthemum, 0.5-5 parts of kudzu root, 3-12 parts of yam, 1-8 parts of poria, 0.1-1 part of ginseng, 0.05-0.9 parts of donkey-hide gelatin, 0.1-1 parts of mangosteen, and 40-100 parts of collagen peptide.

[0008] Furthermore, the composition is composed of the following raw materials in parts by weight: 35-55 parts of hawthorn, 6-10 parts of mulberry leaves, 2-4 parts of emblica, 0.3-1 parts of chrysanthemum, 1-3 parts of kudzu root, 4-9 parts of yam, 2-6 parts of poria, 0.2-0.8 parts of ginseng, 0.1-0.7 parts of donkey-hide gelatin, 0.3-0.9 parts of mangosteen, and 50-90 parts of collagen peptide.

[0009] Furthermore, the composition is composed of the following raw materials in parts by weight: 40 parts of hawthorn, 9 parts of mulberry leaves, 3 parts of emblica, 0.5 parts of chrysanthemum, 2.5 parts of kudzu root, 7 parts of yam, 4 parts of poria, 0.5 parts of ginseng, 0.4 parts of donkey-hide gelatin, 0.5 parts of mangosteen, and 70 parts of collagen peptide.

[0010] The collagen peptide is deep-sea fish collagen peptide or freshwater fish collagen peptide.

[0011] The chrysanthemum is selected from the group consisting of chrysanthemums of Hangbai, Huangshan tribute chrysanthemum, Boju and Chuju; preferably, the chrysanthemum is chrysanthemum of Hangbai.

[0012] The present invention provides a method for preparing the above-mentioned composition, which specifically comprises the following steps:

[0013] (1) Add 400-800 mL of water to the formula amount of hawthorn, emblica fruit, chrysanthemum, mulberry leaf, poria, yam, ginseng, kudzu root, and mangosteen, and boil twice, filter, and combine the filtrates;

[0014] (2) Add the formulated amount of collagen peptide and donkey-hide gelatin to the combined filtrate, add water again and adjust the volume to 1300-1700 mL;

[0015] (3) Sterilize and repackage the fixed volume solution in bottles.

[0016] The ratio of the mass of mangosteen added in the step (1) to the volume of water added is (0.1-1):1.2 g / L.

[0017] The ratio of the mass of the collagen peptide added in step (2) to the volume of water added to the fixed volume is (40-100): 1.5 g / L.

[0018] The present invention provides an oral preparation comprising the above composition.

[0019] The oral preparation further comprises pharmaceutically acceptable additives; the pharmaceutically acceptable additives comprise 0.1-2 parts of an acidulant and 20-70 parts of a sweetener; preferably, the pharmaceutically acceptable additives comprise 0.5-1.5 parts of an acidulant and 30-60 parts of a sweetener; in a specific embodiment, the pharmaceutically acceptable additives comprise 1 part of an acidulant and 45 parts of a sweetener.

[0020] The sweetener is selected from one or more of xylitol, sorbitol, mannitol, lactitol, maltitol, isomalt, erythritol, steviol glycoside, licorice, chia seeds, mogroside, and thaumatin; preferably, the sweetener is selected from one or more of xylitol, sorbitol, erythritol, and steviol glycoside.

[0021] The acidulant is selected from one or more of citric acid, ascorbic acid, gluconic acid, malic acid, tartaric acid, lactic acid, and fumaric acid; preferably, the sweetener is selected from one or more of xylitol, sorbitol, erythritol, and steviol glycosides; in a specific embodiment, the acidulant is selected from one or more of ascorbic acid, gluconic acid, and malic acid.

[0022] According to an embodiment of the present invention, the oral preparation is a powder, a granule, an oral liquid, a capsule or a tablet.

[0023] According to an embodiment of the present invention, when the oral preparation is an oral liquid, the preparation method thereof comprises the following steps:

[0024] (1) Add 400-800 mL of water to the formula amount of hawthorn, emblica fruit, chrysanthemum, mulberry leaf, poria, yam, ginseng, kudzu root, and mangosteen, and boil twice, filter, and combine the filtrates;

[0025] (2) Add the formulated amount of collagen peptide, sweetener, acidulant, and donkey-hide gelatin to the combined filtrate, and add water again to adjust the volume to 1300-1700 mL;

[0026] (3) Sterilize and package the fixed volume solution in bottles to obtain oral solution.

[0027] The ratio of the mass of mangosteen added in the step (1) to the volume of water added is (0.1-1):1.2 g / L.

[0028] The ratio of the mass of the collagen peptide added in step (2) to the volume of water added to the fixed volume is (40-100): 1.5 g / L.

[0029] According to an embodiment of the present invention, when the oral preparation is a powder, the preparation method thereof comprises the following steps:

[0030] (1) Add 400-800 mL of water to the formula amount of hawthorn, emblica fruit, chrysanthemum, mulberry leaf, poria, yam, ginseng, kudzu root, and mangosteen, and boil twice. After filtering, the filtrate is combined, concentrated, dried, and crushed to obtain a solid powder of the extract;

[0031] (2) The solid powder of the extract is mixed evenly with the formulated amount of collagen peptide, sweetener, acidulant and donkey-hide gelatin, and then packaged to obtain a powder.

[0032] The ratio of the mass of mangosteen added in the step (1) to the volume of water added is (0.1-1):1.2 g / L.

[0033] According to a preferred embodiment of the present invention, when the oral preparation is a granule, the steps include:

[0034] (1) Add 400-800 mL of water to the formula amount of hawthorn, emblica fruit, chrysanthemum, mulberry leaf, poria, yam, ginseng, kudzu root, and mangosteen, and boil twice. After filtering, combine the filtrates and concentrate to obtain an extract.

[0035] (2) Add the formulated amount of collagen peptide, sweetener, acidulant and donkey-hide gelatin to the extract, spray granulate and obtain granules.

[0036] The ratio of the mass of mangosteen added in the step (1) to the volume of water added is (0.1-1):1.2 g / L.

[0037] According to an embodiment of the present invention, when the oral preparation is a tablet, the preparation method thereof comprises the following steps:

[0038] (1) Add 400-800 mL of water to the formula amount of hawthorn, emblica fruit, chrysanthemum, mulberry leaf, poria, yam, ginseng, kudzu root, and mangosteen, and boil twice. After filtering, combine the filtrates and concentrate to obtain an extract.

[0039] (2) Adding the formulated amount of collagen peptide, sweetener, acidulant and donkey-hide gelatin to the extract, spray granulating the extract and then pressing the extract into tablets to obtain tablets.

[0040] The ratio of the mass of mangosteen added in the step (1) to the volume of water added is (0.1-1):1.2 g / L.

[0041] According to an embodiment of the present invention, when the oral preparation is a capsule, the preparation method thereof comprises the following steps:

[0042] (1) Add 400-800 mL of water to the formula amount of hawthorn, emblica fruit, chrysanthemum, mulberry leaf, poria, yam, ginseng, kudzu root, and mangosteen, and boil twice. After filtering, combine the filtrates and concentrate to obtain an extract.

[0043] (2) Adding the formulated amount of collagen peptide, sweetener, acidulant and donkey-hide gelatin to the extract, spray granulating the extract and then filling the extract into capsules to prepare capsules.

[0044] The ratio of the mass of mangosteen added in the step (1) to the volume of water added is (0.1-1):1.2 g / L.

[0045] The present invention provides use of the above-mentioned composition and oral preparation thereof in preparing medicines with whitening and spot-removing effects.

[0046] The composition of the present invention can be used as a main raw material in the preparation of oral pharmaceutical preparations with whitening and spot-removing effects.

[0047] The said spot lightening refers to preventing, alleviating or eliminating chloasma, pregnancy spots, sun spots, radiation spots or age spots.

[0048] The beneficial effects of the present invention are:

[0049] The present invention combines a variety of foods that are both medicinal and edible with collagen peptides in a balanced ratio, resulting in a highly acceptable taste, and the taste is even better after adding an appropriate amount of additives. The components work synergistically to achieve the effect of whitening and lightening spots. Volunteers evaluated the product of the present invention for its lightening effect, with an efficacy of over 70%. The oral liquid preparation of the composition of the present invention can inhibit the proliferation activity of B16 cells and reduce local skin melanin deposition caused by the transfer of melanin to the basal cells of the epidermis, thereby reducing the formation of skin spots. It can treat both the symptoms and the root cause and lighten a variety of different types of spots in a short period of time, and is more effective than similar oral liquids. DETAILED DESCRIPTION

[0050] The present invention is further described below by way of specific implementation methods, but the scope of application of the present invention is not limited to the following embodiments. Substitutions and / or combinations of the technical features of the present invention within the content, spirit, and / or scope of the present invention will be obvious to those skilled in the art and are encompassed by the present invention.

[0051] The hawthorn, mulberry leaf, emblica fruit, chrysanthemum, kudzu root, yam, poria, ginseng, mangosteen, and additives used in the present invention are commonly available commercially. The collagen peptide is derived from deep-sea fish or freshwater fish, and the donkey-hide gelatin is purchased from Dong'e, Shandong. The amount of water added for decoction and the volume determination in the preparation method of the present invention are conventional techniques, and the liquid concentration is within the conventional range for oral preparations.

[0052] Example 1

[0053] A composition with whitening and spot-lightening effects, comprising the following components:

[0054] Hawthorn 40g, mulberry leaves 9g, emblica 3g, chrysanthemum 0.5g, kudzu root 2.5g, yam 7g, poria 4g, ginseng 0.5g, donkey-hide gelatin 0.4g, mangosteen 0.5g, collagen peptide 70g.

[0055] Preparation method:

[0056] (1) Add 600 mL of water to the formula amount of hawthorn, emblica fruit, chrysanthemum, mulberry leaf, poria, yam, ginseng, kudzu root, and mangosteen and boil twice, filter, and combine the filtrates;

[0057] (2) Add the formulated amount of collagen peptide and donkey-hide gelatin to the combined filtrate, add water again and adjust the volume to 1500 mL;

[0058] (3) Sterilize and repackage the fixed volume solution in bottles.

[0059] Example 2

[0060] A composition with whitening and spot-lightening effects, comprising the following components:

[0061] Hawthorn 50g, mulberry leaves 7.5g, emblica 2.5g, chrysanthemum 0.8g, kudzu root 1.6g, yam 6g, poria 4g, ginseng 0.5g, donkey-hide gelatin 0.2g, mangosteen 0.7g, collagen peptide 80g.

[0062] The preparation method is the same as that of Example 1.

[0063] Example 3

[0064] A composition with whitening and spot-lightening effects, comprising the following components:

[0065] Hawthorn 35g, mulberry leaf 10g, emblica fruit 2g, chrysanthemum 0.3g, kudzu root 3g, yam 9g, poria 2g, ginseng 0.8g, donkey-hide gelatin 0.1g, mangosteen 0.9g, collagen peptide 90g.

[0066] The preparation method is the same as that of Example 1.

[0067] Example 4

[0068] A composition with whitening and spot-lightening effects, comprising the following components:

[0069] Hawthorn 35g, mulberry leaves 10g, emblica 2g, Huangshan tribute chrysanthemum 0.3g, kudzu root 3g, yam 9g, poria 2g, ginseng 0.8g, donkey-hide gelatin 0.1g, mangosteen 0.9g, collagen peptide 90g.

[0070] The preparation method is the same as that of Example 1.

[0071] Example 5

[0072] A composition with whitening and spot-lightening effects, comprising the following components:

[0073] Hawthorn 55g, mulberry leaf 6g, emblica fruit 4g, chrysanthemum 1g, kudzu root 1g, yam 4g, poria 6g, ginseng 0.2g, donkey-hide gelatin 0.7g, mangosteen 0.3g, collagen peptide 50g.

[0074] The preparation method is the same as that of Example 1.

[0075] Example 6

[0076] A composition with whitening and spot-lightening effects, comprising the following components:

[0077] Hawthorn 25g, mulberry leaves 12g, emblica fruit 1g, chrysanthemum 0.1g, kudzu root 5g, yam 3g, poria 8g, ginseng 0.1g, donkey-hide gelatin 0.9g, mangosteen 0.1g, collagen peptide 40g.

[0078] The preparation method is the same as that of Example 1.

[0079] Example 7

[0080] A composition with whitening and spot-removing effects, the components and preparation method thereof are as follows:

[0081] Hawthorn 60g, mulberry leaves 4g, emblica 6g, chrysanthemum 1.2g, kudzu root 0.5g, yam 12g, poria 1g, ginseng 1g, donkey-hide gelatin 0.05g, mangosteen 1g, collagen peptide 100g.

[0082] The preparation method is the same as that of Example 1.

[0083] Example 8

[0084] An oral liquid with whitening and spot-lightening effects, comprising the following components:

[0085] Hawthorn 40g, mulberry leaf 9g, emblica fruit 3g, chrysanthemum 0.5g, kudzu root 2.5g, yam 7g, poria 4g, ginseng 0.5g, donkey-hide gelatin 0.4g, mangosteen 0.5g, collagen peptide 70g, erythritol 45g, L-malic acid 1g.

[0086] Preparation method:

[0087] (1) Add 600 mL of water to the formula amount of hawthorn, emblica fruit, chrysanthemum, mulberry leaf, poria, yam, ginseng, kudzu root, and mangosteen and boil twice, filter, and combine the filtrates;

[0088] (2) Add the formulated amount of collagen peptide, sweetener, acidulant, and donkey-hide gelatin to the combined filtrate, and add water again to make the volume 1500 mL;

[0089] (3) Sterilize and package the fixed volume solution in bottles to obtain oral solution.

[0090] Example 9

[0091] An oral liquid with whitening and spot-lightening effects, comprising the following components:

[0092] Hawthorn 50g, mulberry leaves 7.5g, emblica 2.5g, chrysanthemum 0.8g, kudzu root 1.6g, yam 6g, poria 4g, ginseng 0.5g, donkey-hide gelatin 0.2g, mangosteen 0.7g, collagen peptide 80g, erythritol 51g, L-malic acid 1.2g.

[0093] The preparation method is the same as Example 8.

[0094] Example 10

[0095] An oral liquid with whitening and spot-lightening effects, comprising the following components:

[0096] Hawthorn 35g, mulberry leaf 10g, emblica fruit 2g, Huangshan tribute chrysanthemum 0.3g, kudzu root 3g, yam 9g, poria 2g, ginseng 0.8g, donkey-hide gelatin 0.1g, mangosteen 0.9g, collagen peptide 90g, erythritol 60g, L-malic acid 0.5g.

[0097] The preparation method is the same as Example 8.

[0098] Example 11

[0099] An oral liquid with whitening and spot-lightening effects, comprising the following components:

[0100] Hawthorn 25g, mulberry leaf 12g, emblica fruit 1g, chrysanthemum 0.1g, kudzu root 5g, yam 3g, poria 8g, ginseng 0.1g, donkey-hide gelatin 0.9g, mangosteen 0.1g, collagen peptide 40g, erythritol 20g, L-malic acid 2g.

[0101] The preparation method is the same as Example 8.

[0102] Example 12

[0103] A powder with whitening and spot-lightening effects, comprising the following components:

[0104] Hawthorn 40g, mulberry leaf 9g, emblica fruit 3g, chrysanthemum 0.5g, kudzu root 2.5g, yam 7g, poria 4g, ginseng 0.5g, donkey-hide gelatin 0.4g, mangosteen 0.5g, collagen peptide 70g, erythritol 45g, L-malic acid 1g.

[0105] Preparation method:

[0106] (1) Add 600 mL of water to the formula amount of hawthorn, emblica fruit, chrysanthemum, mulberry leaf, poria, yam, ginseng, kudzu root, and mangosteen and boil twice, filter and combine the filtrates, concentrate, dry, and grind to obtain a solid powder of the extract;

[0107] (2) The solid powder of the extract is mixed evenly with the formulated amount of collagen peptide, sweetener, acidulant and donkey-hide gelatin, and then packaged to obtain a powder.

[0108] Example 13

[0109] A tablet with whitening and spot-lightening effects, comprising the following components:

[0110] Hawthorn 50g, mulberry leaves 7.5g, emblica 2.5g, chrysanthemum 0.8g, kudzu root 1.6g, yam 6g, poria 4g, ginseng 0.5g, donkey-hide gelatin 0.2g, mangosteen 0.7g, collagen peptide 80g, erythritol 51g, L-malic acid 1.2g.

[0111] Preparation method:

[0112] (1) Add 600 mL of water to the formula amount of hawthorn, emblica fruit, chrysanthemum, mulberry leaf, poria, yam, ginseng, kudzu root, and mangosteen, and boil twice. After filtering, combine the filtrate and concentrate to obtain an extract.

[0113] (2) Adding the formulated amount of collagen peptide, sweetener, acidulant and donkey-hide gelatin to the extract, spray granulating the extract and then pressing the extract into tablets to obtain tablets.

[0114] Example 14

[0115] A capsule with whitening and spot-lightening effects, comprising the following components:

[0116] Hawthorn 35g, mulberry leaf 10g, emblica fruit 2g, Huangshi tribute chrysanthemum 0.3g, kudzu root 3g, yam 9g, poria 2g, ginseng 0.8g, donkey-hide gelatin 0.1g, mangosteen 0.9g, collagen peptide 90g, erythritol 60g, L-malic acid 0.5g.

[0117] Preparation method:

[0118] (1) Add 600 mL of water to the formula amount of hawthorn, emblica fruit, chrysanthemum, mulberry leaf, poria, yam, ginseng, kudzu root, and mangosteen, and boil twice. After filtering, combine the filtrate and concentrate to obtain an extract.

[0119] (2) Adding the formulated amount of collagen peptide, sweetener, acidulant and donkey-hide gelatin to the extract, spray granulating the extract and then filling the extract into capsules to prepare capsules.

[0120] Example 15

[0121] A granule with whitening and spot-lightening effects, comprising the following components:

[0122] Hawthorn 25g, mulberry leaf 12g, emblica fruit 1g, chrysanthemum 0.1g, kudzu root 5g, yam 3g, poria 8g, ginseng 0.1g, donkey-hide gelatin 0.9g, mangosteen 0.1g, collagen peptide 40g, erythritol 20g, L-malic acid 2g.

[0123] Preparation method:

[0124] (1) Add 600 mL of water to the formula amount of hawthorn, emblica fruit, chrysanthemum, mulberry leaf, poria, yam, ginseng, kudzu root, and mangosteen, and boil twice. After filtering, combine the filtrate and concentrate to obtain an extract.

[0125] (2) Add the formulated amount of collagen peptide, sweetener, acidulant and donkey-hide gelatin to the extract, spray granulate and obtain granules.

[0126] Example 16

[0127] An oral liquid with whitening and spot-lightening effects, comprising the following components:

[0128] Hawthorn 40g, mulberry leaf 9g, emblica fruit 3g, chrysanthemum 0.5g, kudzu root 2.5g, yam 7g, poria 4g, ginseng 0.5g, donkey-hide gelatin 0.4g, mangosteen 0.5g, collagen peptide 70g, maltitol 45g, citric acid 1g.

[0129] The preparation method is the same as Example 8.

[0130] Example 17

[0131] An oral liquid with whitening and spot-lightening effects, comprising the following components:

[0132] Hawthorn 40g, mulberry leaf 9g, emblica fruit 3g, chrysanthemum 0.5g, kudzu root 2.5g, yam 7g, poria 4g, ginseng 0.5g, donkey-hide gelatin 0.4g, mangosteen 0.5g, collagen peptide 70g, erythritol 20g, L-malic acid 2g.

[0133] The preparation method is the same as Example 8.

[0134] Example 18

[0135] A powder with whitening and spot-lightening effects, comprising the following components:

[0136] Hawthorn 40g, mulberry leaves 9g, emblica 3g, chrysanthemum 0.5g, kudzu root 2.5g, yam 7g, poria 4g, ginseng 0.5g, donkey-hide gelatin 0.4g, mangosteen 0.5g, collagen peptide 70g, xylitol 70g, ascorbic acid 0.1g.

[0137] The preparation method is the same as Example 12.

[0138] Example 19

[0139] An oral liquid with whitening and spot-lightening effects, comprising the following components:

[0140] Hawthorn 40g, mulberry leaf 9g, emblica fruit 3g, chrysanthemum 0.5g, kudzu root 2.5g, yam 7g, poria 4g, ginseng 0.5g, donkey-hide gelatin 0.4g, mangosteen 0.5g, collagen peptide 70g, mannitol 45g, lactitol 5g, tartaric acid 1g, lactic acid 0.5g.

[0141] The preparation method is the same as Example 8.

[0142] Comparative Example 1

[0143] AXXZIA AG fifth-generation anti-sugar oral liquid, product number: 100020357100.

[0144] Comparative Example 2

[0145] A composition with whitening and spot-lightening effects, comprising the following components:

[0146] Hawthorn 15g, mulberry leaf 15g, emblica fruit 7g, chrysanthemum 1.5g, kudzu root 6g, yam 14g, poria 9g, ginseng 1.2g, donkey-hide gelatin 1g, mangosteen 1.3g, collagen peptide 110g.

[0147] The preparation method is the same as that of Example 1.

[0148] Comparative Example 3

[0149] A composition with whitening and spot-lightening effects, comprising the following components:

[0150] 2.5g of Pueraria root, 7g of Chinese yam, 4g of Poria cocos, 0.5g of ginseng, 0.4g of donkey-hide gelatin, 0.5g of mangosteen, and 70g of collagen peptide.

[0151] Preparation method:

[0152] (1) Add 600 mL of water to the formula amount of Poria cocos, Chinese yam, ginseng, Pueraria root, and mangosteen and boil twice, filter, and combine the filtrates;

[0153] (2) Add the formulated amount of collagen peptide and donkey-hide gelatin to the combined filtrate, add water again and adjust the volume to 1500 mL;

[0154] (3) Sterilize and repackage the fixed volume solution in bottles.

[0155] Comparative Example 4

[0156] A composition with whitening and spot-lightening effects, comprising the following components:

[0157] Hawthorn 40g, mulberry leaves 9g, emblica 3g, chrysanthemum 0.5g, mangosteen 0.5g, collagen peptide 70g.

[0158] Preparation method:

[0159] (1) Add 600 mL of water to the formula amount of hawthorn, emblica fruit, chrysanthemum, mulberry leaf, and mangosteen and boil twice, filter, and combine the filtrates;

[0160] (2) Add the formulated amount of collagen peptide to the combined filtrate, add water again and adjust the volume to 1500 mL;

[0161] (3) Sterilize and repackage the fixed volume solution in bottles.

[0162] Comparative Example 5

[0163] An oral liquid with whitening and spot-lightening effects, comprising the following components:

[0164] Hawthorn 15g, mulberry leaf 15g, emblica fruit 7g, chrysanthemum 1.5g, kudzu root 6g, yam 14g, poria 9g, ginseng 1.2g, donkey-hide gelatin 1g, mangosteen 1.3g, collagen peptide 110g, erythritol 75g, L-malic acid 4g.

[0165] The preparation method is the same as Example 8.

[0166] Comparative Example 6

[0167] An oral liquid with whitening and spot-lightening effects, comprising the following components:

[0168] Pueraria root 2.5g, Chinese yam 7g, Poria cocos 4g, ginseng 0.5g, donkey-hide gelatin 0.4g, mangosteen 0.5g, collagen peptide 70g, erythritol 45g, L-malic acid 1g.

[0169] Preparation method:

[0170] (1) Add 600 mL of water to the formula amount of Poria cocos, Chinese yam, ginseng, Pueraria root, and mangosteen and boil twice, filter, and combine the filtrates;

[0171] (2) Add the formulated amount of collagen peptide, sweetener, acidulant, and donkey-hide gelatin to the combined filtrate, and add water again to make the volume 1500 mL;

[0172] (3) Sterilize and package the fixed volume solution in bottles to obtain oral solution.

[0173] Comparative Example 7

[0174] An oral liquid with whitening and spot-lightening effects, comprising the following components:

[0175] Hawthorn 40g, mulberry leaf 9g, emblica 3g, chrysanthemum 0.5g, mangosteen 0.5g, collagen peptide 70g, erythritol 45g, L-malic acid 1g.

[0176] Preparation method:

[0177] (1) Add 600 mL of water to the formula amount of hawthorn, emblica fruit, chrysanthemum, mulberry leaf, and mangosteen and boil twice, filter, and combine the filtrates;

[0178] (2) Add the formulated amount of collagen peptide, sweetener, and acidulant to the combined filtrate, and add water again to make the volume up to 1500 mL;

[0179] (3) Sterilize and package the fixed volume solution in bottles to obtain oral solution.

[0180] Comparative Example 8

[0181] An oral liquid with whitening and spot-lightening effects, comprising the following components:

[0182] Hawthorn 40g, mulberry leaf 9g, emblica fruit 3g, chrysanthemum 0.5g, kudzu root 2.5g, yam 7g, poria 4g, ginseng 0.5g, donkey-hide gelatin 0.4g, mangosteen 0.5g, collagen peptide 70g, erythritol 17g, L-malic acid 3g.

[0183] The preparation method is the same as Example 8.

[0184] Experimental Example 1 Effect of the Oral Liquid of the Present Invention on the Proliferation Activity of B16 Cells

[0185] 1. Materials

[0186] 1.1 Cells: B16 mouse melanoma cells were obtained from the New Drug Pharmacology Center of Lunan Pharmaceutical Group Co., Ltd.

[0187] 1.2 Drugs and reagents

[0188] 1.2.1 Medication

[0189] Oral liquids of Example 8, Example 9 and Comparative Example 1 of the present invention. Vitamin C was purchased from Sigma, USA.

[0190] 1.2.2 Reagents

[0191] RPMI 1640 culture medium and fetal bovine serum (FBS) were purchased from Gibco, USA; dimethyl sulfoxide (DMSO) and methazolylthiocyanate (MTT) were purchased from Sigma, USA.

[0192] 1.2.3 Dosage

[0193] The oral solutions of Example 8, Example 9 and Comparative Example 1 were diluted 10-fold with PBS-sterilized distilled water. Vitamin C was prepared into 4 mg / mL with sterilized distilled water.

[0194] 2. Experimental Procedure

[0195] B16 cells were inoculated in RPMI-1640 medium containing 10% FBS, 1% double-antibody (100 U / mL penicillin, 0.1 g / L streptomycin sulfate), and cultured in a cell culture incubator at 37°C and saturated humidity with 5% CO2 for 24 h, after which the medium was changed once. On the third day after cell inoculation, cells were digested and passaged with 0.25% trypsin. Cells were passaged to the fourth generation, and cells in the logarithmic growth phase were used for experiments.

[0196] The MTT assay was used. Cells in the logarithmic growth phase were digested with 0.25% trypsin, counted, and prepared into a 4×104 / mL single-cell suspension. The suspension was then inoculated into a 96-well cell culture plate, with 100 μL of the single-cell suspension added to each well. After 24 hours of inoculation, the culture medium was replaced with serum-free RPMI-1640 medium and set aside. An experimental group and a control group (Vc) were set up, with three replicate wells in each group. After sample intervention, the cells were cultured at 37°C, 5% CO2, and saturated humidity, with 24 and 48 h exposure time groups set up, respectively.

[0197] Carefully discard the supernatant of the cells when the action time has expired, add 5g / LMTT solution to each well, and continue to act in an incubator at 37°C, 5% CO2 for 4 hours. Gently aspirate the supernatant, add 150μL DMSO, and shake for 10 minutes. Measure the absorbance A at 490nm and calculate the inhibition rate.

[0198]

[0199] 3. Results

[0200] Skin melanocytes can transfer melanin to cells in the basal layer of the epidermis, causing localized melanin deposition and leading to the formation of spots. Therefore, the B16 cell proliferation rate is an important indicator for evaluating the effectiveness of spot lightening. Calculations showed that the B16 mouse melanoma cell activity inhibition rate in Example 8 was 80.55%, and that in Example 9 was 69.66%. This compares to the 52.20% inhibition rate achieved by the commercially available whitening oral solution in Comparative Example 1. This indicates that the oral formulation of the present invention exhibits a high inhibition rate against B16 mouse melanoma cells and outperforms the commercially available product described in Comparative Example 1, demonstrating excellent spot lightening activity.

[0201] Experimental Example 2 Evaluation of the Spot-Lightening Effect of the Composition of the Present Invention

[0202] 1. Subject population

[0203] A total of 270 volunteers aged 25-50 were selected for the trial. All were healthy women with no history of trauma, skin diseases, infectious diseases, or long-term medication. Their facial skin had varying degrees of pregnancy spots, chloasma, sun spots, and age spots.

[0204] 2. Experimental process

[0205] The test subjects were divided into nine groups, 30 in each, based on pigmentation intensity and age. The first group tried the product of Example 1, the second group tried the product of Example 2, the third group tried the product of Example 3, the fourth group tried the product of Example 4, the fifth group tried the product of Example 6, the sixth group tried the product of Comparative Example 1, the seventh group tried the product of Comparative Example 2, the eighth group tried the product of Comparative Example 3, and the ninth group tried the product of Comparative Example 4. Each subject took one 30 mL vial once daily after meals for 30 consecutive days. During this period, no cosmetics with freckle-removing or similar properties were used.

[0206] A questionnaire survey was conducted to assess the subjective evaluations of trial users after use, and a detailed comparison of their makeup before and after use was conducted. Results were statistically analyzed by comparing the before and after photos of the users' natural appearance. Significant results were defined as changes evident in both the subjective evaluation and the comparison photos; effective results were defined as changes difficult to discern in the subjective evaluation, but visible in the comparison photos; and ineffective results were defined as no changes in either evaluation. The statistical results are shown in Table 1.

[0207] 3. Results

[0208] Table 1 Subjects' evaluation of spot-lightening effect

[0209]

[0210]

[0211] As can be seen from the results in the table, changes in the content and composition of the formula components of Examples 1-6 and Comparative Examples 1-4 will cause changes in the lightening effect. Within the scope of protection of the present invention, the lightening effect of Example 1 is the most significant, and the efficacy of Examples 1 to 3 is relatively high. The chrysanthemum in Example 4 is selected from Huangshan Gongju, and the lightening effect is worse than that of the chrysanthemum selected from Hangbaiju in the formula of Example 3. When the formula quantity is not appropriate (Comparative Example 2) or the formula is incomplete (Comparative Examples 3 and 4), the lightening effect is obviously not as good as the example products. In addition, the products of the present invention are all better than the products of Comparative Example 1 (commercially available products), indicating that the composition of the present invention has a significant lightening effect.

[0212] Experimental Example 3 Taste Test of the Oral Preparation of the Composition of the Present Invention

[0213] The products obtained in Examples 8, 9, 16, 17, Comparative Example 1, and 8 were subjected to a taste test. Specifically, 90 volunteers were randomly divided into 6 groups, with 15 people in each group. They were asked to taste the six groups of products selected above and evaluate and score the taste of the products, with a total score of 5 points.

[0214] 5 = good taste, acceptable; 4 = good taste, acceptable; 3 = average taste, relatively acceptable; 2 = poor taste, barely acceptable; 1 = very poor taste, unacceptable. This scale includes the ability to use 0.1 points, so there is a possibility of 50 level differences. The results are as follows:

[0215] result

[0216] Table 2 Oral preparation taste test results

[0217]

[0218] From the above scoring results, it can be seen that the taste of the products is acceptable to the public, and the taste of Example 8 is the best. Except for Comparative Example 8, the taste of most of the products is better than the commercial products to which Comparative Example 1 belongs.

Claims

1. A composition, characterized in that The effective ingredients of the composition are composed of the following raw materials in parts by weight: 25-60 parts of hawthorn, 4-12 parts of mulberry leaves, 1-6 parts of emblica, 0.1-1.2 parts of chrysanthemum, 0.5-5 parts of kudzu root, 3-12 parts of yam, 1-8 parts of poria, 0.1-1 parts of ginseng, 0.05-0.9 parts of donkey-hide gelatin, 0.1-1 parts of mangosteen, and 40-100 parts of collagen peptide; or 35-55 parts of hawthorn, 6-10 parts of mulberry leaves, 2-4 parts of emblica, 0.3-1 parts of chrysanthemum, 1-3 parts of kudzu root, 4-9 parts of yam, 2-6 parts of poria, 0.2-0.8 parts of ginseng, 0.1-0.7 parts of donkey-hide gelatin, 0.3-0.9 parts of mangosteen, and 50-90 parts of collagen peptide; or 40 parts of hawthorn, 9 parts of mulberry leaves, 3 parts of emblica, 0.5 parts of chrysanthemum, 2.5 parts of kudzu root, 7 parts of yam, 4 parts of poria, 0.5 parts of ginseng, 0.4 parts of donkey-hide gelatin, 0.5 parts of mangosteen, and 70 parts of collagen peptide; the collagen peptide is deep-sea fish collagen peptide or freshwater fish collagen peptide.

2. The composition according to claim 1, wherein The chrysanthemum is selected from the group consisting of Hangbai chrysanthemum, Huangshan tribute chrysanthemum, Bozhou chrysanthemum and Chuzhou chrysanthemum.

3. An oral preparation, characterized in that The oral preparation comprises the composition according to claim 1 or 2.

4. The oral preparation according to claim 3, wherein The oral preparation further comprises pharmaceutically acceptable additives.

5. The oral preparation according to claim 4, wherein The pharmaceutically acceptable additives include 0.1-2 parts of a sour agent and 20-70 parts of a sweetener.

6. The oral preparation according to claim 5, wherein The sweetener is selected from one or more of xylitol, sorbitol, erythritol, and stevioside; the acidulant is selected from one or more of ascorbic acid, gluconic acid, and malic acid.

7. The oral preparation according to claim 3, wherein The oral preparation is powder, granule, oral liquid, capsule or tablet.

8. Use of the composition according to any one of claims 1 to 2 or the oral preparation according to any one of claims 3 to 7 in the preparation of a medicament having whitening and spot-removing effects.

9. The oral preparation according to claim 8, wherein The said spot lightening refers to preventing, alleviating or eliminating chloasma, pregnancy spots, sun spots, radiation spots or age spots.

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