Freckle removing composition and application thereof

Abstract

The invention provides a freckle-removing composition. The freckle-removing composition comprises the following components in parts by weight: 30-100 parts of white poria; 10-50 parts by weight of coix seeds; 10-50 parts by weight of radix puerariae; 30 to 100 parts by weight of dahurian angelica root; 30 to 80 parts by weight of rhizoma typhonii; 30-80 parts by weight of white ginseng; 30 to 50 parts by weight of semen cuscutae; 10-50 parts by weight of rhizoma bletillae; 10-50 parts by weight of rhizoma kaempferiae; 10-50 parts by weight of pomegranate rind; 10-50 parts by weight of persimmon leaves; 30-70 parts by weight of Japanese snakegourd root; 10-30 parts by weight of safflower; and 10-30 parts by weight of red sage root. The traditional Chinese medicine composition obtained by compounding the components can improve skin lesion caused by chloasma, reduce numerical values of surface pigments, brown regions and deep pigments under a CBS skin cloud mirror, improve life quality and reduce traditional Chinese medicine symptom scores, has relatively high total effective rate of treatment and patient satisfaction, and has a relatively good treatment effect on chloasma.

Description

Technical Field

[0001] The present invention relates to the technical field of pharmaceutical preparations, and particularly relates to a freckle-removing composition and its use. Background Art

[0002] Melasma is a chronic, acquired facial hyperpigmentation skin disease. The clinical manifestation is light brown or dark brown patches with uneven depths and unclear boundaries symmetrically distributed on the cheeks, forehead and lower jaw. It often worsens after sun exposure and has no other obvious symptoms. While melasma affects the appearance of patients, it also brings serious psychological pressure to patients. Some patients even show adverse psychological phenomena such as anxiety, loneliness, and low self-esteem. These adverse emotions will further aggravate the condition of melasma. Therefore, melasma is not only a pigment metabolism disorder skin disease, but also a physiological, mental and psychological disease that affects social interaction and should be taken seriously.

[0003] Traditional Chinese medicine has a long history of understanding melasma, and there are various names for melasma in ancient books, such as "facial dust", "lentigo", "liver spot", "butterfly spot", "pregnancy spot", etc. The prior art has disclosed a variety of traditional Chinese medicine compositions for treating or alleviating melasma, but the currently disclosed compositions can only alleviate the patches on the skin surface and have no obvious effect on removing the pigments in the deep layer of the skin. Summary of the Invention

[0004] In view of this, the present invention provides a freckle-removing composition and its application. The freckle-removing composition provided by the present application can remove the pigments on the skin surface and in the deep layer, and has a good therapeutic effect on skin patches such as melasma.

[0005] The present application provides a freckle-removing composition, comprising:

[0006] 30 to 100 parts by weight of Poria cocos;

[0007] 10 to 50 parts by weight of Coix lacryma-jobi;

[0008] 10 to 50 parts by weight of Pueraria lobata;

[0009] 30 to 100 parts by weight of Angelica dahurica;

[0010] 30 to 80 parts by weight of Typhonium giganteum;

[0011] 30 to 80 parts by weight of Panax ginseng;

[0012] 30 to 50 parts by weight of Cuscuta chinensis;

[0013] 10 to 50 parts by weight of Bletilla striata;

[0014] 10 to 50 parts by weight of Kaempferia galanga;

[0015] 10 to 50 parts by weight of pomegranate peel;

[0016] 10 to 50 parts by weight of persimmon leaves;

[0017] 30 to 70 parts by weight of trichosanthes root;

[0018] 10 to 30 parts by weight of safflower;

[0019] 10 to 30 parts by weight of salvia miltiorrhiza.

[0020] The composition provided by this application includes: poria cocos, coix seed, kudzu root, angelica dahurica, typhonium giganteum, white ginseng, cuscuta chinensis, bletilla striata, kaempferia galanga, pomegranate peel, persimmon leaves, trichosanthes root, safflower, salvia miltiorrhiza, etc. In this application, the pungent-warm typhonium giganteum is combined with coix seed to resolve phlegm and dissipate nodules, and dredge the meridians; the pungent-warm and aromatic angelica dahurica is combined with kudzu root to dispel wind and dredge the meridians, and expel pathogenic factors; the sweet-warm ginseng is combined with cuscuta chinensis to tonify qi and nourish blood, and moisten the skin. The whole formula together exerts the functions of tonifying qi and nourishing blood, promoting blood circulation and regulating qi, removing stasis and eliminating macules, and moistening the skin.

[0021] Specifically, Poria cocos and Coix lacryma-jobi L. var. ma-yuen (Roman.) Stapf help regulate the internal environment of the body through the effects of promoting diuresis and excreting dampness and strengthening the spleen, reduce the unsmooth flow of qi and blood caused by damp pathogens, and then improve the qi and blood circulation of the face. Combined with their antioxidant effects, they jointly promote the fading of chloasma; Pueraria lobata (Willd.) Ohwi clears heat and relieves the exterior syndrome, raises yang and stops diarrhea through its characteristics, and active ingredients such as puerarin it contains can scavenge free radicals to enhance the antioxidant capacity of the skin, and can also improve blood circulation, thus helping to reduce melanin deposition and improve chloasma; Angelica dahurica (Fisch. ex Hoffm.) Benth. et Hook. f. ex Franch. et Sav., especially its volatile oil, has certain whitening activity. It can inhibit the activity of tyrosinase, reduce the activity of tyrosinase, thereby inhibiting melanin production, and at the same time has antioxidant activity and the ability to scavenge free radicals in vitro; Typhonium giganteum Engl. promotes blood circulation and dredges the meridians through its pungent and warm nature, and has the effect of inhibiting the activity of tyrosinase, thus helping to reduce pigmentation and improve chloasma, and can be used to treat pigment-increasing skin diseases such as chloasma; Panax ginseng C. A. Mey., especially the ginseng flower oligosaccharide it contains, can enhance the antioxidant capacity of a variety of related enzymes and reduce the damage of the body caused by oxidation. Ginseng flower polysaccharide can significantly scavenge a variety of free radicals in vitro; Cuscuta chinensis Lam., especially its water extract, can act on the tyrosinase of zebrafish embryo melanocytes, inhibit melanin synthesis, and can inhibit melanin synthesis, and at the same time has a good anti-aging effect; Bletilla striata (Thunb.) Reichb. has good whitening, antioxidant, anti-aging and other effects. It has a significant inhibitory effect on tyrosinase, thus effectively reducing the production of melanin and playing a whitening role. In addition, Bletilla striata polysaccharide has antioxidant effect in vitro; Kaempferia galanga L. can regulate qi and dispel cold, and promote the flow of qi and blood, while Punica granatum L. peel can astringe to stop bleeding, clear heat and promote diuresis, jointly assisting in improving qi and blood stasis and heat-toxin symptoms, and synergistically acting to reduce chloasma; Diospyros kaki Thunb. leaves clear heat and moisten the lungs, cool the blood and stop bleeding through their bitter and cold nature, while Trichosanthes cucumeroides (Ser.) Maxim. roots play the role of clearing heat and detoxifying, dissipating swelling and dissipating nodules with their bitter and cold nature. Both may assist in improving chloasma symptoms by reducing skin inflammation and promoting blood circulation; Carthamus tinctorius L. has the effects of promoting blood circulation to remove blood stasis and dredging the meridians to relieve pain, and Salvia miltiorrhiza Bunge can promote blood circulation to remove blood stasis and relax tendons and activate collaterals. Both can promote blood circulation and improve microcirculation, thus helping to reduce pigmentation and fade chloasma.

[0022] The experimental results show that when the above components are compounded in this application, the obtained traditional Chinese medicine composition can not only remove the pigments on the skin surface, but also remove the pigments deep in the skin, and has a good therapeutic effect on skin patches such as chloasma. Especially the addition of Kaempferia galanga L. and Trichosanthes cucumeroides (Ser.) Maxim. roots can significantly reduce the pigment content deep in the skin on the basis of reducing the number of uses; when reducing or replacing one or both of Kaempferia galanga L. and Trichosanthes cucumeroides (Ser.) Maxim. roots, although the obtained composition can still remove the pigments on the skin surface, the effect of removing the pigments deep in the skin is poor, and there is a significant difference from the composition provided in this application.

[0023] In some specific implementation manners, the freckle-removing composition includes:

[0024] 40 to 80 parts by weight of Poria cocos;

[0025] 20 to 40 parts by weight of Coix lacryma-jobi;

[0026] 20 to 40 parts by weight of Pueraria lobata;

[0027] 40 to 80 parts by weight of Angelica dahurica;

[0028] 40 to 60 parts by weight of Typhonium giganteum;

[0029] 40 to 60 parts by weight of Panax ginseng;

[0030] 35 to 45 parts by weight of Cuscuta chinensis;

[0031] 20 to 40 parts by weight of Bletilla striata;

[0032] 20 to 40 parts by weight of Kaempferia galanga;

[0033] 20 to 40 parts by weight of Punica granatum peel;

[0034] 20 to 40 parts by weight of Persimmon leaf;

[0035] 40 to 60 parts by weight of Trichosanthes cucumeroides root;

[0036] 15 to 25 parts by weight of Carthamus tinctorius;

[0037] 15 to 25 parts by weight of Salvia miltiorrhiza.

[0038] In some specific implementation manners, the freckle-removing composition includes:

[0039] 50 to 70 parts by weight of Poria cocos;

[0040] 25 to 35 parts by weight of Coix lacryma-jobi;

[0041] 25 to 35 parts by weight of Pueraria lobata;

[0042] 50 to 70 parts by weight of Angelica dahurica;

[0043] 45 to 55 parts by weight of Typhonium giganteum;

[0044] 45 to 55 parts by weight of Panax ginseng;

[0045] 35 to 45 parts by weight of Cuscuta chinensis;

[0046] 25 to 35 parts by weight of Bletilla striata;

[0047] 25 to 35 parts by weight of Kaempferia galanga;

[0048] 25 to 35 parts by weight of Punica granatum peel;

[0049] 25 to 35 parts by weight of Persimmon leaf;

[0050] 45 to 55 parts by weight of Trichosanthes cucumeroides root;

[0051] 15 to 25 parts by weight of Carthamus tinctorius flower;

[0052] 15 to 25 parts by weight of Salvia miltiorrhiza root.

[0053] In some specific implementation manners, the freckle-removing composition includes:

[0054] 55 to 65 parts by weight of Poria cocos;

[0055] 25 to 35 parts by weight of Coix lacryma-jobi;

[0056] 25 to 35 parts by weight of Pueraria lobata root;

[0057] 55 to 65 parts by weight of Angelica dahurica root;

[0058] 45 to 55 parts by weight of Typhonium giganteum rhizome;

[0059] 45 to 55 parts by weight of Panax ginseng;

[0060] 35 to 45 parts by weight of Cuscuta chinensis;

[0061] 25 to 35 parts by weight of Bletilla striata;

[0062] 25 to 35 parts by weight of Kaempferia galanga;

[0063] 25 to 35 parts by weight of Punica granatum peel;

[0064] 25 to 35 parts by weight of Diospyros kaki leaf;

[0065] 45 to 55 parts by weight of Trichosanthes cucumeroides root;

[0066] 15 to 25 parts by weight of Carthamus tinctorius flower;

[0067] 15 to 25 parts by weight of Salvia miltiorrhiza root.

[0068] In some specific implementation manners, the Poria cocos, Coix lacryma-jobi, Pueraria lobata root, Angelica dahurica root, Typhonium giganteum rhizome, Panax ginseng, Cuscuta chinensis, Bletilla striata, Kaempferia galanga, Punica granatum peel, Diospyros kaki leaf, Trichosanthes cucumeroides root, Carthamus tinctorius flower and Salvia miltiorrhiza root are independently decoction extracts. The present application has no special limitation on the method for obtaining the decoction extract, and it is preferably prepared according to the following method:

[0069] Crush and mix the Poria cocos, Coix lacryma-jobi, Pueraria lobata root, Angelica dahurica root, Typhonium giganteum rhizome, Panax ginseng, Cuscuta chinensis, Bletilla striata, Kaempferia galanga, Punica granatum peel, Diospyros kaki leaf, Trichosanthes cucumeroides root, Carthamus tinctorius flower and Salvia miltiorrhiza root to obtain a mixture;

[0070] Soak the mixture in water and then decoct it, and filter to obtain a medicinal liquid;

[0071] Homogenize the medicinal liquid.

[0072] In this application, Poria cocos, Coix lacryma-jobi, Pueraria lobata, Angelica dahurica, Typhonium giganteum, Panax ginseng, Cuscuta chinensis, Bletilla striata, Kaempferia galanga, Punica granatum peel, Persimmon leaves, Trichosanthes cucumeroides, Carthamus tinctorius, and Salvia miltiorrhiza are first crushed respectively to obtain medicinal powders. There are no special restrictions on the crushing method in this application, and it can be ultrafine crushing. There are no special restrictions on the parameters of the ultrafine crushing, and the parameters commonly used by those skilled in the art can be used.

[0073] After the respective drugs are crushed, they are mixed to obtain a mixture. In some specific implementation manners, after obtaining the mixture, it is packaged in a non-woven fabric bag. On the one hand, it prevents the intrusion of moisture and microorganisms, ensuring the quality and efficacy of the medicinal powder; on the other hand, it is convenient for processing the medicinal powder.

[0074] After obtaining the medicinal powder, it is first soaked in water and then decocted, and the medicinal liquid can be obtained after separation. In this application, the medicinal powder is first soaked in water for 20 min to 60 min, preferably 25 min to 45 min. During the soaking process, it is turned and stirred every 10 min to make the soaking more uniform. In some specific implementation manners, the mass ratio of the medicinal powder to water is 1:10 to 30, preferably 1:15 to 25, and more preferably 1:16.

[0075] After soaking, the obtained mixture is decocted. In some specific implementation manners, it is first decocted under high heat for 20 min to 60 min, preferably 30 min to 50 min, and then continued to be decocted under low heat until the volume of the medicinal liquid is concentrated by 20% to 40%. After filtration and cooling, the medicinal liquid is obtained. There are no special restrictions on the decoction in this application, and it can be carried out in a decocting machine. There are no special restrictions on the filtration in this application. When the medicinal powder is packaged in a non-woven fabric bag, the non-woven fabric bag can be directly taken out. There are no special restrictions on the cooling in this application, and it can be naturally cooled at room temperature, preferably cooled to below 70 °C.

[0076] After obtaining the medicinal liquid, it is homogenized. In some specific implementation manners, the homogenization is carried out in a homogenizer. In some specific implementation manners, the rotation speed of the homogenization is 8000 revolutions per minute to 11000 revolutions per minute. In some specific implementation manners, at least one of sodium hyaluronate, glycerol, and p-hydroxyacetophenone is added during the homogenization process, and preferably sodium hyaluronate, glycerol, and p-hydroxyacetophenone are added in sequence. In some specific implementation manners, the addition amounts of sodium hyaluronate, glycerol, and p-hydroxyacetophenone are independently 0.05% to 0.5%, 1% to 5%, and 0.05% to 0.5% of the volume of the medicinal liquid, preferably 0.1%, 2%, and 0.1%.

[0077] The above-mentioned composition provided by the present application can be used externally and prepared into forms such as facial masks, creams, lotions, etc., and applied to the skin surface to achieve the effect of reducing pigments from the inside out, simultaneously on the surface layer and the deep layer.

[0078] In some specific implementation manners, the composition further includes a second freckle-removing composition, and the second freckle-removing composition includes:

[0079] 50 to 150 parts by weight of peach kernels;

[0080] 10 to 110 parts by weight of safflower;

[0081] 50 to 150 parts by weight of red peony roots;

[0082] 100 to 300 parts by weight of rehmannia roots;

[0083] 10 to 120 parts by weight of chuanxiong rhizomes;

[0084] 50 to 150 parts by weight of angelica roots;

[0085] 150 to 300 parts by weight of dodder seeds;

[0086] 100 to 200 parts by weight of taxillus twigs;

[0087] 70 to 170 parts by weight of bupleurum roots;

[0088] 50 to 150 parts by weight of campsis flowers;

[0089] 150 to 350 parts by weight of coix seeds;

[0090] 50 to 150 parts by weight of dahurian angelica roots;

[0091] 50 to 150 parts by weight of atractylodes rhizomes;

[0092] 100 to 300 parts by weight of turmeric roots;

[0093] 50 to 150 parts by weight of schizonepetae herbs;

[0094] 50 to 150 parts by weight of ledebouriella roots;

[0095] 100 to 200 parts by weight of poria cocos;

[0096] 10 to 150 parts by weight of alisma rhizomes.

[0097] In some specific implementation manners, the second freckle-removing composition includes:

[0098] 60 to 130 parts by weight of peach kernels;

[0099] 20 to 100 parts by weight of safflower;

[0100] 60 to 130 parts by weight of Paeonia lactiflora Pall.;

[0101] 110 to 280 parts by weight of Rehmannia glutinosa Libosch.;

[0102] 20 to 110 parts by weight of Ligusticum wallichii Franch.;

[0103] 60 to 140 parts by weight of Angelica sinensis (Oliv.) Diels;

[0104] 160 to 290 parts by weight of Cuscuta chinensis Lam.;

[0105] 110 to 190 parts by weight of Taxillus sutchuenensis (Lecomte) Danser;

[0106] 80 to 160 parts by weight of Bupleurum chinense DC.;

[0107] 60 to 140 parts by weight of Campsis grandiflora (Thunb.) Loisel.;

[0108] 160 to 340 parts by weight of Coix lacryma-jobi L.;

[0109] 60 to 140 parts by weight of Angelica dahurica (Fisch.) Benth. et Hook. f. ex Franch. et Sav.;

[0110] 60 to 140 parts by weight of Atractylodes macrocephala Koidz.;

[0111] 110 to 290 parts by weight of Curcuma aromatica Salisb.;

[0112] 60 to 140 parts by weight of Schizonepeta tenuifolia Briq.;

[0113] 60 to 140 parts by weight of Saposhnikovia divaricata (Turcz.) Schischk.;

[0114] 110 to 190 parts by weight of Poria cocos (Schw.) Wolf;

[0115] 20 to 140 parts by weight of Alisma orientale (Sam.) Juzep.;

[0116] In some specific implementation manners, the second freckle-removing composition includes:

[0117] 70 to 120 parts by weight of Prunus persica (L.) Batsch;

[0118] 30 to 90 parts by weight of Carthamus tinctorius L.;

[0119] 70 to 120 parts by weight of Paeonia lactiflora Pall.;

[0120] 120 to 270 parts by weight of Rehmannia glutinosa Libosch.;

[0121] 30 to 100 parts by weight of Ligusticum wallichii Franch.;

[0122] 70 to 130 parts by weight of Angelica sinensis (Oliv.) Diels;

[0123] 170 to 280 parts by weight of Cuscuta chinensis Lam.;

[0124] 120 to 180 parts by weight of Taxillus sutchuenensis (Lecomte) Danser;

[0125] 90 to 150 parts by weight of Bupleuri Radix;

[0126] 70 to 130 parts by weight of Campsis Flos;

[0127] 170 to 330 parts by weight of Coicis Semen;

[0128] 70 to 130 parts by weight of Angelicae Dahuricae Radix;

[0129] 70 to 130 parts by weight of Atractylodis Macrocephalae Rhizoma;

[0130] 120 to 280 parts by weight of Curcumae Radix;

[0131] 70 to 130 parts by weight of Schizonepetae Herba;

[0132] 70 to 130 parts by weight of Saposhnikoviae Radix;

[0133] 120 to 180 parts by weight of Poria;

[0134] 30 to 130 parts by weight of Alismatis Rhizoma.

[0135] The second freckle-removing composition uses Angelicae Sinensis Radix and Chuanxiong Rhizoma as the monarch drugs. Angelicae Sinensis Radix aims to enrich blood and promote blood circulation. It is sweet and warm in nature and is a holy drug in blood. While enriching blood, it is also good at promoting blood circulation and removing stasis without leaving stasis. Chuanxiong Rhizoma aims to promote blood circulation to remove stasis and regulate qi and relieve stagnation. It is pungent and warm in nature and is partial to pungent fragrance and dispersing. It is a qi drug in blood. The combination of the two enriches and activates simultaneously, allowing qi and blood to move together and complementing each other.

[0136] The second freckle-removing composition uses Persicae Semen, Carthami Flos, Rehmanniae Radix Preparata, and Paeoniae Radix Rubra as the minister drugs. Persicae Semen is good at promoting blood circulation to remove stasis. It is flat in nature and bitter, which can dredge and purge, and is good at removing blood stasis blockage. Carthami Flos is pungent and warm in nature and enters the heart and liver blood aspects. Its function is to promote blood circulation and dredge meridians, disperse stasis and eliminate freckles, and can remove facial stasis points and macules. Persicae Semen and Carthami Flos are commonly used paired herbs in traditional Chinese medicine. The combination of the two can eliminate blood stasis, and when the blood stasis is removed, the macules and papules will disappear naturally. Rehmanniae Radix Preparata is sweet and warm in nature. It can not only enrich blood and nourish yin to treat various syndromes of blood deficiency, but also replenish essence and marrow and tonify the liver and kidney. Paeoniae Radix Rubra is bitter and cold in nature and is good at clearing heat and cooling blood, dispersing stasis and relieving pain. The combination of Persicae Semen, Carthami Flos, Rehmanniae Radix Preparata, and Paeoniae Radix Rubra assists the monarch drugs in enriching blood and promoting blood circulation, removing stasis and eliminating freckles.

[0137] The second freckle-removing composition uses dodder seeds, taxillus twig, Chinese trumpet creeper flower, coix seed, dahurian angelica root, largehead atractylodes rhizome, fineleaf schizonepeta herb, divaricate saposhnikovia root, bupleurum root, and turmeric root tuber as adjuvant drugs. Dodder seeds and taxillus twig aim to tonify the liver and kidney, enrich the yin and blood to nourish the vessels, and when combined with the removal of old stasis, the macules can be eliminated. Coix seed is sweet and bland in flavor and is good at strengthening the spleen and removing dampness. Dahurian angelica root is pungent and warm, with fragrant properties to dry dampness and transform turbidity. Largehead atractylodes rhizome is sweet and warm, replenishing qi and strengthening the spleen. The three together play the role of strengthening the spleen and removing dampness, and fragrant dampness transformation, effectively removing phlegm turbidity from the skin to eliminate skin macules. Bupleurum root is pungent and bitter in flavor and is good at soothing the liver and relieving depression, enabling the smooth flow of liver qi and the relaxation of emotions. Turmeric root tuber is cold in nature and pungent and bitter in flavor, with the efficacy of promoting blood circulation to relieve pain and also capable of promoting qi and relieving depression. It enters both the qi aspect and the blood aspect. When combined with bupleurum root, in addition to regulating the smooth flow of qi movement, it can also assist in promoting blood circulation and removing stasis. Chinese trumpet creeper flower is cold in nature and sweet, sour in flavor, and is good at promoting blood circulation to dredge the meridians, cooling blood and dispelling wind, promoting blood circulation without generating heat and consuming yin.

[0138] The second freckle-removing composition has a synergistic effect with the above-mentioned components, and can further enhance the effect of removing chloasma.

[0139] In some specific implementation manners, the peach kernel, safflower, red peony root, rehmannia root, chuanxiong rhizome, Chinese angelica, dodder seeds, taxillus twig, bupleurum root, Chinese trumpet creeper flower, coix seed, dahurian angelica root, largehead atractylodes rhizome, turmeric root tuber, fineleaf schizonepeta herb, divaricate saposhnikovia root, poria cocos, and oriental waterplantain rhizome are independently in powder form. There is no special limitation on the preparation method of the powder in this application, and it can be obtained by pulverization.

[0140] In some specific implementation manners, the second freckle-removing composition is water pills. There is no special limitation on the water pills in this application. After pulverizing each drug, they can be made into pills by a water pill machine and then dried to obtain.

[0141] The second freckle-removing composition can be taken orally to further increase the effect of the drug composition in removing chloasma.

[0142] This application also provides a traditional Chinese medicine facial mask, including a mask cloth and a traditional Chinese medicine liquid loaded on the mask cloth. The traditional Chinese medicine liquid is the decocted liquid of the freckle-removing composition described in the above technical solution and does not include the second freckle-removing composition. When this application combines poria cocos, coix seed, kudzu root, dahurian angelica root, typhonium rhizome, ginseng, dodder seeds, bletilla striata, kaempferia galanga, pomegranate peel, persimmon leaf, trichosanthes root, safflower, salvia miltiorrhiza, etc. to make a facial mask for the treatment of chloasma, it can not only remove the surface pigment of the skin, but also remove the deep pigment of the skin, and has a good therapeutic effect on skin patches such as chloasma. In particular, the combination of kaempferia galanga and trichosanthes root can significantly reduce the pigment content in the deep layer of the skin; while reducing or replacing one or more of these drugs, especially kaempferia galanga and trichosanthes root, although it can still remove the surface pigment of the skin, the effect of removing the deep pigment of the skin is poor.

[0143] In some specific implementation manners, the mask cloth is a plant polysaccharide hydrogel. There is no special limitation on the plant polysaccharide hydrogel in this application. It can be purchased from the market or made by oneself.

[0144] The present application also provides the use of the above composition in the preparation of products for removing chloasma. Specifically, the above composition can improve the skin lesions caused by chloasma; the above composition can reduce the values of surface pigment, brown area and deep pigment under the CBS skin cloud mirror; the above composition can improve the quality of life and reduce the TCM syndrome score; the above composition has a high total treatment effective rate and patient satisfaction.

[0145] The present application uses the CBS cloud mirror to detect chloasma, significantly improving the evaluation accuracy of the treatment effect of chloasma and helping to achieve the goals of individualized treatment and prevention of recurrence.

[0146] The freckle-removing composition provided by the present application includes: Poria cocos, Coix lacryma-jobi, Pueraria lobata, Angelica dahurica, Typhonium giganteum, Panax ginseng, Cuscuta chinensis, Bletilla striata, Kaempferia galanga, Punica granatum peel, Diospyros kaki leaf, Trichosanthes cucumeroides root, Carthamus tinctorius, Salvia miltiorrhiza, etc. The present application combines the above components, and the obtained traditional Chinese medicine composition can improve the skin lesions caused by chloasma; the above composition can reduce the values of surface pigment, brown area and deep pigment under the CBS skin cloud mirror; the above composition can improve the quality of life and reduce the TCM syndrome score; the above composition has a high total treatment effective rate and patient satisfaction, and has a good treatment effect on chloasma. In addition, the freckle-removing composition provided by the present application can not only remove the surface pigment of the skin, but also remove the deep pigment of the skin. When one or more of the drugs are reduced or replaced, especially Kaempferia galanga and Trichosanthes cucumeroides root, although the surface pigment of the skin can still be removed, the effect of removing the deep pigment of the skin is poor. Description of the Drawings

[0147] Figure 1 It is a diagram of the area proportion of facial sub-regions. Detailed Embodiments

[0148] It should be understood that the expression "one or more of..." individually includes each of the objects recited after the expression and various different combinations of two or more of the recited objects, unless otherwise understood from the context and usage. The expression "and / or" combined with three or more recited objects should be understood to have the same meaning, unless otherwise understood from the context.

[0149] The terms "comprising", "having" or "containing", including the use of their grammatical synonyms, should generally be understood as open and non-limiting, for example, not excluding other unrecited elements or steps, unless otherwise specifically stated or understood from the context.

[0150] It should be understood that as long as the present invention is still operable, the order of steps or the order of performing certain actions is not important. In addition, two or more steps or actions can be carried out simultaneously.

[0151] The use of any and all examples or exemplary language such as "for example" or "including" in this document is merely intended to better illustrate the invention and does not limit the scope of the invention unless a claim is made. Any language in this specification should not be construed as indicating that any unclaimed element is essential for the practice of the invention.

[0152] In addition, the numerical ranges and parameters used to define the present invention are approximate values. The relevant numerical values in the specific embodiments have been presented as precisely as possible herein. However, any numerical value inherently and inevitably contains standard deviations resulting from individual testing methods. Therefore, unless otherwise clearly stated, it should be understood that all ranges, quantities, numerical values, and percentages used in this disclosure are modified by the term "about". Herein, "about" generally means that the actual value is within plus or minus 10%, 5%, 1%, or 0.5% of a specific value or range.

[0153] This application provides a freckle-removing composition, comprising:

[0154] 30 to 100 parts by weight of Poria cocos;

[0155] 10 to 50 parts by weight of Coix lacryma-jobi;

[0156] 10 to 50 parts by weight of Pueraria lobata;

[0157] 30 to 100 parts by weight of Angelica dahurica;

[0158] 30 to 80 parts by weight of Typhonium giganteum;

[0159] 30 to 80 parts by weight of Panax ginseng;

[0160] 30 to 50 parts by weight of Cuscuta chinensis;

[0161] 10 to 50 parts by weight of Bletilla striata;

[0162] 10 to 50 parts by weight of Kaempferia galanga;

[0163] 10 to 50 parts by weight of Punica granatum peel;

[0164] 10 to 50 parts by weight of Persimmon leaves;

[0165] 30 to 70 parts by weight of Trichosanthes cucumeroides root;

[0166] 10 to 30 parts by weight of Carthamus tinctorius;

[0167] 10 to 30 parts by weight of Salvia miltiorrhiza.

[0168] The freckle-removing composition provided by this application includes: Poria cocos, Coix lacryma-jobi, Pueraria lobata, Angelica dahurica, Typhonium giganteum, Panax ginseng, Cuscuta chinensis, Bletilla striata, Kaempferia galanga, Punica granatum peel, Persimmon leaves, Trichosanthes cucumeroides root, Carthamus tinctorius, Salvia miltiorrhiza, etc. The above components are compounded in this application, and the obtained traditional Chinese medicine composition can improve the skin lesions caused by chloasma; the above composition can reduce the values of surface pigment, brown area and deep pigment under the CBS skin cloud mirror; the above composition can improve the quality of life and reduce the TCM syndrome score; the above composition has a high total treatment efficiency and patient satisfaction, and has a good treatment effect on chloasma. In addition, the composition provided by this application can not only remove the surface pigment of the skin, but also remove the deep pigment of the skin. When one or more of the drugs are reduced or replaced, especially Kaempferia galanga and Trichosanthes cucumeroides root, although the surface pigment of the skin can still be removed, the effect of removing the deep pigment of the skin is poor.

[0169] The following further illustrates the freckle-removing composition provided by this application and its application in combination with examples.

[0170] The following medicinal materials are from the traditional Chinese medicine pharmacy of Yan'an University Affiliated Hospital.

[0171] Preparation of traditional Chinese medicine facial masks in Examples 1 to 3

[0172] According to the formula shown in Table 1, each traditional Chinese medicine decoction piece is respectively subjected to ultrafine pulverization treatment, and then mixed evenly. The evenly mixed medicinal powder is packed in a non-woven cloth bag to prevent the intrusion of moisture and microorganisms, and ensure the quality and efficacy of the medicinal powder. The packed non-woven cloth bags are placed in a cool and dry place, avoiding direct sunlight and high temperature. During the whole preparation process, the Good Manufacturing Practice (GMP) of drug production is strictly observed to ensure the safety and efficacy of the medicinal powder.

[0173] Take 500 g of medicinal powder and soak it in 8 L of normal-temperature pure drinking water for 30 min. During the soaking process, the medicinal liquid is turned and stirred every 10 min. After 30 min, pour the medicinal liquid into a decocting machine (Dingli decocting machine, 13 L). First, decoct it with strong fire for 40 min, and then turn to slow fire and decoct until the medicinal liquid remains 5 L and then take out the medicinal liquid. Cool the medicinal liquid to below 70 °C at room temperature, and under the stirring of a homogenizer (Shanghai HuXi, model: JRJ300-SH), homogenize it at a speed of 10,000 revolutions per minute. During the homogenization process, add sodium hyaluronate, pure glycerol, and p-hydroxyacetophenone in three times according to the proportions of 0.1%, 2%, and 0.1% of the total volume of the medicinal liquid, and then carry out sub-packaging, 245 ml / bag, and refrigerate in the refrigerator;

[0174] Using the plant polysaccharide gel combined with liposome membrane cloth developed by the School of Chemical Engineering of Yan'an University and purchased from Shaanxi Fuluo Co., Ltd. as the carrier, soak the carrier in the medicinal liquid for 5 - 10 min to obtain a traditional Chinese medicine facial mask.

[0175] Table 1 Formulas of traditional Chinese medicine facial masks prepared in Examples 1 to 3 and Comparative Examples 1 to 3

[0176]

[0177]

[0178] Comparative Examples 1-2

[0179] According to the formula shown in Table 1, a traditional Chinese medicine facial mask was prepared in the same method as in Example 1. Among them, in Comparative Example 1, the addition of kaempferia galanga was reduced, and in Comparative Document 2, kaempferia galanga was replaced with the same amount of ginger.

[0180] Test Example 1

[0181] 1. Research purpose

[0182] To observe the clinical efficacy of the traditional Chinese medicine facial mask and its combination with Huayu Quban Prescription in the treatment of melasma, and to evaluate the efficacy of the traditional Chinese medicine facial mask combined with Huayu Quban Prescription in the treatment of melasma by using CBS Skin Cloud Mirror, Melasma Area and Severity Index (MASI), Traditional Chinese Medicine Syndrome Score, and Chinese Version of Melasma Quality of Life Scale (Ch-MELASQOL), so as to explore a method for objectively evaluating the efficacy of melasma, provide new ideas for clinical treatment, and provide a basis for further research.

[0183] 2. Research objects

[0184] 2.1 Case source and general information

[0185] 2.1.1 Case source

[0186] Sixty patients with melasma were recruited from the Department of Traditional Chinese Medicine of the Affiliated Hospital of Yan'an University for the study. All participants met the inclusion and exclusion criteria and voluntarily participated in the study. This study has passed the review of the Ethics Committee of the Affiliated Hospital of Yan'an University (Ethical Number: YAS—H01-202312006), and all patients signed the informed consent form after fully understanding the research content and potential risks. The patients were divided into the internal and external treatment group and the external treatment group according to the principle of random equal ratio, with 30 cases in each group.

[0187] 2.1.2 General information

[0188] Subjects' names, ages, genders, ethnicities, contact information, current addresses, menstrual and reproductive histories, current medical histories, past medical histories, medication histories, and family histories.

[0189] 2.2 Diagnostic criteria

[0190] 2.2.1 Western medicine clinical diagnostic criteria

[0191] Referring to the "Diagnosis and Treatment Standards for Melasma and Vitiligo" (2010 edition) formulated by the Pigment Disease Group of the Dermatology and Venereology Professional Committee of the Chinese Association of Integrative Medicine, the western medicine diagnostic criteria for melasma are as follows:

[0192] ① Skin lesions appear as light brown to dark brown patches on the face, usually distributed symmetrically, without inflammation or scaling;

[0193] ② It is more common in women, mainly occurring after puberty;

[0194] ③The condition may be seasonal, often more severe in summer and milder in winter;

[0195] ④ Rule out skin diseases such as post-inflammatory pigmentation, malar nevus, Riehl's melanosis and pigmented lichen planus.

[0196] 2.2.2 TCM Symptom Diagnostic Criteria

[0197] According to the syndrome differentiation criteria and classification of chloasma in the Expert Consensus on TCM Treatment of Chloasma (2019 edition) and TCM Surgery (ed. by Chen Hongfeng), patients with two or more of the main and secondary symptoms can be diagnosed as liver depression and spleen deficiency type:

[0198] Main symptoms: Yellow-brown patches on the face, which may be light or dark, with clear boundaries, symmetrically distributed on the wings of the nose, forehead, around the mouth and around the cheekbones.

[0199] Secondary symptoms: ① Irritable or depressed temperament, chest and flank pain, abdominal distension; ② Women may have irregular menstruation; ③ Breast swelling or pain; ④ Loose stools; ⑤ Red tongue with greasy tongue coating; ⑥ Slow and stringy pulse.

[0200] 2.3 Inclusion criteria

[0201] ① Those aged between 20 and 55 years old, with no previous systemic diseases;

[0202] ② Female patients who meet the above-mentioned Western medical diagnostic criteria for chloasma and the TCM diagnostic criteria for liver depression and spleen deficiency;

[0203] ③ No chemical peeling, laser or other treatments were performed within 2 weeks before enrollment, no topical medications were used, and no medications related to the disease were taken within 30 days;

[0204] ④Sign the informed consent form and voluntarily cooperate with the research plan.

[0205] 2.4 Exclusion criteria

[0206] This study excluded people who met any of the following criteria:

[0207] ① Patients with active chloasma: patients with recent symptoms such as enlargement of skin lesions, deepening of color, redness of skin lesions, or redness after itching;

[0208] ②Sunlight exposure time: patients exposed to sunlight for more than 3 hours per day;

[0209] ③Severe cardiovascular and cerebrovascular diseases or mental disorders: Patients with severe cardiovascular and cerebrovascular diseases, mental disorders, intellectual or behavioral disorders;

[0210] ④Pregnant and lactating women: Women in the gestational or lactation period are not included in the study to protect the safety of the mother and baby and avoid interference with the research results due to changes in hormone levels.

[0211] 2.5 Exclusion criteria

[0212] ①Poor compliance, unable to adhere to treatment according to the specified time and frequency of medication;

[0213] ②During the treatment period, receiving other relevant freckle removal treatments or participating in other experimental studies that interfere with this study;

[0214] ③Those allergic to the drugs used in this trial.

[0215] 2.6 Withdrawal criteria

[0216] ①Those who need to withdraw from the study halfway due to personal physical reasons, time arrangements or other reasons and have not completed this trial;

[0217] ②Serious adverse events or side effects occur, or the subject shows no response to the treatment, or the disease deteriorates.

[0218] Note: For withdrawn patients, try to understand the reasons for withdrawal and record adverse events if necessary.

[0219] 2.7 Termination / suspension criteria for the trial:

[0220] ①Serious adverse events occur during the treatment process;

[0221] ②During the treatment process, the data shows that the test drug or treatment is significantly ineffective.

[0222] 3. Research methods

[0223] 3.1 Random grouping

[0224] In this study, a total of 60 patients with chloasma meeting the research criteria were included. These patients were randomly assigned to two research groups, namely the internal and external combined treatment group and the external treatment group, with 30 patients in each group. In terms of treatment implementation, patients in the internal and external combined treatment group received the treatment plan of the traditional Chinese medicine facial mask prepared in Example 1 combined with the Huayu Quban prescription, while patients in the external treatment group only received the single traditional Chinese medicine facial mask prepared in Example 1.

[0225] 3.2 Treatment methods

[0226] 3.2.1 Basic treatment

[0227] Patients should take effective sun protection measures during outdoor activities, including using physical sun protection methods such as carrying an umbrella or wearing a sun hat, and applying chemical sun protection products such as sunscreen to reduce the damage of ultraviolet rays to the skin; patients should relieve anxiety and depression through appropriate means and maintain a good mental state; ensure sufficient sleep time and avoid staying up late to promote the natural repair of the body and skin; have a light diet and reduce the intake of greasy and spicy foods; when choosing skin care products and cosmetics, avoid using ingredients containing hormones or other substances that may irritate the skin to reduce the burden on the skin and the risk of allergies.

[0228] 3.2.2 Internal and external combined treatment group: Treatment with traditional Chinese medicine facial mask combined with Huayu Quban formula

[0229] As shown in Example 1, after preparing the medicinal liquid, refrigerate it in the refrigerator. When using, apply it according to the following steps: Take 35 ml of the medicinal liquid and place it in a measuring cup. Immerse the film cloth in the medicinal liquid for 5 - 10 minutes and then take it out until there is no dripping. Then apply it on the face. Apply it once every other day. Each time when applying, you can time for 30 minutes. If timing is inconvenient, you can take the mask off when the film cloth at the philtrum part becomes dry. After removing the mask, wash it with clean water and then perform normal skin care.

[0230] Preparation of Huayu Quban formula:

[0231] ① Preparation of Huayu Quban formula: Processed by Yan'an Pharmaceutical Co., Ltd. Take 100 g of peach kernels, 60 g of safflower, 100 g of red peony root, 250 g of rehmannia root, 100 g of chuanxiong rhizome, 100 g of angelica root, 200 g of dodder seeds, 150 g of taxillus twig, 120 g of bupleurum root, 100 g of campsis grandiflora, 300 g of coix seeds, 100 g of dahurian angelica root, 100 g of atractylodes macrocephala, 300 g of turmeric root-tuber, 100 g of schizonepeta, 100 g of ledebouriella root, 10 g of poria cocos, and 100 g of oriental waterplantain rhizome. After passing through a traditional Chinese medicine grinder (model: YK - 12), a drum-type water pill machine (manufactured by Shandong Weinuo Medical Equipment Manufacturing Co., Ltd.), a drying oven (YK - 21), and other auxiliary equipment such as screening equipment, weighing equipment, stirrers, and sprayers, make them into traditional Chinese medicine water pills and seal them in a sterile vacuum bag.

[0232] ② Administration method: Instruct the patient to take it after meals to reduce the risk of gastrointestinal adverse reactions. The administration method is 6 g / time, 2 times / day.

[0233] 3.2.3 External treatment group

[0234] (1) Application of traditional Chinese medicine facial mask

[0235] Simply apply the traditional Chinese medicine facial mask prepared in Example 1 for treatment. The treatment steps, operations, and treatment time are the same as those in the internal and external combined treatment group.

[0236] 3.2.4 Course of treatment and follow-up records

[0237] The treatment course for both groups was 3 months; medications were collected every half month, and dermascope examination and MASI scores were rechecked every month for observation and recording.

[0238] 3.3 Observation indicators and scoring methods

[0239] 3.3.1 Melasma area and severity index (MASI)

[0240] Referring to the melasma area and severity index (MASI) scoring criteria in the "Expert Consensus on the Diagnosis and Treatment of Melasma in China (2021 Edition)", the area and color of melasma of different degrees (including color depth and uniformity) were scored. See Table A1 for details.

[0241] Table A1 MASI scoring criteria

[0242]

[0243] MASI scoring formula:

[0244] MASI = forehead [0.3 * A * (D + H)] + left cheek [0.3 * A * (D + H)] + right cheek

[0245] [0.3 * A * (D + H)] + chin [0.1 * A * (D + H)]

[0246] Scoring period: The researcher performed MASI scoring on patients before treatment, 1 month after treatment, 2 months after treatment, and 3 months after treatment respectively;

[0247] The diagram of the area proportion of facial regions is as Figure 1 shown.

[0248] 3.3.2 CBS dermascope detection and change rate of melasma improvement

[0249] The CBS dermascope skin detector, namely CBS dermascope, shows a high correlation with MASI scores by referring to the absolute scores generated by the CBS dermascope system, making this device play an important role in the classification, auxiliary diagnosis, and follow-up of the treatment effect of melasma.

[0250] Combined with the pathological characteristics of melasma and the characteristics of the main traditional Chinese medicine components in the facial mask liquid, this study selected surface pigmentation, deep pigmentation, and brown areas as the key indicators for evaluating the treatment effect of melasma. Surface pigmentation is mainly manifested as brown or black spots on the skin surface, while deep pigmentation is located in the dermis layer. As skin cells are renewed, these pigments will gradually move towards the epidermis and eventually fall off. Brown spots, including but not limited to melasma, freckles, nevus spilus, and senile lentigines, are located deeper in the dermis and are recessive pigmented spots. With age or the weakening of the skin barrier function, these spots may gradually appear on the skin surface.

[0251] 3.3.3 Quality of Life Score for Melasma (Ch-MELASQOL)

[0252] Refer to the Chinese version of the Quality of Life Scale for Melasma (Ch-MELASQOL), and self-assessment is conducted by patients with melasma.

[0253] Chinese version of the Quality of Life Scale for Melasma (Ch-MELASQOL):

[0254] According to the scale from 1 point (never bothered) to 7 points (always bothered), you need to make a score based on your own feelings:

[0255]

[0256] * 1 point: never bothered; 2 points: rarely bothered; 3 points: less bothered; 4 points: medium level; 5 points: sometimes bothered; 6 points: almost always bothered; 7 points: always bothered.

[0257] The quality of life score for melasma ranges from 10 to 70 points. The higher the score, the worse the health-related quality of life and the heavier the disease burden.

[0258] 3.3.4 Traditional Chinese Medicine Syndrome Score

[0259] Evaluation is carried out using the clinical scoring form for the main syndromes of traditional Chinese medicine. Self-assessment is conducted by patients before treatment and 3 months after treatment respectively. See Table C1 for details.

[0260] Table C1 Clinical Scoring Form for the Main Syndromes of Traditional Chinese Medicine

[0261]

[0262]

[0263] Note: The total score of traditional Chinese medicine syndrome = total score of main syndromes (MASI score) + total score of concurrent syndromes * 0.5.

[0264] 3.4 Safety Observation

[0265] During the clinical trial, in order to comprehensively evaluate the health status of the subjects and the safety of the trial, the research protocol stipulates that all participants need to complete a series of standard laboratory tests before and at the end of the trial. The specific test items include: blood routine, urine routine, fecal routine, liver and kidney function tests. These test results will provide important baseline data for the research and will be used for comparison and analysis after the trial to ensure the safety and effectiveness of the trial intervention. All laboratory tests are carried out according to the standardized operating procedures and are performed by the technical personnel of the Clinical Laboratory of the Affiliated Hospital of Yan'an University to ensure the accuracy and comparability of the data.

[0266] 3.5 Adverse Reaction Monitoring

[0267] (1) Conduct a detailed examination of the patient before admission to comprehensively understand the patient's past health status, medical history, medication history, and allergy history. First, take a small amount of the liquid medicine for an allergy test behind the ear. If there is no problem, then apply it to the face.

[0268] (2) If adverse reactions occur when using a traditional Chinese medicine facial mask, such as skin redness, swelling, heat, itching, and pain, the following measures can be taken: ① Immediately stop using: If skin redness, itching, stinging, or other discomfort symptoms occur after using the traditional Chinese medicine facial mask, stop using the mask immediately and clean the face to remove the remaining product; ② Cold compress or cold spray: For local skin redness and swelling, cold compress or cold spray can be used to relieve it, which helps to constrict blood vessels and reduce inflammation and discomfort; ③ Use anti-allergy drugs: When an allergic reaction occurs, anti-allergy drugs, such as antihistamines, can be used under the guidance of a doctor to relieve symptoms; ④ Topical drug treatment: According to the specific symptoms of the skin, topical drugs may be needed, such as ointments or lotions for soothing, reducing redness, calming, and repairing. If adverse reactions occur after taking traditional Chinese medicine pills, such as diarrhea, abdominal pain, or other adverse reactions in other systems such as the skin, nervous system, cardiovascular system, urinary system, and hematological system, those with mild symptoms that can be tolerated can continue to observe and treat, while those with severe symptoms or mild symptoms that do not improve or even worsen should stop taking the medicine immediately.

[0269] (3) If critical manifestations such as unexplained high fever and shock occur during the medication period, immediately terminate the trial and seek medical treatment.

[0270] 4. Efficacy evaluation

[0271] 4.1 Efficacy evaluation criteria

[0272] (1) Refer to the efficacy evaluation criteria for melasma in the "Diagnosis and Treatment Standards for Melasma and Vitiligo" formulated by the Pigment Disease Group of the Chinese Society of Dermatology and Venereology of Integrated Traditional Chinese and Western Medicine in 2010. The specific grading and calculation method of the MASI decrease index are as follows:

[0273] ① Basically cured: ≥80%;

[0274] ② Markedly effective: 50% ≤ MASI decrease index < 80%;

[0275] ③ Effective: 30% ≤ MASI decrease index < 50%;

[0276] ④ Ineffective: MASI decrease index < 30%.

[0277] MASI decrease index = (score before treatment - score after treatment) / score before treatment × 100%.

[0278] Total effective rate = (number of basically cured + number of markedly effective + number of effective) ÷ total sample size of each group

[0279] × 100%.

[0280] 5. Patient satisfaction evaluation

[0281] The patient satisfaction criteria refer to the Chinese Expert Consensus on the Diagnosis and Treatment of Melasma (2021), which is divided into very satisfied, satisfied, average, and dissatisfied.

[0282] Satisfaction = (number of very satisfied + satisfied) cases / total number of cases × 100%.

[0283] 6. Statistical methods

[0284] In this study, all the collected data were entered into the database created by Excel and statistically analyzed using SPSS 26.0 software. For quantitative data, a normality test was first performed. If the data conforms to a normal distribution, the mean and standard deviation are used to describe it; if the data does not satisfy the normal distribution, the median is used for representation. When performing within-group comparisons, if the data follows a normal distribution, a paired t-test is used to analyze the differences; if the data does not follow a normal distribution, a non-parametric test method for paired samples is used. For between-group comparisons, when the data satisfies the normal distribution and homogeneity of variance, an independent sample t-test is used to evaluate the differences; if the data does not conform to the normal distribution, an independent sample non-parametric test is used. If the P-value is less than 0.05, it is considered that there is a statistically significant difference between the populations represented by the two samples; if the P-value is less than 0.01, it is considered that there is a more significant statistical difference; if the P-value is greater than 0.05, it is considered that there is no statistical difference between the populations represented by the two samples.

[0285] 7. Research results

[0286] 7.1. Analysis of general information of the enrolled patients

[0287] According to the inclusion and exclusion criteria, a total of 60 patients were included in this study. No dropouts occurred during the experiment. 30 cases were completed in each of the internal and external treatment group and the external treatment group. The comparative analysis of the age and disease course of each group is as follows.

[0288] Internal and external treatment group (30 cases): The youngest age was 31 years old, the oldest was 50 years old, and the average age was 39.50 ± 5.48 years; External treatment group (30 cases): The youngest age was 31 years old, the oldest was 54 years old, and the average age was 40.43 ± 5.85 years.

[0289] Table 2 Comparison of age and disease course between the two groups of patients

[0290]

[0291] The ages and courses of disease of the two groups of patients were tested and found to follow a normal distribution. By independent-sample t-test, for age: P = 0.526 > 0.05, the difference was not statistically significant, so the two groups of patients were comparable; for course of disease: P = 0.508 > 0.05, the difference was not statistically significant, so the two groups of patients were comparable.

[0292] 7.2. Comparison of each observation index before treatment between the two groups of patients

[0293] 7.2.1 Comparison of MASI score, quality of life, and traditional Chinese medicine syndrome score data before treatment

[0294] Table 3 Comparison of MASI, quality of life, and traditional Chinese medicine syndrome scores before treatment between the two groups of patients

[0295] Scoring items Internal and external treatment group External treatment group t P MASI score 14.76±1.05 14.29±1.09 -1.707 0.677 Quality of life score 47.60±15.99 37.47±13.12 1.032 0.306 Traditional Chinese medicine syndrome score 18.34±3.56 18.67±3.45 -0.371 0.712

[0296] The MASI scores, quality of life, and traditional Chinese medicine syndrome scores of the two groups of patients before treatment were tested and found to conform to a normal distribution. Independent-sample t-test was used, and P > 0.05. The difference between the two groups was not statistically significant, so they were comparable.

[0297] 7.2.2 Comparison of the values of epidermal pigment, dermal pigment, and brown area in the CBS cloud mirror data of the two groups before treatment

[0298] Table 4 Comparison of CBS test values before treatment between the internal and external treatment group and the external treatment group

[0299]

[0300]

[0301] The values of epidermal pigment and dermal pigment in the CBS cloud mirror data of the two groups of patients before treatment were tested and found to conform to a normal distribution. Independent-sample t-test was used, and P > 0.05. The difference was not statistically significant, so they were comparable; the value of the brown area did not conform to a normal distribution after testing, so the Mann-Whitney U test was used, and P = 0.379 > 0.05 was obtained. The difference was not statistically significant, so they were comparable.

[0302] 7.3. Comparison of relevant data before and after treatment between the two groups of patients

[0303] 7.3.1 Inter-group comparison of MASI scores before and after treatment between the two groups of patients

[0304] Table 5 Inter-group comparison of MASI scores at each time point before and after treatment (points, )

[0305]

[0306] After statistical analysis, it was found that after 1 month of treatment, P = 0.163 (P > 0.05), indicating that there was no significant statistical difference in the MASI scores between the two groups, that is, there was no significant difference in the improvement of skin lesions between the two groups of patients; as the treatment time extended, after 2 months and 3 months of treatment, P < 0.01 was obtained when comparing the two groups, and there was a significant statistical difference in the comparison of the MASI scores between the two groups. The above results indicated that there were differences in the improvement of melasma skin lesions between the two groups of patients after 2 and 3 months of treatment, and the internal and external combined treatment group was superior to the external treatment group.

[0307] 7.3.2 Intragroup comparison of MASI scores of two groups of patients before and after treatment

[0308] Table 6 Intragroup comparison of MASI scores of two groups of patients before and after treatment (score, )

[0309]

[0310]

[0311] Statistical results showed that in the internal and external combined treatment group, compared with before treatment, the MASI scores after 1 month, 2 months, and 3 months of treatment were all significantly decreased (P < 0.01), and the scores after 2 months and 3 months of treatment were further decreased compared with after 1 month of treatment (P < 0.01), and the score after 3 months of treatment was also decreased compared with after 2 months of treatment (P < 0.01). In the external treatment group, the MASI scores after 1 month, 2 months, and 3 months of treatment were also significantly lower than those before treatment (P < 0.01), and the scores continued to improve as the treatment time extended.

[0312] 7.3.3 Comparison of quality of life scores and traditional Chinese medicine syndrome scores after treatment within the two groups of patients

[0313] By comparing the quality of life scores and traditional Chinese medicine syndrome scores after treatment within the two groups of patients, it was found that both groups of patients had significant improvements compared with before treatment (P < 0.01), and the differences were statistically significant; by separately comparing the quality of life and traditional Chinese medicine syndrome scores of the two groups of patients before and after treatment, it was found that the differences were all (P < 0.01) statistically significant, indicating that the quality of life and traditional Chinese medicine syndrome scores of both groups of patients had certain degrees of improvement. See Tables 7 and 8 for details.

[0314] Table 7 Intragroup comparison of quality of life and traditional Chinese medicine syndrome score data of two groups of patients (score, )

[0315]

[0316] Table 8 Intergroup comparison of quality of life and traditional Chinese medicine syndrome score data of two groups of patients after treatment (score, )

[0317] Group Number of cases (n) Quality of life score Traditional Chinese medicine syndrome score Internal and external treatment group 30 17.10±4.99 5.21±3.89 External treatment group 30 22.10±4.67 8.30±4.45 t 4.000 -2.96 P ＜0.001 ＜0.001

[0318] 7.3.4 Comparison of the scores of surface pigment, deep pigment, and brown area in the CBS cloud mirror before and after treatment in two groups of patients

[0319] By comparing the scores of surface pigment, deep pigment, and brown area in the CBS cloud mirror before and after treatment in two groups of patients respectively, it was found that P < 0.01, and the difference was statistically significant, indicating that the surface pigment, deep pigment, and brown area of the two groups of patients had certain degrees of improvement after treatment. See Tables 9 and 10 for details.

[0320] Table 9 Comparison of the scores of surface pigment, deep pigment, and brown area in the internal and external treatment group of patients at each time point

[0321]

[0322] Note: Compared with before treatment, ·P < 0.01; compared with 1 month after treatment, ◆P < 0.01; compared with 2 months after treatment, *P < 0.01.

[0323] Table 10 Comparison of the scores of surface pigment, deep pigment, and brown area in the external treatment group of patients at each time point

[0324]

[0325] Note: Compared with before treatment, ·P < 0.01; compared with 1 month after treatment, ◆P < 0.01; compared with 2 months after treatment, *P < 0.01.

[0326] 7.4. Comparison of the curative effects between the two groups

[0327] Table 11 Comparison of the curative effects between the two groups (n, %)

[0328] Group Number of cases Basically cured Markedly effective Improved Ineffective Total effective rate Internal and external treatment group 30 3(10.0) 6(20.00) 18(60.00) 3(10.00) 90.00 External treatment group 30 0(0.00) 17(56.67) 8(26.67) 5(16.67) 83.33

[0329] After the rank sum test, P = 0.002, and the difference in the curative effects between the two groups was significantly statistically significant (P < 0.01). The curative effect of the internal and external treatment group was better than that of the external treatment group.

[0330] 7.5. Comparison of patient satisfaction

[0331] Table 12 Comparison of patient satisfaction between the two groups (n, %)

[0332] Group Number of cases Very satisfied Satisfied Average Dissatisfied Total satisfaction Internal and external treatment group 30 17(56.67) 8(36.67) 2(6.67) 3(10.00) 83.33 External treatment group 30 9(30.00) 14(46.67) 4(13.33) 3(10.00) 76.67

[0333] After the rank sum test, P = 0.081, and there was no significant statistical significance in the comparison of patient satisfaction between the two groups (P > 0.05).

[0334] 7.6 Observation of adverse reactions

[0335] In this study, a total of 60 patients received treatment. In the internal and external combined treatment group, 2 patients reported symptoms of skin dryness after using the facial mask. In response, it was recommended that patients apply a moisturizing cream after using the facial mask to relieve discomfort. This measure effectively alleviated the discomfort of the patients and did not affect the continuation of treatment. In the external treatment group, 3 patients developed mild facial skin redness and itching after using drug treatment for too long. In response to this situation, the patients were instructed to adjust the application time of the drug to comply with the recommended usage specifications. After adjustment, the patients no longer reported redness and itching symptoms, and the treatment proceeded smoothly. These observation results indicate that appropriate guidance and adjustment of treatment measures can effectively manage the discomfort symptoms of patients during treatment, ensuring the safety and continuity of treatment.

[0336] 8. Clinical efficacy analysis

[0337] 8.1 In terms of overall efficacy

[0338] After the treatment ended, the total effective rate of the internal and external combined treatment group was 90.00%, and the total effective rate of the external treatment group was 83.33%. Statistical analysis found that both groups had efficacy, and the overall efficacy of the internal and external combined treatment group was better than that of the external treatment group.

[0339] 8.2 In terms of the skin lesion scores of the two groups after treatment

[0340] After 1 month of treatment, the skin lesion scores of both groups decreased, and there were significant differences compared with before treatment. However, statistical analysis showed that the differences between the two groups were not significant. Considering that the internal and external combined treatment method focuses on overall regulation, emphasizing internal regulation of the zang-fu organs to treat the root cause, and improving the qi and blood status of the face by regulating the functions of the zang-fu organs, it therefore takes a certain amount of time to accumulate to show the effect of eliminating facial brown spots. The external treatment method directly applies the Five-White Chinese medicine facial mask to the local skin lesions to take effect quickly, mainly acting on treating the symptoms. Generally speaking, as the treatment time extends, especially after 2 months and 3 months of treatment, both groups can significantly improve the skin lesions, and the internal and external combined treatment group has a better effect in improving the skin lesions than the external treatment group during the same period.

[0341] 8.3 In terms of the improvement of the quality of life and traditional Chinese medicine syndromes of the two groups after treatment

[0342] Both treatments can effectively reduce the patients' quality of life scores and TCM symptom scores, which indicates that both treatments are effective in improving the patients' overall quality of life and alleviating TCM clinical symptoms. After 3 months of treatment, the quality of life scores and TCM symptom scores of both groups of patients showed a significant decrease compared with those before treatment. In addition, when the data at the end of the two groups were compared and analyzed, the results showed that there were significant differences between the two groups, and the internal and external treatment group performed better in reducing the quality of life scores and TCM symptom scores, which indicates that the internal and external treatment group is more effective than the external treatment group in improving the patients' quality of life and TCM symptoms.

[0343] 8.4 CBS Cloud Mirror Pigment Score

[0344] In the first month of treatment, the surface pigment, brown area and deep pigment scores of both groups of patients were significantly reduced compared with those before treatment, but at this time point, the difference in scores between the internal and external treatment group and the external treatment group was not significant. As the treatment continued, in the second and third months of treatment, the pigment scores of both groups of patients continued to decline, and the score decline in the internal and external treatment group was more significant at this time. Compared with the external treatment group, the pigment score of the internal and external treatment group decreased more significantly, and the difference in scores between the two groups became statistically significant.

[0345] 8.5 Satisfaction

[0346] After the treatment, the satisfaction rate of the combined internal and external treatment group was 83.33%, and that of the external treatment group was 76.67%. Statistical analysis showed that there was no significant difference in patient satisfaction between the two groups.

[0347] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. Freckle-removing composition, comprising: 30 to 100 parts by weight of Poria cocos; 10 to 50 parts by weight of Coix lacryma-jobi; 10 to 50 parts by weight of Pueraria lobata; 30 to 100 parts by weight of Angelica dahurica; 30 to 80 parts by weight of Typhonium giganteum; 30 to 80 parts by weight of Panax ginseng; 30 to 50 parts by weight of Cuscuta chinensis; 10 to 50 parts by weight of Bletilla striata; 10 to 50 parts by weight of Kaempferia galanga; 10 to 50 parts by weight of Punica granatum peel; 10 to 50 parts by weight of Persimmon leaves; 30 to 70 parts by weight of Trichosanthes cucumeroides root; 10 to 30 parts by weight of Carthamus tinctorius; 10 to 30 parts by weight of Salvia miltiorrhiza.

2. The freckle-removing composition according to claim 1, wherein, Comprising: 40 to 80 parts by weight of Poria cocos; 20 to 40 parts by weight of Coix lacryma-jobi; 20 to 40 parts by weight of Pueraria lobata; 40 to 80 parts by weight of Angelica dahurica; 40 to 60 parts by weight of Typhonium giganteum; 40 to 60 parts by weight of Panax ginseng; 35 to 45 parts by weight of Cuscuta chinensis; 20 to 40 parts by weight of Bletilla striata; 20 to 40 parts by weight of Kaempferia galanga; 20 to 40 parts by weight of Punica granatum peel; 20 to 40 parts by weight of Persimmon leaves; 40 to 60 parts by weight of Trichosanthes cucumeroides root; 15 to 25 parts by weight of Carthamus tinctorius; 15 to 25 parts by weight of Salvia miltiorrhiza.

3. The freckle-removing composition according to claim 1 or 2, characterized in that, The Poria cocos, Coix lacryma-jobi, Pueraria lobata, Angelica dahurica, Typhonium giganteum, Panax ginseng, Cuscuta chinensis, Bletilla striata, Kaempferia galanga, Punica granatum peel, Persimmon leaves, Trichosanthes cucumeroides root, Carthamus tinctorius and Salvia miltiorrhiza are independently decoction extracts.

4. The freckle-removing composition according to claim 3, characterized in that, It further comprises at least one of sodium hyaluronate, glycerol and p-hydroxyacetophenone.

5. The freckle-removing composition according to claim 1 or 2, characterized in that, It further comprises a second composition; the second composition comprises: 50 to 150 parts by weight of Prunus persica; 10 to 110 parts by weight of Carthamus tinctorius; 50 to 150 parts by weight of Paeonia lactiflora; 100 to 300 parts by weight of Rehmannia glutinosa; 10 to 120 parts by weight of Ligusticum chuanxiong; 50 to 150 parts by weight of Angelica sinensis; 150 to 300 parts by weight of Cuscuta chinensis; 100 to 200 parts by weight of Taxillus chinensis; 70 to 170 parts by weight of Bupleurum chinense; 50 to 150 parts by weight of Campsis grandiflora; 150 to 350 parts by weight of Coix lacryma-jobi; 50 to 150 parts by weight of Angelica dahurica; 50 to 150 parts by weight of Atractylodes macrocephala; 100 to 300 parts by weight of Curcuma aromatica; 50 to 150 parts by weight of Schizonepeta tenuifolia; 50 to 150 parts by weight of Saposhnikovia divaricata; 100 to 200 parts by weight of Poria cocos; 10 to 150 parts by weight of Alisma orientale.

6. The freckle-removing composition according to claim 5, characterized in that, The second composition comprises: 60 to 130 parts by weight of Prunus persica; 20 to 100 parts by weight of Carthamus tinctorius; 60 to 130 parts by weight of Paeonia lactiflora; 110 to 280 parts by weight of Rehmannia glutinosa; 20 to 110 parts by weight of Ligusticum chuanxiong; 60 to 140 parts by weight of Angelica sinensis; 160 to 290 parts by weight of Cuscuta chinensis; 110 to 190 parts by weight of Taxillus chinensis; 80 to 160 parts by weight of Bupleurum chinense; 60 to 140 parts by weight of Campsis grandiflora; 160 to 340 parts by weight of Coix lacryma-jobi; 60 to 140 parts by weight of Angelica dahurica; 60 to 140 parts by weight of Atractylodes macrocephala; 110 to 290 parts by weight of Curcuma aromatica; 60 to 140 parts by weight of Schizonepeta tenuifolia; 60 to 140 parts by weight of Saposhnikovia divaricata; 110 to 190 parts by weight of Poria cocos; 20 to 140 parts by weight of Alisma orientale.

7. The freckle-removing composition according to claim 5, wherein The peach kernels, safflower, red peony roots, rehmannia roots, chuanxiong rhizomes, angelica sinensis, dodder seeds, taxillus twigs, bupleurum roots, campsis grandiflora, coix seeds, dahurian angelica roots, atractylodes macrocephala, turmeric roots, schizonepeta, ledebouriella roots, poria cocos, and alisma orientale are independently in powder form.

8. A traditional Chinese medicine facial mask, comprising a mask cloth and a traditional Chinese medicine liquid loaded on the mask cloth, wherein the traditional Chinese medicine liquid is a decoction of the freckle-removing composition according to claim 1 or 2.

9. The traditional Chinese medicine facial mask according to claim 8, wherein, The mask cloth is a plant polysaccharide hydrogel.

10. Use of the freckle-removing composition according to any one of claims 1 to 7 in the preparation of a product for removing chloasma.

11. A freckle-removing traditional Chinese medicine composition, comprising: 50 to 150 parts by weight of peach kernels; 10 to 110 parts by weight of safflower; 50 to 150 parts by weight of red peony roots; 100 to 300 parts by weight of rehmannia roots; 10 to 120 parts by weight of chuanxiong rhizomes; 50 to 150 parts by weight of angelica sinensis; 150 to 300 parts by weight of dodder seeds; 100 to 200 parts by weight of taxillus twigs; 70 to 170 parts by weight of bupleurum roots; 50 to 150 parts by weight of campsis grandiflora; 150 to 350 parts by weight of coix seeds; 50 to 150 parts by weight of dahurian angelica roots; 50 to 150 parts by weight of atractylodes macrocephala; 100 to 300 parts by weight of turmeric roots; 50 to 150 parts by weight of schizonepeta; 50 to 150 parts by weight of ledebouriella roots; 100 to 200 parts by weight of poria cocos; 10 to 150 parts by weight of alisma orientale.

12. The freckle-removing traditional Chinese medicine composition according to claim 11, wherein, Comprising: 60 to 130 parts by weight of peach kernels; 20 to 100 parts by weight of safflower; 60 to 130 parts by weight of red peony roots; 110 to 280 parts by weight of rehmannia roots; 20 to 110 parts by weight of chuanxiong rhizomes; 60 to 140 parts by weight of angelica sinensis; 160 to 290 parts by weight of dodder seeds; 110 to 190 parts by weight of taxillus twigs; 80 to 160 parts by weight of bupleurum roots; 60 to 140 parts by weight of campsis grandiflora; 160 to 340 parts by weight of coix seeds; 60 to 140 parts by weight of dahurian angelica roots; 60 to 140 parts by weight of atractylodes macrocephala; 110 to 290 parts by weight of turmeric roots; 60 to 140 parts by weight of schizonepeta; 60 to 140 parts by weight of ledebouriella roots; 110 to 190 parts by weight of poria cocos; 20 to 140 parts by weight of alisma orientale.

13. The freckle-removing traditional Chinese medicine composition according to claim 11, characterized in that, The peach kernels, safflower, red peony roots, rehmannia roots, chuanxiong rhizomes, angelica sinensis, dodder seeds, taxillus twigs, bupleurum roots, campsis grandiflora, coix seeds, dahurian angelica roots, atractylodes macrocephala, turmeric roots, schizonepeta, ledebouriella roots, poria cocos, and alisma orientale are independently in powder form.

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