A traditional Chinese medicine composition, a traditional Chinese medicine preparation, a preparation method thereof and application

Abstract

The application provides a traditional Chinese medicine composition, a traditional Chinese medicine preparation and a preparation method and application thereof. The traditional Chinese medicine composition comprises angelica sinensis, licorice, motherwort, cuscuta chinensis and ginseng. The face cream prepared from the traditional Chinese medicine composition has the characteristics of quick effect, low recurrence rate, high cost performance, less drug resistance and good safety.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine, specifically to a traditional Chinese medicine composition, a traditional Chinese medicine preparation, its preparation method, and its application. Background Technology

[0002] Melasma, post-inflammatory hyperpigmentation, and age spots are primarily caused by abnormalities in melanin and melanocytes, and their impact on patients' physical and mental health is particularly significant. The condition mainly affects the face, causing changes in local skin color, impacting appearance, psychology, and social activities, and consequently negatively affecting daily life and overall well-being. Therefore, the development of skin-lightening and pigmentation-removing products has always been a key focus and challenge in the field of dermatology.

[0003] Western medicine treatment focuses on reducing melanin production, reducing inflammation, inhibiting angiogenesis, repairing the skin barrier, and combating photoaging. Clinical treatment methods include oral systemic medications, topical depigmenting agents, chemical peels, and laser therapy. Treatment often combines single or multiple topical methods with oral medications, supplemented by laser therapy. For reducing melanin production, tranexamic acid, vitamin C and vitamin E, and glutathione can be used, along with topical hydroquinone and its derivatives, retinoids, azelaic acid, and tranexamic acid. For anti-inflammatory treatment, glycyrrhizin can be chosen. For inhibiting angiogenesis, tranexamic acid is the first choice. For repairing the skin barrier, *Prickly pear* fruit oil can promote the secretion of ceramides, cholesterol, and free fatty acids by keratinocytes, thus repairing the skin barrier. For combating photoaging, preventative measures such as avoiding sun exposure and using sunscreen are primary. Numerous scholars have conducted statistical analyses of topical traditional Chinese medicines for treating melasma by mining various databases. Qin Tiange identified 12 core medications for treating melasma through a search. These medications primarily fall into three categories: those that promote blood circulation and remove blood stasis, those that calm the liver and extinguish wind, and those that tonify deficiency. Pharmacologically, the active ingredients in Angelica dahurica, Poria cocos, Atractylodes macrocephala, Ampelopsis japonica, and Aconitum carmichaelii can inhibit tyrosinase activity, thereby suppressing melanin production and lightening pigmentation. Ligusticum chuanxiong, Angelica sinensis, Carthamus tinctorius, and Aconitum carmichaelii can promote blood circulation and remove blood stasis, improving local microcirculation by promoting peripheral vasodilation, increasing blood flow, and inhibiting platelet aggregation. Salvia miltiorrhiza and Bombyx batryticatus can also reduce blood viscosity and improve local vascular congestion. The active ingredients in Ampelopsis japonica, Bletilla striata, and pearl have antioxidant activity, effectively scavenging free radicals and reducing pigmentation.

[0004] The "Chinese Expert Consensus on the Treatment of Melasma (2021)" points out that oral tranexamic acid can easily lead to decreased menstruation and gastrointestinal reactions. While topical medications for fading pigmentation, including bleaching agents and keratolytic agents, are effective, overuse can cause side effects such as local erythema and burning sensations. Laser treatment can also achieve some efficacy in treating melasma, but recurrence is common. Improper use of laser treatment can easily cause irritation, leading to post-inflammatory hyperpigmentation and worsening of the condition.

[0005] Traditional Chinese medicine (TCM) treatment for hyperpigmentation-related skin diseases often focuses on promoting blood circulation and removing blood stasis through topical medications. This is often combined with TCM principles of visceral differentiation, supplemented by methods to soothe the liver, strengthen the spleen, and tonify the kidneys. Although the disease primarily arises from imbalances in liver, spleen, and kidney function, as well as imbalances in the Chong and Ren meridians and obstruction of the collaterals, treatment should not solely focus on tonifying the kidneys, regulating the Chong meridian, promoting blood circulation, and soothing the liver. Appropriate use of heat-clearing and dampness-removing herbs, tailored to individual circumstances, is also necessary to reduce skin pigmentation and blemishes, brighten the complexion, and improve skin health. Summary of the Invention

[0006] The purpose of this invention is to overcome the shortcomings of the prior art and provide a traditional Chinese medicine composition, a traditional Chinese medicine preparation, a method for preparing the same, and its application.

[0007] In a first aspect, the present invention provides a traditional Chinese medicine composition comprising angelica, licorice, motherwort, dodder seed and ginseng.

[0008] In some embodiments, the traditional Chinese medicine composition further includes one or more of the following: silkworm pupae, kudzu root, Panax notoginseng, mother-of-pearl, Poria cocos, Atractylodes macrocephala, Rehmannia glutinosa, Andrographis paniculata, Hedyotis diffusa, Tricholoma matsutake, Edelweiss, Astragalus membranaceus, or Bletilla striata.

[0009] In some embodiments, the traditional Chinese medicine composition includes angelica, licorice, motherwort, dodder seed, ginseng, silkworm, kudzu root, and notoginseng.

[0010] In some embodiments, the traditional Chinese medicine composition includes angelica, licorice, motherwort, dodder seed, ginseng, silkworm, notoginseng, and mother-of-pearl.

[0011] In some embodiments, the traditional Chinese medicine composition includes angelica, licorice, motherwort, dodder seed, ginseng, silkworm, kudzu root, and mother-of-pearl.

[0012] In some embodiments, the traditional Chinese medicine composition includes angelica, licorice, motherwort, dodder seed, ginseng, silkworm, kudzu root, notoginseng and poria.

[0013] In some embodiments, the traditional Chinese medicine composition includes angelica, licorice, motherwort, dodder seed, ginseng, atractylodes macrocephala, and notoginseng.

[0014] In some embodiments, the traditional Chinese medicine composition includes Angelica sinensis, licorice, Leonurus japonicus, Cuscuta chinensis, ginseng, Bombyx mori, Pueraria lobata, Rehmannia glutinosa, Andrographis paniculata, Hedyotis diffusa, Tricholoma matsutake, Edelweiss, Poria cocos, Atractylodes macrocephala, Astragalus membranaceus, Bletilla striata, Panax notoginseng, and mother-of-pearl.

[0015] In some embodiments, the traditional Chinese medicine composition includes Angelica sinensis, licorice, Leonurus japonicus, Cuscuta chinensis, ginseng, Bombyx mori, Pueraria lobata, Rehmannia glutinosa, Andrographis paniculata, Hedyotis diffusa, Tricholoma matsutake, and Edelweiss.

[0016] In some embodiments, the traditional Chinese medicine composition includes Angelica sinensis, licorice, Leonurus japonicus, Cuscuta chinensis, ginseng, Bombyx mori, Pueraria lobata, Rehmannia glutinosa, Hedyotis diffusa, Tricholoma matsutake, and Poria cocos.

[0017] In some embodiments, the traditional Chinese medicine composition includes Angelica sinensis, licorice, Leonurus japonicus, Cuscuta chinensis, ginseng, Bombyx mori, Pueraria lobata, Rehmannia glutinosa, Andrographis paniculata, Tricholoma matsutake, Atractylodes macrocephala, and mother-of-pearl.

[0018] In some embodiments, the traditional Chinese medicine composition includes Angelica sinensis, licorice, Leonurus japonicus, Cuscuta chinensis, ginseng, Bombyx mori, Pueraria lobata, Rehmannia glutinosa, Andrographis paniculata, Hedyotis diffusa, Tricholoma matsutake, and Edelweiss.

[0019] In some embodiments, the traditional Chinese medicine composition includes Angelica sinensis, licorice, Leonurus japonicus, Cuscuta chinensis, ginseng, Bombyx mori, Pueraria lobata, Rehmannia glutinosa, Andrographis paniculata, Hedyotis diffusa, Tricholoma matsutake, Edelweiss, and Bletilla striata.

[0020] In some embodiments, the traditional Chinese medicine composition includes Angelica sinensis, licorice, Leonurus japonicus, Cuscuta chinensis, ginseng, Pueraria lobata, Rehmannia glutinosa, Andrographis paniculata, Hedyotis diffusa, Tricholoma matsutake, Edelweiss, and Poria cocos.

[0021] In some embodiments, the traditional Chinese medicine composition includes Angelica sinensis, licorice, Leonurus japonicus, Cuscuta chinensis, ginseng, Bombyx mori, Pueraria lobata, Rehmannia glutinosa, Andrographis paniculata, Hedyotis diffusa, Edelweiss, Poria cocos, Atractylodes macrocephala, and Astragalus membranaceus.

[0022] In some embodiments, the traditional Chinese medicine composition includes Angelica sinensis, licorice, Leonurus japonicus, Cuscuta chinensis, ginseng, Pueraria lobata, Rehmannia glutinosa, Andrographis paniculata, Hedyotis diffusa, Edelweiss, Bletilla striata, Panax notoginseng, and mother-of-pearl.

[0023] In some embodiments, the traditional Chinese medicine composition includes Angelica sinensis, licorice, Leonurus japonicus, Cuscuta chinensis, ginseng, Bombyx mori, Pueraria lobata, Rehmannia glutinosa, Andrographis paniculata, Hedyotis diffusa, Tricholoma matsutake, and Edelweiss.

[0024] In some embodiments, the traditional Chinese medicine composition comprises, by weight, 3-20 parts of Angelica sinensis (e.g., 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 parts or any value therebetween), 3-25 parts of Glycyrrhiza uralensis (e.g., 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 parts or any value therebetween), and 3-25 parts of Leonurus japonicus (e.g., 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25 parts or any value therebetween), and 3-25 parts of Leonurus japonicus (e.g., 3, 4, 5, 6, 7, 8, 9, 10 parts, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25 parts or any value therebetween), 5-25 parts of dodder seed (e.g., 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 23, 24, 25 or any value between them), and 5-20 parts of ginseng (e.g., 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25 or any value between them).

[0025] In some embodiments, the traditional Chinese medicine composition further includes, by weight, 3-25 parts of *Bombyx mori* (e.g., 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25 parts or any value therebetween), 3-25 parts of *Pueraria lobata* (e.g., 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25 parts or any value therebetween), and 5-15 parts of *Panax notoginseng* (e.g., 5 parts, ...). 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 parts or any value therein); mother-of-pearl 5-30 parts (e.g., 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25 parts or any value therein); Poria cocos 5-20 parts (e.g., 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 parts or any value therein); Atractylodes macrocephala 3-20 parts (e.g., 3, 4, 5, 6, 7 parts, ... 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 parts or any value therein), 5-20 parts of Rehmannia glutinosa (e.g., 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 parts or any value therein), 5-20 parts of Andrographis paniculata (e.g., 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 parts or any value therein), 3-20 parts of Hedyotis diffusa (e.g., 3, 4, 5, 6, 7, 8 parts, ... 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 parts or any value therein), 3-20 parts of *Tricholoma matsutake* (e.g., 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 parts or any value therein), 3-20 parts of *Edelweiss* (e.g., 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 parts or any value therein), 5-20 parts of *Astragalus membranaceus* (e.g., 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 parts or any value therein),8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 parts or any value therein) or 5-12 parts (e.g., 5, 6, 7, 8, 9, 10, 11, 12 parts or any value therein).

[0026] In some embodiments, the traditional Chinese medicine composition comprises, by weight, 3-20 parts of Angelica sinensis (e.g., 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 parts), 3-20 parts of Glycyrrhiza uralensis (e.g., 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 parts), and 3-20 parts of Leonurus japonicus (e.g., 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 parts). 9 portions, 20 portions), Cuscuta chinensis 5-20 portions (e.g., 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 portions), Ginseng 5-20 portions (e.g., 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 portions), Bombyx mori 5-20 portions (e.g., 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 portions), Kudzu root 5-20 portions (e.g., 5, 6, 7, 8, 9, 10 portions) 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 parts or any value therein), 5-20 parts of Rehmannia glutinosa (e.g., 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 parts), 5-20 parts of Andrographis paniculata (e.g., 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 parts or any value therein), 3-20 parts of Hedyotis diffusa (e.g., 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 parts), 13, 14, 15, 16, 17, 18, 19, 20 portions), 3-20 portions of matsutake mushrooms (e.g., 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 portions or any value between them), 5-20 portions of Edelweiss (e.g., 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 portions or any value between them), 5-12 portions of Poria cocos (e.g., 5, 6, 7, 8, 9, 10, 11, 12 portions or any value between them).Atractylodes macrocephala 3-15 parts (e.g., 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 parts or any value therein), Astragalus membranaceus 5-20 parts (e.g., 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 parts or any value therein), Bletilla striata 5-12 parts (e.g., 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 parts or any value therein), 7, 8, 9, 10, 11, 12 parts or any value therein); 5-12 parts of Panax notoginseng (e.g., 5, 6, 7, 8, 9, 10, 11, 12 parts or any value therein); 5-20 parts of mother-of-pearl (e.g., 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 parts or any value therein).

[0027] In some embodiments, the traditional Chinese medicine composition comprises, by weight, 3-20 parts of Angelica sinensis, 3-20 parts of Glycyrrhiza uralensis, 3-20 parts of Leonurus japonicus, 5-20 parts of Cuscuta chinensis, 5-20 parts of Panax ginseng, 5-20 parts of Bombyx mori, 5-20 parts of Pueraria lobata, 5-20 parts of Rehmannia glutinosa, 5-20 parts of Andrographis paniculata, 3-20 parts of Hedyotis diffusa, 3-20 parts of Tricholoma matsutake, 5-20 parts of Edelweiss, and 5-12 parts of Poria cocos.

[0028] In some embodiments, the traditional Chinese medicine composition comprises, by weight, 3-20 parts of Angelica sinensis, 3-20 parts of Glycyrrhiza uralensis, 3-20 parts of Leonurus japonicus, 5-20 parts of Cuscuta chinensis, 5-20 parts of Panax ginseng, 5-20 parts of Bombyx mori, 5-20 parts of Pueraria lobata, 5-20 parts of Rehmannia glutinosa, 5-20 parts of Andrographis paniculata, 3-20 parts of Hedyotis diffusa, and 5-20 parts of Edelweiss.

[0029] In some embodiments, the traditional Chinese medicine composition comprises, by weight, 5-10 parts of Angelica sinensis, 10-15 parts of Glycyrrhiza uralensis, 15-20 parts of Leonurus japonicus, 15-20 parts of Cuscuta chinensis, 10-15 parts of Panax ginseng, 5-12 parts of Pueraria lobata, 5-12 parts of Rehmannia glutinosa, 5-10 parts of Andrographis paniculata, 5-10 parts of Hedyotis diffusa, 10-15 parts of Tricholoma matsutake, 15-20 parts of Edelweiss, and 10-15 parts of Poria cocos.

[0030] In some embodiments, the traditional Chinese medicine composition comprises, by weight, 10-15 parts of Angelica sinensis, 15-20 parts of Glycyrrhiza uralensis, 15-20 parts of Leonurus japonicus, 15-20 parts of Cuscuta chinensis, 5-10 parts of Panax ginseng, 5-10 parts of Bombyx mori, 5-10 parts of Pueraria lobata, 5-10 parts of Rehmannia glutinosa, 5-10 parts of Andrographis paniculata, 3-8 parts of Hedyotis diffusa, 5-10 parts of Edelweiss, 10-15 parts of Poria cocos, 10-20 parts of Atractylodes macrocephala, and 10-20 parts of Astragalus membranaceus.

[0031] In some embodiments, the traditional Chinese medicine composition comprises, by weight, 5-10 parts of Angelica sinensis, 15-25 parts of Glycyrrhiza uralensis, 15-25 parts of Leonurus japonicus, 15-25 parts of Cuscuta chinensis, 5-10 parts of Panax ginseng, 3-8 parts of Pueraria lobata, 10-15 parts of Rehmannia glutinosa, 10-15 parts of Andrographis paniculata, 3-8 parts of Hedyotis diffusa, 3-8 parts of Edelweiss, 8-12 parts of Bletilla striata, 10-15 parts of Panax notoginseng, and 15-25 parts of mother-of-pearl.

[0032] In some embodiments, the traditional Chinese medicine composition comprises, by weight, 15-20 parts of Angelica sinensis, 15-25 parts of Glycyrrhiza uralensis, 15-25 parts of Leonurus japonicus, 15-25 parts of Cuscuta chinensis, 15-20 parts of Panax ginseng, 15-25 parts of Bombyx mori, 15-25 parts of Pueraria lobata, 15-20 parts of Rehmannia glutinosa, 10-15 parts of Andrographis paniculata, 5-10 parts of Hedyotis diffusa, 15-20 parts of Tricholoma matsutake, and 10-15 parts of Edelweiss.

[0033] In some embodiments, the traditional Chinese medicine composition comprises, by weight, 3-5 parts of Angelica sinensis, 5-12 parts of Glycyrrhiza uralensis, 5-10 parts of Leonurus japonicus, 5-10 parts of Cuscuta chinensis, 5-10 parts of Panax ginseng, 3-8 parts of Bombyx mori, 3-8 parts of Pueraria lobata, 5-15 parts of Rehmannia glutinosa, 5-15 parts of Andrographis paniculata, 3-5 parts of Hedyotis diffusa, 5-15 parts of Tricholoma matsutake, and 3-10 parts of Edelweiss.

[0034] In some embodiments, the traditional Chinese medicine composition comprises, by weight, 15 parts Angelica sinensis, 20 parts Glycyrrhiza uralensis, 15 parts Leonurus japonicus, 10 parts Cuscuta chinensis, 5 parts Ginseng, 5 parts Bombyx mori, 15 parts Pueraria lobata, 3 parts Hedyotis diffusa, 3 parts Tricholoma matsutake, and 5 parts Edelweiss.

[0035] In some embodiments, the traditional Chinese medicine composition includes: 15 parts Angelica sinensis, 20 parts Glycyrrhiza uralensis, 15 parts Leonurus japonicus, 10 parts Cuscuta chinensis, 5 parts Ginseng, 5 parts Bombyx mori, 15 parts Pueraria lobata, 10 parts Rehmannia glutinosa, 3 parts Hedyotis diffusa, 3 parts Tricholoma matsutake, and 5 parts Poria cocos.

[0036] In some embodiments, the traditional Chinese medicine composition includes: 15 parts Angelica sinensis, 20 parts Glycyrrhiza uralensis, 15 parts Leonurus japonicus, 10 parts Cuscuta chinensis, 5 parts Panax ginseng, 5 parts Bombyx mori, 15 parts Pueraria lobata, 10 parts Rehmannia glutinosa, 5 parts Andrographis paniculata, 3 parts Tricholoma matsutake, 5 parts Atractylodes macrocephala, and 20 parts Mother-of-Pearl.

[0037] In some embodiments, the traditional Chinese medicine composition includes: 15 parts Angelica sinensis, 20 parts Glycyrrhiza uralensis, 15 parts Leonurus japonicus, 10 parts Cuscuta chinensis, 5 parts Ginseng, 5 parts Bombyx mori, 15 parts Pueraria lobata, 10 parts Rehmannia glutinosa, 5 parts Andrographis paniculata, 3 parts Hedyotis diffusa, 3 parts Tricholoma matsutake, and 5 parts Edelweiss.

[0038] In some embodiments, the traditional Chinese medicine composition includes: 15 parts Angelica sinensis, 20 parts Glycyrrhiza uralensis, 15 parts Leonurus japonicus, 10 parts Cuscuta chinensis, 5 parts Panax ginseng, 5 parts Bombyx mori, 15 parts Pueraria lobata, 10 parts Rehmannia glutinosa, 5 parts Andrographis paniculata, 3 parts Hedyotis diffusa, 3 parts Tricholoma matsutake, 5 parts Edelweiss, and 10 parts Bletilla striata.

[0039] In some embodiments, the traditional Chinese medicine composition includes: 15 parts Angelica sinensis, 20 parts Glycyrrhiza uralensis, 15 parts Leonurus japonicus, 10 parts Cuscuta chinensis, 5 parts Panax ginseng, 5 parts Bombyx mori, 15 parts Pueraria lobata, 10 parts Rehmannia glutinosa, 5 parts Andrographis paniculata, 3 parts Hedyotis diffusa, 3 parts Tricholoma matsutake, 5 parts Edelweiss, 10 parts Bletilla striata, and 10 parts Angelica dahurica.

[0040] In some embodiments, the traditional Chinese medicine composition includes: 9 parts Angelica sinensis, 12 parts Glycyrrhiza uralensis, 20 parts Leonurus japonicus, 20 parts Cuscuta chinensis, 12 parts Panax ginseng, 9 parts Pueraria lobata, 9 parts Rehmannia glutinosa, 6 parts Andrographis paniculata, 6 parts Hedyotis diffusa, 12 parts Tricholoma matsutake, 18 parts Edelweiss, and 12 parts Poria cocos.

[0041] In some embodiments, the traditional Chinese medicine composition includes: 12 parts Angelica sinensis, 20 parts Glycyrrhiza uralensis, 20 parts Leonurus japonicus, 20 parts Cuscuta chinensis, 5 parts Ginseng, 5 parts Bombyx mori, 6 parts Pueraria lobata, 5 parts Rehmannia glutinosa, 5 parts Andrographis paniculata, 3 parts Hedyotis diffusa, 8 parts Edelweiss, 12 parts Poria cocos, 15 parts Atractylodes macrocephala, and 15 parts Astragalus membranaceus.

[0042] In some embodiments, the traditional Chinese medicine composition includes: 9 parts Angelica sinensis, 20 parts Glycyrrhiza uralensis, 20 parts Leonurus japonicus, 20 parts Cuscuta chinensis, 9 parts Panax ginseng, 5 parts Pueraria lobata, 12 parts Rehmannia glutinosa, 12 parts Andrographis paniculata, 5 parts Hedyotis diffusa, 5 parts Edelweiss, 10 parts Bletilla striata, 12 parts Panax notoginseng, and 20 parts Mother-of-Pearl.

[0043] In some embodiments, the traditional Chinese medicine composition includes: 18 parts Angelica sinensis, 20 parts Glycyrrhiza uralensis, 20 parts Leonurus japonicus, 20 parts Cuscuta chinensis, 18 parts Ginseng, 20 parts Bombyx mori, 20 parts Pueraria lobata, 18 parts Rehmannia glutinosa, 12 parts Andrographis paniculata, 9 parts Hedyotis diffusa, 18 parts Tricholoma matsutake, and 12 parts Edelweiss.

[0044] In some embodiments, the traditional Chinese medicine composition includes: 3 parts Angelica sinensis, 10 parts Glycyrrhiza uralensis, 8 parts Leonurus japonicus, 8 parts Cuscuta chinensis, 8 parts Ginseng, 5 parts Bombyx mori, 5 parts Pueraria lobata, 9 parts Rehmannia glutinosa, 10 parts Andrographis paniculata, 3 parts Hedyotis diffusa, 10 parts Tricholoma matsutake, and 5 parts Edelweiss.

[0045] In a second aspect, the present invention provides a traditional Chinese medicine preparation comprising an extract of the traditional Chinese medicine composition described in the first aspect.

[0046] In some embodiments, the extract is an aqueous extract.

[0047] In some embodiments, the extract is an oil extract.

[0048] In some embodiments, the dosage form of the traditional Chinese medicine preparation is selected from one or more of the following: lotion, ointment, cream, hydrogel, essential oil, or cream.

[0049] In a third aspect, the present invention provides a method for preparing a traditional Chinese medicine preparation, comprising the following steps:

[0050] S1, Extract the traditional Chinese medicine composition described in the first aspect.

[0051] S2, the extract obtained in step S1 is mixed with a drug-loaded matrix or excipient to form a formulation, thereby obtaining the traditional Chinese medicine preparation.

[0052] In some embodiments, the extraction method is selected from one or more of solvent extraction, distillation, extraction, inclusion, or microbial fermentation.

[0053] In some embodiments, the solvent in the solvent extraction is one or more of water, alcohol, or a mixture of alcohol and water.

[0054] In some embodiments, the extraction method is water extraction.

[0055] In some embodiments, before extracting the traditional Chinese medicine composition, the composition is dried, pulverized, or ground into a fine powder and passed through an 80-100 mesh sieve.

[0056] In some embodiments, the drug-loaded matrix and / or excipients include one or more of glycerol, emulsifiers, stabilizers, water, butylene glycol, and disodium EDTA.

[0057] In some embodiments, when the traditional Chinese medicine preparation is a cream, the preparation process of the cream is as follows:

[0058] (1) Mix glycerol with emulsifier and stabilizer evenly to prepare the oil phase;

[0059] (2) Mix water with butanediol, disodium EDTA and other materials evenly to prepare an aqueous phase;

[0060] (3) Mix the oil phase and the water phase evenly, and then emulsify them;

[0061] (4) Add the extract and mix well;

[0062] (5) Titrate with aminomethylpropanol, adjust the pH value, add polyglycerol-3 and carbomer and stir thoroughly to obtain the drug-loaded cream.

[0063] In some embodiments, the emulsifier includes agarol and / or agarstearyl olive oil ester.

[0064] In some embodiments, the stabilizer includes aminomethylpropanol and / or carbomer.

[0065] In a fourth aspect, the present invention provides an application of the traditional Chinese medicine preparation described in the second aspect as a medicine or skin care product.

[0066] In a fifth aspect, the present invention provides the application of the traditional Chinese medicine composition described in the first aspect or the traditional Chinese medicine preparation described in the second aspect in the preparation of a medicament for treating melasma, post-inflammatory hyperpigmentation, and age spots.

[0067] In some embodiments, the preferred formulation of the present invention for treating melasma is a 45-60g / tube cream, applied topically twice daily after cleansing.

[0068] The pharmaceutical composition of this invention can improve dull skin; simultaneously, active ingredients such as licorice can effectively inhibit tyrosinase activity, thereby inhibiting melanin formation and effectively brightening skin tone; it can also replenish skin nutrition and moisture, providing sufficient energy for skin metabolism; it can reduce fine lines and brighten skin tone; it moisturizes and hydrates, leaving skin gradually smooth, supple, bright, and soft. The face cream made from the traditional Chinese medicine composition of this invention has the characteristics of rapid effect, low recurrence rate, high cost-effectiveness, low drug resistance, and good safety.

[0069] The traditional Chinese medicine composition described in this invention is mainly used to treat melasma, post-inflammatory hyperpigmentation, and age spots. While these conditions are relatively easy to diagnose, treatment faces challenges such as poor efficacy, slow onset of action, long treatment cycles, and high recurrence rates. Currently, Western medicine treatments are mainly divided into systemic drug therapy, topical drug therapy, and physiochemical therapy. Systemic and topical drug therapies have long treatment cycles, some patients experience significant adverse reactions, and there is a lack of specific treatments targeting the pathological changes of photoaging. Physiochemical therapies, mainly chemical peels and phototherapy, are limited in their application to active melasma and cannot be used as a long-term maintenance method. Compared to Western medicine treatments, the cream containing the drug composition described in this invention, in addition to fading spots, brightening skin tone, and improving complexion, also has advantages such as good safety, low recurrence rate, no limitation by the active phase of pigmentation, and continuous use. It can also reduce fine lines and replenish skin nutrition. However, due to the different depths of pigmentation and the influence of endogenous hormones, pigmentation can be divided into deep pigmentation and superficial pigmentation. The traditional Chinese medicine composition described in this invention has a significant effect on superficial pigmentation, but the treatment of deep pigmentation requires the use of oral traditional Chinese medicine, and the treatment course is relatively long.

[0070] In the traditional Chinese medicine composition described in this invention, Angelica sinensis is pungent, sweet, and warm in nature, and functions to nourish and invigorate blood, promoting blood circulation and reducing oxidative damage to the skin; Glycyrrhiza uralensis is sweet and neutral in nature, and functions to invigorate qi and strengthen the exterior, inhibiting melanin formation and effectively brightening the skin tone; Leonurus japonicus is pungent, bitter, and slightly cold in nature, and can invigorate blood and regulate menstruation. Ginseng is sweet, bitter, and warm in nature, tonifying the spleen and lungs, replenishing qi and nourishing blood, improving dull skin, and replenishing skin nutrition and moisture. The entire formula works synergistically to nourish the kidneys, regulate the Chong meridian, invigorate blood, and unblock the meridians. Attached Figure Description

[0071] Figure 1 Example 7: Before and after treatment of melasma using a microscope;

[0072] Figure 2 Example 8: Cloud-like microscope comparison before and after treatment for post-inflammatory hyperpigmentation;

[0073] Figure 3 Example 9: Cloud-like mirror comparison before and after treatment of seborrheic keratosis;

[0074] Figure 4 This is a comparison image of the patient's skin brightness, color, and fine lines before and after treatment in Example 10. Detailed Implementation

[0075] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to embodiments and accompanying drawings. The specific embodiments described herein are for illustrative purposes only and are not intended to limit the scope of the invention in any way.

[0076] The endpoints and any values ​​of the ranges disclosed herein are not limited to the precise ranges or values, and these ranges or values ​​should be understood to include values ​​close to these ranges or values. For numerical ranges, the endpoint values ​​of the various ranges, the endpoint values ​​of the various ranges and individual point values, and individual point values ​​can be combined with each other to obtain one or more new numerical ranges, which should be considered as specifically disclosed herein.

[0077] Unless otherwise defined, the technical terms used in the following embodiments have the same meaning as commonly understood by those skilled in the art. Unless otherwise specified, the reagents used in the following embodiments are conventional biochemical reagents; the raw materials, instruments, and equipment used in the following embodiments can all be obtained commercially or by existing methods; unless otherwise specified, the reagent dosages are those used in routine experimental operations; unless otherwise specified, the experimental methods are conventional methods.

[0078] The inclusion and exclusion criteria in this invention refer to: Western medicine diagnosis conforming to the "Chinese Expert Consensus on the Treatment of Melasma (2021)" and TCM syndrome diagnosis criteria conforming to the "Chinese Expert Consensus on the Diagnosis and Treatment of Melasma (2021 Edition)": Liver Qi stagnation syndrome, or Qi stagnation and blood stasis syndrome, or Spleen deficiency and dampness obstruction syndrome, or Liver and kidney Yin deficiency syndrome; age between 18 and 70 years, gender not limited; duration of disease not limited. Patients with a history of systemic use of glucocorticoids within three months prior to treatment are excluded; patients who need prolonged sun exposure for various reasons during treatment are excluded; patients with other facial skin diseases are excluded; patients with serious primary diseases of the cardiovascular, cerebrovascular, liver, kidney, and hematopoietic systems, or severe mental illness are excluded; pregnant or lactating women are excluded; patients with known allergies to the investigational drug are excluded; and patients currently participating in other drug clinical trials are excluded.

[0079] Unless otherwise specified, the parts in this invention refer to parts by weight.

[0080] Example 1

[0081] The formula of the traditional Chinese medicine composition is as follows: Angelica sinensis 9 parts, Glycyrrhiza uralensis 12 parts, Leonurus japonicus 20 parts, Cuscuta chinensis 20 parts, Panax ginseng 12 parts, Pueraria lobata 9 parts, Rehmannia glutinosa 9 parts, Andrographis paniculata 6 parts, Hedyotis diffusa 6 parts, Tricholoma matsutake 12 parts, Edelweiss 18 parts, Poria cocos 12 parts.

[0082] Example 2

[0083] The formula of the Chinese herbal composition is as follows: Angelica sinensis 12 parts, Glycyrrhiza uralensis 20 parts, Leonurus japonicus 20 parts, Cuscuta chinensis 20 parts, Panax ginseng 5 parts, Bombyx mori 5 parts, Pueraria lobata 6 parts, Rehmannia glutinosa 5 parts, Andrographis paniculata 5 parts, Hedyotis diffusa 3 parts, Edelweiss 8 parts, Poria cocos 12 parts, Atractylodes macrocephala 15 parts, Astragalus membranaceus 15 parts.

[0084] Example 3

[0085] The formula of the traditional Chinese medicine composition is as follows: Angelica sinensis 9 parts, Glycyrrhiza uralensis 20 parts, Leonurus japonicus 20 parts, Cuscuta chinensis 20 parts, Panax ginseng 9 parts, Pueraria lobata 5 parts, Rehmannia glutinosa 12 parts, Andrographis paniculata 12 parts, Hedyotis diffusa 5 parts, Edelweiss 5 parts, Bletilla striata 10 parts, Panax notoginseng 12 parts, and pearl powder 20 parts.

[0086] Example 4

[0087] The formula of the Chinese herbal medicine composition is as follows: Angelica sinensis 18 parts, Glycyrrhiza uralensis 20 parts, Leonurus japonicus 20 parts, Cuscuta chinensis 20 parts, Ginseng 18 parts, Bombyx mori 20 parts, Pueraria lobata 20 parts, Rehmannia glutinosa 18 parts, Andrographis paniculata 12 parts, Hedyotis diffusa 9 parts, Tricholoma matsutake 18 parts, and Edelweiss 12 parts.

[0088] Example 5

[0089] The formula of the Chinese herbal medicine composition is as follows: Angelica sinensis 3 parts, Glycyrrhiza uralensis 10 parts, Leonurus japonicus 8 parts, Cuscuta chinensis 8 parts, Panax ginseng 8 parts, Bombyx mori 5 parts, Pueraria lobata 5 parts, Rehmannia glutinosa 9 parts, Andrographis paniculata 10 parts, Hedyotis diffusa 3 parts, Tricholoma matsutake 10 parts, and Edelweiss 5 parts.

[0090] Using the traditional Chinese medicine composition formulations in Examples 1-5, a drug-loaded cream was prepared, comprising the following steps:

[0091] 1. Weigh the traditional Chinese medicine compositions from Examples 1-5 according to the prescribed amounts;

[0092] 2. Extract the effective components of the above-mentioned raw materials using water extraction method to obtain an aqueous extract for later use;

[0093] 3. Glycerin, agarol, agaristearyl oleate, aminomethylpropanol, and carbomer are mixed evenly to prepare the oil phase;

[0094] 4. Mix water with butanediol and disodium EDTA until homogeneous to prepare an aqueous phase;

[0095] 5. Mix the oil phase and water phase evenly, and then emulsify;

[0096] 6. Add the extract and mix well;

[0097] 7. Titrate with aminomethylpropanol, adjust the pH to 5.5, add polyglycerol-3 and carbomer, and stir thoroughly to obtain the drug-loaded cream.

[0098] Example 6

[0099] Clinical efficacy evaluation and comparison of traditional Chinese medicine compositions in Examples 1-5.

[0100] 1. Study subjects and source of participants

[0101] All study subjects were patients who visited the Dermatology Clinic of Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, between August and November 2023. All patients were diagnosed by clinical dermatologists and met the Western medicine diagnostic criteria of the *Chinese Expert Consensus on the Treatment of Melasma (2021)*, and also met the TCM syndrome diagnosis criteria of the *Chinese Expert Consensus on the Diagnosis and Treatment of Melasma (2021 Edition)*: Liver Qi Stagnation Syndrome, or Qi Stagnation and Blood Stasis Syndrome, or Spleen Deficiency and Dampness Obstruction Syndrome, or Liver and Kidney Yin Deficiency Syndrome; their ages were between 18 and 70 years, regardless of gender; and the duration of disease was not limited. Patients with a history of systemic use of glucocorticoids within three months prior to treatment were excluded; patients who needed prolonged sun exposure for any reason during treatment were excluded; patients with other facial skin diseases were excluded; patients with serious primary diseases of the cardiovascular, cerebrovascular, liver, kidney, and hematopoietic systems, or severe mental illness were excluded; pregnant or lactating women were excluded; patients with known allergies to the study drug were excluded; and patients currently participating in other drug clinical trials were excluded.

[0102] 2. Treatment methods

[0103] Subjects were randomly divided into 5 groups and applied the creams described in Examples 1-5 twice daily for 4 weeks (28 days per course of treatment, with 3 consecutive courses of treatment (12 weeks)). MASI scores and adverse events were recorded at weeks 0, 1, 2, 4, 8, and 12 of treatment. Cumulative area was assigned to four regions: forehead, right cheek, left cheek, and jawline, with weights of 30%, 30%, 30%, and 10%, respectively. Melasma area (A): 1 point = <10%, 2 points = 10%–29%, 3 points = 30%–49%, 4 points = 50%–69%, 5 points = 70%–89%, 6 points = 90%–100%. Color depth (D) and color uniformity (H) scores: 0 points = none, 1 point = mild, 2 points = moderate, 3 points = noticeable, 4 points = severe.

[0104] MASI = Forehead [0.3A(D+H)] + Right cheek [0.3A(D+H)] + Left cheek [0.3A(D+H)] + Jaw [0.1A(D+H)]. The maximum score for MASI is 48 points. The higher the MASI score, the more severe the melasma.

[0105] 3. Evaluation of therapeutic effect

[0106] Before treatment and after three courses of treatment, two experienced dermatologists scored the severity of melasma according to the MASI scoring system. For those with differences, the average score was taken to calculate the efficacy rate. At the same time, a patient satisfaction survey was conducted.

[0107] Significant effect: MASI score decrease of ≥70%;

[0108] Improvement: MASI score decreases by ≥50%;

[0109] Effective: MASI score decrease of ≥30%;

[0110] Invalid: MASI score decrease of <30%.

[0111] MASI score decrease percentage = (pre-treatment - post-treatment) score / pre-treatment score × 100%.

[0112] Effectiveness = Number of effective cases / Total number of cases × 100%.

[0113] 4. Test Results

[0114] The efficacy rates of each group during the treatment period are shown in Table 1. After treatment, the efficacy rate of patients using the cream in Example 5 was 50.00%, which was significantly higher than that of the other four groups in the example.

[0115] Table 1

[0116]

[0117]

[0118] To further verify the effectiveness of the present invention, a series of theoretical, experimental and test verifications were carried out, as detailed in Examples 7-12.

[0119] Example 7

[0120] Clinical efficacy evaluation and safety observation of traditional Chinese medicine compositions.

[0121] 1. Study subjects and source of participants

[0122] All study subjects were patients who visited the Dermatology Clinic of Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, between January and March 2024. All patients were diagnosed by clinical dermatologists and met the Western medicine diagnostic criteria of the *Chinese Expert Consensus on the Treatment of Melasma (2021)*, and also met the TCM syndrome diagnosis criteria of the *Chinese Expert Consensus on the Diagnosis and Treatment of Melasma (2021 Edition)*: Liver Qi Stagnation Syndrome, or Qi Stagnation and Blood Stasis Syndrome, or Spleen Deficiency and Dampness Obstruction Syndrome, or Liver and Kidney Yin Deficiency Syndrome; their ages were between 18 and 70 years, regardless of gender; and the duration of disease was not limited. Patients with a history of systemic use of glucocorticoids within three months prior to treatment were excluded; patients who needed prolonged sun exposure during treatment were excluded; patients with other facial skin diseases were excluded; patients with serious primary diseases of the cardiovascular, cerebrovascular, liver, kidney, and hematopoietic systems, or severe mental illness were excluded; pregnant or lactating women were excluded; patients with known allergies to the study drug were excluded; and patients currently participating in other drug clinical trials were excluded.

[0123] 2. Treatment methods

[0124] The cream of Example 5 of this invention was applied topically twice daily for 4 weeks (28 days) as one course of treatment. Three consecutive courses of treatment (12 weeks) were performed. MASI score, SKINDEX-16 score, CBS cloud mirror skin images and adverse events were recorded at weeks 0, 1, 2, 4, 8 and 12 of treatment.

[0125] The primary outcome indicators were MASI, CBS Cloud Mirror Skin Value, and SKINDEX-16 score. Cumulative area was weighted at 30%, 30%, 30%, and 10% for the four regions: forehead, right cheek, left cheek, and jawline. Melasma area (A): 1 point = <10%, 2 points = 10%–29%, 3 points = 30%–49%, 4 points = 50%–69%, 5 points = 70%–89%, and 6 points = 90%–100%. Color depth (D) and color uniformity (H) scores: 0 points = none, 1 point = mild, 2 points = moderate, 3 points = noticeable, and 4 points = severe.

[0126] MASI = Forehead [0.3A(D+H)] + Right cheek [0.3A(D+H)] + Left cheek [0.3A(D+H)] + Jaw [0.1A(D+H)]. The total MASI score ranges from 0 to 48.

[0127] CBS cloud imaging uses specialized equipment to capture relevant skin data, primarily employing various spectral filtering modes to instantly measure and analyze the area of ​​spots in the epidermis and dermis. This study mainly collected data on the area of ​​superficial UV spots and the area of ​​deep UV spots for before-and-after comparison.

[0128] The SKINDEX-16 rating scale is used in dermatology to assess the impact of skin conditions on quality of life. It covers three aspects: symptoms, emotional state, and function. Specifically, it includes 16 items, each scored from 0 to 6, with an initial total score of 96. The final score is calculated as ∑initial score × 16.6667 / 16, for a total of 100 points. A higher score indicates a more severe impact of skin conditions on quality of life.

[0129] 3. Statistical methods

[0130] Statistical analysis was performed using SPSS software (SPSS version 25.0). For numerical variables, the mean and standard deviation (χ±S) of the measurement data were calculated, and paired t-tests were used for categorical data. P < 0.1 was considered statistically significant.

[0131] 4. Test Results

[0132] (1) General situation

[0133] Based on the inclusion and exclusion criteria, this study ultimately included 21 subjects, all of whom were female.

[0134] (2) Comparison of MASI scores before and after treatment for melasma

[0135] All 21 patients completed treatment and follow-up. The MASI score before treatment was 5.51±3.23. As treatment progressed, the MASI score gradually decreased, reaching 3.90±3.26 after treatment, a statistically significant difference compared to the pre-treatment score (P<0.1). The trends in MASI score changes during the treatment period for both groups are detailed in Table 2.

[0136] Table 2

[0137] 5.51±3.23 3.90±3.26 4.462 ＜0.001

[0138] (3) Comparison of skin physiological function indicators before and after treatment of melasma

[0139] Table 3 shows the changes in skin physiological function indicators during the treatment period. After treatment, the area of ​​superficial UV spots and deep UV spots decreased significantly compared with before treatment, and the difference was statistically significant (P<0.1).

[0140] Table 3

[0141]

[0142] (4) Comparison of SKINDEX-16 before and after treatment for melasma

[0143] Table 4 shows the changes in SKINDEX-16 scores during the treatment period compared to baseline. The SKINDEX-16 scores after treatment decreased compared to before treatment, but the difference was statistically significant (P<0.1).

[0144] Table 4

[0145] 29.98±21.08 17.72±22.47 3.383 0.004

[0146] This demonstrates that the product prepared in Example 5 of the present invention is effective in treating melasma, as can be seen from the before-and-after comparison images. Figure 1 .

[0147] Example 8

[0148] Clinical efficacy evaluation and safety observation of traditional Chinese medicine compositions.

[0149] 1. Study subjects and source of participants

[0150] All study subjects were patients who visited the Dermatology Clinic of Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, between January and March 2024. All patients were diagnosed by clinical dermatologists and met the Western medical diagnostic criteria of *Traditional Chinese Medicine Cosmetic Dermatology*, as well as the TCM syndrome differentiation criteria of *Traditional Chinese Medicine Cosmetic Dermatology*: Liver Qi stagnation syndrome, Qi stagnation and blood stasis syndrome, Spleen deficiency and dampness obstruction syndrome, or Liver and kidney Yin deficiency syndrome; their ages ranged from 18 to 70 years, with no gender restriction; and the duration of their disease was not limited. Patients with a history of systemic use of glucocorticoids within three months prior to treatment were excluded; patients who needed prolonged sun exposure during treatment were excluded; patients with other facial skin diseases were excluded; patients with serious primary diseases of the cardiovascular, cerebrovascular, liver, kidney, and hematopoietic systems, as well as severe mental illness, were excluded; pregnant or lactating women were excluded; patients with known allergies to the study drug were excluded; and patients currently participating in other drug clinical trials were excluded.

[0151] 2. Treatment methods

[0152] The product of Example 5 of this invention was used externally twice daily for 2 weeks (14 days) as one course of treatment. Two consecutive courses of treatment (4 weeks) were used. CBS cloud mirror skin images, SKINDEX-16 scores, and adverse events were recorded at weeks 0, 1, 2, and 4 of treatment.

[0153] CBS Cloud Lens uses professional equipment to capture relevant skin data. This study mainly collects two data points: the area of ​​superficial UV spots and the area of ​​deep UV spots, for before-and-after comparison.

[0154] The SKINDEX-16 rating scale is used in dermatology to assess the impact of skin conditions on quality of life. It covers three aspects: symptoms, emotions, and function. Specifically, it includes 16 items, each worth 6 points, for a total initial score of 96 points. The final score is calculated as ∑initial score × 16.6667 / 16, with a total final score of 100 points. A higher score indicates a more severe impact of skin conditions on quality of life.

[0155] 3. Statistical methods

[0156] Statistical analysis was performed using SPSS software (SPSS version 25.0). For numerical variables, the mean and standard deviation (χ±S) of the measurement data were calculated, and paired t-tests were used for categorical data. P < 0.1 was considered statistically significant.

[0157] 4. Test Results

[0158] (1) General situation

[0159] Based on the inclusion and exclusion criteria, a total of 16 subjects were ultimately included in the study, all of whom were female.

[0160] (2) Comparison of skin physiological function indicators before and after treatment for post-inflammatory hyperpigmentation

[0161] The changes in skin physiological function indicators during the treatment period are shown in Table 5. After treatment, the area of ​​superficial UV spots and deep UV spots in the treatment group decreased significantly compared with before treatment, and the difference was statistically significant (P<0.1).

[0162] Table 5

[0163] <![CDATA[UV superficial spot area (mm 2 )]]> 320.47±134.61 247.61±99.93 4.300 0.003 <![CDATA[UV deep spot area (mm 2 )]]> 276.62±235.13 221.47±227.22 3.146 0.016

[0164] (3) Comparison of SKINDEX-16 before and after treatment for post-inflammatory hyperpigmentation

[0165] Table 6 shows the changes in SKINDEX-16 scores during the treatment period. The SKINDEX-16 scores after treatment decreased compared with those before treatment, but the difference was statistically significant (P<0.1).

[0166] Table 6

[0167] 44.27±18.26 21.88±12.26 5.436 0.001

[0168] This demonstrates that the product prepared in Example 5 of the present invention is effective in treating post-inflammatory hyperpigmentation, as shown in the before-and-after cloud-like images. Figure 2 .

[0169] Example 9

[0170] Clinical efficacy evaluation and safety observation of traditional Chinese medicine compositions.

[0171] 1. Study subjects and source of participants

[0172] All study subjects were patients who visited the Dermatology Clinic of Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, between January and March 2024. All patients were diagnosed by clinical dermatologists and met the Western medicine and TCM syndrome differentiation criteria of *Clinical Dermatology*: Liver Qi stagnation syndrome, Qi stagnation and blood stasis syndrome, Spleen deficiency and dampness obstruction syndrome, or Liver and kidney Yin deficiency syndrome; aged 18-70 years, regardless of gender; and regardless of disease duration. Patients with a history of systemic use of glucocorticoids within three months prior to treatment were excluded; patients requiring prolonged sun exposure during treatment were excluded; patients with other facial skin diseases were excluded; patients with serious primary diseases of the cardiovascular, cerebrovascular, liver, kidney, and hematopoietic systems, or severe mental illness were excluded; pregnant or lactating women were excluded; patients with known allergies to the study drug were excluded; and patients currently participating in other drug clinical trials were excluded.

[0173] 2. Treatment methods

[0174] The product of Example 5 of this invention was applied topically twice daily for 4 weeks (28 days) as one course of treatment, and three consecutive courses (12 weeks) were used. CBS cloud mirror skin images, SKINDEX-16 scores, and adverse events were recorded at weeks 0, 1, 2, 4, 8, and 12 of treatment. Among them, the cloud mirror quantitative index was the primary outcome indicator.

[0175] CBS Cloud Lens uses professional equipment to capture relevant skin data. This study mainly collects two data points: the area of ​​superficial UV spots and the area of ​​deep UV spots, for before-and-after comparison.

[0176] The SKINDEX-16 rating scale is used in dermatology to assess the impact of skin conditions on quality of life. It covers three aspects: symptoms, emotions, and function. The SKINDEX-16 rating scale consists of 16 items, each scored from 0 to 6, with an initial total score of 96 points. The final score is calculated as ∑initial score × 16.6667 / 16, with a final score of 100 points. A higher score indicates a more severe impact on quality of life due to skin conditions.

[0177] 3. Statistical methods

[0178] Statistical analysis was performed using SPSS software (SPSS version 25.0). For numerical variables, the mean and standard deviation (χ±S) of the measurement data were calculated, and paired t-tests were used for categorical data. P < 0.1 was considered statistically significant.

[0179] 4. Test Results

[0180] (1) General situation

[0181] Based on the inclusion and exclusion criteria, a total of 18 subjects were ultimately included in the study, all of whom were female.

[0182] (2) Comparison of skin physiological function indicators before and after treatment of seborrheic keratosis

[0183] Table 7 shows the changes in skin physiological function indicators during the treatment of seborrheic keratosis. After treatment, the area of ​​superficial UV spots and deep UV spots in the treatment group decreased significantly compared with before treatment, and the difference was statistically significant (P<0.1).

[0184] Table 7

[0185] <![CDATA[UV superficial spot area (mm 2 )]]> 481.44±253.49 324.90±205.99 5.061 0.001 <![CDATA[UV deep spot area (mm 2 )]]> 519.55±314.98 414.19.±294.29 4.768 0.001

[0186] (3) Comparison of SKINDEX-16 before and after treatment for seborrheic keratosis

[0187] The changes in SKINDEX-16 scores during the treatment of seborrheic keratosis are shown in Table 8. The SKINDEX-16 scores after treatment decreased compared with those before treatment, but the difference was statistically significant (P<0.1).

[0188] Table 8

[0189] 20.95±16.43 7.75±7.60 2.825 0.022

[0190] This demonstrates that the product prepared in Example 5 of this invention is effective in treating seborrheic keratosis, as shown in the before-and-after comparison images. Figure 3 .

[0191] Example 10

[0192] To evaluate the efficacy of this invention's product in brightening skin tone, improving complexion, and reducing fine lines, this study used a CBS cloud lens to collect and observe images before and after treatment. The study showed that this product can significantly reduce the area of ​​superficial and deep UV spots, effectively brightening skin tone and improving complexion; it can also significantly reduce the area of ​​deep wrinkles, superficial wrinkles, and fine lines, effectively reducing fine lines. Changes in these values ​​before and after treatment are shown in Table 9. Comparison images of skin brightness, complexion, and fine lines before and after treatment using a CBS cloud lens are available. Figure 4 .

[0193] Table 9

[0194] <![CDATA[UV superficial spots (mm 2 )]]> 625.29 396.68 <![CDATA[UV deep pigmentation (mm 2 )]]> 810.58 738.41 <![CDATA[Deep wrinkles (mm 2 )]]> 574.99 427.73 <![CDATA[Superficial wrinkles (mm 2 )]]> 282.63 187.74 <![CDATA[Fine lines (mm 2 )]]> 153.84 51.58

[0195] Example 11

[0196] Safety observation of traditional Chinese medicine compositions.

[0197] Based on Examples 6, 7, 8, and 9 above, a total of 95 subjects with melasma, post-inflammatory hyperpigmentation, and seborrheic keratosis underwent safety observation. No allergic reactions, blisters, itching, redness, swelling, pain, or irritation occurred during the experiment. This indicates that the product of this invention has good clinical safety.

[0198] Example 12

[0199] To assess the safety of the product of this invention, the product of Example 5 was tested for hygiene indicators in accordance with the 2015 edition of the "Cosmetic Safety Technical Specifications". Based on the comprehensive test results, it can be determined that the product of this invention is safe and non-toxic and complies with the cosmetic safety technical specifications.

[0200] According to hygiene testing, the product of Example 5 of the present invention complies with the 2015 edition of the "Cosmetic Safety Technical Specifications", as shown in Table 10.

[0201] Table 10

[0202] mercury ≤1mg / Kg Compliant qualified lead ≤40mg / Kg Compliant qualified arsenic ≤10mg / Kg Compliant qualified methanol ≤2000mg / Kg Compliant qualified Total bacterial count ≤1000 CFU / g Compliant qualified Total number of molds and yeasts ≤1000 CFU / g Compliant qualified fecal coliforms Not detectable Not detected qualified Staphylococcus aureus Not detectable Not detected qualified Pseudomonas aeruginosa Not detectable Not detected qualified

[0203] In summary, the product prepared according to the traditional Chinese medicine composition formula of this invention has definite therapeutic effects on melasma, post-inflammatory hyperpigmentation, and seborrheic keratosis, and also has certain effects on brightening skin tone, improving complexion, and reducing fine lines. The product is safe and non-toxic, and complies with cosmetic safety technical specifications.

[0204] The preferred embodiments of the present invention have been described in detail above; however, the present invention is not limited thereto. Within the scope of the inventive concept, various simple modifications can be made to the technical solutions of the present invention, including combinations of various technical features in any other suitable manner. These simple modifications and combinations should also be considered as the content disclosed in the present invention and are all within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating melasma, comprising 5-10 parts of Angelica sinensis, 10-15 parts of Glycyrrhiza uralensis, 15-20 parts of Leonurus japonicus, 15-20 parts of Cuscuta chinensis, 10-15 parts of Panax ginseng, 5-12 parts of Pueraria lobata, 5-12 parts of Rehmannia glutinosa, 5-10 parts of Andrographis paniculata, 5-10 parts of Hedyotis diffusa, 10-15 parts of Tricholoma matsutake, 15-20 parts of Edelweiss, and 10-15 parts of Poria cocos.

2. A traditional Chinese medicine composition for treating melasma, comprising 9 parts Angelica sinensis, 12 parts Glycyrrhiza uralensis, 20 parts Leonurus japonicus, 20 parts Cuscuta chinensis, 12 parts Panax ginseng, 9 parts Pueraria lobata, 9 parts Rehmannia glutinosa, 6 parts Andrographis paniculata, 6 parts Hedyotis diffusa, 12 parts Tricholoma matsutake, 18 parts Edelweiss, and 12 parts Poria cocos.

3. A traditional Chinese medicine composition for treating melasma, comprising 10-15 parts of Angelica sinensis, 15-20 parts of Glycyrrhiza uralensis, 15-20 parts of Leonurus japonicus, 15-20 parts of Cuscuta chinensis, 5-10 parts of Panax ginseng, 5-10 parts of Bombyx mori, 5-10 parts of Pueraria lobata, 5-10 parts of Rehmannia glutinosa, 5-10 parts of Andrographis paniculata, 3-8 parts of Hedyotis diffusa, 5-10 parts of Edelweiss, 10-15 parts of Poria cocos, 10-20 parts of Atractylodes macrocephala, and 10-20 parts of Astragalus membranaceus.

4. A traditional Chinese medicine composition for treating melasma, comprising 12 parts Angelica sinensis, 20 parts Glycyrrhiza uralensis, 20 parts Leonurus japonicus, 20 parts Cuscuta chinensis, 5 parts Panax ginseng, 5 parts Bombyx mori, 6 parts Pueraria lobata, 5 parts Rehmannia glutinosa, 5 parts Andrographis paniculata, 3 parts Hedyotis diffusa, 8 parts Edelweiss, 12 parts Poria cocos, 15 parts Atractylodes macrocephala, and 15 parts Astragalus membranaceus.

5. A traditional Chinese medicine composition for treating melasma, comprising 5-10 parts of Angelica sinensis, 15-25 parts of Glycyrrhiza uralensis, 15-25 parts of Leonurus japonicus, 15-25 parts of Cuscuta chinensis, 5-10 parts of Panax ginseng, 3-8 parts of Pueraria lobata, 10-15 parts of Rehmannia glutinosa, 10-15 parts of Andrographis paniculata, 3-8 parts of Hedyotis diffusa, 3-8 parts of Edelweiss, 8-12 parts of Bletilla striata, 10-15 parts of Panax notoginseng, and 15-25 parts of mother-of-pearl.

6. A traditional Chinese medicine composition for treating melasma, comprising 9 parts Angelica sinensis, 20 parts Glycyrrhiza uralensis, 20 parts Leonurus japonicus, 20 parts Cuscuta chinensis, 9 parts Panax ginseng, 5 parts Pueraria lobata, 12 parts Rehmannia glutinosa, 12 parts Andrographis paniculata, 5 parts Hedyotis diffusa, 5 parts Edelweiss, 10 parts Bletilla striata, 12 parts Panax notoginseng, and 20 parts Mother-of-Pearl.

7. A traditional Chinese medicine composition for treating melasma, comprising 15-20 parts of Angelica sinensis, 15-25 parts of Glycyrrhiza uralensis, 15-25 parts of Leonurus japonicus, 15-25 parts of Cuscuta chinensis, 15-20 parts of Panax ginseng, 15-25 parts of Bombyx mori, 15-25 parts of Pueraria lobata, 15-20 parts of Rehmannia glutinosa, 10-15 parts of Andrographis paniculata, 5-10 parts of Hedyotis diffusa, 15-20 parts of Tricholoma matsutake, and 10-15 parts of Edelweiss.

8. A traditional Chinese medicine composition for treating melasma, comprising 18 parts Angelica sinensis, 20 parts Glycyrrhiza uralensis, 20 parts Leonurus japonicus, 20 parts Cuscuta chinensis, 18 parts Panax ginseng, 20 parts Bombyx mori, 20 parts Pueraria lobata, 18 parts Rehmannia glutinosa, 12 parts Andrographis paniculata, 9 parts Hedyotis diffusa, 18 parts Tricholoma matsutake, and 12 parts Edelweiss.

9. A traditional Chinese medicine composition for treating melasma, post-inflammatory hyperpigmentation, and age spots, comprising 3-5 parts of Angelica sinensis, 5-12 parts of Glycyrrhiza uralensis, 5-10 parts of Leonurus japonicus, 5-10 parts of Cuscuta chinensis, 5-10 parts of Panax ginseng, 3-8 parts of Bombyx mori, 3-8 parts of Pueraria lobata, 5-15 parts of Rehmannia glutinosa, 5-15 parts of Andrographis paniculata, 3-5 parts of Hedyotis diffusa, 5-15 parts of Tricholoma matsutake, and 3-10 parts of Edelweiss.

10. A traditional Chinese medicine composition for treating melasma, post-inflammatory hyperpigmentation, and age spots, comprising 3 parts Angelica sinensis, 10 parts Glycyrrhiza uralensis, 8 parts Leonurus japonicus, 8 parts Cuscuta chinensis, 8 parts Panax ginseng, 5 parts Bombyx mori, 5 parts Pueraria lobata, 9 parts Rehmannia glutinosa, 10 parts Andrographis paniculata, 3 parts Hedyotis diffusa, 10 parts Tricholoma matsutake, and 5 parts Edelweiss.

11. A traditional Chinese medicine preparation for treating melasma, made from an extract of the traditional Chinese medicine composition according to any one of claims 1-8.

12. A traditional Chinese medicine preparation for treating melasma, post-inflammatory hyperpigmentation, and age spots, made from an extract of the traditional Chinese medicine composition according to claim 9 or 10.

13. The traditional Chinese medicine preparation according to claim 11 or 12, characterized in that, The extract of the traditional Chinese medicine composition is an aqueous extract.

14. The traditional Chinese medicine preparation according to claim 11 or 12, characterized in that, The dosage form of the traditional Chinese medicine preparation is selected from one or more of the following: lotion, ointment, cream, hydrogel, essential oil, and cream.

15. The method for preparing a traditional Chinese medicine preparation according to claim 11 or 12, comprising the following steps: S1, extracting the traditional Chinese medicine composition according to any one of claims 1-10 with water; S2, mixing the extract obtained in step S1 with a drug-loaded matrix or excipient to form the traditional Chinese medicine preparation.

16. The preparation method according to claim 15, wherein, The drug-loaded matrix or excipient includes one or more of glycerol, water, butylene glycol, and disodium EDTA.

17. The use of a traditional Chinese medicine composition according to any one of claims 1-8 or a traditional Chinese medicine preparation according to claim 11 in the preparation of a medicament or skin care product for treating melasma.

18. The use of a traditional Chinese medicine composition according to any one of claims 9-10 or a traditional Chinese medicine preparation according to claim 12 in the preparation of a medicament or skin care product for treating melasma, post-inflammatory hyperpigmentation, and age spots.

Images