A natural plant composition for treating acne and its use

Abstract

The present application relates to a kind of natural plant composition for treating acne and its application, the composition includes extractum scutellariae, extractum clematidis, extractum violae, extractum magnoliae, extractum paeoniae, extractum ophiopogonis, extractum sylvestris and extractum gastrodii.Following the compatibility theory of traditional Chinese medicine, the above-mentioned composition formula has synergistic effect, can effectively inhibit the growth of propionibacterium acnes, reduce the occurrence of skin inflammation and the generation of post-acne erythema and acne mark, promote the regression of acne and skin repair, effectively treat acne.The composition formula is stable in quality, safe and has no skin irritation, provides a new idea for the treatment of acne and skin repair, and has good market application prospect.

Description

TECHNICAL FIELD

[0001] The present application relates to a natural plant composition for treating acne and its application, belonging to the technical field of medicine, disinfectant products or daily chemical products. BACKGROUND

[0002] "Acne", also known as "acne vulgaris", is a chronic inflammatory skin disease involving the pilosebaceous follicle, which often occurs on the face and the front and back of the chest. Clinically, it is mainly manifested as comedones, papules, pustules, cysts or nodules, often accompanied by enlarged pores and sebum overflow.

[0003] It is currently believed that the pathogenesis of acne vulgaris is mainly related to the over-secretion of sebum induced by androgens, abnormal keratinization of the pilosebaceous duct orifice, proliferation of microorganisms such as Propionibacterium acnes, and immune inflammatory response. Androgens are the starting factors for the proliferation of sebaceous glands and the excessive secretion of sebum. Androgens induce excessive keratinization of the pilosebaceous orifice, which narrows the orifice. Excessive sebum and shed keratinocytes accumulate in the pilosebaceous orifice, forming whitehead comedones. Sebum is oxidized and mixed with dirt on the skin surface, forming blackhead comedones. The accumulation of large amounts of sebum provides rich nutrients for microorganisms such as Propionibacterium acnes, Staphylococcus aureus and Malassezia, promoting the proliferation of microorganisms. The enzymes produced by bacteria decompose triglycerides into a large number of free fatty acids, further stimulating the inflammation of the superficial dermal pilosebaceous follicle, forming papules and pustules. The worsening inflammation induces the rupture of the pilosebaceous wall, and lipids, microorganisms and other substances enter the deep dermis, causing inflammation of the pilosebaceous follicle and surrounding tissue, forming deep cysts and nodules. In clinical practice, acne can be divided into three degrees and four levels according to the degree of skin lesions: mild (grade I, only comedones), moderate (grade II and III, inflammatory papules and pustules), and severe (grade IV, nodules and cysts).

[0004] Under the influence of factors such as genetics and elevated androgen levels, keratinocytes in the duct proliferate and keratinize excessively, causing the diameter of the duct orifice to become smaller, narrower or even blocked. This prevents sebum from being excreted normally and causes it to accumulate in the pilosebaceous follicle, forming comedones. Androgens stimulate the proliferation of sebaceous gland cells and the secretion of sebum, and excessive sebum provides a good culture medium for the growth of microorganisms such as Propionibacterium acnes. Propionibacterium acnes will multiply rapidly, while stimulating inflammatory reactions in the pilosebaceous follicle and surrounding tissue. Inflammatory mediators such as interleukins cause the surrounding tissue of the pilosebaceous follicle to become red and swollen, causing pain and forming various inflammatory lesions of acne. Severe inflammatory reactions can further damage the pilosebaceous wall, allowing sebum and inflammatory substances to enter the surrounding tissue and penetrate the dermis, forming nodules, cysts and even scars.

[0005] The treatment of acne in the existing stage is diverse, and needs to be selected according to the severity, type of acne and individual condition of the patient. The main external treatment drugs are: retinoid drugs (such as tretinoin cream, adapalene gel) which can improve the keratinization of the sebaceous duct, dissolve microcomedones and acne, and benzoyl peroxide which has antibacterial and anti-inflammatory effects. If the infection is more serious, antibiotics such as fusidic acid cream and metronidazole gel can be used to inhibit the growth of pathogenic microorganisms.

[0006] In the existing treatment of acne, skin irritation symptoms such as erythema, desquamation, burning sensation often occur in the initial stage of the use of retinoid drugs, and some patients have difficulty tolerating it, resulting in reduced compliance. With the extension of the use time, the skin may develop resistance to external drugs such as benzoyl peroxide and antibiotics, causing the effect of the drugs to gradually decrease. Irritation and drug resistance are important factors affecting the treatment of acne, further leading to poor treatment efficacy of acne. SUMMARY

[0007] The purpose of the present application is to provide a natural plant composition for treating acne and its application. The natural plant composition according to the present application, based on the pathogenesis of acne, inhibits and repairs the comedones, blackheads, redness, papules, acne, pustules, acne marks and skin barrier damage caused by Propionibacterium acnes and inflammation from multiple pathways such as inhibition of Propionibacterium acnes proliferation, regulation of sebum metabolism and inhibition of skin cell inflammation, and is a natural plant composition with good stability, safety and no irritation to the skin, and good anti-acne efficacy.

[0008] The first aspect of the present application provides a natural plant composition for treating acne, comprising at least two or more of Scutellaria baicalensis extract, Cnidium monnieri extract, Viola yedoensis extract, Magnolia officinalis extract, Paeonia lactiflora extract, Ophiopogon japonicus extract, Silybum marianum extract and Gastrodia elata extract.

[0009] Further, in the natural plant composition, the Scutellaria baicalensis extract is not more than 80%, the Cnidium monnieri extract is not more than 50%, the Viola yedoensis extract is not more than 25%, the Magnolia officinalis extract is not more than 35%, the Paeonia lactiflora extract is not more than 80%, the Ophiopogon japonicus extract is not more than 40%, the Silybum marianum extract is not more than 50%, and the Gastrodia elata extract is not more than 50% by weight fraction.

[0010] According to an embodiment of the present application, each extract is a pharmacopoeia part of selected medicinal materials, which is crushed, extracted, separated and purified to preliminarily obtain an extract crude solid powder. The extraction method can be selected from water extraction or solvent extraction, and the separation and purification process can be a membrane separation method acceptable in pharmacy, to finally obtain a solution of each plant extract.

[0011] As a specific example, the preparation method of the Gastrodia extract is as follows: selecting and drying Gastrodia roots, crushing, adding a solvent for extraction, filtering, concentrating, drying, and obtaining a crude extract; adding butanediol and water to the crude extract, dissolving, and then high-speed centrifuging; microfiltrating through a ceramic membrane with a pore size of 100 nm, and then passing through a 1000 Da molecular weight roll-type membrane to intercept the desired target component, to obtain a Gastrodia extract solution.

[0012] The preparation methods of the Scutellaria extract, Cnidium extract, Violae Herba extract, Magnolia extract, Paeonia extract, Ophiopogon extract, and Silybum extract refer to the preparation method of the Scutellaria extract above, according to the pharmacopoeia part of each medicinal material.

[0013] As some embodiments of the present application, the preparation of the natural plant composition includes water agent, gel agent, emulsion agent, cream agent, ointment agent, etc.

[0014] The preparation process of the natural plant composition water agent can include adding one or more humectants, such as glycerol, propylene glycol, etc., and one or more preservatives, such as p-hydroxyacetophenone, phenoxyethanol, etc., to the natural plant composition to prepare. The humectants and preservatives are not limited to this.

[0015] The preparation process of the natural plant composition gel agent can include taking a certain amount of thickening agent, such as carbomer, xanthan gum, etc.; humectant, such as glycerol, propylene glycol, sodium hyaluronate, etc.; preservative, such as p-hydroxyacetophenone, phenoxyethanol, etc.; pH adjuster, such as triethanolamine, sodium hydroxide, etc., and preparing with the natural plant composition. The thickening agent, humectant, preservative, pH adjuster, etc. are not limited to this.

[0016] The preparation process of the natural plant composition emulsion agent and cream agent can include taking two or more of emollients, such as liquid paraffin, vaseline, squalane, cetyl octadecanol, caprylic capric triglyceride, ethyl hexyl glycerol, glyceryl caprylate, etc.; one or more of emulsifiers, such as stearic acid polyoxyl 40 ester, polyglyceryl-10 penta stearate, sodium stearoyl lactate, polysorbate-60, sorbitan isostearate, etc.; humectants, such as glycerol, propylene glycol, sodium hyaluronate, etc.; preservatives, such as p-hydroxyacetophenone, phenoxyethanol, etc., slowly adding the oil phase into the water phase at a certain temperature, emulsifying, homogenizing, cooling, and preparing with the natural plant composition. The emollients, emulsifiers, humectants, preservatives, etc. are not limited to this.

[0017] According to one embodiment of the present application, the natural plant composition can include Scutellaria extract, Cnidium extract, Violae Herba extract, and Magnolia extract, for antipruritic, antibacterial, acne-removing, and anti-inflammatory purposes.

[0018] Baicalin in Huangqi can inhibit the activity of 5α-reductase, reduce the conversion of androgens into dihydrotestosterone, which is the main reason for the excessive secretion of sebaceous glands. Thus it can inhibit the production of dihydrotestosterone and reduce oil secretion from the source (Ju Q, Zhao JB, Xia LQ. Effects of hydrochloric acid and baicalin on mRNA expression of type 1 5α-reductase in SZ95 human sebaceous gland cells [J]. Chinese Journal of Dermatovenereology, 2009, 25(12): 868-870).

[0019] Cnidium fruit contains cnidium fruit, which not only has anti-inflammatory effect, but also can stop itching and reduce the itching caused by acne skin damage (“Natural Coumarin Cnidium Fruit Achieves Anti-itching Effect by Selectively Inhibiting Skin Temperature-sensitive TRPV3 Channel”, Molecular Pharmacology, 2018, 94(4), 1164-1173).

[0020] Viola yedoensis has good inhibitory effect on common pathogenic bacteria (Li JX, Yang FQ, Wang HQ, et al. Inhibitory effect of Viola yedoensis from Ningxia and Qinghai on 8 strains of bacteria [J]. Journal of Ningxia Medical University, 2019, 41(1): 49-52). At the same time, Viola yedoensis can reduce the expression of inflammatory factors IL-1β, IL-6 and TNF-α, and reduce the expression of pro-inflammatory proteases COX-2 and iNOS, and has a significant inhibitory effect on inflammation in eczema skin (“Anti-atopic effect of Viola yedoensis ethanol extract on 2,4-dinitrochlorobenzene-induced atopic dermatitis-like skin dysfunction”, Journal of Ethnopharmacology, 2021; 280(0): 114474-114474).

[0021] Magnolia officinalis contains magnolol and honokiol, which has the effect of inhibiting Propionibacterium acnes, and also has the effect of reducing skin inflammation (Park, Junho, et al. “In vitro antibacterial and anti-inflammatory effects of magnolol and honokiol on propionibacterium acnes”, European Journal of Pharmacology, Volume 496, Issues 1-3 (2004): 189-95).

[0022] From the perspective of antibacterial and bacteriostatic, the combination of Scutellaria extract, Cnidium extract, Herba Violae extract and Magnolia extract is different from single antibacterial or anti-inflammatory ingredients, which reduces the risk of bacterial drug resistance, covers a wider range of flora, relieves inflammatory symptoms from immune response and neural perception, and protects hair follicle epithelial cells and reduces sebum oxidation accumulation. At the same time, the combination of Scutellaria extract, Cnidium extract, Herba Violae extract and Magnolia extract can significantly relieve the itching symptoms of acne. This combination scheme simultaneously targets the four core problems of "bacteria-inflammation-oxidative stress-itching" of acne, improves the comprehensiveness of treatment, and can reduce bacterial drug resistance caused by long-term use of single ingredients. The antipruritic effect of Cnidium can reduce the dependence on external hormones or antibiotics, and reduce the side effects of drugs (such as skin atrophy, dysbiosis, etc.). The combination of natural ingredients is more suitable for sensitive skin or mild acne patients, reduces the irritation of chemical synthetic ingredients, and provides a safe and efficient solution for the acute treatment of acne.

[0023] According to another embodiment of the present application, the natural plant composition can comprise Peony extract, Ophiopogon extract and Gastrodia extract for repairing barrier damage caused by inflammation. Gastrodia, Ophiopogon and Peony contain Gastrodin, Ophiopogon polysaccharide and Ophiopogon saponin, and Paeoniflorin, etc. Among them, Gastrodin, polysaccharide, baliensin, flavonoids and trace elements in Gastrodia have antioxidant effects, and Gastrodin, polysaccharide and flavonoids have antibacterial, anti-inflammatory and whitening effects (Hu Feng, Chen Hao, Huang Bangli, et al. Application potential of Gastrodia in cosmetics [J]. Agricultural Products Processing, 2023, (04): 96-100); the main active ingredient of Peony is Paeoniflorin, which has both anti-allergic effect (Ruan Yonglan et al. Paeoniflorin relieves CFA-induced inflammatory pain by inhibiting TRPV1 and succinate / SUCNR1-HIF-1α / NLPR3 pathways. International Immunopharmacology, Volume 101, (2021): 108364) and anti-inflammatory effect (Paeoniflorin extract relieves antibiotic and DNCB-induced atopic dermatitis symptoms by inhibiting inflammation and changing the composition of mouse intestinal microbiota. Biomedicine & Pharmacotherapy, October 2022; 154: 113574), which can not only reduce the inflammatory response during the onset of acne, but also reduce skin sensitivity and relieve the "pain" and "itch" caused by redness and inflammation, and has a soothing effect on the skin. Ophiopogon extract contains Ophiopogon polysaccharide and Ophiopogon saponin, etc., among which Ophiopogon saponin has a significant anti-inflammatory effect (Ophiopogon saponin reduces brain ischemia-induced blood-brain barrier dysfunction by inhibiting TXNIP / NLRP3 inflammasome activation and MAPK pathway), and Ophiopogon polysaccharide has the effect of repairing eczema skin and can repair the skin barrier damaged by acne inflammation.

[0024] Different from single anti-inflammatory or barrier repair ingredients, the combination of Paeonia extract, Ophiopogon extract and Gastrodia extract simultaneously solves the three core problems of "inflammatory response-barrier damage-allergic itching", targets the pathological mechanism of acne in multiple dimensions, and cooperatively interferes with acne inflammation. Paeonol in Paeonia extract has the effects of reducing inflammation and anti-allergy, while Ophiopogon polysaccharide and Gastrodia polysaccharide have the effects of enhancing skin moisturizing ability and restoring barrier lipid structure. From the skin structure, Paeonia extract repairs the skin barrier, Paeonol reduces secondary inflammation caused by barrier damage, and protects the skin immune barrier. Combined with the immune regulation (Paeonia), antioxidant (Gastrodia) and barrier repair (Ophiopogon) of natural ingredients, it provides a safe and efficient solution for long-term repair and management of acne.

[0025] According to another embodiment of the present application, the natural plant composition can comprise Paeonia extract and Silybum extract for removing acne marks and pigmentation. Paeonia extract can inhibit the TRPV1 pathway, which can reduce the redness, tingling and burning of the skin ("Paeonol alleviates CFA-induced inflammatory pain by inhibiting TRPV1 and succinate / SUCNR1-HIF-1a / NLPR3 pathways"), and Paeonol in Paeonia extract can reduce the red blood vessels caused by vasodilation and capillary permeability ("Paeonia extract alleviates antibiotic and DNCB-induced atopic dermatitis symptoms by inhibiting inflammation and changing the composition of mouse gut microbiota", Biomedicine & Pharmacotherapy, October 2022; 154: 113574). Therefore, Paeonia extract can reduce acne marks and pigmentation caused by acne inflammation / acne inflammation. At the same time, Paeonol has antioxidant activity ("Extraction process and antioxidant activity of paeonol", Journal of Binzhou Medical University, 2020, 43(5): 373-376), which can reduce pigmentation caused by oxidative stress damage of keratinocytes.

[0026] Silybum extract has strong antioxidant activity ("In vitro antioxidant activity of silymarin", Journal of Enzyme and Medicinal Chemistry), which can play an antioxidant role by down-regulating the expression of ROS and MDA ("Antioxidant and neuroprotective effects of silymarin and silymarin: differences in H2O2-induced oxidative stress in PC12 cells", Natural Products Communications, 2016; 11(5)"). Silybum can inhibit the production of melanin ("Silymarin inhibits melanin synthesis in melanocytes", Journal of Pharmacy and Pharmacology, Volume 61, Issue 5 (2009): 663-7), reduce chloasma ("Silymarin cream for the treatment of chloasma", BMC Dermatology, Volume 12, Issue 18 (2012)) and reduce pigmentation ("Silymarin alleviates ultraviolet and air pollution-induced oxidative stress and inflammation in human epidermis and activates beta-endorphin release through cannabinoid receptor type 2").

[0027] In the treatment of acne, the repair process of "red pimple marks", "black pimple marks", and acne scars caused by cell damage is as follows: the safflower extract can reduce vascular leakage by inhibiting TRPV1 / NLRP3, thereby breaking the vicious cycle of "inflammation-vascular dilation-pigment deposition"; the silybum extract can inhibit oxidative stress by eliminating ROS, thereby protecting keratinocytes and avoiding excessive activation of melanocytes. The safflower extract and the silybum extract inhibit pigmentation from the whole path of "synthesis-transport-deposition", the safflower extract targets inflammatory vascular response, and the silybum extract targets melanin metabolism, forming a three-dimensional intervention mode of "anti-inflammatory-antioxidant-melanin inhibition". At the same time, they reduce cell oxidative stress and cell damage, reduce the production of acne scars, and play a role in covering new acne lesions (reducing the risk of pigmentation), repairing old pimple marks (accelerating pigment metabolism), and reducing the production of acne scars in the long-term repair of acne.

[0028] According to a preferred embodiment of the present application, the natural plant composition can comprise a Scutellaria extract, a Cnidium extract, a Viola extract, a Magnolia extract, a Paeonia extract, an Ophiopogon extract, a Silybum extract, and a Gastrodia extract.

[0029] In the above preferred embodiment, further, in the natural plant composition, the Scutellaria extract is not more than 80%, the Cnidium extract is not more than 50%, the Viola extract is not more than 25%, the Magnolia extract is not more than 35%, the Paeonia extract is not more than 80%, the Ophiopogon extract is not more than 40%, the Silybum extract is not more than 50%, and the Gastrodia extract is not more than 50% by weight fraction.

[0030] Further, in the natural plant composition, the Scutellaria extract is 1-80%, the Cnidium extract is 1-50%, the Viola extract is 1-25%, the Magnolia extract is 1-35%, the Paeonia extract is 1-80%, the Ophiopogon extract is 1-40%, the Silybum extract is 1-50%, and the Gastrodia extract is 1-50% by weight fraction.

[0031] Still further, in the natural plant composition, the Scutellaria extract is 5-30%, the Cnidium extract is 5-25%, the Viola extract is 5-25%, the Magnolia extract is 1-15%, the Paeonia extract is 1-15%, the Ophiopogon extract is 1-20%, the Silybum extract is 1-30%, and the Gastrodia extract is 1-25% by weight fraction.

[0032] Further, the natural plant composition comprises, in terms of weight fraction, 10-25% of the Scutellaria extract, 10-20% of the Cnidium extract, 10-20% of the Herba Violae extract, 5-12.5% of the Magnolia extract, 5-12.5% of the Paeonia extract, 5-15% of the Ophiopogon extract, 5-25% of the Silybum extract, and 5-20% of the Gastrodia extract.

[0033] Further, the natural plant composition comprises, in terms of weight fraction, 10-25% of the Scutellaria extract, 10-20% of the Cnidium extract, 10-20% of the Herba Violae extract, 5-12.5% of the Magnolia extract, 5-12.5% of the Paeonia extract, 5-15% of the Ophiopogon extract, 5-25% of the Silybum extract, and 5-20% of the Gastrodia extract.

[0034] Further, the natural plant composition comprises, in terms of weight fraction, 10-25% of the Scutellaria extract, 10-20% of the Cnidium extract, 10-20% of the Herba Violae extract, 5-12.5% of the Magnolia extract, 5-12.5% of the Paeonia extract, 5-15% of the Ophiopogon extract, 5-25% of the Silybum extract, and 5-20% of the Gastrodia extract.

[0035] According to an embodiment of the present application, the natural plant composition can further comprise a pharmaceutically acceptable excipient. The excipient can be selected from any one or a combination of at least two of humectants, thickening agents, preservatives, emulsifiers, and emollients.

[0036] The second aspect of the present application provides a preparation method of the natural plant composition, comprising: weighing the Scutellaria extract, the Cnidium extract, the Herba Violae extract, the Magnolia extract, the Paeonia extract, the Ophiopogon extract, the Silybum extract, and the Gastrodia extract according to the weight fraction, and uniformly mixing two or more to obtain a compatible composition.

[0037] The third aspect of the present application provides an application of the natural plant composition in preparing a product for preventing, improving, or treating acne, especially in preparing a product for improving acne comedones, whiteheads, blackheads, pimples, papules, pustules, acne marks, pigmentation, and oil acne skin, oil sensitive skin, antibacterial, anti-inflammatory soothing skin, removing acne marks, and removing pigmentation.

[0038] The product includes a pharmaceutical product, a disinfectant product, and a daily chemical product.

[0039] A fourth aspect of the present application provides a pharmaceutical preparation for preventing, improving, or treating acne, comprising the natural plant composition. The dosage form of the pharmaceutical preparation can be selected from any one of an aqueous agent, a gel, an emulsion, a cream, and an ointment.

[0040] A fifth aspect of the present application provides a daily chemical product for preventing and improving acne, comprising the natural plant composition.

[0041] Beneficial effects:

[0042] In the natural plant composition of the present application, there is a significant synergistic effect among the Scutellaria baicalensis Georgi extract, the Cnidium monnieri extract, the Viola yedoensis extract, the Magnolia officinalis extract, the Paeonia lactiflora Pall extract, the Ophiopogon japonicus extract, the Silybum marianum extract, and the Gastrodia elata extract, which can synergistically and rapidly inhibit the growth and proliferation of Propionibacterium acnes, reduce inflammation factors induced by Propionibacterium acnes, reduce the level of inflammation factors in keratinocytes, relieve and repair post-acne erythema and acne marks, and promote the regression of acne and self-repair of the skin. Around the pathogenesis of acne, the “antibacterial-immune regulation-inhibition of inflammation-barrier repair-relief of itching-inhibition of vascular dilation-reduction of pigment deposition” and other pathways of acne onset are “coordinated and targeted”, so as to inhibit the proliferation of Propionibacterium acnes, reduce the level of inflammation factor IL-1β produced by keratinocytes induced by Propionibacterium acnes, inhibit the level of barrier damage factor IL-1α in keratinocytes, and treat acne and improve various symptoms of acne such as redness, comedones, blackheads, inflammatory papules, acne marks, and acne scars. Furthermore, the natural plant composition of the present application is prepared from natural plant extracts, and the composition formula is stable in quality and safe without skin irritation, which provides a new idea for the treatment of acne and skin repair, and has a good market application prospect. BRIEF DESCRIPTION OF DRAWINGS

[0043] Figure 1 is a graph showing the inhibition rate of each group on Propionibacterium acnes in Test Example 1.

[0044] Figure 2 is a graph showing the effect of each group on the expression level of inflammation factor IL-1β in keratinocytes induced by Propionibacterium acnes in Test Example 2.

[0045] Figure 3 is a graph showing the effect of each extract composition on the expression level of keratinocyte barrier damage IL-1a induced by stimulating factors (TNF-α / IFN-γ and LPS) in Test Example 3.

[0046] Figure 4is a graph showing the inhibitory effect of the composition in different dosage forms on the symptoms of acne in mice in Test Example 5.

[0047] Figure 5 is a graph showing the scores of the symptoms of acne in mice treated with the composition in different dosage forms in Test Example 5.

[0048] Figure 6 is a graph showing the photographs of the skin of guinea pigs treated with the composition in different dosage forms in Test Example 6 (72h). DETAILED DESCRIPTION

[0049] The technical solutions of the present application are further illustrated below by means of specific embodiments. Those skilled in the art should understand that the following examples are only to help understand the present application and should not be regarded as specific limitations on the present application.

[0050] The process, conditions, reagents, test methods, etc. for implementing the present application, except for the contents mentioned below, are ordinary knowledge and common sense in the art, and the present application is not particularly limited. The test methods in each embodiment, unless otherwise specified, are generally carried out according to the conventional conditions or according to the conditions recommended by the manufacturer.

[0051] Unless otherwise specified, the meanings of all professional terms and scientific terms used in this specification are the same as those generally understood by the skilled person in the technical field to which the present application belongs, but if there is a conflict, the present specification containing the definition shall prevail.

[0052] The amounts used in the preparation examples and embodiments of the present application are weight fractions, and the materials and instruments used in the preparation examples, embodiments and test examples of the present application can be purchased from the market.

[0053] Preparation Example. Preparation of a natural plant extract solution for treating acne

[0054] Preparation of Gastrodia extract (H):

[0055] The Gastrodia medicinal material raw material was crushed and passed through a 20-mesh sieve to remove fine powder and impurities, obtaining a crude medicinal material powder. The crude medicinal material powder was poured into an extraction tank, and 10-12 times the weight of the medicinal material of 50% ethanol solution was added and soaked for 50 min. The soaked medicinal material was heated and extracted for 4-6 h, filtered, and the filtrate was collected. The filtrate was transferred to an evaporation tank and concentrated by rotary evaporation to obtain a dry product, which was crushed and sieved to obtain a crude Gastrodia extract.

[0056] The 2% crude Gastrodia extract was dissolved in 45% butanediol and 53% water, centrifuged at 20000 r / min for 10 min, then microfiltered through a ceramic membrane with a pore size of 100 nm, and then passed through a roll-type membrane with a molecular weight of 1000 Da to remove impurities, obtaining a Gastrodia extract solution.

[0057] The preparation method and process of Scutellaria extract (A), Cnidium extract (B), Hedyseri extract (C), Magnolia extract (D), Paeonia extract (E), Ophiopogon extract (F) and Silybum extract (G) refer to the preparation method of Gastrodia extract (H) above.

[0058] Example 1. Preparation of natural plant composition for treating acne

[0059] According to the extract solution of each single medicinal material obtained in the above preparation example, the following composition is prepared, and the single extract components are mixed in the following proportions:

[0060] Scutellaria extract (60%) and Paeonia extract (40%) are compounded in a ratio of 3:2 to obtain composition 1;

[0061] Scutellaria extract (80%) and Hedyseri extract (20%) are compounded in a ratio of 4:1 to obtain composition 2;

[0062] Scutellaria extract (80%) and Ophiopogon extract (20%) are compounded in a ratio of 4:1 to obtain composition 3;

[0063] Paeonia extract (75%) and Hedyseri extract (25%) are compounded in a ratio of 3:1 to obtain composition 4;

[0064] Paeonia extract (60%) and Ophiopogon extract (40%) are compounded in a ratio of 3:2 to obtain composition 5;

[0065] Scutellaria extract (50%), Paeonia extract (25%) and Hedyseri extract (25%) are compounded in a ratio of 2:1:1 to obtain composition 6;

[0066] Scutellaria extract (40%), Ophiopogon extract (20%) and Paeonia extract (40%) are compounded in a ratio of 2:1:2 to obtain composition 7;

[0067] Scutellaria extract (30%), Cnidium extract (20%), Hedyseri extract (15%) and Magnolia extract (35%) are compounded in a ratio of 3:2:1.5:3.5 to obtain composition 8;

[0068] Scutellaria extract (20%), Cnidium extract (15%), Hedyseri extract (15%), Magnolia extract (12.5%), Paeonia extract (12.5%), Ophiopogon extract (5%), Silybum extract (15%) and Gastrodia extract (5%) are compounded in a ratio of 4:3:3:2.5:2.5:1:3:1 to obtain composition 9.

[0069] Scutellaria extract (10%), Cnidium extract (10%), Hedy s extract (10%), Magnolia extract (5%), Paeonia extract (5%), Ophiopogon extract (15%), Sibirica extract (25%), Gastrodia extract (20%) were compounded in a ratio of 2:2:2:1:1:3:5:4 to obtain composition 10.

[0070] Scutellaria extract (25%), Cnidium extract (20%), Hedy s extract (20%), Magnolia extract (10%), Paeonia extract (10%), Ophiopogon extract (5%), Sibirica extract (5%) and Gastrodia extract (5%) were compounded in a ratio of 5:4:4:2:2:1:1:1 to obtain composition 11.

[0071] Scutellaria extract (5%), Cnidium extract (25%), Hedy s extract (20%), Magnolia extract (5%), Paeonia extract (5%), Ophiopogon extract (5%), Sibirica extract (30%) and Gastrodia extract (5%) were compounded in a ratio of 1:5:4:1:1:1:6:1 to obtain composition 12.

[0072] Scutellaria extract (20%), Cnidium extract (5%), Hedy s extract (5%), Magnolia extract (5%), Paeonia extract (5%), Ophiopogon extract (20%), Sibirica extract (30%) and Gastrodia extract (10%) were compounded in a ratio of 4:1:1:1:1:4:6:2 to obtain composition 13.

[0073] Scutellaria extract (20%), Cnidium extract (5%), Hedy s extract (5%), Magnolia extract (15%), Paeonia extract (15%), Ophiopogon extract (20%), Sibirica extract (10%) and Gastrodia extract (10%) were compounded in a ratio of 4:1:1:3:3:4:2:2 to obtain composition 14.

[0074] Example 2. Preparation of gel, emulsion, cream of natural plant composition for treating acne

[0075] The composition in this example is composed of the following weight fractions of components (i.e., composition 11): Scutellaria extract 25%, Cnidium extract 20%, Hedy s extract 20%, Magnolia extract 10%, Paeonia extract 10%, Ophiopogon extract 5%, Sibirica extract 5% and Gastrodia extract 5%.

[0076] Preparation method:

[0077] (1) Preparation of composition 11 gel:

[0078] Gel preparation: 0.6% carbomer was taken and swelled in water overnight for standby use;

[0079] After 5% glycerin, 0.2% sodium hyaluronate, 0.1% ekduin, 0.5% p-hydroxyacetophenone are stirred uniformly, 10% composition 11 is added, and finally an appropriate amount of triethanolamine is added and stirred uniformly to obtain a transparent composition 11 gel.

[0080] (2) Preparation of composition 11 emulsion:

[0081] Oil phase: 0.5% behenyl alcohol, 1% polyglyceryl-10 pentastearate, 0.5% sodium stearoyl lactylate, 2% caprylic capric triglyceride, 1% ethylhexylglycerin, 1% glyceryl caprylate, 2% ethylhexyl palmitate are added to a beaker, heated and stirred uniformly, and kept at 70-80°C as an oil phase for standby;

[0082] Water phase: 1% polysorbate-60, 0.8% sorbitan isostearate, 0.2% hydroxyethyl acrylate / sodium acryloyldimethyl taurate copolymer, 1% polyglyceryl-10 laurate are added to a beaker, and after stirring and dissolving with purified water, 5% glycerin and 0.5% p-hydroxyacetophenone are added and stirred uniformly, and kept at 70-80°C as a water phase;

[0083] Emulsification and homogenization: the oil phase is slowly added to the water phase, emulsified for 2-5 min, and then homogenized for 3-5 min;

[0084] Cooling: when the temperature decreases to 40-50°C, 0.2% sodium hyaluronate, 0.1% ekduin and 10% composition 11 are added, and stirred uniformly to obtain composition 11 emulsion.

[0085] (3) Preparation of composition 11 cream:

[0086] Oil phase: 5% cetostearyl alcohol, 5% liquid paraffin, 5% vaseline, 5% glycerin monostearate and distearate are added to a beaker, heated and stirred uniformly, and kept at 70-80°C as an oil phase for standby;

[0087] Water phase: 5% stearoxyl 40 is added to a beaker, stirred and dissolved with purified water, then 0.5% p-hydroxyacetophenone and 5% glycerin are added, and kept at 70-80°C as a water phase;

[0088] Emulsification and homogenization: the oil phase is slowly added to the water phase, emulsified for 2-5 min, and then homogenized for 3-5 min;

[0089] Cooling: when the temperature decreases to 40-50°C, 0.2% sodium hyaluronate, 0.1% ekduin and 10% composition 11 are added, and stirred uniformly to obtain composition 11 cream.

[0090] Test Example 1. Test for inhibiting growth of P. acnes in vitro by single extracts and compositions

[0091] Test for inhibiting growth of P. acnes in vitro by single extract components and extract compositions.

[0092] Test method: P. acnes was cultured to logarithmic growth phase, and OD 600 of the bacterial solution was determined by a microplate reader. The concentration of the bacterial solution was adjusted, and 100 μL / 2.5 x 10 5 CFU / mL of the P. acnes suspension was added to each well of a 96-well plate. Each plant extract (the preparation method and concentration of each extract are described below) was prepared as a test group, and a positive control group (BHI medium + 2.5 x 10 5 CFU / mL of P. acnes) and a negative control group (medium) were set. The inoculated 96-well plate was placed in an anaerobic culture bag and incubated in an incubator at 37°C for 48 h. The bacteriostatic rate was calculated according to the OD value measured at OD 600 nm: Bacteriostatic rate (%) = (OD value of the positive control group - OD value of the test group) / (OD value of the positive control group - OD value of the negative control group) x 100%.

[0093] The preparation method and concentration of each extract are as follows:

[0094] 1 g of each single plant extract prepared in the preparation example was weighed, and purified water was added to make up to 10 mL, to obtain a 100 mg / mL test stock solution for use. Before the test, the BHI medium was diluted to obtain a concentration of 2 mg / mL of the Scutellaria extract test solution (A), the Cnidium extract test solution (B), the Herba Violae extract test solution (C), the Magnolia officinalis extract test solution (D), the Paeonia extract test solution (E), the Ophiopogon extract (F), the Silybum extract (G), and the Gastrodia extract (H), and 100 μL / well was added to the test well, and the final concentration of all test solutions was 1 mg / mL.

[0095] 1 g of each composition extract prepared in Example 1 was weighed, and purified water was added to make up to 10 mL, to obtain a 100 mg / mL test stock solution for use. Before the test, the BHI medium was diluted to obtain a concentration of 2 mg / mL of the composition 1 test solution, the composition 2 test solution, the composition 3 test solution, the composition 4 test solution, the composition 5 test solution, the composition 6 test solution, the composition 7 test solution, the composition 8 test solution, the composition 9 test solution, the composition 10 test solution, the composition 11 test solution, the composition 12 test solution, the composition 13 test solution, and the composition 14 test solution, and 100 μL / well was added to the test well, and the final concentration of all test solutions was 1 mg / mL.

[0096] Test results:

[0097] Figure 1 The results of Table 1 show that Scutellaria extract, Cnidium extract, Hedyseri extract, Magnolia extract and Paeonia extract all have certain inhibitory effect on the growth of P. acnes. Ophiopogon extract, Silybum extract and Gastrodia extract have weaker inhibitory effect on the growth of P. acnes.

[0098] After the natural plant compounds are combined, it is found that, compared with single extract, Scutellaria extract + Paeonia extract (composition 1), Scutellaria extract + Hedyseri extract (composition 2), Paeonia extract + Hedyseri extract (composition 4), Scutellaria extract + Paeonia extract + Hedyseri extract (composition 6), Scutellaria extract + Cnidium extract + Hedyseri extract + Magnolia extract (composition 8), and Scutellaria extract + Cnidium extract + Hedyseri extract + Magnolia extract + Paeonia extract + Ophiopogon extract + Silybum extract + Gastrodia extract (compositions 9, 10 and 11) still have significant bacteriostatic effect on P. acnes, while the bacteriostatic effect of compositions 3, 5, 7 and 12, 13, 14 on P. acnes decreases or is basically unchanged. The antibacterial effect of compositions 1, 2, 4, 6, 8, 9, 10 and 11 is significantly improved, and the bacteriostatic rates of these compositions are all >80%, among which the bacteriostatic rates of compositions 6, 9 and 11 are >90%.

[0099] Among them, the effect of inhibiting P. acnes is: composition 11 > composition 9 > composition 6 > composition 2 > composition 4 > composition 10 > composition 8, indicating that in this test, composition 11 has the optimal synergistic effect on inhibiting P. acnes.

[0100] The above results also show that, in the composition of Scutellaria extract + Cnidium extract + Hedyseri extract + Magnolia extract + Paeonia extract + Ophiopogon extract + Silybum extract + Gastrodia extract, by controlling the proportion of each single extract within a proper range, a better synergistic effect can be achieved. If the proportion of each single extract exceeds a certain range, they do not have synergistic effect or the synergistic effect is not strong.

[0101] Table 1 Bacteriostatic rates (average value ± standard deviation) of each test extract and composition on P. acnes

[0102]

[0103] Test Example 2. Test of inhibiting the level of inflammatory factor interleukin 1β (IL-1β) in keratinocytes in vitro by single extract and composition

[0104] An in vitro assay was conducted to investigate the inhibition of interleukin-1β (IL-1β) levels in keratinocytes by single extract components and extract compositions.

[0105] Experimental methods: Human keratinocytes (HaCaT cells) in the logarithmic growth phase were collected, and the cell concentration was adjusted to 2 × 10⁻⁶ cells / cells. 5 Cells were seeded at a density of [number] cells / well in 24-well cell culture plates and cultured for 24 h. After culture, the experimental samples shown in Table 2 below were added to each well to ensure the same final concentration at each dose (sample preparation was the same as in Experiment 1, except that BHI medium was replaced with DMEM medium). After 1 h of pretreatment, except for the blank control group, 4 × 10⁶ inactivated Propionibacterium acnes (C. acnes) were added to each well. 7 CFU / well, with additional plant extracts or extract combinations added to the experimental groups. After culturing for another 23 h, cells were collected and RNA extracted for qPCR detection, using 2 -ΔΔCt The relative mRNA expression level of IL-1β was calculated using this method.

[0106] in:

[0107] The blank control group consisted of DMEM medium + HaCaT cells, without plant extracts and Propionibacterium acnes.

[0108] The model group consisted of DMEM medium, HaCaT cells, and Propionibacterium acnes, without any plant extracts.

[0109] The experimental group consisted of DMEM medium + HaCaT cells + Propionibacterium acnes + various plant extracts;

[0110] Experimental results:

[0111] Depend on Figure 2 The results in Table 2 show that the extracts of Scutellaria baicalensis, Cnidium monnieri, Viola yedoensis, Magnolia officinalis, and Paeonia lactiflora can all inhibit the expression level of interleukin-1β (IL-1β mRNA), an inflammatory factor in keratinocytes induced by Propionibacterium acnes. This indicates that these extracts have the effect of inhibiting the inflammatory response induced by Propionibacterium acnes and have the effect of resisting acne skin inflammation. They can further reduce redness, swelling, inflammatory papules, and skin damage caused by inflammation.

[0112] The natural plant was found to be compounded: compared with single scutellaria extract, peony extract, scutellaria extract + ophiopogon extract compound (composition 3) did not significantly enhance the inhibitory effect on IL-1β mRNA expression (anti-inflammatory). Compared with single peony extract, ophiopogon extract, peony extract + ophiopogon extract (composition 5) did not significantly enhance the inhibitory effect on IL-1β mRNA expression (anti-inflammatory). At the same time, compared with single scutellaria extract, ophiopogon extract, peony extract, scutellaria extract + ophiopogon extract + peony extract (composition 7) did not significantly enhance the inhibitory effect on IL-1β mRNA expression (anti-inflammatory). This shows that composition 3, composition 5 and composition 7 do not show synergistic anti-inflammatory effect.

[0113] In addition, scutellaria extract + cnidium extract + viola extract + magnolia extract + peony extract + ophiopogon extract + milk thistle extract + gastrodia extract (composition 12, 13, 14) has weaker inhibitory effect on IL-1β mRNA expression (anti-inflammatory) than single cnidium extract, viola extract, scutellaria extract, milk thistle extract and magnolia extract, indicating that composition 12, 13 and 14 do not show synergistic anti-inflammatory effect.

[0114] Among them, the down-regulation effect on IL-1β mRNA expression is: composition 11 > composition 9 > composition 4 > composition 6 > composition 2 > composition 8 > composition 1 > composition 10. Scutellaria extract + viola extract (composition 2), peony extract + viola extract (composition 4), scutellaria extract + peony extract + viola extract (composition 6) and scutellaria extract + cnidium extract + viola extract + magnolia extract + peony extract + ophiopogon extract + milk thistle extract + gastrodia extract (composition 9 and 11) have significantly enhanced down-regulation effect on IL-1β mRNA expression, and have certain synergistic effect. Compared with single extract, scutellaria extract + cnidium extract + viola extract + magnolia extract + peony extract + ophiopogon extract + milk thistle extract + gastrodia extract (composition 10) has enhanced effect or basically the same effect.

[0115] For the combination of "Scutellaria extract, Cnidium extract, Herba Violae extract, Magnolia extract, Paeonia extract, Ophiopogon extract, Silybum extract, and Gastrodia extract", the inhibitory effect (anti-inflammatory effect) on IL-1β mRNA expression was "5:4:4:2:2:1:1:1" (Composition 11) > "4:3:3:2.5:2.5:1:3:1" (Composition 9) > "2:2:2:1:1:1:1:1" (Composition 10) > "1:5:4:1:1:1:6:1" (Composition 12) > "4:1:1:1:1:4:6:2" (Composition 13) > "4:1:1:3:3:4:2:2" (Composition 14), wherein the synergistic anti-inflammatory effect of "5:4:4:2:2:1:1:1" (Composition 11) was the strongest.

[0116] The above results show that, in the combination of Scutellaria extract + Cnidium extract + Herba Violae extract + Magnolia extract + Paeonia extract + Ophiopogon extract + Silybum extract + Gastrodia extract, by controlling the ratio of each single extract within an appropriate range, a better synergistic effect can be achieved. If the ratio of each single extract exceeds a certain range, they do not have a synergistic effect or the synergistic effect is not strong. This is similar to the results in Test Example 1.

[0117] Specifically, Composition 11 had the most optimal inhibitory effect on IL-1β mRNA expression, which indicates that, among the compositions, the synergistic effect of Composition 11 with a ratio of Scutellaria extract:Cnidium extract:Herba Violae extract:Magnolia extract:Paeonia extract:Ophiopogon extract:Silybum extract:Gastrodia extract = 5:4:4:2:2:1:1:1 was the strongest. Composition 11 of the present application has the most optimal synergistic effect on the inhibition of IL-1β, an inflammatory factor secreted by Propionibacterium acnes-induced human HaCaT cells, can effectively reduce acne and blackheads on acne skin, and has a stronger therapeutic effect on acne symptoms such as redness, inflammatory papules, and skin damage caused by inflammation.

[0118] Table 2 Effect of each extract and composition on the expression level of IL-1β, an inflammatory factor secreted by Propionibacterium acnes-induced human HaCaT cells (average ± standard deviation)

[0119]

[0120] Test Example 3. Test for inhibiting the level of interleukin 1α (IL-1α), a keratinocyte barrier damage level induced by the diffusion of an inflammatory factor, in vitro by a composition

[0121] In this test example, the test for inhibiting the level of interleukin 1α (IL-1α), a keratinocyte barrier damage level induced by the diffusion of an inflammatory factor, in vitro by different plant extract compositions was compared.

[0122] Acne is a common, complex, multifactorial inflammatory skin disease and is associated with epidermal barrier dysfunction, and the follicular epithelial barrier is directly involved in the changes that occur during the development of comedones and inflammatory stages. The absolute amount of IL-1a protein varies depending on the cell type, but barrier cells such as endothelial cells and epithelial cells express this cytokine in large amounts in a steady state. Cell damage or infection can cause passive leakage of cytosolic IL-1a into the surrounding environment and activate inflammation in an interleukin receptor (IL-1RI)-dependent manner (Zouboulis CC, Eady A, Philpott M, Goldsmith LA, Orfanos C, Cunliffe WC, et al. What is the pathogenesis of acne? Experimental Dermatology. 2005; 14: 143). The more severe the barrier damage, the more IL-1a is released. In this test example, HaCaT cells were induced with tumor necrosis factor alpha (TNF-a) and gamma-interferon (IFN-g) for 18 h, and then infected with LPS, and ELISA detection found that the IL-1a content in the supernatant was significantly increased.

[0123] Test method: HaCaT cells in the logarithmic growth phase were inoculated in a 24-well plate at a density of 3.5 x 10 4 cells / well in 0.5 mL of HaCaT cell suspension. After conventional culture overnight, the culture medium containing each test sample was replaced and pre-treated for 1 h, TNF-a / IFN-g (final concentration 20 ng / mL) was added, and HaCaT cells were induced for 18 h, then bacterial lipopolysaccharide (LPS) (final concentration 10 μg / mL) was added, and the induction culture was continued for 2 h. The cell culture supernatant was collected and operated according to the kit instructions.

[0124] Among them: the preparation and concentration of each test sample are the same as in Test Example 1, and the BHI culture medium is replaced with DMEM culture medium;

[0125] Blank control group: only DMEM culture medium + HaCaT cells, without test sample, stimulating factor TNF-a / IFN-g and LPS;

[0126] Model group (T / I+lps): DMEM culture medium + HaCaT cells + stimulating factor TNF-a / IFN-g and LPS, without test sample;

[0127] Test hole: DMEM culture medium + HaCaT cells + stimulating factor TNF-a / IFN-g and LPS + each test sample;

[0128] From Figure 3The results of Table 3 show that each of the extract composition groups has an inhibitory effect on the expression of the keratinocyte barrier damage factor IL-1a. This indicates that each of the extract compositions has a certain effect of reducing keratinocyte barrier damage induced by stimulatory factors (TNF-a / IFN-g and LPS), and has an effect of repairing keratinocytes.

[0129] Among the various compositions, the Scutellaria extract + Paeonia extract (Composition 2), the Paeonia extract + Ophiopogon extract (Composition 5), the Scutellaria extract + Paeonia extract + Viola yedoensis extract (Composition 6), and the Scutellaria extract + Cnidium extract + Viola yedoensis extract + Magnolia officinalis extract + Paeonia extract + Ophiopogon extract + Silybum extract + Gastrodia extract (Composition 9, 10, and 11) have stronger effects of reducing the barrier damage factor IL-1a than the other composition groups.

[0130] Among the various compositions, the Scutellaria extract + Paeonia extract (Composition 2), the Paeonia extract + Ophiopogon extract (Composition 5), the Scutellaria extract + Paeonia extract + Viola yedoensis extract (Composition 6), and the Scutellaria extract + Cnidium extract + Viola yedoensis extract + Magnolia officinalis extract + Paeonia extract + Ophiopogon extract + Silybum extract + Gastrodia extract (Composition 9, 10, and 11) have stronger effects of reducing the barrier damage factor IL-1a than the other composition groups.

[0131] The above results show that, compared to the other compositions, Composition 9 (Scutellaria extract: Cnidium extract: Viola yedoensis extract: Magnolia officinalis extract: Paeonia extract: Ophiopogon extract: Silybum extract: Gastrodia extract = 4:3:3:2.5:2.5:1:3:1) has the strongest effect of repairing keratinocyte barrier damage.

[0132] Table 3 Effects of various extract compositions on the expression level of the keratinocyte barrier damage IL-1a induced by stimulatory factors (TNF-a / IFN-g and LPS) (average ± standard deviation)

[0133]

[0134] Test Example 4. Transdermal release test of different dosage forms of the composition

[0135] Taking Composition 11 as an example, the transdermal release amount of different formulations of the composition was measured using cnidimide and silybum as the test substances.

[0136] Test method: The back skin of 10-12 weeks old Bama mini-pigs was shaved with a razor, and the subcutaneous fat layer was removed to ensure uniform thickness of the skin, which was then cut into 25 mm diameter skin discs as the release skin. The skin surface was upwardly fixed on the release pool, and 0.3±0.05 g of each formulation of the composition 11 prepared in Example 2 was applied to the skin in each release area, and the edges were gently pressed with a spatula to remove the gaps between the formulation and the skin surface, and the surface was scraped flat with a spatula and weighed. The release medium, normal saline, was added to the receiving pool, and stirred at 32°C at a stirring speed of 600 r / min; samples were taken at 2 h, 4 h, 6 h, 8 h, and 12 h, and the concentration of the detected substance in the medium was measured.

[0137] Table 4 Transdermal release level of different dosage forms of composition 11

[0138]

[0139] Test conclusion: From the results of the transdermal test, it can be seen that the transdermal release rates of the composition 11 gel and the composition 11 emulsion are comparable at the 12 h detection point, and are higher than that of the cream. In addition, the transdermal release rate of the composition 11 gel is significantly higher than that of the emulsion group and the cream group at 2 h, 4 h, and 6 h, and gradually reaches the release plateau at 8 h and 12 h, indicating that the composition 11 gel can quickly release the effective ingredient after being applied to the skin and be quickly absorbed by the skin.

[0140] Test Example 5. Test of inhibitory effect of different dosage forms of composition on acne symptoms in mice

[0141] In this test example, the inhibitory effect of different dosage forms of plant composition on acne symptoms in mice was compared, taking composition 11 as an example.

[0142] Test method: Male BALB / c mice were randomly divided into 6 groups (normal control group, model group, composition 11 cream group, composition 11 gel group, composition 11 emulsion group, and positive control group (tretinoin erythromycin gel)) after being shaved. 50 μL of P. acnes suspension was injected intradermally on the left side of the back of the shaved area, and 50 μL of P. acnes suspension was injected again 24 h later to establish the model. After modeling, 20 μL of sebum was applied to the injection site every day for the test groups and the positive control group, and 0.1 g of drug was applied to the injection site 2 h after the application of sebum.

[0143] The study included: a normal control group (no modeling or drug application); a model group (modeling but no application of Composition 11); experimental groups (Composition 11 cream, Composition 11 gel, Composition 11 emulsion): 0.1g of each of the compositions prepared in Example 2 was applied once daily for 6 consecutive days; and a positive control group (Isotretinoin erythromycin gel): 0.1g of isotretinoin erythromycin gel was applied once daily for 6 consecutive days. Acne symptoms and scores on the backs of mice in each group were observed.

[0144] Depend on Figure 4 , Figure 5 The results in Table 5 show that all treatment groups can effectively alleviate the symptoms and scores of the skin on the back of acne-prone mice. The improvement effect on acne symptoms is as follows: Composition 11 gel > Composition 11 emulsion > Composition 11 cream. Furthermore, the effects of Composition 11 gel and Composition 11 emulsion are better than those of the positive control group isotretinoin erythromycin gel.

[0145] Table 5. Scores of different formulations of Composition 11 on acne symptoms in mice (mean ± standard deviation)

[0146]

[0147] Test Example 6. Test on skin irritation of the composition after a single transdermal administration to guinea pigs.

[0148] In this experimental example, taking composition 11 as an example, a single transdermal skin irritation test was conducted on guinea pigs to observe whether different formulations of the composition caused local skin irritation.

[0149] Experimental Methods: Before administration, the hair on both sides of the back of guinea pigs in each group was removed, with a hair removal area of ​​approximately 5 cm × 5 cm. A 3 cm × 3 cm patch of the preparation was percutaneously applied to the skin of each guinea pig's back at a dose of 0.5 g of the preparation per animal. The application area was covered with cellophane (approximately 4 cm × 4 cm) and gauze, and then sealed with medical tape. Six hours after application, the patch was removed, and any residual preparation on the skin of each animal was washed with 0.9% sodium chloride injection. Skin irritation scores and irritation intensity were evaluated at 24 h, 48 h, and 72 h according to the scoring criteria shown in Table 6 below.

[0150] Among them, the normal control group: guinea pigs that were not treated and only had their hair removed; the composition 11 cream group: guinea pigs were treated with composition 11 cream; the composition 11 gel group: guinea pigs were treated with composition 11 gel; and the composition 11 emulsion group: guinea pigs were treated with composition 11 emulsion.

[0151] Table 6 Scoring criteria for skin erythema and edema

[0152]

[0153] Table 7. Scores (mean ± standard deviation) of guinea pig skin irritation for different formulation types of Composition 11

[0154]

[0155] From Figure 6 The results of Table 7 show that the skin of the administration sites on the back of the guinea pigs did not show erythema and edema, and the scores were all 0, indicating that none of the different formulations of Composition 11 showed irritation.

Claims

1. A natural plant composition for treating acne, characterized in that, The natural plant composition is composed of Scutellaria extract, Cnidium extract, Herba Violae extract, Magnolia officinalis extract, Paeonia extract, Ophiopogon extract, Silybum marianum extract and Gastrodia extract with a weight ratio of 4-5:3-4:3-4:2-2.5:2-2.5:1:1-3:

1.

2. The natural plant composition according to claim 1, characterized in that, The natural plant composition is composed of Scutellaria extract, Cnidium extract, Herba Violae extract, Magnolia officinalis extract, Paeonia extract, Ophiopogon extract, Silybum marianum extract and Gastrodia extract with a weight ratio of 4:3:3:2.5:2.5:1:3:1, or composed of Scutellaria extract, Cnidium extract, Herba Violae extract, Magnolia officinalis extract, Paeonia extract, Ophiopogon extract, Silybum marianum extract and Gastrodia extract with a weight ratio of 5:4:4:2:2:1:1:

1.

3. The natural plant composition according to any one of claims 1-2, characterized in that, Each extract is a pharmacopoeia part of selected medicinal materials, which is finally obtained by crushing, extraction, separation and purification, The extraction method is selected from solvent extraction method, and the separation and purification process is a pharmaceutically acceptable membrane separation method.

4. The natural plant composition according to any one of claims 1-2, characterized in that, The natural plant composition is further composed of Scutellaria extract, Cnidium extract, Herba Violae extract, Magnolia officinalis extract, Paeonia extract, Ophiopogon extract, Silybum marianum extract, Gastrodia extract and a pharmaceutically acceptable excipient, The excipient is selected from any one or a combination of at least two of humectants, thickening agents, preservatives, emulsifiers and emollients.

5. Use of the natural plant composition according to any one of claims 1-4 in the preparation of a pharmaceutical or daily chemical product for preventing, improving or treating acne.

6. A pharmaceutical preparation for preventing, ameliorating or treating acne, characterized by, The pharmaceutical preparation is composed of the natural plant composition according to any one of claims 1-4.

7. The pharmaceutical preparation according to claim 6, characterized in that The dosage form of the pharmaceutical preparation is selected from any one of aqueous agent, gel, emulsion, cream and ointment.

8. A daily cosmetic product for preventing and improving acne, characterized by, The daily chemical product is composed of the natural plant composition according to any one of claims 1-4.

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