Traditional Chinese medicine composition for treating and / or preventing acne

Abstract

The invention discloses a traditional Chinese medicine composition for treating and / or preventing acne. The traditional Chinese medicine composition is prepared from the following traditional Chinese medicinal materials in parts by weight: 5-20 parts of scutellaria baicalensis, 10-50 parts of chrysanthemum, 5-25 parts of white mulberry root-bark, 5-30 parts of cortex lycii radicis, 10-50 parts of dried rehmannia root, 10-40 parts of red paeony root, 5-30 parts of moutan bark, 10-50 parts of salvia miltiorrhiza, 10-50 parts of hawthorn, 10-50 parts of coix seed, 5-25 parts of akebiaquinata, 10-50 parts of oldenlandia diffusa, 5-30 parts of spina gleditsiae and 5-20 parts of immature bitter orange. The traditional Chinese medicine composition has the effects of clearing heat, purging fire, cooling blood and promoting blood circulation to remove blood stasis, and is mainly used for treating or improving various symptoms caused by lung heat and blood heat, including light and moderate acnes represented by comedo, papule, pustules and the like.

Description

Technical Field

[0001] The present application belongs to the technical field of traditional Chinese medicines, and specifically relates to a traditional Chinese medicine composition for treating and / or preventing acne, and a preparation method and use thereof. Background Art

[0002] Acne, also known as blackheads, is a common chronic inflammatory skin disease that mainly occurs on the cheeks, forehead and mandible, and can also extend to the trunk such as the front chest, back and shoulder blades. The overall presentation is characterized by blackheads, papules, pustules, nodules, cysts and scars, accompanied by sebum secretion. The high-risk population is mainly adolescent boys and girls, with an incidence rate of up to 54%. The causes of acne are complex, including abnormal androgen levels in the body, excessive secretion of sebaceous glands, abnormal keratinization of cells around hair follicles, and inflammatory reactions caused by Propionibacterium. Acne belongs to the scope of lung wind blackheads in traditional Chinese medicine, and is mostly caused by excessive yang heat in the body, blood heat in the internal organs, and stagnation of qi and blood. The treatment of this disease in traditional Chinese medicine should be to clear the heat of the lungs and stomach, detoxify, dissipate blood stasis and disperse knots, and flatten blackheads. Appropriate treatment of this disease in traditional Chinese medicine can produce good therapeutic effects. At present, there is a need for traditional Chinese medicine that can effectively treat acne in clinical practice. Summary of the invention

[0003] One or more embodiments of the present application provide a Chinese medicine composition for treating and / or preventing acne, which is prepared from the following Chinese medicinal materials in parts by weight: 5-20 parts (e.g., 10, 15 parts) of Scutellaria baicalensis, 10-50 parts (e.g., 20, 30, 40 parts) of Chrysanthemum, 5-25 parts (e.g., 10, 15, 20 parts) of Morus alba, 5-30 parts (e.g., 10, 15, 20, 25 parts) of Lycium bark, 10-50 parts (e.g., 20, 30, 40 parts) of Rehmannia root, 10-40 parts (e.g., 20, 30, 40 parts) of Paeonia lactiflora, ), 5-30 parts (e.g. 10, 20, 25 parts) of Paeonia suffruticosa, 10-50 parts (e.g. 20, 30, 40 parts) of Salvia miltiorrhiza, 10-50 parts (e.g. 20, 30, 40 parts) of Crataegus pinnatifida, 10-50 parts (e.g. 20, 30, 40 parts) of Coix seeds, 5-25 parts (e.g. 10, 15, 20 parts) of Akebia, 10-50 parts (e.g. 20, 30, 40 parts) of Hedyotis diffusa, 5-30 parts (e.g. 10, 20, 25 parts) of Gleditsia sinensis, and 5-20 parts (e.g. 10, 15 parts) of Citrus aurantium.

[0004] In one or more embodiments, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 5-15 parts of Scutellaria baicalensis, 20-40 parts of Chrysanthemum, 10-20 parts of Morus alba bark, 15-20 parts of Lycium bark, 25-45 parts of Rehmannia root, 20-30 parts of Red Peony Root, 10-20 parts of Paeonia suffruticosa root, 20-40 parts of Salvia miltiorrhiza, 20-40 parts of Crataegus pinnatifida, 20-40 parts of Coix seeds, 5-15 parts of Akebia, 20-40 parts of Hedyotis diffusa, 10-20 parts of Gleditsia sinensis, and 10-15 parts of Citrus aurantium.

[0005] In one or more embodiments, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 10 parts of Scutellaria baicalensis, 35 parts of Chrysanthemum, 12 parts of Morus alba bark, 18 parts of Lycium bark, 40 parts of Rehmannia root, 25 parts of Red Peony Root, 12 parts of Paeonia suffruticosa, 25 parts of Salvia miltiorrhiza, 25 parts of Crataegus pinnatifida, 25 parts of Coix seeds, 10 parts of Akebia, 25 parts of Hedyotis diffusa, 12 parts of Gleditsia sinensis, and 13 parts of Citrus aurantium.

[0006] In one or more embodiments, the Chinese medicine composition of the present application is prepared by the following method:

[0007] Method 1

[0008] (1) Weighing the above-mentioned medicinal materials by weight;

[0009] (2) After washing the scutellaria baicalensis with water, simmer it in boiling water for 10-30 minutes (e.g., 20 minutes), filter out the boiled water, and concentrate it to obtain a scutellaria baicalensis boiled liquid;

[0010] (3) After washing the chrysanthemum, peony bark, and immature bitter orange, the chrysanthemum, peony bark, and immature bitter orange are placed in a distiller and distilled for 30-60 minutes (e.g., 40 minutes) to obtain volatile oil;

[0011] (4) soaking the residues after distillation of Morus alba bark, Lycium bark, Radix Rehmanniae, Radix Paeoniae Rubra, Salvia miltiorrhiza, Crataegus pinnatifida, Semen Coicis, Akebia, Hedyotis diffusa, Gleditsia sinensis, Chrysanthemum, Paeonia suffruticosa, and Immaturus citrus with boiled Scutellaria baicalensis in water for 3-5 hours (e.g., 4 hours), then decocting for 1-3 times (e.g., 2 times), filtering, and obtaining a filtrate;

[0012] (5) allowing the filtrate to stand for 12-24 hours, filtering, mixing with the scutellaria baicalensis solution and concentrating to obtain a concentrated solution;

[0013] (6) mixing the concentrated solution with the volatile oil to obtain the Chinese medicine composition;

[0014] or

[0015] Method 2

[0016] (1) Weighing the above-mentioned medicinal materials by weight;

[0017] (2) After washing the scutellaria baicalensis with water, simmer it in boiling water for 10-30 minutes (e.g., 20 minutes), filter out the boiled water, and concentrate it to obtain a scutellaria baicalensis boiled liquid;

[0018] (3) After washing the chrysanthemum, peony bark, and immature bitter orange, the chrysanthemum, peony bark, and immature bitter orange are placed in a distiller and distilled for 30-60 minutes (e.g., 40 minutes) to obtain volatile oil; ultrasonically encapsulating the volatile oil with β-cyclodextrin, filtering, and obtaining a volatile oil inclusion compound;

[0019] (4) soaking the residues after distillation of Morus alba bark, Lycium bark, Radix Rehmanniae, Radix Paeoniae Rubra, Salvia miltiorrhiza, Crataegus pinnatifida, Semen Coicis, Akebia, Hedyotis diffusa, Gleditsia sinensis, Chrysanthemum, Paeonia suffruticosa, and Fructus Aurantii Immaturus together with boiled Scutellaria baicalensis in water for 3-5 hours (e.g., 4 hours), then decocting 1-3 times, filtering, and obtaining a filtrate;

[0020] (5) allowing the filtrate to stand for 12-24 hours and filtering to obtain a filtrate;

[0021] (6) extracting the filter residue obtained after filtering in step (5) with ethanol, recovering the ethanol, and obtaining an extract;

[0022] (7) mixing the filtrate obtained in step (5) with the scutellaria baicalensis solution, and concentrating the mixture to obtain a thick paste;

[0023] (8) Mixing the extract obtained in step (6) and the thick paste obtained in step (7) with the volatile oil inclusion compound obtained in step (3) to obtain the traditional Chinese medicine composition.

[0024] In one or more embodiments, the traditional Chinese medicine composition is prepared as an oral preparation.

[0025] In one or more embodiments, the oral preparation is a granule, a pill, a tablet, a capsule, or a paste.

[0026] One or more embodiments of the present application provide a method for preparing the Chinese medicine composition of the present application, which comprises:

[0027] Method 1

[0028] (1) Weighing the above-mentioned medicinal materials by weight;

[0029] (2) After washing the scutellaria baicalensis with water, simmer it in boiling water for 10-30 minutes (e.g., 20 minutes), filter out the boiled water, and concentrate it to obtain a scutellaria baicalensis boiled liquid;

[0030] (3) After washing the chrysanthemum, peony bark, and immature bitter orange, the chrysanthemum, peony bark, and immature bitter orange are placed in a distiller and distilled for 30-60 minutes (e.g., 40 minutes) to obtain volatile oil;

[0031] (4) soaking the residues after distillation of Morus alba bark, Lycium bark, Radix Rehmanniae, Radix Paeoniae Rubra, Salvia miltiorrhiza, Crataegus pinnatifida, Semen Coicis, Akebia, Hedyotis diffusa, Gleditsia sinensis, Chrysanthemum, Paeonia suffruticosa, and Immaturus citrus with boiled Scutellaria baicalensis in water for 3-5 hours (e.g., 4 hours), then decocting for 1-3 times (e.g., 2 times), filtering, and obtaining a filtrate;

[0032] (5) allowing the filtrate to stand for 12-24 hours, filtering, mixing with the scutellaria baicalensis solution and concentrating to obtain a concentrated solution;

[0033] (6) mixing the concentrated solution with the volatile oil to obtain the Chinese medicine composition;

[0034] or

[0035] Method 2

[0036] (1) Weighing the medicinal materials in the weight portions described in claims 1 to 3;

[0037] (2) After washing the scutellaria baicalensis with water, simmer it in boiling water for 10-30 minutes (e.g., 20 minutes), filter out the boiled water, and concentrate it to obtain a scutellaria baicalensis boiled liquid;

[0038] (3) After washing the chrysanthemum, peony bark, and immature bitter orange, the chrysanthemum, peony bark, and immature bitter orange are placed in a distiller and distilled for 30-60 minutes (e.g., 40 minutes) to obtain volatile oil; ultrasonically encapsulating the volatile oil with β-cyclodextrin, filtering, and obtaining a volatile oil inclusion compound;

[0039] (4) soaking the residues after distillation of Morus alba bark, Lycium bark, Radix Rehmanniae, Radix Paeoniae Rubra, Salvia miltiorrhiza, Crataegus pinnatifida, Semen Coicis, Akebia, Hedyotis diffusa, Gleditsia sinensis, Chrysanthemum, Paeonia suffruticosa, and Immaturus citrus with boiled Scutellaria baicalensis in water for 3-5 hours (e.g., 4 hours), then decocting for 1-3 times (e.g., 2 times), filtering, and obtaining a filtrate;

[0040] (5) allowing the filtrate to stand for 12-24 hours and filtering to obtain a filtrate;

[0041] (6) extracting the filter residue obtained after filtering in step (5) with ethanol, recovering the ethanol, and obtaining an extract;

[0042] (7) mixing the filtrate obtained in step (5) with the scutellaria baicalensis solution, and concentrating the mixture to obtain a thick paste;

[0043] (8) Mixing the extract obtained in step (6) and the thick paste obtained in step (7) with the volatile oil inclusion compound obtained in step (3) to obtain the traditional Chinese medicine composition.

[0044] One or more embodiments of the present application provide a traditional Chinese medicine preparation, which comprises the traditional Chinese medicine composition of the present application and a pharmaceutically acceptable excipient.

[0045] One or more embodiments of the present application provide use of the Chinese medicine composition or the Chinese medicine preparation of the present application in the preparation of a drug for treating and / or preventing acne.

[0046] In one or more embodiments, the acne is caused by lung heat and / or blood heat.

[0047] One or more embodiments of the present application provide the use of the Chinese medicine composition or the Chinese medicine preparation of the present application in the preparation of a drug for lowering blood lipids.

[0048] One or more embodiments of the present application provide use of the Chinese medicine composition or the Chinese medicine preparation of the present application in preparing a medicine for clearing lung heat and / or clearing blood heat.

[0049] Scutellaria baicalensis is the dried root of Scutellaria baicalensis Georgi, a plant of the Lamiaceae family.

[0050] Chrysanthemum is the dried inflorescence of Chrysanthemum morifolium Ramat., a plant of the Asteraceae family.

[0051] Mulberry bark is the dried root bark of Morus alba L., a plant of the Moraceae family.

[0052] Lycium bark is the dried root bark of Lycium chinense Mil1. or Lycium barbarum L. of the Solanaceae family.

[0053] Raw Rehmannia is the fresh or dried root of Rehmannia glutinosa Libosch., a plant of the Scrophulariaceae family.

[0054] Red peony root is the dried root of Paeonia lactiflora Pall. or Paeonia veitchiiLynch, a plant of the Ranunculaceae family.

[0055] Paeonia suffruticosa Andr. is the dried root bark of Paeonia suffruticosa Andr., a plant of the Ranunculaceae family.

[0056] Salvia miltiorrhiza is the dried root and rhizome of Salvia miltiorrhiza Bge., a plant of the Lamiaceae family.

[0057] Hawthorn is the dried mature fruit of Crataegus pinnatifida Bge.var.majorN.E.Br. or Crataegus pinnatifida Bge. of the Rosaceae family.

[0058] Job's tears are the dried mature kernels of the Poaceae plant Coix lacryma-jobi L.var.ma-yuen (Roman.) Stapf.

[0059] Akebia is the woody stem of Akebia quinate (Houtt.) Decne., a plant of the Akebiaceae family.

[0060] Oldenlandia diffusa is the dried whole herb of Oldenlandia diffusa (Willd.) Roxb., a plant of the genus Hedyotis in the Rubiaceae family.

[0061] Gleditsia sinensis Lam., a plant of the Leguminosae family, is a dried thorn of the soapberry.

[0062] Citrus aurantium is the dried young fruit of the sour orange Citrus aurantium L and its cultivated varieties or the sweet orange Citrussinensis Osbeck of the Rutaceae family.

[0063] The Chinese medicine composition of the present application has the effects of clearing away heat and purging fire, cooling blood, promoting blood circulation and removing blood stasis. It is mainly used to treat or improve various symptoms caused by lung heat and blood heat, including mild and moderate acne manifested as acne, papules, pustules, etc., oral sores, toothache due to stomach fire, sore throat, red eyes, constipation, yellow and red urine, etc.

[0064] The Chinese medicine composition of the present application uses Scutellaria baicalensis and Rehmannia glutinosa as the main drugs, which can clear away heat, dry dampness, cool blood and detoxify, and is aimed at lung heat, blood heat and dampness and heat stasis, which is the basis of the whole prescription treatment method; Morus alba bark, Lycium bark, Red Peony Root, Salvia miltiorrhiza and Paeonia suffruticosa are used as the assistant drugs, among which Morus alba bark and Lycium bark are specifically used to clear lung heat and cool blood, so that the main drugs' heat-clearing and fire-purging effects are concentrated in the lung defense, which is more suitable for the main symptoms; Red Peony Root, Salvia miltiorrhiza and Paeonia suffruticosa have the effects of promoting blood circulation, cooling blood and removing blood stasis, strengthening the main drugs' heat-clearing and fire-purging effects. The medicine has the ability to treat blood heat and blood stasis, and directly improves a series of symptoms caused by blood stasis. It uses chrysanthemum, hawthorn, coix seed, akebia, oldenlandia diffusa, sapodilla thorn, and immature bitter orange as adjuvants. Among them, chrysanthemum helps clear heat, hawthorn helps resolve blood stasis, coix seed and akebia help promote dampness, oldenlandia diffusa helps detoxify, sapodilla thorn and immature bitter orange break up qi and disperse nodules. All of them, under the leadership of the main medicine, either enhance the power of symptom treatment or assist in eliminating the cause of the disease, and together achieve the effects of clearing heat, drying dampness, cooling blood, and detoxifying.

[0065] The Chinese medicine composition of the present application also has a significant lipid-lowering effect.

[0066] The Chinese medicine composition of the present application clears away heat and purges fire, cools blood, promotes blood circulation and removes blood stasis, and can be used for acne (blackheads) caused by lung heat and blood heat, with symptoms such as sores in the mouth and tongue, toothache due to stomach fire, sore throat, red eyes, constipation, yellow and red urine, etc.

[0067] The Chinese medicine composition of the present application can be applied to mild and moderate acne, with specific symptoms of comedones, papules, and pustules. After taking the medicine, the acne gradually disappears and the oil secretion on the face is reduced. DETAILED DESCRIPTION

[0068] Preparation Example

[0069] Weigh the following Chinese medicinal materials in parts by weight: 10 parts of Scutellaria baicalensis, 35 parts of Chrysanthemum, 12 parts of Morus alba, 18 parts of Lycium bark, 40 parts of Rehmannia root, 25 parts of Red Peony Root, 12 parts of Paeonia suffruticosa, 25 parts of Salvia miltiorrhiza, 25 parts of Crataegus pinnatifida, 25 parts of Coix seeds, 10 parts of Akebia, 25 parts of Hedyotis diffusa, 12 parts of Gleditsia sinensis, and 13 parts of Citrus aurantium.

[0070] 1. Oral liquid preparation process

[0071] (1) Extraction and filtration process

[0072] Rinse the radix scutellariae with water quickly, then put it into boiling water and simmer for 10 minutes. Filter and concentrate the boiled water for later use. Boil the radix scutellariae with other medicinal materials.

[0073] After washing chrysanthemum, peony bark and immature bitter orange, put them into a distiller and distill for 30 minutes, and collect the volatile oil for later use;

[0074] Add water to soak the residues after distillation of Morus alba bark, Lycium bark, Radix Rehmanniae, Paeonia lactiflora, Salvia miltiorrhiza, Crataegus pinnatifida, Coix seed, Akebia, Hedyotis diffusa, Gleditsia sinensis, Chrysanthemum, Paeonia suffruticosa, and Immaturus aurantium together with boiled Scutellaria baicalensis for 3-5 hours, and decoct in water for 3 times; filter and set aside the filtrate.

[0075] (2) Concentration process

[0076] The filtrate was allowed to stand for 24 hours, filtered and then mixed with the boiled Scutellaria baicalensis solution, and the filtrate was heated and concentrated to a suitable volume.

[0077] (3) Liquid preparation process

[0078] Mix the concentrated liquid medicine with volatile oil, add flavoring agent, co-solvent and corrosion inhibitor, mix well and set aside.

[0079] (4) Packaging process

[0080] Wash and dry the 10mL glass bottle, then use a filling machine to fill it with the liquid medicine; use a capping machine to roll on the aluminum-plastic cap.

[0081] (5) Packaging

[0082] The sealed liquid medicine is labeled and packaged in boxes of 10.

[0083] 2. Capsule preparation process

[0084] (1) Extraction and filtration process

[0085] Rinse the Scutellaria baicalensis quickly with water, then simmer in boiling water for 10 minutes, filter the boiled water and set aside;

[0086] After washing chrysanthemum, peony bark and immature bitter orange, put them into a distiller and distill for 30 minutes, and collect the volatile oil for later use;

[0087] Add water to soak the residues of Morus alba, Lycium bark, Radix Rehmanniae, Radix Paeoniae Rubra, Salvia miltiorrhiza, Crataegus pinnatifida, Coix seed, Akebia, Hedyotis diffusa, Gleditsia sinensis, Chrysanthemum, Paeonia suffruticosa, and Fructus Aurantii Immaturus for 3-5 hours, and boil them for 3 times; filter after leaving for 24 hours to obtain the filtrate for use;

[0088] The filter residue after the above filtrate is extracted with ethanol, and the ethanol extract is used to recover ethanol to obtain an extract, which is dried and powdered for later use.

[0089] (2) Concentration process

[0090] The filtrate is mixed with the boiled water of Scutellaria baicalensis, and the mixture is heated and concentrated to obtain a thick paste, which is then dried and ground into powder for later use.

[0091] (3) Encapsulation process of volatile oil

[0092] Add an appropriate amount of β-CD cyclodextrin to water, heat it to dissolve it in water, heat it in a water bath, mix the volatile oil and anhydrous ethanol in equal amounts, ultrasonically include it for a certain period of time, let it stand in a refrigerator for 24 hours, filter it, wash it with petroleum ether and then dry it at about 40°C to obtain the inclusion compound for use.

[0093] (4) Granulation and packaging

[0094] The two powders and the volatile oil inclusion compound are first mixed uniformly, and then auxiliary materials are added, low-temperature drying is performed, granulation is performed, and sieving is performed.

[0095] The sieved drug powder is filled into capsules using a capsule filling machine and 12 capsules are sealed with aluminum-plastic blisters.

[0096] (5) Packaging

[0097] Put three plastic-sealed medicated capsules into a box and put them into an outer packaging box for packaging.

[0098] Active Examples

[0099] 1 Antipyretic effect

[0100] Antipyretic effect of carrageenan on fever induced by rats

[0101] 30 SD male rats weighing 180-220g were selected, with body temperature fluctuations not exceeding 0.3℃, and randomly divided into 3 groups, 10 rats in each group, and administered by gavage. One group was given 3ml / rat of normal saline (NS), one group was given 3ml / rat of the test drug (oral solution), and one group was given aspirin (positive drug) at 100mg / kg body weight. After administration, 0.1mL / paw of 1% carrageenan suspension was immediately injected subcutaneously in the plantar of the two paws of the right hind paw of the rats, and the rectal temperature of the rats was measured on time thereafter. The results are shown in the table:

[0102] Effect of antipyretic effect on carrageenan-induced fever in rats ( n=10)

[0103]

[0104] As can be seen from the above table, the antipyretic effect of the test drug group on fever in rats caused by carrageenan after 4 hours was equivalent to that of aspirin. The test drug had the effect of inhibiting fever in rats, indicating that the test drug had an antipyretic effect.

[0105] 2. Lipid-lowering effect

[0106] Effects on blood lipids in experimental hyperlipidemia rats

[0107] Select SD rats weighing 120-150g, half male and half female, and randomly divide them into 3 groups, 10 rats in each group. The first group is the normal control group, which is fed with ordinary feed for 15 consecutive days. From the 16th day, 3ml / rat is given normal saline (NS) every day for 4 consecutive weeks; the second group is the high-fat control group, which is fed with high-fat feed for 15 consecutive days. From the 16th day, 3ml / rat is given normal saline (NS) every day for 4 consecutive weeks; the third group is the test drug group, which is fed with high-fat feed for 15 consecutive days. From the 16th day, 3ml / rat is given the test drug (oral solution) every day for 4 consecutive weeks. At the end of the experiment, after fasting for 12 hours but not water, the carotid artery and venous blood of the rats are taken respectively, the blood is mixed and centrifuged, and the serum is taken to measure the cholesterol and triglyceride of each group respectively.

[0108] The results are shown in the table below:

[0109] Effects on blood lipids in experimental hyperlipidemia rats n=10)

[0110] Group Cholesterol (mg%) Triglyceride (mg%) Normal control group 110.2±28.5 63.1±20.3 High-fat control group 703.6±189.9 253.1±137.2 Test drug group 495.4*28.5 1 77.3*90.6

[0111] As can be seen from the above table, the test drug group had a significant effect on reducing serum cholesterol and triglycerides in rats with experimental hyperlipidemia compared with the high-fat control group. The results showed that the test drug had a lipid-lowering effect.

[0112] 3. Effect on acne

[0113] In clinical practice, the Chinese medicine composition of the present application has been used in the clinical treatment of about 20,000 acne patients for more than 20 years, and its clinical efficacy is good. For most patients, the medicine is taken continuously for 1 month. The median onset time is 2 weeks, and the acne disappears within 1 month.

[0114] 3.1 Some clinical patient cases

[0115] 3.1.1 Case source: 70 outpatients admitted to Zigong Traditional Chinese Medicine Hospital from 2002 to 2003, who were diagnosed with facial acne and TCM lung heat and blood heat syndromes.

[0116] 3.1.2 General data: Among the 70 patients, there were 32 males and 28 females, aged 14 to 31 years, with an average age of 23 years. The shortest course of disease was 1 month, the longest was 10 years, and the average was 2.3 years. Pregnant or lactating women were not included. According to the severity classification, there were 16 cases of grade I, 30 cases of grade II, 17 cases of grade III, and 7 cases of grade IV.

[0117] 3.1.3 Diagnostic criteria

[0118] Western medicine diagnostic criteria are based on the Journal of Clinical Dermatology [1] The diagnostic criteria for acne vulgaris are as follows: (1) Young men and women; (2) Blackheads, papules, pustules, and nodules on the face and front and back of the chest; (3) Symmetrical distribution.

[0119] TCM lung heat and blood heat syndrome standards: refer to the "Guidelines for Clinical Research of New Chinese Medicines" [2] There are papules and herpes on the facial skin, local itching and pain, or pustules and nodules, facial flushing, hot or burning skin, hot nasal breath, dry mouth, constipation, short and dark urine, red tongue, yellow tongue coating, and rapid pulse.

[0120] The severity of the disease is graded according to Pillsbury's disease: Grade I: blackheads, scattered to multiple, scattered inflammatory rashes; Grade II: Grade I + superficial pustular inflammation, the number of rashes increases, and is limited to the face; Grade III: Grade II + deep rashes, occurring on the face, neck, chest, and back; Grade IV: Grade III + cysts, prone to scarring, occurring on the upper body.

[0121] 3.2 Treatment and observation methods

[0122] 3.2.1 Treatment methods

[0123] A total of 5 groups were divided, and each group of patients took the following Chinese medicine formulas (all decocted in water) in the same way.

[0124] Each group of patients took one dose per day, divided into three times in the morning, noon and evening, and one course of treatment was four weeks. The efficacy was determined after one course of treatment. During the treatment period, other oral and topical medications that may affect the treatment of acne were not used. At the same time, patients were advised to avoid or eat less spicy, fatty, greasy and irritating foods, maintain a regular lifestyle, and avoid squeezing the rash.

[0125] Study group (20 cases): water decoction of the Chinese medicine composition of the preparation example;

[0126] Control group 1 (Xiebaisan, 10 cases): 30g of Radix Lycii, 30g of Morus alba (fried), 3g of Radix Glycyrrhizae (roasted);

[0127] Control group 2 (monarch drug group, 10 cases): 5-20g of Scutellaria baicalensis and 10-50g of Rehmannia glutinosa;

[0128] Control group 3 (ministerial drug group, 10 cases): Morus alba bark 5-25g, Lycium bark 5-30g, Paeonia lactiflora 10-40g, Paeonia suffruticosa 5-30g, Salvia miltiorrhiza 10-50g;

[0129] Control group 4 (adjuvant group, 10 cases): 10-50g of chrysanthemum, 10-50g of hawthorn, 10-50g of coix seed, 5-25g of akebia, 10-50g of oldenlandia diffusa, 5-30g of gleditsia thorn, and 5-20g of immature bitter orange.

[0130] 3.2.2 Observation methods and content

[0131] Observe the rash once a week, including changes in rash distribution, color, growth and decline, number of pustules, etc.

[0132] 3.3 Treatment effect

[0133] 3.3.1 The efficacy standard refers to the "Guidelines for Clinical Research of New Chinese Medicines". Cured: all skin lesions disappear, leaving only pigmentation, and no new rashes appear; markedly effective: skin lesions disappear by more than 70%, with less than 5 new rashes; effective: skin lesions disappear by 30% to 69%, with less than 10 new rashes; ineffective: after one course of treatment, the skin lesions disappear by less than 30% or there is no obvious change or even worsening.

[0134] 3.3.2 Treatment outcomes

[0135] Research Group:

[0136] Study group (full prescription, 20 cases): 13 cases (65%) were cured, 4 cases (20%) were markedly effective, 2 cases (10%) were effective, 1 case (5%) was ineffective, and the total effective rate was (95%).

[0137] Control group 1 (Xiebaisan, 20 cases): 8 cases (40%) were cured, 1 case (5%) was markedly effective, 2 cases (10%) were effective, 9 cases (45%) were ineffective, and the total effective rate was (55%);

[0138] Control group 2 (Junyao group, 10 cases): 3 cases (30%) were cured, 2 cases (20%) were markedly effective, 1 case (10%) was effective, 4 cases (40%) were ineffective, and the total effective rate was (60%).

[0139] Control group 3 (mineral drug group, 10 cases): 1 case was cured (10%), 2 cases were markedly effective (20%), 2 cases were effective (20%), 5 cases were ineffective (50%), and the total effective rate was (50%);

[0140] Control group 4 (adjuvant group, 10 cases): 0 cases were cured (0%), 1 case was markedly effective (10%), 1 case was effective (20%), 8 cases were ineffective (80%), and the total effective rate was (20%).

[0141] References

[0142] [1] Zhao Bian. Clinical Dermatology[M]. 3rd edition. Nanjing: Jiangsu Science and Technology Press, 2002: 935-938

[0143] [2] Ministry of Health of the People’s Republic of China. Guiding principles for clinical research of new Chinese medicines (Volume 3) [S]. 1997: 89-90.

Claims

1. A Chinese medicine composition for treating and / or preventing acne, which is prepared from the following Chinese medicinal materials in parts by weight: 5-20 parts of Scutellaria baicalensis, 10-50 parts of Chrysanthemum, 5-25 parts of Morus alba bark, 5-30 parts of Lycium bark, 10-50 parts of Rehmannia root, 10-40 parts of Red Peony Root, 5-30 parts of Paeonia suffruticosa root, 10-50 parts of Salvia miltiorrhiza, 10-50 parts of Crataegus pinnatifida, 10-50 parts of Coix seeds, 5-25 parts of Akebia, 10-50 parts of Hedyotis diffusa, 5-30 parts of Gleditsia sinensis, and 5-20 parts of Citrus aurantium.

2. The Chinese medicine composition as claimed in claim 1, which is prepared from the following Chinese medicinal materials in parts by weight: 5-15 parts of Scutellaria baicalensis, 20-40 parts of Chrysanthemum, 10-20 parts of Morus alba bark, 15-20 parts of Lycium bark, 25-45 parts of Rehmannia root, 20-30 parts of Red Peony Root, 10-20 parts of Paeonia suffruticosa root, 20-40 parts of Salvia miltiorrhiza, 20-40 parts of Crataegus pinnatifida, 20-40 parts of Coix seeds, 5-15 parts of Akebia, 20-40 parts of Hedyotis diffusa, 10-20 parts of Gleditsia sinensis, and 10-15 parts of Citrus aurantium.

3. The Chinese medicine composition as claimed in claim 1, which is prepared from the following Chinese medicinal materials in parts by weight: 10 parts of Scutellaria baicalensis, 35 parts of Chrysanthemum, 12 parts of Morus alba bark, 18 parts of Lycium bark, 40 parts of Rehmannia root, 25 parts of Red Peony Root, 12 parts of Paeonia suffruticosa, 25 parts of Salvia miltiorrhiza, 25 parts of Crataegus pinnatifida, 25 parts of Coix seeds, 10 parts of Akebia, 25 parts of Hedyotis diffusa, 12 parts of Gleditsia sinensis, and 13 parts of Citrus aurantium.

4. The Chinese medicine composition according to any one of claims 1 to 3, which is prepared by the following method: Method 1 (1) Weighing the medicinal materials in the weight portions described in claims 1 to 3; (2) After washing the scutellaria baicalensis with water, simmer it in boiling water for 10-30 minutes, filter out the boiled water, and concentrate it to obtain a scutellaria baicalensis boiled liquid; (3) After washing the chrysanthemum, peony bark, and immature bitter orange, place them in a distiller and distill for 30-60 minutes to obtain volatile oil; (4) soaking the residues after distillation of Morus alba bark, Lycium bark, Radix Rehmanniae, Radix Paeoniae Rubra, Salvia miltiorrhiza, Crataegus pinnatifida, Coix seeds, Akebia, Hedyotis diffusa, Gleditsia sinensis, Chrysanthemum, Paeonia suffruticosa, and Immaturus aurantium with boiled Scutellaria baicalensis for 3-5 hours, then decocting 1-3 times, filtering, and obtaining a filtrate; (5) allowing the filtrate to stand for 12-24 hours, filtering, mixing with the scutellaria baicalensis solution and concentrating to obtain a concentrated solution; (6) mixing the concentrated solution with the volatile oil to obtain the Chinese medicine composition; or Method 2 (1) Weighing the medicinal materials in the weight portions described in claims 1 to 3; (2) After washing the scutellaria baicalensis with water, simmer it in boiling water for 10-30 minutes, filter out the boiled water, and concentrate it to obtain a scutellaria baicalensis boiled liquid; (3) washing chrysanthemum, peony bark and immature bitter orange, placing them in a distiller, and distilling for 30-60 minutes to obtain volatile oil; ultrasonically encapsulating the volatile oil with β-cyclodextrin, filtering, and obtaining a volatile oil inclusion compound; (4) soaking the residues after distillation of Morus alba bark, Lycium bark, Radix Rehmanniae, Radix Paeoniae Rubra, Salvia miltiorrhiza, Crataegus pinnatifida, Coix seeds, Akebia, Hedyotis diffusa, Gleditsia sinensis, Chrysanthemum, Paeonia suffruticosa, and Immaturus aurantium with boiled Scutellaria baicalensis for 3-5 hours, then decocting 1-3 times, filtering, and obtaining a filtrate; (5) allowing the filtrate to stand for 12-24 hours and filtering to obtain a filtrate; (6) extracting the filter residue obtained after filtering in step (5) with ethanol, recovering the ethanol, and obtaining an extract; (7) mixing the filtrate obtained in step (5) with the scutellaria baicalensis solution, and concentrating the mixture to obtain a thick paste; (8) Mixing the extract obtained in step (6) and the thick paste obtained in step (7) with the volatile oil inclusion compound obtained in step (3) to obtain the traditional Chinese medicine composition.

5. The Chinese medicine composition according to claim 1, which is prepared as an oral preparation; preferably, the oral preparation is a granule, a pill, a tablet, a capsule, or a paste.

6. A method for preparing the Chinese medicine composition according to any one of claims 1 to 5, comprising: Method 1 (1) Weighing the medicinal materials in the weight portions described in claims 1 to 3; (2) After washing the scutellaria baicalensis with water, simmer it in boiling water for 10-30 minutes, filter out the boiled water, and concentrate it to obtain a scutellaria baicalensis boiled liquid; (3) After washing the chrysanthemum, peony bark, and immature bitter orange, place them in a distiller and distill for 30-60 minutes to obtain volatile oil; (4) soaking the residues after distillation of Morus alba bark, Lycium bark, Radix Rehmanniae, Radix Paeoniae Rubra, Salvia miltiorrhiza, Crataegus pinnatifida, Coix seeds, Akebia, Hedyotis diffusa, Gleditsia sinensis, Chrysanthemum, Paeonia suffruticosa, and Immaturus aurantium with boiled Scutellaria baicalensis for 3-5 hours, then decocting 1-3 times, filtering, and obtaining a filtrate; (5) allowing the filtrate to stand for 12-24 hours, filtering, mixing with the scutellaria baicalensis solution and concentrating to obtain a concentrated solution; (6) mixing the concentrated solution with the volatile oil to obtain the Chinese medicine composition; or Method 2 (1) Weighing the medicinal materials in the weight portions described in claims 1 to 3; (2) After washing the scutellaria baicalensis with water, simmer it in boiling water for 10-30 minutes, filter out the boiled water, and concentrate it to obtain a scutellaria baicalensis boiled liquid; (3) washing chrysanthemum, peony bark and immature bitter orange, placing them in a distiller, and distilling for 30-60 minutes to obtain volatile oil; ultrasonically encapsulating the volatile oil with β-cyclodextrin, filtering, and obtaining a volatile oil inclusion compound; (4) soaking the residues after distillation of Morus alba bark, Lycium bark, Radix Rehmanniae, Radix Paeoniae Rubra, Salvia miltiorrhiza, Crataegus pinnatifida, Coix seeds, Akebia, Hedyotis diffusa, Gleditsia sinensis, Chrysanthemum, Paeonia suffruticosa, and Immaturus aurantium with boiled Scutellaria baicalensis for 3-5 hours, then decocting 1-3 times, filtering, and obtaining a filtrate; (5) allowing the filtrate to stand for 12-24 hours and filtering to obtain a filtrate; (6) extracting the filter residue obtained after filtering in step (5) with ethanol, recovering the ethanol, and obtaining an extract; (7) mixing the filtrate obtained in step (5) with the scutellaria baicalensis solution, and concentrating the mixture to obtain a thick paste; (8) Mixing the extract obtained in step (6) and the thick paste obtained in step (7) with the volatile oil inclusion compound obtained in step (3) to obtain the traditional Chinese medicine composition.

7. A Chinese medicine preparation comprising the Chinese medicine composition according to any one of claims 1 to 5 and a pharmaceutically acceptable excipient.

8. Use of the Chinese medicine composition according to any one of claims 1 to 5 or the Chinese medicine preparation according to claim 7 in the preparation of a medicament for treating and / or preventing acne; preferably, the acne is caused by lung heat and / or blood heat.

9. Use of the Chinese medicine composition according to any one of claims 1 to 5 or the Chinese medicine preparation according to claim 7 in the preparation of a medicament for lowering blood lipids.

10. Use of the Chinese medicine composition according to any one of claims 1 to 5 or the Chinese medicine preparation according to claim 7 in the preparation of a medicament for clearing lung heat and / or clearing blood heat.

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