A traditional Chinese medicine composition for treating acne and its preparation

Abstract

The present invention belongs to the technical field of traditional Chinese medicines and natural medicines, and discloses a traditional Chinese medicine composition and its preparation. The traditional Chinese medicine composition is mainly composed of Scutellaria baicalensis Georgi, Eriobotrya japonica Thunb., Hedyotis diffusa Willd., Crataegus pinnatifida Bunge, Hovenia acerba Lindl., Angelica dahurica (Fisch. ex Hoffm.) Benth. et Hook. f. ex Franch. et Sav., Lycium chinense Mill., Coix lacryma-jobi L. and Salvia miltiorrhiza Bunge in a certain weight ratio combination. The traditional Chinese medicine composition is obtained by soaking, extracting, concentrating and removing impurities to obtain an extract. On the basis of this extract, appropriate excipients are added, and a spray-dried powder is obtained through spray drying technology, and an appropriate wetting agent is added to make a traditional Chinese medicine granule. The traditional Chinese medicine composition has the effects of clearing heat and detoxifying, cooling blood and dissipating carbuncles, promoting blood circulation and promoting granulation, and is used for treating acne.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine and natural medicine, and particularly relates to a traditional Chinese medicine composition for treating acne and its preparation. Background Art

[0002] Acne is a skin disease of hair sebaceous glands, mainly occurring in the face, chest and back with more fat areas. Clinically, it is mainly manifested as polymorphic skin lesions such as comedones, papules, pustules and nodules, often accompanied by sebum overflow. Through research, it is found that the onset of acne is related to multiple factors. The main causes include disharmony between thoroughfare and conception vessels, disharmony of qi and blood, stagnation of liver qi, heat excess breaking blood, improper diet, accumulation of heat in the stomach and intestines, and physical weakness. The incidence group of acne involves all age groups, and more than 95% of people will have acne to varying degrees. The incidence rate of adolescents in puberty is the highest, reaching 70%-87%. If the disease is not properly treated, it will seriously affect the social life of patients and cause psychological disorders such as inferiority and depression. Therefore, as the eighth largest disease in the world, acne has received important attention from people.

[0003] The Baidi Quzhi compound prescription is an empirical prescription of Professor Xia Han, a famous traditional Chinese medicine dermatologist in Shanghai Yueyang Hospital. It has been clinically applied for more than 20 years, used to treat acne and other skin itching diseases. The annual average dosage reaches more than 10,000 bottles, and the number of treated cases has exceeded more than 10,000. The clinical effective rate is about 90%, creating good economic and extensive social benefits. However, its prescription contains 14 kinds of medicinal materials, with many prescription components and cumbersome ratios.

[0004] Scutellaria baicalensis: Its root is used as medicine, which is bitter in taste and cold in nature, and has the effects of clearing heat and drying dampness, purging fire and detoxifying, stopping bleeding, and preventing miscarriage. It is mainly used to treat warm febrile diseases, upper respiratory tract infections, lung heat cough, damp-heat jaundice, pneumonia, dysentery, hemoptysis, red eyes, threatened abortion, hypertension, carbuncles and furuncles, etc.

[0005] Folium Eriobotryae: The leaves of Eriobotrya japonica, a plant of the Rosaceae family. It is slightly cold in nature and bitter in taste, and has the effects of clearing the lung and relieving cough, and descending adverse qi and stopping vomiting. It is often used to treat lung heat cough, dyspnea and asthma, stomach heat vomiting, restlessness and thirst, etc.

[0006] Oldenlandia diffusa: Its finished medicine is bitter, light and cold in nature. The main effects are clearing heat and detoxifying, dissipating swelling and resolving nodules, and promoting diuresis and removing dampness. It is especially good at treating various types of inflammation. Clinically, it is often used to treat lung heat and cough, sore throat, intestinal abscess, furuncles and sores, snake bites, stranguria with pain, edema, dysentery, enteritis, damp-heat jaundice, and is good at treating various cancers.

[0007] Hawthorn: After being dried, it can be used as medicine. It is a unique tree species in China that can be used both as medicine and fruit. It has the effects of reducing blood lipid, blood pressure, strengthening the heart, and anti-arrhythmia. At the same time, it is also a good medicine for strengthening the spleen and stomach, promoting digestion and resolving stagnation, and activating blood circulation and resolving phlegm. It has good curative effects on symptoms such as chest and diaphragm fullness, hernia, blood stasis, amenorrhea, etc. At the same time, it also has a strong antibacterial effect on Shigella, Proteus, Escherichia coli, Staphylococcus aureus, etc.

[0008] Fructus Hoveniae: It is the mature seed of Hovenia dulcis Thunb. var. glabra Nakai and Hovenia acerba Lindl. var. trichocarpa (Hance) Rehd. of the family Rhamnaceae. It has the effects of relieving alcoholism, quenching thirst and relieving vexation, stopping vomiting, and promoting urination and defecation. It is mainly used to treat drunkenness, vexatious thirst, vomiting, and unfavorable urination and defecation.

[0009] Angelica Dahurica: Pungent, warm. Meridian tropism: entering the lung, spleen, and stomach meridians. Its functions and indications are to expel wind, dry dampness, reduce swelling, and relieve pain. It is used to treat headache, pain in the supraorbital ridge, toothache, nasal sinusitis, cold-damp abdominal pain, intestinal wind and hemorrhoids, leukorrhea with red and white discharge, carbuncles and sores, dry skin itching, scabies and tinea.

[0010] Cortex Lycii: Also known as Cortex Lycii Radicis, it is a plant of the family Solanaceae and the genus Lycium. It has the effects of clearing heat and removing steaming, cooling blood and removing steaming, clearing the lung and reducing fire, etc.

[0011] Coix Seed: It is the dry and mature seed kernel of Coix lacryma-jobi L. of the family Gramineae. It tastes sweet and light, and is cool in nature. It belongs to the spleen, stomach, and lung meridians. It has the effects of promoting diuresis and percolating dampness, strengthening the spleen and stopping diarrhea, removing obstruction in the meridians, discharging pus, and detoxifying and dissipating nodules.

[0012] Salvia Miltiorrhiza: It is the dry root and rhizome of Salvia miltiorrhiza Bunge of the family Labiatae. It tastes bitter and is slightly cold. It belongs to the heart and liver meridians. It promotes blood circulation to remove stasis, dredges the meridians to relieve pain, clears the heart and removes vexation, cools the blood and dissipates carbuncles. It is used for chest pain due to chest impediment, pain in the epigastric region and hypochondrium, mass accumulation, arthralgia due to heat pathogen, restlessness and insomnia, irregular menstruation, dysmenorrhea and amenorrhea, sores and carbuncles with swelling and pain. Summary of the Invention

[0013] In view of the phenomenon of relatively many traditional Chinese medicine flavors in the Whitening and Lipid-Removing Compound Traditional Chinese Medicine, through a large number of tests and screenings and optimizations, the present invention obtains a new traditional Chinese medicine composition with fewer flavors and remarkable efficacy. This composition has the effects of clearing the lung and expelling wind, cooling blood and dissipating nodules, activating blood circulation and reducing swelling, and is used to treat acne.

[0014] Another object of the present invention is to provide a preparation method of the above-mentioned traditional Chinese medicine composition.

[0015] To achieve the above object, the present invention provides the following technical solutions:

[0016] A traditional Chinese medicine composition for treating acne, by weight, comprises: Scutellaria baicalensis Georgi 10 - 30 parts, Folium Eriobotryae 20 - 40 parts, Hedyotis diffusa Willd. 30 - 60 parts, Hawthorn 20 - 40 parts, Fructus Hoveniae 10 - 30 parts, Angelica Dahurica 0 - 20 parts, Cortex Lycii 10 - 30 parts, Coix Seed 30 - 60 parts, Salvia Miltiorrhiza 10 - 30 parts.

[0017] Preferably, the traditional Chinese medicine composition, by weight, comprises: 10-30 parts of Scutellaria baicalensis Georgi, 15-40 parts of Eriobotrya japonica Thunb., 30-35 parts of Hedyotis diffusa Willd., 25-40 parts of Crataegus pinnatifida Bunge, 10-25 parts of Hovenia acerba Lindl., 5-20 parts of Angelica dahurica (Fisch.) Benth. et Hook., 10-25 parts of Cortex Lycii Radicis, 35-40 parts of Coix lacryma-jobi L., and 10 parts of Salvia miltiorrhiza Bunge.

[0018] More preferably, the traditional Chinese medicine composition, by weight, comprises: 15-30 parts of Scutellaria baicalensis Georgi, 15 parts of Eriobotrya japonica Thunb., 30-35 parts of Hedyotis diffusa Willd., 25-40 parts of Crataegus pinnatifida Bunge, 25 parts of Hovenia acerba Lindl., 5-10 parts of Angelica dahurica (Fisch.) Benth. et Hook., 10-25 parts of Cortex Lycii Radicis, 35-40 parts of Coix lacryma-jobi L., and 10 parts of Salvia miltiorrhiza Bunge.

[0019] Even more preferably, the traditional Chinese medicine composition, by weight, comprises: 15 parts of Scutellaria baicalensis Georgi, 15 parts of Eriobotrya japonica Thunb., 35 parts of Hedyotis diffusa Willd., 25 parts of Crataegus pinnatifida Bunge, 25 parts of Hovenia acerba Lindl., 10 parts of Angelica dahurica (Fisch.) Benth. et Hook., 25 parts of Cortex Lycii Radicis, 40 parts of Coix lacryma-jobi L., and 10 parts of Salvia miltiorrhiza Bunge.

[0020] The traditional Chinese medicine composition of the present invention can be prepared by the following method: Weigh the Chinese medicinal materials according to the above parts by weight of the Chinese medicinal materials, add 8-16 times the amount of water for soaking, heat under reflux for extraction for 20-120 min, concentrate the extract under reduced pressure to a density of 1.10 g / ml, remove impurities, filter, and then concentrate the filtrate again into an extract with a density of 1.05 g / ml to obtain the traditional Chinese medicine composition.

[0021] The present invention also provides a granule of the traditional Chinese medicine composition, which can be prepared by the following method: Take the traditional Chinese medicine composition, add dextrin accounting for 20% of the weight of the traditional Chinese medicine composition respectively, stir evenly, perform spray drying to obtain spray-dried powder, add an appropriate amount of an ethanol solution of 8% polyvinylpyrrolidone as a wetting agent to make soft materials, granulate, and dry to obtain the granule.

[0022] Preferably, the parameters of the spray drying are as follows: the inlet air temperature is 170 °C, the liquid feeding speed is 450 ml / h, the outlet air temperature is 100 °C, and the air frequency is 45 Hz.

[0023] The traditional Chinese medicine composition of the present invention can be made into various preparations for treating acne, including but not limited to oral or topical administration preparations such as mixture, granule, pill, capsule, syrup, spray, powder, suspension, tablet, gel, etc.

[0024] Based on the theory of traditional Chinese medicine, starting from using multiple components and multiple targets to improve the drug efficacy, through different combinations of 14 kinds of Chinese medicinal materials in the Baidi Quzhi compound, a new composition with rapid action and significant efficacy is obtained. Compared with the Baidi Quzhi compound, the number of medicinal flavors is reduced and the efficacy is improved. A large number of animal experiments show that the above prescription has better efficacy than the Baidi Quzhi compound.

[0025] In the present invention, Scutellaria baicalensis Georgi, Eriobotrya japonica Thunb, and Salvia miltiorrhiza Bunge are the monarch drugs, which mainly clear the lung and purge heat; Coix lacryma-jobi L., Cortex Lycii, and Hedyotis diffusa Willd clear heat and expel pus, and Hedyotis diffusa Willd detoxifies and eliminates carbuncles, all of which are ministerial drugs; Hovenia dulcis Thunb has the effects of clearing heat, detoxifying, and promoting diuresis, and when combined with Crataegus pinnatifida Bunge, it can inhibit sebum secretion and is the adjuvant drug in the formula. Angelica dahurica (Fisch. ex Hoffm.) Benth. et Hook. f. ex Franch. et Sav. promotes blood circulation and generates flesh and has the function of guiding drug. All the drugs combined together can achieve the effects of clearing heat and detoxifying, cooling blood and eliminating carbuncles, and promoting blood circulation and generating flesh.

[0026] The positive and progressive effects of the present invention are as follows: the raw material medicinal materials are common and easy to obtain, the preparation process is simple, and it has been proved by the mouse ear swelling model induced by dimethylbenzene, the ear keratinization model induced by oleic acid, and the ear acne model induced by Propionibacterium acnes that this new traditional Chinese medicine composition is superior to the existing Baidi Quzhi compound with a clinical basis. Detailed implementation mode

[0027] The present invention will be further described below through examples. The following examples are only typical examples of the present invention, and the protection scope of the present invention is not limited to the content described in the examples.

[0028] Table 1 Proportion of Chinese medicinal materials in Examples 1-5 (parts)

[0029] Medicinal materials Formula 1 Formula 2 Formula 3 Scutellaria baicalensis 10 30 15 Eriobotrya japonica leaf 40 15 15 Oldenlandia diffusa 30 30 35 Hawthorn 40 40 25 Hovenia acerba 10 25 25 Angelica dahurica 20 5 10 Lycium chinense Mill 10 10 25 Coix seed 30 35 40 Salvia miltiorrhiza 10 10 10

[0030] Example 1:

[0031] Preparation of traditional Chinese medicine extract: Weigh each Chinese medicinal material according to the proportion of Chinese medicinal materials in Table 1, add 8 times the amount of water and soak for 2 h, heat under reflux for extraction for 20 min, extract 2 times, combine the filtrates, filter, and concentrate under reduced pressure at 80 °C to an extract with a density of 1.10 g / ml, thus obtaining combined extracts 1, 2, and 3.

[0032] Example 2:

[0033] Preparation of the granule of the pharmaceutical composition: Take any one of the combined extracts in Example 1, add 20% of dextrin based on the amount of the extract, stir evenly and then carry out spray drying to obtain the spray-dried powder, add an appropriate amount of ethanol solution of 8% polyvinylpyrrolidone to make soft materials, granulate, and dry to obtain the granules. The conditions for spray drying are as follows: the inlet air temperature is 170 °C, the liquid inlet speed is 450 ml / h, the air frequency is 45 Hz, and the outlet air temperature is 100 °C.

[0034] Example 3:

[0035] 1. Test substances: The granule of formula 1, the granule of formula 2, and the granule of formula 3 prepared in Example 2, and the positive control drug dexamethasone.

[0036] 2. Experimental animals: ICR mice, male, weighing 18-22 g, SPF grade, provided by Shanghai SIPPR-BK Laboratory Animal Co., Ltd., and the animal production license number: SCXK (Shanghai) 2018-0006.

[0037] 3. Instruments and Equipment: Gavage needle, Shanghai Huake Laboratory Equipment Co., Ltd., specification: 12#; Vernier caliper: Shanghai Meinaite Industrial Co., Ltd.

[0038] 4. Experimental Methods:

[0039] Grouping: After 3 days of adaptive feeding of ICR mice, they were randomly grouped according to body weight into 6 groups, namely the model group, positive group, Baidi Quzhi group, and experimental groups 1 - 3, with 5 mice in each group. The thickness of the right ear of each group of mice was measured using a digital vernier caliper. The midpoint of the right ear was used as the marking point, and the thickness at the marking point was measured 3 times. The average value was recorded as the right ear thickness at 0 h.

[0040] Dosage and Administration Method: The control group and experimental groups were intragastrically administered the corresponding drugs at a fixed time every morning at a dose of 0.2 ml / 10 g, and the model group was intragastrically administered an equal volume of water. The administration was continuous for 4 days.

[0041] Inflammation Induction: 1 hour after the last administration, 20 μl of xylene was aspirated and evenly coated on the front and back sides of the right ear of each group of mice. After coating, the mice were fixed for 30 s to prevent them from rubbing the xylene on the ear.

[0042] Detection: 30 minutes after inflammation induction, the thickness of the midpoint marking of the right ear of each group of mice was measured using a digital vernier caliper. The thickness at the same marking point was measured 3 times, and the average value was recorded as the right ear thickness at 0.5 h. It was compared with the right ear thickness at 0 h, and the swelling rate and swelling inhibition rate were calculated.

[0043] Swelling degree = (right ear thickness at 0.5 h - right ear thickness at 0 h) / right ear thickness at 0.5 h × 100%

[0044] Swelling inhibition rate = (swelling degree of the model group - swelling degree of the administered group) / swelling degree of the model group × 100%

[0045] Data Statistics and Analysis: SPSS 20.0 software was used for data processing, and all data were expressed as presented.

[0046] 5. Experimental Results:

[0047] Table 2 Results of ear swelling degree and ear swelling degree inhibition rate in mice (%, n = 5)

[0048] Group Swelling degree % Swelling degree inhibition rate % Model group 10.54±1.76 - Positive group 4.13±3.01 60.83 Bai Di Qu Zhi group 4.34±1.60 58.77 Experiment group 1 2.86±0.78* 72.84 Experiment group 2 2.71±0.65* 74.26 Experiment group 3 2.17±2.85** 80.49

[0049] Note: Compared with the Baidi Quzhi group, *p ≤ 0.05, **p ≤ 0.01.

[0050] The results showed that the granules of Formulas 1, 2, and 3 could all reduce the ear swelling degree of mice to varying degrees and increase the swelling inhibition rate; there were statistically significant differences between the experimental groups 1 - 3 and the Baidi Quzhi group (p ≤ 0.05 or p ≤ 0.01). Among them, compared with the Baidi Quzhi group, the experimental group 3 had a significant therapeutic effect on the acute ear inflammation of mice (p ≤ 0.01).

[0051] 6. Conclusion: The granules of Formulas 1, 2, and 3 have better therapeutic effects on the acute ear inflammation of mice than the Baidi Quzhi mixture.

[0052] Example 4:

[0053] 1. Test substances: The granule of Formula 1, the granule of Formula 2, and the granule of Formula 3 prepared in Example 2; the positive drug, Tanshinone Capsules.

[0054] 2. Experimental animals: ICR mice, male, weighing 18 - 22 g, SPF grade, provided by Shanghai SIPPR - BK Laboratory Animal Co., Ltd., animal production license number: SCXK (Shanghai) 2018 - 0006.

[0055] 3. Instruments and equipment: Gavage needles, Shanghai Huake Experimental Equipment Co., Ltd., specification: 12#; Vernier calipers: Shanghai Meinaite Industrial Co., Ltd.

[0056] 4. Experimental methods:

[0057] Model establishment and grouping: Every day at a fixed time in the afternoon, 15 μl of oleic acid was evenly applied to the right ear of ICR mice for 3 consecutive days. Liquid paraffin was applied to the left ear as a control. After 3 days, the mice were evenly grouped according to the ear swelling situation, and were divided into a model group, a positive group, a Baidi Quzhi group, and experimental groups 1 - 3. During the drug administration period, oleic acid was continued to be applied for model establishment.

[0058] Drug administration method: On the fourth day of model establishment, the control group and the experimental groups were gavaged with the corresponding drugs at a fixed time every morning and afternoon, 0.2 ml / 10 g, and the model group was gavaged with an equal volume of water.

[0059] Detection:

[0060] Ear thickness: The thickness of the right ear of mice was measured every day starting from the third day of model establishment. The measurement position was the middle part of the right and left ears of the mice, and the same site was measured 3 times and the average value was taken. Record the ear thickness of mice and calculate the swelling degree and the swelling inhibition rate.

[0061] Swelling degree = (ear thickness after drug administration - ear thickness before drug administration) / ear thickness before drug administration × 100%

[0062] Swelling inhibition rate = (swelling degree of the model group - swelling degree of the drug administration group) / swelling degree of the model group × 100%

[0063] Right ear thickness, hardness, and roughness: The thickness, hardness, and roughness of the modeled ear were scored daily.

[0064] Scoring criteria:

[0065] Thickness: Same as the normal group (0 points); slightly thickened (1 point); moderately thickened (2 points); significantly thickened (3 points)

[0066] Hardness: Same as the normal group (0 points); slightly hardened (1 point); moderately hardened (2 points); significantly hardened (3 points)

[0067] Roughness: Same as the normal group (0 points); slightly rough (1 point); moderately rough (2 points); significantly rough (3 points)

[0068] Severity == (thickness score + hardness score + roughness score) / 3

[0069] Data statistics and analysis: SPSS 20.0 software was used for data processing, and all data were expressed as indicated.

[0070] 5. Experimental results:

[0071] Table 3 Results of ear swelling degree in mice (%, n = 5)

[0072] Group 3d 4d 5d 6d 7d Model group 6.75±1.86 9.33±1.79 13.62±3.04 14.80±2.75 14.84±2.63 Positive group 4.96±1.49 6.94±1.93 9.51±1.44 10.18±1.69 10.21±1.53 Bai Di Qu Zhi group 5.02±1.45 7.22±2.33 9.60±2.74 9.86±3.38 9.74±0.96 Experiment group 1 5.16±1.81 7.29±1.97 8.75±2.72 9.01±3.24 8.41±2.57 Experiment group 2 4.88±1.96 7.11±2.25 8.61±2.74 8.67±3.85 7.62±2.22 Experiment group 3 4.95±1.25 7.14±1.81 8.30±3.19 8.11±2.91 7.43±2.08

[0073] Note: Compared with the Baidi Quzhi group, *p ≤ 0.05, **p ≤ 0.01.

[0074] Table 4 Results of ear swelling degree inhibition rate in mice (%, n = 5)

[0075] Group 3d 4d 5d 6d 7d Positive group 26.52 30.1 30.21 31.23 31.24 Bai Di Qu Zhi group 25.66 27.35 29.5 33.35 34.38 Experiment group 1 23.62 26.66 35.74 39.09 43.36 Experiment group 2 27.67 28.71 36.81 41.4 48.65 Experiment group 3 26.71 28.12 39.1 45.17 49.92

[0076] Note: Compared with the Baidi Quzhi group, *p ≤ 0.05, **p ≤ 0.01.

[0077] The results showed that on the 7th day of drug administration, the ear swelling degrees of mice in Experiments 1 - 3 were all lower than those in the Baidi Quzhi group, and the ear swelling degree inhibition rates were higher than those in the Baidi Quzhi group, with no significant differences.

[0078] Table 5 Results of ear severity score in mice (%, n = 5)

[0079] Group 3d 4d 5d 6d 7d Model group 2.60±0.55 3.80±0.84 5.40±1.14 6.20±0.84 6.60±0.55 Positive group 2.40±0.55 3.20±0.45 4.40±0.55 5.40±0.55 5.60±0.89 Bai Di Qu Zhi group 2.40±0.89 3.40±0.55 4.20±0.45 5.20±0.84 5.40±0.89 Experiment group 1 2.00±1.00 3.20±0.84 3.60±0.55* 4.20±0.84* 3.80±1.48* Experiment group 2 2.40±0.55 3.20±0.45 3.40±0.55* 4.00±1.00* 3.60±1.14** Experiment group 3 2.40±0.55 3.40±0.55 3.20±1.10* 3.20±0.45** 3.60±0.55**

[0080] Note: Compared with the Baidi Quzhi group, *p ≤ 0.05, **p ≤ 0.01.

[0081] The results showed that on the 7th day of the experiment, the roughness and swelling of the ears of the mice in experimental groups 1-3 were better, and there were statistically significant differences compared with the Baidi Quzhi group (p≤0.05 or p≤0.01); experimental groups 2 and 3 had significant effects on treating acne in mice compared with the Baidi Quzhi mixture (p≤0.01). 6. Conclusion: The therapeutic effects of formula 1, 2, and 3 granules on ear acne in mice are better than those of the Baidi Quzhi mixture, and the effects of formula 2 and 3 are more significant.

[0082] Example 5

[0083] 1. Test substance: Formula 1 granule prepared in Example 2; positive drug Tanshinone Capsule.

[0084] 2. Experimental animals: ICR mice, male, weighing 30-35 g, SPF grade, provided by Shanghai Xipu-Bikai Animal Experiment Co., Ltd., animal production license number: SCXK (Shanghai) 2018-0006.

[0085] 3. Instruments and equipment: Gavage needle, Shanghai Huake Experimental Equipment Co., Ltd., specification: 12#.

[0086] 4. Experimental method

[0087] Preparation of Propionibacterium acnes suspension: Propionibacterium acnes (General Microbiology Center of China Committee for Culture Collection of Microorganisms), stored at 4°C under anaerobic conditions. Take a certain amount of liquid from a test tube of Propionibacterium acnes liquid culture and place it in a 10 ml EP tube, centrifuge for 5 min (8000 r / min), discard the supernatant (culture solution), measure 3 ml of PBS solution into the EP tube, mix well and wash, centrifuge again for 5 min, repeat the washing 3 times, and then dissolve the colonies at the bottom with a certain amount of PBS solution to obtain the Propionibacterium acnes suspension, 1.22×10 10 .

[0088] Modeling and grouping: Anesthetize the mice by intraperitoneal injection of 4% chloral hydrate at 0.1 ml / 10 g of body weight. When the mice are in the anesthetized state, inject intradermally once at the same site on the inner side of the right ear of each group of mice except the blank control group, 20 μl / mouse. Group the mice according to the ear conditions 2 days later into negative control group, model group, positive group, Baidi Quzhi mixture group, and experimental groups 1-3.

[0089] Drug administration: On the 3rd day after modeling, each group of mice was gavaged with different drugs at 0.2 ml / 10 g, 2 times / d for 5 d.

[0090] Detection:

[0091] Acne score of mice ears: Score the auricle skin of the mice.

[0092] Auricle scoring criteria:

[0093] The auricle skin at the injection site has no skin lesions such as erythema, papules, pustules, etc., scored 0 points;

[0094] The main manifestation of the auricle skin at the injection site is erythema, scored 1 point;

[0095] The auricle skin at the injection site is erythema combined with inflammatory papules, scored 2 points;

[0096] In addition to erythema and inflammatory papules, the auricle skin at the injection site is combined with pustules, scored 3 points;

[0097] The auricle skin at the injection site has a lot of erythema, inflammatory papules and pustules, and is combined with abscesses, scored 4 points.

[0098] According to statistical analysis: analyzed by SPSS 20.0 software, the data are expressed as X±SD.

[0099] 5. Experimental results

[0100] Table 6 Results of ear score of mice

[0101]

[0102] Note: Compared with the Baidi Quzhi group, *p≤0.05, **p≤0.01.

[0103] The results showed that on the 8th day of the experiment, the scores of papules, erythema and abscesses on the ears of mice in experimental groups 1-3 were significantly different from those in the Baidi Quzhi group (p≤0.05 or p≤0.01); experimental groups 2 and 3 had a significant therapeutic effect on acne in mice compared with the Baidi Quzhi mixture (p≤0.01).

[0104] 6. Conclusion: The therapeutic effects of formula 1, 2, and 3 granules on ear acne in mice are better than those of the Baidi Quzhi mixture, and the effects of formula 2 and 3 are more significant.

Claims

1. A traditional Chinese medicine composition for treating acne, characterized in that, by weight, it is made from the following raw materials: 10 - 30 parts of Scutellaria baicalensis, 15 - 40 parts of Eriobotrya japonica, 30 - 35 parts of Hedyotis diffusa, 25 - 40 parts of Crataegus pinnatifida, 10 - 25 parts of Hovenia dulcis, 5 - 20 parts of Angelica dahurica, 10 - 25 parts of Cortex lycii radicis, 35 - 40 parts of Coix lacryma-jobi, and 10 parts of Salvia miltiorrhiza.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, by weight, it is made from the following raw materials: 15 - 30 parts of Scutellaria baicalensis, 15 parts of Eriobotrya japonica, 30 - 35 parts of Hedyotis diffusa, 25 - 40 parts of Crataegus pinnatifida, 25 parts of Hovenia dulcis, 5 - 10 parts of Angelica dahurica, 10 - 25 parts of Cortex lycii radicis, 35 - 40 parts of Coix lacryma-jobi, and 10 parts of Salvia miltiorrhiza.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, by weight, it is made from the following raw materials: 15 parts of Scutellaria baicalensis, 15 parts of Eriobotrya japonica, 35 parts of Hedyotis diffusa, 25 parts of Crataegus pinnatifida, 25 parts of Hovenia dulcis, 10 parts of Angelica dahurica, 25 parts of Cortex lycii radicis, 40 parts of Coix lacryma-jobi, and 10 parts of Salvia miltiorrhiza.

4. The traditional Chinese medicine composition according to any one of claims 1 - 3, characterized in that, it is prepared by the following method: Weigh the Chinese medicinal materials according to the quality parts, add 8 - 16 times the amount of water for soaking, heat under reflux for extraction for 20 - 120 min, concentrate the extract under reduced pressure to a density of 1.10 g / ml, remove impurities, filter, and then concentrate the filtrate into an extract with a density of 1.05 g / ml to obtain the said traditional Chinese medicine composition.

5. A granule prepared from the traditional Chinese medicine composition according to any one of claims 1 - 3, characterized in that, it is prepared by the following method: Take the traditional Chinese medicine composition described in claim 4, add dextrin accounting for 20% of the weight of the traditional Chinese medicine composition respectively, stir evenly, then carry out spray drying to obtain spray-dried powder, add an appropriate amount of ethanol solution of 8% polyvinylpyrrolidone as a wetting agent to make soft materials, granulate, and dry to obtain the granule.

6. The granule prepared from the traditional Chinese medicine composition according to claim 5, characterized in that, the parameters of the said spray drying are as follows: the inlet air temperature is 170 °C, the liquid feeding speed is 450 ml / h, the outlet air temperature is 100 °C, and the air frequency is 45 Hz.

7. Application of the traditional Chinese medicine composition according to any one of claims 1 - 3 or its preparation in the preparation of a drug for treating acne.

8. The application according to claim 7, characterized in that, the said preparation is selected from mixture, granule, pill, capsule, syrup, spray, powder, suspending agent, tablet or gel.

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