Traditional Chinese medicine composition for treating acne and preparation method thereof

Abstract

The invention provides a traditional Chinese medicine composition for treating acne and a preparation method thereof. The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 290-310 parts of radix bupleuri, 90-110 parts of scutellaria baicalensis, 90-110 parts of pinellia ternate, 20-40 parts of rheum officinale, 90-110 parts of fossil fragments, 90-110 parts of oysters, 20-40 parts of cinnamon, 70-90 parts of codonopsis pilosula, 90-110 parts of poria cocos, 50-70 parts of dried ginger, 70-90 parts of bighead atractylodes rhizome and 50-70 parts of Chinese dates. The whole formula has reasonable compatibility of monarch, minister, assistant and guide, and has the effects of soothing liver, benefiting gallbladder, resolving Shaoyang, reducing phlegm, resolving masses, relaxing bowels and removing heat. The traditional Chinese medicine composition is clinically used for acne caused by liver depression transforming into fire, dampness-heat of spleen and stomach and the like, is especially suitable for acute stage and subacute stage of acne, and is safe and effective for relieving symptoms such as red and swollen, pustules, nodules and the like.

Description

TECHNICAL FIELD

[0001] The application provides a traditional Chinese medicine composition for treating acne and a preparation method thereof, and belongs to the field of traditional Chinese medicine. BACKGROUND

[0002] Acne is a common chronic inflammatory skin disease, mainly involving the sites of hair follicles and sebaceous glands, and is clinically manifested as various skin lesions such as comedones, papules, pustules, nodules and cysts, and is mainly found in adolescents and adults. According to statistics, about 85% of adolescents in the world are troubled by acne, and about 20%-30% of patients have symptoms persisting into adulthood, which seriously affects the psychological health and quality of life of patients. Its occurrence is related to many factors such as increased androgen secretion, hyperplasia and hypersecretion of sebaceous glands, obstruction of hair follicle sebaceous duct, bacterial infection, etc. Modern medical research has further shown that psychological factors and eating habits are closely related to the occurrence and development of acne. Clinical observation has found that the state of depression and anxiety is widespread in the adolescent group, which is characterized by typical emotional instability: sometimes nervous and timid, sometimes anxious and irritable. The young adult group is generally in a chronic psychological stress state due to job competition and life pressure. At the same time, the excessive intake of high-sugar, high-fat and dairy products in the modern diet structure has been confirmed to exacerbate the disorder of sebaceous gland secretion function through various pathways, thereby inducing or aggravating the condition of acne. This phenomenon has been fully verified in clinical diagnosis and treatment.

[0003] Modern acne treatment mainly adopts a comprehensive treatment plan, including local external administration treatment (such as antibiotic ointment, retinoid cream), oral administration treatment (such as oral isotretinoin, antibiotics) and physical treatment (such as photodynamic therapy, chemical resurfacing, laser therapy, etc.) and other means. However, due to the chronic and recurrent clinical characteristics of acne, the treatment cycle is usually long, making it difficult for some patients to adhere to standard medication. More notably, the existing treatment plan mainly targets the pathological link of acne and fails to effectively address internal factors such as psychological stress and improper diet, resulting in a high clinical recurrence rate and less-than-ideal cure results. According to statistics, most patients will have different degrees of sequelae after acne subsides, including post-acne erythema, pigmentation and scarring, etc. These skin lesions can last for months or even years, affecting the appearance and psychological health of patients.

[0004] Traditional Chinese medicine (TCM) believes that acne is closely related to various factors, including heat in the lung meridian, damp-heat in the spleen and stomach, emotional imbalance, and improper diet. Its pathogenesis can be traced back to the *Suwen* (Plain Questions) chapter "On the Vital Energy Connecting Heaven," which states, "Exhaustion and sweating followed by wind, or exposure to cold and dampness, leads to chapping; stagnation then causes acne," and the *Wai Ke Qi Xuan* (Surgical Enlightenment), which states, "When the lungs are affected by wind-heat or the face is exposed to wind, acne develops, caused by damp-heat evil qi." If long-term emotional distress leads to liver stagnation and fire, as stated in *Danxi Xinfa* (Danxi's Heart Method), "When qi and blood are in harmony, a hundred diseases do not arise; once there is stagnation, all diseases arise." If liver fire ascends along the meridians, red and swollen acne will appear on the face. Improper diet can cause internal damp-heat in the spleen and stomach. However, the *Suwen* states that excessive consumption of rich and fatty foods causes damp-heat to accumulate in the skin, resulting in pustules. Furthermore, *Yizong Jinjian Wai Ke Xinfa* (Golden Mirror of Medicine: Surgical Heart Method) points out that "this disease is mostly caused by blood heat in the lung meridian," and if lung heat is also present, papules with a red color will appear. The "Orthodox Manual of Surgery" emphasizes that boils are a "rapid-on disease," and that untreated acne can lead to deep-seated toxins.

[0005] This study systematically reviewed patent literature with similar efficacy to the formulation in this application. CN110893229A describes a traditional Chinese medicine composition for treating cold-type facial acne, comprising the following raw materials in parts by weight: 30-40 parts prepared aconite root, 5-15 parts cinnamon bark, 15-30 parts codonopsis root, 25-35 parts stir-fried atractylodes macrocephala, 25-35 parts dried ginger, 15-25 parts prepared licorice root, 5-15 parts amomum villosum, 25-35 parts pinellia tuber, 10-20 parts angelica sinensis, 25-35 parts red peony root, 15-25 parts magnolia bark, 10-20 parts tangerine peel, and 5-15 parts evodia fruit. This traditional Chinese medicine composition shows a significantly higher efficacy rate in treating cold-type facial acne than other methods, with a low recurrence rate, and is safe, reliable, and without toxic side effects. CN105213852A describes a traditional Chinese medicine preparation for treating facial acne, formulated from the following medicinal materials in parts by weight: 25-35 parts buffalo horn, 20-30 parts rehmannia root, 20-30 parts red peony root, 20-30 parts peony bark, 20-30 parts dictamnus root bark, 20-30 parts glehnia root, 10-20 parts loquat leaf, 10-20 parts chrysanthemum, 10-20 parts angelica root, 15-25 parts sophora root, 12-25 parts imperata root, and 10-20 parts bamboo shavings. This medicinal composition possesses the effects of clearing heat and detoxifying, promoting blood circulation and removing blood stasis, reducing swelling and dissipating nodules, and removing blemishes and beautifying the skin.

[0006] There are many products for treating acne, but there are the following problems: ①, the treatment effect is limited: acne treatment drugs are mainly topical, such as ointments containing benzoic acid, benzoyl peroxide and other ingredients, although the above drugs can inhibit the growth of propionibacterium acnes and reduce inflammation. But for the root problem of acne - internal dampness, blood stasis, weak spleen and stomach, etc. The conditioning effect is limited, it is difficult to fundamentally improve the skin condition of patients, and it is easy to cause acne to recur. ②, obvious side effects: due to the use of some oral antibiotics, although it has certain anti-inflammatory and bactericidal effect, but long-term use can easily lead to drug resistance, causing intestinal flora imbalance, gastrointestinal discomfort and other side effects. ③, long treatment cycle: some traditional Chinese medicine prescriptions have the potential to regulate the body and treat acne, but due to the complex composition of traditional Chinese medicine compound, improper compatibility or single dosage form, it is difficult to achieve root treatment, the treatment cycle is long, and the patient's compliance is poor. In view of the particularity and frequent occurrence of acne caused by emotional depression and weak spleen and stomach in clinical treatment, it is particularly important to develop traditional Chinese medicine preparations with the effects of soothing liver and resolving depression, invigorating spleen and stomach. SUMMARY

[0007] The present application provides a traditional Chinese medicine composition for treating acne and a preparation method thereof. The traditional Chinese medicine composition has the characteristics of scientific and reasonable prescription compatibility, significant clinical efficacy and small side effects. The combination of all drugs in the prescription can clear heat and resolve toxicity, cool blood and remove stasis, reduce swelling and nodules, and invigorate the spleen and warm the middle. It can also effectively improve the symptoms of acne, reduce inflammation, and promote skin repair. In the prescription, Chaihu is combined with Huangqin to soothe the liver and clear heat, thereby resolving emotional depression and fire. Banxia is combined with Fuling and Baishu to invigorate the spleen and eliminate dampness, thereby eliminating food stagnation. Longgu and Muli can calm the nerves and stabilize the mind, thereby regulating the disorder of yin and yang. Dahuang can purge heat, and Dangshen can tonify qi and support the healthy. The prescription has both supplementation and drainage, and ascending and descending, and has the functions of supporting the healthy and eliminating evil. Compared with the traditional heat-clearing and blood-cooling method, this prescription combines soothing the liver and invigorating the spleen in one prescription, resolves emotional depression and eliminates stagnation in the middle, and treats both the symptoms and the root cause. The whole prescription can soothe the liver and resolve depression, calm the nerves and stabilize the mind, and invigorate the spleen and eliminate dampness. It can regulate emotional depression, eliminate spleen and stomach stagnation, and treat both the symptoms and the root cause. It is especially suitable for stubborn acne with insomnia, anxiety, and gastrointestinal disorders, has definite curative effect, and has small side effects. In addition, the traditional Chinese medicine decoction is bitter and inconvenient to carry when going out, while the traditional Chinese medicine granules have the advantages of small amount, good taste, and convenient carrying and taking.

[0008] The preparation method of the present application is scientific and reasonable, which can extract the effective components of traditional Chinese medicine completely and prepare oral granules with good clinical compliance. It is clinically used for treating acne caused by dampness-heat and blood-heat, and is especially suitable for patients in the inflammation and recovery stages of acne.

[0009] The technical solution of the present application is as follows:

[0010] A traditional Chinese medicine composition for treating acne, which is prepared from the following raw medicinal materials in the weight ratio: Radix Bupleuri 290-310 parts, Radix Scutellariae 90-110 parts, Rhizoma Pinelliae 90-110 parts, Radix et Rhizoma Rhei 20-40 parts, Cornu 90-110 parts, Ostreae 90-110 parts, Cinnamomi Cassiae 20-40 parts, Radix Codonopsis 70-90 parts, Poria 90-110 parts, Rhizoma Zingiberis Recens 50-70 parts, Rhizoma Atractylodis Macrocephalae 70-90 parts, Fructus Jujubae 50-70 parts.

[0011] Preferably, the Radix Bupleuri is 300 parts, the Radix Scutellariae is 100 parts, the Rhizoma Pinelliae is 100 parts, the Radix et Rhizoma Rhei is 30 parts, the Cornu is 100 parts, the Ostreae is 100 parts, the Cinnamomi Cassiae is 30 parts, the Radix Codonopsis is 80 parts, the Poria is 100 parts, the Rhizoma Zingiberis Recens is 60 parts, the Rhizoma Atractylodis Macrocephalae is 80 parts, and the Fructus Jujubae is 60 parts.

[0012] Preferably, the traditional Chinese medicine composition is prepared from the following raw medicinal materials in the weight ratio: Radix Bupleuri 300 parts, Radix Scutellariae 100 parts, Rhizoma Pinelliae 110 parts, Radix et Rhizoma Rhei 40 parts, Cornu 100 parts, Ostreae 100 parts, Cinnamomi Cassiae 30 parts, Radix Codonopsis 100 parts, Poria 110 parts, Rhizoma Zingiberis Recens 60 parts, Rhizoma Atractylodis Macrocephalae 100 parts, and Fructus Jujubae 60 parts.

[0013] The preparation method comprises the following steps:

[0014] Step 1: weigh the Radix Bupleuri, Radix Scutellariae, Rhizoma Pinelliae, Radix et Rhizoma Rhei, Cornu, Ostreae, Cinnamomi Cassiae, Radix Codonopsis, Poria, Rhizoma Zingiberis Recens, Rhizoma Atractylodis Macrocephalae, and Fructus Jujubae in the above weight ratio, add water in an amount of 8-12 times the weight of the medicinal materials, reflux extract 1-3 times, each time for 0.5-2 hours, filter, combine the filtrates, and concentrate the filtrate under reduced pressure or spray dry the filtrate, then dry the powder;

[0015] Step 2: add the dried powder from Step 1, crush, and add appropriate medicinal adjuvants to prepare a traditional Chinese medicine oral dosage form.

[0016] Preferably, in Step 1 of the preparation method, water in an amount of 10 times the weight of the medicinal materials is added, and the reflux extraction is performed twice, each time for 1 hour.

[0017] Preferably, in Step 1 of the preparation method, the reduced pressure concentration is performed at a pressure of 0.06-0.08 MPa and a temperature of 63-67℃.

[0018] Further preferably, in Step 1 of the preparation method, the reduced pressure concentration is performed at a pressure of 0.07 MPa and a temperature of 65℃.

[0019] Preferably, in Step 1 of the preparation method, the spray drying conditions are as follows: the inlet air temperature is 88-92℃, the outlet air temperature is 52-58℃, the material temperature is 68-72℃, the atomization pressure is 0.23-0.27 MPa, and the spray speed is 5-9 mL / s.

[0020] Preferably, the pharmaceutical excipient used in step 2 of the preparation method is lactose, which is moistened with 80% ethanol, made into soft material, dried, and sieved to obtain granules.

[0021] Preferably, the oral dosage form in step 2 of the preparation method is granules, oral liquid, capsules, dripping pills, or tablets.

[0022] The application of the traditional Chinese medicine composition in the preparation of a medicine for treating acne.

[0023] The traditional Chinese medicine prescription of the application for treating acne is based on the traditional prescription of Chaihu Jia Longgu Muli Decoction, and is optimized repeatedly according to the feedback of clinical patients and the clinical diagnosis and treatment experience of the core inventor for more than 20 years. The traditional Chinese medicine prescription can resolve Shaoyang, invigorate the spleen and warm the middle, clear heat and resolve phlegm, and calm the nerves and disperse the knots. The whole prescription takes soothing the liver and benefiting the gallbladder and regulating cold and heat as the core, takes into account the deficiency of cold in the middle and the heat in the upper, is suitable for Shaoyang dysfunction, spleen and stomach dampness, qi stagnation and blood stasis, phlegm and stasis, and heat in the lung channel type acne (such as repeated pustules, accompanied by bitter mouth, irritability, loose stool, cold limbs and other cold and heat mixed syndromes).

[0024] The etiology and pathogenesis of acne treated by the traditional Chinese medicine external preparation of the application are as follows:

[0025] It is found through clinical observation that most acne patients will have symptoms such as dry mouth, bitter taste; red tongue, thick and greasy fur; irritability, insomnia, body discomfort, irritability, constipation, pulse stringy and forceful, chest and hypochondrium distention, oliguria, leg heaviness, which are often related to emotional disorders and improper diet. There are many depressed young people, and most of them have palpitation and timidity. They are nervous when answering questions from doctors and patients, but they scold their parents immediately. Middle-aged people are under great pressure in life and work. All of these are manifestations of liver and gallbladder qi stagnation, and combined with yangming and fu heat, which causes the fire of upper drinking to be unable to descend, resulting in acne on the face.

[0026] In addition, young children often have cold after cold and are treated with acupuncture and medicine. Although the surface symptoms are temporarily relieved, phlegm and fluid remain in the whole body, especially in the chest and hypochondrium. The symptoms include: eating cold drinks, white and greasy fur on the tongue, pulse stringy and slippery, yellow and red urine, and dry and hard stool. Middle-aged people may have difficulty in planning, liver stagnation and qi stagnation, and improper conditioning after cold, resulting in phlegm and fluid remaining in the chest and hypochondrium, and heat rising to the face and causing acne. In addition, modern people like to eat thick and greasy food, meat, eggs, milk and sugar, which helps to increase dampness and heat, and further increases the disease. Therefore, based on Chaihu Jia Longgu Muli Decoction, one dose of Baishu is added to invigorate the spleen, dry dampness, and harmonize the stomach and qi, so that the effect of the whole prescription is more prominent, and the treatment is more extensive.

[0027] The types of acne treated by the prescription of the application are mainly spleen and stomach dampness, combined with qi stagnation and blood stasis, phlegm and stasis, and heat in the lung channel.

[0028] The prescription of the traditional Chinese medicine composition of the application and the inventive concept are as follows:

[0029] Acne is caused by stagnation of liver qi, stagnation of qi transforming into fire, and fire toxin spreading to the skin. Therefore, the main treatment of this prescription is to soothe the liver and relieve depression, clear heat and drain fire. This prescription uses a large amount of North Chaihu, which is the main drug of the Shao Yang channel. It has the effects of bitter and cold, and can resolve Shao Yang, clear heat and resolve the inside and outside, clear liver heat, and soothe the liver and stomach. In addition, Huangqi is also used in the prescription. It has the effects of bitter and cold, and can clear and drain Shao Yang heat, remove liver fire, and remove pus. Huangqi and Chaihu are the main drugs in the prescription, which can soothe and clear, regulate the function of liver and gallbladder, and improve the ascending and descending function of Shao Yang. They can also clear and drain heat and toxin, and improve the inflammatory reaction such as redness and papules on the face.

[0030] In addition, the important pathogenesis of acne recurrence is spleen and stomach dampness and internal retention of phlegm. Therefore, the prescription is supplemented with Qing Banxia, which is a warm and pungent herb that can dry dampness, resolve phlegm, and descend adverse flow and warm the stomach. It can also resolve the pathogenesis of phlegm and dampness in acne. It can also resolve Shao Yang phlegm and heat with Chaihu and Huangqi. The addition of Sheng Dahuang can break up stagnation and accumulation, and clean the intestines and stomach. The prescription can also resolve heat from the interior, descend fire, and promote blood circulation and remove blood stasis. Acne patients often have redness and papules, and pustules due to excessive heat in the lungs and stomach, or heat toxin stagnation. Sheng Dahuang can resolve heat from the interior and harmonize stomach qi, and has good effects. The prescription is also supplemented with Longgu and Muli, which can calm the mind, soften and remove nodules. The two drugs can also have the effect of heavy downward and astringent. They can also treat nodules and cysts in acne, and symptoms such as restlessness and insomnia. Qing Banxia, Sheng Dahuang, Longgu, and Muli are the ministerial drugs in the prescription, which can enhance the effects of resolving phlegm and nodules, and resolving heat from the interior.

[0031] In addition, the prescription is also supplemented with Dangshen, Baizhu, and Fuling, which are based on the essence of the four gentlemen decoction in the Taiping Hui Ming He Ji Ju Fang, which can benefit qi and invigorate the spleen. Dangshen and Baizhu can benefit qi and invigorate the spleen, support the healthy qi and eliminate pathogenic factors, repair the function of transportation and transformation in the middle jiao, and prevent the spleen and stomach from being damaged by bitter and cold herbs. They can also regulate the function of qi transformation in the triple energizer. Fuling can benefit urination, calm the heart and mind. Sheng Jiang and Rougui can warm the middle and dispel cold, and also enter the yin. Huangqi, Dahuang, and Fuling can form a pattern of cold and heat, which can treat the pathogenesis of excessive heat in the upper part and cold in the lower part in acne patients. Therefore, Dangshen, Baizhu, Fuling, Sheng Jiang, and Rougui are used as the auxiliary drugs in the prescription, which can invigorate the spleen and warm the middle, and regulate cold and heat. Finally, the prescription is supplemented with Dazao, which is warm and sweet, and can calm the stomach and spleen, and harmonize all herbs. It can also benefit the spleen and stomach, and benefit qi and nourish yin. It can also enhance the effects of warming the middle and regulating the stomach when combined with Sheng Jiang.

[0032] The combination of all the herbs in the prescription can soothe the liver and benefit the gallbladder, resolve Shao Yang, resolve phlegm and nodules, and resolve heat from the interior. The combination of all the herbs in the prescription can penetrate and resolve heat, dry dampness and resolve toxin, and also invigorate the spleen and warm the middle without damaging the spleen and stomach. It can also regulate the ascending and descending of qi, and the balance of ying and wei. The prescription can not only rapidly relieve the acute inflammatory reaction of acne, but also reduce the recurrence of acne by regulating the function of zang and fu organs, and achieve the treatment of both symptoms and root cause.

[0033] Characteristics of the compatibility of the prescription: The prescription focuses on the combination of cold and warm, and the combination of attack and tonification. Both Chaihu and Huangqin can clear liver fire, and Rougui and Shengjiang can warm the middle warmer. This is in line with the complex pathogenesis of acne, which is "deficiency in root and excess in branch, and cold and heat mixed". The prescription also uses dry dampness and phlegm, and invigorates the spleen and stomach as an auxiliary. Qianbanxia, mufu baizhu, and fuling can dry dampness and phlegm, invigorate the spleen and stomach, regulate the function of the spleen and stomach, promote the discharge of dampness, and reduce the seepage of skin oil.

[0034] ①, treating both the symptoms and the root cause: through the careful compatibility of traditional Chinese medicine ingredients, it can effectively relieve the external symptoms of acne, such as redness, pus, pain, etc., and regulate the root problems of dampness, blood stasis, spleen and stomach weakness, etc. in the body. Chaihu, Huangqin, Banxia and other ingredients can soothe the liver, relieve depression, clear heat and dry dampness, harmonize the stomach and reduce adverse flow, regulate the function of the spleen and stomach, and promote the discharge of dampness in the body, so as to achieve the effect of treating both the symptoms and the root cause.

[0035] ②, rapid and lasting drug effect: the prescription has been applied to hundreds of patients in clinical practice, and it is found that the drug effect is rapid, and early use can quickly relieve various discomforts of the body and reduce or block the progression of acne. At the same time, since it focuses on regulating the spleen and stomach, preserving stomach qi and storing body fluid, most patients have a significantly reduced recurrence rate after the symptoms of acne are relieved, and the drug effect is lasting.

[0036] ③, small side effects: all traditional Chinese medicine ingredients are natural herbs, which are strictly screened and compatible, have no toxic side effects, and will not cause adverse effects on the patient's body after long-term use, with high safety.

[0037] ④, various dosage forms, convenient to take: through a large number of clinical uses, the prescription and dosage of the present application are gradually fixed, and the dosage forms mainly include ordinary self decoction, machine bag decoction, granules, etc., which can meet the needs of different patients and improve the patient's compliance.

[0038] In summary, the present application solves the problems of limited treatment effect, obvious side effects and long treatment cycle in the existing acne treatment by unique compatibility of traditional Chinese medicine ingredients and dosage form design, and provides a safe, effective and convenient new choice for acne patients.

[0039] In order to reflect the scientificity and rationality of the preparation method of the traditional Chinese medicine composition in the present application, part of the experimental contents of the preparation process parameter optimization are arranged as follows.

[0040] Preparation process optimization experiment of the present application:

[0041] I. Prescription composition

[0042] North Chaihu, Huangqin tablet, Qianbanxia, Rougui, Dangshen tablet, Fuling, Longgu, Muli, Shengdahuang, Ganjiang, Mufu Baizhu, Jinyinhua, Lianqiao.

[0043] II. Dosage form selection

[0044] The original prescription is in the form of decoction, but decoction needs to be prepared fresh, is prone to mold when stored for a long time, is inconvenient to carry, and has a large oral dosage, which is difficult to meet the requirements of modern preparations, such as exact therapeutic effect, controllable quality, convenient production, and convenient clinical use. In addition, patients need to take medicine for a long time, so it is more suitable to make oral preparations. Currently, the commonly used oral preparations are tablets, granules, capsules, and mixtures. Mixtures are developed and improved on the basis of decoction and maintain the characteristics of decoction. The dosage is smaller than that of decoction, can be produced in batches, and the quality is relatively stable, which is convenient for taking, carrying, and storing, and suitable for industrial production. Therefore, the mixture is selected as the dosage form of the product.

[0045] III. Rationality research of process and process design

[0046] In order to obtain a scientific and reasonable preparation process, we analyzed the role of each medicine in the prescription according to the requirements of traditional Chinese medicine theory and clinical medication, and determined the preparation process design of the preparation according to the physicochemical properties of the effective components contained in each traditional Chinese medicinal material and the needs of the preparation forming process.

[0047] 1. Theoretical basis of process design

[0048] North Chaihu: The root of Bupleurum chinense DC. or Bupleurum scorzonella of the Umbelliferae family. It is slightly cold in nature and bitter and pungent in taste, and has the functions of soothing the liver and relieving depression, lifting yang qi, resolving Shaoyang, reducing fever and malaria, and lifting and sinking. It is used for colds, fever, Shaoyang syndrome, malaria, cold and heat, chest and abdominal pain, irregular menstruation, and other diseases.

[0049] Huangqin tablets: The root of Scutellaria baicalensis Georgi of the Labiatae family. It is cold in nature and bitter in taste, and has the functions of clearing heat and drying dampness, purging fire and detoxifying, cooling blood and stopping bleeding, and soothing the fetus. It is used for wet and warm chest tightness, vomiting and aversion to cold, damp heat, diarrhea, jaundice, lung heat cough, high fever, and other diseases.

[0050] Raw Dahuang: The dried rhizome of Rheum palmatum, L, Rheum tanguticum Maxim. ex Balf. or Rheum officinale Baill. of the Polygonaceae family. It is cold in nature and bitter in taste, and has the functions of purging heat and toxic substances, breaking accumulation and stagnation, and removing blood stasis. It is used for constipation due to excess heat, delirium, food accumulation and fullness, initial stage of dysentery, tenesmus, heat and epidemic diseases, acute eye pain, hematemesis, epistaxis, edema, carbuncle and abscess, and other diseases.

[0051] Dragon bone: The fossilized bone of ancient mammals such as elephants, rhinoceroses, and three-toed horses. It is neutral in nature and sweet in taste, with the functions of calming the nerves, soothing the liver and subduing the yang. It is used to treat restlessness, palpitations, insomnia, epilepsy, mania, dizziness, and incontinence.

[0052] Oyster shell: The shell of the long oyster (Ostrea gigas Thunberg), Otalianwhanensis Crosse, or D. rivularis Gould. It is slightly cold in nature and salty in taste, with the functions of calming the nerves, soothing the liver and subduing the yang, softening and resolving, and astringing. It is used to treat restlessness, palpitations, insomnia, liver yang hyperactivity, dizziness, goiter, chronic diarrhea, spermatorrhea, sweating, metrorrhagia, and leukorrhagia.

[0053] Pinellia: The rhizome of Pinellia ternata (Thunb.) Breit. after processing. It is warm in nature and pungent in taste, with the functions of drying dampness, resolving phlegm, descending adverse qi, and stopping vomiting. It is used to treat damp and cold phlegm, cough with excessive phlegm, dizziness with phlegm, dizziness with phlegm, headache with phlegm, vomiting and regurgitation, chest and diaphragm distention, phlegm node, and carbuncle.

[0054] Cassia bark: The bark of Cinnamomum cassia Presl. It is hot in nature and pungent in taste, with the functions of tonifying fire and yang, guiding fire to the origin, dispelling cold and relieving pain, and warming and unblocking meridians. It is used to treat impotence, cold uterus, cold pain in the waist and knees, shortness of breath, dizziness, red eyes, cold abdominal pain, cold hiccups, and dysmenorrhea.

[0055] Codonopsis slice: The root of Codonopsis pilosula (Franch.) Nannf. sliced. It is neutral in nature and sweet in taste, with the functions of tonifying the center and replenishing qi, and invigorating the spleen and lung. It is used to treat spleen deficiency with poor appetite, fatigue, loose stool, weakness, lung deficiency with cough and shortness of breath, pale complexion, heart palpitations, thirst, diabetes, metrorrhagia, prolapse of the rectum, and uterine prolapse.

[0056] Poria cocos: The sclerotium of Poria cocos (Schw.) Wolf. It is neutral in nature and sweet and bland in taste, with the functions of promoting water metabolism and clearing dampness, and invigorating the spleen and calming the heart. It is used to treat edema, oliguria, dizziness with phlegm, spleen deficiency with poor appetite, loose stool, restlessness, insomnia, and palpitations.

[0057] Dried ginger: The dried rhizome of Zingiber officinale Rosc. It is hot in nature and pungent in taste, with the functions of warming the center and dispelling cold, restoring yang and unblocking meridians, drying dampness and resolving phlegm. It is used to treat cold abdominal pain, vomiting and diarrhea, cold limbs and weak pulse, and phlegm with cough and shortness of breath.

[0058] Bupleurum fufangchaotai: it is the rhizome of Atractylodes macrocephala Koidz. of Compositae. It is made by frying with bran. It is warm in nature and sweet and bitter in flavor. It has the functions of strengthening the spleen and tonifying qi, drying dampness and promoting water excretion, stopping sweating and calming the fetus. It is used clinically for treating spleen deficiency, poor appetite, abdominal distension and diarrhea, phlegm-dampness and palpitation, edema and oliguria, spontaneous sweating and night sweating, and fetal movement.

[0059] 1. Preparation process optimization design research

[0060] 1.1 Instruments and reagents

[0061] Waters UPLC H-CLSS type ultra-high performance liquid chromatograph, PDA ultraviolet visible detector, Empower chemical workstation, ACQUITY UPLC BEH C18 column (50 mm x 2.1 mm, 1.7 µm), ultrasonic cleaner (H66025T), BP211D type analytical balance (Germany Sartorius), WS70-1 type infrared rapid drying oven (manufactured by Shanghai Wusong Hardware Factory), FW135 type pulverizer (Tianjin Teset Instrument Co., Ltd.), 101 type electric heating air drying oven (Beijing Yongguangming Medical Instrument Factory), HCTP11B10 tray pharmaceutical balance (Beijing Xicheng District Balance Factory). Methanol is chromatographically pure, water is pure water, and other reagents are analytical pure. Saikosaponin reference substance (for content determination, 110715-202203) is purchased from China Institute for Drug Control.

[0062] 1.2 Extraction process screening

[0063] From the data analysis, it can be seen that Bupleurum chinense, Huangqin tablets, Qingbanxia, raw rhubarb, dragon bone, oyster, cassia, Dangshen tablets, Poria cocos, dried ginger, bran-fried atractylodes, and jujube are water decocted, which is beneficial to the dissolution of effective components and does not increase the production cost, and it meets the preparation requirements of the mixture. Therefore, we designed it as water decoction. Through orthogonal test, the content of saikosaponin in Bupleurum chinense was used as the index for investigation, and the dry extract amount was comprehensively analyzed, focusing on the extraction times, water amount and extraction time to determine the optimal water extraction process conditions. saikosaponin

[0064] 1.2.1 Determination of factor levels and selection of orthogonal table

[0065] In order to determine the optimal extraction conditions, orthogonal test was used to optimize the conditions involved in the water extraction process. Under normal circumstances: extraction time, water amount, and extraction times have greater influence on the extraction results. Therefore, water amount (A), extraction time (B), and extraction times (C) were selected as influencing factors, and each was selected at three levels. The test was arranged according to the L9 (3 levels and 4 factors) table to screen the best extraction process conditions. The factor level table is shown in Table 1. ​

[0066] Table 1 Factor Level Table

[0067]

[0068] 1.2.2 Test Methods

[0069] Weigh out the following ingredients according to the prescription ratio: 30g of Bupleurum chinense, 10g of Scutellaria baicalensis, 10g of Pinellia ternata, 3g of Rheum palmatum, 10g of Os draconis, 10g of Ostrea gigas, 3g of Cinnamomum cassia, 8g of Codonopsis pilosula, 10g of Poria cocos, 6g of Zingiber officinale, 8g of Atractylodes macrocephala (stir-fried with wheat bran), and 6g of Ziziphus jujuba; a total of 9 portions, randomly numbered ① to ⑨, and arranged according to the L9(34) orthogonal array (see Table 3) for the experiment. Filter the extract, measure the total volume, and set aside for later use.

[0070] 1.2.3 Preparation of dry paste

[0071] Accurately measure 50 mL of each of the above extracts and place them in pre-weighed evaporating dishes. Evaporate to dryness in a water bath. Dry the residue at 105℃ for 3 hours, remove it, place it in a desiccator for 30 minutes, weigh it, and calculate the results. The results are shown in Table 2.

[0072] 1.2.4 Determination of Saikosaponin Content

[0073] Referencing the 2020 edition of the Chinese Pharmacopoeia, Part I bupleurum The content of saikosaponins under this item was determined by a method for determination.

[0074] Chromatographic conditions: Column: ACQUITY UPLC BEH C18 column (50 mm × 2.1 mm, 1.7 µm); Mobile phase: methanol-0.1% phosphoric acid water (47:53); Flow rate: 0.3 mL / min; Column temperature: room temperature; Detection wavelength: 280 nm; Injection volume: 1.0 μL for reference standard and 0.5 μL for sample.

[0075] Preparation of reference solution: Accurately weigh an appropriate amount of saikosaponin reference standard, add methanol to prepare a solution containing 0.268 mg per 1 mL.

[0076] Preparation of the test solution: Take the water decoction extract obtained from each orthogonal experiment, centrifuge for 3500 r, 20 min, collect the supernatant, and filter it through a microporous membrane (0.22 μm) to obtain the test solution.

[0077] The sample content was determined according to General Chapter 0512 of Part IV of the Chinese Pharmacopoeia 2020 edition. 1.0 μL of the reference solution and 0.5 μL of the test solution were accurately pipetted into the liquid chromatograph and determined. The results are shown in Table 2.

[0078] Table 2 Orthogonal Experiment Arrangement and Data Analysis Table

[0079]

[0080] Integrated value = ( (wet extract amount / maximum wet extract amount) * 70 + (dry extract amount / maximum dry extract amount) * 30 saikosaponin saikosaponin Integrated value = ( (wet extract amount / maximum wet extract amount) * 70 + (dry extract amount / maximum dry extract amount) * 30

[0081] 3.2.5 Analysis of variance

[0082] According to the orthogonal test arrangement in Table 2 and the data in the data analysis, the analysis of variance is carried out, and the results are shown in Table 3.

[0083] Table 3 Analysis of variance table

[0084] factor sum of squares of deviation degree of freedom F ratio F critical value significance water amount 172.10 2 0.22 19.0 extraction time 19.97 2 0.026 19.0 extraction times 1321.31 2 1.717 19.0 * error 769.63 2

[0085] As shown by the range R value in Table 2, the primary and secondary factors are C > A > B, the analysis of variance (Table 3) shows that factor C has a significant effect, and the extraction of 2 times R value reaches 93% of the extraction of 3 times; factors A and B have no significant effect. Combining the above results, while considering the production cost, A2B1C2, i.e. 10 times the amount of water, 2 times of decoction, and 1.0 hour each time, is selected as the optimal extraction process.

[0086] 3.2.6 Verification test

[0087] According to the prescription proportion, the medicinal materials are weighed, and the verification test is carried out according to the optimized process conditions, and the results are shown in Table 4.

[0088] Table 4 Verification test results

[0089] sample quantity of medicinal materials (g) quantity of dry extract (g) quantity of saikosaponin (mg) 1 176 35.78 1811.60 2 176 35.07 1790.57 3 176 34.61 1785.66 average value 35.15 1793.37

[0090] From the results in Table 4, the effective material content of saikosaponin and the dry extract amount in the traditional Chinese medicine composition in the application are relatively stable, which also shows that the optimized extraction conditions are scientific, reasonable and feasible.

[0091] The traditional Chinese medicine composition in the application can be made into granules and oral liquid dosage forms according to the optimized preparation process, which meets the convenience of medication for clinical patients.

[0092] 3.3 Forming process screening

[0093] 3.3.1 Granule process optimization

[0094] 3.3.1.1 Drying

[0095] The product is a granule, and the traditional Chinese medicine dry extract powder obtained by preparation is mixed with excipients to form a soft material, which is dried and sieved to obtain a granule.

[0096] 3.3.1.2 Selection of excipients

[0097] ​The common excipients are dextrin, lactose, microcrystalline cellulose, and the hygroscopicity of lactose is low, and the taste evaluation is good, therefore, lactose is selected as the excipient.

[0098] 3.3.1.3 Selection of excipient ratio

[0099] The traditional Chinese medicine dry extract powder is mixed with the excipient in different proportions (4:3, 5:4, 6:3), the hygroscopicity and taste of the granules are investigated, and the results are shown in Table 5.

[0100] Table 5 Influence of excipient ratio on the quality of granules

[0101] proportion of excipients moisture absorption rate (%) taste evaluation 4:3 5.8 slight astringency 5:4 4.2 moderate sweetness, no odor 6:3 6.5 obvious powder feeling

[0102] As shown in Table 5, when the traditional Chinese medicine dry extract powder: excipient = 5:4, the hygroscopicity of the prepared granules is low, and the taste evaluation is good.

[0103] 3.3.1.4 Selection of drying temperature

[0104] The wet granules are dried at 50℃, 60℃ and 70℃, the water content and the effective component retention rate are determined, and the results are shown in Table 6.

[0105] Table 6 Influence of drying temperature on the quality of granules

[0106] temperature (℃) moisture content (%) retention rate of active ingredients (%) 50 4.1 98.5 60 3.3 97.8 70 2.1 94.3

[0107] As shown in Table 6, when dried at 60℃, the water content meets the standard (≤5%), and the component retention rate is high (97.8%), and 60℃ is selected as the best temperature.

[0108] 3.3.1.5 Pilot production verification

[0109] Three batches of granules are produced according to the preferred process, and the results are shown in Table 7.

[0110] Table 7 Results of three batches of pilot tests

[0111] batch number 20241204 20241205 20241206 quantity of medicinal materials (kg) 50.0 50.0 50.0 quantity of lactose (g) 30 30 30 drying temperature (℃) 60 60 60 yield of dry extract (%) 21.3 20.8 21.1 yield of granules (%) 88.6 89.2 87.9 dissolution time (min) 3.1 2.8 3.0

[0112] The pilot test results show that the process of the three batches of granules is stable, the quality meets the standard, and the production can be scaled up.

[0113] 3.3.2 Optimization of oral liquid process

[0114] 3.3.2.1 Concentration

[0115] The extracted traditional Chinese medicine extract solution is concentrated to meet the required volume.

[0116] 3.3.2.2 Selection of preservative

[0117] The mixture belongs to a solution, and we select hydroxyphenyl ethyl ester as a preservative, and the amount is 0.5g per liter according to the relevant provisions.

[0118] 3.3.2.3 Flavoring agent selection

[0119] Common flavoring agents include sucrose powder, stevioside, and sucralose. Among them, sucralose has a sweetness of 600 times that of sucrose, is the only sweetener made from sucrose, has pure taste, high stability, does not participate in metabolism and is not absorbed, and is suitable for people with diabetes, obesity, and cardiovascular diseases. Therefore, we select sucralose as the flavoring agent.

[0120] 3.3.2.4 Flavoring agent dosage selection

[0121] The concentrated liquid is added with different proportions of sucralose, and the taste is tasted, and the results are shown in Table 8.

[0122] Table 8 Comparison of taste of sucralose with different dosages

[0123] group concentrate (ml): sucralose (g) taste 1 100:0.01 bitter 2 100:0.05 less bitter 3 100:0.1 sweetness appropriate 4 100:0.15 too sweet

[0124] As can be seen from the results in Table 8, the proportion of traditional Chinese medicine concentrated liquid:sucralose = 100:0.1 prepared in the present application has appropriate sweetness and good taste.

[0125] 3.3.2.5 Pilot study of oral liquid

[0126] 3.3.2.5.1 Pilot prescription

[0127] Beichaihu 1710 g, Huangqin tablet 570 g, Qingbanxia 570 g, Shengdahuang 171 g, Longgu 570 g, Muli 570 g, Ruzhi 171 g, Dangshen tablet 456 g, Fuling 570 g, Ganjiang 342 g, Futo Baizhu 456 g, Dazao 342 g;

[0128] 3.3.2.5.2 Pilot preparation process

[0129] The above eleven ingredients are respectively decocted with 10 times the amount of water twice, each time for 1.0 hour, filtered, combined the filtrate, concentrated to an appropriate amount, added with an appropriate amount of sucralose (0.1g / 100ml) and hydroxyphenyl ethyl ester (0.05g / 100ml), mixed, and added with water to adjust to 10000ml.

[0130] 3.3.2.3 Pilot preparation results

[0131] Table 9 Results of three batches of pilot tests

[0132] batch number 20241201 20241202 20241203 quantity of medicinal materials for extraction (Kg) 10.03 10.03 10.03 quantity of concentrate (Kg) 9.98 10.01 9.97 quantity of sucralose powder (g) 10 10 10 quantity of hydroxyphenyl ethyl ester (g) 5 5 5 quantity of medicinal liquid (L) 10 10 10 quantity of finished products (bottle) 96 95 95

[0133] The pilot results are shown in Table 9, which indicates that the concentrated liquid amount and the finished product amount are basically stable, and the process is feasible for mass production.

[0134] Advantages of the traditional Chinese medicine composition

[0135] (1) The traditional Chinese medicine prescription is based on the years of clinical experience of Professor Zheng, the core inventor, and is optimized through continuous research and exploration. The prescription is composed of Biejia, Huangqi Pian, Qingbanxia, Sheng Dahuang, Longgu, Muli, Ruzhi, Dangshen Pian, Fuling, Ganjiang, Futo Baizhu, and Dazao. The whole prescription is reasonably matched, and the combination of the whole prescription can achieve the functions of soothing liver and promoting bile secretion, resolving Shaoyang, resolving phlegm and resolving stasis, and promoting bowel movement and heat elimination. It is clinically used for acne caused by liver stagnation and fire, and spleen and stomach dampness, and is especially suitable for the acute and subacute stages of acne, and is safe and effective for relieving symptoms such as redness, pustules, and nodules.

[0136] (2) The optimized extraction and preparation process parameters of the present application are as follows: adding water in an amount of 10 times, decocting twice, and each time for 1.0 hour. The effective material dry extract amount of the three batches of traditional Chinese medicine compositions of the present application is 34.61-35.78 g, and the effective component saikosaponin amount is 1785.66-1811.60 mg. This also shows that the extraction, concentration, and drying conditions of the present application are scientific, reasonable, and feasible, and effectively ensure the stability of the material content.

[0137] (3) The corresponding hospital preparation name of the traditional Chinese medicine composition of the present application is Longmuchaohuang Granules. Through years of clinical application verification, the traditional Chinese medicine composition of the present application has a high treatment effect on treating acne inflammation, pigmentation, and scar symptoms, and the clinical symptoms of patients are obviously improved, and the effective rate is more than 85%. And no adverse reactions are found in the process of clinical treatment observation. The above clinical statistical results show that the traditional Chinese medicine in the treatment of acne has a significant clinical effect, and is safe and convenient to take, and is worthy of being actively promoted and applied in clinical practice.

[0138] (4) In the clinical application of the traditional Chinese medicine composition of the present application, its function and indication are mainly for acne (acne vulgaris) and related symptoms, and are especially suitable for the following types of acne patients: damp-heat accumulation type: redness, pain, pustules, nodules, and other acne lesions appear on the face, chest, back, and other parts, accompanied by dry mouth, bitter taste, sticky and uncomfortable stool, yellow urine, red tongue, yellow and greasy fur, and slippery pulse; liver qi stagnation type: acne repeatedly occurs, accompanied by depression, chest and hypochondrium distention, premenstrual aggravation, menstrual irregularity, dark red tongue, and thin pulse; spleen and stomach weakness type: acne is accompanied by loss of appetite, indigestion, loose stool, pale face, limb weakness, pale tongue, white fur, and weak pulse. In addition, the prescription can also be used for the treatment of other discomfort symptoms caused by acne, such as oily skin, itching, dry mouth, halitosis, constipation, and the like. BRIEF DESCRIPTION OF DRAWINGS

[0139] The drawings described herein are used to provide further understanding of the present application, and form a part of the present application, wherein the Chinese medicine composition of the present application is prepared from Bupleurum chinense, Scutellaria baicalensis, Rhizoma Pinelliae, Rhizoma Rhei, Cornu Bovis, Ostreae Concha, Cinnamomum cassia, Radix Codonopsis, Poria cocos, Rhizoma Zingiberis, Poria cocos, Radix Paeoniae Alba, Fructus Jujubae. The schematic embodiments of the present application and the descriptions thereof are used to explain the present application, and do not constitute improper limitation on the present application.

[0140] figure 1 , the picture of a female patient before clinical use of the present application.

[0141] figure 2 , the picture of a female patient after taking the Chinese medicine composition of the present application.

[0142] figure 3 , the picture of a male patient before clinical use of the present application.

[0143] figure 4 , the picture of a male patient after taking the Chinese medicine composition of the present application.

[0144] figure 5 , the hospital preparation product corresponding to the Chinese medicine composition of the present application is: the real object picture of Longmu Chaihuang Granules, and the side view of the real object packaging box.

[0145] figure 6 , the front view of the real object packaging box. DETAILED DESCRIPTION

[0146] In order to more fully understand the implementation of the present application, one or more experimental examples are listed below, and the present application is further described below through typical embodiments.

[0147] Embodiment 1

[0148] The prescription dosage of the Chinese medicine composition is: Bupleurum chinense 300g, Scutellaria baicalensis 100g, Rhizoma Pinelliae 100g, Rhizoma Rhei 30g, Cornu Bovis 100g, Ostreae Concha 100g, Cinnamomum cassia 30g, Radix Codonopsis 80g, Poria cocos 100g, Rhizoma Zingiberis 60g, Poria cocos 80g, and Fructus Jujubae 60g.

[0149] The preparation method is as follows:

[0150] Step 1: weigh the above-mentioned Bupleurum chinense, Scutellaria baicalensis, Rhizoma Pinelliae, Rhizoma Rhei, Cornu Bovis, Ostreae Concha, Cinnamomum cassia, Radix Codonopsis, Poria cocos, Rhizoma Zingiberis, Poria cocos, Radix Paeoniae Alba, and Fructus Jujubae, and add 10 times the amount of water to the medicinal materials, reflux extraction 2 times, each time for 1 hour, filter, combine the filtrate, and reduce the pressure to concentrate under the pressure of 0.07Mpa and the concentration temperature of 65℃, and concentrate into dry paste powder for standby;

[0151] Step 2: Add the dry extract powder of step 1, crush, add appropriate lactose, wet with appropriate amount of 80% (v / v) ethanol, make soft material, dry at 60°C, pass through 12 mesh sieve once, and separate fine powder with 60 mesh sieve, to obtain granules.

[0152] Example 2

[0153] The prescription and dosage of the traditional Chinese medicine composition are: Radix Bupleuri 300 g, Radix Scutellariae 100 g, Rhizoma Pinelliae 100 g, Radix et Rhizoma Rhei 30 g, Galla Ranae 100 g, Concha Margaritiferae 100 g, Cortex Cinnamomi 30 g, Radix Codonopsis 80 g, Poria 100 g, Rhizoma Zingiberis Recens 60 g, Rhizoma Atractylodis Macrocephalae 80 g, Fructus Jujubae 60 g;

[0154] The preparation method is as follows:

[0155] Step 1: Weigh Radix Bupleuri, Radix Scutellariae, Rhizoma Pinelliae, Radix et Rhizoma Rhei, Galla Ranae, Concha Margaritiferae, Cortex Cinnamomi, Radix Codonopsis, Poria, Rhizoma Zingiberis Recens, Rhizoma Atractylodis Macrocephalae and Fructus Jujubae according to the above weight ratio, add water with a weight of 12 times that of the medicinal materials, reflux extract for 1 time, each time for 3 hours, filter, combine the filtrates, and reduce the pressure to concentrate the filtrate into dry extract powder under the condition of 0.06 MPa and 67°C;

[0156] Step 2: Add the dry extract powder of step 1, crush, add appropriate lactose, wet with appropriate amount of 80% (v / v) ethanol, make soft material, dry at 60°C, pass through 12 mesh sieve once, and separate fine powder with 60 mesh sieve, to obtain granules.

[0157] Example 3

[0158] The prescription and dosage of the traditional Chinese medicine composition are: Radix Bupleuri 300 g, Radix Scutellariae 100 g, Rhizoma Pinelliae 110 g, Radix et Rhizoma Rhei 40 g, Galla Ranae 100 g, Concha Margaritiferae 100 g, Cortex Cinnamomi 30 g, Radix Codonopsis 100 g, Poria 110 g, Rhizoma Zingiberis Recens 60 g, Rhizoma Atractylodis Macrocephalae 100 g, Fructus Jujubae 60 g;

[0159] The preparation method is as follows:

[0160] Step 1: Weigh Radix Bupleuri, Radix Scutellariae, Rhizoma Pinelliae, Radix et Rhizoma Rhei, Galla Ranae, Concha Margaritiferae, Cortex Cinnamomi, Radix Codonopsis, Poria, Rhizoma Zingiberis Recens, Rhizoma Atractylodis Macrocephalae and Fructus Jujubae according to the above weight ratio, add water with a weight of 8 times that of the medicinal materials, reflux extract for 3 times, each time for 0.5 hour, filter, combine the filtrates, and reduce the pressure to concentrate the filtrate into dry extract powder under the condition of 0.08 MPa and 63°C;

[0161] Step 2: Add the dry extract powder of step 1, crush, add appropriate lactose, wet with appropriate amount of 80% (v / v) ethanol, make soft material, dry at 60°C, pass through 12 mesh sieve once, and separate fine powder with 60 mesh sieve, to obtain granules.

[0162] Example 4

[0163] Traditional Chinese medicine composition formula dosage ratio: Bupleurum 310g, Scutellaria 90g, Pinellia 90g, Rhubarb 40g, Oyster shell 110g, Concha Mallei 90g, Cinnamon 40g, Codonopsis 90g, Poria 110g, Dried ginger 50g, Atractylodes 90g, Jujube 50g;

[0164] Step 1: weigh the above weight ratio of Bupleurum, Scutellaria, Pinellia, Rhubarb, Oyster shell, Concha Mallei, Cinnamon, Codonopsis, Poria, Dried ginger, Atractylodes, Jujube medicinal materials, add 10 times the weight of medicinal materials, reflux extraction 2 times, each time for 1 hour, filter, combine the filtrate, and reduce the pressure to concentrate the filtrate to concentrated medicinal liquid under the conditions of 0.07 MPa and 64℃;

[0165] Step 2: add the concentrated medicinal liquid in step 1, add appropriate amount of sucralose (0.1g / 100ml), hydroxyphenyl ethyl ester (0.05g / 100ml), mix well, add water to adjust to oral liquid preparation, and obtain.

[0166] Example 5

[0167] Traditional Chinese medicine composition formula dosage ratio: Bupleurum 290g, Scutellaria 110g, Pinellia 110g, Rhubarb 20g, Oyster shell 90g, Concha Mallei 110g, Cinnamon 20g, Codonopsis 70g, Poria 90g, Dried ginger 70g, Atractylodes 70g, Jujube 70g;

[0168] Step 1: weigh the above weight ratio of Bupleurum, Scutellaria, Pinellia, Rhubarb, Oyster shell, Concha Mallei, Cinnamon, Codonopsis, Poria, Dried ginger, Atractylodes, Jujube medicinal materials, add 9 times the weight of medicinal materials, reflux extraction 2 times, each time for 1 hour, filter, combine the filtrate, and spray dry under the conditions of inlet air temperature 80℃, outlet air temperature 54℃, material temperature 70℃, atomization pressure 0.25 MPa, spray speed 7mL / s, and spray dry into dry paste;

[0169] Add appropriate amount of PEG4000 and PEG6000, mix and stir evenly, and drop at medicinal liquid temperature 90℃ and condensate temperature 5℃ to form traditional Chinese medicine drop pills.

[0170] Example 6

[0171] Traditional Chinese medicine composition formula dosage ratio: Bupleurum 300g, Scutellaria 110g, Pinellia 110g, Rhubarb 30g, Oyster shell 100g, Concha Mallei 100g, Cinnamon 30g, Codonopsis 90g, Poria 90g, Dried ginger 70g, Atractylodes 80g, Jujube 60g;

[0172] Step 1: Take the above weight-proportioned Bupleurum, Scutellaria, Pinellia, Rheum, Oyster shell, Concha Mollisca, Cinnamomum, Codonopsis, Poria, Ginger, Atractylodes, and Jujube medicinal materials, add water in an amount of 10 times the weight of the medicinal materials, reflux extract 2 times, each time for 1 hour, filter, combine the filtrates, and spray dry under the following conditions: inlet air temperature 88℃, outlet air temperature 58℃, material temperature 68℃, atomization pressure 0.23 MPa, spray speed 5 mL / s, to obtain dry extract;

[0173] Then add an appropriate amount of carboxymethyl cellulose, granulate, dry, add magnesium stearate, mix, and compress into traditional Chinese medicine tablets.

[0174] Example 7

[0175] Traditional Chinese medicine composition formula dosage proportioning: Bupleurum 310g, Scutellaria 100g, Pinellia 100g, Rheum 40g, Oyster shell 110g, Concha Mollisca 110g, Cinnamomum 40g, Codonopsis 80g, Poria 100g, Ginger 60g, Atractylodes 70g, and Jujube 50g;

[0176] Step 1: Take the above weight-proportioned Bupleurum, Scutellaria, Pinellia, Rheum, Oyster shell, Concha Mollisca, Cinnamomum, Codonopsis, Poria, Ginger, Atractylodes, and Jujube medicinal materials, add water in an amount of 11 times the weight of the medicinal materials, reflux extract 2 times, each time for 1.5 hours, filter, combine the filtrates, and spray dry under the following conditions: inlet air temperature 92℃, outlet air temperature 52℃, material temperature 72℃, atomization pressure 0.27 MPa, spray speed 9 mL / s, to obtain dry extract;

[0177] Then add an appropriate amount of starch and mannitol, granulate, dry, add talc, mix, and fill into traditional Chinese medicine capsules.

[0178] Test Example 1: Clinical treatment effect observation of the traditional Chinese medicine preparation of the present application in treating different patients with acne

[0179] 1.1 General information

[0180] 229 patients with acne of the lung wind-heat syndrome, the spleen-stomach damp-heat syndrome, and the liver depression with fire syndrome who met the clinical standard requirements (Xi'an Jiaotong University First Affiliated Hospital) were collected. The selected patients were comparable in terms of age (15-33 years old), disease duration (1 week-3 years), and disease severity, and had no statistical significance (P>0.05).

[0181] 1.2 Diagnosis standard

[0182] 1.2.1 Western medicine diagnosis standard

[0183] 1.2.1.1 Acne vulgaris diagnosis standard:

[0184] Clinical manifestations:

[0185] Comedones: caused by the obstruction of follicular orifices by plugs of sebum, which are classified as open comedones (blackheads) and closed comedones (whiteheads).

[0186] Papules and pustules: when P. acnes colonizes closed comedones, sebum is broken down into free fatty acids, which irritate the follicular epithelium, causing an inflammatory response of neutrophils and lymphocytes, further damaging the epithelium, resulting in papules and pustules.

[0187] Nodules and cysts: nodules are deeper lesions that can involve more than one follicle, while cysts are larger nodules with fluctuance.

[0188] Scarring and pigmentation: scarring can occur after resolution of inflammatory acne lesions, and can manifest as small and deep pits (ice-pick scars), larger pits, superficial pits, hypertrophic scars, and keloids, and can also be accompanied by pigmentation.

[0189] 1.2.1.2 Other types of acne diagnostic criteria:

[0190] Polyetthogenic acne: lesions are polymorphic, and can include various inflammatory and non-inflammatory lesions, and the condition is often severe.

[0191] Acne fulminans: many inflammatory lesions suddenly appear, forming nodules and ulcers, accompanied by local pain and discomfort, and systemic fever and multiple joint pain, and can leave significant scarring.

[0192] 1.2.2 TCM syndrome criteria

[0193] TCM syndrome diagnostic criteria (reference GB / T 16751.2-1997 Clinical Diagnosis and Treatment Terms of Traditional Chinese Medicine Part and Guidelines for Clinical Research on New Drugs of Traditional Chinese Medicine 2002)

[0194] 1.2.2.1 Lung meridian wind-heat syndrome

[0195] Main symptoms: comedones, papules, and pustules appear on the face, chest, back, and other parts, with red and swollen lesions and pain, accompanied by dry mouth, thirst, and dry and hard stools. Secondary symptoms: red tongue, thin yellow fur, and floating and rapid pulse.

[0196] 1.2.2.2 Spleen and stomach damp-heat syndrome

[0197] Main symptoms: comedones, papules, and pustules appear on the face, chest, back, and other parts, with greasy lesions, accompanied by dry mouth, bitter taste, bad breath, and sticky and unsmooth stools. Secondary symptoms: red tongue, yellow and greasy fur, and slippery and rapid pulse.

[0198] 1.2.2.3 Liver stagnation with fire syndrome

[0199] Main symptoms: acne, papules, pustules on the face, chest and back, accompanied by depression, chest pain, and premenstrual aggravation. Secondary symptoms: dark red tongue, thin yellow fur, and thin pulse.

[0200] Based on clinical practice, we summarized the types of patients as "damp-heat accumulation", "liver qi stagnation", "spleen deficiency", etc.

[0201] 1.3 Inclusion criteria

[0202] Meet the above diagnostic criteria.

[0203] 1.4 Exclusion criteria

[0204] 1) Allergic constitution or allergic to multiple drugs, or have a history of allergy to the components of the drugs used in this trial; 2) Have used other drugs for treating the disease after onset; 3) Unable to determine efficacy due to not taking the drug as prescribed, or incomplete data; 4) Have severe primary cardiovascular disease, liver disease, kidney disease, hematological disease, lung disease, or serious diseases that affect their survival, such as cancer or AIDS.

[0205] 1.5 Treatment method

[0206] Dosage: Take the granules prepared in Example 1 of the present application, take 114g twice a day. For children, reduce the dosage by half. Avoid spicy and stimulating foods during medication, and drink more water and rest.

[0207] Precautions:

[0208] 1. Allergic constitution should be used with caution. 2. Do not use if the appearance of the product changes. 3. This product is suitable for patients with damp-heat accumulation, liver qi stagnation, spleen deficiency, and blood stasis and phlegm accumulation. The earlier the application, the better the effect. 4. Please keep the product out of reach of children. 5. If you are using other medications, please consult a doctor or pharmacist before using this product.

[0209] 1.6 Efficacy evaluation criteria

[0210] Efficacy index (nimodipine method) = (pre-treatment score - post-treatment score) / pre-treatment score x 100%

[0211] Cure: clinical symptoms disappear or basically disappear, and the syndrome score decreases by ≥95%.

[0212] Marked effect: clinical symptoms improved significantly, and the syndrome score decreased by ≥70%.

[0213] Effective: clinical symptoms improved partially, and the syndrome score decreased by ≥30%.

[0214] No effect: no significant improvement or even worsening of clinical symptoms, and the syndrome score decreased by less than 30%.

[0215] 1.7 Treatment results

[0216] The clinical effects of inflammation, pigmentation and scarring symptoms of 229 acne patients were observed 2 weeks, 4 weeks and 8 weeks after treatment, and the results are as follows:

[0217] Table 10 Clinical effect results of patients treated with the traditional Chinese medicine composition of the present application

[0218] group case recovery marked effect effective ineffective total effective rate treatment group 229 12 75 108 34 85%

[0219] As can be seen from the clinical observation results in Table 10, the total effective rate of the traditional Chinese medicine of the present application in treating acne symptoms is 85%, and the inflammatory symptoms of most patients can be relieved within 2 weeks. As can be seen from the clinical observation results, after taking the traditional Chinese medicine of the present application, the total effective rate of acne patients is 85% (195 cases), of which the cure rate is 5% (12 cases), the effective rate is 80% (183 cases), and the inflammatory symptoms of most patients can be relieved within 2 weeks. The symptoms of pigmentation and scarring of the patients have high treatment effects, and the clinical symptoms of the patients are significantly improved.

[0220] 1.8 Adverse reactions

[0221] Moreover, no adverse reactions were found during the clinical treatment observation of the traditional Chinese medicine of the present application. The above clinical statistical results show that the traditional Chinese medicine of the present application has a significant clinical effect in treating acne, is safe and convenient to take, and is worthy of active promotion and application in clinical practice.

[0222] In order to illustrate the treatment effect of the traditional Chinese medicine composition of the present application in clinical use, we specially collect and select some case medication records, so that the technical personnel in the art can more clearly understand and implement the present application.

[0223] Typical cases:

[0224] Case 1, Li, male, 24 years old, chief complaint: facial acne, papules for more than 5 years. Present history: The patient had facial erythema and papules for more than 5 years without obvious predisposing factors. The fingertips were cold, and he did not like to drink water. The prescription: Baidahu 30g, Huangqipian 10g, Qingbanxia 10g, Shengdahuang 3g, Longgu 10g, Muli 10g, Rougui 3g, Dangshenpian 8g, Fuling 10g, Ganjiang 6g, Mutao 6g. A total of 28 doses, decoction-free granules, 2 doses per day, the method of taking: 100-120ml of boiled water, 2 times a day. After taking the medicine for 4 weeks, the patient's facial erythema and papules were significantly reduced, the temperature of hands and feet was normal, he could eat cold food, there was no obvious discomfort after eating cold food, the sweating was normal, the stool was 1-2 times a day, the shape was not sticky, and the sleep was normal.

[0225] Case 2, Li, female, 23 years old, chief complaint: facial acne, papules for more than 2 years. Present history: The patient had no obvious facial erythema papules for 2 years ago, with itching, pain, hands and feet cool, cold, cold drinks, dry mouth, difficulty falling asleep, dysmenorrhea. Prescription: Bupleurum 30g, Huangqin tablets 10g, Qingbanxia 10g, raw rhubarb 3g, dragon bone 10g, 10g of oyster, cassia 3g, Dangshen tablets 8g, 10g of Poria cocos, 6g of dried ginger, 8g of bran fried atractylodes, 6g of jujube. A total of 28, free decoction granules, two doses a day, method of taking: with 100-120ml of water, 2 times a day.

[0226] After 4 weeks of medication, the patient's facial erythema papules decreased significantly, and the dry mouth improved, the hands and feet temperature was normal and the sleep was good.

[0227] Case 3, Li, male, 16 years old, chief complaint: facial erythema papules for more than half a year. Present history: The patient had no obvious facial erythema papules for more than half a year, cold water, eat hot sweat, intense exercise only sweat, dream a lot. Prescription: Bupleurum 30g, Huangqin tablets 10g, Qingbanxia 10g, raw rhubarb 3g, dragon bone 10g, 10g of oyster, cassia 3g, Dangshen tablets 8g, 10g of Poria cocos, 6g of dried ginger, 8g of bran fried atractylodes, 6g of jujube. A total of 24, free decoction granules, two doses a day, method of taking: with 100-120ml of water, 2 times a day.

[0228] After 2 weeks of medication, the patient's facial erythema papules decreased significantly, and the sweat was normal, the sleep was good, and the general love to eat cold.

[0229] Case 4, Lv, female, 15 years old, chief complaint: facial erythema papules for more than 2 years. Present history: The patient had no obvious facial erythema papules for more than half a year during menstruation, cold, hot feet, eat hot sweat, winter don't eat ice, sticky stool, dream a lot, dysmenorrhea, halitosis, dry mouth. Prescription: Bupleurum 30g, Huangqin tablets 10g, Qingbanxia 10g, raw rhubarb 3g, dragon bone 10g, 10g of oyster, cassia 3g, Dangshen tablets 8g, 10g of Poria cocos, 6g of dried ginger, 8g of bran fried atractylodes, 6g of jujube. A total of 24, free decoction granules, two doses a day, method of taking: with 100-120ml of water, 2 times a day.

[0230] After 2 weeks of medication, the patient's facial erythema papules decreased significantly, and the sweat was normal, the sleep was good, and the general love to eat cold.

[0231] Case 5, Shi Moumou, male, 24 years old, chief complaint: facial erythema papules for more than 2 years. Present history: The patient had facial erythema papules for more than 2 years, with no special cause, and had furuncles, fear of heat, dry mouth, warm water, sticky stool. Prescription: Bupleurum 30g, Huangqin tablets 10g, Qingbanxia 10g, raw rhubarb 3g, dragon bone 10g, oyster 10g, cassia 3g, Dangshen tablets 8g, Poria 10g, dried ginger 6g, fried white atractylodes 8g, jujube 6g. A total of 24, free decoction granules, two doses a day, method of taking: with 100-120ml of water, 2 times a day.

[0232] After taking medicine for 4 weeks, the patient's facial erythema papules were significantly reduced, furuncles were reduced, stool was formed, sleep was good, and there was no dry mouth.

[0233] Case 6, Yang Mou, female, 40 years old, chief complaint: facial rosacea for more than 4 years. Present history: The patient had facial rosacea for more than 4 years, with no obvious cause, and had hand and foot heat, sweating, love to eat cold, eat cold stomach pain, halitosis, difficulty falling asleep, irregular menstruation. Prescription: Bupleurum 30g, Huangqin tablets 10g, Qingbanxia 10g, raw rhubarb 3g, dragon bone 10g, oyster 10g, cassia 3g, Dangshen tablets 8g, Poria 10g, dried ginger 6g, fried white atractylodes 8g, jujube 6g. A total of 24, free decoction granules, two doses a day, method of taking: with 100-120ml of water, 2 times a day.

[0234] After taking medicine for 4 weeks, the patient's facial rosacea was significantly reduced, there was no hand and foot cold and hot, love to eat cold, eat cold without discomfort, normal sweating, regular menstruation.

[0235] Case 8, Zhou Moumou, female, 17 years old, chief complaint: facial erythema papules for more than 5 years. Present history: The patient had facial erythema papules for more than 5 years, with no obvious cause, and had occasional itching, less drinking, sticky stool, easy sweating, menstrual blood clots, chest tightness and shortness of breath. Prescription: Bupleurum 30g, Huangqin tablets 10g, Qingbanxia 10g, raw rhubarb 3g, dragon bone 10g, oyster 10g, cassia 3g, Dangshen tablets 8g, Poria 10g, dried ginger 6g, fried white atractylodes 8g, jujube 6g. A total of 24, free decoction granules, two doses a day, method of taking: with 100-120ml of water, 2 times a day.

[0236] After taking medicine for 4 weeks, the patient's facial erythema papules were significantly reduced, the skin lesions were improved, the hands and feet were cool and hot, sweating was less, diet was available, and there was no chest tightness and shortness of breath.

[0237] Case 9: Ma Moumou, female, 25 years old, chief complaint: facial erythema papules for more than 10 years. Present history: The patient had facial erythema papules for more than 10 years, with no obvious cause, and had taken oral and external traditional Chinese medicine and western medicine, with general effect, love to eat cold, less sweating, stool 3-4 days, formed, dry, not sticky, no dry mouth and bitter, sleep well.

[0238] Prescription: Bupleurum 30g, Huangqi tablet 10g, Baihuashanxia 10g, raw rhubarb 3g, Dragon bone 10g, Oyster 10g, Cassia 3g, Dangshen tablet 8g, Poria 10g, Dried ginger 6g, Fried by bran Baizhu 8g, Jujube 6g. A total of 14, free decoction granules, two doses a day, the method of taking: with 100-120ml water, 2 times a day.

[0239] After 2 weeks of medication, the patient's facial erythema papules decreased significantly, increased sweating, 1 day 1 times, shaped.

[0240] Case 10: Wang, male, 29 years old, chief complaint: facial erythema papules 3 years. Present history: the patient more than 10 years ago without obvious facial erythema papules, oral and external use of traditional Chinese medicine, western medicine, the application of gold needle, the effect is general, cold hands and feet, not love to eat cold, less sweating. Prescription: Bupleurum 30g, Huangqi tablet 10g, Baihuashanxia 10g, raw rhubarb 3g, Dragon bone 10g, Oyster 10g, Cassia 3g, Dangshen tablet 8g, Poria 10g, Dried ginger 6g, Fried by bran Baizhu 8g, Jujube 6g. A total of 14, free decoction granules, two doses a day, the method of taking: with 100-120ml water, 2 times a day.

[0241] After 2 weeks of medication, the patient's facial erythema papules decreased significantly, cold hands and feet, increased sweating.

[0242] Case 11: Ye, male, 31 years old, chief complaint: facial acne, papules 5 years. Present history: the patient 5 years ago without obvious facial erythema papules, hot hands, like to eat cold, not like to drink water, dry mouth, 1-2 times a day, sticky toilet, sleep difficult. Prescription: Bupleurum 30g, Huangqi tablet 10g, Baihuashanxia 10g, raw rhubarb 3g, Dragon bone 10g, Oyster 10g, Cassia 3g, Dangshen tablet 8g, Poria 10g, Dried ginger 6g, Fried by bran Baizhu 8g, Jujube 6g. A total of 28, free decoction granules, two doses a day, the method of taking: with 100-120ml water, 2 times a day.

[0243] After 4 weeks of medication, the patient's facial erythema papules decreased significantly, the temperature of hands and feet was normal, could eat cold, no obvious discomfort after eating cold, normal sweating, no dry mouth and bitter, 1 day 1 times, shaped not sticky, sleep.

[0244] Case 12: Zhang, female, 21 years old, chief complaint: facial erythema, papules, pustules for 2 years. Present history: The patient had facial erythema, papules, pustules for 2 years without obvious cause. She had cold hands, less sweating, mild dry mouth in the morning, small appetite. Prescription: Bupleurum 30g, Huangqin tablet 10g, Qingbanxia 10g, raw rhubarb 3g, dragon bone 10g, oyster 10g, cassia 3g, Dangshen tablet 8g, Poria 10g, dried ginger 6g, fried white atractylodes 8g, jujube 6g. A total of 28 doses, decoction-free granules, two doses a day, method of taking: with 100-120ml of boiled water, twice a day. After 4 weeks of taking medicine, the patient's facial erythema and papules were significantly reduced, the temperature of hands and feet was normal, sweating was normal, there was no dry mouth and bitter mouth, and food intake was normal.

[0245] Case 13: He, male, 29 years old, chief complaint: facial erythema and papules for more than 1 year. Present history: The patient had facial erythema and papules for more than 1 year. He had diarrhea after eating cold food, excessive sweating, dry mouth, and small appetite. Prescription: Bupleurum 30g, Huangqin tablet 10g, Qingbanxia 10g, raw rhubarb 3g, dragon bone 10g, oyster 10g, cassia 3g, Dangshen tablet 8g, Poria 10g, dried ginger 6g, fried white atractylodes 8g, jujube 6g. A total of 24 doses, decoction-free granules, two doses a day, method of taking: with 100-120ml of boiled water, twice a day.

[0246] After 4 weeks of taking medicine, the patient's facial erythema and papules were significantly reduced, eating cold food was normal, eating cold food was less uncomfortable, sweating was normal, there was no dry mouth, and food intake was normal.

[0247] Case 14: Lv, female, 14 years old, chief complaint: facial erythema and papules for 2 years. Present history: The patient had facial erythema and papules for more than 2 years. She was afraid of cold, had hot hands and cold feet, sweating after eating hot food, was afraid of wind after sweating, had bad breath and dry mouth, stomach pain, acid reflux, and frequent dreams. Past history: whole body dermatitis with itching since childhood.

[0248] Prescription: Bupleurum 30g, Huangqin tablet 10g, Qingbanxia 10g, raw rhubarb 3g, dragon bone 10g, oyster 10g, cassia 3g, Dangshen tablet 8g, Poria 10g, dried ginger 6g, fried white atractylodes 8g, jujube 6g. A total of 14 doses, decoction-free granules, two doses a day, method of taking: with 100-120ml of boiled water, twice a day.

[0249] After 2 weeks of taking medicine, the patient's facial erythema and papules were significantly reduced, the fear of cold was relieved, sweating was normal, there was no dry mouth, eating was normal, and whole body dermatitis was reduced.

[0250] Case 15: Miss Feng, female, 32 years old, chief complaint: facial erythema papules for more than 5 years. Present history: The patient had facial erythema papules for more than 5 years, accompanied by cold hands and feet, excessive sweating, and difficulty falling asleep. Prescription: Bupleurum 30g, Huangqin tablet 10g, Qingbanxia 10g, raw rhubarb 3g, dragon bone 10g, oyster 10g, cassia 3g, Dangshen tablet 8g, Poria 10g, dried ginger 6g, fried white atractylodes 8g, jujube 6g. A total of 14 copies, free decoction granules, two doses a day, the method of taking: with 100-120ml of boiled water, twice a day. After taking medicine for 2 weeks, the patient's facial erythema papules decreased significantly, cold hands and feet were relieved, sweating was normal, and difficulty falling asleep was reduced.

[0251] Case 16, Miss Hu, female, 34 years old, chief complaint: facial acne, papules for half a year. Present history: The patient had facial acne, papules for half a year, accompanied by cold hands and feet, dry mouth, bitter mouth, sticky stool, and poor appetite. Prescription: Bupleurum 30g, Huangqin tablet 10g, Qingbanxia 10g, raw rhubarb 3g, dragon bone 10g, oyster 10g, cassia 3g, Dangshen tablet 8g, Poria 10g, dried ginger 6g, fried white atractylodes 8g, jujube 6g. A total of 14 copies, free decoction granules, two doses a day, the method of taking: with 100-120ml of boiled water, twice a day. After taking medicine for 2 weeks, the patient's facial acne, papules decreased significantly, cold hands and feet were relieved, dry mouth, bitter mouth, and sticky stool were reduced, and appetite returned to normal.

[0252] Case 17, Miss Xu, female, 33 years old, chief complaint: facial erythema papules for 5 years. Present history: The patient had facial erythema papules for 5 years, accompanied by not liking cold, diarrhea after eating cold, morning bitter mouth, poor appetite, and difficulty falling asleep.

[0253] Prescription: Bupleurum 30g, Huangqin tablet 10g, Qingbanxia 10g, raw rhubarb 3g, dragon bone 10g, oyster 10g, cassia 3g, Dangshen tablet 8g, Poria 10g, dried ginger 6g, fried white atractylodes 8g, jujube 6g. A total of 28 copies, free decoction granules, two doses a day, the method of taking: with 100-120ml of boiled water, twice a day. After taking medicine for 4 weeks, the patient's facial acne, papules decreased significantly, and the rest of the bitter mouth, appetite improved, and sleep was acceptable.

[0254] Case 18, Miss Liu, female, 35 years old, chief complaint: facial acne, papules for more than 3 years. Present history: The patient had facial acne, papules for more than 3 years, accompanied by excessive sweating, dry mouth, bitter mouth, and poor appetite. Prescription: Bupleurum 30g, Huangqin tablet 10g, Qingbanxia 10g, raw rhubarb 3g, dragon bone 10g, oyster 10g, cassia 3g, Dangshen tablet 8g, Poria 10g, dried ginger 6g, fried white atractylodes 8g, jujube 6g. A total of 28 copies, free decoction granules, two doses a day, the method of taking: with 100-120ml of boiled water, twice a day.

[0255] After 4 weeks of treatment, the patient's facial acne and papules were significantly reduced, and the other symptoms were basically disappeared.

Claims

1. A traditional Chinese medicine composition for treating acne, characterized in that, The traditional Chinese medicine composition comprises the following raw materials in the indicated weight proportions: Bupleurum chinense 290-310 parts, Scutellaria baicalensis 90-110 parts, Pinellia ternata 90-110 parts, Rheum palmatum 20-40 parts, Os draconis 90-110 parts, Ostrea gigas 90-110 parts, Cinnamomum cassia 20-40 parts, Codonopsis pilosula 70-90 parts, Poria cocos 90-110 parts, Zingiber officinale 50-70 parts, Atractylodes macrocephala 70-90 parts, and Ziziphus jujuba 50-70 parts.

2. The traditional Chinese medicine composition for treating acne as described in claim 1, characterized in that, The traditional Chinese medicine composition comprises the following raw materials in the indicated weight proportions: 300 parts Bupleurum, 100 parts Scutellaria baicalensis, 100 parts Pinellia ternata, 30 parts Rheum palmatum, 100 parts Dragon bone, 100 parts Oyster shell, 30 parts Cinnamomum cassia, 80 parts Codonopsis pilosula, 100 parts Poria cocos, 60 parts Dried ginger, 80 parts Atractylodes macrocephala, and 60 parts Jujube.

3. The traditional Chinese medicine composition for treating acne as described in claim 1, characterized in that, The traditional Chinese medicine composition comprises the following raw materials in the indicated weight proportions: 300 parts Bupleurum, 100 parts Scutellaria baicalensis, 110 parts Pinellia ternata, 40 parts Rheum palmatum, 100 parts Dragon bone, 100 parts Oyster shell, 30 parts Cinnamomum cassia, 100 parts Codonopsis pilosula, 110 parts Poria cocos, 60 parts Dried ginger, 100 parts Atractylodes macrocephala, and 60 parts Jujube.

4. The method for preparing the traditional Chinese medicine composition according to any one of claims 1 to 3, characterized in that, The preparation method includes the following steps: Step 1: Weigh out the following herbs in the above weight ratio: Bupleurum, Scutellaria baicalensis, Pinellia ternata, Rheum palmatum, Dragon bone, Oyster shell, Cinnamon, Codonopsis pilosula, Poria cocos, Dried ginger, Atractylodes macrocephala, and Jujube. Add 8 to 12 times the weight of the herbs in water, reflux and extract 1 to 3 times, each extraction time being 0.5 to 2 hours. Filter, combine the filtrates, concentrate the filtrate under reduced pressure or spray dry it to obtain a dry extract powder. Step 2: Add the dry powder from step 1 above, pulverize it, and then add appropriate pharmaceutical excipients to make an oral dosage form of traditional Chinese medicine.

5. The preparation method according to claim 4, characterized in that, In step (1) of the preparation method, add water equal to 10 times the weight of the medicinal material, and reflux extract twice, with each extraction lasting 1 hour.

6. The preparation method according to claim 4, characterized in that, In step (1) of the preparation method, the vacuum concentration pressure is 0.06-0.08 MPa and the concentration temperature is 63-67℃.

7. The preparation method according to claim 4, characterized in that, The preparation method step (1) spray drying conditions are as follows: inlet air temperature is 88-92℃, outlet air temperature is 52-58℃, material temperature is 68-72℃, atomization pressure is 0.23-0.27 MPa, and spray speed is 5-9 mL / s.

8. The preparation method according to claim 4, characterized in that, The pharmaceutical excipient selected in step (2) of the preparation method is lactose, which is moistened with 80% ethanol, made into a soft mass, dried, and sieved to obtain granules.

9. The preparation method according to claim 4, characterized in that, The oral dosage forms of the traditional Chinese medicine in step (2) of the preparation method are: granules, oral liquids, capsules, pills, and tablets.

10. The use of the traditional Chinese medicine composition as described in claims 1 to 3 in the preparation of a drug for treating acne.

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