A medicine for treating chronic eczema and its preparation method

Abstract

The application discloses a medicine for treating chronic eczema, and the medicine is prepared from Tripterygium wilfordii, Coptis chinensis, Rheum officinale, Saposhnikovia divaricata, Schizonepeta, Angelica sinensis, Radix Paeoniae Alba, Sophora flavescens, borneol, licorice and menthol. The medicine has the functions of clearing heat and resolving toxins, dispelling wind and dampness, and harmonizing blood and stopping itching, and is suitable for people with chronic eczema of the type of wind (damp) heat accumulating on the skin.

Description

TECHNICAL FIELD

[0001] The present application relates to a kind of medicine for treating chronic eczema and preparation method thereof, belong to the technical field of pharmaceuticals. BACKGROUND

[0002] Eczema is due to complex internal and external factors and causes a skin inflammatory response. Chronic eczema is generally localized with infiltration and hypertrophy, severe itching, and easy recurrence. The causes of the disease are complex, and internal and external factors interact with each other, often in many ways. Patients are often allergic constitution, which is related to genetic factors, so the disease occurs in a specific population. Common internal factors such as gastrointestinal dysfunction, mental stress, neurological dysfunction, endocrine disorders, body infection foci, intestinal parasites, etc. External factors such as sunlight, wind, cold, heat, scratching, rubbing, and contact with soap, cosmetics, etc., animal fur, plants, chemicals, etc. can also induce.

[0003] Traditional Western medicine treats eczema regardless of patients and disease types, and focuses on eliminating surface inflammation. Most of them use one treatment. Western medicine usually simply uses some antibiotics to treat eczema, such as tacrolimus ointment or zinc oxide ointment, which can also be combined with antihistamine drugs. This can only be used for external medication treatment, and cannot solve the root cause of eczema and allergens, which is prone to recurrence. Traditional Western medicine treats eczema symptomatically rather than fundamentally, and is not treated internally. It mainly uses oral hormones combined with instruments, which can produce toxic side effects and cause great harm to the human body, and is prone to rebound and recurrence.

[0004] The present application is aimed at chronic eczema population, treating chronic eczema of wind (damp) heat accumulation on the skin, advocating the treatment principle of "combining syndrome differentiation with disease differentiation and body differentiation", and is a special prescription for treating chronic eczema. SUMMARY

[0005] The technical problem to be solved by the present application is to provide a medicine for treating chronic eczema and a preparation method thereof. The present application has the effects of clearing heat and detoxifying, expelling wind and dampness, and stopping itching by promoting blood circulation, and is suitable for people with chronic eczema.

[0006] To solve the above technical problems, the present application adopts the following technical scheme:

[0007] A medicine for treating chronic eczema, the medicinal effective components are calculated by weight components: 20-100 parts of Tripterygium wilfordii, 25-80 parts of Coptis chinensis, 10-60 parts of Radix et Rhizoma Rhei, 10-60 parts of Saposhnikovia divaricata, 10-60 parts of Schizonepeta, 10-60 parts of Angelica sinensis, 10-60 parts of Radix Paeoniae Alba, 10-60 parts of Sophora flavescens, 1-20 parts of borneol, 5-35 parts of licorice, and 1-20 parts of menthol.

[0008] The medicine for treating chronic eczema comprises, by weight, 40-80 parts of Tripterygium wilfordii, 30-70 parts of Coptis chinensis, 15-50 parts of Rheum officinale, 15-50 parts of Saposhnikovia divaricata, 15-50 parts of Schizonepeta tenuifolia, 15-50 parts of Angelica sinensis, 15-50 parts of Radix Paeoniae Alba, 15-50 parts of Sophora flavescens, 5-15 parts of borneol, 10-30 parts of Glycyrrhiza uralensis, and 5-15 parts of menthol.

[0009] Specifically, the medicine for treating chronic eczema comprises, by weight, 60 parts of Tripterygium wilfordii, 50 parts of Coptis chinensis, 30 parts of Rheum officinale, 30 parts of Saposhnikovia divaricata, 30 parts of Schizonepeta tenuifolia, 30 parts of Angelica sinensis, 30 parts of Radix Paeoniae Alba, 30 parts of Sophora flavescens, 10 parts of borneol, 20 parts of Glycyrrhiza uralensis, and 10 parts of menthol.

[0010] The medicine for treating chronic eczema can be prepared into an ointment or a cream.

[0011] The preparation method of the ointment is performed according to the following steps:

[0012] (1) The medicines except borneol and menthol are weighed according to the prescription ratio, crushed into coarse powder, and soaked in 95% alcohol for 25-35 minutes, and then extracted by refluxing at a temperature of 180-220 ℃ for 1.5-2.5 hours. The medicine residue is reserved, and the medicine juice obtained by filtration is concentrated at 55-65 ℃ to obtain a medicine liquid containing 10-15 g of crude drug per milliliter, thereby obtaining an alcohol extraction concentrated liquid, i.e. A product;

[0013] (2) The medicine residue filtered in step (1) is added with water to cover the medicine surface, extracted by refluxing at a temperature of 180-220 ℃ for 1.5-2.5 hours, and then the residue is removed and the juice is concentrated at 55-65 ℃ to obtain a medicine liquid containing 10-15 g of crude drug per milliliter, thereby obtaining a water extraction concentrated liquid, i.e. B product;

[0014] (3) A product and B product are combined together and stirred uniformly, thereby obtaining C product;

[0015] (4) Liquid paraffin 8-11 ml, vaseline 2.5-3.5 g, stearic acid 10-15 g, and lanolin 4-6 g are dissolved at a constant temperature of 80-90 ℃ and stirred uniformly, thereby obtaining an oil phase, i.e. D product;

[0016] (5) Borneol and menthol are separately taken according to the prescription ratio, crushed into coarse powder, and dissolved in 3.5-4.5 g of glyceryl monostearate. After the dissolution is completed, the mixture is added into D product and stirred uniformly, thereby obtaining E product;

[0017] (6) Hydroxyphenyl ethyl ester 0.2-0.4 g and glycerol 5-7 ml are dissolved in distilled water 40-60 ml, thereby obtaining an aqueous phase, i.e. F product;

[0018] (7) Take 22-26g E product into F product, constant temperature 80-90℃, uniform speed stirring 5-15min, and add 0.3-0.4ml of triethanolamine, stop heating, continue stirring to room temperature, get the matrix, then take 18-22ml of C product into the above matrix, uniform stirring, get the ointment.

[0019] Specifically, the foregoing ointment preparation method is carried out according to the following steps:

[0020] (1) According to the prescription proportion, weigh each medicinal material except for borneol and menthol, crush into coarse powder, soak the medicinal material surface in 95% alcohol for 30min, then reflux extract at 190-210℃ for 2h, collect the medicinal juice by filtration, and reserve the residue for use, concentrate the medicinal juice obtained by filtration at 60℃ to a medicinal liquid containing 12.4g / ml of crude drug, get the alcohol extract concentrate, i.e. A product;

[0021] (2) Add water to cover the medicinal material surface of the residue filtered in step (1), reflux extract at 190-210℃ for 2h, and concentrate the juice to a medicinal liquid containing 12.4g / ml of crude drug at 60℃, get the water extract concentrate, i.e. B product;

[0022] (3) Combine A product and B product together and stir uniformly, i.e. get C product;

[0023] (4) Dissolve liquid paraffin 9.5ml, vaseline 3g, stearic acid 12g, and lanolin 5g at 85℃ constant temperature, stir uniformly, get the oil phase, i.e. D product;

[0024] (5) Take borneol and menthol of the prescription amount, crush into coarse powder, add 4g glyceryl monostearate to dissolve, add to D product and mix uniformly, i.e. get E product;

[0025] (6) Take 0.3g of hydroxyphenyl ethyl ester and 6ml of glycerol, add to 50ml of distilled water to dissolve, get the water phase, i.e. F product;

[0026] (7) Take 24g E product into F product, stir at 85℃ constant temperature for 10min, add 0.36ml of triethanolamine, stop heating, continue stirring to room temperature, get the matrix, then take 20ml of C product into the above matrix, stir uniformly, get the ointment.

[0027] The foregoing cream preparation method is carried out according to the following steps:

[0028] (1) According to the prescription proportion, each medicinal material except borneol and menthol is weighed, crushed into coarse powder, soaked in 95% alcohol for 25-35 minutes, and then extracted by reflux at a temperature of 180-220 ℃ for 1.5-2.5 hours. The medicinal juice is collected by filtration, and the residue is reserved. The medicinal juice obtained by filtration is concentrated at 55-65 ℃ to a medicinal liquid containing 10-15 g of crude drug per milliliter, to obtain an alcohol extraction concentrate, i.e., product a;

[0029] (2) The residue obtained by filtration in step (1) is added with water to cover the medicinal surface, extracted by reflux at a temperature of 180-220 ℃ for 1.5-2.5 hours, and then the residue is removed and the juice is concentrated at 55-65 ℃. The concentrated medicinal liquid contains 10-15 g of crude drug per milliliter, to obtain a water extraction concentrate, i.e., product b;

[0030] (3) Products a and b are combined and stirred uniformly to obtain product c;

[0031] (4) Liquid paraffin 8-11 ml, vaseline 2.5-3.5 g, stearic acid 10-15 g, and lanolin 4-6 g are dissolved at a constant temperature of 80-90 ℃ and stirred uniformly to obtain an oil phase, which is reserved at 70 ℃ for standby, i.e., product d;

[0032] (5) Borneol and menthol of the prescription amount are crushed into coarse powder, and then added with 4.5-5.5 g of nipagin alcohol, 18-21 ml of triethanolamine, 5-7 ml of glycerol, and 40-60 ml of distilled water for dissolution. After the dissolution is completed, the water phase is obtained and heated to 70 ℃ for standby, i.e., product e;

[0033] (6) Product d is slowly added into product e at 70 ℃, and then saponified by stirring to obtain a water-in-oil emulsion base. Then 18-22 mL of product c is added into the water-in-oil emulsion base, and stirred uniformly to obtain a cream.

[0034] Specifically, the aforementioned cream preparation method is performed according to the following steps:

[0035] (1) According to the prescription proportion, each medicinal material except borneol and menthol is weighed, crushed into coarse powder, soaked in 95% alcohol for 30 minutes, and then extracted by reflux at a temperature of 190-210 ℃ for 2 hours. The medicinal juice is collected by filtration, and the residue is reserved. The medicinal juice obtained by filtration is concentrated at 60 ℃ to a medicinal liquid containing 12.4 g of crude drug per milliliter, to obtain an alcohol extraction concentrate, i.e., product a;

[0036] (2) The residue obtained by filtration in step (1) is added with water to cover the medicinal surface, extracted by reflux at a temperature of 190-210 ℃ for 2 hours, and then the residue is removed and the juice is concentrated at 60 ℃. The concentrated medicinal liquid contains 12.4 g of crude drug per milliliter, to obtain a water extraction concentrate, i.e., product b;

[0037] (3) a and b are combined together and stirred to obtain c;

[0038] (4) liquid paraffin 9.5ml, vaseline 3g, stearic acid 12g, lanolin 5g are dissolved at 85℃ constant temperature, stirred to obtain oil phase, namely d;

[0039] (5) another prescription amount of borneol and menthol are crushed into coarse powder, added into 5g nipagin, 20ml triethanolamine, 6ml glycerol and 50ml distilled water to dissolve, after dissolution, water phase is obtained, heated to 70℃ for standby, namely e;

[0040] (6) d is taken at 70℃, slowly added into 70℃ e, stirred to saponify into oil-in-water emulsion base, 20mL of C is taken and added into the oil-in-water emulsion base, stirred to obtain cream.

[0041] Compared with the prior art, the present application has the following beneficial effects:

[0042] The medicine for treating chronic eczema is prepared from Tripterygium wilfordii Hook F, Coptis chinensis Franch., Rheum palmatum L., Saposhnikovia divaricata (Turcz.) Schischk., Schizonepeta tenuifolia Briq., Angelica sinensis, Radix Paeoniae Alba, Sophora flavescens, borneol, Glycyrrhiza uralensis and menthol. The properties and effects of each component are as follows: Tripterygium wilfordii Hook F is a liana shrub of Celastraceae; it is pungent and cold in nature, bitter in taste, and enters the liver channel and the spleen and kidney channels; it has the effects of expelling wind and dampness, activating blood and unblocking collaterals, eliminating swelling and relieving pain, killing insects and detoxifying. Coptis chinensis Franch. is the dried rhizome of Ranunculaceae Coptis chinensis Franch., Coptis deltoidea C.Y.Cheng et Hsiao or Coptis teeta Wall.; it is bitter and cold in nature, and returns to the heart, spleen, stomach, liver, gallbladder and large intestine channels; it has the effects of clearing heat and drying dampness, purging fire and detoxifying; it is used for treating damp-heat distention, vomiting and acid regurgitation, dysentery, jaundice, high fever and coma, heart fire, insomnia, palpitation, blood-heat hematemesis, red eyes, toothache, diabetes, carbuncle and sores; it is used for treating eczema and tinea outside. Rheum palmatum L. is the dried root and rhizome of Polygonaceae Rheum palmatum L., Rheum tanguticum Maxim.ex Bal or Rheum officinale Bail1.; it is bitter and cold in nature, and returns to the spleen, stomach, large intestine, liver and pericardium channels; it has the effects of purgation for removing accumulation, clearing heat and purging fire, cooling blood and detoxifying, removing blood stasis and unblocking channels, removing dampness and reducing jaundice; it is used for treating constipation due to accumulation of heat, blood-heat hematemesis, red eyes and swelling of the throat, carbuncle and sores, intestinal abscess and abdominal pain, blood stasis and amenorrhea, postpartum blood stasis, injury, dysentery due to damp heat, jaundice and red urine, stranguria and edema; it is used for treating burns outside. Saposhnikovia divaricata (Turcz.) Schischk. is the dried root of Umbelliferae Saposhnikovia divaricata (Turcz.) Schischk.; the root of the plant is collected in spring and autumn, and then the rootlets and mud are removed and dried; it is pungent and sweet in taste, and slightly warm in nature; it returns to the bladder, liver and spleen channels; it has the effects of dispelling wind and relieving superficies, removing dampness and relieving pain, and stopping convulsion; it is used for treating common cold with headache, rheumatic arthralgia, wind-itch and tetanus. Schizonepeta tenuifolia Briq. is the dried aboveground part of Labiatae Schizonepeta tenuifolia Briq.; it is collected in summer and autumn, and then impurities are removed and dried; it is pungent and slightly warm in nature; it returns to the lung and liver channels; it has the effects of relieving superficies and dispelling wind, removing rash and resolving sore; it is used for treating common cold, headache, measles, wind-itch and sore at the early stage.Angelica sinensis (Oliv.) Diels, a plant in the Apiaceae family, is the dried root of the plant. It is harvested in late autumn, with the fibrous roots and soil removed. After the moisture has slightly evaporated, it is bundled into small bunches, placed on a rack, and slowly dried using smoke. It has a sweet and pungent taste and is warm in nature; it enters the liver, heart, and spleen meridians. It has the effects of nourishing blood and promoting blood circulation, regulating menstruation and relieving pain, and moistening the intestines and promoting bowel movements. It is used for blood deficiency and chlorosis, dizziness and palpitations, irregular menstruation, amenorrhea and dysmenorrhea, abdominal pain due to deficiency and cold, rheumatic arthralgia, traumatic injuries, carbuncles and sores, and constipation due to intestinal dryness. Wine-processed Angelica sinensis promotes blood circulation and regulates menstruation; it is used for amenorrhea and dysmenorrhea, rheumatic arthralgia, and traumatic injuries. White peony root is the dried root of Paeonia lactiflora Pall., a plant in the Ranunculaceae family. It is bitter and sour in taste, and slightly cold in nature. It enters the liver and spleen meridians. It has the effects of nourishing blood and regulating menstruation, astringing yin and stopping sweating, softening the liver and relieving pain, and calming liver yang. It is used for blood deficiency and chlorosis, irregular menstruation, spontaneous sweating, night sweats, hypochondriac pain, abdominal pain, limb spasms, headache, and dizziness. Sophora flavescens root is the dried root of Sophora flavescens Ait., a plant in the Fabaceae family. It is bitter and cold in nature. It enters the heart, liver, stomach, large intestine, and bladder meridians. It has the effects of clearing heat and drying dampness, killing parasites, and promoting diuresis. It is used for dysentery, hematochezia, jaundice and urinary retention, leukorrhea, vulvar swelling and itching, eczema, damp sores, pruritus, scabies, and leprosy. Externally, it is used to treat trichomonal vaginitis. Borneol is extracted and processed from the fresh branches and leaves of Cinnamomum camphora (L.) Presl, a plant of the Lauraceae family. It has a pungent and bitter taste and is cool in nature. It enters the heart, spleen, and lung meridians and has the functions of opening the orifices and refreshing the mind, clearing heat and relieving pain. It is used for febrile coma, convulsions, stroke with phlegm syncope, qi stagnation and sudden syncope, coma due to evil, chest pain, red eyes, mouth sores, sore throat, and ear discharge. Licorice is the dried root and rhizome of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat., or Glycyrrhiza glabra L., belonging to the Fabaceae family. It is harvested in spring and autumn, the fibrous roots are removed, and it is sun-dried. It has a sweet taste and neutral properties; it enters the heart, lung, spleen, and stomach meridians. It has the effects of tonifying the spleen and replenishing qi, clearing heat and detoxifying, resolving phlegm and relieving cough, relieving spasms and pain, and harmonizing other herbs. It is used for spleen and stomach weakness, fatigue, palpitations, shortness of breath, cough with excessive phlegm, abdominal and limb spasms and pain, carbuncles and boils, and to alleviate the toxicity and harshness of other drugs. Menthol is a saturated cyclic alcohol obtained by steam distillation, freezing, and recrystallization of the fresh stems and leaves of Mentha haplocalyx Briq., a plant of the Lamiaceae family. It is 1-1-methyl-4-isopropylcyclohexanol-3. It has the effects of dispelling wind, clearing heat, and detoxifying. It is mainly used to treat headaches, red eyes, external wind-heat, sore throat and toothache, and itchy skin.

[0043] Fang Jie

[0044] Principal ingredient: Tripterygium wilfordii

[0045] Tripterygium wilfordii, also known as Huangtenggen or Nansheteng, is described in the Shennong Bencao Jing as having a "pungent taste and warm nature, entering the liver and spleen meridians, and unblocking the twelve meridians." It is used to treat "muscle and bone pain, wind-cold-dampness bi syndrome, numbness, paralysis, weakness, and phlegm due to dampness," etc. It can dispel wind and unblock the meridians, relax muscles and promote blood circulation, reduce swelling and relieve pain, kill parasites and detoxify. It has the effect of treating damp sores and is the principal herb.

[0046] Assistant herbs: Coptis chinensis, rhubarb

[0047] Coptis chinensis is bitter and cold in nature, and has the functions of clearing heat and drying dampness, purging fire and detoxifying. When combined with Tripterygium wilfordii, it enhances its heat-clearing, dampness-drying, and detoxifying effects, making it an assistant herb. Rhubarb is bitter and cold in nature, and has the functions of clearing heat and purging fire, cooling blood and detoxifying, and clearing heat from the bowels, allowing damp-heat and stagnant toxins to be expelled from below. Moreover, the lungs and large intestine are internally and externally related, and when combined with Schizonepeta tenuifolia and Saposhnikovia divaricata, it can relieve both the exterior and interior, thus simultaneously relieving both. The combined use of rhubarb and Coptis chinensis works to clear and purge the damp-heat and toxins of the three jiaos, providing an outlet for pathogens, and together they serve as assistant herbs.

[0048] Adjuvant herbs: Saposhnikovia divaricata, Schizonepeta tenuifolia, Angelica sinensis, Paeonia lactiflora, Sophora flavescens

[0049] "When wind prevails, itching occurs." For itchy skin diseases, dispelling wind is essential. Appropriately adding light and mild wind-dispelling herbs can expel the pathogenic factors, providing an outlet and effectively preventing recurrence. Fangfeng (Saposhnikovia divaricata) is pungent and sweet in nature, a key herb for relieving exterior symptoms. Combined with Jingjie (Schizonepeta tenuifolia), it enhances the wind-dispelling and dampness-removing power of Leigongteng (Tripterygium wilfordii) while mitigating its toxicity. Known as a "screen," it can resist the invasion of wind pathogens. Together, they relieve exterior symptoms, open up stagnation, promote blood circulation, raise yang qi, dispel wind and dampness, and guide the flow of qi through the meridians, restoring the function of wei yang, protecting ying yin, and harmonizing ying and wei. Danggui (Angelica sinensis) is sweet and pungent in nature, possessing the effect of nourishing and activating blood. "Treat wind by first treating blood; when blood flows smoothly, wind will naturally subside." While treating wind, attention should be paid to the blood, so that blood and qi will naturally circulate. The heat is also relieved. Adding Angelica sinensis, which nourishes and invigorates blood, can help ensure smooth flow of Qi and blood. White peony root is bitter and sour, and slightly cold in nature. It enters the liver and spleen meridians and has the effects of nourishing blood and regulating menstruation, astringing Yin and stopping sweating, softening the liver and relieving pain, and calming liver Yang. When combined with Tripterygium wilfordii, it can restrain its pungent nature. When combined with white peony root, it can enhance its blood-regulating effect and serve as an adjuvant. Sophora flavescens is bitter and cold in nature and enters the liver, kidney, large intestine, and small intestine meridians. The Shennong's Classic of Materia Medica states that it treats abdominal distension, masses and accumulations, jaundice, dribbling urine, promotes urination, eliminates carbuncles and swellings, tonifies the middle Jiao, brightens the eyes and stops tears. "Its effects of reducing fever and clearing damp heat are similar to those of Scutellaria baicalensis, Coptis chinensis, and Gentiana scabra, but its bitterness is more intense and its drying effect is even stronger. Therefore, it can kill parasites caused by damp heat, and its effect is more potent than that of Scutellaria baicalensis and Coptis chinensis. It is also said that 'Sophora flavescens nourishes the liver and gallbladder qi, calms the five internal organs, stabilizes the mind and benefits essence, benefits the nine orifices, removes latent heat and intestinal dysentery, quenches thirst, relieves hangovers, treats yellow and reddish urine, heals malignant sores and ulcers on the lower body, regulates stomach qi, and makes people more appetiteful.' This formula uses its effects of clearing heat and drying dampness and killing parasites as an adjuvant."

[0050] Used ingredients: borneol, menthol, licorice

[0051] Borneol is acrid, bitter and slightly cold, and it is attributed to heart, spleen and lung channels. It is acrid and pungent, and it can be used to clear away all kinds of toxins. It has the effects of clearing away heat, relieving pain, removing toxins, and relieving itching. Peppermint is light and cool, and it can be used to dispel pathogenic factors, dredge the channels and collaterals, and relax the muscles and the skin. Borneol and peppermint can be used together to open the orifices, dispel stagnated heat, and relieve itching.

[0052] Gancao can be used to clear away heat and toxins, and to harmonize other herbs. It can be used with Baishao to form the classical prescription Shao-yao Gancao Decoction. Baishao is bitter and sour, and it is cold. It can be used to treat blood deficiency, and to regulate the flow of qi. It has the effects of nourishing blood, soothing liver, relieving pain, and calming liver yang. Gancao is sweet and warm. It can be used to tonify the center and to replenish qi when it is roasted. It can also be used to clear away heat and toxins when it is raw. It can also relieve pain, and it can be used to harmonize other herbs. Baishao can be used to regulate the flow of qi, and Gancao can be used to relieve adverse qi. When they are used together, they can be used to regulate the flow of blood and to relieve pain.

[0053] The present application has the effects of clearing away heat and toxins, dispelling wind and dampness, and regulating blood and relieving itching. It is suitable for people who have chronic eczema caused by wind (dampness) and heat. BRIEF DESCRIPTION OF DRAWINGS

[0054] Figure 1 The left and right upper limbs before treatment in the classical case 1 (A is the left upper limb; B is the right upper limb);

[0055] Figure 2 The left and right upper limbs after treatment in the classical case 1 (A is the left upper limb; B is the right upper limb);

[0056] Figure 3 The left and right lower limbs before treatment in the classical case 2 (A is the left lower limb; B is the right lower limb);

[0057] Figure 4 The left and right lower limbs after treatment in the classical case 2 (A is the left lower limb; B is the right lower limb). DETAILED DESCRIPTION

[0058] The present application will be further described below with reference to the examples, but it should not be limited to the examples.

[0059] Example 1.

[0060] 1. Prescription: Leigongteng 60g, Huanglian 50g, Dahuang 30g, Fangfeng 30g, Jingjie 30g, Danggui 30g, Baishao 30g, Kushen 30g, Borneol 10g, Gancao 20g, and Peppermint 10g.

[0061] 2. Preparation method of the ointment:

[0062] (1) Take the prescription medicine except borneol and menthol, crush into coarse powder, soak the medicine surface with 95% alcohol for 30 minutes, reflux extract at 200°C for 2 hours, collect the medicine juice by filtration, collect the medicine juice by filtration, and reserve the residue for use, concentrate the filtered medicine juice to a medicine liquid containing 12.4g / ml of crude drug, obtain the alcohol extraction concentrate, i.e. A product;

[0063] (2) Add water to the residue of step (1) to cover the medicine surface, heat and reflux extract at 200°C for 2 hours, remove the residue and collect the juice, concentrate at 60°C to a medicine liquid containing 12.4g / ml of crude drug, obtain the water extraction concentrate, i.e. B product;

[0064] (3) Combine A product and B product together and stir evenly, i.e. C product;

[0065] (4) Dissolve liquid paraffin 9.5ml, vaseline 3g, stearic acid 12g, and lanolin 5g at 85°C constant temperature, stir evenly, and obtain the oil phase, i.e. D product;

[0066] (5) Take the prescription amount of borneol and menthol, crush into coarse powder, add to 4g glyceryl monostearate and dissolve, after complete dissolution, add to D product, i.e. E product;

[0067] (6) Take hydroxyphenyl ethyl ester 0.3g and glycerol 6ml, add to distilled water 50ml and dissolve, obtain the water phase, i.e. F product;

[0068] (7) Take 24g E product and add to F product, stir at 85°C constant temperature at a uniform speed for 10 minutes, add 0.36ml of triethanolamine, stop heating, continue stirring to room temperature, obtain the base, and then take 20ml of C product and add to the base, stir evenly, obtain the ointment.

[0069] Usage and dosage: externally use, take an appropriate amount of ointment and evenly apply to the affected area, three times a day.

[0070] Example 2.

[0071] 1. Prescription: Tripterygium 20g, Coptis 25g, Rhubarb 10g, Saposhnikovia 10g, Schizonepeta 10g, Angelica 10g, White Peony Root 10g, Sophora 10g, borneol 1g, Licorice 5g, menthol 1g.

[0072] 2. Ointment preparation method:

[0073] (1) Take the prescription medicine except borneol and menthol, crush into coarse powder, soak the medicine surface with 95% alcohol for 25 minutes, reflux extract at 180°C for 1.5 hours, collect the medicine juice by filtration, collect the medicine juice by filtration, and reserve the residue for use, concentrate the filtered medicine juice to a medicine liquid containing 10g / ml of crude drug at 55°C, obtain the alcohol extraction concentrate, i.e. A product;

[0074] (2) Take the filtered drug residue in step (1) and add water to cover the drug surface. Heat to reflux at a temperature of 180°C for 1.5 hours. Remove the residue and collect the juice. Concentrate at 55°C. Concentrate to a drug liquid containing 10g / mL of crude drug. Obtain the water extraction concentrate, i.e. B product;

[0075] (3) Combine A product and B product together and stir evenly to obtain C product;

[0076] (4) Dissolve liquid paraffin 8ml, vaseline 2.5g, stearic acid 10g, lanolin 4g at a constant temperature of 80°C. Stir evenly to obtain oil phase, i.e. D product;

[0077] (5) Take the prescribed amount of borneol and menthol, crush into coarse powder, add 3.5g of glyceryl monostearate, dissolve, and then add the liquid to D product, i.e. E product;

[0078] (6) Take hydroxyphenyl ethyl ester 0.2g and glycerol 5ml, dissolve in distilled water 40ml to obtain water phase, i.e. F product;

[0079] (7) Take 22g of E product and add to F product. Constant temperature at 80°C, uniform speed stirring for 5min, and add 0.3ml of triethanolamine. Stop heating, continue stirring to room temperature to obtain the base. Take 18mL of C product and add to the above base. Stir evenly to obtain the ointment.

[0080] Usage and dosage: external use, take an appropriate amount of ointment and apply evenly to the affected area, three times a day.

[0081] Example 3.

[0082] 1. Prescription: Tripterygium 100g, Coptis 80g, Rhubarb 60g, Saposhnikovia 60g, Schizonepeta 60g, Angelica 60g, White Peony Root 60g, Sophora 60g, borneol 20g, licorice 35g, menthol 20g.

[0083] 2. Ointment preparation method:

[0084] (1) Take the prescription drug except borneol and menthol, crush into coarse powder, soak in 95% alcohol for 35 minutes, then reflux extract at a temperature of 220°C for 2.5 hours. Filter to collect the juice. The residue is reserved. Concentrate the filtered juice to a drug liquid containing 15g / mL of crude drug at 65°C. Obtain the alcohol extraction concentrate, i.e. A product;

[0085] (2) Take the filtered drug residue in step (1) and add water to cover the drug surface. Heat to reflux at a temperature of 220°C for 2.5 hours. Remove the residue and collect the juice. Concentrate at 65°C. Concentrate to a drug liquid containing 15g / mL of crude drug. Obtain the water extraction concentrate, i.e. B product;

[0086] (3) Take A and B together, stir evenly, get C;

[0087] (4) Dissolve liquid paraffin 11 ml, vaseline 3.5 g, stearic acid 15 g, lanolin 6 g at 90 ℃ constant temperature, stir evenly, get oil phase, namely D product;

[0088] (5) Take the prescribed amount of borneol and menthol, crush into coarse powder, add 4.5 g of glyceryl monostearate to dissolve, after dissolution is completed, add liquid to D product, namely E product;

[0089] (6) Take hydroxyphenyl ethyl ester 0.4 g and glycerol 7 ml to dissolve in distilled water 60 ml, get water phase, namely F product;

[0090] (7) Take 26 g of E product to F product, constant temperature 90 ℃, uniform speed stirring 15 min, and add 0.4 ml of triethanolamine, stop heating, continue stirring to room temperature, get base, take C product 22 ml to the above base, stir evenly, get ointment.

[0091] Usage and dosage: external use, take appropriate amount of ointment and evenly apply to the affected area, three times a day.

[0092] Example 4.

[0093] 1. Prescription: Tripterygium 80 g, Coptis 50 g, Rhubarb 60 g, Saposhnikovia 10 g, Schizonepeta 40 g, Angelica 30 g, White Peony Root 20 g, Sophora 40 g, borneol 15 g, licorice 10 g, menthol 20 g.

[0094] 2. Ointment preparation method:

[0095] (1) Take the prescription of borneol and menthol, crush into coarse powder, soak the drug surface with 95% alcohol for 30 minutes, then reflux extract at 190 ℃ for 2 hours, filter to collect the drug juice, filter to collect the drug juice, and the drug residue is reserved. The drug juice obtained by filtration is concentrated at 60 ℃ to a drug liquid containing 12.4 g of crude drug per ml, to get alcohol extract concentrate, namely A product;

[0096] (2) Add water to the filtered drug residue in step (1) to cover the drug surface, heat reflux extract at 190 ℃ for 2 hours, remove the residue and collect the juice, concentrate at 65 ℃ to a drug liquid containing 12.4 g of crude drug per ml, to get water extract concentrate, namely B product;

[0097] (3) Take A and B together, stir evenly, get C;

[0098] (4) Take liquid paraffin 10 ml, vaseline 3.5 g, stearic acid 12 g, lanolin 5 g, dissolve at constant temperature of 80-90℃, stir evenly, get oil phase, namely D product;

[0099] (5) Take the prescribed amount of borneol and menthol, crush into coarse powder, add 4 g of glyceryl monostearate to dissolve, after dissolution is completed, add the liquid to D product, namely E product;

[0100] (6) Take hydroxyphenyl ethyl ester 0.35 g and glycerol 6 ml, add to distilled water 55 ml to dissolve, get water phase, namely F product;

[0101] (7) Take 25 g of E product and add to F product, constant temperature 80℃, uniform speed stirring 10 min, and add 0.3 ml of triethanolamine, stop heating, continue stirring to room temperature, get base, then take C product 20 ml and add to the above base, stir evenly, get ointment.

[0102] Usage and dosage: external use, take appropriate amount of ointment and evenly apply to the affected area, three times a day.

[0103] Example 5.

[0104] 1. Prescription: Tripterygium 40 g, Coptis 25 g, Rhubarb 30 g, Saposhnikovia 20 g, Schizonepeta 60 g, Angelica 50 g, White Peony Root 10 g, Sophora 45 g, borneol 10 g, licorice 20 g, menthol 10 g.

[0105] 2. Ointment preparation method:

[0106] (1) Take the prescription of borneol and menthol, crush into coarse powder, soak the drug surface with 95% alcohol for 25 minutes, then reflux extract at 210℃ for 2.5 hours, filter to collect the drug juice, filter to collect the drug juice, and the drug residue is reserved, the filtered drug juice is concentrated at 55℃ to a drug liquid containing 13 g of crude drug per ml, get alcohol extract concentrate, namely A product;

[0107] (2) Add water to the filtered drug residue in step (1) to cover the drug surface, heat reflux extract at 210℃ for 1.5 hours, remove the residue and concentrate the juice at 60℃ to a drug liquid containing 13 g of crude drug per ml, get water extract concentrate, namely B product;

[0108] (3) Combine A product and B product together and stir evenly to get C product;

[0109] (4) Put liquid paraffin 11 ml, vaseline 2.5 g, stearic acid 12 g, lanolin 5.5 g into a beaker and dissolve at constant temperature of 85℃, get oil phase, namely D product;

[0110] (5) Take the prescribed amount of borneol and menthol, crush into coarse powder, dissolve in 3.5 g of glyceryl monostearate, after dissolution, add the liquid to D product, i.e. E product;

[0111] (6) Take 0.4 g of hydroxyphenyl ethyl ester and 5 ml of glycerol, dissolve in 50 ml of distilled water to obtain the aqueous phase, i.e. F product;

[0112] (7) Take 23 g of E product and add to F product, constant temperature at 85°C, uniform speed stirring for 13 min, and add 0.36 ml of triethanolamine, stop heating, continue stirring to room temperature, to obtain the base, then take 20 ml of C product and add to the above base, uniform stirring, to obtain the ointment.

[0113] Usage and dosage: external use, take an appropriate amount of ointment and evenly apply to the affected area, three times a day.

[0114] Example 6.

[0115] 1. Prescription: Tripterygium 60 g, Coptis 50 g, Rhubarb 30 g, Saposhnikovia 30 g, Schizonepeta 30 g, Angelica 30 g, White Peony Root 30 g, Sophora 30 g, borneol 10 g, licorice 20 g, menthol 10 g.

[0116] 2. Preparation method of cream:

[0117] (1) According to the prescription proportion, take each medicinal material except borneol and menthol, crush into coarse powder, soak in 95% alcohol for 30 min, then reflux extract at 190-210°C for 2 hours, filter to collect the medicinal juice, and reserve the residue for use, then concentrate the filtered medicinal juice at 60°C to obtain a medicinal liquid containing 12.4 g of crude drug per ml, i.e. a product;

[0118] (2) Add water to cover the medicinal residue filtered in step (1), then reflux extract at 190-210°C for 2 hours, discard the residue and concentrate the juice at 60°C to obtain a medicinal liquid containing 12.4 g of crude drug per ml, i.e. b product;

[0119] (3) Mix a product and b product together, i.e. c product;

[0120] (4) Dissolve 9.5 ml of liquid paraffin, 3 g of vaseline, 12 g of stearic acid, and 5 g of lanolin at 85°C, i.e. d product;

[0121] (5) Take the prescribed amount of borneol and menthol, crush into coarse powder, dissolve in 5 g of glycerol monostearate, 20 ml of triethanolamine, 6 ml of glycerol, and 50 ml of distilled water, i.e. e product;

[0122] (6) Take d product at 70 DEG C, slowly add 70 DEG C e product, stirring saponification into oil-in-water emulsion base, take 20 mL of C product is added to the oil-in-water emulsion base, uniform stirring, get ointment.

[0123] Method of use: external use, take the appropriate amount of ointment evenly on the affected area, three times a day.

[0124] The present application has carried on a great deal of experimental research, the following is the experimental research results of the present application:

[0125] 1, classic case

[0126] Classic case 1

[0127] Zhou, female, 28 years old.

[0128] Complaint: recurrent double upper limbs red papulovesicles with itching 1+ years, recurrence 5 days.

[0129] Present illness history: 1+ years ago, no obvious cause of red papulovesicles on both upper limbs, obvious itching, self-purchased external use drugs (specific unknown) after use, skin lesions subsided, after that the upper symptoms recurred, no systematic diagnosis and treatment. 5 days ago, no obvious cause of the above symptoms aggravation, near for the combination of traditional Chinese and Western medicine system treatment, with the clinic in our hospital. TCM four diagnosis: red tongue, thin yellow fur, slippery pulse.

[0130] Physical examination: both upper limbs are light red spots, papules, and some skin lesions have a small amount of pigmentation.

[0131] Diagnosis:

[0132] (1) TCM diagnosis: dampness - wind (damp) heat skin syndrome.

[0133] (2) Western medicine diagnosis: chronic eczema.

[0134] Treatment plan:

[0135] (1) Chinese medicine oral:

[0136] Angelica 6g, schizonepeta 6g, wind 6g, periostracum cicada 6g, gips 6g, anemarrhena 6g, sophora 6g, hemp 6g, radix rehmanniae 6g, arctium 6g, licorice 3g, clematis 3g.

[0137] Chinese medicine 10, one dose (three times a day), oral.

[0138] (2) Chinese medicine rubbing treatment: thunder god soft ointment (preparation of example 1) (right upper limb).

[0139] (3) Dampness and itching ointment: (left upper limb).

[0140] Continuous medication for two weeks, recheck, the patient's right upper limb skin lesions were lighter than before, the itching was significantly relieved than before, the left upper limb skin lesions were not significantly relieved, the itching was slightly relieved. After evaluation, compound thunder god vine preparation (preparation of example 1) was used externally on both upper limbs, and the patient was rechecked after two weeks, the erythema and papules were significantly subsided, there was no itching, and a small amount of pigmentation was seen in the original lesion area. (See Figure 1 、 Figure 2 )

[0141] Classical case 2

[0142] Li, male, 42 years old.

[0143] Complaint: Recurrent red papules on both lower limbs for 2+ years, accompanied by itching.

[0144] Present history: 2+ years ago, red papules appeared on both lower limbs without obvious inducement, accompanied by obvious itching, and a small amount of exudation after scratching. The patient was diagnosed as "eczema" in an external hospital (details unknown), and the skin lesions were significantly relieved after treatment with external drugs (details unknown). Since then, the skin lesions have recurred, and the patient has not paid attention to it. Now the itching in the original lesion area is aggravated, and the patient comes to our hospital for further diagnosis and treatment.

[0145] TCM four diagnoses: red tongue, thin yellow fur, slippery pulse.

[0146] Physical examination: Both lower limbs are dark red, with a small amount of papules, thick and rough skin, mild infiltration in the lesion area, and lichenoid changes.

[0147] Diagnosis:

[0148] (1) TCM diagnosis: Shixuan—Feng (Shi) Re Yunchen.

[0149] (2) Western medicine diagnosis: Chronic eczema.

[0150] Treatment plan:

[0151] (1) Chinese medicine oral:

[0152] Angelica 6g, Schizonepeta 6g, Saposhnikovia 6g, Periostracum Cicadae 6g, Gypsum Fibrosum 6g, Anemarrhena 6g, Sophora 6g, Sesamum indicum 6g, Rehmannia glutinosa 6g, Atractylodes 6g, Arctium lappa 6g, Licorice 3g, Sargentcreeper 3g.

[0153] Chinese medicine 10, one dose per day (three times a day), oral.

[0154] (2) Chinese medicine rubbing treatment: Thunder God Vine Ointment (preparation of example 1) (left lower limb).

[0155] (3) Dampness and itching ointment: (right lower limb).

[0156] Continuous medication for two weeks, recheck, the patient's left lower limb papules were lighter than the right lower limb, the itching was significantly relieved than before, and a small amount of scales were seen in the original lesion area. (SeeFigure 1 、 Figure 2 )

[0157] Case 3

[0158] Zhang, male, 60 years old.

[0159] Complaint: Recurrent scattered red papules on both lower limbs with itching for 1+ years.

[0160] Present illness: 1+ years ago, the patient had no obvious cause of red papules on both lower limbs, with obvious itching, and a small amount of exudation after scratching. He was diagnosed with "eczema" in an external hospital (details unknown) and his skin lesions were significantly improved after treatment with external drugs (details unknown), with papules reduced, scabbed, and a small amount of scales. Since then, the skin lesions have recurred, and the patient has not paid attention to them or sought systematic diagnosis and treatment. Now the primary lesion area is more itchy, and there are scattered erythema and papules on both lower limbs. Today, he seeks further diagnosis and treatment in our hospital clinic.

[0161] TCM four examinations: red tongue, yellow and greasy fur, slippery pulse.

[0162] Physical examination: scattered erythema and papules on both lower limbs, thick and rough skin, mild infiltration in the lesion area, moss-like changes, scattered pigmented spots, and no obvious exudation.

[0163] Diagnosis:

[0164] (1) TCM diagnosis: Shixuan—Feng (Shi) Re Yufen syndrome.

[0165] (2) Western medical diagnosis: Chronic eczema.

[0166] Treatment plan:

[0167] (1) Chinese medicine oral:

[0168] Angelica 6g, Schizonepeta 6g, Saposhnikovia 6g, Periostracum Cicadae 6g, Gypsum Fibrosum 6g, Anemarrhena 6g, Sophora 6g, Sesamum indicum 6g, Rehmannia 6g, Atractylodes 6g, Arctium 6g, Licorice 3g, Sargentcolumbo 3g.

[0169] Chinese medicine 10, one dose per day (three times a day), oral.

[0170] (2) Chinese medicine rubbing treatment: Leigongteng ointment (preparation of Example 1) (right lower limb).

[0171] (3) Dampness and itching ointment: (left lower limb)

[0172] Continuous medication for two weeks, recheck, the patient's right lower limb is significantly improved than the left lower limb, the erythema and papules are reduced, the itching is relieved, and a small amount of scales are seen in the primary lesion area. The treatment plan is adjusted according to the patient's condition.

[0173] 2. Clinical experiment or pharmacodynamics experiment

[0174] 2.1 Case source

[0175] All cases of this subject come from the outpatients of the Department of Dermatology of the First Affiliated Hospital of Guizhou University of Chinese Medicine from April 2022 to January 2023, who meet the inclusion criteria and exclusion criteria. A total of 36 samples were collected, 2 were dropped, and 34 were completed.

[0176] 2.2 Diagnostic criteria

[0177] 2.2.1 Western diagnostic criteria

[0178] The skin lesions are dark red patches and papules, with a small amount of bran-like scales on the scratches, local skin thickening, rough surface, moss-like changes, varying in scope, pigmentation or regression, and obvious itching, mostly paroxysmal. Repeated attacks, sometimes mild, sometimes severe, lasting for several months or even longer. When acute, there may be obvious exudation.

[0179] Western diagnostic criteria: "Clinical Dermatology", "Dermatology and Venereology", "Chinese Medicine Diagnosis and Treatment Expert Consensus on Eczema (Dermatitis)"

[0180] 2.2.2 Chinese diagnostic criteria

[0181] Wind (wet) heat skin syndrome:

[0182] The main manifestations of skin lesions are red papules, scales, scabs, and not very obvious exudation, skin burning, unbearable itching and pain, and symptoms such as irritability and thirst, tongue edge red or tongue red with little moss, and pulse floating or floating.

[0183] Chinese diagnostic criteria: "Traditional Chinese Medicine Dermatology and Venereology", "Chinese Medicine Diagnosis and Treatment Expert Consensus on Eczema (Dermatitis)"

[0184] 2.3 Inclusion criteria

[0185] ① Meet the diagnostic criteria of western chronic eczema

[0186] ② Meet the diagnostic criteria of Chinese "chronic dermatitis"

[0187] ③ Age 18-75 years old

[0188] ④ Severity of disease: body surface area ≤20%

[0189] ⑤ Selection of target lesions: symmetrical distribution of lesions on limbs and trunk

[0190] ⑥ Sign the informed consent and voluntarily accept the test

[0191] 2.4 Exclusion criteria

[0192] ① Progress to acute and subacute eczema

[0193] ② Within the last 2 weeks, oral use of antihistamines and steroids, or external use of glucocorticoid preparations (moderate intensity)

[0194] ③ Patients with severe diseases of liver, kidney, hematopoietic system, etc. or mental disorders affecting the completion of the test

[0195] ④ Pregnant or lactating women

[0196] ⑤ Patients with known allergy to the drug components of this study

[0197] ⑥ Patients with respiratory distress, chest tightness, palpitations, shortness of breath, etc.

[0198] ⑦ Patients participating in other drug clinical trials

[0199] ⑧ Patients deemed by the investigator to be unsuitable for this trial

[0200] 2.5 Case loss and treatment

[0201] ① Patients with adverse events and complications who are not suitable for further testing

[0202] ② Patients with poor compliance who are not suitable for drug effect evaluation

[0203] ③ After case loss, complete the test CRF form

[0204] ④ Patients who drop out due to adverse reactions must be recorded in the CRF form and informed to the project leader after follow-up and determination of association with the test drug.

[0205] 2.6 Case termination and exclusion

[0206] ① During the test, if symptoms worsen or serious adverse reactions occur

[0207] ② Non-standardized treatment

[0208] ③ Occurrence of other diseases affecting test observation in the experiment, as judged by the researchers, to suspend observation of the test subjects

[0209] ④ Test subjects who are unwilling to continue observation and voluntarily withdraw

[0210] ⑤ Poor compliance makes it difficult to evaluate the effects of the drug

[0211] 2.7 Treatment regimen

[0212] Table 1 Treatment Method Table

[0213]

[0214] Note: The oral prescription is Xiaofengsan, and the specific prescription is:

[0215] Angelica sinensis 6g, Schizonepeta tenuifolia 6g, Saposhnikovia divaricata 6g, Cicadae periostracum 6g, Gypsum 6g, Anemarrhena asphodeloides 6g, Sophora flavescens 6g, Sesame 6g, Rehmannia glutinosa 6g, Atractylodes lancea 6g, Arctium lappa 6g, Glycyrrhiza uralensis 3g, Akebia trifoliata 3g.

[0216] 2.8 Course of medication

[0217] The study lasted for four weeks, with relevant observations, records, and analyses conducted at weeks 0, 2, and 4 of treatment.

[0218] 2.9 Efficacy observation indicators

[0219] The subjects' eczema area and severity index (EASI), pruritus intensity (VAS) were scored at weeks 0, 2, and 4 of treatment. The lesion area and DLQI score were measured before and after treatment.

[0220] 3. Eczema Area and Severity Index (EASI)

[0221] As shown in Tables 2 and 3, the area and severity of eczema on the skin lesions in the experimental group and the control group were scored respectively. The EASI value was calculated for each part, and finally the total EASI value of the two groups was calculated (total EASI score = A + B + C + D).

[0222] Table 2 EASI Scoring Table

[0223] Site EASI score A Head and neck (E+I+Ex+L) x area x 0.1 B Upper limbs (E+I+Ex+L) x area x 0.2 C Trunk (E+I+Ex+L) x area x 0.3 D Limbs (E+I+Ex+L) x area x 0.4

[0224] Note: E represents erythema, I represents edema or papules, Ex represents epidermal exfoliation, and L represents lichenification.

[0225] Table 3 EASI Scoring Table

[0226]

[0227]

[0228] 3.1 Variational Approach (VAS) for Itching Intensity

[0229] According to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines" (2002, China Medical Science and Technology Press), as shown in Table 4:

[0230] Table 4 VAS Scoring Table

[0231] Score Itching degree 0 points No itching 1 point Occasional itching, no need to take medicine, and will not affect normal life 2 points Paroxysmal itching, affecting normal life, need to take medicine 3 points Severe itching, severely affecting life

[0232] Note: Each level can be scored on a scale of 0.5.

[0233] 3.2 Measurement of target lesion area

[0234] ImageJ software is a multi-dimensional image processing software based on Java platform developed by the National Institutes of Health (NIH) in the United States, with the characteristics of open source, free, small size, etc. ImageJ is widely used in the medical field. As an objective evaluation method, through the setting of parameters, more accurate and repeatable data can be obtained, which is less affected by subjective cognition and experience [7] . Therefore, this topic uses digital camera combined with Image J medical image analysis software to more objectively measure the size of skin lesions and reduce errors.

[0235] 3.3 DLQI score

[0236] DLQI was filled in the CRF form before and after 4 weeks of treatment to observe the score changes.

[0237] 3.4 Patient self-evaluation

[0238] The color, odor, and texture of compound lepiglumine ointment were scored according to the four-level standard: 3 = excellent, 2 = good, 1 = medium, and 0 = poor.

[0239] 3.5 Overall efficacy evaluation

[0240] Efficacy indicators: A, B change value and improvement. The change value and improvement rate of EASI score are defined as follows:

[0241] EASI score change value = A - B

[0242] EASI score improvement rate = (A - B) ÷ A × 100%

[0243] Note: A: EASI score before treatment; B: EASI score after treatment

[0244] According to the clinical improvement degree, the overall efficacy was evaluated according to the four-level standard of recovery, significant effect, effectiveness, and ineffectiveness.

[0245] According to the clinical improvement before and after treatment, the main efficacy indicators were statistically analyzed, and the four-level standard was used to evaluate the recovery, significant effect, effectiveness, and ineffectiveness.

[0246] Recovery: EASI score improvement rate > 90%, basically no itching

[0247] Significant effect: EASI score improvement rate 60% - 89%, itching significantly reduced

[0248] Effective: EASI score improvement rate 20% - 59%, itching slightly relieved

[0249] Invalid: EASI score improvement rate <20%, itching is the same before and after treatment, or even worse 3.5 Clinical observation points and related matters needing attention

[0250] ①EASI score method of lesion area and severity index, record once before treatment, record once at 2 weeks and 4 weeks during treatment. Note the changes in the disease, and record if it is aggravated.

[0251] ②Patient self-assessment of pruritus score (VAS), record once before treatment, record once at 2 weeks and 4 weeks during treatment. Note the changes in the disease, and record if it is aggravated.

[0252] ③Target lesion area measurement: using digital camera combined with Image J medical image analysis software method, record once before treatment, record once at 2 weeks and 4 weeks during treatment.

[0253] ④Combined medication: record all the combined medications of patients during the study period, as well as external medications and emergency medications. And explain the specific drug situation.

[0254] ⑤For patient compliance: strengthen the pre-entry propaganda, sign the informed consent form, inform the patient of possible problems such as erythema and blister, and tell the use time and method in detail, and do not use drugs unrelated to this topic.

[0255] 3.6 Safety observation and evaluation

[0256] Table 5 Safety rating grading standard score

[0257]

[0258] Table 6 Degree of adverse reaction grading

[0259]

[0260]

[0261] Note: 1. Pay attention to the follow-up time after administration, record possible situations, and pay attention to whether there are skin irritation problems, including erythema, blisters and papules.

[0262] Laboratory tests: record blood routine, liver and kidney function before and after treatment, pay attention to whether the results are abnormal, and recheck if necessary. Evaluate whether it is related to the drug in this study, and record it. Patients with a history of serious adverse events are monitored, and the incidence of adverse reactions = the number of cases / total number of cases*100%.

[0263] 3.7 Statistical methods

[0264] The statistical software used is SPSS 25.0, and the measurement data is analyzed by The data are normal. The t-test was used for independent group comparisons and the paired samples t-test was used for paired group comparisons. Repeated measures data were analyzed using repeated measures ANOVA, and the LSD test was used for post-hoc pairwise comparisons. Count data are expressed as n (%), and the Mann-Whitney U test was used for comparisons between ordinal data. The significance level was set at P < 0.05 to indicate that the difference was statistically significant.

[0265] 4 Results

[0266] 4.1 General Situation Analysis

[0267] This study collected 36 samples, 2 of which were lost, resulting in 34 samples being completed.

[0268] 4.1.1 Gender composition of the research subjects

[0269] Figure 1 The gender distribution of 34 eczema patients is shown in the figure. Males accounted for 38.2% (13 cases), and females accounted for 61.8% (21 cases). Since the experimental and control groups used the same left and right sides of the patients for comparison, there was no difference in gender between the two groups, making them comparable.

[0270] 4.2 Efficacy Analysis

[0271] 4.2.1 Changes in EASI values ​​before and after treatment in the two groups

[0272] Table 7 Results of Repeated Measures ANOVA of EASI Scores Between the Two Groups

[0273]

[0274] Note: Repeated measures ANOVA was used for comparisons; *P<0.05 indicates within-group comparisons before treatment; # P indicates a comparison with the same group after 2 weeks of treatment;

[0275] The main effect of time on the comparison of EASI scores between the experimental group and the control group was statistically significant (F). 时间 =126.433, P 时间 <0.05), the main effect of group was statistically significant (F <0.05). 时间 =4.074, P 时间 <0.05), and the interaction between time and group was also statistically significant (F <0.05). 组别x时间 =7.379, P 组别x时间 <0.05).

[0276] Intergroup analysis showed no statistically significant difference in EASI scores between the two groups before treatment and at 2 weeks of treatment (P>0.05). At 4 weeks of treatment, the EASI scores in the experimental group were significantly lower than those in the control group, with statistical significance (P<0.05).

[0277] From the group analysis, EASI score test group, control group at different time difference were statistically significant (P<0.05), pairwise comparison results showed that EASI score before treatment and treatment 2 weeks, before treatment and treatment 4 weeks, treatment 2 weeks and treatment 4 weeks difference were statistically significant (P<0.05).

[0278] 4.2.2 Scratching degree score comparison

[0279] Table 8 Results of repeated measurement analysis of variance of VAS scores between the two groups

[0280]

[0281] Note: Comparison using repeated measurement analysis of variance; *P<0.05 indicates comparison before treatment; # P indicates comparison with the same group 2 weeks of treatment;

[0282] The time main effect of VAS score comparison between the test group and the control group was statistically significant (F 时间 = 607.667, P 时间 <0.05), the group main effect was statistically significant (F 时间 = 4.419, P 时间 <0.05), and the interaction of time and group was also statistically significant

[0283] (F 组别x时间 = 23.363, P 组别x时间 <0.05).

[0284] From the group analysis, VAS score before treatment, 2 weeks after treatment, the difference between the two groups was not statistically significant (P>0.05). VAS score 4 weeks after treatment, the test group was significantly lower than the control group, both were statistically significant (P<0.05).

[0285] From the group analysis, VAS score test group, control group at different time difference were statistically significant (P<0.05), pairwise comparison results showed that VAS score before treatment and treatment 2 weeks, before treatment and treatment 4 weeks, treatment 2 weeks and treatment 4 weeks difference were statistically significant (P<0.05).

[0286] 4.2.3 Comparison of curative effects of the two groups after treatment

[0287] Table 9 Comparison of clinical curative effects between the two groups of people

[0288]

[0289]

[0290] Note: Mann-Whitney U test was used for comparison; the difference in clinical efficacy between the two groups was statistically significant (P <0.05) by test, the rank mean of the test group was lower than that of the control group, indicating that the clinical efficacy of the test group was significantly better than that of the control group.

[0291] 4.2.4 Comparison of lesion area before and after treatment

[0292] Table 10 Comparison of lesion area level changes before and after treatment between the two groups

[0293]

[0294] Note: ImageJ medical image analysis software was used to calculate the lesion area, and the difference before and after treatment met the normality test, independent sample t test and paired sample t test were used for comparison; *P <0.05 indicates comparison between groups after treatment.

[0295] From the intergroup analysis, the difference in lesion area between the test group and the control group before treatment was not statistically significant (P >0.05) by independent sample t test. The lesion area of the test group was significantly lower than that of the control group after treatment, and the difference was statistically significant (P <0.05).

[0296] From the intra-group analysis, the difference in lesion area before and after treatment in the test group and the control group was statistically significant (P <0.05) by paired sample t test, indicating that the lesion area of the two groups after treatment was significantly smaller than that before treatment, and the lesion area of the test group was significantly lower than that of the control group, and the test group was better.

[0297] 4.2.5 Comparison of DLQI before and after treatment between the two groups

[0298] Table 11 Comparison of DLQI level changes before and after treatment between the two groups

[0299]

[0300] Note: The difference before and after treatment met the normality test, independent sample t test and paired sample t test were used for comparison; *P <0.05 indicates comparison between groups after treatment.

[0301] From the intergroup analysis, the difference in DLQI between the test group and the control group before treatment was not statistically significant (P >0.05) by independent sample t test. The DLQI of the test group was significantly lower than that of the control group after treatment, and the difference was statistically significant (P <0.05).

[0302] From the intra-group analysis, the difference in DLQI before and after treatment in the test group and the control group was statistically significant (P <0.05) by paired sample t test, indicating that the DLQI of the two groups after treatment was significantly lower than that before treatment, and the DLQI of the test group was significantly lower than that of the control group, and the test group was better.

[0303] 4.3 Patient self-evaluation

[0304] 4.3.1 Evaluation of the properties of the test drug

[0305] As shown in Table 12, 18 patients (52.94%) considered the color to be excellent, 16 patients (47.05%) considered the color to be good; 25 patients (73.52%) considered the texture to be excellent, 9 patients (26.47%) considered the texture to be good; 19 patients (55.88%) considered the odor to be excellent, and 15 patients (44.11%) considered the odor to be good.

[0306] Table 12 Evaluation of the properties of the compound tripterygium paste

[0307] Group Excellent Good Medium Poor Color 18(52.94) 16(47.05) 0(0.00) 0(0.00) Texture 25(73.52) 9(26.47) 0(0.00) 0(0.00) Odor 19(55.88) 15(44.11) 0(0.00) 0(0.00)

[0308] 4.4 Safety evaluation

[0309] During the treatment, no adverse reactions occurred in the test group and the control group, and no abnormalities were found in the blood routine, liver and kidney function of the subjects, and no adverse events occurred.

[0310] Table 13 Comparison of the incidence of adverse reactions

[0311] Group Number of cases Adverse reaction cases Test group 34 0 Control group 34 0

[0312] Table 14 Case dropout

[0313] Group Test group Control group Total Adverse events 0 0 0 Lost to follow-up 0 0 0 Work reasons 1 1 1 Other reasons 1 1 1

[0314] 5. Discussion

[0315] The theory of external treatment is the same as internal treatment, and the medicine of external treatment is the same as internal treatment, which laid the foundation for the theory of external treatment of TCM. External treatment of TCM is the characteristic and advantage of TCM, and has a long history. Compared with the traditional oral and injection administration, external treatment can avoid the 'first pass effect' of liver, improve the drug / metabolite ratio, reduce the gastrointestinal irritation, maintain constant blood drug concentration, prolong the action time of the drug, and the administration is relatively convenient, with good patient compliance and strong acceptability, and is widely used in clinical practice. Radix et Rhizoma Tripterygii has the effect of expelling wind and dampness, promoting blood circulation and removing obstruction in the collaterals, killing insects and detoxifying, which can be taken orally or used externally, and even can be made into tincture and ointment. Modern pharmacological studies have shown that the effective active ingredients of Radix et Rhizoma Tripterygii have the effect of inhibiting the expression of inflammatory factors. Based on the combination of the TCM theory of the drug and the pathogenesis of eczema, the compound Radix et Rhizoma Tripterygii ointment is used for external use in clinic. Radix et Rhizoma Tripterygii is bitter and cold in nature, and has the effects of expelling wind and dampness, promoting blood circulation and detoxification, which is the monarch drug for treating eczema. Rhizoma Coptidis is bitter and cold in nature, and has the effects of clearing heat and drying dampness, purging fire and detoxification, which is the ministerial drug when combined with Radix et Rhizoma Tripterygii. Radix et Rhizoma Rhei is bitter and cold in nature, and has the effects of clearing heat and purging fire, cooling blood and detoxification, and promoting dampness, which is the ministerial drug. 'Wind is the cause of itching', and expelling wind is essential for the treatment of pruritic skin diseases. Radix et Rhizoma Saposhnikoviae is pungent and sweet in nature, and is the main drug for relieving the exterior, which is characterized by warming and unblocking, and is combined with Herba Schizonepetae to enhance the ability of Radix et Rhizoma Tripterygii to expel wind and dampness, and to alleviate the toxicity of Radix et Rhizoma Tripterygii, which is known as'screening wind'. Radix et Rhizoma Angelicae is sweet and pungent in nature, and has the effects of tonifying blood and promoting blood circulation. 'Treat wind by treating blood first, and the wind will be eliminated when the blood flows', so attention should be paid to the blood aspect when treating wind, so that the blood and heat will be activated. Radix et Rhizoma Paeoniae is bitter in nature, and has the effect of nourishing blood, which can regulate the pungent nature of Radix et Rhizoma Tripterygii, and enhance the effect of treating blood, and is the auxiliary drug. Radix Sophorae is bitter in nature, and has the effects of clearing heat and drying dampness, and killing insects, which is the auxiliary drug. Borneol has the effects of clearing heat, detumescence, detoxification and relieving itching, and is combined with menthol to be the ministerial drug. Glycyrrhiza has the effects of clearing heat and detoxification, and regulating the compatibility of drugs, which is the ministerial drug. However, due to some shortcomings of external wash, such as inconvenience, difficulty in controlling water temperature, poor patient compliance, and other shortcomings, the preparation will be improved to facilitate the use of patients, improve the bioavailability of the drug, and enhance the clinical efficacy.

[0316] The external compound Radix et Rhizoma Tripterygii ointment has obvious effect in the treatment of eczema, can improve the EASI score, VAS score, DLQI score and the area of skin lesions of patients, has good properties and safety, and is worthy of further research and use in clinic.

Claims

1. A medicament for treating chronic eczema, characterized by: The medicinal effective components are calculated by weight components: 20-100 parts of Radix et Rhizoma Tripterygii, 25-80 parts of Rhizoma Coptidis, 10-60 parts of Radix et Rhizoma Rhei, 10-60 parts of Radix Saposhnikoviae, 10-60 parts of Herba Schizonepetae, 10-60 parts of Radix Angelicae Sinensis, 10-60 parts of Radix Paeoniae Alba, 10-60 parts of Radix Sophorae Flavescentis, 1-20 parts of Borneolum Syntheticum, 5-35 parts of Radix Glycyrrhizae, and 1-20 parts of Menthol; The medicine for treating chronic eczema is an external preparation, which is an ointment or a cream; The ointment preparation method is performed according to the following steps: (1) according to the prescription proportion, the medicines except Borneolum Syntheticum and Menthol are weighed and crushed into coarse powder, then soaked in 95% alcohol for 25-35 minutes, and extracted by refluxing at 180-220 DEG C for 1.5-2.5 hours, the medicine residue is reserved, the filtrate is concentrated at 55-65 DEG C to obtain a medicine liquid containing 10-15g / ml of crude drug, and an alcohol extraction concentrated liquid is obtained, which is a product A; (2) the medicine residue in step (1) is added with water to cover the medicine surface, extracted by refluxing at 180-220 DEG C for 1.5-2.5 hours, and the residue is removed, and the filtrate is concentrated at 55-65 DEG C to obtain a medicine liquid containing 10-15g / ml of crude drug, and a water extraction concentrated liquid is obtained, which is a product B; (3) the products A and B are combined and stirred uniformly to obtain a product C; (4) liquid paraffin 8-11ml, vaseline 2.5-3.5g, stearic acid 10-15g, and lanolin 4-6g are dissolved at 80-90 DEG C to obtain an oil phase, which is a product D; (5) Borneolum Syntheticum and Menthol are crushed into coarse powder, added into 3.5-4.5g of glyceryl monostearate, dissolved, and then added into the product D to obtain a product E; (6) 0.2-0.4g of hydroxyphenyl ethyl ester and 5-7ml of glycerol are added into 40-60ml of distilled water to obtain an aqueous phase, which is a product F; (7) 22-26g of the product E is added into the product F, stirred at 80-90 DEG C for 5-15 minutes, 0.3-0.4ml of triethanolamine is added, and then the mixture is stirred until it is cooled to room temperature to obtain a base, and 18-22ml of the product C is added into the base and stirred uniformly to obtain an ointment; The cream preparation method is performed according to the following steps: (1) according to the prescription proportion, the medicines except Borneolum Syntheticum and Menthol are weighed and crushed into coarse powder, then soaked in 95% alcohol for 25-35 minutes, and extracted by refluxing at 180-220 DEG C for 1.5-2.5 hours, the medicine residue is reserved, the filtrate is concentrated at 55-65 DEG C to obtain a medicine liquid containing 10-15g / ml of crude drug, and an alcohol extraction concentrated liquid is obtained, which is a product a; (2) the medicine residue in step (1) is added with water to cover the medicine surface, extracted by refluxing at 180-220 DEG C for 1.5-2.5 hours, and the residue is removed, and the filtrate is concentrated at 55-65 DEG C to obtain a medicine liquid containing 10-15g / ml of crude drug, and a water extraction concentrated liquid is obtained, which is a product b; (3) the products a and b are combined and stirred uniformly to obtain a product c. (3) a and b are mixed together and stirred to obtain c; (4) liquid paraffin 8-11 ml, vaseline 2.5-3.5 g, stearic acid 10-15 g, lanolin 4-6 g are dissolved at 80-90 °C constant temperature, stirred to obtain oil phase, stored at 70 °C for standby, namely d; (5) another prescription amount of borneol and menthol are crushed into coarse powder, added into 4.5-5.5 g of nipagin, 18-21 ml of triethanolamine, 5-7 ml of glycerol and 40-60 ml of distilled water to dissolve, after dissolution, water phase is obtained, heated to 70 °C for standby, namely e; (6) d is taken at 70 °C, slowly added into 70 °C e, stirred to saponify into oil-in-water emulsion base, 18-22 ml of c is taken and added into the oil-in-water emulsion base, stirred to obtain cream.

2. The medicament for treating chronic eczema according to Claim 1, wherein: The medicinal effective components are calculated according to weight components: 40-80 parts of tripterygium, 30-70 parts of coptis, 15-50 parts of rhubarb, 15-50 parts of siler, 15-50 parts of schizonepeta, 15-50 parts of angelica, 15-50 parts of white peony root, 15-50 parts of sophora, 5-15 parts of borneol, 10-30 parts of licorice and 5-15 parts of menthol are prepared.

3. The medicament for treating chronic eczema according to Claim 2, wherein: The medicinal effective components are calculated according to weight components: 60 parts of tripterygium, 50 parts of coptis, 30 parts of rhubarb, 30 parts of siler, 30 parts of schizonepeta, 30 parts of angelica, 30 parts of white peony root, 30 parts of sophora, 10 parts of borneol, 20 parts of licorice and 10 parts of menthol are prepared.

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