Traditional Chinese medicine composition for treating psoriasis as well as preparation method and application thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating psoriasis as well as a preparation method and application thereof. The traditional Chinese medicine composition for treating psoriasis is characterized by being prepared from the following raw materials in parts by weight: 2 to 16 parts of radix gentianae macrophyllae, 4 to 11 parts of radix sophorae flavescentis, 14 to 31 parts of herba hedyotidis diffusae, 14 to 31 parts of caulis lonicerae, 9 to 16 parts of caulis spatholobi and 9 to 16 parts of ramulus uncariae cum uncis. The traditional Chinese medicine composition for treating psoriasis not only plays a local treatment role through mechanisms of penetrating through striae and interstices, relaxing meridians, regulating qi and blood, expelling evil and strengthening body resistance and the like, but also penetrates into viscera through skin hair orifices to play a role of internal and external combined treatment. The traditional Chinese medicine composition is simple and convenient to use, convenient to carry and easy to popularize, the medication compliance of patients is effectively improved, and a guarantee is provided for the continuity of psoriasis treatment.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating psoriasis, and a preparation method and application thereof. Background Art

[0002] Psoriasis is one of the intractable diseases that are currently being studied in the field of dermatology at home and abroad. The disease is chronic and difficult to treat, and it recurs repeatedly. Long-term non-healing has a huge impact on the patient's physical and mental health and social life. At present, there is no consensus on the pathogenesis of the disease. Most people believe that it is caused or aggravated by certain genetic factors and various environmental factors. The disease has a long course, is prone to recurrence, and may damage the face, which has a huge impact on the patient's life and social interaction. The patient is in a state of depression and anxiety for a long time, and there is an urgent need to explore effective treatment methods.

[0003] The use of traditional Chinese medicine to treat psoriasis has certain advantages. It can not only effectively relieve the patient's skin lesions and itching pain, reduce recurrence, and improve the patient's quality of life, but also has few side effects and is inexpensive. Traditional Chinese medicine has long known about psoriasis. The records of "wind tinea", "dry psoriasis", "snake lice", "white scabies", and "white shell sores" in ancient books are similar to the characteristics of the disease, which is long, easy to relapse, lingering and difficult to cure. In severe cases, it spreads all over the body, with dry skin, hypertrophy, desquamation, and itching. Modern and contemporary doctors generally agree that "white scabies" is the TCM name for psoriasis. They believe that the onset of white scabies is caused by internal factors such as excessive constitution, emotional disorders, and improper diet, and external factors such as wind, cold, dampness, heat, and poison. Both internal and external evils are accumulated in the blood, so the treatment is mostly based on the blood.

[0004] Traditional Chinese medicine is effective in treating psoriasis vulgaris, and some progress has been made in verifying the etiology and pathogenesis. However, the pathological mechanism of psoriasis is complex, the course of the disease is long and difficult to cure, and further research is needed to clarify the cause of the disease and explore effective treatment methods to help patients reduce their pain. Summary of the invention

[0005] The technical problem solved by the present invention is that the pathological mechanism of psoriasis is complex, the course of the disease is long-lasting and difficult to cure.

[0006] In view of the above technical problems, the present invention provides a Chinese medicine composition and an extract thereof for treating psoriasis, which are used for the treatment of psoriasis and have achieved significant clinical effects.

[0007] Provide a traditional Chinese medicine for treating psoriasis

[0008] Specifically, the present invention provides the following technical solutions:

[0009] In the first aspect, the present invention provides a traditional Chinese medicine composition for treating psoriasis. The raw materials include, by weight: 2-16 parts of Gentiana macrophylla, 4-11 parts of Sophora flavescens, 14-31 parts of Hedyotis diffusa, 14-31 parts of Honeysuckle vine, 9-16 parts of Millettia spatholobi and 9-16 parts of Uncaria rhynchophylla.

[0010] Preferably, in parts by weight, the raw materials of the Chinese medicine composition include 2 to 8 parts of Gentiana macrophylla or 10 to 16 parts of Gentiana macrophylla; more preferably, the raw materials of the Chinese medicine composition include 5 to 7 parts of Gentiana macrophylla or 14 to 16 parts of Gentiana macrophylla. And / or

[0011] Preferably, the raw materials of the Chinese medicine composition include 5 to 11 parts of Sophora flavescens; more preferably, the raw materials of the Chinese medicine composition include 5 to 7 parts of Sophora flavescens or 9 to 11 parts of Sophora flavescens. And / or

[0012] Preferably, the raw materials of the Chinese medicine composition include 13 to 17 parts of Hedyotis diffusa; more preferably, the raw materials of the Chinese medicine composition include 14 to 16 parts of Hedyotis diffusa. And / or

[0013] Preferably, the raw materials of the Chinese medicine composition include 14 to 16 parts of honeysuckle vine. And / or

[0014] Preferably, the raw materials of the Chinese medicine composition include 14 to 16 parts of Millettia reticulata. And / or

[0015] Preferably, the raw materials of the traditional Chinese medicine composition include 9-11 parts of Uncaria rhynchophylla or 14-16 parts of Uncaria rhynchophylla. And / or

[0016] Preferably, the raw materials of the Chinese medicine composition also include Sargentodoxae, Achyranthes bidentata, Kochia scoparia, Cynanchum paniculatum, Bletilla striata and Angelica dahurica;

[0017] More preferably, the raw materials of the Chinese medicine composition include, by weight, 9-16 parts of Sargentodoxae, 5-10 parts of Achyranthes bidentata, 9-16 parts of Kochia scoparia, 4-11 parts of Cynanchum wilfordii, 9-16 parts of Bletilla striata, and 4-11 parts of Angelica dahurica.

[0018] Further preferably, in parts by weight, the raw materials of the Chinese medicine composition include 9-11 parts of Sargentodoxae; and / or, the Chinese medicine composition includes 8-10 parts of Achyranthes bidentata; and / or, the raw materials of the Chinese medicine composition include 14-16 parts of Kochia scoparia; and / or, the raw materials of the Chinese medicine composition include 9-11 parts of Cynanchum indica; and / or, in parts by weight, the raw materials of the Chinese medicine composition include 9-11 parts of Sophora flavescens; and / or, the Chinese medicine composition includes 9-11 parts of Angelica dahurica. and / or

[0019] Preferably, in parts by weight, the raw materials of the traditional Chinese medicine composition include: 5-7 parts of Gentiana macrophylla, 5-7 parts of Sophora flavescens, 14-16 parts of Hedyotis diffusa, 14-16 parts of Lonicera japonica, 14-16 parts of Millettia spatholobi, 9-11 parts of Uncaria rhynchophylla, 9-11 parts of Sargentodoxa chinensis, 8-10 parts of Achyranthes bidentata, 14-16 parts of Kochia scoparia, 9-11 parts of Cynanchum wilfordii, 9-11 parts of Bletilla striata and / or 9-11 parts of Angelica dahurica.

[0020] In a second aspect, the present invention provides a method for preparing a Chinese medicine composition for treating psoriasis, comprising the following steps: preparing the Chinese medicine composition by water extraction using raw materials of the Chinese medicine composition.

[0021] Preferably, the water extraction is decocting with water; and / or, preferably, the decocting is performed 2 to 3 times; more preferably, the decocting is performed 2 times. and / or

[0022] Preferably, 1 to 3 times the amount of water is added during the first decoction; more preferably, 1 to 2 times the amount of water is added during the first decoction; and / or, 1 to 3 times the amount of water is added during the second decoction; more preferably, 1 to 2 times the amount of water is added during the second decoction. and / or

[0023] And / or, preferably, the first decoction time is 15 to 30 minutes; more preferably, the first decoction time is 18 to 22 minutes; and / or, preferably, the second decoction time is 10 to 20 minutes; more preferably, the second decoction time is 13 to 17 minutes.

[0024] Preferably, the method further comprises concentrating and drying the decoction.

[0025] More preferably, the concentration is selected from the group consisting of reduced pressure evaporation concentration, thin film concentration, centrifugal separation or thin film evaporation; and / or, more preferably, the drying is selected from the group consisting of vacuum drying, spray drying, freeze drying or microwave drying.

[0026] Preferably, a traditional Chinese medicine composition for treating psoriasis is prepared by the method for preparing the traditional Chinese medicine composition for treating psoriasis.

[0027] In a third aspect, the present invention provides a traditional Chinese medicine preparation for treating psoriasis, wherein the traditional Chinese medicine preparation for treating psoriasis comprises the traditional Chinese medicine composition for treating psoriasis.

[0028] Preferably, the Chinese medicine preparation for treating psoriasis comprises an external medicine preparation or an internal medicine preparation. And / or

[0029] Preferably, the mass percentage of the Chinese medicine composition for treating psoriasis in the external medicine preparation is greater than 10%; more preferably, the mass percentage of the Chinese medicine composition for treating psoriasis in the external medicine preparation is 10% to 20%. And / or

[0030] Preferably, the mass percentage of the Chinese herbal composition for treating psoriasis in the internal medicine preparation is greater than 60%; more preferably, the mass percentage of the Chinese herbal composition for treating psoriasis in the internal medicine preparation is 60% to 80%.

[0031] Preferably, the Chinese medicine preparation for treating psoriasis further contains pharmaceutical excipients. And / or

[0032] Preferably, the oral drug preparation includes pills, pills, powders, tablets, pastes, decoctions, granules or capsules;

[0033] Alternatively, the external medicine preparation includes powder, aqueous solution, oil, tincture, vinegar, ointment, paste, emulsion, lotion, plaster, fumigation, colloidal solution, suppository, film, aerosol, gel, spray or pill. And / or

[0034] In a fourth aspect, the present invention provides a use of the Chinese medicine composition for treating psoriasis or the Chinese medicine preparation for treating psoriasis in the preparation of a drug for treating psoriasis;

[0035] Preferably, the invention is used in the preparation of a drug for treating blood stasis syndrome of psoriasis.

[0036] Beneficial Effects of the Invention

[0037] The Chinese medicine composition for treating psoriasis provided by the present invention can directly reach the affected area, is safe and convenient, and can improve symptoms and signs such as erythema and itching. It not only exerts a local therapeutic effect through the mechanisms of penetrating the pores, relaxing the meridians, regulating qi and blood, and expelling evil and strengthening the body, but also penetrates into the internal organs through the skin pores to play a role of internal and external treatment. Moreover, it is simple to use, easy to carry, easy to promote, effectively improves the patient's medication compliance, and provides a guarantee for the continuity of chronic disease treatment. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Figure 1 This is a diagram showing the distribution of patients' disease course.

[0039] Figure 2 This is a chart showing the patients' self-assessment of the inducing or aggravating factors. DETAILED DESCRIPTION

[0040] As described above, the object of the present invention is to provide a Chinese medicine composition for treating psoriasis and a preparation method and application thereof.

[0041] In the present invention, the first purpose is to provide a traditional Chinese medicine composition for treating psoriasis, wherein, by weight, its raw materials include: 2 to 16 parts of Gentiana macrophylla, 4 to 11 parts of Sophora flavescens, 14 to 31 parts of Hedyotis diffusa, 14 to 31 parts of Honeysuckle vine, 9 to 16 parts of Millettia spatholobi and 9 to 16 parts of Uncaria rhynchophylla.

[0042] Preferably, in parts by weight, the raw materials of the Chinese medicine composition for treating psoriasis also include 9-16 parts of Sargentodoxae, 5-10 parts of Achyranthes bidentata, 9-16 parts of Kochia scoparia, 4-11 parts of Cynanchum wilfordii, 9-16 parts of Bletilla striata and 4-11 parts of Angelica dahurica.

[0043] In some embodiments, the raw materials of the Chinese medicine composition for treating psoriasis include 2 to 16 parts of Gentiana macrophylla by weight. For example, in a specific embodiment, the raw materials of the Chinese medicine composition for treating psoriasis include 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 13.5, 14, 14.5, 15, 15.5 or 16 parts of Gentiana macrophylla, or contain Gentiana macrophylla within a numerical range consisting of any two of the above specific numerical values ​​as endpoints; and / or,

[0044] In some embodiments, the raw materials of the Chinese medicinal composition for treating psoriasis include 4 to 11 parts of Sophora flavescens by weight. For example, in a specific embodiment, the raw materials of the Chinese medicinal composition for treating psoriasis include 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 10.5 or 11 parts of Sophora flavescens, or Sophora flavescens within a numerical range consisting of any two of the above specific values ​​as endpoints; and / or,

[0045] In some embodiments, the raw materials of the Chinese medicinal composition for treating psoriasis include 14 to 31 parts of Hedyotis diffusa by weight. For example, in a specific embodiment, the raw materials of the Chinese medicinal composition for treating psoriasis include 14, 14.5, 15, 15.5, 16, 16.5, 17, 17.5, 18, 18.5, 19, 19.5, 20, 20.5, 21, 21.5, 22, 22.5, 23, 23.5, 24, 24.5, 25, 25.5, 26, 26.5, 27, 27.5, 28, 28.5, 29, 29.5, 30, 30.5 or 31 parts of Hedyotis diffusa, or contain Hedyotis diffusa within a numerical range consisting of any two of the above specific values ​​as endpoints; and / or,

[0046] In some embodiments, the raw materials of the Chinese medicinal composition for treating psoriasis include 14 to 31 parts of honeysuckle vine by weight. For example, in a specific embodiment, the raw materials of the Chinese medicinal composition for treating psoriasis include 14, 14.5, 15, 15.5, 16, 16.5, 17, 17.5, 18, 18.5, 19, 19.5, 20, 20.5, 21, 21.5, 22, 22.5, 23, 23.5, 24, 24.5, 25, 25.5, 26, 26.5, 27, 27.5, 28, 28.5, 29, 29.5, 30, 30.5 or 31 parts of honeysuckle vine, or contain honeysuckle vine within a numerical range consisting of any two of the above specific values ​​as endpoints; and / or,

[0047] In some embodiments, the raw materials of the Chinese medicinal composition for treating psoriasis include 9 to 16 parts of Millettia reticulata by weight. For example, in a specific embodiment, the raw materials of the Chinese medicinal composition for treating psoriasis include 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 13.5, 14, 14.5, 15, 15.5 or 16 parts of Millettia reticulata, or Millettia reticulata within a numerical range consisting of any two of the above specific values ​​as endpoints; and / or,

[0048] In some embodiments, the raw materials of the Chinese medicinal composition for treating psoriasis include 9 to 16 parts of Uncaria rhynchophylla by weight. For example, in a specific embodiment, the raw materials of the Chinese medicinal composition for treating psoriasis include 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 13.5, 14, 14.5, 15, 15.5 or 16 parts of Uncaria rhynchophylla, or Uncaria rhynchophylla within a numerical range consisting of any two of the above specific values ​​as endpoints; and / or,

[0049] In some embodiments, the raw materials of the Chinese medicinal composition for treating psoriasis include 9 to 16 parts of Sargentodoxae in parts by weight. For example, in a specific embodiment, the raw materials of the Chinese medicinal composition for treating psoriasis include 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 13.5, 14, 14.5, 15, 15.5 or 16 parts of Sargentodoxae, or Sargentodoxae within a numerical range consisting of any two of the above specific values ​​as endpoints; and / or,

[0050] In some embodiments, the raw materials of the Chinese medicine composition for treating psoriasis include 5 to 10 parts of Liujiu in parts by weight. For example, in a specific embodiment, the raw materials of the Chinese medicine composition for treating psoriasis include 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5 or 10 parts of Liujiu, or Liujiu within a numerical range consisting of any two of the above specific values ​​as endpoints; and / or,

[0051] In some embodiments, the raw materials of the Chinese medicinal composition for treating psoriasis include 9 to 16 parts of Kochia scoparia seeds by weight. For example, in a specific embodiment, the raw materials of the Chinese medicinal composition for treating psoriasis include 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 13.5, 14, 14.5, 15, 15.5 or 16 parts of Kochia scoparia seeds, or contain Kochia scoparia seeds within a numerical range consisting of any two of the above specific values ​​as endpoints; and / or,

[0052] In some embodiments, the raw materials of the Chinese medicine composition for treating psoriasis include 4 to 11 parts of Cynanchum chinense by weight. For example, in a specific embodiment, the raw materials of the Chinese medicine composition for treating psoriasis include 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 10.5 or 11 parts of Cynanchum chinense, or contain Cynanchum chinense within a numerical range consisting of any two of the above specific values ​​as endpoints; and / or,

[0053] In some embodiments, the raw materials of the Chinese medicinal composition for treating psoriasis include 9 to 16 parts of Bletilla striata in parts by weight. For example, in a specific embodiment, the raw materials of the Chinese medicinal composition for treating psoriasis include 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 13.5, 14, 14.5, 15, 15.5 or 16 parts of Bletilla striata, or Bletilla striata within a numerical range consisting of any two of the above specific values ​​as endpoints; and / or,

[0054] In some embodiments, the raw materials of the traditional Chinese medicine composition for treating psoriasis include 4 to 11 parts of Angelica dahurica by weight. For example, in a specific embodiment, the raw materials of the traditional Chinese medicine composition for treating psoriasis include 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 10.5 or 11 parts of Angelica dahurica, or contain Angelica dahurica within a numerical range consisting of any two of the above specific numerical values ​​as endpoints.

[0055] Formula Analysis

[0056] The patient's skin lesions persist for a long time and the disease recurs repeatedly, and the "dampness", "heat" and "stasis" are transformed into "poison". In the present invention, in the first group of six Chinese medicinal compositions: Uncaria, Sophora flavescens and Gentiana macrophylla are used to clear away heat and detoxify, and Hedyotis diffusa is used to remove blood stasis and detoxify, strengthen the body and expel evil; Millettia spatholobi is used to cool blood and promote blood circulation, dredge meridians and activate collaterals, and relieve hypertrophic and chapped skin lesions; Gentiana macrophylla, Uncaria and Lonicera japonica can eliminate internal and external wind evils, and relieve the symptoms of itching and desquamation caused by wind evils invading the skin; Sophora flavescens can eliminate dampness, remove dampness, and dry dampness, which can eliminate stubborn dampness and promote the disappearance of hypertrophic rash; long-term heat consumes yin blood, and the skin is not nourished, which can also cause dryness and desquamation in patients. Gentiana macrophylla and Millettia spatholobi can achieve the purpose of harmonizing qi and blood, and promoting blood circulation and unblocking collaterals. Gentiana macrophylla and Millettia reticulata are the main drugs, which can clear away heat, dispel wind, and activate blood circulation and dredge collaterals; Sophora flavescens and Uncaria rhynchophylla are the assistant drugs, which can clear away heat, dry dampness, activate blood circulation and detoxify; Hedyotis diffusa can detoxify and strengthen the body, and Honeysuckle can clear away heat, detoxify, and dredge collaterals, and they are the adjuvant drugs. Together, they have the effects of clearing away heat, dispelling wind, removing dampness, activating blood circulation, removing blood stasis and dredge collaterals.

[0057] In the second group of twelve Chinese herbal medicine compositions: Uncaria rhynchophylla, Sargentodoxae, Sophora flavescens and Gentiana macrophylla are used to clear away heat and detoxify, Hedyotis diffusa and Bletilla striata are used to remove blood stasis, detoxify, strengthen the body and expel evil; Millettia spatholobi, Achyranthes bidentata and Cynanchum grandiflorum are used to cool blood and promote blood circulation, dredge meridians and activate collaterals, and relieve hypertrophic and chapped skin lesions; Gentiana macrophylla, Uncaria rhynchophylla, Lonicera japonica, Cynanchum grandiflorum and Angelica dahurica can remove internal and external wind evil, and relieve the symptoms of itching and desquamation caused by wind evil invading the skin; Cynanchum grandiflorum, Angelica dahurica, Sophora flavescens and Kochia scoparia can remove dampness, eliminate dampness and dry dampness, which can eliminate stubborn dampness and promote the disappearance of hypertrophic rash; long-term heat can damage yin and blood, and the skin lacks nourishment, which can also lead to dryness and desquamation in patients. Gentiana macrophylla, Millettia spatholobi and Sargentodoxae can achieve the purpose of harmonizing qi and blood, and activating blood circulation and dredge collaterals. Gentiana macrophylla and Millettia reticulata are the main drugs, which can clear away heat, dispel wind, and activate blood circulation and dredge collaterals; Sargentodon grandiflora, Sophora flavescens, Kochia scoparia, and Uncaria rhynchophylla are the assistant drugs, which can clear away heat, dry dampness, activate blood circulation and detoxify; Angelica dahurica and Cynanchum chinense can dispel wind and dampness, Hedyotis diffusa and Bletilla striata can detoxify and strengthen the body, Achyranthes bidentata can break blood circulation and dredge menstruation, and Honeysuckle can clear away heat, detoxify, and dispel wind and dredge collaterals, which are the adjuvant drugs. Together, they can achieve the effects of clearing away heat, dispelling wind and dampness, activating blood circulation, removing blood stasis and dredge collaterals.

[0058] Compared with the first group of Chinese medicine compositions, the second group of Chinese medicine compositions has added Radix Sargentodoxae, Rhizoma Achyranthis Bidentatae, Fructus Kochiae, Radix Cynanchum, Rhizoma Bletillae and Radix Angelicae Dahuricae. It has enhanced the effect of "clearing away heat and detoxifying", and is more suitable for patients with blood stasis syndrome of psoriasis accompanied by joint pain caused by "dampness", "heat" and "stasis" combined into "toxicity". It has enhanced the effect of treating patients with blood stasis syndrome of psoriasis accompanied by sadness and trance. Rhizoma Cynanchum "relieves depression and regulates blood, replenishes qi and nourishes the kidney, calms the five internal organs, and harmonizes the mind", regulates emotions, regulates qi and blood, and can make the five internal organs calm, the emotions comfortable, and the qi and blood smooth. In addition, Liu Ji Nu can heal sores and reduce swelling, and treat psoriasis with blood stasis syndrome, in which the rash is red and swollen, and there is infection and swelling due to stimulation of the skin by external factors such as the six evils or internal injuries and the seven emotions; Bai Ying can clear away heat and detoxify, and treat the burning rash of psoriasis, obvious inflammatory reaction, or accompanied by sore throat and toxic heat; Bai Zhi can relieve the symptoms and dispel cold, and unclog the nasal passages, and treat psoriasis with blood stasis syndrome due to nasal obstruction caused by cold evil; Bai Zhi can reduce swelling and discharge pus to treat the burning rash of psoriasis with blood stasis syndrome, and obvious inflammatory reaction; the second group of Chinese medicine compositions has the function of treating psoriasis with blood stasis syndrome accompanied by toxic heat symptoms.

[0059] The Chinese medicine composition for treating psoriasis provided by the present invention reuses sweet and cold and bitter and cold products. Bitter and cold products are often used to treat psoriasis when using cooling blood and detoxifying drugs. Bitterness can dry dampness and release heat, and coldness can purge fire and detoxify, which is better than clearing heat and cooling blood. However, bitter and cold products are easy to consume and damage stomach yin and stomach yang when used for a long time. Large-scale use can damage the spleen and stomach, causing spleen and stomach deficiency and coldness, and Yangming stomach dryness. Nourishing yin and moistening dryness will hinder yang qi, and warming yang and replenishing qi will damage yin. Therefore, sweet and cold drugs are used together. Sweet drugs enter the spleen and have the effect of tonifying and harmonizing the middle. Sweet and cold drugs are used together to eliminate fire without offending the stomach, clear the heat of the blood, and can also produce body fluids to tonify the middle and protect the spleen and stomach. They are especially used when the course of the disease is long.

[0060] Composition drug analysis

[0061] Qinjiao, with a pungent, bitter and slightly cold nature, enters the stomach, liver and gallbladder meridians. It has the effects of removing rheumatism, relaxing tendons and collaterals, and clearing away heat. The "Famous Doctors' Records" believes that Qinjiao "treats wind, regardless of age". The "Compendium of Materia Medica" records that Qinjiao is "a moisturizer among wind-clearing medicines and a tonic among dispersing medicines", "moisturizing when wind is removed and tonic when dampness is removed", which can remove dampness and dissipate wind without drying the skin. It can also harmonize blood and relieve pain. The "Shennong's Herbal Classic" mentions that this medicine "controls cold and hot evil spirits, cold and dampness, and wind arthralgia", "arthralgia in the veins causes blood stasis". Wind, dampness and heat arthralgia block the blood vessels and cause blood stasis. Qinjiao can remove wind and dampness to nourish blood and unblock the veins. The "Revised Compendium of Materia Medica" records that it "is good at nourishing blood, so it can reduce fever and relax tendons". Professor Zhao Bingnan and Professor Zhang Zhili believe that Qinjiao has the effects of removing wind and unblocking the meridians and harmonizing qi and blood. Gentiana macrophylla contains a variety of chemical components, mainly iridoids, lignans, flavonoids, triterpenes, alkaloids, etc., which have anti-inflammatory, analgesic, antiviral, anticancer, and immunosuppressive activities. Saravanan et al. found that scutellaria baicalensis can significantly improve the symptoms of arthritis in rats, and its mechanism of action may be related to the reduction of IL-1β, the accelerated release of IL-10 and IL-4, and the inhibitory protein of nuclear transcription factor κB.

[0062] Sophora flavescens, bitter in taste and cold in nature, enters the heart, liver, stomach, large intestine and small intestine meridians, has the effects of clearing heat and drying dampness, dispelling wind and relieving itching, and is used to treat skin itching, scabies, malignant sores, genital sores, wet itching, burns, etc. "Bielu" records that it can "treat malignant sores in the lower part of the body", and "Yao Xing Lun" also records that Sophora flavescens can "treat heat toxic wind, skin and muscle irritability and sores." "Yunnan Materia Medica" says: "Cooling blood, relieving heat toxicity, scabies, pus nests and sores. Treat skin itching, blood wind ringworm sores, and naughty white scales." It indicates that Sophora flavescens can treat stubborn psoriasis, which can not only clear heat and detoxify, but also dry spleen dampness to resolve dampness and heat. As a commonly used Chinese medicine in clinical practice, Sophora flavescens has a lot of research on its main active ingredients such as oxymatrine, matrine and flavonoid compounds, and has confirmed its antibacterial, antiviral, hypoglycemic, hypolipidemic, antioxidant, anti-inflammatory, sedative, analgesic, anti-tumor, immunomodulatory, and cardioprotective effects. Zhang Lihua et al. found that the water extract of Sophora flavescens can reduce the levels of IL-6 and TNF-α in serum, increase the level of IL-10, and inhibit the expression of transcription factor RORγt, thereby reducing the differentiation of cells into Th17, thereby inhibiting the inflammatory response. Sang Xiuxiu et al. found that oxymatrine can significantly increase the levels of IL-10 and IL-27 in mouse serum, significantly reduce the expression of CD4+IL-17A, increase the proportion of regulatory T cell subsets, and reduce inflammatory cell infiltration.

[0063] Uncaria rhynchophylla is sweet in taste and slightly cold in nature. It belongs to the liver and pericardium meridians. It has the effects of clearing away heat and calming the liver, extinguishing wind and calming convulsions, and strengthening the effects of relaxing muscles and extinguishing wind. "Compendium of Materia Medica" records that it "relaxes muscles and eliminates dizziness, relieves qi and relieves fullness." "Compendium of Materia Medica" says: "It dispels wind evil without being dry, and is a product that is very moderate and harmonious." "Compendium of Materia Medica" says: "This thing is light, clear and cool, can relieve fire and calm wind. It is light and can penetrate hair, and clear and can relieve heat." Modern pharmacological studies have found that the chemical components in Uncaria rhynchophylla are of various types, mainly including alkaloids, terpenes, flavonoids and organic acids. It has multiple pharmacological effects such as protecting nerves, anti-atherosclerosis, anti-depression, and anti-inflammatory. Li Chao et al. found through the study of oxidative stress-induced inflammatory response that total Uncaria rhynchophylla alkaloids can protect vascular endothelial cells by enhancing autophagy to reduce the inflammatory response induced by oxidative stress. Its monomer rhynchophylline can also play a role in improving atherosclerosis through anti-thrombotic, anti-coagulant and anti-plate mechanisms. The alkaloid components of Uncaria rhynchophylla can exert antidepressant effects through multiple pathways, such as regulating the function of the hypothalamic-pituitary-adrenal axis, enhancing neurotrophic factors and reducing neuroinflammation.

[0064] Honeysuckle vine, sweet in taste, cold in nature, belongs to the lung and heart meridians, mainly clears away heat and detoxifies, dispels wind and dredges the collaterals, and is used for heat-toxic bloody diarrhea, carbuncle, sore, rheumatism and heat arthralgia. "Compendium of Materia Medica" records that it can "cure all rheumatism and swelling, carbuncle, scabies, bayberry sores, and dissipate heat and detoxify" as "the main medicine for reducing swelling, dispersing toxins, and treating sores." Modern medicine believes that it has pharmacological effects such as antibacterial, antiviral, anti-inflammatory, immunomodulatory, antioxidant, liver-protecting and gallbladder-promoting, anti-tumor, and hypoglycemic and lipid-lowering. Liu Lei et al.'s research shows that honeysuckle vine polysaccharide has strong in vivo and in vitro antioxidant activity, and has a strong scavenging ability for diphenyl picroyl free radicals in vitro, and the scavenging ability increases with the increase of polysaccharide concentration; in vivo, it significantly increases the activity of superoxide dismutase and glutathione peroxidase in the serum and liver of mice with liver damage, and reduces the content of malondialdehyde. Studies have shown that honeysuckle vine has strong antibacterial and anti-inflammatory effects. Sun Zhiping et al. used the drug pair of Millettia reticulata and Lonicera japonica to treat autoimmune diseases such as Henoch-Schonlein purpura and systemic lupus erythematosus, and achieved good clinical results.

[0065] Millettia reticulata tastes bitter and slightly sweet, is warm in nature, and enters the heart and spleen meridians. It nourishes blood, activates blood circulation, and promotes blood circulation. It can remove blood stasis and promote new blood circulation. It is a tonic among blood-moving medicines. Among the blood-nourishing and blood-activating medicines, Mr. Zhao loves Millettia reticulata the most, aiming to give full play to its important role in regulating the circulation of qi and blood in the human body, so as to achieve the purpose of harmonizing yin and yang. "New Reference to Medicinal Pieces" states that it "removes blood stasis, promotes new blood, and circulates the meridians." Modern research shows that the chemical components contained in Millettia reticulata are complex and diverse, mainly including flavonoids, anthraquinones, lignans, triterpenes and volatile oils, etc., showing multiple pharmacological activities such as regulating the blood system, anti-tumor, anti-inflammatory, antioxidant and immune regulation, and has an inhibitory effect on the activity of IL-2 and the transformation function of T lymphocytes. Wang Shanshan's research has confirmed that the ethanol extract of Millettia reticulata can improve the hematopoietic disorder of mice by increasing the number of white blood cells, regulating the level of hematopoietic factors, increasing the body's immune ability and the proliferation and differentiation of bone marrow hematopoietic progenitor cells. Yang Ranran found that the total extract of Millettia spatholobi can inhibit thrombosis induced by epinephrine hydrochloride, and the water extract has a higher thrombosis inhibition rate. Liu et al. showed that the three isoflavone compounds in Millettia spatholobi, formononetin sodium, formononetin, and chickpea sprouts, have the strongest anti-inflammatory activity. In addition, Millettia spatholobi also has anti-depression, immunomodulatory, and anti-obesity effects.

[0066] Oldenlandia diffusa is bitter and sweet in taste, cold in nature, and enters the heart, large intestine, liver, and spleen meridians. It mainly clears away heat, detoxifies, and promotes the removal of dampness. It can treat carbuncle, furuncle, and snake bites. This medicine is distributed in various places from southeast to southwest my country. The Chinese medicine records in Guangxi and Fujian and other places record that it can "externally treat white blister and snake scabies"; "clear away heat and detoxify, reduce inflammation and relieve pain"; "clear heat and disperse blood stasis, eliminate carbuncle and detoxify, and treat carbuncle, ulcer, and ulcer". Oldenlandia diffusa contains chemical components such as cyclopentane, flavonoids, and anthraquinones. Among them, cyclopentane is its main component, which has multiple pharmacological effects such as anti-inflammatory and anti-fibrosis. He et al. found that both sarcoside and sarcoside can significantly downregulate the levels of nitric oxide, TNF-α and interleukin-6 (IL-6) in cells, inhibit the high expression of inducible nitric oxide synthase (iNOS), cyclooxygenase-2 (COX-2), TNF-α and IL-6 mRNA, suggesting that its anti-inflammatory effect is related to the related proteins of nuclear transcription factor κB and mitogen-activated protein kinase signaling pathway. Geniposide protects melanocytes from hydrogen peroxide-induced oxidative damage by regulating the expression of downstream proteins in the PI3K-Akt pathway.

[0067] Sargentodendron chinense is bitter and neutral in nature. It belongs to the large intestine and liver meridians. It has the effects of clearing away heat and detoxifying, promoting blood circulation and removing wind. The "Compendium of Materia Medica" says that it can "attack blood and treat blood clots", which indicates the effect of Sargentodendron chinense in promoting blood circulation and removing blood stasis. Modern medicine shows that Sargentodendron chinense contains active ingredients such as rhubarb, rhubarb methyl ether, β-sitosterol, carotene, chrysophanol, vanillic acid, and protocatechuic acid. It has anti-inflammatory, anti-tumor, antibacterial, and immunosuppressive effects. It has the effect of promoting blood circulation and removing blood stasis. It can improve myocardial microcirculation, increase myocardial perfusion, reduce the degree of tissue adhesion, and has a certain therapeutic effect on infertility caused by fallopian tube obstruction. Liu Qing et al.'s research shows that Sargentodendron chinense can reduce the content of IL-6 and tumor necrosis factor-α (TNF-α) in the serum of rats with chronic inflammation, and inhibit the expression of inflammatory mediators and inflammatory factors. Jia Jiaojiao et al. found that total phenolic acids from Sargentodoxae can reduce the levels of IL-6 and TNF-α in animal brain tissue and serum neuron-specific enolase, increase the level of IL-10 in brain tissue, improve the degree of pathological damage in the hippocampus and cortex of the brain, and antagonize the decrease in the average perfusion volume of animal meningeal microcirculation.

[0068] Liu Ji Nu, bitter in taste and warm in nature, enters the heart, liver and spleen meridians, can break blood and dredge menstruation, heal sores and reduce swelling, treat amenorrhea, postpartum blood stasis, bleeding from wounds, carbuncle and swelling. "Tang Materia Medica": "It is mainly used to break blood and relieve swelling." "Kaibao Materia Medica": "It is an important medicine for treating wounds and stopping bleeding; it is also used for postpartum residual diseases, bleeding and pain relief." "Compendium of Materia Medica" says that Liu Ji Nu is "a magical medicine for breaking blood, it is good at moving, and it specifically enters the blood. It tastes bitter and enters the heart, and its warm nature is suitable for the spleen, so it enters both. The heart governs blood, and the spleen wraps blood, so it is specially used to treat blood diseases." "Compendium of Materia Medica" mentions that this medicine "bitterness can descend, pungent and warm can pass, and blood can flow when it is heated, so it can mainly break blood and relieve swelling." Modern medical research believes that it has certain anti-inflammatory and anticoagulant effects. In vitro experiments by Pan Yifeng and others found that Liujinu exhibited anti-inflammatory, anti-oxidative nitration, anti-platelet aggregation and vasodilatory effects, and may play a role in inhibiting vascular inflammation. Zhang Dandan and others found that ethyl acetate is one of the anti-inflammatory active components of Liujinu, which inhibits the expression of iNOS and COX-2 genes and proteins through the extracellular signal-regulated kinase signaling pathway in mitogen-activated protein kinase to achieve anti-inflammatory effects.

[0069] Kochia seeds are bitter and cold in nature. They are used in kidney and bladder meridians. They are mainly used for diuresis, stranguria, heat-clearing and dampness-removing, and itching. They can treat urticaria, sores, scabies, and genital itching. "Bielu" says that it can "remove heat from the skin, disperse sores, hernias, strengthen the yin, and make people moisturized." "Southern Yunnan Materia Medica" records that it can "wash away the wind from the skin." "Original Materia Medica" says: "Remove heat from the skin and eliminate itching from the skin." The main active ingredients of Kochia seeds are saponins, volatile oils, flavonoid compounds, etc., which have pharmacological effects such as hypoglycemic, anti-inflammatory, itching, and anti-infection. The triterpenoid saponins contained in Kochia seeds are the main biologically active ingredients, which have significant anti-inflammatory pharmacological effects. Liu Jianping et al. found that Kochia seeds total saponins can inhibit immediate allergic reactions, and the anti-allergic pruritus effect is stronger than the inflammatory effect of anti-allergic mediators. Li Peiyuan et al. found that Kochia seeds extracts showed good free radical decomposition and scavenging oxidation ability, and its scavenging oxidation ability increased with increasing concentration.

[0070] Xu Changqing is pungent and warm in nature and flavor. It belongs to the liver and stomach meridians. It mainly dispels wind and dampness, activates blood circulation and detoxifies. It is used for rheumatic pain, injuries from falls, urticaria, eczema, and stubborn ringworms. Ancient books record that it can "replenish qi, expel wind, and dredge collaterals and regulate blood." Xu Changqing has a variety of chemical components. So far, volatile oils, steroids, polysaccharides, flavonoids, etc. have been found. Modern pharmacological studies have shown that it has a wide range of analgesic, anti-inflammatory, antiviral, and neuroprotective effects. Among them, the main component, paeonol, has anti-inflammatory, antiviral, immune regulation, and cardiovascular and cerebrovascular protection. Wei et al. found that basil A and basil C in Xu Changqing can reduce the levels of TNF-α, IL-6, and IL-1β in the body by regulating the nuclear transcription factor κB and mitogen-activated protein kinase signaling pathways, and reduce the IL-1mRNA expressed by vascular endothelial cells, showing strong anti-inflammatory and antiviral effects. Wang Shunchun et al. found that the polysaccharide components of Cynanchum cyrtonema can affect the proliferation of immune cells, enhance the function of immune cells, and improve the body's immune ability. Jang et al. found that anthofen can directly inhibit the expression of peroxisome proliferator-activated receptor γ protein, thereby downregulating the expression of adipogenic genes and exerting an effective anti-lipogenesis effect.

[0071] Solanum lycopersicum is bitter in taste and slightly cold in nature. It belongs to the liver and stomach meridians. It mainly clears away heat and detoxifies, promotes dampness and reduces swelling. It can treat malignant sores, damp-heat jaundice, carbuncle, swelling, rheumatism and pain. "Shennong's Herbal Classic" says that it "tonifies the middle and replenishes qi, and long-term use can make the body light and prolong life." This corresponds to the anti-cancer effect of modern research. "Compendium of Materia Medica" records that it can treat "rubella, erysipelas, malaria". The effective ingredients of Solanum lycopersicum include water extract, alcohol extract, Solanum lycopersicum alkaloids, Solanum lycopersicum polysaccharides, etc. In addition to significant anti-cancer effects, it also has pharmacological effects such as regulating immunity, anti-oxidation, antibacterial, and anti-inflammatory. Solanum lycopersicum can mainly regulate innate immunity. Solanum lycopersicum alkaloids can significantly promote the proliferation and phagocytosis of T cells, B cells and peritoneal macrophages by increasing the index of immune organs such as spleen and thymus of animals and the level of interferon-γ in animal serum. And it has a bidirectional immune regulation ability related to the dosage. For example, at high concentrations, Solanum lycopersicum steroidal alkaloids show obvious immunosuppressive effects. White steroid compounds can also increase the mitochondrial membrane potential of inflammatory cells and achieve their anti-inflammatory effects by protecting mitochondria.

[0072] Angelica dahurica is pungent and warm in nature. It enters the stomach and lung meridians and can dispel wind and dampness, reduce swelling and relieve pain. It is used for carbuncle, ulcer, dry and itchy skin, and scabies. "Rihuazi Materia Medica" records that it can "break up old blood, replenish new blood... sores, scabies, relieve pain and promote tissue regeneration." "Yunnan Materia Medica" emphasizes that Angelica dahurica can "remove the wandering wind of the skin." "Shennong's Materia Medica" proposes that Angelica dahurica can protect the skin, "grow skin, moisturize its color", and can also whiten and remove spots. Angelica dahurica is a very widely used drug in clinical applications. At present, the research on the chemical composition of Angelica dahurica is mostly focused on volatile oils and coumarins. Studies have found that it has multiple effects such as analgesia, anti-inflammatory, anti-cancer, infection prevention, antioxidant, nerve protection, blood circulation improvement, and hypoglycemic. Ni Hongxia et al. found that the total coumarins and volatile oil compositions of Angelica dahurica may restore the balance of vasoactive substances, regulate the level and function of vasoactive substances, thereby reducing further damage to blood vessels and nerves and alleviating neurogenic inflammation. At the same time, Angelica dahurica has antioxidant activity and the ability to scavenge free radicals in vitro.

[0073] In the present invention, the second object is to provide a method for preparing a Chinese medicine composition for treating psoriasis, comprising the following steps:

[0074] The raw materials of the Chinese medicine composition are prepared by decocting with water. The decocting times are 2 times, 1 to 3 times the amount of water is added for the first decocting, the first decocting time is 15 to 30 minutes, and 1 to 3 times the amount of water is added for the second decocting, the second decocting time is 10 to 20 minutes.

[0075] Preferably, the method for preparing the traditional Chinese medicine composition for treating psoriasis further comprises concentrating and drying the decoction.

[0076] In the present invention, the third purpose is to provide a traditional Chinese medicine preparation for treating psoriasis, which comprises the traditional Chinese medicine composition for treating psoriasis or the traditional Chinese medicine composition for treating psoriasis and pharmaceutical excipients.

[0077] Preferably, the pharmaceutical excipients include one or more selected from the group consisting of plasticizers, colorants, opacifiers, flavoring agents, fillers and surfactants.

[0078] More preferably, the plasticizer comprises one or more selected from the group consisting of glycerol, ethylene glycol and sorbitol. And / or

[0079] More preferably, the colorant comprises a common food coloring. And / or

[0080] More preferably, the sunscreen comprises titanium dioxide. And / or

[0081] More preferably, the flavoring agent comprises sucrose and / or stevioside. And / or

[0082] More preferably, the filler comprises calcium carbonate and / or starch. And / or

[0083] More preferably, the surfactant includes one or more selected from the group consisting of polysorbate 80, sodium lauryl sulfate and soybean lecithin.

[0084] In the present invention, the fourth object is to provide a use of the Chinese medicine composition or the Chinese medicine preparation in the preparation of a drug for treating psoriasis;

[0085] Preferably, the invention is used in the preparation of a drug for treating blood stasis syndrome of psoriasis.

[0086] Psoriasis vulgaris is divided into blood heat syndrome, blood stasis syndrome and blood dryness syndrome. In clinical observation, it was found that patients with plaque psoriasis often have a long course of disease, with obvious leather-like hypertrophy and infiltration of skin lesions, dark red base color, difficult to subside, layers of scales, accompanied by varying degrees of itching, and can be diagnosed as blood stasis syndrome. In addition, most patients have severe conditions, which seriously affect their lives and work, and are easily accompanied by emotional disorders such as depression and anxiety. Blood stasis, that is, poor blood circulation, will block blood vessels. The onset of psoriasis is closely related to the disorder of "blood". Blood stasis is the main axis of the pathological transformation of syndromes and runs through the disease. The skin lesions are infiltrated and thickened for a long time, and the scales are layered. It is advisable to promote blood circulation and remove blood stasis. Blood stasis syndrome is characterized by chronicity and difficulty in healing. It is believed that it is closely related to long-term illness, weakness, dampness and blood stasis, and stagnation and obstruction of collaterals. It is often treated from the perspective of removing blood stasis and unblocking collaterals, breaking blood and dispersing knots, removing wind and dampness, and cooling blood and detoxifying.

[0087] Unless otherwise specified, the various reagents / instruments used in the examples and comparative examples of the present invention are conventional commercially available products. The source information of the reagents used in the present invention is shown in Table 1.

[0088] Table 1 Source information of reagents

[0089] Reagents purity Seller Gentiana macrophylla 100％ Beijing Xinglin Pharmaceutical Co., Ltd. Uncaria rhynchophylla 100％ Beijing Xinglin Pharmaceutical Co., Ltd. Sarcandra chinensis 100％ Beijing Xinglin Pharmaceutical Co., Ltd. Millettia reticulata 100％ Beijing Xinglin Pharmaceutical Co., Ltd. Liu Jinu 100％ Beijing Xinglin Pharmaceutical Co., Ltd. Kochia scoparia 100％ Beijing Xinglin Pharmaceutical Co., Ltd. Xu Changqing 100％ Beijing Xinglin Pharmaceutical Co., Ltd. Hedyotis diffusa 100％ Beijing Xinglin Pharmaceutical Co., Ltd. Bai Ying 100％ Beijing Xinglin Pharmaceutical Co., Ltd. Sophora flavescens 100％ Beijing Xinglin Pharmaceutical Co., Ltd. Angelica dahurica 100％ Beijing Xinglin Pharmaceutical Co., Ltd. Honeysuckle 100％ Beijing Xinglin Pharmaceutical Co., Ltd.

[0090] It should be noted that any commercially available or homemade Gentiana macrophylla, Uncaria rhynchophylla, Sargentodoxae, Millettia spatholobi, Achyranthes bidentata, Kochia scoparia, Cynanchum wilfordii, Hedyotis diffusa, Bletilla striata, Sophora flavescens, Angelica dahurica and Caulis lonicerae that meet the national drug standards of the Chinese Pharmacopoeia can be used in the present invention.

[0091] In order to better understand the technical solution of the present invention, the technical solution of the present invention is described in detail below in conjunction with specific embodiments.

[0092] Example 1

[0093] A traditional Chinese medicine composition for treating psoriasis, comprising, by weight, 6 parts of gentiana macrophylla, 6 parts of sophora flavescens, 15 parts of oldenlandia diffusa, 15 parts of honeysuckle vine, 15 parts of millettia spatholobi, 10 parts of Uncaria rhynchophylla, 10 parts of Sargentodoxa chinensis, 9 parts of Achyranthes bidentata, 15 parts of Kochia scoparia, 10 parts of Cynanchum wilfordii, 10 parts of Bletilla striata and 10 parts of Angelica dahurica.

[0094] Put all the above raw materials into a pot, soak them first, add water and boil them twice. For the first time, add 1 times the amount of water, soak for 30 minutes, boil over high heat, then switch to low heat and continue to boil for 20 minutes, pour out the liquid medicine for later use; for the second time, add 1 times the amount of water, boil over high heat, then switch to low heat and continue to boil for 15 minutes, pour out the liquid medicine. Mix the liquid medicine obtained from the first decoction and the liquid medicine obtained from the second decoction to obtain Qinteng Huoxue Decoction, and use it in clinical trials, see Application Example 1.

[0095] Example 2

[0096] A traditional Chinese medicine composition for treating psoriasis, comprising, by weight, 3 parts of gentiana macrophylla, 9 parts of sophora flavescens, 30 parts of oldenlandia diffusa, 30 parts of honeysuckle vine, 10 parts of millettia spatholobi, 12 parts of Uncaria rhynchophylla, 15 parts of Sargentodoxa macrophylla, 6 parts of Achyranthes bidentata, 10 parts of Kochia scoparia, 5 parts of Cynanchum wilfordii, 15 parts of Bletilla striata and 5 parts of Angelica dahurica.

[0097] Put all the above ingredients into a pot, soak them first, add water and boil them twice. For the first time, add 1 times the amount of water, soak for 30 minutes, boil over high heat, then switch to low heat and continue to boil for 20 minutes, pour out the liquid medicine and set aside; for the second time, add 1 times the amount of water, boil over high heat, then switch to low heat and continue to boil for 15 minutes, pour out the liquid medicine. Mix the liquid medicine obtained from the first decoction and the liquid medicine obtained from the second decoction to obtain Qinteng Huoxue Decoction.

[0098] The Qinteng Huoxue Decoction obtained in Example 2 also has the effect of treating psoriasis.

[0099] Example 3

[0100] A traditional Chinese medicine composition for treating psoriasis, wherein the raw materials include, by weight, 15g of gentiana macrophylla, 10g of sophora flavescens, 15g of oldenlandia diffusa, 15g of honeysuckle vine, 15g of millettia spatholobi and 15g of Uncaria rhynchophylla.

[0101] Put all the above raw materials into a pot, soak them first, add water and boil them twice. For the first time, add twice the amount of water, soak for 30 minutes, boil over high heat, then continue to boil over low heat for 20 minutes, pour out the liquid medicine for later use; for the second time, add 1 times the amount of water, boil over high heat, then continue to boil over low heat for 15 minutes, and pour out the liquid medicine. Mix the liquid medicine obtained by the first decoction and the liquid medicine obtained by the second decoction to obtain Qinteng Huoxue Decoction, and use it in clinical trials, see Application Examples 2 and 3.

[0102] Example 4

[0103] A traditional Chinese medicine composition for treating psoriasis, wherein the raw materials include, by weight, 10g of gentiana macrophylla, 6g of sophora flavescens, 30g of oldenlandia diffusa, 30g of honeysuckle vine, 10g of millettia spatholobi and 10g of Uncaria rhynchophylla.

[0104] Put all the above ingredients into a pot, soak them first, add water and boil them twice. For the first time, add twice the amount of water, soak for 30 minutes, boil over high heat, then switch to low heat and continue to boil for 20 minutes, pour out the liquid medicine and set aside; for the second time, add 1 times the amount of water, boil over high heat, then switch to low heat and continue to boil for 15 minutes, pour out the liquid medicine. Mix the liquid medicine obtained from the first decoction and the liquid medicine obtained from the second decoction to obtain Qinteng Huoxue Decoction.

[0105] The Qinteng Huoxue Decoction obtained in Example 4 also has the effect of treating psoriasis.

[0106] Application Example 1 (Clinical Study on the Qinteng Huoxue Decoction Obtained in Example 1)

[0107] Clinical trials

[0108] 1.1 Research Methods

[0109] 1.1.1 Basic Information

[0110] The observed cases were all patients with psoriasis vulgaris and blood stasis syndrome who visited the Dermatology Outpatient Department of Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University from December 2021 to February 2023.

[0111] 1.1.2 Diagnostic criteria

[0112] 1.1.2.1 Western medicine diagnostic criteria for psoriasis vulgaris

[0113] The diagnostic criteria for psoriasis vulgaris were established according to the Chinese Journal of Clinical Dermatology (2nd edition):

[0114] (1) Most cases develop acutely, and initially present as inflammatory red papules, about the size of millet or mung bean, which may gradually expand or merge into brown-red plaques with clear boundaries and obvious basal infiltration. The surface is covered with multiple layers of dry silvery-white scales. When the scales are scraped off, a layer of light red, shiny, translucent film gradually appears. When the film is scraped off again, punctate bleeding may be seen.

[0115] (2) Skin lesions are diverse in form and can be divided into various types such as guttate, coin-shaped, map-shaped, ring-shaped, band-shaped, plaque-shaped, and mixed, but with obvious boundaries.

[0116] (3) The rash can occur anywhere on the body, but is most common on the scalp and extensor side of the limbs. The nails and mucous membranes may also be affected, often in a symmetrical distribution, or in a few cases confined to a certain area.

[0117] 1.1.2.2 TCM diagnostic criteria for blood stasis syndrome in psoriasis vulgaris (white psoriasis)

[0118] Based on the Evidence-Based Clinical Practice Guidelines of Traditional Chinese Medicine for Psoriasis Vulgaris (White Bile) (2013 Edition) and referring to the syndrome differentiation criteria of blood stasis syndrome in the Chinese Psoriasis Diagnosis and Treatment Guidelines (2018 Complete Edition) issued by the Psoriasis Committee of the Chinese Society of Dermatology and Venereology:

[0119] Main symptoms: (1) The base of the rash is dark red; (2) The skin lesions are thickened and infiltrated, and the scales are firm.

[0120] Secondary symptoms: (1) The disease course is long, and the skin lesions are localized and do not disappear for a long time; (2) There may be varying degrees of itching, and the systemic symptoms are not obvious; (3) The tongue is dark red or has petechiae and ecchymosis; (4) The pulse is sluggish or thready.

[0121] Syndrome determination: A diagnosis can be made if all the main symptoms and two secondary symptoms are present.

[0122] 1.1.2.3 Disease severity classification standards

[0123] The severity of psoriasis is graded according to the body surface area score (BSA): mild: lesion area < 3% of body surface area; moderate: lesion area is 3% to 10% of body surface area; severe: lesion area > 10% of body surface area.

[0124] 1.1.3 Inclusion criteria

[0125] (1) Meet the diagnostic criteria for psoriasis vulgaris in Western medicine;

[0126] (2) Meet the syndrome differentiation criteria of white abscess and blood stasis in traditional Chinese medicine;

[0127] (3) Aged between 18 and 70 years old, regardless of gender;

[0128] (4) Disease severity: The degree of skin lesions is moderate (3<BSA<10).

[0129] 1.1.4 Sample size calculation

[0130] The design type of this study is a single-arm clinical trial. The main purpose is to observe the effectiveness of Qinteng Huoxue Decoction in the treatment of psoriasis with blood stasis syndrome. Therefore, the corresponding target value is selected for sample size calculation.

[0131] According to a multicenter randomized controlled study on the treatment of psoriasis vulgaris by oral administration of Chinese herbal decoctions by Chen Weiwen et al. (Chen Weiwen, Zhou Dongmei, Wang Ping, et al. Study on the treatment of psoriasis vulgaris by standardized prescriptions and medicines based on “blood differentiation as the main approach and blood-based treatment” [J]. Chinese Journal of Traditional Chinese Medicine, 2015, 30(10): 3614-3618), the total effective rate of 56.41% in the blood stasis syndrome group was used as the historical control (i.e., π0=56.41%). According to the previous clinical application, this study estimates that the total effective rate of Qinteng Huoxue Decoction prepared in Example 1 for the treatment of psoriasis blood stasis syndrome is 80% (i.e., π1=80%). According to the sample size calculation method of the single-group target value method (Formula 1), the single-group rate difference test was adopted, α=0.05, β=0.2 were set, and the sample size calculation was carried out. The estimated sample size was 27 cases. Considering the dropout rate of 10%, the sample size was expected to be 30 cases.

[0132]

[0133] Where n is the sample size, which is 27 according to the formula, α is the type I error or significance level, α = 0.05, 1-α is the confidence level, Z 1-α is the standard normal distribution of the significance level, β is the type II error, β = 0.2, 1-β is the test power, Z 1-β is the fraction of the standard normal distribution of power. π0 is the total effective rate of 56.41% in historical control, and π1 is the total effective rate of 80% expected in this study.

[0134] 1.1.5 Intervention methods

[0135] Take 400 mL of the Qinteng Huoxue Decoction obtained in Example 1 and divide it into 2 bags, each bag has 200 mL, take one bag each time, and take it warm half an hour after breakfast or dinner.

[0136] Treatment course: The treatment course is set at 8 weeks, and clinically cured patients will be followed up regularly.

[0137] Concomitant medication: Stop taking other dermatological drugs during treatment, and apply moisturizing preparations such as white vaseline and silicone cream externally.

[0138] Emergency medication: When the patient experiences unbearable itching, the doctor may give loratadine tablets 10 mg po Qn (orally, every night) according to the situation and record the dosage and number of times used.

[0139] Precautions: During clinical treatment, eat a light diet, avoid spicy and greasy foods, seafood, mutton and other irritating foods, and refrain from smoking and drinking; reduce the number of bathing times, reduce the use of daily chemical products with complex ingredients, avoid hot water washing and scratching; control your daily life, relax your emotions, and avoid wind and cold.

[0140] 1.1.6 Observation indicators

[0141] 1.1.6.1 General Data Observation

[0142] General information includes demographic indicators: age, gender, etc.; vital signs: height, weight, BMI, blood pressure, etc.; allergy history: history of allergies to drugs, food, and body surface contact; personal history: smoking, drinking history, weekly exercise volume; past history and treatment history: course of psoriasis, family history, previous inducing or aggravating factors, other diseases and treatment history; Chinese medicine symptoms: appetite, sleep, defecation, tongue, and pulse.

[0143] 1.1.6.2 Primary outcome measures

[0144] The internationally recognized Psoriasis Area and Severity Index (PASI) score was used to determine the clinical efficacy. Lesion area score (A): The body parts are divided into four major parts: head, upper limbs, trunk and lower limbs, accounting for 10%, 20%, 30% and 40% of the body surface area respectively, and the score is 0-6 points. Lesion severity score: It is divided into three items: erythema (E), infiltration (I), and scaling (D). The severity of each item is divided into 0-4 points, 0 points for no lesions, 1 point for mild, 2 points for moderate, 3 points for severe, and 4 points for very severe. See Table 2.

[0145] Table 2 Psoriasis Area and Severity Index (PASI) score

[0146]

[0147]

[0148] 1.1.6.3 Secondary outcome measures

[0149] (1) Main clinical syndrome scoring indicators of TCM for psoriasis blood stasis syndrome

[0150] Referring to the symptom classification and quantitative standard of white spot blood stasis syndrome in the "Guidelines for Clinical Research of New Chinese Medicines", four aspects of erythema color, degree of infiltration, degree of scaling, and degree of itching were selected to formulate the TCM syndrome score (tongue and pulse were not included in the score). According to the severity, it was recorded in order: 0 points = none, 3 points = mild, 5 points = moderate, and 7 points = severe. See Table 3.

[0151] Table 3 TCM syndrome scoring table for blood stasis syndrome in psoriasis vulgaris

[0152]

[0153]

[0154] (2) Patient self-assessed pruritus score (NRS)

[0155] The patient-rated pruritus score (NRS) is a numerical scale that asks patients to rate their worst perceived pruritus caused by psoriasis in the past 24 hours at each visit and describe it numerically. The pruritus NRS score ranges from 0 (no itch) to 10 (unbearable worst itch). This method requires patients to describe the itch intensity with 11 numbers from 0 to 10, with 0 being no itch, 1-3 being mild itch, 4-7 being moderate itch, >7 being severe itch, and 10 being unbearable itch.

[0156] (3) Dermatology Life Quality Index (DLQI)

[0157] The quality of life of patients before and after treatment was evaluated based on the DLQI score. There were 10 questions in total, including five aspects: symptoms, psychological activities, work status, daily behavior, and entertainment and leisure. Each question was scored from 0 to 3 points, with 0 points indicating no impact and 3 points indicating severe impact. The total score was 30 points. The higher the score, the worse the quality of life index. See Table 4.

[0158] Table 4 Dermatology Life Quality Index (DLQI)

[0159]

[0160]

[0161] (4) Nonspecific quality of life scale (SF-36)

[0162] The SF-36 scale is a brief health questionnaire developed by the Boston Health Research Institute in the United States in 1988. The development of the Chinese version of the SF-36 scale was basically completed in the 1990s. The SF-36 scale includes 8 dimensions, namely physical function, physiological function, pain, general health, vitality, social function, emotional function, mental health, and 1 self-assessment of health changes. The score is scored on a percentage basis, and the higher the score, the better the quality of life.

[0163] (5) Skin lesion area score (BSA)

[0164] The BSA score is an important indicator for calculating the overall skin lesion area of ​​psoriasis. BSA1% ≈ the skin lesion area, which is the size of a palm. Estimating the skin lesion area in this way can roughly judge the severity of the disease.

[0165] (6) Changes in the number of glomeruli under dermatoscope

[0166] All patients underwent dermoscopy before and after treatment to observe background color, scale morphology and vascular density. The distribution of blood vessels under the microscope was observed and counted. Under a 50x magnification lens, each dermoscopic field of view was divided into three equal parts horizontally and vertically to form a nine-square grid. The number of glomeruli in each grid was counted in the 1st, 3rd, 5th, 7th and 9th grids in the field of view, and the average value was taken.

[0167] 1.1.6.4 Safety indicators

[0168] (1) Observation of vital signs.

[0169] (2) Physical and chemical examination indicators: routine blood test, routine urine test, liver and kidney function test, etc.

[0170] (3) Skin irritation symptoms: burning, swelling, itching, etc.

[0171] 1.1.7 Efficacy evaluation indicators

[0172] The change in PASI score before and after treatment was used as the main efficacy indicator, and the four-level efficacy evaluation of the nimodipine method was adopted. The efficacy grading is as follows:

[0173] (1) Clinical recovery: efficacy index ≥ 95%;

[0174] (2) Markedly effective: 95%> efficacy index ≥ 70%;

[0175] (3) Effective: 70%> efficacy index ≥50%;

[0176] (4) Ineffective: efficacy index <50%.

[0177] Efficacy index = (PASI score before treatment - PASI score after treatment) / PASI score before treatment × 100, where the unit of efficacy index is %.

[0178] Total effective rate = (number of clinically cured cases + number of significantly effective cases + number of effective cases) / total number of cases × 100, where the unit of total effective rate is %, taking the unit of number of clinically cured cases as an example, the unit of number of significantly effective cases as an example, the unit of number of effective cases as an example, and the unit of total number of cases as an example.

[0179] 1.1.8 Observation time points

[0180] At week 0, the general information of the enrolled patients was recorded, including age, gender, vital signs, allergy history, family history, medical history, TCM symptoms, inducing and aggravating factors, and other comorbidities. Before treatment, the skin lesions were photographed, and blood routine, urine routine, liver function and renal function tests were performed, and dermoscopy was performed. The clinician filled in the TCM syndrome score, skin lesion area and severity score (PASI), and instructed the patients to fill in the TCM body weight scale, skin disease life quality score (DLQI), SF-36 scale, and NRS score of pruritus. The skin lesions were photographed again during the follow-up visits at the 2nd, 4th and 6th weeks of treatment, and the TCM syndrome score of the patients and the BSA score, PASI score, and NRS score of pruritus were recorded. After 8 weeks of treatment, blood routine, urine routine, liver function and renal function tests were rechecked, and dermoscopy was performed. The clinician completed the TCM syndrome analysis, skin lesion area and severity score (PASI), and the patients filled in the skin disease life quality score (DLQI), SF-36 scale, and NRS score of pruritus. Regular follow-up was conducted after the end of the study, and timely re-examination was conducted when the condition worsened, and the recurrence of the disease was recorded.

[0181] 1.1.9 Statistical analysis

[0182] SPSS26.0 statistical software was used to analyze the collected clinical data. The corresponding t test was used for the measurement data that conformed to the normal distribution; if not, the corresponding nonparametric test was used. The chi-square test was used for the count data, and the rank sum test was used for the rank data. The measurement data were expressed as mean ± standard deviation (x ± s). The test level was α = 0.05, P < 0.05 indicated that the difference was statistically significant, and P > 0.05 indicated that the difference was not statistically significant.

[0183] 1.2 Results

[0184] 1.2.1 Clinical case selection and completion status

[0185] From December 2021 to February 2023, a total of 30 patients with blood stasis syndrome of psoriasis vulgaris who met the inclusion and exclusion criteria were enrolled.

[0186] 1.2.2 General Data Analysis

[0187] A total of 30 patients were included in this study, including 17 male patients, accounting for 56.67% of the total number; 13 female patients, accounting for 43.33% of the total number; the oldest was 63 years old, the youngest was 27 years old, and the average age was 39.47±9.66 years old; the longest course of disease was 42 years, the shortest was 1 year, and the average course of disease was 13.67±9.57 years. Figure 1; 9 patients (30%) had a family history of psoriasis vulgaris, and 21 patients (70%) had no family history. In terms of concomitant diseases, 3 patients suffered from hypertension and reported that their blood pressure was well controlled; 2 patients suffered from diabetes and reported that their blood sugar control was acceptable; all of the above patients took relevant medications, and the recent review of relevant indicators showed no obvious abnormal fluctuations compared with the previous period. Among them, 7 patients had a history of smoking (23.33%), and none of them quit smoking; 5 patients had a history of drinking (16.67%), and 3 of them had quit drinking; the maximum amount of exercise was 10 hours / week, and the minimum amount of exercise was 0 hours / week. 16 patients did not exercise at all (53.33%), 6 patients exercised 2 hours / week (20%), 4 patients exercised 3-5 hours / week (13.33%), and 4 patients exercised 6-10 hours / week (13.33%).

[0188] According to the Chinese standard classification of BMI index, there were 4 patients with severe obesity (13.33%), all of whom were male (100%); 7 patients were obese (23.33%), including 4 males (57.14%) and 3 females (42.86%); 7 patients were slightly fat (23.33%), including 4 males (57.14%) and 3 females (42.86%); 12 patients were normal (40%), including 5 males (41.67%) and 7 females (58.33%).

[0189] According to the TCM constitution classification and determination table formulated by Professor Wang Qi of the Chinese Medical Association in 2009, the patients' constitution tendencies were analyzed. The results showed that there were 6 patients (20%) with damp-heat constitution, 6 patients (20%) with phlegm-damp constitution, 6 patients (20%) with blood stasis constitution, 4 patients (13.33%) with yang deficiency constitution, 3 patients (10%) with yin deficiency constitution, 2 patients (6.67%) with balanced constitution, 2 patients (6.67%) with qi stagnation constitution, and 1 patient (3.33%) with qi deficiency constitution.

[0190] 1.2.3 Predisposing or aggravating factors

[0191] Modern medicine is committed to studying the etiology and pathogenesis of psoriasis vulgaris. Current studies mostly believe that diet, living environment, infection, emotions, etc. are related to the induction or aggravation of the disease. Statistics of factors that patients self-assessed as being related to their own onset or aggravation showed that they were related to diet (spicy, seafood, beef and mutton), living environment (poor sleep quality, lack of exercise, moisture, fatigue, drinking, weather, smoking, seasonal changes), emotions (irritability, anxiety, irritability, tension), concurrent infection, trauma or pregnancy. Among them, the most common influencing factors were lack of exercise (40%), poor sleep quality (36.67%), eating seafood (36.67%), spicy food (30%), and anxiety (30%). See Figure 2 .

[0192] 1.2.4 TCM signs and symptoms

[0193] Traditional Chinese medicine emphasizes the importance of patients' appetite, sleep, bowel movements, tongue and pulse in disease diagnosis and syndrome differentiation and treatment, which are important components of observation, auscultation, inquiry and palpation in TCM medical records. Statistics on patients' appetite, sleep and bowel movements showed that most patients had good appetite (83.33%), peaceful sleep (60%), and regular bowel movements (90%); some patients had poor sleep quality, difficulty falling asleep (23.33%), easy awakening (20%), and late sleep (16.67%); some patients were thirsty (13.3%), had bitter taste in the mouth (3.33%), frequent yellow urine (3.33%), loose stools (3.33%), and dry and loose stools (3.33%). See Table 4.

[0194] The tongue and pulse of the patients were counted. The tongue color can be divided into red (60%), light red (16.67%), dark red (23.33%), and there are also side tooth marks (40%), middle cracks (13.33%), and tongue prick marks (6.67%). The tongue coating can be divided into yellow (36.67%) and white (63.33%). The coating can be divided into thin (26.67%), thick (10%), greasy (63.33%), moist (6.67%), and dry (3.33%). The pulse can be divided into floating (23.33%), slippery (63.33%), stringy (40%), rapid (30%), deep (16.67%), slow (3.33%), strong (3.33%), and thin (6.67%). See Table 5-8.

[0195] Table 5: Patients' sleep and bowel movements (per person)

[0196]

[0197]

[0198] Table 6 Patient tongue quality table (person)

[0199] red Light red Dark red Teeth marks crack Puncture 18 5 7 12 4 2

[0200] Table 7 Patients' tongue coating conditions (person)

[0201] white yellow Thin greasy thick Run dry 19 11 8 19 3 2 1

[0202] Table 8 Patient pulse condition table (person)

[0203] float slip string number Shen slow flood thin 7 19 12 9 5 1 1 2

[0204] 1.2.5 Body Surface Area Score (BSA)

[0205] The body surface area score (BSA) of the patients was evaluated. The BSA scores before and after treatment were in accordance with normal distribution (P>0.05), and paired T test was used. After treatment, the BSA score decreased from the 4th week compared with that before treatment, and the difference was statistically significant (P<0.01), indicating that the treatment can effectively reduce the area of ​​skin lesions. As shown in Table 9.

[0206] Table 9 Changes in BSA scores at each visit point before and after treatment (points)

[0207]

[0208] 1.2.6 TCM Syndrome Scoring

[0209] The TCM syndrome scores of patients at each visit point before and after treatment did not conform to normal distribution (P < 0.05), and the rank sum test was used. As shown in Table 10.

[0210] Table 10 Comparison of total and individual TCM syndrome scores of patients at each visit point (points)

[0211]

[0212] Note: Compared with week 0, *P<0.05, **P<0.01, ***P<0.001

[0213] As shown in Table 10, after 2 weeks of treatment, the total score of TCM syndrome was significantly different (P < 0.01); after 4 weeks of treatment, the total score of TCM syndrome was very significantly different (P < 0.001). Specifically, the symptom-related indicators of erythema color, infiltration degree, itching degree and scaling degree were analyzed, and the improvement of each indicator was not synchronized. After 2 weeks of treatment, only the itching degree was improved to a certain extent, and the difference was statistically significant (P < 0.05). After 4 weeks of treatment, it can be observed that the scores of various indicators have decreased. With the passage of time, the improvement of each TCM syndrome is different, especially the improvement of itching is the most obvious, and the comparison of TCM syndrome scores is very significantly different (P < 0.001). Among them, the improvement of erythema color was statistically significant at 4 weeks of treatment (P < 0.05), and the improvement was very significantly different after 6 weeks of treatment (P < 0.001). The degree of infiltration and scaling showed significant statistical improvement at 4 weeks of treatment (P < 0.01), and after 6 weeks of treatment, the improvement was very significant (P < 0.001). After 8 weeks of treatment, the scores of all indicators decreased. However, except for the pruritus score, the scores of the other indicators did not decrease by more than half, which means that the apparent improvement of skin lesions is lower than the subjective score of pruritus, which is also consistent with the long-term and difficult to cure of blood stasis syndrome in psoriasis. It can be seen that the improvement of hypertrophic infiltration, deep red base, layers of scaling and skin lesion area is a long-term and chronic process, which requires joint efforts of both doctors and patients to ensure the patient's medication compliance and positive and optimistic attitude, and correctly understand the intractability of this disease.

[0214] 1.2.7 NRS score for pruritus

[0215] Itch is an important symptom that troubles patients with skin diseases. Patients often form a vicious cycle of "itch-scratch-itch". Severe scratching can cause skin scratches and blood scabs. Therefore, the evaluation of the patient's itching level can also reflect the treatment effect of psoriasis. In this study, the pruritus numerical NRS score was used to evaluate the subjective itching caused by psoriasis. The higher the score, the more severe the itching. It is an effective method to quantify the patient's itching level. NRS is a digital and intuitive expression method. Its advantage is that it is more intuitive and uses numbers to express the intensity of the itching. It has a higher completion rate, is easy to understand and express, and is convenient to record. It is a simple and effective evaluation method suitable for patients with chronic itching.

[0216] The patients' pruritus numerical rating scale (NRS) was evaluated, and the NRS scores at each visit point before and after treatment were partially analyzed using paired T test and partially using rank sum test, as shown in Table 11.

[0217] Table 11 Changes in NRS scores at each visit point before and after treatment (points)

[0218]

[0219] As shown in Table 11, in the second week of treatment, the NRS score of the patients was significantly lower than that before treatment (P < 0.001), which was consistent with the TCM syndrome score. This shows that oral Qinteng Huoxue Decoction has a great improvement on the degree of itching.

[0220] 1.2.8 Psoriasis Area and Severity Score (PASI)

[0221] The Psoriasis Area and Severity Score (PASI) is currently the gold standard for evaluating the efficacy of psoriasis. The PASI scores of patients at each visit point before and after treatment were in accordance with normal distribution (P>0.05), and paired T test was used. As shown in Table 12.

[0222] Table 12 Changes in PASI scores at each visit point before and after treatment (points)

[0223]

[0224]

[0225] As can be seen from Table 12, after 2 weeks of treatment, the PASI score of the patients was lower than that before treatment, and the difference was statistically significant (P < 0.05). After 4 weeks of treatment, the PASI score had a very significant difference (P < 0.001). This shows that oral administration of Qinteng Huoxue Decoction prepared in Example 1 can effectively improve the area and severity of skin lesions in patients.

[0226] 1.2.9 Effectiveness of each visit point

[0227] Based on the PASI score, the effective rate at each visit point was calculated according to the nimodipine method, as shown in Table 13.

[0228] Table 13 Effectiveness of each visit point before and after treatment (person)

[0229] Each visit point Clinical recovery Significant effect efficient invalid Total effective rate (%) Week 2 0 0 0 30 0.00 Week 4 0 0 3 27 10.00 Week 6 0 3 6 21 30.00 Week 8 3 5 10 12 60.00

[0230] As shown in Table 13, in the second week of treatment, none of the patients achieved effective results; in the fourth week of treatment, three patients achieved effective results, with a total effective rate of 10%; in the sixth week of treatment, three patients achieved marked effect, and six patients achieved effective results, with a total effective rate of 30%; in the eighth week of treatment, three patients achieved clinical cure, five patients achieved marked effect, and ten patients achieved effective results, with a total effective rate of 60%.

[0231] 1.2.10 Number of glomeruli under dermatoscope

[0232] Dermatoscope is a simple, low-cost and non-invasive microscopic image analysis technology, which is widely used in inflammatory skin diseases. It can observe the skin background color, blood vessel morphology and distribution, scale thickness and color and other characteristics. Dermatoscope can magnify the subcutaneous tissue of the epidermis and papillary dermis, and is used to analyze the skin microcirculation from the morphological and functional perspectives, capture the image digitally and store it.

[0233] Psoriasis is one of the most common erythematosquamous skin diseases, and its main dermoscopic features are evenly distributed punctate blood vessels, silvery white scales, and bright red background. In recent years, there have been more and more studies on the use of dermoscopic changes to evaluate the efficacy of psoriasis vulgaris, and the improvement trend of psoriasis characteristics under dermoscopy is often correlated with the PASI score.

[0234] The number of glomeruli under dermatoscopy in the included patients was evaluated. The number of glomeruli before and after treatment did not conform to the normal distribution (P < 0.05). The rank sum test was used for comparison. As shown in Table 14.

[0235] Table 14 Changes in the number of glomeruli under dermatoscope before and after treatment (unit)

[0236] Dermoscopic indicators Before treatment After 8 weeks of treatment Z P Number of glomeruli under the microscope 15.95±7.03 7.41±5.05 -4.785 0.000

[0237] As can be seen from Table 14, the number of glomeruli in patients after treatment was significantly lower than that before treatment, and the difference was very significant (P<0.001), indicating that the Qinteng Huoxue Decoction prepared in Example 1 for oral administration has a good therapeutic effect on improving the microvascular function status under dermatoscopy in patients with psoriasis with blood stasis syndrome.

[0238] 1.2.11 Quality of life evaluation

[0239] The Dermatology Life Quality Index (DLQI) is a scale designed to develop more favorable treatment plans based on the way and degree of impact of dermatological diseases on patients' quality of life. The DLQI scale has only 10 questions, and the research content is mainly the impact of skin diseases on patients in the past 7 days, including physical, psychological, social activities, interpersonal relationships and occupational restrictions, family, treatment, etc. Each question uses a digital 4-level scoring method (0, 1, 2 and 3). It is suitable for evaluating the impact of skin diseases on patients and the efficacy of drugs. It is widely used to evaluate the degree of change in psoriasis before and after intervention, and has good reliability and validity for the quality of life of dermatological diseases. As a concise measurement scale, SF-36 has become the most widely used quality of life assessment tool in the world. It includes 8 dimensions and studies the impact on patients' quality of life from multiple angles, which is relatively comprehensive.

[0240] In this study, the patients' dermatological life quality scores (DLQI) were evaluated. The DLQI scores before and after treatment did not conform to the normal distribution (P < 0.05), and the paired sample nonparametric test was used. The patients' health survey short form (SF-36) scores were evaluated. The SF-36 scores before and after treatment conformed to the normal distribution (P > 0.05), and the paired T test was used. As shown in Table 15.

[0241] Table 15 Changes in the dermatology life quality score (DLQI) and health survey short form (SF-36) scores of patients before and after treatment (points)

[0242] Quality of life score Before treatment After 8 weeks of treatment Z / t P DLQI score 8.23±6.60 5.93±5.41 -4.581 0.000 SF-36 score 84.65±6.10 88.63±5.53 -9.654 0.000

[0243] As shown in Table 15, after treatment, the patient's dermatological life quality score (DLQI) decreased, and the difference was very significant (P < 0.001). After treatment, the patient's health survey short form (SF-36) score decreased, and the difference was very significant (P < 0.001). This shows that oral administration of Qinteng Huoxue Decoction prepared in Example 1 has a positive significance for improving the quality of life of patients with psoriasis and blood stasis syndrome.

[0244] 1.2.12 Safety indicators

[0245] In this study, 30 patients underwent laboratory safety tests before and after treatment, and no obvious abnormalities were found in the blood routine, urine routine, liver and kidney function and other examination indicators. No obvious adverse reactions were observed in the patients before and after treatment. One patient had a recurrence of rash, which was controlled after persistent treatment.

[0246] Application Example 2 (Clinical study of the Qinteng Huoxue Decoction prepared in Example 3)

[0247] The clinical observation came from patients with psoriasis and blood stasis syndrome who visited the outpatient clinic of the Dermatology Department of Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University from February 2022 to February 2024.

[0248] Among them, the diagnostic criteria, inclusion criteria, intervention methods, observation indicators, efficacy evaluation indicators and statistical analysis were the same as those in Application Example 1. The observation time point was once every 2 weeks, which was extended to 12 weeks. Among the observation indicators, the Psoriasis Lesion Area and Severity Score (PASI) standard, the Traditional Chinese Medicine Syndrome Scoring Standard, the Itch NRS Scoring Standard, and the Quality of Life Scoring (DLQI) standard were the same as those in Application Example 1.

[0249] Sample size calculation

[0250] The design type of this study is a single-arm clinical trial, and the main purpose is to observe the effectiveness of Qinteng Huoxue Recipe in treating psoriasis with blood stasis syndrome. Therefore, the corresponding target value is selected for sample size calculation.[3] A multicenter randomized controlled study on the treatment of psoriasis with oral Chinese herbal decoctions was conducted. The total effective rate of 56.41% in the blood stasis syndrome group was used as the historical control (i.e., π0 = 56.41%). Based on the previous clinical application, this study estimated that the total effective rate of Qinteng Huoxue Fang in the treatment of psoriasis blood stasis syndrome was 69% (i.e., π1 = 69%). According to the sample size calculation method of the single-group target value method, the difference test of the single-group rate was used, with α = 0.05, β = 0.2, and Z 1-α =1.96, Z 1-β =0.84 was substituted into the sample size calculation, and the estimated sample size was 81 cases. Taking into account the dropout rate of 20%, the expected sample size was 100 cases.

[0251]

[0252] Where n is the sample size, which is 81 according to the formula, α is the type I error or significance level, α = 0.05, 1-α is the confidence level, Z 1-α is the standard normal distribution of the significance level, β is the type II error, β = 0.2, 1-β is the test power, Z 1-β is the fraction of the standard normal distribution of power. π0 is the total effective rate of historical control, 56.41%, and π1 is the total effective rate expected in this study, 69%.

[0253] 1. Research Methods

[0254] Treatment medicine: Oral administration of the Qinteng Huoxue Decoction prepared in Example 3. Medicine composition: 15g of Gentiana macrophylla, 15g of Millettia spatholobi, 15g of Honeysuckle vine, 15g of Uncaria rhynchophylla, 10g of Sophora flavescens and 15g of Hedyotis diffusa.

[0255] Intervention method: Take 400 mL of Qinteng Huoxue Decoction obtained in Example 3, divide it into 2 bags, each bag is 200 mL, take one bag each time, and take it warm half an hour after breakfast and dinner. The course of treatment is set at 12 weeks, and clinically cured patients are followed up regularly.

[0256] Concomitant medication: Stop taking other dermatological drugs during treatment, and apply moisturizing preparations such as white vaseline and silicone cream externally.

[0257] Emergency medication: When the patient experiences unbearable itching, the doctor may give loratadine tablets 10 mg po Qn (orally, every night) according to the situation and record the dosage and number of times used.

[0258] 2. Results

[0259] 2.1 Patients’ demographics and baseline clinical data

[0260] A total of 100 clinical research samples were screened in this study, and 96 were actually included, including 59 males and 37 females; the oldest was 65 years old, the youngest was 23 years old, and the average age was 37.96±10.21 years old; the longest course of disease was 41 years, the shortest was 1.5 years, and the average course of disease was 12.65±8.46 years; 21 patients had a family history of psoriasis vulgaris, and 75 patients had no family history; in terms of concomitant diseases, 10 patients had hypertension and reported that their blood pressure was well controlled; 16 patients had diabetes and reported that their blood sugar control was acceptable; all of the above patients took relevant medications, and the recent review of relevant indicators showed no obvious abnormal fluctuations compared with the previous ones. Among them, 21 patients had a history of smoking, and none of them quit smoking; 15 patients had a history of drinking, and 3 of them had quit drinking.

[0261] According to the TCM constitution classification and determination table formulated by Professor Wang Qi of the Chinese Medical Association in 2009, the patients' constitution tendencies were analyzed. The results showed that the largest proportion of people with balanced constitution was 21 cases (21.9%), followed by damp-heat constitution in 20 cases (20.7%), phlegm-damp constitution in 13 cases (13.5%), qi stagnation constitution in 11 cases (11.5%), yin deficiency constitution in 9 cases (9.4%), blood stasis constitution in 9 cases (9.4%), qi deficiency constitution in 6 cases (6.3%), yang deficiency constitution in 3 cases (3.1%), and special constitution in 4 cases (4.2%).

[0262] 2.2 Evaluation of efficacy

[0263] (1) Qinteng Huoxue Decoction in the treatment of psoriasis area and severity index (PASI) score

[0264] The PASI score baseline value before treatment was compared with the follow-up time after treatment. The data of 96 patients were included and the repeated measures analysis of variance test was used. The results are shown in Table 16.

[0265] Table 16 Changes in PASI scores at each visit point before and after treatment (points)

[0266]

[0267]

[0268] As shown in Table 16, the PASI score decreased 2 weeks after the start of treatment. As the treatment time increased, the total score showed a gradual downward trend. After 8 weeks of treatment, the PASI total score dropped from 6.86±3.14 to 3.72±2.15. After 12 weeks of treatment, the PASI total score dropped to 2.95±1.93.

[0269] (2) Clinical efficacy of Qinteng Huoxue prescription in treating psoriasis

[0270] The effectiveness was assessed according to the PASI score reduction index, and the effective rate was calculated as shown in Table 16.

[0271] The change in PASI score before and after treatment was used as the main efficacy indicator, and the four-level efficacy evaluation of the nimodipine method was adopted. The efficacy grading is as follows:

[0272] 1) Clinical recovery: efficacy index ≥ 95%;

[0273] 2) Markedly effective: 95%> efficacy index ≥ 70%;

[0274] 3) Effective: 70%> efficacy index ≥ 50%;

[0275] 4) Ineffective: efficacy index <50%.

[0276] Efficacy index = (PASI score before treatment - PASI score after treatment) / PASI score before treatment × 100, where the unit of efficacy index is %.

[0277] Total effective rate = (number of clinically cured cases + number of significantly effective cases + number of effective cases) / total number of cases × 100, where the unit of total effective rate is %, taking the unit of number of clinically cured cases as an example, the unit of number of significantly effective cases as an example, the unit of number of effective cases as an example, and the unit of total number of cases as an example.

[0278] Table 17 Comparison of clinical efficacy of Qinteng Huoxue prescription in the treatment of psoriasis

[0279]

[0280] As can be seen from Table 17, after 2 weeks of treatment, 0 patients achieved effectiveness; after 4 weeks of treatment, 12 patients achieved effectiveness, with a total effective rate of 12.50%; after 6 weeks of treatment, 1 patient was clinically cured; 5 patients achieved marked effect, 21 patients achieved effectiveness, with a total effective rate of 28.12%; after 8 weeks of treatment, 3 patients were clinically cured; 14 patients achieved marked effect, 32 patients achieved effectiveness, with a total effective rate of 51.04%; after 12 weeks of treatment, 7 patients were clinically cured, 19 patients achieved marked effect, 45 patients achieved effectiveness, with a total effective rate of 73.96%.

[0281] (3) Numerical Rating Scale (NRS) for Itch

[0282] The patients' pruritus numerical rating score (NRS) was evaluated and statistically analyzed using repeated measures ANOVA test, as shown in Table 18.

[0283] Table 18 Changes in NRS scores at each visit point before and after treatment (points)

[0284]

[0285] As shown in Table 18, the NRS score was 1.94±1.37 after 12 weeks of treatment, which was significantly lower than 6.17±1.76 before treatment, indicating that the control of psoriasis pruritus attacks was better than before treatment.

[0286] (4) Life quality index (DLQI)

[0287] The patient's life quality score (DLQI) was evaluated. The DLQI scores at each visit point before and after treatment were approximately normal distribution, and the paired t test was used for statistical analysis, as shown in Table 19.

[0288] Table 19 Changes in DLQI scores at each visit point before and after treatment (points)

[0289]

[0290] As shown in Table 19, after 12 weeks of treatment, the total DLQI score decreased by 3.90 (3.23-4.56) to 4.98±4.31, and the difference was statistically significant.

[0291] (5) TCM syndrome scoring

[0292] The TCM syndrome scores of the patients were evaluated. The TCM syndrome scores at each visit point before and after treatment were approximately normal distribution, and the paired t-test was used for statistical analysis. See Table 20.

[0293] Table 20 Total score of TCM syndromes of patients at each visit point (points)

[0294]

[0295] As shown in Table 20, the total score of TCM syndrome after treatment was lower than that before treatment (P < 0.001). After 12 weeks of treatment, the TCM syndrome score was 7.82 ± 7.79, which was significantly lower than before.

[0296] Application Example 3 (Basic Research on Qinteng Huoxue Decoction Obtained in Example 3)

[0297] The Qinteng Huoxue prescription containing 6 traditional Chinese medicines obtained in Example 3 can effectively improve the immune-inflammatory serological indicators of patients with plaque psoriasis.

[0298] Ten patients with plaque psoriasis were enrolled from October 2023 to January 2024. Among them, the diagnostic criteria, intervention methods, observation indicators, efficacy evaluation indicators, observation time points and statistical analysis were the same as those in Application Example 2. The Qinteng Huoxue Recipe obtained in Example 3 was used for oral treatment, and the observation period was 12 weeks. As shown in Table 21.

[0299] Table 21 Comparison of IL-17, IL-6, IL-23, VEGFA and CaMK4 in plasma of psoriasis patients before and after treatment

[0300] Detection indicators Before treatment After treatment P IL-17 20.85±9.66 9.95±4.55 ＜0.001 IL-6 1.96±0.60 1.21±0.45 0.001 IL-23 92.03±17.31 63.18±17.90 ＜0.001 VEGFA 9.12±2.83 7.57±2.89 0.116 CaMK4 202.26±49.71 132.14±64.90 0.003

[0301] As shown in Table 21, analysis of the serological indicators of patients before and after treatment shows that after treatment with Qinteng Huoxue Recipe, the levels of IL-17, IL-6, IL-23, CaMK4 and VEGFA tend to decrease. This indicates that the Qinteng Huoxue Recipe in Example 3 can effectively reduce the level of inflammatory factors in patients with psoriasis and improve the state of skin inflammation. Its mechanism may be related to its participation in regulating the CaMK4 protein and abnormal angiogenesis.

[0302] Although the above describes the specific implementation methods of the present invention, it does not limit the scope of protection of the present invention. Based on the technical solution of the present invention, various modifications or variations that can be made by those skilled in the art without creative work are still within the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for treating psoriasis, characterized in that: The raw materials include, by weight, 2-16 parts of gentiana macrophylla, 4-11 parts of sophora flavescens, 14-31 parts of oldenlandia diffusa, 14-31 parts of honeysuckle vine, 9-16 parts of millettia spatholobi and 9-16 parts of Uncaria rhynchophylla.

2. The Chinese medicine composition for treating psoriasis according to claim 1, wherein: In parts by weight, the raw materials of the Chinese medicine composition include 2 to 8 parts of Gentiana macrophylla or 10 to 16 parts of Gentiana macrophylla; preferably, the raw materials of the Chinese medicine composition include 5 to 7 parts of Gentiana macrophylla or 14 to 16 parts of Gentiana macrophylla; And / or, in parts by weight, the raw materials of the Chinese medicine composition include 5 to 11 parts of Sophora flavescens; preferably, the raw materials of the Chinese medicine composition include 5 to 7 parts of Sophora flavescens or 9 to 11 parts of Sophora flavescens; And / or, in parts by weight, the raw materials of the Chinese medicine composition include 13 to 17 parts of Hedyotis diffusa; preferably, the raw materials of the Chinese medicine composition include 14 to 16 parts of Hedyotis diffusa; And / or, in parts by weight, the raw materials of the Chinese medicine composition include 14 to 16 parts of honeysuckle vine; And / or, in parts by weight, the raw materials of the Chinese medicine composition include 14 to 16 parts of Millettia reticulata; And / or, in parts by weight, the raw materials of the traditional Chinese medicine composition include 9 to 11 parts of Uncaria rhynchophylla or 14 to 16 parts of Uncaria rhynchophylla.

3. The Chinese medicine composition for treating psoriasis according to claim 1 or 2, wherein: The raw materials of the Chinese medicine composition also include Sargentophyllum sphaerocephalum, Achyranthes bidentata, Kochia scoparia, Cynanchum paniculatum, Bletilla striata and Angelica dahurica; Preferably, the raw materials of the Chinese medicine composition include, by weight, 9-16 parts of Sargentodoxae, 5-10 parts of Achyranthes bidentata, 9-16 parts of Kochia scoparia, 4-11 parts of Cynanchum wilfordii, 9-16 parts of Sophora flavescens, and 4-11 parts of Angelica dahurica. More preferably, in parts by weight, the raw materials of the traditional Chinese medicine composition include 9 to 11 parts of Sargentodoxa chinensis; and / or, in parts by weight, the raw materials of the traditional Chinese medicine composition include 8 to 10 parts of Achyranthes bidentata; and / or, in parts by weight, the raw materials of the traditional Chinese medicine composition include 14 to 16 parts of Kochia scoparia; and / or, in parts by weight, the raw materials of the traditional Chinese medicine composition include 9 to 11 parts of Cynanchum wilfordii; and / or, in parts by weight, the raw materials of the traditional Chinese medicine composition include 9 to 11 parts of Sophora flavescens; and / or, in parts by weight, the raw materials of the traditional Chinese medicine composition include 9 to 11 parts of Radix Angelicae Dahuricae.

4. The Chinese medicinal composition for treating psoriasis according to any one of claims 1 to 3, wherein: The raw materials include, by weight: 5-7 parts of Gentiana macrophylla, 5-7 parts of Sophora flavescens, 14-16 parts of Hedyotis diffusa, 14-16 parts of Caulis Loniceraes, 14-16 parts of Caulis Millettiae, 9-11 parts of Uncaria rhynchophylla, 9-11 parts of Caulis Sargentodoxae, 8-10 parts of Achyranthes bidentata, 14-16 parts of Kochia scoparia, 9-11 parts of Cynanchum chinense, 9-11 parts of Bletilla striata and / or 9-11 parts of Angelica dahurica.

5. A method for preparing a Chinese medicine composition for treating psoriasis, characterized in that: The method comprises the following steps: extracting the raw material of the Chinese medicine composition according to any one of claims 1 to 4 by water.

6. The method for preparing the Chinese medicine composition for treating psoriasis according to claim 5, wherein: The water extraction is to add water and boil; And / or, the decoction is performed 2 to 3 times; preferably, the decoction is performed 2 times; Preferably, 1 to 3 times the amount of water is added during the first decoction; more preferably, 1 to 2 times the amount of water is added during the first decoction; and / or, 1 to 3 times the amount of water is added during the second decoction; more preferably, 1 to 2 times the amount of water is added during the second decoction; And / or, preferably, the first decoction time is 15 to 30 minutes; more preferably, the first decoction time is 18 to 22 minutes; and / or, preferably, the second decoction time is 10 to 20 minutes; more preferably, the second decoction time is 13 to 17 minutes.

7. The method for preparing the Chinese medicine composition for treating psoriasis according to claim 6, wherein: further comprising concentrating and drying the decoction; Preferably, the concentration is selected from the group consisting of reduced pressure evaporation concentration, thin film concentration, centrifugal separation or thin film evaporator evaporation; And / or, preferably, the drying is selected from vacuum drying, spray drying, freeze drying or microwave drying.

8. A Chinese medicine composition for treating psoriasis, characterized in that: The psoriasis-treating Chinese medicinal composition is prepared by the method for preparing the Chinese medicinal composition for treating psoriasis according to any one of claims 5 to 7.

9. A Chinese medicine preparation for treating psoriasis, characterized in that: The Chinese medicine preparation for treating psoriasis comprises the Chinese medicine composition for treating psoriasis according to any one of claims 1 to 4 or the Chinese medicine composition for treating psoriasis according to claim 8.

10. The Chinese medicinal preparation for treating psoriasis according to claim 9, wherein: It includes external or internal medicine preparations; Preferably, the mass percentage of the Chinese medicine composition for treating psoriasis in the external medicine preparation is greater than 10%; more preferably, the mass percentage of the Chinese medicine composition for treating psoriasis in the external medicine preparation is 10% to 20%; And / or, preferably, the mass percentage of the Chinese herbal composition for treating psoriasis in the internal medicine preparation is greater than 60%; more preferably, the mass percentage of the Chinese herbal composition for treating psoriasis in the internal medicine preparation is 60% to 80%.

11. The Chinese medicinal preparation for treating psoriasis according to claim 9 or 10, wherein: The traditional Chinese medicine preparation for treating psoriasis also contains pharmaceutical excipients.

12. The Chinese medicinal preparation for treating psoriasis according to any one of claims 9 to 11, wherein: The oral drug preparations include pills, pills, powders, tablets, pastes, decoctions, granules or capsules; Alternatively, the external medicine preparation includes powder, aqueous solution, oil, tincture, vinegar, ointment, paste, emulsion, lotion, plaster, fumigation, colloidal solution type medicine, suppository, film coating, aerosol, gel, spray or pill.

13. Use of the Chinese medicinal composition for treating psoriasis according to any one of claims 1 to 3, the Chinese medicinal composition for treating psoriasis according to claim 8, or the Chinese medicinal preparation for treating psoriasis according to any one of claims 9 to 12 in the preparation of a drug for treating psoriasis; Preferably, the invention is used in the preparation of a drug for treating blood stasis syndrome of psoriasis.

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