CN115137796A

CN115137796A - Traditional Chinese medicine composition and traditional Chinese medicine pill for treating psoriasis and preparation method thereof

Info

Publication number: CN115137796A
Application number: CN202211031694.6A
Authority: CN
Inventors: 刘红霞; 刘朝霞; 张成会; 丰靓; 姚尚萍; 李鹏英; 李斌; 任成茵; 左永杰
Original assignee: Fourth Affiliated Hospital of Xinjiang Medical University
Current assignee: Fourth Affiliated Hospital of Xinjiang Medical University
Priority date: 2022-08-26
Filing date: 2022-08-26
Publication date: 2022-10-04

Abstract

The invention provides a traditional Chinese medicine composition for treating psoriasis, and belongs to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition provided by the invention takes rhizoma smilacis glabrae and rhizoma dioscoreae septemlobae as monarch drugs, cortex phellodendri, rhizoma atractylodis macrocephalae, semen coicis and poria cocos as ministerial drugs, and radix sophorae flavescentis, oldenlandia diffusa, radix salviae miltiorrhizae and fructus forsythiae as adjuvant drugs, and the whole formula is compatible with rigidity and flexibility, and is applied in a scattered and received mode, so that the effects of tonifying spleen, supplementing qi, removing dampness, not damaging the body fluid, strengthening spleen, detoxifying, moistening dryness and relieving itching are achieved, aiming at the characteristic of spleen deficiency and excessive dampness of psoriasis, the spleen deficiency state of a patient can be effectively improved, both symptoms and root causes are treated, and the PASI and DLQI scores are effectively reduced.

Description

Traditional Chinese medicine composition and traditional Chinese medicine pill for treating psoriasis and preparation method thereof

Technical Field

The invention relates to the technical field of traditional Chinese medicines, and in particular relates to a traditional Chinese medicine composition for treating psoriasis, a traditional Chinese medicine pill and a preparation method thereof.

Background

Psoriasis is a chronic inflammatory skin disease induced by internal and external environmental factors such as infection, metabolism, stress and the like under a certain genetic background. According to statistics, the prevalence rate of psoriasis in adults in China is estimated to be 0.51 to 11.43 percent, and the prevalence rate of psoriasis in children is estimated to be 0.2 to 1.37 percent. Epidemiological and basic research has led us to recognize that psoriasis is not only a skin disease but also an important systemic disease, can be complicated with various systemic and metabolic diseases, seriously affects the physical and mental health and the quality of life of patients, and is classified as one of the important diseases affecting human health by the world health organization. Psoriasis is the result of cytokine, chemokine interactions in a genetic background. The western medicine treatment method mainly inhibits epidermal hyperplasia and inflammation of psoriasis, commonly uses vitamin A acids, anti-inflammatory and immunosuppressant, and the external medicine comprises corticosteroid hormone, vitamin A acids, vitamin D3 derivatives, etc. The biological agent can effectively block immune inflammatory reaction and is commonly used for treating moderate and severe psoriasis. However, each biological therapy is different in effectiveness, safety, side effects and other characteristics, and the biological agent is expensive, the economic burden of patients is heavy, and the clinical popularization is difficult.

Disclosure of Invention

In view of the above, the invention aims to provide a traditional Chinese medicine composition for treating psoriasis, a traditional Chinese medicine pill and a preparation method thereof, the traditional Chinese medicine composition for treating psoriasis provided by the invention has the advantages of compatibility, hardness, softness, compatibility, dispersion and recovery, simultaneous application, effects of strengthening spleen, tonifying qi, removing dampness without damaging the body fluid, effects of strengthening spleen, detoxifying, moistening dryness and relieving itching, and can effectively improve the spleen deficiency state of patients, treat both symptoms and root causes, and effectively reduce the PASI and DLQI scores aiming at the characteristic of spleen deficiency and excessive dampness of psoriasis.

In order to achieve the above object, the present invention provides the following technical solutions: a traditional Chinese medicine composition for treating psoriasis is composed of the following raw materials in parts by weight: 25 to 40 portions of glabrous greenbrier rhizome, 5 to 30 portions of sevenlobed yam rhizome, 5 to 30 portions of amur corktree bark, 5 to 30 portions of lightyellow sophora root, 10 to 40 portions of weeping forsythia capsule, 5 to 30 portions of Indian buead, 5 to 30 portions of largehead atractylodes rhizome, 10 to 30 portions of coix seed, 5 to 30 portions of danshen root and 10 to 30 portions of spreading hedyotis herb.

Preferably, the traditional Chinese medicine composition for treating psoriasis comprises the following raw materials in parts by weight: 27 to 35 portions of glabrous greenbrier rhizome, 7 to 20 portions of sevenlobed yam rhizome, 7 to 20 portions of amur corktree bark, 7 to 20 portions of lightyellow sophora root, 10 to 30 portions of weeping forsythia capsule, 5 to 20 portions of Indian buead, 5 to 20 portions of largehead atractylodes rhizome, 10 to 20 portions of coix seed, 5 to 20 portions of danshen root and 12 to 20 portions of spreading hedyotis herb.

The invention also provides a traditional Chinese medicine pill for treating psoriasis, which is prepared from the traditional Chinese medicine composition.

The invention also provides a preparation method of the traditional Chinese medicine pill, which comprises the following steps;

1) Weighing rhizoma Smilacis Glabrae, rhizoma Dioscoreae Septemlobae, cortex Phellodendri, radix Sophorae Flavescentis, fructus forsythiae, poria, atractylodis rhizoma, coicis semen, saviae Miltiorrhizae radix, and herba Hedyotidis Diffusae;

2) Mixing the salvia miltiorrhiza, the fructus forsythiae and the rhizoma smilacis glabrae in the step 1) and then crushing to obtain fine powder;

3) Mixing the rhizoma dioscoreae septemlobae, the golden cypress, the radix sophorae flavescentis, the poria cocos, the bighead atractylodes rhizome, the semen coicis, the oldenlandia diffusa and water in the step 1) and then extracting to obtain an extracting solution;

4) Sequentially filtering and concentrating the extracting solution in the step 2) to obtain thick paste;

5) Mixing the thick paste in the step 3), the fine powder in the step 2) and honey, and then kneading, extruding and rolling the mixture in sequence to obtain the traditional Chinese medicine pills.

Preferably, the extraction in the step 3) is reflux extraction, the reflux extraction is performed for 2 to 4 times, and the extraction time is 1 to 2 hours each time.

Preferably, the amount of the water in the step 4) is 8-20 times of the total weight of the yam rhizome, the phellodendron bark, the lightyellow sophora root, the tuckahoe, the largehead atractylodes rhizome, the coix seed and the spreading hedyotis herb.

Preferably, the relative density of the thick paste in the step 4) at 60 ℃ is 1.35.

Preferably, the amount of the honey in the step 5) is 5-15% of the weight of the thick paste in the step 4).

The beneficial technical effects are as follows: the invention provides a traditional Chinese medicine composition and a traditional Chinese medicine pill for treating psoriasis, the traditional Chinese medicine composition takes glabrous greenbrier rhizome and rhizoma dioscoreae septemlobae as monarch drugs, golden cypress, largehead atractylodes rhizome, coix seed and poria cocos as ministerial drugs, and lightyellow sophora root, spreading hedyotis herb, salvia miltiorrhiza and weeping forsythia as adjuvant drugs, the whole formula is compatible and rigid and flexible, the medicines are applied in a scattered and accepted mode, the effects of tonifying spleen, tonifying qi, removing dampness, not damaging the body fluid are achieved, the effects of tonifying spleen, detoxifying, moistening dryness and relieving itching are achieved, the spleen deficiency state of a patient can be effectively improved according to the characteristic of spleen deficiency and excessive dampness of psoriasis, both symptoms and root causes are treated, and the scores of PASI and DLQI are effectively reduced.

Drawings

Fig. 1 shows the ear skin condition of guinea pigs in the blank control group;

FIG. 2 shows the skin condition of the ears of guinea pigs at 1 week of molding;

fig. 3 shows the skin condition of guinea pig ear 2 weeks after molding;

FIG. 4 shows the pathological morphology of the ears in the placebo group (HE staining, x 10);

FIG. 5 shows the pathological morphology of the ears in the model group (HE staining, X10).

Detailed Description

The invention provides a traditional Chinese medicine composition for treating psoriasis, which comprises the following raw materials in parts by weight: 25 to 40 portions of glabrous greenbrier rhizome, 5 to 30 portions of sevenlobed yam rhizome, 5 to 30 portions of amur corktree bark, 5 to 30 portions of lightyellow sophora root, 10 to 40 portions of weeping forsythia capsule, 5 to 30 portions of Indian buead, 5 to 30 portions of largehead atractylodes rhizome, 10 to 30 portions of coix seed, 5 to 30 portions of danshen root and 10 to 30 portions of spreading hedyotis herb.

The traditional Chinese medicine composition comprises 25-40 parts by weight of glabrous greenbrier rhizome, preferably 27-35 parts by weight of glabrous greenbrier rhizome, and more preferably 30 parts by weight of glabrous greenbrier rhizome.

In the present invention, the smilax glabra is preferably a dried rhizome of smilax glabra of the family liliaceae; the processing method of the rhizoma smilacis glabrae is to soak, clean, moisten, slice and dry the rhizoma smilacis glabrae which is not sliced. The glabrous greenbrier rhizome is a monarch drug, and is sweet, bland and mild. It enters liver and stomach meridians and has the actions of invigorating spleen, removing dampness and removing toxicity. The glabrous greenbrier rhizome of the invention can reduce the expression of proliferating cell nuclear antigen, promote epidermal cell differentiation, inhibit vaginal epithelial cell mitosis and reduce the level of plasma endothelin 1.

Based on the amount of rhizoma smilacis glabrae, the traditional Chinese medicine composition comprises 5-30 parts by weight of rhizoma dioscoreae septemlobae, preferably 7-20 parts by weight of rhizoma dioscoreae septemlobae, and more preferably 10 parts by weight of rhizoma dioscoreae septemlobae.

In the present invention, the dioscorea spongiosa is preferably a dried rhizome of dioscorea spongiosa or dioscorea fuzhou belonging to the family dioscoreaceae; the processing method of rhizoma Dioscoreae Septemlobae comprises removing fibrous root, cleaning, slicing, and sun drying. The rhizoma dioscoreae septemlobae is a monarch drug, and is bitter and mild. Enters kidney and stomach meridians and has the effects of expelling wind-damp and removing dampness.

The invention takes glabrous greenbrier rhizome and rhizoma dioscoreae septemlobae as monarch drugs, wherein the glabrous greenbrier rhizome has the functions of detoxifying, removing dampness and benefiting joints, the rhizoma dioscoreae septemlobae has the functions of removing dampness and damp-heat, and the glabrous greenbrier rhizome and the rhizoma dioscoreae septemlobae are matched for the functions of eliminating dampness, detoxifying and dredging collaterals.

Based on the amount of rhizoma smilacis glabrae, the traditional Chinese medicine composition comprises 5-30 parts of cortex phellodendri, preferably 7-20 parts of cortex phellodendri, and more preferably 10 parts of cortex phellodendri.

The phellodendron bark is preferably dried bark of phellodendron amurense of potato rutaceae; the processing method of the golden cypress comprises the steps of peeling the bark, removing the rough bark and drying in the sun. The phellodendron bark is a ministerial drug, and is bitter and cold. It enters kidney and bladder meridians and has the effects of clearing heat, drying dampness, removing toxicity and treating sore. The bibliography: treating infantile convulsion in the skin, hot and red eyes and mouth sores. "

Based on the using amount of the glabrous greenbrier rhizome, the traditional Chinese medicine composition comprises 5-30 parts of poria cocos, preferably 5-20 parts of poria cocos, and more preferably 10 parts of poria cocos.

The poria cocos wolf is preferably dried sclerotium of poria cocos wolf which is a fungus of Polyporaceae; the processing method of the tuckahoe comprises the steps of removing silt, piling up the tuckahoe to cause sweating, spreading the tuckahoe and drying the tuckahoe until the surface is dry. The poria cocos is a ministerial drug, sweet, bland and mild. Induce diuresis and drain dampness, invigorate spleen and calm heart. The main indications of the recipe are recorded: "stopping diarrhea, relieving deficient heat, opening striae and promoting the production of body fluid". Pachyman contained in Poria has effects of enhancing cellular immunity and humoral immunity.

Based on the amount of rhizoma smilacis glabrae, the traditional Chinese medicine composition comprises 5-30 parts of rhizoma atractylodis macrocephalae, preferably 5-20 parts, and more preferably 10 parts by weight.

The rhizoma atractylodis macrocephalae is preferably dried rhizome of rhizoma atractylodis macrocephalae of compositae; the processing method of the rhizoma atractylodis macrocephalae comprises the steps of removing silt, drying or drying in the sun, and then removing fibrous root. The bighead atractylodes rhizome is bitter, sweet and warm in taste and is a ministerial drug. It has the effects of invigorating spleen, replenishing qi, eliminating dampness and inducing diuresis. The medical inspiration is: dampness removal and dryness benefiting, spleen and stomach dampness removal, body fluid generation, muscle heat domination, limb sleepiness, lassitude, sleepiness and poor appetite. The single-ingredient rhizoma atractylodis macrocephalae has the function of immunoregulation, can obviously increase TH cells and correct the distribution disorder state of T cells.

Based on the amount of rhizoma smilacis glabrae, the traditional Chinese medicine composition comprises 10-30 parts of coix seeds, preferably 10-20 parts, and more preferably 15 parts by weight.

The coix seed of the invention is preferably dried mature seed kernel of coix seed of gramineous plants; the processing method of the coix seeds comprises the steps of cutting fruits, drying in the sun, removing shells, tawny seed coats and impurities, and collecting kernels. The coix seeds are used as ministerial drugs, are sweet, bland and cool. It enters spleen, stomach and lung meridians, and has the effects of invigorating spleen, eliminating dampness, clearing away heat and expelling pus. The Coicis semen can protect vascular endothelial cells, and reduce release of plasma endothelin 1 and soluble E selectin.

The invention takes phellodendron, tuckahoe, atractylodes and coix seed as ministerial drugs, wherein the tuckahoe and the atractylodes are loaded in Shennong herbal Jing at first, wherein the tuckahoe has sweet, light and flat flavor, and has the effects of inducing diuresis and excreting dampness, invigorating spleen and calming heart, the atractylodes has sweet, bitter and warm flavor, and has the effects of invigorating qi and strengthening spleen, eliminating dampness and inducing diuresis, stopping sweating and preventing abortion, so that the two drugs have the effects of invigorating spleen and eliminating dampness, and the spleen is fond of dryness and disliking dampness; the white atractylodes rhizome, sweet in taste, is used for strengthening the spleen, the bitter in taste is used for eliminating dampness, the tuckahoe, sweet in taste, is used for strengthening the spleen, the light in taste is used for removing dampness, the coix seed, sweet, light and slightly cold in taste enters spleen, stomach and lung channels, is used for promoting diuresis and excreting dampness, strengthening the spleen and removing arthralgia, the phellodendron bark, which is used for clearing heat and eliminating dampness, purging intense heat and removing toxicity, the four medicines are used together, one is used for drying and one is used for excreting, the combination of transportation and diuresis is used for removing water and dampness and strengthening spleen qi, and the other is used for strengthening spleen qi and transporting water and dampness, so the Chinese medicinal preparation is a mild tonifying and soothing and benefiting.

Based on the amount of rhizoma smilacis glabrae, the traditional Chinese medicine composition comprises 5-30 parts of radix sophorae flavescentis, preferably 7-20 parts of radix sophorae flavescentis, and more preferably 10 parts of radix sophorae flavescentis.

The sophora flavescens is preferably dried roots of sophora flavescens of leguminous plants; the processing method of radix Sophorae Flavescentis comprises cleaning, drying, or slicing and drying. The radix sophorae flavescentis is an adjuvant drug and is bitter and cold. It is entered into heart, liver, stomach, large intestine and bladder meridians, and has the actions of clearing heat, drying dampness and killing parasites. The Yunnan herbal medicine: blood cooling, heat toxin relieving, skin pruritus treating, tinea and sore due to wind-evil and obstinate psoriasis. "

Based on the amount of rhizoma smilacis glabrae, the traditional Chinese medicine composition comprises 10-40 parts of fructus forsythiae, preferably 10-30 parts of fructus forsythiae, and more preferably 15 parts of fructus forsythiae.

The forsythia suspense is preferably dried fruit of forsythia suspense of the family of meliaceae; the processing method of fructus forsythiae comprises cleaning impurities, rubbing, and removing branch and stalk; the forsythia is an adjuvant drug and is bitter and slightly cold. Clear heat, relieve exterior syndrome, relieve swelling and dissipate nodulation. The compendium of materia Medica records: "Lian Qiao-like human heart" \ 8230 \ 8230and jueyin wrapping collaterals Qi system main drugs also. All sores and ulcers with pain and itching are all heart fire, so they are the saint drugs for the twelve-meridian sores, and they are also indicated for the feverish sensation in the extremities and the heat in the three-meridian qi of the hand yang. The aqueous solution of the forsythia suspense alcohol extract has good functions of reducing exudation and reducing vascular inflammation and fragility through intraperitoneal injection in rat croton oil experiments, and shows that the forsythia suspense can promote the formation of inflammatory barriers.

Based on the amount of rhizoma smilacis glabrae, the traditional Chinese medicine composition comprises 5-30 parts of salvia miltiorrhiza, preferably 5-20 parts, and more preferably 10 parts by weight.

The salvia miltiorrhiza is preferably the dried root and rhizome of salvia miltiorrhiza belonging to the family labiatae; the processing method of the salvia miltiorrhiza comprises the steps of removing silt and drying. The salvia miltiorrhiza is an adjuvant drug, and is bitter and slightly cold. Dispel stasis and alleviate pain, activate blood and dredge meridians, clear heart fire and relieve restlessness. Record of Shenghui Fang: for acute urticaria on skin due to wind-heat, itching and bitter scabies. "

Based on the amount of rhizoma smilacis glabrae, the traditional Chinese medicine composition comprises 10-30 parts of oldenlandia diffusa, preferably 12-20 parts of oldenlandia diffusa, and more preferably 15 parts of oldenlandia diffusa.

The spreading hedyotis herb is an adjuvant drug, and is bitter and mild. They enter kidney and stomach meridians. Dispel wind-damp and remove dampness. Quanzhou materia Medica: clearing heat, removing blood stasis, eliminating carbuncle and removing toxicity. It is indicated for abscess, deep-rooted sores, ulcers and scrofula. It can clear lung fire and purge lung heat. It is indicated for dyspnea with rapid and rapid lung heat, cough, dyspnea with oppression in chest. Herba Hedyotidis Diffusae has antiinflammatory effect by stimulating proliferation of lymphocyte and macrophage.

The invention takes lightyellow sophora root, weeping forsythia, salvia miltiorrhiza and oldenlandia diffusa as adjuvant drugs, the lightyellow sophora root clears away heat, dries dampness and kills worms, the weeping forsythia clears away heat and toxic materials, the oldenlandia diffusa clears away heat, promotes diuresis, detoxifies and eliminates carbuncle, and the combination has the effects of clearing away heat and toxic materials, drying dampness and relieving itching; salvia miltiorrhiza, bitter in taste and slightly cold in nature, enters heart, pericardium and liver meridians and is a product for activating blood circulation to dissipate blood stasis, cooling blood to cure carbuncle, nourishing blood and tranquilization. The compendium of materia medica considers that the medicine is: promoting blood circulation, moistening dryness, relieving pain, eliminating swelling, and dredging channels. The salvia miltiorrhiza, which has the effects of preventing the spleen-strengthening dampness-drying medicine from being too dry and warm and inhibiting the detoxification medicine from being too cold and cool, is used together with the forsythia, the oldenlandia diffusa and the sophora flavescens as adjuvant medicines to achieve the effects of clearing heat, detoxifying, drying dampness, nourishing blood and relieving itching.

The preparation method of the traditional Chinese medicine pill comprises the following steps:

1) Weighing rhizoma Smilacis Glabrae, rhizoma Dioscoreae Septemlobae, cortex Phellodendri, radix Sophorae Flavescentis, fructus forsythiae, poria, atractylodis rhizoma, coicis semen, saviae Miltiorrhizae radix, and herba Hedyotidis Diffusae according to weight parts;

3) Mixing the sevenlobed yam rhizome, the amur corktree bark, the lightyellow sophora root, the Indian buead, the largehead atractylodes rhizome, the coix seed, the spreading hedyotis herb and the water in the step 1) and then extracting to obtain an extracting solution;

According to the weight parts of the raw materials of the traditional Chinese medicine composition for treating psoriasis, the invention weighs glabrous greenbrier rhizome, sevenlobed yam rhizome, amur corktree bark, lightyellow sophora root, weeping forsythia capsule, indian buead, largehead atractylodes rhizome, coix seed, danshen root and spreading hedyotis herb.

The invention mixes and crushes the weighed salvia miltiorrhiza, forsythia and glabrous greenbrier rhizome to obtain fine powder. The particle size of the fine powder is not particularly limited in the present invention, and may be selected from those known to those skilled in the art.

The invention mixes and extracts the weighed rhizoma dioscoreae septemlobae, phellodendron, radix sophorae flavescentis, poria cocos, bighead atractylodes rhizome, semen coicis, oldenlandia diffusa and water to obtain an extracting solution. In the invention, the extraction is preferably reflux extraction, the reflux extraction frequency is preferably 2 to 4 times, more preferably 3 times, and each extraction time is preferably 1 to 2 hours, more preferably 1 hour; the dosage of the water is preferably 8 to 20 times of the total weight of the yam rhizome, the phellodendron, the radix sophorae flavescentis, the tuckahoe, the bighead atractylodes rhizome, the coix seed and the oldenlandia diffusa, and more preferably 10 to 14 times.

After the extracting solution is obtained, the extracting solution is sequentially filtered and concentrated to obtain thick paste. In the present invention, the relative density of the thick paste at 60 ℃ is preferably 1.35.

After the thick paste is obtained, the thick paste, the fine powder and the honey are mixed and then are kneaded, extruded and rolled in sequence to obtain the traditional Chinese medicine pills. In the present invention, the honey is preferably old honey; the amount of honey is preferably 5-15%, more preferably 10% by weight of the thick paste.

The traditional Chinese medicine composition is prepared into pills which are convenient to carry and store, and the pills are prepared by extracting clear paste or extract from medicinal materials or partial medicinal materials and fine powder of other medicinal materials or proper excipients in a prescription, so that the pills have good disintegration property and are easy to absorb by patients, and the pills are solid dosage forms, easy to seal and store and better in stability than liquid dosage forms. And because the pill shape is small, the pill is easy to take, and the defect that most patients have difficulty in swallowing the tablet is overcome. The invention reduces the procedures of granulation and the like in the production process, can reduce the production cost and lighten the economic burden of patients. The research on the aspects of pharmaceutics, quality control, stability and the like proves that the concentrated pill has the advantages of obvious dosage (equivalent to 15.45g of raw material dosage taken per person per day), convenient taking and stable quality.

In order to better understand the present invention, the following examples are further provided to illustrate the present invention, but the present invention is not limited to the following examples.

Example 1

A traditional Chinese medicine composition for treating psoriasis is composed of the following raw materials, by weight, 30 parts of glabrous greenbrier rhizome, 10 parts of rhizoma dioscoreae septemlobae, 10 parts of golden cypress, 10 parts of lightyellow sophora root, 15 parts of weeping forsythia, 10 parts of poria cocos, 10 parts of bighead atractylodes rhizome, 15 parts of coix seed, 10 parts of salvia miltiorrhiza and 15 parts of spreading hedyotis herb.

1) Weighing the traditional Chinese medicine composition according to the parts by weight;

2) Mixing the weighed salvia miltiorrhiza, fructus forsythiae and rhizoma smilacis glabrae, and then crushing to obtain fine powder;

mixing rhizoma Dioscoreae Septemlobae, cortex Phellodendri, radix Sophorae Flavescentis, poria, atractylodis rhizoma, coicis semen and herba Hedyotidis Diffusae, adding 14 times of water, reflux extracting for 2 times, each time for 1 hr to obtain extractive solution;

3) Sequentially filtering and concentrating the extractive solution to obtain soft extract with relative density of 1.35 at 60 deg.C;

4) Mixing the obtained soft extract, fine powder and old honey, putting into a kneading machine to obtain plastic mass, putting into a spiral strip-discharging machine to obtain pill strip, putting into a double-drum pill rolling machine to obtain 1000 pills, drying, inspecting quality, and packaging into bottles.

The using method comprises the following steps: it is administered orally, 3 times daily, 20 pills each time.

Example 2

A traditional Chinese medicine composition for treating psoriasis comprises, by weight, 40 parts of glabrous greenbrier rhizome, 30 parts of rhizoma dioscoreae septemlobae, 30 parts of golden cypress, 30 parts of lightyellow sophora root, 40 parts of weeping forsythia, 30 parts of poria cocos, 30 parts of largehead atractylodes rhizome, 30 parts of coix seed, 30 parts of salvia miltiorrhiza and 30 parts of spreading hedyotis herb.

The preparation method and the using method are the same as those of the example 1.

Example 3

A traditional Chinese medicine composition for treating psoriasis is composed of the following raw materials, by weight, 35 parts of glabrous greenbrier rhizome, 15 parts of rhizoma dioscoreae septemlobae, 15 parts of golden cypress, 15 parts of lightyellow sophora root, 20 parts of weeping forsythia, 15 parts of poria cocos, 15 parts of bighead atractylodes rhizome, 20 parts of coix seed, 15 parts of salvia miltiorrhiza and 20 parts of spreading hedyotis herb.

Example 4

Zhangong, male, case ID:000XXXXX16, 24 years old.

A chief complaint: the erythema, macula and plaque scale are repeated for 6 years, and the weight is increased for 2 months. The current medical history: the patient has no incentive and has red pimple on both lower limbs before 6 years, scales are on the rash, the glucocorticoid medicine is taken orally in local clinic of Henan, the rash is rapidly eliminated, the rash is rapidly expanded after stopping taking the medicine, then a certain hospital in Henan province is diagnosed to be psoriasis, the rash is better when the medicine such as tripterygium glycosides tablet, aminopeptide tablet, compound glycyrrhizin tablet and the like is taken orally, but the rash is aggravated in spring and autumn, and the summer is better. Before 2 months, the skin rash is aggravated due to weather changes, more new red spots and pimples appear on the head, the face, the trunk and the limbs, the new red spots and the pimples are partially fused into larger patches, thicker desquamation exists on the patches, the pruritus is obvious, repeated scratching is carried out, and the skin rash is gradually increased. Pingsu and regular sleep, smooth and convenient urination, yellow and red urine, red tongue, swollen tongue with white and greasy coating, wiry and slippery pulse. Special examination: the spots at the hairline part are walnut-sized spots and fasciculate hairs, spots and papules on the scalp and cheeks can be seen, spots and papules on the abdomen, the back and the limbs are more, spots from broad beans to the palm are large, spots on the back and the lower limb are combined into large spots, the spots are heavily infiltrated, thick silvery scales are on the spots, and toenails are thickened and coarse. And (3) Western diagnosis: psoriasis vulgaris (quiescent phase). Traditional Chinese medicine diagnosis: and (4) the psoriasis. Traditional Chinese medicine syndrome differentiation: syndrome of spleen deficiency with dampness accumulation. Therapeutic method: to invigorate spleen, eliminate dampness, clear heat and relieve itching. When the medicine is used for treatment, the medicine is matched with a local skin lesion removal tank, the external calcipotriol betamethasone ointment and the common ointment, the symptoms are obviously improved after 1 month of treatment, the rash is eliminated after 1 month of continuous application, and no recurrence is seen after 3 months of follow-up visit. In order to ensure the privacy of patients, the identity of the patients is not disclosed here, and the identity information and case number of the patients are filed in the archive office of the traditional Chinese medicine hospital in Uygur autonomous area of Xinjiang for reference.

EXAMPLE 5 Effect test

1. General data

By adopting a random digital table method, 60 plaque psoriasis patients with spleen deficiency and excessive dampness syndrome meeting the group entry standard are selected, 30 patients in each group are signed with informed consent, the cases come from outpatients of traditional Chinese medicine hospitals in the autonomous region of Uygur autonomous region of Xinjiang, and finally 2 cases are lost to finish 58 effective cases.

2. Diagnostic criteria

Western diagnostic criteria:

the method is formulated by referring to the diagnosis standards of the plaque psoriasis in Chinese clinical dermatology (third edition, published by 2017) and Chinese psoriasis diagnosis and treatment guidelines (2018 edition):

the rash is a maculopapule, a dark red plaque or an infiltrative erythema with clear borders, and white and silvery scales are attached on the maculopapule to slightly scrape off the scales on the surface to expose a light red and shiny semitransparent film, which is called as a 'pellicle phenomenon'. And then the film is scraped off, so that sieve-like punctate bleeding (Auspitz characteristic) can be seen, the condition is stable, new eruptions do not occur, old eruptions are not resolved, and inflammation is relieved.

The traditional Chinese medicine diagnosis standard is as follows:

the diagnosis standard of spleen deficiency and excessive dampness syndrome is drawn according to the diagnosis curative effect standard of traditional Chinese medicine syndrome (2017 edition): the main symptoms are: (1) pale and swollen with teeth marks on the edges, white or white and greasy tongue coating (2) slow and weak pulse (3) sallow complexion (4) lassitude and hypodynamia. The secondary symptoms are as follows: (1) poor appetite (2) irregular stool (loose, hard first then loose, sticky) (3) abdominal distension, borborygmus, poor appetite, emaciation or puffiness.

3. Inclusion criteria

(1) The age is 18-65 years old, and the nature is not limited; (2) the standard of the plaque psoriasis is met in the western medicine diagnosis; (3) the traditional Chinese medicine distinguishes the syndrome standard of psoriasis due to spleen deficiency and excessive dampness; (4) the course of the disease is 3 months to 20 years (5) without any of the following exclusion criteria.

4. Exclusion criteria

(1) Systemic treatment was received within 3 months; (2) other types of psoriasis; (3) combined with mental diseases, advanced malignant tumors, AIDS, serious heart, brain, kidney and other medical diseases; (4) pregnant and lactating women.

5. Treatment regimens

Treatment groups: example 1

Control group: abamectin A capsule (provided by Chongqing Huabang pharmaceutical Co., ltd., 10 mg/capsule, and the batch number national drug standard H20010126) is orally taken 1 time, 20mg and 2 times/d.

Two groups of basic treatments are common coptis ointment (product batch number: B20020647) for external use, which is applied on a thin layer after the affected part is cleaned, and then the ointment is repeatedly rubbed several times to make the medicine be fully stuck on the skin 1 time per night.

6. The curative effect evaluation method comprises the following steps:

6.1 psoriasis clinical signs area and severity of disease score (PASI)

Evaluation formula: PASI total score =0.1 × head area score × head severity score +0.3 × trunk area score × trunk severity score +0.2 × upper limb area score × upper limb severity score +0.4 × lower limb area score × lower limb severity score. The severity of the skin lesions was the sum of the rash erythema (E), scaling (S) and infiltration (T) scores. E. The S and T judgment standards are as follows: erythema, scaling, and infiltration were classified into 4 grades. The score is given according to the proportion of the area of each part of the head and neck (H), the trunk (T), the upper limb (U) and the lower limb (L). Area of skin damage: 0 min =0%;1 point =0% -9%; 2 min =10% -29%; 3 min =30% -49%; 4 min =50% -69%; 5 min =70% -89%; 6 min =90% -100%. Calculation of PASI Total score: PASI total score =0.1 × head area score × head severity score +0.3 × trunk area score × trunk severity score +0.2 × upper limb area score × upper limb severity score +0.4 × lower limb area score × lower limb severity score.

6.2 Life therapeutic index (DLQI)

The DLQI questionnaire reflects the effect of disease on patients over the past 1 week and includes 10 questions: (1) itching and pain (2) embarrassment (3) shopping, family labor (4) clothes and food (5) social interaction, leisure (6) sports activities (7) learning, work (8) personal relationship (9) treatment in sexual life. Each question has 4 answers to choose from, none, few, very big and very serious, corresponding to 0, 1, 2, 3 points, respectively. Each problem score is added up to 30 points and 0 point at least. Before treatment and after the end of administration.

Patients underwent a PSAI score, DLQI score before treatment, and 4 weeks after treatment. Refer to the clinical research guideline of new Chinese medicine, therapeutic index (nimodipine method) = [ (integral before treatment-integral after treatment)/integral before treatment ] × 100%. The integral reduction is more than or equal to 95 percent after the cure; the obvious effect is more than or equal to 90 percent, and the integral reduction is more than or equal to 70 percent; the integral reduction is more than or equal to 30% when the ratio is 70%, and the integral reduction is less than 30% when the ratio is invalid. The effective rate of the score = [ (number of cure cases + number of effective cases)/total number of cases in the group ] × 100%.

6.3 serum TNF-alpha

Serum TNF-alpha was measured in the treatment group by ELISA kit (supplied by Wuhan doctor Ded bioengineering Co., ltd.) for comparison before and after treatment, and serum TNF-alpha was measured in 10 healthy subjects.

7. Statistical processing

Statistical treatment is carried out by SPSS26.0 software, t test is adopted for measuring data, and the obtained data are averaged to +/-standard deviation

X for representing and counting data ² And (5) checking, wherein the checking level is alpha =0.05.

8. Results

8.1 general data

According to the proposed research scheme, 58 effective cases are finally completed, wherein 30 patients in the treatment group and 28 patients in the control group are statistically processed and analyzed, and the difference between the treatment group and the control group in terms of gender, disease course and age is not statistically significant (P is more than 0.05).

8.2 efficacy analysis of two groups of patients

The total effective rate of the treatment group is 76.67%, the total effective rate of the control group is 78.57%, and the comparison difference of the two groups has no statistical significance (P is more than 0.05), which is shown in table 1.

TABLE 1 analysis of the efficacy of clinical PASI scoring in two groups of patients

Group of	Total number of cases	Recovery method	Show effect	Is effective	Nullification	Total effective rate	χ ²	P
									Treatment group	30	1	8	14	7	76.67％	0.03	0.86
Control group	28	1	11	10	6	78.57％

8.3 quality of Life (DLQI) score for skin disease in two groups of patients

The DLQI score of the patients in the treatment group is reduced after the medication is finished (P is less than 0.05); the DLQI score in the control group also decreased after dosing compared to before dosing (P < 0.05). The DLQI scores of the two groups were comparable before administration (P > 0.05), and after the administration, the DLQI scores of the treated group were lower than those of the control group (P < 0.05), as shown in Table 2.

TABLE 2 clinical DLQI score efficacy in two groups of patients

Group of	Number of examples	Before treatment	After treatment
				Treatment group	30	9.13±3.20	5.67±3.51
Control group	28	9.00±3.50	7.31±4.38*

Note: p < 0.05 compared to treatment group

8.4 treatment groups and results on Normal human serum TNF- α levels

The serum TNF-alpha content of the psoriasis patients before treatment is obviously higher than that of the psoriasis patients after treatment and a control group of normal people, the comparison difference before treatment and after treatment has statistical significance (P is less than 0.01), the serum TNF-alpha content of the psoriasis patients after treatment is still higher than that of the normal people, but the difference has no statistical significance (P is more than 0.05), and the table 3 shows.

TABLE 3 results of TNF-alpha levels in serum versus normal human serum of patients in the treatment group

Group of	Number of examples	TNF-α/(pg·mL ^-1 )
			Before treatment	30	56.45±10.99
After treatment	30	13.66±3.09*
			Control of Normal human	10	6.28±1.98*

Note: p < 0.05 compared to before treatment

Example 6 basic experiment

1. Experimental animals: 68 common-grade guinea pigs, 250-300 g of male and female, without limitation.

2. Grouping preparations: blank group, model group, high-dosage group of Chinese medicinal pill, medium-dosage group of Chinese medicinal pill, low-dosage group of Chinese medicinal pill, and positive control group.

3. The experimental process comprises the following steps: guinea pig induced by propranolol is used as animal model of psoriasis, and in vivo efficacy test is carried out, and serum TNF-alpha, IL-20 and pathological section of skin lesion are adopted to evaluate curative effect. 68 common-grade guinea pigs are selected and randomly divided into 6 groups, each group comprises 10-12 animals, depilatory cream is used to remove back hair one day before administration, one group is not treated as blank control group, and the other 5 groups are uniformly applied to the skin of left ear and back of guinea pig with commercially available 5% emulsion and glass rod, the application thickness is about 1.0mm, 2 times per day, and 14 days are continuously applied. Except for the model group, only 5% propranolol emulsion is smeared, and the traditional Chinese medicine pill high dose group, the traditional Chinese medicine pill medium dose group, the traditional Chinese medicine pill low dose group and the positive control group are respectively given with the medicines with different doses for treatment every day. Guinea pig serum samples, ear skin lesion samples, and spleen deficiency score were obtained on day 14.

4. Results of the experiment

4.1 Guinea pig model for psoriasis spleen deficiency syndrome

4.1.1 ear skin changes

As can be seen from fig. 1, the hair of the ears of the guinea pigs in the blank control group is normal, no shedding occurs, the skin temperature is not high, and the capillary vessels on the backs of the ears of the rats are hidden and visible; as can be seen from fig. 2, when the guinea pig is molded for 1 week, the hair of the ear of the mouse falls off, the skin is red and swollen, the skin is obviously thickened, the color is reddish, and a small amount of scales are covered on the skin; as can be seen from FIG. 3, after 2 weeks of molding, the hair had all appeared to be significantly thickened and reddish, and the surface was covered with a thick layer of scales, which appeared to bleed punctiform after being removed.

4.1.2 histopathological Scoring of psoriasis-like Guinea pig after model building

The difference of the two groups is evaluated by applying a Baker pathological tissue integration method, and the result shows that the difference has statistical significance (P is less than 0.01) when the model group is compared with the blank group, and the table 4 shows.

TABLE 4 pathological tissue integration

Grouping	n	Baker integral
			Blank group	10	0.85±0.47
Model set	10	5.05±1.01
			t		-11.08
p		0.00

4.1.3 spleen deficiency type body weight changes in guinea pigs after Molding

The body weights of the model groups are obviously different before and after the model is manufactured, so that the change of the body weights influenced by the model is shown, and the difference has statistical significance (P < 0.01); the variance analysis of the body weight difference value is adopted to compare the difference of the body weight changes of the two groups, the difference has statistical significance (P is less than 0.01), the difference of the body weight improvement of the two groups is also different, the blank group is the body weight increase after the model is made, and the model group is the body weight reduction, which is shown in table 5.

TABLE 5 body weight differences before and after molding

Group of	n	Before modeling (g)	After moulding (g)	Difference (g)
					Model set	10	271.20±14.98	243.10±13.37	-28.10±6.94
Blank group	10	268.90±13.14	338.70±20.36	69.80±16.95

Note: difference value: t =16.91; p =0.00; blank groups before and after molding: t =9.11, p =0.00; model group before and after molding: t =4.37, p =0.00.

4.2 TNF-. Alpha.and IL-20 level analysis

The model group showed significantly higher TNF-. Alpha.and IL-20 levels in guinea pigs compared to the blank control group. Compared with the model group, the high-dose group, the medium-dose group, the low-dose group and the positive control group of the traditional Chinese medicine pill are all obviously reduced, and the traditional Chinese medicines with different concentrations have obvious dose-effect relationship, which is shown in table 6.

TABLE 6 TNF-. Alpha.and IL-20 level analysis

Group of	n	TNF-α	IL-20
				Blank group	10	0.16±0.03	0.42±0.05
Model set	10	2.43±0.27	4.37±0.19
				High dose group of Chinese medicinal pills	12	0.50±0.04	1.85±0.12
Chinese medicinal pill medium dosage group	12	1.11±0.09	2.21±0.17
				Low-dose group of traditional Chinese medicine pills	12	1.90±0.06	3.49±0.33
Positive control group	12	0.55±0.28	1.84±0.15
				F		305.49	560.44
P		0.00	0.00

4.3 Guinea pig ear pathological tissue section Observation

As can be seen from FIG. 4, the skin structure of the ear back of the guinea pig in the blank control group was regular, the cell morphology was normal, the boundary of the epidermis was clear, there was no edema, the subcutaneous tissue structure was normal and clear, and there was no obvious inflammation such as vasodilatation and inflammatory cell infiltration. As can be seen from FIG. 5, the pathological section of the model group shows that the epidermis is thickened, the spinous layer is thickened, the dermal capillary vessel is proliferated and expanded, the dermal superficial layer is infiltrated by single nuclear cells, after the drug is administered, the pathological changes of the model skin can be improved to different degrees by the positive control group and each administration group, such as the epithelial hyperplasia is thinned, the cell infiltration quantity is obviously reduced, the inflammatory infiltration is obviously reduced, and the like.

4.4 weight changes in Guinea pigs

Through statistical analysis of the weight changes before and after the intragastric administration, whether the weight changes of all groups before and after the intragastric administration are different or not is compared. The results of statistical analysis indicate that the weight of each administration group changes before and after the gavage, which indicates that the gavage affects the weight change, compared with the model group, the weight difference of the positive control group has no significant difference (P is more than 0.05), and the weight difference of each administration group has statistical significance (P is less than 0.01), which indicates that the food intake of the guinea pigs is improved after the gavage, but the weight of the guinea pigs of each administration group is increased significantly, and the traditional Chinese medicines with different concentrations present significant dose-effect relationship, which is shown in Table 7.

TABLE 7 weight (g) differences before and after model building in the blank and model guinea pigs

Group of	n	Before gavage (g)	After gavage (g)	Difference (g)
					Blank group	10	291.20±13.48	342.7±11.55	30.20±6.71
Model set	10	243.10±13.73	276.1±10.25	16.60±378
					High dose group of Chinese medicinal pills	12	249.25±8.57	319.92±6.83	37.42±4.76
Chinese medicinal pill medium dosage group	12	249.83±11.96	300.5±15.42	25.75±9.35
					Low dose group of Chinese medicinal pills	12	243.00±11.12	283.5±10.53	20.67±4.31
Positive control group	12	250.83±7.70	287.3±10.93	19.00±4.97

The foregoing is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, various modifications and amendments can be made without departing from the principle of the present invention, and these modifications and amendments should also be considered as the protection scope of the present invention.

Claims

1. The traditional Chinese medicine composition for treating psoriasis is characterized by comprising the following raw materials in parts by weight: 25 to 40 portions of glabrous greenbrier rhizome, 5 to 30 portions of sevenlobed yam rhizome, 5 to 30 portions of amur corktree bark, 5 to 30 portions of lightyellow sophora root, 10 to 40 portions of weeping forsythia capsule, 5 to 30 portions of Indian buead, 5 to 30 portions of largehead atractylodes rhizome, 10 to 30 portions of coix seed, 5 to 30 portions of danshen root and 10 to 30 portions of spreading hedyotis herb.

2. The traditional Chinese medicine composition for treating psoriasis according to claim 1, which is prepared from the following raw materials in parts by weight: 27 to 35 portions of glabrous greenbrier rhizome, 7 to 20 portions of sevenlobed yam rhizome, 7 to 20 portions of amur corktree bark, 7 to 20 portions of lightyellow sophora root, 10 to 30 portions of weeping forsythia capsule, 5 to 20 portions of Indian buead, 5 to 20 portions of largehead atractylodes rhizome, 10 to 20 portions of coix seed, 5 to 20 portions of danshen root and 12 to 20 portions of spreading hedyotis herb.

3. A traditional Chinese medicine pill for treating psoriasis, which is characterized by being prepared from the traditional Chinese medicine composition of claim 1 or 2.

4. The preparation method of the traditional Chinese medicine pill for treating psoriasis is characterized by comprising the following steps:

1) Weighing rhizoma smilacis glabrae, rhizoma dioscoreae septemlobae, cortex phellodendri, radix sophorae flavescentis, fructus forsythiae, poria cocos, rhizoma atractylodis macrocephalae, semen coicis, radix salviae miltiorrhizae and oldenlandia diffusa according to the parts by weight of the components in the claims 1 or 2;

2) Mixing the salvia miltiorrhiza, the fructus forsythiae and the rhizoma smilacis glabrae in the step 1), and then crushing to obtain fine powder;

4) Sequentially filtering and concentrating the extracting solution in the step 3) to obtain thick paste;

5) Mixing the thick paste in the step 4), the fine powder in the step 2) and honey, and then kneading, extruding and rolling the mixture in sequence to obtain the traditional Chinese medicine pills.

5. The method according to claim 4, wherein the extraction in step 3) is reflux extraction, the number of times of reflux extraction is 2 to 4, and each extraction time is 1 to 2 hours.

6. The preparation method according to claim 4, wherein the amount of water used in step 3) is 8 to 20 times of the total weight of rhizoma Dioscoreae Septemlobae, cortex Phellodendri, radix Sophorae Flavescentis, poria, atractylodis rhizoma, coicis semen and herba Hedyotidis Diffusae.

7. The method according to claim 4, wherein the relative density of the thick paste in step 4) at 60 ℃ is 1.35.

8. The preparation method according to claim 4, wherein the amount of honey used in the step 5) is 5-15% of the weight of the thick paste used in the step 4).