Traditional Chinese medicine composition for treating psoriasis and preparation method thereof

Abstract

The invention relates to the technical field of traditional Chinese medicine compositions, in particular to a traditional Chinese medicine composition for treating psoriasis and a preparation method thereof.The composition is prepared from, by weight, 16-32 parts of rhizoma smilacis glabrae, 8-16 parts of radix paeoniae rubra, 8-16 parts of folium isatidis, 5-11 parts of moutan bark, 2-6 parts of felwort, 8-16 parts of oldenlandia diffusa, 10-20 parts of rhizoma cimicifugae, 5-11 parts of fried burdock and 8-16 parts of sculellaria barbata. The traditional Chinese medicine composition disclosed by the invention is rapid in improvement of clinical symptoms of blood-heat syndrome psoriasis, good in effect, capable of improving the inflammation level and improving the life quality of patients, capable of clearing heat, cooling blood, removing spots, detoxifying and the like, rapid in curative effect and low in price by relieving immune inflammation infiltration and hyperplasia of epidermis.

Description

Technical Field

[0001] The present invention relates to the technical field of Chinese medicine compositions, and in particular to a Chinese medicine composition for treating psoriasis and a preparation method thereof. Background Art

[0002] Psoriasis is a common chronic complex inflammatory skin disease, characterized by excessive epidermal proliferation and capillary hyperplasia in the lesion area, manifested as erythema, papules, plaques, covered with white scales, and can also affect the skin, mucous membranes, nails and joints. This disease is a global common disease, not limited to age, gender and race, with an incidence rate of about 1% to 3%, and is increasing year by year. Due to the visibility of lesions, subjective symptoms such as itching, and the easy compounding of the disease, it brings serious mental stress and experience burden to individuals and society.

[0003] Psoriasis is similar to "white psoriasis", "snake lice" and "psoriasis wind" recorded in Chinese medical literature. Chinese medicine believes that this disease is mostly caused by emotional injury, stagnation of qi, long-term depression turns into fire, hyperactivity of heart fire, toxic heat hidden in the blood; or due to improper diet, excessive intake of fishy food that causes wind, spleen and stomach disharmony, poor qi movement, long-term depression turns into heat, and wind, heat and toxic evils cause the disease; if the disease lasts for a long time or recurs repeatedly, yin blood is consumed, qi and blood are out of harmony, dryness turns into wind or meridians are blocked, then qi and blood coagulate and the skin is not nourished.

[0004] Currently, psoriasis cannot be cured. Commonly used drugs for the treatment of psoriasis include vitamin D derivatives, retinoic acid, immunosuppressants, calcineurin inhibitors, corticosteroids, biological agents, and phototherapy. Although good results have been achieved in the early stages of drug treatment, poor drug tolerance, cumulative toxicity, expensive biological agents, and the risk of secondary infection or cancer have affected the further improvement of the clinical efficacy of psoriasis. Continuous desquamation and erythema bring great psychological pressure to patients, and long-term recurring illnesses also cause a lot of medical expenses. Summary of the invention

[0005] In view of the problems that there is no clinically effective drug for psoriasis in the prior art and long-term treatment with western medicine is prone to cause adverse reactions, the present invention provides a Chinese medicine composition for treating psoriasis and a preparation method thereof.

[0006] In order to solve the above technical problems, this application provides the following technical solutions:

[0007] The pathogenesis of psoriasis in TCM lies in "poison accumulation in the blood". The disease is located in the blood and the pathogenesis is heat toxicity. Professor Zhao Bingnan first proposed the pathogenesis of psoriasis blood heat syndrome "internal heat accumulation, stagnation in the blood", and proposed that the main TCM syndromes of psoriasis are blood heat syndrome, blood dryness syndrome, and blood stasis syndrome, and established a syndrome differentiation system based on blood. By analyzing the syndrome differentiation characteristics and medication rules of 15 experts such as Zhao Bingnan, Zhu Renkang, Jin Qifeng, Zhang Zhili, and Zhang Zuozhou in the treatment of psoriasis, they all generally realized that the disease is located in the "blood". Further analysis of the medication rules showed that blood-regulating agents such as cooling blood, activating blood circulation, and nourishing blood are the common medication rules for the treatment of psoriasis. Psoriasis has the characteristic of being "toxic". Traditional Chinese medicine believes that "toxicity is the accumulation of evil qi". The "Secrets of Traditional Chinese Medicine Surgery" states: "All stubborn and difficult to cure diseases in surgery and dermatology... their causes can be called poison." Psoriasis has a genetic background (selective, dependent), and the progressive stage is rapid and spreads throughout the body (sudden, widespread). In severe cases, there are pustular, articular and erythrodermic psoriasis, with organic damage (severe), a long course of disease, and lingering and difficult to cure (filthy), which meets the pathogenic characteristics of evil qi.

[0008] When studying the prescription for treating psoriasis, the present invention follows the theory of "toxicity accumulated in the blood" and introduces the method of "clearing heat and cooling blood, removing spots and detoxifying" to treat the disease. The clinical application of this prescription to treat psoriasis has achieved good therapeutic effects and is worthy of clinical promotion.

[0009] The traditional Chinese medicine composition of the invention consists of cimicifuga, smilax glabra, red peony root, oldenlandia diffusa, peony bark, gentian, isatis indigo leaf, burdock fruit and scutellaria barbata.

[0010] "Ben Jing": "Cimicifuga heracleifolia is used to cure all kinds of poisons, ward off febrile diseases, and prevent evil spirits (also known as miasma and evil spirits)"

[0011] "Compendium of Materia Medica": "Smilax glabra can strengthen the spleen and stomach, strengthen the tendons and bones, remove rheumatism, benefit the joints, and stop diarrhea. It can treat cramps, bone pain, and malignant sores and carbuncles."

[0012] "Ben Jing": "Red peony root can cure abdominal pain caused by evil qi, eliminate blood stasis, break up hard masses, treat cold and heat hernia, relieve pain, promote urination, and replenish qi."

[0013] "Quanzhou Materia Medica": "White Flower Hedyotis diffusa, clears away heat and dissipates blood stasis, eliminates carbuncle and detoxifies. Treats carbuncle, ulcer, and scrofula."

[0014] "Compendium of Materia Medica": "Peony bark can regulate blood, generate blood, and cool blood. It can treat fire hidden in the blood and eliminate restlessness and heat."

[0015] "Ben Jing": "Gentian grass can cure cold and heat between bones, shock and paralysis, evil spirits, heal broken bones, stabilize the five internal organs, and kill poison."

[0016] "Compendium of Materia Medica" states: "Indigo leaf can cure plague, heat toxins, madness, wind-heat rashes, carbuncle swelling and pain, thirst, nosebleeds, vomiting blood, and kill malnutrition, wounds and arrow poison. For those with both heat and poison, it is advisable to use the juice of indigo leaf."

[0017] "Compendium of Materia Medica": "Burdock seeds can eliminate rashes and rashes."

[0018] "Quanzhou Materia Medica": "Scutellaria barbata can dredge meridians, clear away heat and detoxify, dispel wind and disperse blood, promote qi and diuresis, break up blood stasis and relieve pain."

[0019] In this prescription, Smilax glabra is sweet, light, and flat, and it enters the liver and stomach meridians. It has the effect of detoxification and dehumidification, and is the main drug; Cimicifuga heracleifolia is pungent, slightly sweet, and slightly cold, and enters the lung, spleen, stomach, and large intestine meridians. It can disperse the evil qi of the muscle surface and the Yangming meridian and release the exterior, and clear away heat and toxins and detoxify, and is the ministerial drug; Red peony root clears heat and cools blood, disperses blood stasis and relieves pain, and Paeonia suffruticosa cools blood and clears heat, and activates blood circulation and removes blood stasis. Both are adjuvants. Hedyotis diffusa is bitter and cold, clears away heat and toxins, and dissipates carbuncle; Gentiana scabra clears liver fire and removes dampness and heat, and Isatis indigotica clears heat and detoxifies, cools blood and eliminates spots, and is the adjuvant. Arctium lappa dissipates wind-heat, detoxifies and relieves sore throat, and Scutellaria barbata clears heat and detoxifies, dispels wind and disperses blood, and is the adjuvant. All the drugs work together to achieve the effects of clearing heat and cooling blood, detoxification and removing spots.

[0020] Furthermore, it is composed of the following raw medicinal materials in parts by weight: 16-32 parts of Smilax glabra, 8-16 parts of red peony root, 8-16 parts of isatis indigotica, 5-11 parts of peony bark, 2-6 parts of gentian, 8-16 parts of oldenlandia diffusa, 10-20 parts of cimicifuga, 5-11 parts of stir-fried burdock seeds, and 8-16 parts of Scutellaria barbata.

[0021] Furthermore, the drug is composed of the following raw materials in parts by weight: 20-28 parts of Smilax glabra, 10-14 parts of red peony root, 10-14 parts of isatis indigotica, 7-9 parts of peony bark, 3-5 parts of gentian, 10-14 parts of oldenlandia diffusa, 13-17 parts of cimicifuga, 6-10 parts of stir-fried burdock seeds, and 10-14 parts of Scutellaria barbata.

[0022] Specifically, the drug is composed of the following raw materials in parts by weight: 15 parts of Cimicifuga, 24 parts of Smilax glabra, 12 parts of Paeonia lactiflora, 12 parts of Hedyotis diffusa, 8 parts of Paeonia suffruticosa, 4 parts of Gentiana scabra, 12 parts of Folium Isatidis, 8 parts of stir-fried Burdock seeds, and 12 parts of Scutellaria barbata.

[0023] Wherein, the psoriasis is blood-heat syndrome psoriasis.

[0024] The preparation method of the Chinese medicine composition of the present invention specifically comprises:

[0025] The preparation method of the water extract is as follows: first, according to the weight powder, weigh Cimicifuga, Smilax glabra, Paeonia lactiflora, Hedyotis diffusa, Paeonia suffruticosa, Gentiana scabra, Folium Isatidis, stir-fried Burdock seeds, and Scutellaria barbata, add water and boil twice, adding 10 times the amount of water each time, boiling for 1.5 hours each time, combining the decoctions, filtering, and concentrating the filtrate under reduced pressure to a clear paste with a relative density of 1.30 to 1.35, and drying to obtain the water extract.

[0026] Preparation method of granules: firstly, according to the weight of the powder, weigh Cimicifuga, Smilax glabra, Paeonia lactiflora, Hedyotis diffusa, Paeonia suffruticosa, Gentiana scabra, Folium Isatidis, Fructus Arctii, Scutellaria barbata, add water and boil twice, add 10 times the amount of water each time, boil for 1.5 hours each time, combine the decoctions, filter, concentrate the filtrate under reduced pressure to a clear paste with a relative density of 1.30-1.35, dry, crush, add an appropriate amount of dextrin, mix well, add an appropriate amount of ethanol, make granules, dry, make the granules into 20-30 mesh, and fill them in a composite film packaging bag to obtain granules.

[0027] Preparation method of decoction: weigh Cimicifuga, Smilax glabra, Paeonia lactiflora, Hedyotis diffusa, Paeonia suffruticosa, Gentiana scabra, Folium Isatidis, Fructus Arctii, Scutellaria barbata according to weight powder, add water and boil twice, add 10 times the amount of water each time, boil for 1.5 hours each time, and combine the decoctions to obtain the decoction.

[0028] In addition to the above two dosage forms, tablets, capsules, powders, pills, fluid extracts, etc. can also be prepared. Various pharmaceutical excipients acceptable to humans can be added to various dosage forms. Decoctions or granules are preferred.

[0029] Compared with the prior art, the Chinese medicine composition for treating psoriasis and the preparation method of the present invention have at least the following beneficial effects:

[0030] The Chinese medicine composition for treating psoriasis of the present invention can improve the clinical symptoms related to psoriasis quickly and effectively, can reduce skin lesions, improve subjective symptoms such as itching, has the effects of cooling blood and detoxifying, clearing away heat and removing spots, and improves immune infiltration, reduces epidermal proliferation, and inhibits skin inflammation. It has rapid efficacy and is inexpensive.

[0031] The Chinese medicine composition for treating psoriasis and the preparation method of the present invention are further described below in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figure 1 The figure shows the effects of different treatments on imiquimod-induced psoriasis lesions in mice.

[0033] Figure 2 The graph shows the effects of different treatments on the PASI scores of imiquimod-induced psoriasis mice.

[0034] Figure 3 HE staining of mouse skin tissue and comparison of epidermal thickness.

[0035] Figure 4 The staining results of mouse CD3+T cells.

[0036] Figure 5 This is the staining result of mouse Ki67.

[0037] Figure 6 The results of mouse PCNA staining.

[0038] Figure 7 This is the skin lesion condition of clinical case 1.

[0039] Figure 8 This is a dermoscopic image of the skin lesions in clinical case 1.

[0040] Fig. 9 This is the skin lesion condition of clinical case 2.

[0041] Fig.10 This is the dermoscopic image of the skin lesions in clinical case 2. DETAILED DESCRIPTION

[0042] Example 1 Chinese medicine composition for treating psoriasis (water extract)

[0043] Take 16-32g of Smilax glabra, 8-16g of red peony root, 8-16g of isatis indigo leaf, 5-11g of peony bark, 2-6g of gentian, 8-16g of white flower oldenlandia diffusa, 10-20g of cimicifuga, 5-11g of fried burdock seed, 8-16g of Scutellaria barbata; add water and decoct twice, add 10 times the amount of water (m:V) each time, decoct for 1.5 hours each time, combine the decoction, filter, concentrate the filtrate under reduced pressure to a clear paste with a relative density of 1.30-1.35 (50°C), dry, and obtain 14.5g-34.8g of dry paste. The extraction rate is 21%-25%.

[0044] Example 2 Chinese medicine composition granules for treating psoriasis

[0045] Take 16-32g of Smilax glabra, 8-16g of red peony root, 8-16g of isatis indigo leaf, 5-11g of peony bark, 2-6g of gentian, 8-16g of white flower oldenlandia diffusa, 10-20g of cimicifuga, 5-11g of fried burdock seed, 8-16g of Scutellaria barbata, add water and boil twice, add 10 times of water (m:V) each time, boil for 1.5 hours each time, combine the decoction, filter, concentrate the filtrate under reduced pressure to a clear paste with a relative density of 1.30-1.35 (50°C), dry, crush, add appropriate amount of dextrin, mix well, add appropriate amount of ethanol, make granules, dry, and make granules of 20-30 mesh. Fill in polyester / aluminum / polyethylene composite film packaging bags for pharmaceutical packaging.

[0046] Example 3 Chinese medicine composition (decoction) for treating psoriasis

[0047] Take 15 parts of Cimicifuga heracleifolia, 24 parts of Rhizoma Smilacis Glabrae, 12 parts of Radix Paeoniae Rubra, 12 parts of Herba Hedyotis diffusae, 8 parts of Cortex Moutan, 4 parts of Herba Gentianae, 12 parts of Folium Isatidis, 8 parts of Fructus Arctiae Saposhnikoviae, and 12 parts of Scutellariae Barbatae, add water and decoct twice, adding 10 times the amount of water each time (m:V), decocting for 1.5 hours each time, combining the decoctions, and naming it Ling Ma Hua Ban Jie Du Fang.

[0048] Example 4 Animal Experiment

[0049] 1. Establishment of Imiquimod-induced Psoriasis Mouse Model

[0050] 36 healthy male C57BL / 6J mice aged 6 to 8 weeks, weighing 20-22g, SPF grade, provided by Sibeifu (Beijing) Biotechnology Co., Ltd., license number SCXK (Beijing) 2019-0010. After 1 week of adaptive feeding, the back hair was removed, with an area of ​​about 2×3cm. The 36 mice were randomly divided into a blank group, a model group, a high-, medium-, and low-dose group of Lingma Huaban Jiedu Fang, and a methotrexate group by a random number table method, with 6 mice in each group. After confirming that there was no damage to the depilated area of ​​the mice 24 hours after skin preparation, the model was started. The blank group mice were smeared with 62.5mg of vaseline daily on the skin preparation area, and the other groups were smeared with an equal mass of 5% imiquimod cream for 7 consecutive days.

[0051] The high, medium and low doses of Lingma Huaban Jiedu Recipe (the clinical dosage is the medium dose, the concentration of 1 times is the high dose, and the dilution of 1 times is the low dose) and methotrexate groups, 6 mice in each group. After confirming that there was no damage to the depilated area of ​​the mice 24 hours after skin preparation, the model was established. The blank group mice were smeared with 62.5 mg of vaseline on the skin preparation area every day, and the other groups were smeared with the same mass of 5% imiquimod cream for 7 consecutive days.

[0052] 2. Intervention Experiment

[0053] After modeling, each group was fed with standard feed and had free access to water, and the bedding was changed every 3 days. Intervention was performed on the second day of modeling. The adult (70 kg) dose was converted into the oral dose for mice, with the clinical equivalent dose as the medium dose, the high dose as 1-fold concentration, and the low dose as 1-fold dilution. Each dose group of Lingma Huaban Jiedu was given the corresponding Chinese medicine by oral gavage, the methotrexate group was given methotrexate tablet suspension by oral gavage, and the blank group and the model group were given normal saline by oral gavage. Once a day, 0.2 mL each time.

[0054] 3. Treatment methods

[0055] On the 7th day of the experiment, the specimens were prepared and mice were anesthetized by intraperitoneal injection of Avertin (50 mg / kg). After being killed by cervical dislocation, 1) blood was collected from the eyeballs; 2) 1.3 cm × 1.3 cm of skin from the lesion on the back was cut and divided into 4 pieces at 1 / 4, 1 / 4, 1 / 4, and 1 / 4, ensuring that each piece of skin had a wound surface. One piece of tissue was fixed in 4% paraformaldehyde, dehydrated, paraffin-embedded, sectioned, and HE-stained. Three stained sections were selected for observation and photography for each specimen; 2 pieces were placed in cryopreservation tubes and stored in a -80 degree refrigerator for PCR and Western Blot experiments; one piece of tissue was embedded in OCT complex and frozen tissue sections were prepared.

[0056] 4. Observation indicators

[0057] ①Evaluation of skin lesion changes in mice in each group

[0058] During the model establishment and treatment period, the changes in skin lesions of mice in each group were observed daily, and photos of the same site were taken and recorded. According to the PASI score as the standard, the severity of scales, infiltration, and erythema were scored, and the sum of the three scores was calculated to represent the severity of skin lesions. The average total score of each group was taken daily to draw a trend line to reflect the changes in skin lesions in mice.

[0059] ②Skin tissue staining and observation

[0060] An appropriate amount of skin tissue was taken from each group and placed in a 4% formaldehyde / formalin solution for 24 to 48 hours, dehydrated, paraffin-embedded, dewaxed, sliced, and then HE staining and immunohistochemical staining were performed. HE staining was used to confirm that the tissue taken in the experiment was psoriasis skin tissue and to observe the pathological morphological characteristics. Immunohistochemical staining was used to detect CD3 in skin tissue. The slices incubated with the primary antibody were stained with a DAB kit. After the slices were dehydrated, they were fixed with neutral glue and then observed under a microscope. Immunofluorescence staining was used to stain the slices to observe the fluorescence distribution of KI67 in the cells.

[0061] SPSS 20.0 statistical software was used to process the data, and unpaired t-test was used to calculate the difference between the two groups and the 95% confidence interval. The measurement data were expressed as mean ± standard deviation (x ± s), and the count data were expressed as rate (%). The chi-square test was used for comparison. P < 0.05 was used as the test level.

[0062] The results are as follows Figure 1 As shown, the back skin of mice in the blank group was smooth, without erythema or scales, and the color was grayish white. With the application of the drug, the skin lesions in the model group became increasingly severe. Compared with the blank group, the skin color gradually deepened, with erythema, increased scales, and obvious thickening of skin infiltration, and psoriasis-like lesions appeared. Compared with the model group, the skin lesions in the methotrexate group were significantly improved, with significantly less scale coverage, less erythema, and significantly less infiltration; the skin lesions in the Lingma Huaban Jiedu Fang were significantly alleviated, with less scales and erythema, and the lesions were significantly thinner. The PASI score trend chart shows that Figure 2 On the second day of medication, mice in each group developed erythema, scaling, infiltration and other symptoms; after 3 days of medication, there were obvious differences in the above aspects among the groups; in the total integral graph, it can be seen that the model group was the most serious; compared with the model group, the severity of the Ling Ma Hua Ban Jie Du Fang was significantly reduced, the disease development trend was slow, and the methotrexate group had the mildest skin lesions.

[0063] Mouse skin tissues were stained with HE, and 4 stained sections were selected from each specimen to observe histopathological changes. The pictures were taken under 20x and 40x objective lenses, and the epidermal thickness was measured using the ZEN image analysis system for the pictures under the 40x objective lens. Figure 3As shown in the figure, one week after modeling and drug administration, the blank group had a thin epidermis, only 2 to 3 layers, and less subcutaneous lymphocyte infiltration. The epidermis of the mice in the model group was significantly thickened, with a large number of lymphocytes infiltrating the dermis, elongated epidermal processes, incomplete keratinization, retained nuclei of keratinocytes, thickened epidermal spinous layer, and more nuclear divisions of basal cells, similar to psoriasis-like skin lesions. Compared with the model group, the epidermal thickness of the drug-treated groups became thinner to varying degrees, the number of parakeratotic cells was significantly reduced, and the lymphocyte infiltration was also reduced to varying degrees. Compared with the blank group, the epidermis of the model group was significantly thickened (P < 0.01); compared with the model group, the epidermal thickness of the methotrexate group and the Ling Ma Hua Ban Jie Du Fang group was significantly reduced (P < 0.05); there was no significant difference between the Ling Ma Hua Ban Jie Du Fang group and the methotrexate group. See Figure 3 .

[0064] CD3 marks T lymphocytes in the dermis. Immunohistochemistry was used to detect CD3 expression in the skin lesions of mice in each group, and brown granules were precipitated as positive points. In the blank group, a small amount of brown positive granules were found in the dermis, but no brown positive granules were found in the epidermis. Compared with the blank group, the brown positive granules in the dermis of the model group increased significantly, and brown precipitates also appeared in the epidermis (P < 0.01); compared with the model group, the infiltration of CD3+T lymphocytes in the methotrexate group and the Lingma Huaban Jiedu Fang group was significantly reduced (P < 0.05), as shown in Table 1. Figure 4 .

[0065] Effect of Ling Ma Hua Ban Jie Du Fang on Ki67 expression in the epidermis of psoriasis-like mice: Green marks are positive, and there are very few positive points distributed in the basal layer in the blank group; compared with the blank group, the number of layers of positive points in the model group increased significantly (P < 0.01), about 3 to 4 layers; compared with the model group, the distribution of positive points in the methotrexate group decreased significantly (P < 0.01), and basically showed a single-layer linear distribution. Compared with the model group, the number of positive points in the Ling Ma Hua Ban Jie Du Fang group decreased significantly (P < 0.05), and the distribution occupied 1 to 2 layers, as shown in Figure 2. Figure 5 .

[0066] Effect of Lingma Huaban Jiedu Recipe on PCNA expression in the epidermis of psoriasis-like mice: PCNA can reflect the proliferation degree of keratinocytes. Figure 6 As shown in the figure, brown-yellow marks are positive, PCNA was expressed in the epidermis of mice in the blank group, and the expression of PCNA-positive cells in the epidermis of mice in the model group increased significantly. Compared with the model group, the expression of PCNA-positive cells in the epidermis of mice in the Lingma Huaban Jiedu group and the methotrexate group was significantly reduced, and the difference was statistically significant (P < 0.05).

[0067] Example 5

[0068] 30 patients with psoriasis who visited the applicant's hospital outpatient clinic were selected and treated with the Ling Ma Hua Ban Jie Du Fang of Example 3 with modifications. The results are reported as follows.

[0069] All patients met the diagnostic criteria for psoriasis established in the "Guidelines for the Diagnosis and Treatment of Psoriasis in China (2018 Edition)" and the diagnostic criteria for white spot and blood-heat syndrome established in the "Expert Consensus on Traditional Chinese Medicine Treatment of Psoriasis (2017 Edition)".

[0070] On the basis of health education, the patient was given oral treatment with Lingma Huaban Jiedu prescription 200mL Bid for 28 consecutive days.

[0071] The observation indicators were the lesion area and severity score (PASI score), as shown in Table 1.

[0072] Table 1 PASI score table

[0073]

[0074] Skin lesion area: The whole body can be divided into four parts: head and neck, upper limbs, trunk, and lower limbs, which account for 10%, 20%, 30% and 40% of the body surface area respectively.

[0075] PASI score = (E head + I head + D head) × A head × 0.1 + (E upper limb + I upper limb + D upper limb) × A upper limb × 0.2 + (E trunk + I trunk + D trunk) × A trunk × 0.3 + (E lower limb + I lower limb + D lower limb) × A lower limb × 0.4

[0076] The efficacy evaluation criteria were formulated with reference to the efficacy evaluation criteria for "white ulcer" in the "Efficacy Standards for Diagnosis and Efficacy of TCM Diseases and Syndromes" of the TCM industry standard of the People's Republic of China as follows: ① Cured: skin lesions completely disappeared or disappeared by more than 95%; ② Significantly effective: skin lesions disappeared by more than 50%; ③ Effective: skin lesions disappeared by more than 30%; ④ Ineffective: skin lesions disappeared by less than 30%. Total effective rate = [(effective cases + markedly effective cases + cured cases) / total cases] × 100%.

[0077] The results of the 30 patients after treatment in this study were as follows: 15 cases (50.00%) were markedly effective, 4 cases (13.33%) were effective, 1 case (3.33%) was ineffective, and the total effective rate was 96.67%.

[0078] Clinical Case 1

[0079] Hao, male, 34 years old, was diagnosed with "allergic erythema with scales for 10 years and aggravated for 4 years" on April 24, 2024. The patient was diagnosed with "psoriasis" in another hospital and was given topical treatment with hormone drugs (unknown details), which was effective and recurred after stopping the drug. It was not fully controlled after an external infection 4 years ago. At present: irritable temperament, occasional palpitations and fatigue, dry mouth, good appetite and sleep, dry stool, 1 line a day, and yellow urine. Specialist physical examination: scattered red needle tip to soybean-sized lesions all over the body, covered with white scales. Western medicine diagnosis: psoriasis; Chinese medicine diagnosis: white lesions, blood heat syndrome. Prescription: Lingma Huaban Jiedu Decoction: Cimicifuga 15g, Smilax glabra 24g, Red Peony 12g, Isatis indigo leaf 12g, Paeonia suffruticosa 8g, Gentiana 4g, Hedyotis diffusa 12g, Arctium 8g, Scutellaria barbata 12g. A total of 14 doses, 1 dose per day, decocted in water once, taken warm twice a day after meals in the morning and evening.

[0080] Second visit: May 8, 2024. After taking the medicine, the patient had no new skin lesions, the skin lesions were relieved compared with the previous ones, the original skin lesions became thinner, and the itching was relieved. At present: dry mouth is slower than before, bowel movements are once a day, the quality is good, and the urine is regular. Specialist physical examination: scattered light red needle tip to soybean-sized skin lesions on the whole body, covered with white scales, accompanied by color sinking. If the effect is not changed, continue to take the previous prescription: Lingma Huaban Jiedu Decoction: Cimicifuga 15g, Smilax glabra 24g, Red Peony 12g, Daqingye 12g, Paeonia suffruticosa 8g, Gentiana 4g, Hedyotis diffusa 12g, Burdock seeds 8g, Scutellaria barbata 12g. A total of 14 doses, 1 dose per day, decocted once, divided into 2 times, warm after meals in the morning and evening.

[0081] On May 29, 2024, the patient was re-examined and the original rash subsided, with no new rash. Figure 7 As shown, the skin lesions under dermatoscope are as follows Figure 8 shown.

[0082] Clinical Case 2

[0083] Ma, male, 48 years old, was diagnosed with "white scales on the upper limbs and chest and back erythema for 2 years" on July 3, 2024. Two years ago, the patient had red patches on the upper limbs and chest and back without obvious causes, covered with white scales. He was diagnosed with "psoriasis" and intermittent treatment. The rash was sometimes mild and sometimes severe. It worsens every summer after drinking and eating irregularly. Red patches are now scattered all over the body, covered with white scales, and there is no new rash. Drink 2-3 times a week. At present: no joint pain, dry mouth and like cold drinks, good appetite and sleep, dry stool, 1 line every 2-3 days, and yellow urine. Specialist physical examination: red patches on both upper limbs, chest and back, covered with white scales. Western medicine diagnosis: psoriasis; Chinese medicine diagnosis: white skin, blood heat syndrome. Prescription: Lingma Huaban Jiedu Decoction: Cimicifuga 15g, Smilax glabra 24g, Radix Paeoniae Rubra 12g, Folium Isatidis 12g, Cortex Moutan 8g, Gentiana 4g, Hedyotis diffusa 12g, Fructus Arcti 8g, Scutellaria barbata 12g. A total of 14 doses, 1 dose per day, decocted once, taken warm in 2 doses in the morning and evening after meals.

[0084] Second visit: July 17, 2024. Dark red to light brown patches are now seen all over the body, covered with a small amount of white scales, and no new rash. Drink 2-3 times a week. At present: no joint pain, dry mouth, dry stool, yellow urine color is less than before, and there is no discomfort. Specialist physical examination: Dark red to light brown patches are seen scattered on both upper limbs, chest and back, covered with white scales. Western medicine diagnosis: psoriasis; Chinese medicine diagnosis: white ulcer, blood heat syndrome. Prescription: Lingma Huaban Jiedu Decoction: Cimicifuga 15g, Smilax glabra 24g, Red peony 12g, Daqingye 12g, Paeonia suffruticosa 8g, Gentiana 4g, Hedyotis diffusa 12g, Burdock seeds 8g, Scutellaria barbata 12g. A total of 14 doses, 1 dose per day, decocted once, divided into 2 times, warm after meals in the morning and evening.

[0085] On July 31, 2024, the patient was re-examined and the original lesions had mostly subsided, with no new rashes. Fig. 9 As shown, the skin lesions under dermatoscope are as follows Fig.10 shown.

[0086] The embodiments described above are merely descriptions of preferred implementation modes of the present invention and are not intended to limit the scope of the present invention. Without departing from the design spirit of the present invention, various modifications and improvements made to the technical solutions of the present invention by ordinary technicians in this field should all fall within the protection scope determined by the claims of the present invention.

Claims

1. A Chinese medicine composition for treating psoriasis, characterized in that: Including Cimicifuga, Smilax glabra, Red Peony Root, Oldenlandia diffusa, Paeonia suffruticosa, Gentiana scabra, Isatis indigotica, fried burdock seeds, and Scutellaria barbata.

2. The Chinese medicine composition for treating psoriasis according to claim 1, characterized in that: The invention is composed of the following raw materials in parts by weight: 16-32 parts of Rhizoma Smilacis Glabrae, 8-16 parts of Radix Paeoniae Rubra, 8-16 parts of Folium Isatidis, 5-11 parts of Cortex Moutan, 2-6 parts of Gentiana Scabra, 8-16 parts of Hedyotis Diffusa, 10-20 parts of Cimicifuga Herba, 5-11 parts of stir-fried Fructus Arctii and 8-16 parts of Scutellaria Barbatae.

3. The Chinese medicine composition for treating psoriasis according to claim 2, characterized in that: The invention is composed of the following raw materials in parts by weight: 20-28 parts of Rhizoma Smilacis Glabrae, 10-14 parts of Radix Paeoniae Rubra, 10-14 parts of Folium Isatidis, 7-9 parts of Cortex Moutan, 3-5 parts of Gentiana, 10-14 parts of Hedyotis Diffusa, 13-17 parts of Cimicifuga heracleifolia, 6-10 parts of stir-fried Fructus Arctii and 10-14 parts of Scutellaria Barbatae.

4. The Chinese medicine composition for treating psoriasis according to claim 3, characterized in that: The invention is composed of the following raw materials in parts by weight: 15 parts of Cimicifuga heracleifolia, 24 parts of Smilax glabra, 12 parts of Paeonia lactiflora, 12 parts of Hedyotis diffusa, 8 parts of Paeonia suffruticosa, 4 parts of Gentiana scabra, 12 parts of Folium Isatidis, 8 parts of stir-fried Fructus Arctii and 12 parts of Scutellaria barbata.

5. The Chinese medicine composition for treating psoriasis according to claim 4, characterized in that: The psoriasis is blood-heat syndrome psoriasis.

6. The method for preparing the Chinese medicine composition according to any one of claims 1 to 5, characterized in that: The preparation method of the water extract is as follows: first, according to the weight powder, weigh Cimicifuga, Smilax glabra, Paeonia lactiflora, Hedyotis diffusa, Paeonia suffruticosa, Gentiana scabra, Folium Isatidis, stir-fried Burdock seeds, and Scutellaria barbata, add water and boil twice, add 10 times the amount of water each time, boil for 1.5 hours each time, combine the decoctions, filter, and concentrate the filtrate under reduced pressure to a clear paste with a relative density of 1.30 to 1.35, and dry to obtain the water extract.

7. The method for preparing the Chinese medicine composition according to any one of claims 1 to 5, characterized in that: The preparation method of the granules comprises the following steps: firstly, according to the weight of the powder, weigh cimicifuga, smilax glabra, red peony root, oldenlandia diffusa, peony bark, gentian, isatis indigo leaf, fried burdock fruit and Scutellaria barbata, add water and boil twice, add 10 times the amount of water each time, boil for 1.5 hours each time, combine the decoctions, filter, concentrate the filtrate under reduced pressure to a clear paste with a relative density of 1.30-1.35, dry, crush, add an appropriate amount of dextrin, mix well, add an appropriate amount of ethanol, make granules, dry, make the granules into 20-30 meshes, and fill them into a composite film packaging bag to obtain the granules.

8. The method for preparing the Chinese medicine composition according to any one of claims 1 to 5, characterized in that: The preparation method of the decoction is as follows: first, according to the weight powder, weigh Cimicifuga, Smilax glabra, Paeonia lactiflora, Hedyotis diffusa, Paeonia suffruticosa, Gentiana scabra, Folium Isatidis, stir-fried Burdock seeds, and Scutellaria barbata, add water and boil twice, adding 10 times the amount of water each time, boiling for 1.5 hours each time, and combining the decoctions to obtain the decoction.

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