Traditional Chinese medicine compound composition and application thereof in treating chronic kidney disease related pruritus

Abstract

The invention discloses a traditional Chinese medicine compound composition and application thereof in treating chronic kidney disease related pruritus, and belongs to the field of pruritus disease treatment. The traditional Chinese medicine compound composition is prepared from the following raw materials in parts by mass: 45 parts of radix sophorae flavescentis, 45 parts of cortex dictamni, 30 parts of herba schizonepetae, 30 parts of rhizoma alismatis, 30 parts of salted semen plantaginis, 20 parts of oldenlandia diffusa, 20 parts of folium mori, 20 parts of angelica sinensis, 20 parts of ligusticum wallichii, 20 parts of radix polygoni multiflori preparata, 20 parts of astragalus membranaceus, 20 parts of semen coicis and 15 parts of pogostemon cablin. After decoction and rotary evaporation, the traditional Chinese medicine compound composition can be used for lotion / ointment for treating chronic kidney disease related pruritus, and the lotion / ointment is smeared on pruritus parts for treatment; the lotion / ointment is obvious in effect, low in cost, free of toxic and side effects, wide in medicine source and simple and feasible in treatment method.

Description

Technical Field

[0001] This invention belongs to the field of pruritus treatment, specifically involving a traditional Chinese medicine compound composition and its application in the treatment of pruritus associated with chronic kidney disease. Background Technology

[0002] Currently, there are two main methods for the clinical treatment of pruritus associated with chronic kidney disease: 1) Western medicine treatment mainly uses moisturizing, skin-nourishing and skin barrier-protecting drugs, anesthetics, antiepileptic drugs, and opioid receptor agonists and antagonists, and kidney transplantation can be performed for end-stage renal disease; 2) Traditional Chinese medicine treatment mainly uses oral decoctions of Chinese herbs.

[0003] Both of the aforementioned treatment methods have certain limitations. Western medicine primarily treats chronic kidney disease-related itching with topical and oral medications. However, due to the unclear pathogenesis and lack of a unified theoretical basis for targeted treatment, existing medications are mostly symptomatic rather than addressing the underlying cause. Traditional drugs are often ineffective; for example, antihistamines (such as loratadine) are ineffective for most patients with chronic kidney disease-related itching and may cause side effects such as drowsiness and dry mouth. Corticosteroid ointments only relieve local inflammation, and long-term use can lead to skin atrophy and increased risk of infection. Gabapentin / pregabalin, while capable of regulating nerve signals, are only effective for some patients and have side effects such as dizziness, drowsiness, and neurotoxicity. Dosage adjustments are necessary based on kidney function, making them inconvenient to use. Traditional Chinese medicine treatment for chronic kidney disease-related itching using decoctions is cumbersome and not suitable for consistent patient adherence. Summary of the Invention

[0004] In view of the shortcomings of the prior art, the purpose of this invention is to provide a traditional Chinese medicine compound composition and its application in the treatment of chronic kidney disease-related pruritus, thereby solving the problems in the prior art.

[0005] The objective of this invention can be achieved through the following technical solutions: The traditional Chinese medicine compound composition includes the following raw materials in parts by weight: 45 parts Sophora flavescens, 45 parts Dictamnus dasycarpus, 30 parts Schizonepeta tenuifolia, 30 parts Alisma plantago-aquatica, 30 parts Plantago asiatica (processed with salt), 20 parts Hedyotis diffusa, 20 parts Morus alba, 20 parts Angelica sinensis, 20 parts Ligusticum chuanxiong, 20 parts Polygonum multiflorum (processed), 20 parts Astragalus membranaceus, 20 parts Coix lacryma-jobi, and 15 parts Pogostemon cablin.

[0006] The above-mentioned traditional Chinese medicine compound composition is used as an active ingredient in the preparation of drugs for treating chronic kidney disease-related pruritus.

[0007] Furthermore, the drug is a lotion or ointment.

[0008] Furthermore, the preparation process of the lotion is as follows: the lotion is obtained by decocting the traditional Chinese medicine compound composition.

[0009] Furthermore, the preparation process of the ointment is as follows: the decoction of the traditional Chinese medicine compound composition is subjected to rotary evaporation under reduced pressure to obtain the active ingredients; the active ingredients are mixed with the ointment matrix to obtain the traditional Chinese medicine ointment.

[0010] Furthermore, the method of using the lotion / ointment is as follows: rub it on the itchy skin area for 30 seconds, once a day, for a course of treatment lasting four weeks.

[0011] A lotion for treating chronic kidney disease-related itching, with the above-mentioned traditional Chinese medicine compound composition as the active ingredient.

[0012] A cream for treating chronic kidney disease-related itching, with the above-mentioned traditional Chinese medicine compound composition as the active ingredient.

[0013] A method for preparing a lotion for treating chronic kidney disease-related itching includes: decocting the above-mentioned traditional Chinese medicine compound composition.

[0014] A method for preparing a herbal ointment for treating chronic kidney disease-related pruritus includes: decocting the above-mentioned traditional Chinese medicine compound composition, followed by rotary evaporation under reduced pressure to obtain active ingredients; and mixing the active ingredients with an ointment base to obtain a traditional Chinese medicine ointment.

[0015] The beneficial effects of this invention are: Based on the theories of traditional Chinese medicine and the compatibility of herbs, as well as clinical practice, this invention provides a compound Chinese medicine formula and a lotion / ointment for treating pruritus associated with chronic kidney disease. This lotion / ointment is effective, low in cost, has a wide range of medicinal sources, and is easy to use. It acts directly on the peripheral itchy area without side effects such as dizziness, drowsiness, or neurotoxicity, and does not require dosage adjustment based on kidney function, making it safer. Attached Figure Description

[0016] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, for those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0017] Figure 1 This is a schematic diagram of the Visual Analogue Scale (VAS) of the present invention; Figure 2 This is a schematic diagram of the Digital Rating Scale (NRS) of this invention. Detailed Implementation

[0018] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0019] Example 1 The traditional Chinese medicine compound composition includes the following raw materials in parts by weight: 45 parts Sophora flavescens, 45 parts Dictamnus dasycarpus, 30 parts Schizonepeta tenuifolia, 30 parts Alisma plantago-aquatica, 30 parts Plantago asiatica (processed with salt), 20 parts Hedyotis diffusa, 20 parts Morus alba, 20 parts Angelica sinensis, 20 parts Ligusticum chuanxiong, 20 parts Polygonum multiflorum (processed), 20 parts Astragalus membranaceus, 20 parts Coix lacryma-jobi, and 15 parts Pogostemon cablin.

[0020] In this embodiment, 1g represents 1 part.

[0021] The preparation process of this traditional Chinese medicine compound composition is as follows: 1) Based on traditional Chinese medicine theory, search for authentic Chinese medicinal herbs with similar efficacy; Sophora flavescens: According to the *Compendium of Materia Medica*, it "treats wind-related ailments, kills parasites, dries dampness, and relieves itching." It is cold in nature and bitter in taste, entering the heart and liver meridians, and is an essential medicine for damp-heat itchy sores. The active ingredient in Sophora flavescens, matrine F, inhibits mast cell degranulation, reduces histamine and IgE release, inhibits the nuclear factor κB pathway, and reduces the expression of pro-itch factors such as interleukin-4. Sophora flavescens has a good inhibitory rate against Staphylococcus aureus and Candida albicans, reducing secondary infectious pruritus.

[0022] Dictamnus dasycarpus root bark: According to the *Treatise on the Properties of Medicinal Herbs*, it "treats all kinds of heat toxins and wind, and itchy skin." It is cold in nature and bitter in taste, entering the spleen and stomach meridians, and is particularly effective at clearing damp-heat from the skin. Pharmacological studies show that its active ingredient, dictamnus alkaloid, blocks capsaicin receptor channels, reducing the stimulation of nerve endings by pruritus mediators (such as endothelin). The polysaccharides in Dictamnus dasycarpus root bark can enhance the hydration capacity of the stratum corneum, relieving dryness and itching.

[0023] Schizonepeta tenuifolia (Jingjie): In the *Yizong Jinjian* (Golden Mirror of Medicine), Xiaofeng San (Wind-Dispelling Powder) uses Schizonepeta tenuifolia as the principal ingredient, combined with Saposhnikovia divaricata (Fangfeng) and Cicadae Periostracum (Chan Tui), primarily treating "wind-heat rashes and itching." It relieves skin discomfort by dispersing wind-evil and promoting rash eruption and detoxification. The *Compendium of Materia Medica* states that Schizonepeta tenuifolia "disperses wind-heat, clears the head and eyes, benefits the throat, and reduces sores and swelling," making it suitable for itchy rashes caused by wind-heat or wind-dampness affecting the skin. Schizonepeta tenuifolia volatile oil contains dextrorotatory limonene (62%), menthone, etc., which can penetrate the stratum corneum and act on mast cells in the dermis, inhibiting histamine release with effects comparable to the antihistamine loratadine. Schizonepeta tenuifolia glycosides, by inhibiting the nuclear factor κB pathway, reduce the production of pruritogenic factors such as interleukin-31 and tumor necrosis factor-α, thus blocking the vicious cycle of itching and scratching.

[0024] Alisma plantago-aquatica: In ancient texts, the *Compendium of Materia Medica* records that Alisma plantago-aquatica can "drain damp-heat and resolve phlegm," mentioning that its decoction applied externally can relieve skin itching. The *Prescriptions Worth a Thousand Gold* also mentions that Alisma plantago-aquatica applied externally can relieve eczema and skin itching. Modern pharmacological studies show that Alisma plantago-aquatica contains triterpenoid compounds such as alisol, which can inhibit the nuclear factor κB pathway and reduce the release of pruritogenic factors such as interleukin-31 and tumor necrosis factor-α, thus being effective for damp-heat type eczema.

[0025] Plantain Seed: The *Waitai Miyao* records that "Plantain seeds should be boiled in three liters of water three times, the dregs removed, and used to wash itchy and painful areas," directly used to treat vulvar or skin itching and swelling. Modern pharmacological research shows that plantain seeds contain psyllic acid and flavonoids that inhibit Staphylococcus aureus and Candida albicans (commonly seen in infectious pruritus), with an antibacterial rate exceeding 70%. It can also block the nuclear factor κB inflammatory pathway, reducing pruritogenic factors and decreasing the release of interleukin-31 and tumor necrosis factor-α. Its active ingredient, mucin (polysaccharide), forms a protective film, reducing friction and promoting wound healing.

[0026] Oldenlandia diffusa: According to *Minnan Folk Herbal Medicine*, applying a poultice of fresh, mashed Oldenlandia diffusa can relieve swelling, heat, and pain. Its cooling properties clear damp heat and reduce itching caused by redness, swelling, and exudation. Modern pharmacological studies show that flavonoids (such as quercetin) and iridoid glycosides (such as cypermethrin) in Oldenlandia diffusa can block the nuclear factor κB inflammatory pathway and reduce the release of pruritogenic factors such as interleukin-31 and tumor necrosis factor-α. Its polysaccharide components enhance macrophage activity, correct Th1 / Th2 immune shift, and reduce IgE-mediated allergic reactions.

[0027] Mulberry leaves: According to the Compendium of Materia Medica, mulberry leaves, when decocted for bathing, can dispel wind and relieve itching. Frost-covered mulberry leaves can be used externally to treat dandruff and dry skin. Modern research shows that they contain rutin, quercetin, and other components, which have antihistamine effects, promote epidermal cell differentiation, and repair the skin barrier.

[0028] Angelica sinensis: The *Shengji Zonglu* records that angelica sinensis, combined with schizonepeta and saposhnikovia divaricata, is decocted and used for fumigation and washing to treat wind-induced itching (i.e., chronic pruritus). The *Wai Ke Zheng Zong* records the ancient formula "Run Ji Gao" (Skin-Nourishing Ointment): angelica sinensis, sesame oil, and beeswax are boiled into an ointment for external application, targeting chapped skin and dry itching. Modern pharmacological research shows that: in terms of antihistamine and antipruritic effects, ferulic acid can inhibit mast cell degranulation and histamine release, blocking the capsaicin receptor pruritus neural pathway; in terms of anti-inflammatory and immunomodulatory effects, angelica sinensis polysaccharides can regulate the Th1 / Th2 balance, reducing IgE and inflammatory factor levels; in terms of skin barrier repair, volatile oils promote keratinocyte proliferation and ceramide synthesis; and in terms of improving microcirculation, ferulic acid inhibits platelet aggregation and improves skin blood supply.

[0029] Chuanxiong (Ligusticum striatum): According to the *Shengji Zonglu*, chuanxiong, combined with schizonepeta and saposhnikovia, is decocted and used for fumigation and washing to treat "wind-induced itching" (chronic pruritus), utilizing its pungent and warm properties to penetrate the skin. The *Compendium of Materia Medica* emphasizes that chuanxiong "ascends to the head and eyes, descends to the blood sea," meaning that when used externally, it can guide the medicine to the skin surface, improving itching caused by blood stasis. In the *Orthodox Manual of Surgery*, chuanxiong is often added to the Runji Ointment (Angelica sinensis + sesame oil + beeswax) to enhance its blood-activating properties and treat chapped itching. Modern pharmacology shows that it contains ligustrazine and volatile oils, which can inhibit platelet-activating factor, reduce the release of inflammatory mediators, and have local anesthetic and antipruritic effects.

[0030] Processed Polygonum multiflorum: The *Compendium of Materia Medica* records that raw Polygonum multiflorum, combined with Saposhnikovia divaricata, Sophora flavescens, and Mentha haplocalyx, decocted into a soup for external washing, treats "widespread sores, swelling, itching, and pain." The *Kaibao Materia Medica* mentions that raw Polygonum multiflorum "treats wind sores on the head and face," suitable for facial eczema and seborrheic dermatitis with itching. Modern pharmacological research shows that the main active ingredient in processed Polygonum multiflorum, stilbene glycoside, can block capsaicin receptor channels, reduce itch nerve signal transmission, decrease Th2 cytokine expression, and reduce IgE-mediated allergic reactions. Its active ingredient, anthraquinone derivatives, can inhibit mast cell degranulation, reduce the release of itch mediators such as histamine and leukotrienes, and alleviate acute urticaria wheals.

[0031] Astragalus: The *Medical Records of Integrating Chinese and Western Medicine* states that "Astragalus can replenish Qi; when Qi is sufficient, blood circulation is smooth, the skin is nourished, and itching naturally subsides." The *Corrections of Errors in Medical Classics* uses Astragalus in combination with Paeonia lactiflora and Saposhnikovia divaricata to treat stubborn skin conditions caused by blood deficiency and wind-dryness. Modern pharmacological studies have shown that Astragalus polysaccharides and flavonoids can stabilize mast cell membranes, inhibit histamine release (a study published in the *Chinese Journal of Traditional Chinese Medicine* in 2020), and reduce the level of pruritus mediators. Astragaloside A blocks pruritus signal transduction by inhibiting capsaicin receptor channels.

[0032] Coix seed: The *Jinkui Yaolue* (Essentials from the Golden Cabinet) uses Coix seed combined with ephedra and apricot kernel to treat general pain and itchy eczema caused by "wind-dampness on the surface," simultaneously relieving both exterior and interior symptoms through sweating and dampness elimination. The *Wenbing Tiaobian* (Treatise on Warm Diseases) uses Coix seed combined with bamboo leaves and talc to clear damp-heat from the triple burner, improving itchy, oozing herpes caused by damp-heat invading the skin. Modern pharmacological research shows that coix seed esters and coixol can reduce the levels of interleukin-31, interleukin-33, and interleukin-4 (*Journal of Dermatological Science*, 2021), blocking itching caused by the Th2 inflammatory pathway. Coix polysaccharides activate peroxisome proliferator-activated receptor γ-receptors, accelerating the synthesis of ceramides and free fatty acids (*International Journal of Molecular Sciences*, 2020), repairing the damaged skin barrier.

[0033] Patchouli: The Compendium of Materia Medica records that it "treats swelling caused by wind-dampness, dispels foul odors, and treats itchy skin rashes," making it a core medicine for itching caused by dampness accumulating on the skin surface. The Compendium of Materia Medica states that it is "pungent, warm, and aromatic, able to open pores and expel dampness and toxins," used for eczema and urticaria caused by damp-heat. Modern pharmacology shows that it contains patchouli alcohol, baicalein, and other components, possessing broad-spectrum antifungal activity (especially against Malassezia). The evaporation of ethanol induces a cooling reflex, providing instant antipruritic effects.

[0034] 2) Prepare the appropriate authentic Chinese medicinal herbs; Sophora flavescens (Shanxi), Dictamnus dasycarpus (Heilongjiang), Schizonepeta tenuifolia (Shandong), Alisma plantago-aquatica (Sichuan), Plantago asiatica (Sichuan), Hedyotis diffusa (Jiangxi), Morus alba (Anhui), Angelica sinensis (Gansu), Ligusticum chuanxiong (Sichuan), Polygonum multiflorum (Hubei), Astragalus membranaceus (Gansu), Coix lacryma-jobi (Guizhou), Pogostemon cablin (Guangxi).

[0035] 3) Formulating prescriptions based on traditional Chinese medicine theory The formula is based on the combination of thirteen Chinese medicinal herbs, including Sophora flavescens, Dictamnus dasycarpus root bark, Schizonepeta tenuifolia, Alisma plantago-aquatica, Plantago asiatica seed, Hedyotis diffusa herb, Morus alba leaf, Angelica sinensis, Ligusticum chuanxiong rhizome, processed Polygonum multiflorum root, Astragalus membranaceus, Coix lacryma-jobi seed, and Pogostemon cablin. According to the theory of complementary combinations of Chinese medicinal herbs and syndrome differentiation and treatment, the combination of these thirteen herbs can enhance the efficacy.

[0036] The basis for the dosage of the above thirteen Chinese medicines: In this embodiment, the dosage of the above thirteen Chinese medicine decoctions is 335 grams. According to the theory of the compatibility of Chinese medicines, Sophora flavescens and Dictamnus dasycarpus are the principal medicines, used at 45 grams; the assistant medicines are Schizonepeta tenuifolia, Alisma plantago-aquatica and Plantago asiatica, used at 30 grams; the adjuvant medicines are Hedyotis diffusa, Morus alba, Angelica sinensis, Ligusticum chuanxiong, Polygonum multiflorum, Astragalus membranaceus and Coix lacryma-jobi, used at 20 grams; and the guiding medicine is Pogostemon cablin, used at 15 grams.

[0037] In addition, the above-mentioned traditional Chinese medicine compound composition can be used to prepare lotions and ointments; The preparation process of the lotion is as follows: the above-mentioned compound Chinese medicine composition is decocted (water decoction) to obtain the lotion.

[0038] The preparation process of the ointment is as follows: The decoction of the traditional Chinese medicine compound is subjected to rotary evaporation under reduced pressure to obtain the active ingredients; the active ingredients are then mixed with an ointment base to obtain the traditional Chinese medicine ointment. Specifically, the preparation steps of the ointment include: The lotion was subjected to rotary evaporation under reduced pressure at a temperature of 40–65°C, a vacuum of 0.06–0.095 MPa, and a time of 2–4 h to obtain the active ingredient. The active ingredient was then mixed with a medicated ointment base to prepare a traditional Chinese medicine ointment.

[0039] The ointment base is at least one of vegetable oil, animal oil, honey, wax, lanolin, petrolatum, polyethylene glycol, sodium carboxymethyl cellulose, glyceryl monostearate, and octadecyl alcohol.

[0040] The weight ratio of the active ingredient to the ointment base is 5:(4-13).

[0041] Example 2 In this embodiment, the application of the above-mentioned traditional Chinese medicine compound composition in the treatment of chronic kidney disease-related pruritus is described and tested. (1) Clarify the diagnostic criteria for pruritus associated with chronic kidney disease. Western medicine diagnostic criteria: Itching symptoms secondary to chronic kidney disease and which cannot be explained by other causes are mainly manifested as local or generalized skin itching of varying degrees, with or without skin rash, and are episodic, with symptoms being more severe at night than during the day, and the duration of the episodes varies.

[0042] Traditional Chinese Medicine diagnostic criteria: 1) A skin disease with abnormal skin sensation, characterized by itching as the main symptom, without obvious primary skin lesions; 2) Its clinical features are: paroxysmal itching of the skin, and secondary lesions such as scratch marks, blood scabs, pigmentation and lichenification often appear after scratching; 3) It is more common in the elderly and young adults; 4) It should be differentiated from other diseases, such as scabies, lice, and neurodermatitis.

[0043] Traditional Chinese Medicine (TCM) diagnosis and differentiation: The patient has a weak constitution and internal heat in the blood. External pathogens invade, easily causing blood heat to generate wind, thus leading to itching. Prolonged illness weakens the body, resulting in deficiency of qi and blood, allowing wind pathogens to invade. Blood deficiency easily generates wind, leading to malnourishment of the skin and causing this disease. Improper diet, excessive consumption of spicy and greasy foods, or alcohol damages the spleen and stomach, generating internal damp-heat, which transforms into heat and wind. This damp-heat cannot be released internally or externally, stagnating in the skin and causing itching. TCM treatment focuses on clearing heat, cooling the blood, and dispelling wind. 1) Wind-Heat and Blood-Heat Syndrome: Main symptoms: Severe itching, worsened by heat, with blood scabs after scratching; accompanied by irritability, thirst, yellow urine, and dry stools; red tongue with a thin yellow coating, and a floating and rapid pulse. 2) Damp-heat syndrome: Main symptoms: persistent itching, with secondary infection or eczema-like changes after scratching; accompanied by dry mouth and bitter taste, chest and rib distension, poor appetite, dark yellow urine, and constipation; red tongue with yellow and greasy coating, and slippery and rapid or wiry and rapid pulse. 3) Blood deficiency and wind-dryness syndrome: Main symptoms: dry skin, with a small amount of peeling and bloodstains after scratching; emotional fluctuations can trigger attacks or aggravate itching; accompanied by dizziness, blurred vision, insomnia, and dreaminess; red tongue with thin coating, and thready and rapid or wiry and rapid pulse.

[0044] (2) Determine the treatment plan 1) Treatment of chronic kidney disease-related pruritus employs an individualized and step-by-step strategy, with the overall principle being a "gradual, step-by-step treatment approach"; among which, the Visual Analogue Scale (VAS) and the Numerical Rating Scale (NRS) are respectively as follows: Figure 1 and Figure 2 As shown in Table 1, the severity of itching is rated using the Visual Analogue Scale and the Numerical Rating Scale. Table 1. Rating Table for Itching Severity Using Visual Analog Scale and Numerical Rating Scale Step 1: General treatment. This step is basic management and is applicable to all patients with chronic kidney disease-related itching. The focus is on controlling triggering factors and optimizing the management of the underlying disease through non-pharmacological interventions.

[0045] Step Two: Drug Treatment. When general treatment is ineffective or itching is moderate or severe (VAS / NRS score ≥ 3), drug treatment is initiated. This involves topical and systemic medications, primarily including moisturizing, skin-conditioning, and skin barrier-protecting drugs, anesthetics, antiepileptic drugs, and opioid receptor agonists and antagonists. Step 3: Other treatments, including non-drug adjuvant therapies such as ultraviolet phototherapy, traditional Chinese medicine treatments including herbal medicine (oral and topical), acupuncture, and acupressure; Step 4: Kidney transplantation. For severe or refractory pruritus, kidney transplantation is the final step and can significantly relieve or cure symptoms.

[0046] 2) Treatment based on syndrome differentiation The basic pathogenesis of this disease is blood heat and wind heat, so clearing heat, cooling blood, and dispelling wind are the basic treatment methods. At the same time, this disease often involves internal damp-heat, so treatment methods to clear damp-heat should be selected in a timely and appropriate manner according to the condition. Blood deficiency and wind dryness syndrome: Thirteen herbs are used: Sophora flavescens 45g, Dictamnus dasycarpus 45g, Schizonepeta tenuifolia 30g, Alisma plantago-aquatica 30g, Plantago asiatica 30g, Hedyotis diffusa 20g, Morus alba 20g, Angelica sinensis 20g, Ligusticum chuanxiong 20g, Polygonum multiflorum 20g, Astragalus membranaceus 20g, Coix lacryma-jobi 20g, and Pogostemon cablin 15g.

[0047] 3) Efficacy assessment The criteria for judging the efficacy of treatment are as follows: Clinically cured: Significant improvement in TCM clinical symptoms and signs, a reduction of ≥95% in syndrome score, and complete relief from itching; Significant effect: Clinical symptoms and signs in TCM showed improvement, with 95% > syndrome score reduction ≥70% and score level reduction of 2 levels; Effective: Clinical symptoms and signs in Traditional Chinese Medicine improved, with 70% > syndrome score reduced by ≥50% and score level reduced by 1 level; Ineffective: Clinical symptoms and signs in Traditional Chinese Medicine have improved, the syndrome score has decreased by <50%, and the score has not decreased or worsened; Traditional Chinese Medicine (TCM) treatment criteria: Skin diseases secondary to chronic kidney disease without obvious primary skin lesions, characterized by abnormal skin sensation with itching as the main symptom. The skin is paroxysmal itching, and scratching often results in secondary damage such as scratch marks, scabs, pigmentation, and lichenification. 1. Cured: Complete relief from itching; 2. Significantly effective: Score grade decreases by 2 levels; 3. Effective: Score grade decreases by 1 level; 4. Ineffective: Score grade decreases by 1 level.

[0048] (3) Clinical application of the formula 45g of Sophora flavescens, 45g of Dictamnus dasycarpus root bark, 30g of Schizonepeta tenuifolia, 30g of Alisma plantago-aquatica, 30g of Plantago asiatica (wrapped in salt), 20g of Hedyotis diffusa, 20g of Morus alba leaf, 20g of Angelica sinensis, 20g of Ligusticum chuanxiong, 20g of Polygonum multiflorum (processed), 20g of Astragalus membranaceus, 20g of Coix lacryma-jobi, and 15g of Pogostemon cablin. Decoct in water, place in a wash basin, and use a towel to wipe the itchy areas of the skin for 30 seconds on each area, once a day. A course of treatment lasts 4 weeks.

[0049] This formula of lotion was used to treat 100 patients with chronic kidney disease-related pruritus exhibiting different symptoms, and a clinical observation was conducted. Another 100 patients with chronic kidney disease-related pruritus exhibiting different symptoms received a placebo. One course of treatment lasted 4 weeks. All patients achieved significant therapeutic effects after treatment, with significant improvement or disappearance of pruritus symptoms, and the overall effective rate exceeded 80%. Specific experimental data are shown in Table 2 below: Table 2. Statistical analysis of the therapeutic effects of placebo and the lotion formulated in this invention. (4) Comparison of economic benefits Traditional treatment for chronic kidney disease-related itching requires multiple measures, including hemoperfusion and hemodialysis filtration, costing approximately 1500 yuan for four weeks. In contrast, treatment with a traditional Chinese medicine formula as a tea substitute for four weeks costs approximately 814.8 yuan (prices are based on computer-generated data from Shuyang Traditional Chinese Medicine Hospital). Compared to conventional treatment, the traditional Chinese medicine compound treatment for chronic kidney disease-related itching is significantly more cost-effective.

[0050] In summary, the traditional Chinese medicine compound wash for treating chronic kidney disease-related pruritus of the present invention comprises: 45g of Sophora flavescens, 45g of Dictamnus dasycarpus root bark, 30g of Schizonepeta tenuifolia, 30g of Alisma plantago-aquatica, 30g of Plantago asiatica seed, 20g of Hedyotis diffusa, 20g of Morus alba leaf, 20g of Angelica sinensis, 20g of Ligusticum chuanxiong, 20g of processed Polygonum multiflorum, 20g of Astragalus membranaceus, 20g of Coix lacryma-jobi, and 15g of Pogostemon cablin. This mixture has good efficacy and is economical in treating chronic kidney disease-related pruritus.

[0051] In the description of this specification, references to terms such as "an embodiment," "example," "specific example," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0052] The foregoing has shown and described the basic principles, main features, and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited to the above embodiments. The embodiments and descriptions in the specification are merely illustrative of the principles of the invention. Various changes and modifications can be made to the invention without departing from its spirit and scope, and all such changes and modifications fall within the scope of the claimed invention.

Claims

1. A traditional Chinese medicine compound composition, characterized in that, The ingredients include the following parts by weight: 45 parts Sophora flavescens, 45 parts Dictamnus dasycarpus, 30 parts Schizonepeta tenuifolia, 30 parts Alisma plantago-aquatica, 30 parts Plantago asiatica (processed), 20 parts Hedyotis diffusa, 20 parts Morus alba, 20 parts Angelica sinensis, 20 parts Ligusticum chuanxiong, 20 parts Polygonum multiflorum (processed), 20 parts Astragalus membranaceus, 20 parts Coix lacryma-jobi, and 15 parts Pogostemon cablin.

2. The use of the traditional Chinese medicine compound composition according to claim 1 as an active ingredient in the preparation of a drug for treating chronic kidney disease-related pruritus.

3. The application according to claim 2, characterized in that, The drug is a lotion or ointment.

4. The application according to claim 3, characterized in that, The preparation process of the lotion is as follows: the lotion is obtained by decocting the traditional Chinese medicine compound composition.

5. The application according to claim 3, characterized in that, The preparation process of the ointment is as follows: the decoction of the traditional Chinese medicine compound composition is subjected to rotary evaporation under reduced pressure to obtain the active ingredients; the active ingredients are mixed with the ointment matrix to obtain the traditional Chinese medicine ointment.

6. The application according to claim 3, characterized in that, The method of using the lotion / ointment is as follows: rub it on the itchy area for 30 seconds, once a day, for a course of four weeks.

7. A lotion for treating pruritus associated with chronic kidney disease, characterized in that, The traditional Chinese medicine compound composition according to claim 1 is the active ingredient.

8. A cream for treating pruritus associated with chronic kidney disease, characterized in that, The traditional Chinese medicine compound composition according to claim 1 is the active ingredient.

9. A method for preparing a lotion for treating pruritus associated with chronic kidney disease, characterized in that, include: The traditional Chinese medicine compound composition according to claim 1 is obtained by decocting.

10. A method for preparing a cream for treating pruritus associated with chronic kidney disease, characterized in that, include: The traditional Chinese medicine compound composition according to claim 1 is decocted and then subjected to rotary evaporation under reduced pressure to obtain the active ingredient; the active ingredient is mixed with the ointment matrix to prepare a traditional Chinese medicine ointment.

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