A traditional Chinese medicine compound preparation for treating anal eczema, and a preparation method and application thereof

Abstract

The application belongs to the technical field of traditional Chinese medicine compositions, and particularly relates to a traditional Chinese medicine compound preparation for treating anal eczema as well as a preparation method and application thereof. The traditional Chinese medicine compound preparation is prepared from the following raw medicinal materials in parts by weight: 35-45 parts of Sophora flavescens, 35-45 parts of Cnidium monnieri, 18-22 parts of Semen Astragali Complanati, 18-22 parts of Cortex Dictamni, 18-22 parts of Scutellaria baicalensis, 118-22 parts of Phellodendri, 10-14 parts of Chuanxiong Rhizoma, 16-20 parts of Angelica sinensis, 10-14 parts of Radix Paeoniae Alba, 16-20 parts of Saposhnikovia divaricata, and 10-14 parts of Gleditsia sinensis. The application provides a traditional Chinese medicine compound preparation and a Chinese medicine treatment method for treating acute and chronic anal eczema caused by 'damp-heat invasion'. The traditional Chinese medicine compound preparation can not only significantly relieve the perianal pruritus and exudation of the patients with anal eczema, but also effectively reduce the skin lesion area and improve the skin lesion state, and the clinical curative effect is obvious. In addition, the raw materials of the traditional Chinese medicine compound preparation are widely sourced and low in price, the pure traditional Chinese medicine raw materials are used for processing, and the preparation process is simple.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine composition technology, specifically relating to a traditional Chinese medicine compound preparation for treating anal eczema, its preparation method, and its application. Background Technology

[0002] Anal eczema is a common and refractory skin disease in proctology. Clinical symptoms often manifest as paroxysmal or intermittent anal itching, especially at night. The condition is persistent and repetitive scratching of the perianal area can lead to local skin damage, resulting in anal pain, blood on toilet paper after defecation, and other symptoms, impacting the patient's quality of life and psychological well-being. The pathogenesis of this disease is currently unclear. Western medicine research suggests it is an allergic reaction of the perianal skin, possibly related to neuroregulation, environment, immunity, and genetics. Internal factors include gastrointestinal dysfunction, while external factors include skin infections. The simultaneous action of internal and external factors leads to abnormal local skin immune function, increased vascular permeability, and edema and inflammation of the epidermis and dermis. Western medicine treatment primarily involves oral antihistamines, while topical medications include corticosteroids, calcineurin inhibitors, and antibiotics. When conservative treatment is ineffective, surgical treatment and local injection therapy may be considered. However, these medications only treat the symptoms and not the root cause, and their therapeutic effect is limited. Therefore, a new strategy for treating anal eczema is urgently needed. Summary of the Invention

[0003] The purpose of this invention is to provide a traditional Chinese medicine compound preparation for treating anal eczema, which has significant clinical efficacy in the treatment of anal eczema.

[0004] The technical solution adopted in this invention is:

[0005] This invention provides a traditional Chinese medicine compound preparation for treating anal eczema, wherein the traditional Chinese medicine compound preparation is made from the following raw materials in parts by weight:

[0006] Sophora flavescens 35-45 parts, Cnidium monnieri 35-45 parts, Kochia scoparia 18-22 parts, Dictamnus dasycarpus 18-22 parts, Scutellaria baicalensis 18-22 parts, Phellodendron chinense 118-22 parts, Ligusticum chuanxiong 10-14 parts, Angelica sinensis 16-20 parts, Sanguisorba officinalis 10-14 parts, Saposhnikovia divaricata 16-20 parts, Gleditsia sinensis thorns 10-14 parts.

[0007] Preferably, the traditional Chinese medicine compound preparation is made from the following raw materials in parts by weight:

[0008] 40 parts Sophora flavescens, 40 parts Cnidium monnieri, 20 parts Kochia scoparia, 20 parts Dictamnus dasycarpus, 18 parts Scutellaria baicalensis, 18 parts Phellodendron chinense, 12 parts Ligusticum chuanxiong, 18 parts Angelica sinensis, 12 parts Sanguisorba officinalis, 18 parts Saposhnikovia divaricata, and 12 parts Gleditsia sinensis.

[0009] A second aspect of this invention provides a method for preparing the aforementioned traditional Chinese medicine compound preparation, comprising the following steps:

[0010] Weigh out the following ingredients according to the stated weight: Sophora flavescens, Cnidium monnieri, Kochia scoparia, Dictamnus dasycarpus, Scutellaria baicalensis, Phellodendron chinense, Ligusticum chuanxiong, Angelica sinensis, Sanguisorba officinalis, Saposhnikovia divaricata, and Gleditsia sinensis thorns.

[0011] After soaking in water, decoct to obtain the aforementioned compound Chinese medicine preparation.

[0012] Preferably, the soaking time is 0.5h to 1h.

[0013] Preferably, the simmering time is 20 to 30 minutes.

[0014] Preferably, the decocting is performed 2 to 4 times.

[0015] A third aspect of the present invention provides the application of the aforementioned traditional Chinese medicine compound preparation, which is used to prepare a drug for treating anal eczema.

[0016] Preferably, the type of anal eczema is damp-heat type anal eczema.

[0017] Preferably, the drug further includes pharmaceutically acceptable excipients.

[0018] Preferably, the pharmaceutically acceptable excipient is one or more of the following: diluent, disintegrant, precipitation inhibitor, flow aid, binder, dispersant, suspending agent, isotonic agent, thickener, emulsifier, preservative, and stabilizer.

[0019] Preferably, the diluent includes any one of starch, lactose, sucrose, and mannitol.

[0020] Preferably, the disintegrant comprises any one of starch, microcrystalline cellulose, and low-substituted hydroxypropyl cellulose.

[0021] Preferably, the precipitation inhibitor comprises any one of sodium dodecyl sulfate, Tween-80, polyvinylpyrrolidone, and hydroxypropyl methylcellulose.

[0022] Preferably, the flow aid comprises any one of cationic polyacrylamide, polydiallyldimethylammonium chloride, and cationic starch.

[0023] Preferably, the adhesive comprises any one of starch paste, hydroxypropyl methylcellulose, and povidone.

[0024] Preferably, the dispersant comprises any one of sodium dodecyl sulfate, polyvinylpyrrolidone, and sodium carboxymethyl cellulose.

[0025] Preferably, the suspending agent includes any one of gum arabic, tragacanth gum, sodium carboxymethyl cellulose, and hydroxypropyl methylcellulose.

[0026] Preferably, the isotonic agent includes any one of sodium chloride, glucose, and mannitol.

[0027] Preferably, the thickener includes any one of gum arabic, xanthan gum, and sodium carboxymethyl cellulose.

[0028] Preferably, the emulsifier comprises any one of sodium dodecyl sulfate, benzalkonium chloride, and fatty acid sorbitan.

[0029] Preferably, the preservative includes any one of benzoic acid, sorbic acid, methylparaben, and benzalkonium bromide.

[0030] Preferably, the stabilizer comprises any one of sodium sulfite, sodium bisulfite, tocopherol, and disodium EDTA.

[0031] Compared with the prior art, the beneficial effects of the present invention are:

[0032] This invention provides a traditional Chinese medicine compound preparation for treating anal eczema. The compound preparation is made from the following raw materials in parts by weight: 35-45 parts Sophora flavescens, 35-45 parts Cnidium monnieri, 18-22 parts Kochia scoparia, 18-22 parts Dictamnus dasycarpus, 18-22 parts Scutellaria baicalensis, 118-22 parts Phellodendron chinense, 10-14 parts Ligusticum chuanxiong, 16-20 parts Angelica sinensis, 10-14 parts Sanguisorba officinalis, 16-20 parts Saposhnikovia divaricata, and 10-14 parts Gleditsia sinensis thorns. This invention provides a traditional Chinese medicine compound preparation and treatment method for acute and chronic anal eczema caused by "damp-heat invasion." The compound preparation not only significantly alleviates symptoms such as perianal itching and exudation in patients with anal eczema, but also effectively reduces the area of ​​skin lesions and improves the condition of the lesions, showing significant clinical efficacy. Furthermore, the raw materials for this compound preparation are widely available and inexpensive, and the preparation process is simple, using pure traditional Chinese medicine raw materials. Attached Figure Description

[0033] Figure 1 The score was determined 9 days after treatment.

[0034] Figure 2 The score was determined 18 days after treatment.

[0035] Figure 3 The score was determined 27 days after treatment. Detailed Implementation

[0036] The present invention will be further illustrated below with specific embodiments, but these embodiments do not limit the scope of the invention. Modifications or substitutions to the details and form of the technical solutions of the present invention may be made without departing from the spirit and scope of the invention, but all such modifications or substitutions fall within the protection scope of the present invention.

[0037] The inventive concept of this invention is as follows:

[0038] Traditional Chinese medicine (TCM) refers to anal eczema as "blood wind sores," "yin dampness," and "wind-damp sores," among other names. The *Jinkui Gouxuan* (Golden Chamber Prescriptions) states, "When there is stagnation, all kinds of diseases arise," indicating that emotional imbalance and poor blood circulation lead to illness. The *Wai Ke Zheng Zong* (Orthodox Manual of External Medicine) further states, "If one does not reduce their appetite, they will inevitably suffer from unbearable itching and sores," illustrating that dietary indiscretion can cause skin sores and itching. These are the internal causes of this disease. External causes mainly involve the interaction and stagnation of wind, cold, dampness, and heat in the perianal skin, leading to poor local blood circulation and blocked pores, resulting in perianal dampness and itching, thus causing the disease. TCM treatment is divided into internal and external therapies. Based on the principle of syndrome differentiation and treatment, it employs a three-factor approach, prescribing corresponding compound Chinese medicine formulas for oral and external use according to the patient's syndrome type. In addition to drug treatment, it also includes a wide range of TCM-specific therapies such as acupuncture, moxibustion, acupoint embedding, acupoint injection, and auricular acupressure. Among them, external treatment methods of traditional Chinese medicine can not only make up for the first-pass elimination effect of oral drugs in the liver and reduce patients' gastrointestinal symptoms, but also reduce patients' fear of traditional Chinese medicine therapies such as acupuncture. Moreover, it allows the drugs to act directly on the lesion site to achieve the therapeutic purpose.

[0039] Therefore, this invention provides a traditional Chinese medicine compound preparation for treating anal eczema based on traditional Chinese medicine fumigation and wet compress therapy. Traditional Chinese medicine fumigation and wet compress therapy is a treatment method that involves decocting traditional Chinese medicines with specific effects, then using the decoction for fumigation followed by wet compresses. It is simple to operate and easy to master. The medicine is absorbed through the transdermal layer, dilates blood vessels, accelerates circulation, inhibits the expression of inflammatory factors in the skin, and reduces local inflammatory reactions, thus achieving a therapeutic effect.

[0040] The traditional Chinese medicine compound preparation for treating anal eczema described in this invention is as follows:

[0041] 1. Formula.

[0042] Sophora flavescens 35-45 parts, Cnidium monnieri 35-45 parts, Kochia scoparia 18-22 parts, Dictamnus dasycarpus 18-22 parts, Scutellaria baicalensis 18-22 parts, Phellodendron chinense 118-22 parts, Ligusticum chuanxiong 10-14 parts, Angelica sinensis 16-20 parts, Sanguisorba officinalis 10-14 parts, Saposhnikovia divaricata 16-20 parts, Gleditsia sinensis thorns 10-14 parts.

[0043] 2. Compatibility principle.

[0044] Sophora flavescens and Cnidium monnieri are both the principal herbs in this formula. Both have the effects of clearing heat and drying dampness, killing parasites and relieving itching. Sophora flavescens is good at clearing heat and draining damp heat downwards, while Cnidium monnieri dries dampness and damp heat. The above two herbs, plus Salvia miltiorrhiza, form Sophora flavescens powder, which can treat all kinds of scabies and wind-induced itching, which can cause sores when itchy.

[0045] The four herbs, namely, Dictamnus dasycarpus root bark, Kochia scoparia fruit, Scutellaria baicalensis root, and Phellodendron chinense bark, are used as assistant herbs. Both Scutellaria baicalensis root and Phellodendron chinense bark have the effects of clearing heat and drying dampness, purging fire and detoxifying. Scutellaria baicalensis root is good at removing damp heat in the intestines, while Phellodendron chinense bark is good at clearing damp heat in the lower burner. Its effects of purging fire and detoxifying are stronger than those of Scutellaria baicalensis root and are good at treating sores caused by heat toxins, eczema and other diseases.

[0046] The remaining five herbs in this formula—Ligusticum chuanxiong, Angelica sinensis, Sanguisorba officinalis, Saposhnikovia divaricata, and Gleditsia sinensis thorns—serve as adjuvant herbs. Saposhnikovia divaricata excels at dispelling wind and relieving dampness and pain, thus enhancing the wind-dispelling and dampness-removing effects of the compound. Angelica sinensis nourishes and invigorates blood, moisturizes the skin, and, combined with Ligusticum chuanxiong, invigorates blood, removes blood stasis, dispels wind, and relieves pain. Sanguisorba officinalis nourishes and cools blood, clears heat, and astringes sores. The three herbs used together achieve the therapeutic goal of "nourishing without stagnation and moisturizing without drying." Gleditsia sinensis thorns possess broad-spectrum antibacterial, anti-inflammatory, and anti-allergic properties, exhibiting good inhibitory effects against various Gram-negative and Gram-positive bacteria. The combined effects of these herbs achieve the functions of clearing heat and drying dampness, dispelling wind, nourishing blood, and relieving itching.

[0047] 3. The specific steps of the traditional Chinese medicine treatment method for anal eczema and the preparation method of its compound preparation are as follows:

[0048] Weigh out the following ingredients according to the above-mentioned weight proportions: Sophora flavescens, Cnidium monnieri, Kochia scoparia, Dictamnus dasycarpus, Scutellaria baicalensis, Phellodendron chinense, Ligusticum chuanxiong, Angelica sinensis, Sanguisorba officinalis, Saposhnikovia divaricata, and Gleditsia sinensis thorns.

[0049] After soaking in water, decoct to obtain the aforementioned compound Chinese medicine preparation.

[0050] This product is a light brown, clear liquid. Its pH value is 5.0–7.0, and its relative density is 1.15. It meets the requirements according to the Ministry of Health's pharmaceutical hygiene standards and testing methods.

[0051] To enable those skilled in the art to better understand and implement the technical solutions of this invention, the invention will be further described below with reference to specific embodiments. Unless otherwise specified, all reagents used in this invention are commercially available, and all methods used are conventional techniques in the art.

[0052] In the following examples, 1g represents one part by weight.

[0053] Example 1

[0054] A traditional Chinese medicine compound preparation for treating anal eczema, made from the following raw materials in parts by weight:

[0055] Sophora flavescens 40g, Cnidium monnieri 40g, Kochia scoparia 20g, Dictamnus dasycarpus 20g, Scutellaria baicalensis 18g, Phellodendron chinense 18g, Ligusticum chuanxiong 12g, Angelica sinensis 18g, Sanguisorba officinalis 12g, Saposhnikovia divaricata 18g, Gleditsia sinensis 12g.

[0056] Example 2

[0057] A traditional Chinese medicine compound preparation for treating anal eczema, made from the following raw materials in parts by weight:

[0058] Sophora flavescens 45g, Cnidium monnieri 45g, Kochia scoparia 22g, Dictamnus dasycarpus 22g, Scutellaria baicalensis 20g, Phellodendron chinense 20g, Ligusticum chuanxiong 14g, Angelica sinensis 20g, Sanguisorba officinalis 14g, Saposhnikovia divaricata 20g, Gleditsia sinensis 14g.

[0059] Example 3

[0060] A traditional Chinese medicine compound preparation for treating anal eczema, made from the following raw materials in parts by weight:

[0061] Sophora flavescens 35g, Cnidium monnieri 35g, Kochia scoparia 18g, Dictamnus dasycarpus 18g, Scutellaria baicalensis 16g, Phellodendron chinense 16g, Ligusticum chuanxiong 10g, Angelica sinensis 16g, Sanguisorba officinalis 10g, Saposhnikovia divaricata 16g, Gleditsia sinensis 10g.

[0062] Example 4

[0063] A method for preparing a traditional Chinese medicine compound for treating anal eczema includes the following steps:

[0064] The traditional Chinese medicine compound preparations described in Examples 1 to 3 above were all prepared according to the following steps:

[0065] Weigh out the following ingredients according to the stated weights: Sophora flavescens, Cnidium monnieri, Kochia scoparia, Dictamnus dasycarpus, Scutellaria baicalensis, Phellodendron chinense, Ligusticum chuanxiong, Angelica sinensis, Sanguisorba officinalis, Saposhnikovia divaricata, and Gleditsia sinensis thorns.

[0066] Soak the medicine in 500mL of water for 0.5h, then decoct it three times, each time for 20min. Filter while hot, combine the three filtrates and concentrate to 450mL.

[0067] The decoction is prepared in-house to ensure consistent efficacy and quality.

[0068] Example 5

[0069] The application of a traditional Chinese medicine compound preparation for treating anal eczema is as follows:

[0070] This invention selected 30 patients diagnosed with anal eczema at the Department of Anorectal Surgery of Hanzhong Traditional Chinese Medicine Hospital from January 1, 2025 to June 30, 2025 as the research subjects and retrospectively analyzed their clinical data.

[0071] 1. Clinical data.

[0072] This invention selected 30 patients with damp-heat type anal eczema, including 18 male patients and 12 female patients, with a mean age of 52.9 ± 11.6 years. All patients met the diagnostic criteria for acute anal eczema in the "Guidelines for the Diagnosis and Treatment of Eczema" formulated by the Immunology Group of the Dermatology and Venereology Branch of the Chinese Medical Association in 2011, and had or did not have symptoms such as irritability, thirst, yellow urine, dry stool, red tongue, yellow and greasy tongue coating, and slippery pulse.

[0073] 2. Treatment methods.

[0074] The traditional Chinese medicine compound preparations described in this invention are for external use, applied via fumigation and washing. Verification by this invention showed that the traditional Chinese medicine compound preparations prepared according to the formulas in Examples 1-3 had no significant difference in efficacy; therefore, only the results of Example 1 are presented here.

[0075] For each fumigation, take 150mL of the traditional Chinese medicine compound preparation prepared according to the formula in Example 1. First, heat it in a water bath. After the temperature drops to 35℃, fumigate for 3 minutes. Then, soak 4 layers of sterile gauze in the medicinal solution until the gauze is completely wet. Remove the gauze and gently wring it until it no longer drips. Apply the wet compress to the affected area around the anus for 8 minutes each time, once a day. After treatment, use a hair dryer set to cool air to gently dry the affected area and keep the area dry. One course of treatment is 9 days, and the medication should be used continuously for 3 weeks. During the treatment period, patients are advised to avoid staying up late, eat a light diet, not use other medications to fumigate the anus, not use wet toilet paper, smart toilets, etc. to clean the anus, wear loose and breathable pants, and maintain a pleasant mood.

[0076] 3. Observation indicators and evaluation methods.

[0077] In accordance with the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines", the degree of itching, area of ​​skin lesions, morphology of skin lesions, and exudation of patients were observed before treatment and after 9, 18, and 27 days of medication, and scores were recorded.

[0078] According to the "Standards for Diagnosis and Efficacy of Diseases and Syndromes in Traditional Chinese Medicine" issued by the State Administration of Traditional Chinese Medicine, diseases and syndromes are classified into cured, significantly effective, effective, and ineffective, as detailed below:

[0079] Cure: No itching or exudation, 100% complete resolution of skin lesions; Significant effect: Significant reduction in perianal itching and exudation, skin lesion repair ≥75% (excluding 100%); Effective: Improvement in perianal itching and exudation, skin lesion repair ≥25% (and <75%); Ineffective: No reduction or worsening of symptoms such as perianal itching and exudation, skin lesion repair <25%. Efficacy evaluation was calculated using the nimodipine method, as shown in the formula below:

[0080] .

[0081] In the formula, A Therapeutic effect assessment; B Pre-treatment score; C Post-treatment integral. After calculation, A A 100% cure rate is indicated. A A significant effect is defined as a concentration of 75% or higher but less than 100%. A A score of 25% or higher and less than 75% is considered valid; a score less than 25% is considered invalid.

[0082] 4. Results.

[0083] Analysis showed that the efficacy of the treatment significantly improved with treatment time in 30 patients. After 9 days of treatment, only 23 patients were effective, and 7 were ineffective. By day 18, cure and significant improvement were observed, ineffective cases disappeared, and the overall effective rate rose to 100%. By day 27, the cure rate had increased significantly to 21 cases, significant improvement to 8 cases, and only 1 case was effective, with the overall effective rate remaining at 100%. The results indicate that the efficacy of this regimen continues to improve; all patients were effective after 18 days of treatment, and 70% of patients were cured by day 27, confirming the efficacy (see Table 1). Specific scoring criteria are shown in Table 2. Individual patient assessment forms are shown in Table 3.

[0084] Table 1 Overall clinical efficacy of patients at different stages of treatment.

[0085]

[0086] Table 2 Specific Scoring Criteria

[0087]

[0088] Table 3 Individual Patient Assessment Table

[0089]

[0090] 5. Adverse reactions.

[0091] During the three-month follow-up period, the patient did not experience any adverse reactions such as local allergies or worsening of symptoms.

[0092] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0093] The embodiments described above are merely examples of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these modifications and improvements all fall within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine compound preparation for treating damp-heat type anal eczema, characterized in that, The traditional Chinese medicine compound preparation is made from the following raw materials in parts by weight: Sophora flavescens 35-45 parts, Cnidium monnieri 35-45 parts, Kochia scoparia 18-22 parts, Dictamnus dasycarpus 18-22 parts, Scutellaria baicalensis 18-22 parts, Phellodendron chinense 18-22 parts, Ligusticum chuanxiong 10-14 parts, Angelica sinensis 16-20 parts, Sanguisorba officinalis 10-14 parts, Saposhnikovia divaricata 16-20 parts, Gleditsia sinensis thorns 10-14 parts.

2. The traditional Chinese medicine compound preparation as described in claim 1, characterized in that, The traditional Chinese medicine compound preparation is made from the following raw materials in parts by weight: 40 parts Sophora flavescens, 40 parts Cnidium monnieri, 20 parts Kochia scoparia, 20 parts Dictamnus dasycarpus, 18 parts Scutellaria baicalensis, 18 parts Phellodendron chinense, 12 parts Ligusticum chuanxiong, 18 parts Angelica sinensis, 12 parts Sanguisorba officinalis, 18 parts Saposhnikovia divaricata, and 12 parts Gleditsia sinensis.

3. The method for preparing the traditional Chinese medicine compound preparation as described in claim 1, characterized in that, Includes the following steps: Weigh out the following ingredients according to the stated weight proportions: Sophora flavescens, Cnidium monnieri, Kochia scoparia, Dictamnus dasycarpus, Scutellaria baicalensis, Phellodendron chinense, Ligusticum chuanxiong, Angelica sinensis, Sanguisorba officinalis, Saposhnikovia divaricata, and Gleditsia sinensis thorns. After soaking in water, decoct to obtain the aforementioned compound Chinese medicine preparation.

4. The preparation method according to claim 3, characterized in that, The soaking time is 0.5h to 1h.

5. The preparation method according to claim 3, characterized in that, The simmering time is 20 to 30 minutes.

6. The preparation method according to claim 3, characterized in that, The decoction is prepared 2 to 4 times.

7. The application of the traditional Chinese medicine compound preparation as described in claim 1, characterized in that, The traditional Chinese medicine compound preparation is used to prepare a drug for treating anal eczema; The type of anal eczema is damp-heat type anal eczema.

8. The application as described in claim 7, characterized in that, The drug also includes pharmaceutically acceptable excipients.

9. The application as described in claim 8, characterized in that, The pharmaceutically acceptable excipients are one or more of the following: diluents, disintegrants, precipitation inhibitors, flow aids, binders, dispersants, suspending agents, isotonic agents, thickeners, emulsifiers, preservatives, and stabilizers.

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