Traditional Chinese medicine composition for treating haemorrhoids as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for treating haemorrhoids as well as a preparation method and application of the traditional Chinese medicine composition. The traditional Chinese medicine composition for treating haemorrhoids is prepared from 16 to 24 parts of radix sophorae flavescentis, 16 to 24 parts of cortex phellodendri, 8 to 12 parts of radix scutellariae, 12 to 18 parts of radix angelicae sinensis, 12 to 18 parts of rhizoma chuanxiong, 24 to 36 parts of herba taraxaci, 24 to 36 parts of herba portulacae, 16 to 24 parts of radix sanguisorbae, 8 to 12 parts of radix saposhnikoviae, 8 to 12 parts of pericarpium zanthoxyli, 8 to 12 parts of liquorice root, 12 to 18 parts of herba schizonepetae, 16 to 24 parts of rhizoma polygoni cuspidati, 8 to 12 parts of dried alum, 8 to 12 parts of mirabilite, 4.8 to 7.2 parts of borneol and 8 to 12 parts of flos carthami. The traditional Chinese medicine composition disclosed by the invention has the effects of clearing heat and drying dampness, promoting blood circulation to subdue swelling, relieving pain and itching and astringing to stop bleeding. The four medicines of polygonum cuspidatum, borneol, fineleaf schizonepeta herb and szechuan lovage rhizome are linked, and the borneol promotes the permeation of fineleaf schizonepeta herb volatile oil and szechuan lovage rhizome ferulic acid at the same time, so that triple synergy of transdermal, blood activating and itching relieving is formed.

Description

Technical Field

[0001] This invention relates to a traditional Chinese medicine composition, its preparation method and application, and particularly to a traditional Chinese medicine composition for treating hemorrhoids, its preparation method and application, belonging to the field of traditional Chinese medicine compositions. Background Technology

[0002] Hemorrhoids, also known as piles, are soft venous masses formed by the enlargement and varicosity of the venous plexus under the rectal mucosa, anal canal, and perianal margin; or by inflammation, hypertrophy, and connective tissue hyperplasia of the perianal skin folds; or by thrombosis due to ruptured anal veins and blood stasis. Traditional Chinese medicine (TCM) treatment for hemorrhoids is effective, primarily through oral and topical herbal medicine, acupuncture, and fumigation to improve symptoms. TCM treatment for hemorrhoids has advantages such as significant efficacy, addressing both the symptoms and the root cause, and minimal side effects. However, if the herbal formula is not properly formulated, the treatment effect will be less significant, and the cure rate will be lower.

[0003] Therefore, there is a need for a traditional Chinese medicine composition for treating hemorrhoids that is reasonably formulated, has high safety, and a low recurrence rate. Summary of the Invention

[0004] Objectives of the invention: The objective of this invention is to provide a traditional Chinese medicine composition for treating hemorrhoids that is rationally formulated, has high safety, and a low recurrence rate; another objective of this invention is to provide a method for preparing the traditional Chinese medicine composition for treating hemorrhoids; yet another objective of this invention is to provide an application of the traditional Chinese medicine composition for treating hemorrhoids.

[0005] Technical Solution: The present invention provides a traditional Chinese medicine composition for treating hemorrhoids, comprising, by weight, 16-24 parts of Sophora flavescens, 16-24 parts of Phellodendron chinense, 8-12 parts of Scutellaria baicalensis, 12-18 parts of Angelica sinensis, 12-18 parts of Ligusticum chuanxiong, 24-36 parts of Taraxacum mongolicum, 24-36 parts of Portulaca oleracea, 16-24 parts of Sanguisorba officinalis, 8-12 parts of Saposhnikovia divaricata, 8-12 parts of Zanthoxylum bungeanum, 8-12 parts of Glycyrrhiza uralensis, 12-18 parts of Schizonepeta tenuifolia, 16-24 parts of Polygonum cuspidatum, 8-12 parts of alum, 8-12 parts of Glauber's salt, 4.8-7.2 parts of borneol, and 8-12 parts of Carthamus tinctorius.

[0006] In formulas related to hemorrhoid treatment, alum is a commonly used ingredient, while calcined alum is used relatively less. The difference lies in the processing: calcined alum is a product of alum that has lost its water of crystallization after calcination. The use of calcined alum in the above-mentioned technical solutions has the following effects: Enhanced astringent, hemostatic, and drying effects: As a product of alum that has lost its water of crystallization after calcination, calcined alum's astringent and drying properties are significantly enhanced. In hemorrhoid treatment, calcined alum can more effectively promote tissue dehydration and contraction, reducing exudation and thus quickly relieving swelling, pain, and rectal bleeding; this aligns perfectly with the astringent and hemostatic design of the two adjuvant groups in the formula (Sanguisorba officinalis, calcined alum, and Glauber's salt); Optimized adaptability for external application: Calcined alum has a loose and brittle texture, making it easy to grind into a fine powder, facilitating even dispersion in fumigation solutions and adhesion to the affected area, thus improving bioavailability. Alum contains water of crystallization, has poor solubility, and is prone to clumping, which may affect the uniformity of drug penetration. However, calcined alum reduces irritation and improves safety: its cold and astringent properties are weakened, resulting in lower local irritation compared to regular alum. This is particularly important for fumigation treatment of sensitive areas such as the perianal mucosa, reducing the risk of burning pain or allergic reactions during use. Furthermore, calcined alum enhances the overall efficacy of the formula, working synergistically with Glauber's salt (which softens and disperses nodules) and borneol (which guides the medicine through the skin): calcined alum is responsible for tissue contraction and consolidation, Glauber's salt softens nodules, and borneol guides deep penetration. This combination is rarely seen in published literature, enhancing the inventiveness of this invention.

[0007] The four-drug combination of "Polygonum cuspidatum-borneol-Schizonepeta tenuifolia-Ligusticum chuanxiong" used in the above technical solution has not been found in the literature on the treatment of hemorrhoids. Among them: Polygonum cuspidatum + borneol: Borneol, as a "guiding drug", significantly enhances the transdermal absorption rate of emodin and resveratrol in Polygonum cuspidatum, targeting hemorrhoid lesions and enhancing the effects of clearing heat and promoting blood circulation; Schizonepeta tenuifolia + Ligusticum chuanxiong: Schizonepeta tenuifolia dispels wind and relieves itching, and Ligusticum chuanxiong promotes blood circulation and qi circulation, improves perianal microcirculation, and relieves swelling and pain; The four drugs work together: Borneol simultaneously promotes the penetration of volatile oil of Schizonepeta tenuifolia (such as menthone) and ferulic acid of Ligusticum chuanxiong, forming a triple synergy of "transdermal-blood-activating-itch-relieving", which is not clearly recorded in conventional compound prescriptions.

[0008] Preferably, the traditional Chinese medicine composition for treating hemorrhoids, by weight, comprises 16-20 parts of Sophora flavescens, 16-20 parts of Phellodendron chinense, 8-10 parts of Scutellaria baicalensis, 12-15 parts of Angelica sinensis, 12-15 parts of Ligusticum chuanxiong, 24-30 parts of Taraxacum mongolicum, 24-30 parts of Portulaca oleracea, 16-20 parts of Sanguisorba officinalis, 8-10 parts of Saposhnikovia divaricata, 8-10 parts of Zanthoxylum bungeanum, 8-10 parts of Glycyrrhiza uralensis, 12-15 parts of Schizonepeta tenuifolia, 16-20 parts of Polygonum cuspidatum, 8-10 parts of alum, 8-10 parts of Glauber's salt, 4.8-6 parts of borneol, and 8-10 parts of Carthamus tinctorius.

[0009] Preferably, the traditional Chinese medicine composition for treating hemorrhoids, by weight, comprises 20-24 parts of Sophora flavescens, 20-24 parts of Phellodendron chinense, 10-12 parts of Scutellaria baicalensis, 15-18 parts of Angelica sinensis, 15-18 parts of Ligusticum chuanxiong, 30-36 parts of Taraxacum mongolicum, 30-36 parts of Portulaca oleracea, 20-24 parts of Sanguisorba officinalis, 10-12 parts of Saposhnikovia divaricata, 10-12 parts of Zanthoxylum bungeanum, 10-12 parts of Glycyrrhiza uralensis, 15-18 parts of Schizonepeta tenuifolia, 20-24 parts of Polygonum cuspidatum, 10-12 parts of alum, 10-12 parts of Glauber's salt, 6-7.2 parts of borneol, and 10-12 parts of Carthamus tinctorius.

[0010] Preferably, the traditional Chinese medicine composition for treating hemorrhoids, by weight, comprises 20 parts of Sophora flavescens, 20 parts of Phellodendron chinense, 10 parts of Scutellaria baicalensis, 15 parts of Angelica sinensis, 15 parts of Ligusticum chuanxiong, 30 parts of Taraxacum mongolicum, 30 parts of Portulaca oleracea, 20 parts of Sanguisorba officinalis, 10 parts of Saposhnikovia divaricata, 10 parts of Zanthoxylum bungeanum, 10 parts of Glycyrrhiza uralensis, 15 parts of Schizonepeta tenuifolia, 20 parts of Polygonum cuspidatum, 10 parts of alum, 10 parts of Glauber's salt, 6 parts of borneol, and 10 parts of Carthamus tinctorius.

[0011] On the other hand, the present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition for treating hemorrhoids, wherein herbs other than Glauber's salt and borneol are first soaked in water, then boiled and decocted; the decoction is poured into a container, and then Glauber's salt and borneol are added to obtain the traditional Chinese medicine composition for treating hemorrhoids.

[0012] Preferably, the mixture is boiled and then simmered for 15-20 minutes.

[0013] On the other hand, the present invention provides the application of the above-mentioned traditional Chinese medicine composition for treating hemorrhoids in the preparation of a medicine for treating hemorrhoids.

[0014] Preferably, the dosage form of the drug is a topical wash, prepared by combining the traditional Chinese medicine composition with pharmaceutically acceptable excipients.

[0015] In a preferred embodiment, a method for preparing and using the above-mentioned traditional Chinese medicine composition for treating hemorrhoids is provided:

[0016] 1) Usage: Soak all herbs except Glauber's salt and borneol in cold water for 30 minutes, then bring to a boil over high heat, then simmer over low heat for 15-20 minutes. Pour the liquid into a bowl, then add Glauber's salt and borneol (because these two herbs are volatile and should not be simmered for too long).

[0017] 2) First fumigate, then wash: First, fumigate the anus with the steam of the medicinal liquid for 5-10 minutes. When the water temperature drops to a temperature that is not too hot to touch (about 40℃), then sitz bath and soak for 10-15 minutes.

[0018] 3) Treatment course: 1-2 times daily, usually recommended after bowel movements and before bedtime, for 7-10 consecutive days as one course of treatment.

[0019] The efficacy of the above-mentioned traditional Chinese medicine composition for treating hemorrhoids includes: clearing heat and drying dampness, promoting blood circulation and reducing swelling, relieving pain and itching, and astringing and stopping bleeding. Indications: Based on the traditional Chinese medicine understanding of the core pathogenesis of hemorrhoids (especially during flare-ups) as "damp-heat accumulation and qi and blood stagnation." Syndrome classification: Damp-heat accumulation type, qi stagnation and blood stasis type. Indications: External hemorrhoids, mixed hemorrhoids. Contraindications: Contraindicated in patients with allergies.

[0020] The pharmaceutical composition of the present invention is explained as follows: Principal herbs: Sophora flavescens, Phellodendron chinense, and Scutellaria baicalensis clear heat, dry dampness, and detoxify; Assistant herbs: Taraxacum mongolicum, Portulaca oleracea, Polygonum cuspidatum, and Zanthoxylum bungeanum enhance the principal herbs' ability to clear damp-heat and toxins; among them, Taraxacum mongolicum and Portulaca oleracea also have excellent effects in reducing swelling and dissipating nodules; these principal and assistant herbs are mostly bitter and cold in nature, eliminating the root cause of hemorrhoid flare-ups; Adjuvant herb 1: Angelica sinensis, Ligusticum chuanxiong, and Carthamus tinctorius have the effects of promoting blood circulation, removing blood stasis, and relieving pain. "Where there is no flow, there is pain," and poor blood circulation can lead to perianal blood stasis and swelling, aggravating hemorrhoid prolapse and pain; this group of herbs can promote blood circulation, remove blood stasis, and relieve pain, improving local blood circulation, thereby reducing swelling and relieving pain; Adjuvant herb 2: Sanguisorba officinalis, Alum, and Glauber's salt. The formula is astringent, hemostatic, and anti-swelling. Sanguisorba officinalis cools the blood and stops bleeding, specifically targeting hematochezia. Alum and Glauber's salt have strong astringent properties, dehydrating and shrinking swollen hemorrhoid tissue, thus quickly relieving swelling and pain. Glauber's salt is particularly known for its softening and dispersing effects. The adjuvant herbs 3: Saposhnikovia divaricata, Schizonepeta tenuifolia, and Zanthoxylum bungeanum dispel wind, relieve itching, and alleviate pain. Damp-heat is often accompanied by wind-evil, leading to anal itching. These herbs dispel wind and dampness, relieve itching and pain. Zanthoxylum bungeanum also has a local anesthetic effect, which can enhance the analgesic effect. The adjuvant herb 4: Borneol clears heat and relieves pain. Borneol is highly penetrating and can guide the other herbs directly to the affected area, quickly producing a cooling and analgesic sensation. The guiding herb: Glycyrrhiza uralensis moderates the harshness of the other herbs, harmonizes their properties, and clears heat and detoxifies.

[0021] Safety analysis of the pharmaceutical composition of this invention: Toxicity and contraindications: All the medicinal materials marked as "highly toxic" or "toxic" in the Chinese Pharmacopoeia are non-toxic, safe dosage, and there are no "eighteen incompatibilities" or "nineteen taboos" in combination; Safety proof: All the drugs in the formula are commonly used in clinical practice, and the safety is relatively high when they are reasonably combined; There are no toxic side effects when used externally (such as decocting and washing).

[0022] Beneficial effects: Compared with the prior art, the present invention has the following significant advantages:

[0023] (1) The traditional Chinese medicine composition of the present invention has the effects of clearing heat and drying dampness, promoting blood circulation and reducing swelling, relieving pain and itching, and astringing and stopping bleeding. All medicinal materials are non-toxic, safe dosage, and no "eighteen incompatibilities" or "nineteen taboos" in combination. The composition has high safety and low recurrence rate when rationally combined, and has no toxic side effects when used externally (such as decoction and washing).

[0024] (2) The astringent effect of alum in this invention works synergistically with Glauber's salt (softening and dispersing nodules) and borneol (penetrating the skin and guiding the meridians): alum is responsible for tissue contraction and solidification, Glauber's salt softens nodules, and borneol guides deep penetration;

[0025] (3) The combination of four drugs, namely "Polygonum cuspidatum-borneol-Schizonepeta tenuifolia-Ligusticum chuanxiong", used in this invention has not been found in the literature on the treatment of hemorrhoids. Among them: Polygonum cuspidatum + borneol: Borneol, as a "guiding drug", significantly improves the transdermal absorption rate of rhein and resveratrol in Polygonum cuspidatum, targets the hemorrhoid lesions, and enhances the heat-clearing and blood-activating effects; Schizonepeta tenuifolia + Ligusticum chuanxiong: Schizonepeta tenuifolia dispels wind and relieves itching, and works with Ligusticum chuanxiong to activate blood and promote qi circulation, improve perianal microcirculation, and relieve swelling and pain; Four drugs work together: Borneol simultaneously promotes the penetration of volatile oil of Schizonepeta tenuifolia (such as menthone) and ferulic acid of Ligusticum chuanxiong, forming a triple synergy of "transdermal-blood-activating-itch-relieving", which is not clearly recorded in conventional compound prescriptions. Detailed Implementation

[0026] Example 1 Detergent

[0027] This invention provides a traditional Chinese medicine composition for treating hemorrhoids, comprising: 20g of Sophora flavescens, 20g of Phellodendron chinense, 10g of Scutellaria baicalensis, 15g of Angelica sinensis, 15g of Ligusticum chuanxiong, 30g of Taraxacum mongolicum, 30g of Portulaca oleracea, 20g of Sanguisorba officinalis, 10g of Saposhnikovia divaricata, 10g of Zanthoxylum bungeanum, 10g of Glycyrrhiza uralensis, 10g of Schizonepeta tenuifolia, 20g of Polygonum cuspidatum, 10g of alum, 10g of Glauber's salt, 6g of borneol, and 10g of Carthamus tinctorius.

[0028] Soak all herbs except Glauber's salt and borneol in cold water for 30 minutes, then bring to a boil over high heat, and simmer over low heat for 15-20 minutes. Pour the liquid into a basin, then add Glauber's salt and borneol. First, use the steam to fumigate the anus for 5-10 minutes. Once the water temperature has cooled to a comfortable level (around 40℃), then sitz bath for 10-15 minutes. Use 1-2 times daily, usually after bowel movements and before bedtime, for 7-10 days as one course of treatment.

[0029] Example 2 Detergent

[0030] This invention provides a traditional Chinese medicine composition for treating hemorrhoids, comprising: 24g of Sophora flavescens, 24g of Phellodendron chinense, 12g of Scutellaria baicalensis, 18g of Angelica sinensis, 18g of Ligusticum chuanxiong, 36g of Taraxacum mongolicum, 36g of Portulaca oleracea, 24g of Sanguisorba officinalis, 12g of Saposhnikovia divaricata, 12g of Zanthoxylum bungeanum, 12g of Glycyrrhiza uralensis, 18g of Schizonepeta tenuifolia, 24g of Polygonum cuspidatum, 12g of alum, 12g of Glauber's salt, 7.2g of borneol, and 12g of Carthamus tinctorius.

[0031] Soak all herbs except Glauber's salt and borneol in cold water for 30 minutes, then bring to a boil over high heat, and simmer over low heat for 15-20 minutes. Pour the liquid into a basin, then add Glauber's salt and borneol. First, use the steam to fumigate the anus for 5-10 minutes. Once the water temperature has cooled to a comfortable level (around 40℃), then sitz bath for 10-15 minutes. Use 1-2 times daily, usually after bowel movements and before bedtime, for 7-10 days as one course of treatment.

[0032] Example 3 Detergent

[0033] This invention provides a traditional Chinese medicine composition for treating hemorrhoids, comprising: 16g of Sophora flavescens, 16g of Phellodendron chinense, 8g of Scutellaria baicalensis, 12g of Angelica sinensis, 12g of Ligusticum chuanxiong, 24g of Taraxacum mongolicum, 24g of Portulaca oleracea, 16g of Sanguisorba officinalis, 8g of Saposhnikovia divaricata, 8g of Zanthoxylum bungeanum, 8g of Glycyrrhiza uralensis, 12g of Schizonepeta tenuifolia, 16g of Polygonum cuspidatum, 8g of alum, 8g of Glauber's salt, 4.8g of borneol, and 8g of Carthamus tinctorius.

[0034] Soak all herbs except Glauber's salt and borneol in cold water for 30 minutes, then bring to a boil over high heat, and simmer over low heat for 15-20 minutes. Pour the liquid into a basin, then add Glauber's salt and borneol. First, use the steam to fumigate the anus for 5-10 minutes. Once the water temperature has cooled to a comfortable level (around 40℃), then sitz bath for 10-15 minutes. Use 1-2 times daily, usually after bowel movements and before bedtime, for 7-10 days as one course of treatment.

[0035] Comparative Example 1 Detergent

[0036] The difference between this comparative example and Example 1 is that the alum is replaced with calcined alum, and the specific composition includes 20g of Sophora flavescens, 20g of Phellodendron chinense, 10g of Scutellaria baicalensis, 15g of Angelica sinensis, 15g of Ligusticum chuanxiong, 30g of Taraxacum mongolicum, 30g of Portulaca oleracea, 20g of Sanguisorba officinalis, 10g of Saposhnikovia divaricata, 10g of Zanthoxylum bungeanum, 10g of Glycyrrhiza uralensis, 10g of Schizonepeta tenuifolia, 20g of Polygonum cuspidatum, 10g of alum, 10g of Glauber's salt, 6g of borneol, and 10g of Carthamus tinctorius.

[0037] Soak all herbs except Glauber's salt and borneol in cold water for 30 minutes, then bring to a boil over high heat, and simmer over low heat for 15-20 minutes. Pour the liquid into a basin, then add Glauber's salt and borneol. First, use the steam to fumigate the anus for 5-10 minutes. Once the water temperature has cooled to a comfortable level (around 40℃), then sitz bath for 10-15 minutes. Use 1-2 times daily, usually after bowel movements and before bedtime, for 7-10 days as one course of treatment.

[0038] Comparative Example 2 Detergent

[0039] The difference between this comparative example and Example 1 is that Glauber's salt and borneol are directly decocted. The specific composition includes 20g of Sophora flavescens, 20g of Phellodendron chinense, 10g of Scutellaria baicalensis, 15g of Angelica sinensis, 15g of Ligusticum chuanxiong, 30g of Taraxacum mongolicum, 30g of Portulaca oleracea, 20g of Sanguisorba officinalis, 10g of Saposhnikovia divaricata, 10g of Zanthoxylum bungeanum, 10g of Glycyrrhiza uralensis, 15g of Schizonepeta tenuifolia, 20g of Polygonum cuspidatum, 10g of alum, 10g of Glauber's salt, 6g of borneol, and 10g of Carthamus tinctorius.

[0040] Soak all the herbs in cold water for 30 minutes, then bring to a boil over high heat, and simmer over low heat for 15-20 minutes. Pour the liquid into a basin, and first use the steam to fumigate the anus for 5-10 minutes. When the water temperature drops to a comfortable level (about 40℃), then sitz bath for 10-15 minutes. Use 1-2 times daily, usually after bowel movements and before bedtime, for 7-10 days as one course of treatment.

[0041] Comparative Example 3 Detergent

[0042] This comparative ratio only includes 15g of Ligusticum chuanxiong, 15g of Schizonepeta tenuifolia, 20g of Polygonum cuspidatum, and 6g of Borneol.

[0043] Soak all herbs except borneol in cold water for 30 minutes, then bring to a boil over high heat, then simmer over low heat for 15-20 minutes. Pour the liquid into a basin, then add the borneol. First, use the steam to fumigate the anus for 5-10 minutes. Once the water temperature has cooled to a comfortable level (around 40℃), then sitz bath for 10-15 minutes. Use 1-2 times daily, usually after bowel movements and before bedtime, for 7-10 days as one course of treatment.

[0044] Comparative Example 4 Detergent

[0045] The difference between this comparative example and Example 1 is that it lacks Polygonum cuspidatum. The specific composition includes 20g of Sophora flavescens, 20g of Phellodendron chinense, 10g of Scutellaria baicalensis, 15g of Angelica sinensis, 15g of Ligusticum chuanxiong, 30g of Taraxacum mongolicum, 30g of Portulaca oleracea, 20g of Sanguisorba officinalis, 10g of Saposhnikovia divaricata, 10g of Zanthoxylum bungeanum, 10g of Glycyrrhiza uralensis, 15g of Schizonepeta tenuifolia, 10g of Alum, 10g of Glauber's salt, 6g of Borneol, and 10g of Carthamus tinctorius.

[0046] Soak all herbs except Glauber's salt and borneol in cold water for 30 minutes, then bring to a boil over high heat, and simmer over low heat for 15-20 minutes. Pour the liquid into a basin, then add Glauber's salt and borneol. First, use the steam to fumigate the anus for 5-10 minutes. Once the water temperature has cooled to a comfortable level (around 40℃), then sitz bath for 10-15 minutes. Use 1-2 times daily, usually after bowel movements and before bedtime, for 7-10 days as one course of treatment.

[0047] Comparative Example 5 Detergent

[0048] The difference between this comparative example and Example 1 is that it lacks borneol. The specific composition includes 20g of Sophora flavescens, 20g of Phellodendron chinense, 10g of Scutellaria baicalensis, 15g of Angelica sinensis, 15g of Ligusticum chuanxiong, 30g of Taraxacum mongolicum, 30g of Portulaca oleracea, 20g of Sanguisorba officinalis, 10g of Saposhnikovia divaricata, 10g of Zanthoxylum bungeanum, 10g of Glycyrrhiza uralensis, 10g of Schizonepeta tenuifolia, 20g of Polygonum cuspidatum, 10g of alum, 10g of Glauber's salt, and 10g of Carthamus tinctorius.

[0049] Soak all herbs except Glauber's salt in cold water for 30 minutes, then bring to a boil over high heat, and simmer over low heat for 15-20 minutes. Pour the liquid into a basin, then add the Glauber's salt. First, use the steam to fumigate the anus for 5-10 minutes. Once the water temperature has cooled to a comfortable level (around 40℃), then sitz bath for 10-15 minutes. Use 1-2 times daily, usually after bowel movements and before bedtime, for 7-10 days as one course of treatment.

[0050] Comparative Example 6 Detergent

[0051] The difference between this comparative example and Example 1 is that the specific composition includes 20g of Sophora flavescens, 20g of Phellodendron chinense, 10g of Scutellaria baicalensis, 15g of Angelica sinensis, 15g of Ligusticum chuanxiong, 30g of Taraxacum mongolicum, 30g of Portulaca oleracea, 20g of Sanguisorba officinalis, 10g of Saposhnikovia divaricata, 10g of Zanthoxylum bungeanum, 10g of Glycyrrhiza uralensis, 20g of Polygonum cuspidatum, 10g of alum, 10g of Glauber's salt, 6g of borneol, and 10g of Carthamus tinctorius.

[0052] Soak all herbs except Glauber's salt and borneol in cold water for 30 minutes, then bring to a boil over high heat, and simmer over low heat for 15-20 minutes. Pour the liquid into a basin, then add Glauber's salt and borneol. First, use the steam to fumigate the anus for 5-10 minutes. Once the water temperature has cooled to a comfortable level (around 40℃), then sitz bath for 10-15 minutes. Use 1-2 times daily, usually after bowel movements and before bedtime, for 7-10 days as one course of treatment.

[0053] Comparative Example 7 Detergent

[0054] The difference between this comparative example and Example 1 is that the specific composition of Chuanxiong includes 20g of Kushen, 20g of Huangbai, 10g of Huangqin, 15g of Danggui, 30g of Pugongying, 30g of Machixian, 20g of Diyu, 10g of Fangfeng, 10g of Huajiao, 10g of Gancao, 10g of Jingjie, 20g of Huzhang, 10g of Kufan, 10g of Mangxiao, 6g of Bingpian, and 10g of Honghua.

[0055] Soak all herbs except Glauber's salt and borneol in cold water for 30 minutes, then bring to a boil over high heat, and simmer over low heat for 15-20 minutes. Pour the liquid into a basin, then add Glauber's salt and borneol. First, use the steam to fumigate the anus for 5-10 minutes. Once the water temperature has cooled to a comfortable level (around 40℃), then sitz bath for 10-15 minutes. Use 1-2 times daily, usually after bowel movements and before bedtime, for 7-10 days as one course of treatment.

[0056] Comparative Example 8: Similar Prescription (Pain Relief Decoction)

[0057] The comparative example selected in this invention, "Zhitong Rushen Tang" (Pain-Relieving Miracle Decoction), is a classic formula for treating similar diseases, widely recognized and considered the preferred choice for efficacy comparison. Its formulation principles (clearing heat and drying dampness, promoting blood circulation and relieving pain) are similar to those of the present invention, but the specific combinations and the principles of monarch-minister-assistant-guide are different; therefore, this invention compares it with this formula. The dosage in the comparative example follows its classic literature, aiming to verify the relative efficacy advantage of the present invention at its respective optimal traditional dosage.

[0058] composition:

[0059] Gentian root 10g, peach kernel 10g, soapberry seed 10g, atractylodes rhizome 10g, saposhnikovia root 10g, phellodendron bark 6g, angelica root tail 6g, alisma rhizome 6g, areca nut 3g, prepared rhubarb 10g.

[0060] Preparation and usage methods:

[0061] Except for peach kernels, soapberry seeds, and areca nuts, soak the remaining herbs in cold water for 30 minutes. Bring to a boil over high heat, then simmer over low heat for 15-20 minutes. Add the peach kernels, soapberry seeds, and areca nuts, and simmer for another 5-8 minutes. Filter the liquid and use it to steam the anus for 5-10 minutes while it's still hot. Once the water temperature drops to approximately 40℃, soak the anus in a sitz bath for 10-15 minutes. Use once daily, preferably after bowel movements. A course of treatment is 7 days.

[0062] Indications:

[0063] It clears heat and dries dampness, invigorates blood and relieves pain. It is used for hemorrhoid swelling and pain attacks, belonging to the damp-heat syndrome.

[0064] Comparative Example 9 Chemical Drugs

[0065] The control group used Angtai ointment for external application, applying it twice daily for 10 days.

[0066] Example 4: Efficacy Evaluation

[0067] I. Evaluation of the treatment effect of external hemorrhoids

[0068] 1. Clinical trials

[0069] 1.1 Source of Cases

[0070] The 381 patients were all from the outpatient department of the Department of Anorectal Surgery of Lianyungang Traditional Chinese Medicine Hospital from February 2018 to December 2024. Among them, there were 235 males and 146 females. The youngest patient was 23 years old and the oldest was 65 years old, with an average age of (42.3±10.8) years.

[0071] 1.2 Diagnostic Criteria (Diagnostic basis, syndrome classification, and efficacy evaluation of external hemorrhoids—Standards for Diagnosis and Efficacy Evaluation of Internal Medicine Diseases in Traditional Chinese Medicine of the People's Republic of China (ZY / T001.1-94) [J]. Journal of Liaoning University of Traditional Chinese Medicine, 2017, 19(03):21.)

[0072] (1) Traditional Chinese Medicine diagnostic criteria:

[0073] Diagnosis: External hemorrhoids.

[0074] Syndrome diagnosis:

[0075] Damp-heat syndrome: A raised mass is present at the anal margin, accompanied by burning pain or discharge, and either dry or loose stools. The tongue is red with a yellow, greasy coating, and the pulse is slippery and rapid.

[0076] Qi stagnation and blood stasis syndrome: A lump protrudes from the anal margin, which may enlarge during defecation, causing a foreign body sensation, distending pain or a feeling of heaviness, and a hard nodule may be palpable locally. The tongue is purple with a pale yellow coating, and the pulse is wiry and hesitant.

[0077] (2) Western medicine diagnostic criteria

[0078] (1) Skin damage or infection at the anal margin, presenting as redness, swelling or ulceration with pus, and significant pain. Commonly seen in inflammatory external hemorrhoids.

[0079] (2) A sudden bluish-purple swelling appears under the skin at the anal margin, with local skin edema. The swelling is initially soft, but the pain is severe. It gradually hardens, becomes mobile, and is tender to the touch. This is commonly seen in thrombosed external hemorrhoids.

[0080] (3) During defecation or prolonged squatting, soft, bluish-purple lumps (varicose vein lumps) may appear on the perianal skin, accompanied by a feeling of heaviness. The lumps may disappear after pressing. This is commonly seen in varicose external hemorrhoids.

[0081] 1.3 Inclusion Criteria

[0082] The patient must meet all of the following conditions:

[0083] (1) Age 18-65 years old, gender not limited.

[0084] (2) Meets the above-mentioned Western medicine diagnostic criteria for external hemorrhoids and the traditional Chinese medicine diagnostic criteria for damp-heat accumulation or qi stagnation and blood stasis syndrome.

[0085] (3) No other hemorrhoid treatments (such as ointments, suppositories, oral medications, etc.) were received within one week prior to enrollment.

[0086] (4) Voluntarily participate in this study and sign the informed consent form.

[0087] 1.4 Exclusion Criteria

[0088] Applicants meeting any of the following conditions must be excluded:

[0089] (1) Patients with serious primary diseases of the heart, liver, kidney, hematopoietic system or mental illness.

[0090] (2) Pregnant or lactating women.

[0091] (3) Individuals with allergic constitution or allergies to known components of the drugs used in this study.

[0092] (4) Patients with other anorectal diseases such as anal fistula, perianal abscess, anal fissure, rectal polyp, tumor, etc.

[0093] (5) Hemorrhoids that are incarcerated, necrotic, or accompanied by a large amount of active bleeding.

[0094] (6) Those who have recently undergone anal surgery.

[0095] (7) Poor compliance, unable to cooperate in completing the treatment plan and follow-up.

[0096] 1.5 Efficacy Evaluation Indicators and Scoring Standards

[0097] Table 1. Quantitative Scoring Table for Clinical Efficacy Evaluation of Hemorrhoids

[0098]

[0099] Cure: Symptoms and signs disappear, and the efficacy index is ≥95%.

[0100] Significant effect: Symptoms and signs are significantly improved, with 70% ≤ efficacy index < 95%.

[0101] Effective: Symptoms and signs improve, with 30% ≤ efficacy index < 70%.

[0102] Ineffective: Symptoms and signs do not improve or worsen, efficacy index <30%.

[0103] Therapeutic effect index (%) = [(Total score before treatment - Total score after treatment) ÷ Total score before treatment] × 100%

[0104] Calculate the overall effective rate ((cured + significantly effective + effective) / total number of cases × 100%).

[0105] 6. Recurrence rate

[0106] For patients who have achieved the criteria for cure, significant effect, or effectiveness after treatment, any of the following conditions occurring within 3 months after the end of treatment constitutes a relapse:

[0107] (1) The hemorrhoids swell again, become painful, or new lesions appear.

[0108] (2) Recurrence of rectal bleeding symptoms

[0109] (3) The perianal edema score increased by ≥2 points compared with the end of treatment.

[0110] (4) Pain VAS score increased by ≥3 points compared to the end of treatment.

[0111] 7. Experimental Results

[0112] 1. Treatment efficacy statistics

[0113] Table 2. Statistical table of treatment efficacy rates in the examples and comparative cases.

[0114]

[0115] 2. Comparison of quantitative scores of various clinical efficacy before and after treatment

[0116] Table 3. Comparison of quantitative scores of various clinical efficacy before and after treatment in the examples and comparative cases.

[0117] II. Evaluation of the efficacy of mixed hemorrhoid treatment

[0118] 1. Clinical trials

[0119] 1.1 Source of Cases

[0120] The 312 patients were all from the outpatient department of the Department of Anorectal Surgery of Lianyungang Traditional Chinese Medicine Hospital from January 2018 to December 2024. Among them, there were 143 males and 169 females. The youngest patient was 18 years old and the oldest was 65 years old, with an average age of (43.2±12.4) years.

[0121] 1.2 Diagnostic Criteria (Diagnostic basis, syndrome classification, and efficacy evaluation of mixed hemorrhoids—Standards for Diagnosis and Efficacy Evaluation of Internal Medicine Diseases in Traditional Chinese Medicine of the People's Republic of China (ZY / T001.1-94) [J]. Journal of Liaoning University of Traditional Chinese Medicine, 2017, 19(05):216.)

[0122] (1) Traditional Chinese Medicine diagnostic criteria:

[0123] Diagnosis: Mixed hemorrhoids.

[0124] Syndrome diagnosis:

[0125] Damp-heat syndrome: Bright red and copious blood in stool, prolapse, swelling, burning pain, or watery discharge from the anus; dry or loose stools; scanty and dark urine. Red tongue with yellow and greasy coating; slippery and rapid pulse.

[0126] Qi stagnation and blood stasis syndrome: A mass prolapses outside the anus, is edematous, contains thrombi, or may be incarcerated. The surface is dark purple, eroded, and oozing. The pain is severe, with significant tenderness, and the anal canal is constricted. Constipation and difficulty urinating are also present. The tongue is dark purple or has ecchymosis, and the pulse is wiry or hesitant.

[0127] (2) Western medicine diagnostic criteria

[0128] (1) Bleeding and swelling in the anal area, with possible anal distension, foreign body sensation or pain.

[0129] (2) It may be accompanied by local secretions or itching.

[0130] (3) A mass appears in the same position above and below the dentate line in the anal canal (or skin tag below the dentate line).

[0131] 1.3 Inclusion Criteria

[0132] The patient must meet all of the following conditions:

[0133] (1) Age 18-65 years old, gender not limited.

[0134] (2) Meets the above-mentioned Western medicine diagnostic criteria for mixed hemorrhoids and the traditional Chinese medicine diagnostic criteria for damp-heat accumulation or qi stagnation and blood stasis syndrome.

[0135] (3) No other hemorrhoid treatments (such as ointments, suppositories, oral medications, etc.) were received within one week prior to enrollment.

[0136] (4) Voluntarily participate in this study and sign the informed consent form.

[0137] 1.4 Exclusion Criteria

[0138] Applicants meeting any of the following conditions must be excluded:

[0139] (1) Patients with serious primary diseases of the heart, liver, kidney, hematopoietic system or mental illness.

[0140] (2) Pregnant or lactating women.

[0141] (3) Individuals with allergic constitution or allergies to known components of the drugs used in this study.

[0142] (4) Patients with other anorectal diseases such as anal fistula, perianal abscess, anal fissure, rectal polyp, tumor, etc.

[0143] (5) Hemorrhoids that are incarcerated, necrotic, or accompanied by a large amount of active bleeding.

[0144] (6) Those who have recently undergone anal surgery.

[0145] (7) Poor compliance, unable to cooperate in completing the treatment plan and follow-up.

[0146] 1.5 Efficacy Evaluation Indicators and Scoring Standards

[0147] Table 4 Quantitative Scoring Table for Clinical Efficacy Evaluation of Hemorrhoids

[0148]

[0149] Cure: Symptoms and signs disappear, and the efficacy index is ≥95%.

[0150] Significant effect: Symptoms and signs are significantly improved, with 70% ≤ efficacy index < 95%.

[0151] Effective: Symptoms and signs improve, with 30% ≤ efficacy index < 70%.

[0152] Ineffective: Symptoms and signs do not improve or worsen, efficacy index <30%.

[0153] Therapeutic effect index (%) = [(Total score before treatment - Total score after treatment) ÷ Total score before treatment] × 100%

[0154] Calculate the overall effective rate ((cured + significantly effective + effective) / total number of cases × 100%).

[0155] 6. Recurrence rate

[0156] For patients who have achieved the criteria for cure, significant effect, or effectiveness after treatment, any of the following conditions occurring within 3 months after the end of treatment constitutes a relapse:

[0157] (1) The hemorrhoids swell again, become painful, or new lesions appear.

[0158] (2) Recurrence of rectal bleeding symptoms

[0159] (3) The perianal edema score increased by ≥2 points compared with the end of treatment.

[0160] (4) Pain VAS score increased by ≥3 points compared to the end of treatment.

[0161] 7. Experimental Results

[0162] 1. Treatment efficacy statistics

[0163] Table 5. Statistical table of treatment efficacy rates in the examples and comparative cases.

[0164]

[0165] 2. Comparison of quantitative scores of various clinical efficacy before and after treatment

[0166] Table 6. Comparison of quantitative scores of various clinical efficacy before and after treatment in the examples and comparative cases.

[0167]

Claims

1. A traditional Chinese medicine composition for treating hemorrhoids, characterized in that, The traditional Chinese medicine composition for treating hemorrhoids comprises, in parts by weight, Sophora flavescens 16-24 parts, Phellodendri Chinensis Cortex 16-24 parts, Scutellaria baicalensis 8-12 parts, Angelica sinensis 12-18 parts, Chuanxiong 12-18 parts, Taraxacum 24-36 parts, Herba Portulacae 24-36 parts, Radix Sanguisorbae 16-24 parts, Saposhnikovia divaricata 8-12 parts, Zanthoxylum bungeanum 8-12 parts, Glycyrrhiza uralensis 8-12 parts, Schizonepeta 12-18 parts, Polygonum cuspidatum 16-24 parts, Mallotus 8-12 parts, Sodium Sulfate 8-12 parts, Borneol 4.8-7.2 parts, Carthamus tinctorius 8-12 parts.

2. The traditional Chinese medicine composition for treating hemorrhoids according to claim 1, characterized in that, The traditional Chinese medicine composition for treating hemorrhoids comprises, in parts by weight, Sophora flavescens 16-20 parts, Phellodendri Chinensis Cortex 16-20 parts, Scutellaria baicalensis 8-10 parts, Angelica sinensis 12-15 parts, Chuanxiong 12-15 parts, Taraxacum 24-30 parts, Herba Portulacae 24-30 parts, Radix Sanguisorbae 16-20 parts, Saposhnikovia divaricata 8-10 parts, Zanthoxylum bungeanum 8-10 parts, Glycyrrhiza uralensis 8-10 parts, Schizonepeta 12-15 parts, Polygonum cuspidatum 16-20 parts, Mallotus 8-10 parts, Sodium Sulfate 8-10 parts, Borneol 4.8-6 parts, Carthamus tinctorius 8-10 parts.

3. The traditional Chinese medicine composition for treating hemorrhoids according to claim 1, characterized in that, The traditional Chinese medicine composition for treating hemorrhoids comprises, in parts by weight, Sophora flavescens 20-24 parts, Phellodendri Chinensis Cortex 20-24 parts, Scutellaria baicalensis 10-12 parts, Angelica sinensis 15-18 parts, Chuanxiong 15-18 parts, Taraxacum 30-36 parts, Herba Portulacae 30-36 parts, Radix Sanguisorbae 20-24 parts, Saposhnikovia divaricata 10-12 parts, Zanthoxylum bungeanum 10-12 parts, Glycyrrhiza uralensis 10-12 parts, Schizonepeta 15-18 parts, Polygonum cuspidatum 20-24 parts, Mallotus 10-12 parts, Sodium Sulfate 10-12 parts, Borneol 6-7.2 parts, Carthamus tinctorius 10-12 parts.

4. The traditional Chinese medicine composition for treating hemorrhoids according to claim 1, characterized in that, The traditional Chinese medicine composition for treating hemorrhoids comprises, in parts by weight, Sophora flavescens 20 parts, Phellodendri Chinensis Cortex 20 parts, Scutellaria baicalensis 10 parts, Angelica sinensis 15 parts, Chuanxiong 15 parts, Taraxacum 30 parts, Herba Portulacae 30 parts, Radix Sanguisorbae 20 parts, Saposhnikovia divaricata 10 parts, Zanthoxylum bungeanum 10 parts, Glycyrrhiza uralensis 10 parts, Schizonepeta 15 parts, Polygonum cuspidatum 20 parts, Mallotus 10 parts, Sodium Sulfate 10 parts, Borneol 6 parts, Carthamus tinctorius 10 parts.

5. A method for preparing the traditional Chinese medicine composition for treating hemorrhoids according to any one of claims 1-4, characterized in that, The herbs except for Sodium Sulfate and Borneol are soaked in water, and then boiled and decocted; the decoction is poured into a container, and then Sodium Sulfate and Borneol are added, to obtain the traditional Chinese medicine composition for treating hemorrhoids.

6. The method of claim 5, wherein the preparation of the Chinese medicinal composition for treating hemorrhoids is characterized by, The boiling and decocting is performed for 15-20 minutes.

7. Use of the traditional Chinese medicine composition for treating hemorrhoids according to any one of claims 1-4 in the preparation of a medicament for treating hemorrhoids.

8. The use according to claim 1, characterized in that, The medicament is in the form of a lotion for external use, and is prepared by combining the traditional Chinese medicine composition with pharmaceutically acceptable adjuvants.

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