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

Abstract

The invention relates to a traditional Chinese medicine composition for treating haemorrhoids and a preparation method and application thereof.The traditional Chinese medicine composition is prepared from, by weight, 20-60 parts of sargentgloryvine stem, 15-45 parts of moutan bark, 20-40 parts of dandelion, 20-40 parts of rheum officinale, 20-40 parts of radix paeoniae rubra and 10-30 parts of lithospermum erythrorhizon. The traditional Chinese medicine composition has the effects of cooling blood and detoxifying, promoting blood circulation to remove blood stasis and relieving swelling and pain through combination of all the medicines, can remarkably relieve inflammation and pain of haemorrhoids through test verification, and has the potential of industrial production and popularization.

Description

Technical Field

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

[0002] Hemorrhoids are a common disease located in the anal area. They can occur at any age, but the incidence gradually increases with age, typically between 45 and 65 years old. The main symptoms of hemorrhoids are rectal bleeding and prolapse. Rectal bleeding refers to repeated bleeding during bowel movements, which can lead to significant iron loss and potentially iron-deficiency anemia. Prolapse refers to internal hemorrhoids protruding outside the anus, making the mucous membrane easily irritated, increasing mucus secretion, and causing the perianal skin to become moist, itchy, inflamed, or develop eczema. Therefore, hemorrhoid patients should take timely intervention measures to prevent the condition from worsening. Most cases of hemorrhoids are related to factors such as irregular diet (spicy and irritating foods), prolonged sitting or standing, excessive fatigue, irregular lifestyle, pregnancy, and other unhealthy habits. Extending this to Traditional Chinese Medicine theory, these behaviors often lead to internal accumulation of toxins and heat, stagnation of qi and blood, and the mutual binding of stasis and toxins, thus triggering hemorrhoids.

[0003] Currently, the treatment principle for hemorrhoids is that asymptomatic hemorrhoids do not require treatment. Mild hemorrhoids are a self-limiting disease, and lifestyle adjustments can effectively control their progression, preventing them from worsening or even leading to a complete cure. However, if redness, swelling, pain, or large lumps affect quality of life, medication should be taken promptly. Most commonly used Western medicines are oral medications that relieve discomfort through anti-inflammatory and analgesic effects. However, many oral Western medicines have drawbacks such as slow onset of action, high recurrence rates, uncertain efficacy, and significant side effects. Traditional Chinese medicine (TCM) has a long history of treating hemorrhoids, and its compound herbal formulas have relatively stable efficacy and certain advantages in preventing recurrence. Currently, the most common syndromes for hemorrhoids are: wind-heat intestinal collaterals syndrome, qi stagnation and blood stasis syndrome, damp-heat descending syndrome, and spleen deficiency and qi sinking syndrome. Wind-heat intestinal collaterals syndrome is treated with cooling blood and stopping bleeding, such as Sophora japonica fruit pills; qi stagnation and blood stasis syndrome is treated with promoting blood circulation and reducing swelling, such as Peach Blossom and Four Substances Decoction; damp-heat descending syndrome is treated with clearing heat and drying dampness, such as Zanglian pills; and spleen deficiency and qi sinking syndrome is treated with tonifying qi and lifting qi, such as Buzhong Yiqi Decoction. CN113797283A provides a traditional Chinese medicine composition for treating hemorrhoids, which has significant clinical efficacy for hemorrhoids of the damp-heat accumulation and spleen deficiency with qi sinking type. It is prepared from the following raw materials by weight: rhubarb 218-238 parts, coptis 35-55 parts, sanguisorba officinalis 218-238 parts, phellodendron chinense 126-146 parts, sophora flavescens 218-238 parts, gromwell root 218-238 parts, cinnabar 7-25 parts, calamine 198-218 parts, dragon's blood 41-61 parts, sodium sulfate 41-61 parts, borneol 5-25 parts, borax 20-40 parts, licorice 94-114 parts, bletilla striata 198-218 parts, and artificial musk 1-2 parts. It is not entirely suitable for hemorrhoids caused by internal accumulation of toxic heat, qi stagnation and blood stasis, and mutual binding of blood stasis and toxicity. Therefore, combining traditional Chinese medicine theory to develop a safe, effective, easy-to-use, and patient-compliant Chinese medicine composition and preparation for the treatment of hemorrhoids has great market significance. Summary of the Invention

[0004] The technical problem to be solved by the present invention is to provide a traditional Chinese medicine composition for treating hemorrhoids, and at the same time provide its preparation method and application.

[0005] To solve the above problems, the technical solution adopted by the present invention is as follows: In a first aspect, the present invention provides a traditional Chinese medicine composition for treating hemorrhoids, which is prepared from the following raw materials in parts by weight: 20-60 parts of Sargentodoxa cuneata, 15-45 parts of Paeonia suffruticosa, 20-40 parts of Taraxacum mongolicum, 20-40 parts of Rheum palmatum, 20-40 parts of Paeonia lactiflora, and 10-30 parts of Lithospermum erythrorhizon.

[0006] As a further improvement of the present invention, a formula prepared from any of the following raw materials in any part by weight is provided: Prescription 1: 40 parts of Sargentodoxa cuneata, 30 parts of Paeonia suffruticosa, 30 parts of Taraxacum mongolicum, 30 parts of Rheum palmatum, 30 parts of Paeonia lactiflora, and 20 parts of Lithospermum erythrorhizon.

[0007] Prescription 2: 20 parts of Sargentodoxa cuneata, 15 parts of Paeonia suffruticosa, 20 parts of Taraxacum mongolicum, 20 parts of Rheum palmatum, 20 parts of Paeonia lactiflora, and 10 parts of Lithospermum erythrorhizon.

[0008] Prescription 3: 60 parts of Sargentodoxa cuneata, 45 parts of Paeonia suffruticosa, 30 parts of Taraxacum mongolicum, 30 parts of Rheum palmatum, 30 parts of Paeonia lactiflora, and 20 parts of Lithospermum erythrorhizon.

[0009] Prescription 4: 40 parts of Spatholobus suberectus, 30 parts of Paeonia suffruticosa, 40 parts of Taraxacum mongolicum, 40 parts of Rheum palmatum, 40 parts of Paeonia lactiflora, and 30 parts of Lithospermum erythrorhizon.

[0010] Secondly, the present invention provides a traditional Chinese medicine preparation, the key feature of which is that the traditional Chinese medicine preparation is selected from fumigation agents, ointments, suppositories, powders, decoctions, pills, granules, tablets and capsules.

[0011] As a further improvement of the present invention, the traditional Chinese medicine preparation is a traditional Chinese medicine suppository, comprising the traditional Chinese medicine composition of the first aspect and the suppository matrix.

[0012] As a further improvement of the present invention, the suppository base is selected from one or more combinations of mixed fatty acid glycerides, liquid paraffin, and lanolin.

[0013] As a further improvement of the present invention, the suppository base is a mixture of liquid paraffin or lanolin and mixed fatty acid glycerides, wherein the mass fraction of the liquid paraffin or lanolin in the mixture is 0.1-10%, and the mass fraction of the mixed fatty acid glycerides is 90-99.9%.

[0014] Thirdly, the present invention provides a method for preparing the above-mentioned traditional Chinese medicine preparation, the key of which is that it includes the following steps: S1. Weigh each raw material according to the prescription ratio, add solvent for soaking, extract, and obtain extract; S2. The extract obtained in S1 is concentrated under reduced pressure, dried, and pulverized to obtain medicinal powder.

[0015] S3. Add the powder obtained in S2 to the excipients to obtain the final product.

[0016] As a further improvement of the present invention, the solvent in step S1 is an ethanol solution with a concentration of 60% to 90%.

[0017] As a further improvement of the present invention, the soaking and extraction method in step S1 is any of the following: Law 1: a. Add solvent equivalent to 6-12 times the mass of the raw material, and soak for 20-90 minutes; b. Heat under reflux for 0.5-1 h, filter, and obtain the extract.

[0018] Method 2: a. Add solvent equivalent to 6-12 times the mass of the raw material, and soak for 20-90 minutes; b. Extract by reflux for 0.5-1.5 hours, filter, and retain the filtrate; c. Extract the filter residue 1-2 times, with the amount of solvent added each time being 6-12 times the mass of the raw material. Heat and reflux for 0.5-1.5 hours, filter, combine the filtrates, and obtain the extract.

[0019] As a further improvement of the present invention, the traditional Chinese medicine preparation is a suppository. S3 involves adding the powder obtained in S2 into the suppository base and mixing it thoroughly. S4 involves pouring the above-mentioned well-mixed mixture into a mold to solidify and shape, then refrigerating and demolding to obtain the final product. The mass of the medicinal powder in the mixed mixture accounts for 30% to 45% of the mass of the mixture.

[0020] Fourthly, the present invention provides the application of the traditional Chinese medicine composition provided in the first aspect in the preparation of a treatment for hemorrhoids with blood stasis and toxin accumulation syndrome.

[0021] The pharmacological and formulation explanations of the compositions of this invention are as follows: The two main herbs, *Sargentodoxa cuneata* and *Paeonia suffruticosa*, are the principal herbs. *Sargentodoxa cuneata* is bitter and neutral in nature, entering the large intestine and liver meridians. It has the effects of clearing heat and detoxifying, promoting blood circulation, and dispelling wind, and is often used for abdominal pain, intestinal abscesses, and sores caused by heat toxins. The ethyl acetate fraction and polysaccharides of *Sargentodoxa cuneata* have anti-inflammatory effects, and its water-soluble extract inhibits platelet aggregation and promotes deaggregation. It is the main component responsible for promoting blood circulation, removing blood stasis, clearing heat, and detoxifying. *Paeonia suffruticosa* is bitter, pungent, and slightly cold, entering the heart, liver, and kidney meridians. It has the effects of clearing heat and cooling blood, promoting blood circulation, and removing blood stasis. *Ben Cao Jing Shu* states that it is "pungent to disperse stagnation, bitter and cold to remove blood heat, entering the blood, and is an essential medicine for cooling blood heat." Modern research has found that its main components are monoterpenes and glycosides, phenols and glycosides, flavonoids, and triterpenoids, possessing various pharmacological effects such as clearing heat and cooling blood, promoting blood circulation, removing blood stasis, and relieving pain. Targeting the pathogenesis of hemorrhoids caused by blood stasis, the combination of these two herbs both cools the blood and detoxifies, and promotes blood circulation, rapidly improving the symptoms of hemorrhoids with blood stasis, swelling, and pain.

[0022] Dandelion, red peony root, and rhubarb are used as assistant herbs. Dandelion is bitter, sweet, and cold in nature, and enters the liver and stomach meridians. It has the effects of clearing heat and detoxifying, reducing swelling and dissipating nodules, and promoting urination. Modern research has found that it has anti-inflammatory, antibacterial, and antioxidant effects. It can enhance the heat-clearing and detoxifying effects of the principal herb, *Sargentodoxa cuneata*. Red peony root is bitter and slightly cold, and enters the liver meridian. It clears heat, cools the blood, disperses blood stasis, and relieves pain. The *Shennong Bencao Jing* states that it "treats abdominal pain caused by pathogenic factors, removes blood stasis, breaks up hard masses, relieves pain, promotes urination, and benefits qi." Zhang Xichun stated that it "can resolve blood stasis caused by toxic heat and prevent suppuration." Both dandelion and the principal herb, peony bark, enter the blood level. When used together, they enhance the effects of cooling the blood, detoxifying, activating blood circulation, and dispersing blood stasis. Modern research has also found that the anti-inflammatory and blood-activating effects are significantly enhanced when used together. Rhubarb is bitter and cold in nature, and enters the large intestine, spleen, stomach, liver, and heart meridians. It has the effects of purging heat from the bowels, cooling the blood, detoxifying, dispelling blood stasis, and promoting menstruation. It not only helps the large-stemmed vine to invigorate blood circulation, remove blood stasis, reduce swelling, and relieve pain, but also cleanses the intestines and stomach of accumulated stagnation to purge heat and promote bowel movements. The large-stemmed vine and rhubarb enter the large intestine meridian, guiding the medicine directly to the affected area. The three herbs work synergistically to enhance the effects of clearing heat, cooling blood, invigorating blood circulation, and removing blood stasis.

[0023] Lithospermum erythrorhizon is used as an adjuvant herb; it is sweet, salty, and cold in nature, and enters the heart and liver meridians. It has the effects of clearing heat and cooling blood, promoting blood circulation and detoxifying, and promoting rash eruption and eliminating spots. The *Compendium of Materia Medica* states that "its strength lies in cooling and promoting blood circulation, and benefiting the large and small intestines." Modern research has found that it has anti-inflammatory effects, protects the local skin, and promotes wound healing. Lithospermum erythrorhizon's blood-cooling and blood-activating effects assist the blood-activating and meridian-clearing effects of Sargentodoxa cuneata, and also strengthens the blood-cooling and hemostatic effects of Paeonia suffruticosa. Combined with dandelion, it enhances the antibacterial effect and reduces inflammatory responses.

[0024] According to the pathogenesis of hemorrhoids, the disease is mostly caused by internal accumulation of toxic heat, qi stagnation and blood stasis, and the mutual binding of stasis and toxicity. This formula targets the main cause of "stasis and toxicity," employing the treatment principles of cooling the blood and detoxifying, and promoting blood circulation and removing blood stasis. It selects *Sargentodoxa cuneata* and *Paeonia suffruticosa* as the principal herbs, directly addressing the pathogenesis. *Taraxacum mongolicum*, *Paeonia lactiflora*, *Rheum palmatum*, and *Lithospermum erythrorhizon* work synergistically, exerting their effects through multiple therapeutic pathways. The entire formula is innovative, providing a new approach to the treatment of hemorrhoids in traditional Chinese medicine. The combined effects of these herbs are to cool the blood and detoxify, promote blood circulation and remove blood stasis, reduce swelling and relieve pain.

[0025] The beneficial effects of adopting the above technical solution are as follows: 1. The traditional Chinese medicine composition of the present invention takes a different approach to treatment. Targeting the main cause of "blood stasis and toxins", it adopts the treatment principle of cooling blood and detoxifying, promoting blood circulation and removing blood stasis. It selects large-stem vine and peony bark as the principal herbs, which directly address the pathogenesis and have good effects.

[0026] 2. The traditional Chinese medicine suppositories of the present invention are safe, effective, convenient to use, and have good patient compliance. They also avoid the first-pass effect of oral medications. Preliminary experimental verification shows that they can significantly relieve the inflammation and pain of hemorrhoids and have the potential for industrial production and promotion. Attached Figure Description

[0027] Figure 1 The graph shows the ulcer area as an example of the effectiveness of this invention. Detailed Implementation

[0028] To make the objectives, technical solutions and advantages of the present invention clearer, the following describes the invention clearly and completely with reference to specific embodiments.

[0029] In the traditional Chinese medicine composition of the present invention, the introduction of each raw material is as follows: Sargentodoxa Cuneata is the dried vine stem of Sargentodoxa cuneata (Oliv.) Rehd. et Wils. of the family Lardizabalaceae. It is harvested in autumn and winter, the lateral branches are removed, cut into sections, dried, and cut into small sections of 2 - 4 cm.

[0030] Moutan Cortex is the dried root bark of Paeonia suffruticosa Andr. of the family Ranunculaceae. The roots are dug in autumn, the fine roots and sediment are removed, the root bark is peeled off and dried in the sun; or the rough bark is scraped off, the woody core is removed, and dried in the sun. The former is commonly known as "Lian丹皮", and the latter is commonly known as "刮丹皮", and cut into slices with a thickness of 1 - 2 mm.

[0031] Dandelion is the dried whole herb of Taraxacum mongolicum Hand.-Mazz., Taraxacum borealisinense Kitam. or several species of the same genus of the family Compositae. It is dug when the flowers begin to bloom from spring to autumn, the impurities are removed, washed, dried, and cut into small sections of 3 - 5 cm.

[0032] Paeoniae Radix Rubra is the dried root of Paeonia lactiflora Pall. or Paeonia veitchii Lynch of the family Ranunculaceae. It is dug in spring and autumn, the rhizome, fibrous roots and sediment are removed, dried in the sun, and cut into slices with a thickness of 1 - 2 mm.

[0033] Rhei Radix et Rhizoma is the dried root and rhizome of Rheum palmatum L., Rheum tanguticum Maxim. ex Balf. or Rheum officinale Baill. of the family Polygonaceae. It is dug at the end of autumn when the stems and leaves wither or before germination in the next spring, the fine roots are removed, the outer bark is scraped off, cut into petals or sections, strung with ropes and dried or directly dried, and cut into slices with a thickness of 5 - 10 mm. <​​​​​​​

[0036] Its preparation method is as follows: S1. After mixing all the raw materials, add 10 times the mass of 70% ethanol aqueous solution to the raw materials, soak for 30 minutes, heat the soaked solution under reflux for 60 minutes, filter, and keep the filtrate. S2. Add 10 times the mass of 70% ethanol aqueous solution to the filter residue, heat under reflux for 30 min, filter, combine the filtrates, and obtain the extract; S3. Concentrate the extract under reduced pressure at 60°C to a density of 1.1, and dry the concentrate under reduced pressure at 60°C to obtain the dried product; S4. Crush the dried product obtained in step S3 through a 200-mesh sieve to obtain the Chinese medicine powder.

[0037] Example 2 Traditional Chinese Medicine Composition A traditional Chinese medicine composition for treating hemorrhoids, comprising the following raw materials in parts by weight: 20 parts of Sargentodoxa cuneata, 15 parts of Paeonia suffruticosa, 20 parts of Taraxacum mongolicum, 20 parts of Rheum palmatum, 20 parts of Paeonia lactiflora, and 10 parts of Lithospermum erythrorhizon.

[0038] Its preparation method is as follows: S1. After mixing all the raw materials, add 10 times the mass of 70% ethanol aqueous solution to the raw materials, soak for 30 minutes, heat the soaked solution under reflux for 60 minutes, filter, and keep the filtrate. S2. Add 10 times the mass of 70% ethanol aqueous solution to the filter residue, heat under reflux for 30 min, filter, combine the filtrates, and obtain the extract; S3. Concentrate the extract under reduced pressure at 60°C to a density of 1.1, and dry the concentrate under reduced pressure at 60°C to obtain the dried product; S4. Crush the dried product obtained in step S3 through a 200-mesh sieve to obtain the Chinese medicine powder.

[0039] Example 3 Traditional Chinese Medicine Composition A traditional Chinese medicine composition for treating hemorrhoids, comprising the following raw materials in parts by weight: 60 parts of Sargentodoxa cuneata, 45 parts of Paeonia suffruticosa, 30 parts of Taraxacum mongolicum, 30 parts of Rheum palmatum, 30 parts of Paeonia lactiflora, and 20 parts of Lithospermum erythrorhizon.

[0040] Its preparation method is as follows: S1. After mixing all the raw materials, add 10 times the mass of 70% ethanol aqueous solution to the raw materials, soak for 30 minutes, heat the soaked solution under reflux for 60 minutes, filter, and keep the filtrate. S2. Add 10 times the mass of 70% ethanol aqueous solution to the filter residue, heat under reflux for 30 min, filter, combine the filtrates, and obtain the extract; S3. Concentrate the extract under reduced pressure at 60°C to a density of 1.1, and dry the concentrate under reduced pressure at 60°C to obtain the dried product; S4. Crush the dried product obtained in step S3 through a 200-mesh sieve to obtain the Chinese medicine powder.

[0041] Example 4 Traditional Chinese Medicine Composition A traditional Chinese medicine composition for treating hemorrhoids, comprising the following raw materials in parts by weight: 40 parts of Sargentodoxa cuneata, 30 parts of Paeonia suffruticosa, 40 parts of Taraxacum mongolicum, 40 parts of Rheum palmatum, 40 parts of Paeonia lactiflora, and 30 parts of Lithospermum erythrorhizon.

[0042] Its preparation method is as follows: S1. After mixing all the raw materials, add 10 times the mass of 70% ethanol aqueous solution to the raw materials, soak for 30 minutes, heat the soaked solution under reflux for 60 minutes, filter, and keep the filtrate. S2. Add 10 times the mass of 70% ethanol aqueous solution to the filter residue, heat under reflux for 30 min, filter, combine the filtrates, and obtain the extract; S3. Concentrate the extract under reduced pressure at 60°C to a density of 1.1, and dry the concentrate under reduced pressure at 60°C to obtain the dried product; S4. Crush the dried product obtained in step S3 through a 200-mesh sieve to obtain the Chinese medicine powder.

[0043] Example 5 A traditional Chinese medicine composition for treating hemorrhoids, comprising the following raw materials in parts by weight: 40 parts of Sargentodoxa cuneata, 30 parts of Paeonia suffruticosa, 30 parts of Taraxacum mongolicum, 30 parts of Rheum palmatum, 30 parts of Paeonia lactiflora, and 20 parts of Lithospermum erythrorhizon.

[0044] Its preparation method is as follows: S1. After mixing all the raw materials, add 10 times the mass of 90% ethanol aqueous solution to the raw materials, soak for 30 minutes, heat the soaked solution under reflux for 60 minutes, filter, and keep the filtrate. S2. Add 10 times the mass of 90% ethanol aqueous solution to the filter residue, heat under reflux for 30 min, filter, combine the filtrates, and obtain the extract; S3. Concentrate the extract under reduced pressure at 60°C to a density of 1.1, and dry the concentrate under reduced pressure at 65°C to obtain the dried product; S4. Crush the dried product obtained in step S3 through a 200-mesh sieve to obtain the Chinese medicine powder.

[0045] Example 6 A traditional Chinese medicine composition for treating hemorrhoids, comprising the following raw materials in parts by weight: 40 parts of Sargentodoxa cuneata, 30 parts of Paeonia suffruticosa, 30 parts of Taraxacum mongolicum, 30 parts of Rheum palmatum, 30 parts of Paeonia lactiflora, and 20 parts of Lithospermum erythrorhizon.

[0046] Its preparation method is as follows: S1. After mixing all the raw materials, add 10 times the mass of 60% ethanol aqueous solution to the raw materials, soak for 30 minutes, heat the soaked solution under reflux for 60 minutes, filter, and keep the filtrate. S2. Add 10 times the mass of 60% ethanol aqueous solution to the filter residue, heat under reflux for 30 min, filter, combine the filtrates, and obtain the extract; S3. Concentrate the extract under reduced pressure at 60°C to a density of 1.1, and dry the concentrate under reduced pressure at 60°C to obtain the dried product; S4. Crush the dried product obtained in step S3 through a 200-mesh sieve to obtain the Chinese medicine powder.

[0047] Example 7 A traditional Chinese medicine composition for treating hemorrhoids, comprising the following raw materials in parts by weight: 40 parts of Sargentodoxa cuneata, 30 parts of Paeonia suffruticosa, 30 parts of Taraxacum mongolicum, 30 parts of Rheum palmatum, 30 parts of Paeonia lactiflora, and 20 parts of Lithospermum erythrorhizon.

[0048] Its preparation method is as follows: S1. After mixing all the raw materials, add 10 times the mass of 70% ethanol aqueous solution to the raw materials, soak for 30 minutes, heat the soaked solution under reflux for 90 minutes, filter, and keep the filtrate. S2. Add 10 times the mass of 70% ethanol aqueous solution to the filter residue, heat under reflux for 90 min, filter, combine the filtrates, and obtain the extract; S3. Concentrate the extract under reduced pressure at 60°C to a density of 1.1, and dry the concentrate under reduced pressure at 60°C to obtain the dried product; S4. Crush the dried product obtained in step S3 through a 200-mesh sieve to obtain the Chinese medicine powder.

[0049] Example 8: Chinese medicine suppositories Weigh out the Chinese herbal powders prepared in Examples 1-7 respectively, and add them to a blank matrix composed of mixed fatty acid glycerides and liquid paraffin at a mass percentage of 45% of the Chinese herbal powder. Melt and mix well. The mass ratio of the mixed fatty acid glycerides to liquid paraffin is 9.81:0.19. Pour the above-mentioned mixed liquid into a mold, cool and solidify it, and demold to obtain the suppository with a weight of 1.5g.

[0050] Example 9: Chinese medicine suppositories Weigh the Chinese herbal powder prepared in Example 1, add it to a blank matrix composed of mixed fatty acid glycerides and lanolin at a mass percentage of 30%, and melt and mix it. The mass ratio of the mixed fatty acid glycerides to lanolin is 9.6:0.4. Pour the above-mentioned mixed liquid into a mold, cool and solidify it, and demold it to obtain the final product.

[0051] Comparative Example 1 A traditional Chinese medicine composition for treating hemorrhoids, comprising the following raw materials in parts by weight: 70 parts of peony bark, 30 parts of dandelion, 30 parts of rhubarb, 30 parts of red peony root, and 20 parts of gromwell root.

[0052] Its preparation method is as follows: S1. After mixing all the raw materials, add 10 times the mass of 70% ethanol aqueous solution to the raw materials, soak for 30 minutes, heat the soaked solution under reflux for 60 minutes, filter, and keep the filtrate. S2. Add 10 times the mass of 70% ethanol aqueous solution to the filter residue, heat under reflux for 30 min, filter, combine the filtrates, and obtain the extract; S3. Concentrate the extract under reduced pressure at 60°C to a density of 1.1, and dry the concentrate under reduced pressure at 60°C to obtain the dried product; S4. Crush the dried product obtained in step S3 through a 200-mesh sieve to obtain the Chinese medicine powder.

[0053] Comparative Example 2 A traditional Chinese medicine composition for treating hemorrhoids, comprising the following raw materials in parts by weight: 70 parts of Sargentodoxa cuneata, 30 parts of Taraxacum mongolicum, 30 parts of Rheum palmatum, 30 parts of Paeonia lactiflora, and 20 parts of Lithospermum erythrorhizon.

[0054] Its preparation method is as follows: S1. After mixing all the raw materials, add 10 times the mass of 70% ethanol aqueous solution to the raw materials, soak for 30 minutes, heat the soaked solution under reflux for 60 minutes, filter, and keep the filtrate. S2. Add 10 times the mass of 70% ethanol aqueous solution to the filter residue, heat under reflux for 30 min, filter, combine the filtrates, and obtain the extract; S3. Concentrate the extract under reduced pressure at 60°C to a density of 1.1, and dry the concentrate under reduced pressure at 60°C to obtain the dried product; S4. Crush the dried product obtained in step S3 through a 200-mesh sieve to obtain the Chinese medicine powder.

[0055] Comparative Example 3 A traditional Chinese medicine composition for treating hemorrhoids, comprising the following raw materials in parts by weight: 40 parts of Sargentodoxa cuneata, 30 parts of Paeonia suffruticosa, 30 parts of Taraxacum mongolicum, 30 parts of Paeonia lactiflora, 30 parts of Scutellaria baicalensis, and 20 parts of Lithospermum erythrorhizon.

[0056] Its preparation method is as follows: S1. After mixing all the raw materials, add 10 times the mass of 70% ethanol aqueous solution to the raw materials, soak for 30 minutes, heat the soaked solution under reflux for 60 minutes, filter, and keep the filtrate. S2. Add 10 times the mass of 70% ethanol aqueous solution to the filter residue, heat under reflux for 30 min, filter, combine the filtrates, and obtain the extract; S3. Concentrate the extract under reduced pressure at 60°C to a density of 1.1, and dry the concentrate under reduced pressure at 60°C to obtain the dried product; S4. Crush the dried product obtained in step S3 through a 200-mesh sieve to obtain the Chinese medicine powder.

[0057] Comparative Example 4 A traditional Chinese medicine composition for treating hemorrhoids, comprising the following raw materials in parts by weight: 40 parts peach kernel, 30 parts peony bark, 30 parts dandelion, 30 parts rhubarb, 30 parts red peony root, and 20 parts gromwell root.

[0058] Its preparation method is as follows: S1. After mixing all the raw materials, add 10 times the mass of 70% ethanol aqueous solution to the raw materials, soak for 30 minutes, heat the soaked solution under reflux for 60 minutes, filter, and keep the filtrate. S2. Add 10 times the mass of 70% ethanol aqueous solution to the filter residue, heat under reflux for 30 min, filter, combine the filtrates, and obtain the extract; S3. Concentrate the extract under reduced pressure at 60°C to a density of 1.1, and dry the concentrate under reduced pressure at 60°C to obtain the dried product; S4. Crush the dried product obtained in step S3 through a 200-mesh sieve to obtain the Chinese medicine powder.

[0059] Effect Example Animal Experiment Study This study used SPF-grade healthy adult SD rats, half male and half female (purchased from Spiford (Beijing) Biotechnology Co., Ltd.), weighing 180-200g, for a total of 120 rats.

[0060] After purchase, all laboratory animals were housed in the animal housing room of the laboratory animal center. The room was clean, with the temperature controlled at 20-26°C and the humidity at 40%-70%, with good natural lighting and ventilation. During the experiment, the following indicators were observed: the mice's mental state, fur, activity, diet, and water intake. Their weight was measured before and after the last administration of treatment drugs.

[0061] After feeding rats a normal diet for several days, 120 rats were used to establish a model using a perianal injection of 75% glacial acetic acid. Specifically, after disinfecting the perianal area, 0.05 ml of 75% glacial acetic acid was injected into the skin around the anus using a 0.1 ml syringe. After 24 hours, obvious ulcers formed, ranging in size from 40 to 80 mm², accompanied by redness, swelling, and inflammatory exudation. The perianal local score of the modeled rats was assessed using Table 1 (a score greater than 4 indicates successful modeling). Successfully modeled rats were randomly divided into three groups: the model group, Example 1-4 groups, and Comparative Example 1-4 groups, with 10 rats in each group (half male and half female). The traditional Chinese medicine powders prepared in Examples 1-4 and Comparative Examples 1-4 were used to prepare suppositories using a rat suppository mold according to the suppository preparation method in Example 8. The rats were given suppositories for 7 consecutive days starting from the first day after successful model establishment, at a dosage of 2.7 g / kg / day. The model group was given suppositories prepared using a blank matrix without traditional Chinese medicine powder (mixed fatty acid glycerides and liquid paraffin in a mass ratio of 9.81:0.19), also given for 7 consecutive days starting from the first day after successful model establishment. The ulcer area of ​​the perianal wound was measured on days 2, 4, and 7 after administration (see Table 2).

[0062] Table 1. Scoring criteria for four levels of local symptoms. Score 0 1 2 3 Redness and swelling none Barely visible Edges raised above skin Obvious redness and swelling Inflammatory exudate none Inflammatory exudate Inflammatory exudate Inflammatory exudate Ulcer area none <![CDATA[≤20mm 2 ]]> <![CDATA[20~30mm 2 ]]> <![CDATA[≥30mm 2 ]]> Table 2 Comparison of ulcer area before and after drug administration in animals Grouping Number of animals Before drug administration (ulcer area / mm²) Day 2 (ulcer area / mm²) Day 4 (ulcer area / mm²) Day 7 (ulcer area / mm²) Model group 10 78.53±12.77 73.42±11.90 71.34±13.33 50.17±10.40 Example 1 10 67.98±6.24 46.63±6.85** 36.36±5.39** 22.98±3.01** Example 2 10 73.34±8.91 53.32±9.56** 41.99±7.77** 27.8±5.98** Example 3 10 65.62±10.13 44.39±9.04** 32.23±6.85** 18.44±4.32** Example 4 10 69.81±7.58 51.03±8.86** 41.81±9.42** 27.44±5.69** Comparative Example 1 10 76.28±13.58 <![CDATA[62.85±12.76 ## ]]> <![CDATA[58.22±11.85 ## ]]> <![CDATA[44.70±7.03 ## <!-- 7 -->]]> Comparative Example 2 10 66.95±9.71 <![CDATA[54.60±8.62 # ]]> <![CDATA[50.67±9.90 ## ]]> <![CDATA[40.25±8.75 ## ]]> Comparative Example 3 10 66.41±10.64 48.01±11.48 <![CDATA[44.81±10.50 # ]]> <![CDATA[30.79±9.14 # ]]> Comparative Example 4 10 68.73±11.88 <![CDATA[57.98±10.94 ## ]]> <![CDATA[44.01±9.21 # ]]> <![CDATA[34.98±8.87 ## ]]> Note: t-test, compared with the model group, *P<0.05, **P<0.01; compared with Example 1, the comparative example group... # P<0.05, ## P<0.01.

[0063] Results: Based on the ulcer area data of animals in each group on days 2, 4, and 7 after administration, it was evident that the ulcer area in the Example group was significantly reduced compared to the model group. Example 1 showed a significantly reduced ulcer area compared to Comparative Examples 1-4. The experimental data demonstrate that the traditional Chinese medicine composition of this application has a significant function in improving hemorrhoid inflammation and promoting wound healing.

[0064] Typical Case 1 Mr. Zhao, male, 62 years old, presented with a chief complaint of recurrent hemorrhoids for over 10 years, with a recurrence one week prior. He had suffered from hemorrhoids for over 10 years, experiencing recurrent anal pain and rectal bleeding, and intermittently using topical medications (details unknown). One week prior, after traveling, his hemorrhoids flared up again, with a prolapsed mass about the size of a soybean, accompanied by anal pain and discomfort, slight bleeding, poor sleep, normal appetite, yellow urine, and constipation. His tongue was dark with a yellow, greasy coating, and his pulse was slippery. Traditional Chinese medicine diagnosis indicated a pattern of blood stasis and toxin accumulation. The treatment principle was to cool the blood, detoxify, and promote blood circulation to remove blood stasis. He was given one suppository twice a day, prepared according to the method in Example 8, based on the composition of Example 1. After 10 days, his stool softened, bleeding stopped, the hemorrhoids shrank, and pain subsided. He continued using the suppository for another 10 days; there was no pain during bowel movements, the anal mass disappeared, and his sleep improved.

[0065] Typical Case 2 Ms. Yang, 32 years old, presented with a chief complaint of hemorrhoids for over 10 years, which had worsened in the past 5 days. Ten years ago, she experienced intermittent rectal bleeding, small in amount, dark red in color, without any anal prolapse or pain. She consulted a local hospital and was diagnosed with internal hemorrhoids. Her symptoms improved after using topical hemorrhoid ointment. Five years ago, a small anal lump, about the size of a peanut, appeared during bowel movements. There was no local redness, swelling, or pain, and the lump could spontaneously reduce after defecation. Occasional, small amounts of rectal bleeding occurred, but she did not seek treatment. Five days ago, the lump gradually enlarged, protruding and unable to be reduced, with increased rectal bleeding and a significant feeling of anal distension. She had no chills or fever and intermittently used topical hemorrhoid ointment with little effect. Her tongue was dark red with a yellow, greasy coating, and her pulse was wiry and slippery. Traditional Chinese medicine diagnosis indicated a pattern of blood stasis and toxin accumulation. The treatment principle was to cool the blood, detoxify, and promote blood circulation to remove blood stasis. She was given one suppository of the composition described in Example 1, prepared according to the method in Example 8, twice a day. After 4 days, the bleeding stopped. After 10 days of continued use, the lump decreased in size, and bowel movements returned to normal. After using this medicine for 5 days to consolidate the therapeutic effect, the anal swelling disappeared after 5 days.

[0066] Typical Case 3 Mr. Liu, male, 40 years old, presented with a chief complaint of hemorrhoids for over 20 years, which had worsened in the past 20 days. Twenty years ago, he experienced anal prolapse, which could spontaneously reduce without pain or bleeding, and remained untreated. Six years ago, he began experiencing rectal bleeding, with spurting blood during defecation, particularly after drinking alcohol. He intermittently used hemorrhoid suppositories and traditional Chinese medicine washes. For the past six months, he experienced anal distension and discomfort accompanied by abdominal bloating, and difficulty defecating, approximately 6-8 times per day, with small, unformed stools. In the past 20 days, the amount of rectal bleeding increased, and the blood was dark red. His tongue was pale purple with a thin yellow coating, and his pulse was slippery and rapid. Traditional Chinese medicine diagnosis indicated a pattern of blood stasis and toxin accumulation, and the treatment principle was to cool the blood, detoxify, and promote blood circulation to remove blood stasis. He was given one suppository twice a day, prepared according to the method in Example 8, based on the composition of Example 1. After 4 days, the bleeding decreased. After another 4 days, the bleeding disappeared, and the swelling decreased in size. After another 5 days, the swelling did not prolapse.

[0067] Typical Case 4 Ms. Bai, female, 21 years old, presented with a one-year history of hemorrhoids, which had worsened over the past week. One year prior, she experienced anal prolapse of a mass, approximately the size of a peanut, which spontaneously reduced after defecation without treatment. One week ago, the prolapse recurred, accompanied by anal itching, pain, and discomfort. Her tongue was purplish-dark with a yellow, greasy coating, and her pulse was wiry and rapid. Traditional Chinese medicine diagnosis indicated a pattern of blood stasis and toxin accumulation. The treatment principle was to cool the blood, detoxify, and promote blood circulation to remove blood stasis. She was given one suppository twice daily, prepared according to the method described in Example 8, based on the composition of Example 1. After seven days, the prolapse decreased in size, and the itching and pain lessened. Continued use for another seven days resulted in the complete disappearance of the prolapse, with no further itching or pain.

[0068] Typical Case 5 Mr. Yang, male, 47 years old, presented with a chief complaint of hemorrhoids for over 10 years, which had worsened in the past week. Over 10 years ago, after drinking alcohol, he experienced anal prolapse of a mass, approximately the size of a peanut. The mass would spontaneously reduce after defecation, accompanied by intermittent rectal bleeding and anal pain, especially during and after constipation. He intermittently used hemorrhoid suppositories, which provided some relief, but the symptoms recurred. One week ago, he experienced another episode of anal prolapse, rectal bleeding, and anal pain, which gradually worsened. His tongue was dark red with a yellow coating, and his pulse was slippery. Traditional Chinese medicine diagnosis indicated a pattern of blood stasis and toxin accumulation. The treatment principle was to cool the blood, detoxify, and promote blood circulation to remove blood stasis. He was given one suppository twice a day, prepared according to the method in Example 8, based on the composition of Example 1. After 3 days, the bleeding stopped. After 10 days of continued use, the mass disappeared, bowel movements returned to normal, and the pain lessened. After 5 days of continued use, bowel movements returned to normal, and there was no pain.

[0069] Typical Case 6 Ms. Gu, 51 years old, presented with a 4-year history of hemorrhoids, which had worsened over the past two weeks. Four years ago, she developed a prolapsed anal mass, approximately the size of a peanut, which would spontaneously reduce after defecation without treatment. Over the past two weeks, the mass had enlarged and become irreducible. The use of Antai suppositories did not alleviate her symptoms. She also experienced normal urination and constipation. Her tongue was dark with a yellow, greasy coating, and her pulse was slippery and rapid. Traditional Chinese medicine diagnosis indicated a pattern of blood stasis and toxin accumulation. The treatment principle was to cool the blood, detoxify, and promote blood circulation to remove blood stasis. She was given one suppository twice a day, prepared according to the method described in Example 8, based on the composition of Example 1. After 10 days, the mass decreased in size and spontaneously reduced, and bowel movements returned to normal. After another 10 days of use, the mass disappeared, and bowel movements returned to normal. She continued use for another 5 days to consolidate the therapeutic effect.

[0070] Typical Case 7 Ms. Yao, female, 45 years old, presented with a 25-year history of hemorrhoids, which had worsened over the past 4 months. 25 years ago, she experienced an anal prolapse that could not be reduced after defecation, without rectal bleeding. Her symptoms were relieved after self-medicating with Ma Yinglong hemorrhoid ointment. Four months ago, the prolapsed anal mass enlarged, becoming ring-shaped, accompanied by intermittent rectal bleeding, with moderate amounts of dark red blood (dripping or spurting). She also experienced prolonged defecation time (approximately 60 minutes), and local itching and dampness around the anus. Topical hemorrhoid ointment was ineffective. Her tongue was dark red with a yellow, greasy coating, and her pulse was wiry and slippery. Traditional Chinese medicine diagnosis indicated a pattern of blood stasis and toxin accumulation. The treatment principle was to cool the blood, detoxify, and promote blood circulation to remove blood stasis. She was given one suppository twice daily, prepared according to the method in Example 8, based on the composition of Example 1. After 5 days, the anal mass shrank, the perianal itching lessened, and the rectal bleeding stopped. After another 7 days of use, the bleeding ceased, the anal mass significantly shrank, there was no discomfort around the anus, and bowel movements returned to normal.

[0071] Typical Case 8 Mr. Zhang, male, 26 years old, presented with a 4-year history of hemorrhoids, experiencing a recurrence of the condition for 3 days. Four years prior, he was diagnosed with internal hemorrhoids, accompanied by bleeding, which improved after using Antai suppositories. Three days prior, after consuming a spicy Sichuan hot pot, he experienced rectal bleeding, with blood staining the toilet paper and accompanied by stinging pain. His urination was normal, but he suffered from constipation. His tongue was dark purple with a yellow, greasy coating, and his pulse was wiry and rapid. Traditional Chinese medicine diagnosis indicated a pattern of blood stasis and toxin accumulation. The treatment principle was to cool the blood, detoxify, and promote blood circulation to remove blood stasis. The suppositories prepared according to the method in Example 8, based on the composition of Example 1, were administered twice daily. Bleeding stopped after one day, and the suppositories were continued for 6 days. Bowel movements returned to normal, and there was no discomfort around the anus.

[0072] Typical Case 9 Ms. Liu, 38 years old, presented with a one-week history of rectal prolapse accompanied by pain. One week prior, without any obvious cause, a rectal prolapse occurred during defecation, gradually increasing in size and becoming irreducible after defecation, accompanied by pain and blood on her fingers. She also experienced poor sleep, normal appetite, normal urination, constipation, burning sensation in the anus, and a feeling of heaviness in the rectum. Her tongue was dark red with a yellow, greasy coating, and her pulse was wiry and hesitant. Traditional Chinese medicine diagnosis indicated a pattern of blood stasis and toxin accumulation. The treatment principle was to cool the blood, detoxify, and promote blood circulation to remove blood stasis. She was given one suppository twice a day, prepared according to the method in Example 8, based on the composition of Example 1. After three days, the pain lessened, the prolapse decreased in size, the burning sensation and heaviness in the anus lessened, and bowel movements returned to normal. Continued use for five days resulted in the complete disappearance of pain and the prolapse of the prolapse, normal bowel movements, and the absence of burning sensation and heaviness in the anus. The patient recovered completely.

[0073] Typical Case 10 A 37-year-old male patient presented with a 6-month history of hemorrhoids. Six months prior, he developed a prolapsed anal mass, approximately the size of a peanut, accompanied by pain. The mass could not be spontaneously reduced after defecation, nor could it be reduced manually. Occasionally, there was blood on the toilet paper after wiping. He had intermittently used topical medications (specific details unknown) with poor results. His tongue was dark purple with a yellow, greasy coating, exhibiting a wiry, slippery, and rapid pulse. Traditional Chinese medicine diagnosis indicated a pattern of blood stasis and toxin accumulation. The treatment principle was to cool the blood, detoxify, invigorate blood circulation, and dispel blood stasis. He was given one suppository twice daily, prepared according to the method described in Example 8, based on the composition of Example 1. Bleeding stopped after 4 days, and the anal mass decreased in size. After 10 days of continued use, the mass disappeared, and bowel movements returned to normal.

[0074] Finally, it should be noted that the above content is only used to illustrate the technical solutions of the present invention, and is not intended to limit the scope of protection of the present invention. Those skilled in the art can still modify the technical solutions described in the foregoing embodiments, or make equivalent substitutions for some of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A traditional Chinese medicine composition for treating hemorrhoids, characterized in that, It is prepared from the following raw materials in parts by weight: 20-60 parts of Sargentodoxa cuneata, 15-45 parts of Paeonia suffruticosa, 20-40 parts of Taraxacum mongolicum, 20-40 parts of Rheum palmatum, 20-40 parts of Paeonia lactiflora, and 10-30 parts of Lithospermum erythrorhizon.

2. The traditional Chinese medicine composition for treating hemorrhoids according to claim 1, characterized in that, A formula prepared from any of the following ingredients by weight: Prescription 1: 40 parts of Sargentodoxa cuneata, 30 parts of Paeonia suffruticosa, 30 parts of Taraxacum mongolicum, 30 parts of Rheum palmatum, 30 parts of Paeonia lactiflora, and 20 parts of Lithospermum erythrorhizon; Prescription 2: 20 parts of Sargentodoxa cuneata, 15 parts of Paeonia suffruticosa, 20 parts of Taraxacum mongolicum, 20 parts of Rheum palmatum, 20 parts of Paeonia lactiflora, and 10 parts of Lithospermum erythrorhizon; Prescription 3: 60 parts of Sargentodoxa cuneata, 45 parts of Paeonia suffruticosa, 30 parts of Taraxacum mongolicum, 30 parts of Rheum palmatum, 30 parts of Paeonia lactiflora, and 20 parts of Lithospermum erythrorhizon; Prescription 4: 40 parts of Spatholobus suberectus, 30 parts of Paeonia suffruticosa, 40 parts of Taraxacum mongolicum, 40 parts of Rheum palmatum, 40 parts of Paeonia lactiflora, and 30 parts of Lithospermum erythrorhizon.

3. A traditional Chinese medicine preparation comprising any one of the traditional Chinese medicine compositions of claim 1 or 2, characterized in that, The traditional Chinese medicine preparations are selected from fumigation agents, ointments, suppositories, powders, decoctions, pills, granules, tablets, and capsules.

4. The traditional Chinese medicine preparation according to claim 3, characterized in that, The traditional Chinese medicine preparation is a suppository, and the suppository base is selected from one or more combinations of mixed fatty acid glycerides, liquid paraffin, and lanolin.

5. The traditional Chinese medicine preparation according to claim 4, characterized in that, The suppository base is a mixture of liquid paraffin or lanolin and mixed fatty acid glycerides, wherein the mass fraction of the liquid paraffin or lanolin in the mixture is 0.1-10%, and the mass fraction of the mixed fatty acid glycerides is 90-99.9%.

6. A method for preparing the traditional Chinese medicine preparation as described in claim 3, characterized in that, Includes the following steps: S1. Weigh each raw material according to the prescription ratio, add solvent for soaking, extract, and obtain extract; S2. The extract obtained in S1 is concentrated under reduced pressure, dried, and pulverized to obtain medicinal powder; S3. Add the powder obtained in S2 to the excipients to obtain the final product.

7. The method for preparing a traditional Chinese medicine preparation according to claim 6, characterized in that, In step S1, the solvent is an ethanol solution with a concentration of 60% to 90%.

8. The method for preparing a traditional Chinese medicine preparation according to claim 6, characterized in that, The soaking and extraction method in step S1 is any of the following: Law 1: a. Add solvent equivalent to 6-12 times the mass of the raw material, and soak for 20-90 minutes; b. Heat under reflux for 0.5-1 hour, filter, and obtain the extract; Method 2: a. Add solvent equivalent to 6-12 times the mass of the raw material, and soak for 20-90 minutes; b. Extract by reflux for 0.5-1.5 hours, filter, and collect the filtrate; c. Add 6-12 times the mass of solvent to the filtered residue, heat under reflux for 0.5-1.5 hours, filter, combine the filtrates to obtain the extract; or d. Repeat step c once more, combine the filtrates, and obtain the extract.

9. The method for preparing a traditional Chinese medicine preparation according to claim 6, characterized in that, The preparation is a suppository, and S3 involves adding the powder obtained in S2 to the suppository matrix and mixing it thoroughly. S4 involves pouring the above-mentioned well-mixed mixture into a mold to solidify and shape, then refrigerating and demolding to obtain the final product. The mass of the medicinal powder in the mixed mixture accounts for 30% to 45% of the mass of the mixture.

10. The use of the traditional Chinese medicine composition for treating hemorrhoids as described in claim 1 or 2 in the preparation of a medicine for treating hemorrhoids with blood stasis and toxin accumulation syndrome.

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