Traditional Chinese medicine composition and preparation for treating acute thrombotic external hemorrhoids and preparation method thereof

Abstract

The application provides a traditional Chinese medicine composition, preparation and preparation method for treating acute thrombotic external hemorrhoids. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: cassia twig 15-20 parts, red peony root 15-20 parts, raw ginger 10-20 parts, rhubarb 15-20 parts, earthworm 10-20 parts, sparganium 15-20 parts, zedoary 15-20 parts, pericarpium citri reticulatae viride 10-20 parts. The clinical test proves that the traditional Chinese medicine external preparation has a remarkable curative effect on treating acute thrombotic external hemorrhoids, can rapidly improve the symptoms, and has no toxic side effect.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to traditional Chinese medicine compositions, preparations and preparation methods for treating acute thrombosed external hemorrhoids. Background Technology

[0002] Thrombosed external hemorrhoids are the most common type of acute hemorrhoid. They are often caused by insufficient sleep, constipation, diarrhea, prolonged sitting, coughing, excessive straining, or sustained strenuous exercise, leading to increased intra-abdominal pressure and impaired blood return from the anal margin veins, causing blood clots to form. Clinically, it presents as a sudden, dark purple mass under the skin at the anal margin, which gradually enlarges. The onset is rapid, and most patients seek medical attention due to severe pain from the sudden appearance of the mass around the anus.

[0003] Traditional Chinese medicine believes that dietary imbalances, prolonged sitting, emotional distress, and excessive sexual activity can all lead to obstructed blood flow, stagnation of qi and blood, poor circulation, and accumulation of qi and blood around the anus, resulting in this condition. Blood stasis often develops from stagnation of qi in the collaterals. The *Suwen* (Plain Questions) states, "When the disease is in the vessels, regulate the blood; when the disease is in the blood, regulate the collaterals." The *Suwen* also records, "For diseases of the superficial collaterals, treat the blood in the superficial collaterals." Unblocking the meridians and balancing yin and yang play a crucial role in the treatment of acute thrombosed external hemorrhoids.

[0004] Currently, surgical intervention remains the primary treatment for acute thrombosed external hemorrhoids. However, the intense pain and long healing time associated with surgery are major reasons why some patients cannot accept it. Conservative treatment mainly involves dietary adjustments, laxatives, and intravenous active drugs containing purified micronized flavonoids. These methods are unlikely to achieve rapid pain relief, thrombus reduction, and prevention of recurrence. Therefore, finding a safe, effective, and rapid treatment method is particularly urgent. Summary of the Invention

[0005] The technical problem to be solved by the present invention is to provide a traditional Chinese medicine composition, preparation and preparation method for treating acute thrombosed external hemorrhoids. It has the effects of externally promoting blood circulation and removing blood stasis, clearing heat and relieving pain; and internally regulating the body's vital energy and strengthening the spleen and replenishing qi. It is used for the treatment of acute thrombosed external hemorrhoids. Clinical trials have confirmed that the traditional Chinese medicine external preparation of the present invention has significant curative effect on the treatment of patients with acute thrombosed external hemorrhoids, can rapidly improve symptoms and cure the disease, and has no toxic side effects.

[0006] This invention uses cinnamon twig, ginger, red peony root, rhubarb, ground beetle, sparganium rhizome, turmeric rhizome, and green tangerine peel. The combination of these eight ingredients effectively treats acute thrombosed external hemorrhoids. For significant edema, add catechu and Glauber's salt to promote diuresis and reduce swelling; for significant pain, add prepared licorice root and corydalis rhizome to relieve spasms and pain; for those with spleen and stomach deficiency and cold, add Sichuan pepper and stir-fried atractylodes macrocephala to warm the middle and strengthen the spleen; for hard thrombi, add clematis root and soapberry to break up hardened masses and dissolve blood stasis.

[0007] The efficacy of the medicinal herbs is briefly described below:

[0008] Cinnamon twig: It is pungent and warm in nature. It enters the Liver Meridian of Foot Jueyin and the Bladder Meridian of Foot Taiyang. It mainly relieves muscle tension and releases exterior pathogens. It enters the Liver to circulate blood, travels through the meridians to reach the stagnant blood, is good at dispelling wind pathogens, is most effective in regulating the Liver Qi, raises the clear Yang to prevent collapse, lowers the turbid Yin to prevent rebellion, relaxes muscle spasms, and benefits joint obstruction. It enters the Liver and Gallbladder to disperse stagnation, effectively stops pain, and unblocks the meridians to relieve numbness and stagnation.

[0009] Red peony root: Sour, bitter, and slightly cold; enters the blood aspect of the Foot Jueyin meridian. It moves stagnation in the blood, removes blood stasis, breaks up hard masses, and relieves pain. It unblocks blood vessels, soothes the middle burner, disperses stagnant blood, expels harmful blood, removes dampness, benefits the bladder, large and small intestines, and reduces carbuncles and swellings.

[0010] Ginger: pungent and slightly warm in nature, it enters the lung, heart, spleen, and stomach meridians. It embodies the wood energy of early spring, entering the gallbladder meridian (Foot Shaoyang) and liver meridian (Foot Jueyin). It promotes the flow of qi and blood, is an essential herb for regulating the flow of qi and blood, and is a good medicine for releasing exterior pathogens. It enters the lungs and stomach to dispel turbidity, moves through the liver and spleen to remove stagnation, clears chest congestion, relieves stomach obstruction, effectively clears nasal congestion, and is most effective in stopping abdominal pain. It harmonizes the internal organs and promotes the flow of qi and blood.

[0011] Rhubarb: Bitter and cold in nature, it enters the spleen, stomach, large intestine, heart, and liver meridians. It is primarily used to treat blood stasis, amenorrhea, break up masses and accumulations, promote metabolism, eliminate phlegm, intestinal heat, abdominal distension, cold-induced amenorrhea and distension in women, lower abdominal pain, and various types of blood stasis. It clears heat and promotes blood circulation, resolves obstructions, treats dryness and constipation in the Yangming meridian, eliminates dampness in the Taiyin meridian, unblocks meridians to break up masses, and eliminates carbuncles and pus.

[0012] Ground beetle: Salty in taste, slightly cold in nature, and poisonous; it enters the heart, liver, and spleen meridians. It primarily treats blood stasis, relieving abdominal distension and chills, dispelling hard masses and lumps, and stopping bleeding. It benefits the meridians, effectively resolves blood stasis, and is highly effective in repairing damage. It is used for amenorrhea, postpartum blood stasis, lumps, and pain due to blood stasis.

[0013] Sparganium rhizome: Bitter in taste, neutral in nature, enters the Liver Meridian of Foot Jueyin. It is a qi-regulating herb in the blood, primarily promoting qi and blood circulation. It can dissolve long-standing, stone-like masses into water. It can grind up accumulated masses, effectively break up old blood stasis, unblock menstruation and promote qi circulation, stop menstrual and postpartum pains, relieve pain from falls and injuries, and treat soft sores, carbuncles, and hard swellings. It disperses all blood stasis and qi stagnation, and hard, painful masses.

[0014] Curcuma zedoaria: Bitter and pungent in taste, warm in nature, enters the Liver Meridian of Foot Jueyin. It breaks up stagnation and hard masses, dissolves nodules and promotes blood circulation. It eliminates lumps and masses, breaks up blood stasis, dispels coldness in the internal organs, disperses blood stasis from falls and injuries, unblocks menstruation, relieves pain and dissipates nodules. It breaks up blood stasis within the Qi, and is effective for all cases of pain caused by Qi and blood stagnation. It is mainly used to treat amenorrhea, abdominal pain, and masses caused by Qi stagnation and blood stasis.

[0015] Green tangerine peel: Bitter and sour in taste, warm in nature, it enters the liver and spleen meridians. It primarily breaks up stagnant qi and dissipates hard masses. It guides other herbs to the Jueyin meridian, directs food into the Taiyin meridian, eliminates severe fever and abdominal masses caused by malaria, and relieves pain in the left hypochondrium caused by anger. Its pungent nature disperses, and its warm nature promotes circulation; it breaks up accumulations and resolves masses. It is mainly used to treat hypochondriac pain, breast pain, and hernia pain caused by liver qi stagnation. For masses and accumulations caused by qi stagnation and blood stasis, as well as chronic malaria masses, it can be used with Sparganium and Curcuma zedoaria, all utilizing the woody properties to break up qi stagnation and disperse masses.

[0016] Catechu: Bitter and astringent in taste, cool in nature. It enters the Lung Meridian of Hand-Taiyin. It can reduce swelling and pain, clear heat and resolve phlegm. It can also astringe dampness, promote wound healing, and stop bleeding.

[0017] Glauber's salt: It has a pungent and bitter taste, and is extremely cold in nature. It enters the Small Intestine Meridian of Hand-Taiyang (Cold Water) and the Triple Energizer Meridian of Hand-Shaoyang (Ministerial Fire). It can purge fire and relieve burning sensation, promote urination and relieve urinary tract infections, cleanse the excess heat in the Triple Energizer, intestines and stomach, and eliminate phlegm accumulation in the chest and diaphragm.

[0018] Prepared licorice root: It is sweet, neutral, and mild in nature. It mainly warms the middle jiao and enters the spleen meridian of the foot taiyin and the stomach meridian of the foot yangming. When prepared, it strengthens the spleen and stomach and harmonizes the middle jiao. Its sweet taste relieves urgency, benefits essence and nourishes qi, clears heat and harmonizes the middle jiao, harmonizes blood vessels, relieves liver urgency, dispels pathogenic heat, strengthens tendons and bones, promotes muscle growth, and treats sores and toxins.

[0019] Corydalis Rhizome: Bitter and pungent in taste, slightly warm in nature, it enters the blood aspect of the Hand and Foot Taiyin and Foot Jueyin meridians. It regulates menstruation, breaks up blood stasis, dissolves lumps and masses, and specifically removes stagnant blood. It is used for symptoms such as pain in the heart, abdomen, and limbs caused by stagnation of qi and blood, as it can both invigorate blood and promote qi circulation, and has a good analgesic effect.

[0020] Sichuan pepper: pungent, warm, and very hot in nature. It enters the Stomach Meridian of Foot Yangming, Liver Meridian of Foot Jueyin, Kidney Meridian of Foot Shaoyin, and Spleen Meridian of Foot Taiyin. It opens the pores, unblocks joints, promotes blood circulation, and relieves swelling and pain. It warms the middle jiao (middle burner) and the gate of life (mingmen), dispels cold and dampness, and stops pain.

[0021] Atractylodes macrocephala: Bitter and sweet in taste, warm in nature, it possesses the dryness of the Yangming meridian and enters the Stomach meridian of Foot Yangming, and the earthy flavor of the Zhongzheng meridian and enters the Spleen meridian of Foot Taiyin. It is used for various diseases caused by spleen deficiency, impaired digestion and absorption, and retention of dampness.

[0022] Clematis chinensis: bitter in taste, warm in nature, enters the Spleen Meridian of Foot Taiyin and the Liver Meridian of Foot Jueyin. It removes cold stagnation in the abdomen, dispels intestinal wind, eliminates masses, resolves phlegm and eliminates lumps. It is good at clearing the meridians and can eliminate water retention. It can be used for esophageal obstruction and abdominal masses.

[0023] Gleditsia sinensis thorns: pungent and warm in taste, sharp in nature. Enters the liver and stomach meridians. Dispels wind and kills parasites, mainly treats carbuncles and boils, and can guide other medicines to the ulcerated area of ​​carbuncles and boils. For those that have not yet ulcerated, it can disperse the pus; for those that have already ulcerated, it can drain the pus, allowing the medicine to directly reach the pus site for successful treatment.

[0024] Acute thrombosed external hemorrhoids mainly occur due to spleen and stomach qi deficiency caused by overwork and improper diet, leading to stagnation of qi and blood along the perianal Jueyin Liver Meridian, resulting in obstruction of the meridians and often falling under the category of qi stagnation and blood stasis syndrome. This invention is a compound traditional Chinese medicine preparation for treating acute thrombosed external hemorrhoids. It uses cinnamon twig, red peony root, and ginger as the principal herbs to invigorate the spleen and replenish qi, harmonizing the nutritive and defensive qi; rhubarb and ground beetle as the assistant herbs to clear blockages and promote metabolism; sparganium rhizome and turmeric as adjuvant herbs to break up stagnation, dissolve masses, and promote blood circulation; and green tangerine peel as the guiding herb to the Jueyin meridian to break up stagnant qi and reduce hard masses. This formula is precisely formulated, with the combined herbs working synergistically to address both the root cause and the symptoms, supporting the body's resistance without retaining pathogenic factors, and eliminating pathogenic factors without harming the body's vital energy. It is mainly used to treat various anorectal diseases caused by spleen and stomach weakness and disharmony of nutritive and defensive qi, resulting in local qi stagnation and blood stasis, with particularly significant efficacy in treating acute thrombosed external hemorrhoids.

[0025] To solve the above-mentioned technical problems, the technical solution of the present invention is as follows:

[0026] According to one aspect of the present invention, a traditional Chinese medicine composition for treating acute thrombosed external hemorrhoids is provided, which is made from raw materials, wherein the raw materials include, by weight, 15-20 parts of cinnamon twig, 15-20 parts of red peony root, 10-20 parts of ginger, 15-20 parts of rhubarb, 10-20 parts of ground beetle, 15-20 parts of sparganium rhizome, 15-20 parts of turmeric rhizome, and 10-20 parts of green tangerine peel.

[0027] Optionally, in the above-mentioned traditional Chinese medicine composition for treating acute thrombosed external hemorrhoids, the raw material also includes 10 to 30 parts of functional ingredients, which are selected from one or two of catechu, Glauber's salt and prepared licorice, Corydalis, Sichuan pepper, stir-fried Atractylodes macrocephala, Clematis chinensis, and Gleditsia sinensis thorns.

[0028] According to another aspect of the present invention, a traditional Chinese medicine extract for treating acute thrombosed external hemorrhoids is provided, the extract being prepared from the above-mentioned traditional Chinese medicine composition using conventional traditional Chinese medicine extraction methods.

[0029] Optionally, the above-mentioned herbal extracts are used in the preparation of topical herbal preparations for treating acute thrombosed external hemorrhoids.

[0030] According to another aspect of the present invention, a topical Chinese medicine preparation for treating acute thrombosed external hemorrhoids is provided, the preparation being made from the above-mentioned Chinese medicine composition and pharmaceutically acceptable excipients.

[0031] Optionally, among the above-mentioned topical Chinese medicine preparations for treating acute thrombosed external hemorrhoids, the topical Chinese medicine preparations are sitz baths, sprays, liniments, ointments, powders, film preparations, or gels.

[0032] According to another aspect of the present invention, a method for preparing a topical medicine comprising the above-mentioned traditional Chinese medicine composition for treating acute thrombosed external hemorrhoids is provided, comprising the following steps: weighing the above-mentioned raw materials, washing them, and mixing them according to the weight ratio; adding 8 to 10 times the total weight of the raw materials in water, soaking for 0.5 to 2 hours, decocting twice, each time for 0.5 to 2 hours; combining the two decoctions, filtering; and preparing the topical medicine using conventional preparation processes.

[0033] The use of the above-mentioned traditional Chinese medicine composition in the preparation of a drug for treating acute thrombosed external hemorrhoids.

[0034] The beneficial effects of this invention are as follows:

[0035] The composition of this invention is well-formulated and has the effects of internally regulating the body's vital energy and strengthening the spleen and replenishing qi, and externally removing blood stasis, clearing the meridians, and relieving heat and pain. Clinical trials have proven that it is very effective in treating patients with acute thrombosed external hemorrhoids, can rapidly improve symptoms, and can cure most cases. It is applicable to acute thrombosed external hemorrhoids caused by various reasons. Attached Figure Description

[0036] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the accompanying drawings used in the description of the specific embodiments or the prior art will be briefly introduced below.

[0037] Figure 1 These are effect diagrams of three cases of thrombosed external hemorrhoids (Case 1 to Case 3) before treatment and after treatment with the medicine of the present invention. Detailed Implementation

[0038] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the present invention will be clearly and completely described below in conjunction with specific embodiments.

[0039] All medicinal materials used in the embodiments of this invention were purchased from China National Pharmaceutical Corporation and conform to the standards of the Pharmacopoeia of the People's Republic of China.

[0040] Example 1: Preparation of sitz bath solution

[0041] Weigh out 20g of cinnamon twig, 20g of red peony root, 20g of ginger, 20g of rhubarb, 15g of ground beetle, 15g of sparganium rhizome, 15g of turmeric rhizome, and 15g of green tangerine peel; soak for 2 hours, decoct twice, adding 10 times the amount of water each time, and decoct for 1 hour each time; combine the two decoctions, filter, and the sitz bath solution can be prepared.

[0042] Example 1-1: Preparation of sitz bath solution

[0043] Weigh out 20g of cinnamon twig, 20g of red peony root, 10g of ginger, 15g of rhubarb, 20g of ground beetle, 20g of sparganium rhizome, 20g of turmeric rhizome, and 20g of green tangerine peel; soak for 1 hour, decoct twice, adding 9 times the amount of water each time, and decoct for 1.5 hours each time; combine the two decoctions, filter, and the sitz bath solution can be prepared.

[0044] Example 2: Preparation of the spray

[0045] Weigh out 20g each of cinnamon twig, red peony root, fresh ginger, and rhubarb; 15g each of ground beetle, sparganium rhizome, turmeric rhizome, and green tangerine peel; soak for 30 minutes, then decoct twice, adding 8 times the amount of water each time, for 0.5 hours each time; combine the two decoctions, filter, and concentrate into a fluid extract; dissolve or disperse the fluid extract in a suitable pharmaceutical solvent, add film-forming agents and pharmaceutical excipients, and prepare a spray according to conventional spray preparation methods. The spray form is more convenient to use; it eliminates the need for application, allowing for even administration with a gentle press.

[0046] Example 3: Preparation of the liniment

[0047] Weigh out 20g of cinnamon twig, 20g of red peony root, 20g of ginger, 20g of rhubarb, 15g of ground beetle, 15g of sparganium rhizome, 15g of turmeric rhizome, and 15g of green tangerine peel; soak for 1.5 hours, decoct twice, adding 9 times the amount of water each time, and decoct for 1 hour each time; combine the two decoctions, filter, and concentrate; according to the conventional preparation method of liniment, add pharmaceutically acceptable excipients such as oleyl alcohol to the active ingredients to prepare a liniment.

[0048] Example 4: Preparation of Ointment

[0049] Weigh out 20g of cinnamon twig, 20g of red peony root, 20g of ginger, 20g of rhubarb, 15g of ground beetle, 15g of sparganium rhizome, 15g of turmeric rhizome, and 15g of green tangerine peel; then soak for 40 minutes, decoct twice, adding 8 times the amount of water each time, and decoct for 1 hour each time; combine the two decoctions, filter, and concentrate into a fluid extract; make the fluid extract into a fine paste, then add other medicinal excipients and grind evenly (take a small amount and apply to the hand without a gritty feeling), and prepare the ointment according to the conventional ointment preparation method.

[0050] Example 5: Preparation of film-forming formulation

[0051] Weigh out 20g of cinnamon twig, 20g of red peony root, 20g of ginger, 20g of rhubarb, 15g of ground beetle, 15g of sparganium rhizome, 15g of turmeric rhizome, and 15g of green tangerine peel; then soak for 2 hours, decoct twice, adding 10 times the amount of water each time, and decoct for 2 hours each time; combine the two decoctions, filter, and concentrate into a fluid extract; dissolve or disperse the fluid extract in a pharmaceutical solvent containing film-forming materials, add other pharmaceutical excipients, and prepare a coating preparation according to the conventional preparation method for coating preparations.

[0052] Example 6: Preparation of Powder

[0053] Weigh out 20g each of cinnamon twig, red peony root, fresh ginger, and rhubarb; 15g each of ground beetle, sparganium rhizome, turmeric rhizome, and green tangerine peel; soak for 1 hour, then decoct twice, adding 10 times the amount of water each time, for 2 hours each time; combine the two decoctions, filter, and concentrate into a fluid extract; according to conventional powder preparation methods, dry and pulverize the concentrated fluid extract into a 100-200 mesh powder to make a powder. The powder is easy to store. When using, dissolve it in water at a suitable temperature (e.g., 40℃) for external application.

[0054] Example 7: Preparation of gelling agent

[0055] Weigh out 20g of cinnamon twig, 20g of red peony root, 10g of ginger, 15g of rhubarb, 15g of ground beetle, 20g of sparganium rhizome, 20g of turmeric rhizome, and 20g of green tangerine peel; soak for 2 hours, decoct twice, adding 10 times the amount of water each time, and decoct for 2 hours each time; combine the two decoctions, and mix the decoction and gelling agent in a certain proportion according to the conventional gelling agent preparation method, heat until the gelling agent is completely dissolved, stir evenly, and obtain the gelling agent.

[0056] Example 8: Sitz bath preparation for acute thrombosed external hemorrhoids with significant edema

[0057] Weigh out 15g of cinnamon twig, 10g of ginger, 15g of red peony root, 15g of rhubarb, 10g of ground beetle, 15g of sparganium rhizome, 15g of turmeric rhizome, 10g of green tangerine peel, and 10g of catechu. Soak for 1 hour, decoct twice, adding 9 times the amount of water each time, and decoct for 1 hour each time. Combine the two decoctions, filter, and add 10g of Glauber's salt to the decoction to make a sitz bath, which can enhance the diuretic and swelling-reducing effects.

[0058] Example 9: Sitz bath preparation for acute thrombosed external hemorrhoids with severe pain

[0059] Weigh out 15g of cinnamon twig, 10g of ginger, 15g of red peony root, 15g of rhubarb, 10g of ground beetle, 15g of sparganium rhizome, 15g of turmeric rhizome, 10g of green tangerine peel, 10g of prepared licorice root, and 15g of corydalis rhizome; soak for 1 hour, decoct twice, adding 9 times the amount of water each time, and decoct for 1 hour each time; combine the two decoctions, filter and prepare a sitz bath for use, which can enhance the effect of relieving pain.

[0060] Example 10: Sitz bath preparation for patients with acute thrombosed external hemorrhoids and a constitution of spleen and stomach deficiency and cold.

[0061] Weigh out 15g of cinnamon twig, 10g of ginger, 15g of red peony root, 15g of rhubarb, 10g of ground beetle, 15g of sparganium rhizome, 15g of turmeric rhizome, 10g of green tangerine peel, 15g of Sichuan pepper, and 15g of stir-fried atractylodes macrocephala rhizome; soak for 1 hour, decoct twice, adding 9 times the amount of water each time, and decoct for 1 hour each time; combine the two decoctions, filter and make into a sitz bath solution for use, which can strengthen the spleen and stomach, shorten the recovery time and prevent recurrence.

[0062] Example 11: Sitz bath preparation for acute thrombosed external hemorrhoids with hard thrombosed hemorrhoids

[0063] Weigh out 15g of cinnamon twig, 10g of ginger, 15g of red peony root, 15g of rhubarb, 10g of ground beetle, 15g of sparganium rhizome, 15g of turmeric rhizome, 10g of green tangerine peel, 15g of clematis root, and 15g of soapberry thorn; soak for 1 hour, decoct twice, adding 9 times the amount of water each time, and decoct for 1 hour each time; combine the two decoctions, filter and prepare a sitz bath for use, which can enhance the effect of breaking up hard masses and removing blood stasis.

[0064] Clinical trials and results analysis of this invention for treating acute thrombosed external hemorrhoids

[0065] 1. Materials and Methods

[0066] 1.1 Research Subjects

[0067] The study included 60 patients with acute thrombosed external hemorrhoids (with a course of illness within 5 days) who visited the TCM proctology clinic of a hospital between January 2021 and December 2022. All patients were randomly divided into two groups according to their order of visit: the observation group (n=30, 21 males and 9 females, aged 20-65 years, mean age (35.10±12.35) years, mean course of illness 3.27±1.11 days) and the control group (n=30, 18 males and 12 females, aged 18-82 years, mean age (37.37±16.63) years, mean course of illness 3.03±0.93 days). There were no statistically significant differences in gender, age, or course of illness between the two groups.

[0068] 1.2 Diagnostic criteria for acute thrombosed external hemorrhoids

[0069] According to the diagnostic criteria for thrombosed external hemorrhoids in the "Standards for Diagnosis and Efficacy of Anorectal Diseases in Traditional Chinese Medicine" formulated by the Anorectal Surgery Group of the Surgical Branch of the Chinese Medical Association in 2003: A round, reddish-purple lump suddenly appears under the skin at the anal margin, accompanied by obvious pain and local skin edema. The lump is initially soft but gradually hardens, and a hard nodule can be felt under the skin. It is mobile.

[0070] 1.3 Screening Criteria

[0071] Inclusion criteria: ① Meets the diagnostic criteria for thrombosed external hemorrhoids in the "Standards for Diagnosis and Efficacy of Traditional Chinese Medicine Anorectal Diseases". ② Conscious and able to communicate normally; all patients signed informed consent forms and voluntarily participated in this study. ③ Had not participated in other related treatments or studies.

[0072] Exclusion criteria: ① Patients with other anorectal diseases, such as anal fistula, perianal abscess, anal fissure, incarcerated mixed hemorrhoids, etc., and pregnant women. ② Patients with severe cardiovascular and cerebrovascular diseases, serious primary diseases such as liver and kidney diseases, and patients with mental illness. ③ Patients with a history of anorectal surgery or trauma within one year prior to enrollment.

[0073] 1.4 Methods

[0074] ① The control group used 50ml of Kangfuxin liquid, poured into 1000ml of warm water, with the water temperature controlled between 37-42℃, and fumigated for 10-15 minutes, once in the morning and once in the evening.

[0075] ② The observation group was given the sitz bath solution from Example 1 using the method of unblocking meridians and nourishing blood. 200ml of the solution was added to 1000ml of warm water, with the water temperature controlled between 37-42℃. The patient was fumigated for 10-15 minutes, twice a day, morning and evening. Both groups received treatment for 7 days. During treatment, patients were advised to rest, avoid prolonged sitting or squatting, avoid spicy foods, and maintain regular bowel movements.

[0076] 1.5 Efficacy Criteria

[0077] Efficacy evaluation was recorded on day 7 of treatment. Evaluation criteria were based on the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine (Trial Implementation)" and the "Standards for Diagnosis and Efficacy of Diseases in Traditional Chinese Medicine Anorectal Surgery." Cure: Pain disappeared, and the subcutaneous purplish-blue swelling at the anal margin disappeared; Effective: Pain lessened, and the subcutaneous purplish-blue swelling at the anal margin decreased in size; Ineffective: No significant change in pain or subcutaneous purplish-blue swelling at the anal margin, or no change in pain, and a slight reduction in the size of the subcutaneous purplish-blue swelling at the anal margin. Total effective rate = [(Number of cured cases + Number of effective cases) / Total number of cases] × 100%.

[0078] 1.6 Statistical Analysis

[0079] Statistical analysis was performed using SPSS 16.0 software. Quantitative data were analyzed using... This indicates that t-tests were performed for comparisons between groups; χ² tests were used for count data. 2 Test. A p-value ≤ 0.05 is considered statistically significant.

[0080] 2. Results

[0081] 2.1 Therapeutic Results

[0082] After one course of treatment, the total effective rate in the observation group was significantly higher than that in the control group (P<0.05). In the control group, 24 patients showed improvement and 6 showed no improvement, with a total effective rate of 80%. In the observation group, 1 patient was clinically cured, 28 showed improvement, and 1 showed no improvement, with a total effective rate of 96.67%. The total effective rate in the observation group (96.67%) was significantly higher than that in the control group (80%), and the differences were statistically significant (p<0.05). See Table 1.

[0083] Table 1

[0084]

[0085] Note: *P<0.05 compared with the control group.

[0086] Note: * indicates a statistically significant difference compared to the control group, p<0.05

[0087] To further illustrate the treatment effect, Figure 1 The diagram shows the effects of three patients with thrombosed external hemorrhoids (Case 1-3) before treatment and after treatment with the medication of this invention. Figure 1 As shown, Case 1, a male patient, presented with a mass in the anal region accompanied by severe pain before treatment. A dark purple mass was visible at the 1-3 o'clock position of the anal margin in the lithotomy position, with significant tenderness and prolapsed annular skin tags. After 7 days of treatment with the sitz bath solution of Example 9, the patient returned for a follow-up visit. After 3 days of medication, the pain symptoms were significantly relieved, and the mass gradually decreased in size. Case 2, a male patient, presented with a mass in the anal region accompanied by pain before treatment. A dark purple mass with significant edema was visible at the 6-12 o'clock position of the anal margin in the lithotomy position. After 7 days of treatment with the sitz bath solution of Example 8, the patient returned for a follow-up visit. After 1 day of medication, the pain began to lessen, and the mass gradually decreased in size. A specialist examination revealed a small mass at the 10 o'clock position of the anal margin. Case 3: The male patient presented with a mass and pain in the anal area before treatment. A dark purple mass was visible at the 9 o'clock position in the lithotomy position. The patient had a history of feeling cold and was prone to diarrhea after being exposed to cold. His stools were mostly unformed. His tongue was pale with a white coating and his pulse was weak. After 7 days of treatment with the sitz bath solution from Example 10, he returned for a follow-up visit. After 4 days of medication, the pain gradually decreased, the mass shrank, and he had one bowel movement per day, which was basically formed.

[0088] The results show that the topical Chinese medicine preparation of the present invention has a significant therapeutic effect on patients with acute thrombosed external hemorrhoids.

[0089] The above embodiments are merely specific implementations of the present invention, used to illustrate the technical solutions of the present invention, and are not intended to limit it. The scope of protection of the present invention is not limited thereto. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that any person skilled in the art can still modify or improve the technical solutions described in the foregoing embodiments, or make equivalent substitutions for some of the technical features, within the scope of the technology disclosed in the present invention; and these modifications, changes, 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, and should all be covered within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A topical traditional Chinese medicine composition for treating acute thrombosed external hemorrhoids, characterized in that, Made from raw materials, which include, by weight, 15-20 parts of cinnamon twig, 15-20 parts of red peony root, 10-20 parts of ginger, 15-20 parts of rhubarb, 10-20 parts of ground beetle, 15-20 parts of sparganium rhizome, 15-20 parts of turmeric rhizome, and 10-20 parts of green tangerine peel.

2. A topical traditional Chinese medicine composition for treating acute thrombosed external hemorrhoids with significant edema, characterized in that, It is made from the following raw materials in parts by weight: 15-20 parts of cinnamon twig, 15-20 parts of red peony root, 10-20 parts of ginger, 15-20 parts of rhubarb, 10-20 parts of ground beetle, 15-20 parts of sparganium rhizome, 15-20 parts of turmeric rhizome, 10-20 parts of green tangerine peel, 10-30 parts of catechu, and 10-30 parts of mirabilite.

3. A topical traditional Chinese medicine composition for treating acute thrombosed external hemorrhoids with significant pain, characterized in that, It is made from the following raw materials in parts by weight: 15-20 parts of cinnamon twig, 15-20 parts of red peony root, 10-20 parts of fresh ginger, 15-20 parts of rhubarb, 10-20 parts of ground beetle, 15-20 parts of sparganium rhizome, 15-20 parts of turmeric rhizome, 10-20 parts of green tangerine peel, 10-30 parts of prepared licorice root, and 10-30 parts of corydalis rhizome.

4. A topical traditional Chinese medicine composition for treating acute thrombosed external hemorrhoids with spleen and stomach deficiency and cold, characterized in that, It is made from the following raw materials in parts by weight: 15-20 parts of cinnamon twig, 15-20 parts of red peony root, 10-20 parts of ginger, 15-20 parts of rhubarb, 10-20 parts of ground beetle, 15-20 parts of sparganium rhizome, 15-20 parts of turmeric rhizome, 10-20 parts of green tangerine peel, 10-30 parts of Sichuan pepper, and 10-30 parts of stir-fried atractylodes macrocephala rhizome.

5. A topical traditional Chinese medicine composition for treating acute thrombosed external hemorrhoids with hardened thrombi, characterized in that, It is made from the following raw materials in parts by weight: 15-20 parts of cinnamon twig, 15-20 parts of red peony root, 10-20 parts of ginger, 15-20 parts of rhubarb, 10-20 parts of ground beetle, 15-20 parts of sparganium rhizome, 15-20 parts of turmeric rhizome, 10-20 parts of green tangerine peel, 10-30 parts of clematis root, and 10-30 parts of soapberry thorn.

6. A topical Chinese medicine extract for treating acute thrombosed external hemorrhoids, characterized in that, The topical Chinese medicine extract is prepared from the topical Chinese medicine composition according to any one of claims 1 to 5 using conventional Chinese medicine extraction methods.

7. The use of the topical Chinese medicine extract according to claim 6 in the preparation of a topical Chinese medicine preparation for treating acute thrombosed external hemorrhoids.

8. A traditional Chinese medicine external application preparation for treating acute thrombosed external hemorrhoids, characterized in that, The preparation is made from the topical Chinese medicine composition according to any one of claims 1 to 5 and pharmaceutically acceptable excipients.

9. The topical traditional Chinese medicine preparation for treating acute thrombosed external hemorrhoids according to claim 8, characterized in that, The aforementioned external preparations of traditional Chinese medicine include sitz baths, sprays, liniments, ointments, powders, film preparations, or gels.

10. A method for preparing a topical Chinese medicine composition for treating acute thrombosed external hemorrhoids according to any one of claims 1 to 5 as an active ingredient, comprising the following steps: Weigh out the active pharmaceutical ingredient according to any one of claims 1 to 5, wash it, and mix it according to the weight ratio; Add 8 to 10 times the total weight of the raw materials in water, soak for 0.5 to 2 hours, and decoct twice, each time for 0.5 to 2 hours; Combine the two decoctions and filter. as well as It is prepared using conventional manufacturing processes to produce a topical medication.

11. Use of the topical Chinese medicine composition according to any one of claims 1 to 5 in the preparation of a medicament for treating acute thrombosed external hemorrhoids.

Images