Anti-inflammatory, pain-relieving, antibacterial and itching-relieving hemorrhoid cream and preparation method thereof

Abstract

The invention discloses anti-inflammatory, pain-relieving, antibacterial and itching-relieving hemorrhoid cream and a preparation method thereof. The hemorrhoid ointment is prepared from the following components: calendula infused oil, aloe oil, sea buckthron oil, perilla seed oil, emu oil, pine needle oil, a heracleum hemsleyanum supernatant concentrate, auxiliary materials for preparing the ointment and pharmaceutically acceptable auxiliary materials. The composition can diminish inflammation and inhibit bacteria, quickly relieve itching, activate blood and relieve pain, prevent cracking and cure wound, deeply repair perianal damaged tissue, relieve and calm skin, form a breathable protective film on the skin surface, reduce friction stimulation, continuously supplement nutrition required by skin, promote regeneration and repair of damaged tissue, effectively improve the problems of perianal skin redness and swelling, ulceration and the like, and has a good application prospect. And the traditional Chinese medicine composition has the advantages of quick effect taking, no toxic or side effect and better patent medicine prospect.

Description

Technical Field

[0001] This invention relates to a topical treatment preparation for hemorrhoids, and more particularly to an anti-inflammatory, analgesic, antibacterial, and antipruritic hemorrhoid ointment and its preparation method. Background Technology

[0002] Hemorrhoids are a common disease in anorectal diseases, with pain, rectal bleeding, itching, and a feeling of heaviness as the main symptoms. They not only seriously affect the patient's quality of life and mental health, but long-term and repeated rectal bleeding may also lead to iron deficiency anemia. If treatment is not timely, it can also easily induce complications such as anal fissures and anal fistulas, which can worsen the condition.

[0003] While some existing hemorrhoid creams use natural Chinese medicinal herbs and their extracts to reduce side effects, their natural drug content is low, impurities are numerous, composition is complex, and efficacy is unclear, resulting in limited efficacy, slow onset of action, and long treatment cycles. They cannot quickly relieve symptoms such as pain and bleeding. Some preparations may also cause side effects such as skin allergies and itching, which not only fail to relieve the original pain but also increase the burden and risks of medication for patients.

[0004] Therefore, developing a topical hemorrhoid treatment that can quickly relieve hemorrhoid symptoms with minimal side effects has become an urgent technical problem to be solved. Summary of the Invention

[0005] Purpose of the Invention: The purpose of this invention is to provide an anti-inflammatory, analgesic, antibacterial, and antipruritic hemorrhoid ointment, solving the problems of slow onset of action, insignificant efficacy, and significant side effects in existing topical hemorrhoid treatments. Another purpose of this invention is to propose a method for preparing an anti-inflammatory, analgesic, antibacterial, and antipruritic hemorrhoid ointment, addressing the problem of how to prepare such an ointment.

[0006] Technical solution: The anti-inflammatory, analgesic, antibacterial, and antipruritic hemorrhoid ointment of the present invention comprises the following components: Calendula infused oil, aloe vera oil, sea buckthorn oil, perilla seed oil, emu oil, pine needle oil, and root supernatant concentrate, excipients for ointment preparation, and pharmaceutically acceptable excipients.

[0007] Preferably, it also contains at least one of the following components: eucalyptus oil, rosehip oil, shea butter, peppermint oil, borage oil, lemongrass oil, almond oil, snake oil, beeswax, frankincense alcohol extract, Panax notoginseng alcohol extract, Gleditsia sinensis thorn alcohol extract, Centella asiatica water extract, Artemisia argyi alcohol extract, Sophora japonica alcohol extract, Sophora flavescens water extract, Phellodendron chinense alcohol extract, Gallnut alcohol extract, Stemona japonica alcohol extract, Viola yedoensis water extract, Portulaca oleracea water extract, ginger extract, allantoin, and berberine.

[0008] Gleditsia sinensis thorns can effectively inhibit common pathogenic bacteria such as Staphylococcus aureus. They have the effects of promoting blood circulation, removing blood stasis, reducing swelling, dispersing nodules, and draining pus. They can relieve swelling and have significant effects in relieving pain, shrinking hemorrhoids, and improving bleeding.

[0009] The supernatant concentrate of the root downregulates pro-inflammatory factors, reduces oxidative stress damage, has anti-inflammatory and antibacterial effects, relieves dampness, itching and dryness, and promotes perianal circulation and local tissue repair and regeneration.

[0010] Berberine in Coptis chinensis has anti-inflammatory and antibacterial properties, reduces redness, swelling, and pain, clears damp heat, and inhibits histamine release to relieve itching.

[0011] Sophora flavescens clears heat and dries dampness, dispels wind and relieves itching, alleviates perianal dampness and itching, has a broad antibacterial spectrum, can reduce local redness, swelling, heat and pain caused by inflammatory reactions, can promote local blood circulation, reduce venous congestion, and relieve hemorrhoid congestion and swelling.

[0012] Phellodendron bark has anti-inflammatory activity, which can relieve symptoms such as redness, swelling and pain of hemorrhoids. It also has an inhibitory effect on a variety of bacteria and has astringent properties, which can reduce local exudation of hemorrhoids, reduce edema, shrink the size of hemorrhoids, and relieve discomfort such as perianal dampness and itching.

[0013] Calamine has astringent, antipruritic, antibacterial and antiseptic properties. It can reduce local exudation, alleviate the dampness around the anus, help reduce local tissue edema, and relieve symptoms such as redness, swelling and pain of hemorrhoids.

[0014] Gallnut has astringent and hemostatic properties, promotes wound healing, has antibacterial and antioxidant effects, scavenges free radicals, and promotes the shrinkage of hemorrhoids.

[0015] Panax notoginseng has the effects of stopping bleeding and relieving pain, promoting blood circulation and removing blood stasis, and antibacterial and anti-inflammatory properties. It can stop bleeding by promoting platelet aggregation, inhibiting bacterial growth and reducing inflammation, improving blood circulation in the perianal area, thereby relieving hemorrhoid bleeding, swelling and pain, and promoting the dissipation of inflammation and tissue repair.

[0016] Stemona japonica has anti-inflammatory, antibacterial, and antipruritic effects, which can relieve itching, inflammatory swelling, and pain caused by hemorrhoids.

[0017] Artemisia leaves have anti-inflammatory, analgesic, dampness-removing, itch-relieving, hemostatic, and antibacterial properties. They can improve local blood circulation and accelerate wound healing.

[0018] Viola yedoensis has heat-clearing, detoxifying, blood-cooling, and swelling-reducing properties, and is often used for boils, carbuncles, and other skin conditions. Its anti-inflammatory, antibacterial, and antioxidant effects help relieve skin problems such as itching and eczema, reduce the risk of perianal infections, and promote tissue repair and wound healing.

[0019] Purslane inhibits Shigella and Escherichia coli, reduces the risk of secondary infections in hemorrhoids, suppresses inflammatory factors, and relieves redness, swelling, heat, and pain around the anus, thus achieving anti-inflammatory and analgesic effects.

[0020] Ginger has multi-target regulated anti-inflammatory effects, antioxidant properties, and can eliminate free radicals, promote the repair of hemorrhoids, improve microcirculation, promote blood circulation around the anus, and suppress itching.

[0021] Sophora japonica flowers have the effects of clearing heat, cooling blood, and stopping bleeding. They are effective in treating hemorrhoid bleeding, reducing hemorrhoid swelling, and relieving pain.

[0022] Frankincense has the effects of promoting blood circulation, relieving pain, reducing swelling and promoting tissue regeneration, and antibacterial and anti-inflammatory properties. It can promote blood circulation in the perianal area, reduce swelling and congestion of hemorrhoids, and relieve burning, stinging and distending pain during acute attacks of hemorrhoids. It can also inhibit common perianal pathogens such as Staphylococcus aureus.

[0023] Centella asiatica has detoxifying, swelling-reducing, antibacterial, and anti-inflammatory activities. It can inhibit the release of inflammatory factors, enhance antioxidant capacity, promote collagen synthesis, inhibit the proliferation of pathogenic microorganisms, promote skin protein synthesis, lighten scars, and relieve inflammation.

[0024] Eucalyptus oil reduces inflammation such as redness and pain in tissues, accelerates tissue repair, and has antibacterial and antifungal effects; its cooling sensation can soothe nervous tension.

[0025] Pine needle oil: It dries dampness, kills insects, relieves itching and inflammation, inhibits bacteria, astringes and stops bleeding, relieves pain, and promotes circulation in inflamed areas.

[0026] Shea butter can relieve dryness and itching caused by inflammation and friction, inhibit the release of inflammatory mediators, reduce inflammation in hemorrhoid areas, relieve redness, swelling and pain, and also help promote skin repair and regeneration and wound healing.

[0027] Aloe vera oil reduces inflammation in hemorrhoids, has anti-inflammatory, swelling-reducing, and pain-relieving properties, stimulates fibroblast proliferation, improves perianal blood circulation, promotes wound healing, and alleviates discomfort caused by friction during bowel movements. After use, it provides physical cooling to relieve local burning and itching caused by hemorrhoids.

[0028] Emu oil has nourishing, repairing, and antioxidant properties, which can resist the damage of free radicals. It also has anti-inflammatory and analgesic effects, which can effectively reduce the pain and swelling caused by hemorrhoids, accelerate the healing process, and relieve discomfort caused by dryness in the anal area.

[0029] Borage oil relieves inflammation, redness, pain, and itching, promotes circulation and cell regeneration and repair, and moisturizes to prevent dryness.

[0030] Rosehip oil promotes epidermal cell proliferation and collagen remodeling, which can accelerate wound healing after hemorrhoid surgery, reduce scar hyperplasia and anal skin fibrosis, promote collagen formation, reduce scar formation, promote wound healing, and relieve skin dryness and inflammation.

[0031] Citronella oil has good anti-inflammatory effects, can promote blood circulation and wound healing, reduce the risk of infection, relieve muscle pain, and can prevent perianal itching and white membrane formation caused by Candida albicans infection.

[0032] Perilla seed oil can scavenge free radicals, reduce oxidative stress, improve dry and sensitive skin, promote barrier repair, inhibit the release of inflammatory mediators and the expression of cytokines, and exert anti-inflammatory effects.

[0033] Calendula oil can promote skin healing, effectively kill bacteria, reduce skin inflammation and redness, stimulate fibroblast proliferation, promote collagen synthesis, accelerate the healing of wounds and ulcers, and relieve discomfort symptoms such as dryness, roughness, and itching.

[0034] Sea buckthorn oil has anti-inflammatory, antioxidant, and antibacterial properties. It relieves redness, swelling, pain, and hemorrhoidal venous congestion, prevents infection, and promotes skin regeneration.

[0035] Almond oil can relieve itching, redness, and inflammation around the anus, soothe nerves, alleviate stinging during bowel movements, prevent bleeding, and inhibit pathogens.

[0036] Snake oil relieves dryness and cracking around the anus, reduces congestion, edema and inflammation of hemorrhoids, accelerates wound healing, inhibits the growth of harmful bacteria and mites, regulates the sensitivity of nerve endings in the skin, and is significantly effective for itching caused by hemorrhoids or dryness.

[0037] Peppermint oil has anti-inflammatory, analgesic, and antibacterial bioactivities, exerting anti-inflammatory and analgesic effects. It can reduce itching, relieve muscle tension and pain by promoting local blood circulation, and its cooling sensation can also help relieve inflammation and provide comfort.

[0038] Beeswax has strong antibacterial, anti-inflammatory, detoxifying, and analgesic effects. It can inhibit and eliminate various bacteria, and also has a soothing effect, reducing discomfort caused by hemorrhoids, prolonging the duration of moisturizing, and reducing local dryness and irritation symptoms of hemorrhoids.

[0039] Borneol has the effects of clearing heat and relieving pain, anti-inflammatory and swelling-reducing and antipruritic effects, promoting drug penetration and absorption, improving local blood circulation, and also has a certain inhibitory effect on Staphylococcus aureus, Escherichia coli and other bacteria, which can reduce the risk of bacterial infection.

[0040] Allantoin promotes the repair of perianal tissue and the shrinkage of hemorrhoids, improves regeneration capacity, prevents dryness, and relieves itching and swelling.

[0041] Gleditsia sinensis thorns, Sophora flavescens, Portulaca oleracea, Viola yedoensis, eucalyptus oil, and shea butter inhibit pro-inflammatory factors, reduce local inflammatory responses, and relieve perianal redness and swelling; *Herb extract, berberine, Phellodendron amurense, frankincense, ginger, and Centella asiatica inhibit inflammatory factors and inflammatory cascade reactions; calamine reduces local tissue edema and inhibits the release of inflammatory mediators; Gallnut and pine needle oil combat oxidative stress and reduce edema; Panax notoginseng and Stemona japonica promote inflammation resolution and relieve swelling; Borage oil inhibits the release of inflammatory mediators and reduces leukocyte infiltration; borneol has anti-inflammatory and anti-swelling effects, and all components work synergistically to reduce inflammation and swelling.

[0042] Gleditsia sinensis thorns, Sophora flavescens, Stemona japonica, Phellodendron chinense, Portulaca oleracea, snake oil, Panax notoginseng, Galla chinensis, frankincense, and supernatant concentrate inhibit the growth and reproduction of common pathogenic bacteria, preventing secondary infections; berberine inhibits the proliferation of Staphylococcus aureus and Escherichia coli; Viola yedoensis, Artemisia argyi, and Eucalyptus oil reduce the risk of perianal bacterial and fungal infections; pine needle oil inhibits the activity of Gram-positive bacteria and dermatophytes; citronella oil inhibits Gram-positive / negative bacteria and blocks perianal lesions caused by Candida albicans; sodium benzoate comprehensively inhibits bacteria and fungi. These components work synergistically from multiple dimensions, including inhibiting pathogenic bacteria and reducing infection risk, to jointly construct a perianal antibacterial infection prevention and control network.

[0043] Gleditsia sinensis thorns relieve the pain and discomfort of hemorrhoids; berberine, calamine, sophora flavescens, phellodendron bark, notoginseng, pine needle oil, emu oil, and borage oil relieve the redness, swelling, and pain caused by hemorrhoids; stemona japonica, artemisia argyi, purslane, sea buckthorn oil, and peppermint oil have anti-inflammatory and analgesic effects; sophora japonica flowers relieve pain; frankincense promotes blood circulation and relieves pain; aloe vera oil has anti-inflammatory, swelling-reducing, and analgesic effects; almond oil relieves pain and swelling; beeswax detoxifies and relieves pain; and borneol can reduce the pain during hemorrhoid flare-ups. In summary, the various ingredients work synergistically to relieve the redness, swelling, and pain symptoms of hemorrhoids, significantly reducing the suffering of patients.

[0044] Gleditsia sinensis thorns accelerate the absorption of blood stasis; Panax notoginseng removes blood stasis and stops bleeding; Frankincense relieves qi and blood stagnation; Ginger stimulates vasodilation to enhance blood flow; Artemisia argyi warms the meridians and improves perianal microcirculation; Eucalyptus oil, pine needle oil, and emu oil dilate capillaries; Aloe vera oil optimizes tissue perfusion; Borage oil reduces blood viscosity and improves blood flow efficiency; Perilla seed oil softens blood vessels and prevents venous stasis; Sea buckthorn oil protects the vascular endothelium and ensures smooth circulation; Almond oil enhances capillary elasticity and improves blood flow resistance; Snake oil promotes peripheral circulation regeneration; Peppermint oil optimizes vasomotor function. These ingredients work together through multiple pathways, including promoting qi and blood circulation, warming the meridians, nourishing blood vessels, and improving rheology, to effectively resolve hemorrhoidal venous congestion.

[0045] The extract of *Hemiberella fuciformis* root clears and concentrates to relieve the dampness and itching caused by tissue fluid exudation; berberine from *Coptis chinensis* inhibits histamine release and relieves itching; *Sophora flavescens* dispels wind and relieves itching, alleviating itching and increased secretions; *Phellodendron amurense* clears heat, dries dampness, and astringes to relieve itching; calamine and pine needle oil astringe and relieve itching; *Gallus chinensis* relieves the itching symptoms of hemorrhoids; *Stemona japonica* relieves itching by blocking the release of itching-related neurotransmitters and inhibiting the activation of itching receptors; *Artemisia argyi* dispels dampness and relieves itching; ginger and allantoin can inhibit itching; aloe vera oil effectively relieves the local burning sensation and itching caused by hemorrhoids; borage oil, calendula infused oil, snake oil, shea butter, and sodium alginate relieve dry, rough, and itchy skin; almond oil effectively reduces perianal skin allergies and itching; borneol provides cooling and antipruritic effects. In summary, the various ingredients work synergistically to comprehensively relieve the discomfort of perianal dampness and itching caused by hemorrhoids.

[0046] Eucalyptus oil's cooling sensation can soothe nervous tension and enhance user comfort; the cooling effects of snake oil, aloe vera oil, and peppermint oil can relieve the local burning and itching symptoms caused by hemorrhoids, improving the patient's subjective discomfort; the aroma of perilla seed oil and lemongrass oil can relieve anxiety and soothe the mental stress caused by hemorrhoids; calendula oil has calming and relaxing functions, which can reduce emotional tension and anxiety; in short, multiple ingredients work together to relieve anxiety and improve comfort.

[0047] Preferably, the excipients used in the preparation of the ointment include composite emulsifier AC-402, Sepik 305, gel forming agent QM, ice crystal forming agent AVC, and water; The pharmaceutically acceptable excipients include at least one of borneol, calamine, sodium alginate, 1,2-propanediol, flavoring, and sodium benzoate.

[0048] The compound emulsifier AC-402 effectively emulsifies oils, improving product flowability, moisturizing properties, and gloss, while exhibiting low toxicity and irritation. Sepik 305 possesses excellent emulsifying stability, improving the appearance and stability of traditional formulations, providing good thickening and shaping effects, resulting in a rich, thick base texture that does not leave a white cast upon application, thus enhancing the user experience. The synergistic effect of AC-402 and Sepik 305 together gives this anti-inflammatory, analgesic, antibacterial, and antipruritic hemorrhoid cream a delicate and glossy appearance.

[0049] Sodium alginate exhibits good stability, resulting in a light and refreshing texture with strong water retention after thickening. The ice crystal forming agent AVC requires no neutralization, contributing to a soft, delicate base that spreads evenly without stickiness, reducing irritation to hemorrhoids during application. The gel forming agent QM disperses easily in water without clumping, maintaining good fluidity and minimizing friction during administration. The synergistic effect of these three agents gives this hemorrhoid ointment its suitable viscosity, delicate and smooth texture, and excellent spreadability.

[0050] Furthermore, the fragrance is selected from one or more of the following: osmanthus fragrance, cucumber fragrance, lily fragrance, rose fragrance, lemon fragrance, and lavender fragrance.

[0051] Furthermore, the eucalyptus oil, rosehip oil, shea butter, calendula infused oil, peppermint oil, aloe vera oil, borage oil, lemongrass oil, sea buckthorn oil, almond oil, snake oil, beeswax, perilla seed oil, emu oil, pine needle oil, compound emulsifier AC-402, Sepik 305, frankincense alcohol extract, Panax notoginseng alcohol extract, Gleditsia sinensis thorn alcohol extract, Centella asiatica water extract, Artemisia argyi alcohol extract, Sophora japonica alcohol extract, Sophora flavescens water extract, Phellodendron amurense alcohol extract, Gallnut alcohol extract, Stemona japonica alcohol extract, Viola yedoensis water extract, The solid-liquid ratio of purslane aqueous extract, ginger extract, borneol, allantoin, calamine, berberine, and concentrated supernatant of *Purslane* root, gelling agent QM, sodium alginate, ice crystal forming agent AVC, 1,2-propanediol, water, and flavoring is 0.3-1.2 mL : 0.6-1.5 mL : 0.6-1.6 g : 0.4-1.3 mL : 0.2-1.2 mL : 0.8-1.7 mL : 0.5-1.5 mL : 0.4-1.3 mL : 0.3- 1.2mL: 0.5-1.1mL: 0.5-1.5g: 0.2-1.2g: 0.4-1.3g: 0.5-2.0g: 0.2-1.3mL: 0.1-1.3g: 0.1-1.5g: 0 .1-1.2mL: 0.5-1.5mL: 0.1-1.7mL: 0.3-1.3mL: 0.1-1.5mL: 0.5-1.8mL: 0.5-1.5mL: 0.3-1.5mL: 0. 1-1.3mL: 0.3-1.0mL: 0.3-1.5mL: 0.1-1.2mL: 0.1-1.3mL: 0.01-0.5g: 0.01-0.5g: 0.01-0.3g: 0.0 5-0.3g: 0.05-0.4g: 1.0-5.0g: 0.1-1.0g: 1.0-6.0g: 3.0-15.0mL: 233.0-1250.0mL: 0.01-0.10mL.

[0052] The second aspect of this invention discloses a method for preparing the above-mentioned anti-inflammatory, analgesic, antibacterial, and antipruritic hemorrhoid ointment, comprising the following steps: (1) Sodium alginate was dissolved in water to obtain sodium alginate gel solution; gel forming agent QM was dissolved in water to obtain gel forming agent QM gel solution; ice crystal forming agent AVC was dissolved in water to obtain ice crystal forming agent AVC gel solution; (2) Take eucalyptus oil, rosehip oil, calendula infused oil, peppermint oil, aloe vera oil, lemongrass oil, pine needle oil, borage oil, sea buckthorn oil, almond oil, beeswax, shea butter, emu oil, perilla seed oil and snake oil according to the proportions, heat and stir to mix well to obtain the oil phase; (3) Weigh out composite emulsifier AC-402 and Sepik 305, heat and disperse them in water to obtain an aqueous phase; (4) After the oil phase and the water phase are heated to the same temperature, the water phase is slowly added to the oil phase and stirred to form a uniform emulsion, thus obtaining the emulsion matrix; (5) Take the prescribed amounts of frankincense alcohol extract, Panax notoginseng alcohol extract, Gleditsia sinensis thorn alcohol extract, Centella asiatica water extract, Artemisia argyi alcohol extract, Sophora japonica alcohol extract, Sophora flavescens water extract, Phellodendron chinense alcohol extract, Galla chinensis alcohol extract, Stemona japonica alcohol extract, Viola yedoensis water extract, Portulaca oleracea water extract, fresh ginger extract, borneol, allantoin, calamine, berberine from Coptis chinensis and the supernatant of the root, stir and mix evenly to obtain liquid A; (6) Weigh out the prescribed amount of sodium benzoate, add 1,2-propanediol and water, stir to dissolve and obtain a preservative solution; (7) Add liquid A to the emulsion matrix and stir to mix evenly. While stirring continuously, slowly add gel forming agent QM gel liquid, sodium alginate gel liquid, ice crystal forming agent AVC gel liquid, preservative solution and fragrance in sequence and stir to mix evenly to obtain hemorrhoid ointment.

[0053] This invention combines three gel thickeners (gel forming agent QM, sodium alginate, and ice crystal forming agent AVC) with an emulsion base to give the hemorrhoid ointment a fine and uniform texture, suitable viscosity, good spreadability, excellent absorption, and strong moisturizing properties. The emulsion base contains a variety of synergistic natural active ingredients, which can further achieve antibacterial and anti-infection effects, promote blood circulation and reduce swelling, repair hemorrhoid tissue, promote skin healing, and effectively relieve hemorrhoid inflammation and itching.

[0054] Preferably, in step (5), the method for preparing the concentrated supernatant of the root is as follows: Extract the root powder of *Hemiberle Root* by heating and reflux with water. Filter the extract and collect the supernatant. Concentrate the supernatant to 8-15 times the mass of the root powder. The concentrated supernatant was mixed with an ethanol-water solution to achieve a final ethanol concentration of 60-85%, and then subjected to alcohol precipitation. The mixture was filtered, and the filtrate was concentrated and dried to obtain the supernatant concentrate.

[0055] Preferably, in step (5), the frankincense alcohol extract, Panax notoginseng alcohol extract, Gleditsia sinensis alcohol extract, Artemisia argyi alcohol extract, Sophora japonica alcohol extract, Phellodendron chinense alcohol extract, Galla chinensis alcohol extract, and Stemona japonica alcohol extract are all prepared by soaking and extracting at least once with a 40-80% ethanol aqueous solution.

[0056] In some embodiments, ginger extract is prepared by the following method: Mix fresh ginger with 3-5 times its weight of distilled water and continue juicing for 1.5-2.0 minutes. Filter the resulting juice through four layers of gauze and vacuum filter. The resulting filtrate is the ginger extract.

[0057] In some embodiments, the Panax notoginseng alcohol extract is prepared by the following method: Weigh an appropriate amount of Panax notoginseng coarse powder and extract it three times by heating and reflux: For the first extraction, add 15-20 times the weight of the Panax notoginseng coarse powder in 70% ethanol aqueous solution, soak at room temperature for 0.25-0.75 hours, and then extract for 1.0-1.7 hours; for the second extraction, add 12-18 times the weight of the Panax notoginseng coarse powder in 70% ethanol aqueous solution, and extract for 1.0-1.5 hours; for the third extraction, add 8-12 times the weight of the Panax notoginseng coarse powder in 70% ethanol aqueous solution, and extract for 0.8-1.2 hours; each extract is first filtered through four layers of gauze, the filtrates are combined, filtered by suction, and the volume of the filtrate is concentrated to 3-7 times the weight of the Panax notoginseng coarse powder to obtain Panax notoginseng extract for later use; Boswellia carterii alcohol extract was prepared by the following method: Frankincense was pulverized into coarse powder, and an appropriate amount was weighed and extracted three times by heating and reflux: for the first time, 10-15 times the weight of the coarse frankincense powder in 70% ethanol aqueous solution was added, and the mixture was soaked at room temperature for 0.2-0.7 hours, followed by extraction for 1.1-1.6 hours; for the second time, 9-14 times the weight of the coarse frankincense powder in 70% ethanol aqueous solution was added, and the mixture was extracted for 0.8-1.4 hours; for the third time, 8-12 times the weight of the coarse frankincense powder in 70% ethanol aqueous solution was added, and the mixture was extracted for 0.6-1.0 hours. Each extract was initially filtered through four layers of gauze, and the filtrates were combined, filtered by suction, and the volume of the filtrate was concentrated to 4-8 times the weight of the coarse frankincense powder to obtain frankincense extract. The ethanol extract of soapberry thorns was prepared by the following method: The soapberry thorns were crushed into coarse powder, and an appropriate amount was weighed and extracted three times by heating and reflux: for the first time, 10-14 times the mass of the soapberry thorn coarse powder was added to a 65% ethanol aqueous solution, and the mixture was soaked at room temperature for 0.3-0.8 hours, followed by extraction for 1.0-1.5 hours; for the second time, 8-12 times the mass of the soapberry thorn coarse powder was added to a 65% ethanol aqueous solution, and the mixture was extracted for 0.8-1.3 hours; for the third time, 7-10 times the mass of the soapberry thorn coarse powder was added to a 65% ethanol aqueous solution, and the mixture was extracted for 0.7-1.1 hours. Each extract was first filtered through four layers of gauze, and the filtrates were combined, filtered by suction, and the volume of the filtrate was concentrated to 3-6 times the mass of the soapberry thorn coarse powder to obtain the soapberry thorn extract.

[0058] In some embodiments, the Artemisia argyi alcohol extract is prepared by the following method: Weigh an appropriate amount of coarse Artemisia argyi powder and extract it three times by heating and reflux: For the first extraction, add 15-18 times the weight of the coarse Artemisia argyi powder in 40% ethanol aqueous solution, soak at room temperature for 0.25-0.80 hours, and then extract for 1.0-1.5 hours; for the second extraction, add 10-15 times the weight of the coarse Artemisia argyi powder in 40% ethanol aqueous solution, and extract for 1.0-1.5 hours; for the third extraction, add 8-12 times the weight of the coarse Artemisia argyi powder in 40% ethanol aqueous solution, and extract for 0.8-1.3 hours; filter the extract through four layers of gauze, combine the filtrates, filter by suction, and concentrate the filtrate to 3-7 times the weight of the coarse Artemisia argyi powder to obtain the Artemisia argyi extract; Sophora japonica flower alcohol extract was prepared by the following method: Weigh an appropriate amount of dried Sophora japonica flowers and extract them three times by heating and reflux: For the first extraction, add 15-18 times the weight of the Sophora japonica flowers in an 80% ethanol aqueous solution, soak at room temperature for 0.3-0.8 hours, and then extract for 1.1-1.6 hours; for the second extraction, add 12-15 times the weight of the Sophora japonica flowers in an 80% ethanol aqueous solution, and extract for 1.0-1.2 hours; for the third extraction, add 10-12 times the weight of the Sophora japonica flowers in an 80% ethanol aqueous solution, and extract for 1.0-1.2 hours; each extract is first filtered through four layers of gauze, the filtrates are combined, filtered by suction, and the volume of the filtrate is concentrated to 4-8 times the weight of the Sophora japonica flowers to obtain the Sophora japonica flower extract; The ethanol extract of Phellodendron bark is prepared by the following method: Phellodendron bark is crushed into coarse powder, and an appropriate amount is weighed and extracted three times by heating and reflux: for the first time, 10-15 times the mass of the coarse powder of Phellodendron bark is added to a 70% ethanol aqueous solution, and the mixture is soaked at room temperature for 0.2-0.7 hours, followed by extraction for 1.1-1.8 hours; for the second time, 10-14 times the mass of the coarse powder of Phellodendron bark is added to a 70% ethanol aqueous solution, and the mixture is extracted for 1.0-1.2 hours; for the third time, 8-12 times the mass of the coarse powder of Phellodendron bark is added to a 70% ethanol aqueous solution, and the mixture is extracted for 0.8-1.2 hours. Each extract is first filtered through four layers of gauze, the filtrates are combined, and then filtered by suction. The volume of the filtrate is concentrated to 4-8 times the mass of the coarse powder of Phellodendron bark to obtain the Phellodendron bark extract.

[0059] In some embodiments, the alcoholic extract of Stemona japonica is prepared by the following method: The Stemona japonica was pulverized into coarse powder, and an appropriate amount was weighed and extracted three times by heating and reflux: for the first time, 10-15 times the weight of the coarse Stemona japonica powder in 70% ethanol aqueous solution was added, and the mixture was soaked at room temperature for 0.2-0.7 hours, followed by extraction for 1.1-1.6 hours; for the second time, 10-12 times the weight of the coarse Stemona japonica powder in 70% ethanol aqueous solution was added, and the mixture was extracted for 0.8-1.2 hours; for the third time, 8-12 times the weight of the coarse Stemona japonica powder in 70% ethanol aqueous solution was added, and the mixture was extracted for 0.8-1.0 hours; each extract was initially filtered through four layers of gauze, the filtrates were combined, and the mixture was filtered under vacuum. The volume of the filtrate was concentrated to 4-7 times the weight of the coarse Stemona japonica powder to obtain the Stemona japonica extract. Gallnut alcohol extract was prepared by the following method: The gallnuts were crushed into coarse powder, and an appropriate amount was weighed and extracted three times by heating and reflux: for the first time, 10-15 times the mass of the coarse gallnut powder was added to a 50% ethanol aqueous solution, and the mixture was soaked at room temperature for 0.2-0.7 hours, followed by extraction for 1.1-1.6 hours; for the second time, 10-13 times the mass of the coarse gallnut powder was added to a 50% ethanol aqueous solution, and the mixture was extracted for 0.8-1.2 hours; for the third time, 8-12 times the mass of the coarse gallnut powder was added to a 50% ethanol aqueous solution, and the mixture was extracted for 0.6-1.0 hours. Each extract was first filtered through four layers of gauze, and the filtrates were combined, filtered by suction, and the volume of the filtrate was concentrated to 3-8 times the mass of the coarse gallnut powder to obtain the gallnut extract.

[0060] In some embodiments, Centella asiatica aqueous extract is prepared by the following method: Weigh an appropriate amount of Centella asiatica coarse powder and extract it three times by heating and reflux: For the first extraction, add 15-18 times the weight of the Centella asiatica coarse powder in water, soak for 0.25-0.75 hours, and extract for 1.5-2.0 hours; for the second extraction, add 10-14 times the weight of the Centella asiatica coarse powder in water, and extract for 1.0-1.5 hours; for the third extraction, add 8-12 times the weight of the Centella asiatica coarse powder in water, and extract for 0.5-1.0 hours; filter each extract through four layers of gauze, combine the filtrates, filter by suction, and concentrate the filtrate to 3-9 times the weight of the Centella asiatica coarse powder to obtain Centella asiatica extract; Aqueous extract of purslane was prepared by the following method: Weigh an appropriate amount of purslane coarse powder and extract it three times by heating and reflux: For the first extraction, add 15-18 times the weight of the purslane coarse powder in water, soak for 0.25-0.75 hours, and extract for 1.0-1.8 hours; for the second extraction, add 13-16 times the weight of the purslane coarse powder in water, and extract for 0.9-1.4 hours; for the third extraction, add 8-12 times the weight of the purslane coarse powder in water, and extract for 0.6-1.1 hours. Each extract is first filtered through four layers of gauze, the filtrates are combined, filtered by suction, and the volume of the filtrate is concentrated to 3-8 times the weight of the purslane coarse powder to obtain the purslane extract. Sophora flavescens aqueous extract was prepared by the following method: Weigh an appropriate amount of Sophora flavescens crude powder and extract it three times by heating and reflux: for the first time, add 15-18 times the weight of the Sophora flavescens crude powder in water, soak for 15-25 minutes, and extract for 1.0-1.5 hours; for the second time, add 8-12 times the weight of the Sophora flavescens crude powder in water, and extract for 1.0-1.5 hours; for the third time, add 6-8 times the weight of the Sophora flavescens crude powder in water, and extract for 0.8-1.0 hours; filter the extract through four layers of gauze, combine the filtrates, filter by suction, and concentrate the volume of the filtrate to 3-6 times the weight of the Sophora flavescens crude powder to obtain Sophora flavescens extract; The aqueous extract of Viola yedoensis was prepared by the following method: Weigh an appropriate amount of Viola yedoensis coarse powder and extract it three times by heating and reflux: for the first time, add 15-18 times the weight of Viola yedoensis coarse powder in water, soak for 30-60 minutes, and extract for 1.5-2.0 hours; for the second time, add 10-15 times the weight of Viola yedoensis coarse powder in water, and extract for 1.0-1.5 hours; for the third time, add 8-10 times the weight of Viola yedoensis coarse powder in water, and extract for 0.5-1.0 hours; filter the extract through four layers of gauze, combine the filtrates, filter by suction, and concentrate the filtrate to 3-5 times the weight of Viola yedoensis coarse powder to obtain Viola yedoensis extract.

[0061] In some embodiments, the supernatant concentrate of the root is prepared by the following method: The roots of *Hemiberlesia lingua* are crushed into coarse powder. An appropriate amount is weighed and extracted three times by reflux with water: for the first extraction, 10-15 times the weight of the coarse root powder is added, and the mixture is soaked for 30-60 minutes and extracted for 1.0-2.0 hours; for the second and third extractions, 8-15 times and 6-12 times the weight of the coarse root powder are added, respectively, and each extraction is carried out for 0.8-1.5 hours; the extract is filtered through four layers of gauze, the filtrates are combined and centrifuged, and the supernatant is concentrated to 8-15 times the weight of the coarse root powder. Then, it is precipitated with 80%-100% ethanol at a ratio of 1:3-1:6 (the final ethanol concentration reaches 60%-85%), and after standing at 4℃ for 8-24 hours, it is brought back to room temperature and filtered. The filtrate is then subjected to rotary evaporation to obtain a concentrated liquid, which is then evaporated in an 80-95℃ water bath until it reaches a relatively viscous state, dried in an oven at 55-80℃, and pulverized through an 80-mesh sieve to obtain the concentrated supernatant of *Hemiberlesia lingua* root.

[0062] Preferably, the method for preparing the calendula infused oil is as follows: After mixing calendula petals with 12-20 times their weight of olive oil, extract the mixture for 0.5-1.5 hours at an ultrasonic frequency of 20,000-40,000 Hz. Let it stand and soak at room temperature for 7-15 days, shaking or stirring the mixture during this period. Then filter the mixture and collect the filtrate to obtain calendula infused oil.

[0063] Preferably, in step (1), the ratio of sodium alginate to water is 0.1-1.0g:10-100mL; the ratio of gel forming agent QM to water is 1.0-5.0g:100-500mL distilled water; and the ratio of ice crystal forming agent AVC to water is 1.0-6.0g:100-600mL. The temperatures of both the aqueous and oil phases are 70-90℃; The volume ratio of 1,2-propanediol to water is 3.0-15.0:8.0-20.0; The amount of sodium benzoate added is 0.05-0.15% of the total prescription amount by mass.

[0064] Beneficial effects: Compared with the prior art, the present invention has the following significant advantages: This invention's hemorrhoid cream is based on natural ingredients such as shea butter, exhibiting good safety and tolerability, significantly reducing adverse reactions, and demonstrating outstanding efficacy: it can quickly relieve anal pain, promote local hemostasis, and reduce hemorrhoid edema, while its gentle texture and easy absorption minimize perianal irritation; by improving local microcirculation and regulating perianal metabolism, it reduces the risk of recurrence. Its natural antibacterial and anti-inflammatory components can also inhibit inflammation, reduce swelling, and decrease secondary infections.

[0065] In addition, this hemorrhoid cream can further achieve anti-inflammatory and antibacterial effects, rapid itch relief, blood circulation and pain relief, and prevention of cracking and wound healing. It can deeply repair damaged perianal tissue, soothe the skin, form a breathable protective film on the skin surface to reduce friction, continuously replenish nutrients, promote tissue regeneration, effectively improve perianal redness and ulceration, enhance the skin's tolerance to moist heat stimulation, restore barrier function, take effect quickly and have no toxic side effects, and has a good prospect for becoming a drug. Attached Figure Description

[0066] Figure 1 The appearance and properties of hemorrhoid ointment; Figure 2 The results of the cold and heat stability test of the hemorrhoid ointment prepared in Example 1; Figure 3 The results of centrifugation and room temperature storage experiments for the hemorrhoid ointment prepared in Example 1 are shown below; Figure 4 The results of skin irritation and allergy tests on mice and humans using the hemorrhoid ointment prepared in Example 1 are shown. Figure 5 The results of the antibacterial experiment and the microstructure of the hemorrhoid ointment prepared in Example 1 are shown. Figure 6 Permeability test and regression line graph of anti-inflammatory, analgesic, antibacterial, and antipruritic hemorrhoid ointment; Figure 7 The status of hemorrhoids in rats of each group; Figure 8 HE staining of anal tissue (×200) and NO content in serum of rats in each group were observed. Figure 9 The changes in serum IL-6, IL-17, VEGF and MMP-3 levels in each group of rats were analyzed. Figure 10 The changes in the levels of MDA, T-SOD, GSH, and CAT in the serum of rats in each group were recorded. Figure 11 The study included changes in the levels of Vitamin C and T-CHO in the adrenal glands of rats in each group, as well as the number of itching episodes and writhing responses in mice in each group. Detailed Implementation The technical solution of the present invention will be further described below with reference to the accompanying drawings.

[0067] Example 1: The composition ratio and preparation method of an anti-inflammatory, analgesic, antibacterial, and antipruritic hemorrhoid ointment are as follows: (1) Preparation of various raw material components: Calendula petals are mixed with 16 times their weight of olive oil and extracted at a 30,000 Hz ultrasonic frequency for 1 hour. The mixture is then left to stand at room temperature for 10 days, shaking once every 2 days. The mixture is then filtered through four layers of gauze to obtain the filtrate, which is the calendula infused oil.

[0068] Mix fresh ginger with four times its weight of distilled water and continue juicing for 2.0 minutes. Filter the resulting juice through four layers of gauze and vacuum filter. The resulting filtrate is the ginger extract.

[0069] Weigh an appropriate amount of Panax notoginseng coarse powder and extract it three times by heating and reflux: For the first extraction, add 17 times the mass of the Panax notoginseng coarse powder in 70% ethanol aqueous solution, soak at room temperature for 0.5 hours, and then extract for 1.5 hours; for the second extraction, add 15 times the mass of the Panax notoginseng coarse powder in 70% ethanol aqueous solution, and extract for 75 minutes; for the third extraction, add 10 times the mass of the Panax notoginseng coarse powder in 70% ethanol aqueous solution, and extract for 1 hour; each extract is first filtered through four layers of gauze, the filtrates are combined, filtered by suction, and the volume of the filtrate is concentrated to 5 times the mass of the Panax notoginseng coarse powder to obtain Panax notoginseng alcohol extract; Frankincense was crushed into coarse powder, and an appropriate amount was weighed and extracted three times by heating and reflux: for the first time, 13 times the mass of the coarse frankincense powder in 70% ethanol aqueous solution was added, and the mixture was soaked at room temperature for 0.5 hours and then extracted for 1.3 hours; for the second time, 12 times the mass of the coarse frankincense powder in 70% ethanol aqueous solution was added, and the mixture was extracted for 1 hour; for the third time, 10 times the mass of the coarse frankincense powder in 70% ethanol aqueous solution was added, and the mixture was extracted for 50 minutes; each extract was initially filtered through four layers of gauze, the filtrates were combined, and the mixture was filtered under vacuum. The volume of the filtrate was concentrated to 6 times the mass of the coarse frankincense powder to obtain the frankincense alcohol extract.

[0070] The soapberry thorns were crushed into coarse powder, and an appropriate amount was weighed and extracted three times by heating and reflux: for the first time, 12 times the mass of the soapberry thorn coarse powder in 65% ethanol aqueous solution was added, and the mixture was soaked at room temperature for 0.5 hours and then extracted for 75 minutes; for the second time, 10 times the mass of the soapberry thorn coarse powder in 65% ethanol aqueous solution was added, and the mixture was extracted for 1 hour; for the third time, 8.5 times the mass of the soapberry thorn coarse powder in 65% ethanol aqueous solution was added, and the mixture was extracted for 1 hour; each extract was filtered through four layers of gauze, the filtrates were combined, and the mixture was filtered under vacuum. The volume of the filtrate was concentrated to 4.5 times the mass of the soapberry thorn coarse powder to obtain the soapberry thorn alcohol extract.

[0071] Weigh an appropriate amount of coarse Artemisia argyi powder and extract it three times by heating and reflux: for the first time, add 16.5 times the mass of the coarse Artemisia argyi powder in 40% ethanol aqueous solution, soak at room temperature for 0.5 hours, and then extract for 75 minutes; for the second time, add 12 times the mass of the coarse Artemisia argyi powder in 40% ethanol aqueous solution, and extract for 75 minutes; for the third time, add 10 times the mass of the coarse Artemisia argyi powder in 40% ethanol aqueous solution, and extract for 1 hour; each extract is filtered through four layers of gauze, the filtrates are combined, filtered by suction, and the volume of the filtrate is concentrated to 5 times the mass of the coarse Artemisia argyi powder to obtain the Artemisia argyi ethanol extract.

[0072] Weigh an appropriate amount of dried Sophora japonica flowers and extract them three times by heating and reflux: For the first extraction, add 16 times the mass of the Sophora japonica flowers in 80% ethanol aqueous solution, soak at room temperature for 0.5 hours, and then extract for 1.3 hours; for the second extraction, add 13 times the mass of the Sophora japonica flowers in 80% ethanol aqueous solution, and extract for 1.1 hours; for the third extraction, add 11 times the mass of the Sophora japonica flowers in 80% ethanol aqueous solution, and extract for 1.1 hours; each extract is filtered through four layers of gauze, the filtrates are combined, filtered by suction, and the volume of the filtrate is concentrated to 6 times the mass of the Sophora japonica flowers to obtain the Sophora japonica flower ethanol extract.

[0073] Phellodendron bark was crushed into coarse powder, and an appropriate amount was weighed and extracted three times by heating and reflux: for the first time, 12.5 times the mass of the coarse powder of Phellodendron bark was added to a 70% ethanol aqueous solution, and the mixture was soaked at room temperature for 0.5 hours and then extracted for 1.5 hours; for the second time, 12 times the mass of the coarse powder of Phellodendron bark was added to a 70% ethanol aqueous solution and the mixture was extracted for 1.1 hours; for the third time, 10 times the mass of the coarse powder of Phellodendron bark was added to a 70% ethanol aqueous solution and the mixture was extracted for 1 hour; each extract was initially filtered through four layers of gauze, the filtrates were combined, and then filtered by suction. The volume of the filtrate was concentrated to 6 times the mass of the coarse powder of Phellodendron bark to obtain the ethanol extract of Phellodendron bark.

[0074] The Stemona japonica was crushed into coarse powder, and an appropriate amount was weighed and extracted by heating and reflux three times: for the first time, 13 times the mass of the Stemona japonica coarse powder was added to a 70% ethanol aqueous solution, and the mixture was soaked at room temperature for 0.5 hours and then extracted for 1.3 hours; for the second time, 11 times the mass of the Stemona japonica coarse powder was added to a 70% ethanol aqueous solution and the mixture was extracted for 1 hour; for the third time, 10 times the mass of the Stemona japonica coarse powder was added to a 70% ethanol aqueous solution and the mixture was extracted for 55 minutes; each extract was initially filtered through four layers of gauze, the filtrates were combined, and the mixture was filtered under vacuum. The volume of the filtrate was concentrated to 5 times the mass of the Stemona japonica coarse powder to obtain the Stemona japonica ethanol extract.

[0075] Gallnuts were crushed into coarse powder, and an appropriate amount was weighed and extracted three times by heating and reflux: for the first time, 13 times the mass of the coarse gallnut powder was added to a 50% ethanol aqueous solution, and the mixture was soaked at room temperature for 0.5 hours and then extracted for 1.3 hours; for the second time, 11.5 times the mass of the coarse gallnut powder was added to a 50% ethanol aqueous solution and the mixture was extracted for 1 hour; for the third time, 10 times the mass of the coarse gallnut powder was added to a 50-minute extraction. Each extract was filtered through four layers of gauze, and the filtrates were combined, filtered by suction, and the volume of the filtrate was concentrated to 6 times the mass of the coarse gallnut powder to obtain the gallnut ethanol extract.

[0076] Weigh an appropriate amount of Centella asiatica coarse powder and extract it three times by heating and reflux: for the first time, add 16.5 times the weight of Centella asiatica coarse powder in water, soak for 0.5 hours, and extract for 105 minutes; for the second time, add 12 times the weight of Centella asiatica coarse powder in water and extract for 75 minutes; for the third time, add 10 times the weight of Centella asiatica coarse powder in water and extract for 45 minutes. Each extract is filtered through four layers of gauze, the filtrates are combined, filtered by suction, and the volume of the filtrate is concentrated to 6 times the weight of Centella asiatica coarse powder to obtain Centella asiatica aqueous extract. Weigh an appropriate amount of purslane coarse powder and extract it three times by heating and reflux: for the first time, add 16.5 times the weight of the purslane coarse powder in water, soak for 0.5 hours, and extract for 1.5 hours; for the second time, add 14.5 times the weight of the purslane coarse powder in water and extract for 65 minutes; for the third time, add 10 times the weight of the purslane coarse powder in water and extract for 50 minutes. Each extract is first filtered through four layers of gauze, the filtrates are combined, filtered by suction, and the volume of the filtrate is concentrated to 5 times the weight of the purslane coarse powder to obtain the purslane aqueous extract. Weigh an appropriate amount of Sophora flavescens crude powder and extract it three times by heating and reflux: for the first time, add 16.5 times the weight of Sophora flavescens crude powder in water, soak for 20 minutes, and extract for 75 minutes; for the second time, add 10 times the weight of Sophora flavescens crude powder in water, and extract for 75 minutes; for the third time, add 7 times the weight of Sophora flavescens crude powder in water, and extract for 55 minutes; each extract is first filtered through four layers of gauze, the filtrates are combined, filtered by suction, and the volume of the filtrate is concentrated to 4 times the weight of Sophora flavescens crude powder to obtain Sophora flavescens aqueous extract; Weigh an appropriate amount of Viola yedoensis coarse powder and extract it three times by heating and reflux: for the first time, add 16 times the weight of Viola yedoensis coarse powder in water, soak for 45 minutes, and extract for 105 minutes; for the second time, add 12.5 times the weight of Viola yedoensis coarse powder in water and extract for 75 minutes; for the third time, add 9 times the weight of Viola yedoensis coarse powder in water and extract for 45 minutes. Each extract is first filtered through four layers of gauze, the filtrates are combined, filtered by suction, and the volume of the filtrate is concentrated to 4 times the weight of Viola yedoensis coarse powder to obtain Viola yedoensis aqueous extract.

[0077] The roots of *Hemiberlesia lingua* were crushed into coarse powder. An appropriate amount was weighed and extracted three times by heating and reflux with water. For the first extraction, 12.5 times the mass of the coarse powder of *Hemiberlesia lingua* was added to water, soaked for 45 minutes, and extracted for 1.5 hours. For the second and third extractions, 12 times and 10 times the mass of the powder were added respectively, and each extraction was carried out for 1 hour. Each extract was filtered through four layers of gauze, the filtrates were combined and centrifuged, and the supernatant was concentrated to 11 times the mass of the coarse powder of *Hemiberlesia lingua*. It was then mixed with 90% ethanol aqueous solution at a volume ratio of 1:4.5 for alcohol precipitation. After standing at 4℃ for 16 hours, it was restored to room temperature and filtered. The filtrate was then evaporated by rotary evaporation to obtain a concentrated solution. The solution was placed in a 90℃ water bath and evaporated to a relatively viscous state. It was then dried in a 70℃ oven, crushed and passed through an 80-mesh sieve to obtain the concentrated supernatant of *Hemiberlesia lingua*.

[0078] (2) Weigh 0.5g of sodium alginate, add it to 60mL of distilled water, stir to disperse, put it in a 70℃ water bath and continue stirring for 15min, take it out, let it stand at room temperature for 18h, and wait for it to fully swell to obtain sodium alginate gel solution for later use. Weigh 3.0g of gel forming agent QM, add it to 300mL of distilled water, stir to disperse, and let it stand at room temperature for 18h to allow it to fully swell, thus obtaining the gel forming agent QM gel solution for later use. (3) Weigh 4.0g of ice crystal forming agent AVC, add it to 400mL of distilled water, stir and disperse it, then put it into a 70℃ water bath and continue stirring for 15min. Take it out and let it stand at room temperature for 18h until it is fully swollen to obtain a uniform and transparent ice crystal forming agent AVC gel solution for later use. (4) Take 0.7 mL of eucalyptus oil, 1 mL of rosehip oil, 0.9 mL of calendula infused oil, 0.7 mL of peppermint oil, 1.3 mL of aloe vera oil, 0.85 mL of lemongrass oil, 0.75 mL of pine needle oil, 1 mL of borage oil, 0.75 mL of sea buckthorn oil, 0.8 mL of almond oil, 0.6 g of beeswax, 1.1 g of shea butter, 1.3 g of emu oil, 0.85 g of perilla seed oil, and 1 g of snake oil, place them in a beaker, mix and stir, and heat in a preheated 80°C water bath until the beeswax and solid oils are completely melted. Stir evenly and use as the oil phase for later use. Weigh 0.7g of composite emulsifier AC-402 and 0.8g of Sepik 305, add 23mL of distilled water, stir to disperse, then place in a preheated 80℃ water bath and heat while stirring continuously until completely dissolved. This aqueous phase is used for later use. After both the oil phase and the aqueous phase are heated to 80°C, the aqueous phase is slowly added to the oil phase in a thin stream while stirring in the same direction until a uniform emulsion is formed, thus obtaining the emulsion matrix. (5) Take 0.7 mL of frankincense alcohol extract, 1 mL of Panax notoginseng alcohol extract, 1 mL of Gleditsia sinensis thorn alcohol extract, 0.8 mL of Centella asiatica water extract, 0.8 mL of Artemisia argyi alcohol extract, 1.1 mL of Sophora japonica alcohol extract, 1 mL of Sophora flavescens water extract, 0.9 mL of Phellodendron chinense alcohol extract, 0.7 mL of Galla chinensis alcohol extract, 0.65 mL of Stemona japonica alcohol extract, 0.9 mL of Viola yedoensis water extract, 0.75 mL of Portulaca oleracea water extract, 0.7 mL of fresh ginger extract, 0.25 g of borneol, 0.25 g of allantoin, 0.15 g of calamine, 0.15 g of berberine, and 0.2 g of the supernatant concentrate of Coptis chinensis root, stir and mix evenly to obtain liquid A; (6) Weigh out 0.1 wt% of sodium benzoate from the total prescription amount, add 9 mL of 1,2-propanediol and 14 mL of distilled water, stir to dissolve, and use as a preservative solution for later use; (7) Add the liquid A prepared above to the emulsion matrix and stir to mix evenly. While stirring continuously, slowly add the above gel forming agent QM gel liquid, sodium alginate gel liquid, ice crystal forming agent AVC gel liquid, preservative solution and 0.05mL osmanthus fragrance in sequence and stir to mix evenly to obtain an anti-inflammatory, analgesic, antibacterial and antipruritic hemorrhoid ointment.

[0079] Example 2: The composition ratio and preparation method of an anti-inflammatory, analgesic, antibacterial, and antipruritic hemorrhoid ointment are as follows: (1) Preparation of various raw material components: Calendula petals are mixed with 12 times their weight of olive oil and extracted at a 20,000 Hz ultrasonic frequency for 0.5 hours. The mixture is then left to stand at room temperature for 7 days, shaking once every 2 days. The mixture is then filtered through four layers of gauze to obtain the filtrate, which is the calendula infused oil.

[0080] Mix fresh ginger with three times its weight of distilled water and continue juicing for 1.5 minutes. Filter the resulting juice through four layers of gauze and vacuum filter. The resulting filtrate is the ginger extract.

[0081] Weigh an appropriate amount of Panax notoginseng coarse powder and extract it three times by heating and reflux: for the first time, add 15 times the mass of the Panax notoginseng coarse powder in 70% ethanol aqueous solution, soak at room temperature for 0.25 h, and then extract for 1.0 h; for the second time, add 12 times the mass of the Panax notoginseng coarse powder in 70% ethanol aqueous solution, and extract for 1.0 h; for the third time, add 8 times the mass of the Panax notoginseng coarse powder in 70% ethanol aqueous solution, and extract for 0.8 h; each extract is first filtered through four layers of gauze, the filtrates are combined, filtered by suction, and the volume of the filtrate is concentrated to 3 times the mass of the Panax notoginseng coarse powder to obtain Panax notoginseng ethanol extract; Frankincense was crushed into coarse powder, and an appropriate amount was weighed and extracted three times by heating and reflux: for the first time, 10 times the mass of the frankincense coarse powder was added to a 70% ethanol aqueous solution, and the mixture was soaked at room temperature for 0.2 hours and then extracted for 1.1 hours; for the second time, 9 times the mass of the frankincense coarse powder was added to a 70% ethanol aqueous solution and the mixture was extracted for 0.8 hours; for the third time, 8 times the mass of the frankincense coarse powder was added to a 70% ethanol aqueous solution and the mixture was extracted for 0.6 hours; each extract was initially filtered through four layers of gauze, the filtrates were combined, and the mixture was filtered under vacuum. The volume of the filtrate was concentrated to 4 times the mass of the frankincense coarse powder to obtain frankincense alcohol extract.

[0082] The soapberry thorns were crushed into coarse powder, and an appropriate amount was weighed and extracted by heating and reflux three times: for the first time, 10 times the mass of the soapberry thorn coarse powder was added to a 65% ethanol aqueous solution, and the mixture was soaked at room temperature for 0.3 hours and then extracted for 1.0 hour; for the second time, 8 times the mass of the soapberry thorn coarse powder was added to a 65% ethanol aqueous solution and the mixture was extracted for 0.8 hours; for the third time, 7 times the mass of the soapberry thorn coarse powder was added to a 65% ethanol aqueous solution and the mixture was extracted for 0.7 hours; each extract was initially filtered through four layers of gauze, the filtrates were combined, and then filtered under vacuum. The volume of the filtrate was concentrated to 3 times the mass of the soapberry thorn coarse powder to obtain the soapberry thorn alcohol extract.

[0083] Weigh an appropriate amount of coarse Artemisia argyi powder and extract it three times by heating and reflux: for the first time, add 15 times the mass of the coarse Artemisia argyi powder in 40% ethanol aqueous solution, soak at room temperature for 0.25 h, and then extract for 1.0 h; for the second time, add 10 times the mass of the coarse Artemisia argyi powder in 40% ethanol aqueous solution, and extract for 1.0 h; for the third time, add 8 times the mass of the coarse Artemisia argyi powder in 40% ethanol aqueous solution, and extract for 0.8 h; each extract is first filtered through four layers of gauze, the filtrates are combined, filtered by suction, and the volume of the filtrate is concentrated to 3 times the mass of the coarse Artemisia argyi powder to obtain the Artemisia argyi ethanol extract.

[0084] Weigh an appropriate amount of dried Sophora japonica flowers and extract them three times by heating and reflux: For the first extraction, add 15 times the mass of the Sophora japonica flowers in an 80% ethanol aqueous solution, soak at room temperature for 0.3 hours, and then extract for 1.1 hours; for the second extraction, add 12 times the mass of the Sophora japonica flowers in an 80% ethanol aqueous solution, and extract for 1.0 hour; for the third extraction, add 10 times the mass of the Sophora japonica flowers in an 80% ethanol aqueous solution, and extract for 1.0 hour; each extract is first filtered through four layers of gauze, the filtrates are combined, filtered by suction, and the volume of the filtrate is concentrated to 4 times the mass of the Sophora japonica flowers to obtain the Sophora japonica flower ethanol extract.

[0085] Phellodendron bark was crushed into coarse powder, and an appropriate amount was weighed and extracted three times by heating and reflux: for the first time, 10 times the mass of the coarse powder of Phellodendron bark was added to a 70% ethanol aqueous solution, and the mixture was soaked at room temperature for 0.2 hours and then extracted for 1.1 hours; for the second time, 10 times the mass of the coarse powder of Phellodendron bark was added to a 70% ethanol aqueous solution and the mixture was extracted for 1.0 hour; for the third time, 8 times the mass of the coarse powder of Phellodendron bark was added to a 70% ethanol aqueous solution and the mixture was extracted for 0.8 hours; each extract was initially filtered through four layers of gauze, the filtrates were combined, and the mixture was filtered under vacuum. The volume of the filtrate was concentrated to 4 times the mass of the coarse powder of Phellodendron bark to obtain the ethanol extract of Phellodendron bark.

[0086] The Stemona japonica was crushed into coarse powder, and an appropriate amount was weighed and extracted by heating and reflux three times: for the first time, 10 times the mass of the Stemona japonica coarse powder was added to a 70% ethanol aqueous solution, and the mixture was soaked at room temperature for 0.2 hours and then extracted for 1.1 hours; for the second time, 10 times the mass of the Stemona japonica coarse powder was added to a 70% ethanol aqueous solution and the mixture was extracted for 0.8 hours; for the third time, 8 times the mass of the Stemona japonica coarse powder was added to a 70% ethanol aqueous solution and the mixture was extracted for 0.8 hours; each extract was filtered through four layers of gauze, the filtrates were combined, and the mixture was filtered under vacuum. The volume of the filtrate was concentrated to 4 times the mass of the Stemona japonica coarse powder to obtain the Stemona japonica ethanol extract.

[0087] Gallnuts were crushed into coarse powder, and an appropriate amount was weighed and extracted three times by heating and reflux: for the first time, 10 times the mass of the coarse gallnut powder was added to a 50% ethanol aqueous solution, and the mixture was soaked at room temperature for 0.2 hours and then extracted for 1.1 hours; for the second time, 10 times the mass of the coarse gallnut powder was added to a 50% ethanol aqueous solution and the mixture was extracted for 0.8 hours; for the third time, 8 times the mass of the coarse gallnut powder was added to a 50% ethanol aqueous solution and the mixture was extracted for 0.6 hours; each extract was initially filtered through four layers of gauze, the filtrates were combined, and the mixture was filtered under vacuum. The volume of the filtrate was concentrated to 3 times the mass of the coarse gallnut powder to obtain the gallnut ethanol extract.

[0088] Weigh an appropriate amount of Centella asiatica coarse powder and extract it three times by heating and reflux: for the first time, add 15 times the weight of Centella asiatica coarse powder in water, soak for 0.25 hours, and extract for 1.5 hours; for the second time, add 10 times the weight of Centella asiatica coarse powder in water, and extract for 1 hour; for the third time, add 8 times the weight of Centella asiatica coarse powder in water, and extract for 0.5 hours; filter the extract through four layers of gauze, combine the filtrates, filter by suction, and concentrate the volume of the filtrate to 3 times the weight of Centella asiatica coarse powder to obtain Centella asiatica aqueous extract; Weigh an appropriate amount of purslane coarse powder and extract it three times by heating and reflux: for the first time, add 15 times the weight of the purslane coarse powder in water, soak for 0.25 hours, and extract for 1.0 hour; for the second time, add 13 times the weight of the purslane coarse powder in water, and extract for 0.9 hours; for the third time, add 8 times the weight of the purslane coarse powder in water, and extract for 0.6 hours. Each extract is first filtered through four layers of gauze, the filtrates are combined, filtered by suction, and the volume of the filtrate is concentrated to 3 times the weight of the purslane coarse powder to obtain the purslane aqueous extract. Weigh an appropriate amount of Sophora flavescens crude powder and extract it three times by heating and reflux: for the first time, add 15 times the weight of Sophora flavescens crude powder in water, soak for 15 minutes, and extract for 1.0 h; for the second time, add 8 times the weight of Sophora flavescens crude powder in water, and extract for 1.0 h; for the third time, add 6 times the weight of Sophora flavescens crude powder in water, and extract for 0.8 h; each extract is first filtered through four layers of gauze, the filtrates are combined, filtered by suction, and the volume of the filtrate is concentrated to 3 times the weight of Sophora flavescens crude powder to obtain Sophora flavescens aqueous extract; Weigh an appropriate amount of Viola yedoensis coarse powder and extract it three times by heating and reflux: for the first time, add 15 times the weight of Viola yedoensis coarse powder in water, soak for 30 minutes, and extract for 1.5 hours; for the second time, add 10 times the weight of Viola yedoensis coarse powder in water and extract for 1.0 hour; for the third time, add 8 times the weight of Viola yedoensis coarse powder in water and extract for 0.5 hours; filter the extract through four layers of gauze, combine the filtrates, filter by suction, and concentrate the filtrate to 3 times the weight of Viola yedoensis coarse powder to obtain Viola yedoensis aqueous extract.

[0089] The roots of *Hemiberlesia lingua* were crushed into coarse powder. An appropriate amount was weighed and extracted three times by reflux with water: for the first extraction, 10 times the weight of the coarse powder was added to water, soaked for 30 minutes, and extracted for 1.0 h; for the second and third extractions, 8 times and 6 times the weight of the powder were added to water, respectively, and each extraction was carried out for 0.8 h. Each extract was filtered through four layers of gauze, the filtrates were combined and centrifuged, and the supernatant was concentrated to 8 times the weight of the coarse powder. The supernatant concentrate was then mixed with 80% ethanol aqueous solution at a volume ratio of 1:3 for alcohol precipitation. After standing at 4℃ for 8 h, the mixture was brought back to room temperature and filtered. The filtrate was then subjected to rotary evaporation to obtain a concentrate, which was evaporated in an 80℃ water bath until it reached a relatively viscous state. The concentrate was then dried in an oven at 55℃, crushed, and passed through an 80-mesh sieve to obtain the concentrated supernatant of *Hemiberlesia lingua*.

[0090] (2) Weigh 0.1g of sodium alginate, add it to 10mL of distilled water, stir to disperse, put it in a 60℃ water bath and continue stirring for 5min, take it out and let it stand at room temperature for 12h until it is fully swollen to obtain sodium alginate gel solution for later use. Weigh 1.0g of gel forming agent QM, add it to 100mL of distilled water, stir to disperse, and let it stand at room temperature for 12h to allow it to fully swell, thus obtaining the gel forming agent QM gel solution for later use. (3) Weigh 1.0g of ice crystal forming agent AVC, add it to 100mL of distilled water, stir and disperse it, then put it into a 60℃ water bath and continue stirring for 5min. Take it out and let it stand at room temperature for 12h until it is fully swollen to obtain a uniform and transparent ice crystal forming agent AVC gel solution for later use. (4) Take 0.3 mL of eucalyptus oil, 0.6 mL of rosehip oil, 0.4 mL of calendula infused oil, 0.2 mL of peppermint oil, 0.8 mL of aloe vera oil, 0.4 mL of lemongrass oil, 0.2 mL of pine needle oil, 0.5 mL of borage oil, 0.3 mL of sea buckthorn oil, 0.5 mL of almond oil, 0.2 g of beeswax, 0.6 g of shea butter, 0.5 g of emu oil, 0.4 g of perilla seed oil, and 0.5 g of snake oil, place them in a beaker, mix and stir, and heat in a preheated 70°C water bath until the beeswax and solid oils are completely melted. Stir evenly and use as the oil phase for later use. Weigh out 0.1g of composite emulsifier AC-402 and 0.1g of Sepik 305, add 15mL of distilled water, stir to disperse, then place in a preheated 70℃ water bath and heat while stirring continuously until completely dissolved. This aqueous phase is used for later use. After both the oil phase and the aqueous phase are heated to 70°C, the aqueous phase is slowly added to the oil phase in a thin stream while stirring in the same direction until a uniform emulsion is formed, thus obtaining the emulsion matrix. (5) Take 0.1 mL of frankincense alcohol extract, 0.5 mL of Panax notoginseng alcohol extract, 0.1 mL of Gleditsia sinensis thorn alcohol extract, 0.3 mL of Centella asiatica water extract, 0.1 mL of Artemisia argyi alcohol extract, 0.5 mL of Sophora japonica alcohol extract, 0.5 mL of Sophora flavescens water extract, 0.3 mL of Phellodendron chinense alcohol extract, 0.1 mL of Galla chinensis alcohol extract, 0.3 mL of Stemona japonica alcohol extract, 0.3 mL of Viola yedoensis water extract, 0.1 mL of Portulaca oleracea water extract, 0.1 mL of fresh ginger extract, 0.01 g of borneol, 0.01 g of allantoin, 0.01 g of calamine, 0.05 g of berberine and 0.05 g of the supernatant of the root, stir and mix evenly to obtain liquid A; (6) Weigh out 0.15wt% of sodium benzoate, add 3.0mL of 1,2-propanediol and 8.0mL of distilled water, stir to dissolve, and use as a preservative solution for later use; (7) Add the liquid A prepared above to the emulsion matrix and stir to mix evenly. While stirring continuously, slowly add the gel forming agent QM gel liquid, sodium alginate gel liquid, ice crystal forming agent AVC gel liquid, preservative solution and 0.01 mL of rose fragrance in sequence and stir to mix evenly to obtain an anti-inflammatory, analgesic, antibacterial and antipruritic hemorrhoid ointment.

[0091] Example 3: The composition ratio and preparation method of an anti-inflammatory, analgesic, antibacterial, and antipruritic hemorrhoid ointment are as follows: (1) Preparation of various raw material components: Calendula petals are mixed with 20 times their weight of olive oil and extracted at a 40,000 Hz ultrasonic frequency for 1.5 hours. The mixture is then left to stand at room temperature for 15 days, shaking once every two days. The mixture is then filtered through four layers of gauze to obtain the filtrate, which is the calendula infused oil.

[0092] Mix fresh ginger with five times its weight of distilled water and continue juicing for 2.0 minutes. Filter the resulting juice through four layers of gauze and vacuum filter. The resulting filtrate is the ginger extract.

[0093] Weigh an appropriate amount of Panax notoginseng coarse powder and extract it three times by heating and reflux: for the first time, add 20 times the mass of the Panax notoginseng coarse powder in 70% ethanol aqueous solution, soak at room temperature for 0.75 h, and then extract for 1.7 h; for the second time, add 18 times the mass of the Panax notoginseng coarse powder in 70% ethanol aqueous solution, and extract for 1.5 h; for the third time, add 12 times the mass of the Panax notoginseng coarse powder in 70% ethanol aqueous solution, and extract for 1.2 h; each extract is first filtered through four layers of gauze, the filtrates are combined, filtered by suction, and the volume of the filtrate is concentrated to 7 times the mass of the Panax notoginseng coarse powder to obtain Panax notoginseng alcohol extract; Frankincense was crushed into coarse powder, and an appropriate amount was weighed and extracted three times by heating and reflux: for the first time, 15 times the mass of the frankincense coarse powder was added to a 70% ethanol aqueous solution, and the mixture was soaked at room temperature for 0.7 hours and then extracted for 1.6 hours; for the second time, 14 times the mass of the frankincense coarse powder was added to a 70% ethanol aqueous solution and the mixture was extracted for 1.4 hours; for the third time, 12 times the mass of the frankincense coarse powder was added to a 70% ethanol aqueous solution and the mixture was extracted for 1.0 hour; each extract was initially filtered through four layers of gauze, the filtrates were combined, and the mixture was filtered under vacuum. The volume of the filtrate was concentrated to 8 times the mass of the frankincense coarse powder to obtain frankincense alcohol extract.

[0094] The soapberry thorns were crushed into coarse powder, and an appropriate amount was weighed and extracted three times by heating and reflux: for the first time, 14 times the mass of the soapberry thorn coarse powder was added to a 65% ethanol aqueous solution, and the mixture was soaked at room temperature for 0.8 hours and then extracted for 1.5 hours; for the second time, 12 times the mass of the soapberry thorn coarse powder was added to a 65% ethanol aqueous solution and the mixture was extracted for 1.3 hours; for the third time, 10 times the mass of the soapberry thorn coarse powder was added to a 65% ethanol aqueous solution and the mixture was extracted for 1.1 hours; each extract was initially filtered through four layers of gauze, the filtrates were combined, and then filtered under vacuum. The volume of the filtrate was concentrated to 6 times the mass of the soapberry thorn coarse powder to obtain the soapberry thorn alcohol extract.

[0095] Weigh an appropriate amount of coarse Artemisia argyi powder and extract it three times by heating and reflux: for the first time, add 18 times the mass of the coarse Artemisia argyi powder in 40% ethanol aqueous solution, soak at room temperature for 0.80 h, and then extract for 1.5 h; for the second time, add 15 times the mass of the coarse Artemisia argyi powder in 40% ethanol aqueous solution, and extract for 1.5 h; for the third time, add 12 times the mass of the coarse Artemisia argyi powder in 40% ethanol aqueous solution, and extract for 1.3 h; each extract is first filtered through four layers of gauze, the filtrates are combined, filtered by suction, and the volume of the filtrate is concentrated to 7 times the mass of the coarse Artemisia argyi powder to obtain the Artemisia argyi ethanol extract.

[0096] Weigh an appropriate amount of dried Sophora japonica flowers and extract them three times by heating and reflux: For the first extraction, add 18 times the mass of the Sophora japonica flowers in 80% ethanol aqueous solution, soak at room temperature for 0.8 hours, and then extract for 1.6 hours; for the second extraction, add 15 times the mass of the Sophora japonica flowers in 80% ethanol aqueous solution, and extract for 1.2 hours; for the third extraction, add 12 times the mass of the Sophora japonica flowers in 80% ethanol aqueous solution, and extract for 1.2 hours; each extract is filtered through four layers of gauze, the filtrates are combined, filtered by suction, and the volume of the filtrate is concentrated to 8 times the mass of the Sophora japonica flowers to obtain the Sophora japonica flower ethanol extract.

[0097] Phellodendron bark was crushed into coarse powder, and an appropriate amount was weighed and extracted three times by heating and reflux: for the first time, 15 times the mass of the coarse powder of Phellodendron bark was added to a 70% ethanol aqueous solution, and the mixture was soaked at room temperature for 0.7 hours and then extracted for 1.8 hours; for the second time, 14 times the mass of the coarse powder of Phellodendron bark was added to a 70% ethanol aqueous solution and the mixture was extracted for 1.2 hours; for the third time, 12 times the mass of the coarse powder of Phellodendron bark was added to a 70% ethanol aqueous solution and the mixture was extracted for 1.2 hours; each extract was filtered through four layers of gauze, the filtrates were combined, and the mixture was filtered under vacuum. The volume of the filtrate was concentrated to 8 times the mass of the coarse powder of Phellodendron bark to obtain the ethanol extract of Phellodendron bark.

[0098] The Stemona japonica was crushed into coarse powder, and an appropriate amount was weighed and extracted three times by heating and reflux: for the first time, 15 times the mass of the Stemona japonica coarse powder was added to a 70% ethanol aqueous solution, and the mixture was soaked at room temperature for 0.7 hours and then extracted for 1.6 hours; for the second time, 12 times the mass of the Stemona japonica coarse powder was added to a 70% ethanol aqueous solution and the mixture was extracted for 1.2 hours; for the third time, 12 times the mass of the Stemona japonica coarse powder was added to a 70% ethanol aqueous solution and the mixture was extracted for 1.0 hour; each extract was initially filtered through four layers of gauze, the filtrates were combined, and the mixture was filtered under vacuum. The volume of the filtrate was concentrated to 7 times the mass of the Stemona japonica coarse powder to obtain the Stemona japonica ethanol extract.

[0099] Gallnuts were crushed into coarse powder, and an appropriate amount was weighed and extracted three times by heating and reflux: for the first time, 15 times the mass of the coarse gallnut powder was added to a 50% ethanol aqueous solution, and the mixture was soaked at room temperature for 0.7 hours and then extracted for 1.6 hours; for the second time, 13 times the mass of the coarse gallnut powder was added to a 50% ethanol aqueous solution and the mixture was extracted for 1.2 hours; for the third time, 12 times the mass of the coarse gallnut powder was added to a 50% ethanol aqueous solution and the mixture was extracted for 1.0 hour; each extract was initially filtered through four layers of gauze, the filtrates were combined, and the mixture was filtered under vacuum. The volume of the filtrate was concentrated to 8 times the mass of the coarse gallnut powder to obtain the gallnut ethanol extract.

[0100] Weigh an appropriate amount of Centella asiatica coarse powder and extract it three times by heating and reflux: for the first time, add 18 times the weight of Centella asiatica coarse powder in water, soak for 0.75 hours, and extract for 2.0 hours; for the second time, add 14 times the weight of Centella asiatica coarse powder in water, and extract for 1.5 hours; for the third time, add 12 times the weight of Centella asiatica coarse powder in water, and extract for 1.0 hour. Each extract is first filtered through four layers of gauze, the filtrates are combined, filtered by suction, and the volume of the filtrate is concentrated to 9 times the weight of Centella asiatica coarse powder to obtain Centella asiatica aqueous extract. Weigh an appropriate amount of purslane coarse powder and extract it three times by heating and reflux: for the first time, add 18 times the weight of the purslane coarse powder in water, soak for 0.75 hours, and extract for 1.8 hours; for the second time, add 16 times the weight of the purslane coarse powder in water, and extract for 1.4 hours; for the third time, add 12 times the weight of the purslane coarse powder in water, and extract for 1.1 hours. Each extract is first filtered through four layers of gauze, the filtrates are combined, filtered by suction, and the volume of the filtrate is concentrated to 8 times the weight of the purslane coarse powder to obtain the purslane aqueous extract. Weigh an appropriate amount of Sophora flavescens coarse powder and extract it three times by heating and reflux: for the first time, add 18 times the weight of Sophora flavescens coarse powder in water, soak for 25 minutes, and extract for 1.5 hours; for the second time, add 12 times the weight of Sophora flavescens coarse powder in water, and extract for 1.5 hours; for the third time, add 8 times the weight of Sophora flavescens coarse powder in water, and extract for 1 hour. Each extract was initially filtered through four layers of gauze, the filtrates were combined, filtered by suction, and the volume of the filtrate was concentrated to 6 times the weight of Sophora flavescens coarse powder to obtain Sophora flavescens water extract. Weigh an appropriate amount of Viola yedoensis coarse powder and extract it three times by heating and reflux: for the first time, add 18 times the weight of Viola yedoensis coarse powder in water, soak for 60 minutes, and extract for 2.0 hours; for the second time, add 15 times the weight of Viola yedoensis coarse powder in water and extract for 1.5 hours; for the third time, add 10 times the weight of Viola yedoensis coarse powder in water and extract for 1.0 hour; each extract is filtered through four layers of gauze, the filtrates are combined, filtered by suction, and the volume of the filtrate is concentrated to 5 times the weight of Viola yedoensis coarse powder to obtain Viola yedoensis aqueous extract.

[0101] The roots of *Hemiberlesia lingua* were crushed into coarse powder. An appropriate amount was weighed and extracted three times by reflux with water: for the first extraction, 15 times the weight of the coarse powder was added to water, and the mixture was soaked for 60 minutes and extracted for 2.0 hours; for the second and third extractions, 15 times and 12 times the weight of the coarse powder were added respectively, and the mixture was extracted for 1.5 hours each time. Each extract was filtered through four layers of gauze, the filtrates were combined and centrifuged, and the supernatant was concentrated to 15 times the weight of the coarse powder. The supernatant concentrate was then mixed with anhydrous ethanol at a volume ratio of 1:6 for alcohol precipitation. After standing at 4°C for 24 hours, the mixture was brought back to room temperature and filtered. The filtrate was then subjected to rotary evaporation to obtain a concentrate, which was evaporated in a 95°C water bath until it reached a relatively viscous state. The concentrate was then dried in an 80°C oven, crushed, and passed through an 80-mesh sieve to obtain the concentrated supernatant of *Hemiberlesia lingua*.

[0102] (2) Weigh 1.0g of sodium alginate, add it to 100mL of distilled water, stir to disperse, put it in an 80℃ water bath and continue stirring for 20min, take it out and let it stand at room temperature for 24h until it is fully swollen to obtain sodium alginate gel solution for later use. Weigh 5.0g of gel forming agent QM, add it to 500mL of distilled water, stir to disperse, and let it stand at room temperature for 24h to allow it to fully swell, thus obtaining the gel forming agent QM gel solution for later use. (3) Weigh 6.0g of ice crystal forming agent AVC, add it to 600mL of distilled water, stir and disperse it, then put it into an 80℃ water bath and continue stirring for 20min. Take it out and let it stand at room temperature for 24h until it is fully swollen to obtain a uniform and transparent ice crystal forming agent AVC gel solution for later use. (4) Take 1.2 mL of eucalyptus oil, 1.5 mL of rosehip oil, 1.3 mL of calendula infused oil, 1.2 mL of peppermint oil, 1.7 mL of aloe vera oil, 1.3 mL of lemongrass oil, 1.3 mL of pine needle oil, 1.5 mL of borage oil, 1.2 mL of sea buckthorn oil, 1.1 mL of almond oil, 1.0 g of beeswax, 1.6 g of shea butter, 2.0 g of emu oil, 1.3 g of perilla seed oil, and 1.5 g of snake oil, place them in a beaker, mix and stir, and heat in a preheated 90°C water bath until the beeswax and solid oils are completely melted. Stir well and use as the oil phase for later use. Weigh 1.3g of composite emulsifier AC-402 and 1.5g of Sepik 305, add 30mL of distilled water, stir to disperse, then place in a preheated 90℃ water bath and heat while stirring continuously until completely dissolved. This aqueous phase is used for later use. After both the oil phase and the aqueous phase are heated to 90°C, the aqueous phase is slowly added to the oil phase in a thin stream while stirring in the same direction until a uniform emulsion is formed, thus obtaining the emulsion matrix. (5) Take 1.2 mL of frankincense alcohol extract, 1.5 mL of Panax notoginseng alcohol extract, 1.7 mL of Gleditsia sinensis thorn alcohol extract, 1.3 mL of Centella asiatica water extract, 1.5 mL of Artemisia argyi alcohol extract, 1.8 mL of Sophora japonica alcohol extract, 1.5 mL of Sophora flavescens water extract, 1.5 mL of Phellodendron chinense alcohol extract, 1.3 mL of Galla chinensis alcohol extract, 1.0 mL of Stemona japonica alcohol extract, 1.5 mL of Viola yedoensis water extract, 1.2 mL of Portulaca oleracea water extract, 1.3 mL of fresh ginger extract, 0.5 g of borneol, 0.5 g of allantoin, 0.3 g of calamine, 0.3 g of berberine, and 0.4 g of the supernatant of the root of the plant. Stir and mix them evenly to obtain liquid A. (6) Weigh out 0.05wt% of sodium benzoate from the total prescription amount, add 15.0mL of 1,2-propanediol and 20.0mL of distilled water, stir to dissolve, and use as a preservative solution for later use; (7) Add the liquid A prepared above to the emulsion matrix and stir to mix evenly. While stirring continuously, slowly add the gel forming agent QM gel liquid, sodium alginate gel liquid, ice crystal forming agent AVC gel liquid, preservative solution and 0.10 mL of lavender fragrance in sequence and stir to mix evenly to obtain an anti-inflammatory, analgesic, antibacterial and antipruritic hemorrhoid ointment.

[0103] Comparative Example 1: Everything else is the same as in Example 1, except that: Heat both the oil phase and the aqueous phase to 55°C. Slowly add the aqueous phase into the oil phase in a thin stream while stirring in the same direction until a uniform emulsion is formed, thus obtaining the emulsion matrix. The hemorrhoid ointment produced in this way has the following appearance: Figure 1 As shown in Figure A, the ointment has a noticeable granular texture and lacks a smooth feel. The formulation quality does not meet the requirements, and no further investigation will be conducted.

[0104] Comparative Example 2: Everything else is the same as in Example 1, except that: It does not contain calendula infused oil, aloe vera oil, sea buckthorn oil, perilla seed oil, emu oil, pine needle oil, or root supernatant concentrate.

[0105] Comparative Example 3: Everything else is the same as in Example 1, except that: It does not contain calendula-infused oil, aloe vera oil, or pine needle oil.

[0106] Comparative Example 4: Everything else is the same as in Example 1, except that: Do not add the supernatant concentrate from the root.

[0107] The physicochemical properties and safety of the ointments prepared in Examples 1-3 were evaluated. The experimental methods and results are as follows: 1. Characteristics The hemorrhoid ointments prepared in Examples 1, 2, and 3 are yellow in color, have a suitable viscosity, are fine and uniform, spread well, absorb quickly, and feel comfortable on the skin. Figure 1 Figure B in the middle. Figure 1 Figure B shows the appearance of the hemorrhoid ointment prepared in Examples 1, 2, and 3.

[0108] 2. pH value check A small amount of the hemorrhoid ointment prepared in Examples 1, 2, and 3 was applied to pH test paper. The results showed that its pH value was between 6.0 and 7.0, which is weakly acidic to neutral and meets the requirements of the skin's physiological environment.

[0109] 3. Cold and heat experiment The hemorrhoid ointment of this invention was placed in a sealed container and subjected to thermal stability tests by placing it in a 55°C oven for 2 days and cold stability tests by placing it in a 4°C refrigerator for 7 days. The results are as follows: Figure 2 As shown, the hemorrhoid ointment remained uniform throughout, without oil-water separation, clumping, or discoloration, and its properties and texture remained unchanged, meeting the qualified standards. Figure 2 Figure A shows the result before the thermal experiment, and Figure B shows the result after the thermal experiment. Figure 2 Figure C shows the result before the cold experiment, and Figure D shows the result after the cold experiment.

[0110] 4. Centrifugation experiment The hemorrhoid ointment prepared in Example 1 was placed in a centrifuge tube and centrifuged at 20°C and 3000 rpm for 20 minutes. No stratification was observed. Figure 3 . Figure 3 Figure A shows the result before the centrifugation experiment, and Figure B shows the result after the centrifugation experiment.

[0111] 5. Room temperature placement experiment The hemorrhoid ointment prepared in Example 1 was stored in a sealed cream bottle and left to stand at room temperature for 6 months. No oil-water separation occurred, and there was no change in skin feel or odor after use. Figure 3 . Figure 3 Figure C shows the result before being placed at room temperature, and Figure D shows the result after being placed at room temperature.

[0112] 6. Skin irritation and allergy test 6.1 Irritation and Allergic Reactions to Normal Skin in Rats The hair on both sides of the spine on the back of mice was shaved with an electric shaver. The anti-inflammatory, analgesic, antibacterial, and antipruritic hemorrhoid ointment prepared in Example 1 was applied to the shaved areas. After 1 hour, the mice in each experimental group were observed. No irritation signs or allergic reactions were observed in any of the experimental groups. Figure 4 . Figure 4 Image A shows mice before applying the anti-inflammatory, analgesic, antibacterial, and antipruritic hemorrhoid ointment; Image B shows mice 1 hour after applying the ointment; Image C shows mice 1 hour after applying the ointment.

[0113] 6.2 Irritation and Allergy Tests on Volunteer Test Subjects Forty-eight healthy volunteers aged 18-69 (with no history of skin allergies and intact skin on their hands) had an appropriate amount of the anti-inflammatory, analgesic, antibacterial, and antipruritic hemorrhoid ointment from Example 1 applied to the back of their hands. After one hour, no abnormal reactions such as erythema, itching, or blisters were observed in the applied areas of any of the volunteers, indicating that the hemorrhoid ointment has good skin safety and tolerability. Related observation results are shown in [link to relevant observations]. Figure 4 . Figure 4 Image D shows the hemorrhoid cream before application; Image E shows the hemorrhoid cream after application; and Image F shows the hemorrhoid cream 0.5 hours after application.

[0114] 7. Study on the antibacterial effect of anti-inflammatory, analgesic, antibacterial, and antipruritic hemorrhoid ointment The hemorrhoid ointment of this invention and a gel matrix without active ingredients (neither with preservatives) were prepared in the same laboratory on the same day and left exposed at room temperature (35±3)℃ for one month in summer. The results showed that the gel matrix exhibited obvious rancidity and spoilage phenomena such as foul odor and mold spots, while the hemorrhoid ointment of this invention showed no obvious rancidity or spoilage, fully demonstrating its antibacterial and preservative effects. Figure 5 . Figure 5 Figure A shows the image before placement, and Figure B shows the image after placement. Figure 5 In Figure A, the left side represents the hemorrhoid ointment prepared in Example 1, and the right side represents the gel matrix.

[0115] 8. Examination of microstructure and fineness A small amount of the anti-inflammatory, analgesic, antibacterial, and antipruritic hemorrhoid ointment prepared in Example 1 was applied to a glass slide, covered with a coverslip, and gently pressed into a thin film of suitable thickness. Under a microscope, the ointment was observed to be evenly dispersed, with moderate consistency, and easy to apply. Figure 5 . Figure 5 Image C is a 200x magnified view; Image D is a 400x magnified view.

[0116] 9. Permeability test of anti-inflammatory, analgesic, antibacterial, and antipruritic hemorrhoid ointment Prepare a 1% agar aqueous solution containing 8% ferric ammonium sulfate colorimetric reagent. Add the solution to two test tubes and fill each tube with an equal amount of the hemorrhoid ointment prepared in Example 1 through a 30mm gap at the top. Figure 6 Sample No. 1 in Figures A, B, and C) and Mayinglong Musk Hemorrhoid Cream ( Figure 6 (Sample No. 2 in Figures A, B, and C). The height of the chromogenic zone was measured over time. A straight line was fitted with the square of the chromogenic zone as the ordinate (Y) and time as the abscissa (X). The slope of the regression equation is the diffusion coefficient. The results are as follows: Figure 6 As shown in Figure D, the results indicate that the regression equation for the hemorrhoid ointment prepared in Example 1 is Y = 0.4681X + 1.683 (diffusion coefficient = 0.4681, R² = 0.9628), while that for Ma Yinglong cream is Y = 0.1473X + 0.2395 (diffusion coefficient = 0.1473, R² = 0.861). Because the hemorrhoid ointment of this invention has a larger diffusion coefficient, it proves that its permeability and speed of action are superior to Ma Yinglong Musk Hemorrhoid Cream.

[0117] There were no significant differences in the results of Examples 1, 2, and 3 in Experiments 3-9. Only the results of Example 1 are attached.

[0118] 10. Investigation on the therapeutic effect of the ointments prepared in Examples 1-3 and Comparative Examples 2-4 on an acetic acid-induced rat hemorrhoid model. 10.1 Grouping, Modeling, and Drug Administration Methods After one week of acclimatization, SD rats were randomly divided into four groups: control (Con), model (Ace), positive control (MYL), low-dose hemorrhoid ointment prepared in Example 1 (HOL), high-dose hemorrhoid ointment prepared in Example 1 (HOH), comparative group 2, comparative group 3, and comparative group 4, with eight rats in each group. The hair around the anus of all rats was shaved. Except for the Con group, 0.06 mL of 75% acetic acid solution was injected into the perianal area of ​​the rats to establish a rat perianal inflammation model (simulating the pathological characteristics of hemorrhoids). The dosage was determined through preliminary experiments. Starting from day 2 after modeling, hemorrhoid ointment was applied to the anus of the rats at a fixed time for 7 consecutive days. The dosage was 1.65 g / rat for the MYL group, 2.50 g / rat for the HOL group, 5.00 g / rat for the HOH group, and 5.00 g / rat for the corresponding hemorrhoid ointment in comparative groups 2, 3, and 4. The hemorrhoid condition of the rats in each group was observed and photographed 1 hour after administration on day 7. There were no significant differences in the results of Examples 1, 2, and 3. Only the results of Example 1 are attached. The results of the following animal experiments are also similar.

[0119] Rats were then anesthetized via intraperitoneal injection of 20% ethyl carbamate solution (0.5 mL / 100 g body weight), and blood was collected using the ocular blood sampling method. The blood was centrifuged at 3500 rpm for 15 min at 4°C, and the serum was separated and stored at -80°C. Rats were euthanized by cervical dislocation, and organs such as the adrenal gland, thymus, spleen, and rectum were quickly harvested. Surrounding connective tissue was removed, and the organs were rinsed with physiological saline, blotted dry with filter paper, and weighed. The organ index was calculated. The organ index was calculated as follows: organ weight (g) / animal body weight (g) × 100%; rectal-anal coefficient (%) = rectal tissue weight (g) / rat body weight (g) × 100%. The effects of the HOL and HOH groups on organs related to inflammatory responses, such as the adrenal gland, thymus, spleen, and rectum, were investigated.

[0120] 10.2 Effects of hemorrhoid ointment on hemorrhoid condition in rats Observation after drug administration during modeling showed (e.g.) Figure 7 As shown in the figure): Compared with the Con group, the Ace group rats showed significant hemorrhoid symptoms, with obvious perianal swelling accompanied by mucus secretion and erosion. Compared with the Ace group, the MYL, HOL, and HOH groups showed reduced ulcer area and severity, and improved symptoms such as mucus secretion and erosion. Furthermore, the ulcers in the HOH group were milder than those in the HOL group, indicating that this hemorrhoid ointment can relieve hemorrhoid symptoms. Comparative examples 2-4 showed significantly less relief from hemorrhoids than the HOH group, and even the relatively better-performing comparative example 4 only approached the effect of the HOL group.

[0121] 10.3 Effect of hemorrhoid ointment on the rate of change in rat body weight The rats were weighed on days 3, 5, and 8 after modeling, and the rate of change in rat body weight was calculated.

[0122] Weight change rate (%) = (Weight on a certain day after modeling - Weight before modeling) / Weight before modeling × 100%.

[0123] Before modeling, there was no statistically significant difference in body weight among the groups. Table 1 shows that from day 3 to 8 after modeling, the Con group rats exhibited normal growth and development, with their body weight gradually increasing. On day 3, the Ace group showed a negative rate of change in body weight (…). p< 0.05), on days 5 and 8, the rate of weight change in the Ace group increased slowly ( p< The result was 0.01, indicating that the acetic acid-induced hemorrhoid model was successfully established. On days 5 and 8 after medication, the weight gain in the MYL and HOH groups was significantly greater than that in the Ace group. p< 0.05 or p <0.01). This indicates that the hemorrhoid ointment can alleviate weight loss in rats caused by hemorrhoids.

[0124] Table 1. Effects on the rate of change in body weight in rats (n=8, x ± SD)

[0125] Note:* p< 0.05, ** p< 0.01 vs. Con group; # p< 0.05, ## p< 0.01 vs. Ace Group.

[0126] 10.4 Changes in organ indices and rectal-anal coefficients in different groups of rats Adrenal glands, thymus, spleen, and rectal tissue were collected, and organ indices and rectal-anal coefficients were calculated.

[0127] Organ index (%) = organ mass (g) / rat body weight (g) × 100%; Rectal-anal coefficient (%) = Rectal tissue weight (g) / Rat body weight (g) × 100%.

[0128] The study investigated the effects of the HOL and HOH groups on organs related to inflammatory responses, such as the adrenal glands, thymus, spleen, and rectum.

[0129] As shown in Table 2, there were no significant changes in the thymus and adrenal gland indices among the groups. p >0.05). Compared with the Con group, the spleen index and rectal-anal coefficient were significantly increased in the Ace group ( p< 0.05 or p< 0.01). Compared with the Ace group, the spleen index and rectal-anal coefficient were significantly lower in the MYL, HOL, and HOH groups. p< 0.05); compared with the HOL group, there was no significant difference in spleen index and rectal-anal coefficient in the HOH group rats ( p >0.05). This indicates that the hemorrhoid ointment can alleviate the increase in spleen index and rectal-anal coefficient caused by the modeling process.

[0130] Table 2. Effects on organ index and rectal-anal coefficient in rats (n=8, x ± SD)

[0131] Note:* p< 0.05, ** p< 0.01 vs. Con group; # p< 0.05, ## p< 0.01 vs. Ace Group.

[0132] 10.5 Histopathological observation of rat anal and rectal tissue Rat anal and rectal tissues were collected, fixed in 10% formaldehyde, dehydrated in a gradient manner, embedded in paraffin, and then prepared into tissue sections using a microtome and attached to glass slides. After drying, dewaxing and rehydration, the sections were stained with hematoxylin-eosin (HE) solution and observed and analyzed under an optical microscope to identify histopathological changes in each group.

[0133] Depend on Figure 8 As shown in Figure A, the perianal mucosal epithelium of rats in group Con was intact and morphologically normal. Group Ace showed significant pathological changes, including active angiogenesis, enlarged endothelial cell nuclei, dense aggregation of inflammatory cells, and loose peripheral matrix. Compared to group Ace, groups MYL, HOL, and HOH showed reduced tissue erosion, denser cell arrangement, near-normal mucosal epithelium, and reduced inflammatory cell infiltration. Furthermore, the inflammatory cell infiltration was even less in group HOH than in group HO, indicating that this hemorrhoid ointment alleviates hemorrhoid-related tissue erosion and reduces inflammatory cell infiltration.

[0134] 10.6 Changes in serum NO, IL-6, IL-17, VEGF and MMP-3 levels in different groups of rats Remove the serum stored at -80℃ and allow it to return to room temperature. Then, measure the levels of NO, IL-6, IL-17, VEGF, and MMP-3 in the serum of each group of rats according to the ELISA kit instructions.

[0135] Depend on Figure 8 As shown in Figure B, compared with the Con group, the NO content in the Ace group increased significantly. p <0.01); Compared with the Ace group, the NO content in the MYL, HOL, and HOH groups was significantly decreased ( p <0.01). This indicates that the hemorrhoid cream can reverse the increase in NO levels caused by acetic acid. Figure 8 ** in Figure B** p< 0.01 vs. Con group, ## p< 0.01 vs. Ace Group.

[0136] Depend on Figure 9 It can be seen that, compared with the Con group, the levels of IL-6, IL-17, VEGF, and MMP-3 in the Ace group were all significantly increased. p <0.01); Compared with the Ace group, the levels of IL-6, IL-17, VEGF, and MMP-3 in the MYL, HOL, and HOH groups were significantly decreased ( p <0.05 or p <0.01); Compared with the HOL group, the MMP-3 content in the HOH group was significantly decreased ( p<0.05). This indicates that the hemorrhoid ointment can reduce the elevated levels of IL-6, IL-17, VEGF, and MMP-3 caused by acetic acid, suggesting that the anti-inflammatory and swelling-reducing effects of the hemorrhoid ointment are achieved by inhibiting the release of inflammatory factors. Furthermore, the hemorrhoid ointments in Comparative Examples 2-4 showed significantly lower reductions in these four inflammatory factors compared to the high-dose group in Example 1, only approaching or falling below the low-dose group. Figure 9 middle** p <0.01 vs. Con group; # p <0.05, ## p <0.01 vs. Ace Group; $ p <0.05 vs HOL group.

[0137] Depend on Figure 7 and Figure 9 The results already show that the hemorrhoid ointment in Comparative Examples 2-4 is not as effective as the hemorrhoid ointment in Example 1 in terms of anti-inflammatory and swelling-reducing effects. Therefore, no further investigation of other indicators will be conducted on Comparative Examples 2-4.

[0138] 10.7 Effects on the levels of MDA, GSH, T-SOD and CAT in rat serum Remove the serum stored at -80℃, allow it to warm to room temperature, and measure the levels of MDA, GSH, T-SOD, and CAT in the serum of each group of rats according to the kit instructions.

[0139] Depend on Figure 10 It can be seen that the MDA content in the Ace group was significantly higher than that in the Con group. p <0.01), the contents of GSH, CAT, and T-SOD were all significantly reduced ( p <0.01); the MDA content in both the MYL and HOH groups was significantly lower than that in the Ace group ( p <0.01), the levels of GSH, CAT, and T-SOD all increased significantly ( p <0.01%, the HOL group significantly reduced the MDA content ( p <0.01, significantly increasing GSH and T-SOD levels ( p <0.01); Compared with the HOL group, the MDA content in the HOH group was significantly decreased, while the CAT content was significantly increased ( p <0.05). This indicates that the hemorrhoid cream can reduce the increase in MDA content caused by acetic acid and reverse the decrease in GSH, T-SOD, and CAT content caused by acetic acid. This suggests that the hemorrhoid cream exerts its anti-inflammatory and swelling-reducing effects by inhibiting oxidative stress. Figure 10 middle** p <0.01 vs.Con group; ## p <0.01 vs. Ace Group; $ p <0.05 vs HOL group.

[0140] 10.8 Effects on the levels of Vitamin C and T-CHO in the adrenal glands of rats Rat adrenal glands frozen at -80℃ were thawed to room temperature, and physiological saline with a volume equivalent to 9 times the tissue weight was added. The mixture was manually homogenized in an ice-water bath, then centrifuged at 12,000 rpm for 10 min at 4℃. The supernatant was collected to obtain a 10% homogenate. The contents of Vitamin C and T-CHO were determined according to the kit instructions.

[0141] Depend on Figure 11 As shown in Figures A and B, after rats were given subcutaneous acetic acid injections into the anus, the levels of Vitamin C and T-CHO in the adrenal glands of rats in the Ace group were significantly increased compared to the Con group. p <0.01 indicates successful model establishment. Compared with the Ace group, the contents of Vitamin C and T-CHO in the MYL and HOH groups were significantly decreased ( p <0.01 or p <0.05%, the HOL group only significantly reduced the vitamin C content ( p <0.01). This suggests that the mechanism by which this hemorrhoid ointment improves hemorrhoids in rats may be related to the HPA axis (the adrenal gland is a key target organ of the HPA axis, and changes in its levels of Vitamin C and T-CHO can reflect changes in HPA axis activity). Figure 11 Figures A and B in the middle section** p <0.01 vs. Con group; # p <0.05, ## p <0.01 vs. Ace Group.

[0142] 11. Study on the anti-inflammatory, analgesic, antibacterial, and antipruritic effects of hemorrhoid cream. C57 mice were randomly divided into four groups: Con (blank) group, Mod (model) group, HOL (low-dose hemorrhoid cream prepared in Example 1) group, and HOH (high-dose hemorrhoid cream prepared in Example 1) group, with eight mice in each group. The dosage was determined based on preliminary experimental results. The HOL group received 0.5 g / kg, and the HOH group received 1.0 g / kg, applied to the shaved area on the back of the mice, once daily for 7 consecutive days at a fixed time. One hour after administration on day 7, mice in the Con group received a subcutaneous injection of 0.1 mL of physiological saline in their backs, while mice in the Mod, HOL, and HOH groups received a subcutaneous injection of 0.1 mL of 0.05% histamine solution. Within 30 minutes, the number of times the mice in each group scratched was observed and recorded according to the pruritus behavior criteria (scratching the head with forepaws, scratching the trunk with hind paws, or licking / biting various parts of the body).

[0143] Depend on Figure 11 As shown in Figure C, compared with the Con group, the Mod group mice had a significantly higher number of itching episodes. p <0.01); The number of itching episodes in the hemorrhoid cream group was significantly lower than that in the Mod group ( p <0.01); compared with the HOL group, the number of itching episodes in the HOH group mice was significantly reduced ( p The value <0.05 indicates that the anti-inflammatory, analgesic, antibacterial, and antipruritic hemorrhoid cream has an antipruritic effect, and this effect may be dose-dependent. Figure 11 In the middle C diagram** p <0.01 vs. Con group; ## p <0.01 vs. Mod group; $ p <0.05 vs. HOL group.

[0144] 12. Study on the analgesic effect of anti-inflammatory, analgesic, antibacterial, and antipruritic hemorrhoid ointment C57 mice were randomly divided into four groups: Con (blank) group, Mod (model) group, HOL (low-dose hemorrhoid cream prepared in Example 1) group, and HOH (high-dose hemorrhoid cream prepared in Example 1) group, with eight mice in each group. The dosage was determined based on preliminary experimental results. The HOL group received 0.5 g / kg, and the HOH group received 1.0 g / kg, applied evenly to the shaved area on the back of the mice, once daily for 7 consecutive days at a fixed time. One hour after administration on day 7, mice in the Con group were injected intraperitoneally with 0.1 mL / 10 g saline, while mice in the Mod, HOL, and HOH groups were injected intraperitoneally with 0.1 mL / 10 g 0.7% acetic acid solution. The number of writhing responses was recorded within 20 minutes. A single complete movement of hind limb and trunk extension, abdominal contraction, and hip elevation was counted as one response.

[0145] Depend on Figure 11As shown in Figure D, compared with the Con group, the Mod group mice had a significantly higher number of writhing responses. p <0.01); the number of writhing responses in mice in the HOL and HOH groups was significantly lower than that in the Mod group ( p <0.01); Compared with the HOL group, the number of writhing responses in the HOH group mice was significantly reduced ( p The result was <0.01, indicating that the anti-inflammatory, analgesic, antibacterial, and antipruritic hemorrhoid ointment has an analgesic effect, which may be dose-dependent. Figure 11 ** in the middle D diagram** p <0.01 vs. Con group; ## p <0.01 vs. Mod group; $$ p <0.01 vs. HOL group.

[0146] 13. Comprehensive evaluation of the effects of hemorrhoid cream The efficacy of the three batches of hemorrhoid ointment prepared in Example 1 was evaluated according to Table 3. A subjective rating method was used, selecting 48 volunteers aged 24-76 years as trial subjects. They were randomly divided into three groups, and each group applied one of the three batches of hemorrhoid ointment to their skin three times a day for a total of 12 days. The total score for each effect was 10 points: 10 points was the highest score, indicating very good; 8 points was good; 6 points was acceptable; and below 6 points was unacceptable. The following are the average scores for each item.

[0147] Table 3 Overall Effect Evaluation

[0148] In summary, the average physical user experience score of the three batches of hemorrhoid cream was 9.2-10 points, indicating that the product has suitable viscosity, is fine and even with good gloss, is easy to spread, absorbs quickly, and feels comfortable on the skin. Combined with the results of previous animal experiments, this anti-inflammatory, analgesic, antibacterial, and antipruritic hemorrhoid cream also has good anti-inflammatory, swelling-reducing, analgesic, antibacterial, and antipruritic effects, and promotes local skin repair for hemorrhoids.

Claims

1. An anti-inflammatory analgesic anti-bacterial anti-itching hemorrhoid cream, characterized in that, Comprise the following components: Rosemary oil, aloe oil, sea buckthorn oil, perilla seed oil, emu oil, pine needle oil, and hexen root supernatant concentrate, excipients for ointment preparation and pharmaceutically acceptable excipients.

2. The anti-inflammatory, analgesic, anti-bacterial and anti-itching hemorrhoid cream according to claim 1, characterized in that, Also comprise at least one of the following components: eucalyptus oil, rosehip oil, shea nut oil, peppermint oil, borage oil, citronella oil, almond oil, snake oil, beeswax, frankincense alcohol extract, sanchi alcohol extract, soapstick alcohol extract, yunnan baneberry water extract, mugwort leaf alcohol extract, sophora flower alcohol extract, sophora flavescens water extract, radix styrax water extract, radix violae water extract, raw ginger extract, allantoin, berberine.

3. The anti-inflammatory, analgesic, anti-bacterial and anti-itching hemorrhoid cream according to claim 2, characterized in that, The excipients for ointment preparation include composite emulsifier AC-402, sebik 305, gel forming agent QM, ice crystal forming agent AVC and water; The pharmaceutically acceptable excipients include at least one of borneol, lapis calaminaris, sodium alginate, 1,2-propanediol, essence, sodium benzoate.

4. The anti-inflammatory, analgesic, anti-bacterial and anti-itching hemorrhoid cream according to claim 3, characterized in that, The essence is selected from one or more of osmanthus fragrans essence, cucumber essence, lily essence, rose essence, lemon essence, lavender essence.

5. The anti-inflammatory, analgesic, anti-bacterial and anti-itching hemorrhoid cream according to claim 3, wherein The eucalyptus oil, rosehip oil, shea nut oil, rosemary oil, peppermint oil, aloe oil, borage oil, citronella oil, sea buckthorn oil, almond oil, snake oil, beeswax, perilla seed oil, emu oil, pine needle oil, composite emulsifier AC-402, sebik 305, frankincense alcohol extract, sanchi alcohol extract, soapstick alcohol extract, yunnan baneberry water extract, mugwort leaf alcohol extract, sophora flower alcohol extract, sophora flavescens water extract, radix styrax water extract, radix violae water extract, raw ginger extract, borneol, allantoin, lapis calaminaris, berberine, and hexen root supernatant concentrate, gel forming agent QM, sodium alginate, ice crystal forming agent AVC, 1,2-propanediol, water, essence, the liquid ratio is 0.3-1.2mL:0.6-1.5mL:0.6-1.6g:0.4-1.3mL:0.2-1.2mL:0.8-1.7mL:0.5-1.5mL:0.4-1.3mL:0.3-1.2mL:0.5-1.1mL:0.5-1.5g:0.2-1.2g:0.4-1.3g:0.5-2.0g:0.2-1.3mL:0.1-1.3g:0.1-1.5g:0.1-1.2mL:0.5-1.5mL:0.1-1.7mL:0.3-1.3mL:0.1-1.5mL:0.5-1.8mL:0.5-1.5mL:0.3-1.5mL:0.1-1.3mL:0.3-1.0mL:0.3-1.5mL:0.1-1.2mL:0.1-1.3mL:0.01-0.5g:0.01-0.5g:0.01-0.3g:0.05-0.3g:0.05-0.4g:1.0-5.0g:0.1-1.0g:1.0-6.0g:3.0-15.0mL:233.0-1250.0mL:0.01-0.10mL.

6. A process for the preparation of an anti-inflammatory, analgesic, antiseptic and antipruritic haemorrhoidal cream as claimed in any one of claims 1 to 5, characterised in that, Includes the following steps: (1) Sodium alginate was dissolved in water to obtain sodium alginate gel solution; gel forming agent QM was dissolved in water to obtain gel forming agent QM gel solution; ice crystal forming agent AVC was dissolved in water to obtain ice crystal forming agent AVC gel solution; (2) Take eucalyptus oil, rosehip oil, calendula infused oil, peppermint oil, aloe vera oil, lemongrass oil, pine needle oil, borage oil, sea buckthorn oil, almond oil, beeswax, shea butter, emu oil, perilla seed oil and snake oil according to the proportions, heat and stir to mix well to obtain the oil phase; (3) Weigh out composite emulsifier AC-402 and Sepick 305, heat and disperse them in water to obtain an aqueous phase; (4) After the oil phase and the water phase are heated to the same temperature, the water phase is slowly added to the oil phase and stirred to form a uniform emulsion, thus obtaining the emulsion matrix; (5) Take the prescribed amounts of frankincense alcohol extract, Panax notoginseng alcohol extract, Gleditsia sinensis thorn alcohol extract, Centella asiatica water extract, Artemisia argyi alcohol extract, Sophora japonica alcohol extract, Sophora flavescens water extract, Phellodendron chinense alcohol extract, Galla chinensis alcohol extract, Stemona japonica alcohol extract, Viola yedoensis water extract, Portulaca oleracea water extract, fresh ginger extract, borneol, allantoin, calamine, berberine from Coptis chinensis and the supernatant of the root, stir and mix evenly to obtain liquid A; (6) Weigh out the prescribed amount of sodium benzoate, add 1,2-propanediol and water, stir to dissolve and obtain a preservative solution; (7) Add liquid A to the emulsion matrix and stir to mix evenly. While stirring continuously, slowly add gel forming agent QM gel liquid, sodium alginate gel liquid, ice crystal forming agent AVC gel liquid, preservative solution and fragrance in sequence and stir to mix evenly to obtain hemorrhoid ointment.

7. The process for preparation of anti-inflammatory, analgesic, anti-bacterial and anti-itching hemorrhoid cream as claimed in claim 6, wherein, In step (5), the method for preparing the concentrated supernatant of the root is as follows: Extract the root powder of *Hemiberle Root* by heating and reflux with water. Filter the extract and collect the supernatant. Concentrate the supernatant to 8-15 times the mass of the root powder. The concentrated supernatant was mixed with an ethanol-water solution to achieve a final ethanol concentration of 60-85%, and then subjected to alcohol precipitation. The mixture was filtered, and the filtrate was concentrated and dried to obtain the supernatant concentrate.

8. The process for preparation of anti-inflammatory, analgesic, anti-bacterial and anti-itching hemorrhoid cream as claimed in claim 6, wherein, In step (5), the frankincense alcohol extract, Panax notoginseng alcohol extract, Gleditsia sinensis alcohol extract, Artemisia argyi alcohol extract, Sophora japonica alcohol extract, Phellodendron amurense alcohol extract, Gallnut alcohol extract, and Stemona japonica alcohol extract are all prepared by soaking and extracting at least once with a 40-80% ethanol aqueous solution.

9. The process for preparation of anti-inflammatory, analgesic, anti-bacterial and anti-itching hemorrhoid cream as claimed in claim 6, wherein, The method for preparing the calendula infused oil is as follows: After mixing calendula petals with 12-20 times their weight of olive oil, extract the mixture for 0.5-1.5 hours at an ultrasonic frequency of 20,000-40,000 Hz. Let it stand and soak at room temperature for 7-15 days, shaking or stirring the mixture during this period. Then filter the mixture and collect the filtrate to obtain calendula infused oil.

10. The process for preparation of anti-inflammatory, analgesic, anti-bacterial and anti-itching hemorrhoid cream as claimed in claim 6, wherein, In step (1), the ratio of sodium alginate to water is 0.1-1.0g:10-100mL; the ratio of gel forming agent QM to water is 1.0-5.0g:100-500mL distilled water; and the ratio of ice crystal forming agent AVC to water is 1.0-6.0g:100-600mL. The temperatures of both the aqueous and oil phases are 70-90℃; The volume ratio of 1,2-propanediol to water is 3.0-15.0:8.0-20.0; The amount of sodium benzoate added is 0.05-0.15% of the total prescription amount by mass percentage. The amount of sodium benzoate added is 0.05-0.15% of the total prescription amount by mass percentage.

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