Postoperative traditional Chinese medicine composition for treating haemorrhoids and preparation method of postoperative traditional Chinese medicine composition
By preparing a suppository containing Chinese herbal ingredients such as Coptis chinensis, which directly acts on the lesions after hemorrhoid surgery, the treatment of various complications after hemorrhoid surgery has been solved, achieving rapid and safe treatment results and reducing patients' pain and recovery time.
Patent Information
- Application Number
- CN202511887451.6
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-12-15
- Publication Date
- 2026-02-24
AI Technical Summary
The lack of effective, safe, and easy-to-use traditional Chinese medicine products for treating various complications after hemorrhoid surgery has affected patients' postoperative recovery.
A traditional Chinese medicine composition containing Coptis chinensis, Phellodendron chinense, bear bile, rhubarb, Sanguisorba officinalis charcoal, Schizonepeta tenuifolia charcoal, Galla chinensis, dragon's blood, mother-of-pearl, calamine, Angelica dahurica, borneol, and artificial musk is formulated into suppositories. By unblocking the meridians and promoting blood circulation, it achieves a three-dimensional treatment of clearing heat and detoxifying, cooling blood and stopping bleeding, reducing swelling and promoting tissue regeneration.
This traditional Chinese medicine composition acts directly on the lesion site in suppository form, quickly and effectively relieving postoperative pain, bleeding, swelling and other complications of hemorrhoid surgery. It has few side effects, is suitable for a wide range of people, and the drug stays at the affected area for a long time, reducing the frequency of administration and improving patient compliance.
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Abstract
Description
[0001] A traditional Chinese medicine composition for treating hemorrhoids after surgery and its preparation method Technical Field
[0003] This invention belongs to the field of traditional Chinese medicine composition technology, specifically relating to a traditional Chinese medicine composition for treating hemorrhoids after surgery and its preparation method. Background Technology
[0005] Hemorrhoids, commonly known as piles, are a common anorectal disease caused by congestion or stagnation of the venous plexus in the anal canal or lower rectum, leading to swelling. Based on their location relative to the anus, hemorrhoids can be classified into external hemorrhoids, internal hemorrhoids, and mixed hemorrhoids. Causes of hemorrhoids include anal cushion prolapse, varicose veins, poor bowel habits, chronic diseases, a low-fiber diet, prolonged sitting or standing, pregnancy, and childbirth. Some hemorrhoids may be asymptomatic, but common symptoms include rectal bleeding, anal itching, pain, protrusion and swelling, and difficulty defecating.
[0006] Treatment methods for hemorrhoids include lifestyle and dietary changes, medication, sclerotherapy, rubber band ligation, infrared coagulation therapy, and ultrasound-guided hemorrhoidal artery ligation. It's important to note that non-surgical treatment is the primary approach for hemorrhoids, while surgery may be considered for grade II or higher hemorrhoids or recurrent hemorrhoids. With timely intervention and early treatment, hemorrhoids can usually be cured with a good prognosis.
[0007] Currently, hemorrhoid patients requiring surgical treatment in clinical practice do indeed have more severe symptoms than those who do not undergo surgical treatment, and the likelihood of postoperative complications is significantly increased. For example, pain, edema, bleeding, and constipation are common complications after hemorrhoid surgery. These complications directly or indirectly affect the patient's normal postoperative recovery and have become one of the most challenging problems faced by surgeons. Surgeons typically treat these complications with medication. For instance, when postoperative edema occurs, sitz baths with potassium permanganate solution can be used to reduce swelling. Simultaneously, prolonged sitting or standing should be avoided to reduce pressure on the wound. If postoperative pain is severe, painkillers such as ibuprofen can be taken for pain relief. If there is bleeding from the wound, local pressure can be applied to stop the bleeding. If it is arterial bleeding, a second surgery to ligate the bleeding vessel may be necessary. These treatments only address a single complication, and some may even require a second surgery, causing significant physical and psychological harm to the patient.
[0008] In recent years, traditional Chinese medicine (TCM) has received increasing attention in the treatment of hemorrhoids. TCM treats hemorrhoids by unblocking meridians, promoting qi and blood circulation, and relieving pain. Numerous clinical studies have demonstrated that TCM has unique advantages in treating hemorrhoids, such as the comprehensive effects of multiple components and pathways, fewer side effects, and less harm to the body.
[0009] Traditional Chinese medicine (TCM) has a long history of understanding hemorrhoids, which are referred to as "zhēn" or "zhēn dì" in TCM. It is believed to be closely related to damp-heat accumulation, qi stagnation and blood stasis, and dysfunction of the internal organs. With the deepening of modern research in TCM, more and more prescriptions are being proven to help reduce the size of hemorrhoids and decrease bleeding, showing promising prospects for hemorrhoid treatment.
[0010] However, while there are numerous traditional Chinese medicine products on the market for treating hemorrhoids, there are relatively few products specifically for treating postoperative complications. Therefore, developing a safe, effective, and easy-to-use traditional Chinese medicine product that can treat various postoperative complications of hemorrhoid surgery is of great significance for improving the quality of life for hemorrhoid patients after surgery. Summary of the Invention
[0012] To address the existing problem of how to develop a safe, effective, and convenient traditional Chinese medicine product that can treat various complications after hemorrhoid surgery, this invention provides a traditional Chinese medicine composition and preparation method for treating hemorrhoid surgery.
[0013] The technical solution adopted in this invention is as follows:
[0014] A traditional Chinese medicine composition for treating post-hemorrhoid surgery, comprising the following components by weight:
[0015] 9-11 parts of Coptis chinensis;
[0016] 9-11 parts of Phellodendron bark;
[0017] Bear bile 9-11 parts;
[0018] 9-11 parts rhubarb;
[0019] 19-21 parts of charred Sanguisorba officinalis;
[0020] 19-21 parts of catnip charcoal;
[0021] Gallnut 5-7 parts;
[0022] 20-22 parts of dragon's blood;
[0023] Mother-of-pearl 19-21 parts;
[0024] 19-21 parts calamine;
[0025] Angelica dahurica 9-11 parts;
[0026] 5-7 parts borneol;
[0027] 1-3 parts of artificial musk.
[0028] As a preferred option, the weight ratio of each component is as follows: Coptis chinensis: Phellodendron chinense: Bear bile: Rheum palmatum: Sanguisorba officinalis charcoal: Schizonepeta tenuifolia charcoal: Gallnut: Dragon's blood: Mother-of-pearl: Calamine: Angelica dahurica: Borneol: Artificial musk equals 5:5:5:5:10:10:3:10.5:10:10:5:3:1.
[0029] Preferably, the product, by weight, comprises the following components:
[0030] 100g of Coptis chinensis;
[0031] 100g of Phellodendron bark;
[0032] 100g of bear bile;
[0033] 100g of rhubarb;
[0034] 200g of charred Sanguisorba officinalis;
[0035] 200g of charred catnip;
[0036] Gallnut 60g;
[0037] 210g of dragon's blood;
[0038] Mother-of-pearl 200g;
[0039] 200g of calamine;
[0040] 100g of Angelica dahurica;
[0041] 60g of borneol;
[0042] 20g of artificial musk.
[0043] A method for preparing a traditional Chinese medicine composition for treating hemorrhoids after surgery includes the following steps:
[0044] Step 1: Prepare the raw materials according to the Chinese herbal medicine ingredients and proportions described above;
[0045] Step 2: Crush and sieve the prepared raw materials. The sieved powder should have a mesh size between 200 and 230.
[0046] Step 3: Melt the matrix. Mix the drug powder with the molten matrix to prepare a suppository.
[0047] Preferably, the matrix in step 3 is an oily matrix, the matrix is a semi-synthetic fatty acid glyceride, and the ratio of the matrix to the drug powder is 4:1.
[0048] In summary, due to the adoption of the above technical solution, the beneficial effects of the present invention are:
[0049] (1) This invention provides a new Chinese medicine composition for treating hemorrhoids after surgery. The core of this composition is to dredge the meridians, promote qi and blood circulation and relieve pain. Through a multi-dimensional formulation strategy, it achieves the three-dimensional treatment goal of "clearing heat and detoxifying, cooling blood and stopping bleeding, reducing swelling and promoting tissue regeneration", so as to treat postoperative complications of hemorrhoids.
[0050] (2) The treatment method of suppositories acts directly on the lesion site in the cavity, with direct and sufficient effect. The drug is fast and does not pass through the stomach, blood circulation and liver. It has a rapid onset of action, few side effects, and is suitable for a wide range of people, which can better exert the local therapeutic effect.
[0051] (3) This formula has fewer side effects and is less harmful to the human body. At the same time, the suppository dosage form has good plasticity and temperature adaptability, which can effectively prolong the residence time of the drug at the affected area, enhance the duration of drug efficacy, reduce the frequency of administration, and improve patient compliance. It is especially suitable for patients who are sensitive to postoperative pain and have frequent bowel movements. Detailed Implementation
[0053] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of this application will be clearly and completely described below in conjunction with the embodiments of this application. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments.
[0054] Example
[0055] A traditional Chinese medicine composition for treating post-operative hemorrhoids includes the following components:
[0056] Coptis chinensis: 100g;
[0057] Functions: Coptis chinensis is the principal herb, possessing the functions of purging fire and detoxifying, clearing heat and drying dampness, treating eczema externally, quenching thirst, and regulating the spleen and stomach. Coptis chinensis can penetrate deep into the internal organs to clear heat, and is particularly adept at clearing damp-heat in the middle jiao (spleen and stomach) and lower jiao (large intestine and bladder). Traditional Chinese medicine believes that the core pathogenesis of postoperative complications of hemorrhoids is the obstruction of meridians by damp-heat toxins, resulting in qi and blood stasis, and pain due to obstruction. Coptis chinensis is cold in nature and bitter in taste, and enters the heart, stomach, and large intestine meridians, making it especially suitable for damp-heat type cases accompanied by anal burning, oozing, or bleeding.
[0058] The therapeutic effects of Coptis chinensis on postoperative complications of hemorrhoids are mainly reflected in its astringent, hemostatic, anti-inflammatory, and antibacterial properties. These include: 1. Anti-inflammatory and antibacterial effects: Coptis chinensis contains berberine and other components that can inhibit the release of inflammatory factors. Experiments have shown that berberine has an inhibitory effect on anal infections caused by Staphylococcus aureus and Escherichia coli, reducing surrounding inflammation and providing some prevention of postoperative wound infection. 2. Promoting healing: Coptis chinensis accelerates wound repair by inhibiting inflammatory responses and improving local microcirculation. 3. Astringent and hemostatic effects: Berberine coagulates proteins, forming a protective film and reducing tissue fluid exudation and bleeding.
[0059] Phellodendron bark: 100g;
[0060] Functions: Phellodendron bark is also the principal ingredient, possessing the effects of clearing heat and drying dampness, purging fire and eliminating steaming heat, detoxifying and healing sores, and reducing deficiency heat. In the formula, Coptis chinensis relieves symptoms such as wound exudation and pain caused by surgery.
[0061] The pharmacological effects of Phellodendron bark on postoperative complications of hemorrhoids are mainly reflected in the anti-inflammatory, antibacterial, healing-promoting, and hemostatic effects of its active ingredients. 1. Anti-inflammatory and antibacterial effects: Berberine and other alkaloids in Phellodendron bark can inhibit pathogenic microorganisms such as Staphylococcus aureus and hemolytic streptococci, reduce the release of inflammatory mediators after surgery, and relieve local redness, swelling, heat, and pain. Its bitter and cold properties can clear damp-heat in the intestines, consistent with the pathogenesis of damp-heat stagnation after anorectal surgery. 2. Analgesia and healing promotion: Phellodendron bark reduces pain by decreasing the sensitivity of nerve endings, while stimulating fibroblast proliferation and collagen production, accelerating wound repair. 3. Hemostatic and astringent effects: Phellodendron bark combined with Sanguisorba officinalis and Galla chinensis can cool the blood and stop bleeding, reducing postoperative bleeding. Its astringent effect helps the wound dry and scab over. 4. Immune regulation: Components such as berberine in Phellodendron bark can bidirectionally regulate immune function, inhibit tissue damage caused by excessive immune responses, and enhance the phagocytic capacity of macrophages.
[0062] Bear bile: 100g;
[0063] Functions: Bear bile, as the principal ingredient, has the effects of clearing heat and detoxifying, calming the liver and improving eyesight, relieving wind and stopping spasms, and anti-inflammatory and analgesic. In the formula, bear bile is extremely bitter and cold, which strengthens the effects of clearing heat and detoxifying, relieving spasms and pain, and can quickly relieve anal distension and burning pain.
[0064] The pharmacological effects of bear bile on postoperative complications of hemorrhoid surgery are mainly based on its anti-inflammatory and swelling-reducing properties, as well as its ability to promote wound repair. 1. Anti-inflammatory and swelling-reducing: The bile acids in bear bile can inhibit prostaglandin synthesis, stabilize vascular endothelial cells, reduce capillary leakage caused by inflammation, decrease capillary permeability, and alleviate postoperative tissue edema and inflammatory response. Its antibacterial properties (such as inhibition of Staphylococcus aureus) can prevent wound infection. 2. Promoting wound repair: Bear bile can also improve local microcirculation, accelerate the shedding of necrotic tissue, and stimulate granulation tissue growth. 3. Analgesia: Synergistic components such as borneol can quickly relieve postoperative pain. 4. Hemostatic mechanism: Components such as charred Sanguisorba officinalis can promote platelet aggregation and constrict capillaries, effectively stopping bleeding from the wound. Bear bile is often combined with borneol and mother-of-pearl to enhance its permeability and astringent effects.
[0065] Rhubarb: 100g;
[0066] Functions: As one of the principal herbs, rhubarb has the effects of relieving constipation, reducing internal heat, detoxifying, promoting blood circulation and regulating menstruation. In the formula, rhubarb cleanses the intestines and viscera of stagnation, guides heat and toxins out with feces, and opens up the bowels to allow pathogens to have an outlet.
[0067] The pharmacological mechanism of rhubarb in treating postoperative complications of hemorrhoids is based on its effects on promoting defecation, reducing inflammation and swelling, and clearing heat and detoxifying. Specifically, it can be divided into the following aspects: 1. Promoting defecation and relieving intestinal pressure: Anthraquinone compounds in rhubarb can stimulate intestinal peristalsis, improve defecation difficulties, thereby reducing local pressure on the anus, inhibiting intestinal water absorption, increasing intestinal permeability, forming soft stools, and reducing defecation resistance. 2. Anti-inflammatory and swelling-reducing: Anthraquinone compounds in rhubarb (such as emodin) can inhibit prostaglandin synthesis, reduce capillary permeability, reduce tissue edema and inflammatory response, and its antibacterial properties (such as its inhibitory effect on Staphylococcus aureus) can prevent wound infection. 3. Clearing heat and detoxifying: Rhubarb is bitter and cold in nature, which can clear local heat toxins, cleanse intestinal stagnation, and guide heat toxins out with feces. It is suitable for postoperative redness, swelling, heat, and pain after hemorrhoid surgery, and is often combined with Phellodendron bark and Scutellaria baicalensis to enhance efficacy.
[0068] 200g of charred Sanguisorba officinalis root;
[0069] Functions: As an assistant herb, charred Sanguisorba officinalis has the effects of cooling the blood and stopping bleeding, astringing sores and detoxifying. In prescriptions, charred Sanguisorba officinalis, after being stir-fried until it retains its properties, specifically targets the lower burner, clearing away latent heat in the blood, and is the first choice for treating bloody stools with bright red color.
[0070] The pharmacological mechanism of charred Sanguisorba officinalis in treating postoperative complications of hemorrhoids is as follows: 1. Blood-cooling and hemostatic mechanism: Charred Sanguisorba officinalis is slightly cold in nature and enters the liver and large intestine meridians. After carbonization, its astringent properties are enhanced, which can effectively contract vascular smooth muscle, promote platelet aggregation, and shorten clotting time. Its hemostatic effect on postoperative bleeding is particularly significant, and it is often combined with Sophora japonica and Platycladus orientalis leaves in clinical practice to enhance the effect. Modern research shows that its tannins can inhibit fibrinolysis, reduce capillary permeability, and reduce bleeding. 2. Anti-inflammatory: Charred Sanguisorba officinalis has an inhibitory effect on common wound pathogens such as Staphylococcus aureus and Pseudomonas aeruginosa, and can prevent postoperative infection. 3. Promoting wound healing: Charred Sanguisorba officinalis contains components such as Sanguisorba officinalis saponins, which can stimulate the growth of granulation tissue, accelerate epidermal cell regeneration, reduce scar formation, and promote wound healing.
[0071] Charred catnip: 200g;
[0072] Functions: As one of the auxiliary herbs, charred Schizonepeta tenuifolia has the effects of dispelling wind and cold, anti-inflammatory and antibacterial, relaxing muscles and tendons, promoting rash eruption, eliminating sores, astringing and stopping bleeding, and relieving itching. In the formula, charred Schizonepeta tenuifolia combines pungent dispersing and astringent properties, guiding blood back to its proper channels and preventing excessive cooling.
[0073] The pharmacological mechanism of charred Schizonepeta tenuifolia in treating postoperative complications of hemorrhoids lies in its enhanced astringent and hemostatic properties after carbonization, combined with its wind-dispelling and exterior-releasing effects. Specifically, this manifests in the following ways: 1. Astringent hemostasis and guiding blood back to its proper channels: After being processed by charring, the medicinal properties of charred Schizonepeta tenuifolia change from pungent and warm to bitter and astringent. Its carbonized components can shorten bleeding time and directly constrict blood vessels at the wound site. At the same time, its pungent and dispersing properties are not completely eliminated, which can "guide stagnant blood out of the blood vessels," directing the blood stasis to normal circulation and preventing secondary bleeding caused by blood stasis. This "guiding blood back to its proper channels" effect is particularly important after hemorrhoid surgery, as it can both stop bleeding and prevent local blood stasis. 2. Preventing excessive cooling: Postoperative hemorrhoid surgery often requires cooling the blood to stop bleeding, but excessive cooling may inhibit the circulation of qi and blood. The pungent and dispersing properties of schizonepeta charcoal can neutralize the cold nature of cooling herbs (such as sanguisorba officinalis charcoal and rhubarb), preventing excessive cooling that could hinder blood circulation. Its warming properties can promote wound healing without causing inflammation due to excessive heat and dryness.
[0074] Gallnut: 60g;
[0075] Functions: As one of the auxiliary medicines, gallnut has the effects of relieving cough, diarrhea, sweating, bleeding and promoting wound healing. In the prescription, gallnut has astringent and hemostatic properties, helps wounds heal.
[0076] The pharmacological mechanism of gallnut's effects on postoperative complications of hemorrhoids is based on its astringent, hemostatic, antibacterial, anti-inflammatory, and wound-healing properties. Specifically: 1. Astringent and hemostatic effect: Gallnut is rich in tannins, which can precipitate proteins to form a protective film, constrict blood vessels, and promote platelet aggregation, significantly shortening clotting time and having a direct hemostatic effect on postoperative bleeding after hemorrhoid surgery. Clinically, it is often combined with Sanguisorba officinalis and Sophora japonica to enhance its blood-cooling and hemostatic effects. 2. Antibacterial and anti-inflammatory effects: Gallnut has an inhibitory effect on common perianal pathogens such as Staphylococcus aureus and Escherichia coli, which can reduce the risk of infection. 3. Promotes wound healing: The protective film formed by tannins in gallnut can reduce exudation, stimulate granulation tissue growth, accelerate epidermal cell regeneration, and promote wound repair.
[0077] Dragon's Blood: 210g;
[0078] Functions: As one of the auxiliary medicines, blood dragon has the effects of promoting blood circulation, relieving pain, stopping bleeding and promoting tissue regeneration. In the formula, blood dragon promotes blood circulation, removes blood stasis, relieves pain, and prevents the stagnation from worsening.
[0079] The pharmacological mechanism of dragon's blood in treating postoperative complications of hemorrhoids lies in its ability to promote blood circulation, remove blood stasis, and prevent the aggravation of blood stasis. Specifically: 1. Promoting blood circulation and removing blood stasis: The active ingredients in dragon's blood (such as daphne) can dilate capillaries, promote local blood circulation, and relieve swelling and pain caused by postoperative blood stasis. Its anti-inflammatory effect can inhibit the release of inflammatory mediators such as prostaglandins and reduce tissue congestion. 2. Preventing the aggravation of blood stasis: Dragon's blood has a bidirectional regulatory effect, which can both promote blood circulation and remove blood stasis, and also astringe and stop bleeding, thus preventing blood stasis.
[0080] Mother-of-pearl: 200g;
[0081] Functions: As an adjuvant, mother-of-pearl has the effects of regulating liver fire, relieving anxiety, and improving eyesight. In the formula, calcium-rich preparations absorb exudate and accelerate the growth of granulation tissue.
[0082] The pharmacological mechanism of mother-of-pearl in treating postoperative complications of hemorrhoids lies in its ability to absorb exudate and promote tissue growth. Calcium-rich mother-of-pearl preparations, through their high calcium carbonate content (≥93%) and trace elements, can neutralize the acidic environment of the wound, improve local blood circulation, and eliminate inflammation, thereby promoting granulation tissue growth. Its calcium ions can also activate platelet aggregation and assist in hemostasis, and are commonly used for wounds that heal slowly, such as chronic ulcers and postoperative wounds.
[0083] Calamine lotion: 200g;
[0084] Functions: As an adjuvant, calamine has the effect of drawing out toxins and reducing swelling. In the formula, calamine can treat vulvar sores and prevent secondary infections.
[0085] The pharmacological mechanism of calamine lotion in treating postoperative complications of hemorrhoid surgery lies in its astringent, antipruritic, and mild anti-inflammatory properties, specifically including: 1. Astringent and antipruritic effects: The zinc oxide and zinc carbonate in calamine lotion can absorb exudate around the anus, reducing the irritation of the skin by the moist environment, relieving itching and edema caused by postoperative hemorrhoid surgery, and creating a more stable environment for wound healing. 2. Forming a protective film and assisting in anti-inflammation: Zinc oxide forms a protective film on the skin surface, isolating external irritants (such as fecal friction) and reducing itching. The astringent properties of calamine lotion can indirectly inhibit local inflammatory responses, reduce postoperative redness, swelling, pain, and other inflammatory manifestations of the wound, and help relieve postoperative discomfort.
[0086] Angelica dahurica: 100g;
[0087] Functions: As an adjuvant, it has the effects of dispelling cold and relieving pain, clearing nasal passages, and reducing abnormal secretions. In the formula, Angelica dahurica can dispel wind and relieve pain, and drain pus.
[0088] The pharmacological mechanism of Angelica dahurica in treating postoperative complications of hemorrhoids lies in its ability to dispel wind, relieve pain, reduce swelling, and drain pus. Specifically: 1. Dispelling wind and relieving pain: Angelica dahurica contains volatile oils, coumarins, and other components that can inhibit the release of pain-inducing substances and relieve postoperative wound pain (such as perianal swelling and pain, and postoperative traction pain). 2. Reducing swelling and draining pus: It promotes local blood circulation, reduces postoperative swelling, and assists in wound healing (it has anti-swelling and anti-infection effects on non-ulcerated wounds or postoperative exudative wounds).
[0089] Borneol: 60g;
[0090] As an adjuvant, borneol has the effects of relieving pain and preventing decay, antibacterial and anti-inflammatory properties, clearing heat and relieving pain, clearing away nebula and improving eyesight, and soothing the skin. In the formula, borneol is aromatic, opens the orifices, unblocks the meridians and relieves pain, promotes drug absorption, and enhances efficacy.
[0091] The pharmacological mechanism of borneol in treating postoperative complications of hemorrhoids lies in its aromatic properties of clearing the orifices, promoting blood circulation and relieving pain, and enhancing drug absorption. Specifically: 1. Clearing the orifices and relieving pain: Postoperative hemorrhoids are often accompanied by perianal swelling and pain, as well as pain due to traction on the wound. Borneol's "clearing the orifices and relieving pain" properties can inhibit the release of pain-causing substances, relieve postoperative pain, and reduce patient suffering. 2. Promoting drug absorption: When topical medications are used after hemorrhoid surgery, borneol can enhance the permeability of the medication through the skin / mucous membranes, allowing other healing-aiding drugs (such as anti-inflammatory and tissue-regenerating ingredients) to work more effectively and accelerating wound repair. 3. Aiding in reducing swelling: Borneol's "clearing the orifices" properties can improve local blood circulation, reduce postoperative swelling, and create a more stable environment for wound healing.
[0092] Artificial musk: 20g;
[0093] Functions: As an adjuvant, artificial musk has the effects of opening the orifices and refreshing the mind, promoting blood circulation and regulating menstruation, reducing swelling and relieving pain, improving delirium caused by fever, and treating stroke with phlegm syncope. In the formula, artificial musk is aromatic and opens the orifices, unblocks the meridians and relieves pain, promotes drug absorption, and enhances the therapeutic effect.
[0094] The pharmacological mechanism of artificial musk in treating postoperative complications of hemorrhoids lies in its aromatic properties, ability to clear the meridians and relieve pain, and promotion of drug absorption. Specifically: 1. Clearing the meridians and relieving pain: Postoperative hemorrhoids are often accompanied by perianal swelling and pain, as well as pain from wound traction. The "clearing the meridians and relieving pain" property of artificial musk can inhibit the release of pain-causing substances, alleviate postoperative pain, and reduce patient suffering. 2. Promoting drug absorption: When topical medications are used after hemorrhoid surgery, artificial musk can enhance the permeability of the drug through the skin / mucous membranes, allowing other healing-aiding drugs (such as anti-inflammatory and tissue-regenerating ingredients) to work more effectively and accelerate wound repair. 3. Astringent hemostasis and tissue regeneration: When artificial musk is combined with ingredients such as pearl and calamine, it can promote capillary contraction, reduce the frequency of rectal bleeding, and accelerate wound repair. 4. Assisting in reducing swelling: The "clearing the meridians" property of artificial musk can improve local blood circulation, reduce postoperative swelling, and create a more stable environment for wound healing.
[0095] The interaction mechanism between the components, analyzed from the perspective of the components, is as follows:
[0096] 1. Coptis chinensis, Phellodendron chinense, Rheum palmatum, and bear bile are used as principal herbs. In the pharmacological mechanism of their action on postoperative complications of hemorrhoids, they exert the effects of clearing heat and detoxifying, reducing swelling and relieving pain, cooling blood and stopping bleeding through synergistic effects.
[0097] Specifically, (1) Coptis chinensis and Phellodendron chinense: clear heat and dry dampness, anti-inflammatory and antibacterial. Coptis chinensis (containing berberine) and Phellodendron chinense (containing berberine) are both bitter and cold, which can clear damp heat in the lower burner, inhibit inflammatory response, and reduce congestion and edema. (2) Rheum palmatum: purge heat and promote bowel movement, cool blood and stop bleeding. Raw rheum palmatum contains anthraquinone components, which can stimulate intestinal peristalsis to relieve constipation and improve intestinal pressure. Its tannin components can astringe blood vessels, reduce hematochezia, and reduce constipation. (3) Bear bile: clear heat and detoxify, promote healing. Bear bile powder contains ursodeoxycholic acid, which can inhibit the release of inflammatory factors, relieve swelling and pain, and promote wound repair. The four drugs are used together to clear heat and dry dampness, purge fire and detoxify, and directly target the cause of the disease.
[0098] 2. The charred Sanguisorba officinalis, charred Schizonepeta tenuifolia, Gallnut, and Dragon's Blood are used as assistant herbs, and through synergistic effects, they exert the functions of cooling the blood and stopping bleeding, astringing and reducing swelling, and promoting blood circulation and removing blood stasis.
[0099] Specifically, (1) Burnt Sanguisorba officinalis charcoal and charred Schizonepeta tenuifolia follow the principle of "stir-frying to retain its properties," which enhances hemostasis without harming the stomach qi. Burnt Sanguisorba officinalis charcoal cools the blood and stops bleeding, dispels wind and disperses blood stasis. Burnt Sanguisorba officinalis charcoal (containing tannins) can astringe blood vessels and inhibit bleeding. Charred Schizonepeta tenuifolia (after stir-frying) is warm in nature and can enhance the hemostatic effect. When combined with Burnt Sanguisorba officinalis charcoal, it can balance cold and heat, reduce gastrointestinal irritation, and is suitable for symptoms such as bleeding. (2) Gallnut: astringent and consolidating, antibacterial and anti-inflammatory. Gallnut contains tannic acid, which can coagulate the protein on the wound surface to form a protective film, reduce exudation and bleeding, and promote hemostasis and healing. When combined with Phellodendron chinense to make suppositories, it enhances the anti-inflammatory effect and relieves perianal itching and infection. (3) Dragon's Blood: It promotes blood circulation, removes blood stasis, promotes tissue regeneration and wound healing. Dragon's blood can improve local blood circulation, promote the absorption of blood stasis, relieve postoperative swelling and pain caused by blood stasis, and promote wound repair. When used with the astringent gallnut, it can "both promote blood circulation and astringe" and avoid aggravating blood stasis due to astringency. The four drugs are used together to cool the blood and stop bleeding, and control the main symptoms.
[0100] 3. Mother-of-pearl, calamine, angelica dahurica, borneol, and artificial musk are used as adjuvants. Through synergistic effects, they exert the functions of clearing heat and detoxifying, astringing and stopping bleeding, promoting blood circulation and reducing swelling.
[0101] Specifically, (1) Artificial musk: promotes blood circulation and relieves swelling and pain. Artificial musk contains muscone, which can improve local blood circulation and reduce congestion and edema. When combined with borneol, it can enhance transdermal absorption and quickly relieve pain. (2) Borneol: cool and analgesic, anti-inflammatory and promotes penetration. Borneol (borneol) has local anesthetic and cooling effects, which can quickly relieve anal burning and pain. When combined with artificial musk, it can promote drug penetration and enhance efficacy. (3) Calamine: as an astringent, it can astringe and stop bleeding and protect the wound. Calamine (zinc carbonate) can reduce tissue exudation, relieve anal dampness and itching, and help the wound to dry. When combined with mother-of-pearl, it can enhance the effect of promoting tissue regeneration and healing sores and promote mucosal repair. (4) Mother-of-pearl: promotes tissue regeneration and healing sores, detoxifies and calms the nerves. Mother-of-pearl contains calcium carbonate and trace elements, which can be antibacterial and anti-inflammatory, promote wound healing and accelerate wound healing. When combined with calamine, it can reduce exudation and accelerate the repair of damaged tissue. (5) Angelica dahurica: dispels wind and dries dampness, invigorates blood and relieves pain. Angelica dahurica can improve local microcirculation, reduce inflammatory response, and help reduce postoperative inflammation and edema. When combined with artificial musk, it can enhance the effect of invigorating blood and removing blood stasis, and reduce blood stasis. The five herbs used together reduce swelling and promote tissue regeneration, thus promoting repair.
[0102] This formula is based on the principle of "clearing heat and drying dampness to treat the root cause, cooling blood and stopping bleeding to treat the symptoms, reducing swelling and promoting tissue regeneration to repair damage". Through precise combination of principal, assistant, adjuvant and guide ingredients and innovative suppository process design, it achieves full-process management of "hemostasis-pain relief-promoting healing" after hemorrhoid surgery, and reflects the essence of traditional Chinese medicine surgery treatment of "removing necrotic tissue and promoting tissue regeneration".
[0103] 4. In the formula, charred Schizonepeta (after charring) is warm in nature and can enhance the hemostatic effect. When combined with charred Sanguisorba officinalis, it can balance the cold and heat, reduce gastrointestinal irritation, and simultaneously remove damp heat from the anus, creating better absorption and utilization of other drugs. In traditional Chinese medicine, charred Schizonepeta is considered to have the effects of dispelling wind and cold, stopping bleeding and astringing sores. In the pharmaceutical composition of this invention, when used in combination with other components, it can play the following unique roles.
[0104] Astringent and hemostatic properties: After being roasted, the charred schizonepeta has enhanced astringent properties, which can effectively relieve postoperative bleeding symptoms. Its carbonized components can promote blood clotting in the wound.
[0105] Dispelling wind and dampness: Schizonepeta charcoal is warm in nature and can dispel wind and dampness from the anal area, improving symptoms such as anal distension and itching caused by damp-heat accumulation.
[0106] Promoting blood circulation and removing blood stasis: The charred Schizonepeta tenuifolia has warming properties, improving local blood circulation in hemorrhoids and relieving postoperative swelling and pain.
[0107] Synergistic effects with other medicinal materials:
[0108] Combined with Coptis chinensis and Phellodendron chinense (anti-inflammatory): Schizonepeta tenuifolia charcoal can dispel wind and release the exterior, and stop bleeding, showing good astringent and hemostatic effects for postoperative bleeding. Phellodendron chinense and Coptis chinensis mainly play the role of clearing heat and drying dampness, purging fire and detoxifying, effectively inhibiting inflammatory reactions, reducing redness, swelling, heat and pain of postoperative wounds, and preventing infection. When used together, the hemostatic effect of Schizonepeta tenuifolia charcoal and the anti-inflammatory and antibacterial effects of Phellodendron chinense and Coptis chinensis complement each other, jointly promoting the healing of postoperative wounds.
[0109] With rhubarb: The synergistic effect of charred schizonepeta and rhubarb in treating complications of hemorrhoid surgery lies in the ingenious combination of "one rising and one falling", which can effectively relieve common postoperative problems such as anal swelling and pain, and difficulty in defecation.
[0110] Schizonepeta charcoal is warm in nature and can disperse wind-heat and astringe to stop bleeding, helping to relieve the burning sensation and bleeding in the anus after surgery. Rhubarb is cold in nature and is good at clearing heat and purging fire, promoting bowel movement and removing blood stasis, which can reduce postoperative inflammation, promote intestinal peristalsis and prevent constipation. The two ingredients, one ascending and one descending, can clear heat and promote bowel movement, as well as disperse nodules and reduce swelling, and have a synergistic effect in improving postoperative anal discomfort, pain and edema.
[0111] The core of the treatment of postoperative complications of hemorrhoids with charred catnip and bear bile lies in the fact that one mainly regulates internal bleeding and the other mainly treats external inflammation, thus working together.
[0112] Catnip charcoal is effective for internal hemostasis. It promotes wound clotting by activating the coagulation system and inhibiting fibrinolysis. Its charred components also astringe the wound surface and reduce exudation, showing significant effects on postoperative bleeding and wound exudation. Bear bile, on the other hand, is best used externally. Its heat-clearing, detoxifying, swelling-reducing, and analgesic effects effectively inhibit bacterial infection of the wound, reduce postoperative inflammation and pain, promote granulation tissue growth, and accelerate wound healing.
[0113] The two work together, one internal and one external. The charred catnip improves the coagulation environment from the inside, while the bear bile controls infection and inflammation from the outside, creating favorable conditions for postoperative recovery.
[0114] In treating complications of hemorrhoid surgery, the three herbs—Sanguisorba officinalis charcoal, Sanguisorba officinalis charcoal, and Gallnut—mainly exert their hemostatic, astringent, and wound-healing effects through synergistic action.
[0115] Schizonepeta charcoal can disperse wind-heat and astringe to stop bleeding, helping to relieve postoperative burning sensation and bleeding in the anal area. Sanguisorba officinalis charcoal excels at cooling the blood, stopping bleeding, detoxifying, and astringing sores; its tannins can constrict blood vessels, promote platelet aggregation, shorten bleeding time, and after carbonization, it can also absorb toxins and reduce wound irritation. Gallnut is known for its strong astringent properties; its tannic acid can combine with proteins to form a protective film, astringing the wound, reducing exudation, and accelerating hemostasis.
[0116] When used together, the hemostatic effect of charred Schizonepeta tenuifolia, the blood-cooling and hemostatic effect of charred Sanguisorba officinalis, and the astringent and consolidating effect of Galla chinensis work synergistically to more effectively control postoperative bleeding, reduce wound exudation, and promote wound healing.
[0117] With Dragon's Blood: Schizonepeta charcoal can disperse wind-heat and astringe to stop bleeding, helping to relieve the burning sensation and bleeding in the anal area after surgery. Dragon's Blood is good at promoting blood circulation, removing blood stasis, stopping bleeding and promoting tissue regeneration. Its active ingredients can promote local blood circulation, reduce blood stasis and inflammation, thereby relieving swelling and pain of hemorrhoids, while astringing and stopping bleeding, reducing wound bleeding and promoting tissue repair.
[0118] The combination of the two, one ascending and the other descending, allows the hemostatic effect of charred schizonepeta and the blood-activating, stasis-removing, tissue-regenerating, and wound-healing properties of dragon's blood to work synergistically, which can more effectively control postoperative bleeding, reduce wound exudation, and promote wound healing.
[0119] Combined with Angelica dahurica (for reducing swelling) and Mother-of-Pearl (for repair): Charred Schizonepeta tenuifolia can astringe and stop bleeding, helping to control postoperative wound bleeding. Angelica dahurica excels at reducing swelling and relieving pain; its volatile oil components can effectively reduce local edema and pain in the anal area after surgery. Mother-of-Pearl has calming, sedative, and tissue-regenerating effects, promoting wound repair and reducing the risk of infection.
[0120] When used together, the hemostatic properties of schizonepeta charcoal, the swelling-reducing properties of angelica dahurica, and the astringent and tissue-regenerating properties of mother-of-pearl work synergistically to more effectively control postoperative bleeding, reduce swelling and pain, and promote wound healing.
[0121] Compared to calamine: Nepeta cataria charcoal has astringent and hemostatic properties, helping to control postoperative wound bleeding. Calamine, on the other hand, has astringent and antipruritic effects, promoting wound healing and reducing the risk of infection.
[0122] When used together, the hemostatic properties of schizonepeta charcoal and the astringent and tissue-regenerating properties of calamine lotion work synergistically to more effectively control postoperative bleeding, reduce wound exudation, and promote wound healing.
[0123] With borneol and artificial musk: Charred schizonepeta can astringe and stop bleeding, helping to control postoperative wound bleeding. Borneol has the effects of clearing heat and relieving pain, preventing decay and promoting tissue regeneration, effectively reducing postoperative inflammation and pain, and promoting wound repair. Artificial musk excels at promoting blood circulation, removing blood stasis, reducing swelling and relieving pain; its active ingredients can promote local blood circulation, reduce blood stasis and inflammation, thereby relieving hemorrhoid swelling and pain, while also helping to stop bleeding and promote tissue regeneration.
[0124] When used together, the hemostatic properties of schizonepeta charcoal, the heat-clearing and analgesic properties of borneol, and the blood-activating and stasis-removing properties of artificial musk work synergistically to more effectively control postoperative bleeding, reduce swelling and pain, and promote wound healing.
[0125] With its comprehensive regulatory effects, charred catnip plays a multifaceted role in the formula. It can not only directly treat postoperative complications of hemorrhoids, but also exert a comprehensive effect by working synergistically with other medicinal materials to promote healing, reduce bleeding, relieve pain and edema, promote defecation, and reduce the risk of infection.
[0126] 5. The combination of charred schizonepeta and angelica dahurica, with charred schizonepeta and angelica dahurica respectively possessing hemostatic and astringent properties and reducing swelling and pus drainage effects, allows for both hemostasis and reduction of local edema in the formula, achieving a comprehensive treatment that addresses both the symptoms and the root cause.
[0127] The synergistic effects between the components, based on efficacy analysis, demonstrate the following mechanism of action:
[0128] 1. Clears heat and promotes diuresis
[0129] Coptis chinensis and Phellodendron chinense are both bitter and cold herbs that can clear heat, dry dampness, purge fire, and detoxify. As the principal herbs, they target the cause of the disease. Bear bile clears heat and detoxifies, especially effective for redness and swelling caused by heat toxins. Rhubarb purges heat and promotes bowel movement, guiding damp heat downwards and expelling it through the stool, thus reducing intestinal pressure.
[0130] 2. Reduces swelling and relieves pain
[0131] Angelica dahurica dispels wind and relieves pain, drains pus, and may help reduce inflammation. Borneol and artificial musk are both aromatic and can open the orifices, clear the meridians and relieve pain, promote drug absorption, and enhance efficacy.
[0132] 3. Stops bleeding and promotes tissue regeneration
[0133] Burnt sanguisorba and schizonepeta charcoal belong to the charcoal category and are generally used for hemostasis. Burnt sanguisorba charcoal, in particular, is often used for bleeding in the lower abdomen, such as hematochezia, which aligns with its indication for hematochezia. Calamine, when applied externally, has the effect of absorbing moisture and astringing sores, and can help eliminate edema and secretions.
[0134] In summary, the components of this formula work synergistically to form a comprehensive system of action involving multiple components and pathways. They work together on multiple aspects of the body, employing mechanisms such as clearing heat and dampness, reducing swelling and relieving pain, stopping bleeding and promoting tissue regeneration, to collectively achieve the goal of treating postoperative complications of hemorrhoids. This comprehensive therapeutic effect reflects the holistic concept and syndrome differentiation principles of traditional Chinese medicine, making the formula significantly effective and advantageous in treating postoperative complications of hemorrhoids.
[0135] A method for preparing a traditional Chinese medicine composition for treating hemorrhoids after surgery:
[0136] (1) Raw material preparation
[0137] According to the weight ratio of Example 1, the raw materials were accurately weighed.
[0138] (2) Raw material processing
[0139] The raw materials, including mother-of-pearl, calamine, gallnut, charred sanguisorba officinalis, dragon's blood, charred schizonepeta tenuifolia, borneol, coptis chinensis, phellodendron chinense, rhubarb, angelica dahurica, bear bile, and artificial musk, are pulverized to obtain a powder with a mesh size between 200 and 230.
[0140] (3) Raw material mixing
[0141] The matrix is selected as type 36 semi-synthetic fatty acid glyceride produced by Hubei Weideli Chemical Technology Co., Ltd., which has both suitable hardness and drug release rate. The matrix is heated to 30-40℃, and then the pulverized drug powder and other drug extracts are mixed with the matrix. The mass ratio of matrix to drug is 4:1. This ratio can ensure that the drug is evenly dispersed in the matrix, while ensuring the hardness of the suppository after molding and the comfort during use. When adding, stir until the mixture is uniform.
[0142] (4) Suppository preparation
[0143] The mixture of matrix and drug is injected into a suppository mold (torpedo-type) using injection molding. A water-soluble lubricant is evenly applied to the inner wall of the mold. The hot mixture is then poured into the mold, filling it completely and allowing a slight overflow. The mold is then allowed to cool and solidify completely. The solidified suppository is then ejected from the mold, the overflow portion is trimmed off, and the edges are finished to obtain the final product.
[0144] (5) Quality inspection
[0145] The prepared suppositories undergo quality inspection, including appearance, properties, content determination, and microbial limit testing, to ensure that the formulation quality meets relevant standards.
[0146] (6) Packaging and storage
[0147] The qualified suppositories should be packaged, and the drug name, specifications, usage and dosage, expiration date, storage conditions and other information should be clearly marked. They should be stored in accordance with the prescribed storage conditions to ensure the stability of drug quality.
[0148] By following the above steps, a formulation that meets the requirements can be prepared. In practice, the requirements of the Good Manufacturing Practice (GMP) for pharmaceuticals should be strictly followed to ensure the safety and efficacy of the drug.
[0149] The clinical application data of this traditional Chinese medicine composition are as follows:
[0150] 1. Materials and Methods
[0151] 1.1 General Information
[0152] This study included 240 inpatients with hemorrhoids admitted to our hospital from January 2024 to October 2025. The study group consisted of 68 males and 52 females, aged 25-75 years, with a mean age of (50.00±7.34) years. The control group consisted of 59 males and 61 females, aged 24-76 years, with a mean age of (50.10±7.14) years. General characteristics were comparable between the two groups (P>0.05).
[0153] 1.2 Inclusion and Exclusion Criteria
[0154] Inclusion criteria: (1) Meeting the diagnostic criteria for hemorrhoids in the "Standards for Diagnosis and Efficacy of Diseases and Syndromes in Traditional Chinese Medicine" and the clinical syndrome differentiation is damp-heat syndrome; (2) Age 18-80 years; (3) Voluntary participation in the study; (4) First surgery.
[0155] Exclusion criteria: (1) Accompanied by gastrointestinal infectious diseases, mental illness, diabetes, or severe cardiovascular and cerebrovascular diseases; (2) Severe allergies; (3) Coagulation dysfunction; (4) Pregnant women or women during menstruation; (5) Specific infections; (6) Malignant tumors; (7) Those who have not cooperated with the completion of treatment.
[0156] 1.3 Methods
[0157] The control group used Ma Yinglong Musk Hemorrhoid Suppositories (Wuhan Ma Yinglong Pharmaceutical Group Co., Ltd.; National Drug Approval Number Z42021461; 1.5g / suppository); the study group used the present invention, which is a hospital-prepared formulation provided by the hospital's pharmacy (specification 2g / suppository). Both groups of patients underwent hemorrhoid surgery under local infiltration anesthesia. Postoperatively, the study group received one suppository inserted into the anus, followed by one suppository twice daily (morning and evening). The control group received one Ma Yinglong Musk Hemorrhoid Suppository after surgery, followed by one suppository twice daily (morning and evening). This treatment lasted for one week. During this period, spicy and irritating foods were avoided, and a diet rich in fiber was recommended. Analgesics were contraindicated for 6 hours postoperatively in both groups; after 6 hours, patients experiencing severe pain were given appropriate analgesic treatment.
[0158] 1.4 Observation Indicators
[0159] (1) Efficacy: According to the "Standards for Diagnosis and Efficacy of Diseases and Syndromes in Traditional Chinese Medicine", after treatment, the patient's clinical symptoms (such as rectal bleeding, prolapse of the mass, and a feeling of anal distension) completely disappeared, and the hemorrhoids (hemorrhoid tissue) disappeared or completely shrank, which is considered a cure; the symptoms improved, basically disappeared, and the hemorrhoids shrank or shrank incompletely, which is considered an improvement; the symptoms and signs did not change, which is considered ineffective; the efficacy was statistically analyzed based on the number of cured and improved cases.
[0160] (2) Pain scores at 6 hours, 24 hours, and 1 week post-operation, and visual analog scale (VAS) scores were recorded. The total score was 10 points, with lower scores being better. Bleeding, edema, and urinary retention were assessed at 6 hours and 24 hours post-operation. The total score for bleeding and edema was 3 points, with lower scores being better. The total score for urinary retention was 6 points, with higher scores being better.
[0161] (3) Collect 2 mL of peripheral venous blood and use a fully automated biochemical analyzer to detect liver function aspartate aminotransferase and alanine aminotransferase.
[0162] Table 1 Visual Analogue Pain Rating Scale
[0163]
[0164] Table 2 Assessment Table for Postoperative Bleeding and Edema after Hemorrhoid Surgery
[0165]
[0166] Table 3. Postoperative Urinary Retention Assessment Form for Hemorrhoid Surgery
[0167]
[0168] 1.5 Statistical Analysis
[0169] SPSS 23.0 was used for analysis. The continuous data conformed to a normal distribution, with ( The mean ± standard deviation (x̄ ± s) represents the categorical data, which, after a t-test, are expressed 2 Tests are expressed as percentages (%), and a statistically significant difference is defined as P < 0.05.
[0170] 2 Results
[0171] 2.1 Comparison of therapeutic effects between the two groups
[0172] The therapeutic effect in the study group was significantly higher than that in the control group (P < 0.05). The total effective rate was calculated as (cured + improved) / total number of cases, as shown in Table 4.
[0173] Table 4 Comparison of therapeutic effects between the two groups [n (%)]
[0174]
[0175] The suppository of the present invention has a significantly improved therapeutic effect compared with Mayinglong Musk Hemorrhoid Suppository, with an improvement of 15%.
[0176] 2.2 Comparison of pain perception between the two groups
[0177] The study group had lower pain scores at 6 hours, 24 hours, and 1 week post-surgery (P < 0.05). See Table 5:
[0178] Table 5 Comparison of pain perception between the two groups ( ±s, minutes)
[0179]
[0180] Note: The table compares the results with those of the same group at 6 hours post-operation. * P < 0.05; compared with the same group 24 hours postoperatively, a P < 0.05
[0181] The suppositories of this invention have a significant improvement in pain relief compared to Mayinglong Musk Hemorrhoid Suppositories, and show significant pain relief effects at 6 hours, 24 hours and one week after the procedure.
[0182] 2.3 Comparison of evaluation of bleeding, edema, and urinary retention between the two groups
[0183] The study group showed greater improvement in postoperative bleeding, edema, and urinary retention scores (P < 0.05). See Table 6:
[0184] Table 6 Comparison of bleeding, edema, and urinary retention evaluation between the two groups ( ±s, minutes)
[0185]
[0186] Note: The table compares the results with those of the same group at 6 hours post-operation. * P < 0.05.
[0187] The suppositories of this invention have significantly improved hemostasis, swelling reduction and defecation promotion compared to Mayinglong Musk Hemorrhoid Suppositories. They have better effects on hemostasis, swelling reduction and defecation promotion 6 hours and 24 hours after the operation.
[0188] 2.4 Comparison of the two sets of laboratory indicators
[0189] There was no statistically significant difference in liver function indicators between the two groups on postoperative day 2 (P > 0.05), as shown in Table 7.
[0190] Table 7 Comparison of laboratory indicators between the two groups ( ±s, U / L)
[0191]
[0192] The suppositories of the present invention have the same effect on liver function as Mayinglong Musk Hemorrhoid Suppositories, have good medication safety, and will not cause significant negative impact on liver function.
[0193] 3. Clinical Cases
[0194] Patient Information: Ms. Zhao, female, 60 years old, diagnosed with circumferential mixed hemorrhoids, underwent hemorrhoidectomy with anal plasty and injection of internal hemorrhoid suppositories. After using this suppository post-surgery, the patient experienced pain relief 6 hours post-surgery: the patient reported significant relief from the anal pressure sensation compared to immediately after surgery. Bleeding from the wound stopped, with only a small amount of lightly bloody discharge on the dressing, and no active bleeding. Urination was smooth: spontaneous urination occurred 4 hours post-surgery, with no bladder fullness, normal urine flow, and no urinary retention symptoms. At 24 hours post-surgery, only brief stinging pain occurred during defecation. Occasionally, traces of blood were found on toilet paper after defecation; the wound was dry, with no fresh bleeding points. The patient urinated 4 times within 24 hours, without difficulty or interruption of urination.
[0195] 4. Conclusion
[0196] Hemorrhoids have a high incidence rate in clinical practice, with a certain prevalence across different age groups. The causes are complex, related to poor dietary habits, lack of exercise, and age. Surgery is the mainstream treatment for this disease, removing the hemorrhoids and alleviating symptoms. However, surgery inevitably leads to complications such as bleeding and pain. This is related to the fact that hemorrhoid surgery often uses open incisions, resulting in postoperative necrosis and sloughing of the hemorrhoids; excessive activity and straining during wound healing; postoperative wound infection, tissue necrosis, thrombus detachment; irritation of surrounding nerve endings by exudate, defecation, and dressing changes; obstruction of local blood circulation; and the impact of surgery on the original venous and lymphatic circulation at the wound edge, leading to tissue fluid retention.
[0197] Conventional intervention methods are insufficient to meet clinical intervention needs. Traditional Chinese medicine (TCM) believes that hemorrhoids are related to mechanisms such as dysfunction of the internal organs, poor circulation of qi and blood, and internal generation of damp-heat. The spleen and stomach are the foundation of acquired constitution; weakness of the spleen and stomach leads to reduced digestive function, damp-heat descending, and poor qi circulation, resulting in obstructed blood circulation in the anal area. TCM intervention for hemorrhoids has a long history. Chinese medicine suppositories, by inserting the medication into the cavity, can directly act on the lesion, thus better exerting local therapeutic effects. Furthermore, Chinese medicine suppositories avoid loss of activity due to gastrointestinal pH or digestive enzymes, preventing stomach irritation, and avoid the first-pass effect of oral medications in the liver, exhibiting good therapeutic safety and a wide range of applications.
[0198] This invention uses a traditional Chinese medicine combination suppository for treatment. The results showed that the efficacy of the study group was significantly higher than that of the control group (P<0.05). The study group had lower pain scores at 6h, 24h and 1 week after surgery, and greater improvement in bleeding, edema and urinary retention scores at 6h and 24h after surgery (P<0.05). This suppository treatment can quickly reduce postoperative complications and reduce the surgical burden on patients.
[0199] This suppository preparation mainly consists of musk, bear bile, and Coptis chinensis, among other ingredients. This formula has the effects of clearing heat and dampness, cooling blood and stopping bleeding, detoxifying and relieving pain, reducing swelling and promoting tissue regeneration. The formula has the effects of promoting blood circulation and removing blood stasis, as well as reducing swelling and relieving pain. By promoting blood circulation and removing blood stasis, it can improve blood circulation in the postoperative site of hemorrhoid surgery, relieving symptoms such as swelling and pain. Bear bile has the effects of clearing heat and detoxifying, reducing inflammation and relieving pain, clearing damp heat in the postoperative site of hemorrhoid surgery, reducing the risk of inflammation and infection, and relieving pain and discomfort. Coptis chinensis clears heat and dries dampness, which helps reduce local damp heat and inflammation. In addition, Coptis chinensis also has a strong antibacterial and anti-inflammatory effect, which can inhibit bacterial growth and has a certain effect on hemostasis. The blood-activating and stasis-removing effects of musk and Coptis chinensis can improve blood circulation in the postoperative site of hemorrhoid surgery, which is beneficial for improving local blood circulation, helping to quickly reduce edema and relieve pain. The heat-clearing, detoxifying, anti-inflammatory and analgesic effects of bear bile and Coptis chinensis can reduce the inflammatory response in the postoperative site of hemorrhoid surgery, relieve pain and discomfort, and promote wound healing.
[0200] This invention utilizes rectal administration, facilitating the absorption of musk, bear bile, and Coptis chinensis through the rectum, allowing them to act directly on the lesion and rapidly improve symptoms such as bleeding, pain, and urinary retention. Modern pharmacology suggests that musk can inhibit NF-κB activation, suppress cyclooxygenase activity, reduce prostaglandin synthesis, and alleviate inflammatory responses. Musk can also inhibit pain signal transmission, reduce pain receptor activation, regulate neurotransmitter release, promote angiogenesis, and improve local blood circulation. Coptis chinensis contains various alkaloids, which are highly valuable in inhibiting the activation of inflammatory cells. Studies have indicated that Coptis chinensis has broad-spectrum antibacterial effects, can promote platelet aggregation, accelerate the coagulation process, and simultaneously accelerate vasoconstriction. Ursodeoxycholic acid from bear bile can inhibit the production of inflammatory mediators by reducing oxidative stress and alleviate tissue damage caused by inflammation through mechanisms such as stabilizing mitochondrial membrane potential. This suppository can reduce local inflammation, preventing the continuous accumulation of inflammatory factors in the surgical area. It also accelerates local blood circulation and metabolism, which helps regulate coagulation and immune function, thus exerting hemostatic, analgesic, and anti-inflammatory effects. There was no statistically significant difference in liver function indicators between the two groups 2 days post-operation (P>0.05), indicating that this suppository preparation has good drug safety and will not cause significant negative impacts on patients' liver function. This is because this suppository preparation, as a traditional Chinese medicine suppository, is administered rectally. This route of administration facilitates local absorption of the drug effect without increasing the metabolic burden on the liver, resulting in minimal stimulation and impact on liver function, and thus good drug safety.
[0201] In summary, this suppository has a high therapeutic effect on postoperative complications of hemorrhoids, can reduce the burden of postoperative complications, and promote patients' early recovery.
[0202] The above description of the disclosed embodiments enables those skilled in the art to make or use the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Therefore, the invention is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.
Claims
1. A traditional Chinese medicine composition for treating postoperative hemorrhoids, characterized in that: By weight, it consists of the following components: 9-11 parts of Coptis chinensis; 9-11 parts of Phellodendron bark; Bear bile 9-11 parts; 9-11 parts rhubarb; 19-21 parts of charred Sanguisorba officinalis; 19-21 parts of catnip charcoal; Gallnut 5-7 parts; 20-22 parts of dragon's blood; Mother-of-pearl 19-21 parts; 19-21 parts calamine; Angelica dahurica 9-11 parts; 5-7 parts borneol; 1-3 parts of artificial musk.
2. The traditional Chinese medicine composition for treating postoperative hemorrhoids according to claim 1, characterized in that: The weight ratio of each component is as follows: Coptis chinensis: Phellodendron chinense: Bear bile: Rheum palmatum: Sanguisorba officinalis charcoal: Schizonepeta tenuifolia charcoal: Gallnut: Dragon's blood: Mother-of-pearl: Calamine: Angelica dahurica: Borneol: Artificial musk equals 5:5:5:5:10:10:3:10.5:10:10:5:3:
1.
3. The traditional Chinese medicine composition for treating postoperative hemorrhoids according to claim 1, characterized in that: By weight in grams, it consists of the following components: 100g of Coptis chinensis; 100g of Phellodendron bark; 100g of bear bile; 100g of rhubarb; 200g of charred Sanguisorba officinalis; 200g of charred catnip; Gallnut 60g; 210g of dragon's blood; Mother-of-pearl 200g; 200g of calamine; 100g of Angelica dahurica; 60g of borneol; 20g of artificial musk.
4. A method for preparing a traditional Chinese medicine composition for treating hemorrhoids after surgery, characterized in that: Includes the following steps: Step 1: Prepare the raw materials according to the Chinese herbal medicine raw materials and proportions described in any one of claims 1-3; Step 2: Crush and sieve the prepared raw materials. The sieved powder should have a mesh size between 200 and 230. Step 3: Melt the matrix. Mix the drug powder with the molten matrix to prepare a suppository.
5. The method for preparing a traditional Chinese medicine composition for treating hemorrhoids after surgery according to claim 4, characterized in that: The matrix in step 3 is an oily matrix, which is a semi-synthetic fatty acid glyceride, and the ratio of the matrix to the drug powder is 4:1.