Traditional Chinese medicine granules for treating anorectal diseases and preparation method thereof

By using traditional Chinese medicine granules with ingredients such as Sophora cinnabaria and cypress, the treatment limitations and side effects of the treatment in the treatment of hemorrhoids, anal fissures, anal fissures and perianal abscesses in the prior art are solved, and significant therapeutic effects and safety are achieved.

CN119633056APending Publication Date: 2025-03-18ZHONGWEI TRADITIONAL CHINESE MEDICINE HOSPITAL
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Patent Information

Application Number
CN202411929216.6
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-12-25
Publication Date
2025-03-18

AI Technical Summary

Technical Problem

The prior art has treatment limitations in the treatment of anorectal diseases such as hemorrhoids, anal fissures, anal fistulas and perianal abscesses, which are highly irritating and have many side effects.

Method used

Traditional Chinese medicine granules composed of Sophora cinnabarium, cypress, dandelion, Glauber's salt, Atractylodes, Wind-proof, Jupiter, Red Peony, Orchidaceae, Raw Cypress Leaves, Raw Cypress, Peony Orchid, Peony Orchid, Peony, Peony, Peony, Peony, Peony, Peony and Raw Licorice are used to treat the above anorectal diseases through the pharmacological effects of clearing heat and detoxifying, dehumidifying and swelling, relieving pain and relieving itching.

Benefits of technology

This traditional Chinese medicine granules significantly improve the treatment effect of hemorrhoids, anal fissures, anal fistulas and perianal abscesses, reduce the irritation and side effects of treatment, and are suitable for conservative treatment of a variety of anorectal diseases.

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Abstract

The invention relates to traditional Chinese medicine granules for treating anorectal diseases and a preparation method thereof. The traditional Chinese medicine granules are prepared from the following raw materials in parts by weight: 10 to 20 parts of radix sophorae flavescentis, 7 to 17 parts of cortex phellodendri, 10 to 20 parts of herba taraxaci, 20 to 40 parts of mirabilite, 10 to 20 parts of rhizoma atractylodis, 7 to 17 parts of radix saposhnikoviae, 10 to 20 parts of gallnut, 7 to 17 parts of radix paeoniae rubra, 7 to 17 parts of cacumen biotae, 15 to 25 parts of radix sanguisorbae, 1 to 11 parts of pepper and 7 to 17 parts of radix glycyrrhizae. The traditional Chinese medicine composition follows the medication principle of monarch, minister, assistant and guide of traditional Chinese medicines; amur corktree bark has the effects of clearing heat, drying dampness, detoxifying and treating sores. Dandelion can clear away heat and toxic materials and reduce swelling and remove stasis; mirabilite can moisten dryness, soften hard mass, clear fire and subdue swelling Rhizoma atractylodis has the effects of eliminating dampness and strengthening spleen, and expelling wind and removing cold; radix saposhnikoviae, gallnut, radix paeoniae rubra, cacumen biotae, sanguisorba officinalis and pericarpium zanthoxyli are used as adjuvant drugs; the liquorice is used as a conductant drug for harmonizing the medicines; the medicines are used together to achieve the effects of clearing away heat and toxic materials, removing dampness, relieving swelling and pain and expelling carbuncle, and are suitable for anorectal diseases such as haemorrhoids, anal fissure, anal fistula and perianal abscess.
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Description

Technical Field

[0001] The invention relates to the field of traditional Chinese medicine, and in particular to a traditional Chinese medicine granule for treating anorectal diseases and a preparation method thereof. Background Art

[0002] Hemorrhoids, anal fissures, anal fistulas, etc. are common and frequently occurring diseases in clinic. Among them, hemorrhoids in anorectal department are the diseases with the highest incidence rate among perianal diseases, accounting for 87.2%. Hemorrhoids are pathological hypertrophy and displacement of vascular anal cushions in the dentate line, dilation of subcutaneous blood vessels in the perianal area, resulting in blood stasis or thrombosis, or bulging masses formed by rupture. Clinically, hemorrhoids are generally divided into three types, namely internal hemorrhoids, external hemorrhoids, and mixed hemorrhoids. Mixed hemorrhoids are more common and can occur at any age, and the incidence rate increases with age. The main symptoms are pain, blood in the stool, and edema. According to the condition, it can be divided into four stages: I, II, III, and IV. The nerve endings of the anus are very sensitive, and the pain seriously affects the quality of work and life of patients. Anal fissure is a common disease in anorectal department. At present, its pathogenesis has not been fully elucidated, and the treatment methods are also different. Its pain, bleeding, and anal spasm have a great impact on daily life and reduce the quality of life of patients. The causes of anal fistula are mostly due to residual damp-heat toxins that have not been completely eliminated, which block the anus; or due to long-term damage to anal fissures, forming subcutaneous leakage in the anus; or due to exogenous evil toxins, improper diet, excessive sexual intercourse, and chronic cough and fatigue. The main clinical symptoms and signs of patients are anal swelling and pain, foreign body sensation, damp and itchy anus, and a small amount of bleeding or blood in the stool. Physical examination shows that the skin of the anal margin mucosa is partially raised, edematous or has thrombus, dark purple, some mucosa is ulcerated and bleeding, and there is obvious tenderness. After surgery, the edge of the wound is edematous, there is a small amount of bleeding on the wound, and there is obvious tenderness.

[0003] The causes and pathogenesis of hemorrhoids, anal fissures, anal fistulas and other diseases are still not very clear. The theory of traditional Chinese medicine is summarized as "all are injured by the four elements of dampness, heat, wind and dryness, and heat is the most", which comprehensively interprets the etiology and pathogenesis of hemorrhoids in traditional Chinese medicine. Western medicine generally believes that the pathogenic mechanism is mainly related to physiological defects, upright posture, constipation, infection, pregnancy and childbirth, tumors, portal hypertension, genetics and other factors. There are bacterial constipation theory, varicose vein theory, anal cushion downward migration theory, etc., but there is no unified standard theory, among which the anal cushion downward migration theory is widely accepted. Traditional Chinese medicine is divided into internal treatment and external treatment. The internal treatment divides hemorrhoids into three types of traditional Chinese medicine syndromes, namely spleen deficiency and qi collapse type, damp heat downward injection type, and wind injury to intestinal network type, mainly through traditional Chinese medicine syndrome differentiation and treatment; external treatment includes suppository method, compress method, sitting bath method, fumigation and washing method, etc. Western medicine is divided into conservative treatment and surgical treatment. Conservative treatment is mainly for patients with mild symptoms or no symptoms. No relevant special treatment is required, or medical means are used to reduce or eliminate symptoms for patients in stages I and II. Surgical treatment is for patients with moderate to severe hemorrhoids (grades III to IV). Surgical treatment is still the main treatment in clinical practice. Currently, the commonly used surgical procedures in clinical practice include stapler fixation, simple hemorrhoidectomy, and thrombosed external hemorrhoidectomy. Traditional Chinese medicine treatment is good at regulating the function of the entire body and treating symptoms based on syndrome differentiation. It has unique clinical treatment advantages. Compared with Western medicine, traditional Chinese medicine treatment is less irritating and has fewer side effects, especially in conservative treatment. It has very obvious advantages, such as promoting blood circulation and removing blood stasis, clearing away heat and dampness, reducing swelling and relieving pain, removing dead tissue and promoting muscle regeneration, etc. Because traditional Chinese medicine has a long history and rich experience, it can use more methods and a wider range of choices.

[0004] Therefore, the present invention provides a Chinese medicine granule which has significant curative effect, is more suitable for treating anorectal diseases such as hemorrhoids, anal fissures, anal fistulas and perianal abscesses, has less irritation and less side effects. Summary of the invention

[0005] The purpose of the present invention is to address the treatment limitations of anorectal diseases such as hemorrhoids, anal fissures, anal fistulas and perianal abscesses, and to obtain a Chinese medicine granule for treating anorectal diseases such as hemorrhoids, anal fissures, anal fistulas and perianal abscesses, which has significant efficacy, can be used on a large scale, and has a modern new dosage form, and a preparation method thereof.

[0006] The technical scheme adopted by the present invention is a Chinese medicine granule for treating anorectal diseases, which is composed of the following raw materials in parts by weight: 10-20 parts of sophora flavescens, 7-17 parts of phellodendron, 10-20 parts of dandelion, 20-40 parts of sodium sulfate, 10-20 parts of atractylodes, 7-17 parts of siler, 10-20 parts of gallnut, 7-17 parts of red peony root, 7-17 parts of oriental arborvitae leaves, 15-25 parts of raw sanguisorba officinalis, 1-11 parts of zanthoxylum bungeanum and 7-17 parts of raw liquorice.

[0007] Furthermore, it is composed of the following raw materials in parts by weight: 15 parts of Sophora flavescens, 12 parts of Phellodendron amurense, 15 parts of Taraxacum officinale, 30 parts of Sophora japonica, 15 parts of Atractylodes macrocephala, 12 parts of Saposhnikovia divaricata, 15 parts of Galla chinensis, 12 parts of Paeonia lactiflora, 12 parts of Platycladus orientalis leaves, 20 parts of Sanguisorba officinalis, 6 parts of Zanthoxylum bungeanum, and 12 parts of raw licorice.

[0008] Furthermore, it is composed of the following raw materials in parts by weight: 10 parts of Sophora flavescens, 7 parts of Phellodendron amurense, 15 parts of Taraxacum officinale, 30 parts of Sophora japonica, 15 parts of Atractylodes macrocephala, 12 parts of Saposhnikovia divaricata, 15 parts of Galla chinensis, 12 parts of Paeonia lactiflora, 12 parts of Platycladus orientalis leaves, 20 parts of Sanguisorba officinalis, 6 parts of Zanthoxylum bungeanum, and 12 parts of raw licorice.

[0009] Furthermore, it is composed of the following raw materials in parts by weight: 10 parts of Sophora flavescens, 7 parts of Phellodendron amurense, 20 parts of Taraxacum officinale, 40 parts of Sophora japonica, 20 parts of Atractylodes macrocephala, 17 parts of Saposhnikovia divaricata, 20 parts of Galla chinensis, 17 parts of Paeonia lactiflora, 17 parts of Platycladus orientalis leaves, 25 parts of Sanguisorba officinalis, 11 parts of Zanthoxylum bungeanum, and 17 parts of raw licorice.

[0010] Furthermore, it is composed of the following raw materials in parts by weight: 20 parts of Sophora flavescens, 17 parts of Phellodendron amurense, 10 parts of Taraxacum officinale, 20 parts of Sophora japonica, 10 parts of Atractylodes macrocephala, 7 parts of Saposhnikovia divaricata, 10 parts of Galla chinensis, 7 parts of Red Peony Root, 7 parts of Platycladus orientalis leaves, 15 parts of Sanguisorba officinalis, 1 part of Zanthoxylum bungeanum, and 7 parts of raw Licorice.

[0011] The present invention also provides a method for preparing a Chinese medicine granule for treating anorectal diseases, comprising the following steps:

[0012] (1) weighing sophora flavescens, phellodendron amurense, dandelion, sodium sulfate, atractylodes, siler, gallnut, red peony root, arborvitae leaf, raw sanguisorba officinalis, Zanthoxylum bungeanum, and raw liquorice according to the weight ratio for later use;

[0013] (2) taking Sophora flavescens, Phellodendron amurense, Galla chinensis, Paeonia lactiflora and raw Licorice, adding 8-12 times the amount of water, soaking for 0.5-1 hour, heating and boiling for the first time for 1 hour, filtering, and collecting the first extract and the residue;

[0014] (3) taking dandelion, arborvitae leaves, Zanthoxylum bungeanum, atractylodes, sanguisorba officinalis and siler, adding them to the residues of step (2) and adding 6-10 times the amount of water, performing a first heating and boiling for 0.5 hours, filtering, and collecting a second extract and the residues;

[0015] (4) combining the first extract and the second extract and mixing them together, and letting them stand for 10-12 hours;

[0016] (5) centrifuging the combined extract to remove insoluble impurities and concentrating the extract into a fluid thick extract;

[0017] (6) adding a mixture of talcum powder and xuanming powder to the thick extract, and stirring the mixture thoroughly and uniformly, drying the mixture after stirring the mixture thoroughly and uniformly, and collecting a dry extract block;

[0018] (7) crushing the dry extract block and sieving it for the first time to obtain extract powder for later use;

[0019] (8) adding talc, dextrin and magnesium stearate to the extract powder and mixing them thoroughly, adding a wetting agent, sieving them for a second time to prepare granules, drying the granules sifted for the second time, crushing them again and sifting them for a third time to obtain the extract powder;

[0020] (9) adding a wetting agent again to the extract powder after the pulverization in step (8) and the third sieving, sieving for the fourth time to prepare granules, and drying to obtain the Chinese medicine granules;

[0021] (10) Package, seal, inspect, label, and verify Chinese medicine granules before storage.

[0022] Wherein, the drying temperature of steps (6), (8) and (9) is 60°C-70°C.

[0023] Wherein, the wetting agent in step (8) and step (9) is 75% ethanol.

[0024] Wherein, the density of the thick extract in step (5) is ρ=1.325-1.350 g / mL.

[0025] Wherein, the mesh number of the first screening and the third screening is 80 mesh, and the mesh number of the second screening and the fourth screening is 14 mesh.

[0026] The pharmacological effects of the twelve medicinal materials in the formula of the present invention are as follows:

[0027] (1) Sophora flavescens, which is listed as a medium-grade product in Shennong's Herbal Classic. [Nature and flavor and meridians] Sophora flavescens is cold in nature and bitter in taste. It is used in the heart, liver, stomach, large intestine, and bladder meridians. [Functions and indications] It is used for heat dysentery, blood in stool, jaundice and urine retention, leucorrhea, vaginal swelling and itching, eczema, wet sores, skin itching, scabies and leprosy, and external treatment of trichomoniasis vaginitis. The Compendium of Materia Medica records: Sophora flavescens is cold in nature and bitter in taste. It can nourish the kidney. It is because its bitterness can dry out dampness and cold can eliminate heat. Heat generates wind and dampness generates insects, so it can also treat wind and kill insects. Recent research results have shown that Sophora flavescens has a variety of pharmacological activities such as clearing heat and detoxifying, anti-inflammatory and analgesic, antibacterial and anti-tumor.

[0028] (2) Phellodendron chinense, [nature and flavor] bitter, cold, enters the kidney and bladder meridians. [Functions and indications] It has the effects of clearing away heat and dampness, purging fire and detoxifying, and reducing swelling and removing rot. Phellodendron chinense is used raw because of its cold, bitter and dry nature, which has the effect of purging fire and detoxifying, and has a strong effect of clearing heat and drying dampness. Modern clinical studies have shown that it has anti-bacterial, fungal, viral and other pathogenic microorganisms; it has anti-arrhythmic and anti-hypertensive effects on the cardiovascular system; it has anti-peptic ulcer, intestinal contraction or relaxation, and pancreatic secretion promotion effects on the digestive system; it also has anti-inflammatory, immunomodulatory, blood sugar lowering and anti-cancer effects.

[0029] (3) Dandelion was first recorded in Tang Materia Medica. [Nature and flavor] It has a slight smell, a slightly bitter and sweet taste, and is cold. It enters the liver and stomach meridians. [Functions and indications] It has antibacterial, liver-protecting and choleretic, immune-promoting, anti-endotoxin and anti-gastric damage effects. Dandelion contains a variety of biologically active ingredients, mainly including flavonoids, terpenes, alkaloids, coumarins, stilbenes, esters, sterols, etc. These substances have strong antibacterial, anti-inflammatory and antioxidant biological activities. It is mainly used clinically to treat furunculosis, acne, acute conjunctivitis, acute tonsillitis, acute mastitis, acute bronchitis, acute and chronic appendicitis, rhinitis, pharyngitis, gastritis, peptic ulcer, cholecystitis, cholelithiasis, hepatitis, urinary tract infection, vaginitis, pelvic inflammatory disease, osteomyelitis, mumps and cancer. In recent years, it has been reported that it has significant anticancer activity against breast cancer.

[0030] (4) Glauber's Salt, [Nature and Flavor] Tastes salty and bitter, cold in nature, enters the stomach and large intestine meridians. [Functions and Indications] It has the effects of moistening dryness and softening hard masses, purging and relieving constipation, clearing away heat and reducing swelling. It is used to treat diseases such as excess heat stagnation, abdominal distension and pain, dry stool, and intestinal carbuncle swelling and pain; external use can treat breast carbuncle and hemorrhoid swelling and pain. Modern pharmacological studies have shown that Glauber's Salt has a good anti-inflammatory effect and is highly effective and safe.

[0031] (5) Atractylodes lancea, originally recorded as "Shu" in Shennong's Herbal Classic, is listed as a top-grade product. [Nature and flavor] It tastes pungent and bitter, warm in nature, and enters the spleen, stomach, and liver meridians. [Functions and indications] It has the effects of drying dampness and strengthening the spleen, dispelling wind and cold, and improving eyesight. It is used to treat dampness blocking the middle jiao, abdominal distension, diarrhea, colds, rheumatic pain, edema, beriberi, night blindness, and blurred vision. Studies have shown that Atractylodes lancea extracts also have anti-cancer, anti-obesity and anti-inflammatory effects.

[0032] (6) Saposhnikovia divaricata, [Nature and flavor] Spicy, sweet, slightly warm; enters the bladder, liver, and spleen meridians. [Functions and indications] It has the functions of dispelling wind and relieving exterior symptoms, relieving dampness and relieving pain, and stopping spasms; it is used to treat colds, headaches, rheumatic pain, urticaria, itching, and tetanus. It has antipyretic, analgesic, anti-inflammatory, and anti-tumor pharmacological effects.

[0033] (7) Gallnut, the earliest record of which can be found in the book "Compendium of Materia Medica". [Nature and flavor and meridians] It is cold in nature, sour and astringent in taste, and enters the lung, large intestine, and kidney meridians. [Functions and indications] It has the effects of astringing the lung and reducing fire, astringing the intestine and stopping diarrhea, astringing sweat, stopping bleeding, absorbing moisture and astringing sores. It is used for chronic cough due to lung deficiency, cough with phlegm caused by lung heat, chronic diarrhea and dysentery, spontaneous sweating, night sweats, thirst, blood in stool and hemorrhoids, bleeding due to trauma, carbuncle, sore and ulcer, and wet and rotten skin.

[0034] (8) Red peony root, [nature and flavor and meridians] bitter, slightly cold, enters the liver and spleen meridians. [Functions and indications] It is a heat-clearing and blood-cooling medicine under the category of heat-clearing medicines, and has the effects of clearing heat, cooling blood, dispersing blood stasis and relieving pain. It is used for heat entering the blood, fever-induced rashes, vomiting blood and epistaxis, red and swollen eyes, liver depression and hypochondriacal pain, amenorrhea and dysmenorrhea, abdominal pain due to lumps and masses, injuries from falls, carbuncles, ulcers and sores. Modern research shows that red peony root contains a variety of chemical components such as terpenes, glycosides, flavonoids, flavonoid glycosides, and volatile oils. It has a variety of pharmacological effects such as liver protection, anti-tumor, neuroprotection, cardioprotection, anti-thrombosis, anti-oxidation, and anti-endotoxin. It has good clinical therapeutic effects on the cardiovascular system, nervous system, and blood system. It is especially effective in treating cholestatic hepatitis and severe icteric hepatitis.

[0035] (9) Platycladus orientalis leaves, [nature and flavor] The leaves have a light fragrance, bitter and slightly pungent taste. They are bitter and astringent, and cold in nature. They enter the lung, liver, and spleen meridians. [Functions and indications] They have the effects of cooling blood and stopping bleeding, resolving phlegm and relieving cough, and promoting hair growth and darkening hair. They are used for hematemesis, epistaxis, hemoptysis, blood in stool, metrorrhagia, cough due to lung heat, hair loss due to blood heat, and premature graying of hair. Raw Platycladus orientalis leaves have multiple pharmacological effects such as anti-tumor, antibacterial, anti-inflammatory, antitussive, and antiasthmatic effects, as well as diuretic and stomachic effects, detoxification and blood stasis removal. Their potential medicinal value and clinical auxiliary effects on various diseases are becoming increasingly apparent.

[0036] (10) Raw Sanguisorba officinalis, [nature and flavor and meridians] taste bitter, sour, astringent, slightly cold; enter the liver and large intestine meridians; [functions and indications] has the functions of cooling blood and stopping bleeding, detoxifying and astringing sores; used for blood in stool, hemorrhoids, bloody diarrhea, metrorrhagia, burns caused by water or fire, carbuncle, sore and poison. Modern medical research has found that Sanguisorba officinalis has the functions of stopping bleeding, cooling blood, clearing away heat and detoxifying, astringing diarrhea and inhibiting various pathogenic microorganisms.

[0037] (11) Zanthoxylum bungeanum, [Nature and flavor and meridians] It is pungent and warm. It enters the spleen, stomach, and kidney meridians. [Functions and indications] It has the effects of warming the middle and relieving pain, killing insects and relieving itching. It is used for cold pain in the abdomen, vomiting and diarrhea, and abdominal pain caused by worms; it is also used for external treatment of eczema and vaginal itching. Zanthoxylum bungeanum mainly contains volatile oils, alkaloids, amides, flavonoids, lignin, coumarins, triterpenes and other compounds. Modern research shows that it has pharmacological activities such as anti-inflammatory, antioxidant, antibacterial, and anti-obesity.

[0038] (12) Raw licorice, which was first recorded in Shennong's Herbal Classic. [Nature and flavor] It is sweet, mild, non-toxic, and enters the heart, lung, spleen, and stomach meridians. [Functions and indications] It has the effects of tonifying the spleen and replenishing qi, clearing away heat and detoxifying, removing phlegm and relieving cough, relieving acute pain, and harmonizing various medicines.

[0039] The Chinese medicine granule prescription for treating anorectal diseases provided by the present invention comprises sophora flavescens, phellodendron amurense, dandelion, mirabilite, atractylodes lancea, siler, peony root, cypress leaf, raw sanguisorba officinalis, Chinese prickly ash, and raw liquorice. In the prescription, sophora flavescens is bitter and cold, and enters the heart, liver, stomach, large intestine, and bladder meridians, clears heat and dampness, dispels wind and kills insects; phellodendron amurense is bitter and cold, enters the kidney and bladder meridians, clears heat and dampness, detoxifies and treats sores, and the two are monarch drugs. Dandelion is bitter, sweet, and cold, enters the liver and stomach meridians, clears heat and detoxifies, and relieves swelling and resolves nodules; mirabilite is salty, bitter, and cold, enters the stomach and large intestine meridians, moisturizes and softens hard masses, clears fire and relieves swelling; atractylodes lancea is pungent, bitter, and warm, and enters the spleen, stomach, and liver meridians, drys dampness and strengthens the spleen, dispels wind and relieves cold, and the three are minister drugs. Saposhnikovia divaricata is pungent, sweet and slightly warm, and enters the bladder, liver and spleen meridians, dispels wind and relieves exterior symptoms, overcomes dampness and relieves pain; Gallic acid, astringent and cold, enters the lung, large intestine and kidney meridians, astringes the intestines to stop diarrhea, absorbs dampness and heals sores; Red peony root is bitter and slightly cold, enters the liver meridian, clears heat and cools blood, disperses blood stasis and relieves pain; Platycladus orientalis is bitter, astringent and cold, enters the lung, liver and spleen meridians, cools blood and stops bleeding; Sanguisorba officinalis is bitter, sour, astringent and slightly cold. It enters the liver and large intestine meridians, cools blood and stops bleeding, detoxifies and heals sores; Zanthoxylum bungeanum is pungent and warm, enters the spleen, stomach and kidney meridians, warms the middle and stops pain, kills insects and stops itching, and the six are adjuvants; Licorice is sweet and flat, enters the heart, lung, spleen and stomach meridians, clears heat and detoxifies, relieves urgency and stops pain, and harmonizes all the medicines as the guiding medicine; all the medicines are used together to play the role of clearing heat, detoxifying and removing dampness, reducing swelling, relieving pain and removing carbuncle.

[0040] Compared with the prior art, the present invention has the following beneficial effects: the present invention provides a Chinese medicine granule for treating anorectal diseases, which uses Sophora flavescens, Phellodendron amurense, Taraxacum officinale, Glauber's salt, Atractylodes macrocephala, Saposhnikovia divaricata, Galla chinensis, Paeonia lactiflora, Platycladus orientalis, Sanguisorba officinalis, Zanthoxylum bungeanum and Licorice as raw materials, and follows the medication principle of "monarch, minister, assistant and envoy" of traditional Chinese medicine. In the prescription, Sophora flavescens clears away heat and dampness, dispels wind and kills insects; Phellodendron amurense clears away heat and dampness, detoxifies and treats sores, and the two are both monarch medicines. Dandelion clears away heat and detoxifies, reduces swelling and disperses nodules; Glauber's salt moistens dryness and softens hard masses, clears away fire and reduces swelling; Atractylodes lancea dries dampness and strengthens the spleen, dispels wind and dissipates cold, and the three are collectively the ministers; Saposhnikovia divaricata dispels wind and relieves exterior symptoms, overcomes dampness and relieves pain; Gallnut astringes the intestines and stops diarrhea, absorbs dampness and heals sores; Red peony root clears heat and cools blood, disperses blood stasis and relieves pain; Platycladus orientalis leaves cool blood and stop bleeding; Sanguisorba officinalis cools blood and stops bleeding, detoxifies and heals sores; Zanthoxylum bungeanum warms the middle and stops pain, kills insects and relieves itching, and the six are collectively the adjuvants; Licorice clears heat and detoxifies, relieves urgency and stops pain, and harmonizes the various medicines as the guiding medicine; the combination of these medicines can play the role of clearing heat, detoxifying and removing dampness, reducing swelling, relieving pain and discharging carbuncle, and is suitable for anorectal diseases such as hemorrhoids, anal fissures, anal fistulas and perianal abscesses. DETAILED DESCRIPTION

[0041] The technical scheme of the present invention is further described below in conjunction with specific embodiments. However, it should be understood by those skilled in the art that the following examples are only used to illustrate the present invention and should not be regarded as limiting the present invention. The specific conditions not specified in the examples are carried out according to conventional conditions or conditions recommended by the manufacturer. The reagents or instruments used, unless otherwise specified, are conventional products obtained through commercial channels.

[0042] 1. Implementation Case 1

[0043] 15 parts of Sophora flavescens, 12 parts of Phellodendron chinense, 15 parts of Taraxacum, 30 parts of Sophora japonica, 15 parts of Atractylodes macrocephala, 12 parts of Saposhnikovia divaricata, 15 parts of Galla chinensis, 12 parts of Red Peony Root, 12 parts of Platycladus orientalis, 20 parts of Sanguisorba officinalis, 6 parts of Zanthoxylum bungeanum, and 12 parts of Radix Glycyrrhizae.

[0044] Specifically, Sophora flavescens 15g, Phellodendron chinense 12g, Taraxacum mongolicum 15g, Sodium sulfate 30g, Atractylodes lancea 15g, Saposhnikovia divaricata 12g, Gallnut 15g, Paeonia lactiflora 12g, Platycladus orientalis leaf 12g, Sanguisorba officinalis 20g, Zanthoxylum bungeanum 6g, and Licorice root 12g.

[0045] (1) Weigh the Radix Sophorae Flavescentis, Phellodendron Amurense, Galla Chinensis, Paeonia lactiflora and Radix Glycyrrhizae in the prescription according to the prepared amount, and after checking that they are correct, wrap them in a non-woven bag, put the medicine bag into a Chinese medicine extraction tank, add 10 times the amount of water, soak for 0.75 hours, start heating and boiling for 1 hour, filter, and collect the first extract and the residue; weigh the Radix Taraxaci, Platycladus Orientalis, Zanthoxylum bungeanum, Atractylodes macrocephala, Radix Sanguisorbae and Saposhnikovia divaricatae in the prescription according to the prepared amount, and after checking that they are correct, wrap them in a non-woven bag, and add the medicine bag to the Chinese medicine extraction tank containing the above-mentioned residues in turn, add 8 times the amount of water (the total weight of the residues and the later added medicinal materials), start heating and boiling for 0.5 hours, filter, collect the second extract, combine the two extracts, and let stand for 12 hours. The extract was centrifuged to remove insoluble impurities and concentrated to a fluid thick extract with a density of ρ=1.335 g / mL. A mixture of talcum powder and xuanming powder was added to the thick extract while stirring. After fully stirring, the mixture was placed in a constant temperature oven at 65°C for drying. The dry extract blocks were collected, crushed and sieved through an 80-mesh sieve for later use.

[0046] (2) Wet granulation: talcum powder, dextrin and magnesium stearate are added to the extract powder and mixed thoroughly. Then, 75% ethanol is used as a wetting agent and the granules are passed through a 14-mesh sieve to prepare granules. The granules are placed in a constant temperature oven at 65°C for drying and then crushed and passed through an 80-mesh sieve. Then, 75% ethanol is used as a wetting agent again and the granules are passed through a 14-mesh sieve to prepare granules. The granules are placed in a constant temperature oven at 65°C for drying to obtain whole Chinese medicine granules. The granules are then packaged, sealed, inspected, labeled, and checked for storage.

[0047] 2. Implementation Case 2

[0048] 10 parts of Sophora flavescens, 7 parts of Phellodendron chinense, 15 parts of Taraxacum, 30 parts of Sophora japonica, 15 parts of Atractylodes macrocephala, 12 parts of Saposhnikovia divaricata, 15 parts of Galla chinensis, 12 parts of Red Peony Root, 12 parts of Platycladus orientalis, 20 parts of Sanguisorba officinalis, 6 parts of Zanthoxylum bungeanum, and 12 parts of Radix Glycyrrhizae.

[0049] Specifically, 10g of Sophora flavescens, 7g of Phellodendron amurense, 15g of Taraxacum mongolicum, 30g of Sodium sulfate, 15g of Atractylodes macrocephala, 12g of Saposhnikovia divaricata, 15g of Gallnut, 12g of Red Peony Root, 12g of Platycladus orientalis, 20g of Sanguisorba officinalis, 6g of Zanthoxylum bungeanum, and 12g of Raw Licorice.

[0050] (1) Weigh the Radix Sophorae Flavescentis, Phellodendron Amurense, Galla Chinensis, Paeonia lactiflora and Radix Glycyrrhizae in the prescription according to the prepared amount, and after checking that they are correct, wrap them in a non-woven bag, put the medicine bag into a Chinese medicine extraction tank, add 8 times the amount of water, soak for 0.5 hours, start heating and boiling for 1 hour, filter, and collect the first extract and the residue; weigh the Radix Taraxaci, Platycladus Orientalis, Zanthoxylum bungeanum, Atractylodes macrocephala, Radix Sanguisorbae and Saposhnikovia divaricatae in the prescription according to the prepared amount, and after checking that they are correct, wrap them in a non-woven bag, and add the medicine bag to the Chinese medicine extraction tank containing the above-mentioned residues in turn, add 6 times the amount of water (the total weight of the residues and the later added medicinal materials), start heating and boiling for 0.5 hours, filter, collect the second extract, combine the two extracts, and let stand for 10 hours. The extract was centrifuged to remove insoluble impurities and concentrated to a fluid thick extract with a density of ρ=1.325 g / mL. A mixture of talcum powder and xuanming powder was added to the thick extract while stirring. After fully stirring, the mixture was placed in a constant temperature oven at 65°C for drying. The dry extract blocks were collected, crushed and passed through an 80-mesh sieve for later use.

[0051] (2) Wet granulation: talcum powder, dextrin and magnesium stearate are added to the extract powder and mixed thoroughly. Then, 75% ethanol is used as a wetting agent and the granules are passed through a 14-mesh sieve to prepare granules. The granules are placed in a constant temperature oven at 65°C for drying and then crushed and passed through an 80-mesh sieve. Then, 75% ethanol is used as a wetting agent again and the granules are passed through a 14-mesh sieve to prepare granules. The granules are placed in a constant temperature oven at 65°C for drying to obtain whole Chinese medicine granules. The granules are then packaged, sealed, inspected, labeled, and checked for storage.

[0052] 3. Implementation Case 3

[0053] 10 parts of Sophora flavescens, 7 parts of Phellodendron chinense, 20 parts of Taraxacum, 40 parts of Sodium Sulfate, 20 parts of Atractylodes macrocephala, 17 parts of Saposhnikovia divaricata, 20 parts of Galla chinensis, 17 parts of Red Peony Root, 17 parts of Platycladus orientalis, 25 parts of Sanguisorba officinalis, 11 parts of Zanthoxylum bungeanum, and 17 parts of Radix Glycyrrhizae.

[0054] Specifically, 10g of Sophora flavescens, 7g of Phellodendron amurense, 20g of Taraxacum mongolicum, 40g of Sodium sulfate, 20g of Atractylodes lancea, 17g of Saposhnikovia divaricata, 20g of Gallnut, 17g of Red Peony Root, 17g of Platycladus orientalis, 25g of Sanguisorba officinalis, 11g of Zanthoxylum bungeanum, and 17g of Raw Licorice.

[0055] (1) Weigh the prepared amount of Sophora flavescens, Phellodendron amurense, Galla chinensis, Paeonia lactiflora and Licorice in the prescription, and after checking that they are correct, wrap them in a non-woven bag, put the medicine bag into a Chinese medicine extraction tank, add 12 times the amount of water, soak for 1 hour, start heating and boiling for 1 hour, filter, and collect the first extract and the residue; weigh the Taraxacum officinale, Platycladus orientalis, Zanthoxylum bungeanum, Atractylodes lancea, Sanguisorba officinalis and Saposhnikovia divaricata in the prescription, and after checking that they are correct, wrap them in a non-woven bag, add the medicine bag to the Chinese medicine extraction tank containing the above-mentioned residues in turn, add 10 times the amount of water (the total weight of the residues and the later added medicinal materials), start heating and boiling for 0.5 hour, filter, collect the second extract, combine the two extracts, and let stand for 11 hours. The extract was centrifuged to remove insoluble impurities and concentrated to a fluid thick extract with a density of ρ=1.350 g / mL. A mixture of talcum powder and xuanming powder was added to the thick extract while stirring. After fully stirring, the mixture was placed in a constant temperature oven at 65°C for drying. The dry extract blocks were collected, crushed and sieved through an 80-mesh sieve for later use.

[0056] (2) Wet granulation: talcum powder, dextrin and magnesium stearate are added to the extract powder and mixed thoroughly. Then, 75% ethanol is used as a wetting agent and the granules are passed through a 14-mesh sieve to prepare granules. The granules are placed in a constant temperature oven at 65°C for drying and then crushed and passed through an 80-mesh sieve. Then, 75% ethanol is used as a wetting agent again and the granules are passed through a 14-mesh sieve to prepare granules. The granules are placed in a constant temperature oven at 65°C for drying to obtain whole Chinese medicine granules. The granules are then packaged, sealed, inspected, labeled, and checked for storage.

[0057] 4. Implementation Case 4

[0058] 20 parts of Sophora flavescens, 17 parts of Phellodendron chinense, 10 parts of Taraxacum, 20 parts of Sophora japonica, 10 parts of Atractylodes macrocephala, 7 parts of Saposhnikovia divaricata, 10 parts of Galla chinensis, 7 parts of Red Peony Root, 7 parts of Platycladus orientalis, 15 parts of Sanguisorba officinalis, 1 part of Zanthoxylum bungeanum, and 7 parts of Licorice root.

[0059] Specifically, Sophora flavescens 20g, Phellodendron amurense 17g, Taraxacum officinale 10g, Sodium sulfate 20g, Atractylodes 10g, Saposhnikovia divaricata 7g, Gallnut 10g, Paeonia lactiflora 7g, Platycladus orientalis 7g, Sanguisorba officinalis 15g, Zanthoxylum bungeanum 1g, and Licorice root 7g.

[0060] (1) Weigh the Radix Sophorae Flavescentis, Phellodendron Amurense, Galla Chinensis, Paeonia lactiflora and Radix Glycyrrhizae in the prescription according to the prepared amount, and after checking that they are correct, wrap them in a non-woven bag, put the medicine bag into a Chinese medicine extraction tank, add 10 times the amount of water, soak for 0.75 hours, start heating and boiling for 1 hour, filter, and collect the first extract and the residue; weigh the Radix Taraxaci, Platycladus Orientalis, Zanthoxylum bungeanum, Atractylodes macrocephala, Radix Sanguisorbae and Saposhnikovia divaricatae in the prescription according to the prepared amount, and after checking that they are correct, wrap them in a non-woven bag, and add the medicine bag to the Chinese medicine extraction tank containing the above-mentioned residues in turn, add 8 times the amount of water (the total weight of the residues and the later added medicinal materials), start heating and boiling for 0.5 hours, filter, collect the second extract, combine the two extracts, and let stand for 12 hours. The extract was centrifuged to remove insoluble impurities and concentrated to a fluid thick extract with a density of ρ=1.335 g / mL. A mixture of talcum powder and xuanming powder was added to the thick extract while stirring. After fully stirring, the mixture was placed in a constant temperature oven at 65°C for drying. The dry extract blocks were collected, crushed and sieved through an 80-mesh sieve for later use.

[0061] (2) Wet granulation: talcum powder, dextrin and magnesium stearate are added to the extract powder and mixed thoroughly. Then, 75% ethanol is used as a wetting agent and the granules are passed through a 14-mesh sieve to prepare granules. The granules are placed in a constant temperature oven at 65°C for drying and then crushed and passed through an 80-mesh sieve. Then, 75% ethanol is used as a wetting agent again and the granules are passed through a 14-mesh sieve to prepare granules. The granules are placed in a constant temperature oven at 65°C for drying to obtain whole Chinese medicine granules. The granules are then packaged, sealed, inspected, labeled, and checked for storage.

[0062] Clinical observation of the Chinese medicine for treating eczema in children according to the present invention:

[0063] 1. General information: The cases observed in this study were from outpatients of Zhongwei Traditional Chinese Medicine Hospital. This study included 100 patients with anorectal diseases.

[0064] 2. The present invention is suitable for reducing swelling, relieving pain and relieving itching on the wound surfaces of common hemorrhoids, anal fissures, anal fistulas and perianal abscesses.

[0065] 3. Usage and dosage of the present invention: For external use, disperse in 400 mL of boiled water, 3 times a day, 2 bags each time, fumigate first and then wash, or follow the doctor's advice.

[0066] 3. Precautions for the present invention: 1. Avoid tobacco, alcohol, spicy, cold, and greasy food, and the diet should be light. 2. Children, pregnant women, breastfeeding women, and the elderly and infirm should use this product under the guidance of a physician. 3. Use strictly according to the usage and dosage, and this product should not be used for a long time. 4. If the symptoms are not relieved after 3 days of medication, you should go to the hospital for treatment. 5. People who are allergic to this product are prohibited from using it, and those with allergic constitutions should use it with caution. 6. This product is prohibited from use when its properties change. 7. Children must use it under adult supervision. 8. Please keep this product out of reach of children. 9. If you are using other medicines, please consult a physician or pharmacist before using this product.

[0067] 4. TCM diagnostic criteria

[0068] (1) Hemorrhoids, which are divided into internal hemorrhoids and external hemorrhoids

[0069] Internal hemorrhoids, clinical symptoms: In the early stage, the main symptoms are blood in the stool, which is bright red and may drip or spurt. As the disease progresses, the internal hemorrhoids may protrude from the anus. In the early stage, they can be retracted by themselves, but in the later stage, they need to be pushed back by hand or even cannot be retracted. Patients may feel that there is a swelling protruding from the anus, often accompanied by a feeling of heaviness. Some patients also have mucus discharge, which irritates the skin around the anus and causes itching.

[0070] Tongue and pulse: The tongue is usually red with a thin yellow coating and a stringy and rapid pulse. This is mainly caused by the presence of heat evil in the body, which forces blood to flow indiscriminately and causes blood in the stool. Red tongue, yellow coating and rapid pulse are all manifestations of heat, and a stringy pulse is often related to liver depression or poor blood circulation in the body.

[0071] TCM Syndrome Classification Diagnosis

[0072] Wind-heat and intestinal dryness syndrome: blood in the stool, dripping blood or spurting blood, the blood is bright red, constipation or anal itching, red tongue, thin yellow tongue coating, and rapid pulse.

[0073] Damp-heat descending syndrome: bright red blood in stool, large amount, swelling in the anus falls out and shrinks on its own, burning sensation in the anus, red tongue, yellow greasy coating, slippery and rapid pulse. This is because damp-heat evil accumulates in the lower part of the anus, and excessive heat forces blood to flow, resulting in blood in stool. Severe dampness evil will cause yellow greasy coating.

[0074] Qi stagnation and blood stasis syndrome: the tumor in the anus prolapses, or even gets stuck, the anal canal contracts, there is heaviness and pain, or even thrombosis, anal edema, obvious tenderness, dark purple tongue, white fur, stringy and thin pulse. This syndrome is mostly caused by poor circulation of qi and blood and blood stasis.

[0075] Spleen deficiency and qi collapse syndrome: anus is swollen and prolapsed, the tumor in the anus needs to be pushed back by hand, blood in the stool, bright red or light red, long course of disease, pale complexion, fatigue, poor appetite and loose stools, pale and fat tongue with teeth marks on the edges, thin white fur, weak pulse. Spleen deficiency cannot control blood, which will cause blood in the stool, and qi collapse will cause the tumor to prolapse and cannot be retracted by itself.

[0076] External hemorrhoids, symptoms: Mainly manifested as discomfort in the anus, dampness and uncleanness, and sometimes itching. If thrombosis and subcutaneous hematoma occur, there will be severe pain, which is often more severe and worsens during bowel movements, walking, sitting, etc. Dark purple round tumors can be seen at the anal margin, with clear boundaries, hard texture, and obvious tenderness.

[0077] Tongue and pulse: red tongue or ecchymosis, thin white or yellow fur, stringy or astringent pulse. Ecchymosis and astringent pulse are typical manifestations of blood stasis, while a red tongue and yellow fur indicate heat.

[0078] TCM Syndrome Classification Diagnosis

[0079] Qi stagnation and blood stasis syndrome: There is a protruding swelling at the anus, which may increase in size during bowel movements, and there may be a foreign body sensation, distending pain or heaviness, and hard nodules may be felt locally. The tongue is dark purple, the tongue coating is thin yellow, and the pulse is stringy and wiry.

[0080] Syndrome of damp-heat descending: red, swollen, hot and painful swelling around the anus, feeling of heaviness and discomfort, dry or loose stools, red tongue, yellow and greasy tongue coating, and slippery and rapid pulse.

[0081] Mixed hemorrhoids: They have the characteristics of both internal and external hemorrhoids. When making a diagnosis, it is necessary to comprehensively consider the symptoms, tongue patterns, pulse patterns, and syndrome characteristics of both internal and external hemorrhoids.

[0082] (2) Anal fissure, clinical symptoms: The main symptom is periodic pain. During defecation, the feces stimulate the nerve endings on the ulcerated surface of the anal fissure, and the anus immediately feels a burning or knife-like pain, which is called defecation pain. It can be relieved a few minutes after defecation, which is called the interval period. Then, due to the contraction and spasm of the anal sphincter, the pain will be severe again, which can last for half an hour to several hours, which is called sphincter contracture pain. At the same time, patients often have blood in their stools, which is not much and bright red in color. Most of the blood is on the surface of the stool or on toilet paper. Some patients may experience constipation because they are afraid of pain during defecation and deliberately postpone defecation, resulting in dry stools, which in turn aggravates the anal fissure.

[0083] Tongue and pulse: Pale red tongue, thin white or yellow fur, stringy pulse. Pale red tongue with thin white fur is a normal tongue condition or a slight fever (when the fur is yellow). Stringy pulse is mainly related to the state of physical tension caused by pain.

[0084] TCM syndrome classification diagnosis

[0085] Blood-heat and dry intestine syndrome: dry stool, one bowel movement every two or three days, anal pain, blood dripping from the anus, red cracks, abdominal distension, yellow urine, red tongue, yellow and dry fur, stringy and rapid pulse. This is because the heat in the body burns the body fluids, causing dry stool, heat forces blood to flow, causing blood in the stool, and when the heat is strong, the tongue is red, the fur is yellow, and the pulse is rapid.

[0086] Yin deficiency and fluid deficiency syndrome: dry and hard stools, defecation every few days, pain during defecation, spotting of blood, deep red fissures, dry mouth and throat, fever in the five parts of the body, red tongue, little or no coating, and thready pulse. This syndrome is caused by the deficiency of Yin fluid, which cannot moisten the intestines and anus, resulting in dry and hard stools and fissures that are difficult to heal. Yin deficiency generates internal heat, which will cause fever in the five parts of the body, red tongue, and thready pulse.

[0087] Qi stagnation and blood stasis syndrome: Anal stinging pain, especially during and after defecation, anus contraction, dark purple opening, dark purple tongue, thin fur, stringy or astringent pulse. Because Qi and blood stagnate in the anus, pain occurs when the anus is blocked, so stinging pain, dark purple tongue and stringy or astringent pulse are typical manifestations of Qi stagnation and blood stasis.

[0088] (3) Anal fistula, clinical symptoms: repeated pus discharge, swelling, pain and itching around the anus. When pus is discharged, the amount of pus is related to the length of the fistula and the number of branches. New fistulas have more pus, which is smelly, yellow and thick; chronic anal fistulas have relatively less pus, or it is intermittent and thin. Swelling and pain are caused by pus accumulation in the fistula and poor drainage. When the pus is discharged, the swelling and pain can be relieved. Itching is mainly caused by pus irritating the skin around the anus. Some patients can touch cord-like nodules leading to the anus.

[0089] Tongue and pulse: red tongue, yellow greasy coating, slippery and rapid pulse. This is mainly because anal fistula is mostly caused by damp heat, and the accumulation of damp heat will cause red tongue, yellow greasy coating, and slippery and rapid pulse.

[0090] TCM syndrome classification diagnosis

[0091] Syndrome of damp-heat descending: pus often flows out from the perianal area, which is yellow and thick, there is swelling and pain in the anus, local burning sensation, ulcers around the anus, and when pressed, there are cord-like objects leading to the anus, red tongue, yellow and greasy tongue coating, and slippery and rapid pulse.

[0092] Symptom of deficiency of vital energy and lingering evil: pus discharge from the anus, thin in texture, no obvious pain or only dull pain, dark skin color of the external opening, sometimes ulcerated and sometimes healed, ulcers around the anus, hard to press, or hard cords leading to the anus, accompanied by fatigue, pale complexion, pale red tongue, thin white fur, and soft and thready pulse. This syndrome is due to insufficient vital energy, which cannot expel evil spirits, causing evil spirits to linger and the condition to linger.

[0093] Yin fluid deficiency syndrome: perianal ulcers, sunken external openings, latent fistulas, no obvious local swelling or pain, thin pus, accompanied by hot flashes, night sweats, irritability, dry mouth, red tongue, little coating, and a weak pulse. This is because long-term illness consumes Yin fluid, and Yin deficiency and internal heat lead to symptoms such as hot flashes and night sweats.

[0094] (4) Perianal abscess, clinical symptoms: Mainly manifested as persistent severe pain in the perianal area, the pain is quite severe, and the patient is often restless. Local redness, swelling, fever, obvious nodules and tenderness at the lesion. The disease progresses rapidly, and there may be a sense of fluctuation after the abscess is formed. Some patients also have systemic symptoms, such as fever, chills, fatigue, loss of appetite, etc., which are mainly due to the systemic inflammatory response caused by the infection.

[0095] Tongue and pulse: red tongue, yellow fur, rapid pulse. These manifestations are typical signs of intense heat and toxicity, because perianal abscess is mainly caused by the accumulation of heat and toxicity around the anus.

[0096] TCM syndrome classification diagnosis

[0097] Heat and toxic accumulation syndrome: sudden swelling and pain around the anus, which worsens continuously, accompanied by aversion to cold, fever, constipation, dark urine, redness and swelling around the anus, obvious tenderness, hard texture, hot surface, red tongue, yellow fur, and rapid pulse. This is because the heat and toxic evil accumulates around the anus, and the struggle between the positive and the negative will cause systemic symptoms such as aversion to cold and fever. The heat and toxicity burn the body fluids, leading to constipation and dark urine.

[0098] Syndrome of blazing fire poison: Severe swelling and pain around the anus, lasting for several days, pain like a chicken pecking, difficulty falling asleep, obvious redness, swelling, heat and pain around the anus, fluctuating sensation when pressed, or pus after puncture, persistent high fever, dry mouth and lips, constipation, short and dark urine, red tongue, dry yellow fur, and rapid pulse. This syndrome is a manifestation of further aggravation of heat poison, which leads to the formation of local abscesses and severe symptoms such as systemic high fever.

[0099] Yin deficiency and toxic retention syndrome: perianal swelling and pain, dark red skin, long time for pus formation, thin pus after ulceration, difficult to heal sores, accompanied by afternoon hot flashes, irritability, dry mouth, night sweats, red tongue, little coating, and weak pulse. This is because the body is Yin-deficient, heat and toxic retention, Yin deficiency generates internal heat, afternoon hot flashes and other symptoms, and insufficient positive energy makes the sores difficult to heal.

[0100] Table 1 Clinical use of Chinese herbal granules for anorectal diseases

[0101] years 2019 2020 2021 2022 2023 Dosage / bag 1536 2741 5987 7481 10784

[0102] Table 2 Observation of the efficacy of Chinese herbal granules for anorectal diseases in treating 100 cases of hemorrhoids

[0103]

[0104] According to the results analysis in Table 2, the clinical symptoms of the patients were significantly improved after taking the medicine. In the treatment group, 85 cases (85%) were cured, 12 cases (12%) were significantly effective, 3 cases (3%) were effective, and 0 cases (0%) were ineffective. The effective rate was 100%, indicating that the Chinese herbal granules for the treatment of anorectal diseases have obvious therapeutic effects on anorectal diseases such as hemorrhoids, anal fissures, anal fistulas and perianal abscesses.

[0105] The beneficial effects of the drug of the present invention for treating anorectal diseases are further described by the specific experimental examples in the following table:

[0106] Experimental drugs:

[0107] In the prescription of the present invention, Sophora flavescens and Phellodendron chinense are the main drugs. The inventors have found through experiments that heavy use of Sophora flavescens and Phellodendron chinense is helpful in reducing swelling, relieving pain and relieving itching. When the dosage of the two is reduced and the dosage of other Chinese medicines remains unchanged, the effect is significantly reduced; when the dosage of the two is reduced and the dosage of other Chinese medicines (ministerial medicine, adjuvant medicine, guiding medicine) in the prescription is increased, the therapeutic effect is still significantly reduced compared with when Sophora flavescens and Phellodendron chinense are the main drugs.

[0108] The composition of each formula in Table 3 is as follows:

[0109] Group 1: Sophora flavescens 15g, Phellodendron amurense 12g, Taraxacum officinale 15g, Sodium sulfate 30g, Atractylodes macrocephala 15g, Saposhnikovia divaricata 12g, Galla chinensis 15g, Paeonia lactiflora 12g, Platycladus orientalis 12g, Sanguisorba officinalis 20g, Zanthoxylum bungeanum 6g, Licorice root 12g

[0110] Group 2: Sophora flavescens 10g, Phellodendron amurense 7g, Taraxacum officinale 15g, Sodium sulfate 30g, Atractylodes macrocephala 15g, Saposhnikovia divaricata 12g, Galla chinensis 15g, Paeonia lactiflora 12g, Platycladus orientalis 12g, Sanguisorba officinalis 20g, Zanthoxylum bungeanum 6g, Licorice root 12g

[0111] Group 3: Sophora flavescens 10g, Phellodendron amurense 7g, Taraxacum officinale 20g, Sodium sulfate 40g, Atractylodes macrocephala 20g, Saposhnikovia divaricata 17g, Galla chinensis 20g, Paeonia lactiflora 17g, Platycladus orientalis 17g, Sanguisorba officinalis 25g, Zanthoxylum bungeanum 11g, Licorice root 17g

[0112] Table 3: Experimental example of drug dosage screening (%)

[0113] Grouping get well Significant effect Improvement invalid Total effective 1 group 15(75%) 3(15%) 2(10%) 0(0%) 18(90%) 2 groups 10(50%) 5(25%) 4(30%) 1(5%) 15(75%) 3 groups 9(45%) 3(15%) 7(30%) 1(5%) 12(60%)

[0114] It can be found in Table 3 that the drugs in groups 1-3 of the implementation cases were respectively used for experiments. The experiments show that the best therapeutic effect can be achieved by using both Sophora flavescens and Phellodendron chinense as the main drugs in the prescription of the present invention. When the dosage of the two drugs is reduced as in Group 2 or the dosage of the two drugs is reduced as in Group 3 while the dosage of other drugs is increased, the total effective rate of treatment is significantly reduced.

[0115] Typical treatment cases:

[0116] Case 1, patient Li Moumou, due to spicy and stimulating diet three days ago, the anus prolapsed and swollen body was unbearable pain. Check: the skin and mucous membrane of the anus margin at 3, 7, and 11 o'clock in the perianal lithotomy position was raised, partially edematous, dark purple, and obvious tenderness. The drug used in the present invention was used for external treatment. After three days, the patient's pain was significantly relieved, the mucous skin of the anus margin at 3, 7, and 11 o'clock in the lithotomy position was significantly reduced, and the edema subsided. After 1 week, the pain disappeared, and only the lump protruding from the anus margin at 11 o'clock in the lithotomy position was seen, the edema subsided, and there was no tenderness. After treatment, the patient was cured.

[0117] Case 2, patient Wang, 3 days after surgery for perianal abscess, anal pain during bowel movement, more wound exudate, more exudate on wound surface, obvious tenderness. After 4 days of external washing with the drug of the present invention, anal pain during bowel movement was significantly relieved, the duration of pain after bowel movement was shortened, and wound exudate was reduced. After 8 days, the anus was slightly painful during bowel movement, the pain disappeared after bowel movement, there was no exudate on wound surface, and the granulation tissue on wound surface was fresh. The treatment was effective.

[0118] Case 3, patient Gao Moumou, 10 days after mixed hemorrhoid surgery, anal pain during defecation, anal pain disappeared after defecation, examination: anus is centered, lithotomy position 1, 5, 7, 11 points of the wound are bright red, tenderness is obvious, there is a small amount of exudate, no edema at the wound edge, given this prescription for external washing, anal pain disappeared after 7 days, wound surface shrank. No obvious tenderness.

[0119] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some or all of the technical features therein with equivalents. However, these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A Chinese medicine granule for treating anorectal diseases, characterized in that: The invention is composed of the following raw materials in parts by weight: 10-20 parts of sophora flavescens, 7-17 parts of phellodendron amurense, 10-20 parts of dandelion, 20-40 parts of sodium sulfate, 10-20 parts of atractylodes, 7-17 parts of siler, 10-20 parts of gallnut, 7-17 parts of red peony root, 7-17 parts of oriental arborvitae leaves, 15-25 parts of raw sanguisorba officinalis, 1-11 parts of zanthoxylum bungeanum and 7-17 parts of raw liquorice.

2. A Chinese medicine granule for treating anorectal diseases according to claim 1, characterized in that: The invention is composed of the following raw materials in parts by weight: 15 parts of sophora flavescens, 12 parts of phellodendron amurense, 15 parts of dandelion, 30 parts of sodium sulfate, 15 parts of atractylodes, 12 parts of siler, 15 parts of gallnut, 12 parts of red peony root, 12 parts of oriental arborvitae leaves, 20 parts of raw sanguisorba officinalis, 6 parts of zanthoxylum bungeanum and 12 parts of raw liquorice.

3. A Chinese medicine granule for treating anorectal diseases according to claim 1, characterized in that: The invention is composed of the following raw materials in parts by weight: 10 parts of sophora flavescens, 7 parts of phellodendron amurense, 15 parts of dandelion, 30 parts of sodium sulfate, 15 parts of atractylodes, 12 parts of siler, 15 parts of gallnut, 12 parts of red peony root, 12 parts of oriental arborvitae leaves, 20 parts of raw sanguisorba officinalis, 6 parts of zanthoxylum bungeanum and 12 parts of raw liquorice.

4. A Chinese medicine granule for treating anorectal diseases according to claim 1, characterized in that: The invention is composed of the following raw materials in parts by weight: 10 parts of sophora flavescens, 7 parts of phellodendron amurense, 20 parts of dandelion, 40 parts of sodium sulfate, 20 parts of atractylodes, 17 parts of siler, 20 parts of gallnut, 17 parts of red peony root, 17 parts of oriental arborvitae leaves, 25 parts of raw sanguisorba officinalis, 11 parts of zanthoxylum bungeanum and 17 parts of raw liquorice.

5. The Chinese medicinal granules for treating anorectal diseases according to claim 1, characterized in that: The invention is composed of the following raw materials in parts by weight: 20 parts of sophora flavescens, 17 parts of phellodendron amurense, 10 parts of dandelion, 20 parts of sodium sulfate, 10 parts of atractylodes, 7 parts of siler, 10 parts of gallnut, 7 parts of red peony root, 7 parts of oriental arborvitae leaves, 15 parts of raw sanguisorba officinalis, 1 part of zanthoxylum bungeanum and 7 parts of raw liquorice.

6. A method for preparing the Chinese medicine granules for treating anorectal diseases according to any one of claims 1 to 5, characterized in that: The following steps are involved: (1) weighing sophora flavescens, phellodendron amurense, dandelion, sodium sulfate, atractylodes, siler, gallnut, red peony root, arborvitae leaf, raw sanguisorba officinalis, Zanthoxylum bungeanum, and raw liquorice according to the weight ratio for later use; (2) taking Sophora flavescens, Phellodendron amurense, Galla chinensis, Paeonia lactiflora and raw Licorice, adding 8-12 times the amount of water, soaking for 0.5-1 hour, heating and boiling for the first time for 1 hour, filtering, and collecting the first extract and the residue; (3) taking dandelion, arborvitae leaves, Zanthoxylum bungeanum, atractylodes, sanguisorba officinalis and siler, adding them to the residues of step (2) and adding 6-10 times the amount of water, performing a first heating and boiling for 0.5 hours, filtering, and collecting a second extract and the residues; (4) combining the first extract and the second extract and mixing them together, and letting them stand for 10-12 hours; (5) centrifuging the combined extract to remove insoluble impurities and concentrating the extract into a fluid thick extract; (6) adding a mixture of talcum powder and xuanming powder to the thick extract, and stirring the mixture thoroughly and uniformly, drying the mixture after stirring the mixture thoroughly and uniformly, and collecting a dry extract block; (7) crushing the dry extract block and sieving it for the first time to obtain extract powder for later use; (8) adding talc, dextrin and magnesium stearate to the extract powder and mixing them thoroughly, adding a wetting agent, sieving them for a second time to prepare granules, drying the granules sifted for the second time, crushing them again and sifting them for a third time to obtain the extract powder; (9) adding a wetting agent again to the extract powder after the pulverization in step (8) and the third sieving, sieving for the fourth time to prepare granules, and drying to obtain the Chinese medicine granules; (10) Package, seal, inspect, label, and verify Chinese medicine granules before storage.

7. The method for preparing a Chinese medicine granule for treating anorectal diseases according to claim 6, wherein the drying temperature of steps (6), (8) and (9) is 60°C-70°C.

8. The method for preparing the Chinese medicine granules for treating anorectal diseases according to claim 6, wherein the wetting agent in step (8) and step (9) is 75% ethanol.

9. The method for preparing a Chinese medicine granule for treating anorectal diseases according to claim 6, wherein the density of the thick extract in step (5) is ρ=1.325-1.350 g / mL.

10. The method for preparing a Chinese medicine granule for treating anorectal diseases according to claim 6, wherein the mesh number of the first sieving and the third sieving is 80 mesh, and the mesh number of the second sieving and the fourth sieving is 14 mesh.