External-use traditional chinese medicine composition for treating anorectal diseases, traditional chinese medicine formulation, preparation method therefor, and use thereof

Abstract

An external-use traditional Chinese medicine composition for treating anorectal diseases and / or postoperative complications of anorectal diseases and a preparation method therefor, a formulation and a pharmaceutical use. The composition is prepared from the following raw materials in parts by weight: 50-200 parts of polygonum cuspidatum, 0.1-5 parts of musk, 0.1-5 parts of calculus bovis, 10-80 parts of borneol, 50-200 parts of callicarpa bodinieri, 5-40 parts of dried alum, 1-30 parts of borax, 0.1-5 parts of pearls, and 0.1-5 parts of amber. The preparation method comprises extracting callicarpa bodinieri and polygonum cuspidatum to obtain extract powder, crushing the remaining raw materials, and mixing the raw materials. Experiments show that the composition has the effects of anti-inflammation, hemostasis, analgesia, etc., and has the effects of relieving anorectal swelling, anal ulcer, postoperative anal pain and inflammation, etc.

Description

A topical Chinese medicine composition, Chinese medicine preparation, its preparation method and application for treating anorectal diseases Technical Field

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

[0002] Anorectal diseases refer to a series of diseases that occur in the anus, rectum, and colon, mainly including hemorrhoids, anal cryptitis, constipation, anal fissures, perianal abscesses, anal fistulas, anal canal prolapse, anal eczema, anorectal stenosis, and anal incontinence. Common symptoms include rectal bleeding, pain, swelling, and itching.

[0003] Hemorrhoids are the most common anorectal disease in clinical practice. Statistics show that the incidence of anorectal diseases in my country is 50.1%; among them, the incidence of hemorrhoids is as high as 49.14%, accounting for 98.08% of all anorectal diseases. Based on the location of the disease, hemorrhoids can be divided into internal hemorrhoids, external hemorrhoids, and mixed hemorrhoids. Traditional Chinese medicine believes that the pathogenesis of hemorrhoids is "all due to the deficiency of the internal organs" (Danxi Xinfa), coupled with factors such as excessive consumption of spicy and rich foods, prolonged sitting or squatting, heavy lifting, constipation, straining during pregnancy and childbirth, etc., "leading to internal dampness, heat, and dryness, causing turbid qi and stagnant blood to flow into the anus, all of which can generate hemorrhoids" (Yangyi Daquan). Hemorrhoids are a pathological condition caused by obstruction of the anal meridians due to various factors. Its occurrence and development are closely related to the accumulation and downward movement of stagnant blood. Stagnant blood obstructs the flow of blood, preventing it from circulating properly, or heat scorches the blood vessels, forcing blood to overflow and leak into the intestines, resulting in rectal bleeding. Poor blood flow causes pain; undispersed blood stasis forms lumps, thus manifesting as bleeding, pain, and prolapse of the mass. Treatment methods for anorectal diseases vary depending on the type of disease. Common treatment methods include medication, surgery, and physical therapy; among these, medication is a particularly important approach. For example, for hemorrhoids, there are many traditional Chinese medicine preparations available on the market, such as An Tai ointment, Xiao Zhi ointment, Yunnan Baiyao hemorrhoid ointment, Mayinglong musk hemorrhoid ointment, Jiuhua ointment, Jingwanhong hemorrhoid ointment, and Xiongdan hemorrhoid ointment.

[0004] Some anorectal diseases can be treated surgically. For example, hemorrhoids can be treated surgically if conservative or instrumental treatments are ineffective. Surgical options include hemorrhoidectomy, stapled hemorrhoidectomy, and transanal hemorrhoidal artery ligation. The most basic treatment for perianal abscesses is surgical drainage. However, postoperative complications and slow wound healing are common in anorectal diseases. Early postoperative complications include pain, bleeding, urinary retention, anal tenesmus, and perianal edema. Late postoperative complications include infection, anal stenosis, delayed bleeding, and difficulty defecating. Clinically, treatment often focuses on symptomatic relief. Anti-inflammatory drugs commonly used include cephalosporins or amoxicillin to prevent infection and promote wound healing. Analgesics commonly used include general analgesics (opioids and non-opioids) and long-acting analgesics (such as local injections of methylene blue). Local metronidazole can help reduce postoperative discomfort. Swelling can be reduced with oral diosmin tablets and topical magnesium sulfate wet compresses. In contrast, traditional Chinese medicine external treatments, through methods such as fumigation, sitz baths, enemas, and topical application, allow the medicinal effects to directly target the wound, achieving therapeutic results in a short time. The rational use of topical Chinese medicine can alleviate postoperative pain, reduce perianal edema, and accelerate wound healing, offering unique advantages such as lower production costs, ease of use, and direct efficacy. Currently, the variety of commercially available Chinese patent medicine ointments for postoperative treatment of anorectal diseases is relatively limited. Taking hemorrhoid surgery as an example, only two products are currently available: Jiuhua Ointment and Xiongdan Zhiling Ointment. The product range is far less diverse than for hemorrhoid treatments, because some hemorrhoid treatments are not effective against postoperative complications.

[0005] In fact, there have been some patented technologies reported for treating anorectal diseases. Taking the treatment of hemorrhoids as an example, patent document CN1209118C discloses a drug for treating hemorrhoids, made from seven traditional Chinese medicines: amber, borneol, borax, pearl, calamine, bezoar, and musk. Patent document CN114984084B discloses a traditional Chinese medicine composition for treating hemorrhoids, made from seven traditional Chinese medicines: artificial musk, artificial bezoar, calcined alum, charred schizonepeta, fried sophora japonica fruit, borneol, and borax. These drugs have good efficacy for hemorrhoids, but their efficacy is insufficient for postoperative complications and slow wound healing in anorectal diseases. Patent documents CN100536881C and CN113521166B disclose a drug for treating hemorrhoids and other anorectal diseases, which is made from nine traditional Chinese medicines: amber, borneol, borax, large-leaved purple pearl, pearl, calamine, artificial bezoar, catechu, and artificial musk. The drug has good antibacterial, anti-inflammatory, and analgesic effects. However, because the product contains a large amount of carbonate mineral calamine, and the addition of the new ingredient catechu (containing catechins and epicatechins) makes it difficult to control the stability of the product, it is not easy to achieve large-scale industrial production.

[0006] For example, patent document CN103735868B provides a method for preparing a postoperative medicine pack for anorectal diseases. The medicine pack is prepared from the following raw materials: 10-30 parts of Ficus microcarpa leaves, 6-12 parts of Rhizoma Scutellariae Radix et Rhizoma, 3-10 parts of Dendrobium nobile, 6-12 parts of Herba Epimedii, 3-10 parts of Radix Platycodi, 6-12 parts of Radix Peucedani, 6-12 parts of Semen Benincasae, 6-12 parts of Fructus Hedyotis Diffusae, 6-12 parts of Fructus Pruni, 1-5 parts of Semen Celosiae, 3-10 parts of Radix Chaenomelese, and 10-25 parts of Rhizoma Scutellariae Radix. Ficus microcarpa leaves and Rhizoma Scutellariae Radix are used as the principal ingredients in this formula. The combination of Ficus microcarpa leaves and Rhizoma Scutellariae Radix is ​​said to effectively relieve postoperative pain and hypersensitivity by targeting the wind-toxin and phlegm-fire in the meridians after anorectal disease surgery. However, it can be seen that the above formula can only relieve pain, and the application method is wet compress, which limits its clinical application in terms of both usage scenarios and methods.

[0007] For example, patent document CN104906234A provides a compound preparation for treating postoperative wounds of anorectal diseases and its preparation method. The compound preparation is made from the following raw materials in the indicated weight ratios: 10-40 parts of *Orostachys chinensis*, 10-40 parts of rhubarb, 10-40 parts of *Phellodendron chinense*, 10-30 parts of earthworm, 5-20 parts of pearl, 1-10 parts of borneol, and 1-10 parts of indomethacin. This compound preparation is mainly applied to postoperative wounds of anorectal diseases, effectively clearing bacteria from the wound, effectively reducing local swelling and pain, promoting fresh granulation tissue growth, and accelerating wound healing. However, it can be seen that indomethacin, a non-steroidal anti-inflammatory drug (NSAID), is used, increasing the analgesic and anti-inflammatory effects. While the combination of traditional Chinese and Western medicine in the above compound preparation can achieve certain therapeutic effects, it is not conducive to fully utilizing the advantages of traditional Chinese medicine.

[0008] Therefore, it is essential to provide a drug that is effective in treating anorectal diseases and postoperative complications of anorectal diseases. Technical issues

[0009] In view of the shortcomings of the existing technology, one of the objectives of the present invention is to provide a topical Chinese medicine composition for treating anorectal diseases and / or postoperative complications of anorectal diseases. Through optimization of the formula, it has good efficacy for both anorectal diseases and postoperative complications of anorectal diseases.

[0010] The second objective of this invention is to provide a method for preparing the above-mentioned topical Chinese medicine composition, which is simple in process, controllable in operation, and easy to scale up for production.

[0011] The third objective of this invention is to provide the application of the above-mentioned external Chinese medicine composition in the preparation of a medicine for treating anorectal diseases and postoperative complications of anorectal diseases.

[0012] Another object of the present invention is to provide a traditional Chinese medicine preparation comprising the above-mentioned external application traditional Chinese medicine composition, thereby making the above-mentioned external application traditional Chinese medicine composition into a common traditional Chinese medicine preparation for easy use. Technical solutions

[0013] To achieve the above objectives, the present invention adopts the following technical solution:

[0014] In a first aspect, the present invention provides a topical traditional Chinese medicine composition for treating anorectal diseases and / or postoperative complications of anorectal diseases, comprising the following raw materials in parts by weight: 50-200 parts of Polygonum cuspidatum (e.g., 10, 20, 30, 40, 50, 60, 70, 90, 100, 120, 140, 160, 170, 190, 200 parts), 0.1-5 parts of musk (e.g., 0.2, 0.5, 1, 2, 3, 3.5, 4, 5 parts), 0.1-5 parts of bezoar (e.g., 0.2, 0.5, 1, 2, 3, 3.5, 4, 5 parts), 10-80 parts of borneol (e.g., 10, 20, 30, 50, 70, 80 parts), and 50- 200 parts (e.g., 10, 20, 30, 40, 50, 60, 70, 90, 100, 120, 140, 160, 170, 190, 200 parts), 5-40 parts of alum (e.g., 5, 8, 10, 15, 20, 25, 30, 35, 38, 40 parts), 1-3 parts of borax. 0 parts (e.g., 1 part, 3 parts, 5 parts, 8 parts, 10 parts, 15 parts, 20 parts, 25 parts, 30 parts, 35 parts, 40 parts), pearls 0.1~5 parts (e.g., 0.2 parts, 0.5 parts, 1 part, 2 parts, 3 parts, 3.5 parts, 4 parts, 5 parts), amber 0.1~5 parts (e.g., 0.2 parts, 0.5 parts, 1 part, 2 parts, 3 parts, 3.5 parts, 4 parts, 5 parts).

[0015] The external Chinese medicine composition provided by this invention fully adheres to the theoretical system of traditional Chinese medicine, aiming to relieve anorectal diseases and postoperative symptoms, and alleviate pain through a treatment strategy that utilizes the basic principle of treating dampness, heat, and blood stasis simultaneously. The formula contains Polygonum cuspidatum, which is bitter and cold, effectively targeting the lower burner. It excels at clearing heat and dampness, detoxifying and reducing swelling, dispersing blood stasis and relieving pain, cooling blood and stopping bleeding, and also has the ability to purge heat and promote bowel movements. It primarily targets the underlying nature of hemorrhoids—heat accumulation and toxic stasis—as well as the main symptoms such as swelling, pain, bleeding, and constipation, exerting a comprehensive therapeutic effect. Therefore, it is used as the principal ingredient.

[0016] Musk, pungent and warm in nature, is highly effective in clearing blockages in the orifices and meridians, promoting blood circulation, and relieving swelling and pain. Calculus bovis, sweet and cool in nature, is adept at detoxifying heat and poison; "when used in internal medicine for surgery, it can relieve boils, carbuncles, and other toxic substances; when used in topical medicine, it is remarkably effective in relieving pain and dispersing toxins" (from *Ben Cao Jing Shu*). Borneol, pungent and cold in nature, is highly penetrating and effective in treating both internal and external hemorrhoids, clearing heat and relieving pain. Auricularia astringent, cool in nature, possesses both blood-cooling and astringent hemostatic properties, and can also disperse blood stasis, detoxify, and reduce swelling. These four herbs, along with the principal herb, enhance its hemostatic, analgesic, and swelling-reducing effects by cooling the blood, detoxifying, promoting blood circulation, and relieving swelling. Alum, sour, astringent, and drying, is highly effective at absorbing dampness and is particularly effective in relieving itching when used externally. Combined with the principal herb, it "kills damp-heat parasites and eliminates damp-heat toxins" (from *Shennong Ben Cao Jing Bai Zhong Lu*). All of these are considered assistant herbs.

[0017] Borax, with its cooling properties, clears heat; its sweet taste detoxifies; and its salty nature softens hardened masses. It is used externally to "remove necrotic tissue and dissipate lesions," as described in *Ben Cao Jing Shu*. Pearl, sweet and salty in nature, is cold in nature and is said to "promote tissue regeneration and achieve remarkable effects," as described in *Ben Cao Qiu Zhen*. Amber, sweet and neutral in nature, is said to "stop bleeding, promote tissue regeneration, and heal wounds," as described in *Ben Cao Jing Shu*. The combined use of these three ingredients helps to dissipate hemorrhoids and promote healing, serving as adjuvant herbs.

[0018] The combined effects of these herbs work synergistically to clear heat and dampness, reduce swelling and relieve pain, stop bleeding and promote tissue regeneration. They can clear damp-heat, stop and control rectal bleeding, alleviate swelling and pain, and reduce or eliminate various anal discomfort symptoms. They can also improve postoperative pain and swelling, and promote wound healing.

[0019] Preferably, in some embodiments of the first aspect of the present invention, the above-mentioned external Chinese medicine composition is made from the following raw materials in parts by weight: 50-150 parts of Polygonum cuspidatum, 0.1-3 parts of musk, 0.1-3 parts of bezoar, 20-70 parts of borneol, 50-150 parts of pearl, 10-30 parts of alum, 5-20 parts of borax, 0.1-3 parts of pearl, and 0.1-3 parts of amber.

[0020] More preferably, in some embodiments of the first aspect of the present invention, the above-mentioned external Chinese medicine composition is made from the following raw materials in parts by weight: 80-120 parts of Polygonum cuspidatum, 0.1-1 parts of musk, 0.1-1 parts of bezoar, 30-60 parts of borneol, 80-120 parts of pearl, 10-25 parts of alum, 5-15 parts of borax, 0.1-1 parts of pearl, and 0.1-1 parts of amber.

[0021] For example, the above-mentioned external Chinese medicine composition can be made from the following raw materials in parts by weight: 100 parts of Polygonum cuspidatum, 0.5 parts of musk, 0.3 parts of bezoar, 40 parts of borneol, 100 parts of pearl, 20 parts of alum, 10 parts of borax, 0.3 parts of pearl, and 0.4 parts of amber.

[0022] For example, the above-mentioned external Chinese medicine composition may also be made from the following raw materials in parts by weight: 150 parts of Polygonum cuspidatum, 1.5 parts of musk, 0.1 parts of bezoar, 20 parts of borneol, 70 parts of pearl, 25 parts of alum, 5 parts of borax, 3 parts of pearl, and 0.1 parts of amber.

[0023] For example, the above-mentioned external Chinese medicine composition may also be made from the following raw materials in parts by weight: 120 parts of Polygonum cuspidatum, 0.3 parts of musk, 1 part of bezoar, 10 parts of borneol, 80 parts of pearl, 5 parts of alum, 20 parts of borax, 1.5 parts of pearl, and 0.8 parts of amber.

[0024] For example, the above-mentioned external Chinese medicine composition may also be made from the following raw materials in parts by weight: 80 parts of Polygonum cuspidatum, 0.1 parts of musk, 0.5 parts of bezoar, 50 parts of borneol, 100 parts of pearl, 15 parts of alum, 25 parts of borax, 0.9 parts of pearl, and 1.5 parts of amber.

[0025] For example, the above-mentioned external Chinese medicine composition may also be made from the following raw materials in parts by weight: 120 parts of Polygonum cuspidatum, 1 part of musk, 1.5 parts of bezoar, 30 parts of borneol, 110 parts of pearl, 10 parts of alum, 5 parts of borax, 0.1 parts of pearl, and 2 parts of amber.

[0026] For example, the above-mentioned external Chinese medicine composition may also be made from the following raw materials in parts by weight: 150 parts of Polygonum cuspidatum, 0.2 parts of musk, 0.3 parts of bezoar, 15 parts of borneol, 150 parts of pearl, 9 parts of alum, 1 part of borax, 0.6 parts of pearl, and 1.8 parts of amber.

[0027] For example, the above-mentioned external Chinese medicine composition may also be made from the following raw materials in parts by weight: 100 parts of Polygonum cuspidatum, 1.2 parts of musk, 1.2 parts of bezoar, 38 parts of borneol, 50 parts of pearl, 30 parts of alum, 16 parts of borax, 1.8 parts of pearl, and 2.5 parts of amber.

[0028] For example, the above-mentioned external Chinese medicine composition may also be made from the following raw materials in parts by weight: 160 parts of Polygonum cuspidatum, 0.3 parts of musk, 0.2 parts of bezoar, 20 parts of borneol, 80 parts of pearl, 15 parts of alum, 10 parts of borax, 0.8 parts of pearl, and 3 parts of amber.

[0029] For example, the above-mentioned external Chinese medicine composition may also be made from the following raw materials in parts by weight: 110 parts of Polygonum cuspidatum, 0.5 parts of musk, 0.3 parts of bezoar, 25 parts of borneol, 90 parts of pearl, 25 parts of alum, 15 parts of borax, 0.3 parts of pearl, and 0.4 parts of amber.

[0030] For example, the above-mentioned external Chinese medicine composition may also be made from the following raw materials in parts by weight: 70 parts of Polygonum cuspidatum, 2 parts of musk, 1.8 parts of bezoar, 30 parts of borneol, 70 parts of pearl, 10 parts of alum, 18 parts of borax, 0.5 parts of pearl, and 0.5 parts of amber.

[0031] For example, the above-mentioned external Chinese medicine composition may also be made from the following raw materials in parts by weight: 50 parts of Polygonum cuspidatum, 2.5 parts of musk, 2 parts of bezoar, 20 parts of borneol, 50 parts of pearl, 20 parts of alum, 15 parts of borax, 0.5 parts of pearl, and 0.5 parts of amber.

[0032] For example, the above-mentioned external Chinese medicine composition may also be made from the following raw materials in parts by weight: 200 parts of Polygonum cuspidatum, 0.8 parts of musk, 2 parts of bezoar, 60 parts of borneol, 200 parts of pearl, 10 parts of alum, 18 parts of borax, 0.5 parts of pearl, and 5 parts of amber.

[0033] For example, the above-mentioned external Chinese medicine composition may also be made from the following raw materials in parts by weight: 150 parts of Polygonum cuspidatum, 0.1 parts of musk, 0.1 parts of bezoar, 50 parts of borneol, 100 parts of pearl, 18 parts of alum, 10 parts of borax, 0.8 parts of pearl, and 0.8 parts of amber.

[0034] For example, the above-mentioned external Chinese medicine composition may also be made from the following raw materials in parts by weight: 110 parts of Polygonum cuspidatum, 5 parts of musk, 5 parts of bezoar, 80 parts of borneol, 110 parts of pearl, 22 parts of alum, 15 parts of borax, 1.5 parts of pearl, and 0.5 parts of amber.

[0035] For example, the above-mentioned external Chinese medicine composition may also be made from the following raw materials in parts by weight: 100 parts of Polygonum cuspidatum, 2 parts of musk, 2 parts of bezoar, 50 parts of borneol, 100 parts of pearl, 32 parts of alum, 10 parts of borax, 0.8 parts of pearl, and 0.8 parts of amber.

[0036] For example, the above-mentioned external Chinese medicine composition may also be made from the following raw materials in parts by weight: 120 parts of Polygonum cuspidatum, 0.8 parts of musk, 1.5 parts of bezoar, 25 parts of borneol, 120 parts of pearl, 18 parts of alum, 20 parts of borax, 0.6 parts of pearl, and 0.9 parts of amber.

[0037] For example, the above-mentioned external Chinese medicine composition may also be made from the following raw materials in parts by weight: 120 parts of Polygonum cuspidatum, 3 parts of musk, 0.9 parts of bezoar, 30 parts of borneol, 90 parts of pearl, 16 parts of alum, 8 parts of borax, 1.6 parts of pearl, and 0.8 parts of amber.

[0038] For example, the above-mentioned external Chinese medicine composition may also be made from the following raw materials in parts by weight: 130 parts of Polygonum cuspidatum, 1.8 parts of musk, 0.6 parts of bezoar, 28 parts of borneol, 100 parts of pearl, 15 parts of alum, 15 parts of borax, 0.7 parts of pearl, and 0.7 parts of amber.

[0039] For example, the above-mentioned external Chinese medicine composition may also be made from the following raw materials in parts by weight: 110 parts of Polygonum cuspidatum, 1.4 parts of musk, 1.4 parts of bezoar, 35 parts of borneol, 110 parts of pearl, 10 parts of alum, 10 parts of borax, 1.3 parts of pearl, and 1.3 parts of amber.

[0040] For example, the above-mentioned external Chinese medicine composition may also be made from the following raw materials in parts by weight: 100 parts of Polygonum cuspidatum, 0.7 parts of musk, 0.9 parts of bezoar, 42 parts of borneol, 100 parts of pearl, 12 parts of alum, 14 parts of borax, 2.5 parts of pearl, and 0.9 parts of amber.

[0041] Secondly, the present invention also provides a method for preparing the above-mentioned external application traditional Chinese medicine composition, comprising the following steps:

[0042] (1) Extract and concentrate the mixture of Callicarpa and Polygonum cuspidatum, then dry and pulverize it to obtain extract powder; or, extract and concentrate Callicarpa and Polygonum cuspidatum separately, then mix them and dry and pulverize them to obtain extract powder;

[0043] (2) The musk, bezoar, pearl, amber, borax, borneol and alum are pulverized separately and then mixed to obtain the raw powder of Chinese medicine; or, the above raw materials are mixed and pulverized together to obtain the raw powder of Chinese medicine.

[0044] (3) Mix the extract powder obtained in step (1) and the raw Chinese medicine powder obtained in step (2).

[0045] In this invention, a topical Chinese medicine composition can be obtained by extracting two substances, namely, Polygonum cuspidatum and Polygonum cuspidatum, and then mixing them with other pulverized substances. The production process is simple and easy to scale up.

[0046] Obviously, in this invention, individual raw materials can be extracted separately to obtain extracts, and then the obtained extracts can be mixed; simultaneously, individual raw materials can be pulverized, mixed after processing, and then the extracts and pulverized materials can be mixed to complete the preparation of the traditional Chinese medicine composition. Alternatively, the substances can be mixed and processed together. Specifically, as defined in the above process, in the processing of step (1), *Callicarpa japonica* and *Polygonum cuspidatum* can be processed individually or mixed together; in terms of improving processing efficiency, it is preferable to process them together in actual processing. Similarly, the processing of musk, bezoar, pearl, amber, borax, borneol, and alum can be done individually or mixed together; in terms of improving processing efficiency, it is preferable to process them together in actual processing.

[0047] In some embodiments of the second aspect of the present invention, in step (1), the extraction process is at least one of the following: water decoction, soaking, percolation, reflux, supercritical fluid extraction, ultrasonic extraction, and enzymatic extraction. Among them, decoction is the most commonly used method for extracting traditional Chinese medicine (TCM). It involves boiling the herbs in water to extract the active ingredients. Patent documents CN1259955C and CN100337651C both utilize this method. Immersion involves using a suitable solvent to soak the herbs, allowing the active ingredients to leach out. Patent documents CN101928658A and CN101879240A report on the use of immersion for TCM extraction. Percolation involves placing the herbs in a percolator, adding solvent from the top, and extracting the herbs using the liquid level difference. Patent documents CN1219532C and CN100346798C provide corresponding application reports. Reflux extraction involves soaking the herbs in a solvent, heating it to evaporate the solvent, and then condensing and refluxing it to extract the active ingredients. Patent documents CN1583100A and CN100522... All 197C patents provide corresponding application reports; Supercritical fluid extraction is a method that uses supercritical fluids (such as carbon dioxide) as solvents and extracts the effective components from traditional Chinese medicine by adjusting pressure and temperature, as reported in patent documents CN104173781A and CN104784390A; Ultrasonic extraction is a method that uses ultrasonic technology to assist solvent extraction. It utilizes the cavitation effect and stirring action generated by sound waves to disrupt the cells of medicinal plants, allowing the solvent to quickly penetrate the cells, thereby shortening the extraction time and increasing the extraction rate, as reported in patent documents CN100428948C and CN102743503A; Enzymatic extraction is an extraction method that uses the action of enzymes to promote the release of effective components from traditional Chinese medicine, as reported in patent documents CN1103665A and CN103623014A. The above extraction processes can be flexibly selected according to actual needs, using single or combined processes, which is a general operational skill possessed by those skilled in the art. The present invention uses water extraction and alcohol extraction as examples for illustration, which does not represent a strict limitation or constraint on the above extraction process.For example, when using water extraction, the liquid-to-solid ratio can be 5 to 15, specifically 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, etc. Heating can be performed during water extraction, with a heating temperature of 80 to 100℃. Specifically, one can choose any value from 80℃, 81℃, 82℃, 83℃, 84℃, 85℃, 86℃, 87℃, 88℃, 89℃, 90℃, 91℃, 92℃, 93℃, 94℃, 95℃, 96℃, 97℃, 98℃, 100℃, or any value within the above range. The extraction time can be 0.5 to 6 hours, specifically 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, or any value within the above range. Of course, depending on the needs, water extraction can be performed once, or repeated two or more times. For example, when using alcohol extraction, the ethanol concentration can be 50-75%, specifically choosing a value from 50%, 51%, 52%, 53%, 54%, 55%, 56%, 57%, 58%, 59%, 60%, 61%, 62%, 63%, 64%, 65%, 66%, 67%, 68%, 69%, or 70%, or any value within the above range. The solid-liquid ratio for alcohol extraction can be 5-15, specifically 5, 6, 7, 8, 9, 10, 11, or 12. 13, 14, 15, etc.; During alcohol extraction, heat treatment can be used to improve extraction efficiency. The heating temperature range is 45~65℃, specifically, it can be any value among 45℃, 46℃, 47℃, 48℃, 49℃, 50℃, 51℃, 52℃, 53℃, 54℃, 55℃, 56℃, 57℃, 58℃, 59℃, 60℃, 61℃, 62℃, 63℃, 64℃, and 65℃, or any value within the above range; The alcohol extraction time can be 0.5~6h, specifically, it can be any value among 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, and 6h, or any value within the above range; Similarly, as needed, when performing alcohol extraction, it can be treated once or repeatedly treated two or more times.

[0048] In some embodiments of the second aspect of the present invention, in step (1), the concentration is selected from atmospheric pressure concentration, vacuum concentration, and reverse osmosis concentration. Atmospheric pressure concentration refers to the concentration of the extract at room temperature and pressure using methods such as evaporation and distillation, as described in patent documents CN1053375C and CN100431598C; vacuum concentration refers to the condensation of the extract at low pressure using methods such as evaporation or distillation, as described in patent documents CN1028409C and CN1071840A; reverse osmosis concentration, also known as reverse osmosis, refers to a concentration method in which the solution enters a reverse osmosis membrane, and the solvent water molecules permeate under pressure, achieving the purpose of concentration, as described in patent documents CN102078409A and CN102423328A. In actual use, one of atmospheric pressure concentration, vacuum concentration, and reverse osmosis concentration can be used alone, or a combination of the above concentration processes can be used, such as vacuum concentration followed by atmospheric pressure concentration. Of course, the concentration process can be carried out in a manner known to those skilled in the art, which is a conventional technical method for those skilled in the art. For example, when using vacuum concentration, the pressure can be -0.02 to -0.08 MPa. It is understood that those skilled in the art can use any value among -0.02 MPa, -0.03 MPa, -0.04 MPa, -0.05 MPa, -0.06 MPa, -0.07 MPa, and -0.08 MPa, or any value within the above range. Vacuum concentration can be stopped when the relative density of the material is 1.10 to 1.20 (80°C). Of course, after concentration and before drying, sieving can be performed. The mesh size can be 50 to 150 mesh, or it can be 50 mesh, 80 mesh, 100 mesh, or 150 mesh.

[0049] In some embodiments of the second aspect of the present invention, in step (1), the drying is selected from one of hot air drying, vacuum drying, spray drying, freeze drying, microwave drying, and infrared drying. The purpose of drying is to fully dehydrate the material, and the drying method used is something that those skilled in the art can flexibly choose according to actual production. Preferably, spray drying is used in the present invention, but this does not represent a strict limitation or constraint on the above extraction process. In spray drying, the extract is atomized into fine droplets and rapidly dried in hot air to obtain powder. When using spray drying, the inlet air temperature can be 150~180℃, the outlet air temperature can be 100~110℃, the feed pump speed can be 10~40ml / min, and the atomization frequency can be 200~400HZ. It is understood that the aforementioned inlet air temperature can be any value from 150℃, 151℃, 152℃, 153℃, 154℃, 155℃, 156℃, 157℃, 158℃, 159℃, 160℃, 161℃, 162℃, 163℃, 164℃, 165℃, 166℃, 167℃, 168℃, 169℃, and 170℃, or any specific value within the aforementioned range; similarly, the aforementioned outlet air temperature can be any value from 100℃, 101℃, 102℃, 103℃, 104℃, 105℃, 106℃, 107℃, 108℃, 109℃, and 110℃, or any specific value within the aforementioned range; the feed pump speed can be 10 ml / min, 11 ml / min, 12 ml / min, 13 ml / min, 14 ml / min, 15 ml / min, 16 ... The atomization rate can be any value from the following ranges: 17 ml / min, 18 ml / min, 19 ml / min, 20 ml / min, 21 ml / min, 22 ml / min, 23 ml / min, 24 ml / min, 25 ml / min, 26 ml / min, 27 ml / min, 28 ml / min, 29 ml / min, 30 ml / min, 31 ml / min, 32 ml / min, 33 ml / min, 34 ml / min, 35 ml / min, 36 ml / min, 37 ml / min, 38 ml / min, 39 ml / min, 40 ml / min, or any specific value within the above ranges; the atomization frequency can be 200 Hz, 210 Hz, 220 Hz, 230 Hz, 240 Hz, 250 Hz, 260 Hz, 270 Hz, 280 Hz, 290 Hz, 300 Hz, 310 Hz, 320 Hz, 330 Hz, 40 ml / min, or any specific value within the above ranges. A value from 340 Hz, 350 Hz, 360 Hz, 370 Hz, 380 Hz, 390 Hz, 400 Hz, or any specific value within the above range.Preferably, the inlet air temperature can be 160℃, the outlet air temperature can be 100℃, the feed pump speed can be 12ml / min, and the atomization frequency can be 250HZ.

[0050] Vacuum drying is a drying process conducted under low pressure and low temperature conditions, which can effectively protect active ingredients. Equipment includes vacuum drying ovens, freeze dryers, etc. In some embodiments of the second aspect of this invention, when vacuum drying is used, the main process parameters for vacuum drying can be set as follows: pressure not less than 0.06 MPa, temperature not higher than 60°C.

[0051] Hot air drying is the most common drying method, which uses hot air to heat and dry extracts of traditional Chinese medicine. It includes various forms such as belt drying, fluidized bed drying, and tunnel drying. For example, when hot air drying is used, the drying temperature is 70-90℃, and the drying time is 1-6 hours. It can be understood that the drying temperature can be any value from 70℃, 71℃, 72℃, 73℃, 74℃, 75℃, 76℃, 77℃, 78℃, 79℃, 80℃, 81℃, 82℃, 83℃, 84℃, 85℃, 86℃, 87℃, 88℃, 89℃, and 90℃, or any specific value within the above range; the drying time can be any value from 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 4.5 hours, 5 hours, 5.5 hours, and 6 hours, or any specific value within the above range. For example, you can choose a drying temperature of 75℃ and a drying time of 5 hours; or a drying temperature of 80℃ and a drying time of 4.5 hours.

[0052] Freeze-drying involves freezing the extract into ice crystals and then drying the ice crystals by sublimation under reduced pressure. For example, when freeze-drying is used, the process parameters can be set as follows: freeze-drying temperature -20℃, vacuum degree 8Pa.

[0053] Microwave drying utilizes microwave heating to induce high-frequency vibrations in water molecules, thereby rapidly dehydrating and drying them. For example, when using microwave drying, the process parameters can be set as follows: microwave drying power of 100~500W, drying temperature of 40~60℃, and drying time of 1~6 hours. It can be understood that the microwave drying power can be 100W, 110W, 120W, 130W, 140W, 150W, 160W, 170W, 180W, 190W, 200W, 210W, 220W, 230W, 240W, 250W, 260W, 270W, 280W, 290W, 300W, 310W, 320W, 330W, 340W, 350W, 360W, 370W, 380W, 390W, or 400W. The drying temperature can be any value in W or any specific value within the range mentioned above; the drying temperature can be any value in 40℃, 41℃, 42℃, 43℃, 44℃, 45℃, 46℃, 47℃, 48℃, 49℃, 50℃, 51℃, 52℃, 53℃, 54℃, 55℃, 56℃, 57℃, 58℃, 59℃, 60℃ or any specific value within the range mentioned above; the drying time can be any value in 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h or any specific value within the range mentioned above. For example, a microwave drying power of 200W, a drying temperature of 45℃, and a drying time of 3h can be selected.

[0054] Infrared drying utilizes the principle of infrared heating to dry extracts, offering good controllability. For example, when using infrared drying, the drying temperature is 45-65℃, and the time is 0.5-4 hours. It can be understood that the drying temperature can be any value from 45℃, 46℃, 47℃, 48℃, 49℃, 50℃, 51℃, 52℃, 53℃, 54℃, 55℃, 56℃, 57℃, 58℃, 59℃, 60℃, 61℃, 62℃, 63℃, 64℃, and 65℃, or any specific value within the above range; the drying time can be any value from 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, and 4 hours, or any specific value within the above range. For example, a drying temperature of 50℃ and a drying time of 2 hours can be chosen.

[0055] In some embodiments of the second aspect of the present invention, in step (1), the pulverization is selected from mechanical pulverization and air jet pulverization. Preferably, air jet pulverization is used in the present invention; however, this does not imply a strict limitation or constraint on the above extraction process. When using air jet milling, the air pressure can be 0.5~0.8 MPa, and the milling rate can be 0.5~10 kg / h. This means the air jet milling pressure can be 0.5 MPa, 0.51 MPa, 0.52 MPa, 0.53 MPa, 0.54 MPa, 0.55 MPa, 0.56 MPa, 0.57 MPa, 0.58 MPa, 0.59 MPa, 0.6 MPa, 0.61 MPa, 0.62 MPa, 0.63 MPa, 0.64 MPa, 0.65 MPa, 0.66 MPa, 0.67 MPa, 0.68 MPa, 0.69 MPa, 0.7 MPa, 0.71 MPa, 0.72 MPa, 0.73 MPa, 0.74 MPa, 0.75 MPa, 0.76 MPa, 0.77 MPa, 0.78 MPa, 0.79 MPa. The pressure can be any value from MPa, 0.8 MPa, or any specific value within the above range; the pulverization rate can be any value from 0.5 kg / h, 1.0 kg / h, 2.0 kg / h, 3.0 kg / h, 4.0 kg / h, 5.0 kg / h, 6.0 kg / h, 7.0 kg / h, 8.0 kg / h, 9.0 kg / h, 10.0 kg / h, or any specific value within the above range; for example, the airflow pulverization pressure can be set to 0.65 Pa and the pulverization rate to 3.0 kg / h.

[0056] For example, when using mechanical crushing, the rotation speed of the mechanical crushing is 4000~12000 rpm, and the crushing rate is 5kg / h~50kg / h. Understandably, the rotational speed of mechanical pulverizers can be 4000 rpm, 4100 rpm, 4200 rpm, 4300 rpm, 4400 rpm, 4500 rpm, 4600 rpm, 4700 rpm, 4800 rpm, 4900 rpm, 5000 rpm, 5100 rpm, 5200 rpm, 5300 rpm, 5400 rpm, 5500 rpm, 5600 rpm, 5700 rpm, 5800 rpm, 5900 rpm, 6000 rpm, 6100 rpm, 6200 rpm, 6300 rpm, 6400 rpm, 6500 rpm, 6600 rpm, 6700 rpm, 6800 rpm, 6900 rpm, 7000 rpm, 7100 rpm, 7200 rpm, and 7300 rpm. rpm, 7400 rpm, 7500 rpm, 7600 rpm, 7700 rpm, 7800 rpm, 7900 rpm, 8000 rpm, 8100 rpm, 8200 rpm, 8300 rpm, 8400 rpm, 8500 rpm, 8600 rpm, 8700 rpm, 8800 rpm, 8900 rpm, 9000 rpm, 9100 rpm, 9200 rpm, 9300 rpm, 9400 rpm, 9500 rpm, 9600 rpm, 9700 rpm, 9800 rpm, 9900 rpm, 10000 rpm, 11000 rpm, 12000 The speed can be any value within the specified rpm range or any specific value within the range mentioned above; the grinding rate can be any value within the range of 5 kg / h, 6.0 kg / h, 7.0 kg / h, 8.0 kg / h, 9.0 kg / h, 10.0 kg / h, 20.0 kg / h, 30.0 kg / h, 40.0 kg / h, or 50.0 kg / h. For example, the rotation speed can be set to 5500 rpm, and the grinding rate can be set to 20.0 kg / h.

[0057] Similarly, in some embodiments of the second aspect of the present invention, in step (2), the pulverization is selected from mechanical pulverization and air jet pulverization. Preferably, airflow milling is used in this invention, with an airflow pressure of 0.5~0.8 MPa and a milling rate of 0.5~5 kg / h. It is understood that the airflow milling pressure can be 0.5 MPa, 0.51 MPa, 0.52 MPa, 0.53 MPa, 0.54 MPa, 0.55 MPa, 0.56 MPa, 0.57 MPa, 0.58 MPa, 0.59 MPa, 0.6 MPa, 0.61 MPa, 0.62 MPa, 0.63 MPa, 0.64 MPa, 0.65 MPa, 0.66 MPa, 0.67 MPa, 0.68 MPa, 0.69 MPa, 0.7 MPa, 0.71 MPa, 0.72 MPa, 0.73 MPa, 0.74 MPa, 0.75 MPa, 0.76 MPa, 0.77 MPa, 0.78 MPa, 0.79 MPa, etc. The pressure can be any value among MPa, 0.8 MPa, or any specific value within the above range; the pulverization rate can be any value among 0.5 kg / h, 1.0 kg / h, 2.0 kg / h, 3.0 kg / h, 4.0 kg / h, 5.0 kg / h, or any specific value within the above range; for example, the airflow pulverization pressure can be set to 0.65 Pa and the pulverization rate to 2.0 kg / h.

[0058] Thirdly, this invention provides the application of the above-mentioned topical traditional Chinese medicine composition in the preparation of topical pharmaceutical formulations. That is, based on the effective components of the topical traditional Chinese medicine composition prepared by the above method, it can be combined with other components to prepare various types of topical pharmaceutical formulations for corresponding purposes.

[0059] Fourthly, as a further refinement of the application of the aforementioned topical pharmaceutical preparations, based on the inventors' prior research, the applicant wishes to provide the application of the aforementioned topical traditional Chinese medicine composition in the preparation of drugs for the treatment / prevention of anorectal diseases. That is, based on the effective components of the topical traditional Chinese medicine composition prepared using the above method, drugs for the treatment / prevention of anorectal diseases can be prepared, either alone or in combination with other excipients. The anorectal diseases mentioned above include hemorrhoids, the most common clinical condition, as well as anal cryptitis, anal fissures, perianal abscesses, perianal eczema, anal pruritus, anal cryptitis, constipation, anal fistula, anal prolapse, anorectal stenosis, and anal incontinence, etc. All of the aforementioned anorectal diseases fall within the potential clinical application scenarios of the pharmaceutical preparations of this invention.

[0060] The treatment means to reverse, alleviate, or inhibit the progression of the disease or symptoms, or one or more of the symptoms, or to prevent the disease or symptoms.

[0061] Fifthly, and very importantly, as a further refinement of the application of the aforementioned topical drug formulations, based on the inventors' prior research, the applicant wishes to provide the application of the aforementioned topical traditional Chinese medicine composition in the preparation of drugs for the prevention / treatment of postoperative complications of anorectal diseases. That is, based on the effective components of the topical traditional Chinese medicine composition prepared using the above method, alone or in combination with other excipients, to prepare related drugs for the prevention / treatment of postoperative complications of anorectal diseases. The anorectal diseases mentioned above, as described above, include not only hemorrhoids, the most common clinical condition, but also anal cryptitis, anal fissures, perianal abscesses, perianal eczema, anal pruritus, as well as anal cryptitis, constipation, anal fistula, anal prolapse, anorectal stenosis, and anal incontinence. The concept of "postoperative" can refer to a series of surgeries performed for anorectal diseases, including but not limited to various hemorrhoidectomies and anal fistula surgeries; the concept of "complications" can refer to a series of clinical symptoms occurring after anorectal disease-related surgeries, including but not limited to symptoms such as anal inflammation, swelling, bleeding, pain, or itching. That is, based on the topical Chinese medicine composition provided by this invention, the applicant wishes to provide application scenarios not limited to the following:

[0062] 1) The application of the above-mentioned external Chinese medicine composition in the preparation of drugs for the prevention / treatment of postoperative pain in anorectal diseases;

[0063] 2) The application of the above-mentioned external Chinese medicine composition in the preparation of drugs for the prevention / treatment of postoperative swelling in anorectal diseases;

[0064] 3) The application of the above-mentioned topical Chinese medicine composition in the preparation of drugs for the prevention / treatment of postoperative itching in anorectal diseases;

[0065] 4) The application of the above-mentioned external Chinese medicine composition in the preparation of drugs for the prevention / treatment of postoperative bleeding in anorectal diseases;

[0066] 5) Application of the above-mentioned external Chinese medicine composition in the preparation of drugs for the prevention / treatment of postoperative wound healing in anorectal diseases.

[0067] Sixthly, and very importantly, based on the aforementioned topical Chinese medicine composition of this invention, the applicant wishes to provide a topical Chinese medicine preparation for the prevention / treatment of anorectal diseases or postoperative complications of anorectal diseases. For ease of use, it may consist of a topical Chinese medicine composition and pharmaceutically acceptable excipients.

[0068] In some embodiments of the sixth aspect, the aforementioned external Chinese medicine preparations are clinically or pharmaceutically acceptable dosage forms, including but not limited to ointments, creams, gels, suppositories, sprays, films, pastes, powders, mists, solutions, lotions, or liniments.

[0069] In some embodiments of the sixth aspect, pharmaceutically or clinically acceptable excipients need to be added during the preparation of these dosage forms to enable their realization. This invention does not specifically limit the pharmaceutically acceptable excipients, which include, but are not limited to, drug matrices, emulsifiers, antioxidants, preservatives, thickeners, absorption enhancers, humectants, solvents, pH adjusters, or dispersants, etc., which can be selected by those skilled in the art based on their common knowledge and specific needs. The amount of the above excipients can be obtained by those skilled in the art through orthogonal experiments as needed, which will not directly affect the performance of the product.

[0070] For example, the drug matrix may include an oily matrix and a water-soluble matrix, wherein the oily matrix includes petrolatum, lanolin, liquid paraffin, paraffin, beeswax, squalane, cetyl alcohol, octadecanol, oleogel, etc.

[0071] For example, the emulsifier can be anionic surfactants, such as sodium dodecyl sulfate, triethanolamine, sodium fatty alcohol polyoxyethylene ether sulfate, sodium dodecylbenzene sulfonate, etc.; the emulsifier can be a nonionic surfactant, such as polyethylene glycol fatty acid esters, fatty acid glycerides, fatty acid sorbitans, polysorbates, polyoxyethylene hydrogenated castor oil, polyoxyethylene castor oil, etc.

[0072] For example, the antioxidant is sodium sulfite, sodium bisulfite, sodium metabisulfite, sodium thiosulfate, vitamin C, vitamin E, butylated hydroxyanisole, butylated hydroxytoluene, etc.

[0073] For example, the preservatives include sorbic acid, benzoic acid, benzalkonium chloride, ethylparaben, methylparaben, etc.

[0074] For example, the thickener is cetyl alcohol, octadecanol, glyceryl mono- and di-stearyl esters, glycerol, polyvinyl alcohol, polyvinylpyrrolidone, xanthan gum, sodium carboxymethyl cellulose, paraffin wax, beeswax, etc.

[0075] For example, the moisturizer can be various polyols, such as glycerin, propylene glycol, sorbitol, etc.

[0076] For example, the absorption enhancer may be propylene glycol, dimethyl sulfoxide, azone, etc.

[0077] Of course, it should be emphasized that the aforementioned topical Chinese medicine compositions, extracts, or preparations can be used alone or in combination for the prevention / treatment of anorectal diseases or for the prevention / treatment of postoperative complications of anorectal diseases.

[0078] Unless otherwise specified in this invention:

[0079] Callicarpa, a Chinese medicinal herb, includes common and frequently used species such as *Callicarpa nudiflora*, *Callicarpa nudiflora*, *Callicarpa macrophylla*, *Callicarpa macrophylla*, and *Callicarpa macrophylla*. In this article, *Callicarpa nudiflora* or *Callicarpa macrophylla* may be used as needed. *Callicarpa nudiflora* Hook. & Arn. and *Callicarpa macrophylla* Vahl both belong to the Verbenaceae family. All the raw materials mentioned above were purchased from the market.

[0080] Bezoar is a traditional Chinese medicine. It can be either artificial or natural bezoar. Artificial bezoar is preferred depending on the availability of the material.

[0081] Musk, a Chinese medicinal material, can be either artificial or natural. Artificial musk is preferred depending on the availability of the material.

[0082] Borneol is a traditional Chinese medicine. You can choose either synthetic borneol or natural borneol. Based on the availability of the material, synthetic borneol is preferred.

[0083] Japanese knotweed (scientific name: Reynoutria japonica Houtt.) is a Chinese medicinal herb whose leaves, rhizomes, and roots can be used medicinally.

[0084] In this document, the terms "traditional Chinese medicine composition" and "composition" have similar meanings and may be used interchangeably unless otherwise specified. The terms "weight" and "parts by weight" may also be used interchangeably.

[0085] In this article, the terms "extract powder" and "dry extract powder" have similar meanings and can be used interchangeably unless otherwise specified.

[0086] Unless otherwise specified, all test / operation temperatures in this article are room temperature.

[0087] In this article, the terms “s”, “min” and “h” represent “second”, “minute” and “hour”, respectively.

[0088] In this article, the term "composed of Polygonum cuspidatum, musk, bezoar, borneol, pearl, alum, borax, pearl, and amber" means that it does not contain any other active ingredients besides the specified Polygonum cuspidatum, musk, bezoar, borneol, pearl, alum, borax, pearl, and amber, but does not exclude auxiliary ingredients such as excipients, excipients, and carriers. Beneficial effects

[0089] Compared with the prior art, the present invention has the following beneficial effects:

[0090] (1) The present invention provides a topical Chinese medicine composition for treating anorectal diseases, specifically using nine Chinese medicinal materials: Polygonum cuspidatum, musk, bezoar, borneol, pearl, alum, borax, pearl, and amber. These herbs work together to clear heat and dampness, reduce swelling and relieve pain, stop bleeding and promote tissue regeneration. Modern pharmacodynamic studies show that the Chinese medicine composition of the present invention can simultaneously and effectively improve symptoms such as pain, swelling, bleeding, and inflammation in anorectal diseases and postoperative complications, promote wound healing, and provide patients with a more rapid and definite therapeutic effect, offering a new, safe, and reliable medication option.

[0091] (2) The traditional Chinese medicine composition prescription of the present invention has no toxic medicinal materials and no incompatibilities such as the Eighteen Incompatibilities and Nineteen Antagonisms. The dosage of each medicinal ingredient does not exceed the pharmacopoeia. The safety evaluation test shows that the safety is good and there are no systemic or local adverse reactions.

[0092] (3) The traditional Chinese medicine composition provided by the present invention has a simple preparation process, is easy to make into various external preparations, and is suitable for large-scale production.

[0093] In summary, the external Chinese medicine composition obtained by the inventors through screening is applicable to both the prevention and treatment of anorectal diseases and the prevention and treatment of postoperative complications of anorectal diseases. It has definite curative effects and good market application prospects. Attached Figure Description

[0094] Figure 1 shows the effect on the swelling area of ​​the rat perianal swelling model. (n=10), where compared with the normal control group, ++ P≤0.01; compared with the model control group, * P≤0.05, ** P≤0.01; compared with the positive control group, # P≤0.05, ## P≤0.01; compared with the MYL-A group, △ P≤0.05, △△ P≤0.01; compared with the MYL-B group, ￥ P≤0.05, ￥￥ P≤0.01.

[0095] Figure 2 shows histopathological images of the perianal tissue of rats (HE staining, ×100). A: Normal control group; B: Model control group; C: Positive control group; D: MYL-A group; E: MYL-B group; F: Low-dose MYL group; G: Medium-dose MYL group; H: High-dose MYL group.

[0096] Figure 3 shows the effect of carrageenan on the degree of toe swelling in a rat model of carrageenan-induced toe swelling. (n=10), where compared with the normal control group, ++P≤0.01; compared with the model control group, * P≤0.05, ** P≤0.01; compared with the positive control group, # P≤0.05, ## P≤0.01; compared with the MYL-A group, △ P≤0.05, △△ P≤0.01; compared with the MYL-B group, ￥ P≤0.05, ￥￥ P≤0.01. Embodiments of the present invention

[0097] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to embodiments. Of course, the specific embodiments described herein are only for explaining the invention and are not intended to limit the invention.

[0098] Although the steps in this invention are arranged by reference numerals, this is not intended to limit the order of the steps. Unless the order of the steps is explicitly stated or the execution of a step requires other steps as a basis, the relative order of the steps can be adjusted. It is understood that the term "and / or" as used herein refers to and covers any and all possible combinations of one or more of the associated listed items.

[0099] Unless otherwise specified, all raw materials used in this invention are purchased from the market.

[0100] In the embodiments of this invention, the amount of each substance listed in "parts" refers to parts by weight. In actual use, the amount of each substance can be adjusted according to the above proportions.

[0101] Example 1

[0102] A topical traditional Chinese medicine composition for treating anorectal diseases and / or postoperative complications of anorectal diseases, made from the following raw materials by weight: 100 parts Polygonum cuspidatum, 0.5 parts artificial musk, 0.3 parts artificial bezoar, 40 parts borneol, 100 parts Callicarpa nudiflora, 20 parts alum, 10 parts borax, 0.3 parts pearl, and 0.4 parts amber.

[0103] The above-mentioned traditional Chinese medicine composition is prepared into an ointment. The specific preparation method includes the following steps:

[0104] (1) Weigh out 12 times the amount of water of the total amount of the herbs, including Callicarpa nudiflora, Polygonum cuspidatum, and the herbs according to the prescription. Heat the extract at 90°C twice for 1 hour each time and filter. Concentrate the filtrate under reduced pressure to a relative density of 1.10-1.20 (80°C), pass it through a 100-mesh sieve, and spray dry the obtained fluid extract (inlet air temperature of 160°C, outlet air temperature of 100°C, feed pump speed of 12ml / min, atomization frequency of 250HZ) and then perform air jet milling at an air pressure of 0.65MPa and an air jet milling rate of 3.0kg / h to obtain a dry extract fine powder.

[0105] (2) Weigh artificial musk, artificial bezoar, pearl, amber, borax and alum according to the prescription and perform air jet pulverization. The air jet pressure is 0.62 MPa and the air jet pulverization rate is 2.0 kg / h to obtain the raw powder of Chinese medicine.

[0106] (3) Mix 110 parts of propylene glycol with the dry extract powder obtained in step (1) and stir to disperse evenly to obtain a dry extract powder dispersion; then take 740 parts of yellow petrolatum, 50 parts of lanolin and 40 parts of mono- and di-stearyl glycerides, heat to 75°C and stir, add the prescribed amount of borneol, stir until fully dissolved, cool to 65°C and add the Chinese herbal raw powder obtained in step (2), stir evenly, cool to 45°C and add the dry extract powder dispersion, stir to homogenize evenly, and finally cool to below 40°C to form the ointment, making 1000g, which is the ointment.

[0107] Example 2

[0108] A topical traditional Chinese medicine composition for treating anorectal diseases and / or postoperative complications of anorectal diseases, made from the following raw materials by weight: 150 parts Polygonum cuspidatum, 1.5 parts artificial musk, 0.1 parts artificial bezoar, 20 parts borneol, 70 parts Callicarpa macrocarpa, 25 parts alum, 5 parts borax, 3 parts pearl, and 0.1 parts amber.

[0109] The above-mentioned traditional Chinese medicine composition is prepared into an ointment. The specific preparation method includes the following steps:

[0110] (1) Weigh out 10 times the amount of water of the large-leaved purple pearl, cuspidatum and the total amount of medicinal materials according to the prescription, heat at 85℃ twice, each extraction for 1.5 hours, and filter; concentrate the filtrate under reduced pressure to a relative density of 1.10-1.20 (80℃), pass through a 100-mesh sieve, spray dry the obtained fluid extract (inlet air temperature of 165℃, outlet air temperature of 105℃, feed pump speed of 11ml / min, atomization frequency of 300HZ) and then mechanically pulverize (speed of 5500 rpm, 25 kg / h) to obtain a dry extract fine powder;

[0111] (2) Weigh artificial musk, artificial bezoar, pearl, amber, borax and calcined alum according to the prescription and mechanically pulverize them at a pressure of 0.7 MPa to obtain raw Chinese medicine powder;

[0112] (3) Mix 90 parts of propylene glycol with the dry extract powder obtained in step (1) and stir to disperse evenly to obtain a dry extract powder dispersion; then take 670 parts of yellow petrolatum, 40 parts of lanolin and 50 parts of mono- and di-stearyl glycerides, heat to 76°C and stir, add the prescribed amount of borneol, stir until fully dissolved, cool to 66°C and add the Chinese herbal raw powder obtained in step (2), stir evenly, cool to 45°C and add the dry extract powder dispersion, stir to homogenize evenly, and finally cool to below 40°C to form the ointment, making 1000g, which is the ointment.

[0113] Example 3

[0114] A topical traditional Chinese medicine composition for treating anorectal diseases and / or postoperative complications of anorectal diseases, made from the following raw materials by weight: 120 parts Polygonum cuspidatum, 0.3 parts artificial musk, 1 part artificial bezoar, 10 parts borneol, 80 parts Callicarpa nudiflora, 5 parts alum, 20 parts borax, 1.5 parts pearl, and 0.8 parts amber.

[0115] The above-mentioned traditional Chinese medicine composition is prepared into an ointment. The specific preparation method includes the following steps:

[0116] (1) Weigh out 10 times the amount of 50% ethanol of the total amount of the prescription ingredients of Callicarpa nudiflora, Polygonum cuspidatum and the medicinal materials, heat and extract twice at 50°C for 1 hour each time, and filter; concentrate the filtrate under reduced pressure to a relative density of 1.10-1.20 (80°C), pass it through a 100-mesh sieve, spray dry the obtained fluid extract (inlet air temperature of 180°C, outlet air temperature of 105°C, feed pump speed of 12ml / min, atomization frequency of 220HZ) and then perform air jet milling with an air pressure of 0.8MPa and an air flow rate of 2.0kg / h to obtain a dry extract fine powder;

[0117] (2) Weigh artificial musk, artificial bezoar, pearl, amber, borax and alum according to the prescription and perform air jet pulverization. The air jet pressure is 0.6 MPa and the air jet rate is 1.0 kg / h to obtain the raw powder of Chinese medicine.

[0118] (3) Mix 110 parts of propylene glycol with the dry extract powder obtained in step (1) and stir to disperse evenly to obtain a dry extract powder dispersion; then take 750 parts of yellow petrolatum, 60 parts of lanolin and 50 parts of mono- and di-stearyl glycerides, heat to 76°C and stir, add the prescribed amount of borneol, stir until fully dissolved, cool to 66°C and add the Chinese herbal raw powder obtained in step (2), stir evenly, cool to 44°C and add the dry extract powder dispersion, stir to homogenize evenly, and finally cool to below 40°C to form the ointment, making 1000g, which is the ointment.

[0119] Example 4

[0120] A topical traditional Chinese medicine composition for treating anorectal diseases and / or postoperative complications of anorectal diseases, made from the following raw materials by weight: 80 parts Polygonum cuspidatum, 0.1 parts artificial musk, 0.5 parts artificial bezoar, 50 parts borneol, 100 parts Callicarpa nudiflora, 15 parts alum, 25 parts borax, 0.9 parts pearl, and 1.5 parts amber.

[0121] The above-mentioned traditional Chinese medicine composition is prepared into an ointment. The specific preparation method includes the following steps:

[0122] (1) Weigh out 10 times the total amount of 75% ethanol of the prescription amount of naked flower purple pearl, Japanese knotweed and 10 times the total amount of medicinal materials, heat and extract twice at 55℃, each extraction for 1 hour, and filter; concentrate the filtrate under reduced pressure to a relative density of 1.10-1.20 (80℃), pass through a 100-mesh sieve, spray dry the obtained fluid extract (inlet air temperature of 160℃, outlet air temperature of 100℃, feed pump speed of 13ml / min, atomization frequency of 200HZ) and then perform air jet milling, air pressure of 0.5MPa, air jet milling rate of 2.0kg / h, to obtain dry extract fine powder;

[0123] (2) Weigh artificial musk, artificial bezoar, pearl, amber, borax and alum according to the prescription and perform air jet pulverization. The air jet pressure is 0.5 MPa and the air jet pulverization rate is 1.0 kg / h to obtain the raw powder of Chinese medicine.

[0124] (3) Mix 110 parts of propylene glycol with the dry extract powder obtained in step (1) and stir to disperse evenly to obtain a dry extract powder dispersion; then take 730 parts of yellow petrolatum, 55 parts of lanolin and 40 parts of mono- and di-stearyl glycerides, heat to 74°C and stir, add the prescribed amount of borneol, stir until fully dissolved, cool to 65°C and add the Chinese herbal raw powder obtained in step (2), stir evenly, cool to 43°C and add the dry extract powder dispersion, stir to homogenize evenly, and finally cool to below 40°C to form the ointment, making 1000g, which is the ointment.

[0125] Example 5

[0126] A topical traditional Chinese medicine composition for treating anorectal diseases and / or postoperative complications of anorectal diseases, made from the following raw materials by weight: 120 parts Polygonum cuspidatum, 1 part artificial musk, 1.5 parts artificial bezoar, 30 parts borneol, 110 parts Callicarpa nudiflora, 10 parts alum, 5 parts borax, 0.1 parts pearl, and 2 parts amber.

[0127] The above-mentioned traditional Chinese medicine composition is prepared into an ointment. The specific preparation method includes the following steps:

[0128] (1) Weigh out the total amount of Callicarpa nudiflora, Polygonum cuspidatum and 12 times the amount of water according to the prescription, heat at 85°C for 1.5 hours, filter, add 10 times the amount of water according to the total amount of the medicinal materials and heat for 1 hour, filter; combine the filtrates and concentrate under reduced pressure (-0.05MPa) to a relative density of 1.10-1.20 (80°C), pass through a 100-mesh sieve, dry the obtained fluid extract under reduced pressure and then perform air jet milling, the air pressure is 0.8MPa and the air jet milling rate is 2.0kg / h, to obtain a dry extract fine powder;

[0129] (2) Weigh artificial musk, artificial bezoar, pearl, amber, borax and alum according to the prescription and perform air jet pulverization. The air jet pressure is 0.8 MPa and the air jet pulverization rate is 1 kg / h to obtain the raw powder of Chinese medicine.

[0130] (3) Mix 110 parts of propylene glycol with the dry extract powder obtained in step (1) and stir to disperse evenly to obtain a dry extract powder dispersion; then take 710 parts of yellow petrolatum, 60 parts of lanolin and 50 parts of mono- and di-stearyl glycerides, heat to 75°C and stir, add the prescribed amount of borneol, stir until fully dissolved, cool to 64°C and add the Chinese herbal raw powder obtained in step (2), stir evenly, cool to 45°C and add the dry extract powder dispersion, stir to homogenize evenly, and finally cool to below 40°C to form the ointment, making 1000g, which is the ointment.

[0131] Example 6

[0132] A topical traditional Chinese medicine composition for treating anorectal diseases and / or postoperative complications of anorectal diseases, made from the following raw materials by weight: 150 parts Polygonum cuspidatum, 0.2 parts artificial musk, 0.3 parts artificial bezoar, 15 parts borneol, 150 parts Callicarpa nudiflora, 9 parts alum, 1 part borax, 0.6 parts pearl, and 1.8 parts amber.

[0133] The above-mentioned traditional Chinese medicine composition is prepared into an ointment. The specific preparation method includes the following steps:

[0134] (1) Weigh out the total amount of water (12 times the total amount of the medicinal materials) of the naked flower purple pearl, Japanese knotweed and 12 times the amount of the medicinal materials according to the prescription. Heat and extract twice at 92℃, each time for 1 hour. Filter the extract. Concentrate the filtrate under reduced pressure (-0.045MPa) to a relative density of 1.10-1.20 (80℃). Pass the extract through a 100-mesh sieve. Dry the fluid extract under reduced pressure and then perform air jet milling. The air pressure is 0.6MPa and the air jet milling rate is 3.0kg / h to obtain a dry extract fine powder.

[0135] (2) Weigh artificial musk, artificial bezoar, pearl, amber, borax and alum according to the prescription and perform air jet pulverization. The air jet pressure is 0.6 MPa and the air jet pulverization rate is 2.0 kg / h to obtain the raw powder of Chinese medicine.

[0136] (3) Mix 110 parts of propylene glycol with the dry extract powder obtained in step (1) and stir to disperse evenly to obtain a dry extract powder dispersion; then take 680 parts of yellow petrolatum, 45 parts of lanolin and 45 parts of mono- and di-stearyl glycerides, heat to 75°C and stir, add the prescribed amount of borneol, stir until fully dissolved, cool to 65°C and add the Chinese herbal raw powder obtained in step (2), stir evenly, cool to 45°C and add the dry extract powder dispersion, stir to homogenize evenly, and finally cool to below 40°C to form the ointment, making 1000g, which is the ointment.

[0137] Example 7

[0138] A topical traditional Chinese medicine composition for treating anorectal diseases and / or postoperative complications of anorectal diseases, made from the following raw materials by weight: 100 parts Polygonum cuspidatum, 1.2 parts artificial musk, 1.2 parts artificial bezoar, 38 parts borneol, 50 parts Callicarpa nudiflora, 30 parts alum, 16 parts borax, 1.8 parts pearl, and 2.5 parts amber.

[0139] The above-mentioned traditional Chinese medicine composition is prepared into an ointment. The specific preparation method includes the following steps:

[0140] (1) Weigh out the total amount of Callicarpa nudiflora, Polygonum cuspidatum and water 10 times the total amount of the medicinal materials according to the prescription, heat at 90℃ twice, extract for 1 hour each time, and filter; concentrate the filtrate under reduced pressure (-0.048MPa) to a relative density of 1.10-1.20 (80℃), pass through a 100-mesh sieve, dry the obtained fluid extract under reduced pressure and then perform air jet milling, with an air pressure of 0.7MPa and an air jet milling rate of 2.0kg / h to obtain a dry extract fine powder;

[0141] (2) Weigh artificial musk, artificial bezoar, pearl, amber, borax and alum according to the prescription and perform air jet pulverization with an air pressure of 0.7 MPa to obtain raw Chinese medicine powder;

[0142] (3) Mix 110 parts of propylene glycol with the dry extract powder obtained in step (1) and stir to disperse evenly to obtain a dry extract powder dispersion; then take 760 parts of yellow petrolatum, 60 parts of lanolin and 55 parts of mono- and di-stearyl glycerides, heat to 75°C and stir, add the prescribed amount of borneol, stir until fully dissolved, cool to 66°C and add the Chinese herbal raw powder obtained in step (2), stir evenly, cool to 45°C and add the dry extract powder dispersion, stir to homogenize evenly, and finally cool to below 40°C to form the ointment, making 1000g, which is the ointment.

[0143] Example 8

[0144] A topical traditional Chinese medicine composition for treating anorectal diseases and / or postoperative complications of anorectal diseases, made from the following raw materials by weight: 160 parts of Polygonum cuspidatum, 0.3 parts of artificial musk, 0.2 parts of artificial bezoar, 20 parts of borneol, 80 parts of Callicarpa nudiflora, 15 parts of alum, 10 parts of borax, 0.8 parts of pearl, and 3 parts of amber.

[0145] The above-mentioned traditional Chinese medicine composition is prepared into an ointment. The specific preparation method includes the following steps:

[0146] (1) Weigh out 12 times the amount of water of the total amount of the medicinal materials, including the naked flower purple pearl, the cuspidatum, and the medicinal materials according to the prescription. Heat and extract twice at 92°C for 1 hour each time. Filter the extract. Concentrate the filtrate under reduced pressure to a relative density of 1.10-1.20 (80°C). Pass the filtrate through a 100-mesh sieve. Spray dry the obtained fluid extract (inlet air temperature of 160°C, outlet air temperature of 100°C, feed pump speed of 12ml / min, atomization frequency of 300HZ) and then perform air jet milling. The air pressure is 0.8MPa and the air jet milling rate is 3.0kg / h to obtain a dry extract fine powder.

[0147] (2) Weigh artificial musk, artificial bezoar, pearl, amber, borax and alum according to the prescription and perform air jet pulverization. The air jet pressure is 0.8 MPa and the air jet pulverization rate is 2.0 kg / h to obtain the raw powder of Chinese medicine.

[0148] (3) Mix 110 parts of propylene glycol with the dry extract powder obtained in step (1) and stir to disperse evenly to obtain a dry extract powder dispersion; then take 700 parts of yellow petrolatum, 55 parts of lanolin and 50 parts of mono- and di-stearyl glycerides, heat to 75°C and stir, add the prescribed amount of borneol, stir until fully dissolved, cool to 63°C and add the Chinese herbal raw powder obtained in step (2), stir evenly, cool to 44°C and add the dry extract powder dispersion, stir to homogenize evenly, and finally cool to below 40°C to form the ointment, making 1000g, which is the ointment.

[0149] Example 9

[0150] A topical traditional Chinese medicine composition for treating anorectal diseases and / or postoperative complications of anorectal diseases, made from the following raw materials by weight: 110 parts Polygonum cuspidatum, 0.5 parts artificial musk, 0.3 parts artificial bezoar, 25 parts borneol, 90 parts Callicarpa nudiflora, 25 parts alum, 15 parts borax, 0.3 parts pearl, and 0.4 parts amber.

[0151] The above-mentioned traditional Chinese medicine composition is prepared into a powder. The specific preparation method includes the following steps:

[0152] (1) Weigh out 10 times the amount of water of the total amount of the medicinal materials, including the naked flower purple pearl, the cuspidatum, and the medicinal materials according to the prescription. Heat and extract twice at 88°C for 1 hour each time. Filter the extract. Concentrate the filtrate under reduced pressure to a relative density of 1.10-1.20 (80°C). Pass the filtrate through a 100-mesh sieve. Spray dry the obtained fluid extract (inlet air temperature of 170°C, outlet air temperature of 105°C, feed pump speed of 12ml / min, atomization frequency of 200HZ) and then perform air jet milling. The air pressure is 0.7MPa and the air jet milling rate is 3.0kg / h to obtain a dry extract fine powder.

[0153] (2) Weigh artificial musk, artificial bezoar, pearl, amber, borneol, borax and alum according to the prescription and perform air jet pulverization. The air jet pressure is 0.7 MPa and the air jet pulverization rate is 2.0 kg / h to obtain the raw powder of Chinese medicine.

[0154] (3) Mix the dry extract powder obtained in step (1) with the raw Chinese medicine powder obtained in step (2) evenly to obtain the powder.

[0155] Example 10

[0156] A topical traditional Chinese medicine composition for treating anorectal diseases and / or postoperative complications of anorectal diseases, made from the following raw materials by weight: 70 parts Polygonum cuspidatum, 2 parts artificial musk, 1.8 parts artificial bezoar, 30 parts borneol, 70 parts Callicarpa nudiflora, 10 parts alum, 18 parts borax, 0.5 parts pearl, and 0.5 parts amber.

[0157] The above-mentioned traditional Chinese medicine composition is prepared into a powder. The specific preparation method includes the following steps:

[0158] (1) Weigh out 10 times the amount of water of the total amount of the medicinal materials, including the naked flower purple pearl, the cuspidatum, and the medicinal materials according to the prescription. Heat and extract twice at 95°C for 1 hour each time. Filter the extract. Concentrate the filtrate under reduced pressure (-0.04MPa) to a relative density of 1.10-1.20 (80°C). Pass the filtrate through a 100-mesh sieve. Spray dry the obtained fluid extract (inlet air temperature of 180°C, feed pump speed of 20V, nozzle speed of 200HZ) and then perform air jet milling. The air pressure is 0.7MPa and the air jet milling rate is 3.0kg / h to obtain a dry extract fine powder.

[0159] (2) Weigh artificial musk, artificial bezoar, pearl, amber, borneol, borax and alum according to the prescription and perform air jet pulverization. The air jet pressure is 0.7 MPa and the air jet pulverization rate is 2.0 kg / h to obtain the raw powder of Chinese medicine.

[0160] (3) Mix the dry extract powder obtained in step (1) with the raw Chinese medicine powder obtained in step (2) evenly to obtain the powder.

[0161] Example 11

[0162] A topical traditional Chinese medicine composition for treating anorectal diseases and / or postoperative complications of anorectal diseases, made from the following raw materials by weight: 50 parts Polygonum cuspidatum, 2.5 parts artificial musk, 2 parts artificial bezoar, 20 parts borneol, 50 parts Callicarpa nudiflora, 20 parts alum, 15 parts borax, 0.5 parts pearl, and 0.5 parts amber.

[0163] The above-mentioned traditional Chinese medicine composition is prepared into a powder. The specific preparation method includes the following steps:

[0164] (1) Weigh out 10 times the amount of water of the total amount of the prescription materials of Callicarpa nudiflora, Polygonum cuspidatum and medicinal materials, heat at 95°C twice for 1 hour each time, and filter; concentrate the filtrate under reduced pressure to a relative density of 1.10-1.20 (80°C), pass through a 100-mesh sieve, spray dry the obtained fluid extract (inlet air temperature of 180°C, outlet air temperature of 110°C, feed pump speed of 12ml / min, atomization frequency of 200HZ) and then perform air jet milling with an air pressure of 0.7MPa and an air jet milling rate of 3.0kg / h to obtain a dry extract fine powder;

[0165] (2) Weigh artificial musk, artificial bezoar, pearl, amber, borneol, borax and alum according to the prescription and perform air jet pulverization. The air jet pressure is 0.7 MPa and the air jet pulverization rate is 4.0 kg / h to obtain the raw powder of Chinese medicine.

[0166] (3) Mix the dry extract powder obtained in step (1) with the raw Chinese medicine powder obtained in step (2) evenly to obtain the powder.

[0167] Example 12

[0168] A topical traditional Chinese medicine composition for treating anorectal diseases and / or postoperative complications of anorectal diseases, made from the following raw materials by weight: 200 parts Polygonum cuspidatum, 0.8 parts artificial musk, 2 parts artificial bezoar, 60 parts borneol, 200 parts Callicarpa nudiflora, 10 parts alum, 18 parts borax, 0.5 parts pearl, and 5 parts amber.

[0169] The above-mentioned traditional Chinese medicine composition is prepared into a lotion. The specific preparation method includes the following steps:

[0170] (1) Weigh out 10 times the amount of water of the total amount of the medicinal materials, including the naked flower purple pearl, the cuspidatum, and the medicinal materials according to the prescription. Heat and extract twice at 95°C for 1 hour each time. Filter the extract. Concentrate the filtrate under reduced pressure to a relative density of 1.10-1.20 (80°C). Pass the filtrate through a 100-mesh sieve. Spray dry the obtained fluid extract (inlet air temperature of 170°C, outlet air temperature of 107°C, feed pump speed of 12ml / min, atomization frequency of 250HZ) and then perform air jet milling. The air pressure is 0.8MPa and the air jet milling rate is 3.0kg / h to obtain a dry extract fine powder.

[0171] (2) Weigh artificial musk, artificial bezoar, pearl, amber, borneol, borax and alum according to the prescription and perform air jet pulverization. The air jet pressure is 0.8 MPa and the air jet pulverization rate is 3.0 kg / h to obtain the raw powder of Chinese medicine.

[0172] (3) Mix 600 parts of propylene glycol with the dry extract powder obtained in step (1) and disperse evenly. Then add the Chinese herbal medicine powder obtained in step (2) and mix. Stir until homogeneous and evenly dispersed to obtain the lotion.

[0173] Example 13

[0174] A topical Chinese medicine composition for treating anorectal diseases and / or postoperative complications of anorectal diseases, made from the following raw materials by weight: 150 parts Polygonum cuspidatum, 0.1 parts artificial musk, 0.1 parts artificial bezoar, 50 parts borneol, 100 parts Callicarpa nudiflora, 18 parts alum, 10 parts borax, 0.8 parts pearl, and 0.8 parts amber.

[0175] The above-mentioned traditional Chinese medicine composition is prepared into a lotion. The specific preparation method includes the following steps:

[0176] (1) Weigh out 10 times the amount of water of the total amount of the medicinal materials, including the naked flower purple pearl, the cuspidatum, and the medicinal materials according to the prescription. Heat and extract twice at 90°C for 1 hour each time. Filter the extract. Concentrate the filtrate under reduced pressure to a relative density of 1.10-1.20 (80°C). Pass the filtrate through a 100-mesh sieve. Spray dry the obtained fluid extract (inlet air temperature of 170°C, outlet air temperature of 100°C, feed pump speed of 11 ml / min, atomization frequency of 200 Hz) and then perform air jet milling. The air pressure is 0.8 MPa and the air jet milling rate is 3.0 kg / h to obtain a dry extract fine powder.

[0177] (2) Weigh artificial musk, artificial bezoar, pearl, amber, borneol, borax and alum according to the prescription and perform air jet pulverization. The air jet pressure is 0.8 MPa and the air jet pulverization rate is 2.0 kg / h to obtain the raw powder of Chinese medicine.

[0178] (3) Mix 550 parts of propylene glycol with the dry extract powder obtained in step (1) and disperse evenly. Then add the Chinese herbal medicine powder obtained in step (2) and mix. Stir until homogeneous and evenly dispersed to obtain the lotion.

[0179] Example 14

[0180] A topical traditional Chinese medicine composition for treating anorectal diseases and / or postoperative complications of anorectal diseases, made from the following raw materials by weight: 110 parts Polygonum cuspidatum, 5 parts artificial musk, 5 parts artificial bezoar, 80 parts borneol, 110 parts Callicarpa nudiflora, 22 parts alum, 15 parts borax, 1.5 parts pearl, and 0.5 parts amber.

[0181] The above-mentioned traditional Chinese medicine composition is prepared into a lotion. The specific preparation method includes the following steps:

[0182] (1) Weigh out 12 times the amount of water of the total amount of the prescription materials of Callicarpa nudiflora, Polygonum cuspidatum and medicinal materials, heat at 90°C twice for 1 hour each time, and filter; concentrate the filtrate under reduced pressure to a relative density of 1.10-1.20 (80°C), pass through a 100-mesh sieve, spray dry the obtained fluid extract (inlet air temperature of 180°C, outlet air temperature of 100°C, feed pump speed of 12ml / min, atomization frequency of 250HZ) and then perform air jet milling with an air pressure of 0.7MPa and an air jet milling rate of 3.0kg / h to obtain a dry extract fine powder;

[0183] (2) Weigh artificial musk, artificial bezoar, pearl, amber, borneol, borax and alum according to the prescription and perform air jet pulverization. The air jet pressure is 0.7 MPa and the air jet pulverization rate is 3.0 kg / h to obtain the raw powder of Chinese medicine.

[0184] (3) Mix 580 parts of propylene glycol with the dry extract powder obtained in step (1) and disperse evenly. Then add the Chinese herbal medicine powder obtained in step (2) and mix. Stir until homogeneous and evenly dispersed to obtain the lotion.

[0185] Example 15

[0186] A topical traditional Chinese medicine composition for treating anorectal diseases and / or postoperative complications of anorectal diseases, made from the following raw materials by weight: 100 parts Polygonum cuspidatum, 2 parts artificial musk, 2 parts artificial bezoar, 50 parts borneol, 100 parts Callicarpa nudiflora, 32 parts alum, 10 parts borax, 0.8 parts pearl, and 0.8 parts amber.

[0187] The above-mentioned traditional Chinese medicine composition is prepared into a suppository. The specific preparation method includes the following steps:

[0188] (1) Weigh out 10 times the amount of water of the total amount of the medicinal materials, including the naked flower purple pearl, the cuspidatum, and the medicinal materials according to the prescription. Heat and extract twice at 90°C for 1 hour each time. Filter the extract. Concentrate the filtrate under reduced pressure to a relative density of 1.10-1.20 (80°C). Pass the filtrate through a 100-mesh sieve. Spray dry the obtained fluid extract (inlet air temperature of 170°C, outlet air temperature of 105°C, feed pump speed of 12ml / min, atomization frequency of 200HZ) and then perform air jet milling. The air pressure is 0.6MPa and the air jet milling rate is 3.0kg / h to obtain a dry extract fine powder.

[0189] (2) Weigh artificial musk, artificial bezoar, pearl, amber, borax and alum according to the prescription and perform air jet pulverization. The air jet pressure is 0.6 MPa and the air jet pulverization rate is 3.0 kg / h to obtain the raw powder of Chinese medicine.

[0190] (3) Take 600 parts of type 36 mixed fatty acid glycerides and 250 parts of type 38 mixed fatty acid glycerides, heat them until they melt, and then cool them to 58°C. Add the prescribed amount of borneol and the Chinese herbal raw powder obtained in step (2), stir evenly, cool down to 45°C, add the dry extract powder obtained in step (1), stir until homogeneous, and finally cool down to 35°C. Add the powder to the suppository filling machine, fill it, and then cool it to form the suppository.

[0191] Example 16

[0192] A topical traditional Chinese medicine composition for treating anorectal diseases and / or postoperative complications of anorectal diseases, made from the following raw materials by weight: 120 parts Polygonum cuspidatum, 0.8 parts artificial musk, 1.5 parts artificial bezoar, 25 parts borneol, 120 parts Callicarpa nudiflora, 18 parts alum, 20 parts borax, 0.6 parts pearl, and 0.9 parts amber.

[0193] The above-mentioned traditional Chinese medicine composition is prepared into a suppository. The specific preparation method includes the following steps:

[0194] (1) Weigh out 12 times the amount of water of the total amount of the prescription materials of Callicarpa nudiflora, Polygonum cuspidatum and medicinal materials, heat and extract twice at 95°C for 1 hour each time, and filter; concentrate the filtrate under reduced pressure to a relative density of 1.10-1.20 (80°C), pass it through a 100-mesh sieve, spray dry the obtained fluid extract (inlet air temperature of 160°C, outlet air temperature of 100°C, feed pump speed of 12ml / min, atomization frequency of 250HZ) and then perform air jet milling with an air pressure of 0.7MPa and an air jet milling rate of 2.0kg / h to obtain a dry extract fine powder;

[0195] (2) Weigh artificial musk, artificial bezoar, pearl, amber, borax and alum according to the prescription and perform air jet pulverization. The air jet pressure is 0.7 MPa and the air jet pulverization rate is 3.0 kg / h to obtain the raw powder of Chinese medicine.

[0196] (3) Take 600 parts of type 36 mixed fatty acid glycerides and 250 parts of type 38 mixed fatty acid glycerides, heat them until they melt, and then cool them to 55°C. Add the prescribed amount of borneol and the Chinese herbal raw powder obtained in step (2), stir evenly, cool down to 45°C, add the dry extract powder obtained in step (1), stir until homogeneous, and finally cool down to 35°C. Add the powder to the suppository filling machine, fill it, and then cool it to form the suppository.

[0197] Example 17

[0198] A topical traditional Chinese medicine composition for treating anorectal diseases and / or postoperative complications of anorectal diseases, made from the following raw materials by weight: 120 parts Polygonum cuspidatum, 3 parts artificial musk, 0.9 parts artificial bezoar, 30 parts borneol, 90 parts Callicarpa nudiflora, 16 parts alum, 8 parts borax, 1.6 parts pearl, and 0.8 parts amber.

[0199] The above-mentioned traditional Chinese medicine composition is prepared into a suppository. The specific preparation method includes the following steps:

[0200] (1) Weigh out 12 times the amount of water of the total amount of the prescription materials of Callicarpa nudiflora, Polygonum cuspidatum and medicinal materials, heat at 95°C twice for 1 hour each time, and filter; concentrate the filtrate under reduced pressure to a relative density of 1.10-1.20 (80°C), pass through a 100-mesh sieve, spray dry the obtained fluid extract (inlet air temperature of 170°C, outlet air temperature of 100°C, feed pump speed of 12ml / min, atomization frequency of 200HZ) and then perform air jet milling with an air pressure of 0.7MPa and an air jet milling rate of 2.0kg / h to obtain a dry extract fine powder;

[0201] (2) Weigh artificial musk, artificial bezoar, pearl, amber, borax and alum according to the prescription and perform air jet pulverization. The air jet pressure is 0.7 MPa and the air jet pulverization rate is 2.0 kg / h to obtain the raw powder of Chinese medicine.

[0202] (3) Take 600 parts of type 36 mixed fatty acid glycerides and 250 parts of type 38 mixed fatty acid glycerides, heat them until they melt, and then cool them to 55°C. Add the prescribed amount of borneol and the Chinese herbal raw powder obtained in step (2), stir evenly, cool down to 42°C, add the dry extract powder obtained in step (1), stir until homogeneous, and finally cool down to 35°C. Add the powder to the suppository filling machine, fill it, and then cool it to form the suppository.

[0203] Example 18

[0204] A topical traditional Chinese medicine composition for treating anorectal diseases and / or postoperative complications of anorectal diseases, made from the following raw materials by weight: 130 parts Polygonum cuspidatum, 1.8 parts artificial musk, 0.6 parts artificial bezoar, 28 parts borneol, 100 parts Callicarpa nudiflora, 15 parts alum, 15 parts borax, 0.7 parts pearl, and 0.7 parts amber.

[0205] The above-mentioned traditional Chinese medicine composition is prepared into a gel, and the specific preparation method includes the following steps:

[0206] (1) Weigh out 10 times the amount of water of the total amount of the medicinal materials, including the naked flower purple pearl, the cuspidatum, and the medicinal materials according to the prescription. Heat the extract at 95°C twice, each time for 1 hour, and filter. Concentrate the filtrate under reduced pressure to a relative density of 1.10-1.20 (80°C), pass it through a 100-mesh sieve, and spray dry the obtained fluid extract (inlet air temperature of 160°C, outlet air temperature of 100°C, feed pump speed of 12ml / min, atomization frequency of 200HZ) and then perform air jet milling. The air pressure is 0.8MPa and the air jet milling rate is 2.0kg / h to obtain a dry extract fine powder.

[0207] (2) Weigh artificial musk, artificial bezoar, pearl, amber, borax and alum according to the prescription and perform air jet pulverization. The air jet pressure is 0.8 MPa and the air jet pulverization rate is 1.0 kg / h to obtain the raw powder of Chinese medicine.

[0208] (3) Take 800 parts of purified water, add the dry extract powder obtained in step (1), stir to dissolve, filter, add the prescribed amount of borneol, 40 parts of hydroxypropyl methylcellulose, 15 parts of glycerol, 15 parts of vitamin C, and 1 part of ethylparaben to the filtrate to make a hydrogel, then add the Chinese herbal powder obtained in step (2), stir to homogenize and disperse evenly to obtain the gel.

[0209] Example 19

[0210] A topical traditional Chinese medicine composition for treating anorectal diseases and / or postoperative complications of anorectal diseases, made from the following raw materials by weight: 110 parts Polygonum cuspidatum, 1.4 parts artificial musk, 1.4 parts artificial bezoar, 35 parts borneol, 110 parts Callicarpa nudiflora, 10 parts alum, 10 parts borax, 1.3 parts pearl, and 1.3 parts amber.

[0211] The above-mentioned traditional Chinese medicine composition is prepared into a gel, and the specific preparation method includes the following steps:

[0212] (1) Weigh out 11 times the amount of naked flower purple pearl, cuspidatum and the total amount of medicinal materials according to the prescription, extract with water, heat at 90℃ twice, extract for 1.5 hours each time, filter; concentrate the filtrate under reduced pressure to a relative density of 1.10-1.20 (80℃), pass through a 100-mesh sieve, spray dry the obtained fluid extract (inlet air temperature of 160℃, outlet air temperature of 100℃, feed pump speed of 12ml / min, atomization frequency of 250HZ) and then perform air jet milling, air pressure of 0.6MPa, air jet milling rate of 3.0kg / h, to obtain dry extract fine powder;

[0213] (2) Weigh artificial musk, artificial bezoar, pearl, amber, borax and alum according to the prescription and perform air jet pulverization. The air jet pressure is 0.6 MPa and the air jet rate and time are 3.0 kg / h to obtain the raw powder of Chinese medicine.

[0214] (3) Take 750 parts of purified water, add the dry extract powder obtained in step (1), stir to dissolve, filter, add the prescribed amount of borneol, 35 parts of hydroxypropyl methylcellulose, 15 parts of glycerol, 15 parts of vitamin C, and 1 part of ethylparaben to the filtrate to make a hydrogel, then add the Chinese herbal powder obtained in step (2), stir to homogenize and disperse evenly to obtain the gel.

[0215] Example 20

[0216] A topical traditional Chinese medicine composition for treating anorectal diseases and / or postoperative complications of anorectal diseases, made from the following raw materials by weight: 100 parts Polygonum cuspidatum, 0.7 parts artificial musk, 0.9 parts artificial bezoar, 42 parts borneol, 100 parts Callicarpa nudiflora, 12 parts alum, 14 parts borax, 2.5 parts pearl, and 0.9 parts amber.

[0217] The above-mentioned traditional Chinese medicine composition is prepared into a gel, and the specific preparation method includes the following steps:

[0218] (1) Weigh out 11 times the amount of water of the total amount of the prescription materials of Callicarpa nudiflora, Polygonum cuspidatum and medicinal materials, heat at 95℃ twice for 1.5 hours each time, and filter; concentrate the filtrate under reduced pressure to a relative density of 1.10-1.20 (80℃), pass through a 100-mesh sieve, spray dry the obtained fluid extract (inlet air temperature of 160℃, outlet air temperature of 100℃, feed pump speed of 12ml / min, atomization frequency of 250HZ) and then perform air jet milling with an air pressure of 0.6MPa and an air jet milling rate of 3.0kg / h to obtain a dry extract fine powder;

[0219] (2) Weigh artificial musk, artificial bezoar, pearl, amber, borax and alum according to the prescription and perform air jet pulverization. The air jet pressure is 0.6 MPa and the air jet pulverization rate is 3.0 kg / h to obtain the raw powder of Chinese medicine.

[0220] (3) Take 850 parts of purified water, add the dry extract powder obtained in step (1), stir to dissolve, filter, add the prescribed amount of borneol, 45 parts of hydroxypropyl methylcellulose, 18 parts of glycerol, 15 parts of vitamin C, and 1 part of ethylparaben to the filtrate to make a hydrogel, then add the Chinese herbal raw powder obtained in step (2), stir to homogenize and disperse evenly to obtain the gel.

[0221] Example 21

[0222] A topical traditional Chinese medicine composition for treating anorectal diseases and / or postoperative complications of anorectal diseases, made from the following raw materials by weight: 100 parts Polygonum cuspidatum, 0.5 parts artificial musk, 0.3 parts artificial bezoar, 40 parts borneol, 100 parts Callicarpa nudiflora, 20 parts alum, 10 parts borax, 0.3 parts pearl, and 0.4 parts amber.

[0223] The above-mentioned topical Chinese medicine composition is extracted and utilized, including the following steps:

[0224] (1) Weigh out 12 times the amount of water of the total amount of the herbs, including Callicarpa nudiflora, Polygonum cuspidatum, and the herbs according to the prescription. Heat the extract at 95°C twice for 1 hour each time and filter. Concentrate the filtrate under reduced pressure to a relative density of 1.10-1.20 (80°C), pass it through a 100-mesh sieve, and spray dry the obtained fluid extract (inlet air temperature of 160°C, outlet air temperature of 100°C, feed pump speed of 12ml / min, atomization frequency of 250HZ) and then perform air jet milling at an air pressure of 0.65MPa and an air jet milling rate of 3.0kg / h to obtain a dry extract fine powder.

[0225] (2) Weigh artificial musk, artificial bezoar, pearl, amber, borax and alum according to the prescription and perform air jet pulverization. The air jet pressure is 0.62 MPa and the air jet pulverization rate is 2.0 kg / h to obtain the raw powder of Chinese medicine.

[0226] (3) Mix the dry extract powder obtained in step (1) and the raw Chinese medicine powder obtained in step (2) evenly to obtain the final product.

[0227] Example 22

[0228] A topical traditional Chinese medicine composition for treating anorectal diseases and / or postoperative complications of anorectal diseases, made from the following raw materials by weight: 150 parts Polygonum cuspidatum, 1.5 parts artificial musk, 0.1 parts artificial bezoar, 20 parts borneol, 70 parts Callicarpa macrocarpa, 25 parts alum, 5 parts borax, 3 parts pearl, and 0.1 parts amber.

[0229] The above-mentioned topical Chinese medicine composition is extracted and utilized, including the following steps:

[0230] (1) Weigh out 10 times the amount of water of the large-leaved purple pearl, cuspidatum and the total amount of medicinal materials according to the prescription, heat at 90℃ twice, each extraction for 1.5 hours, and filter; concentrate the filtrate under reduced pressure to a relative density of 1.10-1.20 (80℃), pass through a 100-mesh sieve, spray dry the obtained fluid extract (inlet air temperature of 165℃, outlet air temperature of 105℃, feed pump speed of 11ml / min, atomization frequency of 300HZ) and then mechanically pulverize (speed of 5500rpm, 2.5kg / h) to obtain dry extract fine powder;

[0231] (2) Weigh artificial musk, artificial bezoar, pearl, amber, borax and calcined alum according to the prescription and mechanically pulverize them at a pressure of 0.7 MPa to obtain raw Chinese medicine powder;

[0232] (3) Mix the dry extract powder obtained in step (1) and the raw Chinese medicine powder obtained in step (2) evenly to obtain the final product.

[0233] Example 23

[0234] A topical traditional Chinese medicine composition for treating anorectal diseases and / or postoperative complications of anorectal diseases, made from the following raw materials by weight: 120 parts Polygonum cuspidatum, 0.3 parts artificial musk, 1 part artificial bezoar, 10 parts borneol, 80 parts Callicarpa nudiflora, 5 parts alum, 20 parts borax, 1.5 parts pearl, and 0.8 parts amber.

[0235] The above-mentioned topical Chinese medicine composition is extracted and utilized, including the following steps:

[0236] (1) Weigh out 10 times the amount of 50% ethanol of the total amount of the prescription materials of Callicarpa nudiflora, Polygonum cuspidatum and the medicinal materials, heat and extract twice at 50°C for 1 hour each time, and filter; concentrate the filtrate under reduced pressure to a relative density of 1.10-1.20 (80°C), pass it through a 100-mesh sieve, spray dry the obtained fluid extract (inlet air temperature of 180°C, outlet air temperature of 105°C, feed pump speed of 12ml / min, atomization frequency of 220HZ) and then perform air jet milling with an air pressure of 0.8MPa and an air jet milling rate of 2.0kg / h to obtain a dry extract fine powder;

[0237] (2) Weigh artificial musk, artificial bezoar, pearl, amber, borax and alum according to the prescription and perform air jet pulverization. The air jet pressure is 0.6 MPa and the air jet pulverization rate is 1.0 kg / h to obtain the raw powder of Chinese medicine.

[0238] (3) Mix the dry extract powder obtained in step (1) and the raw Chinese medicine powder obtained in step (2) evenly to obtain the final product.

[0239] Example 24

[0240] A topical traditional Chinese medicine composition for treating anorectal diseases and / or postoperative complications of anorectal diseases, made from the following raw materials by weight: 80 parts Polygonum cuspidatum, 0.1 parts artificial musk, 0.5 parts artificial bezoar, 50 parts borneol, 100 parts Callicarpa nudiflora, 15 parts alum, 25 parts borax, 0.9 parts pearl, and 1.5 parts amber.

[0241] The above-mentioned topical Chinese medicine composition is extracted and utilized, including the following steps:

[0242] (1) Weigh out 10 times the total amount of 75% ethanol of the prescription amount of naked flower purple pearl, Japanese knotweed and 10 times the total amount of medicinal materials, heat and extract twice at 55℃, each extraction for 1 hour, and filter; concentrate the filtrate under reduced pressure to a relative density of 1.10-1.20 (80℃), pass through a 100-mesh sieve, spray dry the obtained fluid extract (inlet air temperature of 160℃, outlet air temperature of 100℃, feed pump speed of 13ml / min, atomization frequency of 200HZ) and then perform air jet milling, air pressure of 0.5MPa, air jet milling rate of 2.0kg / h, to obtain dry extract fine powder;

[0243] (2) Weigh artificial musk, artificial bezoar, pearl, amber, borax and alum according to the prescription and perform air jet pulverization. The air jet pressure is 0.5 MPa and the air jet pulverization time is 3.0 kg / h to obtain the raw powder of Chinese medicine.

[0244] (3) Mix the dry extract powder obtained in step (1) and the raw Chinese medicine powder obtained in step (2) evenly to obtain the final product.

[0245] Example 25

[0246] A topical traditional Chinese medicine composition for treating anorectal diseases and / or postoperative complications of anorectal diseases, made from the following raw materials by weight: 120 parts Polygonum cuspidatum, 1 part artificial musk, 1.5 parts artificial bezoar, 30 parts borneol, 110 parts Callicarpa nudiflora, 10 parts alum, 5 parts borax, 0.1 parts pearl, and 2 parts amber.

[0247] The above-mentioned topical Chinese medicine composition is extracted and utilized, including the following steps:

[0248] (1) Weigh out the total amount of Callicarpa nudiflora, Polygonum cuspidatum and 12 times the amount of water according to the prescription, heat at 95°C for 1.5 hours, filter, add 10 times the amount of water according to the total amount of the medicinal materials and heat at 95°C for 1 hour, filter; combine the filtrates and concentrate under reduced pressure (-0.05MPa) to a relative density of 1.10-1.20 (80°C), pass through a 100-mesh sieve, dry the obtained fluid extract under reduced pressure and then perform air jet milling, the air pressure is 0.8MPa and the air jet milling rate is 2.0kg / h, to obtain dry extract fine powder;

[0249] (2) Weigh artificial musk, artificial bezoar, pearl, amber, borax and alum according to the prescription and perform air jet pulverization. The air jet pressure is 0.8 MPa and the air jet pulverization rate is 2.0 kg / h to obtain the raw powder of Chinese medicine.

[0250] (3) Mix the dry extract powder obtained in step (1) and the raw Chinese medicine powder obtained in step (2) evenly to obtain the final product.

[0251] Example 26

[0252] A topical traditional Chinese medicine composition for treating anorectal diseases and / or postoperative complications of anorectal diseases, made from the following raw materials by weight: 150 parts Polygonum cuspidatum, 0.2 parts artificial musk, 0.3 parts artificial bezoar, 15 parts borneol, 150 parts Callicarpa nudiflora, 9 parts alum, 1 part borax, 0.6 parts pearl, and 1.8 parts amber.

[0253] The above-mentioned topical Chinese medicine composition is extracted and utilized, including the following steps:

[0254] (1) Weigh out the total amount of water (12 times the total amount of the medicinal materials) of the naked flower purple pearl, Japanese knotweed and 12 times the amount of the medicinal materials according to the prescription. Heat and extract twice at 92℃, each time for 1 hour. Filter the extract. Concentrate the filtrate under reduced pressure (-0.045MPa) to a relative density of 1.10-1.20 (80℃). Pass the extract through a 100-mesh sieve. Dry the fluid extract under reduced pressure and then perform air jet milling. The air pressure is 0.6MPa and the air jet milling rate is 3.0kg / h to obtain a dry extract fine powder.

[0255] (2) Weigh artificial musk, artificial bezoar, pearl, amber, borax and alum according to the prescription and perform air jet pulverization. The air jet pressure is 0.6 MPa and the air jet pulverization rate is 2.0 kg / h to obtain the raw powder of Chinese medicine.

[0256] (3) Mix the dry extract powder obtained in step (1) and the raw Chinese medicine powder obtained in step (2) evenly to obtain the final product.

[0257] Example 27

[0258] A topical traditional Chinese medicine composition for treating anorectal diseases and / or postoperative complications of anorectal diseases, made from the following raw materials by weight: 100 parts Polygonum cuspidatum, 1.2 parts artificial musk, 1.2 parts artificial bezoar, 38 parts borneol, 50 parts Callicarpa nudiflora, 30 parts alum, 16 parts borax, 1.8 parts pearl, and 2.5 parts amber.

[0259] The above-mentioned topical Chinese medicine composition is extracted and utilized, including the following steps:

[0260] (1) Weigh out the total amount of Callicarpa nudiflora, Polygonum cuspidatum and water 10 times the total amount of the medicinal materials according to the prescription, heat at 90℃ twice, extract for 1 hour each time, and filter; concentrate the filtrate under reduced pressure (-0.048MPa) to a relative density of 1.10-1.20 (80℃), pass through a 100-mesh sieve, dry the obtained fluid extract under reduced pressure and then perform air jet milling, with an air pressure of 0.7MPa and an air jet milling rate of 2.0kg / h to obtain a dry extract fine powder;

[0261] (2) Weigh artificial musk, artificial bezoar, pearl, amber, borax and alum according to the prescription and perform air jet pulverization with an air pressure of 0.7 MPa to obtain raw Chinese medicine powder;

[0262] (3) Mix the dry extract powder obtained in step (1) and the raw Chinese medicine powder obtained in step (2) evenly to obtain the final product.

[0263] Example 28

[0264] A topical traditional Chinese medicine composition for treating anorectal diseases and / or postoperative complications of anorectal diseases, made from the following raw materials by weight: 160 parts of Polygonum cuspidatum, 0.3 parts of artificial musk, 0.2 parts of artificial bezoar, 20 parts of borneol, 80 parts of Callicarpa nudiflora, 15 parts of alum, 10 parts of borax, 0.8 parts of pearl, and 3 parts of amber.

[0265] The above-mentioned topical Chinese medicine composition is extracted and utilized, including the following steps:

[0266] (1) Weigh out 12 times the amount of water of the total amount of the medicinal materials, including the naked flower purple pearl, the cuspidatum, and the medicinal materials according to the prescription. Heat and extract twice at 92°C for 1 hour each time. Filter the extract. Concentrate the filtrate under reduced pressure to a relative density of 1.10-1.20 (80°C). Pass the filtrate through a 100-mesh sieve. Spray dry the obtained fluid extract (inlet air temperature of 160°C, outlet air temperature of 100°C, feed pump speed of 12ml / min, atomization frequency of 300HZ) and then perform air jet milling. The air pressure is 0.8MPa and the air jet milling rate is 3.0kg / h to obtain a dry extract fine powder.

[0267] (2) Weigh artificial musk, artificial bezoar, pearl, amber, borax and alum according to the prescription and perform air jet pulverization. The air jet pressure is 0.8 MPa and the air jet pulverization rate is 2.0 kg / h to obtain the raw powder of Chinese medicine.

[0268] (3) Mix the dry extract powder obtained in step (1) and the raw Chinese medicine powder obtained in step (2) evenly to obtain the final product.

[0269] Example 29

[0270] A topical traditional Chinese medicine composition for treating anorectal diseases and / or postoperative complications of anorectal diseases, made from the following raw materials by weight: 110 parts Polygonum cuspidatum, 0.5 parts artificial musk, 0.3 parts artificial bezoar, 25 parts borneol, 90 parts Callicarpa nudiflora, 25 parts alum, 15 parts borax, 0.3 parts pearl, and 0.4 parts amber.

[0271] The above-mentioned topical Chinese medicine composition is extracted and utilized, including the following steps:

[0272] (1) Weigh out 10 times the amount of water of the total amount of the medicinal materials, including the naked flower purple pearl, the Japanese knotweed, and the medicinal materials according to the prescription. Heat the extract at 98°C twice, each time for 1 hour, and filter. Concentrate the filtrate under reduced pressure to a relative density of 1.10-1.20 (80°C), pass it through a 100-mesh sieve, and spray dry the obtained fluid extract (inlet air temperature of 170°C, outlet air temperature of 105°C, feed pump speed of 12ml / min, atomization frequency of 200HZ) and then perform air jet milling with an air pressure of 0.7MPa and an air jet milling rate of 2.0kg / h to obtain a dry extract fine powder.

[0273] (2) Weigh artificial musk, artificial bezoar, pearl, amber, borneol, borax and alum according to the prescription and perform air jet pulverization. The air jet pressure is 0.7 MPa and the air jet pulverization rate is 3.0 kg / h to obtain the raw powder of Chinese medicine.

[0274] (3) Mix the dry extract powder obtained in step (1) and the raw Chinese medicine powder obtained in step (2) evenly to obtain the final product.

[0275] Example 30

[0276] A topical traditional Chinese medicine composition for treating anorectal diseases and / or postoperative complications of anorectal diseases, made from the following raw materials by weight: 70 parts Polygonum cuspidatum, 2 parts artificial musk, 1.8 parts artificial bezoar, 30 parts borneol, 70 parts Callicarpa nudiflora, 10 parts alum, 18 parts borax, 0.5 parts pearl, and 0.5 parts amber.

[0277] The above-mentioned topical Chinese medicine composition is extracted and utilized, including the following steps:

[0278] (1) Weigh out 10 times the amount of water of the total amount of the medicinal materials, including the naked flower purple pearl, the cuspidatum, and the medicinal materials according to the prescription. Heat and extract twice at 95°C for 1 hour each time. Filter the extract. Concentrate the filtrate under reduced pressure (-0.04MPa) to a relative density of 1.10-1.20 (80°C). Pass the filtrate through a 100-mesh sieve. Spray dry the obtained fluid extract (inlet air temperature of 180°C, feed pump speed of 20V, nozzle speed of 200HZ) and then perform air jet milling. The air pressure is 0.7MPa and the air jet milling rate is 3.0kg / h to obtain a dry extract fine powder.

[0279] (2) Weigh artificial musk, artificial bezoar, pearl, amber, borneol, borax and alum according to the prescription and perform air jet pulverization. The air jet pressure is 0.7 MPa and the air jet pulverization rate is 2.0 kg / h to obtain the raw powder of Chinese medicine.

[0280] (3) Mix the dry extract powder obtained in step (1) and the raw Chinese medicine powder obtained in step (2) evenly to obtain the final product.

[0281] Example 31

[0282] A topical traditional Chinese medicine composition for treating anorectal diseases and / or postoperative complications of anorectal diseases, made from the following raw materials by weight: 50 parts Polygonum cuspidatum, 2.5 parts artificial musk, 2 parts artificial bezoar, 20 parts borneol, 50 parts Callicarpa nudiflora, 20 parts alum, 15 parts borax, 0.5 parts pearl, and 0.5 parts amber.

[0283] The above-mentioned topical Chinese medicine composition is extracted and utilized, including the following steps:

[0284] (1) Weigh out 10 times the amount of water of the total amount of the medicinal materials, including the naked flower purple pearl, the Japanese knotweed, and the medicinal materials according to the prescription. Heat the extract at 95°C twice, each time for 1 hour, and filter. Concentrate the filtrate under reduced pressure to a relative density of 1.10-1.20 (80°C), pass it through a 100-mesh sieve, and spray dry the obtained fluid extract (inlet air temperature of 180°C, outlet air temperature of 110°C, feed pump speed of 12ml / min, atomization frequency of 200HZ) and then perform air jet milling. The air pressure is 0.7MPa and the air jet milling rate is 2.0kg / h to obtain a dry extract fine powder.

[0285] (2) Weigh artificial musk, artificial bezoar, pearl, amber, borneol, borax and alum according to the prescription and perform air jet pulverization. The air jet pressure is 0.7 MPa and the air jet pulverization rate is 3.0 kg / h to obtain the raw powder of Chinese medicine.

[0286] (3) Mix the dry extract powder obtained in step (1) and the raw Chinese medicine powder obtained in step (2) evenly to obtain the final product.

[0287] Example 32

[0288] A topical traditional Chinese medicine composition for treating anorectal diseases and / or postoperative complications of anorectal diseases, made from the following raw materials by weight: 200 parts Polygonum cuspidatum, 0.8 parts artificial musk, 2 parts artificial bezoar, 60 parts borneol, 200 parts Callicarpa nudiflora, 10 parts alum, 18 parts borax, 0.5 parts pearl, and 5 parts amber.

[0289] The above-mentioned topical Chinese medicine composition is extracted and utilized, including the following steps:

[0290] (1) Weigh out 10 times the amount of water of the total amount of the herbs, including Callicarpa nudiflora, Polygonum cuspidatum, and the herbs according to the prescription. Heat the extract at 95°C twice for 1 hour each time and filter. Concentrate the filtrate under reduced pressure to a relative density of 1.10-1.20 (80°C), pass it through a 100-mesh sieve, and spray dry the obtained fluid extract (inlet air temperature of 170°C, outlet air temperature of 107°C, feed pump speed of 12ml / min, atomization frequency of 250HZ) and then perform air jet milling with an air pressure of 0.8MPa and an air jet milling rate of 2.0kg / h to obtain a dry extract fine powder.

[0291] (2) Weigh artificial musk, artificial bezoar, pearl, amber, borneol, borax and alum according to the prescription and perform air jet pulverization. The air jet pressure is 0.8 MPa and the air jet pulverization rate is 2.0 kg / h to obtain the raw powder of Chinese medicine.

[0292] (3) Mix the dry extract powder obtained in step (1) and the raw Chinese medicine powder obtained in step (2) evenly to obtain the final product.

[0293] Example 33

[0294] A topical Chinese medicine composition for treating anorectal diseases and / or postoperative complications of anorectal diseases, made from the following raw materials by weight: 150 parts Polygonum cuspidatum, 0.1 parts artificial musk, 0.1 parts artificial bezoar, 50 parts borneol, 100 parts Callicarpa nudiflora, 18 parts alum, 10 parts borax, 0.8 parts pearl, and 0.8 parts amber.

[0295] The above-mentioned topical Chinese medicine composition is extracted and utilized, including the following steps:

[0296] (1) Weigh out 10 times the amount of water of the total amount of the medicinal materials, including the naked flower purple pearl, the cuspidatum, and the medicinal materials according to the prescription. Heat the extract at 95°C twice, each time for 1 hour, and filter. Concentrate the filtrate under reduced pressure to a relative density of 1.10-1.20 (80°C), pass it through a 100-mesh sieve, and spray dry the obtained fluid extract (inlet air temperature of 170°C, outlet air temperature of 100°C, feed pump speed of 11ml / min, atomization frequency of 200HZ) and then perform air jet milling. The air pressure is 0.8MPa and the air jet milling rate is 3.0kg / h to obtain a dry extract fine powder.

[0297] (2) Weigh artificial musk, artificial bezoar, pearl, amber, borneol, borax and alum according to the prescription and perform air jet pulverization. The air jet pressure is 0.8 MPa and the air jet pulverization rate is 2.0 kg / h to obtain the raw powder of Chinese medicine.

[0298] (3) Mix the dry extract powder obtained in step (1) and the raw Chinese medicine powder obtained in step (2) evenly to obtain the final product.

[0299] Example 34

[0300] A topical traditional Chinese medicine composition for treating anorectal diseases and / or postoperative complications of anorectal diseases, made from the following raw materials by weight: 110 parts Polygonum cuspidatum, 5 parts artificial musk, 5 parts artificial bezoar, 80 parts borneol, 110 parts Callicarpa nudiflora, 22 parts alum, 15 parts borax, 1.5 parts pearl, and 0.5 parts amber.

[0301] The above-mentioned topical Chinese medicine composition is extracted and utilized, including the following steps:

[0302] (1) Weigh out 12 times the amount of water of the total amount of the medicinal materials, including the naked flower purple pearl, the cuspidatum, and the medicinal materials according to the prescription. Heat and extract twice at 95°C for 1 hour each time. Filter the extract. Concentrate the filtrate under reduced pressure to a relative density of 1.10-1.20 (80°C). Pass the filtrate through a 100-mesh sieve. Spray dry the obtained fluid extract (inlet air temperature of 180°C, outlet air temperature of 100°C, feed pump speed of 12ml / min, atomization frequency of 250HZ) and then perform air jet milling. The air pressure is 0.7MPa and the air jet milling rate is 3.0kg / h to obtain a dry extract fine powder.

[0303] (2) Weigh artificial musk, artificial bezoar, pearl, amber, borneol, borax and alum according to the prescription and perform air jet pulverization. The air jet pressure is 0.7 MPa and the air jet pulverization rate is 3.0 kg / h to obtain the raw powder of Chinese medicine.

[0304] (3) Mix the dry extract powder obtained in step (1) and the raw Chinese medicine powder obtained in step (2) evenly to obtain the final product.

[0305] Example 35

[0306] A topical traditional Chinese medicine composition for treating anorectal diseases and / or postoperative complications of anorectal diseases, made from the following raw materials by weight: 100 parts Polygonum cuspidatum, 2 parts artificial musk, 2 parts artificial bezoar, 50 parts borneol, 100 parts Callicarpa nudiflora, 32 parts alum, 10 parts borax, 0.8 parts pearl, and 0.8 parts amber.

[0307] The above-mentioned topical Chinese medicine composition is extracted and utilized, including the following steps:

[0308] (1) Weigh out 10 times the amount of water of the total amount of the prescription materials of Callicarpa nudiflora, Polygonum cuspidatum and medicinal materials, heat at 95°C twice for 1 hour each time, and filter; concentrate the filtrate under reduced pressure to a relative density of 1.10-1.20 (80°C), pass through a 100-mesh sieve, spray dry the obtained fluid extract (inlet air temperature of 170°C, outlet air temperature of 105°C, feed pump speed of 12ml / min, atomization frequency of 200HZ) and then perform air jet milling with an air pressure of 0.6MPa and an air jet milling rate of 3.0kg / h to obtain a dry extract fine powder;

[0309] (2) Weigh artificial musk, artificial bezoar, pearl, amber, borax and alum according to the prescription and perform air jet pulverization. The air jet pressure is 0.6 MPa and the air jet pulverization rate is 3.0 kg / h to obtain the raw powder of Chinese medicine.

[0310] (3) Mix the dry extract powder obtained in step (1) and the raw Chinese medicine powder obtained in step (2) evenly to obtain the final product.

[0311] Comparative Example 1

[0312] A topical Chinese medicine composition for treating anorectal diseases is made from the following raw materials by weight: 100 parts of charred schizonepeta, 0.8 parts of artificial musk, 0.7 parts of artificial bezoar, 40 parts of borneol, 100 parts of stir-fried sophora japonica fruit, 20 parts of calcined alum, and 10 parts of borax.

[0313] The above-mentioned traditional Chinese medicine composition was prepared into an ointment, and the preparation method was referred to in patent document CN114984084B.

[0314] Comparative Example 2

[0315] A topical Chinese medicine composition for treating anorectal diseases is made from the following raw materials by weight: 100 parts of Phellodendron bark, 0.5 parts of artificial musk, 0.3 parts of artificial bezoar, 40 parts of borneol, 100 parts of Callicarpa nudiflora, 20 parts of alum, 10 parts of borax, 0.3 parts of pearl, and 0.4 parts of amber.

[0316] The above-mentioned traditional Chinese medicine composition was prepared into an ointment, and the preparation method was basically the same as that in Example 1.

[0317] Test case

[0318] To better illustrate the efficacy and safety of the topical Chinese medicine composition for treating anorectal diseases provided in the embodiments of the present invention, the ointments prepared in Example 1 and Comparative Examples 1-2 will be subjected to safety and efficacy tests below. The ointment prepared in Example 1 will be abbreviated as MYL, the ointment prepared in Comparative Example 1 will be abbreviated as MYL-A, and the ointment prepared in Comparative Example 2 will be abbreviated as MYL-B.

[0319] Experimental Example 1

[0320] To illustrate the safety of the traditional Chinese medicine composition of the present invention, a single-dose toxicity test was conducted using the ointment prepared in Example 1 (hereinafter referred to as MYL).

[0321] 1. Experimental Objective

[0322] This study was conducted in accordance with national GLP standards. MYL samples were administered to experimental rabbits four times rectally within 24 hours, and the rabbits were observed for 14 consecutive days. The results of the acute toxicity test were used to understand the degree of toxicity and the organs involved.

[0323] 2. Test methods

[0324] The experiment used ordinary-grade New Zealand rabbits, which were raised in accordance with the environmental conditions requirements for ordinary-grade laboratory animals in the national standard (GB14925-2010). The animals underwent quarantine and environmental acclimatization for 5 days.

[0325] Sixteen qualified experimental rabbits, half male and half female, were randomly divided into four groups (n=4 per group) according to sex and weight: ① intact rectum with blank matrix; ② intact MYL rectum; ③ damaged rectum with blank matrix; and ④ damaged rectum with MYL. For the damaged rectum group, sandpaper was rolled into a small stick of suitable thickness and inserted into the rabbit's rectum about 7-9 cm, then gently rotated once. All animals were administered MYL (matrix) or a MYL sample rectally, 1.0 g / animal / time, four times a day.

[0326] Each group was administered the medication rectally. Close observation and recording were conducted on the day of administration, especially within 0–4 hours after each administration, followed by observation twice daily for 14 consecutive days. Observations included animal appearance, administration site condition (whether erythema and edema appeared in the perianal tissue and post-administration clinical manifestations (such as pain symptoms)), behavior, secretions, excretions, diet, and mortality (time of death, pre-mortem reactions). Animal weight was measured on the day of administration, before administration, and on days 4, 7, 10, and 14 post-administration. Blood samples were collected before administration, and 24 hours, 7 days, and 14 days post-administration for hematological, blood biochemical, electrolyte, and coagulation parameter testing. Urine parameters were measured before administration, and 24 hours and 14 days post-administration. On the 15th day after administration, animals in each group were anesthetized by intravenous injection of propofol solution at 15 mg / kg via the ear vein, followed by femoral artery exsanguination and euthanasia. Gross anatomical examination was performed, and the administration site was observed by visual inspection (after complete incision of the anus and rectum, longitudinal dissection was performed to examine the irritation, damage, and necrosis of the epithelial tissue layer) as well as the color, shape, and size of the surface and cut surfaces of the major organs. Any abnormal tissues or organs were subjected to histopathological examination.

[0327] 3. Test Results

[0328] General clinical observation: MYL samples were administered rectally to rabbits four times within 24 hours. No unexpected illnesses or deaths were observed in the animals during the experiment. No obvious abnormalities were observed in appearance, behavior, appetite, coat, eyes, ears, mouth, nose, skin, limbs, or respiration within 0–4 hours after each administration. No erythema or edema was observed in the perianal tissue of any group of animals. This suggests that MYL has no significant effect on the clinical indicators of the experimental rabbits.

[0329] Body weight: During the experiment, the animals' body weight showed normal physiological growth. Compared with the control group with intact matrix and damaged rectum, the control group with damaged matrix and the control group with intact matrix, and the control group with damaged matrix and the control group with intact matrix, no toxicologically significant changes were observed. The results indicate that MYL has no significant effect on the body weight of the experimental rabbits.

[0330] Hematological, coagulation, blood biochemistry, and electrolyte tests: During the experiment, no toxicologically significant changes were observed in the MYL intact and damaged rectal groups compared with the control group with intact and damaged rectal matrix, the control group with damaged rectal matrix compared with the control group with intact rectal matrix, and the MYL damaged rectal group compared with the control group with intact MYL rectal matrix. The results indicate that MYL has no significant effect on the hematological, coagulation, blood biochemistry, and electrolyte indicators of the experimental rabbits.

[0331] Urine routine examination: During the experiment, no toxicologically significant changes were observed in the MYL intact and damaged rectal groups compared with the blank matrix intact and damaged rectal groups, the blank matrix damaged rectal group compared with the blank matrix intact rectal group, and the MYL damaged rectal group compared with the MYL intact rectal group. The results indicate that MYL has no significant effect on the routine urine indicators of the experimental rabbits.

[0332] Gross observation results of systemic anatomy: No significant changes were observed in the administration sites, color, size, and texture of major organs in each group of animals during the anatomical observation.

[0333] Conclusion: Under the conditions of this experiment, rabbits were given MYL sample 1.0 g / rabbit / time via rectum, 4 times a day, and no obvious acute toxic reactions or deaths were observed.

[0334] Experimental Example 2

[0335] To illustrate the safety of the traditional Chinese medicine composition of the present invention, a repeated-dose toxicity test was conducted using the ointment prepared in Example 1 (hereinafter referred to as MYL) for one month.

[0336] 1. Experimental Objective

[0337] This study was conducted in accordance with national GLP guidelines. Different doses of MYL samples were administered rectally to experimental rabbits for one month (4 weeks), followed by a 4-week recovery period. The toxicity test results of the experimental rabbits were used to predict the possible adverse clinical reactions caused by the test substance.

[0338] 2. Test methods

[0339] This experiment used ordinary-grade New Zealand rabbits, which were raised in accordance with the environmental conditions requirements for ordinary-grade laboratory animals in the national standard (GB14925-2010). The animals underwent quarantine and environmental acclimatization for 5 days.

[0340] Sixty qualified experimental rabbits, half male and half female, were randomly divided into six groups of 10 rabbits each according to sex and weight: ① Intact rectum with blank matrix; ② Damaged rectum with blank matrix; ③ Low-dose MYL damaged rectum; ④ Medium-dose MYL damaged rectum; ⑤ High-dose MYL damaged rectum; and ⑥ High-dose MYL intact rectum. For the damaged rectum groups, sandpaper was rolled into a small stick of suitable thickness, inserted into the rabbit's rectum about 7-9 cm, and then gently rotated once. This was repeated weekly.

[0341] Each group received the medication rectally for one month (4 weeks). At the end of the treatment period (week 4), 36 experimental rabbits (6 rabbits per group, half male and half female) were dissected as planned. At the end of the recovery period (week 8), 24 experimental rabbits (4 rabbits per group, half female and half female) were dissected as planned for examination. The examination included: general clinical observation, weight, food intake, body temperature, ophthalmological examination, hematology, blood biochemistry, coagulation, urine and bone marrow cell smear examination; all euthanized animals underwent gross anatomical observation, organ weighing, and pathological examination of organ tissues.

[0342] 3. Test Results

[0343] General clinical observation: Rabbits were administered MYL rectally for one month (4 weeks) consecutively, followed by a 4-week recovery observation period. No obvious irritation was observed at the administration site in any group of animals. During the experiment, all animals were euthanized as planned, and no animals died unexpectedly.

[0344] Body weight, body temperature and food intake: MYL was administered rectally to rabbits for one month (4 weeks) and had no significant effect on their body weight, body temperature and food intake.

[0345] Hematological, coagulation, blood biochemistry and electrolyte, and routine urine tests: MYL was administered rectally to experimental rabbits for one month (4 weeks) without significant effect on the animals' hematological, coagulation, blood biochemistry and electrolyte, and routine urine indicators.

[0346] Ophthalmological examination: No obvious abnormalities were found in ophthalmological examinations at the end of the administration period and the recovery period, in the group with intact and damaged rectum with blank matrix, the low and medium dose MYL group with damaged rectum, and the high dose MYL group with intact and damaged rectum.

[0347] Organ coefficient: MYL was administered rectally to rabbits for one month (4 weeks) without any significant effect on the organ coefficient indicators.

[0348] Bone marrow cells: MYL was administered rectally to rabbits for one month (4 weeks) without any significant effect on the bone marrow smear parameters.

[0349] Gross anatomy and pathological examination: At the end of the administration period, gross examination of some animals in the damaged rectum group revealed focal hemorrhage in the rectal mucosa. Microscopic examination showed varying degrees of rectal mucosal hemorrhage and inflammatory cell infiltration. Compared with the blank matrix damaged rectum group, the incidence of lesions was increased in the high-dose MYL damaged rectum group, indicating that high-dose MYL has a certain degree of irritation to the damaged rectum. Microscopic examination of some animals in the intact rectum group showed varying degrees of rectal inflammatory cell infiltration. Compared with the blank matrix intact rectum group, the incidence of lesions was increased in the high-dose MYL intact rectum group, suggesting that high-dose MYL has a certain degree of irritation to the intact rectum. By the end of the recovery period, the lesions induced by the test substance had completely recovered, indicating that its irritation was reversible. No pathological changes of toxicological significance were found in other tissues.

[0350] In summary, under the conditions of this experiment, repeated administration of low, medium, and high doses of MYL to rabbits via the rectum for one month did not cause significant systemic toxicity. High doses of MYL were somewhat irritating to both damaged and intact rectums, but the irritation was reversible. Low and medium doses of MYL were not irritating to either damaged or intact rectums.

[0351] Experimental Example 3

[0352] To illustrate the safety of the traditional Chinese medicine composition of the present invention, a local toxicity test was conducted using the ointment prepared in Example 1 (hereinafter referred to as MYL).

[0353] 1. Experimental Objective

[0354] This study was conducted in accordance with national GLP guidelines. By examining the skin allergic reaction of MYL to guinea pigs (closed patch test), the toxicity of the drug on the local and systemic aspects of application was evaluated.

[0355] 2. Test methods

[0356] Sixty SPF-grade Hartley guinea pigs that passed quarantine and whose back hair removal treatments resulted in no damage were selected and divided into four groups: a negative control group, a positive control group, and low- and high-dose test substance groups. The low- and high-dose test substance groups each contained 20 animals, and the remaining groups each contained 10 animals, with half males and half females.

[0357] On days 0, 7, and 14, blank matrix, 1% 1-chloro-2,4-dinitrobenzene, low-concentration MYL, and high-concentration MYL were applied to the corresponding hair-removed areas on the left back of the animals, 0.2 mL / animal or 0.2 g / animal. The application was covered with two layers of gauze and one layer of cellophane, then secured with non-irritating adhesive tape and bandage. The drugs were washed off with warm water after 6 hours. Skin erythema, edema, and other abnormal reactions were observed 1 hour and 24 hours after drug removal. Fourteen days after the last sensitization, during the challenge contact phase, blank matrix, 0.1% 1-chloro-2,4-dinitrobenzene, low-concentration MYL, and high-concentration MYL were applied to the corresponding hair-removed areas on the right side of the animals, covered with two layers of gauze and one layer of cellophane, then secured with non-irritating adhesive tape and bandage. The drugs were washed off with warm water after 6 hours. Skin erythema, edema, and other abnormal reactions were observed 24 hours and 48 hours after drug removal.

[0358] 3. Test Results

[0359] During the experiment (excluding the challenge observation period), no abnormalities were observed in the animals' appearance, behavior, or general condition, and no animal deaths were reported. In the negative control group, the sensitization rate was 0 at both 24 and 48 hours after drug removal, and the skin sensitization evaluation was weak sensitization. In the positive control group, the sensitization rates were 80% and 40% at 24 and 48 hours after drug removal, respectively, and the skin sensitization evaluation was strong and moderate sensitization. In both the low- and high-dose groups, the sensitization rate was 0 at both 24 and 48 hours after drug removal, and the skin sensitization evaluation was weak sensitization.

[0360] In conclusion, under the conditions of this experiment, neither low nor high doses of MYL showed obvious skin allergic reactions in guinea pigs.

[0361] Test Example 4

[0362] To demonstrate the effectiveness of the herbal composition of the present invention in treating hemorrhoids, pharmacodynamic studies were conducted using the ointment prepared in Example 1 (hereinafter referred to as MYL), the ointment prepared in Comparative Example 1 (hereinafter referred to as MYL-A), and the ointment prepared in Comparative Example 2 (hereinafter referred to as MYL-B).

[0363] 1. Experimental Objective

[0364] The therapeutic effects of different doses of MYL, MYL-A, and MYL-B on hemorrhoids were studied using a rat anal swelling model induced by croton oil and a rat anal ulcer model induced by acetic acid.

[0365] 2. Test methods

[0366] 2.1 Effects on croton oil-induced anal swelling model in rats

[0367] 2.1.1 Grouping and Dosing

[0368] Eighty qualified SPF-grade male SD rats, weighing 188.6–254.6 g, were selected. Ten rats were selected as the normal control group, and the remaining rats were used to establish the model. The modeling method was as follows: cotton swabs were soaked in a mixture of croton oil (distilled water, pyridine, ether and croton oil were prepared in a ratio of 1:4:5:10) for 5 min. The soaked cotton swabs were then inserted into the anus of the rats in the model group for 10 s, and the swelling was then observed.

[0369] After successful modeling, the model group was randomly divided into 7 groups according to the size of the swelling area: model control group, positive control group (Ma Yinglong Musk Hemorrhoid Ointment), high-dose MYL group, medium-dose MYL group, low-dose MYL group, MYL-A group, and MYL-B group, with 10 rats in each group. Each group of rats was given the drug. Except for the normal control group, the other groups of rats were given the drug rectally. The model control group was given the matrix, and the other groups were given the corresponding drugs. The drugs were administered twice a day, with an interval of 6 hours between each administration. The dosage was 0.25g / time / animal, and each experimental animal in each group was given 0.5g / day for 7 consecutive days.

[0370] 2.1.2 Detection Indicators

[0371] Anal swelling degree: 30 minutes after the second administration of the drug each day, the diameter of the swelling of the entire perianal tissue in each group of rats was measured with vernier calipers. The product of the average of the long and short diameters (swelling area) was taken as the indicator for measuring the degree of swelling.

[0372] Anal swelling rate: Six hours after the last administration, rats were euthanized under isoflurane anesthesia, and a 15 mm section of rectum from the edge of the anal fur was excised. The severity of swelling was expressed as the rectal-anal swelling rate. Rectal-anal swelling rate = (rectal-anal wet weight - rectal-anal dry weight) / rectal-anal wet weight × 100%.

[0373] 2.2 Effects on acetic acid-induced anal ulcer model in rats

[0374] 2.2.1 Grouping and Dosing

[0375] Eighty qualified SPF-grade male SD rats, weighing 230.0–259.2 g, were selected. Ten rats were used as the normal control group, and the remaining rats were used to establish an anal ulcer model using 99% acetic acid. 6 mm diameter filter paper was applied to the perianal skin and mucous membrane with saturated acetic acid solution for 1 minute each time, and the filter paper was replaced every 0.5 minutes. On the second day after modeling, the degree of ulceration was observed and the ulcer area was calculated. Based on the anal ulcer area and body weight, the rats were randomly divided into six groups: model control group, positive control group (Ma Yinglong Musk Hemorrhoid Ointment), high-dose MYL group, medium-dose MYL group, low-dose MYL group, MYL-A group, and MYL-B group, with 10 rats in each group. Except for the normal control group, rats in the other groups were administered the drug rectally. The model control group rats were given the matrix, and the other groups rats were given the corresponding drug twice a day, with an interval of 6 hours between each administration. The administration volume was 0.25g / time / animal, and each experimental animal in each group was given 0.5g / day for 14 consecutive days.

[0376] 2.2.2 Detection Indicators

[0377] Anal ulcer area: The healing of anal ulcers in rats in each group was observed 30 minutes after the second administration on days 1, 4, 7, 10 and 14 after modeling, and the ulcer area was calculated.

[0378] 3. Statistical methods

[0379] SPSS 23.0 was used for statistical analysis. Quantitative data were expressed as mean ± standard deviation. Normality and homogeneity of variance were tested using Leven's test. If there was no statistical significance (P>0.05), one-way ANOVA was used. If the ANOVA was statistically significant (P≤0.05), the LSD test (parametric method) was used for comparative analysis. If the variances were unequal (P≤0.05), the Kruskal-Wallis test was used. If the Kruskal-Wallis test was statistically significant (P≤0.05), Dunnett's test (nonparametric method) was used for comparative analysis. The statistical results were compared with α=0.05, where P≤0.05 indicated statistical significance, and P≤0.01 indicated a highly significant difference.

[0380] 4. Test Results

[0381] 4.1 Effects on croton oil-induced anal swelling model in rats

[0382] The swelling area and anal swelling rate of rats in the perianal swelling model were detected. The results are shown in Figure 1 and Table 1.

[0383] Table 1. Effects on rectal and anal swelling rate in rats ( (n=10)

[0384]

[0385] Note: Compared with the normal control group, ++ P≤0.01; compared with the model control group, * P≤0.05, ** P≤0.01; compared with the MYL-A group, △ P≤0.05, △△ P≤0.01; compared with the MYL-B group, ￥ P≤0.05, ￥￥ P≤0.01.

[0386] As shown in Figure 1, compared with the normal control group, the perianal swelling area of ​​rats in the model control group was significantly increased on days 1-7 after administration (P≤0.01). Compared with the model control group, the perianal swelling area of ​​rats in the positive control group was significantly reduced on days 5-7 after administration (P≤0.01), the perianal swelling area of ​​rats in the MYL-A group was significantly reduced on days 5-7 after administration (P≤0.01), the perianal swelling area of ​​rats in the MYL-B group was significantly reduced on days 6-7 after administration (P≤0.05), the perianal swelling area of ​​rats in the low-dose MYL group was significantly reduced on days 3-7 after administration (P≤0.01), and the perianal swelling area of ​​rats in the medium-dose and high-dose MYL groups was significantly reduced on days 2-7 after administration (P≤0.01).

[0387] Compared with the positive control group, the perianal swelling area was significantly reduced in rats in the medium- and high-dose MYL groups on days 3-5 after administration (P≤0.05 or P≤0.01), and significantly reduced in rats in the high-dose MYL group on days 3-6 after administration (P≤0.05 or P≤0.01). Compared with the MYL-A group, the perianal swelling area was significantly reduced in rats in the low- and medium-dose MYL groups on days 3-5 after administration (P≤0.05 or P≤0.01), and significantly reduced in rats in the high-dose MYL group on days 3-7 after administration (P≤0.05 or P≤0.01). Compared with the MYL-B group, the perianal swelling area was significantly reduced in rats in the low-dose MYL group on days 3-6 after administration (P≤0.01), and significantly reduced in rats in the medium- and high-dose MYL groups on days 3-7 after administration (P≤0.01).

[0388] As shown in Table 1, compared with the normal control group, the net weight and perianal swelling rate of rats in the model control group were significantly increased on day 7 after drug administration (P≤0.01). Compared with the model control group, the net weight and perianal swelling rate of rats in the positive control group, MYL-A group, MYL-B group, and different dose groups of MYL were significantly decreased on day 7 after drug administration (P≤0.05 or P≤0.01). Compared with the MYL-A group, the perianal swelling rate of rats in the medium-dose and high-dose groups of MYL was significantly decreased on day 7 after drug administration (P≤0.05 or P≤0.01). Compared with the MYL-B group, the perianal swelling rate of rats in the medium-dose and high-dose groups of MYL was significantly decreased on day 7 after drug administration (P≤0.01).

[0389] In summary, different doses of MYL significantly reduced the perianal swelling area, net weight of perianal swelling, and perianal swelling rate in the croton oil-induced rat anal swelling model. It has a significant therapeutic effect on the croton oil-induced rat anal swelling model. The onset time and intensity of the effect are better than those of the positive control drug and the ointment prepared by comparative examples 1-2. Its efficacy is dose-dependent, with medium and high doses of MYL showing the best effect.

[0390] 4.2 Effects on acetic acid-induced anal ulcer model in rats

[0391] The results of the detection of anal ulcer area in rats are shown in Table 2.

[0392] Table 2 Effects on the area of ​​anal ulcers in rats ( (n=10)

[0393]

[0394] Note: Compared with the normal control group, ++ P≤0.01; compared with the model control group, * P≤0.05, ** P≤0.01; compared with the positive control group, # P≤0.05, ## P≤0.01; compared with the MYL-A group, △ P≤0.05, △△ P≤0.01; compared with the MYL-B group, ￥ P≤0.05, ￥￥ P≤0.01.

[0395] As shown in Table 2, compared with the normal control group, the perianal ulcer area of ​​rats in the model control group was significantly increased on D1–D14 after administration (P≤0.01). Compared with the model control group, the perianal ulcer area of ​​rats in the positive control group, MYL-A group, medium-dose MYL group, and high-dose MYL group was significantly reduced on D7–D14 after administration (P≤0.05 or P≤0.01), while the perianal ulcer area of ​​rats in the MYL-B group and low-dose MYL group was significantly reduced on D10–D14 after administration (P≤0.05 or P≤0.01). Compared with the positive control group, the perianal ulcer area of ​​rats in the medium-dose MYL group was significantly reduced on D10–D14 after administration (P≤0.05), and the perianal ulcer area of ​​rats in the high-dose MYL group was significantly reduced on D14 after administration (P≤0.05). Compared with the MYL-A group, the perianal ulcer area of ​​rats in the medium-dose MYL group and high-dose MYL group was significantly reduced on D10–D14 after administration (P≤0.05 or P≤0.01). Compared with the MYL-B group, the perianal ulcer area of ​​rats in the medium-dose MYL and high-dose MYL groups was significantly reduced on days 7 to 14 after administration (P≤0.05 or P≤0.01).

[0396] In summary, different doses of MYL significantly reduced the area of ​​perianal ulcers in rats, indicating that MYL has a significant therapeutic effect on perianal ulcers in rats, and its efficacy is dose-dependent. Among them, the therapeutic effects of the medium-dose and high-dose MYL groups were better than those of the ointment prepared in Comparative Example 1-2, and the therapeutic effect of the medium-dose MYL group was better than that of the positive control drug.

[0397] Experimental Example 5

[0398] To demonstrate the effectiveness of the herbal composition of the present invention in treating postoperative complications of hemorrhoids, pharmacodynamic studies were conducted using the ointment prepared in Example 1 (hereinafter referred to as MYL), the ointment prepared in Comparative Example 1 (hereinafter referred to as MYL-A), and the ointment prepared in Comparative Example 2 (hereinafter referred to as MYL-B).

[0399] 1. Experimental Objective

[0400] This study used a rat anal surgery model to investigate the effects on postoperative anal pain and inflammation.

[0401] 2. Test methods

[0402] Eighty qualified SPF-grade male SD rats, weighing 171.2–201.1 g, were selected. Ten rats were selected as the normal control group. The remaining rats underwent anal surgery pain modeling. After isoflurane anesthesia, the rats were fixed in a prone position. The proximal tail (including the perianal area) was disinfected. After the anus relaxed, the anal skin on the spinal side was incised with a scalpel along the anal margin, extending to the rectal mucosa. The incision was trimmed into a triangular defect, limiting the damage to the deep subcutaneous fascia. After adequate hemostasis, 4-0... The incision was sutured with full-thickness silk thread. After the rats recovered, they were placed in test cages to adapt. Their pain behavior was observed and the pain threshold was measured. The presence of pain-protective behavior and a decrease in the mechanical pain threshold indicated successful modeling. Based on the pain threshold, the model rats were randomly divided into 7 groups: model control group, positive control group (Ma Yinglong Musk Hemorrhoid Ointment), high-dose MYL group, medium-dose MYL group, low-dose MYL group, MYL-A group, and MYL-B group, with 10 rats in each group. Except for the normal control group, all drug administration groups received rectal administration. The model control group received the matrix, and the other groups received the corresponding drugs twice a day, with an interval of 6 hours between each administration. The administration volume was 0.25g / time, and the administration was continued for 7 days.

[0403] 3. Detection indicators

[0404] Pain threshold detection: Pain threshold was measured before modeling, 2 hours after modeling, and before the second administration on days 1, 3, 5, and 7 after drug administration. Changes in mechanical pain in rats were recorded.

[0405] Anal tissue pathological examination: 6 hours after the last administration, rats in each group were anesthetized with isoflurane, and anal tissue was collected, fixed in 10% paraformaldehyde specimen fixative, stained with hematoxylin and eosin (HE), and histopathological changes were observed.

[0406] 4. Analytical Methods

[0407] SPSS 23.0 was used for statistical analysis. Quantitative data were expressed as mean ± standard deviation. Normality and homogeneity of variance were tested using Leven's test. If there was no statistical significance (P > 0.05), one-way ANOVA was used. If the ANOVA was statistically significant (P ≤ 0.05), the LSD test (parametric method) was used for comparative analysis. If the variances were unequal (P ≤ 0.05), the Kruskal-Wallis test was used. If the Kruskal-Wallis test was statistically significant (P ≤ 0.05), Dunnett's test (non-parametric method) was used for comparative analysis. The statistical results were compared with α = 0.05, where P ≤ 0.05 indicated statistical significance, and P ≤ 0.01 indicated a highly significant difference.

[0408] 5. Test Results

[0409] 5.1 Effect on pain threshold in a rat model of postoperative anorectal pain

[0410] As shown in Table 3, compared with the normal control group, the pain threshold of rats in the model control group was significantly reduced on days 1-7 after administration (P≤0.01). Compared with the model control group, the pain threshold of rats in all administration groups was significantly increased on days 1-7 after administration (P≤0.05 or P≤0.01). Compared with the positive control group, the pain threshold of rats in the medium-dose MYL group was significantly increased on days 5-7 after administration (P≤0.01). Compared with the MYL-A group, the pain threshold of rats in the medium-dose and high-dose MYL groups was significantly increased on days 5-7 after administration (P≤0.05 or P≤0.01). Compared with the MYL-B group, the pain threshold of rats in the low-dose MYL group was significantly increased on day 7 after administration (P≤0.05), and the pain threshold of rats in the medium-dose and high-dose MYL groups was significantly increased on days 5-7 after administration (P≤0.01).

[0411] Table 3 shows the effect on pain threshold in the anorectal postoperative pain model. (n=10)

[0412]

[0413] Note: Compared with the normal control group, ++ P≤0.01; compared with the model control group, * P≤0.05, ** P≤0.01; compared with the positive control group, # P≤0.05, ## P≤0.01; compared with the MYL-A group, △ P≤0.05, △△ P≤0.01; compared with the MYL-B group,￥ P≤0.05, ￥￥ P≤0.01.

[0414] 5.2 Effects on anal tissue pathology in a rat model of postoperative anorectal pain

[0415] HE staining results showed that, compared with the normal control group, the anal tissue of rats in the model control group showed significant epidermal thickening, dermal hemorrhage, severe tissue vacuolation, significant fibroblast aggregation, and extensive inflammatory cell infiltration. Compared with the model control group, all drug-treated rats showed improvement in histopathological changes such as epidermal thickening, dermal hemorrhage, tissue vacuolation, fibroblast aggregation, and inflammatory infiltration in the perianal tissue. Specific histopathological images of the rat perianal tissue are shown in Figure 2.

[0416] As shown in Figure 2, no ulcers, edema, bleeding, or inflammatory cell infiltration were observed in the normal control group. In the model control group, the perianal skin showed epidermal thickening, focal ulcers, bleeding, vacuolation, fibroblast aggregation, and inflammatory cell infiltration in the dermis. In the MYL-A group, the perianal skin showed epidermal thickening, bleeding, vacuolation, fibroblast aggregation, and inflammatory cell infiltration in the dermis. In the positive control group, the perianal skin showed epidermal thickening, focal ulcers, bleeding, vacuolation, fibroblast aggregation, and inflammatory cell infiltration in the dermis. In the low-dose MYL group, the perianal skin showed epidermal thickening, bleeding, vacuolation, fibroblast aggregation, and inflammatory cell infiltration in the dermis. In the medium-dose MYL group, no ulcers, edema, bleeding, or inflammatory cell infiltration were observed. In the high-dose MYL group, the perianal skin showed epidermal thickening, bleeding, vacuolation, fibroblast aggregation, and inflammatory cell infiltration in the dermis. Therefore, the medium-dose MYL group showed the most significant improvement.

[0417] In summary, MYL significantly increased the pain threshold in a rat anorectal postoperative pain model and improved histopathological changes such as epidermal thickening, dermal hemorrhage, tissue vacuolation, fibroblast aggregation, and inflammatory infiltration in the perianal tissue of rats. Among them, the medium dose of MYL had a better therapeutic effect on anorectal postoperative pain and inflammation than the positive control drug and the ointment prepared by comparative ratios 1-2.

[0418] Experimental Example 6

[0419] To illustrate the anti-inflammatory effect of the traditional Chinese medicine composition of the present invention, pharmacodynamic tests were conducted on the ointment prepared in Example 1 (hereinafter referred to as MYL), the ointment prepared in Comparative Example 1 (hereinafter referred to as MYL-A), and the ointment prepared in Comparative Example 2 (hereinafter referred to as MYL-B).

[0420] 1. Experimental Objective

[0421] This study used acute and chronic inflammation models (carrageenan-induced toe swelling model and chronic granuloma model) to investigate the anti-inflammatory effect of MYL.

[0422] 2. Test methods

[0423] 2.1 Effects on carrageenan-induced rat paw edema model

[0424] 2.1.1 Grouping and Dosing

[0425] Eighty qualified SPF-grade male SD rats, weighing 193.6–260.9 g, were randomly divided into eight groups according to their weight: normal control group, model control group, positive control group (Ma Yinglong Musk Hemorrhoid Ointment), high-dose MYL group, medium-dose MYL group, low-dose MYL group, MYL-A group, and MYL-B group, with 10 rats in each group. Except for the normal control group, the drug was applied to the right hind paw of the rats in the other groups. Oil-proof paper was cut into 2*3 cm pieces, and after applying the drug, the oil-proof paper was attached to the application site and wrapped with medical tape. The dosage was 0.25 g / rat / time, twice a day, with an interval of 6 hours between each administration, for 7 consecutive days. On the 7th day of drug administration, except for the normal control group, each rat in the other groups was injected with 0.1 mL of 1% carrageenan into the sole of its paw before the last administration to induce paw swelling. Immediately after modeling, the rats were administered the drug again. The model control group was given the matrix, and the rats in the other groups were given the corresponding drugs. The paw volume of the rats was measured before modeling, after modeling, and at 30 min, 1 h, 2 h, 4 h, and 6 h after drug administration using a rat paw volume measuring instrument. The degree and rate of paw swelling were also calculated.

[0426] 2.1.2 Detection Indicators

[0427] Toe swelling degree: Toe swelling degree = swelling volume of toes after administration - swelling volume of toes before administration.

[0428] Toe swelling rate: Toe swelling rate = (toe swelling volume after administration - toe swelling volume before administration) / toe swelling volume before administration * 100%.

[0429] 2.2 Effects on a rat model of chronic granulomatosis

[0430] 2.2.1 Grouping and Dosing

[0431] Eighty qualified SPF-grade male SD rats, weighing 196.0–225.9 g, were randomly divided into eight groups according to their weight: sham-operated group, model control group, positive control group (Ma Yinglong Musk Hemorrhoid Ointment), high-dose MYL group, medium-dose MYL group, low-dose MYL group, MYL-A group, and MYL-B group, with 10 rats in each group. Except for the sham-operated group, the other rats were anesthetized with isoflurane, and a 1.5 cm incision was made along the midline of the abdomen. 20 mg sterile cotton balls were inserted into the left and right lower abdomen inguinal regions, and the inguinal region was sutured postoperatively. On the second day after surgery, each group of rats was given the corresponding drug. The drug was evenly applied to the cotton ball packing site, and a 2 cm * 2 cm oil-resistant paper adhesive tape was used to seal the site. The administration was twice daily, with an interval of 6 hours between each administration, at a dose of 0.22 g / time / rat, for 7 consecutive days. The animals were sacrificed the day after the last administration, and the cotton balls from both sides were dissected, weighed, and the granuloma inhibition rate and granuloma coefficient were calculated.

[0432] 2.2.2 Detection Indicators

[0433] Granuloma inhibition rate: Granuloma inhibition rate (%) = (Granoma weight in control group - Granoma weight in drug group) / Granoma weight in control group × 100%.

[0434] Granuloma coefficient: Granuloma coefficient (%) = Granuloma weight / Rat body weight × 100%.

[0435] 3. Analytical Methods

[0436] SPSS 23.0 was used for statistical analysis. Quantitative data were expressed as mean ± standard deviation. Normality and homogeneity of variance were tested using Leven's test. If there was no statistical significance (P > 0.05), one-way ANOVA was used. If the ANOVA was statistically significant (P ≤ 0.05), the LSD test (parametric method) was used for comparative analysis. If the variances were unequal (P ≤ 0.05), the Kruskal-Wallis test was used. If the Kruskal-Wallis test was statistically significant (P ≤ 0.05), Dunnett's test (non-parametric method) was used for comparative analysis. The statistical results were compared with α = 0.05, where P ≤ 0.05 indicated statistical significance, and P ≤ 0.01 indicated a highly significant difference.

[0437] 4. Test Results

[0438] 4.1 Effects on carrageenan-induced rat paw edema model

[0439] The effects of MYL on the degree and rate of toe swelling in a carrageenan-induced rat toe swelling model are shown in Figure 3 and Table 4, respectively.

[0440] As shown in Figure 3, compared with the normal control group, the paw swelling of rats in the model control group was significantly increased at 30 min, 1 h, 2 h, 4 h, and 6 h after administration (P≤0.01). Compared with the model control group, at 30 min after administration, the paw swelling of rats in the medium-dose and high-dose MYL groups was significantly reduced (P≤0.05 or P≤0.01); at 1 h, 2 h, 4 h, and 6 h after administration, the paw swelling of rats in all MYL dose groups and the positive control group was significantly reduced (P≤0.05 or P≤0.01); at 6 h after administration, the paw swelling of rats in the MYL-A and MYL-B groups was significantly reduced (P≤0.05). Compared with the positive control group, at 1 h after administration, the paw swelling of rats in the medium-dose and high-dose MYL groups was significantly reduced (P≤0.05 or P≤0.01); at 2 h and 4 h after administration, the paw swelling of rats in the medium-dose MYL group was significantly reduced (P≤0.05 or P≤0.01). Compared with the MYL-A group, at 1 hour after administration, the paw swelling of rats in the low-dose MYL group was significantly reduced (P≤0.05); at 1 hour, 2 hours, and 4 hours after administration, the paw swelling of rats in the medium-dose and high-dose MYL groups was significantly reduced (P≤0.05 or P≤0.01); at 6 hours after administration, the paw swelling of rats in the high-dose MYL group was significantly reduced (P≤0.05). Compared with the MYL-B group, at 1 hour after administration, the paw swelling of rats in the low-dose MYL group was significantly reduced (P≤0.05); at 1 hour, 2 hours, and 4 hours after administration, the paw swelling of rats in the medium-dose and high-dose MYL groups was significantly reduced (P≤0.05 or P≤0.01); at 6 hours after administration, the paw swelling of rats in the high-dose MYL group was significantly reduced (P≤0.05).

[0441] As shown in Table 4, compared with the normal control group, the paw swelling rate of rats in the model control group was significantly increased at 30 min, 1 h, 2 h, 4 h, and 6 h after administration (P≤0.01). Compared with the model control group, at 30 min after administration, the paw swelling rate of rats in the medium-dose and high-dose MYL groups was significantly reduced (P≤0.05 or P≤0.01); at 1 h, 2 h, 4 h, 4 h, and 6 h after administration, the paw swelling rate of rats in the positive control group and all dose groups of MYL was significantly reduced (P≤0.05 or P≤0.01); at 6 h after administration, the paw swelling of rats in the MYL-A and MYL-B groups was significantly reduced (P≤0.05). Compared with the positive control group, at 1 h after administration, the paw swelling rate of rats in the medium-dose and high-dose MYL groups was significantly reduced (P≤0.05 or P≤0.01); at 2 h and 4 h after administration, the paw swelling rate of rats in the medium-dose MYL group was significantly reduced (P≤0.05 or P≤0.01). Compared with the MYL-A group, at 1 h, 2 h, and 4 h after administration, the paw swelling rate of rats in the medium-dose and high-dose MYL groups was significantly reduced (P≤0.05 or P≤0.01); at 6 h after administration, the paw swelling rate of rats in the high-dose MYL group was significantly reduced (P≤0.05). Compared with the MYL-B group, at 1 h, 2 h, and 4 h after administration, the paw swelling rate of rats in the medium-dose and high-dose MYL groups was significantly reduced (P≤0.05 or P≤0.01); at 6 h after administration, the paw swelling rate of rats in the high-dose MYL group was significantly reduced (P≤0.05).

[0442] Table 4. Effects of carrageenan on the rate of toe swelling in a rat model of toe swelling ( (n=10)

[0443]

[0444] Note: Compared with the normal control group, ++ P≤0.01; compared with the model control group, * P≤0.05, ** P≤0.01; compared with the positive control group, # P≤0.05, ## P≤0.01; compared with the MYL-A group, △ P≤0.05, △△ P≤0.01; compared with the MYL-B group, ￥ P≤0.05, ￥￥ P≤0.01.

[0445] 4.2 Effects on a rat model of chronic granulomatosis

[0446] The effects of MYL on the granuloma inhibition rate and granuloma coefficient of a rat chronic granuloma model are shown in Tables 5-6.

[0447] As shown in Table 5, after administration on day 7, the granuloma inhibition rates of the model control group, positive control group, MYL-A group, MYL-B group, low-dose MYL group, medium-dose MYL group, and high-dose MYL group were 0.0%, 21.7%, 19.9%, 17.5%, 36.3%, 41.7%, and 39.1%, respectively. As shown in Table 6, compared with the model control group, the granuloma coefficient of all administration groups was significantly reduced (P≤0.01); compared with the positive control group, MYL-A group, and MYL-B group, the granuloma coefficient of all MYL dose groups was significantly reduced (P≤0.05 or P≤0.01).

[0448] Table 5. Effects on granuloma inhibition rate in a rat chronic granuloma model ( (n=10)

[0449]

[0450] Table 6. Effects on granuloma coefficient in rat chronic granuloma model ( (n=10)

[0451]

[0452] Note: Compared with the model control group, * P≤0.05, ** P≤0.01; compared with the positive control group, # P≤0.05, ## P≤0.01; compared with the MYL-A group, △ P≤0.05, △△ P≤0.01; compared with the MYL-B group, ￥ P≤0.05, ￥￥ P≤0.01.

[0453] Experimental Example 7

[0454] To illustrate the hemostatic effect of the traditional Chinese medicine composition of the present invention, pharmacodynamic tests were conducted on the ointment prepared in Example 1 (hereinafter referred to as MYL), the ointment prepared in Comparative Example 1 (hereinafter referred to as MYL-A), and the ointment prepared in Comparative Example 2 (hereinafter referred to as MYL-B).

[0455] 1. Experimental Objective

[0456] This study used a mouse tail-cutting hemorrhage model to investigate the hemostatic effect of MYL.

[0457] 2. Test methods

[0458] 2.1 Grouping and Dosing

[0459] One hundred and sixty qualified SPF-grade ICR mice were selected, with half males and half females. Females weighed 20.0–26.8g and males weighed 21.2–27.2g. They were randomly divided into eight groups according to their weight: model control group, positive control group (Ma Yinglong Musk Hemorrhoid Ointment), Yunnan Baiyao group, MYL-A group, MYL-B group, high-dose MYL group, medium-dose MYL group, and low-dose MYL group, with 20 mice in each group, half males and half females. Except for the model control group, the mice in the other groups were given the corresponding drugs. The administration site was 0.5–2cm from the tail tip, and the dosage was 0.1g / mouse / time. After application, the mice were bandaged and fixed. The drugs were administered twice a day for 7 consecutive days, with an interval of 6 hours between each administration.

[0460] 2.2 Detection Indicators

[0461] Hemostasis time test: Before the last administration, cut off about 1 cm of the tip of the mouse tail with scissors, and immediately after administration, observe the hemostasis time at the tail stump.

[0462] 3. Analytical Methods

[0463] SPSS 23.0 was used for statistical analysis. Quantitative data were expressed as mean ± standard deviation. Normality and homogeneity of variance were tested using Leven's test. If there was no statistical significance (P > 0.05), one-way ANOVA was used. If the ANOVA was statistically significant (P ≤ 0.05), the LSD test (parametric method) was used for comparative analysis. If the variances were unequal (P ≤ 0.05), the Kruskal-Wallis test was used. If the Kruskal-Wallis test was statistically significant (P ≤ 0.05), Dunnett's test (non-parametric method) was used for comparative analysis. The statistical results were compared with α = 0.05, where P ≤ 0.05 indicated statistical significance, and P ≤ 0.01 indicated a highly significant difference.

[0464] 4. Experimental Results

[0465] The effect of MYL on hemostasis time in a mouse tail-barre model is shown in Table 7. As shown in Table 7, compared with the model control group, the hemostasis time of mice in all treatment groups was significantly reduced (P≤0.01). Compared with the positive control group, the hemostasis time of mice in all MYL dose groups, the MYL-A group, and the Yunnan Baiyao group was significantly reduced (P≤0.05 or P≤0.01). Compared with the Yunnan Baiyao group, the hemostasis time of mice in the medium-dose MYL group was significantly reduced (P≤0.05). Compared with the MYL-A group, the hemostasis time of mice in the medium-dose MYL group was significantly reduced (P≤0.05). Compared with the MYL-B group, the hemostasis time of mice in all MYL dose groups was significantly reduced (P≤0.01).

[0466] Table 7 Effects on hemostasis time in mouse tail-barre model ( (n=20)

[0467]

[0468] Note: Compared with the model control group, * P≤0.05, ** P≤0.01; compared with the positive control group, # P≤0.05, ## P≤0.01; compared with the Yunnan Baiyao group, $ P≤0.05; compared with the MYL-A group, △ P≤0.05, △△ P≤0.01; compared with the MYL-B group, ￥ P≤0.05, ￥￥ P≤0.01.

[0469] This experimental study shows that all doses of MYL have significant hemostatic effects and the efficacy is dose-dependent. The hemostatic effect of all doses of MYL is better than that of the positive control drug. The hemostatic effect of the medium dose group of MYL is better than that of the product prepared by comparative example 1-2, and even better than Yunnan Baiyao.

[0470] Experimental Example 8

[0471] To illustrate the analgesic effect of the traditional Chinese medicine composition of the present invention, pharmacodynamic tests were conducted on the ointment prepared in Example 1 (hereinafter referred to as MYL), the ointment prepared in Comparative Example 1 (hereinafter referred to as MYL-A), and the ointment prepared in Comparative Example 2 (hereinafter referred to as MYL-B).

[0472] 1. Experimental Objective

[0473] This study used an acetic acid-induced writhing pain model in mice to investigate the analgesic effect of MYL.

[0474] 2. Test methods

[0475] 2.1 Grouping and Dosing

[0476] Eighty qualified SPF-grade male ICR mice, weighing 19.3–25.4 g, were randomly divided into eight groups based on weight: model control group, positive control group (Ma Yinglong Musk Hemorrhoid Ointment), diclofenac diethylamine emulsion group, MYL-A group, MYL-B group, high-dose MYL group, medium-dose MYL group, and low-dose MYL group, with ten mice in each group. Hair was removed from the abdomen of each mouse in a 3cm*3cm area. Except for the model control group, the mice in each group received the drug via abdominal application. After application, the area was bandaged with a medical bandage. The dosage was 0.25 g / mouse, twice daily, with a 6-hour interval between each administration, for 7 consecutive days. On the 7th day of administration, 30 minutes after the last administration, each mouse was intraperitoneally injected with 0.6% glacial acetic acid at a volume of 10 mL / kg. The time to first writhing (latency period) and the number of writhing episodes within 30 minutes were observed.

[0477] 2.2 Detection Indicators

[0478] Writhing latency and number of writhing events: 0.6% glacial acetic acid was injected intraperitoneally 30 minutes after the last administration in each group. The writhing latency and the number of writhing responses (abdominal concavity, hind limb extension, and hip elevation) within 30 minutes were observed in mice.

[0479] 3. Analytical Methods

[0480] SPSS 23.0 was used for statistical analysis. Quantitative data were expressed as mean ± standard deviation. Normality and homogeneity of variance were tested using Leven's test. If there was no statistical significance (P > 0.05), one-way ANOVA was used. If the ANOVA was statistically significant (P ≤ 0.05), the LSD test (parametric method) was used for comparative analysis. If the variances were unequal (P ≤ 0.05), the Kruskal-Wallis test was used. If the Kruskal-Wallis test was statistically significant (P ≤ 0.05), Dunnett's test (non-parametric method) was used for comparative analysis. The statistical results were compared with α = 0.05, where P ≤ 0.05 indicated statistical significance, and P ≤ 0.01 indicated a highly significant difference.

[0481] 4. Test Results

[0482] The effects of acetic acid on the writhing response in mice are shown in Table 8. As shown in Table 8, compared with the model control group, the writhing latency was significantly increased in all treatment groups (P≤0.05 or P≤0.01). Compared with the positive control group, diclofenac diethylamine latex group, MYL-A group, and MYL-B group, the writhing latency was significantly increased in the medium-dose and high-dose MYL groups (P≤0.05). Compared with the model control group, the number of writhing movements was significantly reduced in all treatment groups (P≤0.01), and no significant differences were found among the other groups.

[0483] Table 8 Effects of acetic acid-induced writhing response in mice (n=10)

[0484]

[0485] Note: Compared with the model control group, * P≤0.05, ** P≤0.01; compared with the positive control group, # P≤0.05, ## P≤0.01; compared with diclofenac diethylamine latex, $ P≤0.05; compared with the MYL-A group, △ P≤0.05, △△ P≤0.01; compared with the MYL-B group, ￥ P≤0.05, ￥￥ P≤0.01.

[0486] This experimental study shows that all concentrations of MYL have significant analgesic effects and the efficacy is dose-dependent. Among them, the analgesic latency of medium and high doses of MYL is better than that of the products prepared by comparative examples 1-2, as well as the positive control drugs Mayinglong Musk Hemorrhoid Ointment and Diclofenac Diethylamine Emulsion.

[0487] Experimental Example 9

[0488] In order to illustrate the clinical effects of the traditional Chinese medicine composition of the present invention, a clinical trial was conducted using the ointment prepared in Example 1 of the present invention (hereinafter referred to as MYL) to make a correct, objective and truthful evaluation of the effectiveness and safety of the product in promoting wound healing and relieving anal symptoms such as pain after hemorrhoid surgery.

[0489] 1. Trial method

[0490] The trial population consisted of individuals who met the Western medical diagnostic criteria for mixed hemorrhoids before surgery, with the internal hemorrhoids conforming to Goligher classification III or IV, ≤5 hemorrhoids, and underwent either external stripping and internal ligation or external stripping and internal incision, resulting in ≤5 surgical incisions. The sample size was 60 participants, aged 18–65 years, with no gender restriction. They were randomly divided into a treatment group (n=30) and a control group (n=30). Postoperatively, the treatment group received MYL wound dressing, while the control group received a placebo. Both groups received the same basic treatment.

[0491] Instructions for use and dosage: For external use only. Administer 8g once daily, twice daily (morning and evening), rectally and / or through the anal canal and perianal area.

[0492] 2. Efficacy observation indicators

[0493] (1) Wound healing time: Wound healing is defined as the complete coverage of the wound by epithelial tissue.

[0494] (2) Average time for anal pain to disappear. The anal pain score was calculated using the VAS (0-10 points, where 10 points is unbearable pain and the lower the score, the milder the pain). Anal pain disappearance was defined as an anal pain score of 0 for 24 hours on that day.

[0495] 3. Trial Results

[0496] (1) Wound healing time

[0497] After the trial ended, the average wound healing time in the treatment group was 24.3 days (5 subjects healed in 23 days, 15 subjects in 24 days, 8 subjects in 25 days, and 2 subjects in 27 days), while the average wound healing time in the control group was 29.9 days (2 subjects healed in 25 days, 6 subjects in 28 days, 11 subjects in 30 days, 7 subjects in 31 days, and 4 subjects in 33 days). The treatment group showed significantly better efficacy than the control group.

[0498] (2) Time for anal pain to disappear

[0499] After the trial period, the average time for anal pain to disappear in the treatment group was 10.37 days (20 subjects experienced pain disappearance in 10 days, 9 subjects in 11 days, and 1 subject in 12 days), while the average time for anal pain to disappear in the control group was 14.03 days (1 subject experienced pain disappearance in 12 days, 8 subjects in 13 days, 10 subjects in 14 days, and 11 subjects in 15 days). The treatment group showed significantly better efficacy than the control group.

[0500] (3) Product safety

[0501] Of the trial participants, 60 (100%) reported no adverse symptoms after using the product.

[0502] In summary, the ointment of this invention has a rapid onset of action, effectively promotes the healing of surgical wounds after hemorrhoid surgery, and has a significant analgesic effect, effectively relieving anal pain symptoms in hemorrhoid patients after surgery. It also provides timely relief of patients' pain symptoms and has high clinical efficacy in treating postoperative complications of anal diseases. Furthermore, the ointment of this invention does not cause any local irritation or allergic reactions during trial use, and has high safety for clinical use.

[0503] The present invention has been illustrated through the above embodiments, but the present invention is not limited to the above embodiments, that is, it does not mean that the present invention must rely on the above embodiments to be implemented. Those skilled in the art should understand that any improvements to the present invention, equivalent substitutions of individual raw materials in the product of the present invention, addition of auxiliary components, selection of specific methods, etc., all fall within the protection scope and disclosure scope of the present invention.

Claims

1. A topical traditional Chinese medicine composition for treating anorectal diseases and / or postoperative complications of anorectal diseases, characterized in that, It is made from the following raw materials in parts by weight: 50-200 parts Polygonum cuspidatum, 0.1-5 parts musk, 0.1-5 parts bezoar, 10-80 parts borneol, 50-200 parts pearl, 5-40 parts alum, 1-30 parts borax, 0.1-5 parts pearl, and 0.1-5 parts amber.

2. The topical traditional Chinese medicine composition for treating anorectal diseases and / or postoperative complications of anorectal diseases according to claim 1, characterized in that, The external Chinese medicine composition is made from the following raw materials in parts by weight: 50-150 parts of Polygonum cuspidatum, 0.1-3 parts of musk, 0.1-3 parts of bezoar, 20-70 parts of borneol, 50-150 parts of pearl, 10-30 parts of alum, 5-20 parts of borax, 0.1-3 parts of pearl, and 0.1-3 parts of amber.

3. A topical traditional Chinese medicine composition for treating anorectal diseases and / or postoperative complications of anorectal diseases according to claim 1 or 2, characterized in that, The external Chinese medicine composition is made from the following raw materials in parts by weight: 80-120 parts of Polygonum cuspidatum, 0.1-1 parts of musk, 0.1-1 parts of bezoar, 30-60 parts of borneol, 80-120 parts of pearl, 10-25 parts of alum, 5-15 parts of borax, 0.1-1 parts of pearl, and 0.1-1 parts of amber.

4. The topical traditional Chinese medicine composition for treating anorectal diseases and / or postoperative complications of anorectal diseases according to claim 3, characterized in that, The external Chinese medicine composition is made from the following raw materials in parts by weight: 100 parts Polygonum cuspidatum, 0.5 parts musk, 0.3 parts bezoar, 40 parts borneol, 100 parts pearl, 20 parts alum, 10 parts borax, 0.3 parts pearl, and 0.4 parts amber.

5. A topical traditional Chinese medicine composition for treating anorectal diseases and / or postoperative complications of anorectal diseases according to claim 1 or 2, characterized in that, The external Chinese medicine composition is made from the following raw materials in parts by weight: 150 parts Polygonum cuspidatum, 1.5 parts musk, 0.1 parts bezoar, 20 parts borneol, 70 parts pearl, 25 parts alum, 5 parts borax, 3 parts pearl, and 0.1 parts amber.

6. A topical traditional Chinese medicine composition for treating anorectal diseases and / or postoperative complications of anorectal diseases according to claim 1 or 2, characterized in that, The external Chinese medicine composition is made from the following raw materials in parts by weight: 120 parts Polygonum cuspidatum, 0.3 parts musk, 1 part bezoar, 10 parts borneol, 80 parts pearl, 5 parts alum, 20 parts borax, 1.5 parts pearl, and 0.8 parts amber.

7. A method for preparing the external application traditional Chinese medicine composition according to any one of claims 1 to 6, characterized in that, Includes the following steps: (1) Extract and concentrate the mixture of Callicarpa and Polygonum cuspidatum, then dry and pulverize it to obtain extract powder; or, extract and concentrate Callicarpa and Polygonum cuspidatum separately, then mix them and dry and pulverize them to obtain extract powder; (2) The musk, bezoar, pearl, amber, borax, borneol and alum are pulverized separately and then mixed to obtain the raw powder of Chinese medicine; or, the above raw materials are mixed and pulverized together to obtain the raw powder of Chinese medicine. (3) Mix the extract powder obtained in step (1) and the raw Chinese medicine powder obtained in step (2).

8. The preparation method according to claim 7, characterized in that, In step (1), the extraction process is at least one of the following: water decoction, soaking, percolation, reflux, supercritical fluid extraction, ultrasonic extraction, and enzymatic extraction.

9. The preparation method according to claim 7, characterized in that, In step (1), the concentration is selected from one of atmospheric pressure concentration, vacuum concentration, and reverse osmosis concentration.

10. The preparation method according to claim 7, characterized in that, In step (1), the drying process is selected from one of the following: hot air drying, vacuum drying, spray drying, freeze drying, microwave drying, and infrared drying.

11. The preparation method according to claim 7, characterized in that, In step (1), the pulverizing process is selected from mechanical pulverizing and air jet pulverizing.

12. The preparation method according to claim 7, characterized in that, In step (2), the pulverization is selected from mechanical pulverization and air jet pulverization.

13. The use of the topical Chinese medicine composition according to any one of claims 1 to 6 in the preparation of topical pharmaceutical formulations.

14. The use of the topical Chinese medicine composition according to any one of claims 1 to 6 in the preparation of a medicine for treating / preventing anorectal diseases.

15. The application according to claim 14, characterized in that, The anorectal disease mentioned is at least one of hemorrhoids, anal sinusitis, anal fissure, perianal abscess, perianal eczema, and anal pruritus.

16. The use of the topical Chinese medicine composition according to any one of claims 1 to 6 in the preparation of a medicament for the prevention / treatment of postoperative complications of anorectal diseases.

17. The application according to claim 16, characterized in that, The anorectal disease mentioned is at least one of hemorrhoids, anal sinusitis, anal fissure, perianal abscess, perianal eczema, and anal pruritus.

18. The application according to claim 16, characterized in that, The postoperative procedures include, but are not limited to, various types of hemorrhoidectomy and anal fistula surgery.

19. The application according to claim 16, characterized in that, The complications include, but are not limited to, anal inflammation, swelling, bleeding, pain, or itching.

20. A topical traditional Chinese medicine preparation for the prevention / treatment of anorectal diseases or postoperative complications of anorectal diseases, characterized in that, It is composed of the topical Chinese medicine composition according to any one of claims 1 to 6 and pharmaceutically acceptable excipients.

21. The external application traditional Chinese medicine preparation according to claim 20, characterized in that, The external Chinese medicine preparations are clinically or pharmaceutically acceptable dosage forms, including but not limited to ointments, creams, gels, suppositories, sprays, films, pastes, powders, mists, solutions, lotions, or liniments.

22. The external application traditional Chinese medicine preparation according to claim 20, characterized in that, The excipients include, but are not limited to, drug matrix, emulsifier, antioxidant, preservative, thickener, absorption enhancer, humectant, solvent, pH adjuster or dispersant.

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