Traditional Chinese medicine composition as well as preparation method and application thereof

Abstract

The invention relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition and a preparation method and application thereof. The traditional Chinese medicine composition comprises the following traditional Chinese medicine components in parts by weight: 10-20 parts of wine-processed scutellaria baicalensis, 20-30 parts of radix sophorae flavescentis, 15-20 parts of raw rhubarb, 6-12 parts of angelica sinensis, 8-12 parts of cinnamon, 6-12 parts of elecampane, 15-20 parts of mirabilite, 3-5 parts of wine-processed coptis chinensis and 20-30 parts of golden cypress. According to the traditional Chinese medicine composition prepared by the invention, the red, swollen and pain caused by acute attack of anal diseases are relieved according to the drug compatibility principle of monarch, minister, assistant and guide; and the occurrence of complications such as anal diseases, postoperative pain, edema, anal pendant expansion and the like is obviously reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and in particular to a traditional Chinese medicine composition and a preparation method and application thereof. Background Art

[0002] Acute attacks of anal diseases refer to acute attacks of anal diseases such as inflammatory external hemorrhoids, mixed hemorrhoids, incarcerated internal hemorrhoids, perianal abscesses, anal fistulas, and anal fissures. Anal diseases are common and frequently-occurring diseases unique to humans. As a treatment method for anal diseases, surgery occupies an important position. However, due to the particularity of anal anatomy and the stimulation of normal defecation, patients often experience postoperative complications such as anal edema, anal swelling, and local pain after surgery. If not properly handled, wound healing may be interfered with, hospitalization time may be prolonged, and the patient's pain may be increased. At the same time, anal diseases are often accompanied by severe pain and swelling around the anus during acute attacks, which brings great inconvenience and pain to the patient's life. For the acute attacks of anal diseases and symptoms such as pain and swelling caused by surgery, the treatment methods are mainly internal and external treatments, but oral medications often have side effects and irritation to the digestive tract. External treatments are mainly potassium permanganate fumigation and bathing, ointment application, anal suppositories, and acupuncture, which have the disadvantages of irritation to the anus caused by rectal administration, unsatisfactory effects, heavy discomfort during medication, and limited use. Exploring the treatment of anal swelling and pain caused by various reasons is currently a hot topic in the anorectal field. The main solutions for treating anal swelling and pain caused by anal surgery and acute anal disease include:

[0003] (1) Mayinglong Musk Hemorrhoid Ointment is applied to the patient's surgical wound and perianal skin once a day in the morning and evening for a total of 6 days. It has the effects of clearing away heat and dampness, reducing swelling and relieving pain, removing dead tissue and promoting tissue regeneration, but the therapeutic effect is relatively limited.

[0004] (2) Anal fumigation with potassium permanganate solution. Usage of potassium permanganate: Take 4 tablets of potassium permanganate produced by Jinan Kangfusheng Pharmaceutical Co., Ltd. and dissolve them in 2000 ml of warm water. Mix gently and then perform anal fumigation. It has a local disinfection effect, but has no obvious therapeutic effect on swelling and pain. The concentration of potassium permanganate should not be too high, as it can easily cause a burning sensation in the anus and the anal skin will appear purple.

[0005] It can be seen that the existing Mayinglong Musk Hemorrhoid Cream has limited therapeutic effect in treating anal diseases. Although potassium permanganate solution is helpful in assisting the treatment effect of Mayinglong Musk Hemorrhoid Cream, the auxiliary effect is not good, and it is easy to cause a burning sensation in the anus, and the anal skin will appear purple. Therefore, it is urgent to provide a safe drug that assists in improving the treatment effect of Mayinglong Musk Hemorrhoid Cream. Summary of the invention

[0006] In order to provide a drug for anal diseases with multiple functions such as pain relief, swelling reduction, wound healing promotion, and anal cleaning, the present invention provides a Chinese medicine composition. The Chinese medicine composition prepared by the present invention can relieve the redness, swelling, and pain caused by acute attacks of anal diseases through the drug compatibility principle of monarch, minister, assistant, and envoy; significantly reduce the occurrence of complications such as postoperative pain, edema, and anal swelling of anus, and promote postoperative wound healing.

[0007] The invention provides a traditional Chinese medicine composition, which is composed of the following traditional Chinese medicine components in parts by weight: 10-20 parts of scutellaria baicalensis wine, 20-30 parts of sophora flavescens, 15-20 parts of raw rhubarb, 6-12 parts of angelica sinensis, 8-12 parts of cinnamon bark, 6-12 parts of costusroot, 15-20 parts of sodium sulfate, 3-5 parts of coptis chinensis wine, and 20-30 parts of phellodendron amurense.

[0008] The above-mentioned Chinese medicine composition provided by the present invention, the whole prescription uses Scutellaria baicalensis, Phellodendron chinense and Coptis chinensis as the main medicine, and is used to treat heat-clearing and damp-drying, detoxifying and purging fire, and removes the evil of damp-heat in the three burners, and uses Sophora flavescens as the ministerial medicine to cooperate with the main medicine to clear heat and dry dampness, and can also remove intestinal wind in the body, play the effect of dispelling wind and relieving itching, and prevent and treat the local itching sensation of the anus after surgery, Sophora flavescens is good at clearing damp-heat in the lower burner, and is an important medicine for treating skin diseases, and is used to dry dampness and stop itching; Angelica sinensis and raw rhubarb are used as auxiliary medicines, so that blood stasis is removed and regenerated, and qi and blood are regulated, so the pain disappears; Cinnamon bark is used as an auxiliary medicine, one is to replenish fire and assist yang, and the yang qi of the human body is supported, and the other is to counter-assist the cold nature of heat-clearing and detoxifying drugs; Aucklandia lappa and Glauber's salt are used as the envoys, and bitterness is used to relieve warmness, regulate the whole body qi, and work together to promote qi and relieve pain. The whole prescription is used together to achieve the effects of clearing heat and dampness, reducing swelling and relieving pain, detoxifying and purging fire, and promoting blood circulation and removing blood stasis. It is suitable for the redness, swelling and pain caused by acute attacks of anal diseases, as well as the pain and edema after anorectal surgery, and for promoting wound healing.

[0009] Further, it is composed of the following Chinese medicinal components in parts by weight:

[0010] 15 parts of wine-scented Scutellaria baicalensis, 30 parts of Sophora flavescens, 20 parts of raw rhubarb, 10 parts of Angelica sinensis, 10 parts of cinnamon bark, 10 parts of costusroot, 20 parts of sodium sulfate, 5 parts of wine-scented Coptis chinensis, and 30 parts of Phellodendron chinense.

[0011] The invention also provides a medicine, which uses the traditional Chinese medicine composition as the only effective ingredient.

[0012] Furthermore, the medicine is a fumigation solution, powder, paste, granules, tincture or spray.

[0013] The present invention also provides a method for preparing the drug, comprising the following steps:

[0014] Weigh the Chinese medicinal components according to weight: wine-skinned scutellaria, sophora flavescens, raw rhubarb, angelica sinensis, cinnamon bark, costusroot, sodium sulfate, wine-skinned coptis root and phellodendron chinense;

[0015] Add the weighed Chinese medicine components into clean water and soak for 30min to 40min;

[0016] The dosage ratio of the traditional Chinese medicine components and clean water is 150g-200g:2500ml-3000ml.

[0017] After soaking, boil over high heat until boiling, then simmer over low heat for 30 to 40 minutes to obtain the medicinal solution.

[0018] Boil the liquid to 500ml-600ml, remove the dregs, filter out and obtain the fumigation solution.

[0019] The present invention also provides the use of the Chinese medicine composition in preparing a medicine for treating or preventing anal diseases. The Chinese medicine composition is made into a fumigation liquid for fumigating the affected area. Before fumigating the anus and the perianal area, the fumigation liquid is diluted 5 times and heated to 37°C to 42°C.

[0020] Furthermore, the fumigation liquid preparation process comprises the following steps:

[0021] Weigh the Chinese medicinal components according to weight: wine-skinned scutellaria, sophora flavescens, raw rhubarb, angelica sinensis, cinnamon bark, costusroot, sodium sulfate, wine-skinned coptis root and phellodendron chinense;

[0022] Add the weighed Chinese medicine components into clean water and soak for 30min to 40min;

[0023] The dosage ratio of the Chinese medicine component and clean water is 150g-200g:2500ml-3000ml;

[0024] After soaking, boil over high heat until boiling, then simmer over low heat for 30 to 40 minutes to obtain the medicinal solution.

[0025] Boil the liquid to 500ml-600ml, remove the dregs, filter out and obtain the fumigation solution.

[0026] Furthermore, the anal disease is inflammatory external hemorrhoids, mixed hemorrhoids, incarcerated internal hemorrhoids, perianal abscess, anal fistula or anal fissure.

[0027] Furthermore, the Chinese medicine composition is used to prepare a medicine for relieving acute anal pain and edema.

[0028] Furthermore, the Chinese medicine composition is used to prepare a medicine for reducing swelling, relieving pain and promoting wound healing after anal disease surgery.

[0029] Compared with the prior art, the present invention has the following beneficial effects:

[0030] 1. The present invention utilizes pure natural Chinese medicine to prepare Chinese medicine fumigation and washing agent to treat the acute attack of various anal diseases and anal edema and pain caused by postoperative operation. It is safe to use, has no obvious adverse reactions and has significant curative effect. Through the fumigation and washing of the Chinese medicine fumigation and washing agent, it can effectively promote the dilation of local subcutaneous blood vessels in the affected part, promote blood and lymphatic circulation, improve metabolism, thereby achieving the therapeutic effect of edema disappearance, pain relief, and inflammation absorption. The Chinese medicine fumigation and washing agent prepared by the present invention significantly reduces the time of complications such as acute attack period of anal diseases and postoperative pain, edema, promotes wound healing, has significant clinical efficacy, has no toxic and side effects, and takes into account the dual purpose of treatment and cleaning.

[0031] 2. The present invention provides a Chinese medicinal fumigation and washing agent for treating swelling and pain caused by postoperative and acute attacks of anorectal diseases. The Chinese medicinal fumigation and washing agent is prepared according to the theory of traditional Chinese medicine by screening Chinese medicinal formulas and scientifically and reasonably proportioning. The Chinese medicinal components are prepared into a fumigation and washing liquid for clinical treatment of postoperative complications of anorectal diseases. The fumigation and washing liquid can relieve the redness, swelling and pain caused by acute attacks of anal diseases, significantly reduce the occurrence of complications such as postoperative pain, edema, and anal swelling after anal diseases, and promote wound healing. The clinical efficacy is significant, the side effects are non-toxic, and the fumigation and washing liquid is safe and effective. The Chinese medicinal fumigation and washing liquid prepared by the present invention is particularly suitable for redness, swelling and pain caused by acute attacks of anal diseases, as well as pain and edema after anorectal diseases, and promotes wound healing, and is worthy of clinical promotion.

[0032] 3. According to the historical records of traditional Chinese medicine, the pharmacological activities of the raw material components in the traditional Chinese medicine composition provided by the present invention are as follows:

[0033] Scutellaria baicalensis: clears away heat and dampness, purges fire and detoxifies, and stabilizes pregnancy. Indications: (1) It is used for fever due to dampness and heat, chest tightness, thirst without desire to drink, as well as dampness and heat diarrhea, jaundice, etc. (2) It is used for fever, high fever, thirst, or cough due to lung heat, or vomiting blood, nosebleed, bloody stool, metrorrhagia, etc. due to excessive heat and blood overflow, as well as heat-toxic sores, etc.

[0034] Sophora flavescens: clears away heat and dampness, dispels wind and kills insects, relieves itching, and is a diuretic. Indications: (1) Used for damp-heat diarrhea, jaundice, leucorrhea, genital itching, etc. (2) Used for general itching, scabies, stubborn ringworm, leprosy, etc.

[0035] Rhubarb: It can attack stagnation and relieve stagnation, clear away heat and purge fire, cool blood and detoxify, promote blood stasis and menstruation, and relieve dampness and jaundice. Indications: (1) It is used for dry and hard stools, stagnation and diarrhea, as well as heat-induced constipation and high fever with yellow tongue coating. (2) It is used for excessive heat, forced blood overflow, red and painful eyes, and heat-induced sores and boils. (3) It is used for abdominal pain caused by postpartum stasis, blood stasis, menstrual disorders, injuries, and pain caused by stasis. (4) In addition to being taken internally, rhubarb can also be applied externally to treat heat-induced carbuncle, burns caused by water or fire, also for its effect of purging fire and detoxifying.

[0036] Angelica sinensis: replenishes blood and regulates menstruation, promotes blood circulation and relieves pain. Indications: (1) Used for irregular menstruation, dysmenorrhea, amenorrhea, metrorrhagia, and blood deficiency and physical weakness. (2) Used for pain caused by bruises, pain caused by blood stasis due to carbuncle, abdominal pain caused by blood stasis after childbirth, rheumatic pain, and meridian dysfunction. (3) Moisturizes the intestines and promotes bowel movements. It can be used for constipation caused by blood deficiency and dry intestines.

[0037] Cinnamon bark: warms the middle and replenishes Yang, dispels cold and relieves pain. Indications: (1) Used for kidney yang deficiency, chills and cold limbs, spleen yang deficiency, cold pain in the abdomen, loss of appetite and loose stools. (2) Used for kidney yang deficiency, chills and cold limbs, spleen yang deficiency, cold pain in the abdomen, loss of appetite and loose stools. (3) Used for cold pain in the abdomen, cold arthralgia and low back pain, abdominal pain during menstruation.

[0038] Muxiang: It can promote qi circulation, relieve pain, warm the middle and harmonize the stomach. It is used to treat qi stagnation caused by cold in the middle, chest and abdominal distension and pain, vomiting, diarrhea, tenesmus, and cold hernia.

[0039] Glauber's Salt: Clears away heat and relieves constipation. Used for heat stagnation and constipation. External use can clear away heat and reduce swelling. For skin sores, or red heat, itching and pain from herpes, this product can be dissolved in cold boiled water and applied.

[0040] Coptis chinensis: clears away heat and dampness, purges fire and detoxifies. (1) It is used for internal damp-heat, chest heat and fullness, yellow and greasy tongue coating, jaundice, as well as damp-heat retention in the stomach and intestines, vomiting, diarrhea, hemorrhoids, etc. (2) It is used for high fever, thirst, irritability, even coma and delirium, hyperactivity of heart fire, insomnia, restlessness, blood heat, vomiting blood, nosebleeds, and heat-toxic sores. In addition, Coptis chinensis can also be used for Zhongxiao syndrome with blazing stomach fire.

[0041] Huangbai: Clears away heat and dampness, purges fire and detoxifies, and clears heat from the deficiency. (1) It is used for damp-heat diarrhea, damp-heat jaundice, and dribbling and painful urination, red and white vaginal discharge, swelling and pain in the genitals, swelling and pain in the feet and knees, and weakness. (2) It is used for heat-toxic sores, eczema, etc. (3) It is used for fever due to yin deficiency, or nocturnal emission and spermatorrhea.

[0042] The drug compatibility principles of the Chinese medicine composition provided by the present invention are as follows:

[0043] The whole prescription uses Scutellaria baicalensis, Phellodendron chinense and Coptis chinensis as the main medicines, which can clear away heat and dampness, detoxify and purge fire, and remove the evil of dampness and heat in the three burners. Sophora flavescens is the assistant medicine to cooperate with the main medicine to clear away heat and dampness, and can also remove intestinal wind in the body, play the effect of dispelling wind and relieving itching, and prevent and treat local itching of the anus after surgery. Sophora flavescens is good at clearing dampness and heat in the lower burner, and is an important medicine for treating skin diseases, which can dry dampness and stop itching; Angelica sinensis and raw rhubarb are auxiliary medicines, which can remove blood stasis and regenerate new life, and regulate qi and blood, so the pain will disappear; cinnamon bark is used as a counter-assistant, which can replenish fire and support yang, and support the yang energy of the human body, and secondly, it can counter-assist the cold nature of heat-clearing and detoxifying drugs; costus root and mirabilite are used as messengers, which are bitter, warm and unblocked, regulate the whole body's qi, and work together to promote qi and relieve pain. The combination of all the medicines in the whole prescription can achieve the effects of clearing heat and dampness, reducing swelling and relieving pain, detoxifying and purging fire, and promoting blood circulation and removing blood stasis.

[0044] Fumigation and washing refers to fumigating the affected area with the steaming medicinal vapor, and then washing the affected area with the medicinal soup while it is still hot, relying on the medicinal power and heat to directly act on the anorectal lesions, so that the pores in the area are unblocked and the qi and blood flow smoothly, thereby achieving the effects of clearing away heat and dampness, activating blood circulation and reducing swelling, relieving pain and stopping bleeding, and astringing and relieving itching. Modern clinical medical observations and studies have found that Chinese medicine fumigation and washing can promote the expansion of local subcutaneous blood vessels in the affected area, promote blood and lymphatic circulation, and improve metabolism, thereby achieving the therapeutic effects of eliminating edema, relieving pain, and absorbing inflammation. DETAILED DESCRIPTION

[0045] The specific embodiments of the present invention are described in detail below, but it should be understood that the protection scope of the present invention is not limited by the specific embodiments. Based on the embodiments in the present invention, all other embodiments obtained by ordinary technicians in this field without creative work belong to the scope of protection of the present invention. The experimental methods described in the embodiments of the present invention are conventional methods unless otherwise specified, and the materials, reagents, etc. used in the following embodiments can be obtained from commercial channels unless otherwise specified.

[0046] Embodiment 1: A Chinese medicine fumigation and washing solution and preparation method thereof.

[0047] S1. Weigh 15g of wine-soaked Scutellariae Radix, 30g of Sophora flavescens, 20g of raw rhubarb, 10g of Angelica sinensis, 10g of cinnamon bark, 10g of costusroot, 20g of sodium sulfate, 5g of wine-soaked Coptis chinensis, and 30g of Phellodendron amurense, and set aside;

[0048] S2, adding the Chinese medicinal materials of step S1 into 2500 ml of clean water and soaking for 30 minutes;

[0049] S3, boiling the Chinese medicinal materials soaked in step S2, boiling over high heat and then simmering over low heat for 30 minutes to obtain a medicinal solution;

[0050] S4, removing the dregs from the medicinal solution obtained in step S3, filtering it out, and bottling it to obtain the Chinese medicinal fumigation and washing solution.

[0051] Application Example 1: The Chinese medicinal fumigation solution prepared in Example 1 is used to prevent and treat ear swelling in mice.

[0052] Twenty-four male Kunming mice weighing 18 g to 20 g were purchased from the Experimental Animal Center of Southwest Medical University and randomly divided into three groups, namely, blank control group, Chinese medicine group and diclofenac sodium group, with 8 mice in each group. The specific experimental treatment process of each group is as follows:

[0053] Blank control group: 50 μL of normal saline was applied to the right ear of mice.

[0054] Chinese medicine group: 50 μL of Chinese medicine fumigation solution was applied to the right ear of the mice.

[0055] Diclofenac sodium group: 50 μL of 1% diclofenac sodium solution was applied to the right ear of the mice.

[0056] The 1% by mass diclofenac sodium solution is obtained by mixing diclofenac sodium sustained-release tablets with physiological saline to form a 1% by mass diclofenac sodium solution.

[0057] The specific operation of applying the right ear of mice is: evenly apply the left and right sides of the right ear twice a day, with an interval of 30 minutes between application and administration, and apply and administer for 6 days continuously. 30 minutes after the last administration, 100 μL of xylene was applied to both sides of the right auricle of the mice in the blank control group, diclofenac sodium group and traditional Chinese medicine group, and the left ear was not applied as a control. After 1 hour, the mice were killed by dislocation of the neck, and the discs of the same part of the left and right ears were removed with an 8mm puncher and weighed on an analytical balance. The weight of the right ear minus the weight of the left ear is the swelling degree.

[0058] Swelling inhibition rate = (1-average swelling degree of the drug-treated group / average swelling degree of the blank control group) × 100%;

[0059] Among them, the average swelling degree of the drug-treated group represents the average swelling degree of the right ear of the blank control group, diclofenac sodium group or traditional Chinese medicine group; the average swelling degree of the normal control group represents the average swelling degree of the left ear of the blank control group, diclofenac sodium group or traditional Chinese medicine group.

[0060] Table 1 Effects of Chinese herbal fumigation on xylene-induced ear swelling in mice ( n=8)

[0061] Group Number of mice / n Swelling degree / mg Swelling inhibition rate / % Blank control group 8 11.65±0.98 - Diclofenac sodium group 8 6.60±4.58* 43.35 Chinese Medicine Group 8 6.01±2.65* 48.39

[0062] Note: P value refers to the probability of a more extreme result than the sample observation result when the original hypothesis is true; compared with the blank control group, * means P < 0.05, indicating statistical significance. "-" means no, The swelling degree is shown as mean ± SD.

[0063] The experimental results are shown in Table 1. The swelling degree of mice in the Chinese medicine group and the diclofenac sodium group was significantly lower than that in the blank control group, and the swelling inhibition rate of the Chinese medicine group was basically equivalent to that of the diclofenac sodium group, indicating that the Chinese medicine fumigation and washing solution prepared by the present invention has a significant detumescent effect, and the effect is equivalent to that of diclofenac sodium.

[0064] Application Example 2: The Chinese medicinal fumigation solution prepared in Example 1 is used to prevent and treat rat foot swelling.

[0065] Twenty-four male rats weighing 180g to 220g were selected and randomly divided into three groups according to their weight, with 8 rats in each group. They were divided into a blank control group, a diclofenac sodium group, and a Chinese medicine group. Before the experiment, the volume of the left toes of the rats in each group before inflammation was measured and recorded. The specific experimental treatment process of each group is as follows:

[0066] Before the experiment, a homemade foot volume meter was used to measure the volume of the right hind paw of each group of rats before inflammation, and then 0.1 ml of carrageenan was injected into the plantar part of the right hind paw of each rat. The specific experimental treatment process of each group is as follows:

[0067] Then, each group was given 2 ml of topical medication, with the same concentration as the auricle swelling test. Cotton balls were used to dip the drug and applied to the toes of the right hind feet of the rats. The right hind feet were wrapped and fixed with a dressing. The medication operation was repeated after measurement every 1 hour. The swelling degree of the toes of the rats and the swelling inhibition rate were recorded 1, 2, 3, and 4 hours after the injection of carrageenan. Swelling degree (ml) = volume of the plantar after inflammation - volume of the plantar before inflammation; swelling inhibition rate (%) = [(swelling degree of the blank control group - swelling degree of the drug group) / swelling degree of the blank control group] × 100%. The results are shown in Table 2.

[0068] Table 2 Determination of foot swelling and swelling inhibition rate of rats in each group ( n=8)

[0069]

[0070] Note: P value refers to the probability of a more extreme result than the sample observation result when the original hypothesis is true; compared with the blank control group, * means P < 0.05, indicating statistical significance; ** means P < 0.01, indicating a significant statistical difference; *** means P < 0.001, indicating an extremely significant statistical difference; "-" means no difference; n = 8 means the number of mice in each group is 8, The swelling degree or swelling inhibition rate is shown as the mean ± standard deviation.

[0071] The experimental results are shown in Table 2. The swelling degree of the mouse feet in the Chinese medicine group and the diclofenac sodium group was significantly lower than that in the blank control group, and the swelling degree in the Chinese medicine group was equivalent to that in the diclofenac sodium group, indicating that the Chinese medicine fumigation and washing solution prepared by the present invention has an anti-edema effect after external application to rats, and the therapeutic effect is equivalent to that of diclofenac sodium.

[0072] Application Example 3: The analgesic effect of the traditional Chinese medicine fumigation solution prepared in Example 1 on mice.

[0073] Hot plate method: 24 male Kunming mice and 24 female mice weighing 18g-20g were purchased from the Experimental Animal Center of Southwest Medical University. Before the experiment, 24 qualified animals with a reaction latency of 5s-30s were screened and randomly divided into 3 groups, 8 in each group, including blank control group, Chinese medicine group and diclofenac sodium group.

[0074] The specific treatments were as follows: blank control group: 400 μL of normal saline was evenly applied to the soles of the four limbs and feet of the mice. Chinese medicine group: 400 μL of Chinese medicine fumigation and washing solution was evenly applied to the soles of the four limbs and feet of the mice. Diclofenac sodium group: 400 μL of 1% diclofenac sodium solution was evenly applied to the soles of the four limbs and feet of the mice.

[0075] During the application process, a cotton ball was used to dip the drug and apply it to the soles of the feet of the mice. The two hind feet were wrapped and fixed with sterile dressings. The mice were placed on a hot plate analgesia instrument preheated to 55°C 30min, 60min, and 120min after the drug was administered. The time from the time the mouse was placed in the hot plate analgesia instrument to the time when the licking reaction of the hind feet appeared was taken as the pain threshold index, recorded as the incubation period. If the incubation period exceeded 60 seconds, it was counted as 60 seconds. The experimental results are shown in Table 3.

[0076] Table 3 Effects of different treatments on the pain induced by hot plate in mice ( n=8)

[0077] Group Before administration(s) 30 minutes(s) 60 minutes(s) 120 minutes(s) Blank control group 13.21±4.79 13.58±2.27 13.34±3.71 12.54±3.58 Diclofenac sodium group 13.44±2.84 23.69±3.90* 26.11±7.75* 25.45±9.32* Chinese Medicine Group 13.84±3.77 22.82±5.51* 24.96±7.32* 24.64±9.06*

[0078] Note: P value refers to the probability of a more extreme result than the sample observation result when the null hypothesis is true; compared with the blank control group, * indicates P < 0.05, indicating statistical significance; n = 8 means that the number of mice in each group is 8, The time parameters in the table are shown as mean ± standard deviation.

[0079] The experimental results are shown in Table 3. The latent period of the Chinese medicine group and the diclofenac sodium group was significantly higher than that of the blank control group, indicating that the Chinese medicine fumigation and washing solution prepared by the present invention has a good analgesic effect on mice.

[0080] Acetic acid writhing method: 24 male Kunming mice were selected and randomly divided into 3 groups, namely blank control group, Chinese medicine group and diclofenac sodium group, with 8 mice in each group. The specific treatments are as follows:

[0081] Blank control group: intragastrically administered with 200 μL of distilled water;

[0082] Chinese medicine group: 200 μL of Chinese medicine fumigation and washing solution was gavaged intragastrically;

[0083] Diclofenac sodium group: 200 μL of 1% diclofenac sodium solution was intragastrically administered.

[0084] Each group was given the drug once a day for 6 consecutive days according to the above settings. 30 minutes after the last administration, 200 μL of 0.07% acetic acid solution was injected into the abdomen of each group of mice. The number and time of the writhing reaction within 15 minutes after the injection of acetic acid solution were observed and recorded, and the writhing inhibition rate of mice was calculated. The writhing reaction was manifested as: abdominal contraction and depression, extension of hind limbs, elevation of buttocks, and crawling. The results are shown in Table 4.

[0085] The calculation formula of the writhing inhibition rate is: writhing inhibition rate = (1-the number of writhing times in the drug-treated group / the number of writhing times in the blank control group) × 100%;

[0086] The number of writhing times in the drug-treated group refers to the number of writhing times in the mice in the diclofenac sodium group or the traditional Chinese medicine group; the number of writhing times in the blank control group refers to the number of writhing times in the mice in the blank control group gavaged with 200 μL of distilled water.

[0087] Table 4 Effects of Chinese herbal fumigation on acetic acid writhing reaction in mice ( n=8)

[0088] Group Number of mice / n Twist reaction times Torsion inhibition rate / % Blank control group 8 35.25±8.72 - Diclofenac sodium group 8 23.38±5.37** 27.5 Chinese Medicine Group 8 24.63±4.44* 30.1

[0089] Note: P value refers to the probability of a more extreme result than the sample observation result when the original hypothesis is true; compared with the blank control group, * means P < 0.05, indicating statistical significance; ** means P < 0.01, indicating significant statistical difference; "-" means no difference. n = 8 means the number of mice in each group is 8, The mean ± standard deviation of the writhing reaction number

[0090] The experimental results are shown in Table 4. The number of twisting reactions in the Chinese medicine group and the diclofenac sodium group was significantly lower than that in the blank control group. The number of twisting reactions in the Chinese medicine group was equivalent to that in the diclofenac sodium group. This indicates that the Chinese medicine fumigation and washing solution prepared by the present invention has a significant analgesic effect.

[0091] Application Example 4: Effect of the Chinese medicine fumigation solution prepared in Example 1 on postoperative pain in rats.

[0092] Thirty-two healthy clean-grade SD male rats were randomly divided into 4 groups, 8 rats in each group, namely, blank group, model group, diclofenac sodium group, and swelling and pain fumigation and washing solution group.

[0093] The rats in the blank group were raised normally. Two hours after the drug intervention of the plantar incision of the rats, the rats in the other groups were placed on the test platform for 20 minutes of adaptation. According to the literature method, a set of Von-frey filaments were used to vertically stimulate the center of the right hind foot of the rat from the bottom of the platform. When the filaments touched or left the sole of the foot, the rats lifted their feet, licked their feet, etc., which was considered a positive reaction, and the corresponding value on the filament handle was recorded at this time. Each rat in each group was measured once every 5 minutes, and the average value was taken for a total of 3 measurements. This is the mechanical stimulation foot withdrawal reaction threshold of the rat, expressed as PWMT. The measurement time of the pain behavior test was set at 1 day before modeling, 2 hours after surgery, 8 hours after surgery, 1 day after surgery, 2 days after surgery, and 4 days after surgery. The journal information of the above pain behavior test is "Brennan TJ. A rat model of postoperative pain. Curr Protoc Pharmacol. 2004 May 1; Chapter 5: Unit 5.34.". Comparison of pain behavior test results of rats in each group: In this experiment, the basic pain threshold of rats in each group was tested 1 day before surgery. The results showed that there was no significant difference in the basic pain threshold of rats in each group. The mechanical withdrawal threshold of rats in each group decreased significantly 2 hours after surgery and did not return to the preoperative level until 4 days after surgery, indicating that the postoperative incision pain model of rats was successfully established. All experimental rats showed mechanical hyperalgesia after surgery. The results are shown in Table 5.

[0094] Table 5 Mechanical pain thresholds of rats in each group at different time points ( n=8)

[0095]

[0096] Note: F value is a statistic used to compare whether the difference between two or more sample variances is significant. P value refers to the probability of a more extreme result than the obtained sample observation result when the null hypothesis is true. a: compared with the model group, P < 0.05; b: compared with the swelling and pain fumigation and washing solution group, P < 0.05; P> 0.05, indicating no statistical difference; P < 0.05, indicating statistical significance; P < 0.001, indicating a very significant statistical difference.

[0097] The test results are shown in Table 5. At each time point from 2h to 4d after surgery, the PMWT of the four groups of rats were significantly lower than the basal pain threshold 1d before surgery; compared with the other two groups, the PWMT of the model group decreased more significantly at each time point after surgery; there was no statistical difference in PWMT between 2h and 2d after surgery in the Chinese medicine group; 4d after surgery, the PMWT of the Chinese medicine group was higher than that of the diclofenac sodium group. The above pain behavior test results show that both Chinese medicine fumigation and diclofenac sodium can reduce the postoperative mechanical pain response of rats, but have poor effects on acute postoperative pain 2h after surgery, among which the Chinese medicine fumigation and washing solution has better analgesic effect 4d after surgery.

[0098] Application Example 5: The Chinese medicinal fumigation and washing solution prepared in Example 1 can relieve the symptoms of acute hemorrhoids combined with pain and edema.

[0099] 1. Inclusion criteria

[0100] A total of 60 patients with acute hemorrhoids complicated with pain and edema who chose conservative treatment were included and randomly divided into a control group and a treatment group with 30 cases in each group. Hemorrhoids include mixed hemorrhoids and external hemorrhoids.

[0101] 1. Inclusion criteria:

[0102] 1) Patients with acute hemorrhoids complicated by pain and edema; 2) Patients who choose conservative treatment and refuse surgical treatment; 3) Healthy adults aged 18 to 65 years old; 4) Patients who cooperate with the doctor's diagnosis and treatment plan; 5) Patients who are willing to be included in the study after being informed of the relevant situation and signing the informed consent form.

[0103] 2. Exclusion criteria: 1) Patients with rectal mucosal prolapse, annular mixed hemorrhoids, and stage IV internal hemorrhoids; 2) Patients with combined rectal tumors, rectal polyps, perianal abscesses, anal fistulas, anal fissures and other diseases; 3) Patients with combined inflammatory bowel diseases such as ulcerative colitis, Crohn's disease, intestinal tuberculosis, and irritable bowel syndrome; 4) Patients with serious underlying diseases in the heart, lungs, liver, and kidneys who cannot tolerate surgery; 5) Patients with mental illness and anorectal somatization disorders; 6) Patients with coagulation disorders; 7) Women in lactation, pregnancy and menstruation; 8) Patients with allergic constitution or scar constitution; 9) Patients who are undergoing other clinical research projects.

[0104] 3. Exit Indicators

[0105] 1) Patients with poor compliance and unable to persist in treatment and provide timely feedback;

[0106] 2) Incomplete data or loss of follow-up, affecting the judgment of efficacy or safety;

[0107] 3) Those who cannot continue treatment due to serious adverse reactions, serious complications, or even other special circumstances that are life-threatening.

[0108] From the first day of the attack, the treatment group used Mayinglong Musk Hemorrhoid Cream 10g / tube, 2.5g / time, twice a day, and used Chinese herbal fumigation solution for anal fumigation treatment, 20min / time, once a day, for 7 consecutive days.

[0109] The basic prescription and usage of Chinese herbal fumigation solution are:

[0110] The Chinese medicine fumigation and washing solution prepared in Example 1 was added with 2500 mL of water, and decocted to 1500 mL before anal fumigation and washing treatment. 20 min / time, once / day, for 7 consecutive days.

[0111] The control group was treated with Mayinglong Musk Hemorrhoid Cream (10 g / tube), 2.5 g / time, 2 times / day, and anal fumigation with 0.02% potassium permanganate solution.

[0112] Usage of potassium permanganate: Take 4 tablets of potassium permanganate produced by Jinan Kangfusheng Pharmaceutical Co., Ltd., dissolve in 2000mL of warm boiled water, mix gently and then perform anal fumigation treatment, 20 minutes / time, once / day, for 7 consecutive days.

[0113] Potassium permanganate specifications: 0.1g / tablet; Approval number: National Medicine Approval H37022233.

[0114] 2. Observation indicators:

[0115] Two trained professionals in the department evaluated anal pain, edema, and adverse reactions, and assessed the reduction of anal pain and edema in the patients before fumigation treatment and on the 1st, 4th, and 7th days after treatment based on the 2002 edition of the "Guidelines for Clinical Research of New Chinese Medicines", and filled out the clinical questionnaire truthfully.

[0116] Efficacy indicators:

[0117] According to the 2002 edition of the "Guidelines for Clinical Research of New Chinese Medicines", the complications such as anal pain and edema of the enrolled patients were evaluated before treatment and on the first, fourth and seventh days after treatment. The details are as follows:

[0118] 1. Edema

[0119] No edema or mild edema but no impact on activity was scored as 0 points;

[0120] If there is one edema tissue with a diameter of no more than 10 mm and the activity is affected, it is scored as 2 points;

[0121] If there is one or more edema tissues with a diameter of 10 to 20 mm and the activity is affected, it is scored as 4 points;

[0122] If there is one or more edematous tissues with a diameter exceeding 20 mm and the activity is affected, it will be scored as 6 points.

[0123] 2. Anal pain

[0124] No pain was scored as 0 points;

[0125] Those who occasionally had pain during defecation were scored as 2 points;

[0126] Intermittent pain, but still tolerable, was scored as 4 points;

[0127] If the pain was persistent and required analgesic treatment, it was scored as 6 points.

[0128] Therapeutic effect index calculation formula:

[0129] [(score before treatment - score after treatment) / score before treatment] × 100%.

[0130] 3. Cured: After 7 days of treatment, the symptoms and signs basically disappear, there is no pain or slight pain in the anus, and there is no obvious edema at the anus. The efficacy index is ≥95%;

[0131] 4. Significant effect: After 7 days of treatment, symptoms and signs are significantly improved, anal pain is mild, anal opening may have mild edema, and efficacy index is ≥70%;

[0132] 5. Effective: After 7 days of treatment, the symptoms and signs are significantly improved, with mild to moderate anal pain, mild to moderate edema at the anus, and a small amount of exudate on the wound surface. The efficacy index is ≥30%.

[0133] 6. Ineffective: No significant improvement in symptoms and signs after 1 day of treatment, anal pain and edema remain the same, anal exudate does not improve significantly, and the efficacy index is <30%;

[0134] 7. Safety indicators: During the fumigation treatment, the patient's adverse reactions, such as allergies, dizziness, headache, nausea, vomiting, palpitations, fatigue, profuse sweating, etc., were closely observed. After symptomatic treatment, detailed records were made and the cases were excluded and withdrawn from this study.

[0135] 8. Statistical analysis:

[0136] SPSS 20.0 software package was used for statistical analysis of the collected data. The count data were expressed as percentages, and the chi-square test was used for comparison between the two groups.

[0137] The measurement data were expressed as "mean ± standard deviation", the t-test was used for inter-group comparison, and the paired t-test was used for intra-group comparison before and after treatment; when P < 0.05, it indicated statistical difference.

[0138] 3. Experimental Results

[0139] 1. Baseline data

[0140] The baseline data of the patients included in this embodiment are shown in Table 6, and the initial information of the treatment group and the control group was statistically recorded.

[0141] Table 6 Comparison of baseline data of two groups of patients

[0142] index Treatment Group Control group <![CDATA[x 2 Value]]> P-value gender 0.601 0.438 male 17 14 female 13 16 Age (years) 2.424 0.489 ＜30 2 4 31-40 21 23 41-50 4 2 51-65 3 1 Internal hemorrhoids staging 2.222 0.329 Phase I 10 8 Phase II 15 12 Stage III 5 10 External hemorrhoids classification 0.718 0.869 Thrombotic 7 9 Inflammatory 17 15 Connective tissue 3 4 Varicose veins 3 2

[0143] Note: The P-value refers to the probability of a result more extreme than the obtained sample observation result when the null hypothesis is true; x 2 The value is the chi-square value, a statistic used to determine whether there is a significant difference between the observed value and the theoretical value.

[0144] Baseline data: The baseline data such as gender, age, internal hemorrhoid stage, and external hemorrhoid classification of the two groups of patients before treatment were similar, and the differences were not statistically significant.

[0145] 2. Comparison of edema scores of two groups of patients after treatment

[0146] Table 7 Edema scores and comparison of two groups of patients after treatment ( points)

[0147] Group Number of cases Before fumigation treatment 4 days after fumigation treatment 7 days after fumigation treatment Treatment Group 30 2.77±0.63 1.03±0.61 0.50±0.57 Control group 30 2.70±0.79 1.67±0.66 1.06±0.69 t-value - 0.361 -3.843 -3.458 P-value - 0.719 <0.001 0.001

[0148] Note: The t-value reflects the degree of difference between the sample mean and the population mean, and the P-value is used to judge whether this difference is significant through statistical testing of the t-value; P < 0.01 indicates a significant statistical difference, and p < 0.001 indicates a highly significant statistical difference; represents the mean ± standard deviation of the scores; "-" indicates none.

[0149] The results are shown in Table 7. The edema scores of the two groups of patients before and after fumigation and washing treatment were similar, and the differences were not statistically significant: t = 0.361, P > 0.05; the edema of both groups of patients improved after fumigation and washing treatment, and the edema scores of the treatment group on the 4th and 7th days after fumigation and washing treatment were less than those of the control group, and the differences were statistically significant.

[0150] 3. Comparison of pain evaluation scores of two groups of patients after treatment

[0151] Table 8 Pain scores and comparison of two groups of patients after treatment ( points)

[0152] Group Number of cases Before fumigation treatment 4 days after fumigation treatment 7 days after fumigation treatment Treatment Group 30 5.20±0.89 2.23±0.68 0.80±1.16 Control group 30 4.97±0.85 2.67±0.55 1.50±1.14 t-value - 1.040 -2.723 -2.364 P-value - 0.303 0.009 0.021

[0153] Note: The t-value reflects the degree of difference between the sample mean and the population mean, and the P-value is used to judge whether this difference is significant through statistical testing of the t-value; 0.01 < P < 0.05 indicates a significant difference; represents the mean ± standard deviation of the scores. "-" indicates none.

[0154] The results are shown in Table 8. The pain scores of the two groups of patients were similar before and after fumigation treatment, and the difference was not statistically significant: t=1.040, P>0.05. The swelling and heaviness of the two groups of patients were improved after fumigation treatment. The pain scores of the treatment group were lower than those of the control group on the 4th and 7th days after fumigation treatment, and the difference was statistically significant.

[0155] 4. Observation results of therapeutic efficacy of the two groups of patients after treatment

[0156] Table 9 Comparison of treatment effects between the two groups of patients

[0157] Group Number of cases get well Significant effect efficient invalid Recovery rate Total Effectiveness Z value P-value Observation Group 30 9 18 1 2 30％ 93.3％ -2.789 0.005 Control group 30 3 15 7 5 10％ 83.3％ - -

[0158] Note: Z value is the standard score, which is the difference between a number and the mean divided by the standard deviation; P value refers to the probability of a more extreme result than the sample observation result when the null hypothesis is true; "-" means none.

[0159] The results of clinical efficacy observation are shown in Table 9. The comparison of the effects before and after treatment between the two groups of patients showed that the difference was statistically significant. The results of clinical efficacy observation showed that the Chinese medicine fumigation and washing solution prepared by the present invention has a definite therapeutic effect on anal swelling and pain caused by acute anal diseases, and has the advantages of good therapeutic effect, safe clinical application, and no toxic side effects.

[0160] Application Example 6: Effects of the Chinese medicinal fumigation and washing solution prepared in Example 1 on patients undergoing mixed hemorrhoid surgery.

[0161] 1. Experimental Methods

[0162] A total of 76 patients with mixed hemorrhoids who were scheduled for surgery were included and randomly divided into a control group and a treatment group with 38 cases in each group.

[0163] 1. Inclusion criteria

[0164] 1) Meet the above diagnostic criteria for mixed hemorrhoids of stage II to III internal hemorrhoids;

[0165] 2) Healthy adults aged 18 to 65 years;

[0166] 3) Those who cooperate with the physician’s diagnosis and treatment plan;

[0167] 4) Willing to undergo mixed hemorrhoid surgery and sign the informed consent form to be included in the study.

[0168] 2. Exclusion criteria

[0169] 1) Rectal mucosal prolapse, annular mixed hemorrhoids, and internal hemorrhoids stage IV;

[0170] 2) Patients with combined rectal tumors, rectal polyps, perianal abscesses, anal fistulas, anal fissures, etc.;

[0171] 3) Patients with inflammatory bowel diseases such as ulcerative colitis, Crohn's disease, intestinal tuberculosis, and irritable bowel syndrome;

[0172] 4) Patients with serious underlying diseases in the heart, lung, liver, kidney, etc. who cannot tolerate surgery;

[0173] 5) Patients with mental illness or anorectal somatization disorder;

[0174] 6) Patients with coagulation disorders;

[0175] 7) Women during lactation, pregnancy and menstruation;

[0176] 8) People with allergic or scar-prone constitutions;

[0177] 9) Those who are conducting other clinical research projects.

[0178] 3. Exit Indicators

[0179] 1) Patients with poor compliance and unable to persist in treatment and provide timely feedback;

[0180] 2) Incomplete data or loss of follow-up, which affects the judgment of efficacy or safety;

[0181] 3) Other conditions were found during the operation, and the operation was not performed or the operation method was changed;

[0182] 4) Severe postoperative pain, requiring the use of analgesics;

[0183] 5) Those who cannot continue treatment due to serious adverse reactions, serious complications, or even other special circumstances that are life-threatening.

[0184] 4. Medication

[0185] Starting from the first day after mixed hemorrhoid surgery, the treatment group used Mayinglong Musk Hemorrhoid Ointment 10g / tube, 2.5g / time, twice a day, and applied it to the wound surface, and used Chinese medicine fumigation solution to fumigate the anus for 20min / time, once a day, for 7 consecutive days.

[0186] The basic prescription and usage of the Chinese medicine fumigation and washing solution are as follows: add 2500 mL of water to the Chinese medicine fumigation and washing solution prepared in Example 1, boil it to 1500 mL, and then perform anal fumigation and washing treatment. 20 minutes / time, once / day, for 7 consecutive days.

[0187] The control group was treated with Mayinglong Musk Hemorrhoid Ointment 10g / tube, 2.5g / time, twice a day, and anal fumigation with 1:5000 potassium permanganate solution.

[0188] Usage of potassium permanganate: Take 4 tablets of potassium permanganate produced by Jinan Kangfusheng Pharmaceutical Co., Ltd. and dissolve them in 2000mL of warm boiled water. After gently mixing, you can perform anal fumigation treatment, 20 minutes / time, once / day, for 7 consecutive days.

[0189] Potassium permanganate specifications: 0.1g / tablet; Approval number: National Medicine Approval H37022233.

[0190] 5. Observation indicators:

[0191] Two trained professionals in our department recorded the time for complete wound healing, edema disappearance, and adverse reactions of the patients, and assessed the complications such as anal pain, heaviness, edema, and wound healing time of the included patients before fumigation treatment and on the 1st, 4th, and 7th days after treatment according to the 2002 edition of the "Guidelines for Clinical Research of New Chinese Medicines", and filled out the clinical questionnaire truthfully.

[0192] 6. Efficacy indicators:

[0193] According to the 2002 edition of the Guiding Principles for Clinical Research of New Chinese Medicines, the complications such as anal pain, edema, and heaviness as well as the wound healing time of the included patients were assessed before treatment and on the 1st, 4th, and 7th days after treatment.

[0194] (1) Edema

[0195] No edema or mild edema without affecting activities was scored as 0 points;

[0196] If there is one edema tissue with a diameter of no more than 10 mm and the activity is affected, it is scored as 2 points;

[0197] If there is one or more edema tissues with a diameter of 10 mm to 20 mm and the activity is affected, it is scored as 4 points;

[0198] If there is one or more edematous tissues with a diameter exceeding 20 mm and the activity is affected, it will be scored as 6 points.

[0199] (2) Anal pain

[0200] No pain was scored as 0 points;

[0201] Those who occasionally had pain during defecation were scored as 2 points;

[0202] Intermittent pain, but still tolerable, was scored as 4 points;

[0203] If the pain was persistent and required analgesic treatment, it was scored as 6 points.

[0204] (3) Swelling

[0205] Those without a feeling of heaviness and distension were scored as 0 points;

[0206] Occasional swelling in the anus, especially before defecation, was scored as 2 points;

[0207] Those who often have obvious anal distension are scored as 4 points;

[0208] A significant feeling of heaviness and distension in the anus and frequent urge to defecate but inability to do so were scored as 6 points.

[0209] Therapeutic effect index calculation formula:

[0210] [(score before treatment - score after treatment) / score before treatment] × 100%;

[0211] (4) Recovery:

[0212] After 7 days of treatment, the symptoms and signs basically disappeared, there was no pain or slight pain in the anus, no obvious edema of the incision, and basically no exudate on the wound surface. The efficacy index was ≥95%;

[0213] (5) Significant effect:

[0214] After 7 days of treatment, the symptoms and signs were significantly improved, the anus was mildly painful, the incision was slightly edematous, and there was basically no exudate on the wound surface. The efficacy index was ≥70%;

[0215] (6) Effective:

[0216] After 7 days of treatment, the symptoms and signs were significantly improved, with mild to moderate anal pain, mild to moderate edema of the incision, and a small amount of exudate on the wound surface. The efficacy index was ≥30%;

[0217] (7) Invalidity:

[0218] After 14 days of treatment, there was no significant improvement in symptoms and signs, the degree of anal pain and edema was the same as before, there was no significant improvement in wound exudate, and the efficacy index was <30%;

[0219] (8) Safety indicators:

[0220] During the fumigation treatment, the patients' adverse reactions, such as allergies, dizziness, headache, nausea, vomiting, palpitations, fatigue, profuse sweating, etc., were closely observed. After symptomatic treatment, detailed records were made and the cases were excluded and withdrawn from this study.

[0221] 7. Statistical analysis:

[0222] SPSS20.0 software package was used to perform statistical analysis on the collected data. The count data were expressed as percentages, and the chi-square test was used for comparison between the two groups. The measurement data were expressed as "mean ± standard deviation", and the t-test was used for comparison between the groups. The paired t-test was used before and after treatment within the group; when P < 0.05, it indicated statistical significance.

[0223] 2. Experimental Results

[0224] 1. Baseline data

[0225] Table 10 Comparison of baseline data between the two groups of patients

[0226] index Treatment Group Control group <![CDATA[x 2 Value]]> P-value gender 0.213 0.645 male 16 18 female 22 20 Age (years) 0.385 0.943 ＜30 5 4 31-40 26 28 41-50 4 4 51-65 3 2 Internal hemorrhoids staging 0.844 0.358 Phase II 20 16 Stage III 18 22 External hemorrhoids classification 2.101 0.552 Thrombotic 19 17 Inflammatory 13 14 Connective tissue 4 2 Varicose veins 2 5

[0227] Note: P value refers to the probability of a more extreme result than the sample observation result when the null hypothesis is true; 2 The value is the chi-square value, which is a statistic used to determine whether the observed value is significantly different from the theoretical value.

[0228] As shown in Table 10, the baseline data of the treatment group and the control group before treatment, such as gender, age, internal hemorrhoid stage, and external hemorrhoid classification, were similar, with no statistically significant differences.

[0229] 2. Anal pain before and after treatment

[0230] Table 11 Anal pain scores of the two groups of patients before and after fumigation treatment

[0231] Group Number of cases Before treatment Day 1 after treatment 4 days after treatment 7 days after treatment Treatment Group 38 cases 4.66±1.17 3.63±1.65 1.97±0.89 0.68±0.74 Control group 38 cases 4.58±1.06 4.03±1.53 2.50±0.56 1.50±0.69 t-value - 0.309 -1.080 -3.102 -4.981 P-value - 0.758 0.284 0.003 <0.001

[0232] Note: The t value reflects the difference between the sample mean and the overall mean. The P value determines whether the difference is significant through a statistical test of the t value. P<0.01 indicates a significant statistical difference, and p<0.001 indicates an extremely significant statistical difference. The scores are expressed as mean ± standard deviation; “-” means none.

[0233] The results are shown in Table 11. Before and after fumigation treatment, the anal pain scores of the two groups of patients were generally similar, and the difference was not statistically significant. On the first day after fumigation treatment, the anal pain scores of the treatment group and the control group were generally reduced, but the difference between the two groups was not statistically significant. On the 4th and 7th days after fumigation treatment, the anal pain scores of the two groups were generally reduced, and the treatment group was better than the control group, and the difference was statistically significant.

[0234] 3. The degree of anal swelling before and after treatment

[0235] Table 12 Anal swelling scores of the two groups of patients before and after fumigation treatment

[0236] Group Number of cases Before treatment Day 1 after treatment 4 days after treatment 7 days after treatment Treatment Group 38 cases 5.76±2.55 4.82±2.18 1.95±0.77 0.92±0.75 Control group 38 cases 5.74±2.31 4.95±1.94 2.37±0.59 1.32±0.74 t-value - 0.047 -0.278 -2.679 -2.312 P-value - 0.963 0.782 0.009 0.024

[0237] Note: The t value reflects the difference between the sample mean and the overall mean. The P value determines whether the difference is significant through a statistical test of the t value. P<0.01 indicates a significant statistical difference, and p<0.001 indicates an extremely significant statistical difference. The scores are expressed as mean ± standard deviation; “-” means none.

[0238] The results are shown in Table 12. Before and after fumigation treatment, the scores of anal distension degree in the two groups of patients were similar, and the difference was not statistically significant. On the first day after fumigation treatment, the scores of anal distension degree in the treatment group and the control group were generally reduced, but the difference between the two groups was not statistically significant. On the fourth and seventh days after fumigation treatment, the scores of anal distension degree in the two groups were generally reduced, and the treatment group was better than the control group, and the difference was statistically significant.

[0239] 4. Anal edema degree before and after treatment

[0240] Table 13 Anal edema scores of the two groups of patients before and after fumigation treatment

[0241] Group Number of cases Before treatment Day 1 after treatment 4 days after treatment 7 days after treatment Treatment Group 38 1.08±0.71 2.95±0.66 1.58±0.55 0.82±0.61 Control group 38 1.03±0.49 3.18±0.51 1.92±0.63 1.37±0.59 t-value - 0.375 -1.755 -2.514 -4.021 P-value - 0.709 0.083 0.014 <0.001

[0242] Note: The t value reflects the difference between the sample mean and the overall mean. The P value determines whether the difference is significant through a statistical test of the t value. P<0.01 indicates a significant statistical difference, and p<0.001 indicates an extremely significant statistical difference. The scores are expressed as mean ± standard deviation; “-” means none.

[0243] The results are shown in Table 13. Before and after fumigation treatment, the scores of postoperative anal edema in the two groups were similar, and the difference was not statistically significant. On the first day after fumigation treatment, the scores of postoperative anal edema in the treatment group and the control group were generally reduced, but the difference between the two groups was not statistically significant. On the fourth and seventh days after fumigation treatment, the scores of postoperative anal edema in the two groups were generally reduced, and the treatment group was better than the control group, and the difference was statistically significant.

[0244] 5. Wound healing time after treatment

[0245] Table 14 Wound healing time of the two groups of patients after fumigation treatment

[0246] Group Number of cases Wound healing time (days) Treatment Group 38 11.97±2.79 Control group 38 16.13±1.76 P-value - <0.001

[0247] Note: P value is used to determine whether the difference is significant through statistical test of t value; P<0.01 indicates significant statistical difference, and p<0.001 indicates extremely significant statistical difference; It represents the mean ± standard deviation of wound healing time; “-” means no.

[0248] The results are shown in Table 14. The wound healing time in the treatment group was shorter than that in the control group, and the difference was statistically significant.

[0249] 6. Comparison of efficacy between the two groups of patients

[0250] Table 15 Comparison of the efficacy of fumigation treatment in two groups of patients

[0251] Group Number of cases get well Significant effect efficient invalid Recovery rate Total Effectiveness Z value P-value Treatment Group 38 4 28 3 3 10.5％ 92.1％ -3.806 <0.001 Control group 38 2 11 19 6 5.3％ 84.2％ - -

[0252] Note: Z value is the standard score, which is the difference between a number and the mean divided by the standard deviation; P value refers to the probability of a more extreme result than the sample observation result when the null hypothesis is true; "-" means none.

[0253] The results of clinical efficacy observation are shown in Table 15. The comparison of the effects before and after treatment between the two groups of patients showed that the difference was statistically significant. The results of clinical efficacy observation showed that the Chinese medicine fumigation and washing solution of the present invention has a definite therapeutic effect on anal pain, edema, swelling and wound healing caused by anal disease surgery, and has the advantages of good therapeutic effect, safe clinical application, and no toxic side effects.

[0254] Although preferred embodiments of the present invention have been described, additional changes and modifications may occur to these embodiments once those skilled in the art are aware of the basic inventive concepts.

[0255] Obviously, those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include these modifications and variations.

Claims

1. A Chinese medicine composition, characterized in that: The invention is composed of the following traditional Chinese medicine components in parts by weight: 10-20 parts of scutellaria baicalensis wine, 20-30 parts of sophora flavescens, 15-20 parts of raw rhubarb, 6-12 parts of angelica sinensis, 8-12 parts of cinnamon bark, 6-12 parts of costusroot, 15-20 parts of sodium sulfate, 3-5 parts of coptis chinensis wine, and 20-30 parts of phellodendron amurense.

2. The Chinese medicine composition according to claim 1, characterized in that: It is composed of the following Chinese medicinal components in parts by weight: 15 parts of wine-scented Scutellaria baicalensis, 30 parts of Sophora flavescens, 20 parts of raw rhubarb, 10 parts of Angelica sinensis, 10 parts of cinnamon bark, 10 parts of costusroot, 20 parts of sodium sulfate, 5 parts of wine-scented Coptis chinensis, and 30 parts of Phellodendron chinense.

3. A drug, characterized in that The Chinese medicine composition according to any one of claims 1 to 2 is the only effective ingredient.

4. The drug according to claim 3, characterized in that The medicine is in the form of fumigation solution, powder, paste, granules, tincture or spray.

5. A method for preparing the drug according to claim 4, characterized in that: The steps include: Weigh the Chinese medicinal components according to weight: wine-skinned scutellaria, sophora flavescens, raw rhubarb, angelica sinensis, cinnamon bark, costusroot, sodium sulfate, wine-skinned coptis root and phellodendron chinense; Add the weighed Chinese medicine components into clean water and soak for 30min to 40min; The dosage ratio of the Chinese medicine component and clean water is 150g-200g:2500ml-3000ml; After soaking, boil over high heat until boiling, then simmer over low heat for 30 to 40 minutes to obtain the medicinal solution. Boil the liquid to 500ml-600ml, remove the dregs, filter out and obtain the fumigation solution.

6. Use of the Chinese medicine composition according to claim 1 in preparing a drug for treating or preventing anal diseases, characterized in that: The Chinese medicine composition is made into a fumigation liquid for fumigating the affected area. Before fumigating the anus and perianal area, the fumigation liquid is diluted 5 times and heated to 37°C to 42°C.

7. Use of the Chinese medicine composition according to claim 6 in preparing a drug for treating or preventing anal diseases, characterized in that: The fumigation and washing liquid preparation process comprises the following steps: Weigh the Chinese medicinal components according to weight: wine-skinned scutellaria, sophora flavescens, raw rhubarb, angelica sinensis, cinnamon bark, costusroot, sodium sulfate, wine-skinned coptis root and phellodendron chinense; Add the weighed Chinese medicine components into clean water and soak for 30min to 40min; The dosage ratio of the Chinese medicine component and clean water is 150g-200g:2500ml-3000ml; After soaking, boil over high heat until boiling, then simmer over low heat for 30 to 40 minutes to obtain the medicinal solution. Boil the liquid to 500ml-600ml, remove the dregs, filter out and obtain the fumigation solution.

8. Use of the Chinese medicine composition according to claim 7 in preparing a drug for treating or preventing anal diseases, characterized in that: The anal disease is inflammatory external hemorrhoids, mixed hemorrhoids, incarcerated internal hemorrhoids, perianal abscess, anal fistula or anal fissure.

9. Use of the Chinese medicine composition according to claim 8 in preparing a drug for treating or preventing anal diseases, characterized in that: The traditional Chinese medicine composition is used for preparing medicine for relieving acute anal pain and edema.

10. Use of the Chinese medicine composition according to claim 9 in preparing a drug for treating or preventing anal diseases, characterized in that: The traditional Chinese medicine composition is used for preparing medicine for reducing swelling, relieving pain and promoting wound healing after anal disease surgery.

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