A traditional Chinese medicine composition for treating colitis, a preparation method and an external preparation

Abstract

The application discloses a traditional Chinese medicine composition for treating colitis, a preparation method and an external preparation, and belongs to the technical field of colitis treatment. According to weight parts, the traditional Chinese medicine composition comprises 6-10 parts of forsythia suspense, 4-8 parts of radix paeoniae alba, 2-6 parts of lonicera japonica, 2-6 parts of taraxacum mongolicum, 2-6 parts of phellodendron, 1-5 parts of saposhnicovia divaricata and 0.15-0.35 parts of centipede. The traditional Chinese medicine composition adds radix paeoniae alba and saposhnicovia divaricata to the compound phellodendron liquid coating, so that the various medicinal materials in the formula can play a synergistic role, and the shortcomings of the compound phellodendron liquid in treatment can be overcome, and the treatment effect on colitis is better.

Description

Technical Field

[0001] This application relates to a traditional Chinese medicine composition for treating colitis, its preparation method, and an external preparation, belonging to the field of colitis treatment technology. Background Technology

[0002] In today's society, with the improvement of people's living standards, dietary structure and lifestyle have also undergone significant changes, and the incidence of colitis is showing a year-on-year increasing trend. Ulcerative colitis can be equated with various traditional Chinese medicine terms such as "diarrhea," "dysentery," "intestinal bleeding," "intestinal wind," "hematochezia," and "relapsing dysentery." It is a digestive tract disease characterized by chronic diffuse inflammation of the colonic mucosa. The "Expert Consensus on the Diagnosis and Treatment of Ulcerative Colitis with Traditional Chinese Medicine (2017)" classifies this disease under the category of "chronic dysentery." Clinically, it is mainly manifested by recurrent diarrhea, abdominal pain, mucus and bloody stools, tenesmus, and varying degrees of systemic symptoms. The course of the disease is prolonged and the recurrence rate is high. Currently, due to the lack of specific treatments for this disease, complications are relatively serious, and the World Health Organization has classified it as a modern intractable disease.

[0003] Traditional Chinese medicine offers a variety of treatments for colitis, including oral medication, combined internal and external treatments, integrated traditional Chinese and Western medicine, and enema therapy. The appropriate method of administration is chosen based on the location of the colon affected by the lesion. For example, rectal or left-sided colonic colitis can be treated with Chinese medicine enemas or suppositories, while extensive colonic colitis can be treated with a combination of oral and enema administration of Chinese medicine.

[0004] Compound Phellodendron Amurense Liquid Topical Solution is a highly effective external medication for purulent infections, providing antibacterial and anti-inflammatory effects. Some literature and patents demonstrate its efficacy in treating colitis. Clinically, it is administered as a liquid enema for colitis. Rectal administration can relieve symptoms and promote the repair of intestinal mucosal damage. Rectal administration allows the drug to enter the bloodstream directly without passing through the stomach and liver, preventing the destructive effects of gastric acid and various enzymes, and avoiding the first-pass effect of the liver. It also avoids gastrointestinal irritation and discomfort such as vomiting, making it suitable for patients who are unwilling or unable to take oral medication, especially children. The researchers in this application found that using Compound Phellodendron Amurense Liquid alone to treat colitis has disadvantages such as slow treatment effect, long treatment cycle, poor tolerability, and the need for combination therapy with other drugs. Summary of the Invention

[0005] To address the aforementioned issues, a traditional Chinese medicine composition for treating colitis is provided. This composition adds two medicinal herbs, white peony root and saposhnikovia root, to the compound berberine liquid ointment, enabling the various herbs in the formula to exert a synergistic effect. This overcomes the shortcomings of the current compound berberine liquid in treatment and provides a better therapeutic effect for colitis.

[0006] According to one aspect of this application, a traditional Chinese medicine composition for treating colitis is provided, comprising, by weight:

[0007] Forsythia suspensa 6-10 parts, Paeonia lactiflora 4-8 parts, Lonicera japonica 2-6 parts, Taraxacum mongolicum 2-6 parts, Phellodendron chinense 2-6 parts, Saposhnikovia divaricata 1-5 parts, Scolopendra subspinipes 0.15-0.35 parts.

[0008] Optionally, by weight, it comprises:

[0009] Forsythia suspensa 7-9 parts, Paeonia lactiflora 5-7 parts, Lonicera japonica 3-5 parts, Taraxacum mongolicum 3-5 parts, Phellodendron chinense 3-5 parts, Saposhnikovia divaricata 2-4 parts, Scolopendra subspinipes 0.18-0.32 parts.

[0010] The herbal composition for treating colitis in this application consists of Forsythia suspensa, Paeonia lactiflora, Lonicera japonica, Taraxacum mongolicum, Phellodendron chinense, Saposhnikovia divaricata, and Scolopendra subspinipes. Forsythia suspensa is bitter and cool in nature. According to "Medical Records of Integrating Chinese and Western Medicine", it "has the power of ascending and dispersing, promotes the circulation of qi and blood, treats blood stasis and qi stagnation in the twelve meridians, and is an essential medicine for sores... and has the ability to expel toxins". According to "Ben Cao Jing Shu", it "removes damp heat in the spleen and stomach and treats blood disorders in the middle part of the body". According to "Ben Cao Chong Yuan", it "is aromatic and awakens the spleen". Its ascending and dispersing nature has the functions of clearing heat and detoxifying, promoting the circulation of qi and blood, removing dampness and healing sores. It is especially effective for sores and carbuncles caused by the mutual combination of damp heat and evil toxins and blood stasis and qi stagnation. Paeonia lactiflora is sour and bitter and slightly cold in nature. It has the functions of nourishing blood and astringing yin, softening the liver and relieving pain. It is an essential medicine used by Danxi to treat diarrhea and abdominal pain caused by disharmony between the liver and spleen. Together with Forsythia suspensa, it is the principal medicine.

[0011] Honeysuckle has a sweet taste and cold nature, and functions to clear heat and detoxify, and disperse wind-heat; dandelion has a sweet and slightly bitter taste and cold nature, and functions to clear heat and detoxify, reduce swelling and dissipate nodules. According to "Ben Cao Zheng Yi", it "treats all kinds of sores, carbuncles, redness, swelling and heat toxins, and can be taken orally or applied topically". The two herbs work together to help Forsythia suspensa clear heat and detoxify, dissipate nodules and treat sores, and together they are assistant herbs.

[0012] Phellodendron bark is bitter and cold in nature, and its function is to clear heat and dry dampness. It is good at removing damp heat in the large intestine to treat diarrhea and dysentery. When combined with other herbs, it enhances the effects of clearing heat and detoxifying, drying dampness and stopping diarrhea. Saposhnikovia root has the properties of ascending and dispersing. Its pungent nature can disperse liver stagnation, and its fragrance can soothe the spleen. It can disperse qi stagnation, and it can also eliminate dampness and stop diarrhea. Moreover, it is a spleen-regulating and meridian-guiding herb. Dongyuan said, "If you want to tonify the spleen and stomach, you cannot do it without this guide." When combined with white peony root, it can disperse liver stagnation to stop diarrhea and relieve abdominal pain. Its function is both assistant and guiding.

[0013] Centipede has the properties of attacking toxins, dispersing nodules, clearing the meridians, and relieving pain. It has the ability to travel and guide the medicine through the meridians, making it an adjuvant. When used together with other herbs, it works to clear heat, resolve dampness, detoxify, and heal ulcers, and is used for ulcerative colitis.

[0014] The traditional Chinese medicine composition of this application focuses on clearing heat and dampness, detoxifying and healing sores. It adds peony and saposhnikovia to a large number of heat-clearing herbs, and incorporates the structure of Danxi's "Painful Diarrhea Formula". It can not only soothe the liver and relieve pain, but also enhance the function of dispersing liver stagnation. At the same time, the pungent and warm nature of saposhnikovia can prevent the whole formula from being too cold. It can clear heat and dampness without being too cold.

[0015] Optionally, the weight ratio of the forsythia, white peony root, and saposhnikovia root is 8:6:3;

[0016] The weight ratio of Forsythia suspensa to Lonicera japonica is 2:1.

[0017] Optionally, the weight ratio of the forsythia, dandelion, and phellodendron bark is 2:1:1;

[0018] The weight ratio of the forsythia to the centipede is 1:0.03.

[0019] Optionally, the traditional Chinese medicine composition includes, by weight parts:

[0020] Forsythia suspensa 8 parts, Paeonia lactiflora 6 parts, Lonicera japonica 4 parts, Taraxacum mongolicum 4 parts, Phellodendron chinense 4 parts, Saposhnikovia divaricata 3 parts, Scolopendra subspinipes 0.24 parts.

[0021] According to another aspect of this application, a method for preparing the traditional Chinese medicine composition for treating colitis as described in any of the above claims is provided, characterized by comprising the following steps:

[0022] (1) Weigh the above raw materials, add water and boil to obtain the decoction;

[0023] (2) The decoction is concentrated into a concentrated solution, alcohol is added to the concentrated solution to obtain an alcohol precipitate, the alcohol precipitate is filtered, and the filtrate is concentrated until there is no alcohol taste, and the product is obtained.

[0024] Optionally, in step (1), water is added and decocted at least twice, with the amount of water being 6-10 times that of the raw material, and the decoction is combined to obtain the decoction liquid. The decoction time for each time is 60-120 minutes.

[0025] Optionally, in step (2), the concentration temperature of the decoction is 50-90℃, and the relative density of the concentrate is 1.04-1.14.

[0026] Optionally, in step (2), the alcohol is ethanol, and ethanol is added to the concentrate to make the alcohol content reach 60%-80%, and the alcohol precipitation time is 12-72h.

[0027] According to another aspect of this application, a topical preparation for treating colitis is provided, the topical preparation comprising any of the above-described traditional Chinese medicine compositions, and / or made with pharmaceutically acceptable excipients, carriers, and matrices.

[0028] Optionally, the topical preparation may be formulated into dosage forms including liquid preparations, enemas, and suppositories.

[0029] The beneficial effects of this application include, but are not limited to:

[0030] 1. The traditional Chinese medicine composition for treating colitis in this application consists of forsythia, white peony root, honeysuckle, dandelion, phellodendron bark, saposhnikovia root, and centipede, which enables the various medicinal materials to work synergistically to achieve the best therapeutic effect on colitis without producing side effects.

[0031] 2. The traditional Chinese medicine composition of this application can improve the therapeutic effect on colitis, shorten the treatment time, has good tolerability, improve the patient's experience, and avoid abdominal pain. Attached Figure Description

[0032] The accompanying drawings, which are included to provide a further understanding of this application and form part of this application, illustrate exemplary embodiments and are used to explain this application, but do not constitute an undue limitation of this application. In the drawings:

[0033] Figure 1 These are photographs of rat colon tissue from the normal control group, model control group, positive control group, and groups 1-3 of Examples involved in this application.

[0034] Figure 2 These are photographs of the colon tissues of rats from comparative examples 1-6 involved in this application;

[0035] Figure 3 These are photographs of histopathological sections of rat colon tissue from the normal control group involved in this application;

[0036] Figure 4 These are photographs of histopathological sections of rat colon tissue from the control group of the model involved in this application;

[0037] Figure 5 Photographs of histopathological sections of rat colon tissue from the positive control group involved in this application;

[0038] Figure 6 These are photographs of histopathological sections of rat colon tissue from Example 1 of this application.

[0039] Figure 7 These are photographs of pathological sections of rat colon tissue from Example 2 of this application.

[0040] Figure 8 These are photographs of pathological sections of rat colon tissue from Example 3 of this application.

[0041] Figure 9 Photographs of histopathological sections of rat colon tissue from Comparative Example 1 involved in this application;

[0042] Figure 10 These are photographs of pathological sections of rat colon tissue from the two comparative groups involved in this application.

[0043] Figure 11 These are photographs of pathological sections of rat colon tissue from the three comparative groups involved in this application.

[0044] Figure 12 These are photographs of pathological sections of rat colon tissue from the four comparative groups involved in this application.

[0045] Figure 13 These are photographs of pathological sections of rat colon tissue from the five comparative groups involved in this application.

[0046] Figure 14 These are photographs of histopathological sections of rat colon tissue from the six comparative groups involved in this application. Detailed Implementation

[0047] The present application is described in detail below with reference to the embodiments, but the present application is not limited to these embodiments.

[0048] Unless otherwise specified, all raw materials used in the embodiments of this application were purchased through commercial channels.

[0049] Example 1

[0050] This embodiment relates to a traditional Chinese medicine composition for treating colitis and its preparation method. The traditional Chinese medicine composition includes: 80g of Forsythia suspensa, 60g of Paeonia lactiflora, 40g of Lonicera japonica, 40g of Taraxacum mongolicum, 40g of Phellodendron chinense, 30g of Saposhnikovia divaricata, and 2.4g of Scolopendra subspinipes.

[0051] The preparation method of this traditional Chinese medicine composition includes the following steps:

[0052] (1) Weigh the above raw materials, add 8 times the amount of water, soak for 60 minutes, heat to boiling, maintain a gentle boil for 90 minutes, filter, add 6 times the amount of water to the filter residue, maintain a gentle boil for 90 minutes, filter, add 6 times the amount of water to the filter residue, maintain a gentle boil for 90 minutes, filter, combine the three filtrates to obtain the filtrate;

[0053] (2) Concentrate the filtrate at 80°C to a relative density of 1.08. Add ethanol to the concentrate to make the alcohol content reach 70%. After standing for 24 hours, filter and concentrate the filtrate until there is no alcohol taste.

[0054] Example 2

[0055] This embodiment relates to a traditional Chinese medicine composition for treating colitis and its preparation method. The traditional Chinese medicine composition includes: 60g of Forsythia suspensa, 40g of Paeonia lactiflora, 20g of Lonicera japonica, 20g of Taraxacum mongolicum, 20g of Phellodendron chinense, 10g of Saposhnikovia divaricata, and 1.5g of Scolopendra subspinipes.

[0056] The preparation method of this traditional Chinese medicine composition includes the following steps:

[0057] (1) Weigh the above raw materials, add 10 times the amount of water, soak for 60 minutes, heat to boiling, keep boiling for 60 minutes, filter, add 6 times the amount of water to the filter residue, keep boiling for 60 minutes, filter, combine the two filtrates to obtain the filtrate;

[0058] (2) Concentrate the filtrate at 60°C to a relative density of 1.14. Add ethanol to the concentrate to make the alcohol content 60%. After standing for 48 hours, filter and concentrate the filtrate until there is no alcohol taste.

[0059] Example 3

[0060] This embodiment relates to a traditional Chinese medicine composition for treating colitis and its preparation method. The traditional Chinese medicine composition includes: 100g of Forsythia suspensa, 80g of Paeonia lactiflora, 60g of Lonicera japonica, 60g of Taraxacum mongolicum, 60g of Phellodendron chinense, 50g of Saposhnikovia divaricata, and 3.5g of Scolopendra subspinipes.

[0061] The preparation method of this traditional Chinese medicine composition includes the following steps:

[0062] (1) Weigh the above raw materials, add 8 times the amount of water, soak for 60 minutes, heat to boiling, maintain a gentle boil for 120 minutes, filter, add 6 times the amount of water to the filter residue, maintain a gentle boil for 120 minutes, filter, add 6 times the amount of water to the filter residue, maintain a gentle boil for 120 minutes, filter, combine the three filtrates to obtain the filtrate.

[0063] (2) Concentrate the filtrate at 70°C to a relative density of 1.04. Add ethanol to the concentrate to make the alcohol content reach 80%. After standing for 72 hours, filter and concentrate the filtrate until there is no alcohol taste.

[0064] Comparative Example 1

[0065] The comparative example used was a compound berberine extract coating.

[0066] Comparative Example 2

[0067] The difference between this comparative example and Example 1 is that honeysuckle is used instead of wild honeysuckle, otherwise it is the same as Example 1.

[0068] Comparative Example 3

[0069] The difference between this comparative example and Example 1 is that the amount of honeysuckle is 8 parts, while the rest is the same as in Example 1.

[0070] Comparative Example 4

[0071] The difference between this comparative example and Example 1 is that the amount of white peony root is 10 parts, while the rest is the same as in Example 1.

[0072] Comparative Example 5

[0073] The difference between this comparative example and Example 1 is that the windproofing is 8 parts, while the rest is the same as in Example 1.

[0074] Comparative Example 6

[0075] The difference between this comparative example and Example 1 is that the centipede is 0.5 parts, while the rest is the same as in Example 1.

[0076] Test case

[0077] Animal experiments were conducted on the traditional Chinese medicine composition products prepared in the above embodiments and comparative examples. The specific experimental methods are as follows:

[0078] Model building:

[0079] Before modeling, the rats were fasted for about 24 hours, but water was not restricted.

[0080] Eight rats were randomly selected as normal control rats. The remaining 112 rats were used to induce an ulcerative colitis model using 4% acetic acid solution. The specific method was as follows: rats were anesthetized by intramuscular injection of a compound anesthetic. After anesthesia, a drug delivery device was inserted into the rat's anus, with the tip approximately 8 cm from the anus. 0.8 mL of 4% acetic acid solution was injected, followed immediately by 5 mL of 0.9% sodium chloride injection for flushing after 20 seconds. This flushing process was repeated three times. The normal control rats underwent the same procedure, receiving the same volume of 0.9% sodium chloride injection for model induction and flushing. A total of 112 rats were induced with 4% acetic acid solution to develop the ulcerative colitis model. One rat died of asphyxiation after anesthesia, and two rats were found dead the day after model induction. A total of 109 rats successfully developed the model.

[0081] Animal grouping:

[0082] The rats were grouped on the day following modeling (D1). 109 rats were randomly divided into 11 groups according to body weight using the standard Latin method: model control group, positive control group, Example 1 group, Example 2 group, Example 3 group, Comparative Example 1 group, Comparative Example 2 group, Comparative Example 3 group, Comparative Example 4 group, Comparative Example 5 group, and Comparative Example 6 group. Except for Comparative Example 2 group (n=9), the other groups had 10 rats each. Eight normal control rats served as the normal control group.

[0083] Animal administration:

[0084] The administration began on the day following model establishment (D1) via enema. Rats were restrained using a rat restraint device, with the posterior half elevated approximately 30–45° to elevate the rat's hind limbs. The administration device was slowly inserted into the rat's anus, injecting the appropriate volume of medication when the tip was approximately 8 cm from the anus. The anus was then clamped and the device withdrawn, followed by sealing the anus with a silicone plug. The medication remained in the intestines for 10 minutes before the rats were removed from the restraint device and returned to their cages. Administration was repeated once daily for 7 consecutive days. The normal control and model control groups received 0.9% sodium chloride injection, the positive control group received mesalazine enema (5.4 mL / kg), and groups 1 through 6 of the above-mentioned traditional Chinese medicine compositions were administered. Except for the positive control group, the administration volume for all other groups was 3 mL / kg.

[0085] Testing indicators:

[0086] 1. Body weight: The body weight of rats in each group was measured before administration on days 1, 4 and 7 to analyze the differences in body weight among the groups.

[0087] 2. Colonic Mucosal Injury Index (CMDI) Score: On the day following drug administration (D8), rats were euthanized using carbon dioxide inhalation, and colonic tissue was removed from the abdominal cavity. The intestinal tract was dissected, rinsed thoroughly with physiological saline, and laid flat. The degree of colonic lesions was visually observed, and the Colonic Mucosal Injury Index (CMDI) score was calculated and photographed for record-keeping.

[0088] Gross scoring criteria for colon tissue: 0 points for smooth and flat mucosa without damage; 1 point for mild congestion and edema of the mucosa; 2 points for rough mucosa with erosion or intestinal adhesions; 3 points for punctate or linear ulcers on the intestinal surface, thickening of the intestinal wall or inflammatory polyps; 4 points for patchy ulcers on the intestinal surface, severe congestion and edema, and necrosis of the entire intestinal wall.

[0089] 3. Histopathological examination: A 4-6 cm section of diseased intestinal tissue was taken from an area 1 cm or more above the anus and fixed in 10% neutral formalin solution. Routine sampling, paraffin embedding, sectioning, and HE staining were performed. Pathological changes in the intestinal mucosa were observed under a light microscope, and histopathological scoring was conducted.

[0090] Pathological scoring criteria: Scoring is based on the depth of colonic lesions, the extent of mucosal damage, and the degree of inflammation, with a score range of 0-11 points. See the table below for specific scoring criteria.

[0091] Table 1. Scoring criteria for colonic histopathology

[0092]

[0093]

[0094] The data collection and analysis for the above results are as follows:

[0095] All raw data will be collected manually or using data acquisition software according to the experimental protocol requirements. Manually collected data can be transcribed into software for analysis and reporting. The main software / data systems used in this application are as follows:

[0096] Office 2019 is a suite of utilities for working with word and data.

[0097] Honeywell EBI R430.1 Environmental Monitoring System

[0098] Statistical Analysis of Grapgpad Prism 8.0.1

[0099] All numerical data (such as weight, pathological quantitative indicators, etc.) were presented as individual values ​​using Excel spreadsheets, and statistical analysis was performed on the measurement data. General observations were not statistically analyzed.

[0100] All numerical data are expressed as mean ± standard deviation. The data were plotted and statistically analyzed using Graphpad Prism 8.0.1. All data were analyzed using one-way ANOVA. If the one-way ANOVA was statistically significant (*P<0.05), the LSD test was used for multiple comparisons, comparing the mean of each group with the mean of the model control group. If the one-way ANOVA was not statistically significant (P>0.05), the statistical analysis was terminated. *P<0.05 was considered statistically significant.

[0101] Test results:

[0102] General observation: During the administration period, animal identification number 7729 in the control group died on day 2, animal identification number 7721 in the model control group died on day 3, and the remaining animals showed no abnormalities during the administration period.

[0103] 1. The weight measurement results are shown in the table below:

[0104] Table 2. Rat body weight

[0105] normal control group 355±10 369±11 376±10 8 Model control group 349±28 366±25 375±29 9 Positive control group 347±27 359±30 365±34 10 Example 1 Group 346±28 364±18 373±19 10 Example 2 group 349±15 365±11 376±14 10 Example 3 Group 347±17 360±14 371±14 10 Comparative Example 1 351±17 361±21 374±22 10 Comparative Example 2 350±26 366±27 373±29 9 Comparative Example 3 Groups 347±17 357±14 372±15 9 Comparative Example 4 Groups 346±17 359±13 381±18 10 Comparative Example 5 Groups 345±18 342±31 357±39 10 Comparative Example 6 Groups 344±18 353±14 369±17 10

[0106] The data in the table above shows that there was no significant difference in the body weight of rats in each group during the drug administration period.

[0107] 2. The Colonic Mucosal Injury Index (CMDI) score is shown in the table below:

[0108] Table 3. CMDI scores of rats in each group

[0109]

[0110]

[0111] *P<0.05, ****P<0.0001 VS Model Control Group

[0112] According to the data in the table above, compared with the model control group, the average CMDI scores of rats in each group of the examples, each group of the comparative examples, and the positive control group were reduced, with the CMDI scores of the Example 1 group, Example 3 group, and the positive control group being significantly reduced (*P<0.05).

[0113] Photographs of the colon tissue of each group of rats are shown below. Figure 1 , Figure 2As shown in the figure, the colonic mucosa of rats in the model control group was rough, with most showing punctate ulcers and no patchy ulcers; the colonic mucosa of rats in each group of the example, the comparative group, and the positive control group was mainly congested and edematous, with some showing punctate ulcers.

[0114] 3. According to the pathological scoring criteria in Table 1, the depth of colonic lesions, the extent of mucosal damage, and the degree of inflammation in each group of rats were scored, and the scores were added together to obtain the total score. The results of the total scores are shown in Table 4. The pathological score of the colon tissue of the rats in the model control group was significantly increased (***P<0.001), indicating that 4% acetic acid caused damage to the colonic tissue structure. The pathological scores of the positive control group, the example group, and the comparative group decreased, with the most significant decrease in the example group 2 (**P<0.01).

[0115] Table 4. Pathological scores of rat colon tissue in each group

[0116]

[0117]

[0118] **P<0.01, ***P<0.001 VS Model Control Group

[0119] The histopathological examination results of each group are shown below. Figure 3-14 Two in each group, we can see that:

[0120] In the normal control group, the colon tissue of rats showed normal structure in all layers, and no histopathological changes such as erosion, ulceration, hemorrhage, necrosis and inflammatory cell infiltration were observed in the mucosa.

[0121] In the model control group, the colon tissue structure of rats was severely damaged, with lesions extending from the submucosa to the serosa. The degree of lesion ranged from moderate to severe. The mucosal epithelial cells were necrotic and delaminated, and inflammatory cells infiltrated the mucosal layer. Some crypts in this area were missing or almost no crypts were observed, and the mucosal damage area was greater than 75%.

[0122] In the positive control group, the colonic tissue lesions of rats extended from the mucosa to the muscle layer, with the degree of lesions ranging from mild to moderate. The mucosal tissue showed degeneration, necrosis, and inflammatory cell infiltration, and the lesion ranged from 26% to 50%. Some rats only showed submucosal edema and inflammatory cell infiltration, and the mucosal tissue basically returned to normal.

[0123] In Example 1, the colonic tissue lesions of rats involved the mucosa and submucosa, with the lesion severity ranging from mild to moderate. The mucosa showed tissue degeneration, necrosis, and inflammatory cell infiltration, while the submucosa showed inflammatory cell infiltration.

[0124] In Example 2, the colonic lesions in the rats involved the mucosa and submucosa. The degree of lesion was mild, with mucosal tissue degeneration, necrosis, and inflammatory cell infiltration. The mucosal damage ranged from 26% to 50%.

[0125] In Example 3, the colonic lesions in the rats involved the mucosa and submucosa, with the severity of the lesions ranging from mild to moderate. The mucosa showed tissue degeneration, necrosis, and inflammatory cell infiltration, and some crypts in the mucosa were missing.

[0126] In the control group 1 rats, the colonic lesions involved the submucosa to the serosa, with mucosal tissue degeneration, necrosis and inflammatory cell infiltration, partial crypt loss and regeneration, and the degree of lesion was mild to moderate.

[0127] In the control group 2 rats, the colonic lesions invaded from the submucosa to the serosa, with mucosal tissue degeneration, necrosis and inflammatory cell infiltration, some crypt degeneration and necrosis, and submucosa edema and inflammatory cell infiltration.

[0128] In the control group of 3 rats, the colonic lesions involved the mucosa to the muscle layer, and the degree of lesion ranged from mild to moderate, with mucosal tissue degeneration, necrosis and a small amount of inflammatory cell infiltration.

[0129] In the four control groups of rats, the colonic tissue lesions extended from the submucosa to the serosa, with the severity of the lesions ranging from moderate to severe. The mucosal tissue showed degeneration, necrosis, and inflammatory cell infiltration, and crypts were missing.

[0130] In the five control groups of rats, the colonic tissue lesions extended from the submucosa to the serosa, with the severity of the lesions ranging from moderate to severe. The lesions included mucosal tissue degeneration, necrosis, and inflammatory cell infiltration, as well as crypt loss.

[0131] In the comparative group of 6 rats, the colon tissue lesions involved the mucosa to the muscle layer, and the degree of lesion ranged from mild to moderate, with mucosal tissue degeneration, necrosis and inflammatory cell infiltration.

[0132] Therefore, based on the above tests, there was no significant difference in the body weight of rats in each group during the administration period. Macroscopic observation and histopathological examination revealed that the modeling with 0.8 mL of 4% acetic acid solution induced the formation of punctate ulcers on the surface of the rat colon, resulting in tissue damage and lesions that even penetrated the serosa. According to the data from Examples 1, 2, and 3, the traditional Chinese medicine composition of this application can effectively reduce colonic mucosal damage and ulcer formation in rats, and significantly improve the degree and extent of tissue lesions.

[0133] Clinical data

[0134] The extract from Example 1 was used for clinical treatment. A specific example is as follows:

[0135] Case 1:

[0136] The patient, a female, first visited the clinic on January 26, 2021.

[0137] [Past medical history and medication use]

[0138] E1 (rectal lesions), bowel movements 2-5 times daily, with blood in the stool;

[0139] No hormones were used; mesalazine tablets and suppositories were taken orally; gentamicin and lidocaine enemas were administered.

[0140] [Inspection Results]

[0141] Colonoscopy was performed on E1, sigmoid colon, and ileocecal junction. The endoscope was advanced approximately 10cm into the terminal ileum. The terminal ileal mucosa was smooth. The ileocecal junction mucosa was congested, edematous, and eroded, with shallow ulceration. The appendiceal orifice was clearly visible, and the mucosa was smooth. Upon withdrawal of the endoscope, the ascending colon, transverse colon, and descending colon mucosa were smooth. A 2cm diameter patch of congested, edematous, and eroded mucosa with shallow ulceration was observed in the sigmoid colon. Two biopsies were taken. Diffuse congestion, edema, and erosion of the rectal mucosa less than 12cm from the anus, with shallow ulceration and purulent discharge, was observed on the surface.

[0142] [Detection and Diagnosis]

[0143] Ulcerative colitis (chronic relapsing type, active phase, moderate, E1+ sigmoid colon + ileocecal junction)

[0144] [Treatment Process]

[0145] On January 26, 2021, after testing, the extract from Example 1 was prescribed for enemas, once nightly, along with mesalazine suppositories once daily and mesalazine tablets orally. On February 8, 2021, during the second visit, bowel movements were twice daily with a significant reduction in bloody stools. The extract from Example 1 was continued for enemas once daily, with no other medications prescribed. On February 22, 2021, during the third visit, bowel movements were twice daily with occasional rectal bleeding. The extract from Example 1 was continued for enemas once daily. On March 8, 2021, during the fourth visit, bowel movements were 2-3 times daily with occasional rectal bleeding. The extract from Example 1 was continued for enemas, which were well tolerated with no blood in the stool. After the initial treatment, compound berberine solution was used for enemas, but this was poorly tolerated, causing abdominal discomfort.

[0146] The above description is merely an embodiment of this application, and the scope of protection of this application is not limited to these specific embodiments, but is determined by the claims of this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the technical concept and principles of this application should be included within the scope of protection of this application.

Claims

1. A traditional Chinese medicine composition for treating colitis, characterized in that, By weight, it includes: Forsythia suspensa 6-10 parts, Paeonia lactiflora 4-8 parts, Lonicera japonica 2-6 parts, Taraxacum mongolicum 2-6 parts, Phellodendron chinense 2-6 parts, Saposhnikovia divaricata 1-5 parts, Scolopendra subspinipes 0.15-0.35 parts.

2. The traditional Chinese medicine composition for treating colitis according to claim 1, characterized in that, By weight, it includes: Forsythia suspensa 7-9 parts, Paeonia lactiflora 5-7 parts, Lonicera japonica 3-5 parts, Taraxacum mongolicum 3-5 parts, Phellodendron chinense 3-5 parts, Saposhnikovia divaricata 2-4 parts, Scolopendra subspinipes 0.18-0.32 parts.

3. The traditional Chinese medicine composition for treating colitis according to claim 1, characterized in that, The weight ratio of Forsythia suspensa, Paeonia lactiflora and Saposhnikovia divaricata is 8:6:3; The weight ratio of Forsythia suspensa to Lonicera japonica is 2:

1.

4. The traditional Chinese medicine composition for treating colitis according to claim 1, characterized in that, The weight ratio of the forsythia, dandelion, and phellodendron bark is 2:1:1; The weight ratio of the forsythia to the centipede is 1:0.

03.

5. A method for preparing the traditional Chinese medicine composition for treating colitis according to any one of claims 1-4, characterized in that, Includes the following steps: (1) Weigh the above raw materials, add water and boil to obtain the decoction; (2) The decoction is concentrated into a concentrated solution, alcohol is added to the concentrated solution to obtain an alcohol precipitate, the alcohol precipitate is filtered, and the filtrate is concentrated until there is no alcohol taste, and the product is obtained.

6. The preparation method according to claim 5, characterized in that, In step (1), water is added and decocted at least twice, with the amount of water being 6-10 times that of the raw materials. The decoction is then combined to obtain the decoction liquid. Each decoction takes 60-120 minutes.

7. The preparation method according to claim 5, characterized in that, In step (2), the concentration temperature of the decoction is 50-90℃, and the relative density of the concentrate is 1.04-1.

14.

8. The preparation method according to claim 5, characterized in that, In step (2), the alcohol is ethanol. Ethanol is added to the concentrate to make the alcohol content reach 60%-80%, and the alcohol precipitation time is 12-72h.

9. A topical preparation for treating colitis, characterized in that, The topical preparation contains the traditional Chinese medicine composition according to any one of claims 1-4, and / or is made with pharmaceutically acceptable excipients, carriers, and matrices.

10. The topical preparation for treating colitis according to claim 9, characterized in that, The topical preparations can be formulated into dosage forms including liquid preparations, enemas, and suppositories.

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