Traditional Chinese medicine composition for preventing recurrence of colorectal adenoma after endoscopic treatment, and preparation method and application thereof

Abstract

The present invention discloses a traditional Chinese medicine composition for preventing recurrence of colorectal adenoma after endoscopic treatment. The traditional Chinese medicine composition is prepared from the following raw materials in the following weight ratios: 25-35 parts of astragalus, 8-15 parts of black plum, 6-12 parts of white mustard seeds, 5-10 parts of zedoaria, 8-15 parts of bombyx batryticatus, 25-35 parts of coix seed, and 25-35 parts of oyster. The traditional Chinese medicine compound composition for preventing recurrence of colorectal adenoma after endoscopic treatment provided by the present invention has been shown, through a large number of clinical trials, to be effective in preventing recurrence of colorectal adenoma after endoscopic treatment, and has achieved excellent technical results.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine, and in particular to a traditional Chinese medicine compound composition for preventing recurrence of colorectal adenoma after endoscopic treatment, as well as a preparation method and application thereof. Background Art

[0002] Colorectal adenomas (CRA) are neoplastic polyps with a four-fold increased risk of canceration compared to healthy individuals. Studies have shown that 80% of adenomas progress to colorectal cancer. Currently, endoscopic resection is the most effective treatment for this disease. However, simple resection of CRA has a high recurrence rate, reaching 40.8% within 5 years, and the long-term efficacy is not ideal. Therefore, reducing the recurrence rate and improving the short- and long-term clinical efficacy of patients undergoing endoscopic resection of CRA are key challenges in the current treatment of colorectal adenomas. Summary of the Invention

[0003] The purpose of the present invention is to provide a traditional Chinese medicine compound composition for preventing the recurrence of colorectal adenoma after endoscopic treatment.

[0004] In order to achieve the above object, the present invention provides a traditional Chinese medicine composition for preventing recurrence of colorectal adenoma after endoscopic treatment. The traditional Chinese medicine composition is prepared from the following raw materials in the following weight ratio: 25-35 parts of astragalus, 8-15 parts of black plum, 6-12 parts of white mustard seeds, 5-10 parts of zedoaria, 8-15 parts of bombyx batryticatus, 25-35 parts of coix seeds, and 25-35 parts of oyster.

[0005] Preferably, the oysters are raw oysters.

[0006] In some embodiments, preferably, the Chinese medicine composition of the present invention is prepared from the following raw materials in the following weight ratio: 30 parts of astragalus, 12 parts of black plum, 9 parts of white mustard seeds, 6 parts of zedoary turmeric, 10 parts of bombyx batryticatus, 30 parts of coix seed, and 30 parts of oyster.

[0007] The present invention also provides a preparation method of the above-mentioned traditional Chinese medicine compound composition, comprising the following steps: crushing oysters, wrapping them with gauze, and decocting them in water for 15 to 30 minutes; soaking astragalus, black plum, white mustard seed, zedoaria, bombyx batryticatus and coix seed in water for 30 to 50 minutes, adding the mixture to the oyster decoction, decocting them over high heat for 30 to 45 minutes, filtering, and boiling the decoction for later use; boiling the residue in water for 20 to 30 minutes, filtering the residue, combining the decoction and stirring evenly.

[0008] The amount of water added when decocting the above-mentioned oyster powder is 5 to 10 times; the amount of water added when soaking the astragalus, black plum, white mustard seed, zedoaria, bombyx batryticatus and coix seed is 5 to 10 times, and the amount of water added when decocting for the second time is 4 to 8 times.

[0009] When mass production is carried out in a factory, the preparation method of the Chinese herbal compound composition of the present invention is preferably as follows: oysters are crushed, mixed with astragalus, black plum, white mustard seed, zedoaria, bombyx batryticatus and coix seed, soaked in water for 30 to 50 minutes, heated and extracted for 2 to 3 hours, filtered, and the water extract is reserved. Water is added to the residue and heated and extracted for 1.5 to 3 hours. The residue is filtered, the water extract is combined, and stirred evenly.

[0010] After the above mixing and feeding, the amount of water added in the first heating extraction is 5 to 10 times, and the amount of water added in the second heating extraction is 4 to 8 times.

[0011] The present invention also provides a traditional Chinese medicine preparation for preventing recurrence of colorectal adenoma after endoscopic treatment. The traditional Chinese medicine preparation is a decoction prepared by using the traditional Chinese medicine composition.

[0012] The Chinese medicine preparation of the present invention can also be prepared by adding pharmaceutical excipients to the above-mentioned Chinese medicine composition, including oral liquid, granules, tablets, capsules, pills or decoctions.

[0013] Specifically, the decoction obtained by combining the above decoctions is concentrated under reduced pressure at 40-80° C. to a concentrated solution with a density of 1.05-1.25, and pharmaceutically acceptable excipients are added to prepare an oral solution.

[0014] The decoction obtained by combining the above decoctions is concentrated under reduced pressure at 40-80° C. to a concentrated solution with a density of 1.15-1.30, and pharmaceutically acceptable excipients are added to prepare a decoction paste.

[0015] The decoction obtained by combining the above decoctions is concentrated under reduced pressure at 40-80°C to a clear paste with a density of 1.25-1.40, the concentrated clear paste is dried at 50-90°C, the dry paste is crushed and pharmaceutically acceptable excipients are added to prepare any one of granules, tablets, capsules and pills.

[0016] The present invention also provides the use of the above-mentioned traditional Chinese medicine composition in preparing a medicine for preventing the recurrence of colorectal adenoma after endoscopic treatment.

[0017] Compared with the prior art, the present invention has the following advantages:

[0018] In Traditional Chinese Medicine (TCM), CRA is categorized as "intestinal stasis," "polyps," "diarrhea," and "intestinal tract ulcers." This condition is characterized by both underlying deficiency and superficial excess, with the underlying deficiency being spleen and stomach weakness and the superficial excess being damp-heat, qi stagnation, turbid phlegm, and toxic stasis. Therefore, the present invention treats this condition by addressing both the underlying and superficial aspects, primarily tonifying qi and strengthening the underlying body, supplemented by clearing heat, activating blood circulation, removing stasis, promoting qi circulation, and resolving phlegm.

[0019] The present invention is a prescription composed of astragalus, black plum, white mustard seed, zedoaria, bombyx batryticatus, coix seed and raw oyster, wherein astragalus is the monarch drug, which has the effects of tonifying qi and raising yang, promoting fluid and nourishing blood, and relieving stagnation and numbness; black plum is the ministerial drug, which has the effects of astringing the intestines and eroding the flesh; the monarch and ministerial drugs are compatible, which has the effects of strengthening the body and removing accumulation; white mustard seed dispels phlegm and promotes qi, disperses stagnation and dredges the meridians, and removes phlegm from the skin and membranes; zedoaria promotes qi and dissolves blood, eliminates accumulation and relieves pain; bombyx batryticatus dispels wind and relieves pain, resolves phlegm and disperses stagnation; coix seed strengthens the spleen and eliminates numbness, detoxifies and disperses stagnation; raw oyster suppresses yang and tonifies yin, softens and disperses hard masses, and together they serve as adjuvant drugs. The whole prescription has the effects of tonifying qi and strengthening the spleen, dispelling phlegm and dispersing stagnation, and removing blood stasis.

[0020] The Chinese medicinal compound composition for preventing the recurrence of colorectal adenoma after endoscopic surgery provided by the present invention has been shown through a large number of clinical trials to be able to effectively prevent the recurrence of colorectal adenoma after endoscopic surgery, and has achieved very good technical effects. DETAILED DESCRIPTION

[0021] The present invention is further illustrated below with reference to specific examples. It should be understood that these examples are only used to illustrate the present invention and are not used to limit the scope of the present invention. After reading the present invention, modifications of various equivalent forms of the present invention made by those skilled in the art all fall within the scope defined by the claims attached to this application.

[0022] The raw materials used in the following examples are all commercially available Chinese medicinal materials, and the oysters are raw oysters.

[0023] Example 1

[0024] Weigh 30g of Astragalus, 12g of Prunus mume, 9g of Sinapis alba, 6g of Curcuma zedoaria, 10g of Bombyx batryticatus, 30g of Coix seed, and 30g of raw oyster. Crush the oyster, wrap it with gauze, first add 6 times the amount (by weight) of water, and simmer over high heat for 20 minutes; soak the Astragalus, Prunus mume, Sinapis alba, Curcuma zedoaria, Bombyx batryticatus, and Coix seed in 4 times the amount (by weight) of water for 30 minutes, then add it to the oyster decoction, simmer twice over high heat for 40 minutes, filter, add 6 times the amount (by weight) of water to the residue, simmer for 30 minutes, filter the residue, combine the decoction, and stir evenly to obtain a decoction.

[0025] Example 2

[0026] Weigh 30kg of astragalus, 12kg of black plum, 9kg of white mustard seeds, 6kg of zedoary, 10kg of bombyx batryticatus, 30kg of coix seed, and 30kg of raw oyster. Crush the oyster and mix it with the astragalus, black plum, white mustard seeds, zedoary, bombyx batryticatus, and coix seed. Add 10 times the amount of water and soak for 30 minutes. Heat and extract twice: the first extraction for 4 hours and the second extraction for 3 hours with 8 times the amount of water. Filter the residue, combine the aqueous extracts, and stir evenly. Concentrate the aqueous extracts under reduced pressure at 70-80°C to a density of 1.10-1.15. Add pharmaceutically acceptable flavoring agents and other excipients to prepare an oral solution.

[0027] Example 3

[0028] Weigh 25kg of Astragalus, 8kg of Prunus mume, 6kg of Sinapis alba, 6kg of Curcuma zedoaria, 9kg of Bombyx batryticatus, 28kg of Coix seed, and 28kg of raw oyster. Crush the oyster and mix it with the Astragalus, Prunus mume, Sinapis alba, Curcuma zedoaria, Bombyx batryticatus, and Coix seed. Add 8 times the amount of water and soak for 30 minutes. Heat and extract twice: the first extraction for 3 hours and the second extraction for 1.5 hours with 6 times the amount of water. Filter the residue, combine the aqueous extracts, and stir evenly. Concentrate the aqueous extracts under reduced pressure at 70-80°C to a concentrate with a density of 1.18-1.25. Add pharmaceutically acceptable flavoring agents and other excipients to prepare a decoction.

[0029] Example 4

[0030] Weigh 35kg of astragalus, 15kg of black plum, 12kg of white mustard seeds, 10kg of zedoary, 12kg of bombyx batryticatus, 30kg of coix seed, and 30kg of raw oyster. Crush the oyster and mix it with the astragalus, black plum, white mustard seeds, zedoary, bombyx batryticatus, and coix seed. Add 10 times the amount of water and soak for 30 minutes. Heat and extract twice: the first extraction for 3 hours and the second extraction for 2 hours with 8 times the amount of water. Filter the residue, combine the aqueous extracts, and stir evenly. Concentrate the decoction under reduced pressure at 75-80°C to a clear paste with a density of 1.33-1.36. Dry the concentrated paste at 60-80°C, pulverize the dried paste, and add pharmaceutically acceptable excipients, flavoring agents, and other excipients to prepare granules or tablets.

[0031] Example 5 Evaluation of the therapeutic effect on colorectal adenoma model mice

[0032] (1) Modeling and administration: After one week of adaptive feeding, male C57BL / 6 mice were randomly divided into a blank control group, an AOM / DSS model group, and two drug administration groups, with 10 mice in each group. The drug administration groups were given a high dose (30 mg / g bw) or a low dose (15 mg / g bw) of the Chinese herbal composition every day, respectively. The dosage was calculated according to the clinical dose of the Chinese herbal composition and the yield of the decoction. The blank control group and the model group were gavaged with an equal volume of distilled water every day.

[0033] AOM / DSS model group: On the first day of the experiment, AOM (15 mg / kg) was injected intraperitoneally once (day 0 of the first week). One week later, the mice were given water containing 5% DSS for 2 days (week 2), and then pure water for 3 weeks. After drinking 5% DSS for 2 days again (week 5), the mice drank pure water for 3 weeks. The third cycle was the same as the second cycle, with water containing 5% DSS for 2 days (week 8), and then pure water was consumed until week 16, at which point the experiment was terminated.

[0034] Drug-administered group: The aqueous extract of the Chinese medicinal composition prepared in Example 1 was administered by gavage on the day of the first administration of 5% DSS-containing water for drinking, once a day for 14 weeks. The experiment ended at the 16th week.

[0035] (2) Observation indicators: The body weight of mice was measured once a week. After fasting for one night, the mice were anesthetized and killed. The abdominal cavity was opened along the midline of the abdomen, and the intestinal segment from the ileocecal region to the end of the rectum was cut out. The intestinal cavity was opened along the long axis with ophthalmic scissors to observe the occurrence of adenomas on the intestinal surface.

[0036] (3) As shown in Table 1, there was no significant difference in the body weight of mice in each group at the beginning of the experiment; as the experiment progressed, the body weight of mice in each group increased. At the 16th week, the body weight of mice in the model group was significantly lower than that in the blank group (P<0.05), while the body weight of mice in the high-dose and low-dose groups increased significantly compared with the model group (P<0.05), and the weight increase in the high-dose group was more obvious, as shown in Table 1 below.

[0037] Table 1 Body weight changes of mice in each group ( n=10)

[0038]

[0039] Note: #P<0.05 compared with blank control group; *P<0.05 compared with model control group.

[0040] As shown in Table 2, the number of intestinal adenomas in each group of mice was significantly higher in the model group than in the blank group (P<0.05), while the number of intestinal adenomas in the high-dose and low-dose groups was significantly lower than that in the model group (P<0.05).

[0041] Table 2 Number of intestinal adenomas in mice in each group ( n=10)

[0042] Group Number of intestinal adenomas Blank control group 0±0 Model control group 17±5# Chinese medicine high dose group 8±2* Low-dose group of Chinese medicine composition 12±4*

[0043] Note: #P<0.05 compared with blank control group; *P<0.05 compared with model control group.

[0044] Example 6 Evaluation of clinical efficacy of endoscopic surgery in patients with colorectal adenoma

[0045] From June 2020 to June 2021, the Jiangsu Provincial Institute of Traditional Chinese Medicine conducted an observation on the clinical efficacy of the Chinese medicine composition of the present invention on patients with colorectal adenoma after endoscopic surgery. A total of 60 cases were included, including 30 cases in the Chinese medicine composition group of the present invention and 30 cases in the control group. The treatment course was 3 months.

[0046] (1) Diagnostic criteria

[0047] Western medicine diagnostic criteria: Symptoms include changes in bowel habits, shape, frequency, or blood in the stool, or chronic abdominal pain, or symptoms of digestive system diseases such as abdominal distension and discomfort; colonoscopy reveals colon and / or rectal polyps, which may be pedunculated or broad-based and sessile, and may be single or multiple; pathological examination confirms the diagnosis as adenomatous polyps.

[0048] TCM diagnostic standards: refer to the "TCM Disease Diagnosis and Efficacy Standards" formulated by the State Administration of Traditional Chinese Medicine Key Specialty Collaboration Group, which manifests as dampness and blood stasis syndrome, intestinal damp-heat syndrome, qi stagnation and blood stasis syndrome, spleen deficiency and blood stasis syndrome, etc.

[0049] Inclusion criteria for patients: meeting the diagnosis and TCM syndrome differentiation criteria for colorectal adenoma; gender is not limited, age is 30-75 years old; subjects provide informed consent and have good compliance.

[0050] (2) Experimental methods and observation indicators

[0051] All patients were treated with endoscopic resection. When electronic colonoscopy was performed, the number, size, morphology, and position of adenomas found by the initial electronic colonoscopy were recorded in detail, and all adenomas were ensured to be completely removed. Both the postoperative treatment group and the control group were given conventional anti-inflammatory, fluid replacement, symptomatic supportive treatment such as promoting intestinal mucosal repair and preventing bleeding. The Chinese medicine treatment group was given a Chinese medicine composition decoction (prepared in Example 1) on the basis of the control group, 1 dose / d, and a course of treatment of 3 months. Colonoscopy was reviewed again 3 months after surgery.

[0052] Observation indicators:

[0053] Symptom and sign indicators: After 3 months of treatment, the patients' symptoms such as abdominal distension, abdominal pain, tenesmus, loose stools, and poor appetite were scored (severe ≥ 8 points, moderate: 4-8 points, mild: 1-4 points);

[0054] Colonoscopy indicators: The recurrence status of the two groups of patients 3 months after endoscopic resection was compared. The location, number, size and pathological classification of adenomas found during colonoscopy were recorded, and the recurrence rate was calculated.

[0055] (3) Results

[0056] As shown in Table 3 below, the symptom scores of the Chinese medicine combination group and the control group after treatment were significantly better than those before treatment (P<0.05); the symptom scores of the Chinese medicine combination group after treatment were significantly better than those of the control group after treatment (P<0.05).

[0057] Table 3 Comparison of symptom scores before and after treatment ( n=30)

[0058]

[0059] Note: #P<0.05 compared with the group before treatment; *P<0.05 compared with the control group after treatment.

[0060] As shown in Table 4 below, the recurrence rate of the Chinese medicine composition group was 16.7%, which was significantly better than 46.7% of the control group (P<0.05).

[0061] Table 4 Comparison of recurrence rates

[0062] Group n Recurrence (cases) Recurrence rate (%) Chinese medicine combination group 30 5 16.7％* control group 30 14 46.7％

[0063] Note: *P<0.05 compared with the control group.

[0064] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be regarded as within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for preventing recurrence of colorectal adenoma after endoscopic treatment, the traditional Chinese medicine composition being prepared from the following raw materials in the following weight ratio: 25-35 parts of astragalus, 8-15 parts of black plum, 6-12 parts of white mustard, 5-10 parts of zedoaria, 8-15 parts of bombyx batryticatus, 25-35 parts of coix seed, and 25-35 parts of oyster; the traditional Chinese medicine composition being prepared by the following method: crushing the oyster, wrapping it with gauze, and decocting it in water for 15-30 minutes; soaking the astragalus, black plum, white mustard, zedoaria, bombyx batryticatus, and coix seed in water for 30-50 minutes, adding the mixture to the oyster decoction, decocting it over high heat for 30-45 minutes, filtering it, and boiling the decoction for later use, boiling the residue in water for 20-30 minutes, filtering the residue, combining the decoction, and stirring evenly.

2. The Chinese medicine composition according to claim 1, characterized in that The traditional Chinese medicine composition is prepared from the following raw materials in the following weight ratio: 30 parts of astragalus, 12 parts of black plum, 9 parts of white mustard seeds, 6 parts of zedoary turmeric, 10 parts of bombyx batryticatus, 30 parts of coix seeds, and 30 parts of oyster.

3. The method for preparing the Chinese medicine composition according to claim 1 or 2, wherein: The traditional Chinese medicine composition is prepared by the following method: crushing oysters, wrapping them with gauze, and decocting them with water for 15 to 30 minutes; soaking astragalus, black plum, white mustard seeds, zedoaria, bombyx batryticatus and coix seed in water for 30 to 50 minutes, adding the mixture to the oyster decoction, decocting them with high heat for 30 to 45 minutes, filtering, and boiling the decoction for later use; adding water to the residue and decocting them for 20 to 30 minutes; filtering the residue, combining the decoction and stirring them evenly.

4. The method for preparing the Chinese medicine composition according to claim 1 or 2, wherein: The traditional Chinese medicine composition is prepared by the following method: oysters are crushed, mixed with astragalus, black plum, white mustard seed, zedoaria, bombyx batryticatus and coix seed, soaked in water for 30 to 50 minutes, heated for extraction for 2 to 3 hours, filtered, and the water extract is reserved; the residue is further added with water for heating extraction for 1.5 to 3 hours, the residue is filtered, the water extract is combined, and stirred evenly.

5. A traditional Chinese medicine preparation for preventing recurrence of colorectal adenoma after endoscopic treatment, the traditional Chinese medicine preparation being a decoction prepared using the traditional Chinese medicine composition according to claim 1 or 2.

6. A traditional Chinese medicine preparation for preventing recurrence of colorectal adenoma after endoscopic treatment, the traditional Chinese medicine preparation being prepared by adding pharmaceutical excipients to the traditional Chinese medicine composition according to claim 1 or 2, and the traditional Chinese medicine preparation being in the form of oral liquid, granules, tablets, capsules, pills or decoction.

7. Use of the Chinese medicine composition according to claim 1 or 2 in the preparation of a medicament for preventing recurrence of colorectal adenoma after endoscopic treatment.

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