Traditional Chinese medicine composition and application thereof in preparation of product for treating intestinal polyp

Abstract

The invention relates to the technical field of medicines, and particularly discloses a traditional Chinese medicine composition and application thereof in preparation of a product for treating intestinal polyp. The traditional Chinese medicine composition comprises astragalus membranaceus, sargentgloryvine stem, radix paeoniae alba, radix paeoniae rubra, fructus lycii, dandelion and purslane. The novel traditional Chinese medicine composition is developed through the compatibility of specific monarch, minister and adjuvant drugs, and can enhance the basic metabolism of a body, promote blood circulation in intestinal tracts, remove heat toxins in the body and enhance the immunity and repair capacity of the intestinal tracts, so that the purpose of treating intestinal polyp is achieved.

Description

Technical Field

[0001] The present invention relates to the field of medical technology, in particular to a traditional Chinese medicine composition and application thereof in preparing a product for treating intestinal polyps. Background Art

[0002] In traditional Chinese medicine theory, the formation of intestinal polyps is mainly due to the imbalance of the human body and the dysfunction of the internal organs. The specific reasons include: 1. Qi stagnation and blood stasis: When you are in a bad mood or under increased pressure, the Qi is easily blocked, resulting in poor blood circulation and blood stasis. This blood stasis state can affect the normal function of the intestines, leading to local tissue hyperplasia and the formation of polyps.

[0003] 2. Internal accumulation of dampness and heat: Excessive intake of unhealthy foods such as spicy and greasy foods, or the influence of dampness and heat, may lead to accumulation of dampness and heat in the body, causing inflammation and the formation of polyps.

[0004] 3. Spleen deficiency and dry intestines: The spleen is an important organ for digestion and absorption. Its imperfect function will lead to incomplete digestion of food, causing toxins and waste to accumulate in the intestines, thereby increasing the burden on the intestines and eventually forming polyps.

[0005] 4. Emotional factors: Traditional Chinese medicine emphasizes the impact of emotions on health. Long-term negative emotions such as anxiety and depression may cause organ dysfunction, further affect intestinal health, and eventually form polyps.

[0006] Currently, the main treatment for intestinal polyps is to remove them through endoscopic examination (colonoscopy), and there is no specific drug that can treat or eliminate existing intestinal polyps. Therefore, there is an urgent need for a drug that can treat intestinal polyps. Summary of the invention

[0007] One of the purposes of the present invention is to provide a new Chinese medicine composition which can effectively treat intestinal polyps.

[0008] The invention provides a traditional Chinese medicine composition, which comprises astragalus, safflower caulis, white peony root, red peony root, wolfberry, dandelion and purslane.

[0009] In the composition of the present invention, the astragalus root is the dried root of the leguminous plant Astragalus mongolica or Astragalus membranaceus. It is excavated in spring and autumn, the fibrous roots and root heads are removed, and the root is dried in the sun. Nature and flavor: sweet, slightly warm. It enters the lung and spleen meridians. It is used to replenish qi and raise yang, consolidate the exterior and stop sweating, promote diuresis and reduce swelling, promote the production of body fluid and nourish blood, relieve stagnation and relieve arthralgia, support toxins and discharge pus, and heal sores and promote tissue regeneration. It is used for qi deficiency and fatigue, poor appetite and loose stools, sinking of qi in the middle, chronic diarrhea and prolapse of the anus, bloody stool and metrorrhagia, spontaneous sweating due to exterior deficiency, edema due to qi deficiency, internal heat and thirst, sallow complexion due to blood deficiency, hemiplegia, pain and numbness in the arthralgia, carbuncle that is difficult to ulcerate, and long-term ulceration that does not heal.

[0010] Sargentodoxa cuneata is the dried vine stem of the plant Sargentodoxa cuneata in the family Lardizabalaceae. It is harvested in autumn and winter, the lateral branches are removed, cut into sections, and dried. Properties: Bitter, flat. Channels entered: Large Intestine and Liver Channels. It is used for clearing heat and detoxifying, activating blood circulation, dispelling wind and relieving pain. It is used for abdominal pain due to intestinal abscess, heat-toxic sores and ulcers, amenorrhea, dysmenorrhea, swelling and pain from falls and bruises, and rheumatic arthralgia.

[0011] White Peony Root is the dried root of the plant Paeonia lactiflora in the family Ranunculaceae. It is dug in summer and autumn, washed, the head and tail and fine roots are removed, boiled in boiling water and then the outer skin is removed or peeled and then boiled again, and dried in the sun. Properties: Bitter, sour, slightly cold. Channels entered: Liver and Spleen Channels. It is used for nourishing blood and regulating menstruation, astringing yin and stopping sweating, soothing the liver and relieving pain, suppressing liver yang. It is used for sallow complexion due to blood deficiency, irregular menstruation, spontaneous sweating, night sweating, hypochondriac pain, abdominal pain, spasmodic pain of the limbs, headache and dizziness.

[0012] Red Peony Root is the dried root of the plant Paeonia lactiflora or Paeonia veitchii in the family Ranunculaceae. It is dug in spring and autumn, the rhizome, fibrous roots and sediment are removed, and dried in the sun. Properties: Bitter, slightly cold. Channel entered: Liver Channel. It is used for clearing heat and cooling blood, removing stasis and relieving pain. It is used for heat entering nutrient-blood aspect, epidemic toxin-induced maculae, hematemesis and epistaxis, red and painful eyes, hypochondriac pain due to stagnation of liver qi, amenorrhea and dysmenorrhea, abdominal pain due to masses, swelling and pain from falls and bruises, and sores and ulcers.

[0013] Wolfberry Fruit is the dried ripe fruit of the plant Lycium barbarum in the family Solanaceae. It is harvested in summer and autumn when the fruits turn red, dried with hot air, the fruit stalks are removed, or dried in the sun after airing until the skin wrinkles, and the fruit stalks are removed. Properties: Sweet, flat. Channels entered: Liver and Kidney Channels. It is used for tonifying the liver and kidney, benefiting essence and improving eyesight. It is used for consumptive disease with essence deficiency, soreness and weakness of the waist and knees, dizziness and tinnitus, impotence and spermatorrhea, internal heat and thirst, sallow complexion due to blood deficiency, and dim eyesight.

[0014] Dandelion is the dried whole herb of the plant Taraxacum mongolicum, Taraxacum sinicum or several plants of the same genus in the family Compositae. It is dug when the flowers begin to bloom from spring to autumn, impurities are removed, washed, and dried in the sun. Properties: Bitter, sweet, cold. Channels entered: Liver and Stomach Channels. It is used for clearing heat and detoxifying, dissipating swelling and nodules, promoting diuresis and relieving stranguria. It is used for boils and sores, breast abscess, scrofula, red eyes, sore throat, lung abscess, intestinal abscess, damp-heat jaundice, and stranguria with pain.

[0015] Purslane is the dried aerial part of the plant Portulaca oleracea in the family Portulacaceae. It is harvested in summer and autumn, the remaining roots and impurities are removed, washed, and slightly steamed or scalded and then dried in the sun. Properties: Sour, cold. Channels entered: Liver and Large Intestine Channels. It is used for clearing heat and detoxifying, cooling blood and stopping bleeding, relieving dysentery. It is used for dysentery with heat-toxic blood, boils and sores, eczema, erysipelas, snake and insect bites, hematochezia, hemorrhoids bleeding, and metrorrhagia.

[0016] It should be noted that in the present invention, Astragalus membranaceus is the sovereign drug; Sargentodoxa cuneata, White Peony Root and Red Peony Root are the ministerial drugs; Wolfberry Fruit, Dandelion and Purslane are the adjuvant drugs.

[0017] Based on the dialectical characteristics of "deficiency in origin and excess in superficiality, mutual binding of dampness and stasis" of intestinal polyps in traditional Chinese medicine, the traditional Chinese medicine composition of the present invention specifically combines specific components to reconcile deficiency and excess and treat both the principal and secondary aspects simultaneously. Specifically, astragalus membranaceus is used as the monarch drug to strengthen the body's self-regulatory ability by enhancing immunity and replenishing qi to promote yang. Sargentodoxa cuneata is used as the minister drug to clear heat and detoxify, reduce swelling and relieve pain, and white peony root and red peony root play the roles of nourishing blood and regulating qi and relieving pain. Among the assistant drugs, wolfberry fruit is used to nourish the liver and kidney and improve eyesight to further enhance the overall health level; dandelion is used to clear heat and detoxify and promote diuresis to help eliminate toxins in the body; and purslane is used to clear heat and cool blood and reduce inflammation, thus improving the diseases caused by internal toxins and also helping to promote wound healing and reduce the inflammatory response. The above-mentioned components complement each other and act synergistically, having the comprehensive effects of strengthening the spleen and removing dampness, clearing heat and detoxifying, thereby achieving the effective treatment of intestinal polyps.

[0018] In the traditional Chinese medicine composition of the present invention, the mass ratio of astragalus membranaceus to white peony root is (0.43~5.12):1; the mass ratio of Sargentodoxa cuneata, white peony root and red peony root is (0.39~2.88):1:1.

[0019] In the present invention, the mass ratio of astragalus membranaceus to white peony root can be any ratio within the range of (0.43~5.12):1. For example, 0.43:1, 0.5:1, 0.8:1, 1:1, 1.13:1, 1.3:1, 1.5:1, 1.57:1, 1.6:1, 2:1, 2.5:1, 3:1, 3.5:1, 4:1, 5:1, 5.12:1.

[0020] In the traditional Chinese medicine composition of the present invention, by weight, it includes: 10~32 parts of astragalus membranaceus, 9~18 parts of Sargentodoxa cuneata, 6.25~23 parts of white peony root, 6.25~23 parts of red peony root, 5~23 parts of wolfberry fruit, 5~27 parts of dandelion and 6~34 parts of purslane.

[0021] With the component ratios of the present invention, the treatment of intestinal polyps can be better achieved.

[0022] Regarding the weight parts of astragalus membranaceus, 10 - 32 refers to any value within the range of 10 to 32. For example, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31 and 32.

[0023] Regarding the weight parts of Sargentodoxa cuneata, 9 - 18 refers to any value within the range of 9 to 18. For example, 9, 10, 11, 12, 13, 14, 15, 16, 17 and 18.

[0024] Regarding the weight parts of white peony root or red peony root, 6.25 - 23 refers to any value within the range of 6.25 to 23. For example, 6.25, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, and 23.

[0025] Regarding the weight parts of wolfberry fruit, 5 - 23 refers to any value within the range of 5 to 23. For example, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, and 23.

[0026] Regarding the weight parts of dandelion, 5 - 27 refers to any value within the range of 5 to 27. For example, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 18, 20, 22, 24, 25, 26, and 27.

[0027] Regarding the weight parts of purslane, 6 - 34 refers to any value within the range of 6 to 34. For example, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.

[0028] The specific traditional Chinese medicine composition may, by weight, include the following components: Prescription 1: 21 parts of astragalus root, 14 parts of sargentgloryvine stem, 15.7 parts of white peony root, 14.3 parts of red peony root, 23 parts of wolfberry fruit, 14 parts of dandelion, 27 parts of purslane.

[0029] Prescription 2: The traditional Chinese medicine composition for treating intestinal polyps, by weight, includes the following components: 32 parts of astragalus root, 18 parts of sargentgloryvine stem, 23 parts of white peony root, 20.7 parts of red peony root, 23 parts of wolfberry fruit, 27 parts of dandelion, 34 parts of purslane.

[0030] Prescription 3: The traditional Chinese medicine composition for treating intestinal polyps, by weight, includes the following components: 16 parts of astragalus root, 9 parts of sargentgloryvine stem, 10 parts of white peony root, 10 parts of red peony root, 12 parts of wolfberry fruit, 18 parts of dandelion, 9 parts of purslane.

[0031] Prescription 4: The traditional Chinese medicine composition for treating intestinal polyps, by weight, includes the following components: 10 parts of astragalus root, 9 parts of sargentgloryvine stem, 6.25 parts of white peony root, 6.25 parts of red peony root, 5 parts of wolfberry fruit, 5 parts of dandelion, 6 parts of purslane.

[0032] Preferably, in the traditional Chinese medicine composition of the present invention, by weight, it includes: 11 - 30 parts of astragalus root, 10 - 18 parts of sargentgloryvine stem, 7 - 20 parts of white peony root, 7 - 20 parts of red peony root, 5 - 20 parts of wolfberry fruit, 5 - 25 parts of dandelion, and 7 - 30 parts of purslane.

[0033] More preferably, in the traditional Chinese medicine composition of the present invention, by weight, it includes: 14-16 parts of Astragalus membranaceus, 10-12 parts of Sargentodoxa cuneata, 9-11 parts of Paeonia lactiflora, 9-11 parts of Paeonia veitchii, 9-11 parts of Lycium barbarum, 9-11 parts of Taraxacum mongolicum, and 9-11 parts of Portulaca oleracea; Or, 11-13 parts of Astragalus membranaceus, 10-12 parts of Sargentodoxa cuneata, 7-8 parts of Paeonia lactiflora, 7-8 parts of Paeonia veitchii, 5-6 parts of Lycium barbarum, 5-6 parts of Taraxacum mongolicum, 7-8 parts of Portulaca oleracea; Or, 28-30 parts of Astragalus membranaceus, 16-18 parts of Sargentodoxa cuneata, 18-20 parts of Paeonia lactiflora, 18-20 parts of Paeonia veitchii, 18-20 parts of Lycium barbarum, 23-25 parts of Taraxacum mongolicum, and 28-30 parts of Portulaca oleracea.

[0034] Further preferably, in the traditional Chinese medicine composition of the present invention, by weight, it includes: 15 parts of Astragalus membranaceus, 10 parts of Sargentodoxa cuneata, 10 parts of Paeonia lactiflora, 10 parts of Paeonia veitchii, 10 parts of Lycium barbarum, 10 parts of Taraxacum mongolicum, and 10 parts of Portulaca oleracea; Or, 11 parts of Astragalus membranaceus, 10 parts of Sargentodoxa cuneata, 7 parts of Paeonia lactiflora, 7 parts of Paeonia veitchii, 5 parts of Lycium barbarum, 5 parts of Taraxacum mongolicum, 7 parts of Portulaca oleracea; Or, 30 parts of Astragalus membranaceus, 18 parts of Sargentodoxa cuneata, 20 parts of Paeonia lactiflora, 20 parts of Paeonia veitchii, 20 parts of Lycium barbarum, 25 parts of Taraxacum mongolicum, and 30 parts of Portulaca oleracea.

[0035] The unit of "parts by weight" recorded in the present invention can be "g" or "kg", etc., which are well-known mass measurement units in the art.

[0036] The traditional Chinese medicine composition of the present invention can be prepared according to the conventional methods in the art and can be prepared into various dosage forms. Taking the decoction as an example, the specific preparation method is as follows: a. Wash Astragalus membranaceus, Sargentodoxa cuneata, Paeonia lactiflora, Paeonia veitchii, Lycium barbarum, Taraxacum mongolicum, and Portulaca oleracea clean. Soak Lycium barbarum and Taraxacum mongolicum in water.

[0037] b. Chop the above traditional Chinese medicinal materials.

[0038] c. Put the above traditional Chinese medicinal materials into a container and add an appropriate amount (4-12 times the amount of the medicinal materials) of water.

[0039] d. After boiling over high heat, turn to low heat and continue to cook for minutes.

[0040] e. Filter the medicinal liquid, and repeat steps c and d (0-2 times) to obtain the decoction.

[0041] Regarding the "chopping" in the preparation method of the present invention, it can be to cut each traditional Chinese medicinal material into small pieces, or to slightly crush each traditional Chinese medicinal material without completely decomposing it into small pieces or fine powder.

[0042] For the soaking duration of the Chinese medicinal materials in the preparation method of the present invention, it can be any duration within 20 to 45 minutes. For example, soak for 20 minutes, 25 minutes, 30 minutes, 35 minutes, 40 minutes or 45 minutes, but not limited thereto.

[0043] For the decocting duration of the Chinese medicinal materials in the preparation method of the present invention, it can be any duration within 20 to 60 minutes. For example, 20 minutes, 25 minutes, 30 minutes, 35 minutes, 40 minutes, 45 minutes, 50 minutes, 55 minutes or 60 minutes, but not limited thereto.

[0044] For the number of decocting times of the Chinese medicinal materials in the preparation method of the present invention, it can be 1 time, 2 times or 3 times, but not limited thereto.

[0045] It can be understood that the decoction obtained by the preparation method of the present invention can obtain decoctions with any concentration by controlling decocting conditions such as the amount of added water and decocting time. The concentration of the decoction can be any value within the range of 1 g / ml to 10 g / ml of the crude drug content. For example, 1 g / ml, 1.5 g / ml, 2 g / ml, 2.5 g / ml, 3 g / ml, 3.5 g / ml, 4 g / ml, 4.5 g / ml, 5 g / ml, 5.5 g / ml, 6 g / ml, 6.5 g / ml, 7 g / ml, 7.5 g / ml, 8 g / ml, 8.5 g / ml, 9 g / ml, 9.5 g / ml and 10 g / ml.

[0046] It can be understood that the dosage of the decoction obtained by the preparation method of the present invention can be any value within the range of 10 g of crude drug / kg body weight to 50 g of crude drug / kg body weight. For example, 10 g of crude drug / kg body weight, 15 g of crude drug / kg body weight, 20 g of crude drug / kg body weight, 25 g of crude drug / kg body weight, 30 g of crude drug / kg body weight, 35 g of crude drug / kg body weight, 40 g of crude drug / kg body weight, 45 g of crude drug / kg body weight and 50 g of crude drug / kg body weight.

[0047] The present invention also provides the application of the above-mentioned traditional Chinese medicine composition in the preparation of products for treating intestinal polyps.

[0048] In the application of the present invention, the intestinal polyps include at least one of spleen deficiency and dampness stagnation type intestinal polyps, large intestine dampness heat type intestinal polyps, and qi stagnation and blood stasis type intestinal polyps.

[0049] It can be understood that the intestinal polyps can be any one type of intestinal polyps among spleen deficiency and dampness stagnation type intestinal polyps, large intestine dampness heat type intestinal polyps, and qi stagnation and blood stasis type intestinal polyps, or can be intestinal polyps combined with any two types, or can also be intestinal polyps formed by combining the three types.

[0050] The present invention also provides a drug, which includes the above-mentioned traditional Chinese medicine composition, or further includes pharmaceutically acceptable excipients or solvents.

[0051] It is understandable that the drug of the present invention may only contain the above-mentioned traditional Chinese medicine composition, or may also contain pharmaceutically acceptable excipients / diluents.

[0052] In the drug of the present invention, the dosage form of the drug includes at least one of injection, decoction, powder, tablet, capsule, granule and oral liquid.

[0053] The beneficial effects of the present invention are at least as follows: The traditional Chinese medicine composition of the present invention can enhance the body's immunity, improve the intestinal microenvironment, promote blood circulation, relieve intestinal inflammation, and provide a good internal environment for the prevention and improvement of intestinal polyps. At the same time, it can also relieve the discomfort symptoms of patients, improve the quality of life, contribute to the improvement of the overall health level, and provide an effective new method for the treatment of intestinal polyps. Description of the Drawings

[0054] Figure 1 is the test result of the influence of the drugs in each group on the number of intestinal polyps in the experimental examples of the present invention; Figure 2 is the test result of the influence of the drugs in each group on the diameter of intestinal polyps in the experimental examples of the present invention. Detailed Embodiments

[0055] The preferred embodiments of the present invention will be described in detail below in conjunction with the embodiments. It should be understood that the following embodiments are given only for the purpose of illustration and are not used to limit the scope of the present invention. Those skilled in the art can make various modifications and substitutions to the present invention without departing from the purpose and spirit of the present invention.

[0056] Unless otherwise specified, the experimental methods used in the following embodiments are all conventional methods. The materials, reagents, etc. used in the following embodiments can be obtained from commercial sources or prepared by conventional methods in the art unless otherwise specified.

[0057] Example 1 This example provides a traditional Chinese medicine composition for treating intestinal polyps, which includes the following components in parts by weight: Astragalus membranaceus 21 parts, Sargentodoxa cuneata 14 parts, Paeonia lactiflora 15.7 parts, Paeonia veitchii 14.3 parts, Lycium barbarum 23 parts, Taraxacum mongolicum 14 parts, Portulaca oleracea 27 parts.

[0058] This example further prepares the above composition into a decoction, and the preparation method is as follows: a. Wash Astragalus membranaceus, Sargentodoxa cuneata, Paeonia lactiflora, Paeonia veitchii, Lycium barbarum, Taraxacum mongolicum and Portulaca oleracea. Soak Lycium barbarum and Taraxacum mongolicum in water for 30 minutes.

[0059] b. Chop the above Chinese medicinal materials.

[0060] c. Put the above traditional Chinese medicinal materials into a container and add 10 times the amount of water by weight of the medicinal materials.

[0061] d. After boiling over high heat, turn to low heat and continue to cook for 40 minutes.

[0062] e. Filter to obtain the medicinal liquid, and repeat steps c and d twice to obtain the decoction.

[0063] Example 2 This example provides a traditional Chinese medicine composition for treating intestinal polyps, which, by weight, comprises the following components: Astragalus membranaceus 26 parts, Sargentodoxa cuneata 16 parts, Paeonia lactiflora 23 parts, Paeonia veitchii 20.7 parts, Lycium barbarum 9 parts, Taraxacum mongolicum 6 parts, Portulaca oleracea 13 parts.

[0064] This example further prepares the above composition into a decoction, and the preparation method is the same as that of Example 1.

[0065] Example 3 This example provides a traditional Chinese medicine composition for treating intestinal polyps, which, by weight, comprises the following components: Astragalus membranaceus 16 parts, Sargentodoxa cuneata 9 parts, Paeonia lactiflora 10 parts, Paeonia veitchii 10 parts, Lycium barbarum 12 parts, Taraxacum mongolicum 18 parts, Portulaca oleracea 9 parts.

[0066] This example further prepares the above composition into a decoction, and the preparation method is the same as that of Example 1.

[0067] Example 4 This example provides a traditional Chinese medicine composition for treating intestinal polyps, which, by weight, comprises the following components: Astragalus membranaceus 10 parts, Sargentodoxa cuneata 9 parts, Paeonia lactiflora 6.25 parts, Paeonia veitchii 6.25 parts, Lycium barbarum 5 parts, Taraxacum mongolicum 5 parts, Portulaca oleracea 6 parts.

[0068] This example further prepares the above composition into a decoction, and the preparation method is the same as that of Example 1.

[0069] Example 5 This example provides a traditional Chinese medicine composition for treating intestinal polyps, which, by weight, comprises the following components: Astragalus membranaceus 15 parts, Sargentodoxa cuneata 10 parts, Paeonia lactiflora 10 parts, Paeonia veitchii 10 parts, Lycium barbarum 10 parts, Taraxacum mongolicum 10 parts, Portulaca oleracea 10 parts.

[0070] This example further prepares the above composition into a decoction, and the preparation method is the same as that of Example 1.

[0071] Example 6 This example provides a traditional Chinese medicine composition for treating intestinal polyps, which, by weight, comprises the following components: Astragalus membranaceus 11 parts, Sargentodoxa cuneata 10 parts, Paeonia lactiflora 7 parts, Paeonia veitchii 7 parts, Lycium barbarum 5 parts, Taraxacum mongolicum 5 parts, Portulaca oleracea 7 parts.

[0072] In this example, the above composition is further prepared into a decoction, and the preparation method is the same as that in Example 1.

[0073] Example 7 This example provides a traditional Chinese medicine composition for treating intestinal polyps, which includes the following components by weight: Astragalus membranaceus 30 parts, Sargentodoxa cuneata 18 parts, Paeonia lactiflora 20 parts, Paeonia veitchii 20 parts, Lycium barbarum 20 parts, Taraxacum mongolicum 25 parts, and Portulaca oleracea 30 parts.

[0074] In this example, the above composition is further prepared into a decoction, and the preparation method is the same as that in Example 1.

[0075] Comparative Example 1 This comparative example provides a traditional Chinese medicine composition, which includes: Astragalus membranaceus 15 parts, Lycium barbarum 10 parts, Taraxacum mongolicum 10 parts, and Portulaca oleracea 10 parts by weight.

[0076] In this comparative example, the above composition is further prepared into a decoction, and the preparation method is as follows: a. Wash Astragalus membranaceus, Lycium barbarum, Taraxacum mongolicum, and Portulaca oleracea clean. Soak Lycium barbarum and Taraxacum mongolicum in water for 30 minutes.

[0077] b. Chop the above Chinese medicinal materials.

[0078] c. Put the above Chinese medicinal materials into a container and add 10 times the amount of water by weight of the medicinal materials.

[0079] d. After boiling over high heat, turn to low heat and continue to decoct for 40 minutes.

[0080] e. Filter the medicinal liquid, and repeat steps c and d twice to obtain the decoction.

[0081] Comparative Example 2 This comparative example provides a traditional Chinese medicine composition, which includes: Astragalus membranaceus 15 parts, Sargentodoxa cuneata 10 parts, Paeonia lactiflora 10 parts, and Paeonia veitchii 10 parts by weight.

[0082] In this comparative example, the above composition is further prepared into a decoction, and the preparation method is as follows: a. Wash Astragalus membranaceus, Sargentodoxa cuneata, Paeonia lactiflora, and Paeonia veitchii clean.

[0083] b. Chop the above Chinese medicinal materials.

[0084] c. Put the above Chinese medicinal materials into a container and add 10 times the amount of water by weight of the medicinal materials.

[0085] d. After boiling over high heat, turn to low heat and continue to decoct for 40 minutes.

[0086] e. Filter the medicinal liquid and repeat steps c and d twice to obtain the decoction.

[0087] Comparative Example 3 (Example 1 in Chinese Patent 201910994531.X) This comparative example provides a traditional Chinese medicine composition, calculated by weight, including: 840 parts of white peony root, 420 parts of red peony root.

[0088] This comparative example further prepares the above composition into pills, and the specific preparation method is as follows: 1) Mix red peony root and white peony root according to the formula, take 50% of the raw medicinal materials and crush them into fine powder of 2000 meshes to obtain medicinal powder; add 10 times the weight of water to the remaining raw medicinal materials and decoct them twice, each time for 2 hours, combine the decoctions, concentrate, dry and crush them to obtain extract powder; 2) Mix the above medicinal powder and extract powder, add appropriate excipients to make pills (each 1 g of pills is equivalent to containing 1.6 g of raw medicine).

[0089] Comparative Example 4 This comparative example provides a traditional Chinese medicine composition, calculated by weight, including: 15 parts of codonopsis pilosula, 10 parts of sargentodoxa cuneata, 10 parts of white peony root, 10 parts of red peony root, 10 parts of wolfberry fruit, 10 parts of dandelion and 10 parts of purslane.

[0090] This comparative example further prepares the above composition into a decoction, and the preparation method refers to Example 1, with the only difference being that astragalus membranaceus is replaced by codonopsis pilosula.

[0091] Comparative Example 5 This comparative example provides a traditional Chinese medicine composition, calculated by weight, including: 15 parts of astragalus membranaceus, 10 parts of patrinia scabiosaefolia, 10 parts of white peony root, 10 parts of red peony root, 10 parts of wolfberry fruit, 10 parts of dandelion and 10 parts of purslane.

[0092] This comparative example further prepares the above composition into a decoction, and the preparation method refers to Example 1, with the only difference being that sargentodoxa cuneata is replaced by patrinia scabiosaefolia.

[0093] Comparative Example 6 This comparative example provides a traditional Chinese medicine composition, calculated by weight, including: 15 parts of astragalus membranaceus, 10 parts of sargentodoxa cuneata, 10 parts of angelica sinensis, 10 parts of red peony root, 10 parts of wolfberry fruit, 10 parts of dandelion and 10 parts of purslane.

[0094] This comparative example further prepares the above composition into a decoction, and the preparation method refers to Example 1, with the only difference being that white peony root is replaced by angelica sinensis.

[0095] Comparative Example 7 This comparative example provides a traditional Chinese medicine composition, which, in parts by weight, comprises: 15 parts of Astragalus membranaceus, 10 parts of Sargentodoxa cuneata, 10 parts of Paeonia lactiflora, 10 parts of Paeonia veitchii, 10 parts of Lycium barbarum, 10 parts of Viola philippica and 10 parts of Portulaca oleracea.

[0096] This comparative example further prepared the above composition into a decoction. The preparation method can be referred to Example 1, with the only difference being that Taraxacum mongolicum was replaced by Viola philippica.

[0097] Experimental Example 1: Pharmacodynamic investigation 1. Experimental animals and animal models 40 clean-grade APCmin / + male mice aged 4 - 8 weeks and 80 clean-grade C57BL / 6J female mice, with a body weight of 16 - 20 g, were crossbred to obtain offspring mice in a ratio of 1:2, and APCmin / + mice were selected from them.

[0098] 2. Grouping 140 selected APCmin / + mice (male, 4 weeks old, body weight 16 - 20 g) were randomly divided into a high-dose group (A0), a high-dose group (A1), a high-dose group (A2), a high-dose group (A3), a high-dose group (A4), a medium-dose group, a low-dose group, a model group, a positive drug group, a control group (B0), a control group (B1), a control group (B2), a control group (B3), and a control group (B4), with 10 mice in each group.

[0099] 3. Administration Each group was administered for a total of 12 weeks. Among them, The high-dose group (A0) was given the decoction prepared in Example 5 by gavage once a day (the dosage was 25 g of crude drug / kg body weight); The high-dose group (A1) was given the decoction prepared in Comparative Example 1 by gavage once a day (the dosage was 25 g of crude drug / kg body weight); The high-dose group (A2) was given the decoction prepared in Comparative Example 2 by gavage once a day (the dosage was 25 g of crude drug / kg body weight); The high-dose group (A3) was given the decoction prepared in Example 6 by gavage once a day (the dosage was 25 g of crude drug / kg body weight); The high-dose group (A4) was given the decoction prepared in Example 7 by gavage once a day (the dosage was 25 g of crude drug / kg body weight); The medium-dose group was given the decoction prepared in Example 5 by gavage once a day (the dosage was 12.5 g of crude drug / kg body weight); The low-dose group was given the decoction prepared in Example 5 once a day (the dosage was 6.25 g of crude drug / kg body weight); The control group (B0) was intragastrically administered with the pills prepared in Comparative Example 3 once a day (the dosage was 12.5 g of crude drug / kg body weight); The control group (B1) was intragastrically administered with the decoction prepared in Comparative Example 4 once a day (the dosage was 12.5 g of crude drug / kg body weight); The control group (B2) was intragastrically administered with the decoction prepared in Comparative Example 5 once a day (the dosage was 12.5 g of crude drug / kg body weight); The control group (B3) was intragastrically administered with the decoction prepared in Comparative Example 6 once a day (the dosage was 12.5 g of crude drug / kg body weight); The control group (B4) was intragastrically administered with the decoction prepared in Comparative Example 7 once a day (the dosage was 12.5 g of crude drug / kg body weight); The positive drug group was administered with celecoxib once a day (20 mg / kg body weight); The model group was intragastrically administered with normal saline once a day (200 ml / kg body weight).

[0100] The administration doses of the mice in the above groups were obtained by converting according to a human body weight of 60 kg.

[0101] 4. Observation indicators (1) Disease Activity Index (DAI) score: Based on the percentage of body weight loss, fecal viscosity, and fecal occult blood for scoring, DAI = (body weight + stool shape + bleeding condition) / 3, and the score range is 0 - 4 points. The higher the score, the more severe the inflammation. The specific scoring criteria are shown in Table 1.

[0102] Table 1 Fecal viscosity test method: Visual inspection; Fecal occult blood test method: Chemical method (o-toluidine method).

[0103] (2) Number and diameter of polyps At the end of the 12th week, the mice were sacrificed, and the small intestine and colon were longitudinally dissected. The number and diameter of polyps were counted under a dissecting microscope. Measurement data were expressed as and t-test was used. For four-grid table data, χ 2 test was used. P < 0.05 was considered statistically significant.

[0104] (3) Determination of intestinal tissue inflammatory factors IL-1β, IL-6, TNF-α Take the intestinal tissue samples of each group of mice, rinse them with PBS buffer to remove the residual blood or impurities on the tissue surface, weigh and cut the tissue blocks into pieces, add pre-cooled PBS according to a certain ratio, and homogenize them under ice bath conditions. Absorb the homogenate into a centrifuge tube, centrifuge at low temperature (4°C) and 5000 r / min for 5 - 10 min, and take the supernatant to detect the levels of inflammatory factors IL-1β, IL-6, and TNF-α in the intestinal tissues of each group of mice using an ELISA kit.

[0105] 5. Experimental results (1)DAI score There were no significant differences in the body weights of the animals in each group before and after administration. As shown in Table 2 below. The total DAI scores are shown in Table 3.

[0106] Table 2 Body weights of the animals in each group before and after administration Table 3 DAI scores of the animals in each group Note: : Compared with the model group, p < 0.05; : Compared with the model group, p < 0.01; #: Compared with the positive drug group, p < 0.05. Data with P values not specifically marked are not significantly different from the model group.

[0107] According to Tables 2 and 3, the body weights of the animals in each group increased before and after administration, but there were no significant differences among the groups (p > 0.05), indicating that the drug had no obvious effect on body weight. The DAI scores of the positive drug group and the high-dose groups (A0, A1, A2, A3) were significantly lower than those of the model group, indicating that these groups had significant therapeutic effects. Among them, the DAI score of the high-dose group (A0) was significantly lower than that of the model group (p = 0.00019) and significantly better than that of the positive drug group (p = 0.0418), indicating that its therapeutic effect was better than that of the positive drug group. The medium-dose group and the control group (B4) had good effects in improving fecal viscosity and fecal occult blood, but the effects were still not as significant as those of the high-dose group. The DAI scores of the low-dose group and other control groups (A4, B0, B1, B2, B3) were not significantly different from those of the model group. In summary, the decoctions of the high-dose groups (A0, A1, A2, A3) and the medium-dose group were superior to the positive drug group in improving symptoms.

[0108] (2)Changes in the number and diameter of polyps, and the results are shown in Tables 4 to 6.

[0109] Table 4 Summary of the number of polyps in each group after administration Note: : Compared with the model group, p < 0.05; : Compared with the model group, p < 0.01. Data with P values not specifically marked are not significant compared with the model group.

[0110] Table 5 Comparison of polyp diameters in each group after drug administration Note: : Compared with the model group, p < 0.05; : Compared with the model group, p < 0.01; #: Compared with the positive drug group, p < 0.05. Data with P values not specifically marked are not significant compared with the model group.

[0111] Table 6 Polyp distribution in each group after drug administration Note: : Compared with the model group, p < 0.05; : Compared with the model group, p < 0.01; #: Compared with the positive drug group, p < 0.05. X 2 Values not specifically marked are not significant compared with the model group.

[0112] Based on the data in Table 4, Table 5, and Table 6, it can be seen that: In terms of the number and diameter of polyps, the positive drug group was significantly lower than the model group in both the number and diameter of polyps, indicating that it has a certain therapeutic effect. The high-dose groups (A0, A1, A2, A3, A4) showed significant improvement in both the number and diameter of polyps. Among them, the high-dose groups (A0, A4) had more prominent effects, not only being significantly lower than the model group but also superior to the positive drug group (p < 0.05). The medium-dose group also showed significant improvement in the number and diameter of polyps, but the effect was slightly inferior to that of the high-dose groups (A0, A3, A4). The low-dose group and the control groups (B0, B1, B2, B3) had no significant differences from the model group in terms of the number and diameter of polyps, indicating a weak therapeutic effect, but the control group (B4) had a certain improvement in terms of the number and diameter of polyps (1.45 ± 0.60, p = 0.0184).

[0113] In terms of polyp distribution, the positive drug group and the high-dose groups (A0, A1, A2, A3, A4) significantly reduced the number of large polyps > 2 mm. Among them, the high-dose groups (A0, A4) had significantly better effects than the model group (p < 0.01) and the positive drug group (p < 0.05). The medium-dose group was also able to effectively reduce the number of large polyps, but the effect was slightly weaker than that of the high-dose group. The low-dose group and the control groups (B0, B1, B2, B3) had no significant differences from the model group in terms of polyp distribution, but the control group (B4) had a certain therapeutic effect.

[0114] In summary, the high-dose groups (A0, A4) had significant advantages in reducing the number of polyps, shrinking the diameter of polyps, and improving the distribution of polyps, being significantly superior to the model group and the positive drug group; the medium-dose group also had a certain effect on polyp control, but the effect was not as good as that of the high-dose group; while the low-dose group and the control groups (B0, B1, B2, B3) had poor treatment effects, and the control group (B4) had a certain control effect.

[0115] The test results of the effect of the drug on the number of intestinal polyps and the test results of the effect of the drug on the diameter of intestinal polyps are respectively as Figure 1 and Figure 2 shown.

[0116] (3) Determination of inflammatory factors IL-1β, IL-6, and TNF-α in intestinal tissues.

[0117] The results are shown in Table 7.

[0118] Table 7 Determination results of inflammatory factors in intestinal tissues of each group : Compared with the model group, p < 0.05; : Compared with the model group, p < 0.01.

[0119] As can be seen from Table 7, in the determination of inflammatory factors IL-1β, TNF-α, and IL-6, the positive drug group was significantly lower than the model group in all inflammatory factors, showing a good anti-inflammatory effect. The high-dose groups (A0, A1, A2, A3, A4) showed more significant improvements in inflammatory factors, among which the effects of A0, A3, and A4 were particularly prominent, being significantly lower than the model group, and some indicators were better than those of the positive drug group. The medium-dose group also had good improvements in anti-inflammatory effects, but the effect was not as significant as that of the high-dose group. There was no significant difference in inflammatory factors between the low-dose group and the model group, indicating that its anti-inflammatory effect was poor. The control groups (B0, B1, B2, B3, B4) were significantly lower than the model group in all inflammatory factors (p < 0.05), and also had a certain anti-inflammatory effect, but the effect was not as good as that of the high-dose group.

[0120] (4) Conclusion The results showed that the decoctions prepared in Examples 5-7 of the present invention had a significant inhibitory effect on the growth of intestinal polyps in APCmin / + mice, and could effectively improve the symptoms of intestinal polyps. This effect was reflected in the decrease in the disease activity index (DAI) score, the improvement of fecal traits and occult blood conditions, as well as the reduction in the number and diameter of polyps. In addition, the levels of inflammatory factors in intestinal tissues were also significantly reduced. From the test results of each example in improving the disease activity index (DAI), reducing the number of polyps and shrinking the diameter of polyps, it can be seen that the decoctions of Examples 5-7 of the present invention were more effective than the drugs in the positive drug group, indicating that each ingredient in the prescription played a synergistic role in the overall formula, and the reasonable combination of each ingredient in the prescription was crucial for the overall therapeutic effect. The lack of any ministerial drug or adjuvant drug would lead to a weakening of the overall therapeutic effect.

[0121] Experimental Example 2: Clinical Investigation The following is the improvement of intestinal polyps in patients with different types of intestinal polyps after taking the decoction of Example 5. It was administered once a day at a dose of 12.5 g of crude drug / kg body weight for a course of 45 days, with a total of 3 courses. The results are shown in Table 8.

[0122] Table 8 Summary of Clinical Investigation Results As can be seen from Table 8, the traditional Chinese medicine composition for treating intestinal polyps of the present invention had good therapeutic effects on intestinal polyps of the spleen deficiency and dampness stagnation type, large intestine dampness heat type, and qi stagnation and blood stasis type.

[0123] It should also be noted that the term "comprising" and any other variants thereof in the present invention are intended to cover non-exclusive inclusion, so that a process, method, commodity or device comprising a series of elements not only includes those elements, but also includes other elements not expressly listed, or elements inherent to such process, method, commodity or device. Without further limitation, elements defined by the statement "comprising at least one..." do not exclude the presence of additional identical elements in the process, method, commodity or device comprising the said elements.

[0124] The same or similar parts among the various embodiments in this specification can be referred to each other, and each embodiment focuses on the differences from other embodiments.

[0125] Although the present invention has been described in detail above with general descriptions and specific embodiments, based on the present invention, some modifications or improvements can be made, which are obvious to those skilled in the art. Therefore, these modifications or improvements made without departing from the spirit of the present invention all fall within the scope of the present invention claimed.

Claims

1. A traditional Chinese medicine composition, characterized in that, It includes Astragalus membranaceus, Sargentodoxa cuneata, Paeonia lactiflora, Paeonia veitchii, Lycium barbarum, Taraxacum mongolicum and Portulaca oleracea.

2. The traditional Chinese medicine composition according to claim 1, wherein The mass ratio of Astragalus membranaceus to Paeonia lactiflora is (0.43~5.12):1; the mass ratio of Sargentodoxa cuneata, Paeonia lactiflora and Paeonia veitchii is (0.39~2.88):1:

1.

3. The traditional Chinese medicine composition according to claim 2, wherein By weight, it includes: 10~32 parts of Astragalus membranaceus, 9~18 parts of Sargentodoxa cuneata, 6.25~23 parts of Paeonia lactiflora, 6.25~23 parts of Paeonia veitchii, 5~23 parts of Lycium barbarum, 5~27 parts of Taraxacum mongolicum and 6~34 parts of Portulaca oleracea.

4. The traditional Chinese medicine composition according to claim 3, wherein By weight, it includes: 11~30 parts of Astragalus membranaceus, 10~18 parts of Sargentodoxa cuneata, 7~20 parts of Paeonia lactiflora, 7~20 parts of Paeonia veitchii, 5~20 parts of Lycium barbarum, 5~25 parts of Taraxacum mongolicum and 7~30 parts of Portulaca oleracea.

5. The traditional Chinese medicine composition according to claim 4, wherein By weight, it includes: 14~16 parts of Astragalus membranaceus, 10~12 parts of Sargentodoxa cuneata, 9~11 parts of Paeonia lactiflora, 9~11 parts of Paeonia veitchii, 9~11 parts of Lycium barbarum, 9~11 parts of Taraxacum mongolicum and 9~11 parts of Portulaca oleracea; Or, 11~13 parts of Astragalus membranaceus, 10~12 parts of Sargentodoxa cuneata, 7~8 parts of Paeonia lactiflora, 7~8 parts of Paeonia veitchii, 5~6 parts of Lycium barbarum, 5~6 parts of Taraxacum mongolicum, 7~8 parts of Portulaca oleracea; Or, 28~30 parts of Astragalus membranaceus, 16~18 parts of Sargentodoxa cuneata, 18~20 parts of Paeonia lactiflora, 18~20 parts of Paeonia veitchii, 18~20 parts of Lycium barbarum, 23~25 parts of Taraxacum mongolicum and 28~30 parts of Portulaca oleracea.

6. The traditional Chinese medicine composition according to claim 5, characterized in that, By weight, it includes: 15 parts of Astragalus membranaceus, 10 parts of Sargentodoxa cuneata, 10 parts of Paeonia lactiflora, 10 parts of Paeonia veitchii, 10 parts of Lycium barbarum, 10 parts of Taraxacum mongolicum and 10 parts of Portulaca oleracea; Or, 11 parts of Astragalus membranaceus, 10 parts of Sargentodoxa cuneata, 7 parts of Paeonia lactiflora, 7 parts of Paeonia veitchii, 5 parts of Lycium barbarum, 5 parts of Taraxacum mongolicum, 7 parts of Portulaca oleracea; Or, 30 parts of Astragalus membranaceus, 18 parts of Sargentodoxa cuneata, 20 parts of Paeonia lactiflora, 20 parts of Paeonia veitchii, 20 parts of Lycium barbarum, 25 parts of Taraxacum mongolicum and 30 parts of Portulaca oleracea.

7. Use of the traditional Chinese medicine composition according to any one of claims 1-6 in the preparation of a product for treating intestinal polyps.

8. The application according to claim 7, wherein The intestinal polyps include at least one of intestinal polyps of spleen deficiency and dampness stagnation type, large intestine dampness heat type, qi stagnation and blood stasis type.

9. A drug, characterized in that, It includes the traditional Chinese medicine composition according to any one of claims 1-6, or further includes a pharmaceutically acceptable excipient or solvent.

10. The drug according to claim 9, characterized in that, The dosage form of the drug includes at least one of injection, decoction, powder, tablet, capsule, granule and oral liquid.

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