Traditional Chinese medicine agentia for intestinal diseases and preparation method of traditional Chinese medicine agentia

Abstract

The invention discloses a traditional Chinese medicine preparation for intestinal diseases, and belongs to the technical field of traditional Chinese medicine, and the traditional Chinese medicine preparation for intestinal diseases comprises the following raw materials in parts by weight: 25-35 parts of angelica sinensis-paeonia lactiflora powder prescription extract, 10-15 parts of lactose oligosaccharide nano-microspheres, and 15-22 parts of sodium alginate capsule shells containing angelica sinensis-paeonia lactiflora powder prescription dregs, the Chinese angelica and Chinese herbaceous peony powder prescription comprises six medicinal materials of Chinese angelica, Chinese herbaceous peony, poria cocos, rhizoma alismatis, bighead atractylodes rhizome and ligusticum wallichii. According to the finally prepared traditional Chinese medicine preparation for intestinal diseases, the traditional Chinese medicine angelica sinensis and paeonia lactiflora powder is successfully converted into an efficient oral preparation simulating enema administration, the medicine can be prevented from being damaged by the stomach, the active ingredients of the angelica sinensis and paeonia lactiflora powder are accurately delivered to the colon part for targeted release, the whole body effect is reduced, the colon medicine concentration is increased, and the intestinal diseases are treated. Therefore, the administration dosage is reduced, the compliance of a patient is improved, and the bioavailability of the medicine and the treatment effect on ulcerative colitis are improved.

Description

Technical Field

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

[0002] Ulcerative colitis (UC) is a chronic nonspecific intestinal inflammatory disease with an unknown etiology. The lesions mainly involve the rectum, colon mucosa and submucosa. Clinical manifestations are mostly diarrhea, abdominal pain, blood in the stool, etc., which seriously reduce the quality of life of patients and significantly increase the risk of colon cancer. At present, the commonly used drugs in clinical practice are mainly aminosalicylic acids, glucocorticoids and immunomodulators, but long-term use can lead to side effects such as high-dose toxicity, autoimmunity, drug dependence and adverse reactions.

[0003] As a classic Chinese medicine prescription, Danggui Shaoyao San has the effects of nourishing blood and activating blood circulation, strengthening the spleen and promoting diuresis, soothing the liver and relieving depression. In the treatment of ulcerative colitis, Danggui Shaoyao San can regulate the body's immune function, inhibit inflammatory response, and promote the repair and regeneration of intestinal mucosa. However, traditional methods of administration, such as oral administration or enema, have certain limitations. Orally administered drugs will be released, absorbed, and decomposed in the stomach and small intestine after oral administration, resulting in a significant reduction in the amount of drugs reaching the colon, making it difficult to achieve the expected therapeutic effect. If taken orally, there are problems such as large dosage, low drug utilization, and poor patient compliance. Although enema administration can ensure that the drug reaches the colon directly, it is also accompanied by problems such as operational complexity, patient discomfort, and uneven drug distribution. Summary of the invention

[0004] In order to overcome the shortcomings of the prior art, one of the purposes of the present invention is to provide a Chinese medicine for ulcerative colitis, which successfully transforms the traditional Chinese medicine Danggui Shaoyao San into a high-efficiency oral preparation that simulates enema administration, which can prevent the drug from being destroyed by the stomach, and accurately deliver the active ingredients of Danggui Shaoyao San to the colon for targeted release, reduce systemic effects, enhance colon drug concentration, thereby reducing the dosage, improving patient compliance, and increasing the bioavailability of the drug and the therapeutic effect of ulcerative colitis.

[0005] The second object of the present invention is to provide a method for manufacturing a traditional Chinese medicine for intestinal diseases. The method has simple steps and can be used for industrial production of traditional Chinese medicine for intestinal diseases.

[0006] One of the purposes of the present invention is achieved by the following technical solution:

[0007] A traditional Chinese medicine for intestinal diseases comprises, by weight, 25 to 35 parts of Danggui Shaoyao San extract, 10 to 15 parts of oligolactose nanospheres, and 15 to 22 parts of sodium alginate capsule shells containing Danggui Shaoyao San residues; the medicinal materials in the Danggui Shaoyao San are six kinds of ingredients, namely, angelica, peony, tuckahoe, oriental water plantain, atractylodes macrocephala, and ligusticum chuanxiong.

[0008] Furthermore, the raw materials in parts by weight include: 30 parts of Danggui Shaoyao San extract, 13 parts of oligolactose nanospheres, and 19 parts of sodium alginate capsule shells containing Danggui Shaoyao San residues; the medicinal materials in the Danggui Shaoyao San are angelica, peony, Poria, Alisma, Atractylodes and Chuanxiong.

[0009] Furthermore, the preparation method of the Danggui Shaoyao San prescription extract comprises the following steps:

[0010] 1) Wash and roughly chop the above six medicinal materials, namely, angelica sinensis, peony root, Poria cocos, oriental water chestnut, white atractylodes and ligusticum chuanxiong, and soak them in cold water for 30-40 minutes to obtain the decoction;

[0011] 2) The decoction of the medicine in step 1) is boiled over high heat and then decocted over low heat for 30-60 minutes, filtered, and the medicine liquid is concentrated by rotary evaporation to obtain the Danggui Shaoyao San prescription extract.

[0012] Furthermore, the method for preparing the sodium alginate capsule shell containing the dregs of Danggui Shaoyao San prescription comprises the following steps:

[0013] 1) crushing and sieving the residues for preparing the Danggui Shaoyao San extract to obtain a residue particle size of 100-200 μm to obtain a mixed material;

[0014] 2) mixing and dissolving sodium alginate and water at 80-90° C. to obtain a prefabricated glue solution, slowly adding the mixture obtained in step 1) into the prefabricated glue solution and mixing until the Danggui Shaoyao San prescription residue in the mixture can be completely suspended in the prefabricated glue solution to obtain a glue solution;

[0015] 3) After the glue solution in step 2) is allowed to stand and degas, it is formed using a capsule shell mold, and then dried and demolded to obtain the sodium alginate capsule shell containing the Danggui Shaoyao San prescription residue.

[0016] Oligosaccharide nanospheres: Oligosaccharide nanospheres are polymerized from oligosaccharides, and have the prebiotic properties of oligosaccharides and the advantages of nanotechnology. As its main ingredient, oligosaccharides are not only naturally safe, but also can promote the proliferation of beneficial intestinal bacteria such as bifidobacteria and lactic acid bacteria, thereby regulating the balance of intestinal flora to improve intestinal function and have a positive impact on intestinal health. Furthermore, probiotics can secrete a variety of enzymes, which can convert the complex components in the Danggui Shaoyao Powder prescription into small molecular active substances that are more easily absorbed and utilized by the human body through enzymatic hydrolysis, thereby improving the bioavailability and efficacy of Danggui Shaoyao Powder. In addition, oligosaccharide nanospheres are loaded with the active ingredients of the Danggui Shaoyao Powder prescription, so that the drug is continuously and stably released in the intestine, prolonging the drug's action time. Its small size and high specific surface area enable the drug to contact the intestinal mucosa more effectively, improving the bioavailability of the drug.

[0017] Sodium alginate capsule shell containing Danggui Shaoyao San prescription residue: The capsule shell prepared from sodium alginate containing the residue of the present invention has the characteristics of a dual control mechanism, and the capsule shell prepared from sodium alginate has the characteristics of a pH-dependent targeting system, and can select pH sensitivity that is insensitive to acidic environments, and can swell in alkaline environments, so that the drug can be released in specific parts of the colon; the capsule shell containing Danggui Shaoyao San prescription residue is rich in insoluble fiber and has the characteristics of a time-dependent drug delivery system, which can control the gradual release of the drug 3 to 4 hours after gastric emptying. The combination of the two can more accurately control the drug to reach and be released in specific parts of the colon at a specific time, thereby improving the accuracy of drug delivery, reducing systemic effects, and enhancing the effect of local colon concentration.

[0018] The second object of the present invention is achieved by adopting the following technical solution:

[0019] The present invention provides a method for preparing a traditional Chinese medicine for intestinal diseases, comprising the following steps:

[0020] 1) adjusting the pH value of the Danggui Shaoyao San extract to 4-5, adding the formulated amount of oligolactose nanospheres, stirring at 1200 rpm and 30° C. for 20-40 min, and freeze-drying to obtain oligolactose nanospheres containing the Danggui Shaoyao San extract;

[0021] 2) Encapsulating the nano-microspheres containing the Danggui Shaoyao San extract in step 1) into the sodium alginate capsule shell containing the Danggui Shaoyao San residue, thereby obtaining the Chinese medicine for intestinal diseases.

[0022] Compared with the prior art, the present invention has the following beneficial effects:

[0023] In an important medicament for intestinal diseases of the present invention, the capsule shell prepared by sodium alginate containing the dregs of the prescription of Danggui Shaoyao San has the characteristics of a dual control mechanism, and the capsule shell prepared by sodium alginate has the characteristics of a pH-dependent targeting system, and can select pH sensitivity to be insensitive to acidic environments, swell in alkaline environments, and can release drugs in specific parts of the colon; the capsule shell prepared by the dregs of the prescription of Danggui Shaoyao San is rich in insoluble fiber, has the characteristics of a time-dependent drug delivery system, and can control the gradual release of drugs 3 to 4 hours after gastric emptying. The combination of the two can more accurately control the arrival and release of drugs in specific parts of the colon at a specific time, thereby improving the accuracy of drug delivery. Oligosaccharide nanospheres are polymerized by oligosaccharides, and have the prebiotic properties of oligosaccharides and the advantages of nanotechnology. As its main component, oligosaccharides not only have natural safety, but also can promote the proliferation of beneficial intestinal bacteria such as bifidobacteria and lactic acid bacteria, thereby regulating the balance of intestinal flora to improve intestinal function and have a positive impact on intestinal health. Further, probiotics can secrete a variety of enzymes, which can convert the complex components in the Danggui Shaoyao Powder prescription into small molecule active substances that are more easily absorbed and utilized by the human body through enzymolysis, thereby improving the bioavailability and efficacy of Danggui Shaoyao Powder. In addition, oligolactose nano-microspheres load the active ingredients of the Danggui Shaoyao Powder prescription, so that the drug is continuously and stably released in the intestine, prolonging the action time of the drug, and its small size and high specific surface area enable the drug to contact the intestinal mucosa more effectively, thereby improving the bioavailability of the drug. At the same time, the present invention makes the Danggui Shaoyao Powder prescription drug residue into a capsule shell, and the Danggui Shaoyao Powder prescription extract is made into a capsule core, so that the medicinal material is maximized, and while reducing the dosage, the Chinese medicine medicament finally obtained has a more comprehensive pharmacological action, and can more comprehensively treat ulcerative colitis, and improve the therapeutic effect. In summary, the present invention successfully transforms the traditional Chinese medicine Danggui Shaoyao Powder into a high-efficiency oral preparation simulating enema administration by combining a capsule shell containing the Danggui Shaoyao Powder prescription residue and oligolactose nanoparticles loaded with the Danggui Shaoyao Powder prescription extract, which can prevent the drug from being destroyed by the stomach, and enable the active ingredients of Danggui Shaoyao Powder to be accurately delivered to the colon for targeted release, reduce systemic effects, enhance colon drug concentration, thereby reducing the dosage, improving patient compliance, and increasing the bioavailability of the drug and the therapeutic effect of ulcerative colitis. DETAILED DESCRIPTION

[0024] The present invention is further described below in conjunction with specific embodiments. It should be noted that, under the premise of no conflict, the embodiments or technical features described below can be arbitrarily combined to form a new embodiment.

[0025] Example 1

[0026] The raw materials of the traditional Chinese medicine for intestinal diseases provided in this embodiment include, by weight: 25 parts of Danggui Shaoyao San extract, 15 parts of oligolactose nanospheres, and 15 parts of sodium alginate capsule shells containing Danggui Shaoyao San residues; the medicinal materials in the Danggui Shaoyao San are six kinds of Danggui, Paeonia, Poria, Alisma, Atractylodes and Chuanxiong.

[0027] The preparation method of the Danggui Shaoyao San prescription extract comprises the following steps:

[0028] 1) washing and roughly chopping the above six medicinal materials, namely, angelica, peony, poria, oriental water, atractylodes and ligusticum, and soaking them in cold water for 30-40 minutes to obtain a decoction; 2) boiling the decoction in step 1) over high heat, then decocting over low heat for 30-60 minutes, filtering, and concentrating the decoction by rotary evaporation to obtain an extract of angelica shaoyao powder.

[0029] The preparation method of the sodium alginate capsule shell containing the dregs of Danggui Shaoyao San prescription comprises the following steps:

[0030] 1) crushing and screening the drug residues for preparing the Danggui Shaoyao San extract to obtain a drug residue particle size of 100-200 μm to obtain a mixture; 2) mixing and dissolving sodium alginate and water at 80-90° C. to obtain a prefabricated glue solution, slowly adding the mixture obtained in step 1) into the prefabricated glue solution and mixing until the Danggui Shaoyao San drug residues in the mixture can be completely suspended in the prefabricated glue solution to obtain a glue solution; 3) standing the glue solution in step 2) to degas, forming it with a capsule shell mold, and then drying and demolding to obtain the sodium alginate capsule shell containing the Danggui Shaoyao San drug residues.

[0031] The method for preparing a Chinese medicine for intestinal diseases provided in this embodiment comprises the following steps:

[0032] 1) adjusting the pH value of the Danggui Shaoyao San extract to 4-5, adding the formulated amount of oligolactose nanospheres, stirring at 1200 rpm and 30° C. for 20-40 min, and freeze-drying to obtain oligolactose nanospheres containing the Danggui Shaoyao San extract; 2) encapsulating the nanospheres containing the Danggui Shaoyao San extract in step 1) into the sodium alginate capsule shell containing the Danggui Shaoyao San residue, to obtain the traditional Chinese medicine for intestinal diseases.

[0033] Example 2

[0034] The raw materials of the traditional Chinese medicine for intestinal diseases provided in this embodiment include, by weight: 35 parts of Danggui Shaoyao San extract, 10 parts of oligolactose nanospheres, and 22 parts of sodium alginate capsule shells containing Danggui Shaoyao San residues; the medicinal materials in the Danggui Shaoyao San are six kinds of Danggui Shaoyao San, namely, Danggui, Paeonia lactiflora, Poria, Alisma orientalis, Atractylodes macrocephala and Ligusticum chuanxiong.

[0035] The preparation method of the Danggui Shaoyao San prescription extract comprises the following steps:

[0036] 1) washing and roughly chopping the above six medicinal materials, namely, angelica, peony, poria, oriental water, atractylodes and ligusticum, and soaking them in cold water for 30-40 minutes to obtain a decoction; 2) boiling the decoction in step 1) over high heat, then decocting over low heat for 30-60 minutes, filtering, and concentrating the decoction by rotary evaporation to obtain an extract of angelica shaoyao powder.

[0037] The preparation method of the sodium alginate capsule shell containing the dregs of Danggui Shaoyao San prescription comprises the following steps:

[0038] 1) crushing and screening the drug residues for preparing the Danggui Shaoyao San extract to obtain a drug residue particle size of 100-200 μm to obtain a mixture; 2) mixing and dissolving sodium alginate and water at 80-90° C. to obtain a prefabricated glue solution, slowly adding the mixture obtained in step 1) into the prefabricated glue solution and mixing until the Danggui Shaoyao San drug residues in the mixture can be completely suspended in the prefabricated glue solution to obtain a glue solution; 3) standing the glue solution in step 2) to degas, forming it with a capsule shell mold, and then drying and demolding to obtain the sodium alginate capsule shell containing the Danggui Shaoyao San drug residues.

[0039] The method for preparing a Chinese medicine for intestinal diseases provided in this embodiment comprises the following steps:

[0040] 1) adjusting the pH value of the Danggui Shaoyao San extract to 4-5, adding the formulated amount of oligolactose nanospheres, stirring at 1200 rpm and 30° C. for 20-40 min, and freeze-drying to obtain oligolactose nanospheres containing the Danggui Shaoyao San extract; 2) encapsulating the nanospheres containing the Danggui Shaoyao San extract in step 1) into the sodium alginate capsule shell containing the Danggui Shaoyao San residue, to obtain the traditional Chinese medicine for intestinal diseases.

[0041] Example 3

[0042] The raw materials of the Chinese herbal medicine for intestinal diseases provided in this embodiment include, by weight: 30 parts of Danggui Shaoyao San extract, 13 parts of oligolactose nanospheres, and 19 parts of sodium alginate capsule shells containing Danggui Shaoyao San residues; the medicinal materials in the Danggui Shaoyao San are angelica, peony, Poria, Alisma, Atractylodes and Chuanxiong.

[0043] The preparation method of the Danggui Shaoyao San prescription extract comprises the following steps:

[0044] 1) washing and roughly chopping the above six medicinal materials, namely, angelica, peony, poria, oriental water, atractylodes and ligusticum, and soaking them in cold water for 30-40 minutes to obtain a decoction; 2) boiling the decoction in step 1) over high heat, then decocting over low heat for 30-60 minutes, filtering, and concentrating the decoction by rotary evaporation to obtain an extract of angelica shaoyao powder.

[0045] The preparation method of the sodium alginate capsule shell containing the dregs of Danggui Shaoyao San prescription comprises the following steps:

[0046] 1) crushing and screening the drug residues for preparing the Danggui Shaoyao San extract to obtain a drug residue particle size of 100-200 μm to obtain a mixture; 2) mixing and dissolving sodium alginate and water at 80-90° C. to obtain a prefabricated glue solution, slowly adding the mixture obtained in step 1) into the prefabricated glue solution and mixing until the Danggui Shaoyao San drug residues in the mixture can be completely suspended in the prefabricated glue solution to obtain a glue solution; 3) standing the glue solution in step 2) to degas, forming it with a capsule shell mold, and then drying and demolding to obtain the sodium alginate capsule shell containing the Danggui Shaoyao San drug residues.

[0047] The method for preparing a Chinese medicine for intestinal diseases provided in this embodiment comprises the following steps:

[0048] 1) adjusting the pH value of the Danggui Shaoyao San extract to 4-5, adding the formulated amount of oligolactose nanospheres, stirring at 1200 rpm and 30° C. for 20-40 min, and freeze-drying to obtain oligolactose nanospheres containing the Danggui Shaoyao San extract; 2) encapsulating the nanospheres containing the Danggui Shaoyao San extract in step 1) into the sodium alginate capsule shell containing the Danggui Shaoyao San residue, to obtain the traditional Chinese medicine for intestinal diseases.

[0049] Example 4

[0050] The raw materials of the traditional Chinese medicine for intestinal diseases provided in this embodiment include, by weight: 28 parts of Danggui Shaoyao San extract, 14 parts of oligolactose nanospheres, and 18 parts of sodium alginate capsule shells containing Danggui Shaoyao San residues; the medicinal materials in the Danggui Shaoyao San are angelica, peony, Poria, Alisma, Atractylodes and Chuanxiong.

[0051] The preparation method of the Danggui Shaoyao San prescription extract comprises the following steps:

[0052] 1) washing and roughly chopping the above six medicinal materials, namely, angelica, peony, poria, oriental water, atractylodes and ligusticum, and soaking them in cold water for 30-40 minutes to obtain a decoction; 2) boiling the decoction in step 1) over high heat, then decocting over low heat for 30-60 minutes, filtering, and concentrating the decoction by rotary evaporation to obtain an extract of angelica shaoyao powder.

[0053] The preparation method of the sodium alginate capsule shell containing the dregs of Danggui Shaoyao San prescription comprises the following steps:

[0054] 1) crushing and screening the drug residues for preparing the Danggui Shaoyao San extract to obtain a drug residue particle size of 100-200 μm to obtain a mixture; 2) mixing and dissolving sodium alginate and water at 80-90° C. to obtain a prefabricated glue solution, slowly adding the mixture obtained in step 1) into the prefabricated glue solution and mixing until the Danggui Shaoyao San drug residues in the mixture can be completely suspended in the prefabricated glue solution to obtain a glue solution; 3) standing the glue solution in step 2) to degas, forming it with a capsule shell mold, and then drying and demolding to obtain the sodium alginate capsule shell containing the Danggui Shaoyao San drug residues.

[0055] The method for preparing a Chinese medicine for intestinal diseases provided in this embodiment comprises the following steps:

[0056] 1) adjusting the pH value of the Danggui Shaoyao San extract to 4-5, adding the formulated amount of oligolactose nanospheres, stirring at 1200 rpm and 30° C. for 20-40 min, and freeze-drying to obtain oligolactose nanospheres containing the Danggui Shaoyao San extract; 2) encapsulating the nanospheres containing the Danggui Shaoyao San extract in step 1) into the sodium alginate capsule shell containing the Danggui Shaoyao San residue, to obtain the traditional Chinese medicine for intestinal diseases.

[0057] Example 5

[0058] The raw materials of the traditional Chinese medicine for intestinal diseases provided in this embodiment include, by weight: 33 parts of Danggui Shaoyao San extract, 11 parts of oligolactose nanospheres, and 20 parts of sodium alginate capsule shells containing Danggui Shaoyao San residues; the medicinal materials in the Danggui Shaoyao San are angelica, peony, Poria, Alisma, Atractylodes and Chuanxiong.

[0059] The preparation method of the Danggui Shaoyao San prescription extract comprises the following steps:

[0060] 1) washing and roughly chopping the above six medicinal materials, namely, angelica, peony, poria, oriental water, atractylodes and ligusticum, and soaking them in cold water for 30-40 minutes to obtain a decoction; 2) boiling the decoction in step 1) over high heat, then decocting over low heat for 30-60 minutes, filtering, and concentrating the decoction by rotary evaporation to obtain an extract of angelica shaoyao powder.

[0061] The preparation method of the sodium alginate capsule shell containing the dregs of Danggui Shaoyao San prescription comprises the following steps:

[0062] 1) crushing and screening the drug residues for preparing the Danggui Shaoyao San extract to obtain a drug residue particle size of 100-200 μm to obtain a mixture; 2) mixing and dissolving sodium alginate and water at 80-90° C. to obtain a prefabricated glue solution, slowly adding the mixture obtained in step 1) into the prefabricated glue solution and mixing until the Danggui Shaoyao San drug residues in the mixture can be completely suspended in the prefabricated glue solution to obtain a glue solution; 3) standing the glue solution in step 2) to degas, forming it with a capsule shell mold, and then drying and demolding to obtain the sodium alginate capsule shell containing the Danggui Shaoyao San drug residues.

[0063] The method for preparing a Chinese medicine for intestinal diseases provided in this embodiment comprises the following steps:

[0064] 1) adjusting the pH value of the Danggui Shaoyao San extract to 4-5, adding the formulated amount of oligolactose nanospheres, stirring at 1200 rpm and 30° C. for 20-40 min, and freeze-drying to obtain oligolactose nanospheres containing the Danggui Shaoyao San extract; 2) encapsulating the nanospheres containing the Danggui Shaoyao San extract in step 1) into the sodium alginate capsule shell containing the Danggui Shaoyao San residue, to obtain the traditional Chinese medicine for intestinal diseases.

[0065] Comparative Example 1

[0066] The difference from Example 1 is that oligolactose nanoparticles are not added.

[0067] Comparative Example 2

[0068] The difference from Example 1 is that the residue of Danggui Shaoyao San prescription is not prepared into capsule shells.

[0069] Experimental example

[0070] 1. Clinical efficacy observation

[0071] 1.1 General Information

[0072] A total of 135 patients who visited the Affiliated Hospital of North Sichuan Medical College from January to December 2023, were diagnosed with ulcerative colitis and met the diagnosis of spleen deficiency type.

[0073] Inclusion criteria:

[0074] (1) Aged between 18 and 75 years old; (2) Patients diagnosed with ulcerative colitis; (3) Confirmed by the attending physician and chief physician and consistent with the traditional Chinese medicine syndrome differentiation of spleen deficiency.

[0075] Exclusion criteria:

[0076] (1) Those under 18 years old or over 75 years old; (2) Pregnant women or women planning to get pregnant in the near future, and breastfeeding women; (3) Patients with serious diseases such as cardiovascular system, blood system, liver and kidney dysfunction; (4) Those taking other oral medications or receiving other acupuncture treatments; (5) Those who are unable to cooperate, such as those who are unwilling to cooperate or those with neurological or mental illnesses; (6) Those with acute or fulminant enteritis.

[0077] Shedding criteria:

[0078] (1) Patients who experienced adverse events during the trial; (2) Patients who voluntarily withdrew from the trial; (3) Patients who were lost to follow-up during the trial.

[0079] 1.2 Diagnostic criteria

[0080] 1.2.1 Western medicine diagnostic criteria

[0081] Refer to the "Consensus on the Diagnosis and Treatment of Inflammatory Bowel Disease" formulated by the Chinese Medical Association in 2012.

[0082] (1) Clinical manifestations: long-term and recurrent diarrhea, bloody and mucous stools, accompanied by abdominal pain, tenesmus, and varying degrees of systemic symptoms. The course of the disease is generally more than 4 to 6 weeks.

[0083] (2) Colonoscopy: Active stage: Mild inflammation: erythema, mucosal congestion and disappearance of vascular texture; moderate inflammation: disappearance of vascular morphology, mucosal congestion and erosion, often accompanied by mucosal roughness and contact bleeding; severe inflammation: spontaneous mucosal bleeding and ulcers. Remission stage: normal mucosal appearance can be seen, and pseudopolyp formation or scar-like changes can also be seen. Those with a long course of disease may see mucosal atrophy, shallow or disappearance of colon bags, and narrowing of the intestinal cavity.

[0084] (3) Mucosal biopsy: Active stage: ① Diffuse or acute or chronic inflammatory cell infiltration in the lamina propria; ② Crypt structure changes, irregular morphology, disordered arrangement, and reduced goblet cells; ③ Erosion of the mucosal surface, shallow ulcers, and hyperplastic granulation tissue can be seen. Remission stage: ① Mucosal erosion or ulcer healing; ② Chronic inflammatory cell infiltration in the lamina propria decreases, and neutrophil infiltration decreases or disappears; ③ Crypt structure changes can be retained, and Paneth cell metaplasia can be seen.

[0085] (4) Barium enema examination can also be performed when colonoscopy is not possible: ① The mucosa becomes rough and / or granular; ② The edges of the intestine become serrated or burr-like, and there are multiple small filling defects in the intestinal wall; ③ The intestine is shortened, the pouch disappears, and it becomes lead-pipe-like.

[0086] After excluding other diseases, the diagnosis is made according to the following points: (1) Patients with typical clinical manifestations are suspected of diagnosis; (2) Patients with colonoscopic and / or radiological features can be clinically diagnosed; (3) Patients with histopathological characteristics of mucosal biopsy and / or surgical resection specimens can be diagnosed; (4) Patients with atypical clinical manifestations, colonoscopy and biopsy histology in the first case will be followed up but not diagnosed for the time being.

[0087] 1.2.2 TCM diagnostic criteria

[0088] Consensus on the diagnosis and treatment of ulcerative colitis with integrated traditional Chinese and Western medicine (2010).

[0089] (1) Main symptoms: ① Diarrhea; ② Bloody stool; ③ Loss of appetite; ④ Abdominal pain.

[0090] (2) Secondary symptoms: ① Abdominal distension; ② Limb fatigue; ③ Mental fatigue and laziness; ④ Belching; ⑤ Chest distension and tightness.

[0091] Tongue and pulse (not included in the scoring): pale or red tongue, thin white or greasy tongue coating, thin or weak or stringy and slippery pulse.

[0092] Patients with all the main symptoms and 3 or more secondary symptoms (the first one is required) can be diagnosed with ulcerative colitis of spleen deficiency type by referring to the tongue and pulse.

[0093] 1.2 Treatment methods

[0094] Therapeutic drugs: Example 1, Comparative Example 1 and Comparative Example 2 provide a traditional Chinese medicine for intestinal diseases.

[0095] Treatment method: Each group of patients took the medicine half an hour after breakfast and dinner. Each group needed two courses of treatment, each course lasting three weeks.

[0096] 1.4 Observation indicators

[0097] (1) Main clinical symptoms: observe the symptoms of diarrhea, bloody stool, anorexia, and abdominal pain, and score them as follows: 0 points, 2 points, 4 points, and 6 points respectively for no symptoms, mild, moderate, and severe symptoms; observe the symptoms of abdominal distension, limb fatigue, fatigue, belching, and chest and flank distension and pain, and score them as follows: 0 points, 1 point, 2 points, and 3 points respectively for no symptoms, mild, moderate, and severe symptoms. The specific scoring criteria are shown in Table 1 below.

[0098] Table 1 Scores of main clinical symptoms

[0099]

[0100]

[0101] (2) Related examinations: colonoscopy and anoscopy, routine stool examination, blood test, urine test, biochemical routine examination, erythrocyte sedimentation rate, etc.

[0102] 1.5 Criteria for determining efficacy

[0103] 1.5.1 Determination of TCM Syndrome Efficacy

[0104] Formulated with reference to the "Guidelines for Clinical Research of New Chinese Medicines".

[0105] The criteria for judging the efficacy of TCM syndromes were calculated according to the nimodipine method: efficacy index = [(score before treatment - score after treatment) / score before treatment] × 100%.

[0106] Clinical recovery: The patient's clinical symptoms and signs basically disappear, and the syndrome score decreases by ≥95%;

[0107] Markedly effective: The patient's clinical symptoms and signs are significantly improved, and the syndrome score is reduced by ≥70% but <95%;

[0108] Effective: The patient's clinical symptoms and signs are improved, and the syndrome score is reduced by ≥30% but <70%;

[0109] Ineffective: The patient's clinical symptoms and signs did not improve significantly, or even worsened, and the syndrome score decreased by <30%.

[0110] 1.5.2 Modified Mayo Scoring System for Assessing UC Activity

[0111] Table 2 Modified Mayo score

[0112]

[0113] Note: 1) The frequency of bowel movements was compared with each subject's own situation to evaluate the degree of abnormal bowel movements; 2) The score of blood in stool was calculated according to the most serious bleeding situation of the day; 3) The physician's evaluation included the following three criteria: ① The subject's review of abdominal discomfort, ② Overall sense of well-being, and ③ Other manifestations; a score of ≤2 points and a single sub-item score of ≤1 point was considered clinical remission, 3-5 points were considered mild activity, 6-10 points were considered moderate activity, and 11-12 points were considered severe activity; effective treatment was defined as a decrease in the score of ≥30% and ≥3 points, and a decrease in the score of blood in stool of ≥1 point or a score of ≤1 point.

[0114] 1.6 Evaluation criteria for efficacy of mucosal lesions

[0115] Modified Baron criteria: 0 points = Grade 0: normal mucosa; 1 point = Grade I: mucosal congestion and blurred blood vessels; 2 points = Grade II: mucosal contact bleeding; 3 points = Grade III: spontaneous mucosal bleeding; 4 points = Grade IV: ulcers of varying sizes can be seen on the mucosa.

[0116] 1.6 Statistical methods

[0117] SPSS 26.0 statistical software was used to analyze the data, and the measurement data were expressed as mean ± standard deviation. t test was used for the expression of data, and chi-square test was used for the expression of data. 2 P < 0.05 was considered statistically significant.

[0118] 1.7 Results

[0119] 1.7.1 Effect of TCM syndromes before and after treatment

[0120] Table 3 Comparison of TCM syndrome scores

[0121] Group Number of cases Before treatment After treatment Example 1 45 19.63±4.06 5.57±2.10 Comparative Example 1 45 19.73±5.69 10.61±3.21 Comparative Example 2 45 19.76±6.42 10.35±5.22

[0122] Table 4 Syndrome efficacy [n (%)]

[0123] Group get well Significant effect efficient invalid Total Effectiveness Example 1 6 15 23 1 97.78 Comparative Example 1 0 16 19 10 77.78 Comparative Example 2 0 15 20 8 77.78

[0124] As shown in Table 4, the improvement of TCM syndromes, through the monidipine algorithm, the total effective rate of Example 1 is 97.78%, the total effective rate of Comparative Example 1 is 77.78%, and the total effective rate of Comparative Example 1 is 77.78%. After statistical processing, the difference in the clinical TCM syndrome efficacy after treatment of Example 1 and Comparative Example 1 and Comparative Example 2 is statistically significant (P < 0.05).

[0125] 1.7.2 Assessment of mucosal lesion grade

[0126] Table 5 Baron score

[0127] Group Number of cases Before treatment After treatment Example 1 45 3.67±0.34 1.76±0.25 Comparative Example 1 45 3.65±0.82 2.27±0.69 Comparative Example 2 45 3.70±1.34 2.19±0.42

[0128] Six months after treatment, the two groups of patients underwent colonoscopy review in the outpatient clinic to assess the grade of mucosal lesions. As shown in Table 5, there was no statistically significant difference in the Baron scores of the three groups before treatment (P>0.05); after treatment, the three groups were all improved compared with the previous test values, and the differences in Baron scores were statistically significant (P<0.01) whether comparing Example 1 with Comparative Example 1 and Comparative Example 2 within or between groups.

[0129] 1.7.3 Comparison of Mayo scores

[0130] Table 6 Mayo score

[0131] Group Number of cases Before treatment After treatment Example 1 45 8.63±2.31 2.31±1.37 Comparative Example 1 45 8.68±1.93 3.36±1.40 Comparative Example 2 45 8.52±2.18 3.42±2.73

[0132] As shown in Table 6, there was no significant difference in the Mayo scores among the three groups before treatment (P>0.05); after treatment, the three groups were improved compared with the previous test values, and the differences in Mayo scores were statistically significant whether comparing Example 1 with Comparative Example 1 or Comparative Example 2 within or between groups (P<0.01).

[0133] 1.7.4 Analysis of test results

[0134] (1) Erythrocyte sedimentation rate (ESR)

[0135] Table 7 Erythrocyte sedimentation rate ( mm / h)

[0136] Group Number of cases Before treatment After treatment Example 1 45 22.94±4.31 15.68±2.18 Comparative Example 1 45 22.76±3.54 19.51±5.21 Comparative Example 2 45 22.84±6.34 19.62±4.62

[0137] As shown in Table 7, there was no significant difference in the ESR values ​​of the three groups before treatment (P>0.05); after treatment, the ESR values ​​of the three groups of patients decreased, and the ESR values ​​of Example 1 were compared with Comparative Example 1 and Comparative Example 2, and the differences were statistically significant (P<0.05), indicating that the Chinese medicine for intestinal diseases of the present invention can reduce inflammatory indicators in the treatment of ulcerative colitis of spleen and stomach deficiency type.

[0138] (2) Occult blood in feces

[0139] Table 8 Fecal occult blood [n(%)]

[0140]

[0141] As shown in Table 8, the improvement of fecal occult blood is effective in Example 1 at 89.74%, in Comparative Example 1 at 67.5%, and in Comparative Example 2 at 66.67%. After statistical analysis, the difference in clinical TCM syndrome efficacy after treatment between Example 1 and Comparative Example 1 and Comparative Example 2 is statistically significant (P < 0.05).

[0142] The above-mentioned embodiments are only preferred embodiments of the present invention and cannot be used to limit the scope of protection of the present invention. Any non-substantial changes and substitutions made by technicians in this field on the basis of the present invention shall fall within the scope of protection required by the present invention.

Claims

1. A Chinese medicinal preparation for intestinal diseases, characterized in that: The raw materials include, by weight: 25-35 parts of Danggui Shaoyao San extract, 10-15 parts of oligolactose nanospheres, and 15-22 parts of sodium alginate capsule shells containing Danggui Shaoyao San residues; the medicinal materials in the Danggui Shaoyao San are angelica, peony, Poria, Alisma, Atractylodes and Chuanxiong.

2. A Chinese medicinal preparation for intestinal diseases according to claim 1, characterized in that: The raw materials include, by weight: 30 parts of Danggui Shaoyao Powder extract, 13 parts of oligolactose nanospheres, and 19 parts of sodium alginate capsule shells containing Danggui Shaoyao Powder residues; the medicinal materials in the Danggui Shaoyao Powder are angelica, peony, Poria, Alisma, Atractylodes and Chuanxiong.

3. A Chinese medicinal preparation for intestinal diseases according to claim 1 or 2, characterized in that: The preparation method of the Danggui Shaoyao San prescription extract comprises the following steps: 1) Wash and roughly chop the above six medicinal materials, namely, angelica sinensis, peony root, poria cocos, oriental water chestnut, atractylodes macrocephala and ligusticum chuanxiong, and soak them in cold water for 30-40 minutes to obtain the decoction; 2) The decoction of the medicine in step 1) is boiled over high heat and then decocted over low heat for 30-60 minutes, filtered, and the medicine liquid is concentrated by rotary evaporation to obtain the Danggui Shaoyao San prescription extract.

4. A Chinese medicinal preparation for intestinal diseases as claimed in claim 1 or 2, wherein the preparation method of the sodium alginate capsule shell containing the dregs of Danggui Shaoyao San prescription comprises the following steps: 1) crushing and sieving the residues for preparing the Danggui Shaoyao San extract to obtain a residue particle size of 100-200 μm to obtain a mixed material; 2) mixing and dissolving sodium alginate and water at 80-90° C. to obtain a prefabricated glue solution, slowly adding the mixture obtained in step 1) into the prefabricated glue solution and mixing until the Danggui Shaoyao San prescription residue in the mixture can be completely suspended in the prefabricated glue solution to obtain a glue solution; 3) After the glue solution in step 2) is allowed to stand and degas, it is formed using a capsule shell mold, and then dried and demolded to obtain the sodium alginate capsule shell containing the Danggui Shaoyao San prescription residue.

5. A method for preparing a traditional Chinese medicine for intestinal diseases according to any one of claims 1 to 4, characterized in that: The following steps are involved: 1) adjusting the pH value of the Danggui Shaoyao San extract to 4-5, adding the formulated amount of oligolactose nanospheres, stirring at 1200 rpm and 30° C. for 20-40 min, and freeze-drying to obtain oligolactose nanospheres containing the Danggui Shaoyao San extract; 2) Encapsulating the nano-microspheres containing the Danggui Shaoyao San extract in step 1) into the sodium alginate capsule shell containing the Danggui Shaoyao San residue, thereby obtaining the Chinese medicine for intestinal diseases.

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