CN110833586A

CN110833586A - A Chinese medicinal composition for treating colitis

Info

Publication number: CN110833586A
Application number: CN201810938209.0A
Authority: CN
Inventors: 魏玮
Original assignee: WANGJING HOSPITAL OF CHINA ACADEMY OF CHINESE MEDICAL SCIENCES
Current assignee: WANGJING HOSPITAL OF CHINA ACADEMY OF CHINESE MEDICAL SCIENCES
Priority date: 2018-08-16
Filing date: 2018-08-16
Publication date: 2020-02-25

Abstract

The invention provides a traditional Chinese medicine composition for treating colitis, which comprises the following raw material medicines: dark plum, white paeony root, tuckahoe, dahurian patrinia herb, heterophylly falsestarwort root, kudzuvine root, golden thread, liquoric root, costustoot, Chinese angelica, immature bitter orange, largehead atractylodes rhizome, silktree albizzia flower and rose. The traditional Chinese medicine composition has a total clinical effective rate of 93.33 percent for treating ulcerative colitis, has an obvious improvement effect on chronic persistent ulcerative colitis, and particularly has an obvious effect on improving abdominal pain and tenesmus symptoms.

Description

A Chinese medicinal composition for treating colitis

Technical Field

The invention relates to a traditional Chinese medicine composition, in particular to a traditional Chinese medicine composition for treating colitis, and belongs to the field of medicines.

Background

Ulcerative colitis is a chronic nonspecific inflammatory disease of the colon and rectum, the etiology of which is not well understood, and the lesions are limited to the large intestinal mucosa and submucosa. Lesions are localized in the sigmoid colon and rectum and may extend to the descending colon, even the entire colon. The disease course is long and the attack is often repeated.

The cause of ulcerative colitis is still unknown to date. Genetic factors may have a certain position. Psychological factors play an important role in the progression of the disease, with the primary presence of pathophysiological states such as depression or social distance being clearly improved after colectomy. Ulcerative colitis is considered to be an autoimmune disease.

The pathogenesis of inflammatory bowel disease is currently believed to be the result of interactions between foreign substances causing host responses, genes, and immune influences. With this insight, ulcerative colitis and crohn's disease are different manifestations of a disease process. The initial manifestations of ulcerative colitis can take many forms. Bloody diarrhea is the most common early symptom. Other symptoms are abdominal pain, hematochezia, weight loss, tenesmus, vomiting, etc. in turn. Occasionally, arthritis, iridocyclitis, liver dysfunction and skin lesions are mainly manifested. Fever is a relatively uncommon sign, with the disease presenting as a chronic, low malignancy in most patients and as an acute, catastrophic outbreak in a few patients (about 15%). These patients present with frequent bloody stools, up to 30 times/day, and high fever, abdominal pain.

The sulfasalazine salicylic acid preparation is a main medicine for treating the ulcerative colitis at present, such as adisha, mesalazine and the like. The corticosteroid is prednisone or dexamethasone as a common drug, but long-term hormone maintenance is not currently considered to prevent relapse. In acute stage also hydrocortisone or dexamethasone can be used for intravenous drip, and every night hydrocortisone can be added into physiological saline for retention enema, and the value of hormone therapy in acute stage is positive, but in chronic stage it is still different whether hormone should be continuously used, and because it has a certain side effect, so that it is mostly not advocated for long-term use. The value of immunosuppressive agents in ulcerative colitis is questionable. Azathioprine has been reported by Rosenberg et al to have no disease-controlling effect in the exacerbation of the disease, whereas in chronic cases it contributes to a reduction in corticosteroid use.

Disclosure of Invention

Aiming at the problems in the prior art, the invention aims to provide a traditional Chinese medicine composition for treating colitis and application thereof.

As one aspect of the present invention, the present invention provides a traditional Chinese medicine composition for treating colitis, wherein the traditional Chinese medicine composition is prepared from the following raw material medicines: dark plum, white paeony root, tuckahoe, dahurian patrinia herb, heterophylly falsestarwort root, kudzuvine root, golden thread, liquoric root, costustoot, Chinese angelica, immature bitter orange, largehead atractylodes rhizome, silktree albizzia flower and rose.

Preferably, the traditional Chinese medicine composition is prepared from the following raw material medicines: 5-25 parts of dark plum fruit, 5-25 parts of white peony root, 7-30 parts of poria cocos, 5-25 parts of herba patriniae, 10-40 parts of radix pseudostellariae, 5-25 parts of radix puerariae, 2-15 parts of coptis chinensis, 2-18 parts of liquorice, 4-20 parts of radix aucklandiae, 4-22 parts of angelica sinensis, 4-22 parts of immature bitter orange, 7-30 parts of bighead atractylodes rhizome, 7-30 parts of albizia flower and 7-30 parts of rose;

further preferably, the traditional Chinese medicine composition is prepared from the following raw material medicines: 6-20 parts of dark plum fruit, 6-20 parts of white peony root, 10-25 parts of poria cocos, 6-20 parts of herba patriniae, 12-30 parts of radix pseudostellariae, 6-20 parts of radix puerariae, 2-10 parts of coptis chinensis, 3-12 parts of liquorice, 6-15 parts of radix aucklandiae, 6-17 parts of angelica sinensis, 6-17 parts of immature bitter orange, 10-25 parts of bighead atractylodes rhizome, 10-25 parts of albizia flower and 10-25 parts of rose;

or, the traditional Chinese medicine composition is prepared from the following raw material medicines: 9-15 parts of dark plum fruit, 9-15 parts of white peony root, 12-18 parts of poria cocos, 9-15 parts of herba patriniae, 15-25 parts of radix pseudostellariae, 9-15 parts of radix puerariae, 3-8 parts of coptis chinensis, 4-9 parts of liquorice, 7-12 parts of radix aucklandiae, 8-14 parts of angelica sinensis, 8-14 parts of immature bitter orange, 12-18 parts of bighead atractylodes rhizome, 12-18 parts of albizia flower and 12-18 parts of rose;

most preferably, the traditional Chinese medicine composition is prepared from the following raw material medicines: 12 parts of dark plum fruit, 12 parts of white paeony root, 15 parts of poria cocos, 12 parts of dahurian patrinia herb, 20 parts of radix pseudostellariae, 12 parts of kudzu vine root, 5 parts of coptis root, 6 parts of liquorice, 9 parts of costustoot, 10 parts of Chinese angelica, 10 parts of immature bitter orange, 15 parts of largehead atractylodes rhizome, 15 parts of albizia flower and 15 parts of rose flower;

or 10 parts of dark plum fruit, 14 parts of white paeony root, 13 parts of poria cocos, 14 parts of dahurian patrinia herb, 16 parts of radix pseudostellariae, 14 parts of kudzuvine root, 3 parts of coptis chinensis, 8 parts of liquorice, 8 parts of costustoot, 13 parts of Chinese angelica, 9 parts of immature bitter orange, 17 parts of largehead atractylodes rhizome, 13 parts of silktree albizzia flower and 17 parts of rose;

or, 14 parts of dark plum fruit, 10 parts of white paeony root, 17 parts of poria cocos, 10 parts of dahurian patrinia herb, 24 parts of radix pseudostellariae, 10 parts of kudzu vine root, 7 parts of coptis root, 5 parts of liquorice, 11 parts of costustoot, 9 parts of Chinese angelica, 13 parts of immature bitter orange, 13 parts of largehead atractylodes rhizome, 17 parts of albizia flower and 13 parts of rose.

The traditional Chinese medicine composition can be a composition formed by crushing and mixing raw material medicines, can also be an extract obtained by mixing or extracting the raw material medicines independently, or an effective part obtained by further refining and purifying the extract, and can also be a conventional preparation form prepared by adding pharmaceutically acceptable auxiliary materials.

Wherein the extraction method comprises decocting extraction, reflux extraction, immersion extraction, ultrasonic extraction, percolation extraction, microwave extraction, etc.; the purification method comprises water extraction and alcohol precipitation, alkali dissolution and acid precipitation and various column chromatography purification methods, such as a macroporous resin column, a silica gel column, a reverse phase column and the like; the conventional dosage forms include but are not limited to injections, capsules, tablets, granules, gels, sustained-release agents, oral liquids, dropping pills or nano preparations; the pharmaceutically acceptable auxiliary materials comprise: fillers, disintegrants, lubricants, suspending agents, binders, sweeteners, flavoring agents, preservatives, bases, and the like. The filler comprises: starch, pregelatinized starch, lactose, mannitol, chitin, microcrystalline cellulose, sucrose, etc.; the disintegrating agent comprises: starch, pregelatinized starch, microcrystalline cellulose, sodium carboxymethyl starch, crospolyvinylpyrrolidone, low-substituted hydroxypropylcellulose, croscarmellose sodium, etc.; the lubricant comprises: magnesium stearate, sodium lauryl sulfate, talc, silica, and the like; the suspending agent comprises: polyvinylpyrrolidone, microcrystalline cellulose, sucrose, agar, hydroxypropyl methylcellulose, and the like; the binder includes starch slurry, polyvinylpyrrolidone, hydroxypropyl methylcellulose, etc.

In the traditional Chinese medicine composition, besides being fed in the form of raw medicinal materials, the raw medicinal materials can also be fed in the form of extracts (effective parts) of the raw medicinal materials, so that the invention further discloses a traditional Chinese medicine composition for treating colitis, which comprises the following raw materials in parts by weight:

a traditional Chinese medicine composition for treating colitis is prepared from the following raw materials: 5-25 parts of dark plum extract, 5-25 parts of white peony root extract, 7-30 parts of poria cocos extract, 5-25 parts of herba patriniae extract, 10-40 parts of radix pseudostellariae extract, 5-25 parts of radix puerariae extract, 2-15 parts of coptis chinensis extract, 2-18 parts of liquorice extract, 4-20 parts of elecampane extract, 4-22 parts of angelica sinensis extract, 4-22 parts of immature bitter orange extract, 7-30 parts of bighead atractylodes rhizome extract, 7-30 parts of albizia flower extract and 7-30 parts of rose extract;

further preferably, the traditional Chinese medicine composition is prepared from the following raw materials: 6-20 parts of dark plum extract, 6-20 parts of white peony root extract, 10-25 parts of poria cocos extract, 6-20 parts of herba patriniae extract, 12-30 parts of radix pseudostellariae extract, 6-20 parts of radix puerariae extract, 2-10 parts of coptis chinensis extract, 3-12 parts of liquorice extract, 6-15 parts of elecampane extract, 6-17 parts of angelica sinensis extract, 6-17 parts of immature bitter orange extract, 10-25 parts of bighead atractylodes rhizome extract, 10-25 parts of albizia flower extract and 10-25 parts of rose extract;

or, the traditional Chinese medicine composition is prepared from the following raw materials: 9-15 parts of dark plum extract, 9-15 parts of white peony root extract, 12-18 parts of poria cocos extract, 9-15 parts of herba patriniae extract, 15-25 parts of radix pseudostellariae extract, 9-15 parts of radix puerariae extract, 3-8 parts of coptis chinensis extract, 4-9 parts of liquorice extract, 7-12 parts of elecampane extract, 8-14 parts of angelica sinensis extract, 8-14 parts of immature bitter orange extract, 12-18 parts of bighead atractylodes rhizome extract, 12-18 parts of albizia flower extract and 12-18 parts of rose extract;

most preferably, the traditional Chinese medicine composition is prepared from the following raw materials: 12 parts of dark plum extract, 12 parts of white peony root extract, 15 parts of poria cocos extract, 12 parts of herba patriniae extract, 20 parts of radix pseudostellariae extract, 12 parts of radix puerariae extract, 5 parts of coptis chinensis extract, 6 parts of liquorice extract, 9 parts of elecampane extract, 10 parts of angelica sinensis extract, 10 parts of immature bitter orange extract, 15 parts of rhizoma atractylodis macrocephalae extract, 15 parts of albizia flower extract and 15 parts of rose extract;

or, 10 parts by weight of dark plum extract, 14 parts by weight of white peony root extract, 13 parts by weight of poria cocos extract, 14 parts by weight of herba patriniae extract, 16 parts by weight of radix pseudostellariae extract, 14 parts by weight of radix puerariae extract, 3 parts by weight of coptis chinensis extract, 8 parts by weight of liquorice extract, 8 parts by weight of radix aucklandiae extract, 13 parts by weight of angelica sinensis extract, 9 parts by weight of immature bitter orange extract, 17 parts by weight of rhizoma atractylodis macrocephalae extract, 13 parts by weight of flos albiziae extract and 17 parts by weight of rose extract;

or, 14 parts by weight of a dark plum extract, 10 parts by weight of a white peony root extract, 17 parts by weight of a poria cocos extract, 10 parts by weight of a herba patriniae extract, 24 parts by weight of a radix pseudostellariae extract, 10 parts by weight of a radix puerariae extract, 7 parts by weight of a coptis chinensis extract, 5 parts by weight of a liquorice extract, 11 parts by weight of a radix aucklandiae extract, 9 parts by weight of an angelica sinensis extract, 13 parts by weight of a immature bitter orange extract, 13 parts by weight of a rhizoma atractylodis macrocephalae extract, 17 parts by weight of a flos albiziae.

The above crude drug extract can be water extract, organic solvent extract, or refined extract obtained by further refining and purifying water extract/organic solvent extract.

The organic solvent is selected from one or more of methanol, 20-95% ethanol solution and acetone;

the extraction method for preparing the extract comprises any one of reflux extraction, immersion extraction, ultrasonic extraction or percolation extraction, or the combination of different extraction methods.

The raw material medicaments of the traditional Chinese medicine composition comprise dark plum, white paeony root, poria cocos, dahurian patrinia herb, radix pseudostellariae, radix puerariae, coptis chinensis, liquorice, costustoot, Chinese angelica, immature bitter orange, bighead atractylodes rhizome, albizia flower and rose, and all meet the record of Chinese pharmacopoeia (2015 edition). Wherein, the white peony root is preferably fried white peony root, the licorice is preferably honey-fried licorice root, the immature bitter orange is preferably fried immature bitter orange, and the largehead atractylodes rhizome is preferably fried largehead atractylodes rhizome. In the traditional Chinese medicine composition, the dark plum fruit is used as a monarch drug in the prescription for astringing and stopping diarrhea; herba patriniae and coptis chinensis are used as ministerial drugs in the prescription for clearing heat, eliminating dampness, detoxifying and expelling pus; angelica and white peony root have the functions of nourishing blood and promoting blood circulation, softening liver and relieving pain, elecampane and immature bitter orange have the functions of promoting qi circulation and relieving pain, kudzu root has the functions of invigorating yang and relieving diarrhea, radix pseudostellariae, fried bighead atractylodes rhizome and poria have the functions of invigorating spleen and eliminating dampness, albizia flower and rose have the functions of resolving depression and soothing nerves, and the ten medicines are used as adjuvant medicines together; licorice root, radix Glycyrrhizae coordinates the effects of the other drugs in the recipe, and acts as a guiding drug in the recipe.

As another aspect of the invention, the invention also provides application of the traditional Chinese medicine composition in preparing a medicine for treating colitis.

As another aspect of the invention, the invention also provides application of the traditional Chinese medicine composition in preparing a medicine for treating ulcerative colitis.

The clinical experiment research result shows that the total clinical effective rate of the traditional Chinese medicine composition for treating ulcerative colitis is 93.33%, the traditional Chinese medicine composition has an obvious improvement effect on chronic persistent ulcerative colitis, and particularly has an obvious effect on improving abdominal pain and tenesmus symptoms.

Detailed Description

Example 1

The formula is as follows: 12g of dark plum fruit, 12g of fried white paeony root, 15g of poria cocos, 12g of dahurian patrinia herb, 20g of radix pseudostellariae, 12g of radix puerariae, 5g of coptis chinensis, 6g of honey-fried licorice root, 9g of costustoot, 10g of Chinese angelica, 10g of fried immature bitter orange, 15g of fried bighead atractylodes rhizome, 15g of albizia flower and 15g of rose flower;

the preparation method comprises the following steps: taking the raw materials according to a certain proportion, decocting the raw materials except for radix aucklandiae in water for 30min, adding radix aucklandiae, decocting for 5min, filtering, decocting the filter residue in water for 30min, filtering, mixing the filtrates, concentrating to 300ml, and dividing into two parts.

The use method comprises the following steps: the patient takes 150ml of the decoction warm in the morning and at night respectively.

And (3) clinical trials:

1. clinical data

1.1 general data

60 patients with chronic persistent ulcerative colitis in the active stage are selected in an outpatient clinic and all meet the syndrome differentiation standard of cold-heat mixed syndrome of ulcerative colitis in traditional Chinese medicine, wherein 34 men and 26 women have the ages of 18-60 years. The random number table method is adopted to divide the treatment group and the control group into 30 cases respectively, 18 cases for men and 12 cases for women; the age is 19-60 years, the average age is 38.5 years, and the course of disease is 1-5 years. Control group 30, male 16, female 14; the age is 20-58 years, and the average age is 40.5 years; the course of disease is 1-7 years. The disease conditions of two groups of patients are similar, and the difference of general data such as sex, age, course of disease and the like has no statistical significance (P is more than 0.05), and has comparability.

1.2 diagnostic criteria

(1) The western medicine diagnosis standard conforms to the consensus opinion (2012, Guangzhou) of diagnosis and treatment of inflammatory bowel disease (refer to Chenzhishui, Beihai, Zhang Wandai, etc. ulcerative colitis and Chinese and Western medicine integrated diagnosis and treatment guide (draft) (China Union of Chinese and Western medicine institute digestive system disease professional committee, 2010, West Chang) [ J ]. China Union of Chinese and Western medicine digestive system, 2011, 19 (01): 61-65):

the clinical manifestations are as follows: the continuous or repeated-attack diarrhea, mucopurulent bloody stool with abdominal pain, tenesmus and general symptoms of different degrees, and the disease course is more than 4-6 weeks. It can be used for treating intestinal diseases such as skin mucosa, joint, eye, liver and gallbladder.

Colonoscopy shows that lesions mostly start from the rectum and are distributed continuously and diffusely, which is characterized in that ① mucosal vascular textures are fuzzy, disordered or disappeared, hyperemia, edema, crisp, spontaneous or contact bleeding and purulent secretion attachment, mucosa is rough and granular, ② lesions are obviously seen in diffuse, multiple erosions or ulcers, ③ is seen in that the colon pouch becomes shallow, blunt or disappeared, pseudopolyps and bridge mucosa and the like.

The pathological activity stage of the mucosa shows that ① diffuse acute and chronic inflammatory cell infiltration in the inherent membrane comprises neutrophils, lymphocytes, plasma cells, eosinophils and the like, particularly the neutrophil infiltration among epithelial cells, cryptitis and crypt abscess, ② change of the structure of the crypt, irregular size and shape of the crypt, disordered arrangement, reduction of goblet cells and the like, ③ can show erosion of the surface of the mucosa, formation of shallow ulcer and granulation tissue hyperplasia.

Can be used for treating infectious colitis such as bacillary dysentery, amebic dysentery, chronic schistosomiasis, and intestinal tuberculosis, Crohn's Disease (CD), ischemic colitis, and radiation colitis.

(2) The diagnosis standard of the syndrome type of mixed chills and fever in traditional Chinese medicine conforms to the diagnosis and treatment guideline (draft) of the combination of traditional Chinese and western medicine (refer to picrorhizine, qianjiaoping, wu kaichun, etc.. consensus opinion of diagnosis and treatment of inflammatory bowel disease in China (2012, guangzhou) [ J ]. internal medicine theory and practice, 2013, 8 (01): 61-75):

syndrome of intermingled cold and heat

① with symptoms of mucus, bloody stool, ② with continuous abdominal pain, preference for warmth and pressure, ③ with lassitude, aversion to cold, ④ with red or pale red tongue with thin and yellow coating.

The secondary symptoms are ① constipation, ② thirst with no preference for drinking or hot drink, ③ pale yellow urine, ④ thready, slow or soft pulse.

The syndrome type is determined by adding 1 main symptom or 1-2 secondary symptoms to ① and ② essential main symptoms.

1.3 inclusion criteria:

(1) the standard of Western medicine diagnosis is met;

(2) the Chinese medicine syndrome diagnosis standard is met;

(3) the age range of the patients is 18-60 years old;

(4) agree and sign a study informed consent.

1.4 exclusion criteria:

(1) serious complications such as local stenosis, ileus, intestinal perforation, rectal polyps, toxic colon dilatation, colon cancer, rectal cancer and anal diseases;

(2) pregnant or pregnancies, lactating women;

(3) allergic constitution and people allergic to various drugs;

(4) patients with serious primary diseases such as liver, kidney, blood system, immune system, endocrine system and the like and mental disease;

(5) the condition is critical, and the effectiveness and safety of the new medicine are difficult to be evaluated exactly.

1.5 treatment regimens

Treatment groups: the decoction prepared in the example 1 is taken 1 dose per day, and the patient takes 150ml of the decoction warm in the morning and at night respectively.

Control group: 18g of dark plum fruit, 18g of fried white peony root, 18g of poria cocos, 36g of herba patriniae, 18g of radix pseudostellariae, 18g of radix puerariae, 7.2g of coptis chinensis, 7.2g of honey-fried licorice root, 10.8g of costustoot, 12g of angelica sinensis, 12g of fried fructus aurantii immaturus and 12g of fried bighead atractylodes rhizome. The decoction is prepared according to the method of example 1, 1 dose is taken every day, 150ml each in the morning and evening with empty stomach.

The two groups are applied for 12 weeks, and after the treatment course is finished, the improvement of the two groups of clinical symptoms is observed.

1.6 therapeutic effect evaluation index and determination method

1.6.1 evaluation Standard of comprehensive therapeutic Effect

Refer to the evaluation standard of comprehensive curative effect of clinical research guidelines (trial) of Chinese medicine new drug (Zhengxiao cornus).

Significant effect (or complete remission): clinical symptoms disappeared and colonoscopy reviewed mucosal normality. Stopping taking the medicine or only using the maintenance dose of the medicine, and observing no relapse for half a year;

the method has the following advantages: clinical symptoms basically disappear, and the colonoscope rechecks the mild inflammatory reaction of mucosa and the formation of partial pseudopolyp;

and (4) invalidation: no improvement in clinical symptoms, endoscopy and pathological examination.

Total effective rate is (effective + effective)/case number × 100%.

1.6.2. Evaluation criteria for therapeutic effects of chief complaints

Grading and quantifying standard of ulcerative colitis symptoms in the guidelines (trial) of clinical research of new traditional Chinese medicines is referred to for main symptom grading, and grading of abdominal pain, diarrhea and bloody purulent stool is performed.

The record and evaluation of the single main symptom are ① clinical control, symptom disappears, ② shows that the symptom is graded and reduced by 2 grades, ③ shows that the symptom is graded and reduced by 1 grade, ④ shows that the standard persons cannot be met (the graded record of the main symptom is 0 grade, no symptom and 0 grade, I grade, the symptom is slight, the daily life is not influenced and the 1 grade, II grade, the symptom is moderate, the daily life is partially influenced and the 2 grade, and III grade, the symptom is serious, the daily life is influenced and the work is hard to be adhered to and the 3 grade).

1.6.3 statistical processing methods

Statistical analysis was performed using SPSS15.0 statistical software, and χ was used as the count data²And (4) testing, wherein t test is adopted for measuring data, and P is less than 0.05 to indicate that the difference has statistical significance.

2. Results

2.1 comparison of symptoms before and after treatment in two groups

The results are shown in Table 1, the abdominal pain and tenesmus after treatment of the two groups are obviously reduced compared with the group before treatment, and the difference has statistical significance.

TABLE 1 comparison of the score of chief complaints before and after treatment for two groups of patients with chronic persistent ulcerative colitis in active phase

Note: p is less than 0.05 compared with the group before treatment, and delta P is less than 0.05 compared with the control group after treatment

2.2 clinical efficacy comparison of the treatment group with the control group

The results are shown in Table 2. The results show that the total effective rate of the treatment group is obviously higher than that of the control group.

TABLE 2 comparison of clinical efficacy of the treatment groups with the control group (example)

Two groups of comparison differences have statistical significance (P < 0.05)

The clinical test results show that the total clinical effective rate of the traditional Chinese medicine composition for treating ulcerative colitis is obviously higher than that of a control group, the traditional Chinese medicine composition has an obvious improvement effect on chronic persistent ulcerative colitis, and especially has an obvious effect on improving abdominal pain and tenesmus symptoms.

Example 2

The formula is as follows: 10g of dark plum fruit, 14g of white paeony root, 13g of poria cocos, 14g of herba patriniae, 16g of radix pseudostellariae, 14g of radix puerariae, 3g of coptis chinensis, 8g of liquorice, 8g of radix aucklandiae, 13g of angelica sinensis, 9g of immature bitter orange, 17g of bighead atractylodes rhizome, 13g of albizia flower and 17g of rose;

the preparation method comprises the following steps: taking the raw materials according to a certain proportion, adding 70% ethanol, extracting under reflux twice, each time for 1 hour, filtering, mixing filtrates, concentrating, adding conventional adjuvants, and making into tablet.

Example 3

The formula is as follows: 14g of dark plum fruit, 10g of white paeony root, 17g of poria cocos, 10g of herba patriniae, 24g of radix pseudostellariae, 10g of radix puerariae, 7g of coptis chinensis, 5g of liquorice, 11g of elecampane, 9g of angelica sinensis, 13g of immature bitter orange, 13g of bighead atractylodes rhizome, 17g of albizia flower and 13g of rose;

the preparation method comprises the following steps: taking the raw materials according to a certain proportion, adding 50% ethanol, extracting under reflux twice, each time for 1 hour, filtering, mixing filtrates, concentrating, adding conventional adjuvants, and making into capsule.

Example 4

The formula is as follows: 9g of dark plum fruit, 15g of white paeony root, 12g of poria cocos, 15g of herba patriniae, 15g of radix pseudostellariae, 15g of radix puerariae, 3g of coptis chinensis, 9g of liquorice, 7g of elecampane, 14g of angelica sinensis, 8g of immature bitter orange, 18g of bighead atractylodes rhizome, 12g of albizia flower and 18g of rose;

the preparation method comprises the following steps: taking the raw materials according to a certain proportion, adding 90% ethanol, extracting under reflux twice, each time for 1 hour, filtering, combining filtrates, concentrating, adding conventional adjuvants, and making into oral liquid.

Example 5

The formula is as follows: 15g of dark plum fruit, 9g of white paeony root, 18g of poria cocos, 9g of herba patriniae, 25g of radix pseudostellariae, 9g of radix puerariae, 8g of coptis chinensis, 4g of liquorice, 12g of elecampane, 8g of angelica sinensis, 14g of immature bitter orange, 12g of bighead atractylodes rhizome, 18g of albizia flower and 12g of rose;

the preparation method comprises the following steps: taking the raw materials in proportion, adding 50% ethanol, performing ultrasonic extraction twice for 40min each time, filtering, mixing filtrates, concentrating, adding conventional adjuvants, and making into capsule.

Example 6

The formula is as follows: 10g of dark plum fruit, 13g of white paeony root, 14g of poria cocos, 12g of herba patriniae, 23g of radix pseudostellariae, 11g of radix puerariae, 4g of coptis chinensis, 7g of liquorice, 11g of elecampane, 12g of angelica sinensis, 13g of immature bitter orange, 16g of bighead atractylodes rhizome, 16g of albizia flower and 13g of rose;

the preparation method comprises the following steps: taking the raw materials in proportion, adding 70% ethanol, extracting with ultrasound twice for 40min each time, filtering, mixing filtrates, concentrating, adding conventional adjuvants, and making into pill.

Example 7

The formula is as follows: 6g of dark plum fruit, 20g of white paeony root, 10g of poria cocos, 20g of herba patriniae, 12g of radix pseudostellariae, 20g of radix puerariae, 2g of coptis chinensis, 12g of liquorice, 6g of elecampane, 17g of angelica sinensis, 6g of immature bitter orange, 25g of bighead atractylodes rhizome, 10g of albizia flower and 25g of rose;

the preparation method comprises the following steps: taking the raw materials in proportion, adding 90% ethanol, performing ultrasonic extraction twice for 40min each time, filtering, mixing filtrates, concentrating, adding conventional adjuvants, and making into tablet.

Example 8

The formula is as follows: 20g of dark plum fruit, 6g of white paeony root, 25g of poria cocos, 6g of herba patriniae, 30g of radix pseudostellariae, 6g of radix puerariae, 10g of coptis chinensis, 3g of liquorice, 15g of elecampane, 6g of angelica sinensis, 17g of immature bitter orange, 10g of bighead atractylodes rhizome, 25g of albizia flower and 10g of rose;

the preparation method comprises the following steps: the same as in example 1.

Example 9

The formula is as follows: 18g of dark plum fruit, 7g of white paeony root, 22g of poria cocos, 7g of herba patriniae, 28g of radix pseudostellariae, 7g of radix puerariae, 9g of coptis chinensis, 4g of liquorice, 14g of elecampane, 7g of angelica sinensis, 16g of immature bitter orange, 11g of bighead atractylodes rhizome, 22g of albizia flower and 11g of rose;

the preparation method comprises the following steps: the same as in example 1.

Example 10

The formula is as follows: 5g of dark plum fruit, 25g of white paeony root, 7g of poria cocos, 25g of herba patriniae, 10g of radix pseudostellariae, 25g of radix puerariae, 2g of coptis chinensis, 18g of liquorice, 4g of elecampane, 22g of angelica sinensis, 4g of immature bitter orange, 30g of bighead atractylodes rhizome, 7g of albizia flower and 30g of rose;

the preparation method comprises the following steps: the same as in example 1.

Example 11

The formula is as follows: 25g of dark plum fruit, 5g of white paeony root, 30g of poria cocos, 5g of herba patriniae, 40g of radix pseudostellariae, 5g of radix puerariae, 15g of coptis chinensis, 2g of liquorice, 20g of elecampane, 4g of angelica sinensis, 22g of immature bitter orange, 7g of bighead atractylodes rhizome, 30g of albizia flower and 7g of rose;

the preparation method comprises the following steps: the same as in example 1.

Example 12

The formula is as follows: 24g of dark plum fruit, 6g of white paeony root, 28g of poria cocos, 6g of herba patriniae, 38g of radix pseudostellariae, 6g of radix puerariae, 14g of coptis chinensis, 3g of liquorice, 19g of elecampane, 5g of angelica sinensis, 20g of immature bitter orange, 8g of bighead atractylodes rhizome, 29g of albizia flower and 8g of rose;

the preparation method comprises the following steps: the same as in example 1.

Example 13

The formula is as follows: 6g of dark plum fruit, 24g of white paeony root, 8g of poria cocos, 23g of herba patriniae, 11g of radix pseudostellariae, 22g of radix puerariae, 3g of coptis chinensis, 17g of liquorice, 5g of elecampane, 20g of angelica sinensis, 5g of immature bitter orange, 28g of bighead atractylodes rhizome, 8g of albizia flower and 28g of rose;

the preparation method comprises the following steps: the same as in example 1.

Example 14

The formula is as follows: 12g of dark plum extract, 12g of white peony root extract, 15g of poria cocos extract, 12g of herba patriniae extract, 20g of radix pseudostellariae extract, 12g of radix puerariae extract, 5g of coptis chinensis extract, 6g of liquorice extract, 9g of radix aucklandiae extract, 10g of angelica sinensis extract, 10g of immature bitter orange extract, 15g of rhizoma atractylodis macrocephalae extract, 15g of albizia flower extract and 15g of rose extract; the extracts are water extracts.

Mixing the extracts, adding conventional adjuvants, and making into tablet.

Example 15

The formula is as follows: 10g of dark plum extract, 14g of white peony root extract, 13g of poria cocos extract, 14g of herba patriniae extract, 16g of radix pseudostellariae extract, 14g of radix puerariae extract, 3g of coptis chinensis extract, 8g of liquorice extract, 8g of radix aucklandiae extract, 13g of angelica sinensis extract, 9g of immature bitter orange extract, 17g of rhizoma atractylodis macrocephalae extract, 13g of albizia flower extract and 17g of rose extract; each extract was a 50% ethanol extract.

Mixing the extracts, adding conventional adjuvants, and making into capsule.

Example 16

The formula is as follows: 14g of dark plum extract, 10g of white peony root extract, 17g of poria cocos extract, 10g of herba patriniae extract, 24g of radix pseudostellariae extract, 10g of radix puerariae extract, 7g of coptis chinensis extract, 5g of liquorice extract, 11g of radix aucklandiae extract, 9g of angelica sinensis extract, 13g of immature bitter orange extract, 13g of rhizoma atractylodis macrocephalae extract, 17g of albizia flower extract and 13g of rose extract; each extract was a 70% ethanol extract.

Mixing the extracts, adding conventional adjuvants, and making into granule.

Example 17

The formula is as follows: 9g of dark plum extract, 15g of white peony root extract, 12g of poria cocos extract, 15g of herba patriniae extract, 15g of radix pseudostellariae extract, 15g of radix puerariae extract, 3g of coptis chinensis extract, 9g of liquorice extract, 7g of radix aucklandiae extract, 14g of angelica sinensis extract, 8g of immature bitter orange extract, 18g of rhizoma atractylodis macrocephalae extract, 12g of albizia flower extract and 18g of rose extract; each extract was a 90% ethanol extract.

Mixing the extracts, adding conventional adjuvants, and making into oral liquid.

Example 18

The formula is as follows: 15g of dark plum extract, 9g of white peony root extract, 18g of poria cocos extract, 9g of patrinia herb extract, 25g of radix pseudostellariae extract, 9g of radix puerariae extract, 8g of coptis chinensis extract, 4g of liquorice extract, 12g of radix aucklandiae extract, 8g of angelica sinensis extract, 14g of immature bitter orange extract, 12g of bighead atractylodes rhizome extract, 18g of albizia flower extract and 12g of rose extract; the extracts are water extracts.

Example 19

The formula is as follows: 10g of dark plum extract, 13g of white paeony root extract, 14g of poria cocos extract, 12g of herba patriniae extract, 23g of radix pseudostellariae extract, 11g of radix puerariae extract, 4g of coptis chinensis extract, 7g of liquorice extract, 11g of radix aucklandiae extract, 12g of angelica sinensis extract, 13g of immature bitter orange extract, 16g of rhizoma atractylodis macrocephalae extract, 16g of flos albiziae extract and 13g of rose extract; the extracts are water extracts.

Example 20

The formula is as follows: 6g of dark plum extract, 20g of white peony root extract, 10g of poria cocos extract, 20g of herba patriniae extract, 12g of radix pseudostellariae extract, 20g of radix puerariae extract, 2g of coptis chinensis extract, 12g of liquorice extract, 6g of radix aucklandiae extract, 17g of angelica sinensis extract, 6g of immature bitter orange extract, 25g of rhizoma atractylodis macrocephalae extract, 10g of albizia flower extract and 25g of rose extract; each extract was a 40% ethanol extract.

Example 21

The formula is as follows: 20g of dark plum extract, 6g of white peony root extract, 25g of poria cocos extract, 6g of herba patriniae extract, 30g of radix pseudostellariae extract, 6g of radix puerariae extract, 10g of coptis chinensis extract, 3g of liquorice extract, 15g of radix aucklandiae extract, 6g of angelica sinensis extract, 17g of immature bitter orange extract, 10g of rhizoma atractylodis macrocephalae extract, 25g of albizia flower extract and 10g of rose extract; each extract was a 30% ethanol extract.

Example 22

The formula is as follows: 18g of dark plum extract, 7g of white peony root extract, 22g of poria cocos extract, 7g of herba patriniae extract, 28g of radix pseudostellariae extract, 7g of radix puerariae extract, 9g of coptis chinensis extract, 4g of liquorice extract, 14g of radix aucklandiae extract, 7g of angelica sinensis extract, 16g of immature bitter orange extract, 11g of rhizoma atractylodis macrocephalae extract, 22g of albizia flower extract and 11g of rose extract; each extract was a 90% ethanol extract.

Example 23

The formula is as follows: 5g of dark plum extract, 25g of white peony root extract, 7g of poria cocos extract, 25g of herba patriniae extract, 10g of radix pseudostellariae extract, 25g of radix puerariae extract, 2g of coptis chinensis extract, 18g of liquorice extract, 4g of radix aucklandiae extract, 22g of angelica sinensis extract, 4g of immature bitter orange extract, 30g of rhizoma atractylodis macrocephalae extract, 7g of albizia flower extract and 30g of rose extract; the extracts are water extracts.

Example 24

The formula is as follows: 25g of dark plum extract, 5g of white peony root extract, 30g of poria cocos extract, 5g of herba patriniae extract, 40g of radix pseudostellariae extract, 5g of radix puerariae extract, 15g of coptis chinensis extract, 2g of liquorice extract, 20g of radix aucklandiae extract, 4g of angelica sinensis extract, 22g of immature bitter orange extract, 7g of rhizoma atractylodis macrocephalae extract, 30g of albizia flower extract and 7g of rose extract; each extract was a 50% ethanol extract.

Example 25

The formula is as follows: 24g of dark plum extract, 6g of white peony root extract, 28g of poria extract, 6g of herba patriniae extract, 38g of radix pseudostellariae extract, 6g of radix puerariae extract, 14g of coptis root extract, 3g of liquorice extract, 19g of radix aucklandiae extract, 5g of angelica extract, 20g of immature bitter orange extract, 8g of rhizoma atractylodis macrocephalae extract, 29g of albizia flower extract and 8g of rose extract; each extract was a 70% ethanol extract.

Example 26

The formula is as follows: 6g of dark plum extract, 24g of white paeony root extract, 8g of poria cocos extract, 23g of herba patriniae extract, 11g of radix pseudostellariae extract, 22g of radix puerariae extract, 3g of coptis chinensis extract, 17g of liquorice extract, 5g of radix aucklandiae extract, 20g of angelica sinensis extract, 5g of immature bitter orange extract, 28g of rhizoma atractylodis macrocephalae extract, 8g of albizia flower extract and 28g of rose extract; each extract was a 90% ethanol extract.

The compositions prepared in examples 2-26 above all had the effects of treating ulcerative colitis and ameliorating abdominal pain and symptoms of tenesmus.

Claims

1. The traditional Chinese medicine composition for treating colitis is characterized by being prepared from the following raw material medicines: dark plum, white paeony root, tuckahoe, dahurian patrinia herb, heterophylly falsestarwort root, kudzuvine root, golden thread, liquoric root, costustoot, Chinese angelica, immature bitter orange, largehead atractylodes rhizome, silktree albizzia flower and rose.

2. The traditional Chinese medicine composition of claim 1, wherein the traditional Chinese medicine composition is prepared from the following raw material medicines: 5-25 parts of dark plum fruit, 5-25 parts of white peony root, 7-30 parts of poria cocos, 5-25 parts of herba patriniae, 10-40 parts of radix pseudostellariae, 5-25 parts of radix puerariae, 2-15 parts of coptis chinensis, 2-18 parts of liquorice, 4-20 parts of radix aucklandiae, 4-22 parts of angelica sinensis, 4-22 parts of immature bitter orange, 7-30 parts of bighead atractylodes rhizome, 7-30 parts of albizia flower and 7-30 parts of rose;

or 6-20 parts of dark plum fruit, 6-20 parts of white peony root, 10-25 parts of poria cocos, 6-20 parts of herba patriniae, 12-30 parts of radix pseudostellariae, 6-20 parts of radix puerariae, 2-10 parts of coptis chinensis, 3-12 parts of liquorice, 6-15 parts of radix aucklandiae, 6-17 parts of angelica sinensis, 6-17 parts of immature bitter orange, 10-25 parts of bighead atractylodes rhizome, 10-25 parts of albizia flower and 10-25 parts of rose;

or 9-15 parts of dark plum fruit, 9-15 parts of white peony root, 12-18 parts of poria cocos, 9-15 parts of dahurian patrinia herb, 15-25 parts of radix pseudostellariae, 9-15 parts of kudzu root, 3-8 parts of coptis chinensis, 4-9 parts of liquorice, 7-12 parts of costustoot, 8-14 parts of angelica sinensis, 8-14 parts of immature bitter orange, 12-18 parts of bighead atractylodes rhizome, 12-18 parts of albizia flower and 12-18 parts of rose.

3. The traditional Chinese medicine composition of claim 2, wherein the traditional Chinese medicine composition is prepared from the following raw material medicines: 12 parts of dark plum fruit, 12 parts of white paeony root, 15 parts of poria cocos, 12 parts of dahurian patrinia herb, 20 parts of radix pseudostellariae, 12 parts of kudzu vine root, 5 parts of coptis root, 6 parts of liquorice, 9 parts of costustoot, 10 parts of Chinese angelica, 10 parts of immature bitter orange, 15 parts of largehead atractylodes rhizome, 15 parts of albizia flower and 15 parts of rose flower;

4. The traditional Chinese medicine composition of any one of claims 1 to 3, wherein the traditional Chinese medicine composition is a composition prepared by crushing and mixing raw materials, or is an extract prepared by mixing or extracting the raw materials separately, or is an effective part prepared by refining and purifying the extract, or is a conventional preparation prepared by adding pharmaceutically acceptable auxiliary materials.

5. The traditional Chinese medicine composition of claim 4, wherein the conventional dosage form comprises an injection, a capsule, a tablet, a granule, a gel, a sustained-release agent, an oral liquid, a dripping pill or a nano-preparation.

6. A traditional Chinese medicine composition for treating colitis is characterized by being prepared from the following raw materials: 5-25 parts of dark plum extract, 5-25 parts of white peony root extract, 7-30 parts of poria cocos extract, 5-25 parts of herba patriniae extract, 10-40 parts of radix pseudostellariae extract, 5-25 parts of radix puerariae extract, 2-15 parts of coptis chinensis extract, 2-18 parts of liquorice extract, 4-20 parts of elecampane extract, 4-22 parts of angelica sinensis extract, 4-22 parts of immature bitter orange extract, 7-30 parts of bighead atractylodes rhizome extract, 7-30 parts of albizia flower extract and 7-30 parts of rose extract.

7. The traditional Chinese medicine composition of claim 6, wherein the traditional Chinese medicine composition is prepared from the following raw materials: 6-20 parts of dark plum extract, 6-20 parts of white peony root extract, 10-25 parts of poria cocos extract, 6-20 parts of herba patriniae extract, 12-30 parts of radix pseudostellariae extract, 6-20 parts of radix puerariae extract, 2-10 parts of coptis chinensis extract, 3-12 parts of liquorice extract, 6-15 parts of elecampane extract, 6-17 parts of angelica sinensis extract, 6-17 parts of immature bitter orange extract, 10-25 parts of bighead atractylodes rhizome extract, 10-25 parts of albizia flower extract and 10-25 parts of rose extract;

or 9-15 parts of dark plum extract, 9-15 parts of white peony root extract, 12-18 parts of poria cocos extract, 9-15 parts of herba patriniae extract, 15-25 parts of radix pseudostellariae extract, 9-15 parts of radix puerariae extract, 3-8 parts of coptis chinensis extract, 4-9 parts of liquorice extract, 7-12 parts of elecampane extract, 8-14 parts of angelica sinensis extract, 8-14 parts of immature bitter orange extract, 12-18 parts of rhizoma atractylodis macrocephalae extract, 12-18 parts of albizia flower extract and 12-18 parts of rose extract.

8. The traditional Chinese medicine composition of claim 7, wherein the traditional Chinese medicine composition is prepared from the following raw materials: 12 parts of dark plum extract, 12 parts of white peony root extract, 15 parts of poria cocos extract, 12 parts of herba patriniae extract, 20 parts of radix pseudostellariae extract, 12 parts of radix puerariae extract, 5 parts of coptis chinensis extract, 6 parts of liquorice extract, 9 parts of elecampane extract, 10 parts of angelica sinensis extract, 10 parts of immature bitter orange extract, 15 parts of rhizoma atractylodis macrocephalae extract, 15 parts of albizia flower extract and 15 parts of rose extract;

9. Use of a Chinese medicinal composition according to any one of claims 1-3 and 6-8 in the preparation of a medicament for the treatment of colitis.

10. Use of a Chinese medicinal composition as claimed in any one of claims 1-3, 6-8 in the preparation of a medicament for the treatment of ulcerative colitis.