CN113694123A

CN113694123A - Traditional Chinese medicine composition for treating colitis and preparation method and application thereof

Info

Publication number: CN113694123A
Application number: CN202111115493.XA
Authority: CN
Inventors: 曲苗; 吴鑫宇; 庄颖梅; 常惟智; 旺建伟; 孙敏; 隋方宇; 张淼; 关子赫; 田洪昭; 高明珠
Original assignee: Heilongjiang University of Chinese Medicine
Current assignee: Heilongjiang University of Chinese Medicine
Priority date: 2021-09-23
Filing date: 2021-09-23
Publication date: 2021-11-26

Abstract

The invention relates to a traditional Chinese medicine composition for treating colitis and a preparation method and application thereof, and relates to the field of traditional Chinese medicines, aiming at solving the problem of poor symptomatic treatment effect of the traditional Chinese medicine prescription at present, the traditional Chinese medicine composition comprises 15-25 parts of medicated leaven, 10-20 parts of angelica, 10-20 parts of fried white peony root, 10-20 parts of poria cocos, 10-20 parts of raw white atractylodes rhizome, 10-20 parts of purslane, 10-20 parts of plantain herb, 10-20 parts of codonopsis pilosula, 5-15 parts of ligusticum wallichii, 5-15 parts of rhizoma alismatis and 2-7 parts of costus root. The medicine comprises a traditional Chinese medicine composition for treating colitis and an acupoint plaster, and is used for treating colitis. The invention is applied to the field of traditional Chinese medicine.

Description

Traditional Chinese medicine composition for treating colitis and preparation method and application thereof

Technical Field

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

Background

Ulcerative Colitis (UC) belongs to chronic nonspecific inflammatory diseases, mostly invades large intestine mucosa and submucosa, is clinically characterized by using mucopurulent bloody stool as the most common symptom accompanied by abdominal pain, diarrhea and tenesmus, and the pathogenesis of the disease is possibly related to the interaction of various factors such as environment, heredity, infection, immunity and the like. The intestinal ulcer of the patient is recurrent and not healed for a long time, and the treatment difficulty is large. The theory of traditional Chinese medicine considers that: the disease is mainly caused by weakness of the spleen and the stomach, which is mostly caused by improper diet, uncooked and cold food and unclean food; or internal injury due to emotional disorder, excessive seven emotions, liver qi affecting the spleen, and weakness of the spleen and stomach in transportation and transformation; or exogenous pathogenic wind, cold and dampness, especially damp pathogen, which most easily obstructs the function of spleen and stomach, resulting in weakness of spleen and stomach, and undivided clear and turbid pathogens, mixed diarrhea. The pathogenesis of the disease is different, and the key point is that the damp-heat accumulates in the intestine and the blood collaterals of the intestinal wall are injured when pus and bloody stool is taken as the main point; the diarrhea is mainly manifested as deficiency and excess, while the excess syndrome is damp-heat accumulation in the intestine and disorder of the large intestine; deficiency syndrome is spleen deficiency, dampness, transportation and transformation failing to be healthy; for hematochezia, the excess syndrome is damp-heat accumulating in the intestine, damaging the intestinal collaterals and blood overflow; deficiency syndrome refers to the impairment of yin by damp-heat, internal flaming of deficient fire and burning of heat in the intestine, and both have the key pathogenesis of stasis and heat blocking the collaterals, which are forcing the recklessly blood flow. The main pathogenesis of the abdominal pain excess syndrome is that damp-heat accumulates in the intestines, qi and blood are not regulated, the intestinal collaterals are blocked, and pain is caused by obstruction; the deficiency syndrome is caused by earth deficiency, wood excess, liver and spleen disorder, disturbance of deficient wind, and intestine collateral disharmony.

Ulcerative colitis is a common inflammatory disease in clinic, and the clinical treatment method mainly adopts western medicine symptomatic treatment, such as treatment with aminosalicylic acid preparation, corticosteroid hormone or immunosuppressant. However, the drug has great toxic and side effects after long-term administration, easily causes the tolerance degree of patients to be reduced, further influences the treatment effect, and has very undesirable prognosis. Therefore, the need for an effective and safe method for treating ulcerative colitis is an urgent issue for the present clinicians. The traditional Chinese medicine decoction for treating ulcerative colitis has the characteristics of less adverse reaction, low medical expense, obvious curative effect and the like, and is widely applied clinically.

Ulcerative colitis belongs to the categories of chronic dysentery, intestine , diarrhea, and diarrhea in traditional Chinese medicine. The discussion related to "intestine " is closest to the disease. The expression "stool blood in the intestine, white foam … … in the lower part of the body fluid, pus blood in the lower part of the intestine, hematochezia … …" is the earliest in the West question, general comments on deficiency and excess, and is very similar to the common clinical symptoms of the disease. The traditional Chinese medicine considers that the causes of ulcerative colitis are external causes and internal causes, wherein the external causes mainly comprise six exogenous pathogens, particularly damp-heat pathogens, and the internal causes mainly comprise congenital deficiency, emotional disorder, improper diet, viscera deficiency and the like. Suwen Xuanji original disease type six qi' disease states that the disease is caused by dampness-heat more in intestines and stomach and Buddha stagnation, and the disease is also caused by heat. "the medical principle dysentery house" states that dysentery is a disease, which is known to be caused by disharmony of the zang-fu organs, and stagnation of damp-heat in the intestines and stomach cannot be eliminated; it is also caused by wind, cold, summer-heat, and damp. "plain questions, Taiyin Yang Ming Lun" (plain questions, Taiyin Yang Ming Lun) "states that yin is also in earth qi and mainly in … …, improper diet, and occasionally living, … … yin reception of yin enters five zang organs, and entering five zang organs leads to abdominal fullness and obstruction, and finally, 39143indicates diarrhea and intestine for a long time. Su Wen & Tan Lun (plain questions & pain relieving treatises) states that anger causes adverse flow of qi and even hematemesis, and \ 39143; "purges". In the book of Jingyue quan Shu Xie, it is said that the cause of diarrhea is not due to the spleen and stomach. The Chinese medical science has published the opinion on the combined diagnosis and treatment of ulcerative colitis in the spleen and stomach disease division, and the disease is mainly classified into six types, namely large intestine damp-heat syndrome, yin and blood deficiency syndrome, spleen and kidney yang deficiency syndrome, liver depression and spleen deficiency syndrome, blood stasis and intestinal collateral syndrome, cold and heat mixed syndrome and the like according to the common clinical morbidity types of ulcerative colitis. Acute stage is manifested by damp-heat syndrome of large intestine, blood stasis and intestinal collateral syndrome, and cold-heat complicated syndrome, while remission stage is manifested by damp-heat syndrome due to spleen deficiency, liver depression and spleen deficiency, and yang deficiency of spleen and kidney

The major symptoms of the large intestine damp-heat syndrome are: abdominal pain, diarrhea, pus and blood in the mucous under the stool; the tongue is red and the coating is yellow and greasy. The secondary symptoms are as follows: the anus has burning discomfort; tenesmus in tenesmus; fever, scanty and brownish urine; dry mouth with bitter taste, sometimes halitosis; the pulse is smooth and rapid.

The main symptoms of spleen deficiency and dampness accumulation syndrome: loose stool with red, scanty or white jelly mucus; pale-red tongue with teeth marks on the tongue edge and white and greasy coating. The secondary symptoms are as follows: the abdominal pain is dull; abdominal distension, abdominal discomfort and anorexia; lassitude of limbs, mental fatigue and no desire to speak; the pulse is thready, weak or thready and slippery.

The main symptoms of the syndrome of intermingled cold and heat: thin and thin stool with sticky and frozen stool, and repeated attack; the tongue is red, or a pale-red tongue with yellow and thin coating. The secondary symptoms are as follows: the abdominal pain is continuous; the limbs are not warm; burning sensation in the abdomen, polydipsia; the pulse is wiry or thready.

The main symptoms of the liver-stagnation and spleen-deficiency syndrome are as follows: abdominal pain means diarrhea, and pain is relieved after diarrhea; the frequent stool is often increased due to emotional changes or poor diet. The secondary symptoms are as follows: loose stools, or mucous stools; mood depression or anxiety disorder; belching, poor appetite and abdominal distension; the tongue is pale red with thin and white coating; the pulse is wiry or wiry and thready.

The main symptoms of the spleen-kidney yang deficiency syndrome are as follows: chronic diarrhea with white frost accompanied by indigestion and even improper slippage; cold in shape and cold in limbs. The secondary symptoms are as follows: abdominal pain prefers to be warm and press; abdominal distension, poor appetite; soreness of the waist and knees; a pale and fat tongue with teeth marks on the tongue edge and a thin and white tongue coating; deep and thready.

The main symptoms of yin-blood deficiency syndrome are: difficulty in defecation, with a small amount of mucus, bloody pus and stool; the tongue is red and little fluid, and has little or no coating. The secondary symptoms are as follows: dull burning pain in the abdomen; low fever in the afternoon, night sweat; dry mouth and throat; dizziness, restlessness and restlessness; the pulse is thready and rapid.

There are also many traditional Chinese medicines for treating ulcerative colitis, such as the ones for licensed and the like, which are used for syndrome differentiation and type division of UC: modified Baitouweng Tang for damp-heat accumulation; for liver qi stagnation, the recipe of pain-purging herbs is modified; modified Shen Ling Bai Zhu san is used for spleen and stomach weakness. Zhang Yong et al think spleen deficiency and blood stasis are the main pathogenesis of UC intestinal mucosa difficult to heal, advocate using the Tong Li Xiaodu san. The different focus of each kind of Chinese medicine aims at the disease, the oral and external treatment mechanisms are not clear, and the treatment effects are different. Especially, each Chinese medicinal preparation has poor treatment effect on one or more types of ulcerative colitis.

Disclosure of Invention

The invention aims to solve the problem that the conventional traditional Chinese medicine prescription has poor symptomatic treatment effect, and provides a traditional Chinese medicine composition for treating colitis and a preparation method and application thereof.

The traditional Chinese medicine composition for treating colitis comprises, by weight, 15-25 parts of medicated leaven, 10-20 parts of Chinese angelica, 10-20 parts of fried white paeony root, 10-20 parts of poria cocos, 10-20 parts of raw bighead atractylodes rhizome, 10-20 parts of purslane, 10-20 parts of plantain herb, 10-20 parts of codonopsis pilosula, 5-15 parts of ligusticum wallichii, 5-15 parts of rhizoma alismatis and 2-7 parts of costustoot.

Further, the composition comprises, by weight, 20 parts of medicated leaven, 15 parts of Chinese angelica, 15 parts of fried white paeony root, 15 parts of poria cocos, 15 parts of raw bighead atractylodes rhizome, 15 parts of purslane, 15 parts of plantain herb, 15 parts of codonopsis pilosula, 10 parts of ligusticum wallichii, 10 parts of rhizoma alismatis and 5 parts of costus root.

The method of the traditional Chinese medicine composition for treating the colitis is carried out according to the following steps:

1) weighing 15-25 parts of medicated leaven, 10-20 parts of Chinese angelica, 10-20 parts of fried white paeony root, 10-20 parts of poria cocos, 10-20 parts of raw bighead atractylodes rhizome, 10-20 parts of purslane, 10-20 parts of plantain herb, 10-20 parts of codonopsis pilosula, 5-15 parts of ligusticum wallichii, 5-15 parts of rhizoma alismatis and 2-7 parts of costustoot for later use;

2) mixing the above materials, soaking in water, decocting, filtering, decocting the residue with water, mixing decoctions, filtering, and removing impurities to obtain decoction for treating colitis.

The application of a Chinese medicinal composition for treating colitis, which is used for preparing a medicament for treating colitis;

the medicine comprises a traditional Chinese medicine composition for treating colitis and an acupoint plaster;

the traditional Chinese medicine composition for treating colitis comprises, by weight, 15-25 parts of medicated leaven, 10-20 parts of Chinese angelica, 10-20 parts of fried white peony root, 10-20 parts of poria cocos, 10-20 parts of raw bighead atractylodes rhizome, 10-20 parts of purslane, 10-20 parts of plantain herb, 10-20 parts of codonopsis pilosula, 5-15 parts of ligusticum wallichii, 5-15 parts of rhizoma alismatis and 2-7 parts of costustoot;

the acupoint plaster is prepared by the following steps:

1) weighing 5-15 parts of pepper, 10-20 parts of fructus evodiae, 5-15 parts of mangnolia officinalis, 5-15 parts of cinnamon, 5-15 parts of radix sileris, 5-15 parts of clove, 10-20 parts of gallnut, 1-8 parts of dried alum and ginger according to parts by weight;

2) squeezing rhizoma Zingiberis recens to obtain rhizoma Zingiberis recens juice;

3) mixing fructus Piperis, fructus evodiae, cortex Magnolia officinalis, cortex Cinnamomi, radix Saposhnikoviae, flos Caryophylli, Galla chinensis, and dried Alumen, pulverizing, and sieving;

4) mixing the ginger juice obtained in the step 2) and the medicine powder sieved in the step 3) to prepare a paste, and placing the paste at a medicine storage position of the medical acupoint plaster to finish the preparation of the acupoint plaster.

Furthermore, the acupoint plaster is pasted at the Shenque acupoint.

Further, in the step 1), 10 parts of pepper, 15 parts of fructus evodiae, 10 parts of cortex magnoliae officinalis, 10 parts of cinnamon, 10 parts of radix sileris, 10 parts of clove, 15 parts of gallnut, 5 parts of dried alum and ginger are weighed according to parts by weight.

Further, the sieving in the step 3) is 120-mesh sieving.

The invention has the following beneficial effects:

the invention provides a common mode of oral administration and external application for treatment aiming at the problem that the oral administration is difficult to concentrate at the far end of the intestine and is not beneficial to the direct treatment of the focus. Although the enema can directly reach the focus of infection, the effect is quick, the treatment effect is obvious, and a large number of enemas and oral medicines are reported, the problems that the operation of patients is inconvenient, the administration of professional persons is needed, the patients are often painful in the enema and the like exist. The invention selects the external application medicine to assist the oral medicine to jointly treat the ulcerative colitis, and obtains obvious curative effect, thereby providing a colitis treatment scheme which is convenient to operate and has obvious curative effect.

The invention aims at treating common traditional Chinese medicine symptoms in the remission stage of colitis, such as syndrome of dampness obstruction due to spleen deficiency, syndrome of intermingled cold and heat, syndrome of liver depression and spleen deficiency, and the like. The onset of ulcerative colitis is mainly due to spleen deficiency, and dampness is an important factor. The disease course is longer, repeated purgation is performed, the spleen is healed more, and the disease enters the remission stage, the basic pathogenesis is the deficiency of the origin and pathogen lingering, the deficiency is mainly caused, the deficiency of the origin is mainly caused by spleen deficiency, the transportation and transformation are not healthy, and water dampness is generated internally, so the syndrome of spleen deficiency and dampness accumulation is most easily seen. Lingering pathogenic factors in the remission stage refers to the condition of lingering dampness and heat, which is most apt to stagnate in the spleen due to deficiency of the body resistance and lingering pathogenic factors, and the dampness is yin pathogen, resulting in cold-heat syndrome. Spleen deficiency can lead to liver hyperactivity, i.e., wood deficiency, and in remission stage, the patients have poor spirit, worry and worry about liver depression and spleen deficiency. The pathogenesis of the remission stage is the lingering pathogen of the original deficiency, mainly deficiency.

The oral medicine takes the raw white atractylodes rhizome, the codonopsis pilosula, the fried white paeony root and the Chinese angelica as tonifying medicines, strengthens the spleen and transports the middle energizer, dispels wind and promotes blood circulation and dampness, and the poria cocos serves as a dampness-dispelling medicine to jointly play the effects of strengthening the spleen and removing dampness, enabling the spleen to transport water and dampness, and invigorating yang and regulating blood. The elecampane is used for regulating qi, the purslane and the plantain herb are used for clearing away heat and toxic materials, diminishing inflammation and reducing fever, and can promote urination to strengthen stool, promote digestion by medicated leaven, the raw bighead atractylodes rhizome is used for promoting urination by matching with the plantain herb, the raw bighead atractylodes rhizome, the fried white paeony root and the poria cocos are used for dispelling wind, promoting blood circulation and promoting diuresis to strengthen spleen and eliminate dampness, and the functions of invigorating yang and promoting blood circulation are achieved.

The cinnamon is warm in nature and can pass qi and blood channels, warm channels and relieve congealing, and can 'disperse and guide hundreds of drugs', the gallnut can astringe small intestine and relieve intestinal inflammation, the fructus evodiae can warm middle-jiao to dispel cold, expel qi to relieve pain, and the ginger can warm middle-jiao to dispel dampness and benefit spleen and stomach and has the effect of stopping diarrhea; flos caryophyllata is good at reducing stomach qi, radix angelicae is a channel-guiding drug for stomach meridian of foot yangming, and the two drugs are aromatic and easy to disperse and penetrate, and are used as guiding drugs together, so that the percutaneous effect is quick. Dried alum is used as a guiding drug for drying dampness, checking diarrhea and stopping bleeding. Is applied to Shenque acupoint at the pivot of qi movement ascending, descending, exiting and entering, and has effects of dispelling cold, relieving diarrhea, warming interior and dispelling cold.

The oral medicine and the external medicine act together, and have obvious curative effect on the traditional Chinese medicine symptoms in the remission stage (spleen deficiency and dampness obstruction syndrome, cold and heat mixed syndrome, liver depression and spleen deficiency syndrome and the like).

Detailed Description

It will be understood by those of ordinary skill in the art that the foregoing embodiments are specific examples for carrying out the invention, and that various changes in form and details may be made therein without departing from the spirit and scope of the invention in practice.

To make the objects, aspects and advantages of the embodiments of the present invention more apparent, the following detailed description clearly illustrates the spirit of the disclosure, and any person skilled in the art, after understanding the embodiments of the disclosure, may make changes and modifications to the technology taught by the disclosure without departing from the spirit and scope of the disclosure.

The exemplary embodiments of the present invention and the description thereof are provided to explain the present invention and not to limit the present invention.

Example 1

The medicament of this example for treating colitis; the medicine comprises a traditional Chinese medicine composition for treating colitis and an acupoint plaster;

the traditional Chinese medicine for treating colitis is prepared in the following way:

1) weighing 20g of medicated leaven, 15g of Chinese angelica, 15g of fried white paeony root, 15g of poria cocos, 15g of raw bighead atractylodes rhizome, 15g of purslane, 15g of plantain herb, 15g of codonopsis pilosula, 10g of ligusticum wallichii, 10g of rhizoma alismatis and 5g of costustoot for later use;

2) mixing the above materials, soaking in 2 times of water, decocting, filtering, adding water to the residue, decocting again, mixing decoctions, and filtering to remove impurities.

The acupoint plaster is prepared by the following steps:

1) weighing 10g of pepper, 15g of fructus evodiae, 10g of cortex magnoliae officinalis, 10g of cinnamon, 10g of radix sileris, 10g of clove, 15g of gallnut, 5g of dried alum and ginger according to parts by weight;

3) mixing fructus Piperis, fructus evodiae, cortex Magnolia officinalis, cortex Cinnamomi, radix Saposhnikoviae, flos Caryophylli, Galla chinensis, and dried Alumen, pulverizing, and sieving with 120 mesh sieve;

Example 2

And (3) clinical observation:

1. patients were screened according to the following clinical manifestations published by the institute of traditional Chinese medicine and pharmacology, the department of splenic and gastric diseases, the consensus on diagnosis and treatment of ulcerative colitis:

syndrome of spleen deficiency and dampness accumulation

The main symptoms are: firstly, loose stool with a small amount of mucus or purulent blood; ② dull pain in the abdomen; ③ poor appetite and poor appetite. The secondary symptoms are as follows: firstly, abdominal distension and borborygmus; ② lassitude of limbs; third, mental fatigue and no speaking desire; fourthly, the complexion is sallow. Tongue pulse: pale and swollen tongue with teeth marks and white and greasy coating; thready, weak or soft and slow pulse. The syndrome type is determined: it has 2 main symptoms and 1 or 2 secondary symptoms, and is based on tongue pulse condition and physicochemical examination.

Syndrome of intermingled cold and heat

The main symptoms are: firstly, abdominal pain is cold and painful, and people like warm and press; ② diarrhea with sticky jelly; thirdly, the anus is scorched; fourthly, oral ulcer. The secondary symptoms are as follows: firstly, limbs are not warm; ② the belly has burning sensation. Tongue pulse: the tongue is red, thin and yellow with thin coating, and the pulse is deep and thready. The syndrome type is determined: it has 2 main symptoms and 1 or 2 secondary symptoms, and is based on tongue pulse condition and physicochemical examination.

Syndrome of liver depression and spleen deficiency

The main symptoms are: firstly, abdominal pain is diarrhea, pain is reduced after diarrhea, secondly, loose stool or little mucus exists; the above symptoms may be aggravated by inducement such as emotional stress or depressed anger. The secondary symptoms are as follows: firstly, chest distress is favorable for sighing; ② frequent belching; ③ chest and hypochondrium distending pain. Tongue pulse: the tongue is pale red with thin and white coating; the pulse is wiry and thready. The syndrome type is determined: it has 2 main symptoms and 1 or 2 secondary symptoms, and is based on tongue pulse condition and physicochemical examination.

Syndrome of dampness-heat in large intestine

The main symptoms are: firstly, diarrhea, mucus, bloody pus and stool; ② abdominal pain; ③ tenesmus and tenesmus. The secondary symptoms are as follows: firstly, burning the anus; body heat can not be raised; thirsty and bitter taste; fourthly, scanty and brownish urine. Tongue pulse: the tongue is red and yellow with greasy coating; the pulse is smooth and rapid. The syndrome type is determined: it has 2 main symptoms and 1 or 2 secondary symptoms, and is based on tongue pulse condition and physicochemical examination.

Spleen-kidney yang deficiency syndrome

The main symptoms are: firstly, the chronic diarrhea is accompanied by white frost, indigestion food and even inadmissibility of slippage; ② cold in shape and limbs. The secondary symptoms are as follows: firstly, abdominal pain is fond of warmth and pressure; ② abdominal distension, poor appetite and anorexia; third, soreness and weakness of waist and knees; pale and fat tongue with teeth marks on the tongue edge and thin and white tongue coating; deep and thready. It has 2 main symptoms and 1 or 2 secondary symptoms, and is based on tongue pulse condition and physicochemical examination.

Syndrome of yin and blood deficiency

The main symptoms are: firstly, defecating is difficult, and a small amount of mucus, bloody pus and stool are found; ② the tongue is red and little fluid and little or no coating. The secondary symptoms are as follows: firstly, the abdomen is dull and burning; low fever in the afternoon, night sweat; thirdly, the mouth is dry and the throat is dry; fourthly, dizziness, vexation and uneasiness; the pulse is thready and rapid.

It has 2 main symptoms and 1 or 2 secondary symptoms, and is based on tongue pulse condition and physicochemical examination.

2. Colonoscopy: the mucosa under the endoscope is mainly dark red in color, and is light red and purple dark at the same time, the lesions are changed in the form of edema, erosion rough granules or pestle hyperplasia, are seen scattered in lymph follicular hyperplasia and scar generation, no bleeding occurs after contact, the mucosa at the tail end of the ileum is rough, edema and congestion, intestinal irritation does not exist in the enteroscopy process, the course of disease is long, and the disease is recurrent.

3. Examination of mucosal biopsy histology: mucosal erosion or ulcer healing; decrease or disappearance of neutrophils in the mucosa of the lamina propria and decrease of infiltration of chronic inflammatory cells; ③ the structure of the crypt is changed: the structural change of the crypt is more serious than that of the active stage, such as crypt reduction and atrophy, and panne cell metaplasia (far from colon splenic flexure) can be seen.

4. Inclusion criteria were: meets the clinical manifestations, colonoscopy and mucosal biopsy histology examination standards; the clinical manifestations are not improved after the treatment before the visit; patients of 18-70 years old are of unlimited nature.

5. Exclusion criteria

Removing patients in accordance with outbreak; ② patients with diarrhea and bloody purulent stool caused by other diseases of colon (such as specific enteritis, colorectal malignant tumor, Crohn's disease, schistosomiasis, etc.). Thirdly, serious general symptoms, intestinal perforation bleeding, toxic megacolon, canceration intestinal lesions and the like are eliminated; (iv) irritable bowel syndrome-excluded patients (IBS); fifthly, patients with serious diseases and mental diseases such as heart, kidney, brain and hematopoietic system are excluded; sixthly, excluding the patient with periumbilical lesion caused by abdominal trauma or abdominal surgery; seventhly, excluding the female patients in pregnancy or in preparation for pregnancy and in lactation. Eighthly, patients with adhesive plaster allergy are excluded; drugs or other allergic constitution patients.

6. 102 outpatients (age 26-61 years), 43 women and 59 men were collected from Heilongjiang university of medicine outpatient clinic according to the above criteria.

Syndrome of traditional Chinese medicine	Example number (number)	Percent (%)
			Syndrome of spleen deficiency and dampness accumulation	31	30.3％
Syndrome of intermingled cold and heat	25	24.5％
			Syndrome of liver depression and spleen deficiency	20	19.6％
Syndrome of dampness-heat in large intestine	15	14.7％
			Spleen-kidney yang deficiency syndrome	7	6％
Syndrome of yin and blood deficiency	4	4％

The patients with the traditional Chinese medicine syndrome are randomly divided into four groups,

syndrome of traditional Chinese medicine	Treatment group one	Treatment group two	Treatment group III	Control group
					Syndrome of spleen deficiency and dampness accumulation	9	7	6	9
Syndrome of intermingled cold and heat	7	6	7	5
					Syndrome of liver depression and spleen deficiency	5	5	5	5
Syndrome of dampness-heat in large intestine	4	4	4	3
					Spleen-kidney yang deficiency syndrome	1	2	2	2
Syndrome of yin and blood deficiency	1	1	1	1
					In total	27	25	25	25

Four groups had no significant difference in male and female proportions, age and clinical symptoms.

7. Determination criteria of comprehensive efficacy:

1) and (3) evaluation of clinical curative effect: the evaluation was mainly based on the improved Mayo activity index.

Improved Mayo activity index

Note:^aeach subject served as a self-control, thereby evaluating the degree of abnormality in the number of times of defecation;^bthe daily bleeding score represents the most severe bleeding in 1 day;^cthe physician total score includes 3 criteria: a review of abdominal discomfort, overall well-being, and other manifestations of the subject, such as physical findings and subject performance status; the score is less than or equal to 2, no single analysis item score is greater than 1, the clinical remission is judged, the mild activity is judged in the range of 3-5, the moderate activity is judged in the range of 6-10, and the severe activity is judged in the range of 11-12; the effective definition is that the reduction of the score relative to the baseline value is more than or equal to 30 percent and more than or equal to 3 points, and the reduction of the partial score of the hematochezia is more than or equal to 1 point or the partial score is 0 point or 1 point.

Clinical efficacy evaluation criteria:

the clinical effect is as follows: the total Mayo score is reduced by more than or equal to 30 percent or more than or equal to 3 points from the baseline level, and meanwhile, the hematochezia sub-score is reduced by more than or equal to 1 point or the absolute score of the hematochezia sub-score is 0 or 1.

And (3) mucosa healing: the absolute score for the endoscopic sub-score was 0 or 1 for the Mayo score. The mucosa healing rate is the number of mucosa healing people/the total number of people in the group multiplied by 100%.

2) The evaluation of the traditional Chinese medicine syndrome curative effect mainly adopts a nimodipine method, and the curative effect index is (pre-treatment integral-post-treatment integral) ÷ pre-treatment integral multiplied by 100 percent. The clinical recovery: the curative effect index is more than or equal to 95 percent; secondly, effect is displayed: the curative effect index is more than or equal to 70 percent and less than 95 percent; ③ effective: the curative effect index is more than or equal to 30 percent and less than 70 percent; fourthly, invalidation: the curative effect index is less than 30%.

Assessment integration

7. Method of treatment

Treatment group one: the treatment is carried out by adopting the traditional Chinese medicine decoction for treating the colitis and the acupoint plaster in the embodiment 1. The traditional Chinese medicine decoction for treating colitis is taken orally in the morning and evening, 300 ml of the decoction is taken each time, 20 days are a treatment course, and statistics is carried out for 2 treatment courses. The acupoint patch is applied to the Shenque point, and is applied at the interval of two times of administration of Chinese medicinal decoction for treating colitis for at least 6 hr, with the same treatment course as that of the Chinese medicinal decoction for treating colitis, and 2 treatment courses are counted.

Treatment group two: the traditional Chinese medicine decoction for treating colitis in embodiment 1 is taken orally in the morning and evening, 300 ml is taken each time, 20 days is a treatment course, and statistics is carried out for 2 treatment courses.

Treatment group three: the acupoint plaster of the embodiment 1 is used for treatment, and is applied to the Shenque point, the plaster is applied for at least 6 hours within the interval time of taking the traditional Chinese medicine decoction for treating the colitis twice, 20 days are a treatment course, and statistics is carried out for 2 treatment courses.

Control group: mesalazine enteric-coated tablet (Meishaxin) (Heilongjiang Tian Yao pharmaceutical industry, Ltd., Chinese medicine standard H20103359) is taken 4 tablets at a time and 3 times a day according to the course of treatment in the specification.

8. Results of the experiment

1) Effective in clinic

Group of	Number of examples	Is effective	Invalidation	Effective rate (%)
					Treatment group one	27	24	3	88％
Treatment group two	24	19	5	79％
					Treatment group III	25	17	8	68％
Control group	23	18	5	78％

Note: p < 0.05 compared to control.

2) Mucosal healing

Group of	Number of examples	Mucosal healing	Is not healed	Mucosal healing Rate (%)
					Treatment group one	27	15	12	56％
Treatment group two	24	12	12	50％
					Treatment group III	25	11	14	44％
Control group	23	12	11	52％

Note: p < 0.05 compared to control.

3) Integral comparison of main single symptoms of traditional Chinese medicine syndromes

Note: the number of the first case in the treatment group was 27, the number of the second case in the treatment group was 24, the number of the third case in the treatment group was 25, the number of the case in the control group was 23, and P was less than 0.05 in comparison with the control group.

From the above results, it can be seen that the medicine for treating colitis prepared in example 1 has a significant curative effect on colitis, and especially the "spleen deficiency and dampness accumulation syndrome, cold and heat complicated syndrome, liver depression and spleen deficiency syndrome, and large intestine damp-heat syndrome" which account for the larger proportion of the treatment groups, and most of the above syndromes belong to the remission stage symptoms of colitis. Through comparative analysis of the control groups one to three, the effect of the combination of the oral traditional Chinese medicine and the traditional Chinese medicine patch adopted in the example 1 is obviously enhanced.

Claims

1. A traditional Chinese medicine composition for treating colitis is characterized by comprising, by weight, 15-25 parts of medicated leaven, 10-20 parts of Chinese angelica, 10-20 parts of fried white paeony root, 10-20 parts of poria cocos, 10-20 parts of raw bighead atractylodes rhizome, 10-20 parts of purslane, 10-20 parts of plantain herb, 10-20 parts of codonopsis pilosula, 5-15 parts of ligusticum wallichii, 5-15 parts of rhizoma alismatis and 2-7 parts of costus root.

2. The traditional Chinese medicine composition for treating colitis according to claim 1, wherein the composition comprises 20 parts by weight of medicated leaven, 15 parts by weight of Chinese angelica, 15 parts by weight of parched white peony root, 15 parts by weight of tuckahoe, 15 parts by weight of raw white atractylodes rhizome, 15 parts by weight of purslane, 15 parts by weight of plantain herb, 15 parts by weight of radix codonopsis pilosulae, 10 parts by weight of rhizoma ligustici wallichii, 10 parts by weight of rhizoma alismatis and 5 parts by weight of radix aucklandiae.

3. The method for preparing the traditional Chinese medicine composition for treating colitis according to claim 1 is characterized by comprising the following steps:

4. The use of a composition according to claim 1 for the treatment of colitis as a medicament for the treatment of colitis;

the acupoint plaster is prepared by the following steps:

5. The use of the composition of claim 1, wherein the acupoint is applied to SHENQUE acupoint.

6. The application of the traditional Chinese medicine composition for treating colitis as claimed in claim 1, wherein 10 parts of pricklyash peel, 15 parts of evodia rutaecarpa, 10 parts of cortex magnoliae officinalis, 10 parts of cinnamon, 10 parts of radix sileris, 10 parts of clove, 15 parts of gallnut, 5 parts of dried alum and ginger are weighed according to the parts by weight in step 1).

7. The use of the Chinese medicinal composition for the treatment of colitis according to claim 1, wherein the sieving in step 3) is 120 mesh sieving.