CN101091754B - Medicine for treating chronic colitis and ulcerative colitis, and preparation method - Google Patents

Medicine for treating chronic colitis and ulcerative colitis, and preparation method Download PDF

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CN101091754B
CN101091754B CN2007100660073A CN200710066007A CN101091754B CN 101091754 B CN101091754 B CN 101091754B CN 2007100660073 A CN2007100660073 A CN 2007100660073A CN 200710066007 A CN200710066007 A CN 200710066007A CN 101091754 B CN101091754 B CN 101091754B
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杨洪英
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Abstract

The present invention relates to a Chinese medicine for effectively curing chronic colitis and ulcerative colitis with obvious therapeutic effect. Said Chinese medicine is made up by using 10 Chinese medicinal materials of valeriana jatamansi, scutellaria root, lonicera flower, notoginseng, astragalus root and others through a certain preparation process.

Description

The medicine and the method for preparing of treatment chronic colitis and ulcerative colitis
Technical field
The present invention relates to the Chinese herbal medicine is the Chinese patent medicine of feedstock production, specifically treats the medicine and the method for preparing of chronic colitis and ulcerative colitis.
Background technology
Chronic colitis and ulcerative colitis are a kind of pilosity and commonly encountered diseases; In recent years the reported cases number is anxious increases in China; Infer that based on how tame hospital case statistics the sick rate of its patient is respectively 11.6/105 and 1.4/105 and have an anxiety of underestimating, the main diseases that at present should disease have become common disease of digestive system and chronic diarrhea because of; Bring very big influence to social productive forces and personal lifestyle quality, cause that all circles pay much attention to.
The characteristics of colitis are exactly: obstinate difficulty heals, the course of disease is long, be prone to send out repeatedly etc.Because how this disease their early stage does not influence people's orthobiosis and work; Countries in the world are not in place to the research and the propaganda strength of this disease at present in addition; Cause most of patients that the morbidity base reason and the hazardness of this disease are lacked enough understanding and attention; And entertain the fluke mind of " recovering without treatment " after the patient who the has morbidity, incured loss through delay optimal treatment period.Because this disease is not that pathogenic bacterium are caused, most of patient seek medical advice the back abuse of antibiotics simply carry out anti-inflammation and sterilization, not only do not have therapeutical effect but also destroyed the normal flora of gastrointestinal, brought inconvenience and difficult for later conventional therapy! Human beings'health in serious threat owing to above reason and other some malpractice behaviors cause colitis obstinate difficult! Enteropathy is because patient's autodigestion systemic-function imbalance, the disorderly relatively and morbidity of vital organs of the human body function.If treat to the intestinal pathological changes with monotherapy, then a meeting respite symptom can not thoroughly be cured, and is prone to recurrence, brings very big misery to the patient.
Ulcerative colitis UC and chronic enteritis adopt in active stage mostly and control inflammation as early as possible at present; The aminosallcylic acid of relief of symptoms and glucocorticoid; In the state of an illness catabasis with biological preparation if berberine, the peaceful probiotic bacterias of colon etc. are showing effect with the short then 3-5 of this type of medicine repeatedly, long then lifelong medication; And the 5-ASA glucocorticoid does not have the therapeutic effect of keeping and dependency is arranged; 5-ASA and the equal nonresponder of immunosuppressant, should adopt anti-tumor necrosis factor a (TNF-a) monoclonal antibody (infliximab) and colectomy, Therapeutic Method brings great misery and unfavorable to the patient at present.
Summary of the invention
The purpose of this invention is to provide the treatment chronic colitis of a kind of clearing away heat-damp and promoting diuresis, regulating QI to relieve pain, promoting flow of QI and blood, invigorating the spleen and benefiting QI and the medicine and the method for preparing of ulcerative colitis.
Medicine of the present invention is processed by following materials of weight proportions: Rhizoma valerianae latifoliae 10~20, Radix Puerariae 10~20, Radix Scutellariae 10~20, Flos Lonicerae 5~15, Rhizoma Coptidis 10~20, Radix Paeoniae Alba 10~20, the Radix Aucklandiae 10~20, Radix Notoginseng 5~10, Herba Patriniae 5~10, the Radix Astragali 10~20.
Also comprised Rhizoma Zingiberis 3~8 in the raw material, Radix Glycyrrhizae 4~9, Fructus Jujubae 3~8.
The best proportioning of medicine of the present invention is: Rhizoma valerianae latifoliae 15, Radix Puerariae 15, Radix Scutellariae 15, Flos Lonicerae 10, Rhizoma Coptidis 15, Radix Paeoniae Alba 15, the Radix Aucklandiae 15, Radix Notoginseng 8, Herba Patriniae 8, the Radix Astragali 15, Rhizoma Zingiberis 5, Radix Glycyrrhizae 6, Fructus Jujubae 5.
Medicine of the present invention prepares by following method:
1) Radix Notoginseng with 75% soak with ethanol diafiltration in 24 hours be condensed into extractum subsequent use after, medicinal residues are with decocting 3 times, it is subsequent use to filter, be condensed into extractum;
2) Radix Glycyrrhizae, Fructus Jujubae, Radix Puerariae, Rhizoma valerianae latifoliae, Herba Patriniae, Radix Paeoniae Alba, Flos Lonicerae, the Radix Astragali to be condensed into extractum for 3 times with decocting subsequent use;
3) it is subsequent use after Rhizoma Coptidis, Radix Scutellariae, Radix Aucklandiae fine powder 80 orders sieve;
4) with 1), 2) extractum of step adds 3) the step fine powder be mixed in dry below 80 ℃ mixed powder;
5) during being incapsulated, mixed powder promptly gets.
The medicine of the invention also method of available prior art is processed other dosage form.
Medicine of the present invention has good efficacy for the chronic colitis and the ulcerative colitis of the incoordination between the liver and spleen of stagnation of liver-QI with deficiency of the spleen card, retention of damp-heat in the interior card, syndrome of qi stagnation and blood stasis, can clearing away heat-damp and promoting diuresis, regulating QI to relieve pain, promoting flow of QI and blood, invigorating the spleen and benefiting QI.
Below be that medicine of the present invention (intestinal recovering capsule) clinical trial is summed up:
One, test objective
The curative effect of diseases such as stomachache, diarrhoea or the bloody diarrhea that the intestinal recovering capsule is showed chronic diarrhea (incoordination between the liver and spleen card, retention of damp-heat in the interior card, syndrome of qi stagnation and blood stasis), tenesmus, dyspepsia, and further investigate its safety.
Two, physical data
In the out-patient, select 396 routine chronic diarrhea patients as the object of observation, differential diagnosis in tcm is incoordination between the liver and spleen card, retention of damp-heat in the interior card, syndrome of qi stagnation and blood stasis, is divided into two groups at random, wherein test group 304 examples; Matched group 92 examples, male 192 examples, women 112 examples in the test group, minimal ages 18 years old, maximum age 62 years old; 44.5 years old mean age, the longest course of disease is more than 30 years, the shortest course of disease 2 months; Average course of disease 20.8 months, Western medicine diagnose are chronic colitis 208 examples, ulcerative colitis 96 examples.Male 61 examples, women 31 examples in the matched group, minimal ages 19 years old, maximum age 64 years old, 42.8 years old mean age, the longest course of disease 30 years; The shortest course of disease 1 month; Average course of disease 20 months, Western medicine diagnose are chronic colitis 60 examples, ulcerative colitis 32 examples (table 1,2,3,4)
Table 1. sex distributes
Figure G07166007320070802D000031
x 2=0.303, P>0.05, there was no significant difference
Table 2. age distribution
Figure G07166007320070802D000032
T=1.226, P>0.05, there was no significant difference.
Table 3. course of disease distributes
Figure G07166007320070802D000033
T=0.762, P>0.05, there was no significant difference.
The sick kind of table 4. doctor trained in Western medicine distributes
x 2=0.331, P>0.05, there was no significant difference
Two groups of data are planted contrast respectively from sex, age, the course of disease and doctor trained in Western medicine are sick, through statistical test, and P>0.05 there was no significant difference.
Three, the standard of case selection
Tcm syndrome diagnosis (dialectical) standard
Only selecting the chronic colitis and the ulcerative colitis of incoordination between the liver and spleen card, retention of damp-heat in the interior card, syndrome of qi stagnation and blood stasis according to " tcm internal medicine science ", " new Chinese medicine clinical research guideline " this test is the object of observation.
(1) diagnosis (chronic colitis)
1, clinical manifestation
(1) symptom
A. suffer from diarrhoea: stool is rare watery stool or stool folder mucus, or is with a small amount of pus and blood more than 2 times every day; Or the greyish white or little green medicated porridge appearance of stool color, band bubble appearance etc.
B. suffer from abdominal pain: with sigmoid colon and descending colon pathological changes is main; So pain is many at left lower quadrant and left abdomen; Also there is pathological changes to involve transverse colon even total colectomy person, shows as pain or abdominal part multi-section position pain on the umbilicus, be distending pain, angor, tenesmus or stomachache and promptly rush down, rush down the back pain relief.
C. other simultaneous phenomenon: fatigue and weak, listless, or have low grade fever, infection and recurrence to increase the weight of Shi Keyou obviously to generate heat.
(2) sign: health check-up is to the no specificity of chronic colitis diagnosis.The abdominal part local tenderness can be arranged, abdominal part multi-section position tenderness also can be arranged; Intestinal toot sound is hyperfunction; Can there be body temperature slightly to increase; Can be mixed with become thin, the sign of lustreless complexion, chronic malnutrition such as sallow.
(3) complication: chronic colitis can have water and electrolyte balance disorderly when acute relapse, and dehydration causes complication such as shock, acidosis.
2, doctor trained in Western medicine inspection
(1) stool routine examination can be found leukocyte, erythrocyte and a small amount of pus cell.
(2) stool is cultivated and can find pathogenic bacterium.This is significant to diagnosing.
(3) X line barium agent inspection early lesion is at mucosa, and it is not obvious that the X line shows that mucosa develops, and when mucosa erosion and ulcer, the X line representes to have barium point and niche, and the then visible filling defect of long-term chronic pathological changes person, tapering, haustra of colon disappear, the intestinal tube cripetura; Crude indentation in tube wall edge or burr appearance.
(4) there is the mucus purulent exudate on colonoscopy and mucosa biopsy early lesion colonic mucosa surface, and the biopsy Submucosa can have edema, hyperemia and acute inflammatory reaction, also erosion and ulcer can be arranged, and ulcer is generally more shallow, seldom causes intestinal perforation.Control wrong treatment owing to lose, be chronic inflammatory to colonic mucosa and change, different changes such as mucosa hypertrophy, polyp formation, fibrous connective tissue hypertrophy, intestinal wall thicken, luminal stenosis can be arranged.
3, diagnostic criteria
Draft with reference to " new Chinese medicine clinical research guideline ".
(1) acute infective enteritis or alimentary toxicosis medical history are arranged;
(2) diarrhoea period of greater than two months;
(3) stool routine examination show, leukocyte and a small amount of pus cell, stool are cultivated and are found pathogenic bacterium;
(4) colonoscopy and mucosa pathologic finding are chronic colitis and change.
4, syndrome characteristic
(1) center syndrome
Abdominal pain diarrhea, with rare watery stool for seeing more, or folder mucus, or press from both sides a small amount of pus and blood; Or non-smooth diarrhea, or chronic diarrhea do not heal, or stool aqueous-grainy diarrhea, diarrhea before dawn.Stomachache is main with left lower quadrant bitterly, can involve on left midfield, the umbilicus or upper right abdomen, rarely involves full abdomen.Stomachache is dull pain, cold type of pain, distending pain etc. more, or tenesmus, or different manifestations such as back alleviation of pain are promptly rushed down, rushed down to stomachache.
(2) dialectical main points
The mechanism of chronic diarrhea morbidity is spleen-asthenia with excessive damp, and the insufficiency of the spleen deficiency of spleen-QI that shows as for a long time and gas undermines sun, has insufficiency of the spleen stagnation of liver-QI and the disharmony between the liver and spleen person also has insufficiency of the spleen wet resistance, rushes down when half congealed during stool, and lack of appetite abdominal distention belongs to deficiency-weakness of spleen-QI, person due to the middle burnt dysfunction of the spleen in transportation and transformation.It is rare clearly to defecate, aqueous-grainy diarrhea, or diarrhea before dawn, incessant chronic diarrhea, soreness of the waist and knees belong to gas and undermine sun, kidney yang deficiency can not warm spleen sun due to.The loose stool is not well, and defecation is with nervous relevant, and breast side of body feeling of distension and oppression is due to the insufficiency of the spleen stagnation of liver-QI wood soil phase is taken advantage of.Big loose stool, tongue are greasy in vain, due to insufficiency of the spleen wet resistance.
(3) disharmony between the liver and spleen card
Main symptom: 1. have loose bowels and rot just, the companion's stomachache or the bob of expanding are felt, or the loose stool is not well; 2. nervous or depressed having loose bowels when angry increased the weight of.
Inferior card: 1. breast abdominal distention is vexed; 2. heating installation; 3. lack of appetite; 4. body of the tongue is light red, white and thin fur; 5. thready and stringy pulse.
Possess main symptom 1., 2., 3., have 1 that is equipped with in time card concurrently, promptly diagnosable.
Pathogenesis: liver is lost bar and reaches, perverse and unreasonable manner gram spleen.
(2) diagnosis (ulcerative colitis)
1, clinical manifestation
(1) symptom of digestive tract
A. bloody diarrhea: being topmost symptom, also is common first disease, Chang Fanfu outbreak or continue not heal, and the lighter every day 2~5 times, heavy person can reach 10~30 times, and feces character individual variation is very big, and the mucus hemafecia is seen more.Common daystart is had loose bowels and is rushed down after the meal.Individual patients is diarrhoea in early days and replaces with constipation.
B. suffer from abdominal pain: the diarrhoea severe patient is accompanied stomachache more, and pain is then rushed down, and rushes down the back alleviation of pain.Pain is main with distending pain, angor, and is comparatively fixing, is confined to left lower quadrant and left waist and belly more, continues that dull pain person is quite a few to be seen, light-duty do not have stomachache.
C. tenesmus: due to the rectum inflammatory stimulus, often have sacrum portion uncomfortable.
D. dyspepsia: be nonspecific symptom, mainly contain anorexia, epigastrium feeling of repletion, feel sick, vomiting, belch etc.
(2) the normal or rising of General Symptoms body temperature, acute stage, have more existing heating.The whole body toxemia appears in the patient with severe symptoms, loses and anorexia from intestinal because of water, electrolyte, vitamin, protein etc., loses weight and physically-draining and cause.
(3) sign is except that the performance that heating, rapid pulse and dehydration are arranged, and left lower quadrant or full abdominal part often have tenderness, with bowel sound hyperaction, often can touch like hard piped descending colon or sigmoid colon, and the prompting intestinal wall thickens, and is difficult to differentiate mutually with spastic colon.Acute ectocolon person often has abdominal distention, the obvious bulge of epigastrium.The acute widely active stage patient of extent of disease can have tension of abdominal muscle.But light-duty case or levy at catabasis depletion of YANG gonosome.Digital rectal examination often has tenderness, the normal spasm of anal sphincter, but can relax the heavier patient of acute poisoning symptom.Fingerstall can stain.
(4) Clinical typing, a stroke degree reach by stages
A. be divided into 4 types by course of disease process:
1. first hair style: no history of past illness is just sent out the patient.
2. acute fulminant form: rare.Onset is anxious cruelly, and symptom of digestive tract and whole body poisoning symptom are serious.
3. chronic recurrence type: see more.But symptom is lighter.Recurrence phase and catabasis replace.
4. chronic lasting type: symptom duration is more than half a year, and the prompting extent of disease is extensive.
B. be divided into 3 degree by severity extent:
1. slight: suffering from diarrhoea is less than 3 times every day, has blood in stool light or nothing, does not have heating, pulse quickening or anemia etc., and erythrocyte sedimentation rate is normal.
2. moderate: between slight and severe.
3. severe: diarrhoea every day is more than 6 times, obvious mucus hemafecia, and body temperature is greater than 37.5 ℃, and pulse is greater than 90 times/min, and hemoglobin is less than 100g/L, and erythrocyte sedimentation rate is greater than 20mm/h.
C. extent of disease: proctitis, proctosigmoiditis, left hemicolon inflammation, scorching, the regional colitis of right hemicolon, pancolitis.
D. morbid state by stages: active stage, catabasis.
(5) the complication pilosity is born in the patient that the course of disease is long, be in a bad way, and the complication of local and whole body can be arranged.
A. partial complication: be shown in about 1/4 the case.
1. acute ectocolon and perforation: be shown in the acute fulminant form, old people, severe patient Yi Bingfa it.Involve transverse colon or whole colon more.The a large amount of inflations of the colon of getting involved cause abdominal tympanites, hypoactive bowel sounds or disappearance.Because of the whole body poisoning symptom is serious, so have another name called TMC.Hypokalemia, anticholinergic agents, morphine preparation and coloclysis can become risk factor.On the ectocolon basis, be prone to cause the concurrent acute diffuse peritonitis of perforated ulcer.
2. colon and perianal: anal fissure, proctoptosis, abscess, fistulization etc. are arranged.
3. colon is bled profusely: when ulcer corrodes than trunk, the colon massive hemorrhage can be arranged, so that concurrent shock.
4. pseudopolyp of colon forms: but the minority canceration.Mostly occur in young patient, the longer probability of the course of disease is bigger, has document to claim that canceration rate reaches 7%~14% more than 25 years.
5. stenosis of colon and intestinal obstruction: the cicatrix that a large amount of fibrous tissue in the repair process form can cause stenosis of colon and intestinal obstruction, is more common in the colon far-end.
6. hemorrhoid.
B. the complication of whole body: rare, because toxin, due to intestinal absorption was bad, weak etc., some maybe be relevant with autoimmune.
1. skin, mucosa infringement: nodosity property erythema, many types of erythema, aphthous ulcer etc.
2. eye infringement: conjunctivitis, iritis, uveitis etc. can be arranged.
3. arthritis: common hypertrophy property monarthritis, is crossed property migration arthralgia, and idol has ankylosing spondylitis.
4. hepatopathy: fatty liver can be arranged, chronic active hepatitis, postnecrotic cirrhosis, pericholangitis etc.
5. hematology's performance: anemia can be caused by factors such as iron deficiency, autoimmune hemolytic anemia, blood capillary characteristic of disease haemolysis.In addition, the thromboembolism phenomenon can be arranged, because due to thrombocytosis and the disorders of hemostasis.
6. nephropathy: pyelonephritis and renal calculus take place more.
2, doctor trained in Western medicine inspection
(1) barium enema of X line this check in the diagnosis of primary disease with differentiate significant.Adopt double-contrast barium examination to see that colon tension force increases, duplicature is disorderly, and haustra of colon is deepened, the intestinal tube spasm, and shallow table ulcer is filled the air in the prompting of intestinal wall zigzag shade; It is stiff that show as intestinal wall late period, and haustra of colon shoals or disappears, and intestinal tube is the water pipe shape, luminal stenosis, and colon shortens, and filling defect prompting pseudopolyp forms.Barium meal helps to understand whole gastrointestinal situation, and particularly small intestinal has or not pathological changes.
Severe patient, ectocolon person especially, this inspection has the anxiety of the perforation of bringing out, when classifying contraindication as.
(2) splanchnoscopy is because majority of pathologies at rectum and sigmoid colon, adopts SIG value very big, understands the situation of total colectomy like need, then should go fibercolonscopy.This inspection is made a definite diagnosis meaning to primary disease, can confirm extent of disease and extract bigger false polyp.But heavy patient should postpone carrying out in acute stage, in case perforation.
(3) stool examination macroscopy is found blood, pus and mucus.Mirror is found a large amount of erythrocyte, leukocyte, pus cell down.Endameeba histolytica, schistosome ovum, pathogenic bacterium and fungal culture etc. are all negative.
(4) blood test
A. routine blood test: anemia is common, blood figure point out be mostly low pigment, small cell anemia, be that iron deficiency and losing blood causes, also can be relevant with haemolysis., often there is neutrophilic leukocytosis acute stage.
B. erythrocyte sedimentation rate: it is one of simple and easy reliability index of disease activity that erythrocyte sedimentation rate speeds.
C. high blood coagulation state: because the activity of coagulation factor increases with Fibrinogen and increases in the blood plasma, and platelet count can obviously raise, and often causes the thromboembolism phenomenon, sees comparatively with pulmonary infarction and internal organs thrombosis especially more.
D. serum protein electrophoresis: the severe patient serum albumin reduces, a 1And a 2Globulin obviously raises.At catabasis such as a 2When globulin increases, normal signal for recurrence.During this onste, like r globulin decline prompting prognosis mala.
E. other: in serious case, tangible electrolyte disturbance is often arranged, especially with hypokalemia for outstanding.
3, diagnostic criteria
Draft according to " new Chinese medicine clinical research guideline ".
(1) clinical manifestation persistence or repeated relapsing mucus hemafecia, stomachache, with full symptom in various degree, small number of patients has only constipation or does not have hemafecia.To notice in history of past illness and the health check-up that intestinals such as joint, eye, oral cavity, liver, spleen show outward.
(2) colonoscopy finding 1. mucosa has congested, the edema of multiple fester companion, and pathological changes begins from rectum mostly, and is the diffusivity distribution; 2. the coarse fine particulate that is of mucosa, the mucosa blood vessel is fuzzy, crisp be prone to hemorrhage, or with the pus and blood sexual secretion; 3. visible false polyp, haustra of colon is rust or disappearance often.
(3) mucosa biological tissue pathologic finding is inflammatory reaction, with visible erosion, ulcer, crypt abscess, body of gland are arranged unusually often, goblet cell reduces and epithelium changes.
(4) barium coloclysis finding 1. mucosa thick disorderly and (or) have fine grained to change: 2. multiple shallow niche or little filling defect; 3. intestinal tube shortens, and haustra of colon disappears can be in a tubular form.
On the basis of getting rid of infectious colitis such as bacillary dysentery, amebic dysentery, chronic schistosomiasis, tuberculosis of intestine and Crohn colitis, ischemic colitis, radiation colitis, can be by following condition diagnosis.
1.~3. 1 person in can diagnose according to clinical manifestation and barium coloclysis.
Its atypical clinical manifestations and the diagnosable primary disease of colonoscopy or barium coloclysis typical case changer is arranged.
4, syndrome characteristic
(1) center syndrome: diarrhoea, just down rare half congealed, yellow or white, or smelly dirty, or clear indigested food, very then just defecation with blood and pus is suffered from abdominal pain urgently tenesmus.Stomachache is many at lower abdomen and left lower quadrant.Mostly be distending pain.Simultaneous phenomenon is numerous, and visible gastral cavity painful abdominal mass is indigestion and loss of appetite, the lazy speech of lack of appetite, or burning sensation of the anus, fever of the body, aphtha, halitosis, greasy taste in the mouth etc.
(2) dialectical main points: should have or not vomiting and nausea, stomachache, fever of the body from time, color, abnormal smells from the patient, the quality of stool, be anxious back weight, non-smooth diarrhea, burning sensation of the anus, yellow urine is short or symptoms such as clear length, removes to analyze cold and heat and asthenia and sthenia in conjunction with arteries and veins, picture of the tongue, at internal organs dirty.Rush down down and freeze in vain, gastral cavity painful abdominal mass vomiting and nausea is eaten indigestion and loss of appetite stagnating to damp pathogen impairing the spleen, makes a bet in intestinal, and thick fur moderate pulse person is an excess syndrome.Light red tongue is fat, deficient pulse, and the lazy speech of lack of appetite, the loose stool is weak to be insufficiency of the spleen leading to overabundance of dampness.Rush down yellow down gruel, its gas is smelly dirty, burning sensation of the anus, and fever of the body, oliguria with reddish urine, red tongue, yellow fur, rapid pulse is diarrhea of heat type.Doublely see that thick fur is greasy, vague aching of limbs, the gastral cavity painful abdominal mass is indigestion and loss of appetite, is damp and hot rushing down.Rush down rare water down, aqueous-grainy diarrhea, warm pain relieved by pressing is liked in the borborygmus of companion's stomachache, aversion to cold and cold limbs, pale tongue with white fur, the deep-slow pulse person is syndrome of yang deficiency of spleen and kidney, is to be diarrhea due to cold pathogen.It is to fail to keep an appointment in the kidney pass that slippage can't help.Non-smooth diarrhea is the mechanism of qi retardance.Just defecation with blood and pus, the raw meat pain is urgent, tenesmus, oliguria with reddish urine, aphtha of the mouth and tongue, halitosis greasy taste in the mouth, red tongue with yellow fur rapid pulse, the syndrome of dampness-heat in large intestine of meaning.Thermoae fire-transformation is intimately hindered network, and the blood oozing from the body openings or subcuta neous tissue sering is then just descended blood.Stomachache is when distinguishing time, character, happiness evil and relief of symptoms etc.Generally speaking, just pain is at gas, and pain is gone into network for a long time; How real sudden pain is, and how empty pain is for a long time; Tenderness is real, and pain relieved by pressing is empty; Angryly then send out, the aggravation of being worried is taken advantage of spleen for irritability.
(3) retention of damp-heat in the interior card:
Main symptom: folder pus band blood just, burning sensation of the anus.
Inferior card: 1. the stomach painful abdominal mass is indigestion and loss of appetite; 2. red tongue with yellow fur; 3. slippery and rapid pulse; 4. tenesmus, fever of the body; 5. it is dirty smelly to defecate, oliguria with reddish urine.
Possess main symptom and have 2 of time cards concurrently, promptly diagnosable.
Pathogenesis: damp-heat in the large intestine, mechanism of qi retardance.
(4) stagnancy of qi and blood stasis
Main symptom: 1. non-smooth diarrhea, borborygmus abdominal distention or abdominal pain with tenderness; 2. purplish tongue or ecchymosis, petechiae are arranged.
Inferior card: 1. abdominal pain with tenderness, localized pain; 2. abdominal part has mass in the abdomen; Squamous and dry skin; 3. hesitant pulse or string; 4. eructation and poor appetite, fullness and distention in the chest and hypochondrium; 5. complexion is dark dim.
Possess main symptom 1., 1 that has concurrently in other main symptom adds 2 of time cards, promptly diagnosable.
Pathogenesis: intestinal is damp and hot, qi stagnation blood stasis.
Four, curative effect determinate standard
1, clinical cure: clinical symptoms such as stomachache, diarrhoea and sign disappear, and lab testing obviously improves or normally;
2, produce effects: clinical symptoms and sign disappearances such as stomachache, diarrhoea, lab testing improves;
3, effective: clinical symptoms and sign disappearances such as stomachache, diarrhoea, lab testing makes moderate progress;
4, invalid: clinical symptoms such as stomachache, diarrhoea and sign disappear, lab testing no change or increase the weight of.
Five, result of the test
1, total effects is observed
Table 5, total effects contrast
Figure G07166007320070802D000091
U=5.916, there is highly significant property difference P<0.01.
2, the sick observation of curative effect of planting
Table 6, the sick Comparison of therapeutic of planting of doctor trained in Western medicine
The sick kind of two doctors trained in Western medicine organized a Comparison of therapeutic respectively, and through the Ridit check, there is significant difference P<0.01.3, symptom observation of curative effect
Table 7, symptom Comparison of therapeutic
Figure G07166007320070802D000102
Contrast between 7 groups of clinical symptoms are organized respectively, through the Ridit check, hypochondriac pain, abdominal distension and n and V, P<0.01 or<0.05, significant difference is arranged; All the other symptoms: P>0.05, there was no significant difference.
4, tongue, pulse condition observation of curative effect
Table 8. tongue, pulse condition contrast
Figure G07166007320070802D000111
Contrast between tongue, pulse condition organized, through Chi-square Test, P>0.05, there was no significant difference.
5, contrast before and after the routine blood test
Contrast (test group) before and after table 9, the routine blood test
Figure G07166007320070802D000112
X 2=68.24, there is significant difference P<0.05.
7, contrast (test group) before and after the intestinal mirror result
Contrast (test group) before and after the table 11. intestinal mirror:
Figure G07166007320070802D000121
X 2=8.077, P>0.05, there was no significant difference.
8, contrast (test group) before and after the hepatic and renal function
Contrast before and after table 12. hepatic and renal function
Figure G07166007320070802D000122
3 routine abnormal liver function are arranged before the treatment, 2 routine abnormal liver function are arranged after the treatment, 1 example takes a turn for the better, and does not have new unusual case appearance.No abnormal before and after the renal function curing.
9, untoward reaction is observed: two groups of totally 396 routine patients untoward reaction all do not occur and take place during medication.
Six, discuss
1, two groups of case data contrast respectively from sick the kind in the distribution of sex, age, the course of disease and doctor trained in Western medicine, through statistical test, and P>0.05, there was no significant difference.Prompting: two groups of data basically identicals have comparability.
2, total effects is observed: the total obvious effective rate of test group is 50.99%, and total effective rate is 85.20%; The total obvious effective rate of matched group is 23.91%, and total effective rate is 50%.Two groups of Comparison of therapeutic, through statistical test, there is highly significant property difference P<0.01.Prompting: trial drug is superior to control drug (table 5) to the curative effect of incoordination between the liver and spleen, retention of damp-heat in the interior, qi depression to blood stasis.
3, the sick observation of curative effect of planting of doctor trained in Western medicine: ulcerative colitis and chronic colitis are organized a Comparison of therapeutic respectively, and through statistical test, there is highly significant difference P<0.01.Prompting: trial drug is superior to control drug (table 6) to the curative effect of ulcerative colitis, chronic colitis.
4, symptom observation of curative effect: the curative effect to 6 groups of symptoms such as hypochondriac pains is organized a Comparison of therapeutic respectively.Through statistical test, stomachache, diarrhoea, dyspepsia, courageous and upright appearance diarrhoea: there is significant difference P<0.01 or P<0.05, all the other each symptom P>0.05, there was no significant difference.Prompting: trial drug is superior to control drug, the curative effect of all the other symptoms and control drug basically identical to stomachache, diarrhoea, dyspepsia, courageous and upright appearance diarrheal curative effect.(table 7)
5, tongue, pulse condition observation of curative effect: the curative effect to tongue, pulse condition is organized a Comparison of therapeutic respectively, through statistical test, and P>0.05, there was no significant difference.Prompting: the tongue of two groups of medicines, pulse condition curative effect basically identical.(table 8)
6, contrast before and after the routine blood test: total white blood cells and classification in test group 31 routine patients' the routine blood test are treated the front and back contrast through statistical test, and total white blood cells and neutrophilic granulocyte classification: there is significant difference P<0.05; Lymphocyte classification P>0.05 there was no significant difference.Prompting: trial drug has certain improvement effect to total white blood cells in the routine blood test and classification.(table 9)
7, contrast before and after intestinal mirror and the B ultrasonic: test group 32 routine patients' intestinal mirror and 65 routine patients' B ultrasonic result are treated the front and back contrast, and through statistical test, there is significant difference B ultrasonic P<0.05, intestinal mirror P>0.05 there was no significant difference.Prompting: trial drug has certain effect to enteritis, and is little to the endo-enteritis effect under the intestinal mirror.(table 10,11)
8, contrast before and after the hepatic and renal function: test group 31 routine patients' hepatic and renal function is treated the front and back contrast, 3 routine abnormal liver function are arranged before the treatment, be kept to 2 routine abnormal liver function after the treatment, and do not have new unusual case appearance; All no abnormality seen case appearance before and after the renal function curing.Four indices is through statistical test P>0.05, there was no significant difference.Prompting: trial drug is to the harmless effect of hepatic and renal function.(table 11)
9, untoward reaction is observed: two groups totally 396 routine patients do not see all that at period in a medicine untoward reaction takes place.
Seven, conclusion
The intestinal recovering capsule has incoordination between the liver and spleen card, retention of damp-heat in the interior card, the chronic colitis of syndrome of qi stagnation and blood stasis and the effect of ulcerative colitis, is mainly used in the treatment traditional Chinese medical science " stomachache, chronic diarrhea ".Confirm that through clinical trial the clinical efficacy of intestinal recovering capsule is definite, taking convenience has no side effect, really for treating the good medicine of stomachache (incoordination between the liver and spleen card).
The specific embodiment
Embodiment 1:
Get crude drug (unit of weight kilogram): Rhizoma valerianae latifoliae 15, Radix Puerariae 15, Radix Scutellariae 15, Flos Lonicerae 10, Rhizoma Coptidis 15, Radix Paeoniae Alba 15, the Radix Aucklandiae 15, Radix Notoginseng 8, Herba Patriniae 8, the Radix Astragali 15, Rhizoma Zingiberis 5, Radix Glycyrrhizae 6, Fructus Jujubae 5.
Prepare by following method:
1) Radix Notoginseng with 75% soak with ethanol diafiltration in 24 hours be condensed into extractum subsequent use after, medicinal residues are with decocting 3 times, it is subsequent use to filter, be condensed into extractum;
2) Radix Glycyrrhizae, Fructus Jujubae, Radix Puerariae, Rhizoma valerianae latifoliae, Herba Patriniae, Radix Paeoniae Alba, Flos Lonicerae, the Radix Astragali to be condensed into extractum for 3 times with decocting subsequent use;
3) it is subsequent use after Rhizoma Coptidis, Radix Scutellariae, Radix Aucklandiae fine powder 80 orders sieve;
4) with 1), 2) extractum of step adds 3) the step fine powder be mixed in dry below 80 ℃ mixed powder;
5) during being incapsulated, mixed powder promptly gets (every 0.3g).
Embodiment 2:
Get crude drug (unit of weight kilogram): Rhizoma valerianae latifoliae 10, Radix Puerariae 10, Radix Scutellariae 10, Flos Lonicerae 5, Rhizoma Coptidis 10, Radix Paeoniae Alba 10, the Radix Aucklandiae 10, Radix Notoginseng 5, Herba Patriniae 5, the Radix Astragali 10.
Press the method preparation of embodiment 1.
Embodiment 3:
Get crude drug (unit of weight kilogram) Rhizoma valerianae latifoliae 20, Radix Puerariae 20, Radix Scutellariae 20, Flos Lonicerae 15, Rhizoma Coptidis 20, Radix Paeoniae Alba 20, the Radix Aucklandiae 20, Radix Notoginseng 10, Herba Patriniae 10, the Radix Astragali 20.
Press the method preparation of embodiment 1.
Application proportioning of the present invention is not limited to the foregoing description.

Claims (3)

1. a medicine of treating chronic colitis and ulcerative colitis is characterized in that it is the medicine of being processed by following materials of weight proportions: Rhizoma valerianae latifoliae 10~20, Radix Puerariae 10~20; Radix Scutellariae 10~20, Flos Lonicerae 5~15, Rhizoma Coptidis 10~20; Radix Paeoniae Alba 10~20, the Radix Aucklandiae 10~20, Radix Notoginseng 5~10; Herba Patriniae 5~10, the Radix Astragali 10~20.
2. the medicine of treatment chronic colitis according to claim 1 and ulcerative colitis is characterized in that raw material also comprises Rhizoma Zingiberis 3~8, Radix Glycyrrhizae 4~9, Fructus Jujubae 3~8.
3. the medicine of treatment chronic colitis according to claim 1 and ulcerative colitis is characterized in that it is the medicine of being processed by following materials of weight proportions: Rhizoma valerianae latifoliae 15, Radix Puerariae 15, Radix Scutellariae 15; Flos Lonicerae 10, Rhizoma Coptidis 15, Radix Paeoniae Alba 15, the Radix Aucklandiae 15; Radix Notoginseng 8, Herba Patriniae 8, the Radix Astragali 15; Rhizoma Zingiberis 5, Radix Glycyrrhizae 6, Fructus Jujubae 5.
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CN101450204B (en) * 2008-12-19 2011-04-20 段兴 Medicine for treating chronic colitis and ulcerative colitis
CN102266538B (en) * 2010-06-01 2013-04-17 昆明段洪光消化道疾病专科医院有限公司 Traditional Chinese medicinal composition for treating damp-heat dysentery and preparation method thereof
CN102335341B (en) * 2011-09-18 2013-06-12 罗明雷 Chinese medicinal clysis decoction for treating ulcerative colitis
CN102935122B (en) * 2012-09-30 2014-04-30 广西梧州三鹤药业有限公司 Antidiarrheal particle and preparation method thereof
CN103800597B (en) * 2014-02-24 2016-07-06 杜翠云 A kind of Chinese medicine treating retention of damp-heat in the interior type ulcerative colitis
CN103768576B (en) * 2014-02-26 2016-01-20 王风栋 A kind of Chinese medicine for the treatment of due to weakness of spleen and stomach ulcerative colitis
CN105693713B (en) * 2015-05-28 2017-10-24 广州牌牌生物科技有限公司 A kind of pair of flavine, its preparation method and its application
CN105288074A (en) * 2015-12-04 2016-02-03 吴姗姗 Medicine for treating ulcerative colitis due to liver-yang hyperactivity and spleen deficiency
CN107693671B (en) * 2017-09-19 2020-09-29 张璐 Traditional Chinese medicine for treating ulcerative colitis
CN117180361B (en) * 2023-10-20 2024-06-25 河南中医药大学 Traditional Chinese medicine for treating spleen deficiency and qi stagnation combined with damp-heat type ulcerative colitis

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