CN1634192A - Medicine for treating chronic gastroenteritis and colitis - Google Patents
Medicine for treating chronic gastroenteritis and colitis Download PDFInfo
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Abstract
The invention provides a medicine for treating chronic gastroenteritis and colitis, which is prepared from Schizophragma integrifolium, Os Sepiae, bletilla striata, amomum fruit, pilose asiabell root, haw, root of herbaceous peony.
Description
Technical field
The present invention relates to a kind of Chinese medicine medicine, especially a kind of compound Chinese herb pharmaceutical preparation that is used for the treatment of chronic gastroenteritis, chronic colitis.
Background technology
Having loose bowels is a kind of common frequently-occurring disease.From the theory of Chinese medical science analysis, be because of being invaded by exogenous pathogen or diet internal injury cause dysfunction of the spleen in transportation, conduction mistake department causes that times of defecation increases, matter rare half congealed or as water sample be mainly to show disease.This is sick identical with doctor trained in Western medicine diarrheal connotation.The annual patient of taking place to suffer from diarrhoea of China reaches 8.36 hundred million person-times according to statistics, and is quite big to adult and child's health hazard, and at present to the treatment of this class disease, each hospital all uses a large amount of antibiotics.But use antibiotics can not shorten the course of disease, reduce the diarrhoea number of times, can cause the generation of Resistant strain on the contrary, antibiotics was lost efficacy.It is not obvious and comparatively slowly wait not enoughly that existing Chinese medicine preparation then exists curative effect, therefore, is necessary to study and develop a kind of good effect, instant effect, the Chinese traditional compound medicine that has no side effect.
Summary of the invention
The object of the present invention is to provide a kind of chronic gastroenteritis, the Chinese traditional compound medicine of chronic colitis.
Medicine of the present invention is made by the raw material of following weight portion:
Cortex schizophragmatis integrifolii radicis 250-400 part Endoconcha Sepiae 50-65 part
Pseudobulbus Bletillae (Rhizoma Bletillae) 180-210 part Fructus Amomi 30-35 part
Rhizoma Zingiberis 20-33 part Fructus Piperis 30-35 part
Radix Codonopsis 70-90 part Fructus Crataegi 70-90 part
Radix Paeoniae Alba 50-70 part Radix Glycyrrhizae 10-30 part.
The present invention's monarch drug Cortex schizophragmatis integrifolii radicis comes from " the southern regions of the Yunnan Province book on Chinese herbal medicine ", for Chinese herbal medicine commonly used among the people, contains a large amount of tannins, and effects such as astringing to arrest diarrhea, reducing swelling and alleviating pain are arranged, and diseases such as dysentery can be used for suffering from diarrhoea.Other minister, assistant, messenger drug have the effect of astringent or styptic treatment for spontaneous sweating, the warming middle-JIAO to dispel cold of convergence, spleen invigorating, QI invigorating, antidiarrheal.Wherein, Pseudobulbus Bletillae (Rhizoma Bletillae) contains colloid, phlegmatic temperament, the energy astringing to arrest diarrhea; The water-soluble substances of Radix Codonopsis has good anti-gastric mucosa injury effect; Crataegolic acid in the Fructus Crataegi, Quercetin, chlorogenic acid etc. can increase enzyme secretion in the stomach, and facilitating digestion has stronger inhibitory action to dysentery bacterium; Endoconcha Sepiae contains calcium carbonate and phlegmatic temperament etc., and antacid hemostasis, analgesic effect are arranged; The Radix Paeoniae Alba can be removed crampy gastrointestinal pain, and dysentery bacterium, bacillus pyocyaneus, fungus are all had inhibitory action, and the energy raise immunity; Fructus Amomi can be controlled stomach abdomen pain, inappetence, nausea and vomiting, enteritis and dysentery etc.; Fructus Piperis can be controlled gastrofrigid vomiting, stomachache; Rhizoma Zingiberis can make intestinal tube loose, and wriggling slows down, and Bacillus typhi, Salmonella are had inhibitory action; Radix Glycyrrhizae can be alleviated the gastrointestinal smooth muscular spasm, has the effect of relieving spasm to stop pain.
The present invention adopts processing method of the prior art to make, and after soon raw material was cleaned, dried, powder became fine powder, mix homogeneously.Perhaps raw material is decocted with water for several times, collecting decoction filters, and filtrate is condensed into thick paste, and dry, pulverizing makes the acceptable preparation product.
Allocate medical accessory again into prescription of the present invention and promptly can be made into pharmaceutically acceptable any dosage form.
The present invention has following advantage and effect: this medicine has warming middle-JIAO to dispel cold, and invigorating the spleen to arrest diarrhea, is promoted the production of body fluid at benefiting qi and nourishing blood, easing the affected liver to relieve pain, enrich blood yin fluid astringing and middle emergency, restrain effects such as astringent or styptic treatment for spontaneous sweating, be used for the treatment of deficiency-cold in middle-JIAO, coldness and pain in the epigastrium, cold-damp accumulating in the interior, diseases such as the chronic gastroenteritis that loose stool or have loose bowels etc. is showed, chronic colitis, be a kind of having no side effect, good effect, the good medicine among the people of instant effect.
The specific embodiment
Embodiment 1
Get the raw materials ready by following prescription:
Cortex schizophragmatis integrifolii radicis 250 gram Endoconcha Sepiaes 65 grams
Pseudobulbus Bletillae (Rhizoma Bletillae) 180 gram Fructus Amomis 35 grams
Rhizoma Zingiberis 20 KEHU greens pepper 35 grams
Radix Codonopsis 70 Keshan short, bristly hair or beards 90 grams
The Radix Paeoniae Alba 50 gram Radix Glycyrrhizaes 30 grams.
Preparation method: Pseudobulbus Bletillae (Rhizoma Bletillae), Endoconcha Sepiae are ground into fine powder, stand-by; The Radix Paeoniae Alba is measured the reflux, extract, secondary for 8 times with 70% ethanol, and each 2 hours, extracting liquid filtering, merge extractive liquid, is condensed into thick paste; Flavor medicines such as all the other Cortex schizophragmatis integrifolii radiciss decoct with water three times, and each 1 hour, collecting decoction filtered, and is condensed into thick paste, merges all thick pastes, adds above-mentioned fine powder mixing, and are dry, pulverize, sieve, and granulate, incapsulate 1000 capsules that weight is 0.3g.
Embodiment 2
By following prescription, and use the method identical to prepare tablet with embodiment 1:
Cortex schizophragmatis integrifolii radicis 400 gram Endoconcha Sepiaes 50 grams
Pseudobulbus Bletillae (Rhizoma Bletillae) 210 gram Fructus Amomis 30 grams
Rhizoma Zingiberis 33 KEHU greens pepper 30 grams
Radix Codonopsis 90 Keshan short, bristly hair or beards 70 grams
The Radix Paeoniae Alba 70 gram Radix Glycyrrhizaes 10 grams.
Embodiment 3
By following prescription, and use the method identical to prepare electuary with embodiment 1:
Cortex schizophragmatis integrifolii radicis 350 gram Endoconcha Sepiaes 60 grams
Pseudobulbus Bletillae (Rhizoma Bletillae) 200 gram Fructus Amomis 32 grams
Rhizoma Zingiberis 28 KEHU greens pepper 33 grams
Radix Codonopsis 80 Keshan short, bristly hair or beards 80 grams
The Radix Paeoniae Alba 60 gram Radix Glycyrrhizaes 20 grams.
Results of pharmacodynamic test of the present invention is as follows:
One, diarrhea effect of the present invention
Experiment material
Animal: Kunming mouse, body weight 18 ± 2g, male.
Medicine: capsule of the present invention, every loading amount 0.3g (the 1g content is equivalent to crude drug 2.78g) gets capsule 's content and is mixed with the suspension that concentration is 45mg/ml and 90mg/ml with distilled water during experiment; R-1132 (not having the hydrochloric diphenoxylate 2.5mg of sheet, atropine sulfate 0.025mg); Folium Sennae, commercial, through being accredited as the dried leaves of cassia acutifolia Delile Cassia acutifolia Delile,, be mixed with the suspension that concentration is 8% (g/ml) with distilled water during experiment except that being ground into fine powder behind the impurity such as defoliation stalk; Normal saline.
Method and result
Get 48 of healthy mices, be divided into 4 groups (blank group, compound diphenoxylate group, high dose of the present invention and low dose group) at random, 12 every group, lattice is raised, every Mus one lattice, and filter paper is put in the mouse cage lower berth, observes 2 days, has the mice of diarrhoea (muck) then to eliminate.Fasting is each treated animal difference gastric infusion 0.2ml/10g (the blank group waits the normal saline of capacity) after 12 hours, after 1 hour, each treated animal is all with 8% Garfields Tea suspension oral gavage 0.25ml/10g, put and make the muck counting under the mouse cage with being about to the filter paper shop, per hour change paper in 1-6 hour, last counting was once to 24 hours after 7 hours, the total grain of the muck number that each treated animal of observed and recorded is discharged, each organizes dehumidifying excrement number of animals, and the gained data are carried out the t check with statistical method, the results are shown in Table 1.
Experimental result shows that each group all can make mice discharge the minimizing of muck number to some extent, and high and low dose group of the present invention and compound diphenoxylate group anti-diarrhea effect are remarkable, discharge the muck number in 24 hours and are starkly lower than the blank group, and dose-effect relationship is obvious.The result shows that the present invention has tangible anti-diarrhea effect.
Table 1: this has pair Folium Sennae induced mice diarrheal influence
Number of animals dosage muck grain number (grain/24 hours) dehumidifying excrement
Group (only) (g/kg) (
X± SD) P value (only)
Blank group 12-6.8 ± 2.1 12
Compound diphenoxylate group 12 0.01 3.3 ± 2.7＜0.05 11
High dose group of the present invention 12 1.8 0.9 ± 1.6＜0.01 4
Low dose group 12 0.9 2.8 ± 2.4 of the present invention＜0.01 10
Two. the present invention is to the influence of gastrointestinal function
Experiment material
Animal: the same.
Medicine: the present invention's capsule; Purchase HUOXIANG ZHENGQI JIAONANG, neostigmine methylsulfate, methyl orange.
Method and result
1, to the influence of small intestine movement of mice propulsion functions
Method: get the healthy kunming mice of body weight 24 ± 1g, male and female half and half, be divided at random: the blank group, positive drug matched group (HUOXIANG ZHENGQI JIAONANG), high dose group of the present invention and low dose group, 10 of every treated animals, after the fasting 24 hours, the blank group gives normal saline, the positive drug matched group gives HUOXIANG ZHENGQI JIAONANG medicinal liquid 0.47g/kg, high dose group of the present invention gives 1.8g extract/kg, low dose group gives 0.9g extract/kg, and various medicinal liquids are all allocated 10% burnt black ink into, presses 0.2ml/10g medicine liquid irrigation stomach, cut each Mus execution open abdominal cavity after 15 minutes, cutting off the mesentery that is attached on the intestinal tube, intestinal tube is pulled into straight line gently, is that starting point is measured the total length of burnt black ink at the displacement of small intestinal and small intestinal (from pylorus to ileocecus) with the pylorus, the displacement of calculating every mice burnt black ink accounts for the percentage rate of small intestinal total length, relatively the difference between each group.The results are shown in Table 2.
The influence of table 2 pair small intestine movement of mice propulsion functions
Group number of animals (only) dosage (g/kg) intestinal propulsion rate
Blank group 10 NS 86.38 ± 14.1
High dose group 10 1.8 83.10 ± 7.8
Low dose group 10 0.9 82.46 ± 6.44
Positive controls 10 0.47 67.48 ± 21.55
*
*P＜0.05 (comparing) with the blank group
Experimental result shows that high and low dose group of the present invention and blank relatively do not influence P＞0.05 to the propulsion functions of small intestine movement of mice, and HUOXIANG ZHENGQI JIAONANG has inhibitory action P＜0.05 to the propelling of small intestine movement of mice.
2, to the influence of hyperfunction mouse small intestine propulsion functions
Method: the grouping situation is carried out as stated above.Fasting 24 hours, with new this ground bright filling stomach (0.02mg/10g) of methylsulfuric acid, after 10 minutes, the blank group gives normal saline, positive controls gives HUOXIANG ZHENGQI JIAONANG medicinal liquid 0.47g/kg, high dose group of the present invention gives 1.8g extract/kg, low dose group gives 0.9g extract/kg, various medicines are all allocated 10% burnt black ink into, press 0.2ml/10g medicine liquid irrigation stomach, put to death after 15 minutes, take out small intestinal by preceding method, the displacement of calculating every mice burnt black ink accounts for the percentage rate of small intestinal total length, relatively the difference between each group.The results are shown in Table 3.
The influence of table 3 pair hyperfunction mouse small intestine propulsion functions
Form other number of animals (only) dosage (g/kg) intestinal propulsion rate
Blank group 10 NS 92.4 ± 6.4
High dose group 10 1.8 71.87 ± 11.8
*
Low dose group 10 0.9 66.95 ± 10.55
*
Positive controls 10 0.47 86.96 ± 12.89
*
*P＜0.01
*P＜0.05 (comparing) with the blank group
Experimental result shows that the present invention equally has inhibitory action (P＜0.01) to hyperfunction mouse small intestine propulsion functions with HUOXIANG ZHENGQI JIAONANG
3, to the influence of mice gastric emptying
Method: get body weight 22 ± 2g, 30 of healthy Kunming mouses, male and female half and half are divided into three groups of blank group, high and low dose of the present invention at random.Fasting 16 hours, the blank group is given normal saline; High dose group of the present invention is given 1.8g extract/kg, low dose group is given 0.9g extract/kg, each group is all taked subcutaneous injection administration 0.2ml/10g, and administration is after 40 minutes, every mouse stomach 0.2ml0.1% methyl orange solution, take off cervical vertebra after 20 minutes and put to death animal, cut open the belly and win stomach, place the test tube that fills the 10ml distilled water, cut off stomach with cutting from greater gastric curvature for a short time, gastric content is fully washed in the distilled water, use NaHCO
3Solution is regulated pH value to 6.0, with 2000 γ pon centrifugal 10 minutes, get its supernatant, produce Tianjin, island shimadzu UV-90 type ultraviolet spectrophotometer with Japan, measure optical density value in wavelength 420nm place, and add after the 10ml distilled water shakes up with 0.1% methyl orange 0.2ml, measure its optical density as methyl orange optical density radix, calculate stomach methyl orange residual rate.The results are shown in Table 4.
The influence of table 4 pair mice gastric emptying
Group number of animals (only) dosage (g/kg) stomach methyl orange residual rate
X± SD%
Blank group 10 NS 38.91 ± 16.65
High dose group 10 1.8 54.77 ± 16.66
*
Low dose group 10 0.9 58.86 ± 16.21
*
*P＜0.05 (comparing) with the blank group
Experimental result shows that the present invention has inhibitory action to the mice gastric emptying.
Brief summary
The present invention is the pure Chinese medicinal preparation for the treatment of the disease of having loose bowels, and our experiments show that does not have obvious influence to the small intestine movement of mice propulsion functions, and the propulsion functions and the mice gastric emptying of hyperfunction mouse small intestine had inhibitory action.
Three. analgesic activity of the present invention
Experiment material
Animal: Kunming mouse, body weight 18 ± 2g, male and female half and half.
Medicine: capsule of the present invention, every loading amount 0.3g (the 1g content is equivalent to the 2.78g crude drug) is mixed with the suspension that concentration is 45mg/ml and 90mg/ml with capsule 's content with distilled water during experiment; Commercial HUOXIANG ZHENGQI RUANJIAONANG is mixed with the suspension that concentration is 23.4mg/ml with its content with distilled water during experiment; Glacial acetic acid, analytical pure contains CH
3COOH＞99.0%; Normal saline.
Method and result
Get 40 of healthy Kunming mouses, be divided into 4 groups of (blank groups at random, the HUOXIANG ZHENGQI RUANJIAONANG group, high dose group of the present invention and low dose group), every group 10, equal gastric infusion 0.2ml/10g is respectively organized in fasting after 12 hours, and the blank group waits the normal saline of capacity, two dosage groups of the present invention are respectively dose,equivalent and 2 times of equivalents of clinical application, and HUOXIANG ZHENGQI RUANJIAONANG gives by the dose,equivalent of clinical application.Each Mus writhing response number of times in the empty injection of each Mus abdomen 0.6% glacial acetic acid 0.1ml/10g after 30 minutes, observed and recorded 20 minutes the results are shown in Table 5:
Table 5: the present invention is to the analgesic activity of mice
Group number of animals dosage is turned round body number of times P value
(only) (g/kg)
X± SD
Blank group 10-47.9 ± 10.5
HUOXIANG ZHENGQI RUANJIAONANG group 10 0.47 38.1 ± 8.9＜0.05
High dose group 10 1.8 36.4 ± 9.3＜0.05 of the present invention
Low dose group 10 0.9 29.7 ± 12.2＜0.01 of the present invention
Experimental result shows that two dosage groups of the present invention and positive drug matched group (HUOXIANG ZHENGQI RUANJIAONANG group) compare with the blank group, all can obviously reduce mouse writhing reaction times (P＜0.05, P＜0.01).This experiment has been observed analgesic activity of the present invention with the chemical stimulation method, and the result shows that the pain that this product is caused by acetic acid mice has the obvious suppression effect.
Four, the capsular vitro antibacterial activity test report of invention
Investigational agent: the present invention's capsule.
Antibacterial is used in test: staphylococcus aureus, escherichia coli, Bacillus proteus, Bacillus typhi, dysentery bacterium (preservation of microbiology teaching and research room of unming Medical College).
Test method: tube dilution method.
The result: capsule of the present invention does not have antibiotic effect to staphylococcus aureus; To colibacillary minimal inhibitory concentration is 70mg crude drug/ml, is 35mg crude drug/ml to the minimal inhibitory concentration of Bacillus proteus, is 140mg crude drug/ml to the Bacillus typhi minimal inhibitory concentration, is 17.5mg crude drug/ml to the dysentery bacterium minimal inhibitory concentration.Illustrate that the present invention has certain antibacterial action to above-mentioned four kinds of Bacterium entericum.
Five, antiinflammatory action of the present invention
Concrete antiphlogistic effects of the present invention such as table 6:
Conclusion: equivalent of the present invention and high dose group, aspirin group, HUOXIANG ZHENGQI JIAONANG group xylol lead to the swelling of mice auricle that obvious inhibitory action is arranged, and HUOXIANG ZHENGQI JIAONANG group and matched group compare,
Table 6: the influence of gastrointestinal rehabilitation spirit xylol induced mice auricle swelling
Group dosage animal inflammation swelling degree P value suppression ratio
(only) (X ± SD.mg) (%)
Normal saline 0.2ml/ only 10 7.01 ± 2.21
HUOXIANG ZHENGQI JIAONANG 0.47g/kg 10 4.86 ± 1.29＜0.05 30.48
Aspirin 0.2g/kg 10 3.73 ± 0.61＜0.01 41.38
Equivalent 0.9g/kg 10 4.13 ± 0.6 of the present invention＜0.01 35.84
High dose 1.8g/kg 10 3.5 ± 0.54 of the present invention＜0.01 48.2
Difference has significance (P＜0.05), all the other each medicine groups and matched group relatively, difference has highly significant (P＜0.01), and antiinflammatory action of the present invention is relevant with dosage, strengthens with the increase of dosage.
The present invention is as follows to the observation of curative effect result of chronic nonspecific or ulcerative colitis:
One, physical data: this group is totally 100 examples, male 46 examples, women 54 examples; 51 years old mean age (scope 25-82 year), average disease time 4.8 years (scope 1-22).Main clinical manifestation all has diarrhoea, and based on watery stool, Mucous Stool, minority is mixed with mucosanguineous feces.Number of times is not wait 3-11 time/day, and 48 examples are with stomachache, and 4 examples are with heating.Lab testing: all patients have all done the stool routine examination inspection, and based on leukocyte, viscose silk, minority is with erythrocyte.Inflammation is pressed the classification of Barou method under the electronic colonoscope.82 examples are chronic nonspecific colitis, and 11 examples are ulcerative colitis, and 7 examples merge polyp intestinal (extracing the back) for colitis.
Two, efficacy analysis standard: medication all is diagnosed as chronic nonspecific colitis or ulcerative colitis through electronic colonoscopy the last week; Do not reached during the clinical observation and do not added the medicine that can influence inflammation absorption and intestinal movement function with other with any antibiotic.During the treatment based on keep clean, digestible vegetarian diet.Allly be suspected to have the chronic enteritis that colon nuclear, amebic enteritis and other reason cause; Polyp intestinal fails to get rid of the canceration possibility or the intestinal cancer art latter, does not all list within the observation of this group.
Three, observed content and requirement: capsule of the present invention, every day three times, each four ante cibum or take half an hour after meal was a course of treatment with 20 days.This is organized 64 examples and has accepted a course of therapy, and 24 examples have been accepted the treatment of two courses of treatment, and 12 examples have been accepted the treatment of three courses of treatment.Wherein, treat invalid 10 examples and two of treatments, 3 invalid examples of course of treatment course of treatment, all former thereby treatment that do not enter next course of treatment because of other.Treat after a course of treatment with rash the variation of record diarrhoea number of times, stool character and stomachache situation during further consultation.And do the routine test inspection.
Four, therapeutic evaluation index: produce effects: stomachache complete obiteration, stool are shaped or become soft stool, every day 1～2 time, no mucosanguineous feces.Effectively: stomachache disappears substantially, and times of defecation reduces before than medication over half, stool character make moderate progress (becoming pasty state as watery stool).Invalid: doing well,improving is less, and stool routine examination is checked no change.When following up a case by regular visits to, carefully write down the untoward reaction after patient takes medicine.
Five, result:, the observed result of curative effect is listed in table 7 according to Clinical Follow-up, laboratory check result to patient:
Table 7: the curative effect of capsule for treating chronic nonspecific of the present invention or ulcerative colitis
The invalid % of the effective % of number produce effects %
One course of treatment 64 35 54.7 19 29.7 10 15.6
Two courses of treatment 24 13 54.2 8 33.3 3 12.5
Three curative effects 12 5 41.7 7 58.3
Add up to 100 53 34 13
As seen from Table 7, only accept the disease group of a course of treatment, total effective rate is 84.4%, and the total effective rate of accepting two courses of treatment is 87.5%.Clinical observation 100 case total effective rates are 87%.
Discuss: this group is tried 100 examples altogether, and its clinical manifestation and endoscopy all meet the diagnosis of chronic nonspecific or ulcerative colitis.Viewing duration, all other medicines of stopping using.The total effective rate of only accepting a course of therapy is up to 84.4%.The total effective rate that is tried 100 cases is 87%, so far use Chinese medicine preparation treatment chronic nonspecific or ulcerative colitis not to see effective in cure good report as yet clinically merely, so the present invention is a kind of treatment chronic nonspecific or the up-and-coming medicine of ulcerative colitis.
The present invention is as follows to the have loose bowels clinical observation report of disease cold-damp disease of treatment:
One, physical data
Observe case sum 270 examples, test group 200 examples, matched group 70 examples, test group man 77 examples, women 123 examples; Age distribution 18-30 year 38 examples; 31-40 year 30 examples; 41-50 year 35 examples; 51-60 year 57 examples; 61-65 year 40 examples; The course of disease is the shortest 1 day, and is the longest 10 years.Matched group man 31 examples, women 39 examples; Age distribution 18-30 year 12 examples; 31-40 year 16 examples; 41-50 year 15 examples; 51-60 year 16 examples; 11 examples more than 61 years old; The course of disease is the shortest 1 day, and is the longest 10 years, and the statistics of physical data sees Table 8.
The sex age distribution
The total routine number of group
Men and women 18-31-40-51-61-65
Experimental group 200 77 123 38 30 35 57 40
Matched group 70 31 39 12 16 15 16 11
Two groups of sex, age, course of disease situations before treatment are more similar, have comparability.
Two, case choice criteria
1, tcm diagnosis standard
Times of defecation increases, and every day is more than 3 times, with the change (every day, the stool amount surpassed more than the 300g, was shapeless loose stool) or the frequent within a certain period of time watery stool of stool amount and character.Symptom continues more than 1 day.
2, Chinese medical discrimination: the disease of having loose bowels Chinese medical discrimination is divided into cold-damp disease, damp-heat syndrome, dyspepsia disease, stagnation of liver-QI and takes advantage of spleen disease, weakness of the spleen and the stomach diseases, kidney yang deficiency disease etc., and cold-damp disease is mainly selected in this research.Cold-damp disease: have loose bowels loose stool or watery stool clearly, stomachache, borborygmus, gastral cavity is vexed, lack of appetite, body of the tongue is light red, white and thin fur or white greasy, relaxed and soft pulse.
3, the diagnostic criteria of relevant doctor trained in Western medicine disease
The doctor trained in Western medicine disease that primary disease relates to must be carried out by the up-to-date diagnostic criteria of diseases related.
4, include the case standard in and meet primary disease syndrome differential diagnosis standard, symptom continues can include the test case in more than 1 day.
5, get rid of case standard (comprising inadaptation or rejecting standard).
1) tests the complication of carrying out surgical operation in preceding 30 days and causing.
2) suffers from other diseases beyond the diarrhoea, just in Drug therapy and influence the observer of medicine.
3) deadly infectious disease and poisoning symptom person is arranged.
4) under-18s or over-65s patient, gestation or women breast-feeding their children are to this medicine allergy sufferers.
5) be associated with serious primary disease such as cardiovascular, liver, kidney and hemopoietic system, psychotic.
6) do not meet the standard of including in, not medication in accordance with regulations can't be judged that curative effect or data are not congruent to affect the treatment and the judgement person of safety.
Three, observation index
1, safety observation index: blood, routine urinalysis.Liver, renal function.
2, curative effect index: clinical manifestation: every day, times of defecation, amount, outward appearance situation changed, and stomachache, the variation before and after the treatment such as abdominal distention.Stool routine examination.Blood routine examination.
Four, test method
1, group technology: this group adopts the simple random sampling method, is divided into two groups, test group 200 examples, and matched group 70 examples, the test case adds up to 270 examples.
2, control drug: ZHIXIE CHONGJI (commercial).
3, usage and dosage: capsule of the present invention: each 4, every day 3 times, boiled water takes.Contrast medicine group: take by this medicinal method consumption.
4, the course of treatment: 3 days.
Five, curative effect determinate standard
Cure: the transference cure of having loose bowels, stool is shaped, every day 1-2 time, other transference cures.
Produce effects: stool every day 2-3 time, only once other symptoms mostly disappeared or alleviated approximate shaping or loose stool every day.
Effectively: the number of times of having loose bowels reduces, and other symptoms alleviate to some extent.
Invalid: as relatively not have before symptom and the diagnosis and treatment and improve or increase the weight of.
Six, result of the test
To the clinical trial that disease carries out of having loose bowels of 270 examples, the result is as follows by four tame hospitals such as Hospital Affiliated to Yunan Traditional Chinese Medicine College:
1, the have loose bowels improvement of symptom: test group 200 examples, improve 187 examples, effective percentage is 93.5%; Matched group 70 examples are improved 58 examples, and effective percentage is 82.9%.
2, the inspection of stool routine examination: check stool routine examination person 186 examples before test group is taken medicine, unusual person's 85 examples transfer normal person's 75 examples to after taking medicine, and negative conversion rate is 88.2%.Stool routine examination was checked 58 examples before matched group was taken medicine, and unusual person's 32 examples transfer normal person's 26 examples to after taking medicine, and negative conversion rate is 81.35%.
3, the improvement of other symptom: the improvement rate 90.7% of test group stomachache, the improvement rate 87.2% of borborygmus, the improvement rate 80.6% that gastral cavity is vexed, the improvement rate of poor appetite is 82.8%.The improvement rate of matched group stomachache is 85%, and the improvement rate of borborygmus is 81.3%, and the vexed improvement rate of gastral cavity is 77.8%, and the improvement rate of poor appetite is 73.7%.
Two groups of medicines all improve significantly to above-mentioned four kinds of symptoms.In addition, test group and matched group all improve significantly to unusual picture of the tongue, pulse condition.
4, hepatic and renal function, blood routine examination: test group has been carried out liver power checking to 95 examples, 97 routine patients have carried out kidney function test, the all no abnormal change of hepatic and renal function before and after taking medicine, 162 routine patients are carried out blood routine examination, proleukocyte rising person 20 examples of taking medicine, back 10 examples of taking medicine transfer to normally, and all the other do not have change; Matched group has carried out liver function test to 21 routine patients, and 24 examples have been carried out kidney function test, and all no abnormal change before and after taking medicine has been done blood routine examination to 52 routine patients, and wherein 3 routine leukocyte raise, and back 2 examples of taking medicine transfer to normally, and all the other do not see change.
Two kinds of drug test results, curative effect relatively sees Table 9.
Table 9 liang group medicine to 270 examples have loose bowels the patient curative effect relatively
The curative effect total effective rate
The total routine number of group
Clinical cure produce effects enabledisable (%)
Test group 200 63 76 48 13 93.5
Matched group 70 8 25 25 12 82.9
X
2＝5.781 P＜0.05
Result of the test shows that the test group total effective rate is 93.5%, and the matched group total effective rate is 82.9%, learns by statistics and handles, and the curative effect difference significance of P＜0.05, two group medicine shows that the present invention treats the curative effect of having loose bowels and is better than matched group.
Seven, sum up
Carry out clinical trial through patient that 270 examples are had loose bowels, test group 200 examples, produce effects 139 examples, effective 48 examples, total effective rate is 935%; Matched group 70 examples, produce effects 33 examples, effective 25 examples, total effective rate 829%.Result of the test shows that the present invention obviously is better than ZHIXIE CHONGJI to the curative effect of the disease of having loose bowels.Before and after taking medicine, hepatic and renal function, blood routine examination there is no abnormal change, do not find in the therapeutic process that obvious adverse reaction, clinical application are safe.The present invention is a pure Chinese medicinal preparation, and is evident in efficacy to the disease of having loose bowels, take medicine conveniently, and drug safety, suggestion is put on market as early as possible, promotes the use of.
Claims (3)
1, a kind of medicine for the treatment of chronic gastroenteritis, colitis is characterized in that being made by the raw material of following weight portion:
Cortex schizophragmatis integrifolii radicis 250-400 part Endoconcha Sepiae 50-65 part
Pseudobulbus Bletillae (Rhizoma Bletillae) 180-210 part Fructus Amomi 30-35 part
Rhizoma Zingiberis 20-33 part Fructus Piperis 30-35 part
Radix Codonopsis 70-90 part Fructus Crataegi 70-90 part
Radix Paeoniae Alba 50-70 part Radix Glycyrrhizae 10-30 part.
2, medicine according to claim 1 is characterized in that adopting processing method of the prior art to make, and after soon raw material was cleaned, dried, powder became fine powder, mix homogeneously; Perhaps raw material is decocted with water for several times, collecting decoction filters, and filtrate is condensed into thick paste, and dry, pulverizing makes the acceptable preparation product.
3, medicine according to claim 1 is characterized in that allocating medical accessory again into described prescription promptly can be made into pharmaceutically acceptable any dosage form.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102106973A (en) * | 2011-03-28 | 2011-06-29 | 王道国 | Medicament for treating chronic enteritis |
| CN104825965A (en) * | 2015-04-24 | 2015-08-12 | 李万青 | Chinese medicinal composition for treatment of gastroenteritis |
| CN117323402A (en) * | 2023-11-07 | 2024-01-02 | 云南永孜堂制药有限公司 | Pharmaceutical composition for treating enteritis and preparation method thereof |
-
2003
- 2003-12-30 CN CN 200310121021 patent/CN1261156C/en not_active Expired - Lifetime
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102106973A (en) * | 2011-03-28 | 2011-06-29 | 王道国 | Medicament for treating chronic enteritis |
| CN102106973B (en) * | 2011-03-28 | 2012-06-27 | 王道国 | Medicament for treating chronic enteritis |
| CN104825965A (en) * | 2015-04-24 | 2015-08-12 | 李万青 | Chinese medicinal composition for treatment of gastroenteritis |
| CN117323402A (en) * | 2023-11-07 | 2024-01-02 | 云南永孜堂制药有限公司 | Pharmaceutical composition for treating enteritis and preparation method thereof |
| CN117323402B (en) * | 2023-11-07 | 2024-02-23 | 云南永孜堂制药有限公司 | Pharmaceutical composition for treating enteritis and preparation method thereof |
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| CN1261156C (en) | 2006-06-28 |
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