CN101564453A - Medicine for treating chronic nonspecific ulcerative colitis and preparation method thereof - Google Patents

Abstract

The invention relates to a medicine for treating chronic nonspecific ulcerative colitis and a preparation method thereof, which pertain to the field of traditional Chinese medicines; the medicine is prepared from crude drugs with the following parts by weight: 840 to 870 parts of Chinese pulsatilla root, 410 to 440 parts of parslane herb, 410 to 440 parts of amur corktree bark, 100 to 130 parts of costustoot, 270 to 300 parts of radix salviae miltiorrhizae and 70 to 100 parts of cutch. The medicine can significantly improve the symptoms of rats with ulcerative colitis repair mucous membrane of colon, with fast and strong effect.

Description

A kind of medicine for the treatment of chronic non-specific ulcerative colitis and preparation method thereof

Technical field

The invention belongs to the field of Chinese medicines, be specifically related to a kind of medicine for the treatment of chronic non-specific ulcerative colitis and preparation method thereof.

Background technology

Chronic non-specific ulcerative colitis is a clinical common diseases, belongs to categories such as the traditional Chinese medical science " hemorrhoidal hamorrhage ", " dysentery ", " having loose bowels ".Clinical diarrhoea, stomachache, bloody purulent stool, the tenesmus of mainly showing as, the course of disease is slow, state of an illness weight differs, the trend of alleviating and showing effect is repeatedly arranged, the easy carcinogenesis of person more for a long time, primary disease can betide any age, but with person between twenty and fifty for seeing more, the male has a strong impact on development of social productivity more than the women.

Be accompanied by the development of society and the raising of people's living standard at present, people's rhythm of life is also constantly accelerated, what also can cause simultaneously living is irregular, dysfunction of spleen and stomach, and diarrhoea is with persistence or the mucosanguineous feces that shows effect repeatedly, stomachache and General Symptoms in various degree.Therefore study a kind of efficient, nontoxic medicine, it is extremely important just to seem, it is increased work efficiency to the quality of improving the people's livelihood, and promoting the well-being of mankind has very important significance.

Summary of the invention

The invention provides a kind of medicine for the treatment of chronic non-specific ulcerative colitis and preparation method thereof, with the Chinese medical theory is basis and combination clinical treatment experience for many years, a kind of new drug of developing through drug screening repeatedly, hope is removed vast chronic non-specific ulcerative colitis patient's sufferings.

Chronic non-specific ulcerative colitis is though can be divided into chronic recurrence type clinically, chronic lasting type, the acute fulminant form, but wherein see that so that chronic recurrence type more this kind of conditions of patients is outbreak repeatedly often, morbidity shows as diarrhoea, and bloody purulent stool or hemafecia are often accompanied tenesmus, stomachache, abdominal distention, inappetence, nausea and vomiting or sale, weak, heating, anemia etc.Therefore, similar to the traditional Chinese medical science " dysentery ", coincide with " chronic dysentery with frequent relapse " especially.Alleviation can be identical with chronic diarrhea.

The scope of primary disease down performance with mucous hyperemia, edema, erosion, hemorrhage and be graininess, the shallow table ulcer that as seen weight person differs in size, benign polypus causes the colon tube wall to thicken, luminal stenosis shortens with lopsided.Current this disease of Chinese traditional treatment is abideed by macroscopic view more and is debated disease and debate the principle that disease combines with microcosmic, comprehensively debates the disease analysis at the traditional Chinese medical science disease and the endoscopic manifestations of primary disease, and choosing side on this basis, selects medicine.

The traditional Chinese medical science is thought, the generation of dysentery due to damp-heat, and because of damp and hot evil poison, the visitor is in intestinal, and with the rich mutually knot of its QI and blood, fat liquid loses wound, changes corruption and forms pus and blood; The retardance of intestinal QI and blood, evil poison are difficult to get rid of, and cause stomachache, tenesmus.The stage of attack of chronic dysentery with frequent relapse, is also many and dysentery due to damp-heat is approximate, and pathology is common damp and hot unclean, the gesture that cloudy blood has been hindered.

For above-mentioned clinical manifestation, the precious element of Jiang of the Qing Dynasty has proposed to set forth one's views with " interior infections " in " doctor slightly ".Even to this day, debate disease and microcosmic in macroscopic view and debate under the disease principle instructs, the method that adopts whole body therapeutic to combine with topical therapeutic improves curative effect comprehensively.According to the primary disease etiology and pathogenesis, intend with heat-clearing and toxic substances removing promoting flow of QI and blood, the method for treatment of thick intestinal dysentery relieving.

We are monarch drug with the Radix Pulsatillae, and this flavour of a drug hardship is cold in nature, is the product of drop-down; The special heat clearing away haemolysis detoxifcation of merit, the outstanding kind the intestines and stomach pyretic toxicity that removes pents up, and for controlling the good medicine of weight under the hematodiarrhoea, better to the effect of bloody dysentery, " book on Chinese herbal medicine justice " points out this product " dysentery of extensively treating excess-heat poison fire is red white, and a few days ten persons quite see special effect ".So be that treatment dysentery belongs to damp and hot key player on a team.

Minister is with Herba Portulacae, Cortex Phellodendri.The Herba Portulacae sour in the mouth, cold in nature, kind can removing pathogenic heat from blood and toxic substance from the body, the laxation removing food stagnancy is held concurrently and can be stopped blooding, and cures mainly toxic-heat and blood stasis, removes tenesmus, " the southern regions of the Yunnan Province book on Chinese herbal medicine " thinks this product " QI invigorating clearing away summer-heat heat, the alleviating distention in middle-JIAO therapeutic method to keep the adverse QI flowing downwards, the intestine moistening removing food stagnancy parasite killing that stagnates, treatment skin ulcer congestion and swelling pain ".So but principal drug assistance is controlled damp and hot dysentery; The Cortex Phellodendri bitter in the mouth, cold in nature, its merit both can have been let out fire mutually clearly, the dampness detoxifcation, but consolidating YIN protects kidney again, as " herbal classic " said " main the five internal organs, stagnation of pathogenic heat in the breast stomach, jaundice, intestinal infections, stopping leak dysentery.Woman's whitish metrorrhagia, acute vulva ulcer." " must join book on Chinese herbal medicine " say that also " with the Cortex Phellodendri moisturizing, with its YIN-fire that can be general clearly now goes up, fire clearly then Shui gets hard coagulating, and does not mend and mends also." so this product is delayed primary disease, show effect repeatedly, damp and hot unclean, it is particularly suitable to injure cloudy blood person.

Adjuvant drug in Radix Salviae Miltiorrhizae, the Radix Aucklandiae side of being.The Radix Salviae Miltiorrhizae bitter in the mouth, cold nature.The function promoting blood circulation to restore menstrual flow, removing heat from blood detumescence, its removing heat from blood is got in the relieving restlessness that clears away heart-fire among the we, invigorates blood circulation, the merit of collateral dredging detumescence, the power of treatment carbuncle sore tumefacting virus reaches the purpose of " promoting the circulation of blood then pus and blood from holding back ", and " the sensible opinion of married woman " cloud " Radix Salviae Miltiorrhizae is diffusing simply, merit order SIWU TANG " again.With the reason of its speckle dispelling tissue regeneration promoting, reaching to lead to is the purpose of benefit.Therefore, this product first can removing heat from blood, invigorates blood circulation, and with skin infection in the intestinal that disappears, ends pus and blood, promotes the generation of fresh blood first, helps giving birth to the rehabilitation of body.The Radix Aucklandiae, acrid in the mouth, hardship, warm in nature, this product suffering is loose, and hardship is fallen, and temperature is logical, and is fragrant and dry, can rise to fall and lead to the reason three warmers, and outstanding benefaction QI of the spleen and stomach stagnates, and is the key medicine that circulation of qi promoting relieves the pain, double energy strengthening the spleen to promote digestion.Be just accord with the meaning of " circulation of qi promoting then back is heavy from removing ".The Radix Aucklandiae, Radix Salviae Miltiorrhizae two medicine circulation of qi promoting and blood, it is painful to remove heavy pain in the abdomen in back and abdomen, ends the pus and blood hematodiarrhoea, and a warm cold is coordinated mutually, and helping the monarch and his subjects altogether is assistant.

The catechu bitter in the mouth, puckery, property is flat, and external has removing dampness, holds back skin ulcer, and hemostasia effect is used for the many pus of skin infection, does not close up for a long time, and for oral administration have removing heat from the lung and dissipating phlegm, and promote the production of body fluid, stop blooding, diarrhea-relieving function, it is more than also to control dysentery.As Compendium of Material Medica said " go up heat of the diaphragm clearly, act as expectorant, be coated with incised wound, promoting granulation and relieving pain, hemostasis, removing dampness ".But catechu internal and external application among the we, the skin ulcer promoting tissue regeneration and wound healing is treated by through sick institute, and antidiarrheal dysentery again is so be messenger drug.

In a word, our Six-element Chinese medicine is harmonious, and plays clearing away damp-heat altogether, separates evil poison, promoting flow of QI and blood, and detumescence and promoting granulation, thus reach the effect of thick intestinal dysentery relieving, for the stage of attack of chronic dysentery with frequent relapse, belong to properly in fact, chronic non-specific ulcerative colitis sees that this disease person is also rather suitable.

Modern pharmacological research is thought:

The Radix Pulsatillae: effect antibiotic, anti-ameba has inhibitory action to other pathogen, and the sedation and analgesia effect is arranged.

Cortex Phellodendri: the effect of resisting pathogenic microbes is arranged, obvious and persistent hypotensive effect is arranged.

Radix Salviae Miltiorrhizae: bacteriostasis is arranged, improve immunologic function, can alleviate local congestion, microcirculation improvement.

The Radix Aucklandiae: intestinal is had direct relexation, tangible antibacterial action is arranged.

The consumption of drug component of the present invention is also groped to sum up to draw through the inventor in a large number, and each amounts of components is for all having better curative effect in the following portions by weight scope:

840～870 parts of the Radix Pulsatillaes, 410～440 parts of Herba Portulacaes, 410～440 parts of Cortex Phellodendris,

100～130 parts of the Radix Aucklandiae, 270～300 parts of Radix Salviae Miltiorrhizaes, 70～100 parts in catechu.

Preferably:

857.4 parts of the Radix Pulsatillaes, 428.7 parts of Herba Portulacaes, 428.7 parts of Cortex Phellodendris, 114.3 parts of the Radix Aucklandiae, 285.8 parts of Radix Salviae Miltiorrhizaes, 85.7 parts in catechu.

Medicine of the present invention can adopt the conventional method of Chinese medicine preparation to be prepared into any conventional oral preparations.Preferably, the preparation method of medicine activity component of the present invention is as follows, comprises the following steps:

A) take by weighing each crude drug, standby;

B) getting Radix Salviae Miltiorrhizae 2/3 recipe quantity, to be ground into fine powder standby;

C) Cortex Phellodendri powder is broken into coarse powder, with twice of 70%～90% alcohol reflux, each 1～3 hour, merge extractive liquid,, standing over night, get supernatant, reclaim ethanol, being concentrated into relative density, surveying 80 ℃ the time is 1.20, with b) half mixing in the Radix Salviae Miltiorrhizae fine powder of step, drying under reduced pressure, it is standby to be ground into fine powder;

D) Radix Aucklandiae powder is broken into coarse powder, and distillating extracting oil is collected the volatile oil part, uses beta-schardinger dextrin-: volatile oil=10: 1, colloid milling enclose, and drying at room temperature is standby; Aqueous solution after distillation device is in addition collected;

E) Radix Pulsatillae, catechu, Herba Portulacae and remaining 1/3 recipe quantity Radix Salviae Miltiorrhizae add 9～11 times of water gagings and decocted 1～3 hour, filter, and collect filtrate;

F) medicinal residues e) mix with Cortex Phellodendri, Radix Aucklandiae medicinal residues, add 9～11 times of water gagings, decoct 1～3 hour, filter, and merge e), f) filtrate and above-mentioned d) distillate, be concentrated into relative density, survey 60 ℃ the time and be the clear paste of 1.10-1.20;

G) f) the step clear paste adds 3～5 times of amount ethanol, makes to contain the alcohol amount and reach 70～90%, stirs; Standing over night is got supernatant, reclaims ethanol, is concentrated into relative density, surveys 80 ℃ the time and be the thick paste of 1.28-1.30;

H) and b) second half fine powder mixing in the Radix Salviae Miltiorrhizae fine powder of step, drying under reduced pressure is ground into fine powder, with above-mentioned steps c) in fine powder and volatile oil clathrate compound mixing, promptly.

The active component of medicine of the present invention can add various conventional adjuvant required when preparing different dosage form, be prepared into any peroral dosage form commonly used as disintegrating agent, lubricant, binding agent etc. with the method for Chinese medicinal of routine, as pill, powder, tablet, granule, capsule, oral liquid etc.

Pharmacodynamics test of the present invention shows: can suppress the small intestine movement of mice ahead running, alleviate the diarrhoea effect that the Radix Et Rhizoma Rhei decoct causes, can alleviate writhing response, escherichia coli, dysentery bacterium and Bacillus typhi are had tangible bacteriostasis because of the acetic acid induced mice; Can improve the cellular immune function of rat, reduce the content of circulating immune complex, the pathology damage of colon is alleviated or disappear, the alleviating or disappear of outward manifestation feces occult blood.

In sum, medicine of the present invention is to ulcerative colitis rat have clear improvement symptom and mucous membrane of colon repair, and effect obviously is better than JIECHANGYAN WAN than very fast and strong, and this has proposed test basis for further clinical research.Usage and dosage: oral, one time 6,3 times on the one.Every gram medicated powder is equivalent to crude drug 5.64g, the patent medicine labelled amount: the 0.4g/ grain.

The specific embodiment

For observing the main pharmacodynamics of medicine of the present invention (hereinafter to be referred as the colon recovering capsule), immunization is adopted in this experiment, with guinea pig colon mucosa and Freund Freund's complete adjuvant is antigen, immune rat has prepared Animal Model of Ulcerative Colitis, and the therapeutical effect of Animal Model of Ulcerative Colitis observed, experimental result shows that there is the obvious treatment effect in 6 weeks of colon recovering capsule gastric infusion to the ulcerative colitis that immunization caused.Serum albumin is measured and is shown that the administration group has trend of rising.The colon pathologic finding as seen, the mucous membrane of colon of model control group animal has erosion and cell infiltration, and administration group mucous membrane of colon epithelium is complete substantially, the progradation of small intestinal of can slowing down of colon health to the charcoal end, and can alleviate the caused diarrhoea effect of Radix Et Rhizoma Rhei decoct, in the mouse writhing test, high dose group obviously is less than matched group to the writhing response number of times, in immunization experiment is measured as seen, colon health ig administration has immunoregulation effect, makes the interior phagocytic function of body increase and can stimulate the release of hemolysin in the serum.Experiment in vitro shows: the colon health all demonstrates tangible bacteriostasis to escherichia coli, dysentery bacterium and Bacillus typhi.Its minimal inhibitory concentration (MIC) is 112.5mg/ml, and amounting to the crude drug amount is 634.5mg/ml.

Purpose: conform to or akin animal model and relevant pharmacological testing with " disease " or " disease " of the traditional Chinese medical science by setting up, so that the effectiveness of colon recovering capsule is made scientific evaluation.

The colon recovering capsule is a pure Chinese medicinal preparation, clinically is mainly used in treatment and accumulates the type ulcerative colitis in warm, for the pharmacology foundation of clinical application is provided, has carried out following pharmacological evaluation for this reason, existing experimental result is reported as follows.

Experiment material

Medicine: the colon recovering capsule is pale brown toner end, and pharmaceutcal corporation, Ltd provides by Yongkang, Tonghua, lot number: 2000518, and every gram medicated powder is equivalent to crude drug 5.64g, the patent medicine labelled amount: the 0.4g/ grain.Positive control drug: JIECHANGYAN WAN is produced by the Xi'an pharmaceutical factory of traditional Chinese medicine, lot number: 9909104.Said medicine all is mixed with suspension with distilled water, for gastric infusion.Matched group is given simultaneously with the volume distilled water.The nefopam hydrochloride injection is produced by Songjiang, Jilin pharmaceutical factory, lot number: 950905.The neostigmine methylsulfate injection is produced by the Shanghai Xinyi Pharmaceutical Factory, lot number: 970401 morphine hydrochloride injections are produced by Shenyang pharmacy one factory, lot number: 951015.Norfloxacin capsule is produced lot number: 980406 by no pharmaceutical Co. Ltd in the Tianjin.

Reagent: lanoline is produced by Tianjin chemicals factory, lot number: 980602; Liquid paraffin is produced by Kaiyuan City chemical reagent one factory, lot number: 970730; Glacial acetic acid is produced by Changchun chemical reagent one factory, lot number: 960304, and india ink is a commercially available product, uses after supersound process, and Alsever liquid and Dou Shi reagent are by this chamber preparation, and the complement preparation: the fresh serum with Cavia porcellus is used after SRBC absorbs.

Animal: Kunming mouse, body weight 18～22g; The Wistar rat, body weight 130～150g, Cavia porcellus 350～400g, above-mentioned animal male and female are usefulness all, purchases in institute for drug control, Jilin Province animal housing and Norman Bethune Medical University animal housing the quality certification number respectively: 960101016 (mices), 960101032 (rats).

Strain: escherichia coli (ATCC25922); Dysentery bacterium (ATCC51570); Bacillus typhi (ATCC50096) is all available from Ministry of Public Health Beijing biological products assay institute; Bacillus calmette-guerin vaccine (BCG) provided lot number by Changchun Biological Products Institute, Ministry of Public Health: 200416.

Instrument: 721 spectrophotometers are produced by Shanghai the 3rd analytical tool factory; 7150 type automatic clinical chemistry analyzers are made by Japan; H-103 type centrifuge is made by Japan; MA110 type electronic balance is homemade.

Experimental technique and result

Experimental example 1, to the influence (charcoal end propelling method) of intestinal propulsion motion

Get 70 of mices, male and female half and half are divided into 7 groups at random, press dosed administration shown in the table 1, and matched group is given the distilled water with volume, and fasting 24h before the experiment can't help water.Behind the administration 20min, ig 5% charcoal end and 10% arabic gum suspension 20ml/kg, mice is put to death in dislocation behind the 20min, cut open the belly and get complete section small intestinal and be tiled on the glass plate, survey the total length of its small intestinal and write down the distance of forward position, charcoal end, calculate the charcoal end and advance percentage rate, the results are shown in Table 1 to cardia.

Table 1. colon recovering capsule is to the influence of mouse small intestine ahead running (X ± SD)

By table 1 as seen, the ahead running of the inhibition small intestinal that the administration group all can be in various degree, with matched group relatively, significant difference (P＜0.01), but the promotion intestinal motility effect that the colon health can not the antagonism neostigmine.

Experimental example 2, to the anti-diarrhea effect of mice, press feces color dot method color dot method and measure.

Get 50 of mices, male and female half and half are divided into 5 groups at random, after pressing the 1h of dosed administration shown in the table 2, with Radix Et Rhizoma Rhei cooling bath (1.25g/kg) ig, mice is single to be put in the cage that is lined with filter paper 10ml/kg with being about to, and the loose stool after the observation administration on the interior filter paper of 2h is counted and be the results are shown in Table 2.

Table 2. colon recovering capsule is to the influence of mice anti-diarrhea effect (X ± SD)

By table 2 result as seen, colon health and morphine administration group are the diarrhoea due to the antagonism Radix Et Rhizoma Rhei decoct, and with matched group comparing difference remarkable (P＜0.01), JIECHANGYAN WAN also has certain diarrhea effect, compares (P＜0.05) with matched group.

Experimental example 3, analgesic activity

Get 60 of mices, male and female half and half are divided into 6 groups at random, press the ig of dosage shown in the table 3 administration 1h after, ip 0.5% glacial acetic acid 0.2ml/ only, mouse writhing number of times in the record 20min the results are shown in Table 3.

Table 3. colon recovering capsule is to the influence of mice button number of times (X ± SD)

From table 3 result as seen, colon health high dose group can obviously reduce the mouse writhing reaction times and the normal control group compares, significant difference (P＜0.05), though in, low dose group has and reduces mouse writhing reaction times, low dose group not statistically significant (P＞0.05).

Experimental example 4, external bacteriostasis are selected test tube method and punch method respectively for use.

1, selects medicinal liquid dilution method in vitro for use, the concentration of colon health in culture medium is respectively: 225～0.875mg/ml, contrast medicine norfloxacin 1mg/ml, hatch through 6h,, get 0.1ml and be added in respectively in every group of culture tube 1: 1000 times escherichia coli, dysentery bacterium and Bacillus typhi bacterium liquid, after the electronic oscillator mixing, hatching 18h in 37 ℃ of incubators, observe the bacterial growth situation, is asepsis growth with limpid no muddiness.Choose every group of four neighbouring pipes, promptly the bacterial cultures of 4 concentration is seeded in respectively on 4 dull and stereotyped agar culture mediums with scarification, hatch 48h for 37 ℃, observed result with aseptic on the every plating medium or be less than 3 bacterium colonies as the standard of judging MIC, the results are shown in Table 4.

Table 4. colon health extracorporeal bacteria inhibitor test (tube dilution method)

Colon health minimum inhibitory concentration (MIC) 112.5mg/ml is equivalent to give birth to about 634.5mg/ml

2, select agar diffusion method (punch method) for use.

Drug level sees Table 5, measures inhibition zone diameter with diffusion method, the results are shown in Table 5.

Table 5. colon health inhibition zone diameter (unit: mm)

By table 4 as seen, colon health minimum inhibitory concentration (MIC) is 112.5mg/ml, and being equivalent to the crude drug amount is 634.5mg/ml, by the shown colon health concentration of table 5 at 56.2mg/ml, the time to the antibacterial rings of above-mentioned three kinds of bacterium all below 10mm, so be decided to be the MIC value with 112.5mg/ml.

Experimental example 5, to the therapeutical effect of Animal Model of Ulcerative Colitis

The experiment be divided into two the step carry out: the foundation of (1) Animal Model of Ulcerative Colitis; (2) observe the therapeutical effect of colon health ig administration to the rat ulcer colitis.

(1) immunization is adopted in the foundation of Animal Model of Ulcerative Colitis

(a) antigen preparation: get and separate mucosa albumen behind the fresh mucous membrane of colon homogenate of intestinal Mus and the Freund Freund's complete adjuvant is mixed with antigen.

(b) experiment moulding: get 72 of normal rats (male and female half and half), get wherein 12 as normal group, all the other rats all at left back toes subcutaneous injection antigen 0.2ml/ only, after this subcutaneous at left back toes respectively, back, the 10th, 17 and 24 day after first immunisation and groin are respectively injected antigen one time, in the antigen 0.4ml that was not contained Freund on the 31st day by ip of immunity.Total moulding time is 40 days.

Except that the apparent condition of observing animal every day, feed and feces character, and before each immunity, to claim body weight and the certain fecal occult blood of survey during the moulding.

As a result the moulding animal in injections of antigens after 10 days body weight gain obviously slow down, fecal occult blood appears in most animals in the time of 17 days, has the part animal serious dense hemafecia and intestinal mucosa to occur after 24 days and comes off.

(2) colon health ig administration is to the therapeutical effect of rat ulcer colitis

Above-mentioned laboratory animal is pressed the ig of dosage shown in the table 6 administration, once a day, successive administration 42 days, matched group is given the distilled water with volume, and during the administration, apparent condition and the feces of observing animal every day change, and body weight of per 7 days titles is surveyed fecal occult blood simultaneously one time, 2h after the last administration, the sacrificed by decapitation rat is got blood and makes the every index determining of blood biochemical.And get colon and do the pathology inspection.The results are shown in Table 6,7,8 and pathological replacement.

Table 7. colon health is to the influence of ulcerative colitis rat blood biochemical indicator

Compare with matched group ^*P＜0.05, ^*P＜0.01

Table 8. colon health is measured ulcerative colitis rat fecal occult blood

From table 6 result as seen, colon health ig is after 2 weeks of administration, and the weight of animals increases, and apparent condition is clearly better.

Get from the biochemical measurement of table 7, the serum albumin of the heavy dose of animal of administration group has the trend that increases.Total protein and albumin content all are higher than model control group.

As seen, the mucous membrane of colon of model control group animal is visible significantly rotten to the corn, under mucosa and the mucosa cell infiltration is arranged from pathological replacement.And administration group mucous membrane of colon epithelium is complete substantially.

Experimental example 6, to immune influence

(1) to the influence (cleaning up method) of mouse monokaryon macrophage phagocytic function

Get 50 of mices, male and female half and half, be divided into 5 groups at random, press dosage shown in the table 9, every day, ig was administered once, successive administration 7 days, 1h after the last administration, india ink 0.05ml/10g body weight after handling by tail vein injection, respectively at the 2min after the injection and 15min by eye socket venous blood collection 20ul0.1%Na ₂CO ₃In the solution, survey its trap with 721 spectrophotometers at the 680nm wavelength behind the mixing.Calculate respectively and clean up index (K value) and phagocytic index (α value).The results are shown in Table 9.

Table 9. colon recovering capsule is to the influence of mouse monokaryon macrophage phagocytic function (X ± SD)

Compare with matched group ^*P＜0.05.

By table 9 as seen, colon health ig administration has facilitation to phagocytic function in the body of mice.

(2) to the influence (pressing literature method) of hemolysin content in the serum

Get 50 of mices, male and female half and half are divided into 5 groups at random, press dosage shown in the table 10, in immunity beginning in preceding 2 days administration, after this immunity with SRBC 20% concentration ip 0.2ml/ only is administered once every day, after immunity the 4th day by the socket of the eye venous blood collection, separation of serum, is used for experiment after dilution.

Hemolysin is measured: get the serum 1ml of 500 times of above-mentioned dilutions, add 5%SRBC 0.5ml, 10% complement 1ml behind the reaction 30min, takes out cessation reaction in water-bath in 37 ℃ of water-baths.With the centrifugal 5min of 1500rpm, extracting centrifugal liquid 1ml, the Dou Shi preparation of adding 3ml, behind the 10min, the place surveys its trap at the 540nm wavelength.

SRBC HD50 pH-value determination pH: get and survey its trap, HC in the calculation sample after 5%SRBC 0.25ml adds Dou Shi preparation 4ml mixing ₅₀Value.The results are shown in Table 10.

Table 10. colon recovering capsule is to the influence of hemolysin content in the serum (X ± SD)

Compare with matched group ^*P＜0.05.

By the measurement result of table 10 as seen, colon health ig administration has the effect that promotes that serum hemolysin discharges to the SRBC immune animal.

Come further to set forth the preparation method of medicine of the present invention by the following examples.

The capsule preparation of embodiment 1 medicine of the present invention

Radix Pulsatillae 840g, Herba Portulacae 410g, Cortex Phellodendri 410g, Radix Aucklandiae 100g, Radix Salviae Miltiorrhizae 270g, catechu 70g.

A) take by weighing each crude drug, standby;

B) getting Radix Salviae Miltiorrhizae 2/3 recipe quantity, to be ground into fine powder standby;

C) Cortex Phellodendri powder is broken into coarse powder, with 70% alcohol reflux twice, and each 1 hour, merge extractive liquid,, standing over night is got supernatant, reclaims ethanol, and being concentrated into relative density, surveying 80 ℃ the time is 1.20, with b) half mixing in the Radix Salviae Miltiorrhizae fine powder of step, drying under reduced pressure, it is standby to be ground into fine powder;

D) Radix Aucklandiae powder is broken into coarse powder, and distillating extracting oil is collected the volatile oil part, uses beta-schardinger dextrin-: volatile oil=10: 1, colloid milling enclose, and drying at room temperature is standby; Aqueous solution after distillation device is in addition collected;

E) Radix Pulsatillae, catechu, Herba Portulacae and remaining 1/3 recipe quantity Radix Salviae Miltiorrhizae add 9 times of water gagings and decocted 1 hour, filter, and collect filtrate;

F) medicinal residues e) mix with Cortex Phellodendri, Radix Aucklandiae medicinal residues, add 9 times of water gagings, decoct 1 hour, filter, and merge e), f) filtrate and above-mentioned d) distillate, being concentrated into relative density, surveying 60 ℃ the time is 1.10 clear paste;

G) f) the step clear paste adds 3 times of amount ethanol, makes to contain the alcohol amount and reach 70%, stirs; Standing over night is got supernatant, reclaims ethanol, and being concentrated into relative density, surveying 80 ℃ the time is 1.28 thick paste;

H) and b) second half fine powder mixing in the Radix Salviae Miltiorrhizae fine powder of step, drying under reduced pressure is ground into fine powder, with above-mentioned steps c) in fine powder and volatile oil clathrate compound mixing, granulate, encapsulated 1000, promptly.

The preparation of embodiment 2 capsules of the present invention

Radix Pulsatillae 857.4g, Herba Portulacae 428.7g, Cortex Phellodendri 428.7g, Radix Aucklandiae 114.3g, Radix Salviae Miltiorrhizae 285.8g, catechu 85.7g.

A) take by weighing each crude drug, standby;

B) getting Radix Salviae Miltiorrhizae 2/3 recipe quantity, to be ground into fine powder standby;

C) Cortex Phellodendri powder is broken into coarse powder, with 80% alcohol reflux twice, and each 2 hours, merge extractive liquid,, standing over night is got supernatant, reclaims ethanol, and being concentrated into relative density, surveying 80 ℃ the time is 1.20, with b) half mixing in the Radix Salviae Miltiorrhizae fine powder of step, drying under reduced pressure, it is standby to be ground into fine powder;

D) Radix Aucklandiae powder is broken into coarse powder, and distillating extracting oil is collected the volatile oil part, uses beta-schardinger dextrin-: volatile oil=10: 1, colloid milling enclose, and drying at room temperature is standby; Aqueous solution after distillation device is in addition collected;

E) Radix Pulsatillae, catechu, Herba Portulacae and remaining 1/3 recipe quantity Radix Salviae Miltiorrhizae add 10 times of water gagings and decocted 2 hours, filter, and collect filtrate;

F) medicinal residues e) mix with Cortex Phellodendri, Radix Aucklandiae medicinal residues, add 10 times of water gagings, decoct 2 hours, filter, and merge e), f) filtrate and above-mentioned d) distillate, being concentrated into relative density, surveying 60 ℃ the time is 1.15 clear paste;

G) f) the step clear paste adds 4 times of amount ethanol, makes to contain the alcohol amount and reach 80%, stirs; Standing over night is got supernatant, reclaims ethanol, and being concentrated into relative density, surveying 80 ℃ the time is 1.29 thick paste;

H) and b) second half fine powder mixing in the Radix Salviae Miltiorrhizae fine powder of step, drying under reduced pressure is ground into fine powder, with above-mentioned steps c) in fine powder and volatile oil clathrate compound mixing, granulate, press 1000.

The preparation of embodiment 3 granules of the present invention

Radix Pulsatillae 870g, Herba Portulacae 440g, Cortex Phellodendri～440g, Radix Aucklandiae 130g, Radix Salviae Miltiorrhizae 300g, catechu 100g.

A) take by weighing each crude drug, standby;

B) getting Radix Salviae Miltiorrhizae 2/3 recipe quantity, to be ground into fine powder standby;

C) Cortex Phellodendri powder is broken into coarse powder, with 90% alcohol reflux twice, and each 3 hours, merge extractive liquid,, standing over night is got supernatant, reclaims ethanol, and being concentrated into relative density, surveying 80 ℃ the time is 1.20, with b) half mixing in the Radix Salviae Miltiorrhizae fine powder of step, drying under reduced pressure, it is standby to be ground into fine powder;

D) Radix Aucklandiae powder is broken into coarse powder, and distillating extracting oil is collected the volatile oil part, uses beta-schardinger dextrin-: volatile oil=10: 1, colloid milling enclose, and drying at room temperature is standby; Aqueous solution after distillation device is in addition collected;

E) Radix Pulsatillae, catechu, Herba Portulacae and remaining 1/3 recipe quantity Radix Salviae Miltiorrhizae add 11 times of water gagings and decocted 3 hours, filter, and collect filtrate;

F) medicinal residues e) mix with Cortex Phellodendri, Radix Aucklandiae medicinal residues, add 11 times of water gagings, decoct 3 hours, filter, and merge e), f) filtrate and above-mentioned d) distillate, being concentrated into relative density, surveying 60 ℃ the time is 1.20 clear paste;

G) f) the step clear paste adds 5 times of amount ethanol, makes to contain the alcohol amount and reach 90%, stirs; Standing over night is got supernatant, reclaims ethanol, and being concentrated into relative density, surveying 80 ℃ the time is 1.30 thick paste;

H) and b) second half fine powder mixing in the Radix Salviae Miltiorrhizae fine powder of step, drying under reduced pressure is ground into fine powder, with above-mentioned steps c) in fine powder and volatile oil clathrate compound mixing, granulate, promptly.

Claims (3)

1, a kind of medicine for the treatment of chronic non-specific ulcerative colitis is characterized in that being being made by the crude drug of following parts by weight:

840～870 parts of the Radix Pulsatillaes, 410～440 parts of Herba Portulacaes, 410～440 parts of Cortex Phellodendris,

100～130 parts of the Radix Aucklandiae, 270～300 parts of Radix Salviae Miltiorrhizaes, 70～100 parts in catechu.

2, the medicine of treatment chronic non-specific ulcerative colitis according to claim 1 is characterized in that being being made by the crude drug of following parts by weight:

857.4 parts of the Radix Pulsatillaes, 428.7 parts of Herba Portulacaes, 428.7 parts of Cortex Phellodendris, 114.3 parts of the Radix Aucklandiae, 285.8 parts of Radix Salviae Miltiorrhizaes, 85.7 parts in catechu.

3, a kind of preparation method of medicine as claimed in claim 1 or 2 is characterized in that comprising the following steps:

A) take by weighing each crude drug, standby;

B) getting Radix Salviae Miltiorrhizae 2/3 recipe quantity, to be ground into fine powder standby;

C) Cortex Phellodendri powder is broken into coarse powder, with twice of 70%～90% alcohol reflux, each 1～3 hour, merge extractive liquid,, standing over night, get supernatant, reclaim ethanol, being concentrated into relative density, surveying 80 ℃ the time is 1.20, with b) half mixing in the Radix Salviae Miltiorrhizae fine powder of step, drying under reduced pressure, it is standby to be ground into fine powder;

D) Radix Aucklandiae powder is broken into coarse powder, and distillating extracting oil is collected the volatile oil part, uses beta-schardinger dextrin-: volatile oil=10: 1, colloid milling enclose, and drying at room temperature is standby; Aqueous solution after distillation device is in addition collected;

E) Radix Pulsatillae, catechu, Herba Portulacae and remaining 1/3 recipe quantity Radix Salviae Miltiorrhizae add 9～11 times of water gagings and decocted 1～3 hour, filter, and collect filtrate;

F) medicinal residues e) mix with Cortex Phellodendri, Radix Aucklandiae medicinal residues, add 9～11 times of water gagings, decoct 1～3 hour, filter, and merge e), f) filtrate and above-mentioned d) distillate, be concentrated into relative density, survey 60 ℃ the time and be the clear paste of 1.10-1.20;

G) f) the step clear paste adds 3～5 times of amount ethanol, makes to contain the alcohol amount and reach 70～90%, stirs; Standing over night is got supernatant, reclaims ethanol, is concentrated into relative density, surveys 80 ℃ the time and be the thick paste of 1.28-1.30;

H) and b) second half fine powder mixing in the Radix Salviae Miltiorrhizae fine powder of step, drying under reduced pressure is ground into fine powder, with above-mentioned steps c) in fine powder and volatile oil clathrate compound mixing, promptly.