CN1660247A - Chinese traditional medicine for treating ulcerative colitis and endo enteritis and preparation method - Google Patents
Chinese traditional medicine for treating ulcerative colitis and endo enteritis and preparation method Download PDFInfo
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Abstract
A Chinese medicine for treating ulcerative colitis and enteromycodermitis is prepared from 11 Chinese-medicinal materials including coptis root, astragalus root, notoginseng, Dragon's blood, etc. Its preparing process is also disclosed.
Description
[technical field]
The present invention relates to a kind of medicine for the treatment of ulcerative colitis and endo enteritis, is the Chinese patent medicine of feedstock production with the Chinese herbal medicine specifically, the invention still further relates to the preparation method of this medicine.
[background technology]
Ulcerative colitis (Ulcerative Colitis is called for short UC) is a kind of agnogenic chronic colitis, and pathological changes mainly is limited to the mucosa of colon, show as inflammation or ulcer, involve rectum and far-end colon more, but can expand, so that spread all over whole total colectomy to near-end.All can fall ill in the UC whole world, western countries' sickness rate is per 3～14.3/100,000, and prevalence every year is 39～234/100,000, and Asian countries was rare relatively in the past, but report according to Japanology and to be tangible ascendant trend over past ten years.Though China Shang Weiyou is based on crowd's epidemiological study, report increases gradually in recent years, shows the trend that this sick sickness rate is significantly increased.Primary disease acute fulminant form mortality rate height, the easy canceration of chronic lasting type, it is reported that its incidence rate is higher 5～20 times than the normal person, average out to 3.5%～7%, the above person's canceration rate of stadium 5a is 17%, particularly long, the extent of disease of the course of disease extensively, the age is than the lighter, is acknowledged as the precancerous lesion of colon cancer, classified as one of modern difficult treatment by World Health Organization (WHO) at present.
Modern medicine is not illustrated so far as yet to the pathogenic factor of UC.The Western medicine of western medical treatment UC comprises sulfasalazine, corticosteroid, immunosuppressant etc. at present, sulfasalazine is effective to light-duty, the medium-sized UC of part, but curative effect and side reaction are directly proportional with consumption, and it is not good enough to simple proctitis curative effect, the life-time service side effect is big, although the new formulation side effect that has is less, easily recurrence after the drug withdrawal.The prolonged application side effect increases.Hormone is treatment acute fulminant form and severe UC patient's a choice drug, but life-time service easily has side effects and can not prevent recurrence.Immunosuppressant has certain curative effect to sulfasalazine and the invalid UC patient of hormone, yet, relapse rate height after the drug withdrawal, and the life-time service side effect is bigger.The report of domestic in recent years relevant treatment by Chinese herbs UC is increasing, and evident in efficacy, no obvious toxic-side effects, the superiority and the wide prospect of demonstration treatment by Chinese herbs primary disease.Yet in these reports, the randomized controlled trial that argumentation Intensity is high is few, and the overwhelming majority is anecdotal therapeutic test, and the verity of result of study and reliability are doubted.And any Drug therapy all must have strict zoopery, and utilizing the curative effect of animal model checking medicine and studying its mechanism of action is that people use always and effective method.Therefore seeking effective medicine is the task of top priority.
[summary of the invention]
[technical problem that will solve]
In order to improve the curative effect of treatment UC, overcoming Chinese medicine lacks the high randomized controlled trial of argumentation Intensity and does not have strict animal model experiment, but the invention provides a kind of not only can be oral but also the instil Chinese traditional compound medicine of treatment ulcerative colitis and intestinal mucosa inflammation of rectum, this herbal mixture is rigorous by adopting, the perspective study of science/double blinding stratified random comparative study method, verified that this compound recipe pure Chinese medicinal preparation treatment retention of damp-heat in the interior type is master's the ulcerative colitis and the definite clinical effectiveness of endo enteritis, carry out animal acute toxicity test and pharmacodynamics test simultaneously, and utilized the DSS colitis model to verify this compound recipe pure Chinese medicinal preparation curative effect and the mechanism of action thereof first.
Another object of the present invention provides a kind of method for preparing treatment treatment ulcerative colitis and endo-enteritis disease drug.
[summary of the invention]
This medicine is the prescription of being made by following component (consumption is a weight ratio)
Rhizoma Coptidis 3-15, Herba Patriniae 15-60, Radix Astragali 10-90, Radix Notoginseng 5-10, Sanguis Draxonis 0.3-3, Pollen Typhae 5-30, Radix Sanguisorbae 5-30, Pseudobulbus Bletillae (Rhizoma Bletillae) 10-30 Concha Ostreae 15-60, Rhizoma Corydalis 5-15, Halloysitum Rubrum 10-60.
The formula optimization scheme of preparation medicine of the present invention is (consumption is a weight ratio):
Rhizoma Coptidis 5-12, Herba Patriniae 20-40, Radix Astragali 15-60, Radix Notoginseng 6-10, Sanguis Draxonis 0.5-2, Pollen Typhae 8-20, Radix Sanguisorbae 10-20, Pseudobulbus Bletillae (Rhizoma Bletillae) 15-25, Concha Ostreae 20-40, Rhizoma Corydalis 10-15, Halloysitum Rubrum 10-40.
The optimum weight proportioning of medicine of the present invention is (consumption is a weight ratio):
Rhizoma Coptidis 10, Herba Patriniae 30, the Radix Astragali 25, Radix Notoginseng 8, Sanguis Draxonis 1, Pollen Typhae 10, Radix Sanguisorbae 15,
The Pseudobulbus Bletillae (Rhizoma Bletillae) 20, Concha Ostreae 30, Rhizoma Corydalis 15, Halloysitum Rubrum 15.
The technological process of making this medicine is:
1. get the Radix Astragali, the Pseudobulbus Bletillae (Rhizoma Bletillae), Concha Ostreae, Rhizoma Coptidis, Halloysitum Rubrum, Herba Patriniae, Radix Sanguisorbae, Rhizoma Corydalis, Pollen Typhae and add water and cross powder, decoct secondary, each best about 1.5 hours, merge be concentrated into a certain amount of as reserve liquid (1);
2. get Radix Notoginseng and add water and cross powder, decoct three times, preferably about 1.5 hours for the first time, second and third time was about 1 hour, merged the decoction liquor filtering and concentrating to a certain amount of as reserve liquid (2);
3. merge: the Sanguis Draxonis dissolving is added in standby (1) (2) liquid, and adding preservative agent stirs evenly, packing.By above-mentioned technology gained this product is brown band slime body, and mildly bitter flavor is puckery, relative density: 4.5 °～5 °, pH value is: 4.1～4.8
For showing curative effect and the effect of medicine of the present invention to ulcerative colitis and endo enteritis, we have carried out experiment and zoopery when participating in the cintest respectively.
One. clinical experiment
1 data and method
1.1 case is selected
1.1.1 the UC diagnostic criteria [1] that the Western medicine diagnose standard is formulated according to the national chronic non-infection intestinal tract disease scientific seminar that holds in Taiyuan in June, 1993 and formulating.
1.1.2 the 4th the national seminar that tcm syndrome differentiation and typing standard reference in JIUYUE, 1992 is held in Linfen, Shanxi formulated CUC combination of Chinese and Western medicine diagnosis, dialectical standard [2] and formulated.
1.1.3 the adult of the standard of including in all UC of meeting Western medicine diagnoses standard and retention of damp-heat in the interior type or double due to weakness of spleen and stomach or double qi stagnation and blood stasis type UC tcm diagnosis standard (18-79 year) can be used as study subject.
1.1.4 all concurrent acute colitis of exclusion standard are expanded or are bled profusely or stenosis of colon and intestinal obstruction person; Gestation or age of sucking the patient; Merge serious disease persons such as liver, kidney and hemopoietic system.
1.2 the double blinding stratified random method of dividision into groups is taked in the grouping measure, promptly enters age, sex, the occurring degree of test according to UC patient, is divided into corresponding each layer, then by be admitted to hospital and the prescription on individual diagnosis order respectively in each layer the random assortment patient arrive test group or matched group.
1.3 the 128 routine UC patients that this institute of physical data is observed all meet UC Western medicine diagnose standard and retention of damp-heat in the interior type or double due to weakness of spleen and stomach or double qi stagnation and blood stasis type UC tcm diagnosis standard, get rid of concurrent acute colitis expansion bleed profusely or stenosis of colon and intestinal obstruction person, pregnant age of sucking patient, concurrent liver, kidney and serious disease persons such as hemopoietic system.Test group 64 examples wherein, matched group 64 examples.Two groups of cases have comparability in there are no significant sex, age distribution and mean age difference (P 〉=0.05).
1.4 this herbal mixture all adopts aforementioned formula and processing technology to be prepared
1.5 Therapeutic Method
Test group: this herbal mixture water preparation: oral: each 50ml, every day 2 times;
Rectum instils: each 100ml, every day 1 time;
Placebo (simulation sulfasalazine): oral: each 4, every day 2 times.
Matched group: sulfasalazine: oral: each 4, every day 2 times;
Placebo (simulating this herbal mixture water preparation): oral: each 50ml, every day 2 times;
Rectum instils: each 100ml, every day 1 time.
Two groups of rectum drip-injection methods are as follows:
The patient drains greatly after an action of the bowels evening, gets left side knee joint clinostatism, and buttocks bed hedgehopping 30 degree are contained into enema (Celsius temperature is at 37-38 ℃) with the disposable enemas bag, the saxol lubrication conduit inserts anus 15cm, immobilization with adhesive tape, drip fast 60-80 drip/minute, splash into finish after, change position.
1.6 the course of treatment is oral: 8 weeks were a course of treatment
Rectum instils: 28 days is a course of treatment, has a rest second course of treatment of row again, shared 2 courses of treatment two days.
1.7 blind method
Test group (this herbal mixture water preparation) is different with matched group (sulfasalazine) dosage form, for this reason, makes the simulation sheet of color and luster, the no property of medicine that shape is identical with the sulfasalazine agent; Make the simulation water preparation of color and luster, the no property of medicine that shape is identical with this herbal mixture water preparation.Two groups of medicines are compiled and are gone up code name, and doctor and patient all do not know, and be after whole research finishes, just open.
1.8 observation index
Stipulate all indexs according to EXPERIMENTAL DESIGN, comprise observation, inspection, itemized record before and after indexs such as intestinal mucosa, intestinal mucosa histopathology, blood system, hepatic and renal function are treated under clinical syndrome, the intestinal mirror; Simultaneously indexs such as patient's hemorheology, SOD/LPO, nail fold microcirculation, T cell subsets, immunoglobulin are checked and record.
1.9 data processing method
All initial datas adopt medicostatistics process software PEMS2.0 to carry out input, statistical analysis and the correlation computations of data.Carrying out form through WORD 97 again handles and graphical representation.
2 therapeutic outcomes
2.1 the UC criterion of therapeutical effect of formulating on the 4th the national seminar that curative effect determinate standard is held in Linfen, Shanxi according in JIUYUE, 1992 [2].
2.2 efficacy analysis:.
2.2.1 clinical comprehensive total effective rate (total cure rate, total obvious effective rate, total effective rate)
The table 1 liang clinical comprehensive total effects in group treatment back relatively
| The group clinical recovery produce effects total obvious effective rate % of the total cure rate % of the invalid deterioration total effective rate % that takes a turn for the better |
| Test group 19 30 870 29.69% 76.57% 89.07% n=64 example matched groups 5 12 28 17 2 7.80% 26.55% 70.30% n=64 examples |
P＜0.01????P＜0.01????P＜0.01
The clinical comprehensive total effects of test group is apparently higher than matched group
2.2.2 clinical syndrome effective percentage (cure rate, obvious effective rate, effective percentage)
The table 2 liang clinical therapeutic effect of syndrome in group treatment back relatively
| The group clinical recovery produce effects invalid deterioration cure rate % obvious effective rate % effective percentage % that takes a turn for the better |
| Test group 45 9730 70.31% 84.37% 95.31% n=64 example matched groups 23 9 10 22 0 35.94% 50.00% 65.63% n=64 examples |
P＜0.01????P＜0.01????P＜0.01
The clinical therapeutic effect of syndrome of test group is apparently higher than matched group
2.2.3 intestinal mucosa effective percentage under the intestinal mirror (cure rate, obvious effective rate, effective percentage)
The intestinal mucosa curative effect relatively under the table 3 liang group treatment hindgut mirror
| The group clinical recovery produce effects invalid deterioration cure rate % obvious effective rate % effective percentage % that takes a turn for the better |
| Test group 14 32 14 60 21.88% 68.78% 90.63% |
| N=64 example matched group 6 15 21 21 1 9.38% 32.82% 65.63% n=64 examples |
P＜0.01????P＜0.01????P＜0.01
The intestinal mucosa curative effect is apparently higher than matched group under the intestinal mirror of test group
2.2.4 intestinal mucosa histopathology effective percentage (cure rate, obvious effective rate, effective percentage)
Table 4 liang group treatment hindgut mucosa histopathology curative effect relatively
| The group clinical recovery produce effects invalid deterioration cure rate % obvious effective rate % effective percentage % that takes a turn for the better |
| Test group 19 27 990 26.69% 71.88% 85.94% n=64 example matched groups 56 24 27 2 7.80% 17.20% 54.70% n=64 examples |
P＜0.01????P＜0.01????P＜0.01
The intestinal mucosa histopathology curative effect of test group is apparently higher than matched group
2.2.5 two groups of lesion degrees and clinical comprehensive total effects relation
Table 5 liang group lesion degree and clinical comprehensive total effects relation
| The group example number recovery from illness produce effects total obvious effective rate total effective rate of the total cure rate of invalid deterioration that takes a turn for the better |
| In the test group light 34 14 16 220 41.18% 88.24% 94.12% 20 4 11 320 20.00% 75.00% 90.00% |
| Weigh in 10 13330 10.00% 40.00% 70.00% control groups light 38 37 20 80 7.89% 26.32% 78.94% 16 25630 12.5% 43.75% 81.25% heavy 10 00262 0.00% 0.00% 20.00% |
Test group is light, in, the clinical comprehensive total effects of three types that weigh all is higher than matched group
2.2.6 test group routine blood test, liver, renal function leading indicator change:
No significant change before and after test group routine blood test, liver, the renal function curing.Do not find untoward reaction during the treatment of test group case.
2.2.7 side effect relatively after test group and the treatment of control group
Side effect relatively after table 6 test group and the treatment of control group
| The dizzy leukopenia of group case load skin allergy upper abdominal pain |
| Test group 64 0000 matched groups 64 2711 |
This herbal mixture (test group) is without any side effects.And in the 64 routine matched groups, skin allergy appears in 2 examples (accounting for 3.13%); Upper abdominal pain appears in 7 examples (accounting for 10.94%); 1 example (accounting for 1.56%) occurs dizzy; Leukopenia appears in 1 example (accounting for 1.56%).
3. animal acute toxicity test and pharmacodynamics test
The animal acute toxicity test conclusion of " 3.1 this herbal mixture "
In pilot study, find, fail to cause that with the dosage of this herbal mixture extractum maximum volume, Cmax moving animal is poisoned to death, can't measure LD
50So, this test requires to carry out acute toxicity test with reference to the toxicologic study of relevant new Chinese medicine in " study of tcm new drug guide ", the dose that promptly gives maximum volume under the Cmax that animal can tolerate is amounted to primary dose 284.4/k.d, carry out mtd test (convert to be equivalent to be grown up 40 times of consumption every day by body weight), observe the untoward reaction that is produced in 7 days.
The The acute toxicity tests of this herbal mixture of table 7
| Dosage (/k.d) | Mus number (only) | Body weight (, x ± s) | The heart, liver, spleen, lung, kidney, gastrointestinal change | ||
| Before the experiment | After the experiment | Before the experiment | After the experiment | ||
| ????294.4 | ????20 | ????20 | ?20.0±0.0 | ?22.8±1.8 | No abnormality seen |
Conclusion: this herbal mixture is pressed dosage one twice-daily of 147.2/k and is given the mouse stomach administration, observes 7 days, does not see untoward reaction.Experimental result shows that it is 294.4/k.d that this herbal mixture is given the maximum tolerated dose of mouse stomach, and this amount converts by body weight and is equivalent to 40 times of the clinical application amount.
Conclusion: experimental results show that this herbal mixture is safe.
3.2 the pharmacodynamic experiment of this herbal mixture
Require and the expectation clinical application according to examining of " provisions for new drugs approval " heavy Chinese medicine three class medicines, to this herbal mixture carried out antibiotic, analgesia, antidiarrheal, anastalsis, to the gastrointestinal motility function with to Expermental research on main pharmacodynamics such as immunity functions, and similar medicine sulfasalazine compared.
Conclusion:
1. this herbal mixture has bacteriostasis to a certain degree, and wherein the bacteriostasis to staphylococcus aureus, beta hemolytic streptococcus is stronger;
2. this herbal mixture can suppress the mouse writhing reaction that acetic acid causes;
3. this herbal mixture can obviously resist the diarrhea of mouse effect that Oleum Ricini causes;
4. this herbal mixture can obviously shorten the clotting time of mice;
5. this herbal mixture can improve the phagocytic function of immunosuppressive condition Turnover of Mouse Peritoneal Macrophages, impels its phagocytic percentage and phagocytic index to raise;
6. this herbal mixture can improve DTH (delayed hypersensitivity) reaction of immunosuppressant model mice;
7. the enterokinesia that gastrointestinal motility function and the neostigmine of mice caused of this herbal mixture is hyperfunction does not all have a bright influence.
Show by above-mentioned clinical experiment conclusion: this herbal mixture has antibiotic, analgesia, antidiarrheal, anastalsis, and has immunoregulation effect, can improve cellular immunization and the non-specific body defense function of immunologic hypofunction mice.Compare with similar medicine sulfasalazine, this herbal mixture is except that the too late sulfasalazine of bacteriostasis, and its analgesic activity is substantially parallel with sulfasalazine, and antidiarrheal, hemostasis and immunoregulation effect then are better than sulfasalazine.
Two. zoopery:
1, materials and methods
1.1 material
1.1.1 40 of the female BALB/c mouse of laboratory animal cleaning level, in 8～10 ages in week, body weight 18～22 is provided by Zhongshan University's Zhongshan Medical College Experimental Animal Center.
1.1.2 medicine and this Chinese traditional compound medicine of reagent: provide by the standard manufacture processes by Guangzhou institute of traditional Chinese medicine pharmacy.SASP sheet: Shanghai Sunve Pharmaceutical Co., Ltd.'s product (product batch number: 200106c07).DSS (molecular weight=36,000-50,000) is an ICN Biomedicals Inc. product.Taq archaeal dna polymerase, AMV reverse transcriptase, extraction total tissue RNA test kit are precious biological engineering company limited product, and TNF α, IL-1 β, IL-6 and β-actin primer is synthetic by precious biological engineering company limited.
1.2 method
1.2.1 modeling DSS colitis model is with reference to the method for Okayasu
[1]Improvement a little.Promptly replace drinking water to give mice with 3%DSS and drink, 7d gets final product continuously.
1.2.2 medicine preparation and this Chinese traditional compound medicine of usage by principal agents such as Rhizoma Coptidis, the Radix Astragali, Pollen Typhae, Pseudobulbus Bletillae (Rhizoma Bletillae), Rhizoma Corydalis in 2: 5: 3: ratio was made in 4: 3, and every ml contains 3.375 crude drugs.Irritate stomach dosage and be 33.75 crude drugs/(kd), i.e. 0.2ml/ (20d), 2 times of the dosage that is equivalent to be grown up.SASP is milled into powder, is made into the suspension that concentration is 50m/ml, and irritating stomach dosage is 0.5/ (kd), i.e. 0.2ml/ (20d), 2 times of the dosage that is equivalent to be grown up.
1.2.3 grouping is divided into 4 groups with administration at random with 40 mices.Chinese drug-treated group (n=10), Western medicine group (n=10), Chinese medicine and western medicine all give 3%DSS 7d in conjunction with group (n=10) and model group (n=10), and irritated stomach in the 4th day respectively and give this herbal mixture, SASP, this herbal mixture (half amount of Chinese drug-treated group)+SASP (half amount of Western medicine group) and isometric normal saline, continuous 7d.Observe body weight change, stool character and occult blood test with calculate disease activity index (disease activity index, DAI).
Put to death animal 1.2.4 draw materials at the 11st day, take off 1/2 section colon, part is put in the fixative fixing to do the pathology inspection, and part is put liquid nitrogen and preserved standby.
1.2.5 calculate DAI according to Murthy etc.
[2]Method improve a little, see Table 1.
The computational methods of table 1 DAI
| Scoring | (%) loses weight | The stool character | Occult blood/naked eyes are hemorrhage |
| ??0 ??1 ??2 ??3 | ????(-) ????1-5 ????5-10 ????11-15 | Normally soft | Negative (+) (++) (+++) |
| 4＞15 diarrhoea naked eyes hemafecias |
DAI=body weight, stool character and occult blood 3 item rating sum/3
1.2.6 RT-PCR IL-1 β primer: 5 '-CCA ATA A CCC AA CA-3 ', 3 '-CC TTTTC TT ACC A C CCT-5 ' expanding fragment length is 519bp; TNF α primer: 5 '-CA TACA AC CC TA CC-3 ', 3 '-CC CT ACC C ACA ATA-5 ' expanding fragment length is 468bp; The IL-6 primer: 5 '-CTT CCA CC ATT C CTT CT-3 ', 3 '-TTAA TTAC A A-5 ' expanding fragment length is 496bp; β-actin primer: 5 '-ACCACA TC CAT AAATC AC-3 ', 5 '-A TTT CTC CA C CAT-3 ' expanding fragment length is 315bp.Get the 100m of colon and extract total tissue RNA, measure A through ultraviolet spectrophotometer by the test kit step
260/ A
230Ratio, calculate rna content in the extracting solution, every example is got the total RNA of 2.0 μ, in 65 ℃ of degeneration 5min, add 0.5mmol/L dNTP successively, 5 * RTbuffer, 100n Random Primer, 10U reverse transcription, reaction system is 20 μ l, 42 ℃ of 40min, 95 ℃ of 5min, gained TNF α, IL-1 β, IL-6 and β-actin cDNA is standby in-20 ℃ of preservations.The PCR reaction system: get 5 μ l cDNA products, 10 * PCR buffer, 1U Taq archaeal dna polymerase, reaction system is 25 μ l.TNF α amplification condition is: 94 ℃ of 2min, and 94 ℃ of 45s, 50 ℃ of 45s, 72 ℃ of 45s circulate 72 ℃ of 10min 35 times.Get pcr amplification product 10 μ l, through 2% agarose gel electrophoresis, under uviol lamp, observe the fragment length of identifying amplified production, and take pictures, with the ZL-2000 magic magiscan electrophoretic band is carried out gray scale and area scanning, with the ratio of the gray value of the integration gray value of the TNF α mRNA electrophoretic band of same specimen and β-actin mRNA semi-quantitative results as the TNF α mRNA of this specimen.The result of IL-1 β and IL-6 judges identical therewith.
1.2.7 statistical procedures result represents with x ± S, relatively with variance analysis and q check, analyzes with the SPSS10.0 statistical package between many groups.
2 results
2.1 clinical indices
The disease activity index of each group sees Table 2.All animals of model group all can be observed soft or diarrhoea, hemafecia of stool and lose weight after giving 3%DSS 7d, and the stool of 3 treatment groups is than shaping, hemafecia and lose weight more not obvious.From DAI, Chinese drug-treated group and Western medicine group obviously reduce (P＜0.05 and P＜0.01) than model group, but are higher than Chinese medicine and western medicine in conjunction with group (P＜0.01 and P＜0.05), do not have significant difference (P＞0.05) between Chinese drug-treated group and the Western medicine group.
This herbal mixture of table 2 is to the curative effect x ± S of DSS colitis
| Group | ????n | ??DAI |
| Chinese drug-treated group Western medicine group Chinese medicine and western medicine is in conjunction with the group model group | ????10 ????10 ????10 ????10 | ??1.413±0.835*◆◆# ??1.278±0.648**◆ ??0.608±0.449** ??2.167±0.911 |
Relatively combine group with Chinese medicine and western medicine relatively in * P＜0.05 * * P＜0.01 with model group ◆ P＜0.05 ◆ ◆ #P＞0.05 is compared with the Western medicine group in P＜0.01
2.2 MPO activity
Table 3 is the active comparison of each group MPO, and visible Chinese drug-treated group and Western medicine group obviously reduce (P＜0.05 and P＜0.01) than model group, but are higher than Chinese medicine and western medicine in conjunction with group (P＜0.01 and P＜0.05), do not have significant difference (P＞0.05) between Chinese drug-treated group and the Western medicine group.
This herbal mixture of table 3 is to the x ± S that influences of DSS colitis MPO
| Group | ????n | ????MPO(U/) |
| Chinese drug-treated group Western medicine group | ????10 ????10 | ????4.341±0.590*◆◆# ????3.748±0.408**◆ |
| Chinese medicine and western medicine is in conjunction with the group model group | ??10 ??10 | ??1.639±0.211** ??7.020±0.902 |
Relatively combine group with Chinese medicine and western medicine relatively in * P＜0.05 * * P＜0.01 with model group ◆ P＜0.05 ◆ ◆ #P＞0.05 is compared with the Western medicine group in P＜0.01
2.3 the expression of the TNF α of colon, IL-1 β, IL-6 mRNA
The comparison that table 4 is expressed for each group TNF α of colon, IL-1 β, IL-6mRNA, as seen the expression of Chinese drug-treated group and Western medicine group obviously reduces (P＜0.05 and P＜0.01) than model group, but be higher than Chinese medicine and western medicine in conjunction with group (P＜0.01 and P＜0.05), there is not significant difference (P＞0.05) between Chinese drug-treated group and the Western medicine group.
This herbal mixture of table 4 is to the x ± S that influences of the TNF α of colon, IL-1 β, IL-6mRNA expression
| Group | ??n | ??TNFα | ??IL-1β | IL-6 |
| Chinese drug-treated group Western medicine group Chinese medicine and western medicine is in conjunction with the group model group | ??10 ??10 ??10 ??10 | ??0.841±0.190*◆◆# ??0.698±0.108**◆ ??0.339±0.081** ??1.320±0.282 | ??0.641±0.095*◆◆# ??0.548±0.152**◆ ??0.239±0.073** ??0.920±0.082 | 1.241±0.247◆◆# 1.098±0.179**◆ 0.639±0.141** 1.620±0.312 |
Relatively combine group with Chinese medicine and western medicine relatively in * P＜0.05 * * P＜0.01 with model group ◆ P＜0.05 ◆ ◆ #P＞0.05 is compared with the Western medicine group in P＜0.01
3, conclusion
3.1 this research successfully copies dextran sulfate sodium colitis mice animal model.Its clinical manifestation, general form and Histological change are all similar with human ulcerative colitis.
3.2 the treatment of this herbal mixture can improve the clinical and histology performance of DSS colitis, reduces colon's myeloperoxidase (MPO) (myeloperoxidase, MPO) activity simultaneously.And the therapeutic equivalence of this herbal mixture and sulfasalazine (SASP).
3.3 the treatment of this herbal mixture obviously reduces TNF α, cytokines mRNA expression such as IL-1 β, IL-6 in the colon, and suitable with the effect of SASP.Expression and reduction MPO activity by the reduction TNF α of colon, IL-1 β, IL-6mRNA may be one of therapeutic mechanism of this herbal mixture treatment UC.
3.4 after this herbal mixture or SASP or this herbal mixture add the SASP treatment, the DAI of reflection clinical manifestation and histology's performance improve, the TNF α of colon, IL-1 β, IL-6mRNA express obviously and reduce, the therapeutic equivalence of this herbal mixture and SASP wherein, but the curative effect that adds SASP with this herbal mixture is best, it is single with Chinese medicine or Western medicine to illustrate that the bonded curative effect of Chinese medicine and western medicine is better than, and can reduce the dosage of this herbal mixture and SASP, and prompting might reduce side effects of pharmaceutical drugs.
4, the characteristics of this research
4.1 utilize domestic in recent years the report of curative effect of animal model checking Chinese medicine increasing about treatment by Chinese herbs UC, and evident in efficacy, no obvious toxic-side effects, the superiority and the wide prospect of demonstration treatment by Chinese herbs primary disease.Yet in these reports, the randomized controlled trial that argumentation Intensity is high is rare, and the overwhelming majority is anecdotal therapeutic test, and the verity of result of study and reliability are doubted.And any Drug therapy all must have strict zoopery, and utilizing the curative effect of animal model checking medicine and studying its mechanism of action is that people use always and effective method.This research is adopted and to be gained public acceptance at present and be widely used in the model----dextran sulfate sodium of the similar human UC of pharmaceutical intervention research (dextran sulfate sodium, DSS) model are verified the curative effect of this herbal mixture and studied its mechanism of action.The result proves that the treatment of this herbal mixture can improve the clinical and histology performance of DSS colitis, reduces colon's myeloperoxidase (MPO) (myeloperoxidase, MPO) activity simultaneously.And therapeutic equivalence with sulfasalazine (SASP).
4.2 though utilize the report of the domestic in recent years relevant Chinese medicine UC of the mechanism of action of Research of Animal Model for Study Chinese medicine increasing, the applied basic research of Chinese medicine then develops comparatively slow, and this has seriously influenced the modernization development of Chinese medicine.This research and utilization DSS colitis model is studied the mechanism of action of this herbal mixture, the result shows that by expression that reduces the TNF α of colon, IL-1 β, IL-6mRNA and reduction MPO activity may be one of therapeutic mechanism of this herbal mixture treatment UC, UC provides certain theoretical foundation for the treatment of this herbal mixture of clinical practice, has also use up some widow's mites for the modernization that promotes Chinese medicine research.
4.3 utilizing DSS colitis model checking Chinese medicine curative effect DSS colitis model first is to gain public acceptance at present and be widely used in the model of the similar human UC of pharmaceutical intervention research, but domestic do not have as yet use it for the report of verifying curative effect of medication.This research successfully copies DSS colitis mice animal model, and the curative effect and the sulfasalazine (SASP) that utilize it to prove this herbal mixture treatment DSS colitis are suitable.
[beneficial effect]
The compound recipe pure Chinese medicinal preparation that this herbal mixture not only can be oral but also but rectum instils.Perspective study/double blinding stratified random comparative study the method for, science rigorous by adopting has verified that this compound recipe pure Chinese medicinal preparation treatment retention of damp-heat in the interior type is the definite clinical effectiveness of main ulcerative colitis, clinical having no adverse reaction.Prove this Chinese traditional compound medicine safety non-toxic by animal acute toxicity test and pharmacodynamics test, have effects such as antibiotic, analgesia, antidiarrheal, hemostasis, immunomodulating.The present invention utilizes the DSS colitis model that gains public acceptance at present and be widely used in the similar human UC of pharmaceutical intervention research first, verified the curative effect of this Chinese traditional compound medicine treatment DSS colitis, the result proves, clinical and the histology that this Chinese traditional compound medicine treatment can improve DSS colitis shows, and with the therapeutic equivalence of sulfasalazine.Utilize the DSS colitis model to study the mechanism of action of this Chinese traditional compound medicine, the result shows that by expression that reduces the TNF α of colon, IL-1 β, IL-6mRNA and reduction MPO activity may be one of therapeutic mechanism of this Chinese traditional compound medicine treatment UC, and UC provides certain theoretical foundation for the treatment of clinical practice Chinese traditional compound medicine..
[concrete case study on implementation]
For further specifying the present invention, following examples now are provided, this embodiment only is used to illustrate the present invention, does not limit the present invention.
Case study on implementation 1
Take by weighing raw material (unit: restrain) by following proportioning:
Rhizoma Coptidis 10, Herba Patriniae 30, the Radix Astragali 25, Radix Notoginseng 8, Sanguis Draxonis 1, Pollen Typhae 10, Radix Sanguisorbae 15, the Pseudobulbus Bletillae (Rhizoma Bletillae) 20, Concha Ostreae 30, Rhizoma Corydalis 15, Halloysitum Rubrum 15.
Case study on implementation 2
Take by weighing raw material (gram) by following proportioning:
Rhizoma Coptidis 5, Herba Patriniae 20, the Radix Astragali 15, Radix Notoginseng 6, Sanguis Draxonis 0.5, Pollen Typhae 8, Radix Sanguisorbae 10, the Pseudobulbus Bletillae (Rhizoma Bletillae) 15, Concha Ostreae 20, Rhizoma Corydalis 10, Halloysitum Rubrum 10
Case study on implementation 3 (unit: gram):
Take by weighing raw material (gram) by following proportioning:
Rhizoma Coptidis 12, Herba Patriniae 40, the Radix Astragali 60, Radix Notoginseng 10, Sanguis Draxonis 2, Pollen Typhae 20, Radix Sanguisorbae 20, the Pseudobulbus Bletillae (Rhizoma Bletillae) 25, Concha Ostreae 40, Rhizoma Corydalis 15, Halloysitum Rubrum 40
Case study on implementation 4
Take by weighing raw material (gram) by following proportioning:
Rhizoma Coptidis 3, Herba Patriniae 15, the Radix Astragali 10, Radix Notoginseng 5, Sanguis Draxonis 0.3, Pollen Typhae 5, Radix Sanguisorbae 5, the Pseudobulbus Bletillae (Rhizoma Bletillae) 10, Concha Ostreae 15, Rhizoma Corydalis 5, Halloysitum Rubrum 10
Case study on implementation 5
Take by weighing raw material (gram) by following proportioning:
Rhizoma Coptidis 15, Herba Patriniae 60, the Radix Astragali 90, Radix Notoginseng 10, Sanguis Draxonis 3, Pollen Typhae 30, Radix Sanguisorbae 30, the Pseudobulbus Bletillae (Rhizoma Bletillae) 30, Concha Ostreae 60, Rhizoma Corydalis 15, Halloysitum Rubrum 60
Preparation method:
The Chinese medicine of the various proportionings of above-mentioned various 1-5 is prepared by following technology respectively
1. get earlier the Radix Astragali, the Pseudobulbus Bletillae (Rhizoma Bletillae), Concha Ostreae, Rhizoma Coptidis, Halloysitum Rubrum, Herba Patriniae, Radix Sanguisorbae, Rhizoma Corydalis, Pollen Typhae respectively and add water and cross powder, decoct secondary, each 1.5 hours, merge be concentrated into a certain amount of as reserve liquid (1);
2. get Radix Notoginseng then and add water and cross powder, decoct three times, about 1.5 hours for the first time, second and third time was about 1 hour, merged the decoction liquor filtering and concentrating to a certain amount of as reserve liquid (2);
3. merge: at last the Sanguis Draxonis dissolving is added in standby (1) (2) liquid, adding preservative agent stirs evenly, packing promptly makes this medicine.
Claims (6)
1, a kind of Chinese medicine for the treatment of ulcerative colitis and endo enteritis is characterized in that the medicament that it is made by the raw material of following weight ratio:
Rhizoma Coptidis 3-15, Herba Patriniae 15-60, Radix Astragali 10-90, Radix Notoginseng 5-10, Sanguis Draxonis 0.3-3, Pollen Typhae 5-30, Radix Sanguisorbae 5-30, Pseudobulbus Bletillae (Rhizoma Bletillae) 10-30 Concha Ostreae 15-60, Rhizoma Corydalis 5-15, Halloysitum Rubrum 10-60.
2, the Chinese medicine of treatment ulcerative colitis according to claim 1 and endo enteritis is characterized in that the formula optimization weight proportion scope for preparing medicine of the present invention is:
Rhizoma Coptidis 5-10, Herba Patriniae 20-40, Radix Astragali 10-60, Radix Notoginseng 6-10, Sanguis Draxonis 0.5-2, Pollen Typhae 8-20, Radix Sanguisorbae 10-20, Pseudobulbus Bletillae (Rhizoma Bletillae) 15-25, Concha Ostreae 20-40, Rhizoma Corydalis 10-15, Halloysitum Rubrum 10-40.
3, the Chinese medicine of treatment ulcerative colitis according to claim 1 and 2 and endo enteritis is characterized in that the optimum weight proportioning of medicine of the present invention is:
Rhizoma Coptidis 10, Herba Patriniae 30, the Radix Astragali 25, Radix Notoginseng 8, Sanguis Draxonis 1, Pollen Typhae 10, Radix Sanguisorbae 15, the Pseudobulbus Bletillae (Rhizoma Bletillae) 20, Concha Ostreae 30, Rhizoma Corydalis 15, Halloysitum Rubrum 15.
4, a kind of preparation method of Chinese medicine for the treatment of ulcerative colitis and endo enteritis is characterized in that:
(I), by weight ratio be ready to raw material, get the Radix Astragali, the Pseudobulbus Bletillae (Rhizoma Bletillae), Concha Ostreae, Rhizoma Coptidis, Halloysitum Rubrum, Herba Patriniae, Radix Sanguisorbae, Rhizoma Corydalis, Pollen Typhae and add water and cross powder, decoct secondary, merge be concentrated into a certain amount of as reserve liquid (1);
(II), get Radix Notoginseng and add water and cross powder, decoct three times, merge the decoction liquor filtering and concentrating to a certain amount of as reserve liquid (2);
(III), merge: the Sanguis Draxonis dissolving is added in standby (1) (2) liquid, and adding preservative agent stirs evenly, packing.
5, the preparation method of Chinese medicine of treatment ulcerative colitis according to claim 4 and endo enteritis, it is characterized in that: in step (I), get the Radix Astragali, the Pseudobulbus Bletillae (Rhizoma Bletillae), Concha Ostreae, Rhizoma Coptidis, Halloysitum Rubrum, Herba Patriniae, Radix Sanguisorbae, Rhizoma Corydalis and add water and cross powder, decoct secondary, each best about 1.5 hours, merging was concentrated into a certain amount of as reserve liquid (1).
6, according to the preparation method of Chinese medicine of claim 4 or 5 described treatment ulcerative colitiss and endo enteritis, it is characterized in that: in step (II), get Radix Notoginseng and add water and cross powder, decoct three times, preferably about 1.5 hours for the first time, second and third time is about 1 hour, merges the decoction liquor filtering and concentrating to a certain amount of as reserve liquid (2).
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| Application Number | Priority Date | Filing Date | Title |
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| CN 200410077384 CN1660247A (en) | 2004-12-17 | 2004-12-17 | Chinese traditional medicine for treating ulcerative colitis and endo enteritis and preparation method |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100446805C (en) * | 2005-09-05 | 2008-12-31 | 天津中新药业集团股份有限公司达仁堂制药厂 | Medicine for treating chronic diarrhoea |
| CN102335341A (en) * | 2011-09-18 | 2012-02-01 | 罗明雷 | Chinese medicinal clysis decoction for treating ulcerative colitis |
| CN101700296B (en) * | 2009-11-20 | 2012-02-15 | 周云飞 | Chinese herbal preparation for curing gastroenteritis and preparation method thereof |
| CN103800597A (en) * | 2014-02-24 | 2014-05-21 | 王洋 | Traditional Chinese medicine for treating damp-heat accumulation ulcerative colitis |
-
2004
- 2004-12-17 CN CN 200410077384 patent/CN1660247A/en active Pending
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100446805C (en) * | 2005-09-05 | 2008-12-31 | 天津中新药业集团股份有限公司达仁堂制药厂 | Medicine for treating chronic diarrhoea |
| CN101700296B (en) * | 2009-11-20 | 2012-02-15 | 周云飞 | Chinese herbal preparation for curing gastroenteritis and preparation method thereof |
| CN102335341A (en) * | 2011-09-18 | 2012-02-01 | 罗明雷 | Chinese medicinal clysis decoction for treating ulcerative colitis |
| CN103800597A (en) * | 2014-02-24 | 2014-05-21 | 王洋 | Traditional Chinese medicine for treating damp-heat accumulation ulcerative colitis |
| 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 |
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