CN107029084A - A kind of Chinese medicine composition and its pharmaceutical preparation for treating Colon and rectum precancerous lesion and application - Google Patents
A kind of Chinese medicine composition and its pharmaceutical preparation for treating Colon and rectum precancerous lesion and application Download PDFInfo
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- CN107029084A CN107029084A CN201710308870.9A CN201710308870A CN107029084A CN 107029084 A CN107029084 A CN 107029084A CN 201710308870 A CN201710308870 A CN 201710308870A CN 107029084 A CN107029084 A CN 107029084A
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- rectum
- colon
- chinese medicine
- precancerous lesion
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
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Abstract
The present invention relates to tcm field, and in particular to a kind of Chinese medicine composition and its pharmaceutical preparation for treating Colon and rectum precancerous lesion.The Chinese medicine composition of the present invention is made up of the bulk drug of following parts by weight：5 15 parts of rhizoma pinellinae praeparata, 39 parts of rhubarb, 5 15 parts of Rhizoma Arisaematis (processed), 10 30 parts of Paris polyphylla, 3 15 parts of the coptis.The Chinese medicine composition of the present invention can effectively treat Colon and rectum precancerous lesion, and Small side effects, recurrence rate are low.
Description
Technical field
The present invention relates to field of Chinese medicinal composition, and in particular to a kind of Chinese traditional medicine composition for being used to treat Colon and rectum precancerous lesion
Thing and its pharmaceutical preparation.
Background technology
Rise rapidly with China's colorectal cancer (colorectal cancer, CRC) incidence of disease, it is serious to threaten common people's health.
One large-scale clinical data statistics display, the incidence of disease of colorectal cancer has risen to the female malignant incidence of disease the 4th, man
Property the 5th.Colorectal cancer is caused by the factors such as h and E interact, to be related to polygenes, multistage
Complex process.Intestinal mucosa epithelium experienced " no intraepithelial neoplasia (cin)-uncertain intraepithelial neoplasia (cin)-low level intraepithelial neoplasia
The Carcinogenesis of change-intraepithelial neoplasia-cancer ", is process long-term, progressive, by quantitative change to qualitative change, Colon and rectum
Precancerous stage, is the important opportunity for preventing colorectal cancer to occur, and effectively treatment Colon and rectum precancerous lesion, which has become, ties straight
The important topic of intestinal cancer secondary prevention.
Colon and rectum precancerous lesion is a continuous process, and it refers to the boundary shape that lesion is between cytothesis and tumour
State, is pathology definition.The 4th edition WHO guide (2012) of precancerous lesion explicitly points out includes institute by " intraepithelial neoplasia (cin) " one word
There is the precancerous lesion of infiltrating cancer, no matter it whether there is the Morphological Characteristics of traditional tumour, Colon and rectum precancerous lesion includes mistake
Structure knurl correlation dysplasia, inflammatory bowel disease correlation dysplasia are (including increasing property of villiform mucus dysplasia, adenomatous
Dysplasia, zigzag dysplasia), without base of a fruit zigzag polyp/adenoma (not with dysplasia or with dysplasia), adenoma
(including traditional Serrated adenoma and plain edition adenoma) etc..There is data to show more than 80% colorectal cancer by Colon and rectum adenoma
Develop, the canceration rate of adenoma multiple is up to 14%-40%.It is clinical process important before colorectal cancer occurs.
Motherland, which is learned, has no clear and definite " disease before colorectal cancer ", " Colon and rectum precancerous lesion " corresponding name of disease, but according to
Its clinical symptoms, is usually attributed to " dysentery ", " diarrhea ", " stomachache ", " constipation " category.Internal organs are the mansion of conduction, main body fluid metabolism,
Conduct waste matter.Organism metabolic disorder, QI-blood circulation is not smooth, easily gives birth to phlegm wet, internal organs are also the ground of phlegm wet aggregation.《Miscellaneous diseases source stream rhinoceros
Candle diarrhea source stream》Medium cloud：" wetness hyperactivity then let out by supper, is solely due to wet earI do not know that chill heat is empty, though all can be disease, the careless strong nothing of spleen
It is wet, four must not and do it, what is from into rushing downThough being the difference for letting out the hot void of chill, not there is not former in wet person." interpretation of the cause, onset and process of an illness
Key be that damp evil wins partially.Damp and hot invasion and attack internal organs, cause functional activity of QI being not smooth, and body fluid is stagnated, the turbid interior life of phlegm.《Collection of experiences of famous physicians in the Ming Dynasty phlegm
Drink》Said：" it is body fluid that phlegm, which belongs to damp and hot,." phlegm stops coacervation knot by the wet body fluid of water and form, the thick thick one of quality is phlegm.In phlegm is turbid
Volt, it is viscid deadlocked, progressively constitute the important substance basis of environment in internal organs.Turbid phlegm is tangible heresy, is dropped in vivo with gas lift, nothing
Place less than.Phlegm stops poly- internal organs, then internal organs gas does not drop, and causes stool conduction function not normal.Phlegm is evil to be made long, and what is deposited and made a variationIt causes a disease can
Block QI-blood circulation, influence aqueous metabolism, cause a disease extensive, changeful.In bright Huangfu《Bright doctor's fingers and palms dysentery》Cloud " dysentery it
Make, it is non-overnight therefore ... lid eating and drinking without temperance usually, will cease inappropriate, greasy raw food is comfortable to supply food, it is liquor-saturated with wine ...
So that qi and blood is all hindered, diet stops product, damp and hot stifling, turns to foul ... dirty its internal organs sick not by disease, therefore large intestine is by it.”《Spirit
A pivot Ci Jiezhen heresy pieces》Cloud：" save, gas returns it, defended gas and stay it, must not be anti-, body fluid is stayed for a long time, combined into enteroncus ".Body fluid stream
Knot is that phlegm is turbid, and solidifying Tianjin knot phlegm is knurl." phlegm " gradually accumulation, viscid deadlocked, foul corruption, deposit malicious variation, formed " acute purulent lymphadenitis "
(precancerous lesion)." acute purulent lymphadenitis " though can underwent operative method dispel, environment not yet improves in enteric cavity, and phlegm is turbid to be accumulated again, is caused
" acute purulent lymphadenitis " recurrent exerbation, and then form " phlegm knot " (cancer).As can be seen here, phlegm it is turbid in accumulate be Colon and rectum precancerous lesion enteric cavity inner ring
The performance that border changes, is the important substance basis that Colon and rectum precancerous lesion occurs, phlegm heresy is accumulate causes intestines poison accumulation to be Colon and rectum long
The main pathogenesis of precancerous lesion.
In terms of acology, a set of preferable therapeutic scheme is not yet formed at present.Doctor trained in Western medicine under colonoscopy still based on extracing
Want treatment means.But, even if after surgical removal adenoma, still thering is more than 30% patient to grow new adenoma, to long-term steady
Fixed treatment has no positive prevention effect, and could not solve this disease high clinical problem of recurrence, canceration rate repeatedly.
Traditional Chinese medicine has certain superiority in terms of Colon and rectum precancerous lesion is treated, not only can be with multipath, Mutiple Targets
The inflammatory factor level of Colon and rectum precancerous lesion patient is adjusted, and plays the role of to improve prognosis, treatment recurrence, and side effect
Small, no drug dependence, security is preferable.At present there is no literature reported on for treating such disease, and Small side effects, it is difficult
The Chinese medicine composition and its pharmaceutical preparation of recurrence.
The content of the invention
It is an object of the invention to provide a kind of Small side effects, the Chinese medicine group for the treatment of Colon and rectum precancerous lesion uneasy to recur
Compound and its pharmaceutical preparation, and the Chinese medicine composition or pharmaceutical preparation are preparing prevention or treatment Colon and rectum precancerous lesion medicine
Or the application in health food.
Inventor has found in long-term clinical practice, by medicine groups such as rhizoma pinellinae praeparata, Rhizoma Arisaematis (processed), rhubarb, Paris polyphylla, the coptiss
Into Chinese medicine composition focus on that Qinghua phlegm is turbid, logical internal organs toxin expelling, can obviously improve the clinical symptoms of Colon and rectum precancerous lesion, reduction is scorching
Inflammation factor level, and improve prognosis.Further study show that, prescription of the invention can improve scorching by multipath, Mutiple Targets
Disease molecular level, reverses Colon and rectum intestinal mucosa canceration process.Clinical practice is in treatment Colon and rectum precancerous lesion, especially phlegm-damp type
Colon and rectum precancerous lesion has good curative effect.
The first aspect of the present invention there is provided it is a kind of prevent or treatment Colon and rectum precancerous lesion Chinese medicine composition, in this
Drug composition is made up of the bulk drug of following parts by weight：
5-15 parts of rhizoma pinellinae praeparata, 3-9 parts of rhubarb, 5-15 parts of Rhizoma Arisaematis (processed), 10-30 parts of Paris polyphylla, 3-15 parts of the coptis.
Further, preferred Chinese medicine composition of the invention is made up of the bulk drug of following parts by weight：10 parts of rhizoma pinellinae praeparata,
3 parts of rhubarb, 10 parts of Rhizoma Arisaematis (processed), 15 parts of Paris polyphylla, 6 parts of the coptis.
In the Chinese medicine composition, rhizoma pinellinae praeparata and rhubarb are monarch drug in a prescription altogether, and Rhizoma Arisaematis (processed) is ministerial drug, and Paris polyphylla and the coptis are altogether assistant
Medicine.
The second aspect of the present invention there is provided using above-mentioned prevention or treat Colon and rectum precancerous lesion Chinese medicine composition as
The pharmaceutical preparation of active ingredient, the pharmaceutical preparation is the conventional agent being prepared into using this area customary preparation methods in pharmacy
Type.
The treatment Colon and rectum precancerous lesion is granule, tablet, electuary, powder, glue as the pharmaceutical preparation of active component
Wafer, oral liquid or pill.
Further, pharmaceutical preparation of the invention can be used to lower section method prepare：
(A) each medicinal material component is weighed, is soaked more than 2 hours in container after mixing, normal pressure is decocted, and is filtered out decoction, is obtained
The water extract of Chinese medicine composition；
(B) pharmaceutically acceptable carrier is added in water extract, is made using this area customary preparation methods.
The third aspect of the present invention, there is provided above-mentioned Chinese medicine composition and pharmaceutical preparation and is preparing prevention or treatment knot
Application in rectum precancerous lesion medicine or health food.
The dosage of the present invention is therapeutically effective amount, such as the daily g kg body weight of about 2 g kg bodies-about 5.5, preferably
Dosage be the g kg body weight of about 3 g kg body weight-about 4.General administration time is the 6-24 months, preferably the 6-18 months, more
It is good for the 12-18 months.Certainly, administration time is also contemplated that method of administration, patient health situation, and these are all skilled practitioners technical ability
Within the scope of.
In addition, the Chinese medicine composition of the present invention can be used to prevent or treat Colon and rectum precancerosis as sole active composition
Become, can be yet used together with other therapeutic agents, other therapeutic agents such as salicylazosulfapyridine, visit aspirin etc..
Colon and rectum precancerous lesion of the present invention is modern medicine name of disease, is pathological staging, and main clinical manifestation is
Diarrhoea, constipation, dysentery, chronic abdominal pain, weight loss etc., and can further induce generation of colorectal cancer etc..Motherland is medically
Clear and definite " disease before colorectal cancer ", " Colon and rectum precancerous lesion " corresponding name of disease are had no, but according to its clinical symptoms, is usually returned
In " dysentery ", " diarrhea ", " stomachache ", " constipation " category.Its sick position is in intestines, and its etiology and pathogenesis is complicated.
Ancient Chinese medicine doctor thinks that " phlegm " is both the pathological product of body fluid metabolism, is pathogenic factor again.Turbid phlegm is that organism metabolism is disorderly
Random product, interior raw phlegm is turbid, accumulates and accumulates into poison, the metabolite in body can not be discharged in time, further infringement viscera warp
Network and negative and positive of qi and blood.Phlegm it is turbid in accumulate be in the enteric cavity of Colon and rectum precancerous lesion environment change performance, be Colon and rectum precancerous lesion
The important substance basis of generation, phlegm heresy accumulates the main pathogenesis for causing intestines poison accumulation to be Colon and rectum precancerous lesion long.The present invention is with this
Principle is foundation, and the Chinese medicine composition of preparation proves that the clinical symptoms of patient, and poison can be significantly improved through long-term clinical practice
Small side effects, recurrence rate is low, and a kind of more preferable therapeutic modality is provided for Colon and rectum precancerous lesion patient.
Full side plays dissolving phlegm with rhizoma pinellinae praeparata, rhubarb for monarch drug in a prescription, altogether, leads to the work(of internal organs altogether；Minister is strengthened with Rhizoma Arisaematis (processed) dissolving phlegm dampness elimination
Dissolving phlegm effect；Assistant is clearing heat and detoxicating with Paris polyphylla, the coptis, makes with radix glycyrrhizae coordinating the drug actions of a prescription.Full side has dissolving phlegm clearing damp, logical internal organs removing toxic substances, soft
Effect of hard dissipating bind.
Nature and flavor, channel tropism and the function of every medicine in the prescription of the present invention, and conventional weight are as follows：
Rhizoma pinellinae praeparata：For the stem tuber of the aroid tuber of pinellia.The net tuber of pinellia is taken, size is separated, is soaked in water to interior without the dry heart,
Take out；Another extracting liquorice is appropriate, adds water to cook secondary, collecting decoction, pours into the lime liquor being made of suitable quantity of water, stir evenly, and adds
The above-mentioned tuber of pinellia being impregnated with, immersion is stirred 1~2 time daily, and keeps immersion liquid pH value more than 12, and to section yellow homogeneous, mouth is tasted
It is micro- to take out when having numb feeling in the tongue, clean, dry in the shade or dry, produce.Rhizoma pinellinae praeparata is pungent, warm-natured.Returns spleen, stomach, lung channel.Effect：Eliminating dampness
Resolving sputum.Cure mainly：For dry throat, abundant expectoration cough and asthma, phlegm retention anti-dazzle nervous, anemophlegmatic vertigo, phlegm and headache.Usual amounts：3~15 grams.
Rhubarb：The medicine materical crude slice of polygonaceae Rheum, i.e. primary crude drug.Bitter, it is cold in nature.Return stomach, large intestine, liver, the spleen channel.Effect：
Work(is stagnant, clearing away damp-heat, purging intense heat, cool blood, dissolving stasis, hemostasis, removing toxic substances.Cure mainly：Control real heat constipation, stagnant stomachache, rush down dysentery not well, damp and hot
Jaundice, blood-head tells nosebleed, hot eyes, pharynx swelling, acute appendicitis furunculosis, blood stasis closed, traumatic injury etc..Usual amounts：3~15 grams.
Rhizoma Arisaematis (processed)：For Yu Nanxing, Southern Star, Yuzhou rhizoma arisaematis are also known as understood, belong to Araeceae.Medicinal effects are its stem tubers.
Net rhizoma arisaematis is taken, is soaked in water respectively by size, water is changed daily 2~3 times, when such as playing foam, changes after water plus alum is (per 100kg
Rhizoma arisaematis, plus alum 2kg), bubble then carries out changing water after one day, to cutting opening taste it is micro- have numb feeling in the tongue when take out rhizoma arisaematis.Bitter
It is pungent, warm-natured, people's lung, liver, the spleen channel.Function：It is eliminating dampness and eliminating phlegm, dispelling wind and relieving convulsion, dissolving lump and resolving mass, Repercusion analgesia.Cure mainly：Cold phlegm, damp phlegm
And stupid productive cough, that chest diaphragm is swollen is vexed；Wind-phlegm syndrome, such as dizziness, heap soil or fertilizer over and around the roots of apoplexy phlegm, epilepsy and lockjaw；Ulcer subcutaneous nodule, arthralgia etc.；
Cancerous swelling.Usual amounts：3~15 grams.
Paris polyphylla：For liliaceous plant Yunnan Rhizoma Paridis or the dry rhizome of paris polyphylla.Bitter, cold nature；It is slightly poisonous.Return
Liver Channel.Effect：It is clearing heat and detoxicating, swelling and pain relieving, cool liver arresting convulsion.Cure mainly：Furunculosis carbuncle swells, abscess of throat, snake bite and insect sting falls and flutters wound
Bitterly, convulsion.Usual amounts：3~30 grams.
The coptis：Taste connects, river connects, Rhizoma Coptidis, category Ranunculaceae, Coptis herbaceos perennial.Bitter, it is cold in nature.Thoughts of returning home warp,
Stomach, Liver Channel, large intestine channel.Effect：Heat-clearing and damp-drying drug, purging intense heat and detonicating.Cure mainly：Stomach and intestine are damp and hot, and vomiting, rush down dysentery, unconsciousness due to high fever is vexed
It is insomnia, blood-head tells nosebleed, sore swollen toxin, otitis media suppurativa, wet sore, gastropyretic toothache.Usual amounts：3~10 grams.
The effect of invention and effect
Chinese medicine composition provided by the present invention for treating Colon and rectum precancerous lesion, it is raw materials used inexpensive, simplicity is prepared,
It is easy to use, Small side effects, can long-term taking, through clinical application for many years and pharmacological research, to treatment Colon and rectum precancerous lesion tool
There is preferable curative effect.In view of Colon and rectum precancerous lesion patient populations are larger, and prevention colorectal cancer clinical position is more and more important,
Current clinic hormone therapy less effective, the compound Chinese medicinal preparation that the present invention is provided has a good application prospect.
Brief description of the drawings
Fig. 1 is that blank group, Western medicine group, Chinese medicine group and a Chinese and Western combination group mouse changes of body mass compare (x ± s) result figure.
Fig. 2 is the result figure of each group mouse NF-kB SABCs index (IHC values).
Fig. 3 is the result figure of each group mouse IL-6 SABCs index (IHC values).
Fig. 4 is the result figure of each group mouse STAT3 SABCs index (IHC values).
Fig. 5 is 6w mouse Intestinal Mucosal Tissues NF-kB, IL-6 and STAT3 protein expression results.
Fig. 6 is 14w mouse Intestinal Mucosal Tissues NF-kB, IL-6 and STAT3 protein expression results.
Fig. 7 is 18w mouse Intestinal Mucosal Tissues NF-kB, IL-6 and STAT3 protein expression results.
Embodiment
In conjunction with embodiment, the present invention is described in detail, but the implementation of the present invention is not only limited to this.
The experimental method of unreceipted actual conditions in the following example, generally according to normal condition, or according to manufacturer
Proposed condition.Medicinal material used in the embodiment of the present invention can be obtained except as otherwise indicating from Chinese medicine sales company.Obtained
Medicinal material except as otherwise indicate, be tcm and herbal slice.Medicine materical crude slice both can obtain or obtain from sales company after through processing
Form.
Embodiment 1：It is prepared by the decoction of Chinese medicine composition
Weigh rhizoma pinellinae praeparata 10g, rhubarb 3g, Rhizoma Arisaematis (processed) 10g, Paris polyphylla 15g, coptis 6g.
Rinsed with water after being soaked more than 2 hours in container, after normal pressure is decocted 20 minutes, filter out decoction, obtain the present invention
The water decoction of Chinese medicine composition.
Embodiment 2：It is prepared by the granule of Chinese medicine composition
Weigh rhizoma pinellinae praeparata 10g, rhubarb 3g, Rhizoma Arisaematis (processed) 10g, Paris polyphylla 15g, coptis 6g.
Rinsed with water after being soaked more than 2 hours in container, after normal pressure is decocted 30 minutes, filter out decoction, obtain the present invention
The water extract of Chinese medicine composition, adds dextrin, Icing Sugar is mixed, with appropriate 70% ethanol softwood after concentration, cross No. 1 sieve series grain,
50 DEG C of dryings 2 hours, dry particle crosses 12~14 mesh sieve whole grains, packing, produces.
Embodiment 3：It is prepared by the tablet of Chinese medicine composition
Weigh rhizoma pinellinae praeparata 10g, rhubarb 3g, Rhizoma Arisaematis (processed) 10g, Paris polyphylla 15g, coptis 6g.
Rinsed with water after being soaked more than 2 hours in container, after normal pressure is decocted 30 minutes, filter out decoction, obtain the present invention
The water extract of Chinese medicine composition, plus microcrystalline cellulose, starch are mixed, and add appropriate 70% ethanol softwood, cross No. 1 sieve series
Grain, 50 DEG C of drying 2 hours, dry particle crosses 12~14 mesh sieve whole grains, adds magnesium stearate, and mixing, tabletting is produced.
Embodiment 4：Clinical observation result
Case is originated：Case, between in December, 2015, is increased collected from January, 2013 with Colon and rectum hamartoma correlation abnormal shape
Life, inflammatory bowel disease correlation dysplasia, Colon and rectum zigzag polyp, Colon and rectum adenoma, ulcerative colitis, Crohn disease
Gone to a doctor Deng main suit in the out-patient of the attached Long March hospital department of traditional Chinese medicine of The 2nd Army Medical College.
Inclusive criteria：
1. confirmed through pathology, clarify a diagnosis meet Colon and rectum precancerous lesion (Colon and rectum hamartoma correlation dysplasia,
Inflammatory bowel disease correlation dysplasia, Colon and rectum zigzag polyp, Colon and rectum adenoma, ulcerative colitis, Crohn disease) examine
Disconnected case.
2. receive the Chinese traditional treatment (treatment time >=6 month) of specification；
3. clinically relevant data is substantially complete.
Exclusion standard：
1. treatment, medication are lack of standardization, treatment time is less than 6 months.
2. it is associated with the underlying diseases patient such as the serious heart, brain, lung, kidney, stomach, liver and tumour, it is contemplated that life cycle is less than 6
Month.
3. in therapeutic process, other malignant diseases are newly diagnosed to be, such as tumour, blood disease, renal insufficiency, hepatic sclerosis, disappear
Change the diseases such as gastrointestinal hemorrhage.
Treatment method：Chinese medicine group patient uses the Chinese medicine composition decoction in the embodiment of the present invention 1 to treat, and gives patient daily
1 dose, it is decocted in water for oral dose, about 500mL divides early, evening to take twice, 28 days are a course for the treatment of, continuously take 6 courses for the treatment of.Control group patient is carried out
Without drug therapy, or conventional western medicine anti-inflammatory treatment.
Evaluation criterion：(1) treated effect：Cure：Enteroscopy prompting intestinal mucosa lesion disappears, clinical symptoms and sign
It is wholly absent；Take a turn for the better：Colonoscopy shows that intestinal mucosa lesion is significantly improved, and clinical symptoms and sign are obviously improved or disappeared；Nothing
Effect：Enteroscopy intestinal mucosa and clinical symptoms and sign are without improvement or sb.'s illness took a turn for the worse.
(2) colonoscopy classification situation：0 grade：Intestinal mucosa is normal；I grades：Intestinal mucosa is slightly congested, and blood vessel is in fuzzy shape
State；II-III grades：Intestinal mucosa moderate is congested；IV grades：Patch sample ulcer not of uniform size is presented in intestinal mucosa.
(3) pathological grading situation：I grades：Intestinal mucosa does not occur neutrophil infiltration lesion；II grades：During intestinal mucosa is presented
Spend neutrophil infiltration lesion；III level：Severe neutrophil infiltration lesion is presented and with abscess in intestinal mucosa, is not true to type
Hyperplasia；IV grades：Form mucosa ulcer or intraepithelial neoplasia.
(4) symptom integral, pathological score and scope scoring：Use UC disease integrations table, pathology respectively afterwards before the treatment
Marking scales (the Histopathology standards of grading proposed with reference to Pullan RD et al.) and scope marking scales are (after improvement
Baron scales) two groups of concrete result for the treatment are judged.
Observation of curative effect：
Use the Chinese medicine composition decoction in the embodiment of the present invention 1 to treat 62 patients included by above-mentioned standard, give
Daily 1 dose of patient, is decocted in water for oral dose, and about 500ml divides early, evening to take twice, and 28 days are a course for the treatment of, continuously take 6 courses for the treatment of.It is simultaneously right
68 patients for not taking Chinese medicine carry out comparative study.The clinical efficacy that two groups of comparative observation.
Observation treatment Patients Before And After clinical treatment curative effect (being shown in Table 1), and clinical symptoms integration, pathological score and scope are commented
Divide situation (table 2), and detect signal path key point (being shown in Table 3) in colorectal cancer generating process, take treatment cross-reference side
Formula judges effects of clinic diagnosis.
1 two groups of clinical efficacy contrasts (n [%]) of table
Compared with control group△P<0.05；*P<0.01
Two groups of symptom integrals, pathological score and scope scoring situation contrast after table 2 is treated
Compared with control group△P<0.05；*P<0.01
Signal path key point NF-kB, IL-6, STAT3 the protein expression level situation of change of table 3
Compared with control groupΔP<0.05；*P<0.01
Clinical observation on the therapeutic effect shows that after Chinese medicine composition of the present invention is intervened, Colon and rectum precancerous lesion patient is in clinical symptoms
A certain degree of improvement is respectively provided with terms of integration and colonoscopy scoring, pathological score；And NF-kB, IL-6, STAT3 expression
Obtain a certain degree of reverse.Illustrate that there is Chinese medicine composition of the present invention certain treatment to make to Colon and rectum precancerous lesion patient
With.
Embodiment 5：The classical case of the present invention
Patient, man, 61 years old.1981 once colonoscopy make a definite diagnosis ulcerative colitis.In October, 2007 is because of stomachache, diarrhoea to hospital
Row enteroscopy, is pointed out：The nearly hepatic region of transverse colon, raw colon, ileocecus are shown in several sub- bases of a fruit or the polyp without the base of a fruit.Pathology：Adenoma sample
Hyperplasia.In the treatment of colonoscopy descending colon polyp APC snares.The remissions such as postoperative bellyache, diarrhoea, constipation.In March, 2011 checks
Colonoscopy shows more than 20 pieces of the colon ascendens, transverse colon Polypus, no base of a fruit, 0.2-0.5cm, successively APC treatments, pathology under 2 row colonoscopies：
Adenomatous hyperplasia is with slight dysplasia.To ask further diagnosis and treatment, come to go to a doctor within 28th in September in 2011.
Symptoms include patient's body is become thin, constipation is have, 3-4 days a line of defecating, difficult defecation, gastric discomfort, no pantothenic acid,
Gas, the product of eating sorghum savoury, bitter taste halitosis, red tongue with yellowish and greasy fur, slippery and rapid pulse.Professor Wei thinks patient's ulcerative colitis disease
With the passing of time history 21 years, the turbid cohesion of internal phlegm changes heat, and refining liquid regenerates phlegm wet, and phlegm is turbid to grow, causes a disease repeatedly in vivo, causes
Patient have the turbid sign of one phlegm such as constipation, dry halitosis.In the course of time, phlegm gathers for poison, formation adenoma.Lid six internal organs are to lead to
With, internal organs not general rule pathological metabolism product excess accumulation in vivo, contain phlegm heresy day, polyp is formed with the damp and hot poison that is cemented to.Control plan
Internal organs is led in dissolving phlegm, and dissipating bind disappears carbuncle.Prescription：Rhizoma pinellinae praeparata 10g, rhubarb 6g, Paris polyphylla 30g, coptis 6g, Rhizoma Arisaematis (processed) 10g.It is multiple after 30 doses
Examine, stool improves, 1-2 days a line, tongue is dark red, tongue is thin white, and arteries and veins is thin.
Patient up on the basis of add and subtract treatment, use alternately rhizoma pinellinae praeparata, Rhizoma Arisaematis (processed) dissolving phlegm dampness elimination, rhubarb, Paris polyphylla, the coptis are clear
Thermal detoxification.Adhere to treatment six months, the check colonoscopy colon ascendens, transverse colon are dispersed in polyp, and quantity is significantly reduced, and stool is normal, receives
Good, peace of sleeping.The check rarely seen 2 pieces of small polyps of colonoscopy on the 19th of September in 2012, again row APC treatments, remaining not described significant discomfort.After
Clothes front treatment January, follow-up so far there are no recurrence.The general principle, principal character and sheet of the present invention has been shown and described above
The advantage of invention.
Embodiment 6：The zoopery of the present invention
First, experiment material
(1) experimental animal and rearing conditions
Experimental animal：Mouse strains：C57BL/6；Rank：Healthy cleaning grade；Mouse age：6 weeks；Sex：Male；Body weight：20g
±2g；Source：Shanghai Slac Experimental Animal Co., Ltd.；Ticket number：SCXK (Shanghai) 2012-0002；
Rearing conditions：Constant temperature：(25 ± 0.5), relative humidity：Raised under (55 ± 5) %, illumination-constant, clean conditions.Raise
Material production card number：Raise card (2014) 04001 in Shanghai；Chinese Academy of Sciences's Shanghai Experimental Animal Center is developed；Shanghai Pu Lu rises biological section
Skill Co., Ltd produces.
(2) Experimental agents
1. the Chinese medicine composition decoction in the embodiment of the present invention 1, is named as " internal organs side is led in dissolving phlegm ".
2. salicylazosulfapyridine：Purchased from attached Long March hospital of The 2nd Army Medical College, lot number：22140205.
2nd, experimental method
(1) experimental animal is grouped
C57BL/6 mouse 90, sub-cage rearing, 18/cage.Raise in pharmaceutical college of The 2nd Army Medical College Animal House air
On laminar-flow rack, adaptability is raised one week, and 5 groups, i.e. blank control group, model group, Western medicine group are randomly divided into by random digits table
(salicylazosulfapyridine group), Chinese medicine group (internal organs side's group is led in dissolving phlegm), (internal organs side is led in salicylazosulfapyridine+dissolving phlegm to combination of Chinese tradiational and Western medicine group
Group).
(2) modeling and medication
Blank control group gives free drinking water；
Model group is using " the four steps three are circulated " molding method improved on the basis of classics AOM/DSS models：AOM(12.5mg/
Kg) intraperitoneal injection (D1) joint DSS circulations feeding (DSS D1-D7+ normal waters D8-D21 is a circulation) is followed for 3 repeatedly
Ring, wherein DSS concentration are 3.5%, meanwhile, model group is given and blank group equivalent distilled water；
Chinese medicine group gives dissolving phlegm logical internal organs side 26g/ (kg.d) concentrates 0.2ml/d；
Western medicine group gives 7.8mg/ pcs/day of salicylazosulfapyridine；
Combination of Chinese tradiational and Western medicine group gives the logical internal organs side of dissolving phlegm and salicylazosulfapyridine simultaneously.
Each group mouse starts administration, 1 times/day, continuous 12 weeks in 6w.
(3) collection of specimens and processing
Each group mouse is weighed weekly after experiment starts.Randomly selected respectively at every group of 6w, 14w, 18w of experiment 6 small
Mouse, eyeball takes blood, stands and is centrifuged after 2h, takes serum, to be detected.Then lower distal colon (from anus 8cm to anus at) is taken, and
And cut total colectomy mucous layer, plane is laid in, is fixed with pin, its mucous membrane of amplification sem observation inflammation occurs, burst
Ulcer, polyp, the situation and degree of adenoma.To 18w selectively materials (picking adenoma, polyp or ulcer are most substantially located), average mark
Into two parts, a portion is rinsed well rapidly with 0.9%NaCl solution, is subsequently placed in the formalin of 10 times of samples of volume
Middle fixation, treats that pathology, SABC detection another part are put into rapidly in EP pipes, inserts Liquid nitrogen storage, be ready for
Westernblot and Real Time-PCR are detected.
(4) observational technique and index
1. basic status is observed
Before modeling and during modeling, the basic feelings such as observation each group mouse diet, drinking-water, spirit, hair, defecation, activity
Condition；Modeling starts mouse and weighed weekly once, records mouse weight situation of change.It is each random respectively at every group of 6,14,18 weekend
Extract 6 mouse neck that breaks to put to death, take lower distal colon (from anus 8cm to anus at), and total colectomy mucous layer is cut, put down
Plane is laid on, is fixed with pin, the situation and journey of inflammation, ulcer, polyp, adenoma occurs in its mucous membrane of amplification sem observation
Degree.While other position situations of observation mouse, whether such as liver, spleen and abdominal cavity position have neoplastic lesion.
2. pathological diagnosis standard
Visually observe and see mucous membrane hyperemia, oedema, vascular lake is disorderly, fuzzy, and semilunar fold is thickened, intestinal tube is in often spasticity
It can be considered that inflammation is formed；Mucous membrane face is roughening, and mucomembranous surface is presented size equalization, diffuses the fine grained of distribution, and surface texture becomes
It is crisp, occur having mucus sexual secretion in nature bleeding or contact bleeding, mucomembranous cavity, you can be considered as mucosal erosion；And laggard one
Step development, mucosal erosion is simultaneously with many whites or yellow stigma for being dispersed in distribution, and this is that crypt abscess forms rear purulence point
Secretion invests syringe needle sample caused by anterior pituitary-adrenal cortex axis, linear or patch shape ulcer and formed.
WHO staging of the pathological diagnosis standard according to international cancer research institution (IARC) publication in 2000《Digestive
System oncological pathology and science of heredity》One book, wherein being made for the diagnosis name of intestines and stomach precancerous lesion and cancer, definition, standard
Regulation.
3. NF-kB, IL-6, STAT3 protein expression content in Immunohistochemical Method detection mouse intestinal mucosa epithelial tissue
Experimental method：DAB develops the color, haematoxylin redyeing, mounting, light Microscopic observation.There is brown color in nucleus or cytoplasm
Particle is the positive, and every section is selected 3 visuals field, entered using medical image quantified system analysis at random under 250 power microscopes
The measure of the positives region area of row SABC image and positive rate and OD values, and Computation immunity group index (IHC),
IHC=positive areas × OD/ the gross areas.
NF-kB, IL-6, STAT3 protein expression content in 4.Western Blot methods detection mouse intestinal mucosa epithelial tissue
Experimental method：Sample 100mg is taken, the cell pyrolysis liquid 500u of ice precooling, tissue homogenate, using anger generation disease is added
Protein content is determined, 12% separation gel and 4% concentration glue is prepared, the discontinuous gel electrophoresis of SDS- polyacrylamides, transfer is miscellaneous
Hand over, alkaline phosphatase colour developing, and using β-catin internal references albumen as control, carry out quantitative analysis.
3rd, experimental result
(1) mouse basic status is observed
After model group male C57BL/6 mouse receive AOM intraperitoneal injections 2 days, start to engender lazy move, apocleisis, stool
Increased frequency, soft stool (pasty state, half form stool that anus can not be adhered to).Symptom peaks after injecting 7 days：DSS first
After circulation is caused scorching 1 week, modeling mouse shows as lazy move, apocleisis, the exacerbation of hogback phenomenon, and times of defecation increases；After 3 circulations, make
Mould mouse hair color it is few it is magnificent, thermophilic it is sleeping flock together, weight declines, be changed to freely drink above-mentioned appearance sign after common sterilized water and gradually delay
Solution.
Normal group C57BL/6 mouse activities are as usual, and reaction is alert and resourceful, and hair is glossy, and diet is normal, and weight increases
It is long, no lazy move, suffer from diarrhoea and the abnormal change such as have blood in stool.Compared with model group, Chinese medicine group, Western medicine group, combination of Chinese tradiational and Western medicine group diarrhoea, meat
The eye purulence just lesser extent and duration is shorter, animal integrality is preferable.
(2) mouse changes of body mass
Each group mouse weight no significant difference (P before modeling starts>0.05).Since 6w, weight occurs between each group
Notable difference (P<0.05), blank group weight increases very fast, and Western medicine group, Chinese medicine group and Chinese and Western combine group and increases slower, model
Group increases most slow.Model group is combined group with blank group, Chinese medicine group, Western medicine group, Chinese and Western and the weight of model group is present significantly
Statistical significance (P<0.01).Specific changes of weight is shown in Table 3 and Fig. 1.
The each group mouse changes of body mass of table 3 (g)
The each group mouse changes of body mass of continued 3 (g)
(3) mouse Colon and rectum adenoma tumor formation rate result
Most there is Colon and rectum adenoma 33.3% earlier than 14w in model group mouse, and average every mouse finds Colon and rectum adenoma 1
(individual), to 18w Colon and rectum incidences up to 100%, average every mouse finds Colon and rectum adenoma 4.3 (individual)；Western medicine group mouse
14w, average every mouse finds Colon and rectum adenoma 0.33 (individual), to 18w, and average every mouse finds Colon and rectum adenoma 1.83
(individual)；The average every mouse of Chinese medicine group mouse 14w finds Colon and rectum adenoma 0.5 (individual), finds that knot is straight to the average every mouse of 18w
Enteric adenoma 2.5 (individual)；The average every mouse of combination of Chinese tradiational and Western medicine group mouse 14w finds Colon and rectum adenoma 0.33 (individual), average to 18w
Every mouse finds Colon and rectum adenoma 1.5 (individual), refers to table 4.
The mouse Colon and rectum adenoma tumor formation rate (it was found that adenoma group number/adenoma number) of table 4
(4) mouse Mucosal Immunity group result
There is brown color fine grained using in nucleus or cytoplasm as positive expression.NF-kB, IL-6, STAT3, AICD are in mould
Type group, Chinese medicine group, the positive expression of Western medicine group and combination of Chinese tradiational and Western medicine group increase, and show as dyeing deep and many.
As shown in Figure 2, Figure 3, Figure 4, compared with model group, NF-kB, IL-6, STAT3, in Chinese medicine group, Western medicine group, Chinese and Western
Doctor combines group positive expression and reduced, and shows as dyed color and shoals and few.
This studies have shown that NF-kB SABCs index is expressed in model group and raised, and is compared with blank group, the difference of model group
It is different to be statistically significant (P<0.01).NF-kB is gradually reduced in Western medicine group, Chinese medicine group, the expression of combination of Chinese tradiational and Western medicine group, with mould
Type group compares, Western medicine group no significant difference (P>0.05), Chinese medicine group and combination of Chinese tradiational and Western medicine group NF-kB SABC indexes
Difference be statistically significant (P<0.01)；Compared with Western medicine group, Chinese medicine group and combination of Chinese tradiational and Western medicine group NF-kB SABCs
Not statistically significant (the P of difference of index>0.05)；Compared with combination of Chinese tradiational and Western medicine group, Chinese medicine group NF-kB SABC indexes
No significant difference (P>0.05) table 5 and Fig. 2, are referred to.
IL-6 SABCs index is expressed in model group and raised, and is compared with blank group, the difference of model group has notable statistics
Learn meaning (P<0.01).IL-6 is reduced in Western medicine group, Chinese medicine group, the expression of combination of Chinese tradiational and Western medicine group, is compared with model group, Western medicine
Not statistically significant (the P of difference of group, Chinese medicine group and combination of Chinese tradiational and Western medicine group IL-6 SABC indexes>0.05)；With Western medicine group
Compare, the statistically significant (P of difference of Chinese medicine group IL-6 SABC indexes<0.05)；Compared with combination of Chinese tradiational and Western medicine group, Chinese medicine
Statistically significant (the P of difference of group IL-6 SABC indexes<0.05) table 5 and Fig. 3, are referred to.
STAT3 SABCs index is expressed in model group and raised, and is compared with blank group, model group STAT3 SABCs refer to
The difference that several difference has model group is statistically significant (P<0.01).STAT3 is in Western medicine group, Chinese medicine group, traditional Chinese and western medicine knot
Charge-coupled STAT3 SABCs index table is compared, Chinese medicine group and combination of Chinese tradiational and Western medicine group STAT3 immune groups up to reducing with model group
The difference for changing index is statistically significant (P<0.01)；Compared with Western medicine group, Chinese medicine group and combination of Chinese tradiational and Western medicine group STAT3 exempt from
The difference of epidemic disease group index is statistically significant (P<0.01)；Compared with combination of Chinese tradiational and Western medicine group, Chinese medicine group STAT3 is immunized
The difference of groupization index is statistically significant (P<0.01) table 5 and Fig. 4, are referred to.
Each group mouse NF-kB, the IL-6 and STAT3 SABC index (IHC values) of table 5 compare (n=6,×10-3)
Note：Compared with blank group, * P<0.05, * * P<0.01；Compared with model group, #P<0.05, ##P<0.01；
(5) Western Blot methods detection mouse Intestinal Mucosal Tissues NF-kB, IL-6, STAT3 protein expression level
1st, 6w mouse Intestinal Mucosal Tissues NF-kB, IL-6 and STAT3 protein expression
Second circulation of 6w, AOM/DSS modeling terminates.Compared with blank group, model group, Western medicine group, Chinese medicine group, traditional Chinese and western medicine
With reference to group NF-kB expressions lower, IL-6, STAT3 and AICD expression is raised；Compared with model group, west
Medicine group, Chinese medicine group, NF-kB, IL-6 and STAT3 expression of combination of Chinese tradiational and Western medicine group change group difference not substantially (see Fig. 5).
2nd, 14w mouse Intestinal Mucosal Tissues NF-kB, IL-6, STAT3, AICD protein expression
The circulation of 14w, AOM/DSS modeling the 3rd terminates latter month.Compared with blank group, model group, Western medicine group, Chinese medicine group
Raised with combination of Chinese tradiational and Western medicine group NF-kB, IL-6, STAT3 expression；Compared with model group, Western medicine group and the combination of Chinese tradiational and Western medicine
Group NF-kB and IL-6 expression up-regulations, STAT3 expressions are lowered；Compared with model group, Chinese medicine group NF-kB expressions
Up-regulation, IL-6 and STAT3 expressions are lowered；Compared with Western medicine group, Chinese medicine group is lowered in NF-kB, IL-6 expression,
STAT3 expressions are raised；Compared with Western medicine group, combination of Chinese tradiational and Western medicine group is lowered in NF-kB expressions, in IL-6, STAT3 table
Raised up to level；Compared with Chinese medicine group, combination of Chinese tradiational and Western medicine group is raised (see figure in NF-kB, IL-6, STAT3 expression
6)。
3rd, 18w mouse Intestinal Mucosal Tissues NF-kB, IL-6, STAT3 protein expression
The circulation of 18w, AOM/DSS modeling the 3rd terminates latter two months.Compared with blank group, the expression of model group NF-kB, IL-6
Level is raised, but the expression of STAT3 expressions is lowered；Compared with model group, Western medicine group, Chinese medicine group and combination of Chinese tradiational and Western medicine group
NF-kB, STAT3 expression are raised, and IL-6 expressions are lowered；Compared with Western medicine group, Chinese medicine group and combination of Chinese tradiational and Western medicine group NF-
KB expressions are raised, and IL-6, STAT3 expression are lowered；Compared with Chinese medicine group, combination of Chinese tradiational and Western medicine group NF-kB, IL-6 and
STAT3 expressions difference is not obvious (see Fig. 7).
It follows that relative to Western medicine group, NF-kB, IL-6, STAT3 expression are lower in Chinese medicine group Mice Body, say
Bright Chinese medicine composition of the invention has curative effect more more preferable than Western medicine to Colon and rectum precancerous lesion, therefore, medicine group in the present invention
Compound has certain treatment or prevention effect to Colon and rectum precancerous lesion patient.
General principle, principal character and the advantages of the present invention of the present invention has been shown and described above.The technology of the industry
Personnel are it should be appreciated that the present invention is not limited to the above embodiments, and the simply explanation described in above-described embodiment and specification is originally
The principle of invention, various changes and modifications of the present invention are possible without departing from the spirit and scope of the present invention, these changes
Change and improvement all fall within the protetion scope of the claimed invention.The claimed scope of the invention by appended claims and its
Equivalent is defined.
Claims (9)
1. a kind of Chinese medicine composition for preventing or treating Colon and rectum precancerous lesion, it is characterised in that the Chinese medicine composition is by such as
The bulk drug composition of lower parts by weight：5-15 parts of rhizoma pinellinae praeparata, 3-9 parts of rhubarb, 5-15 parts of Rhizoma Arisaematis (processed), 10-30 parts of Paris polyphylla, coptis 3-
15 parts.
2. a kind of Chinese medicine composition for preventing or treating Colon and rectum precancerous lesion according to claim 1, it is characterised in that
The Chinese medicine composition is made up of the bulk drug of following parts by weight：10 parts of rhizoma pinellinae praeparata, 3 parts of rhubarb, 10 parts of Rhizoma Arisaematis (processed), Paris polyphylla 15
Part, 6 parts of the coptis.
3. a kind of Chinese medicine composition for preventing or treating Colon and rectum precancerous lesion according to claim 1 or 2, its feature exists
In described Colon and rectum precancerous lesion refers to IBD correlation dysplasia, hamartoma correlation dysplasia, sawtooth
Shape polyp, tubular adenoma, villous adenoma or fine hair tubular adenoma.
4. a kind of Chinese medicine composition for preventing or treating Colon and rectum precancerous lesion according to claim 1 or 2, its feature exists
In described Colon and rectum precancerous lesion is to refer to the chronic abdominal pain, diarrhoea, constipation, dysentery that further induction colorectal cancer occurs
Disease or weight loss.
5. a kind of Chinese medicine composition for the treatment of Colon and rectum precancerous lesion as claimed in claim 1 or 2 is used as the medicine of active ingredient
Thing preparation, it is characterised in that the pharmaceutical preparation is the common formulations being prepared into using this area customary preparation methods in pharmacy.
6. a kind of Chinese medicine composition for treating Colon and rectum precancerous lesion according to claim 5 is used as the medicine of active ingredient
Preparation, it is characterised in that the pharmaceutical preparation is granule, tablet, electuary, powder, capsule, oral liquid or pill.
7. a kind of Chinese medicine composition for the treatment of Colon and rectum precancerous lesion as claimed in claim 1 or 2 is preparing prevention or treated
Application in Colon and rectum precancerous lesion medicine or health food.
8. a kind of Chinese medicine composition for the treatment of Colon and rectum precancerous lesion as described in claim 4 or 5 is used as the medicine of active ingredient
Application of the thing preparation in prevention or treatment Colon and rectum precancerous lesion medicine is prepared.
9. the Chinese medicine composition for the treatment of Colon and rectum precancerous lesion according to claim 8 is used as the pharmaceutical preparation of active ingredient
Application in prevention or treatment Colon and rectum precancerous lesion medicine is prepared, described active ingredient also include salicylazosulfapyridine or
Visit aspirin.
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| CN113713057A (en) * | 2021-09-08 | 2021-11-30 | 段鲜红 | Traditional Chinese medicine composition and application thereof |
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Application publication date: 20170811 |