CN101850091B - Chinese medicament for treating colorectal polypus and preparation method thereof - Google Patents
Chinese medicament for treating colorectal polypus and preparation method thereof Download PDFInfo
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Abstract
The invention provides a Chinese medicament for treating colorectal polypus. The Chinese medicament comprises the following raw materials in percentage by weight: 32 to 38 percent of dark plum fruit, 24 to 32 percent of stiff silkworm, 15 to 24 percent of zedoary, 6 to 18 percent of safflower, 1 to 3 percent of human nail and 10 to 18 percent of rice vinegar. The preparation method comprises the following steps of: processing the dark plum fruit and the human nail first during the preparation of the Chinese medicament, and preparing the raw materials into oral administration preparations comprising pills, capsules, granules, tablets and enteric-coated sustained-release preparations according to the standard preparation process of various formulations, wherein the enteric-coated sustained-release preparations comprise sustained-release enteric-coated tablets, enteric-coated capsules, enteric-coated pills, enteric-coated soft capsules and the like. The Chinese medicament has the effect of softening hardness to dissipate stagnation and melting polypus, and can cure various kinds of polypus and particularly colorectal polypus.
Description
Technical field
The present invention relates to a kind of Chinese medicine for the treatment of polyp.
Background technology
Polyp (polyp) is the title that a kind of naked eyes are described, and is applicable to anyly from mucous membrane surface outstanding and pathological changes of forming in cavity, and its true character is decided according to histologic characteristics.Clinical common have nasal polyp, maxillary sinus bleeding polyp, laryngeal polyp, polyp of vocal cord, esophagopolypus, gastrointestinal polyp, polyp of urethra, colpopolypus etc.
Colorectal polyp accounts for 80% of polyposis intestinalis, and wherein great majority (50%～70%) are positioned at sigmoid colon or rectum, and single-shot sees that multiple person accounts for 15%～42% more.The male is more than the women.Sickness rate increases with the growth at age, and Beijing 20,000 people had a medical check-up in 2003, finds that colonoscope polyp recall rate increases progressively with the age and increases, and recall rate reaches 40% more than 50 years old; According to another autopsy data, 60～80 years old patient Ke Da 25%～50%.
On treatment colorectal polypus scheme, there is report to treat colorectal polypus at present with aspirin, tyrosine kinase inhibitor quinazoline derivant etc., the relapse rate height, untoward reaction is many, and curative effect is dissatisfied.Except that operative treatment, still there is not ideal medicine to carry out the stronger treatment of effective specific aim at present at present.
Comprehensive existing studies show that, the Drug therapy colorectal polypus does not obtain ideal effect at present, and mainly contain following five aspect reasons: the generation mechanism of (1) colorectal polypus is not illustrated as yet fully, can't obtain etiotropic treatment measure; (2) the pathology typing complexity of colorectal polypus tissue is various, development progress takes place differ, and its treatment measure can't be unified; (3) part of colorectal polypus has the canceration possibility, and perhaps itself has been the performance of canceration just, and the expectant treatment risk is bigger; (4) progress of surgery mode in modern medicine is exceedingly fast, and the status is important, and its unilateral thinking model of putting things right once and for all is effectively contained as yet; (5) Chinese medicine lacks initiative spirit in face of the surging field of doctor trained in Western medicine especially surgery, and the status descends gradually.
Do not disclose pathogenetic disease as yet fully as present modern medicine, undeniablely be, colorectal polypus no matter histopathology good pernicious with whether precancerous lesion, its clinical diagnosis is all set up.By study on prevention to colorectal polypus, be expected to improve patient's quality of life, prolong survival time of patients, reduce the sickness rate and the case fatality rate of colorectal cancer.So, traditional Chinese medicine has its unique advantage.
China's Chinese medicine and combination of Chinese and Western medicine scholar have found the Chinese medicine single medicinal material that much each system's proliferative disease is had certain effect in recent years, as Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis, Radix Paeoniae Rubra, Rhizoma Polygoni Cuspidati etc., but treat the principle that the disease with complicated etiology and pathogenesis does not meet Chinese medicine treatment disease with the single medicine.Also found some to the effective Chinese medicine compound of polyp, as Jinsangsanjie ball, literary composition gold loose, benefiting QI for activating blood circulation extract powder etc.Have realized that part Chinese medicine preparation such as Peucedanum praeruptorum DUNN extract, ligustrazine and Radix Salviae Miltiorrhizae Injection can partly improve the pathological change of hyperplastic polyp, demonstrating Chinese medicine prevention chronic hyperplastic polyp has certain superiority.But mostly the research for the treatment of colorectal polypus at present is to control from stasis of blood opinion with clinical effective prescription, does not pay attention to the whole determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs to colorectal polypus, and has just paid attention to one of them aspect.
Summary of the invention
The present invention is directed to the prior art above shortcomings, propose a kind of Chinese medicine that contains the treatment colorectal polypus of Fructus Mume.
The Chinese medicine of the treatment colorectal polypus that the present invention proposes, it is made up of following raw materials by weight percent: Fructus Mume 32%～38%, Bombyx Batryticatus 24%～32%, Rhizoma Curcumae 15%～24%, Flos Carthami 6%～18%, muscle moves back 1%～3%, rice vinegar 10%～18%.
The preferred weight percent of the raw material of this Chinese medicine is: Fructus Mume 36%, and Bombyx Batryticatus 27%, Rhizoma Curcumae 18%, Flos Carthami 6%, muscle moves back 3%, rice vinegar 10%.
This preparation method of Chinese medicine is as follows:
1, medicinal material processing:
Fructus Mume vinegar system Fructus Mume: it is standby with vinegar immersion two weeks to get Fructus Mume before the preparation.
Muscle back skating stone powder scalds the system muscle and moves back: muscle moves back and adds detergent, ultrasonic cleaning 3 times, and ionized water ultrasonic cleaning 3 times is dried.Stir-baked in pulvis TALCI is sliding, and muscle is retracted in the pot that to heave to yellow be degree with frying, and takes out sieve and removes Pulvis Talci, cools, and is standby.
2, preparation process: Chinese medicine of the present invention is fried in shallow oil the soup clothes, though effective in cure, difficult recovery from illness, because of colorectal polypus belongs to chronic disease, clothes can be received slow effect of attacking for a long time, and solid dosage formss such as pill commonly used, capsule, tablet are better than decoction curative effect.Destroyed and inactivation by various digestive enzyme, acidic materials at upper digestive tract for fear of active (peptide material) composition wherein, can be prepared into oral formulations by the technology of preparing means of various dosage form standards, comprise pill, capsule, granule, tablet and enteric-coated sustained-release preparation, enteric-coated sustained-release preparation comprises enteric-coated sustained release tablet, enteric coated capsule, enteric coated drop pill, enteric soft capsules.
Polyp is meant the vegetation that occurs in some position of health.Its etiology and pathogenesis, motherland's medical science think to be that pyretic toxicity is coalescent, cause local meridians to block, and coagulation of QI-blood stays the stasis of blood and the superfluous meat that lives.Each re-entrant portion of whole body is all good to be sent out.Colorectal polypus belongs to categories such as Chinese medicine " intestinal gill fungus ", " intestinal is long-pending ", " dysentery ", " spouting bleeding from anus ", " anorectal carcinoma ", " having blood in stool ", " note of the ancient Chinese abdominal mass "." Ling Shu Miraculous Pivot or Divine Axis five become a piece of writing ": " accumulator in people's the kind sick intestinal ... then the intestines and stomach is disliked dislikes the heresy order and stays it, and gathering is to hinder, between the intestines and stomach, and cold Wen Buci, pathogen is slightly extremely accumulated to stay and is ended, and poly-ly has been greatly." about its treatment, " element ask the most pure virginity will discuss greatly " cloud: " heat is excessive in interior, controls with salty-cold, and assistant is received it with sweetness and bitterness with acid, sends out it with hardship ", cloud again: " treating dryness syndrome by moistening ... hard masses should be treated by softening ... disease caused by accumulations of pathogen should be treated with therapy of dispersion, the disease with retention of pathogen in the body should be treated by elimination therapy ".
Side of the present invention get Fructus Mume, vinegar extremely acid, remove dead flesh, meat is disliked in erosion; The salty suffering of Bombyx Batryticatus and putting down, the network of passing through is changed turbid pathogen, the softening the hard mass knot; Rhizoma Curcumae, Flos Carthami acrid in the mouth promoting the circulation of blood blood stasis dispelling, muscle are moved back the sweet in the mouth saltiness and are put down, and blood circulation promoting and blood stasis dispelling helps Fructus Mume to catch malicious heat clearing away, removing the necrotic tissue and promoting granulation.Six medicine compatibilities, extremely acid is removing dead flesh, meat is disliked in erosion, and hot loosing it, salty with soft it, reinforcement and elimination in combination, in order to do through ruton, QI and blood and, stasis of blood knot looses, polyp is from disappearing.Avoided in the study of compound prescription in the past mostly forming preparation, had the characteristic and an advantage of differentiation of tcm with the simple association of single medicine with function of promoting blood circulation to disperse blood clots.
This Chinese medicine is through clinical various polyps such as nasal polyp, polyp of vocal cord, gastrointestinal polyp, the uterus colpopolypus of being used for, all go through test not well.Once nasopharyngeal carcinoma, uterus carcinoma, rectal cancer etc. are controlled in examination again, also have polyp to fade away, and the not unique curative effect of recurrence of observing at a specified future date.Therefore this Chinese medicine has the function of softening the hard mass, eliminating stagnation, change polyp, and it can cure multiple polyp, illustrate determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs and differential diagnosis of diseases execute control can in conjunction with and be not mutually exclusive, also verified that traditional theory " treating different diseases with the same therapeutic principle " is to come from clinical practice, have the clinical guidance meaning.Now through clinical 60 example checkings, show that this medicine effective percentage is 90.0%, obvious effective rate is 45.0%.
The specific embodiment
Embodiment 1: the concentrated pill preparation
Prescription Fructus Mume 19.2kg, Bombyx Batryticatus 14.4kg, Rhizoma Curcumae 9kg, Flos Carthami 7.2kg, muscle move back 1.2kg, rice vinegar 9kg
Medicinal material processing:
Fructus Mume vinegar system Fructus Mume: getting Fructus Mume before the preparation, to add the soaking in rice vinegar two weeks standby.
Muscle back skating stone powder scalds the system muscle and moves back: muscle moves back and adds detergent, ultrasonic cleaning 3 times, and ionized water ultrasonic cleaning 3 times is dried.The stir-baked in pulvis TALCI of the 40% muscle amount of moving back is sliding, and muscle is retracted in the pot that to heave to yellow be degree with frying, and takes out sieve and removes Pulvis Talci, cools, and is standby.
The concentrated pill preparation: Bombyx Batryticatus, Flos Carthami, muscle move back oven dry below 60 ℃, pulverize, and cross 120 mesh sieves, and mixing is standby.Other gets Rhizoma Curcumae and Fructus Mume and puts and add suitable quantity of water in the frying pan and soak half an hour, adds 10 times of decoctings and boils (time is respectively 60min, 60min, 45min) three times, filters, and merges three filtrates and is condensed into medicine juice (density 1.02～1.12), and is standby.Bombyx Batryticatus, Flos Carthami, muscle are moved back fine powder molding in coating pan, add the general ball of medicine juice medicated powder more repeatedly, molding, capping, closing quotation, dry below 60 ℃, select ball, the encapsulate sugar-coat, air-dry, very smooth, bottling promptly gets concentrated pill.
Embodiment 2: the enteric coated tablet preparation
Prescription Fructus Mume 28.8kg Bombyx Batryticatus 21.6kg Rhizoma Curcumae 14.4kg Flos Carthami 4.8kg muscle moves back 2.4kg rice vinegar 8kg
Medicinal material processing: with embodiment 1
The enteric coated tablet preparation: Bombyx Batryticatus, Flos Carthami, muscle move back oven dry below 60 ℃, and micronizing is standby.Other gets Rhizoma Curcumae and Fructus Mume and puts and add suitable quantity of water in the frying pan and soak half an hour, adding 10 times of decoctings boils three times (time is respectively 60min, 60min, 45min), filter, merge three filtrates and be condensed into clear paste (density 1.15～1.25), add Bombyx Batryticatus, Flos Carthami, muscle moves back micropowder mixing in blender, adds 10% starch slurry mixing again, make suitable soft material, cross 14 mesh sieves and granulate, dry below 60 ℃, 12 mesh sieve granulate, weighing, add 0.6% magnesium stearate mixing, tabletting adds 10% cellulose acetate-phthalate alcoholic solution, the turnadle pan coating coating, dry below 50 ℃, bottling promptly gets tablet.
Embodiment 3: the capsule preparation
Prescription Fructus Mume 38kg Bombyx Batryticatus 24kg Rhizoma Curcumae 15kg Flos Carthami 6kg muscle moves back 2kg rice vinegar 15kg
Medicinal material processing: with embodiment 1
The capsule preparation: first stringing moves back pulverizing, and is standby.Other gets Fructus Mume, Bombyx Batryticatus, Rhizoma Curcumae, Flos Carthami and puts and add suitable quantity of water in the frying pan and soak half an hour, adds 10 times of decoctings and boils (time is respectively 60min, 60min, 45min) three times, filters, merge three filtrates and be condensed into thick paste (density 1.28～1.38), add muscle and move back fine powder mixing in blender, add an amount of mixing of starch again, make suitable soft material, crossing 14 mesh sieves granulates, dry below 60 ℃, 12 mesh sieve granulate, weighing, incapsulate, promptly.
[character] this product inside is yellowish-brown; Sour in the mouth.
[discriminating] gets this product, and put microscopically and observe: pollen grain spheroidal, ellipse, the about 60 μ m of diameter, the outer wall spinosity has 3 germinal aperatures (Flos Carthami).
[inspection] should meet " relevant every regulation under Chinese pharmacopoeia version appendix in 1985 the tablet item.
[function with cure mainly] detoxifcation removing the necrotic tissue and promoting granulation, the promoting flow of QI and blood dissipating blood stasis, dissipating phlegm and resolving masses is promoted the production of body fluid.Be used for laryngeal polyp, knot, rectal polyp etc.
[usage and consumption] is oral.One time 2～4,3 times on the one.
[specification] 0.3g/ grain.
[storage] shady and cool place preserves.
Clinical trial:
1 data and method
1.1 the case inclusion criteria satisfies doctor trained in Western medicine or the arbitrary class of tcm diagnosis standard; Medical history information is complete; Age is greater than 18 years old and less than 65 years old; Signature test Informed Consent Form person.(1) Western medicine diagnose standard
i: there is or do not have corresponding symptom and sign, comprise mainly that stomachache, diarrhoea, abdominal distention, abdominal discomfort, constipation, bowel habit change, become thin, digestive tract hemorrhage, intussusception etc.; X line barium meal, barium coloclysis or double-contrast barium examination inspection can detect polyp of colon; Endoscopy is the best approach of digestive tract polyp diagnosis.(2) tcm diagnosis foundation
Ii: have more and have blood in stool, color is scarlet, can or rectal tenesmus be arranged with mucus; Can there be swollen thing to deviate from outside the anus behind the defecation, can returns voluntarily and receive or manual reduction; The anus touch can touch low level polyp or high-order pedicle skin flap polypus, and swollen thing is soft or tough and tensile, smooth, movable; Proctoscopy shows that vegetation has the base of a fruit or wide base, and the surface is mucosa sample tissue, single-shot or pilosity; Tissue pathology checking can help and clarify a diagnosis.
1.2 exclusion standard meets following each person: medical history information is incomplete; Age was greater than 65 years old person; Age was less than 18 years old person; The anemia of pregnant woman; Pathologic finding shows tissue canceration person; The polyp maximum gauge is greater than 2cm person; Polyp piece number surpasses 5 pieces of persons; With severe cardiac, brain, liver, renal insufficiency person; The Informed Consent Form person is not tested in signature.
1.3 select 60 examples among physical data in February, 2008～2009 year institute's anorectal section's outpatient service in February or the in-patient department patient, meet above-mentioned inclusion criteria, male's 42 examples wherein, women's 18 examples; 23～58 years old age, 42.8 years old mean age; 5 pieces of the maximum persons of polyp, 1 piece of minimum person.Be divided into treatment group, operation group, three groups of each 20 examples of combination of Chinese and Western medicine group by the table of random number method.
1.4 oral observation medicine (every 0.3g of specification), every day 3 times, each 3 are organized in the Therapeutic Method treatment; The operation group is taked polyp excision under the scope (using the Olympus EVIS of company series EF-240I electronic colonoscope, biopsy forceps, microscope), write down polyp simultaneously apart from the anus distance, polyp piece number and diameter, and take the photograph sheet for following up a case by regular visits to contrast, anti symptom treatment such as the conventional hemostasis of postoperative, infection are got pathological tissue biopsy and corresponding inspection; Combination of Chinese and Western medicine group is got the operation group of methods earlier, and it is oral observation medicine that postoperative is got the treatment group of methods.Treatment group and Chinese and western medicine group were 1 course of treatment with 1 month all.Observe three groups of curative effects after 3 courses of treatment.Three groups of check intestinal mirrors after 6 months.Follow up a case by regular visits to and followed the tracks of 1 year.
1.5 symptom and sign changes before and after observation item (1) treatment, comprises that mainly stomachache, diarrhoea, abdominal distention, abdominal discomfort, constipation, bowel habit change, become thin, have blood in stool etc. eight; (2) blood, stool, urine routine before and after the treatment, hepatic and renal function; (3) endoscopy is substantially taken the photograph sheet in the visual field before and after the treatment, observes polyp appearance, color and luster, quality, has or not the base of a fruit, mucosa has NIP to change on every side; (4) histopathologic slide before and after the treatment is with reference to WHO standard
IiiDetermine its position according to colon sign and mucosa characteristics, each pathological changes is got the capable respectively histopathological examination of a block organization at least, fix with 10% formalin solution immediately after taking out tissue, gradient alcohol dehydration, paraffin embedding, the row HE dyeing of conventional section back, tissues observed morphological change under the optical microscope; (5) list of references method before and after the treatment adopts SABC (IHC) method to detect p53 gene mutation of colorectal polyp patient tissue and protein expression respectively.The extraction reference literature method of DNA is carried out in the tissue, the design of p53 gene primer reference literature.
1.6 criterion of therapeutical effect is drafted the clinical efficacy standard with reference to " traditional Chinese medical science disease diagnosis criterion of therapeutical effect ".Wherein every of symptom integral was by metering in 0～4 fen: 0 minute: do not have any symptom, discomfort; 1 minute: slight uncomfortable, or outbreak occasionally, many at ordinary times attentions; 2 minutes: often occur, but symptom is not serious, life is not impacted; 3 minutes: the frequent appearance, and life is caused certain influence; 4 minutes: symptom was comparatively serious, and life is affected greatly.The clinical symptoms total mark is calculated in the treatment back.Integration is 0 to be recovery from illness, and it be produce effects that integration descend to surpass 70%, and it 30%～70% be effective that integration descends, be reduced under the integration 30% or not the descender be invalid.
1.7 statistical procedures adopts the SAS6.12 statistical package to handle.Adopt t check and X
2Check, P＜0.05 is significant statistical significance for difference has.
2 results
5 examples 2.1 relatively treatment group of three groups of clinical efficacies is fully recovered, produce effects 4 examples, effective 9 examples, invalid 2 examples, total effective rate 90.0%; Operation group 6 examples of fully recovering, produce effects 7 examples, effective 4 examples, invalid 3 examples, total effective rate 85.0%; Combination of Chinese and Western medicine group 12 examples of fully recovering, produce effects 7 examples, effective 1 example, total effective rate 100%.Three groups relatively with combination of Chinese and Western medicine group curative effect significantly (P＜0.05).
2.2 relatively operation group of relapse rate and combination of Chinese and Western medicine group be totally 40 routine patients, is subjected to treatment from going into winding, check intestinal mirror was 1 time in per 6 months, followed the trail of altogether 1 year.The operation group recurs 6 examples after 1 year, and combination of Chinese and Western medicine group recurs 2 examples, and relapse rate is respectively 30.0% and 10.0%, two group of its relapse rate of comparison, and there were significant differences (P＜0.01).
Three group three big conventional, hepatic and renal function inspection relatively have no significant change (P all＞0.05) before and after 2.3 three groups of lab testings are relatively treated.
Claims (4)
1. Chinese medicine for the treatment of colorectal polypus, its by following raw materials by weight percent through preparing: Fructus Mume 32%～38%, Bombyx Batryticatus 24%～32%, Rhizoma Curcumae 15%～24%, Flos Carthami 6%～18%, muscle moves back 1%～3%, rice vinegar 10%～18%.
2. the Chinese medicine of treatment colorectal polypus according to claim 1 is characterized in that: described Chinese medicine by following raw materials by weight percent through preparing: Fructus Mume 36% Bombyx Batryticatus 27% Rhizoma Curcumae 18% Flos Carthami 6% muscle moves back 3% rice vinegar 10%.
3. claim 1 or 2 described preparation method of Chinese medicine is characterized in that:
(1) medicinal material processing:
Fructus Mume: soak two weeks with vinegar before the preparation;
Muscle moves back: add detergent, and ultrasonic cleaning, ionized water ultrasonic cleaning is again dried; Stir-baked in pulvis TALCI is sliding then, muscle is retracted in the pot to heave to yellow be degree with frying, and takes out sieve and removes Pulvis Talci, cools, and is standby;
(2) preparation: the standard preparation prepared according to various dosage forms becomes oral formulations, comprises pill, capsule, granule, tablet and enteric-coated sustained-release preparation.
4. preparation method according to claim 3 is characterized in that: described enteric-coated sustained-release preparation comprises enteric-coated sustained release tablet, enteric coated capsule, enteric coated drop pill, enteric soft capsules.
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| CN103182055A (en) * | 2011-12-30 | 2013-07-03 | 新昌县冠阳技术开发有限公司 | Enteric-coated capsules comprising blue turmeric rhizome extract |
| CN104189724B (en) * | 2014-07-25 | 2017-09-19 | 张雯 | A kind of Chinese medicine and preparation method for treating throat's polyp |
| CN104888064A (en) * | 2015-07-01 | 2015-09-09 | 济南方宇文化传媒有限公司 | Oral traditional Chinese medicine for treating rectal polyp and preparation method thereof |
| CN112675223A (en) * | 2019-10-18 | 2021-04-20 | 谢岩 | Traditional Chinese medicine composition for treating multiple colon polyp, hemangioma and lipoma |
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