CN105797085A - Application of traditional Chinese medicine composition to preparation of medicine for treating haemorrhoids - Google Patents
Application of traditional Chinese medicine composition to preparation of medicine for treating haemorrhoids Download PDFInfo
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- CN105797085A CN105797085A CN201610327530.6A CN201610327530A CN105797085A CN 105797085 A CN105797085 A CN 105797085A CN 201610327530 A CN201610327530 A CN 201610327530A CN 105797085 A CN105797085 A CN 105797085A
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- chinese medicine
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Abstract
The invention discloses application of a traditional Chinese medicine composition to the preparation of medicine for treating haemorrhoids, and belongs to the technical field of traditional Chinese medicine. The traditional Chinese medicine composition is prepared from the following ingredients including dragon's blood, dandelion, herba lycopi, selaginella tamariscina, broom cypress fruit, flower of Chinese scholartree, harlequin glorybower leaves, mulberry leaves, pepper, herba schizonepetae, radix curcumae longae, radix isatidis and liquorice roots. The traditional Chinese medicine composition has the advantages that the medicine recipe is reasonable; the obvious efficacies of removing stasis, relieving pain, stopping bleeding, promoting tissue regeneration, reducing swelling, eliminating stagnation and clearing away heat and toxic materials are achieved; the curative effect is obvious; the side effect of the medicine is low; and the traditional Chinese medicine composition has the obvious clinic popularization value.
Description
The application is that the application for a patent for invention that applicant Cui Xinming proposes is (invention entitled: a kind of Chinese medicine treating hemorrhoid
Compositions and preparation method thereof, Application No.: 2015105252018, filing date: on August 25th, 2015) divisional application.
Technical field
The invention belongs to technical field of Chinese medicines, particularly relate to a kind of Chinese medicine composition use in preparing medicine for treaching hemorrhoie
On the way.
Background technology
Hemorrhoid have another name called blood stasis, hemorrhoid disease, haemorrhoids etc., are under rectum end mucosa and venous plexus expansion formation under anal canal skin
Vein group, or the swollen thing that the outer phleborrhexis of hemorrhoid or anus edge skin are formed because of inflammation hypertrophy, in having according to the difference of happening part
Dividing of hemorrhoid, external hemorrhoid and mixed hemorrhoid.Showing according to relevant reconnaissance information, the sickness rate of anorectal disease is 59.1%, and hemorrhoid send out
Sick rate accounts for therein 87.25%, most commonly seen with internal hemorrhoid the most again, accounts for the 52.19% of all anal and intestinal diseases.Men and women all can fall ill,
The sickness rate of women is 67%, and the sickness rate of male is 53.9%；Any age all can fall ill, and wherein the people in 20-40 year is the most
See, and increase the weight of with advancing age and gradually, therefore have saying of " ten people nine hemorrhoid ".The clinical symptoms of hemorrhoid is mainly had blood in stool, hemorrhoid
Block abjection, pain and pruritus etc..Have blood in stool for a long time and understand anemia even hemorrhagic shock in various degree, threat to life；And it is interior
When hemorrhoid abjection anus generation pathological changes can not send anal back to, being referred to as " incarcerated hemorrhoid ", easily there is severe necrosis in incarcerated hemorrhoid long-term existence
And infection, and systemic infection can be caused through blood system, consequence is serious, therefore, has suffered from hemorrhoid and has treated critically important in time.
The etiology and pathogenesis of hemorrhoid is many, the many yang blood and qi prosperity and decline from human body of the traditional Chinese medical science, the suitable inverse friendship of zang-fu differentiation
The aspect such as influence each other of the wrong and inside and outside cause of disease removes to inquire into the etiology and pathogenesis of hemorrhoid, as " danxi's experiential therapy " is pointed out: " hemorrhoid person is all because of dirty
Internal organs deficiency in origin, wound rheumatism, interior intrinsic heat poison, liquor-saturated drink handing-over, it is intended to commit suicide more, so that QI and blood tenesmus, ties poly-anus, dyspepsia does not dissipates, and
Conflict is hemorrhoid person "." Plain Questions vital QI of the body connecting with natural QI opinion " cloud: " thus be satiated with food, flaccidity of muscles and vessels, intestinal is hemorrhoid ".The traditional Chinese medical science thinks that hemorrhoid are bodies
Interior regulative mechanism is not normal, the defect in anatomical physiology and eating and drinking without temperance, constipation, chronic diarrhea chronic dysentery, gestation and menoxenia, sexual life mistake
Degree and bear a series of pathological changes that essence is not penetrated, produced under the external motivation effect such as disorder of emotion and heredity.
Western medical treatment hemorrhoid mainly have operative therapy, ultralow temperature, superhigh temperature therapy, knot set, loop ligature therapy and injection treatment.
Operative therapy can quickly eliminate focus and symptom, but often has complication to occur, postoperative easy recurrence；Ultralow temperature, superhigh temperature therapy are tied
Fruit is similar to operative therapy, and after treatment, relapse rate is high；Knot set, loop ligature therapy can make to make podex blood circulation be obstructed, and easily produce
Raw congestion edema, pain, difficult defecation etc.；Injection treatment method is easy, the most the more commonly used, but injection site and dosage
Being difficult to control to, dose controls improper meeting and causes downright bad massive hemorrhage, tissue necrosis or infection etc., and consequence is serious.
Chinese traditional treatment hemorrhoid emphasize the principle of dialectical treatmert, and the treatment to hemorrhoid can be divided into outer usage and internal treatment.Ancient times
Heat-clearing and toxic substances removing, cooling blood and dissolving stasis are advocated by interior Zhiduo County of hemorrhoid, and carries out treating with card according to different syndrome differentiating.Chinese traditional treatment
The external treatment of hemorrhoid mainly has fumigation-washing therapy, drug of topical application therapy and turunda therapy.Chinese traditional treatment hemorrhoid have evident in efficacy, and specimen is held concurrently
Controlling, drug side effect obvious advantage such as low grade, clinical development has a extensive future.
Chinese patent application 201410807583.9 discloses a kind of for preventing hemorrhoid outbreak and the Chinese medicine for the treatment of hemorrhoid
Compositions, its crude drug includes Rhizoma Coptidis, Myrrha, Poria, Fructus Aurantii Immaturus, Pericarpium Zanthoxyli, Galla Chinensis, the Fructus Kochiae, Folium et Fructus Helwingiae, Crop Gallus domesticus cotyledon, sky
Fluffy grass, Herba Rabdosiae glaucocalycis, Herba Ephedrae, Radix Et Caulis Acanthopanacis Senticosi, Herba Asteris Ageratoidis, Radix Sanguisorbae, Indigo Naturalis, Herba Eleusines Indicae and Folium Symplocoris Caudatae.These traditional Chinese medicine composition for treating hemorrhoid
Have rapid-action, the advantage that drug side effect is low, but need fumigation and washing agent and ZHICHUANG GAO simultaneously with the use of, use very inconvenient.
The oral medicine of hemorrhoid, medicine for external use and patch medicine expectant treatment can improve symptom at present, but it is slow to there is onset, and focus eliminates
The most thoroughly wait deficiency.Seeking a kind of rapid-action, effect is notable, and efficacy stability, treating both the principal and secondary aspects of a disease and Therapeutic Method treat hemorrhoid easily
The active drug of skin ulcer, is urgent needs the most clinically.
Summary of the invention
In order to make up the deficiencies in the prior art, alleviating the misery of hemorrhoid patients, the present invention provides a kind of Chinese medicine composition to exist
Preparing the purposes in medicine for treaching hemorrhoie, this Chinese medicine composition has removing blood stasis and relieving pain, hemostasia and promoting granulation, dispersing swelling and dissipating binds and heat-clearing and toxic substances removing
Effect, possess that rapid-action, therapeutic effect is notable, efficacy stability, treating both the principal and secondary aspects of a disease, applied widely and application easy to spread etc. excellent
Point.
Chinese medicine composition of the present invention is prepared from by the raw material of following parts by weight:
Sanguis Draxonis 18-24 part, Herba Taraxaci 20-27 part, Herba Lycopi's 14-20 part, Herba Selaginellae 12-17 part, Fructus Kochiae 15-23 part, Flos Sophorae 14-22
Part, Folium et Ramulus Clerodendri Trichotomi 7-13 part, Folium Mori 10-16 part, Pericarpium Zanthoxyli 9-17 part, Herba Schizonepetae 8-15 part, Rhizoma Curcumae Longae 5-11 part, Radix Isatidis 11-16 part and
Radix Glycyrrhizae 6-13 part.
Preferably, described Chinese medicine composition is prepared from by the raw material of following parts by weight: Sanguis Draxonis 18 parts, Herba Taraxaci 20
Part, Herba Lycopi 14 parts, Herba Selaginellae 12 parts, the Fructus Kochiae 15 parts, 14 parts of Flos Sophorae, Folium et Ramulus Clerodendri Trichotomi 7 parts, 10 parts of Folium Mori, 9 parts of Pericarpium Zanthoxyli, Herba Schizonepetae 8 parts,
5 parts of Rhizoma Curcumae Longae, Radix Isatidis 11 parts and 6 parts of Radix Glycyrrhizae.
Preferably, described Chinese medicine composition is prepared from by the raw material of following parts by weight: Sanguis Draxonis 24 parts, Herba Taraxaci 27
Part, Herba Lycopi 20 parts, Herba Selaginellae 17 parts, the Fructus Kochiae 23 parts, 22 parts of Flos Sophorae, Folium et Ramulus Clerodendri Trichotomi 13 parts, 16 parts of Folium Mori, 17 parts of Pericarpium Zanthoxyli, Herba Schizonepetae 15
Part, 11 parts of Rhizoma Curcumae Longae, Radix Isatidis 16 parts and 13 parts of Radix Glycyrrhizae.
Preferably, described Chinese medicine composition is prepared from by the raw material of following parts by weight: Sanguis Draxonis 21 parts, Herba Taraxaci 25
Part, Herba Lycopi 17 parts, Herba Selaginellae 15 parts, the Fructus Kochiae 18 parts, 17 parts of Flos Sophorae, Folium et Ramulus Clerodendri Trichotomi 11 parts, 14 parts of Folium Mori, 15 parts of Pericarpium Zanthoxyli, Herba Schizonepetae 13
Part, 9 parts of Rhizoma Curcumae Longae, Radix Isatidis 14 parts and 9 parts of Radix Glycyrrhizae.
The prescription analysis of medicament composing prescription of the present invention:
Medicament composing prescription of the present invention with Resina Draconis and Herba Taraxaci as monarch drug, removing blood stasis and relieving pain, hemostasia and promoting granulation, heat-clearing and toxic substances removing, dispersing swelling and dissipating binds；With
Herba Lycopi, Herba Selaginellae, the Fructus Kochiae and Flos Sophorae are ministerial drug, blood circulation promoting and blood stasis dispelling, reducing swelling and alleviating pain, clearing away heat and cooling blood, dispelling wind for relieving itching；With Folium et Ramulus Clerodendri Trichotomi, Mulberry
Leaf, Pericarpium Zanthoxyli, Herba Schizonepetae, Rhizoma Curcumae Longae and Radix Isatidis are adjuvant drug, heat-clearing and toxic substances removing, warming middle-JIAO to relieve pain, rash of inducing sweat, removing blood stasis circulation of qi promoting；With Radix Glycyrrhizae it is
Make medicine, relieving spasm to stop pain, heat-clearing and toxic substances removing, coordinating the actions of various ingredients in a prescription, make all medicines arrange in pairs or groups, synergism, jointly reach detumescence and promoting granulation, dissipating blood stasis is only
Hemorrhoid are had the most significant therapeutic effect by effect of blood, promoting blood circulation and cooling blood and heat-clearing and toxic substances removing.
The present invention also provide for corresponding manufacturing process by this Chinese medicine ensure to make on the premise of curative effect facilitate easy-to-use
Finished product preparation.
The preparation method of described Chinese medicine composition mainly comprises the steps that
(1) Herba Taraxaci, Herba Lycopi, the Fructus Kochiae, Folium et Ramulus Clerodendri Trichotomi, Folium Mori, Rhizoma Curcumae Longae, Radix Isatidis and Radix Glycyrrhizae are taken, by 4-9 times of medical material gross weight
Boiling 2-3 time, each 2-5h, filter, merging filtrate, being evaporated to relative density under 60-65 DEG C of environment is 1.20-
The extractum of 1.25, drying under reduced pressure, cross 80-100 mesh sieve after pulverizing, obtain extractum fine powder；
(2) take Resina Draconis, Herba Selaginellae, Flos Sophorae, Pericarpium Zanthoxyli and Herba Schizonepetae, be broken into coarse powder, cross 80-100 mesh sieve, mix with extractum fine powder, stirring
Uniformly, this Chinese medicine composition is obtained.
Utilizing modern general Chinese medicine preparation technology, Chinese medicine composition of the present invention can be made into the finished product preparation of clinical needs,
Such as dosage forms such as gel, ointment, suppository or ointments.
Rat Oleum Tiglii hemorrhoid model test shows, Chinese medicine composition of the present invention is used for treating hemorrhoid tool and is significantly improved
The effect of rectum vein permeability；Clinical trial displays that, drug regimen of the present invention is used for treating hemorrhoid total effective rate and reaches 96%,
Therapeutic effect is significantly higher than positive control drug MAYINGLONG MUSK HEMORRHOID UNGUENTUM, and traditional Chinese medicine composition for treating effect of the present invention is notable, can make
Using for medicine for treaching hemorrhoie, clinical generalization value is high.
Compared with prior art, Chinese medicine composition of the present invention has a following technical advantage:
(1) compared with the Therapeutic Method of current hemorrhoid, Chinese medicine composition of the present invention is natural pure Chinese medicinal preparation, untoward reaction and pair
Effect significantly reduces, and Chinese medicine composition effect of the present invention is comprehensive, and medication effect more preferably, and improves the life matter of patient
Amount.
(2) pharmacological evaluation shows, Chinese medicine composition of the present invention as treatment hemorrhoid drug use time, medicine effect is comprehensive
Can obtain the effect significantly improving rectum vein permeability, have rapid-action, good effect etc. significantly treats advantage.
(3) Chinese medicine composition of the present invention preparation is simple, and raw material is easy to get, and also has efficacy stability, secondary work rapid-action, malicious simultaneously
By advantages such as low and application easy to spread.
Detailed description of the invention
Below will by specific embodiment, the present invention is described further, it will be understood by those skilled in the art that this
Bright in addition to following example, it may also be made that other similar changing obtain similar result without deviating from present disclosure and essence
God's scope.
Embodiment 1 prepares the suppository of Chinese medicine composition
Embodiment 1 Chinese medicine composition is prepared from by the raw material of following parts by weight:
Sanguis Draxonis 18 parts, Herba Taraxaci 20 parts, Herba Lycopi 14 parts, Herba Selaginellae 12 parts, the Fructus Kochiae 15 parts, 14 parts of Flos Sophorae, Folium et Ramulus Clerodendri Trichotomi 7 parts, Folium Mori
10 parts, 9 parts of Pericarpium Zanthoxyli, Herba Schizonepetae 8 parts, 5 parts of Rhizoma Curcumae Longae, Radix Isatidis 11 parts and 6 parts of Radix Glycyrrhizae.
Preparation method is as follows:
(1) Herba Taraxaci, Herba Lycopi, the Fructus Kochiae, Folium et Ramulus Clerodendri Trichotomi, Folium Mori, Rhizoma Curcumae Longae, Radix Isatidis and Radix Glycyrrhizae are taken, by the 5 of medical material gross weight extraordinarily
Soak by water 2 times, each 2h, filter, merging filtrate, being evaporated to relative density under 65 DEG C of environment is the extractum of 1.25, decompression
Cross 100 mesh sieves after dry, pulverize, obtain extractum fine powder；
(2) taking Resina Draconis, Herba Selaginellae, Flos Sophorae, Pericarpium Zanthoxyli and Herba Schizonepetae, be broken into coarse powder, cross 100 mesh sieves, mix with extractum fine powder, stirring is all
Even, obtain this Chinese medicine composition powder；
(3) taking semi-synthetic fatty glyceride to be placed in vessel, heating in water bath melts, and treats that temperature is down to about 50 DEG C, in addition
State Chinese medicine composition powder, stir, rear inject to slightly overflowing die orifice for degree in the bolt mould scribbling lubricant, cooling, solidification
After prune spilling part, the demoulding, quality inspection, packaging, to obtain final product.
Embodiment 2 prepares the suppository of Chinese medicine composition
Embodiment 2 Chinese medicine composition is prepared from by the raw material of following parts by weight:
Sanguis Draxonis 24 parts, Herba Taraxaci 27 parts, Herba Lycopi 20 parts, Herba Selaginellae 17 parts, the Fructus Kochiae 23 parts, 22 parts of Flos Sophorae, Folium et Ramulus Clerodendri Trichotomi 13 parts, Folium Mori
16 parts, 17 parts of Pericarpium Zanthoxyli, Herba Schizonepetae 15 parts, 11 parts of Rhizoma Curcumae Longae, Radix Isatidis 16 parts and 13 parts of Radix Glycyrrhizae.
Preparation method is with embodiment 1.
Embodiment 3 prepares the ointment of Chinese medicine composition
Embodiment 3 Chinese medicine composition is prepared from by the raw material of following parts by weight:
Sanguis Draxonis 21 parts, Herba Taraxaci 25 parts, Herba Lycopi 17 parts, Herba Selaginellae 15 parts, the Fructus Kochiae 18 parts, 17 parts of Flos Sophorae, Folium et Ramulus Clerodendri Trichotomi 11 parts, Folium Mori
14 parts, 15 parts of Pericarpium Zanthoxyli, Herba Schizonepetae 13 parts, 9 parts of Rhizoma Curcumae Longae, Radix Isatidis 14 parts and 9 parts of Radix Glycyrrhizae.
Preparation method is as follows:
(1) Herba Taraxaci, Herba Lycopi, the Fructus Kochiae, Folium et Ramulus Clerodendri Trichotomi, Folium Mori, Rhizoma Curcumae Longae, Radix Isatidis and Radix Glycyrrhizae are taken, by the 7 of medical material gross weight extraordinarily
Soak by water 2 times, each 2.5h, filter, merging filtrate, being evaporated to relative density under 65 DEG C of environment is the extractum of 1.25, subtracts
Pressure crosses 100 mesh sieves after dry, pulverize, and obtains extractum fine powder；
(2) taking Resina Draconis, Herba Selaginellae, Flos Sophorae, Pericarpium Zanthoxyli and Herba Schizonepetae, be broken into coarse powder, cross 100 mesh sieves, mix with extractum fine powder, stirring is all
Even, obtain this Chinese medicine composition powder；
(3) take sodium carboxymethyl cellulose to be placed in mortar, add glycerol and grind well, then grind while the ethanol adding ethyl hydroxybenzoate is molten
Liquid, grinds well after swelling, is added by several times by above-mentioned Chinese medicine composition powder, grinds well, obtain the ointment of Chinese medicine composition of the present invention
Agent.
Embodiment 4 prepares the ointment of Chinese medicine composition
Embodiment 4 Chinese medicine composition is prepared from by the raw material of following parts by weight:
Sanguis Draxonis 20 parts, Herba Taraxaci 25 parts, Herba Lycopi 16 parts, Herba Selaginellae 15 parts, the Fructus Kochiae 21 parts, 18 parts of Flos Sophorae, Folium et Ramulus Clerodendri Trichotomi 10 parts, Folium Mori
14 parts, 14 parts of Pericarpium Zanthoxyli, Herba Schizonepetae 12 parts, 7 parts of Rhizoma Curcumae Longae, Radix Isatidis 12 parts and 11 parts of Radix Glycyrrhizae.
Preparation method is with embodiment 3.
Chinese medicine composition pharmacodynamic study of the present invention:
Test one: the Chinese medicine composition of the present invention test to rat Oleum Tiglii hemorrhoid model
1, experimental animal: the SD rat at regular grade 6-8 monthly age 90, body weight 170-330g, male and female half and half, is randomly divided into 9 groups, often
Organize 10.
2, trial drug and dosage regimen:
A group: trial drug is the Chinese medicine composition powder of the present invention that the embodiment of the present invention 1 prepares, and being deployed into concentration with water is
The suspension of 0.6g/ml, 0.4g/ml and 0.2g/ml, standby.Take 3 groups of rats, be labeled as A group high dose group (2.4g/kg), in
Dosage group (1.6g/kg) and low dose group (0.8g/kg), high dose group concentration is the drug suspension of 0.6g/ml, middle dosage
Group concentration is the drug suspension of 0.4g/ml, and high dose group concentration is the drug suspension of 0.2g/ml, and modeling is pressed for first 2 days
Dosage drop rectum with drug every day 2 times, is stained with medicine with 10mg cotton balls, cotton balls is filled in internal rectum, when next time is administered, should first check
Whether internal rectum has cotton balls (should take out if any cotton balls), and last administration should after modeling 2 hours.
B group: trial drug is the Chinese medicine composition powder of the present invention that the embodiment of the present invention 2 prepares, and dosage regimen is with A group.
Model control group: take 1 group of rat, first 2 days isometric(al) normal saline drop rectum with drug every day of modeling 2 times, last
Secondary administration should after modeling 2 hours.
Positive controls: positive control drug is that (traditional Chinese medicines quasi-word Z11020100, Beijing Tongrentang share has diyu huaijiao pills
Limit company Tongrentang Pharmaceutical Factory), it is deployed into the suspension of 0.6g/ml with water, takes 1 group of rat, modeling presses 2.4g/kg's in first 2 days
Dosage drop rectum with drug every day 2 times, last administration should after modeling 2 hours.
Normal group: isometric(al) normal saline drop rectum with drug every day 2 times, successive administration 2 days.
3, rat Oleum Tiglii hemorrhoid model is set up: Oleum Tiglii is a kind of conventional proinflammatory agent, by distilled water, pyridine, ether
With 6% Oleum Tiglii in 1:4:5:10 ratio mix, form Oleum Tiglii mixed liquor.Last be administered before 2h, go model control group and
Drug study group rat, the cotton balls that leaching is inhaled 0.16mL Oleum Tiglii mixed liquor inserts rat anus, takes out, set up after stopping 10s
Rat Oleum Tiglii hemorrhoid model.
4, index determining: after modeling 6h, every rat presses her Wen's orchid physiology salt of dose intravenous injection 1% of 20mg/kg
Aqueous solution, sacrificed by exsanguination rat after 30min, cut-off intestinal and perianal tissue, with acetone normal saline by the ratio of 7:3 after weighing
Example solution soaking 48h, centrifugal, take supernatant and measure its absorbance at 590nm, as evaluating vascular permeability index.
5, result of the test: as shown in table 1.
The comparison of rat absorbance respectively organized by table 1
Note: compare with Normal group, model control group△P ＜ 0.05,△△P ＜ 0.01；Comparing with model control group, medicine tries
Test group*P ＜ 0.05,**P ＜ 0.01；Compare with positive controls, Chinese medicine composition drug test group of the present invention#P ＜ 0.05,##P
＜ 0.01.
6, conclusion (of pressure testing)
Inflammatory reaction can cause vascular permeability to improve, by the evaluation of rectum vein permeability, this test reflects that medicine is to greatly
The therapeutic effect of Mus Oleum Tiglii hemorrhoid model.Test data shows, Chinese medicine composition of the present invention can reduce Oleum Tiglii hemorrhoid well
The rectum vein permeability of skin ulcer rat model, in compositions, various Chinese medicinal components are assisted in terms for the treatment of rat Oleum Tiglii hemorrhoid model
Same-action is strong, Chinese medicine composition A group of the present invention (Chinese medicine composition of the present invention that i.e. embodiment of the present invention 1 prepares) middle and high dosage
Group and Chinese medicine composition B group of the present invention (Chinese medicine composition of the present invention that i.e. embodiment of the present invention 2 prepares) high dose group effect are excellent
In positive controls, it is suitable with positive controls that remaining respectively organizes therapeutic effect.
Test two: the clinical trial of Chinese medicine composition of the present invention
(1) study subject selects
1, tcm diagnosis standard
With reference to " Chinese medical disease Standardization of diagnosis and curative effect " (2012 editions) and " the examining of hemorrhoid of " new Chinese medicine guideline of clinical investigations "
Disconnected foundation " content draft.Diagnostic criteria is:
(1) have blood in stool, with swollen thing abjection anus outside, the initial stage after an action of the bowels can self-resetting, the later stage needs manual reduction, anoscopy: tooth
Mucosal protrusion above line, or visible surface has fibrosis phenomenon；
(2) have blood in stool less or nothing, incarceration occurs, with having an intense pain；
(3) the subcutaneous burst of anus edge livid purple color lump, local skin edema, lump is from the beginning of the softest, and sharp ache, gradual change is hard, can live
Dynamic, touch a tender spot substantially；
(4) during defecation or squatting for a long time, anus edge skin has soft livid purple color agglomerate to swell (varicosis group), can be with falling inflation sense, agglomerate
Can disappear after pressing；
(4) have blood in stool and podex swells thing, can have rectal tenesmus, foreign body sensation or pain, can be with merocrine secretion's thing or pruritus, anal canal
There is swollen thing (also can be superfluous skin under tooth trace) in the upper and lower same orientation of interior tooth trace.
Conformance with standard (1) and (2) person can make internal hemorrhoid diagnosis；Meet (3) and (4) person and can make thrombosed external hemorrhoid or vein
Varicose external hemorrhoid diagnoses；Meet (6) person and can make mixed hemorrhoid diagnosis.
Meet any of the above diagnostic criteria informed consent, be ready that experimenter all can include test case in.4, get rid of and pick
Except case standard
1) inflammatory external hemorrhoid and connective tissue external hemorrhoid (sentinel pile) be not at the row of test；
2) hemorrhoid merge perianal abscess, anal fistula, rectal polyp, rectum carcinoma or intestinal infection disease patient；
3) age is under-18s or over-65s, trimester of pregnancy or women breast-feeding their children, or those who are allergic to this drug；
4) the severe primary diseases such as cardiovascular and cerebrovascular vessel, Liver and kidney and hemopoietic system, psychotic it are associated with；
5) do not meet inclusive criteria, not by regulation medication, cannot judge curative effect or data the most entirely affect the treatment or safety judge
Person.
(2) clinical trial protocol
1, physical data
Gone out 200 examples met the clinical volunteers patient of hemorrhoid diagnostic criteria by diagnosis standard screening, by random, double blinding, parallel, right
According to principle be divided into treatment group and matched group two groups, often organize each 100 examples, age 20-58 year, 37 years old mean age.Two groups of patients
The influence factor such as sex, age, sick kind, state of an illness distribution, through statistical procedures, there was no significant difference, meet packet condition.
2, trial drug and test method
Treatment group: trial drug is the Chinese medicine composition ointment of the present invention of the embodiment of the present invention 3 preparation, defecation before medication, clearly
Water clean affected part, external application or anus of receiving, one time 2 grams, 1 time on the one, 7 days be a course for the treatment of, after 2 courses for the treatment of evaluate curative effect.
Matched group: control drug is that (traditional Chinese medicines quasi-words Z42021920, Ma Yinglong Pharmaceutical group has MAYINGLONG MUSK HEMORRHOID UNGUENTUM
Limit company), medication is with treatment group.
3, curative effect determinate standard
Recovery from illness: after an action of the bowels without hemorrhage, without prolapsus, anoscopy hemorrhoid mucosa recovers normal, blood stasis atresia；
Effective: after an action of the bowels without hemorrhage, without abjection, blood stasis redness substantially disappears, anoscopy hemorrhoid mucosa mild hyperaemia；
Effective: the most still to have the most hemorrhage, accompany slight hemorrhoid to deviate from, anoscopy hemorrhoid mucosa mild hyperaemia；
Invalid: symptom and sign is without improving, even increase the weight of.
4, therapeutic outcome, as shown in table 2
Table 2 therapeutic effect
5, conclusion (of pressure testing)
This clinical trial uses the medicine MAYINGLONG MUSK HEMORRHOID UNGUENTUM for the treatment of hemorrhoid the most conventional as a control group,
By comparing with the therapeutic effect of Chinese medicine composition of the present invention, highlight the curative effect of Chinese medicine composition of the present invention.Clinical examination
Testing data to show, Chinese medicine composition of the present invention is notable for hemorrhoid treating effect, and cure rate reaches 64%, and cure-remarkable-effectiveness rate is more than 80%.This
The total effective rate of invention pharmaceutical composition is 96%, and the total effective rate being significantly higher than comparison medicine is 76%, it was demonstrated that Chinese drug-treated group of the present invention
Compound therapeutic effect is notable, can use as medicine for treaching hemorrhoie, and clinical generalization value is high.
Claims (6)
1. the Chinese medicine composition purposes in preparing medicine for treaching hemorrhoie, it is characterised in that described Chinese medicine composition by
The raw material of following parts by weight is prepared from: Sanguis Draxonis 18-24 part, Herba Taraxaci 20-27 part, Herba Lycopi's 14-20 part, Herba Selaginellae 12-17 part,
Fructus Kochiae 15-23 part, Flos Sophorae 14-22 part, Folium et Ramulus Clerodendri Trichotomi 7-13 part, Folium Mori 10-16 part, Pericarpium Zanthoxyli 9-17 part, Herba Schizonepetae 8-15 part, Rhizoma Curcumae Longae
5-11 part, Radix Isatidis 11-16 part and Radix Glycyrrhizae 6-13 part.
2. Chinese medicine composition purposes in preparing medicine for treaching hemorrhoie as claimed in claim 1, it is characterised in that described
Chinese medicine composition is prepared from by the raw material of following parts by weight: Sanguis Draxonis 18 parts, Herba Taraxaci 20 parts, Herba Lycopi 14 parts, Herba Selaginellae 12 parts,
The Fructus Kochiae 15 parts, 14 parts of Flos Sophorae, Folium et Ramulus Clerodendri Trichotomi 7 parts, 10 parts of Folium Mori, 9 parts of Pericarpium Zanthoxyli, Herba Schizonepetae 8 parts, 5 parts of Rhizoma Curcumae Longae, Radix Isatidis 11 parts and sweet
Grass 6 parts.
3. Chinese medicine composition purposes in preparing medicine for treaching hemorrhoie as claimed in claim 1, it is characterised in that described
Chinese medicine composition is prepared from by the raw material of following parts by weight: Sanguis Draxonis 24 parts, Herba Taraxaci 27 parts, Herba Lycopi 20 parts, Herba Selaginellae 17 parts,
The Fructus Kochiae 23 parts, 22 parts of Flos Sophorae, Folium et Ramulus Clerodendri Trichotomi 13 parts, 16 parts of Folium Mori, 17 parts of Pericarpium Zanthoxyli, Herba Schizonepetae 15 parts, 11 parts of Rhizoma Curcumae Longae, Radix Isatidis 16 parts
With 13 parts of Radix Glycyrrhizae.
4. Chinese medicine composition purposes in preparing medicine for treaching hemorrhoie as claimed in claim 1, it is characterised in that described
Chinese medicine composition is prepared from by the raw material of following parts by weight: Sanguis Draxonis 21 parts, Herba Taraxaci 25 parts, Herba Lycopi 17 parts, Herba Selaginellae 15 parts,
The Fructus Kochiae 18 parts, 17 parts of Flos Sophorae, Folium et Ramulus Clerodendri Trichotomi 11 parts, 14 parts of Folium Mori, 15 parts of Pericarpium Zanthoxyli, Herba Schizonepetae 13 parts, 9 parts of Rhizoma Curcumae Longae, Radix Isatidis 14 parts
With 9 parts of Radix Glycyrrhizae.
5. the purposes in preparing medicine for treaching hemorrhoie of the Chinese medicine composition as described in claim 1-4 is arbitrary, it is characterised in that:
Described Chinese medicine composition is made into gel, ointment, suppository or ointment.
6. the purposes in preparing medicine for treaching hemorrhoie of the Chinese medicine composition as described in claim 1-4 is arbitrary, it is characterised in that
The preparation method of described Chinese medicine composition comprises the following steps:
(1) Herba Taraxaci, Herba Lycopi, the Fructus Kochiae, Folium et Ramulus Clerodendri Trichotomi, Folium Mori, Rhizoma Curcumae Longae, Radix Isatidis and Radix Glycyrrhizae are taken, by 4-9 times of medical material gross weight
Boiling 2-3 time, each 2-5h, filter, merging filtrate, being evaporated to relative density under 60-65 DEG C of environment is 1.20-
The extractum of 1.25, drying under reduced pressure, cross 80-100 mesh sieve after pulverizing, obtain extractum fine powder；
(2) take Resina Draconis, Herba Selaginellae, Flos Sophorae, Pericarpium Zanthoxyli and Herba Schizonepetae, be broken into coarse powder, cross 80-100 mesh sieve, mix with extractum fine powder, stirring
Uniformly, this Chinese medicine composition is obtained.
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| CN201610327530.6A CN105797085A (en) | 2015-08-25 | 2015-08-25 | Application of traditional Chinese medicine composition to preparation of medicine for treating haemorrhoids |
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| CN201610327530.6A CN105797085A (en) | 2015-08-25 | 2015-08-25 | Application of traditional Chinese medicine composition to preparation of medicine for treating haemorrhoids |
| CN201510525201.8A CN105012895A (en) | 2015-08-25 | 2015-08-25 | Traditional Chinese medicine composition for treating hemorrhoids and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN105343578A (en) * | 2015-12-12 | 2016-02-24 | 杨献美 | Medicine composition for treating haemorrhoids |
| CN106362044A (en) * | 2016-09-29 | 2017-02-01 | 武汉安孕堂生物科技有限公司 | Chinese medicine gel used for treating hemorrhoids of pregnant women |
| CN106983847A (en) * | 2017-04-26 | 2017-07-28 | 王保国 | A kind of Chinese medicine preparation and its preparation and application for treating hemorrhoid |
| US20230190846A1 (en) * | 2020-09-11 | 2023-06-22 | Tzung-Yan LEE | Pharmaceutical compositions and uses thereof in treating muscle atrophy |
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| CN103735998A (en) * | 2014-01-24 | 2014-04-23 | 邹洪胜 | Traditional Chinese medicinal composition for treating haemorrhoids |
| CN104474189A (en) * | 2014-12-05 | 2015-04-01 | 广东聚智诚科技有限公司 | Pharmaceutical composition for treating haemorrhoids |
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Application publication date: 20160727 |