CN105998334A - Application of traditional Chinese medicine composition in preparation of medicine for treating haemorrhoids - Google Patents
Application of traditional Chinese medicine composition in preparation of medicine for treating haemorrhoids Download PDFInfo
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Abstract
The invention belongs to the technical field of traditional Chinese medicines and relates to an application of traditional Chinese medicine composition in preparation of a medicine for treating haemorrhoids. The traditional Chinese medicine composition is prepared from raw materials as follows: purslane herb, myrrh, panax notoginseng, frankincense, rhubarb, musk, dandelion, honeysuckle flower, fresh rehmannia root, Japanese honeysuckle stem, garden burnet root, amur corktree bark, forsythia, pod of Japanese pagodatree and licorice. The traditional Chinese medicine composition has the advantages of reasonable medicinal formula, remarkable curative effect, low medicinal side effect and remarkable clinical popularization value, and has remarkable effects of relieving swelling and pain, promoting blood circulation, removing stasis, clearing heat and removing toxicity when treating the haemorrhoids.
Description
The application is that the application for a patent for invention that applicant Qingdao Lan Shengyang medicine bioengineering science and technology limited Company proposes (is sent out
Bright entitled: a kind of Chinese medicine composition treating hemorrhoid and application thereof, Application No.: 2015104816916, filing date:
On August 10th, 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 the anemia even hemorrhagic shock that can cause 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, alleviate the misery of hemorrhoid patients, the invention provides a kind of Chinese medicine composition
Purposes in preparing medicine for treaching hemorrhoie, this Chinese medicine composition has reducing swelling and alleviating pain, blood circulation promoting and blood stasis dispelling, cooling blood for hemostasis, heat clearing away solution
Poison and effect of heat clearing and damp drying, possess rapid-action, therapeutic effect notable, efficacy stability, treating both the principal and secondary aspects of a disease, applied widely and be prone to
The advantages such as popularization and application.
Chinese medicine composition of the present invention is mainly prepared from by the raw material of following parts by weight: Herba Portulacae 28-36 part, do not have
Medicine 26-32 part, Radix Notoginseng 19-25 part, Olibanum 17-22 part, Radix Et Rhizoma Rhei 15-21 part, Moschus 14-19 part, Herba Taraxaci 18-24 part, gold silver
Flower 13-18 part, Radix Rehmanniae 10-15 part, Caulis Lonicerae 9-12 part, Radix Sanguisorbae 11-14 part, Cortex Phellodendri 8-11 part, Fructus Forsythiae 10-15 part, the Fructus Sophorae
7-12 part and Radix Glycyrrhizae 6-13 part.
Preferably, described Chinese medicine composition is mainly prepared from by the raw material of following parts by weight: Herba Portulacae 28 parts, do not have
Medicine 26 parts, Radix Notoginseng 19 parts, Olibanum 17 parts, Radix Et Rhizoma Rhei 15 parts, 14 parts of Moschus, Herba Taraxaci 18 parts, Flos Lonicerae 13 parts, Radix Rehmanniae 10 parts,
Caulis Lonicerae 9 parts, Radix Sanguisorbae 11 parts, Cortex Phellodendri 8 parts, Fructus Forsythiae 10 parts, the Fructus Sophorae 7 parts and 6 parts of Radix Glycyrrhizae.
Preferably, described Chinese medicine composition is mainly prepared from by the raw material of following parts by weight: Herba Portulacae 36 parts, do not have
Medicine 32 parts, Radix Notoginseng 25 parts, Olibanum 22 parts, Radix Et Rhizoma Rhei 21 parts, 19 parts of Moschus, Herba Taraxaci 24 parts, Flos Lonicerae 18 parts, Radix Rehmanniae 15 parts,
Caulis Lonicerae 12 parts, Radix Sanguisorbae 14 parts, Cortex Phellodendri 11 parts, Fructus Forsythiae 15 parts, the Fructus Sophorae 12 parts and 13 parts of Radix Glycyrrhizae.
Preferably, described Chinese medicine composition is mainly prepared from by the raw material of following parts by weight: Herba Portulacae 33 parts, do not have
Medicine 29 parts, Radix Notoginseng 22 parts, Olibanum 19 parts, Radix Et Rhizoma Rhei 18 parts, 17 parts of Moschus, Herba Taraxaci 22 parts, Flos Lonicerae 16 parts, Radix Rehmanniae 13 parts,
Caulis Lonicerae 10 parts, Radix Sanguisorbae 12 parts, Cortex Phellodendri 10 parts, Fructus Forsythiae 13 parts, the Fructus Sophorae 9 parts and 9 parts of Radix Glycyrrhizae.
The source of Chinese crude drug, nature and flavor used by Chinese medicine composition of the present invention, return through and effect:
Herba Portulacae: this product is the dry aerial parts of portulacaceous plant Herba Portulacae.Sour in the mouth, cold in nature；Return liver, large intestine channel；Heat clearing away
Removing toxic substances, dissipates blood detumescence, cooling blood for hemostasis.
Myrrha: this product is Burseraceae bdellium plant myrrh and belongs to him together and plant the factice tree that the trunk skin zone of plant oozes out
Fat.Bitter in the mouth, property is put down；Return Liver Channel；Eliminating stasis to stop pain, detumescence and promoting granulation.
Flos Lonicerae: this product is the dry of caprifoliaceae plant Radix Ophiopogonis, Flos Lonicerae, Flos Lonicerae (hair calyx Radix Ophiopogonis) or hair style Radix Ophiopogonis
Dry Alabastrum or just opened flower.Sweet in the mouth, cold in nature；Return lung, the heart, stomach warp；Heat-clearing and toxic substances removing, wind-heat dissipating.
Radix Rehmanniae: this product is the fresh rhizome of scrophulariaceae rehmannia glutinosa plant.Sweet in the mouth, hardship, cold in nature；GUIXIN, liver, kidney channel；Heat clearing away
Removing heat from blood, promotes the production of body fluid and moisturizes.
Moschus: this product is the dry secretions in animal in deer family woods Moschus moschiferous, horse Moschus moschiferous or former Moschus moschiferous maturation hero body note capsule.Acrid in the mouth, property
Temperature；GUIXIN, spleen channel；Promoting blood circulation to restore menstrual flow, reducing swelling and alleviating pain.
The Fructus Sophorae: this product is the dry mature fruit of leguminous plant Chinese scholartree.Bitter in the mouth, cold in nature；Return liver, large intestine channel；Clearing away heat-fire is cool
Blood stops blooding.
Fructus Forsythiae: this product is the dry fruit of Oleaceae plants Fructus Forsythiae.Bitter in the mouth, cold nature；Return lung, the heart, small intestine meridian；Heat clearing away solution
Poison, dispersing swelling and dissipating binds.
Cortex Phellodendri: this product is the dry bark of rutaceae wampee or Cortex Phellodendri.Bitter in the mouth, cold in nature；Return kidney, bladder warp；Clearly
Hot dampness, pathogenic fire purging is except steaming, detoxification sore treatment.
Radix Sanguisorbae: this product is rosaceous plant Radix Sanguisorbae or the dry root of the Radix Sanguisorbae that comes into leaves.Bitter in the mouth, acid, puckery, cold nature；Return liver, big
Intestinal warp；Cooling blood for hemostasis, heat-clearing and toxic substances removing, sore of detoxifying.
Herba Taraxaci: this product is feverfew Herba Taraxaci, alkali ground Herba Taraxaci or the dry herb belonging to several plants together.Bitter in the mouth,
Sweet, cold in nature；Return liver, stomach warp；Heat-clearing and toxic substances removing, dispersing swelling and dissipating binds, inducing diuresis for treating stranguria syndrome.
Caulis Lonicerae: this product is the dry stem branch of caprifoliaceae plant Radix Ophiopogonis.Sweet in the mouth, cold in nature；Attach to the lung and stomach meridians；Heat-clearing and toxic substances removing, dredges
Wind and removing obstruction in channels.
Radix Et Rhizoma Rhei: this product is the dry root and rhizome of polygonum rheum palmatum, Rheum tanguticum or Rheum officinale.Bitter in the mouth,
Cold in nature；Return spleen, stomach, large intestine, liver, pericardium channel；Purging heat and dredging bowels, removing pathogenic heat from blood and toxic substance from the body, change blood removing blood stasis.
Olibanum: this product is Burseraceae Boswellia carterii platymiscium Boswellia carterii, medicine glue XIANGSHU and wild Boswellia carterii etc., with its trunk skin zone
The oleo-gum-resin that wound oozes out is used as medicine.Acrid in the mouth, hardship, warm in nature；GUIXIN, liver, spleen channel；Promoting blood circulation and stopping pain, regulating qi and activating blood, analgesic therapy, chase after poison.
Radix Notoginseng: this product is the dry root of panax araliaceae plant.Sweet in the mouth, micro-hardship, warm in nature；Return liver, stomach warp；Dissipating blood stasis stops blooding,
Subduing swelling and relieving pain.
Radix Glycyrrhizae: this product is the dry root of glycyrrhizic legume, Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L..Sweet in the mouth, property is put down；GUIXIN, lung,
Spleen, stomach warp；Invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription.
The prescription analysis of medicament composing prescription of the present invention:
Medicament composing prescription of the present invention is with Herba Portulacae and Myrrha as monarch drug, and dissipating blood stasis stops blooding, detumescence and promoting granulation, cooling blood for hemostasis；With Radix Notoginseng, breast
Perfume, Radix Et Rhizoma Rhei, Moschus and Herba Taraxaci are classified as ministerial drug, change blood removing blood stasis, promoting blood circulation and stopping pain, dispersing swelling and dissipating binds；With Flos Lonicerae, Radix Rehmanniae, Radix Ophiopogonis
Rattan, Radix Sanguisorbae, Cortex Phellodendri, Fructus Forsythiae and the Fructus Sophorae are adjuvant drug, heat-clearing and toxic substances removing, wind-heat dissipating, promoting blood circulation and cooling blood, and heat clearing and damp drying is promoted the production of body fluid and moisturized；With
Radix Glycyrrhizae for making 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, dissipate
The stasis of blood is stopped blooding, and promoting blood circulation and cooling blood and effect of heat-clearing and toxic substances removing have the most significant therapeutic effect to hemorrhoid.
The present invention also provides for corresponding manufacturing process and this Chinese medicine is facilitated easy-to-use one-tenth ensureing to make on the premise of curative effect
Product preparation.
The preparation method of described Chinese medicine composition mainly comprises the steps that
(1) taking Herba Portulacae, the Radix Rehmanniae, the Fructus Sophorae, Fructus Forsythiae, Radix Sanguisorbae and Herba Taraxaci, adding volumetric concentration by 4-9 times of medical material gross weight is
The ethanol solution of 60%-95%, reflux, extract, 2-3 time, return time is 2-5h, merging filtrate, filtrate recycling ethanol, concentrating under reduced pressure
To 60-65 DEG C of environment, relative density is the extractum of 1.20-1.25, drying under reduced pressure, crosses 80-100 mesh sieve, soaked after pulverizing
Cream fine powder；
(2) extracting honeysuckle, Moschus, Cortex Phellodendri, Caulis Lonicerae, Radix Et Rhizoma Rhei, Olibanum, Myrrha, Radix Notoginseng and Radix Glycyrrhizae, is broken into coarse powder, crosses 80-100
Mesh sieve, mixes with extractum fine powder, stirs, obtain Chinese medicine composition.
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 of the present invention shows, Chinese medicine composition of the present invention is used for treating hemorrhoid to be had
Significantly improve the effect of rectum vein permeability；Clinical trial displays that, it is total that Chinese medicine composition of the present invention is used for treating hemorrhoid
Effective percentage reaches 93.33%, and therapeutic effect is significantly higher than positive control drug MAYINGLONG MUSK HEMORRHOID UNGUENTUM, and Chinese medicine composition of the present invention is controlled
Therapeutic effect is notable, can use as medicine for treaching hemorrhoie, and 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 complete
Face, it is possible to obtaining 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
The embodiment of the present invention 1 Chinese medicine composition is mainly prepared from by the raw material of following parts by weight: Herba Portulacae 28 parts, Myrrha 26
Part, Radix Notoginseng 19 parts, Olibanum 17 parts, Radix Et Rhizoma Rhei 15 parts, 14 parts of Moschus, Herba Taraxaci 18 parts, Flos Lonicerae 13 parts, Radix Rehmanniae 10 parts, Radix Ophiopogonis
9 parts of rattan, Radix Sanguisorbae 11 parts, Cortex Phellodendri 8 parts, Fructus Forsythiae 10 parts, the Fructus Sophorae 7 parts and 6 parts of Radix Glycyrrhizae.
Preparation method is as follows:
(1) take Herba Portulacae, the Radix Rehmanniae, the Fructus Sophorae, Fructus Forsythiae, Radix Sanguisorbae and Herba Taraxaci, by 7 times of addition volumetric concentrations of medical material gross weight be
The ethanol solution of 80%, reflux, extract, 3 times, return time is 2h, merging filtrate, and filtrate recycling ethanol is evaporated to 60 DEG C of rings
Under border, relative density is the extractum of 1.20, drying under reduced pressure, crosses 100 mesh sieves, obtain extractum fine powder after pulverizing；
(2) extracting honeysuckle, Moschus, Cortex Phellodendri, Caulis Lonicerae, Radix Et Rhizoma Rhei, Olibanum, Myrrha, Radix Notoginseng and Radix Glycyrrhizae, is broken into coarse powder, crosses 100 mesh
Sieve, mixes with extractum fine powder, stirs, 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
The embodiment of the present invention 2 Chinese medicine composition is mainly prepared from by the raw material of following parts by weight: Herba Portulacae 36 parts, Myrrha 32
Part, Radix Notoginseng 25 parts, Olibanum 22 parts, Radix Et Rhizoma Rhei 21 parts, 19 parts of Moschus, Herba Taraxaci 24 parts, Flos Lonicerae 18 parts, Radix Rehmanniae 15 parts, Radix Ophiopogonis
12 parts of rattan, Radix Sanguisorbae 14 parts, Cortex Phellodendri 11 parts, Fructus Forsythiae 15 parts, the Fructus Sophorae 12 parts and 13 parts of Radix Glycyrrhizae.
Preparation method is with embodiment 1.
Embodiment 3
The embodiment of the present invention 3 Chinese medicine composition is mainly prepared from by the raw material of following parts by weight: Herba Portulacae 29 parts, Myrrha 30
Part, Radix Notoginseng 23 parts, Olibanum 20 parts, Radix Et Rhizoma Rhei 20 parts, 18 parts of Moschus, Herba Taraxaci 18 parts, Flos Lonicerae 15 parts, Radix Rehmanniae 13 parts, Radix Ophiopogonis
11 parts of rattan, Radix Sanguisorbae 12 parts, Cortex Phellodendri 9 parts, Fructus Forsythiae 10 parts, the Fructus Sophorae 8 parts and 12 parts of Radix Glycyrrhizae.
Preparation method is as follows:
(1) take Herba Portulacae, the Radix Rehmanniae, the Fructus Sophorae, Fructus Forsythiae, Radix Sanguisorbae and Herba Taraxaci, by 8 times of addition volumetric concentrations of medical material gross weight be
The ethanol solution of 85%, reflux, extract, 3 times, return time is 2h, merging filtrate, and filtrate recycling ethanol is evaporated to 60 DEG C of rings
Under border, relative density is the extractum of 1.20, drying under reduced pressure, crosses 100 mesh sieves, obtain extractum fine powder after pulverizing；
(2) extracting honeysuckle, Moschus, Cortex Phellodendri, Caulis Lonicerae, Radix Et Rhizoma Rhei, Olibanum, Myrrha, Radix Notoginseng and Radix Glycyrrhizae, is broken into coarse powder, crosses 100 mesh
Sieve, mixes with extractum fine powder, stirs, 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
The embodiment of the present invention 4 Chinese medicine composition is mainly prepared from by the raw material of following parts by weight:
Herba Portulacae 33 parts, Myrrha 29 parts, Radix Notoginseng 22 parts, Olibanum 19 parts, Radix Et Rhizoma Rhei 18 parts, 17 parts of Moschus, Herba Taraxaci 22 parts, Flos Lonicerae
16 parts, Radix Rehmanniae 13 parts, Caulis Lonicerae 10 parts, Radix Sanguisorbae 12 parts, Cortex Phellodendri 10 parts, Fructus Forsythiae 13 parts, the Fructus Sophorae 9 parts and 9 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 0.3g/ml, 0.2g/ml and 0.1g/ml, standby.Take 3 groups of rats, be labeled as A group high dose group (dosage 0.9g/
Kg), middle dosage group (dosage 0.6g/kg) and low dose group (dosage 0.3g/kg), high dose group concentration is the medicine of 0.3g/ml
Thing suspension, middle dosage group concentration is the drug suspension of 0.2g/ml, and low dose group concentration is that the medicine of 0.1g/ml mixes
Suspension, modeling according to dosage drop rectum with drug every day 2 times in first 2 days, it is stained with medicine with 10mg cotton balls, cotton balls is filled in internal rectum, under
Secondary when being administered, should first check whether internal rectum has cotton balls (should take out if any cotton balls), last administration should be 2 little after modeling
Time.
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 0.3g/ml with water, takes 1 group of rat, modeling presses 0.9g/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 ＞ 0.01；Compare with model control group, drug 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；
(5) 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 (5) 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.
2, get rid of and reject 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 180 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 90 examples, 20 ~ 58 years old age, 37 years old mean age.Two groups of patients exist
The influence factor such as sex, age, sick kind, state of an illness distribution, through statistical procedures, there was no significant difference, meets 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 4 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 62.22%, and cure-remarkable-effectiveness rate is more than 80%.
The total effective rate of pharmaceutical composition of the present invention is 93.33%, is significantly higher than the total effective rate 77.78% of comparison medicine, it was demonstrated that the present invention
Traditional Chinese medicine composition for treating effect is notable, can use as medicine for treaching hemorrhoie, and clinical generalization value is high.
Claims (5)
1. the Chinese medicine composition purposes in preparing medicine for treaching hemorrhoie, it is characterised in that described Chinese medicine composition former
Material weight portion as follows: Herba Portulacae 28-36 part, Myrrha 26-32 part, Radix Notoginseng 19-25 part, Olibanum 17-22 part, Radix Et Rhizoma Rhei 15-21 part,
Moschus 14-19 part, Herba Taraxaci 18-24 part, Flos Lonicerae 13-18 part, Radix Rehmanniae 10-15 part, Caulis Lonicerae 9-12 part, Radix Sanguisorbae 11-14
Part, Cortex Phellodendri 8-11 part, Fructus Forsythiae 10-15 part, Fructus Sophorae 7-12 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 in described
The weight portion of the raw material of drug composition is as follows: Herba Portulacae 28 parts, Myrrha 26 parts, Radix Notoginseng 19 parts, Olibanum 17 parts, Radix Et Rhizoma Rhei 15 parts, Moschus moschiferous
Fragrant 14 parts, Herba Taraxaci 18 parts, Flos Lonicerae 13 parts, Radix Rehmanniae 10 parts, Caulis Lonicerae 9 parts, Radix Sanguisorbae 11 parts, Cortex Phellodendri 8 parts, Fructus Forsythiae 10 parts,
The Fructus Sophorae 7 parts and 6 parts of Radix Glycyrrhizae.
3. Chinese medicine composition purposes in preparing medicine for treaching hemorrhoie as claimed in claim 1, it is characterised in that in described
The weight portion of the raw material of drug composition is as follows: Herba Portulacae 36 parts, Myrrha 32 parts, Radix Notoginseng 25 parts, Olibanum 22 parts, Radix Et Rhizoma Rhei 21 parts, Moschus moschiferous
Perfume 19 parts, Herba Taraxaci 24 parts, Flos Lonicerae 18 parts, Radix Rehmanniae 15 parts, Caulis Lonicerae 12 parts, Radix Sanguisorbae 14 parts, Cortex Phellodendri 11 parts, Fructus Forsythiae 15
Part, the Fructus Sophorae 12 parts and 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 in described
The weight portion of the raw material of drug composition is as follows: Herba Portulacae 33 parts, Myrrha 29 parts, Radix Notoginseng 22 parts, Olibanum 19 parts, Radix Et Rhizoma Rhei 18 parts, Moschus moschiferous
Perfume 17 parts, Herba Taraxaci 22 parts, Flos Lonicerae 16 parts, Radix Rehmanniae 13 parts, Caulis Lonicerae 10 parts, Radix Sanguisorbae 12 parts, Cortex Phellodendri 10 parts, Fructus Forsythiae 13
Part, the Fructus Sophorae 9 parts and 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 comprises the following steps:
(1) taking Herba Portulacae, the Radix Rehmanniae, the Fructus Sophorae, Fructus Forsythiae, Radix Sanguisorbae and Herba Taraxaci, adding volumetric concentration by 4-9 times of medical material gross weight is
The ethanol solution of 60%-95%, reflux, extract, 2-3 time, return time is 2-5h, merging filtrate, filtrate recycling ethanol, concentrating under reduced pressure
To 60-65 DEG C of environment, relative density is the extractum of 1.20-1.25, drying under reduced pressure, crosses 80-100 mesh sieve, soaked after pulverizing
Cream fine powder；
(2) extracting honeysuckle, Moschus, Cortex Phellodendri, Caulis Lonicerae, Radix Et Rhizoma Rhei, Olibanum, Myrrha, Radix Notoginseng and Radix Glycyrrhizae, is broken into coarse powder, crosses 80-100
Mesh sieve, mixes with extractum fine powder, stirs, obtain Chinese medicine composition.
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| CN105362718A (en) * | 2015-11-18 | 2016-03-02 | 暨南大学 | Folium artemisiae argyi-containing traditional Chinese medicine composition for treating hemorrhoid and preparation method thereof |
| CN105412392A (en) * | 2015-12-07 | 2016-03-23 | 叶宗耀 | Traditional Chinese medicinal composition for treating hemorrhoids and preparation method of traditional Chinese medicinal composition |
| CN105412621A (en) * | 2015-12-12 | 2016-03-23 | 杨献美 | Method for preparing pharmaceutical composition for treating hemorrhoids |
| CN105343578A (en) * | 2015-12-12 | 2016-02-24 | 杨献美 | Medicine composition for treating haemorrhoids |
| CN105477283A (en) * | 2015-12-29 | 2016-04-13 | 贵州万济堂药业有限公司 | Traditional Chinese medicine composition for treating haemorrhoids and preparation method of traditional Chinese medicine composition |
| CN105920169A (en) * | 2016-06-22 | 2016-09-07 | 朱明浩 | Traditional Chinese medicine composition for treating haemorrhoids, external preparation, and preparation method and application thereof |
| CN107890489A (en) * | 2017-12-20 | 2018-04-10 | 王于法 | A kind of traditional Chinese herb medicine for treating hemorrhoid and preparation method thereof |
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| CN101152325A (en) * | 2007-09-18 | 2008-04-02 | 尹克山 | Traditional Chinese medicine for treating various hemorrhoids gall |
| CN101744822B (en) * | 2008-12-14 | 2011-03-23 | 鲁南制药集团股份有限公司 | Medicinal composition for treating hemorrhoids |
| CN101919860B (en) * | 2009-06-12 | 2011-11-30 | 鲁南制药集团股份有限公司 | Medicine composite containing pentoxifyllinum and diclofenac and application thereof |
| CN103830686B (en) * | 2014-03-25 | 2016-03-09 | 青岛华之草医药科技有限公司 | A kind of Chinese medicine composition for the treatment of hemorrhoid and uses thereof |
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