CN105194039B - A kind of Chinese medicine composition, the preparation containing the Chinese medicine composition and its preparation and application - Google Patents
A kind of Chinese medicine composition, the preparation containing the Chinese medicine composition and its preparation and application Download PDFInfo
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- CN105194039B CN105194039B CN201510675019.0A CN201510675019A CN105194039B CN 105194039 B CN105194039 B CN 105194039B CN 201510675019 A CN201510675019 A CN 201510675019A CN 105194039 B CN105194039 B CN 105194039B
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Abstract
The invention discloses a kind of Chinese medicine compositions, the application comprising its external preparation and preparation method thereof and in the drug of preparation treatment hemorrhoid and/or postoperative complication after surgery on hemorrhoid, belong to the field of Chinese medicines.The Chinese medicine composition is mainly made by the medicinal material of following weight parts: 1~4 part of Cortex Phellodendri, 1~4 part of lamiophlomis rotata, 1~2 part of catechu.Chinese medicine composition disclosed by the invention has obvious therapeutic action to hemorrhoid and its postoperative complications, and toxic side effect is low, clinical use more safe ready, and medical expense is low.
Description
Technical field
The present invention relates to the field of Chinese medicines more particularly to a kind of Chinese medicine compositions, the preparation containing the Chinese medicine composition and its system
Standby and application.
Background technique
Tcm theory thinks that hemorrhoid are due to experiencing perverse trend, damp invasion of lower energizer large intestine, the retardance of enteron aisle mechanism of qi, hemostasis shape
At；Or raw in eating and drinking without temperance heat toxin, tenesmus large intestine.And then damp and hot, heat toxin is mutually fought with blood, stagnation of blood stasis and heat, internal organs have void in addition, therefore
With the passing of time it is formed.As " danxi's experiential therapy " is described: " hemorrhoid person, all because of this void of internal organs, wound rheumatism, interior intrinsic heat poison ... ... is with event qi and blood
Tenesmus, ties poly- anus, and place is stagnant not to be dissipated, and conflicting is hemorrhoid." it is also likely to be due to damp invasion of lower energizer, fissure in ano or operation on anus
Afterwards, cult poison is invaded, and leads to that qi and blood is unsmooth or heat toxin compels blood downlink, stasis, which does not dissipate, to be formed.To the Chinese medicine treatment methods of hemorrhoid compared with
More, common diagnosis and prescription is as follows: (1) ailment said due to cold or exposure presss from both sides heat type, and therapy is clearing heat and cooling blood, and wind-dispelling is moisturized；(2) damp heat downward flowing type, therapy
For clearing heat and promoting diuresis；(3) sinking of QI due to deficiency of the spleen type, therapy are that tonifying Qi liter mentions；(4) deficiency of qi and blood type, therapy are qi-blood tonifying.Although hemorrhoid produce
Raw etiology and pathogenesis is complicated, and card type is different, but mostly damp invasion of lower energizer, and blood vessels are unsmooth, and accumulates in simultaneous heat toxin, compels the absurd row of blood and causes
Haemorrhoids swelling and pain or even bleeding inside and outside anus.Therefore heat-clearing and damp-drying drug, purging fire for removing toxin, removing blood stasis and hemostasis, swelling and pain relieving are answered in treatment.
The drug therapy of hemorrhoid can take orally, outstanding suitable local topical.Householder method is more simultaneously, including changes diet knot
Structure is drunk more water, mostly into dietary fiber, holding free movement of the bowels, avoid diarrhea, warm water hip bath, keep perineum cleaning etc..In addition to non-hand
Art (mainly drug) treatment, it is clinical that operative treatment also may be selected.Present Most scholars think that 90% or more hemorrhoid patient can
With row non-operative treatment, surgical operation therapy must not be needed then only less than 10% hemorrhoid patient.Therefore traditional Chinese medicine is selected
Part is wide with adaptation range, but clinical optional drug is limited, therefore there is an urgent need to more multipotencys for treating in hemorrhoid
Medicine preparation meets hemorrhoid patients demand, slows down slight illness, reduces medical expenses.
The Chinese traditional medicine composition for being used to treat postoperative complication after surgery on hemorrhoid comprising Tibet medicine lamivphlomis root is crossed there is presently no document report
Object also crosses the Chinese traditional medicine composition comprising Tibet medicine lamivphlomis root that can be used to treat hemorrhoid and its postoperative complications simultaneously without document report
Object.
Summary of the invention
Technical problem to be solved by the invention is to provide a kind of active constituent content height, the Chinese medicine composition that curative effect is better
And preparation method thereof.
Another technical problem to be solved by this invention is to provide the preparation and preparation method thereof containing the Chinese medicine composition.
Third technical problem to be solved by this invention be to provide the preparation containing the Chinese medicine composition treatment hemorrhoid and/
Or the application in postoperative complication after surgery on hemorrhoid.
To solve the above problems, on the one hand, the present invention provides a kind of Chinese medicine composition, by weight by following medicinal materials
It is made: 1 ~ 4 part of lamiophlomis rotata, 1 ~ 4 part of Cortex Phellodendri, 1 ~ 2 part of catechu.
Preferably, the Chinese medicine composition is made by following medicinal materials by weight: 1 ~ 4 part of lamiophlomis rotata, 2 ~ 4 parts of Cortex Phellodendri,
1 ~ 2 part of catechu.
It is highly preferred that the Chinese medicine composition is made by following medicinal materials by weight by weight: 2 parts of lamiophlomis rotata, Cortex Phellodendri 2
Part, 1 part of catechu.
On the other hand, the present invention provides a kind of preparation method of Chinese medicine composition as described above, wherein above-mentioned lamiophlomis rotata makes
With water extract-alcohol precipitation method extraction purification；Above-mentioned Cortex Phellodendri is extracted using percolation.
In another aspect, the present invention provides a kind of external preparation, including Chinese medicine composition as described above, and pharmaceutically may be used
The auxiliary material of receiving.
In one embodiment of the invention, the external preparation is solid-like preparation, the semisolid for cavity/canal drug administration
Shape preparation, lotion or irrigation.
Preferably, the solid-like preparation for cavity/canal drug administration is suppository or gelling agent, and half for cavity/canal drug administration consolidates
Body shape preparation is ointment.
In one embodiment of the invention, the pharmaceutically acceptable auxiliary material be mixed fatty glycerides,
One of PEG4000~PEG6000 or S-40 or a variety of.
In one embodiment of the invention, the suppository or the drugloading rate of gelling agent are 33%~55%.
In another aspect, the present invention provides a kind of preparation method of above-mentioned external preparation, comprising the following steps:
(1) lamiophlomis rotata, Cortex Phellodendri, catechu are weighed by weight；
(2) it prepares common lamiophlomis root extract: the water of 6 ~ 10 times of its quality being added in lamiophlomis rotata medicinal material, decoct and extract 1 ~ 3 time,
0.5 ~ 1.5h every time merges medical fluid, filtering, obtains filtrate；It is 1.05 ~ 1.20 that the filtrate decompression, which is concentrated into 60 DEG C of relative densities,
Clear cream is cooled to room temperature, and addition ethyl alcohol makes after alcohol content reaches 60%-80% in clear cream, stands 10 ~ 14h, draws alcohol precipitation supernatant
Liquid, is concentrated under reduced pressure into the thick paste that 60 DEG C of relative densities are 1.25 ~ 1.30, which gets dry extract through being dried under reduced pressure to get lamiophlomis rotata
Extract, it is spare；
(3) it prepares phellodendron extract: Cortex Phellodendri pulverizing medicinal materials being soaked with 50%~80% ethanol solution, then use Cortex Phellodendri medicine
Percolate is collected in 50%~80% ethanol solution seepage pressure effects 12~48 hours of 8~20 times of material amount amounts；Percolate is concentrated under reduced pressure
To the thick paste that 60 DEG C of relative densities are 1.25 ~ 1.30, which, which is dried under reduced pressure, gets dry extract to get phellodendron extract, spare；
(4) respectively by the common lamiophlomis root extract that step (2) obtains and phellodendron extract and catechu powder that step (3) obtains
It is broken, be added pharmaceutically acceptable auxiliary material, conventional method preparation to get.
In another aspect, the present invention provides any one of the above Chinese medicine composition or the external application system containing the Chinese medicine composition
Application of the agent in the drug of preparation treatment hemorrhoid and/or postoperative complication after surgery on hemorrhoid.
Cortex Phellodendri property is bitter, cold in the traditional chinese medicine composition of the invention, and row heat-clearing and damp-drying drug, the power of purging fire for removing toxin are to effect a permanent cure in side
Monarch drug in a prescription；Lamiophlomis rotata bitter, temperature with its dry yellow water (clearing away the dampness and heat), and have the benefits of activating blood circulation and reducing swelling, analgesic, hemostasis, as ministerial drug；
Catechu is bitter, puckery, cool, has effects that promoting blood circulation, hemostasis, hygroscopic sore, assists Cortex Phellodendri heat-clearing and damp-drying drug, purging fire for removing toxin with it, and only one
The benefits of taste promoting blood circulation, hemostasis, make for assistant.Three taste compatibilities are synergistic for treating hemorrhoid, play heat-clearing and damp-drying drug, purging intense heat solution jointly
Poison, removing blood stasis and hemostasis, swelling and pain relieving effect.And be lesion local use, it can more improve curative effect.
Cortex Phellodendri is extracted obtains percolation extract for one of Chinese medicine composition crude drug of the present invention.Cortex phellodendri total alkaloid by utilizing mentions
Taking method includes acidic aqueous solution extraction method, alkaline aqueous solution extraction method, ethanol extraction method, ultrasonic extraction, Microwave Extraction
Method, Enzymatic Extraction method, semi-bionic extraction etc. are a variety of.From enterprise practical situation, most often selection alcohol reflux and sour water seep
It filters extraction.Ethanol refluxing process extraction efficiency is suitable with sour water Soakage extraction efficiency, but it is big to consume energy, high production cost.Percolation is
Traditional Traditional Chinese medicine extraction method, its simple process and low cost, no pollution to the environment, securely and reliably.Traditional diacolation method is with acidity
Aqueous solution is Extraction solvent, but because Cortex Phellodendri contains a large amount of mucilaginous substances, acidic aqueous solution can damage cells wall, dissolve out mucilaginous substance,
Increase diacolation difficulty.The present inventor is improved on the basis of traditional percolation, takes ethyl alcohol as solvent seepage pressure effects
Cortex Phellodendri effective component.
One of Chinese medicine composition crude drug of the present invention lamiophlomis rotata is extracted to obtain water extract-alcohol precipitation extract.Water extract-alcohol precipitation
Method (water alcohol method) means that in Chinese medicine water extracting liquid, ethyl alcohol, which is added, to be made up to different alcohol contents, and the ingredient insoluble in cold ethyl alcohol is such as
The Precipitation from solution such as starch, natural gum, mucilaginous substance, protein enables the method that Aqueous extracts refine after separation of solid and liquid.
There are suppository and two kinds of gelling agent for the solid-like preparation of cavity/canal drug administration.The wherein customary preparation methods of suppository are as follows: take
Suppository auxiliary material sets heating and melting in water-bath, is down to about 50 DEG C to temperature, drug (such as Chinese medical extract) fine powder is added by several times,
It stirs evenly rapidly to close and coagulates, cooling in injection bolt mould, solidification strikes off, demoulds to obtain the final product.The customary preparation methods of gelling agent are as follows: card taking
Wave nurse is added in appropriate purified water, and stirring makes to be swollen, and sodium sulfite and propylene glycol stirring and dissolving is added, and stirring is lower to be added dropwise three ethyl alcohol
Amine, is made gel-type vehicle, separately takes drug (such as Chinese medical extract) fine powder and ethyl hydroxy benzoate to be dissolved in ethyl alcohol, is added with stirring
In gel-type vehicle, stir evenly to obtain the final product.
Half for cavity/canal drug administration can be made by conventional method in the traditional chinese medicine composition of the invention with pharmaceutically acceptable auxiliary material
Solid-like preparation, such as ointment.
Lotion can be made by conventional method with pharmaceutically acceptable auxiliary material in the traditional chinese medicine composition of the invention, i.e., for cleaning nothing
The liquid preparation of damaged skin or cavity.
Irrigation can be made by conventional method with pharmaceutically acceptable auxiliary material in the traditional chinese medicine composition of the invention, i.e., for rushing
Wash the sterile solution of open wound or cavity.
Compared with the prior art, the present invention has the following advantages:
1, Chinese medicine composition of the present invention is drafted according to traditional Chinese medical theory, and drug effect is clear, significant effect, to hemorrhoid and its
Postoperative complications have obvious therapeutic action.Therapeutic effect to hemorrhoid: animal efficacy test is the results show that Chinese medicine of the invention
Composition can significantly inhibit mouse ear swelling caused by dimethylbenzene, can fight with the rat paw inflammation swelling caused by Irish moss,
Have the function of the abdominal cavity azovan blue exudation for inhibiting acetic acid inflammatory model mouse, there is certain hemostasis to make mouse docking
With.Therapeutic effect to postoperative complication after surgery on hemorrhoid: hemorrhoid postoperative curative effect observation indicate that, the suppository comprising the Chinese medicine composition
To the curative effect in terms of postoperative edema, rectal tenesmus with too peaceful suppository without significant difference, but effect is better than in terms of analgesia, hemostasis
Too peaceful suppository, the not in due course curative effect for being accordingly used in alleviating anal operation of postop. are more excellent.
2, the Chinese materia medica preparation such as horse of the commercially available treatment hemorrhoid of Chinese medicine composition (containing only three taste medicines) of the present invention and part
Imperial acne cream/bolt (containing ten taste medicines) is answered to compare, flavour of a drug are less, while animal toxicity test is the result shows that the Chinese medicine composition is anxious
Property, long-term toxic side effect it is low, clinical observation result show hemorrhoid it is postoperative safe and reliable.
3, one of Chinese medicine composition crude drug of the present invention Cortex Phellodendri is extracted obtains percolation extract, the seepage pressure effects
Simple process, at low cost, extraction efficiency is high, no pollution to the environment, safe and reliable, is uniquely mentioned using ethyl alcohol as solvent diacolation
The phellodendron extract effective component obtained is high；Lamiophlomis rotata is extracted obtains water extract-alcohol precipitation for one of described Chinese medicine composition crude drug
Extract, the water extract-alcohol precipitation extraction process not only enables the effective components such as flavonoids, iridoids retain, but also alcohol precipitation
Step further eliminates big molecular impurity, reduces solid content, so that common lamiophlomis root extract active constituent content ratio increases,
Reach purification purpose；It is verified repeatedly, Cortex Phellodendri seepage pressure effects technique, lamiophlomis rotata aqueous extraction-alcohol precipitation technology and the packet that the present invention announces
Suppository stable preparation process containing the Chinese medicine composition is feasible and process cycle is short, is suitable for expanding production, is conducive to Chinese Medicine Industry
Change, creates economic benefit.
4, the Chinese medicine suppository drugloading rate comprising the Chinese medicine composition that the present invention announces is big, compliance is good, saves drug, life
Object availability is high, toxic side effect is small；Suppository local application, drug can go directly lesion simultaneously, not by gastrointestinal tract pH or enzyme
It destroys and loses activity, and reduce drug by the destruction of liver first-pass effect, remain to the maximum extent each in Chinese medicine composition
The effective component of flavour of a drug can preferably play curative effect of medication.
Specific embodiment
Embodiment 1
It prepares Chinese medicine composition to be formulated with medicinal material: 2 parts of lamiophlomis rotata, 2 parts of Cortex Phellodendri, 1 part of catechu.
Embodiment 2
It prepares Chinese medicine composition to be formulated with medicinal material: 4 parts of lamiophlomis rotata, 4 parts of Cortex Phellodendri, 1 part of catechu.
Embodiment 3
It prepares Chinese medicine composition to be formulated with medicinal material: 2 parts of lamiophlomis rotata, 4 parts of Cortex Phellodendri, 1 part of catechu.
Embodiment 4
It prepares Chinese medicine composition to be formulated with medicinal material: 1 part of lamiophlomis rotata, 3 parts of Cortex Phellodendri, 2 parts of catechu.
Embodiment 5
It prepares Chinese medicine composition to be formulated with medicinal material: 1 part of lamiophlomis rotata, 1 part of Cortex Phellodendri, 1 part of catechu.
In Examples 1 to 5, Cortex Phellodendri medicinal material, lamiophlomis rotata medicinal material, catechu medicinal material are purchased from Gansu lamiophlomis rotata bio-pharmaceuticals share
Maqu branch company of Co., Ltd, it is identified, meet under one Cortex Phellodendri medicinal material item of page 286~287 of " Chinese Pharmacopoeia " version in 2010
Regulation, meets and provides under one lamiophlomis rotata medicinal material item of page 245~246 of " Chinese Pharmacopoeia " version in 2010, meet " Chinese Pharmacopoeia "
It is provided under the one catechu medicinal material item of page 9~10 of version in 2010.
Embodiment 6 includes the preparation method of the suppository of the Chinese medicine composition of embodiment 1
(1) lamiophlomis rotata, Cortex Phellodendri, catechu are weighed by weight；
(2) it prepares common lamiophlomis root extract: the water of 8 times of its quality being added in lamiophlomis rotata medicinal material, decoct extraction 2 times, every time
1h merges medical fluid, filtering, obtains filtrate；The filtrate decompression is concentrated into the clear cream that 60 DEG C of relative densities are 1.10, is cooled to room
Temperature, addition ethyl alcohol make after alcohol content reaches 70% in clear cream, stand 14h, draw alcohol precipitation supernatant, be concentrated under reduced pressure into 60 DEG C it is opposite
The thick paste that density is 1.25, which, which is dried under reduced pressure, gets dry extract to get common lamiophlomis root extract, spare；
(3) it prepares phellodendron extract: Cortex Phellodendri pulverizing medicinal materials being soaked with 60% ethanol solution, then use Cortex Phellodendri quality of medicinal material
Percolate is collected in 60% ethanol solution seepage pressure effects 48 hours of 20 times of amounts；The percolate be concentrated under reduced pressure to give 60 DEG C it is relatively close
Degree is 1.25 thick pastes, which, which is further dried under reduced pressure, gets dry extract to get phellodendron extract, spare；
(4) common lamiophlomis root extract that step (2) obtains and phellodendron extract and catechu that step (3) obtains are crushed respectively
To most fine powder, intermediate cream powder is obtained；
(5) by 36 type of auxiliary material mixed fatty glycerides, 75 DEG C of heating water baths to melting, then addition step (4) is obtained
Intermediate cream powder, makes its drugloading rate reach 45%, stirs evenly, and when being cooled to 55 DEG C, is poured into bolt mould, solid at -2 ~ 5 DEG C
Change 10 minutes, prune and overflow part, suppository is made after being demoulded, being cooled to room temperature.
Embodiment 7 includes the preparation method of the suppository of the Chinese medicine composition of embodiment 2
(1) lamiophlomis rotata, Cortex Phellodendri, catechu are weighed by weight；
(2) prepare common lamiophlomis root extract: the water of 6 times of its quality being added in lamiophlomis rotata medicinal material, decoct extraction 3 times, every time
1.5h merges medical fluid, filtering, obtains filtrate；The filtrate decompression is concentrated into the clear cream that 60 DEG C of relative densities are 1.05, is cooled to room
Temperature, addition ethyl alcohol make after alcohol content reaches 60% in clear cream, stand 10h, draw alcohol precipitation supernatant, be concentrated under reduced pressure into 60 DEG C it is opposite
The thick paste that density is 1.25, which, which is dried under reduced pressure, gets dry extract to get common lamiophlomis root extract, spare；
(3) prepare phellodendron extract: Cortex Phellodendri pulverizing medicinal materials being soaked with 80% ethanol solution, then use Cortex Phellodendri quality of medicinal material 8
Percolate is collected in 80% ethanol solution seepage pressure effects 48 hours of amount again；The percolate is concentrated under reduced pressure to give 60 DEG C of relative densities
For 1.30 thick pastes, which, which is further dried under reduced pressure, gets dry extract to get phellodendron extract, spare；
(4) common lamiophlomis root extract that step (2) obtains and phellodendron extract and catechu that step (3) obtains are crushed respectively
To fine powder, intermediate cream powder is obtained；
(5) by 75 DEG C of heating water baths of auxiliary material PEG4000 to melting, the intermediate cream powder that step (4) obtain then is added,
So that its drugloading rate is reached 55%, stir evenly, when being cooled to 45 DEG C, be poured into bolt mould, solidifies 8 minutes at -2 ~ 5 DEG C, prune
Part is overflowed, suppository is made after being demoulded, being cooled to room temperature.
Embodiment 8 includes the preparation method of the suppository of the Chinese medicine composition of embodiment 3
(1) lamiophlomis rotata, Cortex Phellodendri, catechu are weighed by weight；
(2) prepare common lamiophlomis root extract: the water of 10 times of its quality being added in lamiophlomis rotata medicinal material, decoct and extract 1 time, 1.5h,
Medical filtration obtains filtrate；The filtrate decompression is concentrated into the clear cream that 60 DEG C of relative densities are 1.20, is cooled to room temperature, and adds second
Alcohol makes after alcohol content reaches 80% in clear cream, stands 14h, draws alcohol precipitation supernatant, and being concentrated under reduced pressure into 60 DEG C of relative densities is 1.30
Thick paste, which, which is dried under reduced pressure, gets dry extract to get common lamiophlomis root extract, spare；
(3) prepare phellodendron extract: Cortex Phellodendri pulverizing medicinal materials being soaked with 70% ethanol solution, then use Cortex Phellodendri quality of medicinal material
Percolate is collected in 70% ethanol solution seepage pressure effects 12 hours of 16 times of amounts；The percolate be concentrated under reduced pressure to give 60 DEG C it is relatively close
Degree is 1.25 thick pastes, which, which is further dried under reduced pressure, gets dry extract to get phellodendron extract, spare；
(4) common lamiophlomis root extract that step (2) obtains and phellodendron extract and catechu that step (3) obtains are crushed respectively
To impalpable powder, intermediate cream powder is obtained；
(5) by 65 DEG C of heating water baths of auxiliary material S-40 to melting, the intermediate cream powder that step (4) obtain then is added, makes it
Drugloading rate reaches 33%, stirs evenly, and when being cooled to 55 DEG C, is poured into bolt mould, solidifies 12 minutes at -2 ~ 5 DEG C, prunes excessive
Suppository is made in part out after being demoulded, being cooled to room temperature.
Embodiment 9 includes the preparation method of the suppository of the Chinese medicine composition of embodiment 4
(1) lamiophlomis rotata, Cortex Phellodendri, catechu are weighed by weight；
(2) prepare common lamiophlomis root extract: the water of 10 times of its quality being added in lamiophlomis rotata medicinal material, decoct extraction 3 times, every time
0.5h merges medical fluid, filtering, obtains filtrate；The filtrate decompression is concentrated into the clear cream that 60 DEG C of relative densities are 1.08, is cooled to room
Temperature, addition ethyl alcohol make after alcohol content reaches 60% in clear cream, stand 10h, draw alcohol precipitation supernatant, be concentrated under reduced pressure into 60 DEG C it is opposite
The thick paste that density is 1.27, which, which is dried under reduced pressure, gets dry extract to get common lamiophlomis root extract, spare；
(3) prepare phellodendron extract: Cortex Phellodendri pulverizing medicinal materials being soaked with 50% ethanol solution, then use Cortex Phellodendri quality of medicinal material
Percolate is collected in 50% ethanol solution seepage pressure effects 12 hours of 16 times of amounts；The percolate be concentrated under reduced pressure to give 60 DEG C it is relatively close
Degree is 1.25 thick pastes, which, which is further dried under reduced pressure, gets dry extract to get phellodendron extract, spare；
(4) common lamiophlomis root extract that step (2) obtains and phellodendron extract and catechu that step (3) obtains are crushed respectively
To fine powder, intermediate cream powder is obtained；
(5) by 70 DEG C of heating water baths of auxiliary material PEG6000 to melting, the intermediate cream powder that step (4) obtain then is added,
So that its drugloading rate is reached 40%, stir evenly, when being cooled to 55 DEG C, be poured into bolt mould, solidifies 12 minutes at -2 ~ 5 DEG C, cut
It goes to overflow part, suppository is made after being demoulded, being cooled to room temperature.
Embodiment 10 includes the preparation method of the suppository of the Chinese medicine composition of embodiment 5
(1) lamiophlomis rotata, Cortex Phellodendri, catechu are weighed by weight；
(2) prepare common lamiophlomis root extract: the water of 10 times of its quality being added in lamiophlomis rotata medicinal material, decoct extraction 2 times, every time
1h merges medical fluid, filtering, obtains filtrate；The filtrate decompression is concentrated into the clear cream that 60 DEG C of relative densities are 1.10, is cooled to room
Temperature, addition ethyl alcohol make after alcohol content reaches 70% in clear cream, stand 12h, draw alcohol precipitation supernatant, be concentrated under reduced pressure into 60 DEG C it is opposite
The thick paste that density is 1.30, which, which is dried under reduced pressure, gets dry extract to get common lamiophlomis root extract, spare；
(3) prepare phellodendron extract: Cortex Phellodendri pulverizing medicinal materials being soaked with 60% ethanol solution, then use Cortex Phellodendri quality of medicinal material
Percolate is collected in 60% ethanol solution seepage pressure effects 24 hours of 20 times of amounts；The percolate be concentrated under reduced pressure to give 60 DEG C it is relatively close
Degree is 1.30 thick pastes, which, which is further dried under reduced pressure, gets dry extract to get phellodendron extract, spare；
(4) common lamiophlomis root extract that step (2) obtains and phellodendron extract and catechu that step (3) obtains are crushed respectively
To most fine powder, intermediate cream powder is obtained；
(5) by 36 type of auxiliary material mixed fatty glycerides, 70 DEG C of heating water baths to melting, step (4) is then added and obtain
Intermediate cream powder, so that its drugloading rate is reached 40%, stir evenly, when being cooled to 45 DEG C ~ 55 DEG C, be poured into bolt mould, -2
~ 5 DEG C solidify 10 minutes, prune and overflow part, and suppository is made after being demoulded, being cooled to room temperature.
Drugloading rate calculation method in embodiment 6~10 are as follows: drug quality/(drug quality+load powder protonatomic mass) ×
100%, wherein the quality of drug quality, that is, step (4) " intermediate cream powder ", carries powder protonatomic mass, that is, auxiliary material quality.
11 pharmacodynamics test of embodiment
Result of the suppository of Chinese medicine composition comprising Examples 1 to 5 announcement in animal efficacy test is close, therefore only
With suppository made from Chinese medicine composition described in embodiment 1, the method as described in embodiment 6 (hereinafter referred to as lamiophlomis rotata suppository)
For illustrate animal efficacy test result.
Following tests example, except illustrating, test animal is mentioned by Sichuan Provincial Academy of Traditional Chinese Medicine SPF Experimental Animal Center
For.Following tests example, except illustrating, test data is indicated with x ± s, and each administration group is examined compared between control group using t
It tests, carries out data point with " Chinese medicine encyclopedia Medical Statistics " statistical package (third edition) PEMS3.1 analysis software
Analysis.
Following tests example, test suppository: lamiophlomis rotata suppository, 1.6g/, every 2.5g containing crude drug, room temperature, closed, screening
Light, kept dry；Blank suppository are as follows: milky suppository, 1.6g/, every 0g containing crude drug, room temperature, closed, shading, dry guarantor
It deposits.
(1) lamiophlomis rotata suppository paraxylene causes the influence of Mice Auricle inflammation swelling:
1. test material:
Animal: KM outbreeding system small white mouse, SPF grades, all-male, 18 ± 2g of weight, totally 60.
Tested material: lamiophlomis rotata suppository, blank suppository.
Positive control drug: prednisone acetate tablets (prednisone), 5mg/ piece, Zhejiang Province XianJu Pharmacy stock Co., Ltd's production,
Lot number: 080901.
Tragacanth: England import packing, 500g/ bottles, lot number: 91-01-08.
Modeling agent: dimethylbenzene, 500ml/ bottles, Chengdu Ke Long chemical reagent factory, lot number: 20051103.
Laboratory apparatus: BS110S electronic balance (d=0.1mg), Beijing Sai Duolisi balance Co., Ltd, 6.5mm punching
Device.
2. test method:
60 male mices of all-male are randomly divided into 5 groups, dimethylbenzene model control group (24 μ l/10g of blank suppository), only one
Taste suppository high dose group (4g crude drug/kg), lamiophlomis rotata suppository middle dose group (2 g crude drugs/kg), lamiophlomis rotata suppository low dose group (1
G crude drug/kg), positive drug prednisone acetate group (50mg/kg).The solution of blank bolt grain melting is smeared in model group auris dextra portion, tested
The medical fluid that medicine group is melted respectively at the lamiophlomis rotata bolt grain that various dose is smeared in auris dextra portion, continuous 5 days.Positive drug, prednisone acetate
Group is in experiment the 4th day, difference gastric infusion 1 time on the 5th, 0.1ml/10g(0.5mg/ml).
The scorching experiment same day is caused, the oral administration of prednisone acetate group, corresponding dosage lamiophlomis rotata bolt is smeared in reagent group auris dextra portion
The solution of blank bolt grain melting is smeared in the medical fluid of grain melting, model group auris dextra portion, and 60min after administration, warm water is wiped residual on auris dextra
The medical fluid stayed, then dimethylbenzene is uniformly smeared on each group mouse right ear exterior feature two sides, and every 20 μ l, cervical dislocation is put to death small after 15 minutes
Mouse, left and right two ear under auricle edge scissor, 6.5mm punch lay auricle weighing, subtract left auricle weight with auris dextra sheet weight
It measures to get swelling is arrived, and calculates ear swelling inhibiting rate.
3. test result (referring to table 1):
The influence (X ± SD) of 1 lamiophlomis rotata suppository paraxylene of table cause mouse ear swelling
Note: compared with model group, p < 0.001 * * p < 0.01, * * *.
Compared with model group, high, medium and low dosage group of lamiophlomis rotata suppository or so ear weight difference substantially reduce (P < 0.01, P <
0.05), swelling inhibiting rate is respectively 51.4%, 45.5%, 30.2%；The extremely significant reduction of prednisone acetate group or so ear weight difference (P <
0.001), swelling inhibiting rate is respectively 54.5%.
(2) lamiophlomis rotata suppository effect on capillary permeability of abdominal cavity in mice:
1. test material: animal: KM outbreeding system small white mouse, SPF grades, all-male, 18 ± 2g of weight, totally 60.
Tested material: lamiophlomis rotata suppository, blank suppository.
Positive control drug: aspirin, White crystal body, the production of Datong District Changxing Pharmaceutical Co, national drug standard
HI4020657, lot number: 0704004, the date of manufacture: on April 7th, 2007, validity period cause in March, 2010.
Modeling agent: glacial acetic acid, 500ml/ bottles, the Chengdu mayor joins chemical reagent Co., Ltd, lot number: 20050301.
Depilatory agent: vulcanized sodium, analysis is pure, and 500g/ bottles, the production of Chengdu chemical reagent factory, lot number: 980923.
Indicator: Evan's Blue, Evans Blue, Sigma reagent, lot number: 2062425.
Laboratory apparatus: spectrophotometer (Japanese Shimadzu uv-730)；Centrifuge (the medical centrifugation factory in Beijing, LDZ4-0.8).
2. test method:
All-male mouse after abdomen is lost hair or feathers is randomly divided into 5 groups, acetic acid model group (24 μ L/10g of blank suppository), lamiophlomis rotata
(1g is raw for suppository high dose group (4g crude drug/kg), lamiophlomis rotata suppository middle dose group (2g crude drug/kg), lamiophlomis rotata suppository low dose group
Medicine/kg), positive drug aspirin group (300mg/kg).Every group 12.Reagent group distinguishes only one that abdomen smears various dose
Medical fluid after the melting of taste bolt grain, is then covered with gauze, immobilization with adhesive tape after external application preservative film package.Model group abdomen smears blank
Solution after the melting of bolt grain, the same administration group of subsequent processing mode, one time a day, continuous 5 days.The oral administration of positive drug aspirin,
0.1ml/10g (30mg/ml), one time a day, continuous 5 days.
Method of acetic acid causes the preparation and dosage regimen of scorching model: mouse is deprived of food but not water 16h before testing, and precise mouse is empty
Abdomen weight.After the oral 60min of positive drug aspirin, after each reagent group abdomen topical application of drug 60min, 2% Yi Wensi of tail vein injection
0.75% acetic acid 0.2ml/ is injected intraperitoneally only in blue normal saline solution 0.1ml/10g immediately after, after 20min, at bloodletting of breaking end
Dead mouse, syringe to mouse peritoneal injecting normal saline 5ml/ only, gently rub abdomen it is several under, open abdominal cavity, collect abdominal cavity washing
Liquid is centrifuged 5min (1000rpm), is returned to zero with physiological saline in test tube, and extinction is measured at uv-730 spectrophotometer 590nm
Degree.Each administration group is calculated to the inhibiting rate of Evans blue seepage discharge.
3. test result (referring to table 2):
2 lamiophlomis rotata suppository effect on capillary permeability of abdominal cavity in mice (X ± S) of table
The inhibiting rate of the abdominal cavity azovan blue exudation of the high, medium and low dosage group Dichlorodiphenyl Acetate inflammatory model mouse of lamiophlomis rotata suppository
Respectively 21.8%, 19.9%, 8.4%, wherein high dose group 4g crude drug/kg, abdominal cavity washing lotion OD value and model group subtract than more significant
Small (p<0.05), in, low dose group abdominal cavity washing lotion OD value also reduced compared with model group, but p>0.05, no difference of science of statistics.
Lamiophlomis rotata suppository has the abdominal cavity azovan blue transudation for inhibiting acetic acid inflammatory model mouse, but dose-dependant closes
It is unobvious.
(3) influence of the lamiophlomis rotata suppository to rat carrageenan foot swelling:
1. test material:
Animal: SD rat, SPF grades, all-male, 250 ~ 300g of weight, totally 60.
Tested material: lamiophlomis rotata suppository, blank suppository.
Positive control drug: prednisone acetate tablets, 5mg/ piece, Zhejiang Province XianJu Pharmacy stock Co., Ltd, lot number: 080801.
Tragacanth: England import packing, 500g/ bottles, lot number: 91-01-08.
Modeling agent: CARRAGEENAN (Irish moss), 25g/ bottles, SIGMA, lot number: 46H0910.
Laboratory apparatus: PV-200 vola pedis capacity measurer, Chengdu TME Technology Co., Ltd..EB-3200D electronic balance (d
=0.01g), Japanese SHIMADZU.New classic electronic balance, MS204S(d=0.1mg), plum Teller-support benefit instrument
(Shanghai) Co., Ltd..
2. test method:
60 all-male rats are randomly divided into 5 groups by weight: (4g is raw for Irish moss model group, lamiophlomis rotata suppository high dose group
Medicine/only), lamiophlomis rotata suppository middle dose group (2g crude drug/only), lamiophlomis rotata suppository low dose group (1g crude drug/only), positive control vinegar
Sour prednisone group (10mg/kg).Reagent group smears the lamiophlomis rotata bolt of various dose respectively at right vola pedis (including between toe web)
Medical fluid after grain melting, model group are then smeared the solution after the melting of blank bolt grain, then will be wrapped enough with dressing.Daily
1 time, continuous 5 days, for positive controls rat in testing the 1st day, 3 days, 5 days, prednisone acetate 1ml/100g(1mg/ was given in stomach-filling
Ml it) 1 time, is administered 3 times altogether.
Irish moss method causes the preparation and anti-inflammatory experiment same day dosage regimen of scorching model: positive controls stomach-filling is given acetic acid and is sprinkled
Buddhist nun is loose, the right foot plantar smearing blank suppository of lamiophlomis rotata suppository, model group is smeared in the right foot plantar of reagent group, and after 30min, each group is big
Mouse successively right 1% 0.1ml/ modeling of Irish moss solution of metapedes plantar subcutaneous injection, after measuring modeling with dedicated vola pedis capacity measurer
Vola pedis volume after 1h, 2h, 3h, 4h, 5h, 6h cause scorching rat swelling right.
Each mouse swelling degree of the paw, each administration group swelling inhibiting rate are calculated with following formula.
3. test result (referring to table 3, table 4):
The influence (X ± S) of 3 lamiophlomis rotata suppository Carrageenan of table cause rat paw edema
Note: compared with model group, p < 0.001 * p < 0.05, * * p < 0.01, * * *.
The influence of 4 lamiophlomis rotata suppository Carrageenan of table cause rat paw edema inhibiting rate
Groups of animals 1h, 2h, 3h pedal swelling rate is in rising trend；4h, 5h, 6h pedal swelling rate are on a declining curve.With
Model group compares, and lamiophlomis rotata suppository high dose group 2h, 3h, 4h, 5h pedal swelling rate significantly reduces, and inhibiting rate is respectively 19.70
%,16.93 %,17.39 %,23.72 %；Middle dose group 3h, 4h pedal swelling rate significantly reduces, and inhibiting rate is respectively 16.79
%,16.32%；Low dose group pedal swelling rate has decreasing trend, no difference of science of statistics；Prednisone acetate group 2h, 3h, 4h, 5h, 6h
The extremely significant reduction of pedal swelling rate, inhibiting rate are respectively 41.28%, 43.01%, 60.10%, 70.86%, 78.16 %.
The above results show that lamiophlomis rotata suppository has the function of rat paw inflammation swelling caused by fighting Irish moss.
(4) influence of the lamiophlomis rotata suppository to the mouse bleeding time:
1. test material:
Animal: KM outbreeding system small white mouse, SPF grades, half male and half female, 18 ~ 22g of weight, totally 50.
Tested material: lamiophlomis rotata suppository, blank suppository.
Positive control drug: Adenaron piece (adrenobazonum), specification: 2.5mg/ piece, 100 pieces/bottle, Jiangsu Ya Bangaipusen
Pharmaceutcal corporation, Ltd produces, lot number: 1010074.
Tragacanth: England import packing, 500g/ bottles, lot number: 91-01-08.
Test apparatus: goldspink board electronic stopclock J9-2 II, Shanghai No.5 Watch Factory；EB-3200D electronic balance (d=0.01g),
Japanese SHIMADZU.
2. test method:
Mouse is randomly divided into 5 groups, blank control group, lamiophlomis rotata suppository high (4g crude drug/kg), in (2g crude drug/kg), low
Dosage group (4g crude drug/kg), positive drug Adenaron group (15mg/kg).Every group 10, half male and half female.Blank control group is small
Blank suppository solution is smeared in rat-tail portion, and reagent group mouse distinguishes the lamiophlomis rotata suppository that various dose is smeared in tail portion, one time a day,
Continuous 5 days, the administration of positive drug adrenobazonum group intragastric administration on mice, 0.1ml/10g (2mg/ml), one time a day, continuous 5 days.
On the day of last dose, 60 minutes after positive drug oral administration, after reagent group is applied with administration 2 hours, drug is wiped
It gently smoothes out with the fingers tens of times, is then cut at Mouse Tail-tip about 0.5cm with sharp scissors, from blood from mouse tail root to tail point immediately afterwards
Liquid starts timing when flowing out naturally, gently suffers drop of blood edge with filter paper every half a minute and sucks blood once, until drop of blood cannot be drawn onto again
Until, stopwatch timing.
3. test result (referring to table 5):
Influence (X ± SD) of the 5 lamiophlomis rotata suppository of table to the mouse docking bleeding time
Note: compared with model group, p < 0.001 * p < 0.05, * *.
Compared with blank suppository control group, the lamiophlomis rotata suppository high dose group mouse docking bleeding time is significantly reduced；Middle dose
The amount group mouse docking bleeding time has the tendency that centainly reducing, no difference of science of statistics；Low dose group is compared with the control group without obvious
Difference；The adrenobazonum group mouse docking bleeding time significantly reduces.
Lamiophlomis rotata suppository high dose 4g crude drug/only, 40 times of quasi- clinical dosage are equivalent to, has and significantly inhibits small
The effect of mouse bleeding time.
12 the traditional chinese medicine composition of the invention toxicity test of embodiment
(hereinafter referred to as solely with suppository made from Chinese medicine composition described in embodiment 1, the method as described in embodiment 6
Suppository simply) for illustrate animal toxicity test.
(1) long term toxicity test:
Test pharmaceutical composition of the present invention are as follows: lamiophlomis rotata suppository, sets dry yin by 1.54 g/, every 2.5g containing crude drug
Cool storage, avoids high temperature and direct sunlight, and 4 DEG C of refrigerators are spare.
Experimental animal: Japan large ear rabbit: weight 1.8 ~ 2.3kg, 90, half male and half female, experimental animal production licence
Number: the river SCXK() 2008-14, the offer of farm of experimental animal special commission of Sichuan Province, quarantine 1 week.
Experimental enviroment: rabbit cage body product is 48 × 38 × 32cm, and room temperature is kept for 20 ~ 24 DEG C, relative humidity 50 ~ 70%.Daylight
Lamp illumination, 12 hours light and dark.Self-timing ventilation, 10 time/hour of frequency of taking a breath.Rabbit particulate material, Sichuan Province
Farm of experimental animal special commission provides.
Test grouping: according to Radix Lamiophlomidis Rotatae capsule (national drug standard Z10970053,1g crude drug/grain, Gansu lamiophlomis rotata biology system
Medicine limited liability company) 180 days oral administration long term toxicity test results of infective use and preclinical rat (28g crude drug/
Kg or less dosage safety), dosage, high, medium and low dosage are arranged using load concentration identical as clinical preparation, different dosing volume
Respectively 1.54g crude drug/kg, 0.77g crude drug/kg, 0.385g crude drug/kg.Be equivalent to human body recommend dosage (0.75g crude drug/
Man day) 123 times, 61.6 times, 30.8 times.
Test method: blank control group, matrix control group, the high, medium and low dosage of lamiophlomis rotata suppository are randomly divided by weight
Group, every group of 18 animals, half male and half female.Groups of animals according to dosage takes medical fluid (clinical preparation load concentration) after suppository thermosol respectively
According to rabbit weight catheter rectum inject administration, kept for 2 hours after drug enema.It is administered daily 1 time, continuous 30 days, is discontinued
Restore 15.
During test, the general status of groups of animals is observed daily；1 weight is measured weekly；1 food ration is surveyed weekly；
Being administered terminates to terminate to take respectively with convalescence 60,30 animals (half male and half female) progress hematologies, blood biochemistries detections for 30 days,
Impose the histopathological examination that system postmortem and respective organization or organ are carried out after being euthanized.
Main detection, testing result are as follows:
General status: during test, the autonomic activities of groups of animals are normal, mental status is good, the cleaning of skin coat, not
See that other signs of toxicity occur.
Weight and food ration: during test, groups of animals weight and food ration are shown no obvious abnormalities.
Hematology and blood biochemistry: each dosage group hematology of lamiophlomis rotata suppository and blood biochemistry indices are shown no obvious abnormalities.
Histopathology: groups of animals is visible by naked eyes lesion.30 days each groups and convalescence each group part rabbit is administered
Liver portal area occur cell infiltration, and kidney interstitial has stove inflammatory cell infiltration, and lesion degree is lighter, and incidence is low,
Blank control group also has identical lesion, and each group compares, without apparent Histopathology difference.Be administered 30 days blank control groups and
There is lung, bladder focal infection lesion in the individual rabbit of convalescence blank control group, and disease incidence is low, and seen above is that rabbit is common certainly
Morbidity becomes.Therefore, pathological change caused by the toxic effect for drug can be excluded.
In conclusion under this experimental condition, the lamiophlomis rotata suppository 1.54g crude drug/continuous rectum of the rabbit of kg or less dosage 30 days
Administration has no toxicity.
(2) acute toxicity test:
Test the traditional chinese medicine composition of the invention are as follows: same to long term toxicity test.
Experimental animal: Japanese white big ear rabbit: weight 1.8 ~ 2.3kg, 12, half male and half female, experimental animal production permit
Card number: the river SCXK() 2008-14, the offer of farm of experimental animal special commission of Sichuan Province, quarantine 1 week.
Experimental enviroment: same to long term toxicity test.
Test grouping: according to Radix Lamiophlomidis Rotatae capsule (national drug standard Z10970053,1g crude drug/grain, Gansu lamiophlomis rotata biology system
Medicine limited liability company) extract powder Mouse oral gastric infusion LD50For 69.39g/kg, it is approximately equivalent to the 462.6 of people's dosage
Times, referring to " Chinese medicine, natural drug studies on acute toxicity technological guidance principle ", using lamiophlomis rotata suppository clinical preparation medical fluid, most
Large volume administration, carries out the measurement of family's rabbit rectum maximum dosage-feeding, and dosage is 3.08g crude drug/kg/ days.Matrix pair is set respectively
According to group, lamiophlomis rotata suppository group, every group 8, half male and half female.
Test method: administration group test dose is calculated by crude drug weight, tests medication preparation method: lamiophlomis rotata suppository, is used
Distilled water is made into 0.375g/ml(and is equivalent to 12.5g crude drug/ml) solution of concentration, volume 4ml/kg, dosage is
3.08g crude drug/kg/ days, matrix control group give isometric matrix suppository.
It is observed continuously after administration 14 days, observes animal general status daily, measure weight, food ration weekly.Observation terminates
Carry out major blood, blood biochemistry detection.Macroscopical anatomy inspection is carried out after imposing euthanasia and Main Organ Coefficients are surveyed
It is fixed.
Main detection, testing result are as follows:
Lamiophlomis rotata suppository medical fluid rabbit rectally group and distilled water control animals upon administration in 14 day observation period not
See death, general status is good, and body weight increase is normal；Major blood, blood biochemistry no abnormality seen change after administration 14 days；Substantially
Each Organ size, form, color, quality etc. is dissected and observed and is showed no abnormal change relevant to test sample.
In conclusion giving 3.08g crude drug/kg/ days or less dosage lamiophlomis rotata suppository medical fluid, rectum under this experimental condition
Administration rabbit has no acute toxic reaction.
According to the above test result it can be extrapolated that the traditional chinese medicine composition of the invention has therapeutic effect, acute, long-term poison to hemorrhoid
Side effect is low, and clinical use is convenient and safe.
13 the traditional chinese medicine composition of the invention of embodiment (suppository) treats the observation of hemorrhoid postoperative curative effect
1 case selection:
(1) hemorrhoid Western medicine diagnostic criteria:
1. it is intermittent just when podex bleeding, show as stool band blood, dye paper, bleed or penetrate blood.
2. after stool or fatigue, having outside cystic mass abjection anus, self-resetting or manipulative reduction capable of being needed or be not capable of resetting.
3. podex foreign body sensation does not accommodate pain with falling inflation.
4. show color cystic mass on tooth trace, before being common in the right side, it is right after, left side, surface mucosa is congested, rotten to the corn or have fiber
Change lesion.
5. mulberry cystic mass at anal canal and anus edge, or burst subcutaneous hematoma or thrombosis.
(2) TCM syndrome diagnostic criteria:
1. stagnancy of wind and heat is demonstrate,proved
Main symptom: archorrhagia when stool, color is scarlet, and severe one blood goes out such as arrow；Tongue is red, veins string.
Secondary card: anus is itched bitterly, inhibited defecation.
2. syndrome of stagnant and jamming dampness-heat
Main symptom: anus swelling, when stool, bleed, and the red tongue fur of tongue is greasy, slippery.
Secondary card: dry throat with a bitter taste, loss of appetite are just done or constipated, and urine color is yellow.
3. deficiency of blood dystrophy is demonstrate,proved
Main symptom: bleeding when long-term stool, color is light, pale tongue, and tongue fur is thin white, and arteries and veins is thin and delicate.
Secondary card: having a dizzy spell, palpitaition tinnitus, lusterless complexion, limbs fatigue, insomnia and dreamful sleep.
4. the deficiency of vital energy is not demonstrate,proved admittedly
Main symptom: haemorrhoids is deviate from when just, difficult runback, and anus tenesmus, pale tongue, tongue fur is thin white, weak pulse.
Secondary card: heartbeat shortness of breath, spiritlessness and weakness, spontaneous perspiration, loss of appetite.
Diagnosis can be made by having two persons of above-mentioned main symptom two and secondary card.
(3) standard is included in:
Age 18 years old or more, 65 years old or less；Mixed hemorrhoid post-operative hospital patient；Patient volunteer participant.
(4) exclusion criteria:
Hemorrhoid merge perianal abscess, anal fistula, rectal polyp, rectum carcinoma or enteric infection disease patient；Gestation is fed
Newborn phase women；Allergic constitution and to a variety of drug allergy persons；Patient is unwilling partner.
(5) reject, fall off and stop testing standard:
It rejects: although the case for not meeting the standard of being included in and being accidentally included in and meeting the standard of being included in and not taking medicine after being included in
Case.
It falls off: meeting the standard of being included in because certain reason does not complete the case of research, belong to the case that falls off.It includes subject
Voluntarily exit the case exited with doctor identification subject.The case to fall off must not exceed the 5% of total cases.More than 5%, need
Bright the reason of falling off；More than 10%, research conclusion is insincere.
The reason of rejecting falls off: subject's compliance is poor, subject voluntarily exits case has not been provided by research approach
At case, serious adverse events, complication and special physiological variation occurs should not continue to receive the case of research.
The disposition of 2 cases:
(1) case is grouped
Each daily crude drug dosage 5g for the treatment of group, a crude drug dosage 2.5g, 2 times a day.
Specific grouping situation: treatment group 1, the lamiophlomis rotata suppository as made from embodiment 1, embodiment 6,30；Treatment group
2, the lamiophlomis rotata suppository as made from embodiment 2, embodiment 7,30；Treatment group 3, as made from embodiment 3, embodiment 8
Lamiophlomis rotata suppository, 30；Treatment group 4, the lamiophlomis rotata suppository as made from embodiment 4, embodiment 9,30；Treatment group 5, passes through
Lamiophlomis rotata suppository made from embodiment 5, embodiment 10,30；Control group, too peaceful bolt, 30.180 observation cases are by random
Single blind principle grouping, the subject number of each processing group such as table 6:
The subject number of each processing group of table 6
(2) intervening measure
Treatment group (T): lamiophlomis rotata suppository in treatment.
1. usage and dosage: rectum, which is included in, through anus after cleaning anus daily uses suppository 2 times, each 1 time, 1 tablet/time sooner or later.
2. the course for the treatment of: just determining 7 days.
3. administration time: morning administration time should be arranged in from morning after defecation, should will be also administered as patient stool is irregular
Time arranges after defecation as far as possible, so that drug stops the time as long as possible in rectum.Evening administration time should fall asleep
Before.Patient fasts are pungent during treatment, stimulate food, eat dietary fiber more.Without other relevant treatments.
Control group (C): too peaceful bolt treatment
1. western medicine method: referring to Western medicine method used.
2. the course for the treatment of: referring to Western medicine method used.
3. administration time: referring to Western medicine method used.
(3) observation index
1. effect index and evaluation method: clinical symptoms and sign；Anoscopy, according to cardinal symptom before and after medication and body
Sign is described or scores according to light and heavy degree, judges curative effect.
Anus pain: the pain condition after medication in 1 to 5 day postoperative to patient records, scoring.Without pain record A, 0
Point；Mild pain record B, 2 points；Pain is more apparent, but can endure record C, and 4 points；Pain is obvious, it is difficult to and it endures and records D, 6 points.
Hematochezia: bleeding records after medication in 2 to 7 days postoperative to patient, scoring.No hematochezia record I, 0 point；Toilet paper
Band blood record II, 2 points；Stool band blood record III, 4 points；Hematochezia in sound of rain pattering shape even spurting record IV, 6 points.
Postoperative anus edge oedema: it to whether there is oedema to carry out data statistics after daily patient medication, is not described.
Crissum falling inflation: rise to whether occurring crissum pendant after daily patient medication and carry out data statistics, be not described.
2. safety indexes: whether there is or not the adverse reactions such as cusalgia, itch for I；Whether there is or not allergic reactions for II local skin.
3. index observation time point is selected as after aftertreatment 1 ~ 7 day.
4. clinical evaluation:
I data statistics (referring to table 7):
7 treatment group of table, control group data statistics
II therapeutic evaluation (referring to table 8)
8 treatment group of table, control group integral contrast (n)
Treatment group and control group pain integral contrast (n)=(treatment group's pain total mark-control group pain total mark)/right
According to a group pain total mark
Treatment group and control group hematochezia integral contrast (n)=(treatment group's hematochezia total mark-control group hematochezia total mark)/right
According to a group hematochezia total mark
To sum up experimental observation compare, statistical analysis, in terms of anus pain and hematochezia, treatment group analgesia, haemostatic effect
Better than control group；Oedema, equal no significant difference in terms of rectal tenesmus after surgery between each group；Do not occur adverse reaction between each group.
Conclusion is as follows: it is safe and reliable that ⑴Ge treatment group is postoperative for hemorrhoid；(2) ease pain after surgery, aspect of stopping blooding, control
Treatment group curative effect is better than the too peaceful bolt of control group；⑶Ge treatment group treatment postoperative edema, in terms of rectal tenesmus with the too peaceful bolt of control group
No significant difference.
14 stability study of embodiment is summarized:
With three batches of suppository samples made from Chinese medicine composition described in embodiment 1, the method as described in embodiment 6 quasi-
In keeping sample 36 months (25 DEG C ± 2 DEG C, relative humidity 60% ± 10%) for a long time and acceleration keeps sample 6 months (temperature 30 under commercially available back
DEG C ± 2 DEG C, relative humidity 65% ± 5%) study on the stability, character identifies, melts and become time limit, microbial limit, assay
Deng having no significant change, meet regulation.
Illustrate lamiophlomis rotata suppository of the present invention long-term 36 months, accelerate 6 months internal stabilities it is preferable.
Claims (10)
1. a kind of Chinese medicine composition, it is characterised in that: be made by weight by following medicinal materials: 1 ~ 4 part of lamiophlomis rotata, Cortex Phellodendri 1 ~ 4
Part, 1 ~ 2 part of catechu.
2. Chinese medicine composition as described in claim 1, it is characterised in that: be made by weight by following medicinal materials: lamiophlomis rotata 1
~ 4 parts, 2 ~ 4 parts of Cortex Phellodendri, 1 ~ 2 part of catechu.
3. Chinese medicine composition as described in claim 1, it is characterised in that: be made by weight by following medicinal materials: lamiophlomis rotata 2
Part, 2 parts of Cortex Phellodendri, 1 part of catechu.
4. the preparation method of the Chinese medicine composition as described in claims 1 to 3 any one, which is characterized in that the lamiophlomis rotata
Use water extract-alcohol precipitation method extraction purification；The Cortex Phellodendri is extracted using percolation.
5. a kind of external preparation, including Chinese medicine composition described in claims 1 to 3 any one and pharmaceutically acceptable
Auxiliary material.
6. external preparation as claimed in claim 5, which is characterized in that the external preparation is the solid-like system for cavity/canal drug administration
Agent, semi-solid preparation, irrigation；The solid-like preparation for cavity/canal drug administration be suppository or gelling agent, it is described to be given for cavity
The semi-solid preparation of medicine is ointment.
7. external preparation as claimed in claim 5, it is characterised in that: the pharmaceutically acceptable auxiliary material is fatty acid mixed
One of glyceride, PEG4000~PEG6000 or S-40 or a variety of.
8. external preparation as claimed in claim 6, it is characterised in that: the suppository or gelling agent drugloading rate are 33%~55%.
9. such as the preparation method of the described in any item external preparations of claim 5~8, comprising the following steps:
(1) lamiophlomis rotata, Cortex Phellodendri, catechu are weighed by weight；
(2) it prepares common lamiophlomis root extract: the water of 6 ~ 10 times of its quality being added in lamiophlomis rotata medicinal material, decoct extraction 1 ~ 3 time, every time
0.5 ~ 1.5h merges medical fluid, filtering, obtains filtrate；The filtrate decompression be concentrated into 60 DEG C of relative densities be 1.05 ~ 1.20 it is clear
Cream is cooled to room temperature, and addition ethyl alcohol makes after alcohol content reaches 60%-80% in clear cream, stands 10 ~ 14h, draws alcohol precipitation supernatant,
It is concentrated under reduced pressure into the thick paste that 60 DEG C of relative densities are 1.25 ~ 1.30, which, which is dried under reduced pressure, gets dry extract to get lamiophlomis rotata extraction
Object, it is spare；
(3) it prepares phellodendron extract: Cortex Phellodendri pulverizing medicinal materials being soaked with 50%~80% ethanol solution, then use Cortex Phellodendri medicinal material matter
50%~80% ethanol solution seepage pressure effects 12~48 hours of 8~20 times of amounts of amount, collect percolate；Percolate is concentrated under reduced pressure into 60
The thick paste that DEG C relative density is 1.25 ~ 1.30, which, which is dried under reduced pressure, gets dry extract to get phellodendron extract, spare；
(4) common lamiophlomis root extract that step (2) obtains and phellodendron extract and catechu that step (3) obtains are crushed respectively, is added
Enter pharmaceutically acceptable auxiliary material, conventional method preparation to get.
10. the external application as described in Chinese medicine composition, claim 5~8 any one as described in claims 1 to 3 any one
Application of the preparation in the drug of preparation treatment hemorrhoid and/or postoperative complication after surgery on hemorrhoid.
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| 熏洗疗法在痔、肛瘘、肛裂治疗中的应用进展;梁宏涛等;《辽宁中医杂志》;20111231;第38卷(第11期);第2295-2297页 |
| 独一味防治混合痔术后并发症的疗效研究;闵春明等;《中药药理与临床》;20101231;第26卷(第5期);第146-148页 |
| 藏药独一味对189例肛肠术后镇痛、止血及伤口愈合的疗效观察;尹玉锑;《甘肃中医》;20021231;第15卷(第3期);第74页 |
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Denomination of invention: A traditional Chinese medicine composition, a preparation containing the same, and its preparation and application Granted publication date: 20190118 Pledgee: Kangxian sub branch of industrial and Commercial Bank of China Ltd. Pledgor: KANGXIAN DUYIWEI BIOLOGICAL PHARMACEUTICAL Co.,Ltd. Registration number: Y2024980018052 |