CN106728628A - Treat the pharmaceutical composition of canker sore - Google Patents

Treat the pharmaceutical composition of canker sore Download PDF

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Publication number
CN106728628A
CN106728628A CN201611133220.7A CN201611133220A CN106728628A CN 106728628 A CN106728628 A CN 106728628A CN 201611133220 A CN201611133220 A CN 201611133220A CN 106728628 A CN106728628 A CN 106728628A
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ethanol
weight
pharmaceutical composition
percent concentration
extract
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不公告发明人
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Jinan Haoyu Qingtian Medicine Technology Co ltd
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Jinan Haoyu Qingtian Medicine Technology Co ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/575—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/11—Pteridophyta or Filicophyta (ferns)
    • A61K36/12—Filicopsida or Pteridopsida
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/89—Cyperaceae (Sedge family)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/55—Liquid-liquid separation; Phase separation

Abstract

Pharmaceutical composition of canker sore and preparation method thereof is treated the invention discloses a kind of, pharmaceutical composition of the present invention is with cucurbitacin L, dichotomous fimbristylis herb, Doryopteris concolor (Langsd et Fisch.) Kuhn as bulk drug, proportioning is formed, and routinely can be made various formulations by preparation process, and treatment canker sore is evident in efficacy.

Description

Treat the pharmaceutical composition of canker sore
Technical field
The invention belongs to technical field of traditional Chinese medicines, more particularly to a kind of pharmaceutical composition for treating canker sore and its preparation side Method.
Background technology
Recurrent oral ulceration belongs to traditional Chinese medicine aphtha, aphthous stomatitis category, and it occurs have close with the imbalance of heat evil, damp evil and internal organ Cut relation.Such as《The big opinion of Plain Questions gas alternation》Say：" year gold too late, people's disease aphtha that scorching fire is up ... ... ", illustrate have with heat evil Close.Spleen-QI connecting with mouth, overfeeding fatness, sweet, thick and oily usually, so that insufficiency of the spleen resulting in production of dampness, wet heap soil or fertilizer over and around the roots heat.Consumption of YIN caused by febrile disease or overstrain cause cloudy liquid not Foot, fire of deficiency type hot smoking oral cavity and send out aphtha.Damp evil stick it is greasy, should not speed go, therefore Blood of Patients with Recurrent Oral does not often recover for a long time.Near In year clinical practice, the author on the basis of dialectical, with reference to how hot, the how wet feature of Lingnan area and tcm theory " spleen master Muscle ", " spleen-QI connecting with mouth ", the spleen being blocked by dampness, the theory of insufficiency of the spleen resulting in production of dampness, it is understood that the cause of disease of Lingnan area recurrent oral ulceration Mostly heat evil, damp evil, while it was observed that, Blood of Patients with Recurrent Oral is simultaneous to see the hot hidrosis of body, restlessness and thirst, scanty drak urine, body The deficiency of both qi and yin performances such as tired few gas, lassitude, deficient and rapid pulse.Because heat is yang pathogens, easy gas consumption hinders Tianjin.Therefore Lingnan area The pathogenic characteristic of recurrent oral ulceration is " damp and hot long bridle, deficiency of both qi and yin ".Based on above-mentioned mechanism, establish with clearing away heat and eliminating dampeness, Recurrent oral ulceration is treated in nourishing yin and promoting granulation ruling by law.In treatment, the compound of clearing away heat and eliminating dampeness, nourishing yin and promoting granulation is constituted.Foundation《Interior warp》 " heat strongly fragrant and send out it ", the easily clear profit of damp evil, Yi Wenhua.
Cucurbitacin L（ Cucurbitacin L）：CAS 1110-02-7, molecular formula C30H44O7, molecular weight 516.67.【It is raw Thing activity】Antitumor (animal Ehrlich ascites carcinoma in vivo, increase in life span 38%~42%）, cell toxicant（KB in Vitro, ED50=0.01~0.1ug/ml, HeLa in vitro, ED50=0.1ug/ml）.【Ingredient origin】Cowbind Bryonia alba, squirting cucumber Ecballium elaterium, without tendril watermelon Citrullus ecirrhosus, coloquintida Citrullus colocynthis。
Dichotomous fimbristylis herb：It is Cyperaceae genus fimbristylis plant two qi dichotomous fimbristylis herb Fimbristylis dichotoma (L) Vahl [Scirpus dichotomus L.;S.annuus All.;Fimbristylis annua(All.)Roem.et Schult] Herb.Summer, autumn harvesting, clean, and dry.【Nature and flavor】It is lightly seasoned；It is cold in nature.【Return through】Kidney；Bladder warp.【Indication】Heat-clearing profit Urine；Removing toxic substances.Main difficult urination；Damp and hot edema；Gonorrhoea；Infant fetal toxin.【Chemical analysis】Containing dihydrocyperaquinone (dihydrooyperaqnone), tetrahydrocyperaquinone.(tetrahydrocyperaquinone), cyperaquinone (cyperapuinone), hydroxyl cyperaquinone (hydroxycyperapuinone), removes first cyperaquinone (demethylcyperapuinone).【Former phytomorph】Not tally dichotomous fimbristylis herb, draft.Stalk is grown thickly, 20-50cm high.Complete stool without Hair has thin pubescence.Leaf is linear, is shorter than stalk, and 1-2.5mm wide, tip is suddenly sharp or blunt；Sheath base portion keratin.Lobate bract under inflorescence 3-4, normal 1-2 pieces, is longer than inflorescence.Cyme is appeared again or simply；Small ear is avette or round shape long is avette, 5-12mm long, 2- wide 3mm, there is most flowers；Scale is avette or Long Circle, 2-2.5mm long, and sepia is glossy, there is 3-5 arteries and veins, and tip has short point；Stamen 2-3；Style is flat, and echinid is arranged at top；Column cap 2.Pyrene obovate wide, biconvex shape, 1-1.2mm long, white to filbert, Surface is grown crosswise circular reticulate pattern, and longitudinal rib 7-9 bars, significant protuberance has brown short handle.Flower, the fruiting period 7-10 months.Record in the big diction of Chinese medicine Allusion quotation.
Doryopteris concolor (Langsd et Fisch.) Kuhn：This product is Sinopteridaceae Doryopteris concolor (Langsd et Fisch.) Kuhn platymiscium Doryopteris concolor (Langsd et Fisch.) Kuhn Doryopteris concolor（Langsd. Et Fisch.）The herb of Kuhn [Pteris concolor Langsd. Et Fisch.].Summer, autumn harvesting, clean, and shine It is dry.【Nature and flavor】Slight bitter；It is puckery；It is cool.【Return through】Enter bladder, the warp of liver two.【Indication】Reducing fever and causing diuresis；Hemostasis.Main stranguria；Wound goes out Blood.【Chemical analysis】Leaf contains 22（29）- hopenen [hop-22（29）- ene], hopanol（hydroxyhopane）, 6,22- what Handkerchief glycol（zeorin）, freidelin（friedelin）, fern -9（11）- alkene [fern-9（11）- ene], squalene （squalene）.【Former phytomorph】Terrestrial pteridophyte, plant 20-35cm high.Rhizome is short and tiny, near upright, is draped over one's shoulders pin There is 1 chestnut black middle rib of thickness in shape scale, light brown, center.Leaf papery, fasciation, a type；Petiole, rachis and pinna rachis are bright Atropurpureus, petiole 6-24cm long is dredged by brown undercoat, and rear dipped beam is slided, and base portion is by scale；The nearly pentagon of blade, length and width are closely equal, 4-8cm, acumen, the wealthy heart-shaped or halberd shape of base portion, several to be split for third, central 1 wealthy rhombus, pinniform drastic crack, 3.5-5cm long is wide 2-4cm, base portion wealthy wedge shape is downward in rachis, and base portion 1 is maximum to pinnule, pinniform partly split or it is shallow split, side life accessory pinna triangle, 3-4.5cm long, 2.5-3.5cm wide, the downward wealthy wing downward with central 1 of base portion are connected, lower base pinnule speciality, pinniform Drastic crack, the 2nd pinnule has bastard, and remaining full edge, upside pinnule is short, full edge；Vein pinniform, scun dichotomy.Spore Sorus is distributed along sliver both sides of the edge, tip and incises infertility；Indusium full edge.Record in dictionary of medicinal plant.
1 bulk drug chemical constitution：
Cucurbitacin L（ Cucurbitacin L）.
The content of the invention
The purpose of the present invention is to overcome the shortcomings of background technology, there is provided a kind of pharmaceutical composition of effective treatment canker sore And preparation method thereof.
The present invention adopts the following technical scheme that realization：
The composition and weight portion for being made the bulk drug of the pharmaceutical composition of the treatment canker sore be：
Cucurbitacin L26-30 weight portion dichotomous fimbristylis herb 1280-1290 weight portion Doryopteris concolor (Langsd et Fisch.) Kuhn 840-846 weight portions.
The pharmaceutical composition for the treatment of canker sore is preferably used in, is made up of the bulk drug of following weight portion：
The weight portion of 1285 weight portion Doryopteris concolor (Langsd et Fisch.) Kuhn of cucurbitacin L28 weight portions dichotomous fimbristylis herb 843.
A kind of pharmaceutical composition for treating canker sore, it is characterised in that pharmaceutical composition can be using the routine of galenic pharmacy Method prepares piece agent or capsule or dripping pill.
A kind of pharmaceutical composition for treating canker sore, it is characterised in that pharmaceutical composition is constituted with chemical drugs or Chinese medicine Treatment stomatocace medicine.
A kind of preparation method of the pharmaceutical composition for treating canker sore, it is characterised in that prepare as follows：
The composition and weight portion of bulk drug be：Cucurbitacin L26-30 weight portion dichotomous fimbristylis herb 1280-1290 weight portion Doryopteris concolor (Langsd et Fisch.) Kuhns 840-846 weight portions；
Preparation method：
（1）Cucurbitacin L, dichotomous fimbristylis herb, Doryopteris concolor (Langsd et Fisch.) Kuhn are taken by bulk drug proportioning, is mixed, with the ethanol of weight percent concentration 33% as molten Agent, takes in 34.5 DEG C of temperature extractions, and extraction time is 7 times, and each extraction time is 2 hours, and each solvent load is that bulk drug is total 21 times of weight, filtration obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, is concentrated into relative density 1.11, filters, liquid By FU-01 large pore resin absorption columns, first wash with water, then it is big with the ethanol solution of weight percent concentration 44.5% wash-out FU-01 Macroporous adsorbent resin post, collects the ethanol eluate of weight percent concentration 44.5%, reclaims ethanol, and concentrate drying obtains final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 66% as solvent, heating and refluxing extraction 5 times is carried every time The time is taken for 1.8 hours, each solvent load is 13 times of dregs of a decoction A weight, and filtration obtains dregs of a decoction B and extract solution B, and extract solution B is returned Ethanol is received, relative density 1.06 is concentrated into, filtered, liquid is first washed with water, then use weight by DM2 large pore resin absorption columns The ethanol solution of percent concentration 77% elutes DM2 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 77%, Ethanol is reclaimed, concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
Preferred a kind of preparation method of the pharmaceutical composition for treating canker sore, it is characterised in that make as follows It is standby：
The composition and weight portion of bulk drug be：The weight portion of 1285 weight portion Doryopteris concolor (Langsd et Fisch.) Kuhn of cucurbitacin L28 weight portions dichotomous fimbristylis herb 843；
Preparation method：
（1）Cucurbitacin L, dichotomous fimbristylis herb, Doryopteris concolor (Langsd et Fisch.) Kuhn are taken by bulk drug proportioning, is mixed, with the ethanol of weight percent concentration 33% as molten Agent, takes in 34.5 DEG C of temperature extractions, and extraction time is 7 times, and each extraction time is 2 hours, and each solvent load is that bulk drug is total 21 times of weight, filtration obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, is concentrated into relative density 1.11, filters, liquid By FU-01 large pore resin absorption columns, first wash with water, then it is big with the ethanol solution of weight percent concentration 44.5% wash-out FU-01 Macroporous adsorbent resin post, collects the ethanol eluate of weight percent concentration 44.5%, reclaims ethanol, and concentrate drying obtains final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 66% as solvent, heating and refluxing extraction 5 times is carried every time The time is taken for 1.8 hours, each solvent load is 13 times of dregs of a decoction A weight, and filtration obtains dregs of a decoction B and extract solution B, and extract solution B is returned Ethanol is received, relative density 1.06 is concentrated into, filtered, liquid is first washed with water, then use weight by DM2 large pore resin absorption columns The ethanol solution of percent concentration 77% elutes DM2 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 77%, Ethanol is reclaimed, concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
A kind of preparation method of the pharmaceutical composition for treating canker sore, it is characterised in that pharmaceutical composition can be using system The conventional method of agent prepares piece agent or capsule or dripping pill.
A kind of preparation method of the pharmaceutical composition for treating canker sore, it is characterised in that pharmaceutical composition and chemical drugs or Chinese medicine composition treatment stomatocace medicine.
Medicine composite for curing canker sore is evident in efficacy.
Specific embodiment
Embodiment 1：Treat pharmaceutical composition of canker sore and preparation method thereof
Treat canker sore pharmaceutical composition bulk drug composition and weight portion be：Cucurbitacin L28g dichotomous fimbristylis herbs 1285g Doryopteris concolor (Langsd et Fisch.) Kuhn 843g；
Preparation method：
（1）Cucurbitacin L, dichotomous fimbristylis herb, Doryopteris concolor (Langsd et Fisch.) Kuhn are taken by bulk drug proportioning, is mixed, with the ethanol of weight percent concentration 33% as molten Agent, takes in 34.5 DEG C of temperature extractions, and extraction time is 7 times, and each extraction time is 2 hours, and each solvent load is that bulk drug is total 21 times of weight, filtration obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, is concentrated into relative density 1.11, filters, liquid By FU-01 large pore resin absorption columns, first wash with water, then it is big with the ethanol solution of weight percent concentration 44.5% wash-out FU-01 Macroporous adsorbent resin post, collects the ethanol eluate of weight percent concentration 44.5%, reclaims ethanol, and concentrate drying obtains final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 66% as solvent, heating and refluxing extraction 5 times is carried every time The time is taken for 1.8 hours, each solvent load is 13 times of dregs of a decoction A weight, and filtration obtains dregs of a decoction B and extract solution B, and extract solution B is returned Ethanol is received, relative density 1.06 is concentrated into, filtered, liquid is first washed with water, then use weight by DM2 large pore resin absorption columns The ethanol solution of percent concentration 77% elutes DM2 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 77%, Ethanol is reclaimed, concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
Embodiment 2：Treat pharmaceutical composition of canker sore and preparation method thereof
Treat canker sore pharmaceutical composition bulk drug composition and weight portion be：Cucurbitacin L26g dichotomous fimbristylis herbs 1290g Doryopteris concolor (Langsd et Fisch.) Kuhn 840g；
Preparation method：
（1）Cucurbitacin L, dichotomous fimbristylis herb, Doryopteris concolor (Langsd et Fisch.) Kuhn are taken by bulk drug proportioning, is mixed, with the ethanol of weight percent concentration 33% as molten Agent, takes in 34.5 DEG C of temperature extractions, and extraction time is 7 times, and each extraction time is 2 hours, and each solvent load is that bulk drug is total 21 times of weight, filtration obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, is concentrated into relative density 1.11, filters, liquid By FU-01 large pore resin absorption columns, first wash with water, then it is big with the ethanol solution of weight percent concentration 44.5% wash-out FU-01 Macroporous adsorbent resin post, collects the ethanol eluate of weight percent concentration 44.5%, reclaims ethanol, and concentrate drying obtains final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 66% as solvent, heating and refluxing extraction 5 times is carried every time The time is taken for 1.8 hours, each solvent load is 13 times of dregs of a decoction A weight, and filtration obtains dregs of a decoction B and extract solution B, and extract solution B is returned Ethanol is received, relative density 1.06 is concentrated into, filtered, liquid is first washed with water, then use weight by DM2 large pore resin absorption columns The ethanol solution of percent concentration 77% elutes DM2 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 77%, Ethanol is reclaimed, concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
Embodiment 3：Treat pharmaceutical composition of canker sore and preparation method thereof
Treat canker sore pharmaceutical composition bulk drug composition and weight portion be：Cucurbitacin L30g dichotomous fimbristylis herbs 1280g Doryopteris concolor (Langsd et Fisch.) Kuhn 846g；
Preparation method：
（1）Cucurbitacin L, dichotomous fimbristylis herb, Doryopteris concolor (Langsd et Fisch.) Kuhn are taken by bulk drug proportioning, is mixed, with the ethanol of weight percent concentration 33% as molten Agent, takes in 34.5 DEG C of temperature extractions, and extraction time is 7 times, and each extraction time is 2 hours, and each solvent load is that bulk drug is total 21 times of weight, filtration obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, is concentrated into relative density 1.11, filters, liquid By FU-01 large pore resin absorption columns, first wash with water, then it is big with the ethanol solution of weight percent concentration 44.5% wash-out FU-01 Macroporous adsorbent resin post, collects the ethanol eluate of weight percent concentration 44.5%, reclaims ethanol, and concentrate drying obtains final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 66% as solvent, heating and refluxing extraction 5 times is carried every time The time is taken for 1.8 hours, each solvent load is 13 times of dregs of a decoction A weight, and filtration obtains dregs of a decoction B and extract solution B, and extract solution B is returned Ethanol is received, relative density 1.06 is concentrated into, filtered, liquid is first washed with water, then use weight by DM2 large pore resin absorption columns The ethanol solution of percent concentration 77% elutes DM2 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 77%, Ethanol is reclaimed, concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
Embodiment 4：The preparation of tablet
The pharmaceutical composition 238g of Example 1, adds starch 255, mixes, and granulation is dried, plus microcrystalline cellulose 134g, stearic Sour magnesium 3g, mixes, and is pressed into 1400, obtains final product medicinal composition tablets.
Embodiment 5：The preparation of capsule
The pharmaceutical composition 237g of Example 2, adds starch 154g, mixes, and granulation is dried, whole grain, adds appropriate stearic acid Magnesium, mixes, and encapsulated 900, obtains final product medicament composition capsule.
Embodiment 6：The preparation of dripping pill
Weigh (80 DEG C) heating of Macrogol 6000 205g water-baths and boil molten, add the pharmaceutical composition 11g of embodiment 3, fully stir Mix uniform, with atoleine as cooling agent, put glass tube（4*80cm）In, chilling temperature is 1 DEG C, and drip internal-and external diameter is 7.0/ 2.0 (mm/mm), drip is 2.0cm away from liquid level, and drop speed is optimum condition with every point 51 drop, and the cold of dripping pill surface is blotted with cotton Solidifying agent, obtains final product medicament composition dropping pills.
Experimental example 1：Treat the experimental study of canker sore
1 clinical data
1.1 physical data
Include the Nian8Yue Wo of in October, 2010-2011 city's hospital outpatient patient 40, the course of disease 28 weeks~4.5 years.It is randomly divided into 2 groups. Treatment group 20, man 10, female 10；9~55 years old age, average (30.5 ± 12.5) year.Control group 20, man 10, Female 10；10~56 years old age, average (32.3 ± 11.8) year.2 groups of sexes, age, courses of disease are statistically analyzed, and difference is equal Without significant (P ＞ 0.05), with comparativity.
1.2 diagnostic criteria
Reference《Oral medicine》With《Practical oral》Relevant criterion.
1. minor aphtha：Ulcer is small and shallow, number is few, 1~3,1~2mm, and redness does not write, and neat in edge has blush, base Bottom is slightly concave flat, heals within general 7~10 days, and heal preventing from scar.
2. stomatitis aphtha：Also known as herpetic aphtha, ulcer table is shallow flat, in irregular shape, can by small rice grain size to Broad bean size, number is more can be merged into each other up to dozens of, have yellow to ooze out, and surrounding is congested substantially, scope is big, and pain is obvious.
3. periglandular aphtha：Also known as huge aphtha, ulcer is big and shallow in cratering, ulcer area can beat more than 1cm, often It is isolated to occur, can also occur simultaneously several, edge is raised substantially, and hyperemia does not write or significantly red, and the course of disease is long, indolence, up to 1 The moon, to the several months, leaves scar after healing.
1.3 Standards of Chinese Medical Syndrome Differentiation
Reference《New Chinese medicine guideline of clinical investigations (tentative)》Relevant criterion, primary symptom：Canker sore, spontaneous pain, excitation Bitterly.Secondary disease：It is simultaneous to see the deficiency of both qi and yin tables such as the hot hidrosis of body, restlessness and thirst, scanty drak urine, the tired few gas of body, lassitude, deficient and rapid pulse It is existing.Physical examination：Stomatocace contrafluxion oedema, skin surface oozes out pseudomembrane, and neat in edge substrate is flat, and ulcer is rounded Or it is oval, around have blush around.All to possess 3~5 persons in above primary symptom and secondary disease, i.e., dialectical is damp and hot long bridle, gas the moon Two asthenic symptoms types.
1.4 exclusion standards
1. Standards of Chinese Medical Syndrome Differentiation and Western medicine diagnostic criteria are not met, the non-damp and hot long bridle of TCM Syndrome Type, type of deficiency of both QI and YIN and doctor trained in Western medicine are examined It is non-RAU to break, such as traumatic ulcer, cancerous ulcer, infectious stomatitis, Behcet's disease and other ulcer persons.
2. purpose gestation or pregnant woman, women breast-feeding their children.
3. allergic constitution and to multi-medicament allergy sufferers.
4. serious disease or the mental patients such as angiocarpy, the cerebrovascular, liver, kidney diaseases and hemopoietic system are merged.
2 treatment methods
2.1 treatment groups
Treated using clearing away heat and eliminating dampeness, nourishing yin and promoting granulation method.Prescription：Pharmaceutical composition（The pharmaceutical composition lot number of embodiment 1 20090806）.Orally, each 1g, three times a day.
2.2 control groups
Using routine of western medicine drug therapy.Dexamethasone, each 0.75mg, three times a day, orally；ACV, every time 200 Mg, three times a day, orally；Levamisol, 50 mg every time, three times a day, orally.2 groups are treated 1 week for 1 course for the treatment of, treatment 2~4 The course for the treatment of.
3 evaluation indexes and statistical method
3.1 evaluation indexes
Reference《Recurrent aphthous ulcer therapeutic evaluation tentative standard》Relevant criterion, total intermittent time (interval, I), comments The valency period is without ulcer temporal summation；Total ulcer number (number, N), evaluates period ulcer recurrence number summation.I1：During total interval Between extension (t check, P ＜ 0.05)；I0：Total intermittent time is without change (t is checked, P ＜ 0.05)；The total ulcer numbers of N1 reduce (t Inspection, P ＜ 0.05)；The total ulcer numbers of N0 are without change (t is checked, P ＜ 0.05).
3.2 statistical methods
Using SPSS11.5 for Windows statistical softwares, data are represented with (x ± s), are checked using t, enumeration data Using χ2Inspection.
4 criterions of therapeutical effect and treatment results
4.1 criterions of therapeutical effect
Recovery from illness：Canker sore terminates recurrence more than 1 year；
It is effective：I1N1；
Effectively：I1N0 or I0N1；
It is invalid：I0N0.
4.2 2 groups of Clinical efficacy comparisons
It is shown in Table 1.Treatment group's total effective rate 95.00%, control group total effective rate 70.00%.2 groups are compared, and difference has conspicuousness Meaning (P ＜ 0.05).
12 groups of Clinical efficacy comparisons example (%) of table
Group n Recovery from illness It is effective Effectively It is invalid Total effective rate (%)
Treatment group 20 8 9 2 1 95.00*
Control group 20 2 4 8 6 70.00
Compare with control group, * P<0.05.
N, I change are compared before and after 4.3 2 groups of treatments
It is shown in Table 2.N, I compare before and after 2 groups of treatments, and difference has significant (P ＜ 0.05).
N, I change are compared (x ± s) before and after 22 groups of treatments of table
Compare with before treatment, * P<0.05.

Claims (8)

1. a kind of pharmaceutical composition for treating canker sore, it is characterised in that be made the bulk drug of the pharmaceutical composition composition and Weight portion is：
Cucurbitacin L26-30 weight portion dichotomous fimbristylis herb 1280-1290 weight portion Doryopteris concolor (Langsd et Fisch.) Kuhn 840-846 weight portions.
2. a kind of pharmaceutical composition for treating canker sore according to claim 1, it is characterised in that be made the drug regimen The composition and weight portion of the bulk drug of thing be：
The weight portion of 1285 weight portion Doryopteris concolor (Langsd et Fisch.) Kuhn of cucurbitacin L28 weight portions dichotomous fimbristylis herb 843.
3. a kind of pharmaceutical composition for treating canker sore according to claim 1, it is characterised in that pharmaceutical composition can be with Piece agent or capsule or dripping pill are prepared using the conventional method of galenic pharmacy.
4. a kind of pharmaceutical composition for treating canker sore according to claim 1, it is characterised in that pharmaceutical composition with change Learn the treatment stomatocace medicine of medicine or Chinese medicine composition.
5. a kind of preparation method of the pharmaceutical composition for treating canker sore, it is characterised in that prepare as follows：
The composition and weight portion of bulk drug be：Cucurbitacin L26-30 weight portion dichotomous fimbristylis herb 1280-1290 weight portion Doryopteris concolor (Langsd et Fisch.) Kuhns 840-846 weight portions；
Preparation method：
（1）Cucurbitacin L, dichotomous fimbristylis herb, Doryopteris concolor (Langsd et Fisch.) Kuhn are taken by bulk drug proportioning, is mixed, with the ethanol of weight percent concentration 33% as molten Agent, takes in 34.5 DEG C of temperature extractions, and extraction time is 7 times, and each extraction time is 2 hours, and each solvent load is that bulk drug is total 21 times of weight, filtration obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, is concentrated into relative density 1.11, filters, liquid By FU-01 large pore resin absorption columns, first wash with water, then it is big with the ethanol solution of weight percent concentration 44.5% wash-out FU-01 Macroporous adsorbent resin post, collects the ethanol eluate of weight percent concentration 44.5%, reclaims ethanol, and concentrate drying obtains final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 66% as solvent, heating and refluxing extraction 5 times is carried every time The time is taken for 1.8 hours, each solvent load is 13 times of dregs of a decoction A weight, and filtration obtains dregs of a decoction B and extract solution B, and extract solution B is returned Ethanol is received, relative density 1.06 is concentrated into, filtered, liquid is first washed with water, then use weight by DM2 large pore resin absorption columns The ethanol solution of percent concentration 77% elutes DM2 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 77%, Ethanol is reclaimed, concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
6. a kind of preparation method of the pharmaceutical composition for treating canker sore according to claim 5, it is characterised in that by such as It is prepared by lower step：
The composition and weight portion of bulk drug be：The weight portion of 1285 weight portion Doryopteris concolor (Langsd et Fisch.) Kuhn of cucurbitacin L28 weight portions dichotomous fimbristylis herb 843；
Preparation method：
（1）Cucurbitacin L, dichotomous fimbristylis herb, Doryopteris concolor (Langsd et Fisch.) Kuhn are taken by bulk drug proportioning, is mixed, with the ethanol of weight percent concentration 33% as molten Agent, takes in 34.5 DEG C of temperature extractions, and extraction time is 7 times, and each extraction time is 2 hours, and each solvent load is that bulk drug is total 21 times of weight, filtration obtains dregs of a decoction A and extract solution A, and extract solution A reclaims ethanol, is concentrated into relative density 1.11, filters, liquid By FU-01 large pore resin absorption columns, first wash with water, then it is big with the ethanol solution of weight percent concentration 44.5% wash-out FU-01 Macroporous adsorbent resin post, collects the ethanol eluate of weight percent concentration 44.5%, reclaims ethanol, and concentrate drying obtains final product extract A；
（2）Take step（1）Dregs of a decoction A, with the ethanol of weight percent concentration 66% as solvent, heating and refluxing extraction 5 times is carried every time The time is taken for 1.8 hours, each solvent load is 13 times of dregs of a decoction A weight, and filtration obtains dregs of a decoction B and extract solution B, and extract solution B is returned Ethanol is received, relative density 1.06 is concentrated into, filtered, liquid is first washed with water, then use weight by DM2 large pore resin absorption columns The ethanol solution of percent concentration 77% elutes DM2 large pore resin absorption columns, collects the ethanol eluate of weight percent concentration 77%, Ethanol is reclaimed, concentrate drying obtains final product extract B；
（3）Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
7. a kind of preparation method of the pharmaceutical composition for treating canker sore according to claim 5, it is characterised in that medicine Composition can prepare piece agent or capsule or dripping pill using the conventional method of galenic pharmacy.
8. a kind of preparation method of the pharmaceutical composition for treating canker sore according to claim 5, it is characterised in that medicine Composition and chemical drugs or Chinese medicine composition treatment stomatocace medicine.
CN201611133220.7A 2016-12-10 2016-12-10 Treat the pharmaceutical composition of canker sore Withdrawn CN106728628A (en)

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