CN110237119A - A kind of pharmaceutical composition that treating mucous membrane of mouth class disease and preparation method and purposes - Google Patents
A kind of pharmaceutical composition that treating mucous membrane of mouth class disease and preparation method and purposes Download PDFInfo
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- 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)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/26—Aristolochiaceae (Birthwort family), e.g. heartleaf
- A61K36/268—Asarum (wild ginger)
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- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/02—Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
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Abstract
The present invention provides a kind of pharmaceutical compositions for treating mucous membrane of mouth class disease, it is prepared by the bulk pharmaceutical chemicals of following weight proportion: 5-80 parts of Radix Astragali, 5-80 parts of dandelion, 3-60 parts of asarum.The present invention further discloses the preparation method and purposes of the pharmaceutical composition.Pharmaceutical composition energy QI invigorating toxin expelling provided by the invention, clearing away heat to and alleviating pain, detumescence and promoting granulation can treat mucous membrane of mouth class disease, promote mucous membrane of mouth healing.Pharmaceutical composition good effect of the present invention, irritation be small, few side effects, is not likely to produce tolerance and drug cost is cheap, suitable for promoting the use of on a large scale, with preferable medical prospect, a kind of new medication selection is provided for clinical treatment mucous membrane of mouth class disease, such as erosive lichen planus of mouth, recurrent aphtha canker sore.
Description
Technical field
The present invention relates to the field of Chinese medicines, and in particular to a kind of pharmaceutical composition for treating mucous membrane of mouth class disease and preparation side
Method and purposes.
Background technique
Oral mucosal disease, that is, oral mucosal disease is normal color, shape, integrality and the function of a certain position mucous membrane in oral cavity
It is oral cavity common disease, frequently-occurring disease etc. the disease to change, brings considerable distress to many patients, can lead to pain, influences
Words and feed, usually enable patient suffer untold misery.More serious person, part mucous membrane of mouth class disease are likely to result in one as gone to a doctor not in time
The generation of a little oral cavities malignant change.In addition many systemic diseases also usually show mucous membrane of mouth, the lesion of mucous membrane of mouth
The often important evidence of these disease early detections, early diagnosis.Oral mucosal disease mainly includes recurrent recurrent Ah not
His canker sore, Behcet's disease, lichen planus and oral leukoplakia etc..The clinical manifestation of oral mucosal disease is although different, but studies carefully it
The cause of disease, modern medicine thinks that the imbalance of category organism endocrine function, autoimmune function are abnormal, caused by genetic disease etc..Currently,
Doctor trained in Western medicine mostly uses glucocorticoid, immunopotentiator, vitamin etc. to the treatment of this disease, but to hyperkeratosis without effect, oral cavity
Easy recurrent exerbation after mucous membrane healing, curative effect is indefinite, and long-term use can generate larger side effect.As recurrent aphtha is burst
Ulcer, lichen planus of mouth class disease easy recurrent exerbation after western medicine, are not easy to cure, bring great puzzlement to patient.Cause
This, finds new treatment mucous membrane of mouth class disease in Chinese medicine or natural materials, promotes the drug of mucous membrane of mouth healing, is in recent years
One of research emphasis.
In recent years, traditional Chinese medicine achieves initial achievements in terms of the research of mucous membrane of mouth class disease.For lichen planus
Treatment, Chinese patent 200610043058.X disclose a kind of drug for treating lichen planus of mouth, and the drug is by honeysuckle 30-
50 parts, 30-50 parts of Caulis Spatholobi, 30-50 parts of Radix Salviae Miltiorrhizae, 15-25 parts of Radix Angelicae Sinensis, raw Radix Astragali 50-150 parts, 30-50 parts of smilax, rough gentian
10-20 parts careless, 10-30 parts of Radix Rehmanniae, 30-50 parts of semen coicis, 15-20 parts of rhizoma atractylodis, 15-30 parts of radix scrophulariae, 10-15 parts of radix bupleuri, bosom ox
10-15 parts of knee, 10-15 parts of cortex dictamni and 10-15 parts of Radix Glycyrrhizae compositions.Chinese patent 201210114967.3 discloses a kind for the treatment of
The compound preparation of Oral diseases, said preparation is by 16-28 parts of lophatherum gracile, 16-28 parts of cimicifugae foetidae, 16-28 parts of toad-cortex, the coptis
16-28 parts, 16-28 parts of japanese rose root, alum 16-28 parts of mountain, 12-25 parts of fructus amomi, 12-25 parts of excrementum pteropi, 12-25 parts of radix aucklandiae, money
12-25 parts of bitter leaf grass, 12-25 parts of Hericium erinaceus, 12-25 parts of Chinese blister beetle, 6-18 parts of radix notoginseng, 6-18 parts of stamen nelumbini, 6-18 parts of eggplant root, poplar
6-18 parts of Japanese apricot skin, 6-18 parts of calculus bovis factitius, 6-18 parts of vitamin C, 1-12 parts of fructus choerospondiatis, 1-12 parts of safflower, flower of Panax ginseng 1-12
Part, 1-12 parts of Chinese honeylocust seed, 1-12 parts of loguat leaf, 1-12 parts of water chestnut compositions.Chinese patent 201910097983.8 discloses one kind
The Chinese medicine composition of recurrent recurrent aphtha canker sore is treated, the drug is by giving birth to 5-25 parts of Radix Astragali, 5-25 parts of gypsum, knowing
3-15 parts female, 5-25 parts of Radix Rehmanniae, 20-40 parts of smilax, 1-11 parts of calamitas urinae hominis, 3-15 parts of Radix picrorrhizae, 3-15 parts of lophatherum gracile, adder-wort
5-25 parts, 2-22 parts of radix paeoniae rubra, 3-15 parts of the root bark of tree peony, 5-25 parts of Biyu San compositions.The above-mentioned published patent is in treatment Oral Lichen tongue fur
Moss, recurrent aphtha recurrent aphtha canker sore have preferable clinical efficacy, but the patent prescription of above-mentioned announcement
Flavour of a drug are more, and production cost is higher, and are difficult in industrialized production to control its impurity content, therefore a kind of flavour of a drug of urgent clinical needs
The significant pharmaceutical composition of clinical efficacy less.And currently, there is not yet treating mucous membrane of mouth class about Radix Astragali, dandelion, asarum
The relevant report of disease.
Summary of the invention
In view of the deficiencies of the prior art, the object of the present invention is to provide a kind of compositions simply, and novel formula treats mouth
The pharmaceutical composition of chamber mucous membrane class disease (such as lichen planus of mouth, recurrent aphtha recurrent aphtha canker sore) promotees
The healing of snout cavity mucous membrane.The pharmaceutical composition have it is at low cost, curative for effect, have no toxic side effect, be not likely to produce tolerance, take
And the advantages that easy to carry.
The purpose of the present invention is to provide a kind of pharmaceutical composition for treating mucous membrane of mouth class disease and preparation method thereof and
Purposes.
The present invention provides a kind of for treating the pharmaceutical composition of mucous membrane of mouth class disease, it is by following weight proportion
Bulk pharmaceutical chemicals be prepared: 5-80 parts of Radix Astragali, 5-80 parts of dandelion, 3-60 parts of asarum.
Further, foregoing pharmaceutical composition is prepared by the bulk pharmaceutical chemicals of following weight proportion: 30 parts of Radix Astragali, Pu Gong
30 parts of English, 20 parts of asarum.
Further, foregoing pharmaceutical composition is that by the medicinal powder of bulk pharmaceutical chemicals of the weight proportion, the water of bulk pharmaceutical chemicals or have
Solvent extract is active constituent, in addition the preparation that pharmaceutically acceptable auxiliary material is prepared.
Further, the preparation is oral preparation, buccal lozenge.
Further, the oral preparation is tablet, pill, oral solution；Buccal lozenge is buccal tablet, mouth paster, contains
Gargle agent, buccal cavity gel agent, film.
Preferably, the auxiliary material of the preparation is starch, chitosan, propylene glycol, azone etc..
The present invention also provides a kind of methods for preparing foregoing pharmaceutical composition, it includes the following steps:
A, the raw material of each weight proportion is weighed；
B, raw material directly beaten to powder, or after adding water or organic solvent to extract, pharmaceutically acceptable auxiliary material or auxiliary is added
Property ingredient is prepared.
The present invention also provides foregoing pharmaceutical compositions in the drug for preparing QI invigorating toxin expelling, clearing away heat to and alleviating pain, detumescence and promoting granulation
Purposes.
Further, the drug is the drug for treating mucous membrane of mouth class disease.
Further, the treatment mucous membrane of mouth class disease is to promote mucous membrane of mouth healing.
Further, the mucous membrane of mouth class disease be erosive oral lichen planus, recurrent aphtha recurrent Ah
Not his canker sore.
The present invention is made of Radix Astragali, dandelion, three herbal medicine of asarum.Radix Astragali, alias silk floss stilbene or continuous Radix Astragali are normal simply
Use tonic Chinese herbal medicine.The platymiscium whole world has more than 1600 kinds, is distributed in other subtropical zones and Temperate Region in China in addition to Oceania.Medicine
It is leguminous mongolian scutellaria Astragalus membranaceus (Fisch.) Bge.var.monghoicus with Radix Astragali
(Bge.) dry root of Hisao or Astragalus membranacus Astragalus mbranaceus (Fisch.) Bge..Radix Astragali is first recorded in " mind
Agriculture book on Chinese herbal medicine warp ", slightly warm in nature is sweet in flavor, enters the warp of spleen and lung two, has ascending YANG and invigorating QI, strengthening exterior and reducing sweat, shengjin nourishing, move stagnation and palsy, Li Shui
Detumescence, pus draining and toxin expelling, expelling pus and promoting granulation and other effects.Present pharmacological research shows that Radix Astragali has and improves immune function, and enhancing is anti-oxidant,
Cardiovascular and cerebrovascular is protected, memory, anticancer, vasodilator smooth muscle, hypoglycemic, reducing blood lipid, reduction diabetic complication etc. are improved
Effect.Dandelion Taraxacummongolicum Hand.Mazz. is composite family (Compositae) Dandelion (Taraxacum
F.H.Wigg.) plant, perennial herb.The Dandelion whole world about more than 2000, main product Northern Hemisphere temperate zone is to subtropical zone
Area, a small number of heat production band South Americas.China has 70 kinds, is distributed in northeast, North China, northwest, Central China, each provinces and regions in East China and southwest, west
South and the Northwest are most, wherein be distributed with dandelion it is most wide, throughout the most provinces and regions in the whole nation, be the common wild vegetable in China and
Chinese herbal medicine.Dandelion is as Chinese medicine, first recorded in Tang Materia Medica.The successive dynasties such as Tang Materia Medica, Compendium of Material Medica, " dictionary of medicinal plant " doctor
Monograph, which is given, to be spoken highly of." Chinese Pharmacopoeia " record for dandelion Taraxacum mongolicum Hand.-Mazz.,
Dandelion Taraxacum borealisinense Kitam. or the drying herbs of several plants is belonged to alkali, bitter, sweet, property
It is cold.Return liver, stomach meridian, have clearing heat and detoxicating, dispersing swelling and dissipating binds, inducing diuresis for treating strangurtia functions, is used for furuncle swelling toxin, acute mastitis, scrofula, hot eyes,
Pharyngalgia, pulmonary abscess, acute appendicitis, jaundice with damp-heat pathogen, puckery pain of heat gonorrhea.The chemical constitution study of dandelion is relatively more, and domestic and foreign scholars are from Pu
Many chemical components are isolated in public English-Chinese extraction, mainly include flavonoids, Sesquiterpene lactones, Coumarins, triterpenes, plant
Sterols, phenolic acid class, carotenoid, pigment, volatile oil, additionally containing there are many fatty acid, sugar, choline, vitamin,
Minerals, pectin, protein etc..Constantly discovering based on dandelion bioactive ingredients and the continuous development of modern pharmacology,
The pharmacological actions such as antibacterial possessed by dandelion, antitumor, anti-oxidant, anti-inflammatory, diuresis, antiallergy, antithrombotic are constantly proved,
And corresponding achievement is all achieved at numerous aspects such as the mechanism of action, clinical application and development and utilization, it is shown that very big opens
Hair prospect.Asarum (Asarum) also known as little Xin, few pungent, thin grass, are conventional Chinese medicine.Asarum source is aristolochiaceae plant Herba Asari
Asarum hetero-tropoides Fr.Schmldt var.mandshuricum (msxim.) Kitag., Seoul asarum
The root and root of Asarum sieboldii Miq.var.seoulcnse Nakai or asarum sieboldii Asarum sieboldii Miq.
Stem, it is acrid flavour, warm-natured, have effects that expelling wind and clearing away cold, sensible analgesic, warming lung and resolving fluid, is used for chill, flu, headache, toothache, nose
Fill in nasosinusitis, rheumatic arthralgia, phlegm retention cough and asthma.Main component contains volatile oil, contains methyleugenol, eucarvone, rheum officinale in oil
Camphor tree ether, nopinene, asarone, saishinone.12 carbon of another isobutyl group containing N-, four enamine and higenamine etc..Modern pharmacology
It learns research shows that asarum has the multiple pharmacological effects such as antipyretic-antalgic, calmness, CNS inhibition, local anaesthesia.
The present invention is rotten to the corn to the part of mucous membrane of mouth to burst using Radix Astragali invigorating qi for strengthening superficies, pus draining and toxin expelling, diuresis, myogenic as monarch drug in a prescription
Ulcer has apparent repair.Dandelion is clearing heat and detoxicating, diuresis dissipating bind, can alleviate the local inflammation reaction of mucous membrane of mouth.Carefully
It is pungent relieving exterior syndrome and dispelling cold, wind-expelling pain-stopping, sensible, there is certain relaxation effect for the inflammatory pain of Topical oral mucous membrane.All medicines share,
The benefits of playing QI invigorating toxin expelling, clearing away heat to and alleviating pain, detumescence and promoting granulation altogether.Pharmaceutical composition of the present invention is for treating mucous membrane of mouth class disease (such as
Lichen planus, recurrent aphtha canker sore) drug effect is clear.
Obviously, above content according to the present invention, according to the ordinary technical knowledge and customary means of relevant art,
Under the premise of not departing from above-mentioned basic fundamental thought of the invention, the modification, replacement or change of other diversified forms can also be made.
The specific embodiment of form by the following examples remakes further specifically above content of the invention
It is bright.But the range that this should not be interpreted as to the above-mentioned theme of the present invention is only limitted to example below.It is all to be based on above content of the present invention
The technology realized all belongs to the scope of the present invention.
Detailed description of the invention
Fig. 1 multiple irritation test of drug gargle of the present invention
Specific embodiment
The preparation of the pharmaceutical composition of the present invention of embodiment 1
(1) raw material: Radix Astragali 30g, dandelion 30g, asarum 20g.
(2) preparation method:
Step 1: weighing bulk pharmaceutical chemicals by above-mentioned weight proportion, 20,16,12 times of water of medicinal material are added after first mixing all raw materials
It extracts 3 times, 45 minutes every time, collects filtrate, be concentrated under 70 DEG C, the pressure of 120mbar.
Step 2: concentrate is cooled to 30 DEG C, adjusts pH value to 3.5-4,1% chitosan of 8%-10% is added (with 1%
Acetum configuration) solution, stirring is to there is a large amount of flocculent deposits to generate, and static 2 hours, filtering, filtrate added water to 1000ml
Drug gargle of the present invention is made.
The preparation of the pharmaceutical composition of the present invention of embodiment 2
(1) raw material: Radix Astragali 25g, dandelion 25g, asarum 15g.
(2) preparation method: being extracted by 1 preparation method of embodiment after concentrating and purifying, and buccal lozenge is added and is prepared into auxiliary material
Buccal tablet.
The preparation of the pharmaceutical composition of the present invention of embodiment 3
(1) raw material: Radix Astragali 25g, dandelion 20g, asarum 15g.
(2) it preparation method: is extracted by 1 preparation method of embodiment after concentrating and purifying, is prepared into mouth paster.
The preparation of the pharmaceutical composition of the present invention of embodiment 4
(1) raw material: Radix Astragali 30g, dandelion 30g, asarum 20g.
(2) preparation method: step 1 is the same as embodiment 1；Step 2: polyvinyl alcohol -124, propylene glycol, azone etc. is added, by solidifying
The preparation method of jelly is prepared into gel.
The preparation of the pharmaceutical composition of the present invention of embodiment 5
(1) raw material: Radix Astragali 30g, dandelion 30g, asarum 20g.
(2) preparation method: step 1 is the same as embodiment 1；Step 2: the film forming agents such as nipalgin, hydroxymethyl cellulose, preparation is added
At pelliculae pro cavo oris.
Beneficial effects of the present invention are proved below by way of specific clinical test and zoopery.
The clinical efficacy of the pharmaceutical composition of the present invention of test example 1
1, case-data
All cases of this research come from November, 2017~2018 year Hospital Affiliated To Chengdu Traditional Chinese Medicine Univ in November oral cavity
The recurrent aphtha canker sore patient of section's outpatient clinic, totally 160.Subject meets oral keritonocytes (recurrent
Aphtha canker sore, erosive oral lichen planus) be included in standard.Into before project, equal signed informed consent form.It adopts
Patient is divided into test group and control group at random with SPSS24.0 software, each 80.Wherein test group recurrent aphtha oral cavity
Ulcer, erosive oral lichen planus each 40, control group recurrent aphtha canker sore, erosive oral lichen planus are each
40.
1.1 diagnostic criteria
Western medicine diagnostic criteria: diagnostic criteria is with reference to " oral mucosal disease " (fourth edition, People's Health Publisher), " clinic
Practice guidelines-dentistry fascicle " (Chinese Medical Association writes, People's Health Publisher), " clinical technique specification-oral cavity
Medicine fascicle " (Chinese Medical Association writes, People's Medical Officer Press).
1.2 are included in standard
(1) meet doctor trained in Western medicine oral keritonocytes is included in standard
Recurrent aphtha canker sore: 1. oral cavity inner circular or oval ulcer have the clinic of " red, yellow, recessed, pain "
Feature and " stage of attack one healing stage one intermittent phase " periodic law different in size, and have the self limiting recovered without treatment.2. at least
There are 2 recurrent aphtha canker sore histories of attack, and medical history 1 year or more, ulcer breaking-out monthly 1 time or more.
Erosive oral lichen planus: the lines structure that 1. mucous membrane is made of the white or canescence papule of grain grain size in mouth
At reticulate pattern disease damage, without clearly boundary between normal mucosa；2. between white line and surrounding can be normal mucosa or have
Even congested, rotten to the corn ulcer.
(2) age is between 18-60 one full year of life；Two groups of genders, age, bleeding percentage etc. compare, and there are no significant for difference
Meaning (P > 0.05).
(3) there is pain identification capability.
(4) this subject study of voluntary participation receives treatment and cooperation observation, signs informed consent form.
1.3 exclusion criteria
(1) systemic diseases such as Behcet's disease, anaemia, peptic ulcer, clone's disease, acute infectious diseases, autoimmunity
Property disease, malignant tumour etc.；Antibiotic and anti-inflammatory drug were used in (2) 1 months；Whole body used cortex class solid in (3) 3 months
Alcohol or immunosuppressor person and to trial drug ingredient allergy sufferers.
1.4 rejecting standards: (1) standard of being included in is not met, the case being strayed into is rejected；(2) compliance difference person gives
To reject；(3) predetermined treatment is not pressed, affect the treatment estimator, is rejected；(4) merge and controlled using what this programme was forbidden to use
Treatment method person, is rejected；(5) case of serious adverse events occurs.
2, therapeutic scheme
Test group gives the gargle treatment of the preparation of the embodiment of the present invention 1, and control group gives golden Cape jasmine clean gum gargle treatment.
The gargle application method of test group and control group: daily 3~5 times, each 5mL, containing gargling 3min, containing no longer using clear water after gargling
It gargles, containing not drinking-water interior when gargling later half and feeds.It checks after a week, inquires and record the subjective feeling of patient, and record each trouble
Person treatment before, treatment after pain index (VAS scoring).Subject does not use other drugs in principle, for the state of an illness person of needs
Systemic administration can be given.
Subject checks in the latter Zhou Jinhang of medication, records subjective feeling and the clinical manifestation of patient, and press unified treatment
Effect criterion determines curative effect.The same test group of application method of the clean gum gargle of control group gold Cape jasmine.
3, observation of curative effect
The standard of curative effect evaluation:
(1) it is commented according to the erosion and pain index (VAS) of the size of recurrent aphtha canker sore, lichen planus of mouth
Point.
(2) changed according to pretherapy and post-treatment syndrome and carry out efficacy determination.Effective: after medication, sings and symptoms, which are obviously improved, (to be treated
Imitate index >=70%), symptom is basic or all disappears, and ulcer is basic or all disappears, and diseased region is without obvious inflammatory reaction；Have
Effect: after medication, sings and symptoms have improvement (therapeutic index >=30%), and symptom improves earlier above, and ulcer number is reduced, ulcer diameter
It is obviously reduced, perilesional inflammatory reaction improves；It is invalid: after medication, sings and symptoms without it is substantially reduced or add severe one (curative effect refers to
Number < 30%), without being clearly better, ulcer number, diameter and surrounding inflammatory reaction are not improved symptom.
Note: therapeutic index=(pain index after pain index-treatment before treating)/pain index × 100% (Buddhist nun before treating
Not Horizon method calculation formula).
4, statistical method
All data for statistical analysis using SPSS24.0, pretherapy and post-treatment to recurrent aphtha canker sore patient
It is for statistical analysis.Measurement data is with mean ± standard deviationIt indicates, variance analysis is used between group, and enumeration data uses
X2It examines, all statistical data use two-sided test, and setting α=0.05 is the level of signifiance, and two groups are indicated if P > 0.05
Between indifference, it is not statistically significant；There is significant difference between indicating two groups if P < 0.05, it is statistically significant.Treatment always has
Efficiency is the sum of obvious effective rate and effective percentage.
5, result
5.1 two groups for the treatment of recurrent aphtha canker sore curative effects compare
1 test group of table is compared with the pretherapy and post-treatment recurrent aphtha canker sore pain index (VAS) of control group
Note: compared with the control group, P < 0.05, difference is statistically significant by *.
2 test group of table (X compared with control group treats recurrent aphtha canker sore total effective rate2It examines)
5.2 two groups for the treatment of erosive oral lichen planus curative effects compare
3 test group of table is compared with the pretherapy and post-treatment Erosive oral lichen planus pain index (VAS) of control group
Note: compared with the control group, P < 0.05, difference is statistically significant by *.
4 test group of table (X compared with control group treats erosive oral lichen planus total effective rate2It examines)
5.3 two groups for the treatment of oral keritonocytes total effective rates compare
It the results are shown in Table 5.
5 test group of table is compared with control group oral keritonocytes total effective rate
Conclusion (of pressure testing): test group and control group treat oral keritonocytes (recurrent aphtha canker sore, erosive type mouth
Chamber lichen planus) before and after pain index (VAS) scoring, comparison among groups difference is statistically significant (P < 0.05)；Test group
Oral keritonocytes total effective rate 87.5% is treated, control group treatment is 75%, therefore test group treatment oral keritonocytes compare
It is good according to group effect.
The multiple irritant experiment of the pharmaceutical composition of the present invention of test example 2
1, experimental material
1.1 test medicines: pharmaceutical composition prepared by the embodiment of the present invention 1 is provided by Pharmacy, Chengdu University of Traditional Chinese Medicine.
The quasi- dosage of clinic: 15ml/ times, 3 times/day, 3 days, no more than 7 days are used in conjunction.
1.2 experimental animals: cavy 30, half male and half female, 180 ± 20g of weight.It is mentioned by farm, animal administration commission, Sichuan Province
For animal certificate number SCXK (river) 2008-14.Adaptable fed starts to test after 3 days.
2, test method
Cavy 30, half male and half female is randomly divided into 3 groups by weight: low dose of Normal group, example 1 drug gargle
Amount group, example 1 drug gargle high dose group, every group 10.Wherein, low dose group is the equivalent dose of quantity, tooth
All inflammation high dose groups are 5 times of dosages of clinical equivalent dosage, and Normal group gives same amount of normal saline.Every group is administered daily 2
Secondary, successive administration 7 days, when administration, made medical fluid be uniformly coated on oral cavity two sides buccal mucosa, and retains 10min.Before being administered daily, see
Examining mucous membrane of mouth, whether there is or not the irritations such as hyperemia, oedema, bleeding, erosion, ulcer.Last dose for 24 hours after, visually observing animal has
Without systemic adverse reactions, whether there is or not local stimulation symptoms for mucous membrane of mouth.
3, test result
As shown in Figure 1.
Experiment conclusion: during experiment, experimental animal does not occur part and whole body bad stimuli response, visually observes mucous membrane
It is showed no mucous membrane hyperemia, phenomena such as oedema.
In conclusion pharmaceutical composition provided by the invention composition is simple, novel formula, can QI invigorating toxin expelling, clearing away heat to and alleviating pain,
Detumescence and promoting granulation is treated mucous membrane of mouth class disease (such as lichen planus of mouth, recurrent aphtha recurrent aphtha canker sore)
It is curative for effect, promote mucous membrane of mouth healing, have at low cost, good effect, have no toxic side effect, be not likely to produce tolerance, taking and
The advantages that easy to carry, provides a kind of new medication selection for clinical treatment mucous membrane of mouth class disease.
Claims (10)
1. a kind of pharmaceutical composition for treating mucous membrane of mouth class disease, it is characterised in that: it is by the raw material of following weight proportion
Medicine is prepared: 5-80 parts of Radix Astragali, 5-80 parts of dandelion, 3-60 parts of asarum.
2. pharmaceutical composition according to claim 1, it is characterised in that: it is the bulk pharmaceutical chemicals preparation by following weight proportion
It forms: 30 parts of Radix Astragali, 30 parts of dandelion, 20 parts of asarum.
3. pharmaceutical composition according to claims 1 to 2, it is characterised in that: it is by the bulk pharmaceutical chemicals of the weight proportion
Medicinal powder, bulk pharmaceutical chemicals water or extractive with organic solvent be active constituent, in addition what pharmaceutically acceptable auxiliary material was prepared
Preparation.
4. pharmaceutical composition according to claim 3, it is characterised in that: the preparation is oral preparation, buccal lozenge.
5. pharmaceutical composition according to claim 4, it is characterised in that: the oral preparation is tablet, pill, takes orally
Liquid；Buccal lozenge is buccal tablet, mouth paster, gargle, buccal cavity gel agent, film.
Preferably, the auxiliary material of the preparation is starch, chitosan, propylene glycol, azone etc..
6. a kind of method for preparing Claims 1 to 5 any one described pharmaceutical composition, it is characterised in that: it includes as follows
Step:
A, the raw material of each weight proportion is weighed；
B, raw material directly beaten to powder, or after adding water or organic solvent to extract, be added pharmaceutically acceptable auxiliary material or it is complementary at
Divide and is prepared.
7. Claims 1 to 5 any one described pharmaceutical composition is in the medicine for preparing QI invigorating toxin expelling, clearing away heat to and alleviating pain, detumescence and promoting granulation
Purposes in object.
8. purposes as claimed in claim 7, it is characterised in that: the drug is the drug for treating mucous membrane of mouth class disease.
9. purposes according to claim 8, it is characterised in that: the treatment mucous membrane of mouth class disease is to promote mucous membrane of mouth
Healing.
10. purposes according to claim 9, it is characterised in that: the mucous membrane of mouth class disease is erosive type Oral Lichen
Moss, recurrent aphtha recurrent aphtha canker sore.
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| CN201910579591.5A CN110237119A (en) | 2019-06-28 | 2019-06-28 | A kind of pharmaceutical composition that treating mucous membrane of mouth class disease and preparation method and purposes |
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| CN201910579591.5A CN110237119A (en) | 2019-06-28 | 2019-06-28 | A kind of pharmaceutical composition that treating mucous membrane of mouth class disease and preparation method and purposes |
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Cited By (1)
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| CN113331422A (en) * | 2021-06-28 | 2021-09-03 | 海南净航科技发展有限公司 | Health food with health function of enhancing immunity |
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