CN104013815A - Traditional Chinese medicine for treating recurrent oral ulcer due to deficiency of yin and excess of heat and preparation method of traditional Chinese medicine - Google Patents
Traditional Chinese medicine for treating recurrent oral ulcer due to deficiency of yin and excess of heat and preparation method of traditional Chinese medicine Download PDFInfo
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Abstract
The invention provides a traditional Chinese medicine for treating recurrent oral ulcer due to deficiency of yin and excess of heat and a preparation method thereof. Material medicines of the traditional Chinese medicine comprise: scrophularia ningpoensis, radix tinosporae, cynachum uilfordii hemsl, orchis, bidens tripartite, sheathed monochoria herb, narrow-leaved lindernia, herb of argun groundsel, eurya chinensis, adder tongue herb, herba eclipta flower, goldencup hypericum, stellaria media and small-flowered beggar's-ticks. The traditional Chinese medicine disclosed by the invention is mainly used for nourishing yin to lessen fire, and clearing away heat and toxic materials, has exact curative effect for recurrent oral ulcer due to deficiency of yin and excess of heat, and has the advantages that acting is quick and relapse is not easy.
Description
Technical field
The present invention relates to contain the medicinal preparation that derives from plant, animal or mineral component, relate in particular to a kind of Chinese medicine and preparation method for the treatment of type of hyperactivity of fire caused by deficiency of YIN recurrent oral ulceration.
Background technology
Recurrent oral ulceration claims again recurrent aphtha, is modal oral mucosal disease.The cause of disease and mechanism of causing a disease are still indefinite at present.Inducement may be local wound, psychentonia, food, medicine, hormonal readiness change and vitamin or trace element deficiency.
Clinical doctor trained in Western medicine adopts the Drug therapys such as hormone, vitamin B more, can obtain certain curative effect, but the course for the treatment of is longer, easily outbreak repeatedly.
Recurrent oral ulceration belongs to Chinese medicine " aphtha " category.The traditional Chinese medical science is thought, feelings will is uncomfortable, diet is not normal, overstrain, spleen and stomach function abnormal ascending-descending of QI are that imbalance of YIN and YANG is the main pathogenesis that recurrent oral ulceration occurs, if feelings will is uncomfortable, taste are become estranged and eating and drinking without temperance, heat is accumulate taste, smoked dispute on heat stagnation fire-transformation, send out aphtha, or because of overstrain, in damp-heat in the spleen and stomach, accumulate cloudy liquid loss, water failing to restrain blazing fire, asthenic fire floating upward and sending out.Type of hyperactivity of fire caused by deficiency of YIN recurrent oral ulceration is many to be had due to fire because of taste.
Summary of the invention
Technical problem to be solved by this invention is, a kind of Chinese medicine and preparation method for the treatment of type of hyperactivity of fire caused by deficiency of YIN recurrent oral ulceration is provided, Chinese medicine of the present invention be take nourishing YIN to lower pathogenic fire, heat-clearing and toxic substances removing as main, type of hyperactivity of fire caused by deficiency of YIN recurrent oral ulceration is had to definite curative effect, have rapid-actionly, be difficult for the advantage of recurrence.
In order to solve the problems of the technologies described above, the invention provides a kind of Chinese medicine for the treatment of type of hyperactivity of fire caused by deficiency of YIN recurrent oral ulceration, its raw medicinal material comprises: Radix Scrophulariae, Radix Tinosporae, Radix cynanchi wilfordii, Herba Orchidis Latifoliae, Herba Bidentis Tripartitae, Herba monochoriae vaginalis, Lindernia angustifolia (Benth.) Wettst., Herba Senecionis Argunensis, Radix Euryae Chinensis, Herba Ophioglossi, Herba Tropaeoli, Herba Hyperici Patuli, Herba malachii aquatici and Herba bidentis parviflorae.
In described Chinese medicine, the ratio of weight and number of each raw medicinal material is as follows: 15～25 parts of Radix Scrophulariaes, 5～15 parts of Radix Tinosporaes, 10～20 parts of Radix cynanchi wilfordii, 30～40 parts of Herba Orchidis Latifoliae, 30～40 parts of Herba Bidentis Tripartitaes, 5～15 parts of Herba monochoriae vaginaliss, 10～20 parts of Lindernia angustifolia (Benth.) Wettst.s, 5～15 parts of Herba Senecionis Argunensiss, 10～20 parts of Radix Euryae Chinensiss, 5～15 parts of Herba Ophioglossis, 10～20 parts of Herba Tropaeolis, 15～25 parts of Herba Hyperici Patulis, 5～15 parts of 10～20 parts of Herba malachii aquaticis and Herba bidentis parvifloraes.
In described Chinese medicine, the ratio of weight and number of each raw medicinal material can be preferably: 15～20 parts of Radix Scrophulariaes, 5～10 parts of Radix Tinosporaes, 10～15 parts of Radix cynanchi wilfordii, 30～35 parts of Herba Orchidis Latifoliae, 30～35 parts of Herba Bidentis Tripartitaes, 5～10 parts of Herba monochoriae vaginaliss, 10～15 parts of Lindernia angustifolia (Benth.) Wettst.s, 5～10 parts of Herba Senecionis Argunensiss, 10～15 parts of Radix Euryae Chinensiss, 5～10 parts of Herba Ophioglossis, 10～15 parts of Herba Tropaeolis, 15～20 parts of Herba Hyperici Patulis, 5～10 parts of 10～15 parts of Herba malachii aquaticis and Herba bidentis parvifloraes.
In described Chinese medicine, the ratio of weight and number of each raw medicinal material also can be preferably: 16 parts of Radix Scrophulariaes, 7 parts of Radix Tinosporaes, 11 parts of Radix cynanchi wilfordii, 34 parts of Herba Orchidis Latifoliae, 31 parts of Herba Bidentis Tripartitaes, 6 parts of Herba monochoriae vaginaliss, 13 parts of Lindernia angustifolia (Benth.) Wettst.s, 8 parts of Herba Senecionis Argunensiss, 14 parts of Radix Euryae Chinensiss, 7 parts of Herba Ophioglossis, 12 parts of Herba Tropaeolis, 18 parts of Herba Hyperici Patulis, 6 parts of 11 parts of Herba malachii aquaticis and Herba bidentis parvifloraes.
In described Chinese medicine, the ratio of weight and number of each raw medicinal material also can be preferably: 18 parts of Radix Scrophulariaes, 6 parts of Radix Tinosporaes, 14 parts of Radix cynanchi wilfordii, 31 parts of Herba Orchidis Latifoliae, 34 parts of Herba Bidentis Tripartitaes, 8 parts of Herba monochoriae vaginaliss, 11 parts of Lindernia angustifolia (Benth.) Wettst.s, 6 parts of Herba Senecionis Argunensiss, 11 parts of Radix Euryae Chinensiss, 8 parts of Herba Ophioglossis, 14 parts of Herba Tropaeolis, 16 parts of Herba Hyperici Patulis, 8 parts of 13 parts of Herba malachii aquaticis and Herba bidentis parvifloraes.
The present invention also provides the preparation method of above-mentioned Chinese medicine, and the dosage form of described Chinese medicine is tablet, and its preparation method comprises the following steps:
The first step: each raw medicinal material of described Chinese medicine preparation is mixed in proportion, add the ethanol that the determining alcohol with respect to 5～7 times of mixture qualities is 50～60%, reflux 2～4 hours, extract, filter and obtain the first extracting solution, the medicinal residues that filter to obtain add the ethanol that the determining alcohol with respect to 2～3 times of medicinal residues quality is 50～60% again, reflux 1～2 hour, extract, filter and obtain the second extracting solution, the first extracting solution and the second extracting solution are merged, concentrating under reduced pressure is removed alcohol solvent, dry, obtain and get dry extract;
Second step: the dry cream that the first step is obtained is placed in super micron mill to be pulverized 1～2 hour, pulverizes and sieves and obtains 200～400 object micropowders;
The 3rd step: add the microcrystalline Cellulose with respect to 0.2～0.4 times of its quality, the lactose of 0.1～0.2 times, the starch of 0.2～0.3 times in the micropowders obtaining at second step, sieve, mix homogeneously, granulate, dry, add the magnesium stearate with respect to 0.002～0.02 times of micropowders quality, granulate, tabletting, makes.
The present invention also provides the preparation method of above-mentioned Chinese medicine, and the dosage form of described Chinese medicine is granule, and its preparation method comprises the following steps:
The first step: described raw medicinal material is mixed in described ratio, add the ethanol that the determining alcohol with respect to 3～5 times, mixture is 85%～95%, be heated to boiling reflux 1～3 hour, filter, adopt percolation with the speed of 1～2ml per minute percolation slowly, collect percolate, the mastic that while being evaporated to 60～70 ℃ subsequently under vacuum 0.03～0.05Mpa, relative density is 1.00～1.02, spraying is dry, 170～180 ℃ of the inlet temperature of spray dryer, 80～90 ℃ of leaving air temps, be ground into subsequently powder, make dried cream powder;
Second step: in the dried cream powder obtaining, add with respect to the cane sugar powder of 0.2～0.4 times of dried cream powder quality and the dextrin of 0.1～0.3 times, granulation, in 50～60 ℃ dry, obtain granule.
Beneficial effect of the present invention: Chinese medicine of the present invention be take nourishing YIN to lower pathogenic fire, heat-clearing and toxic substances removing as main, and type of hyperactivity of fire caused by deficiency of YIN recurrent oral ulceration is had to definite curative effect, has rapid-actionly, is difficult for the advantage of recurrence.
The specific embodiment
The invention provides a kind of Chinese medicine for the treatment of type of hyperactivity of fire caused by deficiency of YIN recurrent oral ulceration, its raw medicinal material comprises: Radix Scrophulariae, Radix Tinosporae, Radix cynanchi wilfordii, Herba Orchidis Latifoliae, Herba Bidentis Tripartitae, Herba monochoriae vaginalis, Lindernia angustifolia (Benth.) Wettst., Herba Senecionis Argunensis, Radix Euryae Chinensis, Herba Ophioglossi, Herba Tropaeoli, Herba Hyperici Patuli, Herba malachii aquatici and Herba bidentis parviflorae.
In described Chinese medicine, the pharmacology of each raw medicinal material is as follows:
Radix Scrophulariae: sweet, hardship, salty, be slightly cold.Return spleen, stomach, kidney channel.Removing heat from blood YIN nourishing, eliminating fire and detoxication.For consumption of YIN caused by febrile disease, crimson tongue excessive thirst, maculae caused by violent heat pathogen, constipation is hindered in Tianjin, hectic fever due to YIN-deficiency chronic cough, conjunctival congestion, pharyngalgia, scrofula, diphtheria, carbuncle sore tumefacting virus.
Radix Tinosporae: hardship, cold.Return spleen, kidney channel.Heat-clearing and toxic substances removing.Treating acute and chronic tonsillitis, acute pharyngolaryngitis, stomatitis, parotitis, mastitis, appendicitis, carbuncle furuncle, acute chronic enteritis, bacillary dysentery, stomachache, cough due to heat aphonia.< < book on Chinese herbal medicine is new > > again: nourishing YIN to lower pathogenic fire, slake thirst and help produce saliva.
Radix cynanchi wilfordii: sweet, hardship, flat.Return spleen, stomach, kidney channel.Yin nourishing tonify deficiency, strengthening the spleen to promote digestion.Control deficient impairment caused by overstrain, dysentery, infantile malnutrition, has a stomachache glutted, leucorrhea, skin ulcer tinea.< < Shaanxi Chinese herbal medicine > >: nourishing YIN and benefiting blood, spleen invigorating is pleasant, sedation-analgesia, lactogenic.The abdominal distention for the treatment of for stomachache, asthenia, lumbago due to renal deficiency, sexual impotence, the abdominal lump of chilren, leucorrhea, hypogalactia.
Herba Orchidis Latifoliae: sweet, flat.GUIXIN, kidney, stomach warp.Tonifying kidney and nourishing yin, invigorating spleen and reinforcing stomach.Main deficiency of YIN consumptive disease heat, irritated thirsty, anorexia, menoxenia.
Herba Bidentis Tripartitae: hardship, sweet, flat.Heat-clearing and toxic substances removing, yin nourishing arresting sweating.For flu, tonsillitis, pharyngolaryngitis, enteritis, dysentery, hepatitis, urinary system infection, pulmonary tuberculosis night sweat, amenorrhea; Furuncle and phyma is controlled in external, eczema, tinea.The herbal > > in east, < < Fujian: yin nourishing lung benefiting, heat-clearing and toxic substances removing.Control cough and pant, laryngopharynx swelling and pain.
Herba monochoriae vaginalis: hardship, cool.Heat-clearing and toxic substances removing.Control dysentery, enteritis, acute tonsillitis, gums abscess, erysipelas, furuncle.
Lindernia angustifolia (Benth.) Wettst.: acrid in the mouth, hardship, property is flat.Clearing away heat-damp and promoting diuresis, removing toxic substances and promoting subsidence of swelling.Main jaundice due to damp-heat, has loose bowels, dysentery, laryngopharynx swelling and pain, traumatic injury.
Herba Senecionis Argunensis: hardship, cold.GUIXIN warp.Heat-clearing and toxic substances removing.Control dysentery, scrofula, acute conjunctivitis, pharyngolaryngitis, carbuncle furuncle, eczema, dermatitis.< < Chinese Herbal Medicine in Xinjiang handbook > >: " heat-clearing and toxic substances removing, removing the necrotic tissue and promoting granulation, liver heat removing and eyesight improving.Control acute conjunctivitis, pharyngolaryngitis, furuncle carbuncle, eczema, dermatitis, venom.
Radix Euryae Chinensis: sweet, light, micro-puckery, cool.Return lung meridian.Removing damp-heat, removing toxic substances sore.Main cold, fever, jaundice due to damp-heat, sore swollen toxin, burn due to hot liquid or fire, snake bite and insect sting, traumatic hemorrhage.
Herba Ophioglossi: hardship, sweet, be slightly cold.Return Liver Channel.Heat-clearing and toxic substances removing, promoting blood circulation to remove blood stasis.Control acute mastitis, furuncle, scabies itching over the body, traumatic injury, swelling and pain due to blood stasis.
Herba Tropaeoli: acrid in the mouth, acid, cool in nature.GUIXIN, kidney channel.Heat-clearing and toxic substances removing, cooling blood for hemostasis.Main conjunctival congestion and swelling pain, furuncle, spits blood, hemoptysis.
Herba Hyperici Patuli: hardship, pungent, cold.Return liver, kidney, urinary bladder channel.Heat-clearing and toxic substances removing, dissipating blood stasis.Main hepatitis, dysentery, gonorrhea, laryngopharynx swelling and pain, stomatitis, carbuncle sore, traumatic injury, nasopharyngeal carcinoma, laryngeal carcinoma, carcinoma of tonsil, pulmonary carcinoma, bladder cancer, carcinoma of prostate.
Herba malachii aquatici: sweet, acid, property is flat.Return liver, stomach warp.Heat-clearing and toxic substances removing, dissipating blood stasis for subsidence of swelling.Main lung-heat cough with asthma, dysentery, carbuncle, hemorrhoid, toothache, menoxenia, infantile malnutrition.
Herba bidentis parviflorae: sweet, micro-hardship, cool.Heat-clearing and toxic substances removing, inducing diuresis and reducing edema, promoting blood circulation by removing blood stasis.For acute tonsillitis, gingivitis, bronchitis, enteritis, urethritis, edema; Herpes zoster is controlled in external, traumatic injury.
In described Chinese medicine, the ratio of weight and number of each raw medicinal material is as follows: 15～25 parts of Radix Scrophulariaes, 5～15 parts of Radix Tinosporaes, 10～20 parts of Radix cynanchi wilfordii, 30～40 parts of Herba Orchidis Latifoliae, 30～40 parts of Herba Bidentis Tripartitaes, 5～15 parts of Herba monochoriae vaginaliss, 10～20 parts of Lindernia angustifolia (Benth.) Wettst.s, 5～15 parts of Herba Senecionis Argunensiss, 10～20 parts of Radix Euryae Chinensiss, 5～15 parts of Herba Ophioglossis, 10～20 parts of Herba Tropaeolis, 15～25 parts of Herba Hyperici Patulis, 5～15 parts of 10～20 parts of Herba malachii aquaticis and Herba bidentis parvifloraes.
In described Chinese medicine, the ratio of weight and number of each raw medicinal material can be preferably: 15～20 parts of Radix Scrophulariaes, 5～10 parts of Radix Tinosporaes, 10～15 parts of Radix cynanchi wilfordii, 30～35 parts of Herba Orchidis Latifoliae, 30～35 parts of Herba Bidentis Tripartitaes, 5～10 parts of Herba monochoriae vaginaliss, 10～15 parts of Lindernia angustifolia (Benth.) Wettst.s, 5～10 parts of Herba Senecionis Argunensiss, 10～15 parts of Radix Euryae Chinensiss, 5～10 parts of Herba Ophioglossis, 10～15 parts of Herba Tropaeolis, 15～20 parts of Herba Hyperici Patulis, 5～10 parts of 10～15 parts of Herba malachii aquaticis and Herba bidentis parvifloraes.
In described Chinese medicine, the ratio of weight and number of each raw medicinal material also can be preferably: 16 parts of Radix Scrophulariaes, 7 parts of Radix Tinosporaes, 11 parts of Radix cynanchi wilfordii, 34 parts of Herba Orchidis Latifoliae, 31 parts of Herba Bidentis Tripartitaes, 6 parts of Herba monochoriae vaginaliss, 13 parts of Lindernia angustifolia (Benth.) Wettst.s, 8 parts of Herba Senecionis Argunensiss, 14 parts of Radix Euryae Chinensiss, 7 parts of Herba Ophioglossis, 12 parts of Herba Tropaeolis, 18 parts of Herba Hyperici Patulis, 6 parts of 11 parts of Herba malachii aquaticis and Herba bidentis parvifloraes.
In described Chinese medicine, the ratio of weight and number of each raw medicinal material also can be preferably: 18 parts of Radix Scrophulariaes, 6 parts of Radix Tinosporaes, 14 parts of Radix cynanchi wilfordii, 31 parts of Herba Orchidis Latifoliae, 34 parts of Herba Bidentis Tripartitaes, 8 parts of Herba monochoriae vaginaliss, 11 parts of Lindernia angustifolia (Benth.) Wettst.s, 6 parts of Herba Senecionis Argunensiss, 11 parts of Radix Euryae Chinensiss, 8 parts of Herba Ophioglossis, 14 parts of Herba Tropaeolis, 16 parts of Herba Hyperici Patulis, 8 parts of 13 parts of Herba malachii aquaticis and Herba bidentis parvifloraes.
The present invention also provides the preparation method of above-mentioned Chinese medicine, and the dosage form of described Chinese medicine is tablet, and its preparation method comprises the following steps:
The first step: each raw medicinal material of described Chinese medicine preparation is mixed in proportion, add the ethanol that the determining alcohol with respect to 5～7 times of mixture qualities is 50～60%, reflux 2～4 hours, extract, filter and obtain the first extracting solution, the medicinal residues that filter to obtain add the ethanol that the determining alcohol with respect to 2～3 times of medicinal residues quality is 50～60% again, reflux 1～2 hour, extract, filter and obtain the second extracting solution, the first extracting solution and the second extracting solution are merged, concentrating under reduced pressure is removed alcohol solvent, dry, obtain and get dry extract;
Second step: the dry cream that the first step is obtained is placed in super micron mill to be pulverized 1～2 hour, pulverizes and sieves and obtains 200～400 object micropowders;
The 3rd step: add the microcrystalline Cellulose with respect to 0.2～0.4 times of its quality, the lactose of 0.1～0.2 times, the starch of 0.2～0.3 times in the micropowders obtaining at second step, sieve, mix homogeneously, granulate, dry, add the magnesium stearate with respect to 0.002～0.02 times of micropowders quality, granulate, tabletting, makes.
The present invention also provides the preparation method of above-mentioned Chinese medicine, and the dosage form of described Chinese medicine is granule, and its preparation method comprises the following steps:
The first step: described raw medicinal material is mixed in described ratio, add the ethanol that the determining alcohol with respect to 3～5 times, mixture is 85%～95%, be heated to boiling reflux 1～3 hour, filter, adopt percolation with the speed of 1～2ml per minute percolation slowly, collect percolate, the mastic that while being evaporated to 60～70 ℃ subsequently under vacuum 0.03～0.05Mpa, relative density is 1.00～1.02, spraying is dry, 170～180 ℃ of the inlet temperature of spray dryer, 80～90 ℃ of leaving air temps, be ground into subsequently powder, make dried cream powder;
Second step: in the dried cream powder obtaining, add with respect to the cane sugar powder of 0.2～0.4 times of dried cream powder quality and the dextrin of 0.1～0.3 times, granulation, in 50～60 ℃ dry, obtain granule.
Below adopt embodiment to describe embodiments of the present invention in detail, fully understand whereby how application technology means solve technical problem in the present invention, reach technique effect and implement according to this.
Embodiment 1 tablet
Get Radix Scrophulariae 160g, Radix Tinosporae 70g, Radix cynanchi wilfordii 110g, Herba Orchidis Latifoliae 340g, Herba Bidentis Tripartitae 310g, Herba monochoriae vaginalis 60g, Lindernia angustifolia (Benth.) Wettst. 130g, Herba Senecionis Argunensis 80g, Radix Euryae Chinensis 140g, Herba Ophioglossi 70g, Herba Tropaeoli 120g, Herba Hyperici Patuli 180g, Herba malachii aquatici 110g and Herba bidentis parviflorae 60g;
Preparation according to the following steps:
The first step: each raw medicinal material of described Chinese medicine preparation is mixed in proportion, adds the ethanol that the determining alcohol with respect to 5 times of mixture qualities is 50%, reflux 4 hours, extract, filter to obtain the first extracting solution, filter the medicinal residues that obtain and add again the ethanol that the determining alcohol with respect to 3 times of medicinal residues quality is 50%, reflux 2 hours, extract, filter and obtain the second extracting solution, the first extracting solution and the second extracting solution are merged, concentrating under reduced pressure is removed alcohol solvent, dry, obtain and get dry extract;
Second step: the dry cream that the first step is obtained is placed in super micron mill to be pulverized 2 hours, pulverizes and sieves and obtains 300 object micropowders;
The 3rd step: add the microcrystalline Cellulose with respect to 0.3 times of its quality, the lactose of 0.1 times, the starch of 0.2 times in the micropowders obtaining at second step, sieve, mix homogeneously, granulate, dry, add the magnesium stearate with respect to 0.008 times of micropowders quality, granulate, tabletting, makes.
Embodiment 2 granules
Get Radix Scrophulariae 180g, Radix Tinosporae 60g, Radix cynanchi wilfordii 140g, Herba Orchidis Latifoliae 310g, Herba Bidentis Tripartitae 340g, Herba monochoriae vaginalis 80g, Lindernia angustifolia (Benth.) Wettst. 110g, Herba Senecionis Argunensis 60g, Radix Euryae Chinensis 110g, Herba Ophioglossi 80g, Herba Tropaeoli 140g, Herba Hyperici Patuli 160g, Herba malachii aquatici 130g and Herba bidentis parviflorae 80g;
Preparation according to the following steps:
The first step: described raw medicinal material is mixed in described ratio, add the ethanol that the determining alcohol with respect to 3 times, mixture is 85%, be heated to boiling reflux 2 hours, filter, adopt percolation with the speed of 2ml per minute percolation slowly, collect percolate, the mastic that while being evaporated to 70 ℃ subsequently under vacuum 0.05Mpa, relative density is 1.02, spraying is dry, 180 ℃ of the inlet temperature of spray dryer, 90 ℃ of leaving air temps, be ground into subsequently powder, make dried cream powder;
Second step: in the dried cream powder obtaining, add with respect to the cane sugar powder of 0.4 times of dried cream powder quality and the dextrin of 0.2 times, granulation, in 60 ℃ dry, obtain granule.
Toxicity test:
Acute toxicity testing: 60 of application mices, male and female half and half, body weight 30-40g, carries out acute toxicity test.Mice is divided into two groups at random, be matched group and administration group, before experiment, fasting is 12 hours, and the Chinese medicinal tablet of embodiments of the invention 1 preparation is dissolved in water, (concentration is 8.12g crude drug/ml, maximum concentration) gavage, gavage volume is 5ml/kg (being that single-dose dosage is 40.6 crude drugs/kg), matched group gives equivalent normal saline, administration in one day 2 times, delivery time 6 hours, after administration, Continuous Observation is 14 days, and record mice toxic reaction and death toll.Experimental result shows: with matched group comparison, after administration, mice has no notable difference, experiment Continuous Observation 14 days, and mice overall health of patients, diet, drinking-water, body weight gain are all normal.Mice oral administration gavage tablet of the present invention is LD50>40.6 crude drug/kg, and every day, maximum dosage-feeding was 81.2 crude drugs/kg/ day.Chinese medicine clinical application amount of the present invention is 8.4g crude drug/day/people, becomes body weight for humans in 60KG, and average dosage is 0.14g crude drug/kg/ day.By weighing machine: the dosis tolerata of mice (average weight take 35g) oral administration gavage Chinese medicine of the present invention is quantity 580 times.Therefore Chinese medicine acute toxicity of the present invention is extremely low, clinical drug safety.
Long term toxicity test: Chinese medicine embodiment 1 tablet of the present invention to mice by 14.21,21.38 and 15 weeks (1.0ml/100g body weight of 42.12g crude drug/kg continuous use, every day 2 times) and drug withdrawal after 3 weeks, result shows: Chinese medicine of the present invention all has no significant effect indexs such as the hair of mice, behavior, defecation, body weight, organ weights, hemogram, hepatic and renal function, blood glucose, blood fat, internal organs naked eyes do not find that difference changes and histological examination result shows, medication 15 weeks and drug withdrawal are after 3 weeks, and Organs of Mice is all without obviously changing.Illustrate that toxicity is little after Chinese medicine of the present invention is to mice long-term prescription, after drug withdrawal, also there is no difference reaction, application safety.
Clinical data:
Case selection: whole 85 routine cases are my Out-patient Department patient of in February, 2010～2013 year February.Patient is divided into treatment group and matched group at random, treatment group 43 people wherein, 18～48 years old age, average (36 ± 7.3) year, the course of disease 1～10 year, average (4.8 ± 2.5) year, 2.4 times/year of recurrence frequencies, light-duty ulcer 16 examples, heavy ulcer 18 examples, herpetiform ulceration 9 examples; Matched group 42 people, 19～49 years old age, average (35 ± 8.4) year, the course of disease 1～10 year, average (4.6 ± 2.2) year, 2 times/year of recurrence frequencies, light-duty ulcer 16 examples, heavy ulcer 19 examples, herpetiform ulceration 7 examples.Two groups at aspects such as age, the course of disease, symptoms Epidemiological Analysis there was no significant difference (p>0.05) by statistics.
Western medicine diagnose standard: 1, medical history rule: (1) recurrent: have pathogenic process of re current history at least 2 times; (2) spontaneity; (3) periodically.2, clinical manifestation: (1) stomatocace is single or several outbreaks repeatedly, and the intermission is irregular; (2) ulcer happening part is more common in non-keratinization mucosa; (3) ulcer is rounded or oval, and center depression, has congested blush around, and there is yellow pseudomembrane on surface; (4) light-duty ulcer diameter 2-5mm, stomatitis type (herpes sample) ulcer diameter is slightly little, can occur more than ten aphthas that are dispersed in distribution to dozens of; Heavy (periglandular aphthae) ulcer can reach Submucosa deeply, Chang Danfa, and diameter is greater than 5mm, often leaves cicatrix after more.(5) ulcer pain is obvious.
Chinese medical discrimination type of hyperactivity of fire caused by deficiency of YIN syndrome: ulcer is shown effect repeatedly, differs in size, circular or oval, be lark, there is a little exudate, neat in edge is clear, and slightly protuberance, around with narrow blush, has slight causalgia around.Dizziness and tinnitus, vexed impatient, feverish sensation in the palms and soles, soreness of the waist and knees, yellowish urine, dry stool.The tip of the tongue or body of the tongue are partially red, tire BOHUANG, deep-thready pulse or thin stringy and rapid pulse.
Meet above-mentioned Western medicine diagnose standard and Chinese medical discrimination type of hyperactivity of fire caused by deficiency of YIN patient, include clinical trial scope in.
Therapeutic Method: treatment group: give 1 tablet every day of the embodiment of the present invention 3 times, each 4,1 week course for the treatment of;
Matched group: conventional western medicine: vitamin B complex tablet is oral, each 2, every day 3 times, VITAMIN C TABLET is oral, each 200mg, every day 3 times, prednisone is oral, each 10-20mg, every day 1 time, 1 week course for the treatment of.
Curative effect judging standard: cure: oral ulcer stops recurrence more than 1 year; Effective: after dental ulcer treatment, in 6 months, do not recur, or total intermittent time (evaluating the period without ulcer temporal summation) to extend and total ulcer number (evaluating period ulcer recurrence number summation) reduces; Effective: total intermittent time (the evaluation period is without ulcer temporal summation) extends and total ulcer number (evaluating period ulcer recurrence number summation) nothing changes, or total intermittent time (evaluating the period without ulcer temporal summation) reduces without change and total ulcer number (evaluating period ulcer recurrence number summation); Invalid: total intermittent time (evaluating the period without ulcer temporal summation) and total ulcer number (evaluating period ulcer recurrence number summation) are without changing.
Therapeutic outcome: general curative effect comparison before and after two groups of treatments, in Table 1.
Table 1 liang group total effects comparison
| Group | n | Cure | Effective | Effectively | Invalid | Effectively total |
| Treatment group | 43 | 20 | 14 | 6 | 3 | 40(93.02％) |
| Matched group | 42 | 12 | 12 | 10 | 8 | 34(80.95％) |
Two groups of curative effect comparison: p<0.05
Ulcer healing required time and recurrence, in Table 2.As shown in Table 2: treatment group is short compared with matched group ulcer healing required time, in 1 year, recur number of cases and number of times is few.Two groups of curative effect comparing differences have very significant.
Table 2 ulcer healing required time and recurrence comparison in 1 year
| Group | n | Ulcer healing required time/d | In 1 year, recur number of cases | Recurrent number in 1 year |
| Treatment group | 43 | (4.1±1.5)d | 4 | 6 |
| Matched group | 42 | (6.9±2.7)d | 28 | 35 |
Model case: Wei, women, 34 years old.First visit on July 13 in 2012.Disease sees that ulcer shows effect repeatedly, differs in size, circular or oval, and center depression, is lark, has a little exudate, and neat in edge is clear, around with narrow blush, has slight causalgia around.Feverish sensation in the palms and soles, soreness of the waist and knees, yellowish urine, dry stool.Body of the tongue is partially red, tire BOHUANG, and deep-thready pulse, is diagnosed as type of hyperactivity of fire caused by deficiency of YIN recurrent oral ulceration.Take 1 tablet every day of Chinese medicine embodiment of the present invention 3 times, each 4, treat recovery from illness afterwards in 5 days, follow up a case by regular visits to not recurrence in 1 year.
The above, be only preferred embodiment of the present invention, is not the present invention to be done to the restriction of other form, and any those skilled in the art may utilize the technology contents of above-mentioned announcement to be changed or be modified as the equivalent embodiment of equivalent variations.But every technical solution of the present invention content that do not depart from, any simple modification, equivalent variations and the remodeling above embodiment done according to technical spirit of the present invention, still belong to the protection domain of technical solution of the present invention.
Claims (9)
1. a Chinese medicine for the treatment of type of hyperactivity of fire caused by deficiency of YIN recurrent oral ulceration, is characterized in that, each raw medicinal material of described Chinese medicine comprises: Radix Scrophulariae, Radix Tinosporae, Radix cynanchi wilfordii, Herba Orchidis Latifoliae, Herba Bidentis Tripartitae, Herba monochoriae vaginalis, Lindernia angustifolia (Benth.) Wettst., Herba Senecionis Argunensis, Radix Euryae Chinensis, Herba Ophioglossi, Herba Tropaeoli, Herba Hyperici Patuli, Herba malachii aquatici and Herba bidentis parviflorae.
2. Chinese medicine as claimed in claim 1, is characterized in that, the ratio of weight and number of described each raw medicinal material of Chinese medicine is as follows: 15～25 parts of Radix Scrophulariaes, 5～15 parts of Radix Tinosporaes, 10～20 parts of Radix cynanchi wilfordii, 30～40 parts of Herba Orchidis Latifoliae, 30～40 parts of Herba Bidentis Tripartitaes, 5～15 parts of Herba monochoriae vaginaliss, 10～20 parts of Lindernia angustifolia (Benth.) Wettst.s, 5～15 parts of Herba Senecionis Argunensiss, 10～20 parts of Radix Euryae Chinensiss, 5～15 parts of Herba Ophioglossis, 10～20 parts of Herba Tropaeolis, 15～25 parts of Herba Hyperici Patulis, 5～15 parts of 10～20 parts of Herba malachii aquaticis and Herba bidentis parvifloraes.
3. Chinese medicine as claimed in claim 1 or 2, is characterized in that, the ratio of weight and number of described each raw medicinal material of Chinese medicine is as follows: 15～20 parts of Radix Scrophulariaes, 5～10 parts of Radix Tinosporaes, 10～15 parts of Radix cynanchi wilfordii, 30～35 parts of Herba Orchidis Latifoliae, 30～35 parts of Herba Bidentis Tripartitaes, 5～10 parts of Herba monochoriae vaginaliss, 10～15 parts of Lindernia angustifolia (Benth.) Wettst.s, 5～10 parts of Herba Senecionis Argunensiss, 10～15 parts of Radix Euryae Chinensiss, 5～10 parts of Herba Ophioglossis, 10～15 parts of Herba Tropaeolis, 15～20 parts of Herba Hyperici Patulis, 5～10 parts of 10～15 parts of Herba malachii aquaticis and Herba bidentis parvifloraes.
4. the Chinese medicine as described in claims 1 to 3, is characterized in that, the ratio of weight and number of described each raw medicinal material of Chinese medicine is as follows: 16 parts of Radix Scrophulariaes, 7 parts of Radix Tinosporaes, 11 parts of Radix cynanchi wilfordii, 34 parts of Herba Orchidis Latifoliae, 31 parts of Herba Bidentis Tripartitaes, 6 parts of Herba monochoriae vaginaliss, 13 parts of Lindernia angustifolia (Benth.) Wettst.s, 8 parts of Herba Senecionis Argunensiss, 14 parts of Radix Euryae Chinensiss, 7 parts of Herba Ophioglossis, 12 parts of Herba Tropaeolis, 18 parts of Herba Hyperici Patulis, 6 parts of 11 parts of Herba malachii aquaticis and Herba bidentis parvifloraes.
5. the Chinese medicine as described in claims 1 to 3, is characterized in that, the ratio of weight and number of described each raw medicinal material of Chinese medicine is as follows: 18 parts of Radix Scrophulariaes, 6 parts of Radix Tinosporaes, 14 parts of Radix cynanchi wilfordii, 31 parts of Herba Orchidis Latifoliae, 34 parts of Herba Bidentis Tripartitaes, 8 parts of Herba monochoriae vaginaliss, 11 parts of Lindernia angustifolia (Benth.) Wettst.s, 6 parts of Herba Senecionis Argunensiss, 11 parts of Radix Euryae Chinensiss, 8 parts of Herba Ophioglossis, 14 parts of Herba Tropaeolis, 16 parts of Herba Hyperici Patulis, 8 parts of 13 parts of Herba malachii aquaticis and Herba bidentis parvifloraes.
6. the Chinese medicine as described in claim 1 to 5, is characterized in that, the dosage form of described Chinese medicine is tablet, and its preparation method comprises the following steps:
The first step: each raw medicinal material of described Chinese medicine preparation is mixed in proportion, add the ethanol that the determining alcohol with respect to 5～7 times of mixture qualities is 50～60%, reflux 2～4 hours, extract, filter and obtain the first extracting solution, the medicinal residues that filter to obtain add the ethanol that the determining alcohol with respect to 2～3 times of medicinal residues quality is 50～60% again, reflux 1～2 hour, extract, filter and obtain the second extracting solution, the first extracting solution and the second extracting solution are merged, concentrating under reduced pressure is removed alcohol solvent, dry, obtain and get dry extract;
Second step: the dry cream that the first step is obtained is placed in super micron mill to be pulverized 1～2 hour, pulverizes and sieves and obtains 200～400 object micropowders;
The 3rd step: add the microcrystalline Cellulose with respect to 0.2～0.4 times of its quality, the lactose of 0.1～0.2 times, the starch of 0.2～0.3 times in the micropowders obtaining at second step, sieve, mix homogeneously, granulate, dry, add the magnesium stearate with respect to 0.002～0.02 times of micropowders quality, granulate, tabletting, makes.
7. the Chinese medicine as described in claim 1 to 5, is characterized in that, the dosage form of described Chinese medicine is granule, and its preparation method comprises the following steps:
The first step: described raw medicinal material is mixed in described ratio, add the ethanol that the determining alcohol with respect to 3～5 times, mixture is 85%～95%, be heated to boiling reflux 1～3 hour, filter, adopt percolation with the speed of 1～2ml per minute percolation slowly, collect percolate, the mastic that while being evaporated to 60～70 ℃ subsequently under vacuum 0.03～0.05Mpa, relative density is 1.00～1.02, spraying is dry, 170～180 ℃ of the inlet temperature of spray dryer, 80～90 ℃ of leaving air temps, be ground into subsequently powder, make dried cream powder;
Second step: in the dried cream powder obtaining, add with respect to the cane sugar powder of 0.2～0.4 times of dried cream powder quality and the dextrin of 0.1～0.3 times, granulation, in 50～60 ℃ dry, obtain granule.
8. a preparation method for Chinese medicine described in claim 1 to 5, is characterized in that, the dosage form of described Chinese medicine is tablet, and its preparation method comprises the following steps:
The first step: each raw medicinal material of described Chinese medicine preparation is mixed in proportion, add the ethanol that the determining alcohol with respect to 5～7 times of mixture qualities is 50～60%, reflux 2～4 hours, extract, filter and obtain the first extracting solution, the medicinal residues that filter to obtain add the ethanol that the determining alcohol with respect to 2～3 times of medicinal residues quality is 50～60% again, reflux 1～2 hour, extract, filter and obtain the second extracting solution, the first extracting solution and the second extracting solution are merged, concentrating under reduced pressure is removed alcohol solvent, dry, obtain and get dry extract;
Second step: the dry cream that the first step is obtained is placed in super micron mill to be pulverized 1～2 hour, pulverizes and sieves and obtains 200～400 object micropowders;
The 3rd step: add the microcrystalline Cellulose with respect to 0.2～0.4 times of its quality, the lactose of 0.1～0.2 times, the starch of 0.2～0.3 times in the micropowders obtaining at second step, sieve, mix homogeneously, granulate, dry, add the magnesium stearate with respect to 0.002～0.02 times of micropowders quality, granulate, tabletting, makes.
9. a preparation method for Chinese medicine described in claim 1 to 5, is characterized in that, the dosage form of described Chinese medicine is granule, and its preparation method comprises the following steps:
The first step: described raw medicinal material is mixed in described ratio, add the ethanol that the determining alcohol with respect to 3～5 times, mixture is 85%～95%, be heated to boiling reflux 1～3 hour, filter, adopt percolation with the speed of 1～2ml per minute percolation slowly, collect percolate, the mastic that while being evaporated to 60～70 ℃ subsequently under vacuum 0.03～0.05Mpa, relative density is 1.00～1.02, spraying is dry, 170～180 ℃ of the inlet temperature of spray dryer, 80～90 ℃ of leaving air temps, be ground into subsequently powder, make dried cream powder;
Second step: in the dried cream powder obtaining, add with respect to the cane sugar powder of 0.2～0.4 times of dried cream powder quality and the dextrin of 0.1～0.3 times, granulation, in 50～60 ℃ dry, obtain granule.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105920352A (en) * | 2016-06-29 | 2016-09-07 | 姚拥军 | Traditional Chinese medicine for treating esophagus cancer and preparation method thereof |
| CN106491885A (en) * | 2016-11-29 | 2017-03-15 | 广西大学 | A kind of spray for treating oral ulcer |
-
2014
- 2014-06-17 CN CN201410267238.0A patent/CN104013815A/en active Pending
Non-Patent Citations (1)
| Title |
|---|
| 周雯 等: "复发性口腔溃疡辨治体会", 《河南医药信息》 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105920352A (en) * | 2016-06-29 | 2016-09-07 | 姚拥军 | Traditional Chinese medicine for treating esophagus cancer and preparation method thereof |
| CN106491885A (en) * | 2016-11-29 | 2017-03-15 | 广西大学 | A kind of spray for treating oral ulcer |
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Application publication date: 20140903 |