CN103520409A - Chinese herba preparation for treating secretory otitis media and preparation method thereof - Google Patents
Chinese herba preparation for treating secretory otitis media and preparation method thereof Download PDFInfo
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Abstract
The invention provides a Chinese herba preparation for treating secretory otitis media and a preparation method thereof. The Chinese herba preparation comprises the following raw medicine materials: saxifraga stolonifera, sterculia nobilis shell, polygonum chinense, myriactis nepalensis, phoenix-tail fern, radix tinosporae, calamus, root of abutilon indicum, rust-brown crotalaria, piemarker, pomelo leaf, lysimachia fortune, pseudodrynaria coronans and small-leaved lemmaphyllum. The Chinese herba preparation has effects of dispelling wind and clearing heat, removing dampness and freeing orifice, and promoting qi to activate blood, has definite curative effect for secretory otitis media, and has small toxic and side effects.
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 preparation for the treatment of secretory otitis media and preparation method thereof.
Background technology
Secretory otitis media is to take the middle ear apyetous inflammatory diseases that middle ear effusion and auditory dysesthesia be feature, is called again secretory otitis media, non-suppurative otitis media, MOM, catarrhal otitis media, hydrotympanum, otitis media serosa, serosity-MOM, aseptic otitis media.If hydrops and thickness and be gelatin person, be called again secretory otitis media.The vexed swollen sense of the ear of take after upper respiratory tract infection, to listen the remote and auditory dysesthesia of sound be cardinal symptom.The visible tympanum of otology training inspection is amber or crocus, also visible air fluid level or bubble, and tympanum mobility reduces.Secretory otitis media child is common.Can cause child's hearing loss, affect speech development of speech, answer highly vigilant of and observe in time treatment.
Often apply clinically the western modern medicine treatments such as Decongestant, antibiotic, glucocorticoid, antihistaminic and operation.But effect is not satisfactory, and primary disease child falls ill morely, uses Western medicine class poisonous side effect of medicine larger, and child growth is had to adverse effect.
Secretory otitis media belongs to the traditional Chinese medical science " bulge of the ear ", " deafness " category.Refer to because exopathogen invasion and attack or the evil poison in ear feeling of distension and oppression of take due to being detained stops up the ear disease that sense, tinnitus, auditory dysesthesia are main manifestations.Bulge of the ear, deafness are the different phases of same disease, and bulge of the ear is at the beginning of disease, mostly is exopathogen and causes; Deafness is disease, due to evil poison delay.Bulge of the ear is controlled not in time or malpractice also may change deafness into.Therapeutic Principle is wind and heat dispersing, and dampness removing is sensible, promoting flow of QI and blood.
Summary of the invention
Technical problem to be solved by this invention is, a kind of Chinese medicine preparation for the treatment of secretory otitis media and preparation method thereof is provided, Chinese medicine preparation wind and heat dispersing of the present invention, and dampness removing is sensible, and promoting flow of QI and blood has definite curative effect to secretory otitis media, and toxic and side effects is little.
In order to solve the problems of the technologies described above, the invention provides a kind of Chinese medicine preparation for the treatment of secretory otitis media, its raw medicinal material comprises: Herba Saxifragae, Pericarpium Sterculiae nobilis, Herb Polygoni Chinensis, oil head grass, Herba Pteridis Multifidae, Radix Tinosporae, Rhizoma Acori Calami, Radix abutili indici, Herba Crotalariae Ferrugineae, Herba Abutili, Folium Citri grandis, Herba Lysimachiae Fortunei, precipice Rhizoma Zingiberis Recens and Lemmaphyllum microphullum Presl.
In described Chinese medicine preparation, the ratio of weight and number of each raw medicinal material is as follows: 5～15 parts of Herba Saxifragaes, 35～45 parts of Pericarpium Sterculiae nobiliss, 5～15 parts of Herb Polygoni Chinensiss, 10～20 parts of oil head grass, 10～20 parts of Herba Pteridis Multifidaes, 15～25 parts of Radix Tinosporaes, 15～25 parts of Rhizoma Acori Calamis, 10～20 parts of Radix abutili indicis, 5～15 parts of Herba Crotalariae Ferrugineaes, 35～45 parts of Herba Abutilis, 10～20 parts of Folium Citri grandis, 15～25 parts of Herba Lysimachiae Fortuneis, 15～25 parts of 10～20 parts of precipice Rhizoma Zingiberis Recens and Lemmaphyllum microphullum Presls.
In described Chinese medicine preparation, the ratio of weight and number of each raw medicinal material can be preferably: 5～10 parts of Herba Saxifragaes, 35～40 parts of Pericarpium Sterculiae nobiliss, 5～10 parts of Herb Polygoni Chinensiss, 10～15 parts of oil head grass, 10～15 parts of Herba Pteridis Multifidaes, 15～20 parts of Radix Tinosporaes, 15～20 parts of Rhizoma Acori Calamis, 10～15 parts of Radix abutili indicis, 5～10 parts of Herba Crotalariae Ferrugineaes, 35～40 parts of Herba Abutilis, 10～15 parts of Folium Citri grandis, 15～20 parts of Herba Lysimachiae Fortuneis, 15～20 parts of 10～15 parts of precipice Rhizoma Zingiberis Recens and Lemmaphyllum microphullum Presls.
In described Chinese medicine preparation, the ratio of weight and number of each raw medicinal material also can be preferably: 6 parts of Herba Saxifragaes, 38 parts of Pericarpium Sterculiae nobiliss, 7 parts of Herb Polygoni Chinensiss, 11 parts of oil head grass, 13 parts of Herba Pteridis Multifidaes, 18 parts of Radix Tinosporaes, 16 parts of Rhizoma Acori Calamis, 13 parts of Radix abutili indicis, 8 parts of Herba Crotalariae Ferrugineaes, 37 parts of Herba Abutilis, 12 parts of Folium Citri grandis, 18 parts of Herba Lysimachiae Fortuneis, 17 parts of 11 parts of precipice Rhizoma Zingiberis Recens and Lemmaphyllum microphullum Presls.
In described Chinese medicine preparation, the ratio of weight and number of each raw medicinal material also can be preferably: 7 parts of Herba Saxifragaes, 36 parts of Pericarpium Sterculiae nobiliss, 6 parts of Herb Polygoni Chinensiss, 13 parts of oil head grass, 11 parts of Herba Pteridis Multifidaes, 17 parts of Radix Tinosporaes, 19 parts of Rhizoma Acori Calamis, 11 parts of Radix abutili indicis, 9 parts of Herba Crotalariae Ferrugineaes, 39 parts of Herba Abutilis, 14 parts of Folium Citri grandis, 16 parts of Herba Lysimachiae Fortuneis, 19 parts of 13 parts of precipice Rhizoma Zingiberis Recens and Lemmaphyllum microphullum Presls.
The present invention also provides the preparation method of above-mentioned Chinese medicine preparation, and the dosage form of described Chinese medicine preparation 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 6～8 times of mixture qualities is 85～95%, reflux 1～3 hour, 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 3～4 times of medicinal residues quality is 85～95% 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 0.1～0.3 times in the micropowders obtaining at second step, sieve, mix homogeneously, granulate, dry, add the magnesium stearate with respect to 0.01～0.05 times of micropowders quality, granulate, tabletting, makes.
The present invention also provides the preparation method of above-mentioned Chinese medicine preparation, and the dosage form of described Chinese medicine preparation 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 4～8 times, mixture is 85%～95%, be heated to boiling reflux 3～5 hours, filter, adopt percolation with the speed of 1～2ml per minute percolation slowly, collect percolate, the mastic that while being evaporated to 50～60 ℃ subsequently under vacuum 0.06～0.09Mpa, relative density is 1.04～1.10, spraying is dry, 160～175 ℃ of the inlet temperature of spray dryer, 80～85 ℃ 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 0.1～0.2 times, granulation, in 40～50 ℃ dry, obtain granule.
Beneficial effect of the present invention: Chinese medicine preparation wind and heat dispersing of the present invention, dampness removing is sensible, and promoting flow of QI and blood has definite curative effect to secretory otitis media, and toxic and side effects is little.
The specific embodiment
The invention provides a kind of Chinese medicine preparation for the treatment of secretory otitis media, its raw medicinal material comprises: Herba Saxifragae, Pericarpium Sterculiae nobilis, Herb Polygoni Chinensis, oil head grass, Herba Pteridis Multifidae, Radix Tinosporae, Rhizoma Acori Calami, Radix abutili indici, Herba Crotalariae Ferrugineae, Herba Abutili, Folium Citri grandis, Herba Lysimachiae Fortunei, precipice Rhizoma Zingiberis Recens and Lemmaphyllum microphullum Presl.
In described Chinese medicine preparation, the pharmacology of each raw medicinal material is as follows:
Herba Saxifragae: bitter in the mouth, pungent, cold.Return lung, spleen, large intestine channel.Dispel the wind, heat clearing away, removing pathogenic heat from blood and toxic substance from the body.Control rubella; Eczema, otitis media, erysipelas, cough is spitted blood, lung abscess, metrorrhagia, haemorrhoids.Guangzhou army " conventional Chinese herbal medicine handbook ": damp eliminating detumescence, cooling blood for hemostasis, heat-clearing and toxic substances removing, controls traumatic hemorrhage, acute and chronic otitis media.
Pericarpium Sterculiae nobilis: sweet, flat.Return small intestine meridian.Blood-activating and qi-promoting.Main dysentery, inguinal hernia, hemorrhoid, otitis media.
Herb Polygoni Chinensis: acrid in the mouth, hardship, cool in nature.Clearing away heat-damp and promoting diuresis, removing pathogenic heat from blood and toxic substance from the body, suppressing the hyperactive liver improving eyesight, relaxing muscles and tendons to promote blood circulation.Main dysentery, has loose bowels, laryngopharynx swelling and pain, diphtheria, cough due to lung-heat, pertussis, hepatitis, leukorrhagia, cancerous protuberance, otitis media, eczema, vertigo and tinnitus, traumatic injury.Guangzhou army " conventional Chinese herbal medicine handbook ": eliminating damp-heat, stagnant removing toxic substances disappears.Control dysentery, enteritis, dyspepsia, hepatitis, tonsillitis, pharyngolaryngitis, furuncle and phyma, osteopatia sprain, dermatitis, eczema, pruritus.Nanchuan " conventional Chinese herbal medicine handbook ": replenishing qi and promoting blood flow, dispels the wind analgesic.Control weakness, wind heat, giddy, vim and vigour pain.
Oil head grass: taste is micro-pungent, property is flat.Heat-clearing and toxic substances removing, anti-inflammatory analgetic.Main dysentery, enteritis, otitis media, measles is sent out not smooth thoroughly, toothache, arthralgia.
Herba Pteridis Multifidae: light, micro-hardship, cool.Clearing away heat-damp and promoting diuresis, removing toxic substances dysentery relieving, cooling blood for hemostasis.For dysentery, gastroenteritis, hepatitis, urinary system infection, cat fever, laryngopharynx swelling and pain, leucorrhea, metrorrhagia, pesticide intoxication; Traumatic hemorrhage is controlled in external, burn and scald." classification medical herbs ": control all pyretic toxicity, detumescence, relieves inflammation or internal heat.Control carbuncle skin ulcer, acute mastitis, stranguria.
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." property of medicine is examined ": removing toxic substances.Throat numbness is anxious, and erosion of mucous membrane of the oral cavity should take.Cellulitis carbuncle carbuncle on the back, snakes and scorpions insect bite, mill is coated with.Control ophthalmalgia, bulge of the ear, cough due to heat, haze miasma, tells nosebleed, all outer diseases.Guangzhou army " conventional Chinese herbal medicine handbook ": heat-clearing and toxic substances removing, relieving sore throat and pain.Control diphtheria, acute pharyngolaryngitis, tonsillitis, heat syndrome cough aphonia, bacillary dysentery, traumatic injury, snakebite.
Rhizoma Acori Calami: hardship, pungent, temperature.Reduce phlegm, have one's ideas straightened out, spleen invigorating, dampness removing.Control epilepsy, palpitate with fear forgetful, obnubilation, humidity hysteresis painful abdominal mass is swollen, dysentery, rheumatalgia, carbuncle scabies." Chinese herbal medicine is commonly used in Shanghai ": tranquillizing and allaying excitement, reduce phlegm, stomach invigorating.Control epilepsy, tinnitus, is thick of hearing, and breast abdominal distention is vexed." Jilin Chinese herbal medicine ": awakening consciousness, and in ward off turbid.Training the mind dusk, tinnitus, forgetful, humidity hysteresis vent plug.
Radix abutili indici: sweet in the mouth, property is flat, nontoxic.Enter spleen, lung, urinary bladder channel.Clearing away heat-damp and promoting diuresis, sensible invigorating blood circulation.Cure mainly xeropulmonary cough, stomachache, stomachache, has loose bowels, stranguria, hernia, traumatic injury, Hiccough and deaf." Guangxi Chinese medicinal herbal ": heat clearing away, damp eliminating, sensible, removing heat from blood.Control infirmities and diseases, xeropulmonary cough.
Herba Crotalariae Ferrugineae: hardship, micro-acid, cold.Return lung meridian.The gas of astringing the lung, spleen reinforcing kidney, diuresis, detumescence poison.Control chronic cough expectorant blood, tinnitus, deafness, nocturnal emission, chronic nephritis, cystitis, renal calculus, tonsillitis, lymphadenitis, furunculosis, malignant boil." vegetation is side just ": invigorating the spleen and replenishing QI, treat tinnitus, the head is giddy, collapses pouring." classification medical herbs ": large spleen reinforcing kidney, control deafness, the deficiency of vital energy.
Herba Abutili: hardship, flat.Return spleen, stomach warp.Clearing away heat-damp and promoting diuresis, removing toxic substances is had one's ideas straightened out.Main dysentery, otitis media, tinnitus, deafness, orchitis, suppurative tonsillitis, swollen ulcer drug." Chinese herbal medicine is commonly used in Shanghai ": herb: removing toxic substances, dispel the wind.Control dysentery, otitis media, tinnitus, deafness, joint aches.
Folium Citri grandis: pungent, hardship, temperature.Return liver, spleen channel.Promoting the circulation of QI to relieve pain, removing toxic substances and promoting subsidence of swelling.Main wind syndrome of head pain, arthralgia due to cold-dampnes, dyspepsia stomachache, acute mastitis, tonsillitis, otitis media.
Herba Lysimachiae Fortunei: hardship, puckery, flat.Invigorate blood circulation, dissipating blood stasis, diuretic, removing dampness.Control traumatic injury, joint rheumatalgia, women's amenorrhea, acute mastitis, scrofula, conjunctival congestion and swelling pain, edema, yellow cellulitis, malaria, dysentery.Jiangxi " medical herbs handbook ": control gastritis, mastitis, otitis media, women leucorrhea." Fujian Chinese herbal medicine ": the circulation of qi promoting of dispeling the wind, promoting blood circulation to remove obstruction in the collateral.
Precipice Rhizoma Zingiberis Recens: hardship, micro-puckery, temperature.Expelling wind and removing dampness, relaxing muscles and tendons and activating QI and blood in the collateral.For rheumatalgia, traumatic injury, fracture, otitis media.
Lemmaphyllum microphullum Presl: sweet, micro-hardship, cold.Return lung, liver, stomach warp.Heat-clearing and toxic substances removing, cooling blood for hemostasis, nourishing the lung to arrest cough.For cough due to lung-heat, pulmonary abscess, hemoptysis of pulmonary tuberculosis, laryngopharynx swelling and pain, parotitis, dysentery, tuberculous lymphadenitis, epistaxis, hematuria, has blood in stool, metrorrhagia; Furuncle swelling toxin is controlled in external, skin pruritus, otitis media.
In described Chinese medicine preparation, the ratio of weight and number of each raw medicinal material is as follows: 5～15 parts of Herba Saxifragaes, 35～45 parts of Pericarpium Sterculiae nobiliss, 5～15 parts of Herb Polygoni Chinensiss, 10～20 parts of oil head grass, 10～20 parts of Herba Pteridis Multifidaes, 15～25 parts of Radix Tinosporaes, 15～25 parts of Rhizoma Acori Calamis, 10～20 parts of Radix abutili indicis, 5～15 parts of Herba Crotalariae Ferrugineaes, 35～45 parts of Herba Abutilis, 10～20 parts of Folium Citri grandis, 15～25 parts of Herba Lysimachiae Fortuneis, 15～25 parts of 10～20 parts of precipice Rhizoma Zingiberis Recens and Lemmaphyllum microphullum Presls.
In described Chinese medicine preparation, the ratio of weight and number of each raw medicinal material can be preferably: 5～10 parts of Herba Saxifragaes, 35～40 parts of Pericarpium Sterculiae nobiliss, 5～10 parts of Herb Polygoni Chinensiss, 10～15 parts of oil head grass, 10～15 parts of Herba Pteridis Multifidaes, 15～20 parts of Radix Tinosporaes, 15～20 parts of Rhizoma Acori Calamis, 10～15 parts of Radix abutili indicis, 5～10 parts of Herba Crotalariae Ferrugineaes, 35～40 parts of Herba Abutilis, 10～15 parts of Folium Citri grandis, 15～20 parts of Herba Lysimachiae Fortuneis, 15～20 parts of 10～15 parts of precipice Rhizoma Zingiberis Recens and Lemmaphyllum microphullum Presls.
In described Chinese medicine preparation, the ratio of weight and number of each raw medicinal material also can be preferably: 6 parts of Herba Saxifragaes, 38 parts of Pericarpium Sterculiae nobiliss, 7 parts of Herb Polygoni Chinensiss, 11 parts of oil head grass, 13 parts of Herba Pteridis Multifidaes, 18 parts of Radix Tinosporaes, 16 parts of Rhizoma Acori Calamis, 13 parts of Radix abutili indicis, 8 parts of Herba Crotalariae Ferrugineaes, 37 parts of Herba Abutilis, 12 parts of Folium Citri grandis, 18 parts of Herba Lysimachiae Fortuneis, 17 parts of 11 parts of precipice Rhizoma Zingiberis Recens and Lemmaphyllum microphullum Presls.
In described Chinese medicine preparation, the ratio of weight and number of each raw medicinal material also can be preferably: 7 parts of Herba Saxifragaes, 36 parts of Pericarpium Sterculiae nobiliss, 6 parts of Herb Polygoni Chinensiss, 13 parts of oil head grass, 11 parts of Herba Pteridis Multifidaes, 17 parts of Radix Tinosporaes, 19 parts of Rhizoma Acori Calamis, 11 parts of Radix abutili indicis, 9 parts of Herba Crotalariae Ferrugineaes, 39 parts of Herba Abutilis, 14 parts of Folium Citri grandis, 16 parts of Herba Lysimachiae Fortuneis, 19 parts of 13 parts of precipice Rhizoma Zingiberis Recens and Lemmaphyllum microphullum Presls.
The present invention also provides the preparation method of above-mentioned Chinese medicine preparation, and the dosage form of described Chinese medicine preparation 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 6～8 times of mixture qualities is 85～95%, reflux 1～3 hour, 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 3～4 times of medicinal residues quality is 85～95% 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 0.1～0.3 times in the micropowders obtaining at second step, sieve, mix homogeneously, granulate, dry, add the magnesium stearate with respect to 0.01～0.05 times of micropowders quality, granulate, tabletting, makes.
The present invention also provides the preparation method of above-mentioned Chinese medicine preparation, and the dosage form of described Chinese medicine preparation 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 4～8 times, mixture is 85%～95%, be heated to boiling reflux 3～5 hours, filter, adopt percolation with the speed of 1～2ml per minute percolation slowly, collect percolate, the mastic that while being evaporated to 50～60 ℃ subsequently under vacuum 0.06～0.09Mpa, relative density is 1.04～1.10, spraying is dry, 160～175 ℃ of the inlet temperature of spray dryer, 80～85 ℃ 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 0.1～0.2 times, granulation, in 40～50 ℃ 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 Herba Saxifragae 60g, Pericarpium Sterculiae nobilis 380g, Herb Polygoni Chinensis 70g, oil head grass 110g, Herba Pteridis Multifidae 130g, Radix Tinosporae 180g, Rhizoma Acori Calami 160g, Radix abutili indici 130g, Herba Crotalariae Ferrugineae 80g, Herba Abutili 370g, Folium Citri grandis 120g, Herba Lysimachiae Fortunei 180g, precipice Rhizoma Zingiberis Recens 110g and Lemmaphyllum microphullum Presl 170g;
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 6 times of mixture qualities is 95%, reflux 3 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 95%, reflux 1 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 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 0.2 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 0.02 times of micropowders quality, granulate, tabletting, makes.
Embodiment 2: granule
Get Herba Saxifragae 70g, Pericarpium Sterculiae nobilis 360g, Herb Polygoni Chinensis 60g, oil head grass 130g, Herba Pteridis Multifidae 110g, Radix Tinosporae 170g, Rhizoma Acori Calami 190g, Radix abutili indici 110g, Herba Crotalariae Ferrugineae 90g, Herba Abutili 390g, Folium Citri grandis 140g, Herba Lysimachiae Fortunei 160g, precipice Rhizoma Zingiberis Recens 130g and Lemmaphyllum microphullum Presl 190g;
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 6 times, mixture is 85%, be heated to boiling reflux 4 hours, filter, adopt percolation with the speed of 2ml per minute percolation slowly, collect percolate, the mastic that while being evaporated to 60 ℃ subsequently under vacuum 0.08Mpa, relative density is 1.07, spraying is dry, 170 ℃ of the inlet temperature of spray dryer, 85 ℃ 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 0.3 times of dried cream powder quality and the dextrin of 0.1 times, granulation, in 50 ℃ dry, obtain granule.
Toxicity test:
Acute toxicity testing: 60 of application mices, male and female half and half, body weight 23～30g, 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 7.28g crude drug/ml, maximum concentration) gavage, gavage volume is that 5ml/kg(is that single-dose dosage is 36.4 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 > 36.4 crude drugs/kg, every day, maximum dosage-feeding was 72.8 crude drugs/kg/ day.Chinese medicine preparation clinical application amount of the present invention is 6.4g crude drug/day/people, becomes body weight for humans in 60KG, and average dosage is 0.107g crude drug/kg/ day.By weighing machine: the dosis tolerata of mice (average weight take 26g) oral administration gavage Chinese medicine preparation of the present invention is quantity 680 times.Therefore Chinese medicine preparation acute toxicity of the present invention is extremely low, clinical drug safety.
Long term toxicity test: Chinese medicine preparation embodiment 1 tablet of the present invention to mice by 13.35,19.26 and 15 weeks (1.0ml/100g body weight of 38.33g crude drug/kg continuous use, every day 2 times) and drug withdrawal after 3 weeks, result shows: Chinese medicine preparation 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 preparation 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 90 examples (96 ear) case is my Out-patient Department patient of in JIUYUE, 2009～2012 year August, male's 50 examples (54 ear), women's 40 examples (42 ear), 6～60 years old age, the course of disease 1 month～3 years, 14 years old following child's 24 example.Cause of disease statistics: Upper Respiratory Tract Infection 50 Cases, nosal inflammation 18 examples, adenoid vegetation 8 examples, tonsillitis 7 examples, parotitis 4 examples, etiology unknown 3 examples; Acoustic immitance shows Type B curve 78 ears, and acoustic immitance shows C type curve 18 ears; Pure tone test shows transmission deafness 82 ears, mixed deafness 14 ears.
Be divided at random treatment group and matched group.Wherein: treatment group 45 people (48 ear), male 25 people (27 ear), women 20 people (21 ear), 6～60 years old age, the course of disease 1 month～3 years, 14 years old following child's 12 examples, cause of disease statistics: upper respiratory tract infection 26 examples, nosal inflammation 10 examples, adenoid vegetation 4 examples, tonsillitis 4 examples, parotitis 2 examples, etiology unknown 1 example; Acoustic immitance shows Type B curve 40 ears, and acoustic immitance shows C type curve 8 ears; Pure tone test shows transmission deafness 41 ears, mixed deafness 7 ears; Matched group 45 people (48 ear), male 25 people (27 ear), women 20 people (21 ear), 6～60 years old age, the course of disease 1 month～3 years, 14 years old following child's 12 examples, cause of disease statistics: upper respiratory tract infection 24 examples, nosal inflammation 8 examples, adenoid vegetation 4 examples, tonsillitis 3 examples, parotitis 2 examples, etiology unknown 2 examples; Acoustic immitance shows Type B curve 38 ears, and acoustic immitance shows C type curve 10 ears; Pure tone test shows transmission deafness 41 ears, mixed deafness 7 ears.Two groups of ages, sex, the course of disease, clinical manifestation and the equal not statistically significants of coincident with severity degree of condition comparing difference (p > 0.05).
Diagnosis basis and inclusive criteria: (1) clinical manifestation: have the symptoms such as tinnitus, ear are vexed, otalgia, auditory dysesthesia; (2) otoscopy: periosteum is complete, cave in, color is lead, pink or faint yellow, and nose air-blowing tympanum is pinched movable poor in the visible fluid level of some patients were; (3) pure tone test: transmission deafness or mixed deafness, moral integrity is led poor >=15dB; (4) acoustic immitance shows Type B or C type curve; (5) expectant treatment 1 month is invalid; (6) otalgia patient age is greater than 6 years old, can coordinate pure tone test.
Exclusion standard: have the pharyngeal opening of auditory tube mechanical obstruction person due to pathological changes around; There are bleeding tendency, nasopharynx part to have organic disease, hepatic and kidney function obstacle, have life-time service glucocorticoid person; Severe hypertension, angina pectoris, cardiac insufficiency or patients with arrhythmia, severe diabetes, thyroid disease or hepatic and kidney function obstacle person.
Therapeutic Method:
Treatment group: auripuncture drawing liquid is 1 time weekly, gives 1 tablet every day of the embodiment of the present invention 3 times, each 3.4 weeks 1 courses for the treatment of;
Matched group: auripuncture drawing liquid is 1 time weekly, attain for profit in oral west, each 10mg, every day 1 time; Bei Lai, each 30mg, every day 2 times.4 weeks 1 courses for the treatment of.
Curative effect judging standard: cure: the clinical symptom disappearance such as ear is vexed, auditory dysesthesia, tinnitus, tympanum position is normal, indicate clear, moral integrity is led poor≤10dB, acoustic immitance reverts to A type curve by Type B or C type curve; Effective: the clinical symptoms such as ear is vexed, auditory dysesthesia, tinnitus take a turn for the better or part disappears, tympanum position approaches normal position, but it is normal that mobility not yet reaches, it is clear that sign is owed, moral integrity is led poor >=10dB, but dwindle >=10dB before treating, acoustic immitance reverts to A type curve or C type curve by Type B curve, and C type curve reverts to A type curve or is still C type curve; Invalid: clinical symptoms and indices are all without improving.
Therapeutic outcome: in auripuncture drawing liquid process, in treatment group, 44 ears are extracted faint yellow water sample or mucoid liquid out weekly, and in matched group, 43 ears are extracted faint yellow water sample or mucoid liquid out.Treat respectively after 1 course for the treatment of for two groups, statistical result is referring to table 1 and table 2.As can be seen from Table 1, adopt treatment by Chinese herbs secretory otitis media of the present invention, with respect to Western medicine, on therapeutic effect, there is significant improvement; As can be seen from Table 2, adopt treatment by Chinese herbs secretory otitis media of the present invention, with respect to Western medicine, treating significantly shortening on the course for the treatment of.
After table 1 liang group is treated respectively 1 course for the treatment of, Clinical efficacy comparison is routine
| Group | n | Cure | Effectively | Invalid | Effectively total |
| Treatment group | 45 | 24 | 19 | 2 | 43(95.56%) |
| Matched group | 45 | 10 | 25 | 10 | 35(77.78%) |
Table 2 liang group is treated respectively healing number and time comparative example (%) after 1 course for the treatment of
| Group | Number of cases | Medication 2 weeks | Medication 3 weeks | Medication 4 weeks |
| Treatment group | 24 | 3(12.5%) | 13(54.2%) | 8(33.3%) |
| Matched group | 10 | 0(0%) | 4(40%) | 6(60%) |
Known according to the clinical statistics in above table, that Chinese medicine provided by the invention has is rapid-action, effective percentage is high, determined curative effect, safe, the advantage that has no side effect; The 10 routine patients that the 24 routine patients that simultaneously treatment group cured and matched group are cured follow up a case by regular visits to respectively 1 year, result statistics, and the routine patient for the treatment of group 24 is without recurrence, and relapse rate is 0%; The routine patient of matched group 10, recurs 2 people, relapse rate 20%.
Concrete case 1: Zhao, male, 6 years old, because of auditory dysesthesia, the child that finds in month often to feel to whisper do not hear, saw gourds is serious, cough is severe, eats cough medicine always and is exactly the ，Lai hospital of not getting better and seek medical advice, on inspection, be diagnosed as because adenoid vegetation causes secretory otitis media, give 1 secondary tympanic membrane tapping weekly, take 1 tablet every day of Chinese medicine preparation embodiment of the present invention 3 times simultaneously, each 3, treat after 3 weeks, recovery from illness, follows up a case by regular visits to not recurrence in 1 year.
Concrete case 2: Wang, male, 30 years old.Before 1 year, occurred that ear is vexed, auditory dysesthesia, the symptoms such as tinnitus do not proceed to my institute after other hospitalizes, otoscopy: periosteum is complete, cave in, color pinkiness, pinches nose air-blowing tympanum movable poor, pure tone test: transmission deafness, moral integrity is led poor >=20dB, acoustic immitance shows Type B curve.Be diagnosed as secretory otitis media.Give 1 secondary tympanic membrane tapping weekly, take 1 tablet every day of Chinese medicine preparation embodiment of the present invention 3 times simultaneously, each 3, to treat after 4 weeks, recovery from illness, follows 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 preparation for the treatment of secretory otitis media, is characterized in that, each raw medicinal material of described Chinese medicine preparation comprises: Herba Saxifragae, Pericarpium Sterculiae nobilis, Herb Polygoni Chinensis, oil head grass, Herba Pteridis Multifidae, Radix Tinosporae, Rhizoma Acori Calami, Radix abutili indici, Herba Crotalariae Ferrugineae, Herba Abutili, Folium Citri grandis, Herba Lysimachiae Fortunei, precipice Rhizoma Zingiberis Recens and Lemmaphyllum microphullum Presl.
2. Chinese medicine preparation as claimed in claim 1, is characterized in that: the ratio of weight and number of described each raw medicinal material of Chinese medicine preparation is as follows: 5～15 parts of Herba Saxifragaes, 35～45 parts of Pericarpium Sterculiae nobiliss, 5～15 parts of Herb Polygoni Chinensiss, 10～20 parts of oil head grass, 10～20 parts of Herba Pteridis Multifidaes, 15～25 parts of Radix Tinosporaes, 15～25 parts of Rhizoma Acori Calamis, 10～20 parts of Radix abutili indicis, 5～15 parts of Herba Crotalariae Ferrugineaes, 35～45 parts of Herba Abutilis, 10～20 parts of Folium Citri grandis, 15～25 parts of Herba Lysimachiae Fortuneis, 15～25 parts of 10～20 parts of precipice Rhizoma Zingiberis Recens and Lemmaphyllum microphullum Presls.
3. Chinese medicine preparation 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 preparation is as follows: 5～10 parts of Herba Saxifragaes, 35～40 parts of Pericarpium Sterculiae nobiliss, 5～10 parts of Herb Polygoni Chinensiss, 10～15 parts of oil head grass, 10～15 parts of Herba Pteridis Multifidaes, 15～20 parts of Radix Tinosporaes, 15～20 parts of Rhizoma Acori Calamis, 10～15 parts of Radix abutili indicis, 5～10 parts of Herba Crotalariae Ferrugineaes, 35～40 parts of Herba Abutilis, 10～15 parts of Folium Citri grandis, 15～20 parts of Herba Lysimachiae Fortuneis, 15～20 parts of 10～15 parts of precipice Rhizoma Zingiberis Recens and Lemmaphyllum microphullum Presls.
4. the Chinese medicine preparation 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 preparation is as follows: 6 parts of Herba Saxifragaes, 38 parts of Pericarpium Sterculiae nobiliss, 7 parts of Herb Polygoni Chinensiss, 11 parts of oil head grass, 13 parts of Herba Pteridis Multifidaes, 18 parts of Radix Tinosporaes, 16 parts of Rhizoma Acori Calamis, 13 parts of Radix abutili indicis, 8 parts of Herba Crotalariae Ferrugineaes, 37 parts of Herba Abutilis, 12 parts of Folium Citri grandis, 18 parts of Herba Lysimachiae Fortuneis, 17 parts of 11 parts of precipice Rhizoma Zingiberis Recens and Lemmaphyllum microphullum Presls.
5. the Chinese medicine preparation 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 preparation is as follows: 7 parts of Herba Saxifragaes, 36 parts of Pericarpium Sterculiae nobiliss, 6 parts of Herb Polygoni Chinensiss, 13 parts of oil head grass, 11 parts of Herba Pteridis Multifidaes, 17 parts of Radix Tinosporaes, 19 parts of Rhizoma Acori Calamis, 11 parts of Radix abutili indicis, 9 parts of Herba Crotalariae Ferrugineaes, 39 parts of Herba Abutilis, 14 parts of Folium Citri grandis, 16 parts of Herba Lysimachiae Fortuneis, 19 parts of 13 parts of precipice Rhizoma Zingiberis Recens and Lemmaphyllum microphullum Presls.
6. the Chinese medicine preparation as described in claim 1 to 5, is characterized in that: when the dosage form of described Chinese medicine preparation is tablet, 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 6～8 times of mixture qualities is 85～95%, reflux 1～3 hour, 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 3～4 times of medicinal residues quality is 85～95% 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 0.1～0.3 times in the micropowders obtaining at second step, sieve, mix homogeneously, granulate, dry, add the magnesium stearate with respect to 0.01～0.05 times of micropowders quality, granulate, tabletting, makes.
7. the Chinese medicine preparation as described in claim 1 to 5, is characterized in that: when the dosage form of described Chinese medicine preparation is granule, 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 4～8 times, mixture is 85%～95%, be heated to boiling reflux 3～5 hours, filter, adopt percolation with the speed of 1～2ml per minute percolation slowly, collect percolate, the mastic that while being evaporated to 50～60 ℃ subsequently under vacuum 0.06～0.09Mpa, relative density is 1.04～1.10, spraying is dry, 160～175 ℃ of the inlet temperature of spray dryer, 80～85 ℃ 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 0.1～0.2 times, granulation, in 40～50 ℃ dry, obtain granule.
8. the preparation method of Chinese medicine preparation described in a claim 1 to 5.It is characterized in that: the dosage form of described Chinese medicine preparation 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 6～8 times of mixture qualities is 85～95%, reflux 1～3 hour, 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 3～4 times of medicinal residues quality is 85～95% 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 0.1～0.3 times in the micropowders obtaining at second step, sieve, mix homogeneously, granulate, dry, add the magnesium stearate with respect to 0.01～0.05 times of micropowders quality, granulate, tabletting, makes.
9. a preparation method for Chinese medicine preparation described in claim 1 to 5, is characterized in that: the dosage form of described Chinese medicine preparation 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 4～8 times, mixture is 85%～95%, be heated to boiling reflux 3～5 hours, filter, adopt percolation with the speed of 1～2ml per minute percolation slowly, collect percolate, the mastic that while being evaporated to 50～60 ℃ subsequently under vacuum 0.06～0.09Mpa, relative density is 1.04～1.10, spraying is dry, 160～175 ℃ of the inlet temperature of spray dryer, 80～85 ℃ 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 0.1～0.2 times, granulation, in 40～50 ℃ dry, obtain granule.
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| CN104189497A (en) * | 2014-09-16 | 2014-12-10 | 黄传峰 | Chinese medicinal preparation for treating secretory otitis media and preparation method thereof |
| CN104491827A (en) * | 2015-01-12 | 2015-04-08 | 刘玉娥 | Traditional Chinese medicine preparation for preventing postpartum hemorrhage and preparation method thereof |
| CN105456541A (en) * | 2015-12-30 | 2016-04-06 | 张晓莉 | Traditional Chinese medicine for treating wind-heat upper accumulation type secretory otitis media and preparation method thereof |
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| CN101455743A (en) * | 2007-12-12 | 2009-06-17 | 天津市中宝制药有限公司 | Ear drops for treating urgent and chronic otitis media |
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| CN101455743A (en) * | 2007-12-12 | 2009-06-17 | 天津市中宝制药有限公司 | Ear drops for treating urgent and chronic otitis media |
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| 吴莉佳: "益聪汤治疗药毒性耳聋举隅", 《实用中医药杂志》, vol. 15, no. 02, 28 February 1999 (1999-02-28), pages 43 - 44 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN104189497A (en) * | 2014-09-16 | 2014-12-10 | 黄传峰 | Chinese medicinal preparation for treating secretory otitis media and preparation method thereof |
| CN104491827A (en) * | 2015-01-12 | 2015-04-08 | 刘玉娥 | Traditional Chinese medicine preparation for preventing postpartum hemorrhage and preparation method thereof |
| CN105456541A (en) * | 2015-12-30 | 2016-04-06 | 张晓莉 | Traditional Chinese medicine for treating wind-heat upper accumulation type secretory otitis media and preparation method thereof |
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