CN105287775A - Method for preparing traditional Chinese medicine preparation capable of treating suppurative otitis media through external application - Google Patents
Method for preparing traditional Chinese medicine preparation capable of treating suppurative otitis media through external application Download PDFInfo
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Abstract
The invention discloses a method for preparing a traditional Chinese medicine preparation capable of treating suppurative otitis media through external application, belonging to the technical field of traditional Chinese medicine. The preparation method comprises the steps of smashing fresh dandelion and juicing, purifying and concentrating sophora flavescens and coptidis rhizome, smashing borneol, dried alum, cuttlebone, dragon bone and musk, grinding, then uniformly mixing the obtained components, adding sesame oil, and stirring to obtain Chinese medicine effective ingredient thin paste. Compared with the existing technology, the traditional Chinese preparation prepared by the preparation method has the technical advantages of being good in effect, quick in result, high in cure rate and difficult in relapse and the like in the treatment of suppurative otitis media, particularly, chronic suppurative otitis media and recurrent otitis media are easily eradicated, and the curative effect is especially obvious. In addition, the traditional Chinese medicine preparation is stable in effect of medicine, convenient to carry and use, simple in preparation process, low in production cost, easy in production transformation and greater social value is created.
Description
Technical field
The invention belongs to technical field of Chinese medicine, relate to a kind of method preparing the Chinese medicine preparation of external application for curing suppurative otitis media.
Background technology
Suppurative otitis media is the suppurative inflammation of middle ear mucosa, is apt to occur in child, be also children's's hearing loss commonly encountered diseases because of.Infectious disease common childhood period that acute suppurative otitis media being, sickness rate is high, easily recurs, complication and sequela many.The auxiliary examinations such as otoscopy, ear's palpation contribute to making a definite diagnosis suppurative otitis media.Infection control, adequate drainage, removing the cause of disease is its Therapeutic Principle.
Suppurative otitis media, suppurates as feature with auditory meatus.Multiplely be born in child.Belong to " otopyosis ", " chronic suppurative otitis media " etc. in Chinese medicine.Be commonly called as " rotten ear ", " eardrum ".Being divided into acute and chronic two large classes to treat primary disease more than clinical, in acute stage as thoroughly do not cured, then delay being become chronic.According to clinical manifestation, primary disease can be divided into two class pattern of syndrome: liver and gall wet fire syndrome and syndrome of hyperactivity of fire due to deficiency of YIN.
1, syndrome of hyperactivity of fire due to deficiency of YIN: for a long time or repeatedly purulent ear, pus is thin, or stream mucus, when in time, go out only, or foul smelling gas, ear not bitterly or hypodynia, auditory dysesthesia, soreness of the waist and knees, diseases caused by exogenous pathogenic factor whenever, then exacerbation of symptoms, can with tinnitus, otalgia, headache, dizzy, low grade fever, mental weariness, the few tongue of red tongue, thready and rapid pulse.Be more common in chronic suppurative otitis media.Controlling should nourishing YIN to lower pathogenic fire.
2, liver and gall wet fire syndrome: purulent ear, the course of disease is heavier, or auditory dysesthesia, and in ear has feeling of distension and oppression sense, otalgia, tinnitus, or has heating, aversion to cold, bitter taste in the mouth and dry throat, yellowish or reddish urine, constipation, red tongue, yellow and greasy fur, wiry and frequent pulse.Be more common in acute otitis media, or chronic otitis media acute attack.Suppurate if continue, pus is how and yellow thick, has fish-stench, otalgia, irritability etc., is then more common in chronic suppurative otitis media again.Control suitable sharp liver and gall, clearing away damp-heat.
Summary of the invention
The technical problem to be solved in the present invention is that exploitation is a kind of can the Chinese medicine preparation and preparation method thereof of external application for curing suppurative otitis media.In order to solve this technical problem, inventor is according to self tcm clinical practice experience for many years, with Chinese medical theory knowledge, to the meticulous compatibility of Chinese crude drug, obtain a prescription, then in conjunction with the effect in the feature of modern Chinese medicine preparation process and clinical practice, the dosage of medical material is carried out to the prescription begun to take shape and kind is repeatedly groped and adjusts, the Chinese prescription that final invention one is brand-new and its preparation method, thus obtained preparation has very significant therapeutic effect to acute-chronic purulent otitis media.This Chinese prescription is expressed as with weight portion: Radix Sophorae Flavescentis 6-24 part, Borneolum Syntheticum 3-10 part, Oleum Sesami 20-45 part, dried Alumen 4-13 part, fresh Herba Taraxaci 30-70 part, Endoconcha Sepiae 6-19 part, Os Draconis 5-17 part, Moschus 0.1-1 part, Rhizoma Coptidis 6-20 part.
In practice process, the preferred prescription proportioning with better curative effect is out respectively:
1, Radix Sophorae Flavescentis 15 parts, Borneolum Syntheticum 6 parts, 30 parts, Oleum Sesami, dried Alumen 9 parts, fresh Herba Taraxaci 50 parts, Endoconcha Sepiae 12 parts, Os Draconis 11 parts, 0.5 part, Moschus, Rhizoma Coptidis 13 parts.
2, Radix Sophorae Flavescentis 18 parts, Borneolum Syntheticum 7 parts, 35 parts, Oleum Sesami, dried Alumen 8 parts, fresh Herba Taraxaci 60 parts, Endoconcha Sepiae 11 parts, Os Draconis 12 parts, 0.3 part, Moschus, Rhizoma Coptidis 11 parts.
The preparation method of Chinese medicine preparation of the present invention is following steps:
(1), ingredients is taken by prescription proportion speed;
(2), by fresh Herba Taraxaci clean up, drain, pulverizing is squeezed the juice, and filters, obtains Herba Taraxaci juice, for subsequent use;
(3), Radix Sophorae Flavescentis, Rhizoma Coptidis are pulverized respectively, add the distilled water of initial medical material 7-15 times weight, soak 8-24 hour, backflow decocts 1-6 hour, filters, then adds the distilled water of initial weight 4-11 times weight, backflow decocts 1-5 hour, filter and retain filtering residue, merging filtrate, being concentrated into 55 DEG C of relative densities is that the concentrated solution of 1.20-1.25 is for subsequent use;
(4), by step (2) gained Herba Taraxaci juice mix homogeneously with step (3) gained concentrated solution, low temperature (30-40 DEG C) concentrates, and drying under reduced pressure obtains dry extract, pulverizes grinding, crosses 80-120 mesh sieve, obtains fine powder a;
(5), Borneolum Syntheticum, dried Alumen, Endoconcha Sepiae, Os Draconis, Moschus be dry, pulverize levigate respectively, cross 80-120 mesh sieve, be mixed to get fine powder b, for subsequent use;
(6), by fine powder a and fine powder b mix homogeneously, add Oleum Sesami and stir, the rare cream of Effective Component of Chinese Medicine can be obtained;
(7), by the rare cream of step (6) gained Effective Component of Chinese Medicine, add suitable adjuvant, utilize modern general Chinese medicine preparation technology to make clinical required finished product Chinese medicine preparation, as dosage forms such as oleol, fluid extract, tincture, opacifiers, ointments.
The character Characteristic of Chinese medicine preparation of the present invention Chinese crude drug used:
Radix Sophorae Flavescentis: this product is the dry root of leguminous plant Radix Sophorae Flavescentis.Bitter in the mouth, cold in nature; GUIXIN, liver, stomach, large intestine, urinary bladder channel; Heat clearing and damp drying, parasite killing, diuresis.
Borneolum Syntheticum: point BORNEOLUM SYNTHETICUM and Blumeae preparatum Tabellae two class.BORNEOLUM SYNTHETICUM is the Borneolum Syntheticum that raw material synthesizes through chemical method with Oleum Terebinthinae, Camphora etc.; Blumeae preparatum Tabellae is the crystallization of fresh leaf through steam distillation, cooling gained of Compositae Herba Blumeae Balsamiferae platymiscium Balsamiferou Blumea Herb, also known as " Chinese mugwort powder " or " sheeting ".Acrid in the mouth, hardship, cold nature; GUIXIN, spleen, lung meridian; To have one's ideas straightened out refreshment, clearing away heat to alleviate pain.
Oleum Sesami: this product is the fatty oil that the mature seed milling process of Pedaliaceae plant sesame obtains.Sweet in the mouth, cool in nature; Enter meridian of Hand-YANG MING; Moistening dryness for relaxing bowels, removing toxic substances, granulation promoting.
Dried Alumen: have another name called calcined Alumen.Get and pick clean Alumen, put heating in marmite and dissolve and be calcined to dried-up, take out, be irregular crystalline solid, not of uniform size, colourless, transparent or semitransparent, surface is slightly level and smooth or uneven, and the fine and closely woven vertical rib of tool, has hyaloid gloss.Puckery, cool in nature; Return lung, liver two warp; Expectorant, dampness, antidiarrheal, hemostasis, removing toxic substances, parasite killing.
Fresh Herba Taraxaci: this product is feverfew Herba Taraxaci, alkali ground Herba Taraxaci or belong to the dry herb of several plants together.Bitter in the mouth, sweet, cold in nature; Return liver, stomach warp; Heat-clearing and toxic substances removing, dispersing swelling and dissipating binds, inducing diuresis for treating stranguria syndrome.
Endoconcha Sepiae: this product is the dry inner shell of Sepiidae animal sepiella maindroni de Rochebrune or golden cuttlefish.Salty in the mouth, puckery, warm in nature; Return spleen, kidney channel; Astringing to arrest bleeding, relieving leukorrhea by astringents, antacid, sore.
Os Draconis: for ancient times mammal as if the Skeletal Fossils of class, rhinoceros class, Hippocampal cortex etc.Sweet-puckery flavor, property is put down; GUIXIN, liver, kidney, large intestine channel; Tranquillizing the mind by relieving convulsion, suppressing the hyperactive liver and subsiding YANG, astringent or styptic treatment for spontaneous sweating, convergence.
Moschus: this product is the dry secretions in the ripe male body note capsule of animal in deer family woods Moschus moschiferous, horse Moschus moschiferous or former Moschus moschiferous.Acrid in the mouth, warm in nature; GUIXIN, spleen channel; To have one's ideas straightened out refreshment, promoting blood circulation to restore menstrual flow, reducing swelling and alleviating pain.
Rhizoma Coptidis: this product is the dry rhizome of ranunculaceae plant Rhizoma Coptidis, Coptis deltoidea C.Y.Cheng et Hsiao or Coptis Teeta Wall.Bitter in the mouth, cold in nature; GUIXIN, spleen, stomach, liver, gallbladder, large intestine channel; Heat clearing and damp drying, eliminating fire and detoxication.
The side of Chinese medicine preparation prescription of the present invention separates:
Chinese prescription of the present invention is with Radix Sophorae Flavescentis, Oleum Sesami, fresh Herba Taraxaci for monarch drug, heat clearing and damp drying, parasite killing diuresis, removing toxic substances and promoting granulation, heat-clearing and toxic substances removing, dispersing swelling and dissipating binds; With Endoconcha Sepiae, Os Draconis, Rhizoma Coptidis for ministerial drug, astringing to arrest bleeding, antacid sore, astringent or styptic treatment for spontaneous sweating convergence, eliminating fire and detoxication; With dried Alumen, Borneolum Syntheticum for adjuvant drug, dampness hemostasis, removing toxic substances parasite killing, clearing away heat to alleviate pain; With Moschus for making medicine, promoting blood circulation to restore menstrual flow, reducing swelling and alleviating pain; The all medicines of monarch coordinate, and synergism, assists each other, jointly reaches the effects such as parasite killing diuresis, removing toxic substances and promoting granulation, dispersing swelling and dissipating binds, astringing to arrest bleeding, clearing away heat to alleviate pain, promoting blood circulation to restore menstrual flow, has very significant curative effect to acute-chronic purulent otitis media.
The present invention is the purposes of claimed above-mentioned Chinese medicine preparation in the therapeutic purulent otitis media medicine of preparation also.
Compared with prior art, Chinese medicine preparation of the present invention has following technical advantage:
1, therapeutic effect is good, instant effect, cure rate are high, not easily recur;
2, easily dig up the roots to the otitis media of chronic suppurative otitis media, recurrent exerbation, curative effect is especially remarkable;
3, preparation efficacy stability, carry with easy to use, preparation technology is easy, production cost is low, is easy to produce transform create larger social value.
Detailed description of the invention
In order to verify the feasibility of technique and prescription, and provide test medication for follow-up test, inventors performed the production operation of following examples, therefore, protection scope of the present invention includes but are not limited to the scope of following examples.
Embodiment 1
Fluid extract is produced with the optimal processing parameter of the arbitrary value within the scope of Chinese prescription medical material of the present invention and preparation method
(1), Radix Sophorae Flavescentis 2400g, Borneolum Syntheticum 300g, Oleum Sesami 4000g, dried Alumen 500g, fresh Herba Taraxaci 6700g, Endoconcha Sepiae 1200g, Os Draconis 1600g, Moschus 50g, Rhizoma Coptidis 2000g is taken by prescription proportion speed;
(2), by fresh Herba Taraxaci clean up, drain, pulverizing is squeezed the juice, and filters, obtains Herba Taraxaci juice, for subsequent use;
(3), Radix Sophorae Flavescentis, Rhizoma Coptidis are pulverized respectively, add the distilled water of initial medical material 12 times of weight, soak 12 hours, backflow decoction 3 hours, filters, then adds the distilled water of initial weight 7 times of weight, backflow decoction 2 hours, filter, merging filtrate, being concentrated into 55 DEG C of relative densities is that the concentrated solution of 1.20-1.25 is for subsequent use;
(4), by step (2) gained Herba Taraxaci juice mix homogeneously with step (3) gained concentrated solution, low temperature (35 DEG C) concentrates, and drying under reduced pressure obtains dry extract, pulverizes grinding, crosses 100 mesh sieves, obtains fine powder a;
(5), Borneolum Syntheticum, dried Alumen, Endoconcha Sepiae, Os Draconis, Moschus be dry, pulverize levigate respectively, cross 100 mesh sieves, be mixed to get fine powder b, for subsequent use;
(6), by fine powder a and fine powder b mix homogeneously, add Oleum Sesami and stir, the rare cream of Effective Component of Chinese Medicine can be obtained;
(7), by the rare cream of step (6) gained Effective Component of Chinese Medicine, add suitable adjuvant, utilize modern general Chinese medicine preparation technology to make fluid extract, specification: 0.36g crude drug/g fluid extract.
Embodiment 2
Fluid extract is produced with the optimal processing parameter of the medical material value of the preferred prescription 1 of Chinese medicine of the present invention and preparation method
(1), Radix Sophorae Flavescentis 1500g, Borneolum Syntheticum 600g, Oleum Sesami 3000g, dried Alumen 900g, fresh Herba Taraxaci 5000g, Endoconcha Sepiae 1200g, Os Draconis 1100g, Moschus 50g, Rhizoma Coptidis 1300g is taken by prescription proportion speed;
(2), by fresh Herba Taraxaci clean up, drain, pulverizing is squeezed the juice, and filters, obtains Herba Taraxaci juice, for subsequent use;
(3), Radix Sophorae Flavescentis, Rhizoma Coptidis are pulverized respectively, add the distilled water of initial medical material 12 times of weight, soak 12 hours, backflow decoction 3 hours, filters, then adds the distilled water of initial weight 7 times of weight, backflow decoction 2 hours, filter, merging filtrate, being concentrated into 55 DEG C of relative densities is that the concentrated solution of 1.20-1.25 is for subsequent use;
(4), by step (2) gained Herba Taraxaci juice mix homogeneously with step (3) gained concentrated solution, low temperature (35 DEG C) concentrates, and drying under reduced pressure obtains dry extract, pulverizes grinding, crosses 100 mesh sieves, obtains fine powder a;
(5), Borneolum Syntheticum, dried Alumen, Endoconcha Sepiae, Os Draconis, Moschus be dry, pulverize levigate respectively, cross 100 mesh sieves, be mixed to get fine powder b, for subsequent use;
(6), by fine powder a and fine powder b mix homogeneously, add Oleum Sesami and stir, the rare cream of Effective Component of Chinese Medicine can be obtained;
(7), by the rare cream of step (6) gained Effective Component of Chinese Medicine, add suitable adjuvant, utilize modern general Chinese medicine preparation technology to make fluid extract, specification: 0.36g crude drug/g fluid extract.
Embodiment 3
Fluid extract is produced with the optimal processing parameter of the medical material value of the preferred prescription 2 of Chinese medicine of the present invention and preparation method
(1), Radix Sophorae Flavescentis 1800g, Borneolum Syntheticum 700g, Oleum Sesami 3500g, dried Alumen 800g, fresh Herba Taraxaci 6000g, Endoconcha Sepiae 1100g, Os Draconis 1200g, Moschus 30g, Rhizoma Coptidis 1100g is taken by prescription proportion speed;
(2), by fresh Herba Taraxaci clean up, drain, pulverizing is squeezed the juice, and filters, obtains Herba Taraxaci juice, for subsequent use;
(3), Radix Sophorae Flavescentis, Rhizoma Coptidis are pulverized respectively, add the distilled water of initial medical material 12 times of weight, soak 12 hours, backflow decoction 3 hours, filters, then adds the distilled water of initial weight 7 times of weight, backflow decoction 2 hours, filter, merging filtrate, being concentrated into 55 DEG C of relative densities is that the concentrated solution of 1.20-1.25 is for subsequent use;
(4), by step (2) gained Herba Taraxaci juice mix homogeneously with step (3) gained concentrated solution, low temperature (35 DEG C) concentrates, and drying under reduced pressure obtains dry extract, pulverizes grinding, crosses 100 mesh sieves, obtains fine powder a;
(5), Borneolum Syntheticum, dried Alumen, Endoconcha Sepiae, Os Draconis, Moschus be dry, pulverize levigate respectively, cross 100 mesh sieves, be mixed to get fine powder b, for subsequent use;
(6), by fine powder a and fine powder b mix homogeneously, add Oleum Sesami and stir, the rare cream of Effective Component of Chinese Medicine can be obtained;
(7), by the rare cream of step (6) gained Effective Component of Chinese Medicine, add suitable adjuvant, utilize modern general Chinese medicine preparation technology to make fluid extract, specification: 0.36g crude drug/g fluid extract.
Embodiment 4
Fluid extract is produced with the optimal processing parameter of Chinese prescription medical material minima of the present invention and preparation method
(1), Radix Sophorae Flavescentis 600g, Borneolum Syntheticum 300g, Oleum Sesami 2000g, dried Alumen 400g, fresh Herba Taraxaci 3000g, Endoconcha Sepiae 600g, Os Draconis 500g, Moschus 10g, Rhizoma Coptidis 600g is taken by prescription proportion speed;
(2), by fresh Herba Taraxaci clean up, drain, pulverizing is squeezed the juice, and filters, obtains Herba Taraxaci juice, for subsequent use;
(3), Radix Sophorae Flavescentis, Rhizoma Coptidis are pulverized respectively, add the distilled water of initial medical material 12 times of weight, soak 12 hours, backflow decoction 3 hours, filters, then adds the distilled water of initial weight 7 times of weight, backflow decoction 2 hours, filter, merging filtrate, being concentrated into 55 DEG C of relative densities is that the concentrated solution of 1.20-1.25 is for subsequent use;
(4), by step (2) gained Herba Taraxaci juice mix homogeneously with step (3) gained concentrated solution, low temperature (35 DEG C) concentrates, and drying under reduced pressure obtains dry extract, pulverizes grinding, crosses 100 mesh sieves, obtains fine powder a;
(5), Borneolum Syntheticum, dried Alumen, Endoconcha Sepiae, Os Draconis, Moschus be dry, pulverize levigate respectively, cross 100 mesh sieves, be mixed to get fine powder b, for subsequent use;
(6), by fine powder a and fine powder b mix homogeneously, add Oleum Sesami and stir, the rare cream of Effective Component of Chinese Medicine can be obtained;
(7), by the rare cream of step (6) gained Effective Component of Chinese Medicine, add suitable adjuvant, utilize modern general Chinese medicine preparation technology to make fluid extract, specification: 0.36g crude drug/g fluid extract.
Embodiment 5
Fluid extract is produced with the optimal processing parameter of Chinese prescription medical material maximum of the present invention and preparation method
(1), Radix Sophorae Flavescentis 2400g, Borneolum Syntheticum 1000g, Oleum Sesami 4500g, dried Alumen 1300g, fresh Herba Taraxaci 7000g, Endoconcha Sepiae 1900g, Os Draconis 1700g, Moschus 100g, Rhizoma Coptidis 2000g is taken by prescription proportion speed;
(2), by fresh Herba Taraxaci clean up, drain, pulverizing is squeezed the juice, and filters, obtains Herba Taraxaci juice, for subsequent use;
(3), Radix Sophorae Flavescentis, Rhizoma Coptidis are pulverized respectively, add the distilled water of initial medical material 12 times of weight, soak 12 hours, backflow decoction 3 hours, filters, then adds the distilled water of initial weight 7 times of weight, backflow decoction 2 hours, filter, merging filtrate, being concentrated into 55 DEG C of relative densities is that the concentrated solution of 1.20-1.25 is for subsequent use;
(4), by step (2) gained Herba Taraxaci juice mix homogeneously with step (3) gained concentrated solution, low temperature (35 DEG C) concentrates, and drying under reduced pressure obtains dry extract, pulverizes grinding, crosses 100 mesh sieves, obtains fine powder a;
(5), Borneolum Syntheticum, dried Alumen, Endoconcha Sepiae, Os Draconis, Moschus be dry, pulverize levigate respectively, cross 100 mesh sieves, be mixed to get fine powder b, for subsequent use;
(6), by fine powder a and fine powder b mix homogeneously, add Oleum Sesami and stir, the rare cream of Effective Component of Chinese Medicine can be obtained;
(7), by the rare cream of step (6) gained Effective Component of Chinese Medicine, add suitable adjuvant, utilize modern general Chinese medicine preparation technology to make fluid extract, specification: 0.36g crude drug/g fluid extract.
The toxicity test of Chinese medicine preparation of the present invention
1, skin irritation test
(1), experimental technique
Depilatory is evenly coated by guinea pig back spinal column both sides, makes unhairing scope be about 20cm
2.Clean depilatory, return cage to observe 24 hours, often organize Cavia porcellus smears embodiment of the present invention 1-5 production respectively fluid extract in depilation district, 3g, 6g and 9g, respectively containing crude drug 1.08g, 2.16g and 3.24g, another group is coated with the every twice-daily of solvent 0.8ml, continuous one week, after experiment terminates, Cavia porcellus is put to death, the heart, liver, kidney and depilation skin do pathological examination.
(2), result
Above-mentioned three groups of medication Cavia porcellus trunks depilation district, having no local skin has edema, hyperemia, erythema, petechia and ulcer.Medication group Cavia porcellus chroma of hair, ingest, the matched group no significant difference such as extremity are movable, histopathologic examination, the administration group heart, liver, kidney and depilation skin with contrast word more also no significant difference.Result is pointed out, and Chinese medicine preparation of the present invention, without local irritant effect, also has no general toxicity performance.Show Chinese medicine for external application use safety of the present invention.
2, animal acute toxicity test research:
Fluid extract of the present invention, through trial test, can not measure LD
50, therefore measure maximum dosage-feeding.Adopt auditory meatus route of administration, the maximum dosage-feeding on the one recording mice is that 61.6g/kg(is in crude drug), be about 513.3 times (people is in 60kg) intending clinical people's consumption (clinical people's consumption is 0.12g crude drug/kg/d).The equal Continuous Observation of laboratory animal one week, its outward appearance sign, the mental status, diet, drinking-water, feces etc. are showed no obvious abnormalities.At the end of experiment, all healthy survival of animal, body weight increases.
3, long-term toxicity test for animals research:
Experimental design medicine of the present invention is high, in, low dose group, Matrix controls group and blank group, auditory meatus route of administration is adopted to give rat, dosage is respectively 9.6g/kg, 7.2g/kg and 4.8g/kg(is in crude drug), be equivalent to intend 80 of clinical patient consumption, 60 and 40 times, successive administration 3 months, in administration process, the body weight of each administration group and matrix group rat, dietary amount, outward appearance sign, behavioral activity, the mental status, hair color, feces character compares with blank group, no significant difference (P > 0.05), the weight of animals increasing value and Main Organ Coefficients and blank group comparing difference are not significantly (P > 0.05), hematology and the indivedual index of blood parameters check result administration group compare zero difference significantly (P > 0.05) with blank group, other indexs and blank comparing difference are not significantly (P > 0.05), administration phase and convalescent period histological examination high dose group animal main organs compare with blank group and have no notable difference, have no slowness toxicity to occur.
By above experiment, illustrate that Chinese medicine fluid extract of the present invention clinical application is safe.
The pharmacodynamic experiment of Chinese medicine preparation of the present invention
(1), Preparatory work of experiment
1, Experimental agents: the embodiment of the present invention 2, embodiment 3, prepared fluid extract, specification: 0.36g crude drug/g fluid extract, contrast medicine: ofloxacin ear drops.
2, laboratory animal: Cavia porcellus, Kun Ming mice, is provided by Fudan University's Experimental Animal Center.
3, statistical method: experimental result with
represent, adopt t inspection to measure the significance of group difference.
(2), experimental technique and result
1, on the impact of histamine phosphate's itch-threshold value:
Cavia porcellus 40, is divided into 4 groups at random, is the fluid extract of blank group, the medicine group 1(embodiment of the present invention 2 of the present invention preparation), the fluid extract of the medicine group 2(embodiment of the present invention 3 of the present invention preparation) and ofloxacin medicine group.1d before experiment, each group Cavia porcellus right back instep depilation coating 1 time.Experiment is worked as daily coarse sandpaper and is abraded right back instep depilation place epidermis 1cm
2, repaste medicine 1 time, after 20min, in scratch depilation, 0.01% histamine phosphate 0.05ml/ Mus is dripped in district, after this, every 3min successively with 0.02,0.03,0.04,0.05% ... the concentration increased progressively drop to Cavia porcellus later lick right back sufficient time histamine's total amount be itch-threshold value, the results are shown in Table 1.
Table 1 on Cavia porcellus caused by histamine phosphate itch threshold value impact (
, n=10)
Note: compare with saline control group, * * P < 0.01; Compare with ofloxacin medicine group,
△p < 0.05.
As shown in Table 1, no matter compare with normal saline group, be medicine group 1 of the present invention, group 2, or ofloxacin medicine group, the Cavia porcellus itch-threshold value all caused histamine phosphate reaches extremely significant diversity effect, shows that the two all has good itching-relieving action; Compare with ofloxacin medicine group, medicine group of the present invention obviously has raising Cavia porcellus itch-threshold value and also reaches significant diversity effect, and point out medicine of the present invention to have good antipruritic ability, this is very effective therapeutical effect for otitis media diseases.
2, antiinflammatory action
(1) impact, on mice ear: get mice 40, be divided into 4 groups at random, every day is administered once, gastric infusion 7d, after last administration 1h, be coated with dimethylbenzene 0.05ml, to 2h after dimethylbenzene in mouse right ear positive and negative, put to death animal, cut ear, sweep away auricle in corresponding site 8mm steel drift, weigh, with the difference of left and right ear weight for swelling degree, the results are shown in Table 2.
Table 2 xylol cause mice ear impact (
, n=10)
Note: compare with saline control group, * * P < 0.01; Compare with ofloxacin medicine group,
△p < 0.05.
(2), on the impact of mouse skin capillary permeability: get mice 40, be divided into 4 groups at random, every day is administered once, gastric infusion 7d, after last administration 1h, tail vein injection 1% Azo-Blue normal saline 0.1ml/10g body weight, and inject histamine 5ug(0.1ml in abdominal part depilation place Intradermal immediately).After 20min, put to death animal, cut blue dye skin graft, be soaked in acetone normal saline (7:3) mixed liquor, after 24min, centrifuging and taking supernatant, in 721 type spectrophotometer wavelength 610nm colorimetrics, the results are shown in Table 3.
Table 3 on the impact of mouse skin capillary permeability (
, n=10)
Note: compare with saline control group, * * P < 0.01; Compare with ofloxacin medicine group,
△p < 0.05.
(3) impact, on mice granuloma induced by implantation of cotton pellets: implant each 1 of 5mg sterilized cotton ball in oxter, mice left and right, grouping administration, every day 1 time, altogether 7d, after last administration 1h, put to death animal, get granuloma induced by implantation of cotton pellets, weigh (weight in wet base), the results are shown in Table 4.
Table 4 on the granulomatous impact of mice cotton balls number (
, n=10)
Note: compare with saline control group, * P < 0.05, * * P < 0.01; Compare with ofloxacin medicine group,
△p < 0.05.
(4), impact on inflammatory exudate PGE content: get mice 40, be divided into 4 groups at random, every day is administered once, gavage medicine 7d, after last administration 1h, in left sufficient plantar aponeurosis hemostasis 1% carrageenin 0.1ml/ only, after 3h, swollen foot is cut from Mus left hind joint, weigh, peeling shreds, steep 40min in 5ml normal saline, get supernatant 0.5ml, add 2ml10.5NKOH methanol solution, isomerization 20min in 50 DEG C of water-baths, add methanol dilution again to 20ml, its optical density is surveyed with 751 type spectrophotometer wavelength 278nm, try to achieve PGE total content, in table 5.
Table 5 on the impact of inflammatory exudate PGE content (
, n=10)
Note: compare with saline control group, * * P < 0.01; Compare with ofloxacin medicine group,
△p < 0.05.
Shown by the experimental result of table 2-5, medicine group of the present invention and ofloxacin medicine group all have good antiinflammatory action in the experiment of above-mentioned antiinflammatory, and compare with normal saline group, the two all reaches the difference of pole significance; Compare with ofloxacin medicine group, medicine group of the present invention all has the effect of the significance difference opposite sex in the antiinflammatory experiments such as the impact on mice ear, capillary permeability, granuloma induced by implantation of cotton pellets, inflammatory exudate PGE content; Above result of the test prompting: Chinese medicine preparation of the present invention has good antiinflammatory action, and this action intensity is significantly better than ofloxacin.
The clinical trial of Chinese medicine preparation of the present invention
The experimenter of this clinical trial all from certain First People's Hospital of city department of otorhinolaryngology, amounts to the clinical trial of 294 routine patient's voluntary participations, subject age 13-58 year, man 156 example, female 138 example.All patients have been made a definite diagnosis by hospital all suffers from suppurative otitis media.Above patient is divided into two groups at random: the fluid extract (specification: 0.36g crude drug/g fluid extract) that all patients for the treatment of group 1 produce by the embodiment of the present invention 2 drips the ear of inflammation, and each one, every day 3 times one week is a course for the treatment of, treats two courses for the treatment of continuously; The fluid extract that all patients for the treatment of group 2 produce by the embodiment of the present invention 3, Therapeutic Method is with treatment group 1; After treatment all terminates, statistics therapeutic outcome is as follows:
Treatment group 1: cure 112 examples, account for 76.2%; Effective 33 examples, account for 22.4%; Invalid 2 examples, 1.4%; Total effective rate is 98.6%;
Treatment group 2: cure 108 examples, account for 73.5%; Effective 36 examples, account for 24.5%; Invalid 3 examples, 2.0%; Total effective rate is 98.0%.
Result of the test shows, and the cure rate for the treatment of group 1 is up to 76.2%, and total effective rate is up to 98.6%, and the Chinese medicine preparation namely prepared by preparation method of the present invention has very significant curative effect to suppurative otitis media.Therefore, Chinese medicine preparation prepared by the present invention achieves breakthrough technological progress in therapeutic purulent otitis media, and its significant technical advantage indicates it and creationaryly to manifest.
Claims (4)
1. prepare a method for the Chinese medicine preparation of external application for curing suppurative otitis media, it is characterized in that, the preparation method of described Chinese medicine preparation is following steps:
(1), Radix Sophorae Flavescentis, Borneolum Syntheticum, Oleum Sesami, dried Alumen, fresh Herba Taraxaci, Endoconcha Sepiae, Os Draconis, Moschus, Rhizoma Coptidis ingredients is taken by prescription proportion speed;
(2), by fresh Herba Taraxaci clean up, drain, pulverizing is squeezed the juice, and filters, obtains Herba Taraxaci juice, for subsequent use;
(3), Radix Sophorae Flavescentis, Rhizoma Coptidis are pulverized respectively, add the distilled water of initial medical material 7-15 times weight, soak 8-24 hour, backflow decocts 1-6 hour, filters, then adds the distilled water of initial weight 4-11 times weight, backflow decocts 1-5 hour, filter and retain filtering residue, merging filtrate, being concentrated into 55 DEG C of relative densities is that the concentrated solution of 1.20-1.25 is for subsequent use;
(4), by step (2) gained Herba Taraxaci juice mix homogeneously with step (3) gained concentrated solution, concentrate at 30-40 DEG C, drying under reduced pressure obtains dry extract, pulverizes grinding, crosses 80-120 mesh sieve, obtains fine powder a;
(5), Borneolum Syntheticum, dried Alumen, Endoconcha Sepiae, Os Draconis, Moschus be dry, pulverize levigate respectively, cross 80-120 mesh sieve, be mixed to get fine powder b, for subsequent use;
(6), by fine powder a and fine powder b mix homogeneously, add Oleum Sesami and stir, obtain the rare cream of Effective Component of Chinese Medicine;
(7), by the rare cream of step (6) gained Effective Component of Chinese Medicine, add suitable adjuvant, utilize modern general Chinese medicine preparation technology to make clinical required finished product Chinese medicine preparation.
2. the method preparing the Chinese medicine preparation of external application for curing suppurative otitis media according to claim 1, it is characterized in that, with parts by weight, in described step (1), the prescription proportioning of each medical material is: Radix Sophorae Flavescentis 6-24 part, Borneolum Syntheticum 3-10 part, Oleum Sesami 20-45 part, dried Alumen 4-13 part, fresh Herba Taraxaci 30-70 part, Endoconcha Sepiae 6-19 part, Os Draconis 5-17 part, Moschus 0.1-1 part, Rhizoma Coptidis 6-20 part.
3. the method preparing the Chinese medicine preparation of external application for curing suppurative otitis media according to claim 2, it is characterized in that, with parts by weight, in described step (1), the prescription proportioning of each medical material is: Radix Sophorae Flavescentis 15 parts, Borneolum Syntheticum 6 parts, 30 parts, Oleum Sesami, dried Alumen 9 parts, fresh Herba Taraxaci 50 parts, Endoconcha Sepiae 12 parts, Os Draconis 11 parts, 0.5 part, Moschus, Rhizoma Coptidis 13 parts.
4. the method preparing the Chinese medicine preparation of external application for curing suppurative otitis media according to claim 2, it is characterized in that, with parts by weight, in described step (1), the prescription proportioning of each medical material is: Radix Sophorae Flavescentis 18 parts, Borneolum Syntheticum 7 parts, 35 parts, Oleum Sesami, dried Alumen 8 parts, fresh Herba Taraxaci 60 parts, Endoconcha Sepiae 11 parts, Os Draconis 12 parts, 0.3 part, Moschus, Rhizoma Coptidis 11 parts.
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| CN105853554A (en) * | 2016-06-02 | 2016-08-17 | 温州雏鹰科技有限公司 | Traditional Chinese medicine composition microfilament for treating tympanitis and preparation method thereof |
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| CN101293034A (en) * | 2008-06-16 | 2008-10-29 | 四川科伦药业股份有限公司 | Medicament composition for treating otitis medium and preparation thereof |
| CN102204938A (en) * | 2011-05-10 | 2011-10-05 | 布焕景 | Medicament for external use for treating otitis media |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101293034A (en) * | 2008-06-16 | 2008-10-29 | 四川科伦药业股份有限公司 | Medicament composition for treating otitis medium and preparation thereof |
| CN102204938A (en) * | 2011-05-10 | 2011-10-05 | 布焕景 | Medicament for external use for treating otitis media |
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| 韩广业等: "化脓性中耳炎治验", 《新中医》 * |
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| CN105853554A (en) * | 2016-06-02 | 2016-08-17 | 温州雏鹰科技有限公司 | Traditional Chinese medicine composition microfilament for treating tympanitis and preparation method thereof |
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Application publication date: 20160203 |