CN102370710A - Medicament for treating otitis media and preparation method thereof - Google Patents
Medicament for treating otitis media and preparation method thereof Download PDFInfo
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Abstract
The invention relates to a medicament for treating otitis media and a preparation method thereof. The medicament for treating otitis media comprises the following major raw materials by weight: 6-60 grams of honeysuckle flower, 6-60 grams of weeping forsythia, 6-55 grams of red-rooted salvia root, 0.2-10 grams of dried alum, 0.2-10 grams of borneol and 0.5-10 grams of boric acid. The preparation method of the medicament for treating otitis media comprises the following steps of: distilling the honeysuckle flower and the weeping forsythia twice with a steam distillation method, and collecting a distillate; putting the distillate into a distillation device for redistilling, and collecting a re-distillate; decocting a mother solution together with decoction dregs and the red-rooted salvia root in two times, filtering with gauze to obtain a filtrate, and concentrating the filtrate to obtain a concentrated solution; adding an ethanol precipitate into the concentrated solution for removing impurities to obtain an alcohol-free concentrated solution, and concentrating the alcohol-free concentrated solution to obtain a re-concentrated solution; combining the re-concentrated solution with the re-distillate, and sterilizing for 40 minutes to obtain a combined solution; and adding a medicinal liquid of dried alum, borneol and boric acid into the combined solution, and adjusting the medicinal liquid with 95 percent ethanol till the alcohol content is 65 percent and the pH value of the solution is 7.5 to obtain the medicament.
Description
Technical field
The present invention relates to medicine of treating otitis media and preparation method thereof.
Background technology
Suppurative otitis media belongs to the traditional Chinese medical science " glue ear " category, is chronic deficiency syndrome, how to be developed by acute glue ear.Near during the last ten years along with the increase of external environment variation and paathogenic factor, the sickness rate of suppurative otitis media also rises thereupon.The suppurative otitis media clinical manifestation is that long-term auditory meatus is suppurated, protracted course of disease, and the lighter shows as auditory dysesthesia, and severe patient can cause necrosis of bone, hinders to work normally study and life.If untimely treatment is very harmful.Mostly the medicine of at present treating glue ear is antibiotics, and reaching the effect of antibiotic, antiinflammatory, evacuation of pus, but traditional antibiotics has following significant disadvantages:
A, the treatment of traditional antibiotics be many can to play the effect of antibiotic, antiinflammatory, evacuation of pus, but often shows unfavorable effect for the answer of prognosis audition;
B, traditional antibiotics be for a long time with the increase that can cause toleration and since suppurative otitis media many should change into chronic, so life-time service causes the decline of therapeutic effect;
C, traditional antibiotics are treated, because clinical life-time service antibiotics causes the to a certain degree increase of drug-resistance of bacteria, cause therapeutic effect not obvious.
So now for suppurative otitis media definite medicine that is of no curative effect.
Summary of the invention
The objective of the invention is to avoid the deficiency of prior art that a kind of medicine of treating otitis media is provided.
Another purpose of the present invention is to provide a kind of process for preparing medicine of treating otitis media.The present invention mainly is to the acute-chronic purulent otitis media, is pure Chinese medicinal preparation.Remedied suppurative otitis media and be of no curative effect and confirm the blank of medicine, the shortcoming that can effectively avoid antibiotics and appeared.
For realizing above-mentioned purpose; The technical scheme that the present invention takes is: a kind of medicine of treating otitis media is characterized in that: its primary raw material is by weight ratio: Flos Lonicerae 6～60g, Fructus Forsythiae 6～60g, Radix Salviae Miltiorrhizae 6～55g, dried Alumen 0.2～10g, Borneolum Syntheticum 0.2～10g, boric acid 0.5～10g.
The medicine of described treatment otitis media is characterized in that raw material also includes by weight:
Radix Scutellariae 6～60g, Chalcanthitum 0.2～3g.
The medicine of described treatment otitis media is characterized in that raw material also includes by weight:
Furazolidone 0.2～5g, Flos Carthami 3～50g.
The medicine of described treatment otitis media is characterized in that raw material also includes by weight:
Indigo Naturalis 0.5～10g, Semen Persicae 6～60g.
The medicine of described treatment otitis media is characterized in that raw material also includes by weight:
Moschus 0.05～5g, metronidazole 0.2～2g.
The medicine of described treatment otitis media is characterized in that raw material also includes by weight:
Herba Asari 6～60g, nitrofural 0.2～5g.
The process for preparing medicine of described treatment otitis media is characterized in that step is:
(1) Flos Lonicerae; Fructus Forsythiae is collected distillate with steam distillation distillation twice, and the distillation liquid measure of collecting for the first time is a distillate: former medicine is 2:1); Collecting for the second time the distillation liquid measure is distillate: former medicine is 1:1, the distillate of twice collection is merged obtain distillate and medicinal residues;
(2) distillate is put into distilling apparatus and carry out redistillation, collect re-distilled liquid, the amount of re-distilled liquid is a re-distilled liquid: crude drug is 1:1, and remaining distillate is continued to employ;
(3) mother solution and medicinal residues, Radix Salviae Miltiorrhizae decoct together at twice, add 5 times of decoctings of crude drug amount for the first time and boil 1.5h, add 3 times of decoctings of crude drug amount for the second time and boil 1h; Filtered through gauze gets filtrate, with filtrate concentrate concentrated solution, the amount of said concentrated solution is a concentrated solution: filtrating is 1:2;
(4) the ethanol precipitation elimination impurity of adding 65% in said concentrated solution; Filter back concentrated solution heating in water bath and reclaim ethanol; Obtain not having pure concentrated solution, will not have pure concentrated solution again and concentrate and to obtain reconcentration liquid, the reconcentration liquid measure that obtains is a reconcentration liquid: crude drug is 1:1;
(5) merge reconcentration liquid and re-distilled liquid sterilization 40min and get amalgamation liquid;
(6) in amalgamation liquid, add dried Alumen, Borneolum Syntheticum, it is 65% to containing the alcohol amount that the medicinal liquid of boric acid, the ethanol of use 95% are regulated medicinal liquid, this moment, the solution pH value was 7.5, got patent medicine.
Further, in described step (3), Radix Scutellariae and Chalcanthitum have also been added.
Further, in described step (3), also add Flos Carthami, in described step (6), also added furazolidone.
Further, in described step (3), Indigo Naturalis and Semen Persicae have also been added.
Further, in described step (3), also added metronidazole, in described step (6), also having added the order number is 80～120 purpose Moschus powder.
Further, in described step (3), also add Herba Asari, in described step (6), also added nitrofural.
Radix Scutellariae: cure mainly diseases such as epidemic febrile disease, upper respiratory tract infection, cough due to lung-heat, damp and hot jaundice, pneumonia, dysentery, hemoptysis, conjunctival congestion, frequent fetal movement, hypertension, carbuncle furuncle.The clinical practice of Radix Scutellariae is antibiotic not worse than Rhizoma Coptidis, and does not develop immunity to drugs.Indigo Naturalis: heat-clearing and toxic substances removing, removing heat from blood, arresting convulsion.Be used for maculae caused by violent heat pathogen, heat in blood is told nosebleed, chest pain hemoptysis, aphtha, mumps, sore throat, pediatric epilepsy scared.Control the epidemic febrile disease intenseness of heat, macule is spitted blood, is spat blood, pediatric epilepsy scared, and skin ulcer is swollen, erysipelas, snake bite and insect sting.Semen Persicae: the effect of blood stasis dispelling blood, antiinflammatory action, anti-allergic effects.Chalcanthitum: emetic, putrefaction removing, detoxifcation; Control wind-phlegm and be jammed, sore throat, epilepsy, ulcerative gingivitis, aphtha, marginal blepharitis eye, hemorrhoid, toxic swelling.Furazolidone: furazolidone is an antibacterial, has wider antimicrobial spectrum.Flos Carthami: promoting blood circulation to restore menstrual flow, blood stasis removing pain relieving.Moschus: be the central nervous excitation agent, external can be eased pain, subsided a swelling.Metronidazole: tool wide spectrum anaerobe resistant and protozoacidal effect, clinical being mainly used in prevented and the microbial infection of treatment anaerobism.Herba Asari: have expelling wind and cold, understand things pain-stopping, the effect of warming the lung to resolve fluid-retention.1. calmness, analgesic activity 2. refrigeration functions 3. antiinflammatories, immunosuppressant and antiallergic action 4. improve metabolic function 5. antibiotic, antivirus action 6. local anesthetic actions of body.Nitrofural: clinical only as Cidex-7, be used for the infection of skin and mucosa, like suppurative otitis media, suppurative dermatitis etc.Several non-stimulated to organizing, pus, blood does not have obvious influence to its disinfective action.
The present invention compared with prior art has following advantage: this medicine is a pure Chinese medicinal preparation, and prescription is made up of Flos Lonicerae, dried Alumen, Borneolum Syntheticum etc.With drainage and detoxification, grabbing wet rot eradicates the effect.Directly splashing into ear uses; The direct Transdermal absorption of medicine after several minutes; Go deep into focus; Toleration, drug resistance and the unfavorable characteristics of prognosis audition that kill pathogenic organisms (being mainly streptococcus pneumoniae, hemophilus influenza etc.) is found effectively to avoid traditional antibiotic and appeared through the clinical observation in 7 years.That this medical instrument has is easy to use, lasting medicine, determined curative effect, characteristics such as have no side effect, and treatment time is short.Administration every day 3 times, each 2～3, all left and right sides state of an illness takes an evident turn for the better, and pus ends, and audition before has significant improvement, and mucous hyperemia disappears.For this medicine of clinical practice provides strong support.
1. the present invention is 96.67% to the effective percentage of acute suppurative otitis media or chronic acute attack; The effective percentage 93.33% of chronic suppurative otitis media; Total effective rate is 95%; And clinical control group (chloromycetin) is 86.67% to the effective percentage of acute suppurative otitis media or chronic acute attack, chronic suppurative otitis media effective percentage 80%, total effective rate 83.33%.Clinical research shows: curative effect of the present invention be superior to chloramphenicol ear drop (between group relatively F=4.22 0.025 p 0.05).
2. pharmacology of the present invention, toxicologic study show: the present invention has antiinflammatory, detumescence, analgesic effect to laboratory animal, acute toxicity test: using dosage is equivalent to 3000 times of the clinical consumption of people, does not see the overt toxicity reaction.Mucomembranous pungency test, irritation test show does not all have the significant stimulation effect.Show mucosa is had no side effect.
3. the HPLC method of setting up measures that the method for chlorogenic acid content among the present invention is easy and simple to handle, the result is accurate, highly sensitive, favorable reproducibility, the response rate is high, disturbs for a short time, can be used as the intrinsic quality control of the present invention.
Description of drawings
Fig. 1: be the schematic flow sheet of method for preparing of the present invention.
The specific embodiment
Below principle of the present invention and characteristic are described, institute gives an actual example and only is used to explain the present invention, is not to be used to limit scope of the present invention.
Embodiment 1: a kind of medicine of treating otitis media is characterized in that: its primary raw material is by weight ratio: Flos Lonicerae 30g, Fructus Forsythiae 30g, Radix Salviae Miltiorrhizae 20g, dried Alumen 1g, Borneolum Syntheticum 1g, boric acid 3g.
Embodiment 2: a kind of medicine of treating otitis media is characterized in that: its primary raw material is by weight ratio: Flos Lonicerae 6g, Fructus Forsythiae 6g, Radix Salviae Miltiorrhizae 6g, dried Alumen 0.2g, Borneolum Syntheticum 0.2g, boric acid 0.5g.
Embodiment 3: a kind of medicine of treating otitis media, its primary raw material is by weight ratio: Flos Lonicerae 60g, Fructus Forsythiae 60g, Radix Salviae Miltiorrhizae 55g, dried Alumen 10g, Borneolum Syntheticum 10g, boric acid 10g.
Embodiment 1-3, the traditional Chinese medical science thinks that acute suppurative otitis media is in early days for the ailment said due to cold or exposure invasion and attack, through the flatulence due to stagnation of QI plug.The chronic suppurative otitis media main diseases is because evil poison is detained, and is due to the qi and blood stagnation, relevant with deficiency of vital QI again.Ear is the official that kidney is had one's ideas straightened out, and its void is at kidney, and suffering from a deficiency of the kidney tinnitus then occurs, deafness.Because of the kidney qi making a deficient case more deficient is not changed water, water is wet general, and the in ear sepage can appear in Gu.Therapeutic Principle by the traditional Chinese medical science then takes QI invigorating, rushes down the method for convergence clearly.Screening and optimization prescription, with Flos Lonicerae, Fructus Forsythiae heat-clearing and toxic substances removing, medicinal powder for relieving pain is become the master.The Radix Salviae Miltiorrhizae blood circulation promoting and blood stasis dispelling, again with the Borneolum Syntheticum clearing away heat to alleviate pain, dried Alumen, boric acid are held back wet share with all medicines of prescription and are played removing toxic substances and promoting pus discharge altogether, hold back the effect of wet putrefaction removing.
Embodiment 4: a kind of medicine of treating otitis media, its primary raw material is by weight ratio: Flos Lonicerae 30g, Fructus Forsythiae 30g, Radix Salviae Miltiorrhizae 20g, dried Alumen 1g, Borneolum Syntheticum 1g, boric acid 3g, Radix Scutellariae 10g, Chalcanthitum 1g.
Embodiment 5: a kind of medicine of treating otitis media, its primary raw material is by weight ratio: Flos Lonicerae 6g, Fructus Forsythiae 6g, Radix Salviae Miltiorrhizae 6g, dried Alumen 0.2g, Borneolum Syntheticum 0.2g, boric acid 0.5g, Radix Scutellariae 6g, Chalcanthitum 0.2g.
Embodiment 6: a kind of medicine of treating otitis media, its primary raw material is by weight ratio: Flos Lonicerae 60g, Fructus Forsythiae 60g, Radix Salviae Miltiorrhizae 55g, dried Alumen 10g, Borneolum Syntheticum 10g, boric acid 10g, Radix Scutellariae 60g, Chalcanthitum 3g.
The foregoing description 4-6 adds Radix Scutellariae, Chalcanthitum on embodiment 1-3 basis.Radix Scutellariae: cure mainly diseases such as epidemic febrile disease, upper respiratory tract infection, cough due to lung-heat, damp and hot jaundice, pneumonia, dysentery, hemoptysis, conjunctival congestion, frequent fetal movement, hypertension, carbuncle furuncle.The clinical practice of Radix Scutellariae is antibiotic not worse than Rhizoma Coptidis, and does not develop immunity to drugs.Strengthen the effect of antibiotic, antiviral and anti inflammatory detoxication.Chalcanthitum: emetic, putrefaction removing, detoxifcation; Control wind-phlegm and be jammed, sore throat, epilepsy, ulcerative gingivitis, aphtha, marginal blepharitis eye, hemorrhoid, toxic swelling.Further strengthen the effect of eliminating stagnation evacuation of pus.
Embodiment 7: a kind of medicine of treating otitis media, its primary raw material is by weight ratio: Flos Lonicerae 30g, Fructus Forsythiae 30g, Radix Salviae Miltiorrhizae 20g, dried Alumen 1g, Borneolum Syntheticum 1g, boric acid 3g, Radix Scutellariae 10g, Chalcanthitum 1g, furazolidone 1g, Flos Carthami 10g.
Embodiment 8: a kind of medicine of treating otitis media, its primary raw material is by weight ratio: Flos Lonicerae 6g, Fructus Forsythiae 6g, Radix Salviae Miltiorrhizae 6g, dried Alumen 0.2g, Borneolum Syntheticum 0.2g, boric acid 0.5g, Radix Scutellariae 6g, Chalcanthitum 0.2g, furazolidone 0.2g, Flos Carthami 3g.
Embodiment 9: a kind of medicine of treating otitis media, its primary raw material is by weight ratio: Flos Lonicerae 60g, Fructus Forsythiae 60g, Radix Salviae Miltiorrhizae 55g, dried Alumen 10g, Borneolum Syntheticum 10g, boric acid 10g, Radix Scutellariae 60g, Chalcanthitum 3g, furazolidone 5g, Flos Carthami 50g.
The foregoing description 7-9 adds the furazolidone and Flos Carthami on embodiment 4-6 basis.Furazolidone: furazolidone is an antibacterial, has wider antimicrobial spectrum.Further strengthen antibacterial action.Flos Carthami: promoting blood circulation to restore menstrual flow, blood stasis removing pain relieving.Strengthen evacuation of pus granulation promoting, healing effect, alleviate patient's otalgia.
Embodiment 10: a kind of medicine of treating otitis media, its primary raw material is by weight ratio: Flos Lonicerae 30g, Fructus Forsythiae 30g, Radix Salviae Miltiorrhizae 20g, dried Alumen 1g, Borneolum Syntheticum 1g, boric acid 3g, Radix Scutellariae 10g, Chalcanthitum 1g, furazolidone 1g, Flos Carthami 10g, Indigo Naturalis 1g, Semen Persicae 30g.
Embodiment 11: a kind of medicine of treating otitis media, its primary raw material is by weight ratio: Flos Lonicerae 6g, Fructus Forsythiae 6g, Radix Salviae Miltiorrhizae 6g, dried Alumen 0.2g, Borneolum Syntheticum 0.2g, boric acid 0.5g, Radix Scutellariae 6g, Chalcanthitum 0.2g, furazolidone 0.2g, Flos Carthami 3g, Indigo Naturalis 0.5g, Semen Persicae 6g.
Embodiment 12: a kind of medicine of treating otitis media, its primary raw material is by weight ratio: Flos Lonicerae 60g, Fructus Forsythiae 60g, Radix Salviae Miltiorrhizae 55g, dried Alumen 2g, Borneolum Syntheticum 2g, boric acid 5g, Radix Scutellariae 60g, Chalcanthitum 3g, furazolidone 5g, Flos Carthami 50g, Indigo Naturalis 10g, Semen Persicae 60g.
The foregoing description 10-12 adds Indigo Naturalis, Semen Persicae on embodiment 7-9 basis.Indigo Naturalis: heat-clearing and toxic substances removing, removing heat from blood, arresting convulsion.Strengthen heat-clearing and toxic substances removing, antiinflammatory action.Semen Persicae: the effect of blood stasis dispelling blood, antiinflammatory action, anti-allergic effects are strengthened putrefaction-removing granulation-promoting, antiinflammatory action.
Embodiment 13: a kind of medicine of treating otitis media, its primary raw material is by weight ratio: Flos Lonicerae 30g, Fructus Forsythiae 30g, Radix Salviae Miltiorrhizae 20g, dried Alumen 1g, Borneolum Syntheticum 1g, boric acid 3g, Radix Scutellariae 10g, Chalcanthitum 1g, furazolidone 1g, Flos Carthami 10g, Indigo Naturalis 5g, Semen Persicae 30g, Moschus 0.2g, metronidazole 0.5g.
Embodiment 14: a kind of medicine of treating otitis media, its primary raw material is by weight ratio: Flos Lonicerae 6g, Fructus Forsythiae 6g, Radix Salviae Miltiorrhizae 6g, dried Alumen 0.2g, Borneolum Syntheticum 0.2g, boric acid 0.5g, Radix Scutellariae 6g, Chalcanthitum 0.2g, furazolidone 0.2g, Flos Carthami 3g, Indigo Naturalis 0.5g, Semen Persicae 6g, Moschus 0.05g, metronidazole 0.2g.
Embodiment 15: a kind of medicine of treating otitis media, its primary raw material is by weight ratio: Flos Lonicerae 60g, Fructus Forsythiae 60g, Radix Salviae Miltiorrhizae 55g, dried Alumen 2g, Borneolum Syntheticum 2g, boric acid 5g, Radix Scutellariae 60g, Chalcanthitum 3g furazolidone 5g, Flos Carthami 50g, Indigo Naturalis 10g, Semen Persicae 60g, Moschus 5g, metronidazole 2g.
The foregoing description 13-15 adds Moschus and metronidazole on embodiment 10-12 basis.Moschus: be the central nervous excitation agent, external can be eased pain, subsided a swelling.Strengthen the effect of antibacterial analgesia, evacuation of pus detumescence, promotion healing.Metronidazole: tool wide spectrum anaerobe resistant and protozoacidal effect, clinical being mainly used in prevented and the microbial infection of treatment anaerobism.Strengthen bactericidal action.
Embodiment 16: a kind of medicine of treating otitis media, its primary raw material is by weight ratio: Flos Lonicerae 30g, Fructus Forsythiae 30g, Radix Salviae Miltiorrhizae 20g, dried Alumen 1g, Borneolum Syntheticum 1g, boric acid 3g, Radix Scutellariae 10g, Chalcanthitum 1g, furazolidone 1g, Flos Carthami 10g, Indigo Naturalis 5g, Semen Persicae 30g, Moschus 0.2g, metronidazole 0.5g, Herba Asari 20g, nitrofural 0.5g.
Embodiment 17: a kind of medicine of treating otitis media, its primary raw material is by weight ratio: Flos Lonicerae 6g, Fructus Forsythiae 6g, Radix Salviae Miltiorrhizae 6g, dried Alumen 0.2g, Borneolum Syntheticum 0.2g, boric acid 0.5g, Radix Scutellariae 6g, Chalcanthitum 0.2g furazolidone 0.2g, Flos Carthami 3g, Indigo Naturalis 0.5g, Semen Persicae 6g, Moschus 0.05g, metronidazole 0.2g, Herba Asari 6g, nitrofural 0.2g.
Embodiment 18: a kind of medicine of treating otitis media, its primary raw material is by weight ratio: Flos Lonicerae 60g, Fructus Forsythiae 60g, Radix Salviae Miltiorrhizae 55g, dried Alumen 2g, Borneolum Syntheticum 2g, boric acid 5g, Radix Scutellariae 60g, Chalcanthitum 3g, furazolidone 5g, Flos Carthami 50g, Indigo Naturalis 10g, Semen Persicae 60g, Moschus 5g, metronidazole 2g, Herba Asari 60g, nitrofural 5g.
The foregoing description 16-18 adds Herba Asari and nitrofural nitrofural on embodiment 13-15 basis: clinical only as Cidex-7, be used for the infection of skin and mucosa, like suppurative otitis media, suppurative dermatitis etc.Several non-stimulated to organizing, pus, blood does not have obvious influence to its disinfective action.Nitrofural also is used as the treatment of suppurative otitis media.Can further strengthen infection, bactericidal antiphlogistic effect.Herba Asari: have expelling wind and cold, understand things pain-stopping, the effect of warming the lung to resolve fluid-retention.1. calmness, analgesic activity 2. refrigeration functions 3. antiinflammatories, immunosuppressant and antiallergic action 4. improve metabolic function 5. antibiotic, antivirus action 6. local anesthetic actions of body.Strengthen the effect that anti-inflammatory analgesic promotes wound healing.
Embodiment 19, and the process for preparing medicine of described treatment otitis media is characterized in that step is:
(1) Flos Lonicerae; Fructus Forsythiae is collected distillate with steam distillation distillation twice, and the distillation liquid measure of collecting for the first time is a distillate: former medicine is 2:1); Collecting for the second time the distillation liquid measure is distillate: former medicine is 1:1, the distillate of twice collection is merged obtain distillate and medicinal residues;
(2) distillate is put into distilling apparatus and carry out redistillation, collect re-distilled liquid, the amount of re-distilled liquid is a re-distilled liquid: crude drug is 1:1, and remaining distillate is continued to employ;
(3) mother solution and medicinal residues, Radix Salviae Miltiorrhizae decoct together at twice, add 5 times of decoctings of crude drug amount for the first time and boil 1.5h, add 3 times of decoctings of crude drug amount for the second time and boil 1h; Filtered through gauze gets filtrate, with filtrate concentrate concentrated solution, the amount of said concentrated solution is a concentrated solution: filtrating is 1:2;
(4) the ethanol precipitation elimination impurity of adding 65% in said concentrated solution; Filter back concentrated solution heating in water bath and reclaim ethanol; Obtain not having pure concentrated solution, will not have pure concentrated solution again and concentrate and to obtain reconcentration liquid, the reconcentration liquid measure that obtains is a reconcentration liquid: crude drug is 1:1;
(5) merge reconcentration liquid and re-distilled liquid sterilization 40min and get amalgamation liquid;
(6) in amalgamation liquid, add dried Alumen, Borneolum Syntheticum, it is 65% to containing the alcohol amount that the medicinal liquid of boric acid, the ethanol of use 95% are regulated medicinal liquid, this moment, the solution pH value was 7.5, got patent medicine.
Administration every day 3 times, each 2～3, all left and right sides state of an illness takes an evident turn for the better, and pus ends, and audition before has significant improvement, and mucous hyperemia disappears.
Pharmacodynamic study:
A, analgesic test of the present invention:
Result of the test:
Table 1 the present invention is to the antagonism of the mice pain due to the hot plate method
* p 0.05, * * p 0.01 (with the normal saline group relatively)
Conclusion (of pressure testing)
By the visible high dose group of the present invention of table 11; 1.5 hour the time for the effect of increasing significantly of the mice threshold of pain due to the hot plate, and middle dose groups has effect, not effect of low dose group; The dipyrone group does not demonstrate due raising effect to the threshold of pain, and effect is gone down in the time of possibly arriving 1 hour.Positive controls has used boric acid Borneolum Syntheticum [that the paroxysmal pain effect is also arranged.Visible the present invention has significant inhibitory effect to the mice pain due to the hot plate by table 1, shows that the present invention has certain analgesic activity, particularly high dose group that significant analgesic activity is arranged.
B, the test of the anti-caused by dimethylbenzene xylene Mus of the present invention otitis disease:
Result of the test:
The anti-mice caused by dimethylbenzene xylene otitis of table 2 the present invention disease
* p 0.05, * * p 0.01 (with the normal saline group relatively)
Conclusion (of pressure testing)
It is thus clear that in anti-mice caused by dimethylbenzene xylene ear inflammation swelling, high dose group of the present invention and normal saline group relatively have significant difference, and middle dose groups is variant, the low dose group indifference is different in nature by table 2.It is thus clear that the mice ear due to the xylol of the present invention has inhibitory action, that is the effect of inflammation due to the anti-xylene is arranged.
C, the anti-Ovum Gallus domesticus album of the present invention cause rat toes swelling test:
Result of the test:
The anti-Ovum Gallus domesticus album of table 3 the present invention cause rat toes swelling experiment (x ± SD, n=10)
Variant * p 0.05, significant difference * * p < 0.01 (comparing with the normal saline group) arranged
Conclusion (of pressure testing):
Visible by table 3; High dose group of the present invention and middle dose groups; Inhibitory action and normal saline group 0.5,1,2, on the 4h time point to the rat toes swelling due to the Ovum Gallus domesticus album relatively have significant difference, and low dose group more also has significant difference with the normal saline group on the 1h time point.Show thus: the present invention has the obvious suppression effect to the rat tissue's swelling due to the Ovum Gallus domesticus album.
D, rat skin infection animal model test of the present invention:
Result of the test:
Table 4, the present invention to the therapeutical effect of rat skin infection (± SD, n=8)
* p 0.05, * * p 0.01 (with the normal saline group relatively)
Conclusion (of pressure testing)
It is thus clear that high dose group of the present invention and middle dose groups and normal saline group relatively have significant difference, explain that the present invention is high, middle dose groups has the rat of promotion wound healing function by table 4 thus.
E, the present invention are to the acute suppurative otitis media model test:
Result of the test:
Table 5 the present invention treat rat acute suppurative otitis media model (± SD, n=10)
The # nonresponder for the treatment 7 days after external auditory meatus still have purulent secretion.After the more back prolongation treatment in 7 days that treatment back positive bacterial culture number is meant 7 days not, the antibacterial picture still detects the inoculation bacterium.
Experiment conclusion:
By the visible high dose group of the present invention of table 5 to the rat acute suppurative otitis media by therapeutical effect preferably, middle dose groups is also effective, and the low dose group effect is poor.Result of the test shows: the present invention has therapeutical effect to the rat acute suppurative otitis media.
5, toxicology test:
A, acute toxicity test of the present invention:
Conclusion: give 240g of the present invention (crude drug)/kg body weight for 20 mice singles, administration does not all have death in 14 days, show mice to 240g of the present invention (crude drug)/kg, is equivalent to recommend 3000 times of human body clinical dosage.Dissect mice after 14 days and do not see that internal organs have obvious pathological change.
B, mucomembranous pungency test of the present invention:
Result of the test:
Table 6 the present invention stimulates integration to the rabbit eye
Table 7 the present invention stimulates evaluation to the rabbit eye
Conclusion:
The present invention can find out by table 7 effect of rabbit eye nonirritant, behind the single administration of the present invention, and equal nonirritant 1,2,24,48, on each time point of 72h.
C, auditory meatus irritation test of the present invention:
Result of the test:
Table 8 the present invention is to rat external auditory meatus and diaphragm-operated stimulation degree score value
Table 9 the present invention is to rat external auditory meatus and diaphragm-operated stimulation stimulus intensity evaluation criterion
Conclusion (of pressure testing)
Test result analysis: by the visible high dose group of the present invention of table 9 after off-test 1 hour; Can see slight zest is arranged; And the slight zest of high dose group of the present invention was also recovered in 24 hours; Other are respectively organized in the equal nonirritant of each time point, and this result of the test shows: the present invention (except that high dose group on 1 hour time point) outer auricle, auditory meatus and the tympanum of rat all do not had tangible zest effect.
D, skin allergy test of the present invention:
Result of the test:
Table 10 the present invention causes the skin allergy degree evaluation of Cavia porcellus
* p < 0.01 (comparing) ▲ p < 0.05 (comparing) with the normal saline group with the positive drug group
Table 11 the present invention causes the skin allergy incidence rate evaluation of Cavia porcellus
Conclusion (of pressure testing):
Visible by table 11, the present invention and positive drug group have significant difference at each time point, and do not have difference with the normal saline group, are 0% by the visible anaphylaxis incidence rate of the present invention of table 11, this shows that the present invention does not have sensitization to guinea pig skin.
6, clinical observation on the therapeutic effect:
Having observed 5～2006 years 10 nineteen ninety-five adopts treatment group case of the present invention (100 routine acute and chronic suppurative otitis media patient) to adopt chloromycetin treatment group case (60 example).
Three groups of clinical efficacies of table 12 relatively
(assembly comparison X2=4.22 0.025 p 0.05)
Of the present invention group of antibacterial of table 13 situation of turning out cloudy with matched group
Embodiment 20, and is identical with embodiment 19, and different is in described step (3), also to have added Radix Scutellariae and Chalcanthitum.
Embodiment 21, and is identical with embodiment 19, and different is in described step (3), also to have added Flos Carthami, in described step (6), has also added furazolidone.
Embodiment 22, and is identical with embodiment 19, and different is in described step (3), also to have added Indigo Naturalis and Semen Persicae.
Embodiment 23, and is identical with embodiment 19, and different is in described step (3), also to have added metronidazole, and in described step (6), also having added the order number is 80 purpose Moschus powder.
Embodiment 24, and is identical with embodiment 19, and different is in described step (3), also to have added Herba Asari, in described step (6), has also added nitrofural.
Embodiment 25, and is identical with embodiment 19, and different is in described step (3), also to have added metronidazole, and in described step (6), also having added the order number is 120 purpose Moschus powder.
Embodiment 26, and is identical with embodiment 19, and different is in described step (3), also to have added metronidazole, and in described step (6), also having added the order number is 100 purpose Moschus powder.
The present invention is used to be pure Chinese medicinal preparation, and preparation technology is simple, and quality control is strict; Determined curative effect, easy to use, have no adverse reaction; To reduce degree of disability for numerous suppurative otitis media patients create the meeting of efficient rehabilitation therapy apparatus, alleviate society and family burden; Must receive doctor and patient's welcome, be worthy of popularization, have a good application prospect.
The above is merely preferred embodiment of the present invention, in order to restriction the present invention, all any modifications of within spirit of the present invention and principle, being done, is not equal to replacement, improvement etc., all should be included within protection scope of the present invention.
Claims (12)
1. medicine of treating otitis media, it is characterized in that: its primary raw material is by weight ratio: Flos Lonicerae 6～60g, Fructus Forsythiae 6～60g, Radix Salviae Miltiorrhizae 6～55g, dried Alumen 0.2～10g, Borneolum Syntheticum 0.2～10g, boric acid 0.5～10g.
2. the medicine of treatment otitis media as claimed in claim 1 is characterized in that raw material also includes by weight:
Radix Scutellariae 6～60g, Chalcanthitum 0.2～3g.
3. the medicine of treatment otitis media as claimed in claim 2 is characterized in that raw material also includes by weight:
Furazolidone 0.2～5g, Flos Carthami 3～50g.
4. the medicine of treatment otitis media as claimed in claim 3 is characterized in that raw material also includes by weight:
Indigo Naturalis 0.5～10g, Semen Persicae 6～60g.
5. the medicine of treatment otitis media as claimed in claim 4 is characterized in that raw material also includes by weight:
Moschus 0.05～5g, metronidazole 0.2～2g.
6. the medicine of treatment otitis media as claimed in claim 5 is characterized in that raw material also includes by weight:
Herba Asari 6～60g, nitrofural 0.2～5g.
7. like the process for preparing medicine of the described treatment otitis media of claim 1 to 6, it is characterized in that step is:
(1) Flos Lonicerae; Fructus Forsythiae is collected distillate with steam distillation distillation twice, and the distillation liquid measure of collecting for the first time is a distillate: former medicine is 2:1; Collecting for the second time the distillation liquid measure is distillate: former medicine is 1:1, the distillate of twice collection is merged obtain distillate and medicinal residues;
(2) distillate is put into distilling apparatus and carry out redistillation, collect re-distilled liquid, the amount of re-distilled liquid is a re-distilled liquid: crude drug is 1:1, and remaining distillate is continued to employ;
Mother solution and medicinal residues, Radix Salviae Miltiorrhizae decoct together at twice, add 5 times of decoctings of crude drug amount for the first time and boil 1.5h, add 3 times of decoctings of crude drug amount for the second time and boil 1h; Filtered through gauze gets filtrate, with filtrate concentrate concentrated solution, the amount of said concentrated solution is a concentrated solution: filtrating is 1:2;
In said concentrated solution, add 65% ethanol precipitation elimination impurity, filter back concentrated solution heating in water bath and reclaim ethanol, obtain not having pure concentrated solution, will not have that pure concentrated solution is concentrated to obtain reconcentration liquid again, the reconcentration liquid measure that obtains is a reconcentration liquid: crude drug is 1:1;
Merge reconcentration liquid and re-distilled liquid sterilization 40min and get amalgamation liquid;
In amalgamation liquid, add dried Alumen, Borneolum Syntheticum, it is 65% to containing the alcohol amount that the medicinal liquid of boric acid, the ethanol of use 95% are regulated medicinal liquid, this moment, the solution pH value was 7.5, got patent medicine.
8. the process for preparing medicine of treatment otitis media as claimed in claim 7 is characterized in that: in described step (3), also added Radix Scutellariae and Chalcanthitum.
9. the process for preparing medicine of treatment otitis media as claimed in claim 7 is characterized in that: in described step (3), also added Flos Carthami, in described step (6), also added furazolidone.
10. the process for preparing medicine of treatment otitis media as claimed in claim 7 is characterized in that: in described step (3), also added Indigo Naturalis and Semen Persicae.
11. the process for preparing medicine of treatment otitis media as claimed in claim 7 is characterized in that: in described step (3), also added metronidazole, in described step (6), also having added the order number is 80～120 purpose Moschus powder.
12. the process for preparing medicine of treatment otitis media as claimed in claim 7 is characterized in that: in described step (3), also added Herba Asari, in described step (6), also added nitrofural.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2010105702106A CN102370710B (en) | 2010-12-02 | 2010-12-02 | Medicament for treating otitis media and preparation method thereof |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103599298A (en) * | 2013-11-18 | 2014-02-26 | 济南伟传信息技术有限公司 | Traditional Chinese medicinal composition for treating acute otitis media |
| CN105055871A (en) * | 2015-07-30 | 2015-11-18 | 青岛海之星生物科技有限公司 | Traditional Chinese medicinal oil for treating pyotorrhea and preparation method of traditional Chinese medicinal oil |
| CN110451289A (en) * | 2018-09-19 | 2019-11-15 | 浙江厚达智能科技股份有限公司 | Chinese medicine automates decoction system |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105362486A (en) * | 2015-10-29 | 2016-03-02 | 陈光辉 | Medicine for treating otitis media |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1663605A (en) * | 2003-12-31 | 2005-09-07 | 赵恒� | Ear drop for treating chronic tympanitis |
| CN1736474A (en) * | 2005-07-28 | 2006-02-22 | 凌沛学 | Reversible heat gelling aquatic pharmaceutical composition of a Chinese medicine and compound prescription thereof |
| CN1813917A (en) * | 2005-11-26 | 2006-08-09 | 安徽省药物研究所 | Medicine for treating acute secretory tympanitis and its preparing method |
| CN101214287A (en) * | 2007-12-27 | 2008-07-09 | 丁林曜 | Medicament for treating otitis medis |
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Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1663605A (en) * | 2003-12-31 | 2005-09-07 | 赵恒� | Ear drop for treating chronic tympanitis |
| CN1736474A (en) * | 2005-07-28 | 2006-02-22 | 凌沛学 | Reversible heat gelling aquatic pharmaceutical composition of a Chinese medicine and compound prescription thereof |
| CN1813917A (en) * | 2005-11-26 | 2006-08-09 | 安徽省药物研究所 | Medicine for treating acute secretory tympanitis and its preparing method |
| CN101214287A (en) * | 2007-12-27 | 2008-07-09 | 丁林曜 | Medicament for treating otitis medis |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103599298A (en) * | 2013-11-18 | 2014-02-26 | 济南伟传信息技术有限公司 | Traditional Chinese medicinal composition for treating acute otitis media |
| CN105055871A (en) * | 2015-07-30 | 2015-11-18 | 青岛海之星生物科技有限公司 | Traditional Chinese medicinal oil for treating pyotorrhea and preparation method of traditional Chinese medicinal oil |
| CN110451289A (en) * | 2018-09-19 | 2019-11-15 | 浙江厚达智能科技股份有限公司 | Chinese medicine automates decoction system |
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| CN102370710B (en) | 2013-08-07 |
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