CN1137917A - Compound jiabing ear drops and preparation method thereof - Google Patents

Abstract

The ear drops for curing acute or chronic tympanitis is prepared from borneol (4-6 portions in wt.), flavescent sophora root (8-12), asarum herb (2-5) and metronidazole (0.2-3) through decocting flavescent sophora root powder twice, merging decoctions, laying aside for 12 hr, filtering and concentration to obtain liquor A; immersing asarum herb powder in 60% alcohol for 24 hr, filtering and dissolving borneol in it to obtain liquor B; disslving metronidazole in water, filtering and regulating pH value to obtain liquor C; mixing A, B and C, addition of glycerol, stirring and regulating pH value with hydrochloric acid.

Description

Compound jiabing ear drops and preparation method thereof

The present invention relates to a kind of Chinese and western medicinal composition, refer to a kind of Chinese and western medicinal composition-compound jiabing ear drops for the treatment of the acute and chronic otitis media and preparation method thereof especially.

Otological diseases such as acute-chronic purulent otitis media are commonly encountered diseases, frequently-occurring disease, through epidemiology statistics mostly the patient be the minor, account for 58.7%, age 1-16 year.Because the child has a low resistance, bring nose and the pharyngeal secretions that contains antibacterial into tympanum through pharyngotympanic tube at cold, flu, sneeze and cough, rhinitis, tonsillitis, pharyngitis, upper respiratory tract infection, infantile appetite or choke when sucking the breast is coughed, baby's suckling position is improper, traumatic injury of ear infects, infect by Eustachian tube when swimming or diving, when sanitary condition is bad, so that various pathogenic bacterias enter auditory meatus and breed in a large number, cause ear to suffer from.

The object of the present invention is to provide a kind of Chinese and western medicinal composition-compound jiabing ear drops for the treatment of the acute and chronic otitis media, this medicine proves through clinical trial, the acute-chronic purulent otitis media that above-mentioned disease is caused, catarrhal otitis media, bullous myringitis, otitis externa etc. are evident in efficacy, and this medical instrument has wide spectrum, efficient and quick sterilization effect.

Another object of the present invention is to provide a kind of preparation method of this Chinese and western medicinal composition.

Pharmaceutical composition provided by the present invention comprises Borneolum Syntheticum, Radix Sophorae Flavescentis, Herba Asari, metronidazole.

Wherein the ratio of each component is (parts by weight are represented): 4-6 part Borneolum Syntheticum: 8-12 part Radix Sophorae Flavescentis: 2-5 part Herba Asari: 0.2-3 part metronidazole.

Wherein the preferred proportion of each component is (parts by weight are represented): 5 parts of Borneolum Syntheticums: 10 parts of Radix Sophorae Flavescentiss: 3 parts of Herba Asaris: 1 part of metronidazole.

Borneolum Syntheticum it is documented to have effects such as detumescence is had one's ideas straightened out, clearing away heat to alleviate pain.Modern pharmacology studies show that this medicine contains dextro Borneolum Syntheticum, volatile oil and multiple terpenoid composition, and antibiotic, analgesia, antiinflammatory, effect such as anticorrosion are arranged, and all easily absorbs at mucosa and subcutaneous tissue.Suppressing capillary permeability in early days in inflammation increases and leukocytic migration, alleviates local edema, and the inflammation later stage is suppressed dual functioies such as granulation tissue hyperplasia.

Radix Sophorae Flavescentis heat clearing and damp drying, antiinflammatory, parasite killing, remove swelling.Modern pharmacology research, Radix Sophorae Flavescentis contains multiple alkaloid, be mainly α-matrine, alpha-oxidation matrine etc., effect with resisting pathogenic microbes, to staphylococcus aureus, streptococcus, tubercule bacillus and multiple fungus etc. all have the obvious suppression effect, and acute exudative inflammation is had tangible antagonism.Its effect is similar to hydrocortisone, but does not have the side effect of hormonelike.This product also has the NSAID (non-steroidal anti-inflammatory drug) characteristic, thereby reduces inflammatory mediator release, plays antiinflammatory action.

Herba Asari antiinflammatory, sensible, pain relieving.Modern pharmacology studies confirm that Herba Asari contains volatile oil about 3%, its Main Ingredients and Appearance is methyleugenol, asaricin and 16 kinds with upper amino acid and 19 kinds of inorganic elementss, alkaloid etc., Herba Asari volatile oil has good surface anesthetic effect, teleneuron, mucosa are all had anesthetic action, and its anesthesia is tired approaching with 1% procaine.Herba Asari has antiinflammatory, antiallergic action and immunosuppressive action, gram positive bacteria, tubercule bacillus, Hemolytic streptococcus etc. all there is inhibitory action, can also increase adrenal cortex function, links such as inflammatory mediator release, the increased capillary permeability to inflammatory process oozes out, leukoplania all have inhibitory action, and therefore reducing swelling and alleviating pain, scleroma are dissipated rapidly." Gong Shi is through proved recipe " ground into powder with Herba Asari simply in addition, makes wax pill with Cera Flava after molten, and, silk floss big as Oletum Ratti norvegici wrapped up in a ball ear plug, controls deafness.

Metronidazole is to the Gram-negative anaerobic bacillus(cillus anaerobicus), and Gram-positive anaerobic spore-bearing bacilli and all anaerobic coccis are all responsive, and the nitro that its anaerobe resistant mechanism is this medicine can be reduced by anaerobe, produces cytotoxic substance, suppresses the synthetic of DNA of bacteria, makes antibacterial death.Therefore studies confirm that anaerobe is the common pathogenic bacteria of various pyogenic infections, metronidazole can reduce wound exudate, infects when purulent secretion occurring and the chronic otitis media disease that do not heal for a long time can obtain good effect with the metronidazole treatment in treatment otology.

This product adopts double solvent, shortcomings such as water, glycerol sterilization and penetration difference have been overcome, lowered alcoholic acid stimulation, make said preparation have advantages such as long action time, Transdermal absorption are good, nonirritant, at in ear bacteria growing inhibiting effectively, prevent that antibacterial from breeding once again, therefore various bacterial infections are all had excellent curative effect.

Above-mentioned each medicine is made into compound preparation and uses, and can bring into play synergism, can promote the infiltration of medicine, strengthens antibacterial activity, has enlarged therapeutic domain, and we think that it is the rational of science that this prescription is formed.

Preparation process of the present invention is:

Coarse powder such as Radix Sophorae Flavescentis add the doubling dose decocting and boil twice, 1.5 hours first time, and 1 hour for the second time, merge decoction liquor, left standstill 12 hours at cold place, filters, and gets filtrate, this filtrate is concentrated into every ml is equivalent to crude drug in whole one gram, gets first liquid;

The Herba Asari coarse powder is made solvent dipping 24h by percolation with 60% ethanol, makes every 100mL be equivalent to the percolate that crude drug in whole 10 restrains with every min 3mL speed percolation to the liquid regulation jg that filters, filtering and impurity removing matter, and add Borneolum Syntheticum, the even second liquid that gets of mixed dissolution;

Metronidazole be dissolved in water medicinal liquid, filter, transfer PH4.5～6.0, third liquid, every 100ml contains 0.2 gram metronidazole;

First, second, the third three liquid are merged according to the above ratio add percolate and glycerol, stir, transfer PH, make into the light green clear liquid with dilute hydrochloric acid to capacity, detects qualified after, be sub-packed in the 10ml sterilization ear bottle by aseptic manipulation, seal, pack promptly.

Compound jiabing ear drops of the present invention is a faintly acid, PH4.5～6.0, because of local pH value when the inflammation many 7.1～7.8.When if the acid mantle of skin surface antibiotic property becomes alkaline adventitia, the probability of bacterial infection just increases, and helps bringing into play antibacterial action so this preparation is made into weakly acidic solution.

Compound jiabing ear drops medicine stability experiment of the present invention: 5 batches of this product were put the normal room temperature reserved sample observing 18 months, detect its stability, content comprises that appearance character, color, clarity, pH value, health examination, clinical efficacy etc., result all meet the requirements, and point out this medicine steady quality at normal temperatures.

Compound jiabing ear drops quality of the pharmaceutical preparations control criterion of the present invention is:

1. this product should meet pertinent regulations and " Chinese Hospitals preparation standard " nineteen ninety-five second edition of rules of preparations in two appendix of Pharmacopoeia of the People's Republic of China nineteen ninety version, the pertinent regulations of ear drop.

2. this product is the clear and bright solution of light green, does not have the no foreign body of precipitation, pH value 4.5～6.0.

3. used medical material must be cleaned, and extracts by prescriptive procedure under each kind item.

4. this product a. contains metronidazole (C ₅H ₉N ₃O ₃) should be labelled amount, 93.0～107.0%, the assay of metronidazole adopts spectrophotography (appendix NA), measures trap at the wavelength place of 277nm, presses C ₆H ₉N ₃O ₃Absorptance (E ^1% _Lom) be 377 calculating.B. contain matrine (C ₁₅H ₂₄N ₂O) calculate, must not be less than 2.0%, by carrying out assay under 176 pages of Radix Sophorae Flavescentis items of Pharmacopoeia of the People's Republic of China nineteen ninety version.

5. packing should be operated by the sterilization preparation requirement.The finished product health examination should be up to specification.

6. this product useful life is tentative 1 year.

Compound jiabing ear drops pharmacology of the present invention, toxicological experiment research

1. external bacteriostatic experiment: extracorporeal bacteria inhibitor test adopts paper disk method and the plate punch method experimentizes to compound jiabing ear drops and tire with the chloromycetin standard substance and to compare.This medicine has inhibitory action to staphylococcus aureus, bacillus pyocyaneus as a result, and auditory meatus is infected common pathogenic bacteria sensitivity.

2. toxicological test: acute toxicity test, the mouse gavaging compound jiabing ear drops is divided into two groups at random with mice, and promptly high dose group and low dose group are irritated stomach respectively.Low dose group is by 100 times of filling stomaches of this medicine Transdermal absorption amount, and high dose group is by 1000 times of filling stomaches of this medicine Transdermal absorption amount.The result gavage the back mice look for food, movable as usual, do not have excited, respiration inhibition phenomenon, none example is dead, illustrates that this medicine is nontoxic, is a kind of medicine of extremely safe as ear drop.

3. skin irritation test: with white rabbit in both sides, the preceding 24 hours backs of administration unhairing, but injured skin not.Getting compound jiabing ear drops 2ml and normal saline 2ml during experiment drips respectively in sterilized filter paper, be affixed on rabbit left side and back, right side, cover with one deck oilpaper and two-layer gauze,, check that respectively at 30 minutes, 60 minutes, 24 hours and 48 hours this medicine is to rabbit skin irritant reaction with the adhesive plaster sealing.Rabbit skin does not all have erythema and edema as a result, illustrates that this medicine does not stimulate skin.

4. indication and usage and dosage

1. indication: learn experimentation according to prescription drug effect and pharmacological toxicology, by clinical observation on the therapeutic effect, compound jiabing ear drops can be treated infection that Gram-negative and positive bacteria, fungus etc. cause and the mixed infection of two or more auditory meatus antibacterial.Be used for otology illness such as the active chronic inflammation of various external ears and otology such as acute and chronic suppurative otitis media, card ground property otitis media, otitis externa, bullous myringitis, fungal otitis media.

2. usage and dosage: face the time spent and clean purulent secretion in the external auditory meatus earlier, clean, splash into medicinal liquid 3-5 then and drip with 3% hydrogen peroxide, 2-3 time on the 1st, or make sliver with this medicine and insert auditory meatus.To actute infection common course of treatment be about 3 days, after the general clinical symptom disappearance, still need continue treatment at least 2 days.Be 1 week the course of treatment.Use this [fluid temperature should not be low excessively, room temperature gets final product.Because of containing Borneolum Syntheticum in the prescription, utmost point individual patients can cause the property a crossed discomfort or a hypodynia, and 3-5 can be alleviated second.

This medicinal liquid should not mix use with other drug.

Compound jiabing ear drops clinical observation on the therapeutic effect of the present invention

From November in January, 1994 to nineteen ninety-five my institute's department of otorhinolaryngology 300 routine patients have been carried out clinical observation on the therapeutic effect, 150 routine patients have been carried out the clinical efficacy controlled observation.The case source all is that my gate is examined and the inpatient.Diagnostic criteria is diagnosed with reference to relevant chapters and sections in " otolaryngology ".

1.300 routine clinical observation on the therapeutic effect

1. data

300 examples all are the otological disease that different bacterium infects, and sick the kind has acute and chronic suppurative otitis media, catarrhal otitis media, otitis externa, furuncle of external auditory canal, myringitis, eczema of external auditory canal etc.Age 1-75 year, 38 years old mean age.Wherein male's 188 examples account for 62.6%, and women's 112 examples account for 37.4%.Sex, age distribution situation see Table one, table two.

Table one

	The man	The woman
			The example number	???188	???112
????％	???62.6	???37.4

Table two

	1-16 year	16-30 year	30-45 year	45-60 year	60-75 year
						The example number	??176	???61	??19	??18	??26
????％	??58.7	???20.3	??6.3	??6	??8.7

Epidemiology, table one shows that the male accounts for 62.6%, and the women accounts for 37.4%, and the male patient is more than the women.By the visible age distribution of table two, mostly the patient is that the minor accounts for 58.7%, and the age is in 1-16 year, this shows that disease pilosity such as acute and chronic otitis media is born in child and teenager.

2. Therapeutic Method: washing external auditory meatus at first, wipe away clearly with 3% hydrogen peroxide, remove pus and secretions, to the more patient of part pus amount, adopt the method for vacuum suction.Next carries out ear and bathes, and gets compound jiabing ear drops 3-5 and drips, and splashes into the trouble ear, and tragus is power a little, enters tympanum in order to medicine, about 10min, or insert the sliver of this medicine.Should keep pharyngotympanic tube unobstructed simultaneously.

3. curative effect determinate standard:

Recovery from illness: clinical symptom disappearance, in ear does not have purulent secretion, and hyperemia is disappeared, dried ear.

Produce effects: transference cure, the more preceding obvious minimizing of auditory meatus endocrine, tympanum hyperemia alleviates, and does not have drawing together property and oozes out.

Invalid: in 1 week of medication, the in ear symptom does not have change.

4. be 7 days drug withdrawal standard-course of treatment.The attending doctor gave itemized record respectively at 3 days, 5 days, 7 days, 14 days.

A. check through the attending doctor, be diagnosed as the cured person drug withdrawal.

B. have side effects after the medication, and intermittently medication person's drug withdrawal.

C. symptom is not seen the person's of taking a turn for the better drug withdrawal (medication 7 days).

5. efficacy analysis

300 routine patients cure 211 people in 1 course of therapy, total cure rate is 70.4%; Produce effects 85 people account for 28.3%; Invalid 4 people account for 1.33%, total effective rate 98%.

Acute suppurative otitis media 50 examples are cured 30 examples, account for 80%; Produce effects 19 examples account for 38%.

Chronic suppurative otitis media 94 examples, 79 examples of fully recovering account for 84%.Produce effects 14 examples account for 14.9%; Invalid 1 example accounts for 1%.

Catarrhal otitis media 116 examples, 78 examples of fully recovering account for 67%, and produce effects 38 examples account for 32.8%.

Bullous myringitis 40 examples, 24 examples of fully recovering account for 60%, and produce effects 14 examples account for 35%.(seeing Table three)

Table three

Percentage ratio is sick plants	The example number	Recovery from illness	Produce effects	Invalid	Cure rate %	Effective percentage %
							Acute suppurative otitis media	50	30	19	1	60％	98％
Chronic suppurative otitis media	94	79	14	1	84％	98％
							Catarrhal otitis media	116	78	38	0	67％	100％
Bullous myringitis	40	24	14	2	60％	95％
							Add up to	300	211	85	4	70.4% (total cure rate)	98% (total effective rate)

Annotate: 1 routine chronic otitis media patient wherein, pus is cultivated and is acid-fast bacilli, is diagnosed as the whole body phthisis miliaris.3 routine patients are the old people in addition, and its cause of invalidity is treated further analysis.

6. course of disease analysis:

Clinical observation 300 routine patients, 3 days recovery from illness 36 examples account for and cured 119 examples in 17.0%, 5 day, account for and cure 56 examples in 56.4%, 7 day, account for 26.6%.See Table four

Table four

The example sky	Recovery from illness	Cure rate	Produce effects	Obvious effective rate
					????3	????36	??17.0％	???21	??24.7％
????5	????119	??56.4％	???38	??44.7％
					????7	????56	??26.6％	???26	??30.6％
Amount to	????211		???85

7. bacteriology checking

The inventor has done the inspection of antibacterial word to 30 routine patients at random, and whole cases are all collected secretions and carried out antibacterial culturing under strict sterile working, detect staphylococcus aureus 9 examples, poultry staphylococcus 1 example.Alpha-Hemolytic streptococcus 4 examples, streptococcus pneumoniae 3 examples, klebsiella pneumoniae 1 example, Pseudomonas aeruginosa 6 examples, proteus mirabilis 5 examples, liquefied Serratia 1 example.See Table five tables five

Strain name	The strain number	Percentage ratio
			Staphylococcus aureus	????9	????30％
Alpha-Hemolytic streptococcus	????4	????13.4％
			The poultry staphylococcus	????1	????3.3％
Streptococcus pneumoniae	????3	????10％
			Klebsiella pneumoniae	????1	????3.3％
Pseudomonas aeruginosa	????6	????20％
			Proteus mirabilis	????5	????16.7％
Liquefied Serratia	????1	????3.3％
			Add up to	????30	????100

By above 30 routine patients' treatment is observed, find compound jiabing ear drops to staphylococcus aureus, Hemolytic streptococcus, streptococcus pneumoniae, external ear, middle ear infection due to the Pseudomonas aeruginosa, strains such as proteus mirabilis have higher antibacterial activity.

2.150 routine clinical efficacy controlled observation

The inventor adopts compound jiabing ear drops, and compound norfloxacin [, neomycin ear drop are treated the infection of external ear, middle ear respectively and carried out clinical comparison.

1. clinical data

The outpatient service and the inpatient of 150 exception ears, middle ear infection are divided into three groups of A, B, C, every group 50 example at random.A group: be " compound jiabing ear drops " treatment group; B group: be " compound norfloxacin [" matched group; C group: be " neomycin ear drop " matched group.

2. respectively organize sex and age situation: A group, male 28 examples, women 22 examples; The B group, male 27 examples, women 23 examples; The C group, male 29 examples, women 21 examples.Average male accounts for 56%, and the women accounts for 44%, and the male is more than the women.See Table six, table seven

Table six

The sex group	The man	The woman	Add up to
				The A group	????28	????22	????50
The B group	????27	????23	????50
				The C group	????29	????21	????50
????％	????56％	????44％

Table seven

The grouping age	The A group	The B group	The C group
				1 year old-12 years old	????20	????22	????21
12 years old-17 years old	????12	????11	????10
				17 years old-40 years old	????7	????5	????6
40 years old-60 years old	????5	????6	????7
				60 years old-75 years old	????6	????6	????6
The maximum age	75 years old	62 years old	68 years old
				Minimal ages	4 months	3 months	6 months
Mean age	38 years old	31.5 year	34.5 year

Patient age distributes as table seven.Through X ²Check, there was no significant difference is compared in three groups of age structures.(P) 0.05), has comparability.

By the above age situation distribution table of respectively organizing, show that it is child or teenager that 64% the external ear and the patient of middle ear infection are arranged.At random 150 routine acute and chronic otitis media patients have been done pure tone test and acoustic impedance, there is dysaudia in most of patient, and the prompting utmost point is is early prevented and treated particularly important.

3. different sick kinds distribute

See disease distribution table eight tables eight

Example number grouping kinds of Diseases	The A group	The B group	The C group
				Acute suppurative otitis media	???10	???9	???8
Chronic suppurative otitis media	???13	???12	???11
				Catarrhal otitis media	???13	???14	???15
Bullous myringitis	???6	???6	???7
				Otitis externa	???8	???9	???9
Amount to	???50	???50	???50

4. Therapeutic Method

A group: use compound jiabing ear drops.Method the same (2. 3.).

B group: use the norfloxacin [, with 3% hydrogen peroxide removing auditory meatus endocrine, splash into this medicine 2-3 again and drip earlier, three times on the one or insert with this medicine sliver.

The C group: use neomycin ear drop, remove the auditory meatus endocrine with 3% hydrogen peroxide equally, splash into this medicine 2-3 again and drip, three times on the one, or use this medicine sliver to insert.

Above-mentioned three groups, begin the itemized record case history from medication, comprise the observation clinical symptoms, sign and adverse effect are to compare.

5. criterion of therapeutical effect: (ditto) (3. 4.)

6. therapeutic outcome: see Table nine table nine A, B, three groups of total effectses of C relatively

Group	Total routine number	Recovery from illness	Produce effects	Invalid	Total effective rate
						The A group	????50	????23	????26	????1	??98％
The B group	????50	????24	????22	????4	??92％
						The C group	????50	????11	????23	????16	??68％

As shown in Table 9: A organizes (compound jiabing ear drops), 23 examples of fully recovering, and produce effects 26 examples, invalid 1 example, total effective rate is 98%.B organizes (compound norfloxacin [), 24 examples of fully recovering, and produce effects 22 examples, invalid 4 examples, total effective rate is 92%.C group (neomycin ear drop) recovery from illness 11 examples, produce effects 23 examples, invalid 16 examples, total effective rate 68%.

The inventor divides three kinds of situations to carry out X 2 test; 1. during A and B organize relatively, X ²=5.991, P＞0.05, no marked difference.2. A and C group compares X ²=12.2033, P＜0.01, difference significance.3. B and C group compares X ²=12.0506, P＜0.01, difference significance.

As above shown in the result: the clinical efficacy of A group and B group is organized apparently higher than C.

Through case history statistical average curative day: A group is 5 days.The B group is 6 days.C group＞7 days.

3. untoward reaction.Untoward reaction is rare, and utmost point individual patients is crossed to hang down because of the medicine temperature and a property discomfort or a hypodynia sense excessively can be occurred, but 3-5 can disappear after second.

4. model case

Example one, Zhang Zhi is all, the man, 61 years old, the auris dextra intermittence is suppurated year surplus in the of 30, and with auditory dysesthesia, suppurate due to the flu recently aggravation and pain, once nearby hospital had an injection, took medicine, put medicine and all do not have positive effect, so come my institute, check that right ear canal has a large amount of heavy-gravity oar fluidity secretions, with 3% the visible tympanum height hyperemia in hydrogen peroxide cleaning back, the tense part large perforation gives, send pus to cultivate, report: liquefied Serratia growth (susceptibility kanamycin, neomycin sensitivity-be ototoxicity antibiotics), have a blood test: WBC, 13.8 * 10 ⁹/ L, N, 82%, L, 18%.Film making is diagnosed as the chronic middle ear mastoiditis.Treatment: " dripping ear No. 6 " sliver is gone up in the hydrogen peroxide cleaning back with 3%, and give No. 6, ear " drip " [and drip ear three times on the one, three days purulent secretions of treatment obviously reduce continuously, the back purulent secretion disappearance of one week, tympanum is congested to take a turn for the better, respectively at ten days, first quarter moon, recurrence is not seen in check after January, conscious audition takes a turn for the better.

Example two, infant Li Mei, the woman, 10 years old, the auris dextra intermittence suppurate 1 year surplus, once had an injection, took medicine, put medicine and all do not have positive effect, after we were with 3% hydrogen peroxide cleaning, pus disappeared after point " dripped ear No. 6 " 5 days, perforation healing in 10 days is followed up a case by regular visits to, recurrence again.

Example three, Wang Zhiyong, man, 25 years old, workman, auris dextra pain, the sense of obstruction three days are arranged, check that the tympanum chamber just is being highly hyperemia and is caving in, movable not good enough, be diagnosed as catarrhal otitis media,, check that tympanum is complete through with " dripping ear No. 6 " 5 days transference cures, the congested disappearance, movable good, audition once was transmission deafness, and auditory rehabilitation is normal after curing.

Example four, grandson * *, woman, 54 years old, year suppurates repeatedly surplus the chronic suppurative otitis media 20, and the pars tensa membranae tympani large perforation is seen in the recurrence in 2 days of catching a cold, oar liquid purulent secretion +++, give vacuum suction after, after cleaning with 3% hydrogen peroxide, insert first ice sliver, change dressings next day, and secretions obviously reduces, 3% hydrogen peroxide cleaning back medicine-feeding, the 3rd day, purulent secretion disappears, and the mucosa of tympanic cavity redness is changed dressings once-a-day with method, after six days, in ear secretions disappearance drum reddening and swelling of mucosa disappears dried ear.

Example five, Liu *, the woman, 7 years old, left side discharging ear was examined over 2 days, checked a large amount of oar liquid of left auditory meatus purulent secretion, saw after 3% the hydrogen peroxide cleaning that the tympanum surface is more mashed, do not see perforation, insert ring third sliver, symptom did not have change on 2nd, used the secretions complete obiteration after 24 hours of first ice sliver instead, added medicine to once in 1st, it is normal that three secondary tympanic membranes recover fully.Therefore:

1. compound jiabing ear drops of the present invention is to be that main Western medicine is the compound preparation of assisting with Chinese medicine.Prescription is formed scientific and reasonable, preparation stabilization, and clinical practice is evident in efficacy, has shown the superiority of motherland's Chinese medicine and modern Western medicine reasonable compatibility, has in research and development to have done good try aspect the novel formulation of China's characteristic.

2. compound jiabing ear drops of the present invention is formed, and synergism is arranged between medicine, has stronger antibacterial activity and wider antimicrobial spectrum, and indication is widely not only arranged, and the effective percentage height.Disease cured rates such as acute and chronic suppurative otitis media to otology reach 70.4%, and total effective rate reaches 98%, and average curative day is 5 days.By the clinicaling curative effect contrast observation as shown in Table 9, A group and B group obviously are better than C group, P＜0.01 significance.Prove that this medicine is the good preparation of otology illness.

3. shortcomings such as it is of a great variety to treat the otology infection medicine at present, and solution, glycerin, alcohol formulations etc. exist penetration power poor respectively, and local irritation is strong.Some medicine also has certain toxic reaction, can cause dysaudia as the [of amide alcohols, aminoglycosides.Ciprofloxacin ear drop, a twenty or thirty unit costs an arm and a leg, and common people are difficult to accept.Compound jiabing ear drops of the present invention adopts Chinese and western drugs to add double solvent and makes, and has not only strengthened penetration power but also has prolonged action time of this medicine, has reduced untoward reaction simultaneously, and low price.These all be other drug can not compare.

4. compound jiabing ear drops 1. of the present invention is difficult for producing drug resistance to antibacterial, but awaits clinical from now on further checking according to the medicine composition analysis.2. find in clinical observation that this medicine can make the patient symptom of some tinnitus and auditory dysesthesia obviously be alleviated, even recover audition, also await further inquiring into its mechanism.3. said preparation lacks sophisticated equipment in preparation process, treats that the preparation fund purchases, advance perfect soon, to improve the quality of the pharmaceutical preparations.4. utmost point individual patient produces the property a crossed discomfort or a hypodynia sense, is further improved.

Claims (4)

1, compound jiabing ear drops comprises Borneolum Syntheticum, Radix Sophorae Flavescentis, Herba Asari, metronidazole.

2, the described compound jiabing ear drops of claim 1, wherein the ratio of each component is (parts by weight are represented): 4-6 part Borneolum Syntheticum: 8-12 part Radix Sophorae Flavescentis: 2-5 part Herba Asari: 0.2-3 part metronidazole.

3, the described compound jiabing ear drops of claim 1, wherein the ratio of each component is (parts by weight are represented): 5 parts of Borneolum Syntheticums: 10 parts of Radix Sophorae Flavescentiss: 3 parts of Herba Asaris: 1 part of metronidazole.

4, any described compound jiabing ear drops preparation method in the claim 1-3 item, comprising: coarse powder such as Radix Sophorae Flavescentis are added the doubling dose decocting boil twice, 1.5 hours for the first time, 1 hour for the second time, merge decoction liquor, left standstill 12 hours at cold place, filter, get filtrate, this filtrate is concentrated into every ml is equivalent to crude drug in whole one gram, get first liquid; The Herba Asari coarse powder is made solvent dipping 24h by percolation with 60% ethanol, make every 100mL be equivalent to the percolate that crude drug in whole 10 restrains to the liquid regulation jg that filters with every min 3mL speed percolation, filtering and impurity removing matter, and add Borneolum Syntheticum, the even second liquid that gets of mixed dissolution; With metronidazole be dissolved in water medicinal liquid, filter, transfer PH4.5～6.0, third liquid, every 100ml contains 0.2 gram metronidazole; First, second, the third three liquid are merged according to the above ratio add percolate and glycerol, stir, transfer PH, make into the light green clear liquid with dilute hydrochloric acid to capacity, detects qualified after, be sub-packed in the 10ml sterilization ear bottle by aseptic manipulation, seal, pack promptly.