CN101584689A - Contain compound recipe [of phenazone and lignocaine and preparation method thereof - Google Patents
Contain compound recipe [of phenazone and lignocaine and preparation method thereof Download PDFInfo
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- CN101584689A CN101584689A CNA2009100519351A CN200910051935A CN101584689A CN 101584689 A CN101584689 A CN 101584689A CN A2009100519351 A CNA2009100519351 A CN A2009100519351A CN 200910051935 A CN200910051935 A CN 200910051935A CN 101584689 A CN101584689 A CN 101584689A
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- lignocaine
- phenazone
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- glycerol
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Abstract
The invention discloses a kind of compound recipe [that contains phenazone and lignocaine and preparation method thereof, comprise phenazone, lignocaine and pharmaceutically acceptable adjuvant, in compound recipe [gross weight, contain the phenazone of 1%-20% and 0.5%～5% lignocaine or its esters.The compound recipe [that contains phenazone and lignocaine of the present invention, act on rapid, evident in efficacy, cost is lower, be used for barotrauma of middle ear, acute and chronic otitis media anti-inflammation works very well, especially have good cure rate at barotrauma of middle ear, have tangible analgesic effect, reduce senses of discomfort such as patient's otalgia, headache, simultaneously easy to use, cheap, preparation is simple, and is quality controllable.
Description
Technical field
The present invention relates to a kind of [, particularly a kind of compound recipe [that contains phenazone and lignocaine and preparation method thereof.
Background technology
Anxious, chronic otitis media is the commonly encountered diseases and the frequently-occurring disease of clinical otology, its pathogenic bacterium mostly are staphylococcus aureus, Pseudomonas aeruginosa, Hemolytic streptococcus, Bacillus proteus etc., the part otitis media can be with the mixed infection of anaerobe etc., its symptom is mainly Ipsilateral ear temporary hearing loss, pain, or with heating, check visible otopiesis or bulging or perforation, cone of light disappears, middle ear ooze out or hydrops, tympanum is congested or hemorrhage, even visible transudate or pus outflow in perforation of ear drum case, and in external auditory meatus, there is tenderness at positions such as mastoid process, or can touch the lymph node of enlargement, or with tenderness in ear week.
Barotrauma of middle ear claims barotraumatic otits media again.When ambient pressure changed, middle ear tympanum internal pressure can not reach balance with ambient pressure moment for a certain reason, and produces corresponding pathological change.Barotrauma of middle ear is a common disease in aviation (especially when aircraft takeoff and landing), the diving (mainly being the dive process).The hearing loss that the symptom of barotrauma of middle ear is mainly and has an intense pain, moment takes place, insufferable pain etc. can cause the reduction of performance capacity, even be forced to interruption operation.Medical inspection visible Ipsilateral ear drum membrane hyperemia or depression or perforation or hemorrhage, cone of light disappears, and the middle ear chamber is oozed out and/or hydrops, and acute stage, can not have tenderness and symptoms such as lymphadenectasis, tenderness.Patient's otalgia continues, and dysacousis can last for hours a couple of days, and what take place usually belongs to conductivity dysacousis.
The [Main Ingredients and Appearance that is used for the treatment of above-mentioned otitis media at present both at home and abroad clinically mostly is antibiotics, disinfection preservative and/or glucocorticoid medicine etc., wherein antibiotics is used chloromycetin (CN1247063A), gentamycin, kanamycin, neomycin, ciprofloxacin (CN 1126073A), metronidazole (CN 1137917A always, CN 1260174A), norfloxacin (CN 1260174A) etc., disinfection preservative is used phenol, boric acid etc. always, and glucocorticoid medicine is used dexamethasone (CN 1247063A) etc. always.
The use of antibiotics is after abusing for many years, its pathogenic bacterium drug resistance phenomenon is very serious, curative effect is restricted, often need carry out to select sensitive antibiotic to treat behind the medicament sensitivity tests of pathogenic bacterium, and antibiotics can enter the middle ear toxigenicity by tympanum, cause irreversible pathological lesion, especially gentamycin, neomycin, chloromycetin, antibiotic such as kanamycin can cause nonvolatil hearing loss, and can cause trouble ear vestibular deficiency, cause patient's tinnitus, deaf, sequela such as deformity are brought huge misery to the patient.
The use of disinfection preservative has certain curative effect, but acts on limitedly, and can suppress cell normal function, easy damaged tympanum and mucosa to some extent.Though the application of glucocorticoid medicine can help the treatment of otitis media, hormone medicine relies on, the adverse consequencess such as hormones reaction of general but life-time service can produce, and be not suitable for athletes, maybe can cause the reaction of athlete's fail doping tests after the use.Clinical otitis media Therapeutic Method commonly used is poor effect in analgesia.
Summary of the invention
The purpose of this invention is to provide a kind of compound recipe [that contains phenazone and lignocaine and preparation method thereof, to overcome the above-mentioned defective that prior art exists.
The compound recipe [that contains phenazone and lignocaine of the present invention, comprise phenazone, lignocaine and pharmaceutically acceptable adjuvant, in compound recipe [gross weight, contain 1%～20% phenazone and 0.5%～5% lignocaine or its esters, preferably, contain 4% phenazone and 1% lidocaine hydrochloride;
Preferably, the described percentage by weight component that contains the compound recipe [of phenazone and lignocaine comprises:
Phenazone or derivatives thereof 1%～20%
Lignocaine or its esters 0.5%～5%
Sodium thiosulfate 0.1%～10%
Ethanol 10%～30%
Glycerol 50%～80%
More than each percentages of ingredients sum be 100%;
Described alcoholic acid volumetric concentration is 75～95%;
Further preferred, the described percentage by weight component that contains the compound recipe [of phenazone and lignocaine comprises:
Phenazone or derivatives thereof 4～6%
Lignocaine or its esters 1～2%
Sodium thiosulfate 0.1%～1.0%
Ethanol 20～25%
Glycerol 68～74.5%
More than each percentages of ingredients sum be 100%;
Described phenazone derivant comprises peace for isopropylantipyrine, than woods methylamine methane, salipyrin, anilipyrine or anilipyrine etc., wherein preferred phenazone;
Described lignocaine salt comprises lidocaine hydrochloride or glucose lignocaine, preferably lidocaine hydrochloride.
Preferably, in the described compound recipe [that contains phenazone and lignocaine, also comprise in isotonic agent, antioxidant, acidity regulator or the antiseptic more than one;
Described isotonic agent can be selected from sorbitol, mannitol, glycerol, propylene glycol, glucose, sucrose, lactose, trehalose or fructose, and the consumption of isotonic agent is 60～95% of the described compound recipe [gross weight that contains phenazone and lignocaine;
Described antioxidant can be selected from sodium sulfite, sodium sulfite, sodium pyrosulfite or vitamin C, and consumption is 0～10% of the described compound recipe [gross weight that contains phenazone and lignocaine;
Acidity regulator or pH regulator agent can be selected from lactic acid, citric acid, acetic acid, sodium carbonate, sodium bicarbonate, sodium citrate, sodium acetate or sodium lactate, and consumption is 0～0.5% of the described compound recipe [gross weight that contains phenazone and lignocaine;
Described antiseptic can be selected from benzoic acid, benzoate, sorbic acid or sorbate, and consumption is 0～0.5% of the described compound recipe [gross weight that contains phenazone and lignocaine.
The preparation method that contains the compound recipe [of phenazone and lignocaine of the present invention comprises the steps:
Phenazone, lignocaine are joined in the ethanol, and mixing joins sodium thiosulfate in the above-mentioned solution then, and the mixing dissolving joins glycerol in the above-mentioned solution then, and the mixing dissolving promptly obtains product;
Preferably, also comprise one or more the step that adds in isotonic agent, antioxidant, acidity regulator or the antiseptic.
In vitro tests proves, the present invention adopts analgesic anti-inflammatory analgesic class medicine-phenazone or derivatives thereof and local anesthetic--drug regimen of lignocaine or its esters, be aided with inorganic matter and Organic substances such as sodium thiosulfate, ethanol, glycerol, make liquid solution, be used for the treatment of barotrauma of middle ear and otitis media has good result.
One aspect of the present invention is so that analgesic anti-inflammatory analgesic class medicine-phenazone or derivatives thereof and local anesthetic--lignocaine or its esters are main ingredient, the characteristic of or aqueous solution soluble in water with it, bring into play the effect of anti-inflammatory analgesic and local analgesia, play the effect of Synergistic treatment otitis media (especially barotrauma of middle ear); On the other hand, as secondary solvent and medium, increase medicine, alleviate the zest of medicine positions such as external auditory meatus, tympanums at the partial absorbance of external ear with inorganic matter such as sodium thiosulfate, ethanol, glycerol and Organic substance.
The compound recipe [that contains phenazone and lignocaine of the present invention, the mode that can splash into by external auditory meatus puts on the patient who needs treatment, the therapeutic dose of recommending is each 4, every day 2～3 times, used 10 days at most continuously, specifically can determine by the specialist according to conditions of patients.
The compound recipe [that contains phenazone and lignocaine among the present invention is faintly acid, pH value 4.5-7.0, the acid or alkali environment that adapts to human body external auditory meatus, reduce the probability of bacterial infection, help the performance of antibacterial action, especially be fit to be applied to barotrauma of middle ear occupation or posies occurred frequently such as aviation, diving, can treat the occupational barotrauma of middle ear, alleviate and reduce the complication and the sequela of barotrauma of middle ear.
The compound recipe [that contains phenazone and lignocaine of the present invention, act on rapid, evident in efficacy, cost is lower, be used for barotrauma of middle ear, acute and chronic otitis media anti-inflammation works very well, especially have good cure rate at barotrauma of middle ear, have tangible analgesic effect, reduce senses of discomfort such as patient's otalgia, headache, simultaneously easy to use, cheap, preparation is simple, and is quality controllable.
The specific embodiment
Below in conjunction with specific embodiment, further illustrate the present invention.Should be understood that these embodiment only to be used to the present invention is described and be not used in and limit the scope of the invention.The experimental technique of unreceipted actual conditions in the following example, usually according to normal condition, or the condition of advising according to manufacturer.Ratio and percentage ratio are based on weight, unless stated otherwise.
Embodiment 1
Phenazone 4g
Lidocaine hydrochloride 1g
Sodium thiosulfate 0.1g
95 (volume) % ethanol 24g
Glycerol 70.9g
Phenazone and lidocaine hydrochloride are dissolved in the alcoholic solution, make solution, then sodium thiosulfate is added in the above-mentioned solution, mixing, glycerol adding again, the mixing dissolving promptly gets [.
This [can splash into external auditory meatus, is used for the external auditory meatus drug treatment.
Embodiment 2
Phenazone 4g
Lidocaine hydrochloride 1g
Sodium thiosulfate 0.5g
95 (volume) % ethanol 20g
Glycerol 74.5g
Preparation method is with embodiment 1.
Embodiment 3.
Phenazone 4g
Lidocaine hydrochloride 2g
Sodium thiosulfate 0.2g
75 (volume) % ethanol 25g
Glycerol 68.8g
Preparation method is with embodiment 1.
Embodiment 4. contains the compound recipe [of phenazone and lignocaine
Phenazone 6g
Lidocaine hydrochloride 2g
Sodium thiosulfate 0.1g
75 (volume) % ethanol 25g
Glycerol 66.9g
Preparation method is with embodiment 1.
Embodiment 5.
Phenazone 6g
Lidocaine hydrochloride 1g
Sodium thiosulfate 0.5g
95 (volume) % ethanol 20g
Glycerol 72.5g
Preparation method is with embodiment 1.
Embodiment 6.
Phenazone 6g
Lidocaine hydrochloride 1g
Sodium thiosulfate 0.1g
95 (volume) % ethanol 24g
Glycerol 68.9g
Preparation method is with embodiment 1.
Embodiment 7, in vitro tests
Compound recipe [pharmacology, the toxicological experiment research that contains phenazone and lignocaine of the present invention
(1) external bacteriostatic experiment: extracorporeal bacteria inhibitor test adopts paper disk method and plate punch method, and compares with the chloromycetin standard substance.This product has inhibitory action to staphylococcus aureus, Pseudomonas aeruginosa as a result, to the common infectious bacteria sensitivity of middle ear.Result of the test sees Table 1
Each embodiment of table 1 and chloromycetin standard substance extracorporeal bacteria inhibitor test inhibition zone average
Unit: millimeter (mm)
Annotate: every group of experiment repeats 3 times
(2) toxicological experiment: acute toxicity test, laboratory mice is divided into two groups at random, 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.None example of mice was dead after the result irritated stomach, illustrated that this medicine is nontoxic, and using as [is a kind of safe drugs.Result of the test sees Table 2
Each embodiment acute toxicity testing of table 2
(3) skin irritation test: white rabbit was equipped with portion's both sides unhairing in preceding 24 hours in administration, but injured skin not.Getting this product [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 is non-stimulated to skin.Result of the test sees Table 3
Each embodiment skin irritation test of table 3
Annotate: "-" expression symptom feminine gender, no erythema and edema
(4) indication and usage and dosage
Learn experimentation according to prescription drug effect and pharmacological toxicology, this product can be used for treating ear disorder in barotrauma of middle ear, acute and chronic otitis media, the catarrhal otitis media etc.
Face with preceding 3% hydrogen peroxide that uses earlier and clean the interior dirt of external auditory meatus, splash into this product medicinal liquid then, each 4, every day 2-3 time, drug withdrawal behind the transference cure was used 10 days at most continuously.
The inventor adopts embodiment 1 pharmaceutical formulation that barotrauma of middle ear patient 16 examples that occur otalgia, slight dysaudia among the diver are treated, total effective rate is 100%, cure rate is 93.75%, and most patients can proceed diving operation in treatment rehabilitation after 2-4 days.Therapeutic outcome sees Table 4.
Table 4 embodiment 1 treatment barotrauma of middle ear patient curative effect statistics
Claims (9)
1. the compound recipe [that contains phenazone and lignocaine, it is characterized in that, comprise phenazone, lignocaine and pharmaceutically acceptable adjuvant,, contain the phenazone of 1%--20% and lignocaine or its esters of 0.5%--5% in compound recipe [gross weight.
2. the compound recipe [that contains phenazone and lignocaine according to claim 1 is characterized in that, contains 4% phenazone and 1% lignocaine or its esters.
3. the compound recipe [that contains phenazone and lignocaine according to claim 1 is characterized in that, the described percentage by weight component that contains the compound recipe [of phenazone and lignocaine comprises:
Phenazone or derivatives thereof 1%～20%
Lignocaine or its esters 0.5%～5%
Sodium thiosulfate 0.1%～10%
Ethanol 10%～30%
Glycerol 50%～80%
Described alcoholic acid volumetric concentration is 75～95%.
4. the compound recipe [that contains phenazone and lignocaine according to claim 1 is characterized in that, the described percentage by weight component that contains the compound recipe [of phenazone and lignocaine comprises:
Phenazone or derivatives thereof 4～6%
Lignocaine or its esters 1～2%
Sodium thiosulfate 0.1%～1.0%
Ethanol 20～25%
Glycerol 68～74.5%
5. according to each described compound recipe [that contains phenazone and lignocaine of claim 1～4, it is characterized in that, described phenazone derivant comprises that peace is for isopropylantipyrine, than woods methylamine methane, salipyrin, anilipyrine or anilipyrine.
6. according to each described compound recipe [that contains phenazone and lignocaine of claim 1～4, it is characterized in that described lignocaine salt comprises lidocaine hydrochloride or glucose lignocaine.
7. according to each described compound recipe [that contains phenazone and lignocaine of claim 1～4, it is characterized in that, in the described compound recipe [that contains phenazone and lignocaine, also comprise in isotonic agent, antioxidant, acidity regulator or the antiseptic one or more.
8. the compound recipe [that contains phenazone and lignocaine according to claim 7 is characterized in that described isotonic agent can be selected from sorbitol, mannitol, glycerol, propylene glycol, glucose, sucrose, lactose, trehalose or fructose;
Described antioxidant can be selected from sodium sulfite, sodium sulfite, sodium pyrosulfite or vitamin C;
Acidity regulator or pH regulator agent can be selected from lactic acid, citric acid, acetic acid, sodium carbonate, sodium bicarbonate, sodium citrate, sodium acetate or sodium lactate;
Described antiseptic can be selected from benzoic acid, benzoate, sorbic acid or sorbate.
9. prepare each described method that contains the compound recipe [of phenazone and lignocaine of claim 1～8, it is characterized in that, comprise the steps: phenazone, lignocaine are joined in the ethanol, mixing, then sodium thiosulfate is joined in the above-mentioned solution, the mixing dissolving joins glycerol in the above-mentioned solution then, the mixing dissolving promptly obtains product.
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| CN2009100519351A CN101584689B (en) | 2009-05-25 | 2009-05-25 | Compound eardrops containing antipyrine and lidocaine the and preparation method thereof |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104645001A (en) * | 2014-06-10 | 2015-05-27 | 陈莉芬 | Bacterium inhibiting and festering preventing ear drop |
| CN105496946A (en) * | 2014-10-16 | 2016-04-20 | 中国人民解放军海军医学研究所 | Aluminum diacetate hydroxide and acetic acid compound ear drops and preparation method thereof |
| EP3263103A4 (en) * | 2015-02-26 | 2018-03-14 | Limited Liability Company "konsortsium-pik" | Pharmaceutical composition for treatment of inflammatory ear diseases, method for producing same and method for treatment using said composition |
| US20190381003A1 (en) * | 2017-08-22 | 2019-12-19 | Limited Liability Company "Konsortsium-Pik" | Pharmaceutical composition for treatment of inflammatory ear diseases, method for producing same and method for treatment using same composition |
| WO2020024246A1 (en) * | 2018-07-30 | 2020-02-06 | 郑州兰茜生物工程有限公司 | Ear drops used for tinnitus and with ear health and relief functions |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20080167281A1 (en) * | 2007-01-05 | 2008-07-10 | Preston David M | Combination Otic Formulation |
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2009
- 2009-05-25 CN CN2009100519351A patent/CN101584689B/en active Active
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104645001A (en) * | 2014-06-10 | 2015-05-27 | 陈莉芬 | Bacterium inhibiting and festering preventing ear drop |
| CN105496946A (en) * | 2014-10-16 | 2016-04-20 | 中国人民解放军海军医学研究所 | Aluminum diacetate hydroxide and acetic acid compound ear drops and preparation method thereof |
| CN105496946B (en) * | 2014-10-16 | 2018-07-27 | 中国人民解放军海军医学研究所 | Compound auristilla and preparation method thereof containing eston and acetic acid |
| EP3263103A4 (en) * | 2015-02-26 | 2018-03-14 | Limited Liability Company "konsortsium-pik" | Pharmaceutical composition for treatment of inflammatory ear diseases, method for producing same and method for treatment using said composition |
| US20190381003A1 (en) * | 2017-08-22 | 2019-12-19 | Limited Liability Company "Konsortsium-Pik" | Pharmaceutical composition for treatment of inflammatory ear diseases, method for producing same and method for treatment using same composition |
| WO2020024246A1 (en) * | 2018-07-30 | 2020-02-06 | 郑州兰茜生物工程有限公司 | Ear drops used for tinnitus and with ear health and relief functions |
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| Publication number | Publication date |
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| CN101584689B (en) | 2011-03-16 |
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