CN1638749A - Ambroxol for treating painful conditions in the mouth and pharyngeal cavity - Google Patents

Ambroxol for treating painful conditions in the mouth and pharyngeal cavity Download PDF

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Publication number
CN1638749A
CN1638749A CNA038047683A CN03804768A CN1638749A CN 1638749 A CN1638749 A CN 1638749A CN A038047683 A CNA038047683 A CN A038047683A CN 03804768 A CN03804768 A CN 03804768A CN 1638749 A CN1638749 A CN 1638749A
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Prior art keywords
pain
ambroxol
oral cavity
cavity
pharmaceutical composition
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安克·埃斯珀里斯特
尤维·普肖恩
让·米歇尔·维克斯
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Boehringer Ingelheim Pharma GmbH and Co KG
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Boehringer Ingelheim Pharma GmbH and Co KG
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Application filed by Boehringer Ingelheim Pharma GmbH and Co KG filed Critical Boehringer Ingelheim Pharma GmbH and Co KG
Publication of CN1638749A publication Critical patent/CN1638749A/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/136—Amines having aromatic rings, e.g. ketamine, nortriptyline having the amino group directly attached to the aromatic ring, e.g. benzeneamine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/4709—Non-condensed quinolines and containing further heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/02—Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/04—Drugs for disorders of the respiratory system for throat disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A61P29/02—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] without antiinflammatory effect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/20—Antivirals for DNA viruses
    • A61P31/22—Antivirals for DNA viruses for herpes viruses

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  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Virology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pain & Pain Management (AREA)
  • Pulmonology (AREA)
  • Neurosurgery (AREA)
  • Nutrition Science (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Molecular Biology (AREA)
  • Rheumatology (AREA)
  • Otolaryngology (AREA)
  • Communicable Diseases (AREA)
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  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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Abstract

The invention relates to the use of ambroxol and the pharmacologically compatible salts thereof for producing a medicament used for treating painful conditions in the mouth and pharyngeal cavity.

Description

The ambroxol that is used for the treatment of oral cavity and pharyngeal cavity pain symptom
Technical field
The invention relates to acceptable salt on ambroxol (ambroxol) and the pharmacology thereof and be used for the treatment of purposes in the medicament of oral cavity and pharyngeal cavity pain symptom in preparation.
Prior art
The analgesic that is used to alleviate oral cavity and pharyngeal cavity pain often has the shortcoming of side effect, for example local excitation side effect.
Active substance ambroxol (anti--4-(2-amino-3,5-dibromo-benzyl amino)-Hexalin) is a kind of known expectorant and mucus distintegrant.Ambroxol is a kind of oral formulations, for example syrup, capsule, tablet, imbedibility solution, drop sucking property tablet maybe.
The objective of the invention is to prepare a kind of good active substance of toleration that is used for the treatment of oral cavity and pharyngeal cavity pain.
Summary of the invention
Find that out of a clear sky it also has the fabulous alleviation oral cavity and the effect of pharyngeal cavity pain except toleration is splendid when with suitable dosage or concentration topical administration ambroxol.
Therefore the present invention relevantly uses acceptable salt on ambroxol or its pharmacology to be used for the treatment of the medicament of oral cavity and pharyngeal cavity pain with preparation, mucosa focus in these pain are selected from pressure spot, oropharynx that acute throat pain, aphtha, gingivitis, periodontal disease, prothesis cause after disposing pain, oral cavity and the pharyngeal cavity and the herpes simplex in oral cavity and the pharyngeal cavity; Mucosa focus in pain, oral cavity and the pharyngeal cavity after particularly aphtha, gingivitis, periodontal disease, the pressure spot of prothesis initiation, oropharynx are disposed and the herpes simplex in oral cavity and the pharyngeal cavity; Especially for the acute throat pain of treatment.Acute throat pain one vocabulary shows that severe has sore throat, and for example has the laryngopharyngitis of burning sensation in dysphagia or the larynx.
The present invention is relevant a kind of pharmaceutical composition in addition, it contains acceptable salt and one or more active substances on ambroxol or a kind of its pharmacology, and this active substance is selected from antibacterial class, vitamins, corticoid class, antiinflammatory class, viral inhibitors (virustatika), antibiotics, antimycotic and proteolytic enzyme class.
Suitably the antibacterial class is for example chlorination spermaceti pyridine, dequalinium chloride (dequalinium-Cl), the husky acridine (ethacridine-lactate) of glucosulfone pickling BITAI (chlorhexidin-digluconat), Benasept or lactic acid.
Suitably vitamins for example is pantothenylol (dexpanthenol) (pantothenic acid) or ascorbic acid.
Suitably the corticoid class is for example Adcortyl (triamcinolon) or meticortelone acetate (prednisolon-acetat).
Suitably the antiinflammatory class is for example benzydamine hydrochloride (benzydamin-Cl) or choline salicylate.
Suitably the antiviral class for example is acyclovir (acyclovir) or idoxuridine (idoxuridin).
Suitably antibiotics is for example Sai Luotuolixin (thyrotricin) or bacitracin (bacitracin).
Suitably antimycotic is for example amphotericin B (amphotericin B) or nystatin (nystatin).
Suitably proteolytic enzyme is for example lysozyme.
Suitably ether be oils for Oleum menthae for example, white in Oleum sesami or Mus tail oil.
Another purpose of the present invention is about a kind of pharmaceutical composition, and it contains on ambroxol or a kind of its pharmacology acceptable salt and one or more are selected from lisozima, glycyrrhizic acid dipotassium, ammonium glycyrrhizinate, cetylpyridinium chloride, chlorphenamine maleate (chlorpheniramin maleat), narcotine (noscapin), dequalinium chloride (dequalinium chloride), dromethan phenolic group phthalate (dextromethorphanphenophthalinat), sulfogaiacol, hydrochloric acid d1 ephedrine, chlorhexidine dihydrochloride, and the active substance in the cresol sulfonic acid potassium.
Ambroxol is the metabolite that Bromhexine (secretolyticums bromhexin) is decomposed in a kind of secretion.Two kinds of active substances are the splendid active compound compositions of toleration, and it influences the ambroxol double effects.
Therefore the present invention is also about a kind of pharmaceutical composition of being made up of acceptable salt and medical auxiliary agent on ambroxol, Bromhexine or its pharmacology, and ambroxol is at 4: 1 to 6: 1 to bromine hexylamine ratio, is more preferred from 5: 1 the scope.
Special good pharmaceutical composition contains 15 to 50 milligrams of ambroxols and is preferably 20 milligrams of ambroxols for single dose wherein.
The invention still further relates to a kind of pharmaceutical composition solid, can suck or slow dissolve dosage form, contain ambroxol and one or more, be selected from the active substance of antibacterial class, vitamins, corticoid class, anti-inflammatory type, antibiotics, antimycotic and proteolytic enzyme apoplexy due to endogenous wind.
To be aforementioned pharmaceutical compositions be used for the treatment of purposes in the medicine of oral cavity and/or pharyngeal cavity pain in preparation to another theme of the present invention, it is selected from pressure spot, the mucosa focus in pain, oral cavity and the pharyngeal cavity after the oropharynx disposal and the herpes simplex in oral cavity and the pharyngeal cavity of acute throat pain, aphtha, gingivitis, periodontal disease, prothesis initiation, and the best is in order to treat acute throat pain.
Further object of the present invention is to be used for the treatment of purposes in the pharmaceutical composition of oral cavity and/or pharyngeal cavity pain about the pharmaceutical composition be made up of ambroxol hydrochloride, a kind of spice, a kind of lubricant, a kind of host material, a kind of sweeting agent and Polyethylene Glycol in preparation, this treatment is selected from pressure spot, oropharynx that acute throat pain, aphtha, gingivitis, periodontal disease, prothesis cause and disposes mucosa focus in back pain, oral cavity and the pharyngeal cavity and the herpes simplex in oral cavity and the pharyngeal cavity, and the best is in order to treat acute laryngalgia.
Suitably spice is Mentha arvensis L. syn.M.haplocalyxBrig, eucalyptus oil or Fructus Citri Limoniae for example, is preferably peppermint flavor.
Suitable matrix material for example is preferably Sorbitol for calcium carbonate, calcium phosphate or Sorbitol.
Suitably sweeting agent for example is preferably saccharin sodium for glucide, saccharin sodium, cyclamate, glycerol or sugar.
Suitable film-making lubricant for example is preferably Macrogol 6000 for polyethylene glycols.
The proper lubrication agent for example is preferably Talcum for Talcum or magnesium stearate.
Further object of the present invention is relevant a kind ofly to contain ambroxol and based on the purposes of sugar alcohol as the tablet sucked of host material, it is characterized by this and can suck tablet optionally except other medical auxiliary agent, correctives or spice also contain pharmaceutically acceptable phyllosilicate and Polyethylene Glycol outward and prepare a kind of pharmaceutical composition that is used for the treatment of oral cavity and/or pharyngeal cavity pain, this treatment is selected from acute throat pain, aphtha, gingivitis, periodontal disease, the pressure spot that prothesis causes, oropharynx is disposed back pain, mucosa focus in oral cavity and the pharyngeal cavity, and the herpes simplex in oral cavity and the pharyngeal cavity, especially for the acute throat pain of treatment.
The purposes that further object of the present invention is relevant ambroxol in a kind of pharmaceutical composition of preparation, it has that the alleviating pain effect can be kept 3 hours at least and preferably more than 3 hour time after dispensing.
The objective of the invention is the relevant pharmaceutical composition that contains ambroxol of using simultaneously preparing a kind of medicine, it has that the alleviating pain effect can be kept 3 hours at least and preferably more than 3 hour time after dispensing.
Pharmaceutical composition according to the present invention is preferably administration every day and is more preferred from every day 2 to 4 times for 1 to 6 time.
The suitable acid that is used to form ambroxol salt for example is preferably hydrochloric acid for hydrochloric acid, hydrobromic acid, sulphuric acid, phosphoric acid, nitric acid, oxalic acid, malonic acid, fumaric acid, maleic acid, tartaric acid, citric acid, ascorbic acid and methanesulfonic acid.
The effect of ambroxol is the embodiment explanation by following clinical trial according to the present invention, has studied the effect that ambroxol can be sucked tablet that contains of varying strength.These embodiment only are used to the present invention is described but not are considered as restriction.
Embodiment 1
It is (anti--4-[(2-amino-3 to contain 20 milligrams of ambroxol hydrochlorides, the 5-dibromo-benzyl) amino] the cyclohexane monohydrochloride hydrochlorate, CAS accession number 18683-91-5) the tablet sucked be used for the treatment of the research of the activity of acute throat pain and toleration and compare with placebo group.
With multicenter, prospect property, placebo serves as that two Time of Day are carried out in the double blinding formula test of contrast and random packet, uses the nearly tablet sucked of 6 ambroxol-hydrochloride-containings every day.
Patient: recruit 218 (97 male, 121 women) patients, 39.4 ± 15 years old mean age (scope in 17-81 year); 215 patient undergoing treatments wherein: 107 are used 20 milligrams of ambroxols and 108 to use placebo.26 patients stop treatment (each 13 of each processed group) in advance.Make (ITT) group that receives treatment comprise 208 patients (accept ambroxol treatment and 103 for 105 and give placebo); 196 patients constitute in accordance with scheme (PP) group (97 service test materials and 99 use placebo).Then consider the patient that all receives treatment as for the drug safety analysis.
Handle: use every day 6 can suck tablet and accept the double blinding formula and handle, can suck tablet and contain 20 milligrams of ambroxols or form (can suck tablet and not contain active substance, but the tangible Mentha arvensis L. syn.M.haplocalyxBrig taste that has similar substances equally) by placebo.
Terminal point: give first the average pain relief that can suck the 3 hour time of beginning behind the tablet time is weighed, be normalized into initial stage pain degree (SPID NOrM); In addition, the assessment of the assessment of effect and toleration is to carry out when the every processing end of day by patient.
The result: the pain intensity in two processed group all alleviates; First can suck average SPID behind the tablet Norm(± SD) is 0.39 ± 0.27 to 20 milligrams of ambroxol hydrochlorides, and is 0.28 ± 0.25 to placebo.
Statistical obvious processing result (p=0.0029; The ambroxol processed group subtracts-95% credibility interval of the mean difference between the placebo group: 0.04 to 0.18) the expression ambroxol obviously is better than placebo.Use can be sucked tablet continuous every day of outpatient service processing when finishing up to 6, it is higher than the effect that gives placebo to show that relatively large significantly patient report on the statistics is accepted the effect that ambroxol hydrochloride handles.Toleration and the placebo of finding substances are good on an equal basis.
Conclusion: when the tablet sucked that contains 20 milligrams of ambroxol hydrochlorides gives acute laryngalgia patient, have effective alleviating pain effect, this pain relief effect is the effect that is better than sucking placebo.
Fig. 1 represent to take (datum line) before the medicine to the pain intensity mean change (PID) of taking the 3 hour time behind first tablet of lozenge sucked that contains 20 milligrams of ambroxol hydrochlorides or placebo with respect to time relation figure.
Embodiment 2
To contain 20 milligrams or 30 milligrams of ambroxol hydrochlorides (anti--4-[(2-amino-3, the 5-dibromo-benzyl) amino] Cyclohexane monohydrochloride hydrochlorate, CAS accession number 18683-91-5) the tablet sucked is used for the treatment of acute sore-throat The research of activity and tolerance and compare with placebo.
Take multicenter, prospect property, placebo as contrast, and the test of the double blinding formula of at random grouping carries out two Time of Day uses the nearly tablet sucked of 6 ambroxol-hydrochloride-containings every day.
Patient: study altogether 331 acute no concurrency laryngalgia of suffering from least medium order of severity, but not The outpatient who suffers from bacillary pharyngitis.
Process: use every day 6 can suck tablet and accept the double blinding formula and process, can suck tablet and contain 20 Milligram or 30 milligrams of ambroxols or formed by placebo and (can suck tablet and not contain active material, but to have equally The obvious peppermint taste of similar test material).
Terminal point: take first the average pain relief that can suck beginning 3 hours behind the tablet time is weighed, be normalized into initial stage pain degree (SPIDnorm); In addition, the assessment of effect and tolerance Assessment carry out when every processing end of day by patient.
The result: all processing all obtains alleviating of pain intensity; Take first and can suck flat behind the tablet Equal SPIDnorm(± SD) is respectively 0.53 ± 0.28 or 0.50 to 20 milligrams and 30 milligrams of ambroxol hydrochlorides ± 0.30, and be 0.38 ± 0.28 to placebo. Treatment effect is obvious in statistics. Obviously show Active processed group is better than placebo, and (acceptance contains the tablet the sucked processed group of 20 or 30 milligrams of bromine ambroxols Subtract 95% confidence level interval (Cl) of the mean difference between the comfort group: 0.08 to 0.23 or 0.05 to 0.20). When use can be sucked lozenge continuous every day of outpatient service processing end up to 6, remarkable relatively large patient on the statistics The effect that the ambroxol hydrochloride processing is accepted in report is higher than throwing the effect of giving placebo. Find the test material in The tolerance of all dosage is all as good as the placebo.
Conclusion: take the acute sore-throat patient of the tablet sucked that contains 20 or 30 milligrams of ambroxol hydrochlorides, Have effective lenitive effect, this pain relief effect is better than sucking the effect of placebo. Two dosage Tolerance on an equal basis good.
Fig. 2 shows before the drug administration that (datum line) can suck lozenge and (contain 20 or 30 millis to taking first Gram hydrochloric acid bromine ammonia rope or placebo) after the pain intensity of 3 hours on average change (PID) with respect to the time Graph of a relation.
Bromine ammonia rope can use separately or make up the other medicines active material and use. Bromine ammonia rope can be with any Being suitable for the local formulation of using uses. Be fit to suck or in the oral cavity slowly the preparation of dissolving for example comprise based on The compressing tablet of sugared or sugar replaced material or sugar-pill or with the tablet class product of Arabic gum or gelatin base.
The semisolid preparation that is applied to oral mucosa is gel for example, particularly based on cellulose or acrylate Gel.
Be suitable for as spraying, gargle and the solvent that washes usefulness comprises the water-based preparation, and preferably add and have Viscosity increases material for example modified cellulose, acrylic acid derivative or polyethylene-based compound.
Semisolid or liquid formulation particularly contain sweetener and NMF for example glycols and sugar alcohol in addition Class.
Various formulations can be oils by adding ether for example with known mode aromatization.
Preparation can be by known method manufacturing in the pharmacy.
Following pharmaceutical preparation embodiment illustrates the present invention and unrestricted its scope:
Embodiment 1)
Can suck tablet                         Every
20.0 milligrams of ambroxol hydrochlorides
16.0 milligrams in Mentha arvensis L. syn.M.haplocalyxBrig essence
1373.5 milligrams of Sorbitols
0.5 milligram of saccharin sodium
6,000 30 milligrams of Macrogol
60 milligrams in Talcum
Embodiment 2)
Can suck tablet Every
20.0 milligrams of ambroxol hydrochlorides
5.0 milligrams of lisozimas
2.5 milligrams of glycyrrhizic acid dipotassiums
1.0 milligrams of cetylpyridinium chloride
1.0 milligrams of chlorphenamine maleate
920.5 milligrams of xylitol
9.5 milligrams of D-mannitols
21.0 milligrams of polyvinyl pyrrolidone
10.0 milligrams of stearic acid
6.0 milligrams of Oleum menthae
1.0 milligrams of light anhydrous silicic acid
1.0 milligrams in Talcum
1.5 milligrams of magnesium stearate
Embodiment 3)
Can suck tablet Every
20.0 milligrams of ambroxol hydrochlorides
5.0 milligrams of narcotines
0.125 milligram of dequalinium chloride
908.675 milligrams of sucrose (pure)
1.0 milligrams of 1-Mentholums
0.6 milligram of Oleum menthae
3.6 milligrams of Fructus Citri Limoniae essence
30.0 milligrams of corn starchs
21.0 milligrams of polyvinylpyrrolidones
10.0 milligrams of magnesium stearate
Embodiment 4)
Can suck tablet Every
20.0 milligrams of ambroxol hydrochlorides
10.0 milligrams of dromethan phenolic group phthalates
23.3 milligrams of sulfogaiacols
1.0 milligrams of cetylpyridinium chloride
869.7 milligrams of sucrose (pure)
16.0 milligrams in Herba Menthae essence
30.0 milligrams in corn pyridine powder
20.0 milligrams of polyvinyl pyrrolidone
10.0 milligrams of magnesium stearate
Embodiment 5)
Can suck tablet Every
20.0 milligrams of ambroxol hydrochlorides
6.25 milligrams of hydrochloric acid d1-methylephedrines
5.0 milligrams of chlorhexidine dihydrochlorides
905.25 milligrams of lactose
25.0 milligrams of the low hydroxypropyl celluloses that replaces
20.0 milligrams of hydroxypropyl celluloses
16.0 milligrams in Mentha arvensis L. syn.M.haplocalyxBrig essence
2.5 milligrams of magnesium stearate
Embodiment 6)
Can suck tablet Every
20.0 milligrams of ambroxol hydrochlorides
1.67 milligrams of ammonium glycyrrhizinates
30.0 milligrams in cresol sulfonic acid potassium
884.83 milligrams of lactose
25.0 milligrams of the low hydroxypropyl celluloses that replaces
20.0 milligrams of hydroxypropyl celluloses
16.0 milligrams in Mentha arvensis L. syn.M.haplocalyxBrig essence
2.5 milligrams of magnesium stearate

Claims (12)

1. the purposes of acceptable salt on an ambroxol or its a kind of pharmacology, it is used to prepare the medicine that is used for the treatment of oral cavity and/or pharyngeal cavity pain, and these pain are selected from pressure spot, oropharynx that acute throat pain, aphtha, gingivitis, periodontal disease, prothesis cause and dispose mucosa focus in back pain, oral cavity and the pharyngeal cavity and the herpes simplex in oral cavity and the pharyngeal cavity.
2. pharmaceutical composition, it contains on ambroxol or its a kind of pharmacology acceptable salt and one or more are selected from the active substance of antibacterial, vitamins, corticoid class, antiinflammatory class, antibiotics, fungistat class and proteolytic enzyme class.
3. pharmaceutical composition, its contain acceptable salt on ambroxol or its a kind of its pharmacology and one or more be selected from lisozima, glycyrrhizic acid dipotassium, ammonium glycyrrhizinate, cetylpyridinium chloride, chlorphenamine maleate (chlorpheniramine maleate), narcotine (noscapine), dequalinium chloride (dequalinium chloride), dromethan phenolic group phthalate (dextromethorphanephenolphthalinate), sulfogaiacol, hydrochloric acid d1 ephedrine, chlorhexidine dihydrochloride, and cresol sulfonic acid potassium in active substance.
4. pharmaceutical composition, it is made up of acceptable salt and pharmaceutical auxiliary agent thereof on ambroxol, Bromhexine or its pharmacology.
5. as the pharmaceutical composition one of in the claim 2 to 4, it is characterized by, single agent contains 15 to 50 milligrams of ambroxols.
One kind solid-state, can suck or slow dissolved drug dosage form, it is a kind of as the pharmaceutical composition one of in the claim 2 to 4.
7. semisolid pharmaceutical dosage form, it is each a pharmaceutical composition in a kind of claim 2 to 5 that is the gel pattern.
8. purposes as the pharmaceutical composition one of in the claim 2 to 5, it is used to prepare the medicine of treatment oral cavity and/or pharyngeal cavity pain, and this pain is selected from pressure spot, oropharynx that acute throat pain, aphtha, gingivitis, periodontal disease, prothesis cause and disposes mucosa focus in back pain, oral cavity and the pharyngeal cavity and the herpes simplex in oral cavity and the pharyngeal cavity.
9. the purposes of a pharmaceutical composition of forming by ambroxol hydrochloride, spice, lubricant, host material, sweeting agent and Polyethylene Glycol, it is used to prepare the medicine for treatment oral cavity and/or pharyngeal cavity pain, and this pain is selected from pressure spot, oropharynx that acute throat pain, aphtha, gingivitis, periodontal disease, prothesis cause and disposes mucosa focus in back pain, oral cavity and the pharyngeal cavity and the herpes simplex in oral cavity and the pharyngeal cavity.
One kind based on sugar alcohol as host material and contain the purposes of the tablet sucked of ambroxol, it is characterized by this and can suck tablet except containing other medicines auxiliary agent, correctives or spice, optionally also contain pharmaceutically acceptable phyllosilicate and Polyethylene Glycol, for treatment oral cavity and/or pharyngeal cavity pain usefulness, this pain is selected from pressure spot, oropharynx that acute throat pain, aphtha, gingivitis, periodontal disease, prothesis cause and disposes mucosa focus in back pain, oral cavity and the pharyngeal cavity and the herpes simplex in oral cavity and the pharyngeal cavity.
11. the purposes of an ambroxol as claimed in claim 1, it is used to prepare a kind of medicament, has the alleviating pain effect its period of at least 3 hours after dispensing once in the process.
12. the purposes as the pharmaceutical composition one of in the claim 2 to 5, it is used to prepare a kind of medicament, and it has lenitive effect at least in process 3 hours period after dispensing once.
CNA038047683A 2002-02-27 2003-02-25 Ambroxol for treating painful conditions in the mouth and pharyngeal cavity Pending CN1638749A (en)

Applications Claiming Priority (2)

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DE10208313A DE10208313A1 (en) 2002-02-27 2002-02-27 Ambroxol for the treatment of painful conditions in the mouth and throat
DE10208313.4 2002-02-27

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CN1638749A true CN1638749A (en) 2005-07-13

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EP (1) EP1480626A1 (en)
JP (1) JP2005518435A (en)
KR (1) KR20040084944A (en)
CN (1) CN1638749A (en)
AR (1) AR038698A1 (en)
AU (1) AU2003210345B2 (en)
BR (1) BR0308038A (en)
CA (1) CA2477105A1 (en)
DE (1) DE10208313A1 (en)
EC (1) ECSP045242A (en)
IS (1) IS7417A (en)
MX (1) MXPA04008220A (en)
MY (1) MY144781A (en)
PE (1) PE20030830A1 (en)
PL (1) PL371584A1 (en)
RU (1) RU2311176C2 (en)
TW (1) TW200306804A (en)
UA (1) UA86741C2 (en)
UY (1) UY27679A1 (en)
WO (1) WO2003072094A1 (en)
ZA (1) ZA200405635B (en)

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CN105769908A (en) * 2016-05-06 2016-07-20 湖北凤凰白云山药业有限公司 Medicine for resolving phlegm and relieving cough and preparation method thereof
CN106727621A (en) * 2016-11-22 2017-05-31 郑州仁宏医药科技有限公司 A kind of Western medicine powder for treating toothache

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JP2005120063A (en) * 2003-10-14 2005-05-12 Boehringer Ingelheim Pharma Gmbh & Co Kg Ambroxol for treating inflammation at pharynx
ITMI20032462A1 (en) * 2003-12-16 2005-06-17 Advance Holdings Ltd METHOD TO PREPARE A CARAMEL CONTAINING AMBROXOLO AND THE CANDY SO OBTAINED
DE102004021992A1 (en) * 2004-05-03 2005-11-24 Boehringer Ingelheim Pharma Gmbh & Co. Kg Topical preparation containing ambroxol
EP2015761A4 (en) * 2006-03-29 2009-07-29 Naveh Pharma 1996 Ltd Methods and composition for treating sore throat
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JP6844394B2 (en) * 2017-04-14 2021-03-17 大正製薬株式会社 Solid composition
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CN1935116B (en) * 2005-09-21 2012-07-04 盛势达有限公司 Composition for oral cavity and selection method for product of oral cavity
CN105769908A (en) * 2016-05-06 2016-07-20 湖北凤凰白云山药业有限公司 Medicine for resolving phlegm and relieving cough and preparation method thereof
CN105769908B (en) * 2016-05-06 2019-03-01 湖北凤凰白云山药业有限公司 A kind of drug of preventing phlegm from forming and stopping coughing and preparation method thereof
CN106727621A (en) * 2016-11-22 2017-05-31 郑州仁宏医药科技有限公司 A kind of Western medicine powder for treating toothache

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EP1480626A1 (en) 2004-12-01
PL371584A1 (en) 2005-06-27
AU2003210345A1 (en) 2003-09-09
WO2003072094A1 (en) 2003-09-04
RU2311176C2 (en) 2007-11-27
MY144781A (en) 2011-11-15
ECSP045242A (en) 2004-09-28
RU2004129284A (en) 2005-06-10
ZA200405635B (en) 2005-05-31
DE10208313A1 (en) 2003-09-11
CA2477105A1 (en) 2003-09-04
IS7417A (en) 2004-08-19
JP2005518435A (en) 2005-06-23
BR0308038A (en) 2004-12-28
UA86741C2 (en) 2009-05-25
KR20040084944A (en) 2004-10-06
AU2003210345B2 (en) 2009-01-29
UY27679A1 (en) 2003-09-30
MXPA04008220A (en) 2004-11-26
PE20030830A1 (en) 2003-10-31
TW200306804A (en) 2003-12-01
AR038698A1 (en) 2005-01-26

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