CN107669636A - A kind of ambroxol spray - Google Patents
A kind of ambroxol spray Download PDFInfo
- Publication number
- CN107669636A CN107669636A CN201610876943.XA CN201610876943A CN107669636A CN 107669636 A CN107669636 A CN 107669636A CN 201610876943 A CN201610876943 A CN 201610876943A CN 107669636 A CN107669636 A CN 107669636A
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- CN
- China
- Prior art keywords
- ambroxol
- beta
- spray
- ambroxol hydrochloride
- schardinger
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Classifications
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- 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
- A61K9/007—Pulmonary tract; Aromatherapy
- A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
-
- 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
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Inorganic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Otolaryngology (AREA)
- Pulmonology (AREA)
- Emergency Medicine (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
The present invention relates to a kind of ambroxol spray, belong to field of pharmaceutical preparations.The ambroxol spray of the present invention includes the 45g of ambroxol hydrochloride TM beta cyclodextrin clathrates 35, the 8g of 2 pyrrolones of N methyl 3, the 0.08g of sorbic acid 0.03, water complements to 100mL, and its is quality controllable, compared with oral liquid, significant effect, and convenient drug administration, patient's compliance is strong, can effectively treat respiratory disease.
Description
Technical field
The present invention relates to field of pharmaceutical preparations, and in particular to a kind of ambroxol spray.
Background technology
In the respiratory tract diseases such as acute and chronic bronchitis, a large amount of sputums are often produced, easy clogs airways, cause to breathe
Often there are expectoration difficulties in difficulty, especially children and old man, often secondary pulmonary infection, so the application of expectorant very must
Will.
Wide variety of ambroxol hydrochloride (ambroxolhydrochloride) external in recent years is clinically to act at present
Most strong expectorant, foreign countries are extremely affirmed to its curative effect.The beginning of the eighties in last century first Germany list, later again Japan,
The numerous and confused listing of many countries in Europe.
Ambroxol hydrochloride is the metabolite of bromhexine, and effect is better than bromhexine, and its mechanism of action is acid in cracking phlegm
Glutinous polysaccharide fiber, glutinous phlegm is reduced, dilutes sputum, and improve bronchial mucosa epithelial cilia motion frequency and transporting power, make phlegm
It is easy to expectoration.Ambroxol hydrochloride can clinically adjust mucus and be secreted with glutinous slurry, activate fibre swing, be easy to dilute sputum,
Strengthen mucus outwards to transport, be easy to discharge, it can also promote pulmonary surfactant to synthesize, and to maintain alveolar tension, ensure
Lung functions index；Antibiotic is promoted, to improve concentration, to strengthen bactericidal action to tissue infiltration；It is anti-oxidant, reduce inflammatory mediator
Release, with the reaction that reduces inflammation；Cooperateed with bronchus spasmolysis material, the effect of to improve spasmolysis medicine.Therefore, the medicine is in clinic
On can be widely applied to control with the acute and chronic respiratory tract disease of respiratory tract abnormal secretion, the eliminating the phlegm of particularly chronic bronchitis
Treat, the auxiliary treatment of transient respiratory distress of the newborn disease and pulmonary surgery, have toxicity low, curative for effect and can be with antibiotic simultaneously
The advantages that with good synergy is produced, it is one of the most frequently used expectorant.
The existing formulation of ambroxol hydrochloride has oral liquid, tablet, capsule, micropill etc., but there is no quality controllable, significant effect
Spray.
The content of the invention
The purpose of the present invention is to provide a kind of quality controllable, ambroxol hydrochloride spray of significant effect.
The present invention solve the technical problem technical scheme be：
A kind of ambroxol spray, include ambroxol hydrochloride-TM- Benexate Hydrochlorides 35-45g, N- methyl -2- pyrroles
Ketone 3-8g, sorbic acid 0.03-0.08g, water complement to 100mL.
The mol ratio of ambroxol hydrochloride and TM- beta-schardinger dextrins is 1 in the ambroxol hydrochloride-TM- Benexate Hydrochlorides:
(2-4)。
The preparation method of the ambroxol hydrochloride-TM- Benexate Hydrochlorides is：It is first that TM- beta-schardinger dextrins is soluble in water
Saturation TM- beta-schardinger dextrin solution is prepared, then ambroxol hydrochloride is added by formula rate, being stirred at room temperature makes its dissolving complete.
Invention also provides the preparation method of above-mentioned ambroxol spray, it is characterised in that its operating procedure is：
(1) by TM- beta-schardinger dextrins preparation saturation TM- beta-schardinger dextrin solution soluble in water, then by formula rate addition hydrochloric acid
Ambroxol, being stirred at room temperature makes its dissolving complete；
(2) N- methyl -2- pyrrolones is added in step (1) resulting solution, sorbic acid, stirs and produces.
The ambroxol hydrochloride spray of the present invention is quality controllable, compared with oral liquid, significant effect, and convenient drug administration, suffer from
Person's compliance is strong, can effectively treat respiratory disease.
Embodiment
With reference to specific embodiment, the present invention is expanded on further.It should be understood that these embodiments are merely to illustrate the present invention
Rather than limitation the scope of the present invention.The experimental method of unreceipted actual conditions in the following example, generally according to conventional strip
Part or according to the condition proposed by manufacturer.Unless otherwise indicated, otherwise all percentage, ratio, ratio or number is pressed
Weight meter.
Unless otherwise defined, anticipated known to all specialties used in text and scientific words and one skilled in the art
Justice is identical.In addition, any method similar or impartial to described content and material all can be applied in the inventive method.Wen Zhong
Described preferable implementation only presents a demonstration with material to be used.
Embodiment 1
It is 1 by the mol ratio of ambroxol hydrochloride and TM- beta-schardinger dextrins:2 ratio and total amount is that 35g amount weighs hydrochloric acid
Ambroxol and TM- beta-schardinger dextrins, by TM- beta-schardinger dextrins preparation saturation TM- beta-schardinger dextrin solution soluble in water, add hydrochloric acid ammonia bromine
Rope, being stirred at room temperature makes its dissolving complete, adds N- methyl -2- pyrrolones 4g, sorbic acid 0.05g, stirs and produce.
Embodiment 2
It is 1 by the mol ratio of ambroxol hydrochloride and TM- beta-schardinger dextrins:3 ratio and total amount is that 40g amount weighs hydrochloric acid
Ambroxol and TM- beta-schardinger dextrins, by TM- beta-schardinger dextrins preparation saturation TM- beta-schardinger dextrin solution soluble in water, add hydrochloric acid ammonia bromine
Rope, being stirred at room temperature makes its dissolving complete, adds N- methyl -2- pyrrolones 6g, sorbic acid 0.06g, stirs and produce.
Embodiment 3
It is 1 by the mol ratio of ambroxol hydrochloride and TM- beta-schardinger dextrins:4 ratio and total amount is that 45g amount weighs hydrochloric acid
Ambroxol and TM- beta-schardinger dextrins, by TM- beta-schardinger dextrins preparation saturation TM- beta-schardinger dextrin solution soluble in water, add hydrochloric acid ammonia bromine
Rope, being stirred at room temperature makes its dissolving complete, adds N- methyl -2- pyrrolones 8g, sorbic acid 0.08g, stirs and produce.
Embodiment 4
Stability test
(1) influence factor is tested
By the ambroxol hydrochloride spray embedding of embodiment 2 in 5mL ampoules, be placed in high temperature (40 DEG C), illumination (4500 ±
500Lx), under the conditions of low temperature (- 18 DEG C), sampled respectively at the 5th, 10 day, each inspection target of stability test is detected, tied
Fruit is shown in Table 1.
The ambroxol hydrochloride spray influence factor result of the test of table 1
As a result show, ambroxol spray of the invention can be stablized after being placed 10 days under high temperature and cryogenic conditions deposits
, content has obvious reduction after being placed 10 days under illumination condition, and relevant material substantially increases, therefore this preparation should lucifuge protect
Deposit.
(2) accelerated test
Embodiment 1-3 ambroxol spray is placed in 40 DEG C, under the conditions of RH75%, respectively at the 0th, 1,2,3, to items
Inspection target is detected, and testing result is as shown in table 2.
The ambroxol hydrochloride spray accelerated test result of table 2
As a result show, ambroxol hydrochloride spray of the invention is placed 6 months under the conditions of 40 DEG C, RH75% and can kept
Stable content, relevant material do not increase.
(3) room temperature keeps sample experiment for a long time
Embodiment 1-3 ambroxol hydrochloride spray is placed under room temperature condition, sampled respectively at the 0th, 3 months, to each
Item inspection target is detected, and the results are shown in Table 3.
The ambroxol hydrochloride spray room temperature of table 3 keeps sample result of the test for a long time
As a result show, ambroxol hydrochloride spray of the invention is placed at ambient temperature can keep content steady for 6 months
Fixed, relevant material does not increase.
Embodiment 5
Irritation test is studied
Wistar rats 16,200~300g of body weight are taken, male and female half and half, experimental animal are divided into 4 groups, are respectively
Physiological saline group, 1% NaTDC group, direct sample group after ambroxol spray doses of the present invention, ambroxol spray of the present invention
Recover one week sampling group after mist agent administration, instilled with microsyringe in the other rat oral cavity of respective sets, each dosage is 100
μ L, keep rat to remain silent 30 seconds after administration, leak outside and be lost in prevent sample, by daily single, continuous 5 days, given in last
Cardiac perfusion puts to death rat after medicine 24h, takes rat maxilla mucous membrane of mouth.Recovery group is raised one week after being discontinued and put to death.By taken group
Knit to be put into soak in 10% formalin solution and fix, specimens paraffin embedding slices, HE dyeing, observed under light microscope.
As a result show, physiological saline negative control group visually observes phenomena such as having no mucous hyperemia, oedema, Histopathology
Display is checked, oral mucosa is complete, is covered by scaly epithelium, and institutional framework is clearly intact, oral mucosas tissue and mucous membrane the following group
Knit no bleeding and cell infiltration；NaTDC positive controls visually observe mucous membrane whiting, there is oedema phenomenon, pathological tissue
Learn and check display, oral mucosa is imperfect, there is phenomenon of rupture, and bleeding and a large amount of inflammation occur in oral mucosas tissue and submucous tissue
Cellular infiltration；Direct sample group visually observes phenomena such as having no mucous hyperemia, oedema after aerosol spray agent administration of the present invention, disease
Microscopic examination showed is managed, oral mucosa is substantially complete, is covered by scaly epithelium, and institutional framework is more visible intact, oral mucosa
Tissue and submucous tissue have a small amount of bleeding and cell infiltration；Recover one week sampling group after aerosol spray agent administration of the present invention
Phenomena such as having no mucous hyperemia, oedema is visually observed, histopathologic examination shows, oral mucosa is complete, is covered by scaly epithelium
Lid, institutional framework is clearly intact, and oral mucosas tissue and submucous tissue are without bleeding and cell infiltration, substantially and physiological saline
Negative control group is consistent.
From experimental result, ambroxol hydrochloride spray of the invention has slight stimulation to rat mucous membrane of mouth, gives
There are a small amount of bleeding and inflammatory cell infiltration after medicine under mucous membrane, but recovers to put to death again for one week after being administered, oral mucosas tissue and glue
The symptom of this bleeding of film undertissue and cell infiltration disappears, and recovers extremely consistent with negative control group, illustrates this damage
It is reversible.
The phenol red secretory volume pharmacological testing of the mouse tracheae of embodiment 6
50 mouse are taken to be randomly divided into 5 groups, respectively blank control group, ambroxol hydrochloride oral liquid group, the ammonia of embodiment 2
Basic, normal, high three dosage groups of bromine rope spray, weigh, mark, dosage is as shown in table 4, and blank control group gives physiology salt
Water, administering mode are gavage.After 30min, after phenol red solution 0.1mL/10g, 30min is injected intraperitoneally respectively, animal, solution are put to death
Polish No. 7 syringe needles are inserted tracheae about 0.3cm under larynx, after being fixed with silk thread ligation, injected with 1mL by subdivision from tracheae
Device extracts sodium bicarbonate solution 0.5mL, by syringe needle lavation respiratory tract 3 times back and forth, extracts irrigating solution out injecting tube last 1 time
In, continuous 3 times of aforesaid operations, rinse 9 times altogether, be pumped irrigating solution about 1.2-1.5mL, be placed in test tube, centrifuge, with 721 types point
Light photometer, wavelength 546nm, read trap OD values.Corresponding phenol red concentration is checked on standard curve, compares each group tracheae
The difference of section phenols contents, as a result as shown in table 4.
The phenol red secretory volume result of the test of the mouse tracheae of table 4
| Group | Dosage (mg/kg) | Phenol red amount (μ g/mL) | Incrementss (%) |
| Blank control group | -- | 0.59±0.24 | -- |
| Oral liquid group | 20 | 0.71±0.24 | 21.12 |
| Spray low dose group | 20 | 0.83±0.19 | 40.22 |
| Spray middle dose group | 40 | 1.03±0.21 | 75.80 |
| Spray high dose group | 60 | 1.33±0.22 | 125.42 |
As a result show, each administration group can substantially increase the phenol red secretory volume of Respiratory Tract of Mice, illustrate play well
Eliminating the phlegm effect, wherein the present invention basic, normal, high three dosage groups of composition increasing is acted on compared with ambroxol hydrochloride oral liquid group
By force, significant difference, and action effect is relevant with the dosage of each composition, effect of high dosage is best.
Claims (4)
1. a kind of ambroxol spray, it is characterised in that include ambroxol hydrochloride-TM- Benexate Hydrochlorides 35-45g, N- first
Base -2- pyrrolones 3-8g, sorbic acid 0.03-0.08g, water complement to 100mL.
2. ambroxol spray according to claim 1, it is characterised in that the ambroxol hydrochloride-TM- beta-schardinger dextrin bags
The mol ratio of ambroxol hydrochloride and TM- beta-schardinger dextrins is 1 in compound:(2-4).
3. ambroxol spray according to claim 1 or 2, it is characterised in that the ambroxol hydrochloride-TM- β-ring paste
The preparation method of inclusion compounds is：First by TM- beta-schardinger dextrins preparation saturation TM- beta-schardinger dextrin solution soluble in water, then by formula
Ratio adds ambroxol hydrochloride, and being stirred at room temperature makes its dissolving complete.
4. the preparation method of the ambroxol spray according to claim any one of 1-3, it is characterised in that its operating procedure
For：
(1) by TM- beta-schardinger dextrins preparation saturation TM- beta-schardinger dextrin solution soluble in water, then by formula rate addition hydrochloric acid ammonia bromine
Rope, being stirred at room temperature makes its dissolving complete；
(2) N- methyl -2- pyrrolones is added in step (1) resulting solution, sorbic acid, stirs and produces.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610876943.XA CN107669636A (en) | 2016-09-30 | 2016-09-30 | A kind of ambroxol spray |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610876943.XA CN107669636A (en) | 2016-09-30 | 2016-09-30 | A kind of ambroxol spray |
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| CN107669636A true CN107669636A (en) | 2018-02-09 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113995721A (en) * | 2020-07-27 | 2022-02-01 | 德国吉麦医疗技术有限公司 | Ambroxol hydrochloride oral spray solution and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
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Application publication date: 20180209 |