CN108158989A - A kind of ambroxol hydrochloride injection composition - Google Patents
A kind of ambroxol hydrochloride injection composition Download PDFInfo
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- CN108158989A CN108158989A CN201810169566.5A CN201810169566A CN108158989A CN 108158989 A CN108158989 A CN 108158989A CN 201810169566 A CN201810169566 A CN 201810169566A CN 108158989 A CN108158989 A CN 108158989A
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- Prior art keywords
- ambroxol hydrochloride
- injection
- composition
- hydrochloride injection
- anesin
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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
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
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- 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
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- 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
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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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
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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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
- A61K9/08—Solutions
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Abstract
The present invention provides a kind of ambroxol hydrochloride injection compositions, and the composition of composition is described in per 1000ml：Ambroxol hydrochloride 7.5g, 2 12g of anesin, 0.5 3g of meglumine, citron acid for adjusting pH to 4.5 5.5, appropriate water for injection.The ambroxol hydrochloride injection of the present invention has many advantages, such as that related content of material is low, stability is high.
Description
Technical field
The present invention relates to pharmaceutical fields, and in particular to a kind of ambroxol hydrochloride injection composition.
Background technology
Ambroxol hydrochloride（Ambroxol Hydrochoride）The metabolite for being bromhexine in human body is that mucus is molten
Antidote, act on it is strong compared with bromhexine, its chemical name is trans- -4- [（2- amino -3,5- dibromo-benzyls）Amino] cyclohexanol hydrochloric acid
Salt, structural formula are as follows：
Ambroxol hydrochloride injection original grinds the Mucosolvin that product is German Boehringer Ingelheim company, containing citric acid, phosphoric acid hydrogen
Disodium and nitrogen charging gas shielded, but it still has stability problem【The stability of two kinds of ambroxol hydrochloride injections compares, Cui
Haze, Shen Jinfang, Chinese pharmacists 2006,9（3）, 219-221】.The related content of material of ambroxol hydrochloride injection is reduced, is improved
Its stability, and then the drug safety of patient is protected, it is always the technical issues of those skilled in the art is needed to put forth effort to solve.
Invention content
During ambroxol hydrochloride injection is developed, it has been found that anesin and meglumine are according to certain
Ratio is used cooperatively, and significantly reduces the related content of material of ambroxol hydrochloride injection, and improves its stability, is achieved
Unexpected technique effect.Based on above-mentioned discovery, it is low, stable to inventor provide a kind of simple for process, related content of material
Property high, ambroxol hydrochloride injection that drug safety is high, and then complete the present invention.
Specifically, the present invention provides a kind of ambroxol hydrochloride injection composition, the group of composition described in per 1000ml
Into as follows：
Ambroxol hydrochloride 7.5g,
Anesin 2-8g,
Meglumine 0.5-2g,
Citron acid for adjusting pH to 4.5-5.5,
Appropriate water for injection.
As the preferred embodiment of the present invention, anesin therein, meglumine weight ratio be 4:1.
In addition, invention especially provides following three kinds of ambroxol hydrochloride injection compositions：
1）A kind of ambroxol hydrochloride injection composition, the composition of composition is as follows described in per 1000ml：
Ambroxol hydrochloride 7.5g,
Anesin 2g,
Meglumine 0.5g,
Citron acid for adjusting pH to 5.0,
Appropriate water for injection.
2）A kind of ambroxol hydrochloride injection composition, the composition of composition is as follows described in per 1000ml：
Ambroxol hydrochloride 7.5g,
Anesin 4g,
Meglumine 1g,
Citron acid for adjusting pH to 5.0,
Appropriate water for injection.
3）A kind of ambroxol hydrochloride injection composition, the composition of composition is as follows described in per 1000ml：
Ambroxol hydrochloride 7.5g,
Anesin 8g,
Meglumine 2g,
Citron acid for adjusting pH to 5.0,
Appropriate water for injection.
On the other hand, the invention further relates to the preparation method of above-mentioned ambroxol hydrochloride injection, step is as follows：
1）The ambroxol hydrochloride of recipe quantity is weighed, is dissolved in the brand-new water for injection of 100 times of weight.
2）Anesin, the meglumine of recipe quantity are weighed, is dissolved in the water for injection of 50 times of weight, solubilization dosage
0.05% 60 DEG C of activated carbon stirs 15 minutes, carbon removal is filtered, with 0.22 μm of membrane filtration.
3）The anesin handled well, meglumine solution are added in ambroxol hydrochloride solution, injected water to complete
Amount, stirs evenly, and with citron acid for adjusting pH to 4.5~5.5, adds in 0.01% needle-use activated carbon, 60 DEG C keep the temperature 20 minutes, filtering, mistake
0.22 μm of filter membrane refined filtration, filtrate is filling in ampoule, and sealing sterilizes 20 minutes in 121 DEG C, and lamp inspection is packed to get the present invention's
Ambroxol hydrochloride injection.
Experiments have shown that the related content of material of ambroxol hydrochloride injection of the invention is low, stability is high, patient medication safety
Property it is high.
Specific embodiment
The specific embodiment of the present invention is only that the present invention is further explained and described, and is not necessarily to be construed as to the present invention's
Any restrictions.
Embodiment 1：The ambroxol hydrochloride injection of the present invention
Ambroxol hydrochloride injection（1000）Composition and content：
Ambroxol hydrochloride 7.5g,
Anesin 2g,
Meglumine 0.5g,
Citron acid for adjusting pH to 4.5~5.5,
Water for injection adds to 1000ml.
Ambroxol hydrochloride injection（1000）Preparation process：
1）The ambroxol hydrochloride of recipe quantity is weighed, is dissolved in the brand-new water for injection of 100 times of weight.
2）Anesin, the meglumine of recipe quantity are weighed, is dissolved in the water for injection of 50 times of weight, solubilization dosage
0.05% 60 DEG C of activated carbon stirs 15 minutes, carbon removal is filtered, with 0.22 μm of membrane filtration.
3）The anesin handled well, meglumine solution are added in ambroxol hydrochloride solution, injected water to complete
Amount, stirs evenly, and with citron acid for adjusting pH to 4.5~5.5, adds in 0.01% needle-use activated carbon, 60 DEG C keep the temperature 20 minutes, filtering, mistake
0.22 μm of filter membrane refined filtration, filtrate is filling in ampoule, and sealing sterilizes 20 minutes in 121 DEG C, and lamp inspection is packed to get the present invention's
Ambroxol hydrochloride injection.
Embodiment 2：The ambroxol hydrochloride injection of the present invention
Ambroxol hydrochloride injection（1000）Composition and content：
Ambroxol hydrochloride 7.5g,
Anesin 4g,
Meglumine 1g,
Citron acid for adjusting pH to 4.5~5.5,
Water for injection adds to 1000ml.
Ambroxol hydrochloride injection（1000）Preparation process：With embodiment 1.
Embodiment 3：The ambroxol hydrochloride injection of the present invention
Ambroxol hydrochloride injection（1000）Composition and content：
Ambroxol hydrochloride 7.5g,
Anesin 8g,
Meglumine 2g,
Citron acid for adjusting pH to 4.5~5.5,
Water for injection adds to 1000ml.
Ambroxol hydrochloride injection（1000）Preparation process：With embodiment 1.
Embodiment 4（Reference examples）：Ambroxol hydrochloride injection
Ambroxol hydrochloride injection（1000）Composition and content：
Ambroxol hydrochloride 7.5g,
Citron acid for adjusting pH to 4.5~5.5,
Water for injection adds to 1000ml.
Ambroxol hydrochloride injection（1000）Preparation process：The ambroxol hydrochloride of recipe quantity is weighed, is dissolved in 100 weight
It in brand-new water for injection again, adds to the full amount of water for injection, stirs evenly, with citron acid for adjusting pH to 4.5~5.5, add in 0.01% needle
With activated carbon, 60 DEG C keep the temperature 20 minutes, and 0.22 μm of filter membrane refined filtration is crossed in filtering, and filtrate is filling in ampoule, and sealing is gone out in 121 DEG C
Bacterium 20 minutes, lamp inspection are packed to get the ambroxol hydrochloride injection of the present invention.
The stability study of experimental example ambroxol hydrochloride injection
Investigate the inspection results such as table 1~3 such as ambroxol hydrochloride injection made from Examples 1 to 4, related substance：
1 ambroxol hydrochloride injection inspection result of table（0 day）
2 ambroxol hydrochloride injection accelerated test result of table（40 DEG C ± 2 DEG C, RH75% ± 5%, 6 months）
Accelerated test shows ambroxol hydrochloride injection of the invention（Embodiment 1-3）Related content of material and stability it is bright
It is aobvious to be better than reference examples（Embodiment 4）.
3 ambroxol hydrochloride injection long-term stable experiment result of table（25 DEG C ± 2 DEG C, RH60% ± 10%, 24 months）
Long-time stability research shows that, ambroxol hydrochloride injection of the invention（Embodiment 1-3）Related content of material and steady
It is qualitative to be substantially better than reference examples（Embodiment 4）.
Claims (5)
1. a kind of ambroxol hydrochloride injection composition, the composition of composition is as follows described in per 1000ml：
Ambroxol hydrochloride 7.5g,
Anesin 2-8g,
Meglumine 0.5-2g,
Citron acid for adjusting pH to 4.5-5.5,
Appropriate water for injection.
2. ambroxol hydrochloride injection composition according to claim 1, wherein, anesin, meglumine weight
Than being 4:1.
3. ambroxol hydrochloride injection composition according to claim 1 or 2, the composition of composition described in per 1000ml is such as
Under：
Ambroxol hydrochloride 7.5g,
Anesin 2g,
Meglumine 0.5g,
Citron acid for adjusting pH to 5.0,
Appropriate water for injection.
4. ambroxol hydrochloride injection composition according to claim 1 or 2, the composition of composition described in per 1000ml is such as
Under：
Ambroxol hydrochloride 7.5g,
Anesin 4g,
Meglumine 1g,
Citron acid for adjusting pH to 5.0,
Appropriate water for injection.
5. ambroxol hydrochloride injection composition according to claim 1 or 2, the composition of composition described in per 1000ml is such as
Under：
Ambroxol hydrochloride 7.5g,
Anesin 8g,
Meglumine 2g,
Citron acid for adjusting pH to 5.0,
Appropriate water for injection.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810169566.5A CN108158989B (en) | 2018-03-01 | 2018-03-01 | Ambroxol hydrochloride injection composition |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810169566.5A CN108158989B (en) | 2018-03-01 | 2018-03-01 | Ambroxol hydrochloride injection composition |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN108158989A true CN108158989A (en) | 2018-06-15 |
| CN108158989B CN108158989B (en) | 2020-08-28 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201810169566.5A Active CN108158989B (en) | 2018-03-01 | 2018-03-01 | Ambroxol hydrochloride injection composition |
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Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1902706A1 (en) * | 2006-09-25 | 2008-03-26 | Divasa-Farmavic, S.A. | Stable pharmaceutical compositions of tetracyclines in solution, method for obtaining them and their uses |
| CN102872462A (en) * | 2012-10-26 | 2013-01-16 | 山东罗欣药业股份有限公司 | Ambroxol hydrochloride composition and preparation thereof |
| CN102920994A (en) * | 2012-11-29 | 2013-02-13 | 罗诚 | Pharmaceutical composition containing animal bone polypeptide |
| WO2013179248A1 (en) * | 2012-05-30 | 2013-12-05 | Fresenius Kabi Oncology Ltd. | Pharmaceutical compositions of pemetrexed |
| CN105326789A (en) * | 2015-12-08 | 2016-02-17 | 青岛正大海尔制药有限公司 | Solution containing ambroxol hydrochloride and salbutamol sulfate |
-
2018
- 2018-03-01 CN CN201810169566.5A patent/CN108158989B/en active Active
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1902706A1 (en) * | 2006-09-25 | 2008-03-26 | Divasa-Farmavic, S.A. | Stable pharmaceutical compositions of tetracyclines in solution, method for obtaining them and their uses |
| WO2013179248A1 (en) * | 2012-05-30 | 2013-12-05 | Fresenius Kabi Oncology Ltd. | Pharmaceutical compositions of pemetrexed |
| CN102872462A (en) * | 2012-10-26 | 2013-01-16 | 山东罗欣药业股份有限公司 | Ambroxol hydrochloride composition and preparation thereof |
| CN102920994A (en) * | 2012-11-29 | 2013-02-13 | 罗诚 | Pharmaceutical composition containing animal bone polypeptide |
| CN105326789A (en) * | 2015-12-08 | 2016-02-17 | 青岛正大海尔制药有限公司 | Solution containing ambroxol hydrochloride and salbutamol sulfate |
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| Publication number | Publication date |
|---|---|
| CN108158989B (en) | 2020-08-28 |
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