CN107115281A - The preparation method of amikacin sulfate injection - Google Patents
The preparation method of amikacin sulfate injection Download PDFInfo
- Publication number
- CN107115281A CN107115281A CN201610105052.4A CN201610105052A CN107115281A CN 107115281 A CN107115281 A CN 107115281A CN 201610105052 A CN201610105052 A CN 201610105052A CN 107115281 A CN107115281 A CN 107115281A
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- CN
- China
- Prior art keywords
- preparation
- injection
- amikacin sulfate
- adds
- decoction
- 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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
- A61K31/7034—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
- A61K31/7036—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin having at least one amino group directly attached to the carbocyclic ring, e.g. streptomycin, gentamycin, amikacin, validamycin, fortimicins
-
- 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
- A61K47/02—Inorganic compounds
-
- 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
- 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
-
- 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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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- General Health & Medical Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Molecular Biology (AREA)
- Dermatology (AREA)
- Inorganic Chemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Abstract
The invention discloses a kind of preparation method of amikacin sulfate injection.Preparation method of the present invention employs multiple aseptic filtration, and overall process is sterile, it is ensured that product quality.
Description
Technical field
The present invention relates to a kind of preparation method of amikacin sulfate injection.
Background technology
Amikacin sulfate is a kind of aminoglycoside antibiotics.This product is to most enterobacteriaceae lactobacteriaceaes, such as
EHEC, Klebsiella, Enterobacter, Proteus, Shigella, Salmonella,
Citrobacter category, Serratia etc. have good action, to pseudomonas aeruginosa and other false lists of part
Born of the same parents bacterium, acinetobacter, alcaligenes etc. also have good action；To meningococcus, gonococcus,
Bacillus influenzae, yersinia's genus, campylobacter fetus, tubercle bacillus and some Mycobacteriums also have preferably
Antibacterial action, its antibacterial activity is lower slightly compared with gentamicin.This product most prominent advantage is that many enteron aisles are removed from office
Aminoglycoside inactive enzyme produced by blue negative bacillus is stable, will not lose antibacterial for such enzymatic inactivation
Activity.At present it is separated to 12 kinds of inactive enzymes in, (6') this product can be only passivated by AAC, in addition
(4') (3')-III idol can cause bacterium to this product intermediate-resistant to AAD with APH.
Amikacin sulfate injection is applied to pseudomonas aeruginosa and other pseudomonads of part, large intestine angstrom
The sensitivities such as uncommon bacterium, Proteus, Klebsiella, Enterobacter, Serratia, acinetobacter
Severe infections caused by gram negative bacilli and staphylococcus (methicillin-sensitivity strain), such as bacteremia or
Septicemia, bacterial endocarditis, ALRI, bone joint infection, infection of biliary tract, abdominal cavity sense
Dye, complexity urinary tract infections, skin soft-tissue infection etc..
The content of the invention
The technical problems to be solved by the invention are to provide a kind of preparation side of amikacin sulfate injection
Method, described preparation method employs multiple aseptic filtration, and overall process is sterile, it is ensured that product quality.
The invention provides a kind of preparation method of amikacin sulfate injection, comprise the following steps：
Step one, in dense preparing tank add amount of preparation about 50% water for injection, add sodium hydrogensulfite,
Sodium citrate, stirring and dissolving；
Step 2, adds amikacin sulfate, stirring while adding to dissolving；
Step 3, adds medical charcoal, stirs, and returns the de- charcoal of filter to after clear and bright with Suzhou sand stick, mistake
Filter is into dilute preparing tank；
Step 4, adds water for injection to full dose, stirs 15 minutes, make it uniform, pH value can use 4N
Sulfuric acid is adjusted；
Step 5, is returned and is filtered to clear and bright with Suzhou sand stick, 0.45 μm and 0.22 μm of fin；
Step 6, sampling and testing intermediate pH value, it is every it is qualified after, decoction is filtered into receiver,
It is filled with nitrogen；
Decoction in step 7, receiver inputs filling surge tank after 0.22 μm of fin filtering of twice
For filling.
Without prejudice to the field on the basis of common sense, above-mentioned each optimum condition, can be combined, and produce this
Invent each preferred embodiments.
Agents useful for same and raw material of the present invention are commercially available.
The positive effect of the present invention is：The preparation method of amikacin sulfate injection of the present invention is adopted
With multiple aseptic filtration, overall process is sterile, it is ensured that product quality.
Embodiment
The present invention is further illustrated below by the mode of embodiment, but is not therefore limited the present invention to
Among described scope of embodiments.The experimental method of unreceipted actual conditions in the following example, according to normal
Rule method and condition, or selected according to catalogue.
Embodiment 1
The preparation method of amikacin sulfate injection, specifically includes following steps：
Step one, in dense preparing tank add amount of preparation about 50% water for injection, add sodium hydrogensulfite,
Sodium citrate, stirring and dissolving；
Step 2, adds amikacin sulfate, stirring while adding to dissolving；
Step 3, adds medical charcoal, stirs, and returns the de- charcoal of filter to after clear and bright with Suzhou sand stick, mistake
Filter is into dilute preparing tank；
Step 4, adds water for injection to full dose, stirs 15 minutes, make it uniform, pH value can use 4N
Sulfuric acid is adjusted；
Step 5, is returned and is filtered to clear and bright with Suzhou sand stick, 0.45 μm and 0.22 μm of fin；
Step 6, sampling and testing intermediate pH value, it is every it is qualified after, decoction is filtered into receiver,
It is filled with nitrogen；
Decoction in step 7, receiver inputs filling surge tank after 0.22 μm of fin filtering of twice
For filling.0.22 μm of fin of this step twice is located at C grades of environment and A grades of environment respectively.By sterile life
Production requires that Bactericidal filter element must carry out sterile assembling under A grades of environmental protection, can ensure degerming mistake
Decoction is sterile after filter.C grades of 0.22 μm of filtration core can effectively carry out bacterium retention, mitigate degerming
Filtration core (filter core assembled under A grades of environment) pressure, improves product sterility barrier.
The preparation method of amikacin sulfate injection employs multiple aseptic filtration, full mistake in the present embodiment
Journey is sterile, it is ensured that product quality.
Although the foregoing describing the embodiment of the present invention, those skilled in the art should manage
Solution, these are merely illustrative of, can be to this on the premise of the principle and essence without departing substantially from the present invention
A little embodiments make various changes or modifications.Therefore, protection scope of the present invention is by appended claims
Book is limited.
Claims (1)
1. a kind of preparation method of amikacin sulfate injection, it is characterised in that comprise the following steps：
Step one, in dense preparing tank add amount of preparation about 50% water for injection, add sodium hydrogensulfite,
Sodium citrate, stirring and dissolving；
Step 2, adds amikacin sulfate, stirring while adding to dissolving；
Step 3, adds medical charcoal, stirs, and returns the de- charcoal of filter to after clear and bright with Suzhou sand stick, mistake
Filter is into dilute preparing tank；
Step 4, adds water for injection to full dose, stirs 15 minutes, make it uniform, pH value can use 4N
Sulfuric acid is adjusted；
Step 5, is returned and is filtered to clear and bright with Suzhou sand stick, 0.45 μm and 0.22 μm of fin；
Step 6, sampling and testing intermediate pH value, it is every it is qualified after, decoction is filtered into receiver,
It is filled with nitrogen；
Decoction in step 7, receiver inputs filling surge tank after 0.22 μm of fin filtering of twice
For filling.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610105052.4A CN107115281A (en) | 2016-02-25 | 2016-02-25 | The preparation method of amikacin sulfate injection |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610105052.4A CN107115281A (en) | 2016-02-25 | 2016-02-25 | The preparation method of amikacin sulfate injection |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN107115281A true CN107115281A (en) | 2017-09-01 |
Family
ID=59717830
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201610105052.4A Pending CN107115281A (en) | 2016-02-25 | 2016-02-25 | The preparation method of amikacin sulfate injection |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN107115281A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110862424A (en) * | 2019-12-03 | 2020-03-06 | 海南顿斯医药科技有限公司 | Amikacin sulfate compound |
| CN111110627A (en) * | 2018-10-30 | 2020-05-08 | 齐鲁制药有限公司 | Amikacin sulfate injection and preparation method thereof |
-
2016
- 2016-02-25 CN CN201610105052.4A patent/CN107115281A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111110627A (en) * | 2018-10-30 | 2020-05-08 | 齐鲁制药有限公司 | Amikacin sulfate injection and preparation method thereof |
| CN111110627B (en) * | 2018-10-30 | 2022-12-02 | 齐鲁制药有限公司 | Amikacin sulfate injection and preparation method thereof |
| CN110862424A (en) * | 2019-12-03 | 2020-03-06 | 海南顿斯医药科技有限公司 | Amikacin sulfate compound |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| WD01 | Invention patent application deemed withdrawn after publication | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20170901 |