CN109820818A - A kind of lavo-ofloxacin hydrochloride composition of plastic ampoule packaging - Google Patents
A kind of lavo-ofloxacin hydrochloride composition of plastic ampoule packaging Download PDFInfo
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- CN109820818A CN109820818A CN201811650288.1A CN201811650288A CN109820818A CN 109820818 A CN109820818 A CN 109820818A CN 201811650288 A CN201811650288 A CN 201811650288A CN 109820818 A CN109820818 A CN 109820818A
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- CN
- China
- Prior art keywords
- lavo
- plastic ampoule
- ofloxacin
- pharmaceutical compositions
- injectable pharmaceutical
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- 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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Abstract
The invention belongs to field of medicine preparing technology, it particularly relates to a kind of lavo-ofloxacin hydrochloride composition of plastic ampoule packaging.It includes lavo-ofloxacin hydrochloride, fastness composition, sodium hydroxide；It is 0.01%~0.5% that the fastness composition, which accounts for Levofloxacin Hydrochloride Injection weight percent,.Compared with prior art, the lavo-ofloxacin hydrochloride injection drug of plastic ampoule packaging of the present invention can solve the problems, such as that color is deepened in Levofloxacin Hydrochloride Injection placement process by increasing fastness composition in prescription；Plastic ampoule can be very good to solve the problems, such as that Levofloxacin Hydrochloride Injection particulate matter increases, and achieve far more than the effect of traditional glass bottle packaging.
Description
Technical field
The invention belongs to field of medicine preparing technology, it particularly relates to a kind of left oxygen of hydrochloric acid of plastic ampoule packaging
Flucloxacillin composition.
Background technique
Lavo-ofloxacin is the optical activity levo form of raceme Ofloxacin, is fully synthetic Comprecin,
Its antimicrobial spectrum is identical as Ofloxacin, and antibacterial activity is then 2 times of Ofloxacin.Using lavo-ofloxacin as the note of active constituent
Liquid is penetrated clinically to be widely used in treating respiratory system, urinary system, reproductive system, soft group of skin caused by sensitive bacterial
It knits, the severe infections such as enteron aisle.
Lavo-ofloxacin hydrochloride is off-white color to pale yellow crystals or crystalline powder；This product is readily soluble in water, in methanol
Middle slightly molten, slightly soluble, almost insoluble in chloroform, ether or petroleum ether in ethanol.In lavo-ofloxacin hydrochloride molecular formula
Hydrochloric acid containing 1 molecule easily dissolves part thereof with the equipment reactions such as material-compound tank, filter in the process for preparation of injection
The iron ion on surface, to form injection the phenomenon that placement process color is deepened.
The Levofloxacin Hydrochloride Injection listed at present simultaneously mostly uses glass ampule to contain greatly, but glass ampule holds
The problem of medical fluid received often causes glass flake to dissolve.Glass ampule needs to break disconnected ampoule when in use first, because of glass
Fragility makes breaking disconnected ampoule while taking a large amount of glass chips out of, is directly entered glass chip in drug, and human eye is to particle point
Distinguish it is 50 microns or more, because human capillary vessel's diameter only has 7 microns, a large amount of not visible glass granules input people with drug
Body has " invisible particle pollution " harm, and the harm of this particle has potentiality and persistence.
Summary of the invention
In order to solve the above technical problems, the present invention provides a kind of lavo-ofloxacin hydrochlorides of plastic ampoule packaging to inject medicine
Object, to overcome existing Levofloxacin Hydrochloride Injection, easily occur in long-standing storage color deepen and it is insoluble
The problem of particle increases.
A kind of lavo-ofloxacin hydrochloride injectable pharmaceutical compositions of plastic ampoule packaging of the present invention, including hydrochloric acid are left
Ofloxacin, fastness composition, sodium hydroxide；The fastness composition accounts for Levofloxacin Hydrochloride Injection weight hundred
Divide than being 0.01%~0.5%.
A kind of lavo-ofloxacin hydrochloride injectable pharmaceutical compositions of plastic ampoule packaging of the present invention, the fastness
Composition is natrium adetate and sodium pyrosulfite mixture；Wherein the weight ratio of natrium adetate and sodium pyrosulfite is 1:1
~2.
A kind of lavo-ofloxacin hydrochloride injectable pharmaceutical compositions of plastic ampoule packaging of the present invention, the edetic acid(EDTA)
The weight ratio of disodium and sodium pyrosulfite is 1:1.5.
A kind of lavo-ofloxacin hydrochloride injectable pharmaceutical compositions of plastic ampoule packaging of the present invention, the fastness
Composition is natrium adetate, sodium pyrosulfite, the mixture for setting beans ketone acid B；Wherein natrium adetate, sodium pyrosulfite, tree
The weight ratio of beans ketone acid B is 1:1.5:0.5.
A kind of lavo-ofloxacin hydrochloride injectable pharmaceutical compositions of plastic ampoule packaging of the present invention, the fastness
It is preferably 0.02%~0.1% that composition, which accounts for Levofloxacin Hydrochloride Injection weight percent,；Further preferably 0.05%.
A kind of lavo-ofloxacin hydrochloride injectable pharmaceutical compositions of plastic ampoule packaging of the present invention, the plastics peace
Material selection polyethylene (PE) plastics of small jar, polyester (PET and PBT) plastics, polypropylene (PP) plastics, polyvinyl chloride (PVC) modeling
One kind of material.
A kind of lavo-ofloxacin hydrochloride injectable pharmaceutical compositions of plastic ampoule packaging of the present invention, the plastics hold
The material of device is preferably one kind of polyethylene (PE) plastics, polypropylene (PP) plastics.Further preferably polypropylene (PP) plastics
The preparation method of Levofloxacin Hydrochloride Injection of the present invention, the preparation method specific steps are as follows: take place
The water for injection of side's amount 80%, temperature are down to 35~40 DEG C, and the natrium adetate, sodium pyrosulfite, tree beans ketone of recipe quantity is added
Sour B, lavo-ofloxacin hydrochloride are stirred to dissolve；PH value is adjusted to 3.8~4.3 with 0.1mol/L sodium hydroxide solution, adds prescription
Carbon content active stirring and adsorbing is filtered with 0.5 μm of stud, 0.22 μm of micropore filter element respectively, after sample detection semi-finished product are qualified,
The micropore filter element that 0.22 μm of terminal is filtered to visible foreign matters qualification, with three-in-one device bottle, filling, sealing, 121 DEG C of sterilizings 15
Minute.
Compared with prior art, the lavo-ofloxacin hydrochloride injection drug of plastic ampoule of the present invention packaging by
Increase fastness composition in prescription, can solve the problems, such as that color is deepened in Levofloxacin Hydrochloride Injection placement process；Modeling
Material ampoule can be very good to solve the problems, such as that Levofloxacin Hydrochloride Injection particulate matter increases, and achieve far more than tradition
The effect of glass bottle packaging.
Specific embodiment
Drug is injected to the lavo-ofloxacin hydrochloride of plastic ampoule of the present invention packaging combined with specific embodiments below
Composition is described further, but the scope of protection of the present invention is not limited thereto.
Embodiment 1
Prescription:
Preparation method are as follows:
The water for injection of recipe quantity 80% is taken, temperature is down to 35 DEG C, and natrium adetate, the pyrosulfurous acid of recipe quantity is added
Sodium, tree beans ketone acid B, lavo-ofloxacin hydrochloride are stirred to dissolve；PH value is adjusted to 3.8 with 0.1mol/L sodium hydroxide solution, is added
Prescription carbon content active stirring and adsorbing is filtered with 0.5 μm of stud, 0.22 μm of micropore filter element respectively, and sample detection semi-finished product close
After lattice, the micropore filter element that 0.22 μm of terminal filter to visible foreign matters qualification, with PP bottle of three-in-one device plastics, it is filling, seal,
121 DEG C sterilize 15 minutes.
Embodiment 2
Prescription:
Technical process:
Preparation method are as follows:
The water for injection of recipe quantity 80% is taken, temperature is down to 40 DEG C, and natrium adetate, the pyrosulfurous acid of recipe quantity is added
Sodium, lavo-ofloxacin hydrochloride are stirred to dissolve；PH value is adjusted to 4.3 with 0.1mol/L sodium hydroxide solution, adds recipe quantity active
Charcoal stirring and adsorbing is filtered with 0.5 μm of stud, 0.22 μm of micropore filter element respectively, after sample detection semi-finished product are qualified, terminal
0.22 μm of micropore filter element is filtered to visible foreign matters qualification, with PP bottles of three-in-one device plastics, filling, sealing, 121 DEG C of sterilizings
15 minutes.
Comparative examples 1
Prescription:
Preparation method are as follows:
The water for injection of recipe quantity 80% is taken, temperature is down to 40 DEG C, and the lavo-ofloxacin hydrochloride stirring that recipe quantity is added makes
Dissolution；PH value is adjusted to 4.3 with 0.1mol/L sodium hydroxide solution, adds prescription carbon content active stirring and adsorbing, respectively with 0.5 μm
Stud, the filtering of 0.22 μm of micropore filter element, after sample detection semi-finished product are qualified, the micropore filter element that 0.22 μm of terminal is filtered to visible
Foreign matter is qualified, and with PP bottles of three-in-one device plastics, filling, sealing, 121 DEG C sterilize 15 minutes.
Comparative examples 2
Prescription:
Preparation method are as follows:
The water for injection of recipe quantity 80% is taken, temperature is down to 35 DEG C, and natrium adetate, the pyrosulfurous acid of recipe quantity is added
Sodium, Cajanonic acid A, lavo-ofloxacin hydrochloride are stirred to dissolve；PH value is adjusted to 3.8 with 0.1mol/L sodium hydroxide solution, is added
Prescription carbon content active stirring and adsorbing is filtered with 0.5 μm of stud, 0.22 μm of micropore filter element respectively, and sample detection semi-finished product close
After lattice, the micropore filter element that 0.22 μm of terminal filter to visible foreign matters qualification, encapsulating in common process clean glass ampule in, in
121 DEG C sterilize 15 minutes.
Two, compliance test result
Select the color of solution, particulate matter that the present invention is explained in further detail for index.Detection method ginseng
According to the inspection of color in current version pharmacopeia annex particulate determination method and Levofloxacin Hydrochloride Injection quality standard
Survey method.
Every result compares
Example 1~2 and comparative examples 1~2 carry out the detection of character, pH value, color and particulate matter, as a result
As shown in table 1.
The measurement result of the various color samples of table 1 and character, pH value and particulate matter number
Claims (10)
1. a kind of lavo-ofloxacin hydrochloride injectable pharmaceutical compositions of plastic ampoule packaging, which is characterized in that including the left oxygen of hydrochloric acid
Flucloxacillin, fastness composition, sodium hydroxide；The fastness composition accounts for Levofloxacin Hydrochloride Injection weight percent
Than being 0.01%~0.5%.
2. the lavo-ofloxacin hydrochloride injectable pharmaceutical compositions of plastic ampoule packaging according to claim 1, feature exist
In the fastness composition is natrium adetate and sodium pyrosulfite mixture；Wherein natrium adetate and sodium pyrosulfite
Weight ratio be 1:1~2.
3. the lavo-ofloxacin hydrochloride injectable pharmaceutical compositions of plastic ampoule packaging according to claim 1, feature exist
In the weight ratio of the natrium adetate and sodium pyrosulfite is 1:1.5.
4. the lavo-ofloxacin hydrochloride injectable pharmaceutical compositions of plastic ampoule packaging according to claim 1, feature exist
In the fastness composition is natrium adetate, sodium pyrosulfite, the mixture for setting beans ketone acid B；Wherein natrium adetate,
Sodium pyrosulfite, the weight ratio for setting beans ketone acid B are 1:1~2:0.5.
5. the lavo-ofloxacin hydrochloride injectable pharmaceutical compositions of plastic ampoule packaging according to claim 1, feature exist
In it is preferably 0.02%~0.1% that the fastness composition, which accounts for Levofloxacin Hydrochloride Injection weight percent,.
6. the lavo-ofloxacin hydrochloride injectable pharmaceutical compositions of plastic ampoule packaging according to claim 1, feature exist
In it is 0.05% that the fastness composition, which accounts for Levofloxacin Hydrochloride Injection weight percent,.
7. the lavo-ofloxacin hydrochloride injectable pharmaceutical compositions of plastic ampoule packaging according to claim 1, feature exist
In the material of the plastic ampoule selects one kind of vinyon, polyester plastics, polypropylene plastics, igelite.
8. the lavo-ofloxacin hydrochloride injectable pharmaceutical compositions of plastic ampoule packaging according to claim 1, feature exist
In the material of the plastic containers is one kind of vinyon, polypropylene plastics.
9. the lavo-ofloxacin hydrochloride injectable pharmaceutical compositions of plastic ampoule packaging according to claim 1, feature exist
In the material of the plastic containers is polypropylene plastics.
10. a kind of preparation method of Levofloxacin Hydrochloride Injection, which is characterized in that the preparation method specific steps are as follows:
The water for injection of recipe quantity 80% is taken, temperature is down to 35~40 DEG C, and the natrium adetate, sodium pyrosulfite, tree of recipe quantity is added
Beans ketone acid B, lavo-ofloxacin hydrochloride are stirred to dissolve；PH value is adjusted to 3.8~4.3 with 0.1mol/L sodium hydroxide solution, is added
Prescription carbon content active stirring and adsorbing is filtered with 0.5 μm of stud, 0.22 μm of micropore filter element respectively, and sample detection semi-finished product close
After lattice, the micropore filter element that 0.22 μm of terminal filter to visible foreign matters qualification, with three-in-one device bottle, it is filling, sealing, 121 DEG C
Sterilizing 15 minutes.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811650288.1A CN109820818A (en) | 2018-12-31 | 2018-12-31 | A kind of lavo-ofloxacin hydrochloride composition of plastic ampoule packaging |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811650288.1A CN109820818A (en) | 2018-12-31 | 2018-12-31 | A kind of lavo-ofloxacin hydrochloride composition of plastic ampoule packaging |
Publications (1)
| Publication Number | Publication Date |
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| CN109820818A true CN109820818A (en) | 2019-05-31 |
Family
ID=66860695
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201811650288.1A Pending CN109820818A (en) | 2018-12-31 | 2018-12-31 | A kind of lavo-ofloxacin hydrochloride composition of plastic ampoule packaging |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110755374A (en) * | 2019-11-22 | 2020-02-07 | 南京知和医药科技有限公司 | Levofloxacin injection and preparation process thereof |
Citations (4)
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|---|---|---|---|---|
| CN102697714A (en) * | 2012-06-25 | 2012-10-03 | 福建天泉药业股份有限公司 | Levofloxacin hydrochloride injection and preparation method thereof |
| JP5624281B2 (en) * | 2009-04-21 | 2014-11-12 | 東亜薬品株式会社 | Liquid formulation containing quinolone antibacterial agent with excellent photostability |
| CN105534891A (en) * | 2016-01-18 | 2016-05-04 | 南京正科医药股份有限公司 | Dexmedetomidine hydrochloride injection |
| CN107496349A (en) * | 2017-07-28 | 2017-12-22 | 海南先通药业有限公司 | Filling ambroxol hydrochloride injection composition of a kind of plastic ampoule and preparation method thereof |
-
2018
- 2018-12-31 CN CN201811650288.1A patent/CN109820818A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP5624281B2 (en) * | 2009-04-21 | 2014-11-12 | 東亜薬品株式会社 | Liquid formulation containing quinolone antibacterial agent with excellent photostability |
| CN102697714A (en) * | 2012-06-25 | 2012-10-03 | 福建天泉药业股份有限公司 | Levofloxacin hydrochloride injection and preparation method thereof |
| CN105534891A (en) * | 2016-01-18 | 2016-05-04 | 南京正科医药股份有限公司 | Dexmedetomidine hydrochloride injection |
| CN107496349A (en) * | 2017-07-28 | 2017-12-22 | 海南先通药业有限公司 | Filling ambroxol hydrochloride injection composition of a kind of plastic ampoule and preparation method thereof |
Non-Patent Citations (1)
| Title |
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| 胡阳亮等: "树豆内酯A粗品皂化产物的化学结构鉴定", 《热带亚热带植物学报》 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110755374A (en) * | 2019-11-22 | 2020-02-07 | 南京知和医药科技有限公司 | Levofloxacin injection and preparation process thereof |
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Application publication date: 20190531 |