CN106265540A - A kind of good fortune department fluconazol lyophilized formulations compositions and preparation method thereof - Google Patents
A kind of good fortune department fluconazol lyophilized formulations compositions and preparation method thereof Download PDFInfo
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- CN106265540A CN106265540A CN201610792726.2A CN201610792726A CN106265540A CN 106265540 A CN106265540 A CN 106265540A CN 201610792726 A CN201610792726 A CN 201610792726A CN 106265540 A CN106265540 A CN 106265540A
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- fluconazol
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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
- A61K31/66—Phosphorus compounds
- A61K31/675—Phosphorus compounds having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate
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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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
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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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
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- Chemical & Material Sciences (AREA)
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Abstract
The present invention proposes a kind of good fortune department fluconazol lyophilized formulations compositions and preparation method thereof, good fortune department fluconazol lyophilized formulations compositions includes good fortune department fluconazol, filler and pH adjusting agent, wherein the mass percent of good fortune department fluconazol and filler is 1:2.5 3.5, described filler includes excipient, stabilizer and PVP K30, wherein excipient is glucose, glucosan, trehalose, sucrose, gelatin, sorbitol, one or both and above compositions thereof in mannitol, good fortune department fluconazol is prepared as lyophilized formulations by the present invention, there is good stability, greatly suppress degradation rate, can store under room temperature state more than 3 years, improve the practicality of good fortune department fluconazol.
Description
Technical field
The present invention relates to pharmaceutical preparations technology field, be specifically related to a kind of good fortune department fluconazol lyophilized formulations compositions and system thereof
Preparation Method.
Background technology
Good fortune department fluconazol (fosfluconazole, Formulas I) is the nucleoside monophosphate prodrugs of fluconazol (formula IV), by fluconazol
The tertiary alcohol be changed into phosphate ester, the most do not introduce chiral centre, too increase water solublity, thus overcome fluconazol for a long time with
Because of the defect that low the caused amount of infusion of water solublity is bigger.It is hydrolyzed into fluorine health under the effect of phosphate in vivo after intravenously administrable
Azoles, plays pharmacological action.Good fortune department fluconazol is by the institute exploitation of central authorities of Hui Duan company of the U.S., and on January 15th, 2004 is in Japan
City, for treat the such as fungemia of the deep infection caused by candidiasis and cryptococcus, fungus in respiratory tract disease, Fangal peritonitis,
Gastrointestinal tract fungus disease, urinary tract fungal infection, fungal meningitis.But, good fortune department fluconazol is only injection, poor stability,
And can only be 1 year in 2～8 DEG C of preservations, effect duration, preserving by this condition, its cost is greatly increased, and hospital or patient are the most not
It is easy to store, is unfavorable for its promotion and application clinically.
Summary of the invention
For the problem of above-mentioned existence, the present invention proposes a kind of good fortune department fluconazol lyophilized formulations compositions and preparation side thereof
Method, the good fortune department fluconazol lyophilized formulations compositions using technical measure to prepare has good stability and solubility,
Practical.
In order to realize above-mentioned purpose, the present invention uses following technical scheme:
A kind of good fortune department fluconazol lyophilized formulations compositions, including good fortune department fluconazol, filler and pH adjusting agent, good fortune department fluorine health
The mass percent of azoles and filler is 1:2.5-3.5, and described filler includes excipient, stabilizer and PVP K30, wherein
Excipient be in glucose, glucosan, trehalose, sucrose, gelatin, sorbitol, mannitol one or both and above
Compositions.
Preferably, excipient, stabilizer, the mass percent of PVP K30 are 1.5-2:0.8-1:1-1.2.
Preferably, during described stabilizer is glycine, alanine, aspartic acid, tryptophan, phenylalanine, nicotinic acid
Plant or two kinds and above compositions.
Preferably, described good fortune department fluconazol lyophilized formulations compositions also includes dehydrated alcohol that mol ratio is 1-3:1 and
The compositions of acetone, the compositions of described dehydrated alcohol and acetone is 1:1 with the mass percent of good fortune department fluconazol.
Preferably, one during described pH adjusting agent is lactic acid, tartaric acid, citric acid, sodium hydroxide, phosphate buffer or
Two kinds and above compositions.
Preferably, the preparation method of good fortune department fluconazol lyophilized formulations compositions, preparation process is as follows:
1) by good fortune department fluconazol, the water for injection of filler 8 times of filler weight portions of addition, blended under agitation, in stirring
During drip dehydrated alcohol and the compositions of acetone, then add the water for injection of 2 times of filler weight portions, stirring
Adding pH adjusting agent regulation pH after uniformly is 8-9, get Fu Si fluconazol aqueous solution；
2) good fortune department fluconazol aqueous solution is carried out filtration sterilization by the filter membrane of 0.2 μm, then filtrate is dispensed into XiLin
In Ping；
3) initial temperature of freezer dryer is adjusted to 5 DEG C, then cillin bottle is placed on shelf, with 2 DEG C/min's
Speed is cooled to-45-40 DEG C, maintains 2h, then opens cold-trap evacuation, when vacuum ＞ 50 μm Hg, with 0.4 DEG C/min
Speed be warming up to-25-20 DEG C, maintain 20h, then be warming up to-10 DEG C with the speed of 0.3 DEG C/min, maintain 10h, then with
The speed of 0.5 DEG C/min is warming up to 30 35 DEG C, maintains 5h, finally closes cold-trap, inflated with nitrogen, tamponade, and get Fu Si fluconazol freezes
Dry preparation compositions.
Preferably, step 2) aqueous solution of good fortune department fluconazol is 3mL or 5mL in cillin bottle.
Owing to using above-mentioned technical scheme, the invention has the beneficial effects as follows: good fortune department fluconazol is prepared gelation by the present invention
Dry preparation, has good stability, greatly suppresses degradation rate, can store more than 3 years, and solubility under room temperature state
By force, sterilized water for injection, normal saline or glucose injection etc. can be directly added into during Clinical practice, can use after dissolving,
Improve the practicality of good fortune department fluconazol.
Detailed description of the invention
For making the purpose of the embodiment of the present invention, technical scheme and advantage clearer, below in conjunction with the embodiment of the present invention,
Technical scheme in the embodiment of the present invention is clearly and completely described.Based on embodiments of the invention, the common skill in this area
The every other embodiment that art personnel are obtained under not making creative work premise, broadly falls into the model of present invention protection
Enclose.
Embodiment 1:
A kind of good fortune department fluconazol lyophilized formulations compositions, including the dehydrated alcohol and third that good fortune department fluconazol, mol ratio are 1:1
The compositions of the compositions of the compositions of ketone, lactic acid and sodium hydroxide, PVP K30, glucose and mannitol, glycine.
The mass percent of good fortune department fluconazol and filler is 1:2.6.
Excipient, stabilizer, the mass percent of PVP K30 are 1.8:0.9:1.1.
The preparation method of good fortune department fluconazol lyophilized formulations compositions, preparation process is as follows:
1) by good fortune department fluconazol, the water for injection of filler 8 times of filler weight portions of addition, blended under agitation, in stirring
During drip dehydrated alcohol and the compositions of acetone, then add the water for injection of 2 times of filler weight portions, stirring
Adding pH adjusting agent regulation pH after uniformly is 8.3, get Fu Si fluconazol aqueous solution；
2) good fortune department fluconazol aqueous solution is carried out filtration sterilization by the filter membrane of 0.2 μm, then filtrate is dispensed into XiLin
In Ping；
3) initial temperature of freezer dryer is adjusted to 5 DEG C, then cillin bottle is placed on shelf, with 2 DEG C/min's
Speed is cooled to-42 DEG C, maintains 2h, then opens cold-trap evacuation, when vacuum ＞ 50 μm Hg, with the speed of 0.4 DEG C/min
Degree is warming up to-23 DEG C, maintains 20h, then is warming up to-10 DEG C with the speed of 0.3 DEG C/min, maintains 10h, then with 0.5 DEG C/min
Speed be warming up to 32 DEG C, maintain 5h, finally close cold-trap, inflated with nitrogen, tamponade, get Fu Si fluconazol lyophilized formulations compositions.
Embodiment 2:
A kind of good fortune department fluconazol lyophilized formulations compositions, including the dehydrated alcohol and third that good fortune department fluconazol, mol ratio are 2:1
The combination of the compositions of the compositions of ketone, tartaric acid and sodium hydroxide, PVP K30, glucose, tryptophan and phenylalanine
Thing.
The mass percent of good fortune department fluconazol and filler is 1:2.5.
Excipient, stabilizer, the mass percent of PVP K30 are 2:0.8:1.2.
The preparation method of good fortune department fluconazol lyophilized formulations compositions, preparation process is as follows:
1) by good fortune department fluconazol, the water for injection of filler 8 times of filler weight portions of addition, blended under agitation, in stirring
During drip dehydrated alcohol and the compositions of acetone, then add the water for injection of 2 times of filler weight portions, stirring
Adding pH adjusting agent regulation pH after uniformly is 8.5, get Fu Si fluconazol aqueous solution；
2) good fortune department fluconazol aqueous solution is carried out filtration sterilization by the filter membrane of 0.2 μm, then filtrate is dispensed into XiLin
In Ping；
3) initial temperature of freezer dryer is adjusted to 5 DEG C, then cillin bottle is placed on shelf, with 2 DEG C/min's
Speed is cooled to-43 DEG C, maintains 2h, then opens cold-trap evacuation, when vacuum ＞ 50 μm Hg, with the speed of 0.4 DEG C/min
Degree is warming up to-25 DEG C, maintains 20h, then is warming up to-10 DEG C with the speed of 0.3 DEG C/min, maintains 10h, then with 0.5 DEG C/min
Speed be warming up to 35 DEG C, maintain 5h, finally close cold-trap, inflated with nitrogen, tamponade, get Fu Si fluconazol lyophilized formulations compositions.
Embodiment 3:
A kind of good fortune department fluconazol lyophilized formulations compositions, including the dehydrated alcohol that good fortune department fluconazol, mol ratio are 2.5:1 and
The compositions of the compositions of acetone, phosphate buffer, PVP K30, sorbitol and mannitol, aspartic acid.
The mass percent of good fortune department fluconazol and filler is 1:3.2.
Excipient, stabilizer, the mass percent of PVP K30 are 1.6:0.9:1.2.
The preparation method of good fortune department fluconazol lyophilized formulations compositions, preparation process is as follows:
1) by good fortune department fluconazol, the water for injection of filler 8 times of filler weight portions of addition, blended under agitation, in stirring
During drip dehydrated alcohol and the compositions of acetone, then add the water for injection of 2 times of filler weight portions, stirring
Adding pH adjusting agent regulation pH after uniformly is 8.2, get Fu Si fluconazol aqueous solution；
2) good fortune department fluconazol aqueous solution is carried out filtration sterilization by the filter membrane of 0.2 μm, then filtrate is dispensed into XiLin
In Ping；
3) initial temperature of freezer dryer is adjusted to 5 DEG C, then cillin bottle is placed on shelf, with 2 DEG C/min's
Speed is cooled to-41 DEG C, maintains 2h, then opens cold-trap evacuation, when vacuum ＞ 50 μm Hg, with the speed of 0.4 DEG C/min
Degree is warming up to-20 DEG C, maintains 20h, then is warming up to-10 DEG C with the speed of 0.3 DEG C/min, maintains 10h, then with 0.5 DEG C/min
Speed be warming up to 30 DEG C, maintain 5h, finally close cold-trap, inflated with nitrogen, tamponade, get Fu Si fluconazol lyophilized formulations compositions.
Embodiment 4:
A kind of good fortune department fluconazol lyophilized formulations compositions, including the dehydrated alcohol and third that good fortune department fluconazol, mol ratio are 3:1
The compositions of ketone, phosphate buffer, PVP K30, mannitol tryptophan and the compositions of nicotinic acid.
The mass percent of good fortune department fluconazol and filler is 1:3.
Excipient, stabilizer, the mass percent of PVP K30 are 1.5:1:1.1.
The preparation method of good fortune department fluconazol lyophilized formulations compositions, preparation process is as follows:
1) by good fortune department fluconazol, the water for injection of filler 8 times of filler weight portions of addition, blended under agitation, in stirring
During drip dehydrated alcohol and the compositions of acetone, then add the water for injection of 2 times of filler weight portions, stirring
Adding pH adjusting agent regulation pH after uniformly is 8, get Fu Si fluconazol aqueous solution；
2) good fortune department fluconazol aqueous solution is carried out filtration sterilization by the filter membrane of 0.2 μm, then filtrate is dispensed into XiLin
In Ping；
3) initial temperature of freezer dryer is adjusted to 5 DEG C, then cillin bottle is placed on shelf, with 2 DEG C/min's
Speed is cooled to-40 DEG C, maintains 2h, then opens cold-trap evacuation, when vacuum ＞ 50 μm Hg, with the speed of 0.4 DEG C/min
Degree is warming up to-22 DEG C, maintains 20h, then is warming up to-10 DEG C with the speed of 0.3 DEG C/min, maintains 10h, then with 0.5 DEG C/min
Speed be warming up to 33 DEG C, maintain 5h, finally close cold-trap, inflated with nitrogen, tamponade, get Fu Si fluconazol lyophilized formulations compositions.
Embodiment 5:
A kind of good fortune department fluconazol lyophilized formulations compositions, is 1.5:1's including good fortune department fluconazol, PVP K30, mol ratio
Dehydrated alcohol and the compositions of the compositions of acetone, tartaric acid and sodium hydroxide, glucose, glucosan, sorbitol, mannitol
Compositions, glycine, alanine, the compositions of phenylalanine.
The mass percent of good fortune department fluconazol and filler is 1:3.5.
Excipient, stabilizer, the mass percent of PVP K30 are 1.7:0.8:1.
The preparation method of good fortune department fluconazol lyophilized formulations compositions, preparation process is as follows:
1) by good fortune department fluconazol, the water for injection of filler 8 times of filler weight portions of addition, blended under agitation, in stirring
During drip dehydrated alcohol and the compositions of acetone, then add the water for injection of 2 times of filler weight portions, stirring
Adding pH adjusting agent regulation pH after uniformly is 8.8, get Fu Si fluconazol aqueous solution；
2) good fortune department fluconazol aqueous solution is carried out filtration sterilization by the filter membrane of 0.2 μm, then filtrate is dispensed into XiLin
In Ping；
3) initial temperature of freezer dryer is adjusted to 5 DEG C, then cillin bottle is placed on shelf, with 2 DEG C/min's
Speed is cooled to-45 DEG C, maintains 2h, then opens cold-trap evacuation, when vacuum ＞ 50 μm Hg, with the speed of 0.4 DEG C/min
Degree is warming up to-21 DEG C, maintains 20h, then is warming up to-10 DEG C with the speed of 0.3 DEG C/min, maintains 10h, then with 0.5 DEG C/min
Speed be warming up to 34 DEG C, maintain 5h, finally close cold-trap, inflated with nitrogen, tamponade, get Fu Si fluconazol lyophilized formulations compositions.
Embodiment 6:
A kind of good fortune department fluconazol lyophilized formulations compositions, including the dehydrated alcohol that good fortune department fluconazol, mol ratio are 1.8:1 and
The compositions of acetone, phosphate buffer, PVP K30, glucose, tryptophan.
The mass percent of good fortune department fluconazol and filler is 1:2.8.
Excipient, stabilizer, the mass percent of PVP K30 are 2:1:1.2.
The preparation method of good fortune department fluconazol lyophilized formulations compositions, preparation process is as follows:
1) by good fortune department fluconazol, the water for injection of filler 8 times of filler weight portions of addition, blended under agitation, in stirring
During drip dehydrated alcohol and the compositions of acetone, then add the water for injection of 2 times of filler weight portions, stirring
Adding pH adjusting agent regulation pH after uniformly is 9, get Fu Si fluconazol aqueous solution；
2) good fortune department fluconazol aqueous solution is carried out filtration sterilization by the filter membrane of 0.2 μm, then filtrate is dispensed into XiLin
In Ping；
3) initial temperature of freezer dryer is adjusted to 5 DEG C, then cillin bottle is placed on shelf, with 2 DEG C/min's
Speed is cooled to-43 DEG C, maintains 2h, then opens cold-trap evacuation, when vacuum ＞ 50 μm Hg, with the speed of 0.4 DEG C/min
Degree is warming up to-24 DEG C, maintains 20h, then is warming up to-10 DEG C with the speed of 0.3 DEG C/min, maintains 10h, then with 0.5 DEG C/min
Speed be warming up to 30 DEG C, maintain 5h, finally close cold-trap, inflated with nitrogen, tamponade, get Fu Si fluconazol lyophilized formulations compositions.
The good fortune department fluconazol added in above example is 20g.
Embodiment of the present invention product is experimental group and three groups of commercially available good fortune department fluconazol lyophilized formulations compositionss are comparison
Group carries out performance test, and data are as follows:
Above example only in order to technical scheme to be described, is not intended to limit；Although with reference to previous embodiment
The present invention is described in detail, it will be understood by those within the art that: it still can be to aforementioned each enforcement
Technical scheme described in example is modified, or wherein portion of techniques feature is carried out equivalent；And these amendment or
Replace, do not make the essence of appropriate technical solution depart from the spirit and scope of various embodiments of the present invention technical scheme.
Claims (7)
1. a good fortune department fluconazol lyophilized formulations compositions, including good fortune department fluconazol, filler and pH adjusting agent, its feature exists
In: the mass percent of good fortune department fluconazol and filler is 1:2.5-3.5, and described filler includes excipient, stabilizer and gathers
Dimension ketone K30, the one during wherein excipient is glucose, glucosan, trehalose, sucrose, gelatin, sorbitol, mannitol or two
Plant and above compositions.
Good fortune department the most according to claim 1 fluconazol lyophilized formulations compositions, it is characterised in that: excipient, stabilizer, poly-
The mass percent of dimension ketone K30 is 1.5-2:0.8-1:1-1.2.
Good fortune department the most according to claim 1 fluconazol lyophilized formulations compositions, it is characterised in that: described stabilizer is sweet ammonia
One or both and above compositions thereof in acid, alanine, aspartic acid, tryptophan, phenylalanine, nicotinic acid.
Good fortune department the most according to claim 1 fluconazol lyophilized formulations compositions, it is characterised in that: described good fortune department fluconazol freezes
Dry preparation compositions also includes dehydrated alcohol and the compositions of acetone that mol ratio is 1-3:1, described dehydrated alcohol and acetone
The mass percent of compositions and good fortune department fluconazol be 1:1.
Good fortune department the most according to claim 1 fluconazol lyophilized formulations compositions, it is characterised in that: described pH adjusting agent is breast
One or both and above compositions thereof in acid, tartaric acid, citric acid, sodium hydroxide, phosphate buffer.
The preparation method of good fortune department the most according to claim 1 fluconazol lyophilized formulations compositions, it is characterised in that preparation step
Rapid as follows:
1) by good fortune department fluconazol, the water for injection of filler 8 times of filler weight portions of addition, blended under agitation, in the mistake of stirring
Journey drips dehydrated alcohol and the compositions of acetone, then adds the water for injection of 2 times of filler weight portions, stir
Rear addition pH adjusting agent regulation pH is 8-9, get Fu Si fluconazol aqueous solution；
2) good fortune department fluconazol aqueous solution is carried out filtration sterilization by the filter membrane of 0.2 μm, then filtrate is dispensed in cillin bottle；
3) initial temperature of freezer dryer is adjusted to 5 DEG C, then cillin bottle is placed on shelf, with the speed of 2 DEG C/min
It is cooled to-45-40 DEG C, maintains 2h, then open cold-trap evacuation, when vacuum ＞ 50 μm Hg, with the speed of 0.4 DEG C/min
Degree is warming up to-25-20 DEG C, maintains 20h, then is warming up to-10 DEG C with the speed of 0.3 DEG C/min, maintains 10h, then with 0.5
DEG C/speed of min is warming up to 30 35 DEG C, maintain 5h, finally close cold-trap, inflated with nitrogen, tamponade, get Fu Si fluconazol lyophilizing system
Agent compositions.
The preparation method of good fortune department the most according to claim 5 fluconazol lyophilized formulations compositions, it is characterised in that: step 2)
In cillin bottle, the aqueous solution of good fortune department fluconazol is 3mL or 5mL.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201610792726.2A CN106265540A (en) | 2016-08-31 | 2016-08-31 | A kind of good fortune department fluconazol lyophilized formulations compositions and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201610792726.2A CN106265540A (en) | 2016-08-31 | 2016-08-31 | A kind of good fortune department fluconazol lyophilized formulations compositions and preparation method thereof |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1565446A (en) * | 2003-06-17 | 2005-01-19 | 刘智 | Freeze-drying fluconazole injection and its preparation method |
| CN101347412A (en) * | 2008-09-02 | 2009-01-21 | 大连美罗药业股份有限公司 | Amifostine trihydrate crystal lyophilized preparation and method of preparing the same |
| CN104873468A (en) * | 2014-02-27 | 2015-09-02 | 陕西合成药业股份有限公司 | Fosfluconazole for injection, a preparing method thereof and uses of the fosfluconazole |
| CN104940133A (en) * | 2015-06-11 | 2015-09-30 | 山东新时代药业有限公司 | Fluconazole injection and preparation method thereof |
-
2016
- 2016-08-31 CN CN201610792726.2A patent/CN106265540A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1565446A (en) * | 2003-06-17 | 2005-01-19 | 刘智 | Freeze-drying fluconazole injection and its preparation method |
| CN101347412A (en) * | 2008-09-02 | 2009-01-21 | 大连美罗药业股份有限公司 | Amifostine trihydrate crystal lyophilized preparation and method of preparing the same |
| CN104873468A (en) * | 2014-02-27 | 2015-09-02 | 陕西合成药业股份有限公司 | Fosfluconazole for injection, a preparing method thereof and uses of the fosfluconazole |
| CN104940133A (en) * | 2015-06-11 | 2015-09-30 | 山东新时代药业有限公司 | Fluconazole injection and preparation method thereof |
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