CN110090200A - A kind of voriconazole injection type composition - Google Patents
A kind of voriconazole injection type composition Download PDFInfo
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- CN110090200A CN110090200A CN201910303651.0A CN201910303651A CN110090200A CN 110090200 A CN110090200 A CN 110090200A CN 201910303651 A CN201910303651 A CN 201910303651A CN 110090200 A CN110090200 A CN 110090200A
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- Prior art keywords
- voriconazole
- injection type
- type composition
- composition according
- powder
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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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
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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
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/10—Antimycotics
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- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
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- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Dermatology (AREA)
- Oncology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Communicable Diseases (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses a kind of voriconazole injection type composition, the composition components include that diluent, the pharmaceutic adjuvant of phosphate buffer, 5%GS or 5%NS that voriconazole powder-injection, the solvent for dissolving voriconazole are pH5.0-8.0 are one of polyethylene glycol, propylene glycol, glycerine and benzyl alcohol or a variety of.The beneficial effects of the present invention are: the pharmaceutic adjuvant of the composition of the voriconazole can make entire voriconazole composition drug effect more stable, pharmaceutic adjuvant majority used is inorganic matter simultaneously, it will not influence drug effect, further promote the stability of voriconazole composition drug effect.
Description
Technical field
The present invention relates to a kind of voriconazole composition, specially a kind of voriconazole injection type composition belongs to volt
Vertical health azoles applied technical field.
Background technique
Voriconazole is a kind of drug for treating fungal infection, is broad-spectrum antifungal medicine, the fungal infection to humans and animals
There is therapeutic effect, is mainly used for treating Aspergillosis, treats bad attack caused by the candida albicans to fluconazole resistant
Sexuality dye;Treat the severe infections as caused by Scedosporium and Fusarium;It is immune scarce to be mainly used for treatment in clinic
Fall into progressive, possibility life-threatening infection in patient.
Propelled since voriconazole cannot be directly used to vein, thus the drug majority containing voriconazole with oral or
Fluid infusion acts on patient, when infusion, needs to merge voriconazole injection to relevant pharmaceutic adjuvant, so as to defeated
Liquid, but voriconazole composition stability made from traditional formula is poor, it is difficult to guarantee drug effect.Therefore, it is asked for above-mentioned
Topic proposes a kind of voriconazole injection type composition.
Summary of the invention
The object of the invention is that providing a kind of voriconazole injection type composition to solve the above-mentioned problems.
The present invention is achieved through the following technical solutions above-mentioned purpose, and a kind of voriconazole injection type composition is described
Composition components include voriconazole powder-injection, solvent for dissolving voriconazole is pH5.0-8.0 phosphate buffer,
Diluent, the pharmaceutic adjuvant of 5%GS or 5%NS is one of polyethylene glycol, propylene glycol, glycerine and benzyl alcohol or a variety of.
Preferably, the voriconazole powder-injection when in use, first injects powder injection bottle with 5ml phosphate buffer, by force
Forced oscillation medicine bottle 30 seconds, 30 minutes are stood, then strength shaking 30 seconds, confirmation drug powder is completely dissolved, solution clarification, without any
Fine crystalline.
Preferably, it is dense eventually after dilution with the dilution dilution agent of 5%GS or 5%NS after the vertical health azoles powder-injection is dissolved
Degree is 200mg/ml.
Preferably, the phosphate buffer helps to maintain constant pH value, and the osmotic pressure and ion concentration of solution are logical
It is often close with human body pH.
Preferably, the polyethylene glycol is the polymer, nontoxic and nonirritant that ethylene oxide hydrolyzes product, is answered extensively
For in various pharmaceutical preparations.
Preferably, the propylene glycol be by dichloropropane in weak base aqueous solution direct hydrolysis at.
Preferably, the glycerine is stored using Aluminum Drum or Galvanized Iron Drum packaging or with the storage tank of phenolic resin lining.
Preferably, the benzyl alcohol is stored in the storehouse of shady and cool ventilation, should be with oxidant, edible far from kindling material, heat source
Chemicals is separately stored, and storage is never mixed.
Preferably, the raw material of the phosphate buffer is potassium dihydrogen phosphate and sodium hydroxide solution.
Preferably, the diluent of the 5%NS is mainly used for patient's use with diabetes.
The beneficial effects of the present invention are: the pharmaceutic adjuvant of the composition of the voriconazole can be such that entire voriconazole combines
Object drug effect is more stable, while pharmaceutic adjuvant majority used is inorganic matter, will not influence drug effect, further promotes voriconazole
The stability of composition drug effect.
Specific embodiment
Technical scheme in the embodiment of the invention is clearly and completely described, it is clear that described embodiment is only
It is a part of the embodiment of the present invention, instead of all the embodiments.Based on the embodiments of the present invention, ordinary skill people
Member's every other embodiment obtained without making creative work, shall fall within the protection scope of the present invention.
Embodiment one:
A kind of voriconazole injection type composition, the composition components include the following:
The composition components include voriconazole powder-injection, the phosphoric acid that solvent for dissolving voriconazole is pH8.0
Salt buffer, 5%GS diluent, pharmaceutic adjuvant are one of polyethylene glycol, propylene glycol, glycerine and benzyl alcohol or a variety of.
Further, the voriconazole powder-injection when in use, first injects powder injection bottle with 5ml phosphate buffer,
Strength oscillation medicine bottle 30 seconds, standing 30 minutes, then strength shaking 30 seconds, confirmation drug powder is completely dissolved, and solution clarification, nothing is appointed
What fine crystalline.
Further, it is whole after dilution with the dilution dilution agent of 5%GS or 5%NS after the vertical health azoles powder-injection is dissolved
Concentration is 200mg/ml.
Further, the phosphate buffer helps to maintain constant pH value, the osmotic pressure and ion concentration of solution
It is usually close with human body pH.
Further, the polyethylene glycol is the polymer, nontoxic and nonirritant that ethylene oxide hydrolyzes product, extensively
Applied in various pharmaceutical preparations.
Further, the propylene glycol be by dichloropropane in weak base aqueous solution direct hydrolysis at.
Further, the glycerine is stored using Aluminum Drum or Galvanized Iron Drum packaging or with the storage tank of phenolic resin lining.
Further, the benzyl alcohol is stored in the storehouse of shady and cool ventilation, should be with oxidant, food far from kindling material, heat source
It is separately stored with chemicals, never mixes storage.
Further, the raw material of the phosphate buffer is potassium dihydrogen phosphate and sodium hydroxide solution.
Above-mentioned voriconazole composition drug effect is relatively stable, applicable to the general population to use.
Embodiment two:
A kind of voriconazole injection type composition, the composition components include the following:
The composition components include voriconazole powder-injection, the phosphoric acid that solvent for dissolving voriconazole is pH6.0
Salt buffer, the diluent of 5%NS, pharmaceutic adjuvant are one of polyethylene glycol, propylene glycol, glycerine and benzyl alcohol or more
Kind.
Further, the voriconazole powder-injection when in use, first injects powder injection bottle with 5ml phosphate buffer,
Strength oscillation medicine bottle 30 seconds, standing 30 minutes, then strength shaking 30 seconds, confirmation drug powder is completely dissolved, and solution clarification, nothing is appointed
What fine crystalline.
Further, it is whole after dilution with the dilution dilution agent of 5%GS or 5%NS after the vertical health azoles powder-injection is dissolved
Concentration is 200mg/ml.
Further, the phosphate buffer helps to maintain constant pH value, the osmotic pressure and ion concentration of solution
It is usually close with human body pH.
Further, the polyethylene glycol is the polymer, nontoxic and nonirritant that ethylene oxide hydrolyzes product, extensively
Applied in various pharmaceutical preparations.
Further, the propylene glycol be by dichloropropane in weak base aqueous solution direct hydrolysis at.
Further, the glycerine is stored using Aluminum Drum or Galvanized Iron Drum packaging or with the storage tank of phenolic resin lining.
Further, the benzyl alcohol is stored in the storehouse of shady and cool ventilation, should be with oxidant, food far from kindling material, heat source
It is separately stored with chemicals, never mixes storage.
Further, the raw material of the phosphate buffer is potassium dihydrogen phosphate and sodium hydroxide solution.
Further, the diluent of the 5%NS is mainly used for patient's use with diabetes.
Above-mentioned voriconazole composition efficacy stability is used suitable for the patient with diabetes.
It is obvious to a person skilled in the art that invention is not limited to the details of the above exemplary embodiments, Er Qie
In the case where without departing substantially from spirit or essential attributes of the invention, the present invention can be realized in other specific forms.Therefore, no matter
From the point of view of which point, the present embodiments are to be considered as illustrative and not restrictive, and the scope of the present invention is by appended power
Benefit requires rather than above description limits, it is intended that all by what is fallen within the meaning and scope of the equivalent elements of the claims
Variation is included within the present invention.
In addition, it should be understood that although this specification is described in terms of embodiments, but not each embodiment is only wrapped
Containing an independent technical solution, this description of the specification is merely for the sake of clarity, and those skilled in the art should
It considers the specification as a whole, the technical solutions in the various embodiments may also be suitably combined, forms those skilled in the art
The other embodiments being understood that.
Claims (10)
1. a kind of voriconazole injection type composition, it is characterised in that: the composition components include voriconazole powder-injection,
Solvent for dissolving voriconazole is the phosphate buffer of pH5.0-8.0, the diluent of 5%GS or 5%NS, pharmaceutic adjuvant
For one of polyethylene glycol, propylene glycol, glycerine and benzyl alcohol or a variety of.
2. a kind of voriconazole injection type composition according to claim 1, it is characterised in that: the voriconazole powder
Injection when in use, first injects powder injection bottle with 5ml phosphate buffer, and strength oscillation medicine bottle 30 seconds stands 30 minutes, then by force
Power shakes 30 seconds, and confirmation drug powder is completely dissolved, solution clarification, without any fine crystalline.
3. a kind of voriconazole injection type composition according to claim 1, it is characterised in that: the vertical health azoles powder needle
After agent is dissolved, with the dilution dilution agent of 5%GS or 5%NS, final concentration of 200mg/ml after dilution.
4. a kind of voriconazole injection type composition according to claim 1, it is characterised in that: the phosphate-buffered
Liquid helps to maintain constant pH value, and the osmotic pressure and ion concentration of solution are usually close with human body pH.
5. a kind of voriconazole injection type composition according to claim 1, it is characterised in that: the polyethylene glycol is
Ethylene oxide hydrolyzes the polymer, nontoxic and nonirritant of product, is widely used in various pharmaceutical preparations.
6. a kind of voriconazole injection type composition according to claim 1, it is characterised in that: the propylene glycol is logical
Cross dichloropropane in weak base aqueous solution direct hydrolysis at.
7. a kind of voriconazole injection type composition according to claim 1, it is characterised in that: the glycerine uses
Aluminum Drum or Galvanized Iron Drum packaging are stored with the storage tank of phenolic resin lining.
8. a kind of voriconazole injection type composition according to claim 1, it is characterised in that: the benzyl alcohol storage
It should separately be stored with oxidant, edible chemical in the storehouse of shady and cool ventilation far from kindling material, heat source, never mix storage.
9. a kind of voriconazole injection type composition according to claim 1, it is characterised in that: the phosphate-buffered
The raw material of liquid is potassium dihydrogen phosphate and sodium hydroxide solution.
10. a kind of voriconazole injection type composition according to claim 1, it is characterised in that: the 5%NS's is dilute
It releases agent and is mainly used for patient's use with diabetes.
Priority Applications (1)
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CN201910303651.0A CN110090200A (en) | 2019-04-16 | 2019-04-16 | A kind of voriconazole injection type composition |
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CN201910303651.0A CN110090200A (en) | 2019-04-16 | 2019-04-16 | A kind of voriconazole injection type composition |
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CN110090200A true CN110090200A (en) | 2019-08-06 |
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CN201910303651.0A Withdrawn CN110090200A (en) | 2019-04-16 | 2019-04-16 | A kind of voriconazole injection type composition |
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Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1861044A (en) * | 2006-06-12 | 2006-11-15 | 南京都药医药科技有限公司 | Voriconazole injection and its prepn. method |
CN103690968A (en) * | 2013-11-21 | 2014-04-02 | 石药集团中奇制药技术(石家庄)有限公司 | Voriconazole composition and preparation method thereof |
-
2019
- 2019-04-16 CN CN201910303651.0A patent/CN110090200A/en not_active Withdrawn
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1861044A (en) * | 2006-06-12 | 2006-11-15 | 南京都药医药科技有限公司 | Voriconazole injection and its prepn. method |
CN103690968A (en) * | 2013-11-21 | 2014-04-02 | 石药集团中奇制药技术(石家庄)有限公司 | Voriconazole composition and preparation method thereof |
Non-Patent Citations (2)
Title |
---|
彭龙希 等: "国产仿制与原研注射用伏立康唑药品说明书对比分析", 《中国药师》 * |
未公开: ""注射用伏立康唑使用注意事项"", 《百度文库》 * |
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Application publication date: 20190806 |