CN107982221A - Injection sulfuric acid Chinese mugwort Saperconazole freeze drying powder injection and preparation method - Google Patents
Injection sulfuric acid Chinese mugwort Saperconazole freeze drying powder injection and preparation method Download PDFInfo
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- CN107982221A CN107982221A CN201610952806.XA CN201610952806A CN107982221A CN 107982221 A CN107982221 A CN 107982221A CN 201610952806 A CN201610952806 A CN 201610952806A CN 107982221 A CN107982221 A CN 107982221A
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- sulfuric acid
- chinese mugwort
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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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- 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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
- A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
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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
- A61K47/02—Inorganic compounds
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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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Abstract
The present invention provides a kind of injection sulfuric acid Chinese mugwort Saperconazole freeze drying powder injection and preparation method.Powder-injection active ingredient containing treatment Chinese mugwort Saperconazole sulfate, excipient and pH adjusting agent dilute sulfuric acid.Injection sulfuric acid Chinese mugwort Saperconazole freeze drying powder injection produced by the present invention, redissolution is quick, complete, stability is good, easy to store and transport, enriches application of the Chinese mugwort Saperconazole sulfate in formulation art.
Description
Technical field
Antimycotic freeze drying powder injection the present invention relates to a kind of sulfuric acid Chinese mugwort Saperconazole and preparation method thereof, belongs to medicine system
Agent field.
Background technology
The Chinese chemical name of sulfuric acid Chinese mugwort Saperconazole：
Glycine, N- methyl-[2- [[[1- [1- [(2R, 3R) -3- [4- (4- cyano-phenyls) -2- thiazolyls] -2- (2,5-
Difluorophenyl) -2- hydroxyls butyl] -4H-1, the interior -4- bases of 2,4- triazoles] ethyoxyl] carbonyl] methylamino] -3- pyridine radicals] methyl esters,
Sulfate；
English language Chemical title：
Glycine,N-methyl-,[2-[[[1-[1-[(2R,3R)-3-[4-(4-cyanophenyl)-2-
thiazolyl]-2-(2,5-difluorophenyl)-2-hydroxybutyl]-4H-1,2,4-triazolium-4-yl]
ethoxy]carbonyl]methylamino]-3-pyridinyl]methylester,sulfate；
Molecular weight:814.853；
CAS registration numbers:946075-13-4
Molecular formula：C35H36F2N8O5S·SO4
Structural formula：
Sulfuric acid Chinese mugwort Saperconazole (isavuconazonium sulfate) be by Ba Sai Leahs pharmaceutcal corporation, Ltd of Switzerland and
What Japanese Astellas (Astellas) company researched and developed jointly is used to treat adult's invasive aspergillosis and aggressive mucor
The new drug of disease, U.S. FDA approval listing is obtained on March 6th, 2015, trade name Cresemba, this time the formulation of approval is mouth
Formulation and intravenous injection.On October 15th, 2015, EU Committee authorizes sulfuric acid Chinese mugwort Saperconazole listing license, for controlling
The adult patients for suffering from invasive aspergillosis are treated, and for treating the adult patients of the unsuitable mucormycosis of amphotericin B.
Sulfuric acid Chinese mugwort Saperconazole belongs to antifungal drug in triazole class, is the water-soluble prodrug form of Chinese mugwort Saperconazole, and vein is noted
After penetrating or being administered orally, Chinese mugwort Saperconazole (Isavuconazole) can be quickly and completely converted under the action of esterase.Ai Shakang
Azoles can inhibit the demethylation of 14 α-sterol of fungal cytochrome P450 mediations, so as to suppress fungal cell membrane ergosterol
Biosynthesis so that ergosterol lack, and toxicity intermediate product lanosterol accumulate, cause permeability of cell membrane enhancing and
Growth inhibition, and then play antifungic action.Compared with other antifungal drugs, he has following advantage：
(1) medicine good water solubility, does not contain cyclodextrin, no potential nephrotoxic risks of auxiliary material in intravenous formulations.
(2) bioavilability is high, has the excellent pharmacokinetic characteristics for the treatment of system fungi medicine：Clearance rate
Low, long half time, volume of distribution are big；Drug interaction is less.
(3) In vitro Bactericidal Experiments show work of the Saperconazole to saccharomycete such as candida albicans, Aspergillus, mucor, cryptococcus that ends
Property be better than or be not inferior to other most of antifungals.
Formulation patent CN101784259 discloses a kind of combination of oral medication, itself and water phase, particularly gastro-intestinal Fluid contact
When self-emulsifying, include Isavuconazole and solubilizer, HLB value be less than 20 carrier；It is protected to be used to treat whole body at the same time
The purposes of property nosomycosis (disseminated aspergillosis or candidiasis).The liquid preparation administering mode is oral, is being difficult to what is swallowed
Application on patient with severe symptoms is restricted, in addition, the composition of self-emulsifying microemulsion system is complicated, process for preparation is cumbersome, in the market
It by successful formulation is self-emulsifying microemulsion system that medicine, which has only a few, and said composition contains surfactant, and there are potential kidney
Risk of toxicity.
So how to enrich the application form of Chinese mugwort Saperconazole, a kind of suitable injection of acquisition, content is high, stability is good, just
In the sulfuric acid of transport and storage Chinese mugwort Saperconazole dosage form, become assistant officer's technical problem to be solved.
The content of the invention：
In view of the above problems, the freeze drying powder injection the present invention provides a kind of injection sulfuric acid Chinese mugwort Saperconazole and its preparation
Method.
A kind of freeze drying powder injection containing sulfuric acid Chinese mugwort Saperconazole provided by the invention, it is characterised in that effective containing treatment
The sulfuric acid Chinese mugwort Saperconazole of amount, excipient and pH adjusting agent.
The mass ratio of the sulfuric acid Chinese mugwort Saperconazole and excipient is 1:2~5:1, preferably 4:1~5:1.
The excipient is one or more mixtures such as mannitol, lactose, sodium chloride, sorbierite, preferably mannitol.
One or more of the pH adjusting agent in sulfuric acid, hydrochloric acid, phosphoric acid, sodium hydroxide, preferably sulfuric acid.
The freeze drying powder injection preparation method of the sulfuric acid Chinese mugwort Saperconazole is as follows：
1) with 50~90% water for injection excipient dissolving, be all cooled to 0~15 DEG C after dissolving, insulation；
2) sulfuric acid Chinese mugwort Saperconazole is added into solution step 1) described, stirring and dissolving, sulphur acid for adjusting pH, adds water for injection
Constant volume, the concentration for making sulfuric acid Chinese mugwort Saperconazole is 60~190mg/ml, is sterile filtered, packing；
3) after half pressure is jumped a queue, -40 DEG C are cooled to, 1~6h is kept the temperature, is warming up to -20 DEG C~0 DEG C 3~8h of lyophilization, then rise
Temperature then is cooled to 5-10 DEG C to 20~40 DEG C, parsing-desiccation 8h~20h, keeps the temperature tamponade after 0.5~3h, offers for sale.
PH value after sulfuric acid is adjusted in above-mentioned preparation method step 2) is 1.0~3.0.
Further, the pH value after sulfuric acid is adjusted in the preparation method is 1.2~1.8.
Lyophilization temperature is -15~0 DEG C in above-mentioned preparation method step 3).
The concentration of sulfuric acid Chinese mugwort Saperconazole is 100~150mg/ml in above-mentioned preparation method step 3).
Further, the packing volume of sulfuric acid Chinese mugwort Saperconazole injection is 2~6ml in the preparation method.
Further, the packing volume of sulfuric acid Chinese mugwort Saperconazole injection is 3~4ml in the preparation method.
The sulfuric acid Chinese mugwort Saperconazole freeze drying powder injection that more than prepared by proportioning and method, can be administered by venous transfusion,
When the venoclysis time is small no less than 1 after 250ml diluent compatibilities.It is sure not as disposable vein inject administration.Dispenser scope
For intravenously administrable 1mg to 30mg per kg body weight per day per kg body weight per day, preferably intravenously administrable 5mg per kg body weight per day
To 30mg per kg body weight per day, each accurate dosage is according to the fungi of patient age, gender and symptomatic condition and diagnosis
Gradient of infection it is different and different.
The sulfuric acid Chinese mugwort Saperconazole freeze drying powder injection that the present invention obtains, products obtained therefrom appearance is plentiful, fine and smooth, quality is loose,
Dissolved rapidly after adding water and recover the original characteristic of liquid；And there is freeze drying powder injection performance to stablize in itself, transport and storage
The characteristic such as convenient；Clinically, the effect of being used in the form of venoclysis, not only having improved medicine, but also expand the model of formulation
Enclose, meet the needs for the treatment of.The present invention provides a kind of suitable preparation method and work for injection sulfuric acid Chinese mugwort Saperconazole father-in-law
Skill, has filled up related blank；Solves the problems, such as the administration of patient with severe symptoms.
Embodiment：
Below by way of embodiment, the present invention will be described, according to ordinary skill knowledge and customary means
Various replacements or combination are made, should all be included within the scope of the invention.
Prepared by 1~7 injection sulfuric acid of embodiment Chinese mugwort Saperconazole freeze-dried powder, each each 10 bottles of embodiment.
Prescription：
1. embodiment of table, 1~7 prescription
Preparation method：Preparation method：Take 50%-90% water for injection excipient dissolving (mannitol, lactose, sodium chloride,
One or more in sorbierite), temperature is all reduced after dissolving to 0-15 DEG C, adds sulfuric acid Chinese mugwort Saperconazole, stirring and dissolving
After settled solution, sulfuric acid tune pH to 1.0-3.0, adds water for injection constant volume, is then sterile filtered, dispenses.It is cold after half pressure is jumped a queue
But -40 DEG C are arrived, after keeping the temperature 3h, is warming up to -20 DEG C~0 DEG C lyophilization 5h, then is warming up to 20~40 DEG C, parsing-desiccation 8~
20h, then be cooled to 5-10 DEG C, keeps the temperature tamponade after 0.5~3h, offers for sale, freeze and terminate.
2. embodiment 1~7 of table investigates result
Prepared by 8~10 injection sulfuric acid of embodiment Chinese mugwort Saperconazole freeze-dried powder, each each 10 bottles of embodiment
Prescription：
3. embodiment of table, 8~9 prescription
| Project | Embodiment 8 | Embodiment 9 | Embodiment 10 |
| Sulfuric acid Chinese mugwort Saperconazole/g | 4 | 4 | 4 |
| Mannitol/g | 0.8 | 1 | 1 |
| The concentrated sulfuric acid | / | / | / |
| Water for injection/ml | 30 | 40 | 30 |
| Amount of preparation | 10 bottles | 10 bottles | 10 bottles |
Preparation method：Preparation method：Take water for injection excipient dissolving (mannitol, lactose, sodium chloride, the mountain of 50-90%
One or more in pears alcohol), after all dissolving, temperature is reduced to 0-15 DEG C, adds sulfuric acid Chinese mugwort Saperconazole, stirring and dissolving
After settled solution, sulfuric acid tune pH to 1.2-1.8, adds water for injection constant volume, is then sterile filtered, dispenses.It is cold after half pressure is jumped a queue
But -40 DEG C are arrived, after keeping the temperature 3h, is warming up to -15 DEG C~0 DEG C lyophilization 5h, then is warming up to 20~40 DEG C, parsing-desiccation 8~
20h, then be cooled to 5-10 DEG C, keeps the temperature tamponade after 1h, offers for sale, freeze and terminate.
4. embodiment 8~10 of table investigates result
| Embodiment 8 | Embodiment 9 | Embodiment 10 | |
| Appearance | Off-white color is to light yellow | Off-white color is to light yellow | Off-white color is to light yellow |
| Character | It is plentiful, quality is loose | It is plentiful, quality is loose | It is plentiful, quality is loose |
| Redissolve | Redissolve fast, complete | Redissolve fast, complete | Redissolve fast, complete |
Prepared by 11 injection sulfuric acid of embodiment Chinese mugwort Saperconazole freeze-dried powder, totally 100 bottles
Prescription：
5. embodiment of table, 11 prescription
| Project | Embodiment 11 |
| Sulfuric acid Chinese mugwort Saperconazole/g | 40 |
| Mannitol/g | 10 |
| The concentrated sulfuric acid | / |
| Water for injection/ml | 300 |
| Amount of preparation | 100 bottles |
Preparation method：Preparation method：Take water for injection excipient dissolving (mannitol, lactose, sodium chloride, the mountain of 50-90%
One or more in pears alcohol), after all dissolving, temperature is reduced to 0-15 DEG C, adds sulfuric acid Chinese mugwort Saperconazole, stirring and dissolving
After settled solution, sulfuric acid tune pH to 1.5, adds water for injection constant volume, is then sterile filtered, dispenses.After half pressure is jumped a queue, cooling
To -40 DEG C, after keeping the temperature 3h, -15 DEG C~0 DEG C lyophilization 5h is warming up to, then is warming up to 20~40 DEG C, 8~20h of parsing-desiccation,
It is cooled to 5-10 DEG C again, keeps the temperature tamponade after 1h, offers for sale, freeze and terminate.
6. embodiment 11 of table investigates result
Prepared by 12 injection sulfuric acid of embodiment Chinese mugwort Saperconazole freeze-dried powder, totally 1000 bottles
Prescription：
7. embodiment of table, 12 prescription
| Project | Embodiment 12 |
| Sulfuric acid Chinese mugwort Saperconazole/g | 400 |
| Mannitol/g | 100 |
| The concentrated sulfuric acid | / |
| Water for injection/ml | 3000 |
| Amount of preparation | 1000 bottles |
Preparation method：Preparation method：Take water for injection excipient dissolving (mannitol, lactose, sodium chloride, the mountain of 50-90%
One or more in pears alcohol), after all dissolving, temperature is reduced to 0-15 DEG C, adds sulfuric acid Chinese mugwort Saperconazole, stirring and dissolving
After settled solution, sulfuric acid tune pH to 1.5, adds water for injection constant volume, is then sterile filtered, dispenses.After half pressure is jumped a queue, cooling
To -40 DEG C, after keeping the temperature 3h, -15 DEG C~0 DEG C lyophilization 5h is warming up to, then is warming up to 20~40 DEG C, 8~20h of parsing-desiccation,
It is cooled to 5-10 DEG C again, keeps the temperature tamponade after 1h, offers for sale, freeze and terminate.
8. embodiment 12 of table investigates result
Experiment shows above, and using above-mentioned lyophilized prescription and preparation process, the injection sulfuric acid Chinese mugwort Saperconazole of preparation freezes
Dry powder pin, is kept in dark place under the conditions of 8 DEG C, and character stable quality, can meet Clinical practice demand completely.
Embodiment above describes basic principle, main feature and the advantages of the present invention of the present invention.The technology of the industry
For personnel it should be appreciated that the present invention is not limited to the above embodiments, the description in above embodiments and description is only used as this hair
Bright preference, is not intended to limit the present invention, and under the premise of the spirit and scope of the present invention are not departed from, the present invention also has each
Kind changes and improvements, these changes and improvements are both fallen within the range of claimed invention.The claimed scope of the invention is
Attached claims and its equivalent thereof.
Claims (10)
1. a kind of freeze drying powder injection containing sulfuric acid Chinese mugwort Saperconazole, it is characterised in that contain treatment active ingredient sulfuric acid Ai Shakang
Azoles, excipient and pH adjusting agent, wherein the one kind or more of the excipient in mannitol, lactose, sodium chloride, sorbierite
Kind, the mass ratio of sulfuric acid Chinese mugwort Saperconazole and excipient is 1:2~5:1.
2. freeze drying powder injection according to claim 1, it is characterised in that the pH adjusting agent be selected from sulfuric acid, hydrochloric acid, phosphoric acid,
One or more in sodium hydroxide.
3. freeze drying powder injection according to claim 2, it is characterised in that the pH adjusting agent is sulfuric acid.
4. freeze drying powder injection according to claim 1, it is characterised in that the excipient is mannitol.
5. freeze drying powder injection according to claim 1, it is characterised in that the mass ratio of sulfuric acid Chinese mugwort Saperconazole and excipient
For 4:1~5:1.
6. the preparation method of the freeze drying powder injection described in a kind of claim 1, it is characterised in that comprise the steps of：
1) with 50~90% water for injection excipient dissolving, be all cooled to 0~15 DEG C after dissolving, insulation；
2) sulfuric acid Chinese mugwort Saperconazole is added into solution step 1) described, stirring and dissolving, sulphur acid for adjusting pH, adds water for injection to determine
Hold, the concentration for making sulfuric acid Chinese mugwort Saperconazole is 60~190mg/ml, is sterile filtered, packing；
3) after half pressure is jumped a queue, -40 DEG C are cooled to, 1~6h is kept the temperature, is warming up to -20 DEG C~0 DEG C 3~8h of lyophilization, then be warming up to
20~40 DEG C, parsing-desiccation 8h~20h, then be cooled to 5-10 DEG C, keep the temperature tamponade after 0.5~3h, offer for sale.
7. preparation method according to claim 4, it is characterised in that the step 2) sulfuric acid adjust after pH value for 1.0~
3.0。
8. preparation method according to claim 4, it is characterised in that the step 2) sulfuric acid adjust after pH value for 1.2~
1.8。
9. preparation method according to claim 4, it is characterised in that the concentration of step 2) sulfuric acid Chinese mugwort Saperconazole is
100~150mg/ml.
10. preparation method according to claim 4, it is characterised in that step 3) the lyophilization temperature is -15~0
℃。
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| CN201610952806.XA CN107982221A (en) | 2016-10-27 | 2016-10-27 | Injection sulfuric acid Chinese mugwort Saperconazole freeze drying powder injection and preparation method |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115300467A (en) * | 2022-08-26 | 2022-11-08 | 开封明仁药业有限公司 | Isaconazole sulfate freeze-dried powder injection for injection and preparation process thereof |
| CN115501781A (en) * | 2022-09-19 | 2022-12-23 | 成都晶富医药科技有限公司 | Liquid preparation device and method of isavuconazole sulfate for injection |
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| CN102225063A (en) * | 2011-05-10 | 2011-10-26 | 江苏奥赛康药业有限公司 | Pantoprazole sodium composition for injection |
| WO2016055918A1 (en) * | 2014-10-08 | 2016-04-14 | Wockhardt Limited | Novel stable polymorphs of isavuconazole or its salt thereof |
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2016
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102225063A (en) * | 2011-05-10 | 2011-10-26 | 江苏奥赛康药业有限公司 | Pantoprazole sodium composition for injection |
| WO2016055918A1 (en) * | 2014-10-08 | 2016-04-14 | Wockhardt Limited | Novel stable polymorphs of isavuconazole or its salt thereof |
Non-Patent Citations (3)
| Title |
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| DRUG@DFA: "CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 207500Orig1s000 / 207501Orig1s000 LABELING", 《CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 207500ORIG1S000 / 207501ORIG1S000 LABELING"，WWW.ACCESSDATA.FDA.GOV/DRUGSATFDA_DOCS/NDA/2015/207500ORIG1207501ORIG1S000LBL.PDF》 * |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115300467A (en) * | 2022-08-26 | 2022-11-08 | 开封明仁药业有限公司 | Isaconazole sulfate freeze-dried powder injection for injection and preparation process thereof |
| CN115501781A (en) * | 2022-09-19 | 2022-12-23 | 成都晶富医药科技有限公司 | Liquid preparation device and method of isavuconazole sulfate for injection |
| CN115501781B (en) * | 2022-09-19 | 2024-04-30 | 成都晶富医药科技有限公司 | Liquid preparation device and method of isaconazole sulfate for injection |
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Application publication date: 20180504 |