Voriconazole phosphate ester for injection and preparation method thereof

A technology for voriconazole phosphate ester and injection, applied in the field of medicine, can solve problems such as renal dysfunction, loss, fracture, etc., and achieve the effects of easy operation, stable performance and good appearance

Active Publication Date: 2010-06-23
HC SYNTHETIC PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Then there are significant changes in organelles, such as mitochondrial swelling and deformation, cells at the base of the Golgi apparatus and smooth endoplasmic reticulum, and irreversible rupture of intercellular tight junctions, which directly lead to decline or even loss of renal function

Method used

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  • Voriconazole phosphate ester for injection and preparation method thereof
  • Voriconazole phosphate ester for injection and preparation method thereof
  • Voriconazole phosphate ester for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Embodiment 1: Preparation of Voriconazole Phosphate for Injection

[0020] Prescription: Voriconazole Phosphate 200g

[0021] Water for injection 2000ml

[0022]

[0023] Makes 1000 bottles

[0024] Add 1500ml of water for injection into the liquid preparation container, add voriconazole phosphate in the exact prescribed amount, stir to dissolve, slowly add sodium hydroxide, adjust the pH to 8.0, add water to the full amount, and then add 0.05%% (W / V ) of medicinal charcoal, stirred for 60 minutes, decarbonized by coarse filtration with a sand filter rod, and finely filtered with a 0.22 μm microporous membrane until the clarity is qualified; after the determination of the intermediate content is qualified, the fixed amount is packed in vials , add a half stopper, decarburize the sample by coarse filtration with a sand filter rod, and fine filter with a 0.22 μm microporous membrane until the clarity is qualified; after the determinati...

Embodiment 2

[0025] Embodiment 2: Preparation of Voriconazole Disodium Phosphate for Injection

[0026] Prescription: Voriconazole Disodium Phosphate 200g

[0027] Water for injection 2000ml

[0028]

[0029] Makes 1000 bottles

[0030] Add 1500ml of water for injection into the liquid preparation container, add voriconazole disodium phosphate disodium phosphate in the exact prescribed amount, stir to dissolve, slowly add acetic acid, adjust the pH to 8.5, add water to the full amount, and then add 0.05%% (W / V ) of medicinal charcoal, stirred for 60 minutes, decarbonized by coarse filtration with a sand filter rod, and finely filtered with a 0.22 μm microporous membrane until the clarity is qualified; after the determination of the intermediate content is qualified, the fixed amount is packed in vials , add a half stopper, decarburize the sample by coarse filtration with a sand filter rod, and fine filter with a 0.22 μm microporous membrane until the c...

Embodiment 3

[0031] Embodiment 3: Preparation of Voriconazole Phosphate for Injection

[0032] Prescription: Voriconazole Phosphate 200g

[0033] Mannitol 2g

[0034] Water for injection 2500ml

[0035]

[0036] Makes 1000 bottles

[0037] Add 2000ml of water for injection in the liquid preparation container, add voriconazole phosphate ester of accurate prescription, mannitol 2g, under stirring, slowly add sodium bicarbonate, adjust pH to be 7.8, add water to full amount, then add 0.05%% ( W / V) medicinal charcoal, stirred for 60 minutes, decarbonized by coarse filtration with a sand filter, and finely filtered with a 0.22 μm microporous membrane until the clarity was qualified; Add a half-stopper to the vial, decarburize the sample by coarse filtration with a sand filter, and fine-filter with a 0.22 μm microporous membrane until the clarity is qualified; after the determination of the intermediate content is qualified, set the amount and divide ...

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Abstract

The invention provides voriconazole phosphate ester for injection and a medicinal salt thereof and a preparation method for the voriconazole phosphate ester for injection and the medicinal salt thereof. The preparation method comprises the following steps: adding 5 to 98 percent water for injection in a liquid preparation container; adding 90 to 110 percent of the accurate formula dosage of voriconazole phosphate ester and the medicinal salt thereof in the container; stirring the mixture; slowly dropwise adding a pH value regulator; regulating pH to between 6.0 and 11; supplementing water to the full dosage and then adding 0.01 to 1.0 percent (weight in volume) medicinal carbon into the product; stirring the mixture for 15 to 60 minutes; using a sand filter stick to carry out rough filtration and decarburization on the obtained product, and using a 0.22mum millipore filter to carry out fine filtration on the product until the clarity is qualified; after determining that the content of the midbody is qualified, determining the filling quantity and subpackaging the finished product in the vial; adding the semi-plug; carrying out freezing and drying on the sample; controlling the moisture content between 1 and 8 percent; pressing the plug; and carrying out capping.

Description

Technical field: [0001] The invention belongs to the technical field of medicine, and relates to voriconazole phosphate for injection or a medicinal salt thereof and a preparation method thereof. technical background: [0002] Voriconazole is a broad-spectrum triazole antifungal drug indicated for the following: treatment of invasive aspergillosis. Treatment of severe invasive infections caused by fluconazole-resistant Candida species (including Candida krusei). Treatment of serious infections caused by Actinomycetes and Fusarium species. This product should be used primarily for the treatment of progressive, potentially life-threatening infections in immunocompromised patients. The prodrug of voriconazole phosphate voriconazole can be rapidly hydrolyzed into voriconazole in the body to take effect. Since voriconazole has very little water solubility, the method of encapsulating voriconazole with hydroxypropyl β-cyclodextrin is used to solubilize voriconazole for injectio...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/506A61K47/02A61K47/12A61K47/18A61P31/10
Inventor 杨成
Owner HC SYNTHETIC PHARMA CO LTD
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