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Voriconazole injection and its preparing method

A voriconazole injection, voriconazole technology, applied in the direction of antifungal agent, aerosol delivery, emulsion delivery, etc., to achieve the effect of improving drug content and stability, reducing toxic and side effects, and facilitating clinical administration

Inactive Publication Date: 2006-08-09
南京都药医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The voriconazole powder injection developed by Pfizer uses sulfobutyl ether β-cyclodextrin as the solubilizer, and the ratio is 200mg of voriconazole with 3200mg sulfobutyl ether β-cyclodextrin for clathrate, but the prescription has been applied for in China Patent, the patent publication number is CN1261287A, and it cannot be used directly as an injection
At present, there is no report about voriconazole injection in the market

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Example 1: In this example, 1000 voriconazole injections (specification 5ml: 50mg) were prepared using the following components.

[0024] Material name Feed amount

[0025] Voriconazole 50g

[0026] Hydroxypropyl-β-cyclodextrin 650g

[0027] Ethanol 150ml

[0028] Water for injection up to 5000ml

[0029] Made 1000 pieces

[0030] Preparation method: put hydroxypropyl-β-cyclodextrin in water for injection to dissolve into a transparent solution, dissolve voriconazole in ethanol, add voriconazole ethanol solution to hydroxypropyl-β-cyclodextrin solution, stir Or ultrasound to obtain voriconazole inclusion solution, then add other auxiliary materials to the inclusion solution, adjust the pH value to 6.0, add 1% activated carbon to warm and adsorb for 15 minutes, decarbonize, and sterilize after precision to obtain voriconazole injection.

Embodiment 2

[0031] Example 2: In this example, 1000 voriconazole injections (specification 10ml: 100mg) were prepared using the following components.

[0032] Material name Feed amount

[0033] Voriconazole 100g

[0034] Hydrochloric acid 5ml

[0035] Hydroxypropyl-β-cyclodextrin 1300g

[0036] Appropriate amount of sodium hydroxide

[0037] Water for injection up to 10000ml

[0038] Made 1000 pieces

[0039] Preparation method: put hydroxypropyl-β-cyclodextrin in water for injection to dissolve into a transparent solution, then add voriconazole, add hydrochloric acid, stir at high speed or sonicate to obtain voriconazole inclusion solution, and then add For other excipients, adjust the pH value to 6.0, add 1% activated carbon to warm and adsorb for 15 minutes, decarbonize, and sterilize after precision to obtain voriconazole injection.

Embodiment 3

[0040] Example 3: In this example, 1000 voriconazole injections (specification 2ml: 50mg) were prepared, using the following components.

[0041] Material name Feed amount

[0042] Voriconazole 50g

[0043] Ethanol 500ml

[0044] Hydroxypropyl-β-cyclodextrin 450g

[0045] Water for injection up to 2000ml

[0046] Made 1000 pieces

[0047] Voriconazole injection was made according to the method of Example 1.

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PUM

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Abstract

The present invention relates to a fuliconazole injection. Said injection includes the following components; (by wt%) fuliconazole 0.01-20%, cyclodextrin or cyclodextrin derivative 0%-60%, water-soluble excipient 0-75%, solubilizer 0%-20% and the rest is injection water. Its preparation method includes the following steps: mixing the above-mentioned raw materials, using active carbon to remove impurity and heat source, filtering, fine filtering, filling, sterilizing, checking and putting in storage.

Description

technical field [0001] The invention relates to a traditional Chinese medicine and a preparation method thereof. More precisely, the invention relates to a voriconazole injection and a preparation method thereof, belonging to the technical field of preparation of traditional Chinese medicine. Background technique [0002] Fungal infection is a common and frequently-occurring disease, which can be divided into three categories in the human body: superficial, subcutaneous and systemic infection, and the most serious life-threatening fungal infection is systemic infection, and immunocompromised patients are likely to Systemic infection caused by commensal and widespread fungi, mainly Candida and Aspergillus species. Fungal infections in immunocompromised patients are associated with high morbidity and mortality, requiring prompt and aggressive treatment. Voriconazole is a new type of second-generation triazole antifungal drug. It is a new triazole antifungal drug studied to fu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/506A61K9/06A61P31/10
Inventor 张广明庄红艳
Owner 南京都药医药科技有限公司
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