Itraconazole injection and its preparation method

An itraconazole injection and a technology of itraconazole, which are applied in the field of itraconazole injection and its preparation, can solve problems such as poor solubility, reduce toxic and side effects, improve content and stability, and facilitate clinical administration. Effect

Inactive Publication Date: 2005-03-23
范敏华
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to its poor solubility, there is no report of itraconazole injection in the market

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Example 1: This example prepares 100 itraconazole injections (specification: 10mg / ml, 25ml / bottle), using the following ingredients:

[0026] Material name Feed amount

[0027] Itraconazole 25g

[0028] Hydroxypropyl-β-cyclodextrin 1000g

[0029] Hydrochloric acid 95ml

[0030] Macrogol 400 62.5ml

[0031] Appropriate amount of sodium hydroxide

[0032] Water for injection up to 2500ml

[0033] Makes 100

[0034] Process steps: Take hydroxypropyl-β-cyclodextrin and put it in water for injection. After dissolving, add itraconazole, stir and sonicate to obtain itraconazole inclusion compound solution, and then add itraconazole to the inclusion compound solution Add other auxiliary materials, adjust the pH of the solution to about 4.5, filter and sterilize to obtain itraconazole injection.

Embodiment 2

[0035] Example 2: In this example, 100 itraconazole powders for injection (specification: 250mg / bottle) were prepared, and the following ingredients were used:

[0036] Material name Feed amount

[0037] Itraconazole 25g

[0038] Hydroxypropyl-β-cyclodextrin 1200g

[0039] Hydrochloric acid 100ml

[0040] Macrogol 400 95ml

[0041] Appropriate amount of sodium hydroxide

[0042] Water for injection up to 2500ml

[0043] Makes 100

[0044] Process steps: Take hydroxypropyl-β-cyclodextrin and put it in water for injection. After dissolving, add itraconazole, stir and sonicate to obtain itraconazole inclusion compound solution, and then add itraconazole to the inclusion compound solution Add other auxiliary materials, adjust the pH of the solution to about 4.5, filter and sterilize, and freeze-dry to obtain the itraconazole powder for injection.

Embodiment 3

[0045] Example 3: In this example, 100 itraconazole powders for injection (specification: 250mg / bottle) were prepared, using the following ingredients:

[0046] Material name Feed amount

[0047]Itraconazole 25g

[0048] Hydroxypropyl-β-cyclodextrin 1200g

[0049] Hydrochloric acid 100ml

[0050] Macrogol 400 95ml

[0051] Mannitol 100g

[0052] Appropriate amount of sodium hydroxide

[0053] Water for injection up to 2500ml

[0054] Makes 100

[0055] Process steps: Take hydroxypropyl-β-cyclodextrin and put it in water for injection. After dissolving, add itraconazole, stir and sonicate to obtain itraconazole inclusion compound solution, and then add itraconazole to the inclusion compound solution Add other auxiliary materials, adjust the pH of the solution to about 4.5, filter and sterilize, and freeze-dry to obtain the itraconazole powder for injection.

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PUM

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Abstract

An injection of itraconzole is prepared from itraconazole, the medical auxiliary composed of cyclodextrin or its derivative, and water-soluble excipient, and water.

Description

technical field [0001] The invention relates to a dosage form of medicine, in particular to an itraconazole injection and a preparation method thereof. Background technique [0002] Fungi are a large class of lower organisms in nature. It is now known that many fungi have pathogenic effects. The clinically common tinea pedis, tinea corporis, jock itch, tinea manuum, and tinea capitis are all caused by molds (a type of fungus). [0003] According to the prevailing standards in the international medical community, fungi can be roughly divided into three categories, namely superficial mycosis, skin mycosis and systemic mycosis. Superficial mycoses refer to fungal infections of cutin (nails, toenails, hair, etc.), and the skin and mucous membranes are very susceptible to "Candida" fungal infections. The above two types of fungal diseases are the most common, but not fatal. The most serious fungal disease is systemic fungal infection, which has a strong...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/496A61P17/00A61P31/10
Inventor 范敏华
Owner 范敏华
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