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Itraconazole soft capsule, and its prepn. method

An itraconazole and capsule technology, which is applied in the field of itraconazole soft capsules and its preparation, can solve the problems of inconvenient administration, slow dissolution of active ingredients, and inability to take effect in time, and achieves convenient administration and high quality Stable and timely effect

Inactive Publication Date: 2005-01-05
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] "Itraconazole Injection", "Itraconazole Tablets" and "Itraconazole Capsules" with itraconazole as the main active ingredient have been approved by the health administrative department for production, but the injections are carried and administered. Inconvenient; tablets and capsules have defects such as slow dissolution of active ingredients and inability to take effect in time

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Component Quantity (g / granule)

[0027] Itraconazole 0.1

[0028] Peanut oil 0.1

[0029] Gelatin 0.08

[0030] Glycerin 0.02

[0031] Ethyl p-hydroxybenzoate 0.00005

Embodiment 2

[0033] Component Quantity (g / granule)

[0034] Itraconazole 0.2

[0035] Polyethylene glycol 0.2

[0036] Gelatin 0.08

[0037] Glycerin 0.02

[0038] Butyl p-hydroxybenzoate 0.00005

Embodiment 3

[0040] Component Quantity (g / granule)

[0041] Itraconazole 0.1

[0042] soybean oil 0.2

[0043] Propylene glycol 0.1

[0044] Gelatin 0.08

[0045] Glycerin 0.04

[0046] Beeswax 0.006

[0047] Ascorbic acid 0.0008

[0048] Propyl p-hydroxybenzoate 0.0005

[0049] The preparation technology of above embodiment itraconazole soft capsule is:

[0050] Weigh gelatin and add it to the reaction tank, add appropriate amount of water while stirring, seal it tightly, add glycerin and appropriate amount of preservative after the gelatin is completely dissolved, stir evenly, vacuumize and degas for 2 hours, put it into a gelatin insulation bucket, and keep warm Let stand overnight and set aside.

[0051] Add the suspending agent to the diluent at room temperature, weigh itraconazole, pulverize, sieve, mix with the diluent, and then add the antioxidant after completely mixing, stir evenly, and stand at room temperature.

[0052] Hang the gelatin insulated bucket to a certain he...

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PUM

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Abstract

A softcapsule of itracnoazole is prepared through dissolving gelatin in water, adding glycerineand antiseptic, vacuum degrassing, adding the suspending aid to vegetable oil, mixing with itraconazole, adding antioxidizing agent, and die pressing.

Description

Technical field: [0001] The invention relates to the technical field of medicine, in particular it is an itraconazole soft capsule and a preparation method thereof. Background technique: [0002] Itraconazole is a triazole oral antifungal drug. Its antibacterial spectrum is similar to that of ketoconazole. It has antibacterial effects on both deep fungi and superficial fungi. Its mechanism of action is highly selective for fungal cytochrome P-450 , to inactivate cytochrome P-450-dependent enzymes, resulting in the accumulation of 14 sterols, inhibiting the synthesis of ergosterol, thereby inhibiting and killing fungi. This product is more effective than ketoconazole at low concentrations, and it is also effective against some fungal infections (such as Aspergillus and Brachymycetes), but ketoconazole is ineffective against molds. This product is well absorbed after oral administration, reaching the peak plasma concentration within 1.5-4 hours after taking the drug, and reac...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/495A61P31/10
Inventor 王淑君
Owner SHENYANG PHARMA UNIVERSITY
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