A kind of itraconazole drops and preparation method thereof

An itraconazole drop and the technology of itraconazole, applied in the field of itraconazole drop and its preparation, can solve the problems of significant individual differences in bioavailability and immature physiological functions of the gastrointestinal tract of infants and young children, etc.

Active Publication Date: 2021-08-31
HAINAN HONZ PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the above preparations all form a supersaturated solution of itraconazole through the pH transition of the human stomach and intestines to improve its bioavailability. The oral absorption of itraconazole is greatly affected by the environment in the stomach. The physiological function is not yet fully mature, and the individual differences in bioavailability are significant

Method used

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  • A kind of itraconazole drops and preparation method thereof
  • A kind of itraconazole drops and preparation method thereof
  • A kind of itraconazole drops and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] Material composition Prescription ratio (g) Itraconazole 3 Vitamin E Acetate 80 Vitamin A1 5 PEG400 10

[0015] Preparation method: 1) Itraconazole is crushed through a 150-mesh sieve, and fully mixed with PEG400; 2) Vitamin E acetate and vitamin A1 are fully mixed; 3) The mixture of step 1) is slowly added to the mixture of step 2), Add while stirring on high speed until fully combined and dissolved. 4) Subpackaged as itraconazole 100mg / bottle.

Embodiment 2

[0017] prescription:

[0018]

[0019]

[0020] Preparation method: 1) Itraconazole is pulverized through a 100-mesh sieve, and fully mixed with PEG400; 2) Vitamin E acetate, vitamin A1 and butylated hydroxyanisole are fully mixed; 3) The mixture in step 1) is slowly added to step 2 ) mixture, add while stirring at high speed until completely mixed and dissolved. 4) Subpackaged as itraconazole 100mg / bottle.

Embodiment 3

[0022] Material composition Prescription ratio (g) Itraconazole 1 Vitamin E Acetate 90 Vitamin A1 9 PEG400 20 Propylparaben 1 2,6-di-tert-butyl-p-cresol 1

[0023] Preparation method: 1) under a nitrogen-filled environment, itraconazole is pulverized through a 100-mesh sieve, and fully mixed with PEG400; 2) under a nitrogen-filled environment, vitamin E acetate, vitamin A1 and preservatives are fully mixed evenly; 3) filled with Under nitrogen environment, slowly add the mixture of step 1) into the mixture of step 2), and stir at high speed while adding, until completely mixed and dissolved. 4) Subpackaged as itraconazole 100mg / bottle.

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PUM

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Abstract

The invention discloses an itraconazole drop and a preparation method thereof, comprising the following components: 1-3 parts by weight of itraconazole, 80-120 parts by weight of vitamin E acetate, 5-15 parts by weight of vitamin A1, 10-30 parts by weight of PEG400. In the itraconazole drops disclosed in the invention, the itraconazole is in a dissolved state and has good stability, and can be directly absorbed without a dissolution step in the gastrointestinal tract, which is beneficial to improve bioavailability. In addition, the preparation process is simple, the auxiliary materials are high in safety, can be administered with milk or added to milk for administration, and is especially suitable for the treatment of infantile hemangioma.

Description

technical field [0001] The invention relates to an itraconazole drop and a preparation method thereof. Background technique [0002] Itraconazole is a triazole broad-spectrum antifungal drug, itraconazole can inhibit fungal cytochrome p450. Cytochrome p450 can catalyze the demethylation of lanosterol at the 14th position to ergosterol, and itraconazole inhibits sterol 14α-demethylase, leading to the accumulation of 14α-methylated sterol, which induces changes in cell membrane permeability, It can cause extravasation of fungal cell content and structural damage, and then cause fungal cell death. Itraconazole has been on the market for more than 20 years and is widely used in the treatment of fungal diseases in infants and young children, including tinea capitis, sporotrichosis, candidiasis, and aspergillosis. Mycosis, histoplasmosis, zygomycosis and other opportunistic fungal infections, etc., and itraconazole can effectively inhibit the proliferation and migration of hemang...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/496A61K47/22A61K47/10A61P35/00A61P31/10
CPCA61K9/0056A61K9/08A61K31/496A61K47/10A61K47/22
Inventor 王稳奇洪丽萍
Owner HAINAN HONZ PHARMA
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