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Posaconazole oral suspension and preparation method thereof

A posaconazole and suspension technology, applied in the field of medicine, can solve the problems of high production equipment cost, high equipment requirements, complex production process, etc., and achieve the effect of reducing production equipment cost, reducing production cost, and simple production process

Active Publication Date: 2015-11-11
JUMPCAN PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Triazole antifungal drugs have stronger antibacterial activity and lower toxicity than amphotericin B and flucytosine, so they are widely used in clinical practice, but the first generation triazole drugs have narrow antibacterial spectrum, low bioavailability and limited Problems such as drug interaction and drug resistance can no longer meet the urgent clinical needs
Its production process is complex and requires other crushing methods for pretreatment
Low-pressure processing requires high equipment and high production equipment costs

Method used

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  • Posaconazole oral suspension and preparation method thereof
  • Posaconazole oral suspension and preparation method thereof
  • Posaconazole oral suspension and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] prescription

[0038]

[0039] Preparation:

[0040] (1) Weigh posaconazole raw materials, polysorbate-80, simethicone, sodium benzoate, citric acid, sodium citrate, glycerin, xanthan gum, maltose syrup, titanium dioxide, flavor according to the batch production order , Strictly implement one-person weighing and one-person review, and fill in the weighing and review records at the same time.

[0041] (2) Add 30% of the prepared purified water and polysorbate-80 into the batching tank, stir and dissolve, add the prescribed amount of posaconazole, continue to stir until the dispersion is uniform, then continue to add simethicone, and disperse evenly, spare.

[0042] (3) The uniformly dispersed drug solution above is processed by a homogenizer (pressure 30-60MPa) until the particle size of the raw material: the number of particles smaller than 3 μm ≥ 65%, the number of particles smaller than 10 μm ≥ 99%, the median value [d( 0.5)] between 1.5 and 1.85 μm, after homo...

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Abstract

The invention belongs to a technical field of medicine, and particularly relates to a posaconazole oral suspension and a preparation method thereof. 100 ml of the posaconazole oral suspension comprises the following ingredients by weight: 4 parts of posaconazole, 1 part of polysorbate-80, 0.3 part of dimethicone, 0.2 part of sodium benzoate, appropriate parts of sodium citrate, appropriate parts of citric acid, 10 parts of glycerol, 0.3 part of xanthan gum, 35 parts of malt syrup, 0.4 part of titanium dioxide, 0.3 part of essence, and the balance of purified water.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a posaconazole oral suspension and a preparation method thereof. Background technique [0002] At present, fungal infection is a common disease that is harmful to human health and endangers human life. In recent years, due to the prevalence of human immunodeficiency disease (HIV) and the use of strong immunosuppressive drugs for cancer and organ transplant patients, severe fungal infections and their mortality rates are on the rise. Triazole antifungal drugs have stronger antibacterial activity and lower toxicity than amphotericin B and flucytosine, so they are widely used in clinical practice, but the first generation triazole drugs have narrow antibacterial spectrum, low bioavailability and limited Problems such as drug interaction and drug resistance can no longer meet the urgent clinical needs. The development of the second-generation triazole antifungal drug p...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/10A61K31/496A61P31/10
Inventor 曹龙祥董自波杭夏清邵建国李萍
Owner JUMPCAN PHARMA GRP
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