Budesonide nano crystallizing preparation and preparation method thereof

A technology of nano-crystallization and desonide, which is applied in the direction of pharmaceutical formulations, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the problems of poor absorption and utilization, improve stability, and improve the preparation process. Ease, facilitate dissolution and absorption

Inactive Publication Date: 2011-02-02
SHANDONG XINBO PHARMA R&D
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, because it is a fat-soluble component and insoluble in water, its absorption and utilization are poor, which is still its main defect

Method used

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  • Budesonide nano crystallizing preparation and preparation method thereof
  • Budesonide nano crystallizing preparation and preparation method thereof
  • Budesonide nano crystallizing preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] A preparation method of budesonide nanocrystal, the preparation steps are as follows:

[0023] (1) Disperse 0.5 g of HPMC, 1 g of lecithin and 0.5 g of TPGS in 100 parts by volume of double distilled water as a dispersion medium to obtain solution A;

[0024] (2) 2g of budesonide is dispersed in the aqueous dispersion medium obtained in step (1) to obtain coarse suspension B;

[0025] (3) the coarse suspension B obtained in step (2) is sheared 3min at 15000rpm with a high-speed shear to obtain suspension C;

[0026] (4) adopting the high pressure homogenization method to homogenize the suspension C prepared in step (3) at 500 for 10 times and 1500bar for 20 times to obtain the budesonide nanocrystalline suspension;

[0027] (5) adding 5% (W / V) mannitol to the above-mentioned budesonide nanocrystalline suspension as a freeze-drying protective agent to obtain budesonide crystals;

Embodiment 2

[0029] A preparation method of budesonide nanocrystal, the preparation steps are as follows:

[0030] (1) Disperse PVP 0.5g, Poloxamer F681g, Tween 800.5g in 100 parts by volume of double distilled water as a dispersion medium to obtain solution A;

[0031] (2) 1 g of budesonide is dispersed in the aqueous dispersion medium obtained in step (1) to obtain coarse suspension B;

[0032] (3) the coarse suspension B obtained in step (2) is sheared 2min at 15000rpm with a high-speed shear to obtain suspension C;

[0033] (4) adopting the high pressure homogenization method to homogenize the suspension C prepared in step (3) at 600 for 10 times and 10 times at 1800 bar to obtain the budesonide nanocrystalline suspension;

[0034] (5) adding 10% (W / V) mannitol to the above-mentioned budesonide nanocrystalline suspension as a freeze-drying protective agent to obtain budesonide crystals;

[0035] Application of budesonide nanocrystalline suspension in drug delivery system:

[0036] 1...

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Abstract

The invention relates to application of a new medicament delivery system in budesonide delivery, in particular to a preparation method for a budesonide nano crystallizing mixed suspension and application thereof. Budesonide has poor water solubility and low bioavailability by oral administration, seriously influences the application in clinic and increases the economical burden of patients. Accordingly, the invention provides the preparation method of the budesonide nano crystallizing mixed suspension for more favorably solving the problem of poor water solubility. The budesonide nano crystallizing mixed suspension can rapidly dissolve effective components, shorten the action time, reduce adverse reaction and is safe and convenient for use. The invention provides the budesonide nano crystallizing mixed suspension which overcomes the defects in current clinic practice and has a plurality of other advantages.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to a prescription and a preparation process of a budesonide nanocrystalline preparation. Background technique [0002] Budesonide is a glucocorticoid with potent local anti-inflammatory effect, which is white or off-white crystalline powder, insoluble in water. It has anti-inflammatory, anti-allergic, antipruritic and anti-exudative properties. It can enhance the stability of endothelial smooth muscle cells and lysosomal membranes, inhibit immune responses and reduce antibody synthesis, thereby reducing the release and activity of allergy-active mediators such as histamine, and can reduce the enzymatic activation of antigen-antibody binding. process, inhibiting the synthesis and release of bronchoconstrictor substances and reducing the contractile response of smooth muscle. Clinically, the aerosols, sprays and powders of budesonide are mainly used in the remissio...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K47/36A61K47/38A61K47/34A61K47/12A61K47/10A61K31/58A61P11/06A61K47/32A61K47/26
Inventor 刘兆平刘亚玲王言才王起伟马迎迎高西辉
Owner SHANDONG XINBO PHARMA R&D
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