Oryzanol nanocrystal capsule preparation and preparation process thereof

A nano-crystal, oryzanol technology, applied in capsule delivery, medical preparations with inactive ingredients, medical preparations containing active ingredients, etc., can solve problems such as poor bioavailability, and achieve increased solubility, improved safety, and reduced Effects of side effects

Inactive Publication Date: 2016-10-12
QILU UNIV OF TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Aiming at the problems of poor clinical oral bioavailability of oryzanol, the present invention adopts multi-entrance vortex mixing technology to prepare oryzanol nano-suspension, freeze-dries the nano-suspension to make nano-crystals, and fills the freeze-dried powder into Capsules from

Method used

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  • Oryzanol nanocrystal capsule preparation and preparation process thereof
  • Oryzanol nanocrystal capsule preparation and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Weigh 1 g of oryzanol and dissolve in 30 ml of medicinal absolute ethanol, weigh 0.1 g of PVP K30 and 0.2 g of lecithin, swell in 150 ml of water for injection, and sonicate for 10 min at room temperature. Inject the ethanol phase and the water phase at a rate of 1:5 from the inlet of the vortex mixer at a constant speed, collect at the outlet, and obtain oryzanol nano-crystal suspension.

[0023] Take the above suspension and add mannitol at a ratio of 5% (w / v), stir to dissolve, and dry it in a spray dryer at a speed of 5ml / min. The temperature is maintained at 80°C-95°C. After spray drying, collect The powder at the bottom of the drier is obtained from oryzanol nanocrystals. The obtained oryzanol nano crystals are filled into hard capsules according to the dosage of 20 mg per capsule, and then the oryzanol nano crystals capsules can be obtained.

Embodiment 2

[0025] Weigh 1 g of oryzanol and dissolve it in 30 ml of medicinal absolute ethanol, weigh 0.2 g of poloxamer F68 and 0.3 g of TPGS, swell in 150 ml of water for injection, and sonicate for 10 min at room temperature. Inject the ethanol phase and the water phase at a rate of 1:5 from the inlet of the vortex mixer at a constant speed, collect at the outlet, and obtain oryzanol nano-crystal suspension.

[0026] Take the above suspension and add trehalose at a ratio of 5% (w / v), stir to dissolve, dry in a spray dryer at a speed of 5ml / min, and maintain the temperature at 80°C-95°C. After spray drying, collect The powder at the bottom of the drier is obtained from oryzanol nanocrystals. The obtained oryzanol nano crystals are filled into hard capsules according to the dosage of 20 mg per capsule, and then the oryzanol nano crystals capsules can be obtained.

Embodiment 3

[0028] Weigh 1 g of oryzanol and dissolve it in 30 ml of medicinal absolute ethanol, weigh 0.4 g of Tween 80 and 0.2 g of TPGS, swell in 150 ml of water for injection, and sonicate for 10 min at room temperature. Inject the ethanol phase and the water phase at a rate of 1:5 from the inlet of the vortex mixer at a constant speed, collect at the outlet, and obtain oryzanol nano-crystal suspension.

[0029] Take the above suspension and add glucose at a ratio of 5% (w / v), stir to dissolve, and dry in a spray dryer at a speed of 5ml / min. The temperature is maintained at 80°C-95°C. After spray drying, collect and dry Powder at the bottom of the container to obtain oryzanol nanocrystals. The obtained oryzanol nano crystals are filled into hard capsules according to the dosage of 20 mg per capsule, and then the oryzanol nano crystals capsules can be obtained.

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Abstract

The invention belongs to the technical field of medicinal preparations, and relates to a formula and a preparation process of an oryzanol nanocrystal capsule preparation. The preparation is composed of oryzanol and stabilizers, nano-suspension is prepared, then spray dispersing agents are added into the nano-suspension, spray drying is performed to obtain oryzanol nanocrystals, and a capsule is filled to obtain an oryzanol nanocrystal capsule. The nanocrystals prepared by vortex blending are uniform in grain diameter, and solubility and dissolution rate are remarkably increased. The preparation has the remarkable advantages that the solubility of the oryzanol can be increased by the nanocrystals, bioavailability of the oral preparation is improved and is less affected by the eating condition of a patient, clinical curative effects are further enhanced, and individual difference is decreased.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations. The invention relates to a prescription and a preparation process of oryzanol nano crystal tablet. Background technique [0002] Oryzanol is a combination lipid of ferulic acid and phytosterol, which can be extracted from rice bran oil, germ oil and other grain oils. Its appearance is white to off-white crystalline powder, odorless, with specific fragrance, soluble in various oils under heating, insoluble in water. Clinically, oryzanol is often used to improve autonomic nerve function and endocrine regulation. In addition, it also has various physiological effects such as anti-oxidation and anti-aging. [0003] Due to the poor water solubility of oryzanol, the bioavailability of ordinary oral preparations is poor, which significantly affects the curative effect. Oryzanol is insoluble in water (the experimentally determined water solubility is 0.08 μg / mL), and ordinary oryza...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K9/19A61K31/575A61K47/34A61K47/32A61K47/24A61K47/22A61K47/26A61P3/06A61P1/16
CPCA61K9/4866A61K9/19A61K9/4858A61K31/575
Inventor 王言才王路路
Owner QILU UNIV OF TECH
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