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Oryzanol medicinal composition

A composition and oryzanol technology, applied in the field of medicine, can solve the problems of easy precipitation, poor long-term stability, easy generation of impurities and the like

Active Publication Date: 2011-05-18
BEIJING CENTURY BIOCOM PHARMA TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the microemulsion preparation improves the particle size of the oryzanol solution state, on the one hand, this scheme needs to use a large amount of excipients, the quality of the obtained drug is difficult to control, and it is easy to produce impurities; on the other hand, it still uses macromolecular oils such as fourteen Isopropyl acetate, coconut oil, etc., have poor long-term stability; 200710015604 discloses an injection of oryzanol, using ethyl oleate as a solubilizer, and the resulting injection has a large particle size and is prone to precipitation; 99103000.1 discloses A water-soluble sitosterol composition comprising a monofunctional surfactant and a multifunctional surfactant has been developed, but its stability is not good due to the need to use a variety of macromolecular surfactants
200410094556 discloses a liposome of oryzanol, which uses phospholipids as an auxiliary material, but still has the problems of large particle size and poor long-term stability

Method used

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  • Oryzanol medicinal composition
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  • Oryzanol medicinal composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Take 20g of S20, heat it to a molten state at 70°C, then add 4g of oryzanol to it, mix and stir for 20min, add the resulting molten liquid into 5L of water for injection and stir until completely dissolved, and the pharmaceutical composition of the present invention is obtained with a concentration of 0.8 mg / ml.

[0044] The resulting solution cleared completely on standing at room temperature for 24 hours.

[0045] The obtained pharmaceutical composition solution is filtered with a 0.45um filter membrane, and after passing the test, it is packed into an oral liquid bottle to obtain 400 oral preparations of the pharmaceutical composition of the present invention.

Embodiment 2

[0047] Take 20g of s8, heat it to a molten state at 60°C, then add 2g of oryzanol to it, mix and stir for 20min, add the obtained molten liquid into 3L of water for injection and stir until completely dissolved, and the pharmaceutical composition of the present invention is obtained with a concentration of 0.7 mg / ml.

[0048] The resulting solution cleared completely on standing at room temperature for 24 hours.

[0049] The obtained pharmaceutical composition solution was stirred with 0.3% activated carbon for injection for 30 minutes, decarbonized and filtered, finely filtered through a 0.22um microporous filter membrane, and filled into vials to obtain 200 injections of the pharmaceutical composition of the present invention.

Embodiment 3

[0051] Take 200g of S40, heat it to a molten state at 70°C, then add 10g of oryzanol to it, mix and stir for 30min, add the resulting molten solution into 3L of water for injection and stir until completely dissolved, and the pharmaceutical composition of the present invention is obtained with a concentration of 3.3 mg / ml.

[0052] The resulting solution cleared completely on standing at room temperature for 24 hours.

[0053] The above pharmaceutical composition solution was added with 0.3% activated carbon for injection and stirred for 30 minutes. After decarburization and filtration, after fine filtration with a 0.22um microporous membrane, the following freeze-drying process was adopted:

[0054] Pre-freezing: The temperature of the product drops to -45°C, and it can be sublimated and dried after 3 hours of heat preservation;

[0055] Sublimation drying: the sublimation drying temperature is controlled below -12°C;

[0056] Re-drying: the maximum temperature in the re-dr...

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Abstract

The invention discloses an oryzanol medicinal composition, and solves the problem that oryzanol is hardly soluble in water. The medicinal composition comprises the oryzanol and polyoxyl stearate. Stable and water-soluble oryzanol medicinal composition solution is obtained by adding the oryzanol into molten polyoxyl stearate. The invention further discloses a preparation method of the medicinal composition solution, and application of a preparation.

Description

technical field [0001] The invention discloses a pharmaceutical composition of oryzanol, which is a solution comprising oryzanol and polyoxyl stearate, and belongs to the field of medicine. Background technique [0002] Oryzanol is a natural mixture composed of cycloartenol-based ferulic acid esters and sterol-based ferulic acid esters. The natural appearance is white or light yellow crystalline powder, of which cycloartenol is ferulic acid The ester content is about 70-80%. Studies have found that oryzanol has a variety of pharmacological activities, including: lowering blood lipids, lowering cholesterol absorption, preventing lipid oxidation, and preventing cardiovascular diseases. Studies in recent years have also found that oryzanol can alleviate various physical obstacles and autonomic nervous disorders in women after menopause, and improve diencephalic dysfunction. [0003] Oryzanol is easily soluble in organic solvents such as chloroform and acetone, but difficult t...

Claims

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Application Information

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IPC IPC(8): A61K31/575A61K47/34A61K9/08A61P3/06A61P9/00A61P15/12A61K47/14
Inventor 郝守祝
Owner BEIJING CENTURY BIOCOM PHARMA TECH