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Oryzanol composition and its preparation method

A technology of composition and oryzanol, which is applied in the direction of drug combination, drug delivery, pharmaceutical formulation, etc., can solve the problems of easy lumps, pain, poor patient compliance, etc.

Active Publication Date: 2006-08-30
SHANDONG BESTCOMM PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the injection using oil as a solvent can only be injected intramuscularly because it is an oil solution, which has the disadvantages of slow onset of action and special pain during injection. Patients need to inject intramuscularly for one month continuously, and lumps are prone to appear at the injection site, and the patient's compliance is poor.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063] Add 30g of soybean oil for injection and 4.5g of oryzanol into the container, place the container in an oil bath, heat to 100°C, stir until the drug dissolves, cool to 80°C, and add 11g of soybean lecithin. Vitamin E 0.1g, stirred until the phospholipids dissolve to form a uniform oil phase. Put 80ml of water for injection in another container, add 2.5g of glycerin, stir and dissolve at 80°C to form a water phase; add the oil phase to the water phase under stirring, continue stirring for 40 minutes to make colostrum, and use sodium hydroxide solution Adjust the pH to 8; add water for injection to 100ml, and use a high-pressure homogenizer or an ultrasonic probe to homogenize the colostrum until the particle size of the milk droplets passes the test. Filter through a filter, pass through nitrogen, dispense into 1ml ampoules, and seal. Use a rotary autoclave to sterilize at 100°C for 30 minutes.

[0064]The prepared fat emulsion was stored in a cool place at room temper...

Embodiment 2

[0067] Add 7.5g of soybean oil for injection, 7.5g of olive oil, and 40mg of oryzanol into a container, place the container in an oil bath, heat to 70°C, and stir until the drug dissolves to form a uniform oil phase. Put 80ml of water for injection into another container, add 1.5g of egg yolk phospholipid, 0.5g of poloxamer, 0.5g of polyethylene glycol 12-position hydroxystearate, 5.0g of glucose, and 0.2g of sodium bisulfite in Stir and dissolve at 70°C to form a water phase; add the water phase to the oil phase under stirring, continue stirring for half an hour to make colostrum, adjust the pH to 8.5 with sodium hydroxide solution; add water for injection to 100ml, and mix the colostrum with high pressure Homogenize with a quality machine or an ultrasonic probe until the particle size of the emulsion droplet is qualified. Filter through a microporous filter membrane, pass through nitrogen, fill and seal. Use a rotary autoclave to sterilize at 115°C for 30 minutes.

[0068]...

Embodiment 3

[0071] Add 10g of soybean oil for injection, 10g of medium-chain fatty acid ester, and 2g of oryzanol into the container, place the container in an oil bath, heat to 70°C, stir until the drug is dissolved, and dissolve 4.0g of 3-phosphatidylcholine with ethanol Add 2.0ml after dissolving, and evaporate the ethanol to form a uniform oil phase. Put 80ml of water for injection into another container, add 5.0g of sorbitol, 4.0g of poloxamer and stir to dissolve at 70°C to form a water phase; add the water phase to the oil phase under stirring, and continue stirring for 1 hour to prepare the initial Milk, add water for injection to 100ml, and adjust the pH to 7.0 with sodium hydroxide solution; use a high-pressure homogenizer or ultrasonic probe to homogenize the colostrum until the milk droplet size inspection is qualified. Filter through a filter, pass through nitrogen, dispense into 2ml ampoules, and seal. Use a rotary autoclave to sterilize at 100°C for 30 minutes.

[0072] T...

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PUM

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Abstract

A thiaminogen composition in the form of injection or freeze-dried powder injection is prepared from the thiaminogen, surfactant, the water for injection and selective excipient.

Description

technical field [0001] The invention relates to an oryzanol composition, in particular to an oryzanol composition for intravenous injection and a preparation method thereof. Background technique [0002] Oryzanol is a ferulic acid ester mixture of several triterpene (en) alcohols and sterols extracted from rice bran oil, which can adjust the function of the diencephalon and activate the hypothalamus and limbic brain related to the autonomic nervous system System, can improve symptoms of autonomic nervous disorders, endocrine balance disorders and mental nervous disorders, so it can treat a variety of diseases related to autonomic nervous disorders, such as periodic mental illness, head trauma syndrome, climacteric syndrome, premenstrual Catatonia, vascular headache, and neurosis mainly based on autonomic nervous disorders have certain curative effects. [0003] Because oryzanol is insoluble in water and easily oxidized, it cannot be made into a stable aqueous injection solu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/575A61K9/08A61K9/19A61P25/00A61P25/04A61P15/12
Inventor 孟凡清牛传芹刘理南
Owner SHANDONG BESTCOMM PHARMA CO LTD
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