Medicinal product of oryzanol and preparation method thereof

An oryzanol and preparation technology, applied in the field of medicine, can solve the problems of patient pain, poor compliance with muscle agglomeration, poor oral effect of oryzanol, difficult control of emulsion particle size, etc. Exponential, effects with long-term stability

Inactive Publication Date: 2009-07-15
BEIJING CENTURY BIOCOM PHARMA TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, this invention still does not fundamentally solve the disadvantages of intramuscular injection caused by oil-soluble preparations, which can easily lead to patient pain, muscle agglomeration, and poor compliance.
Chinese patent application 2004100945568 discloses a technical scheme in which oryzanol raw materials are combined with cholesterol and phospholipids to prepare liposomes. The preparation of the technical scheme of the invention overcomes the problems of poor oral effect and low bioavailability of oryzanol
However, the injection obtained by this scheme is an injection emulsion, which must include an oil phase, and the particle size of the prepared emulsion is relatively difficult to control, and the stability is relatively poor. During the preparation, equipment such as a milk homogenizer is required, and the operation is relatively complicated and the cost is high.
[0004] In the existing technical scheme, the oil-soluble preparation is actually a semi-solid preparation because the vegetable oil cannot be removed, and the stability at room temperature is relatively poor
Virtually all solutions using vegetable oils for solubilization suffer from poor stability

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] first preparation

[0040] Oryzanol 100mg

[0041] Soy Lecithin 1000mg

[0042] Glycodexycholic Acid 200mg

[0043] second preparation

[0044] Glycerol 110mg

[0045] Lysine 10mg

[0046] Tween 80 3mg

[0047] Water for injection 10ml

[0048] Dissolve oryzanol, soybean lecithin, and glycodeoxycholic acid in 10ml of ethanol, remove the ethanol in the solution by evaporating to dryness under reduced pressure under full stirring at 60°C, perform fine filtration with a 0.22um microporous membrane, and pack To the vial, the label is A;

[0049] Dissolve glycerol, lysine, and Tween 80 in 10ml of water, then add 0.05% activated carbon for injection and stir for 30 minutes. After decarburization and filtration, perform fine filtration with a 0.22um microporous membrane, and pack into vials , labeled B.

[0050] For clinical use, add the solution in bottle B to bottle A, shake and mix well before use.

Embodiment 2

[0052] first preparation

[0053] Oryzanol 6mg

[0054] Phosphatidylcholine 50mg

[0055] Phosphatidylethanolamine 50mg

[0056] Sodium Taurocholate 80mg

[0057] second preparation

[0058] Propylene Glycol 50mg

[0059] Lysine 10mg

[0060] Glycine 30mg

[0061] Water for injection 10ml

[0062] Dissolve oryzanol, phosphatidylcholine, sodium taurocholate, and phosphatidylethanolamine in 10ml of acetone, and remove the acetone in the solution by evaporating to dryness under reduced pressure under full stirring at 60°C, and use a 0.22um microporous membrane to filter Fine filtration, sub-package into vials, marked as A;

[0063] Dissolve propylene glycol, lysine, and glycine in 10ml of water, then add 0.05% activated carbon for injection and stir for 30 minutes, add sodium hydroxide solution to adjust the pH to 8.0, after decarbonization and filtration, perform fine filtration with a 0.22um microporous membrane , packed into vials, marked as B.

[0064] For clinical ...

Embodiment 3

[0066] first preparation

[0067] Oryzanol 2mg

[0068] Phosphatidylcholine 20mg

[0069] Taurocholic Acid 40mg

[0070] Propylene Glycol 25mg

[0071] second preparation

[0072] Sodium bisulfite 50mg

[0073] Lactose 10mg

[0074] Water for injection 10ml

[0075] Dissolve oryzanol, phosphatidylcholine, taurocholic acid, and propylene glycol in 10ml of acetone, remove the acetone in the solution by evaporating to dryness under reduced pressure under full stirring at 60°C, and perform fine filtration with a 0.22um microporous membrane. Pack into vials, labeled A;

[0076] Dissolve sodium bisulfite and lactose in 10ml of water, then add 0.05% activated carbon for injection and stir for 30 minutes, add sodium hydroxide solution to adjust the pH to 8.5, after decarburization and filtration, perform fine filtration with a 0.22um microporous membrane, Pack into vials, labeled B.

[0077] For clinical use, add the solution in bottle B to bottle A, shake and mix well before...

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PUM

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Abstract

The invention discloses an officinal product of oryzanol and a preparation method thereof. The product is a kit which contains two unit preparations, wherein the first unit preparation is a composition of oryzanol, phospholipid, bile acid and/or salt of bile acid; and the second unit preparation is a solvent of the first unit preparation. The officinal product of oryzanol solves the problem of poor water solubility of the oryzanol and has simple use and easy storage.

Description

technical field [0001] The invention discloses an oryzanol medicinal product, which contains oryzanol, phospholipid, bile acid and / or its salt, and belongs to the technical 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 appearance is white to light yellow crystalline powder, odorless, and has a specific fragrance. Oryzanol mainly exists in rice bran oil and its oil feet. In rice bran oil oryzanol, the content of cycloartenol ferulate is about 70-80%. Long-term studies have found that oryzanol has a variety of physiological functions, mainly including: lowering blood lipids, lowering serum cholesterol, preventing lipid oxidation and preventing cardiovascular diseases. In addition, oryzanol can also alleviate various physical disorders and autonomic nervous disorders in women after menopause, and improve the dysfunction of the base of the diencephalic ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/575A61K47/24A61P3/06A61P9/00A61P15/12
CPCA61K31/575A61K9/1075A61P3/06A61P9/00A61P15/12
Inventor 郝守祝焦玉焕
Owner BEIJING CENTURY BIOCOM PHARMA TECH
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