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24-methylene cycloartenyl ferulate composition and method for preparing the same

A technology of pineapple alcohol ferulate and methylene ring wood, which is applied in the field of medicine and can solve problems such as muscle agglomeration, slow onset of action, oryzanol insoluble in water, etc.

Inactive Publication Date: 2014-08-27
BEIJING CENTURY BIOCOM PHARMA TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The problem in the application of oryzanol is that oryzanol is insoluble in water and easy to oxidize, which makes it difficult to make oryzanol into a stable preparation
Extremely low solubility and easy oxidation not only lead to low absorption rate, but also difficult to control the quality in production
Some technical schemes for solving the solubility problem of oryzanol are provided in the prior art, such as CN123428, CN2007100156403, CN2004100945568 etc. disclose technical schemes for improving the solubility of oryzanol, but these schemes have their own defects on the one hand, such as when oil-soluble preparations are used clinically Patients have a strong sense of pain, which can easily lead to muscle agglomeration and slow onset of action; the cost of liposomes is high, and the quality of the production process is not easy to control, etc.
On the other hand these schemes also do not disclose how to solve the solubility problem of 24-methylene cycloartenol ferulate

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] 24-Methylenecycloartenol Ferulate 10mg

[0042] Soy Lecithin 50mg

[0043] Glycoursodeoxycholic Acid 50mg

[0044] Glycine 50mg

[0045] Water for injection to 10ml

[0046] Dissolve 24-methylenecycloartenol ferulate, soybean lecithin, and ursodeoxycholic acid in 5ml of ethyl acetate, heat to 80°C and stir until fully dissolved. Distilled by evaporation under reduced pressure to obtain an organic phase. Add water for injection in which glycine has been dissolved to the full amount in the organic phase, and stir well at 60°C to obtain the injection solution of the present invention. Adjust the pH to 7.2 with sodium hydroxide solution, add 0.05% activated carbon for injection and stir for 30 minutes, after decarburization and filtration, perform fine filtration with a 0.22um microporous filter membrane, and pack into vials.

Embodiment 2

[0048] 24-Methylenecycloartenol Ferulate 10mg

[0049] Soy Lecithin 1000mg

[0050] Phosphatidylcholine 100mg

[0051] Chenodeoxycholic Acid 400mg

[0052] Mannitol 100mg

[0053] Water for injection to 10ml

[0054] Dissolve 24-methylene cycloartenol ferulate, chenodeoxycholic acid, soybean lecithin, phosphatidylcholine, and mannitol in 8ml of propylene glycol, heat to 80°C and stir until fully dissolved. Distilled by evaporation under reduced pressure to obtain an organic phase. Add water for injection to the organic phase to the full amount, and fully stir and mix at 70°C to obtain the injection solution of the present invention. Adjust the pH to 7.0 with sodium hydroxide solution, add 0.05% activated carbon for injection and stir for 30 minutes, after decarburization and filtration, perform fine filtration with a 0.22um microporous filter membrane, and pack into vials.

Embodiment 3

[0056] 24-Methylenecycloartenol Ferulate 20mg

[0057] Soy sphingomyelin 100mg

[0058] Taurodeoxycholic Acid 200mg

[0059] Glucose 100mg

[0060] Water for injection to 10ml

[0061] Dissolve 24-methylene cycloartenol ferulate, soybean sphingomyelin, and taurodeoxycholic acid in 10ml of glycerol, heat to 80°C and stir until fully dissolved. Distilled by evaporation under reduced pressure to obtain an organic phase. Add water for injection in which glucose has been dissolved to the full amount in the organic phase, and fully stir and mix at 60° C. to obtain the injection solution of the present invention. Adjust the pH to 6.5 with sodium bicarbonate solution, add 0.05% activated carbon for injection and stir for 30 minutes, after decarburization and filtration, perform fine filtration with a 0.22um microporous filter membrane, and pack into vials.

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PUM

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Abstract

The invention discloses a pharmaceutical composition of 24-methylene cycloartenyl oryzanolum, which comprises the 24-methylene cycloartenyl oryzanolum, phospholipid, bile acid and / or salt of bile acid. The pharmaceutical composition effectively improves the water solubility and the stability of the 24-methylene cycloartenyl oryzanolum and has better grain diameter and stability than the prior product, and further, the invention provides three product forms including injectio, freeze-dried powder and kits of the pharmaceutical composition, and preparation methods thereof.

Description

technical field [0001] The present invention relates to a kind of 24-methylene cycloartenol ferulic acid ester medicinal composition, specifically the invention discloses a kind of 24-methylene cycloartenol ferulic acid ester drug for injection The composition and its preparation method belong 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 appearance is white to light yellow crystalline powder, odorless, and has a specific fragrance. Oryzanol mainly exists in rice bran oil and its oil foot. In rice bran oil oryzanol, the content of cycloartenol ferulate is about 70-80%. After long-term research, researchers have found that oryzanol has a variety of physiological functions. Mainly include: lower blood lipid, lower cholesterol absorption, lower serum cholesterol, prevent lipid oxidation and prevent cardiovascular disease. In addition, oryzanol ...

Claims

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Application Information

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