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Medical composition containing fenofibrate

A fenofibrate and composition technology, applied in the field of pharmaceutical preparations, can solve the problems of poor fluidity, poor content uniformity, low dissolution rate, etc., and achieve the effects of improving curative effect, increasing dissolution rate, and uniform particle size distribution

Inactive Publication Date: 2013-09-11
BEIJING WINSUNNY PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] Through a large number of experiments, the present inventor has developed a composite powder containing fenofibrate, which effectively solves the problems encountered in the production and use of fenofibrate, such as low dissolution rate, poor content uniformity, flow sex difference

Method used

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  • Medical composition containing fenofibrate
  • Medical composition containing fenofibrate
  • Medical composition containing fenofibrate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Preparation of Fenofibrate Compound Powder:

[0041] (1) Dissolve 20g of fenofibrate in 120mL of ethanol to obtain a drug solution;

[0042] (2) Dissolve 33.1g of lactose, 2g of hypromellose, and 2g of sodium lauryl sulfate in 600mL of water to obtain an excipient solution;

[0043] (3) Mix the drug solution and the excipient solution evenly to obtain the mixed solution, and spray it dry to obtain the fenofibrate compound powder.

[0044] Preparation of fenofibrate pharmaceutical composition:

[0045] (1) Mix 41.4g of fenofibrate compound powder and 2g of crospovidone evenly, and dry granulate to obtain drug-containing granules;

[0046] (2) Mix 8.6g microcrystalline cellulose and 4g crospovidone evenly, and dry granulate to obtain blank granules;

[0047] (3) Mix the drug-containing granules in step (1), the blank granules in step (2), 6 g of crospovidone and 0.3 g of magnesium stearate;

[0048] (4) Measure the content of granules, compress into tablets or pack into...

Embodiment 2

[0051] Preparation of Fenofibrate Compound Powder:

[0052] (1) Dissolve 20g of fenofibrate in 130mL of ethanol to obtain a drug solution;

[0053] (2) Dissolve 14g of lactose, 0.45g of hypromellose, and 0.45g of sodium lauryl sulfate in 260mL of water to obtain an excipient solution;

[0054] (3) Mix the drug solution and the excipient solution evenly to obtain the mixed solution, and spray it dry to obtain the fenofibrate compound powder.

[0055] Preparation of fenofibrate pharmaceutical composition:

[0056] (1) Mix 25.3g of fenofibrate compound powder and 1.2g of crospovidone evenly, and dry granulate to obtain drug-containing granules;

[0057] (2) Mix 5.2g of microcrystalline cellulose and 1.8g of crospovidone evenly, and dry granulate to obtain blank granules;

[0058] (3) Mix the drug-containing granules in step (1), the blank granules in step (2), 3 g of crospovidone and 0.1 g of magnesium stearate;

[0059] (4) Measure the content of granules, compress into tabl...

Embodiment 3

[0062] Preparation of Fenofibrate Compound Powder:

[0063] (1) Dissolve 20g of fenofibrate in 125mL of ethanol to obtain a drug solution;

[0064] (2) Dissolve 66.8g of lactose, 4.8g of hypromellose, and 4.9g of sodium lauryl sulfate in 1200mL of water to obtain an excipient solution;

[0065] (3) Mix the drug solution and the excipient solution evenly to obtain the mixed solution, and spray it dry to obtain the fenofibrate compound powder.

[0066] Preparation of fenofibrate pharmaceutical composition:

[0067] (1) Mix 75.2g of fenofibrate compound powder and 3.2g of crospovidone evenly, and dry granulate to obtain drug-containing granules;

[0068] (2) Mix 13.8g microcrystalline cellulose and 5.8g crospovidone evenly, and dry granulate to obtain blank granules;

[0069] (3) Mix the drug-containing granules in step (1), the blank granules in step (2), 9 g of crospovidone and 0.5 g of magnesium stearate;

[0070] (4) Measure the content of granules, compress into tablets ...

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Abstract

The invention discloses fenofibrate compound powder which is prepared by an anti-solvent method. Fenofibrate is accelerated to be dissolved out, so that the deficiency that fenofibrate is hardly soluble in water and the bioavailability is low is solved. Meanwhile, the invention further provides a medical composition containing fenofibrate and a preparation method thereof. The method overcomes difficulty in the preparation production process due to great viscidity of the fenofibrate compound powder, so that the contents of main medicines are good in uniformity. Powder in the pelletization process is prevented from rising, the loss of main medicines is reduced, and the mobility of medicine particles is improved, so that the medical composition is suitable for industrialized production in a large scale.

Description

[0001] technical field [0002] The invention relates to a pharmaceutical composition containing a blood lipid-lowering drug fenofibrate and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0003] Fenofibrate, the chemical name is 2-methyl-2-(4-(4-chlorobenzoyl)phenoxy)isopropyl propionate, the structural formula is: [0004] [0005] It belongs to the third generation of clofibrate ester blood lipid-lowering drugs. It can be used clinically to treat hypertriglyceridemia, high cholesterol and mixed hyperlipidemia. The treatment and prevention of vascular diseases is of great significance. Due to its poor solubility in water, the dissolution rate of common preparations is slow, resulting in low bioavailability and unable to achieve a good therapeutic effect. Experiments have shown that only 60% of ordinary solid preparations are absorbed after oral administration, and the blood concentration can reach the peak va...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K9/20A61K9/48A61K31/216A61P3/06
Inventor 闫中天张志兵李泳耿玉先产运霞李巧刘俊杰
Owner BEIJING WINSUNNY PHARMA CO LTD