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Latrozole co-ground material, preparation method thereof and medicament composition having same

A technology of letrozole and co-grinding, which is applied in the directions of drug combination, antitumor drug, pharmaceutical formulation, etc., can solve the problems of unsatisfactory dissolution rate of letrozole, cytotoxicity and hemolysis, and achieves optimization of clinical efficacy and preparation of drugs. Simple method and improved dissolution rate

Active Publication Date: 2010-11-17
SHANGAI PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The technical problem to be solved by the present invention is to overcome the defects that the dissolution rate of letrozole in the existing micronized letrozole is still not ideal, or that the surfactant contained in the letrozole composition may produce cytotoxicity and hemolysis , providing a co-grind of letrozole, a preparation method thereof and a pharmaceutical composition containing the same

Method used

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  • Latrozole co-ground material, preparation method thereof and medicament composition having same
  • Latrozole co-ground material, preparation method thereof and medicament composition having same

Examples

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Effect test

Embodiment 1

[0026] Preparation of letrozole tablets 1000 pieces

[0027] Letrozole co-grinding preparation process: according to the formula in the table, letrozole is evenly mixed with the hydrophilic material in the table, put into a ball mill, and ball mill for 35 minutes. After testing, the average particle size of letrozole particles was 5 μm.

[0028] In the obtained letrozole co-grinding product, add pharmaceutical auxiliary ingredients according to the formula in the table, mix evenly and directly compress into tablets.

Embodiment 2

[0030] Preparation of letrozole tablets 1000 pieces

[0031] Letrozole co-grind preparation process: according to the formula in the table, letrozole is evenly mixed with the hydrophilic material in the table, put into a ball mill, and ball mill for 40 minutes. After testing, the average particle size of letrozole particles was 1 μm.

[0032] In the obtained letrozole co-grind, add pharmaceutical excipients according to the formula in the table (wherein povidone is dissolved in 50% ethanol aqueous solution as a binder), make soft material and granulate, add hard material to the granule after drying Magnesium fatty acid, ready for tableting.

Embodiment 3

[0034] Preparation of letrozole tablets 1000 pieces

[0035] Letrozole co-ground preparation process: According to the formula in the table, letrozole is evenly mixed with the hydrophilic material in the table, put into a ball mill, and ball mill for 15 minutes. After testing, the average particle size of letrozole particles was 30 μm.

[0036] In the obtained letrozole co-grinding product, add pharmaceutical auxiliary ingredients according to the formula in the table, mix evenly and directly compress into tablets.

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Abstract

The invention discloses a Latrozole co-ground material, a preparation method thereof and a medicament composition having the same. The Latrozole co-ground material comprises Latrozole and a hydrophilic material in a mass ratio of 1:0.5 to 1:20, wherein the hydrophilic material is one or more of polyethylene glycol, lactose, starch, starch derivatives, povidone and mannitol; and an average grain diameter of Latrozole grains is 1 to 100 mu m. In the medicament composition prepared from the Latrozole co-ground material, the dissolution rate of the Latrozole is obviously improved, and the medicament composition has a simple preparation method and is particularly suitable for industrial production.

Description

technical field [0001] The invention relates to a letrozole co-grind, a preparation method thereof and a pharmaceutical composition containing the same. Background technique [0002] Letrozole (Letrozole), the chemical name is 1-[bis(4-cyanophenyl)methyl]-1,2,4-triazole; 4,4'-(1H-1,2,4- Triazol-1-ylmethylene)-bisbenzonitrile belongs to artificially synthesized benzotriazole derivatives. Letrozole reduces the level of estrogen by inhibiting aromatase, thereby eliminating the stimulating effect of estrogen on tumor growth. In vivo and in vitro studies have shown that letrozole can effectively inhibit the transformation of androgen into estrogen, and the estrogen in postmenopausal women mainly comes from the aromatization of androgen precursors in peripheral tissues, so it is especially suitable for postmenopausal breast cancer patients . The in vivo activity of letrozole is 150-250 times stronger than that of the first-generation aromatase inhibitor aminoglutethimide. Beca...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/10A61K47/32A61K47/34A61K47/36A61K47/38A61K31/4196A61P35/00
Inventor 刘文丽弓勇潘弘甘勇韩建生
Owner SHANGAI PHARMA GRP CO LTD