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Oral medicinal composition containing anastrozole and preparation technology thereof

A technology of anastrozole and composition, which is applied in the field of oral pharmaceutical composition containing anastrozole and its preparation technology, and can solve the problems of bitter taste, difficult anastrozole and the like

Inactive Publication Date: 2008-01-16
HAINAN SHENGKE LIFE SCI RES INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] But because anastrozole is difficult to dissolve in water, and mouthfeel is very bitter, so according to existing production conditions, be necessary to work out a kind of suitable prescription composition and preparation technology, make anastrozole make suitable preparation, with good Bioavailability, Compliance and Drug Stability

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Preparation Process

[0021] Anastrozole is pulverized through a 100-mesh sieve, magnesium stearate is passed through a 60-mesh sieve, and the remaining auxiliary materials are respectively passed through a 80-mesh sieve. Dissolve povidone K30 in 40% ethanol solution to prepare 5% povidone K30 alcohol solution as adhesive. Mix anastrozole, lactose and carboxymethyl starch sodium uniformly in a mixer, and granulate with the above-mentioned binder. The wet granules are dried in an oven until the water content is below 3%, and magnesium stearate is added to the dry granules, mixed evenly, and filled into capsules.

Embodiment 2

[0024] Preparation Process

[0025] Anastrozole was crushed through a 100-mesh sieve, magnesium stearate was passed through a 60-mesh sieve, and the rest of the excipients were respectively passed through a 80-mesh sieve, and weighed anastrozole, lactose, microcrystalline cellulose and 1 / 2 amount of crospovidone XL -10 Mix well in a mixer, use water as wetting agent to granulate. Dry the wet granules in an oven until the water content is below 3%, add another 1 / 2 amount of crospovidone XL-10 and magnesium stearate to the dry granules, mix well, measure the content of the main drug in the granules, and determine the tablet weight , Tablets.

Embodiment 3

[0028] Preparation Process

[0029] Anastrozole is pulverized through a 100-mesh sieve, magnesium stearate is passed through a 60-mesh sieve, and the remaining auxiliary materials are respectively passed through a 80-mesh sieve. A 15% starch slurry was prepared as a binder by boiling the pulp. Mix anastrozole, sucrose, tartrazine 60 and mannitol uniformly in a mixer, and granulate with the above-mentioned binder. The wet granules are dried in an oven until the water content is below 3%, the orange essence is added to the dry granules, mixed evenly, and sieved to prepare granules.

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Abstract

Disclosed is a prescription composition of a drug compound containing granules for oral administration and the preparation process, characterized in that the granule contains anastrozole, filler and other pharmaceutical excipient. The anastrozole is produced into suitable preparation with good bioavailability and drug stability in the preparation process.

Description

technical field [0001] The present invention relates to a pharmaceutical composition for oral administration containing granules. Specifically, the present invention relates to a compound containing anastrozole (chemical name is α, α, α', α'-tetramethyl-5-(1H-1,2,4-triazole-1-methyl )-1,3-benzenediacetonitrile) and a pharmaceutical composition for oral administration containing granules, which can be made into oral tablets, capsules and granules. Background technique [0002] Aromatase inhibitors are effective drugs for the treatment of postmenopausal metastatic breast cancer and have experienced three generations of development. Anastrozole is a representative drug of the third-generation aromatase inhibitor, which has the advantages of high selectivity, strong effect, good curative effect, mild side effects, and convenient administration. Anastrozole is used for advanced breast cancer in postmenopausal women who are ineffective after tamoxifen and other anti-estrogen the...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4196A61K47/38A61K9/20A61K9/16A61K9/48A61P35/00
Inventor 李铮莫良侃
Owner HAINAN SHENGKE LIFE SCI RES INST
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