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Preparation method for letrozole tablets with good stability

A technology for the stability of letrozole tablets, which is applied in the field of preparation of letrozole tablets, can solve the problems of easy sticking and punching, poor stability of letrozole tablets, etc., and achieves improved stability, improved dissolution rate and stable sexual effect

Active Publication Date: 2015-05-06
嘉善创越知识产权服务有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The technical problem to be solved by the present invention is: the stability of the letrozole tablet obtained by wet granulation is not good, and the problem of sticking and punching easily occurs in the process of preparation, and its preparation method has been improved

Method used

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  • Preparation method for letrozole tablets with good stability

Examples

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Embodiment 1

[0016] The preparation method of letrozole tablets, the steps are as follows: in parts by weight, 20 parts of letrozole are dissolved in 120 parts of ethanol, 5 parts of titanium oxide, 3 parts of heavy magnesium carbonate and 10 parts of micropowdered silica gel are added, and the pressure is reduced at 25 ° C. Evaporate ethanol to dryness, take out the evaporated composition, and then add 70 parts of filler microcrystalline cellulose, 5 parts of disintegrant sodium carboxymethyl starch, and 4 parts of lubricant magnesium stearate after passing through an 80-mesh sieve, and mix well , obtained after direct compression, each tablet weighs 0.25g.

Embodiment 2

[0018] The preparation method of letrozole tablets, the steps are as follows: in parts by weight, 30 parts of letrozole are dissolved in 180 parts of ethanol, 10 parts of titanium oxide, 6 parts of heavy magnesium carbonate and 20 parts of micropowdered silica gel are added, and the pressure is reduced at 40 ° C. Evaporate ethanol to dryness, take out the evaporated composition, and then add 90 parts of filler microcrystalline cellulose, 10 parts of disintegrant sodium carboxymethyl starch, and 8 parts of lubricant magnesium stearate after passing through an 80-mesh sieve, and mix well , obtained after direct compression, each tablet weighs 0.25g.

Embodiment 3

[0020] The preparation method of letrozole tablets, the steps are as follows: in parts by weight, 25 parts of letrozole are dissolved in 160 parts of ethanol, 7 parts of titanium oxide, 5 parts of heavy magnesium carbonate and 15 parts of micropowdered silica gel are added, and the pressure is reduced at 30 ° C. Evaporate ethanol to dryness, take out the evaporated composition, and then add 80 parts of filler microcrystalline cellulose, 8 parts of disintegrant sodium carboxymethyl starch, and 6 parts of lubricant magnesium stearate after passing through an 80-mesh sieve, and mix well , obtained after direct compression, each tablet weighs 0.25g.

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Abstract

The invention relates to a preparation method for letrozole tablets with good stability, and belongs to the technical field of pharmaceutical preparations. The preparation method comprises the following steps: dissolving 20-30 parts of letrozole in 120-180 parts of alcohol; adding 5-10 parts of titanium oxide, 3-6 parts of heavy magnesium carbonate and 10-20 parts of micro powder silica gel; reducing pressure and evaporating the alcohol to dryness; taking out the dried composition; screening the composition; adding 70-90 parts of a filling agent, 5-10 parts of a disintegrating agent and 4-8 parts of a lubricant; mixing the materials uniformly; directly conducting tabletting to obtain the letrozole tablets. The prepared letrozole tablets are good in medicine stability, and dissolution rate, and avoid sticking of the tablets.

Description

technical field [0001] The invention relates to a preparation method of letrozole tablets with good stability, and belongs to the technical field of pharmaceutical preparations. Background technique [0002] Letrozole is a new generation of highly selective aromatase inhibitors. It is a synthetic benzyltriazole derivative. By inhibiting aromatase, it reduces the level of estrogen, thereby eliminating the stimulating effect of estrogen on tumor growth. The in vivo activity is 150-250 times stronger than the first-generation aromatase inhibitor aminoglutethimide. Because of its high selectivity, it does not affect the function of glucocorticoids, mineralocorticoids and thyroid gland, and large doses have no inhibitory effect on the secretion of adrenal corticosteroids, so it has a high therapeutic index. Various preclinical studies have shown that letrozole has no potential toxicity to various systems and target organs of the body, no mutagenicity and carcinogenicity, and ha...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/4196A61K47/04A61P35/00
Inventor 孟红琳
Owner 嘉善创越知识产权服务有限公司
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