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A kind of preparation method of letrozole tablet 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 poor stability and easy sticking of letrozole tablets, and achieve improved stability, improved dissolution rate and stable sexual effect

Active Publication Date: 2017-06-23
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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  • A kind of preparation method of letrozole tablet with good stability

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Effect test

Embodiment 1

[0016] The preparation method of letrozole tablets is as follows: 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 micronized silica gel are added, and the pressure is reduced at 25°C. The ethanol is evaporated, and the evaporated composition is taken out. After passing through an 80 mesh sieve, add 70 parts of filler microcrystalline cellulose, 5 parts of disintegrant sodium carboxymethyl starch, 4 parts of lubricant magnesium stearate, and mix well. , It is obtained after direct compression, each tablet weighs 0.25g.

Embodiment 2

[0018] The preparation method of letrozole tablets is as follows: 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 micronized silica gel are added, and the pressure is reduced at 40°C. The ethanol is evaporated, and the evaporated composition is taken out. After passing through an 80-mesh sieve, add 90 parts of filler microcrystalline cellulose, 10 parts of disintegrant sodium carboxymethyl starch, 8 parts of lubricant magnesium stearate, and mix well. , It is obtained after direct compression, each tablet weighs 0.25g.

Embodiment 3

[0020] The preparation method of letrozole tablets is 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 micronized silica gel are added, and the pressure is reduced at 30°C. The ethanol is evaporated, and the evaporated composition is taken out. After passing through an 80 mesh sieve, add 80 parts of filler microcrystalline cellulose, 8 parts of disintegrant sodium carboxymethyl starch, and 6 parts of lubricant magnesium stearate, and mix well. , It is obtained after direct compression, each tablet weighs 0.25g.

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Abstract

The invention relates to a preparation method of letrozole tablets with good stability, and belongs to the technical field of pharmaceutical preparations. The method comprises the following steps: in parts by weight, 20-30 parts of letrozole are dissolved in 120-180 parts of ethanol, 5-10 parts of titanium oxide, 3-6 parts of heavy magnesium carbonate and 10-20 parts of micropowder silica gel are added, and the Ethanol is evaporated under pressure, the evaporated composition is taken out, and after sieving, 70-90 parts of filler, 5-10 parts of disintegrating agent and 4-8 parts of lubricant are added, mixed evenly, and directly compressed into tablets. The letrozole tablet prepared by the method has good drug stability and good dissolution rate, and avoids the problem of sticking and punching of the tablet.

Description

Technical field [0001] The invention relates to a method for preparing 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 benztriazole derivative, which reduces the level of estrogen by inhibiting aromatase, thereby eliminating the stimulating effect of estrogen on tumor growth. The in vivo activity is 150 to 250 times stronger than the first generation aromatase inhibitor aminoglutamate. Because of its high selectivity, it does not affect glucocorticoids, mineralocorticoids and thyroid function. Large-dose use has no inhibitory effect on the secretion of adrenal corticosteroids, so it has a higher therapeutic index. Various preclinical studies have shown that letrozole is not potentially toxic to the system and target organs, has no mutagenic and carcinogenic effects, and has less toxic and side effects. I...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/4196A61K47/04A61P35/00
Inventor 沙莎刘叶李永
Owner 嘉善创越知识产权服务有限公司