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Lelrozol tablet and preparation method thereof

A technology of letrozole tablets and letrozole, which is applied in the field of medicine, can solve the problems of unsatisfactory content uniformity, loss of material dust pollution, unfavorable scale-up production, etc., and achieves small dissolution differences, low labor intensity, and reduced fragility sexual effect

Active Publication Date: 2018-02-27
HAINAN JINRUI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, because the adsorption of micronized silica gel on the surface of the powder is not firm, it is easy to cause demixing during material transfer and tabletting. Since letrozole is micronized, its particle size and density are much smaller than other excipients, so after demixing, its It is easier to float and stick to the preparation equipment, which will cause material loss and dust pollution, and cannot obtain satisfactory content uniformity, which is not conducive to industrial scale-up production

Method used

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  • Lelrozol tablet and preparation method thereof
  • Lelrozol tablet and preparation method thereof
  • Lelrozol tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Embodiment 1, letrozole tablet

[0041] prescription:

[0042]

[0043] Preparation:

[0044] (1) Letrozole bulk drug and SMCC, lactose monohydrate, sodium carboxymethyl starch and pregelatinized starch are respectively passed through 80 mesh sieves, weighed and placed in a mixer, and mixed for 30 minutes;

[0045] (2) Add magnesium stearate, mix for 15min, and compress into tablets;

[0046] (3) Put the plain tablet on a high-efficiency coating machine, and control the coating weight gain to 2% to 6%, to obtain the letrozole tablet.

Embodiment 2

[0047] Embodiment 2, letrozole tablet

[0048] prescription:

[0049]

[0050]

[0051] Preparation method: with embodiment 1.

Embodiment 3

[0052] Embodiment 3, letrozole tablet

[0053] prescription:

[0054]

[0055] Preparation method: with embodiment 1.

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PUM

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Abstract

The invention belongs to the technical field of medicine and particularly relates to a lelrozol tablet and a preparation method thereof. The lelrozol tablet is prepared from lelrozol and silicified microcrystalline cellulose, wherein the content of the silicified microcrystalline cellulose accounts for 20 to 60 percent of total weight of the tablets. The particle size D(v, 0.9) of the lelrozol issmaller than or equal to 60mu m, preferably the particle size D(v, 0.9) of the lelrozol is smaller than or equal to 40mu m and more preferably, the particle size D (v, 0.9) of the lelrozol is smallerthan or equal to 8mu m. According to the preparation method of the lelrozol tablet, disclosed by the invention, the silica microcrystalline cellulose is used, so that the trazodone is uniformly dispersed in the mixed powder; in addition, the lelrozol tablet has good fluidity, and the powder can be directly pressured into tablets, so that the technique is simplified, the time is saved and the laborintensity is low; besides, after a crude drug is crushed, the particle size is obviously reduced; by controlling the content of a disintegrating agent, the dissolution rate of the prepared lelrozol tablet is significantly increased, 85 percent or above can be reached in 15 minutes and thereby the lelrozol tablet is rapidly dissolved out.

Description

technical field [0001] The invention belongs to the technical field of medicines, in particular relates to a letrozole tablet and a preparation method thereof, more specifically relates to a letrozole tablet which dissolves very quickly and a preparation method thereof. Background technique [0002] Letrozole is a third-generation aromatase inhibitor, which is a non-steroidal drug. Its structural formula is as follows: [0003] [0004] Letrozole binds to the iron atom in heme and competes with the endogenous substrate for the active site of aromatase, thereby reversibly inhibiting the activity of the enzyme and effectively reducing the level of plasma estrogen, thereby eliminating hormone-sensitive Tumor stimulation. Therefore, it is especially suitable for postmenopausal breast cancer patients. [0005] Patent CN104146974A discloses a composition containing letrozole and its preparation method. The letrozole solid dispersion is prepared by hot-melt extrusion technolo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K31/4196A61K47/38A61P35/00
CPCA61K9/2054A61K9/2095A61K9/28A61K31/4196
Inventor 刘丽媛刘冬马鹰军王印
Owner HAINAN JINRUI PHARMA CO LTD
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