A kind of letrozole tablet and preparation method thereof

Abstract

The invention belongs to the technical field of medicines, and in particular relates to a letrozole tablet and a preparation method thereof. The letrozole tablet includes letrozole and silicified microcrystalline cellulose, and the content of the silicified microcrystalline cellulose accounts for 20% to 60% of the total weight of the tablet. The particle size D of the letrozole (v,0.9) ≤60μm, preferably the particle size D of letrozole (v,0.9) ≤40μm, more preferably the particle size D of letrozole (v,0.9) ≤8μm. The silicified microcrystalline cellulose used in the present invention makes letrozole evenly dispersed in the mixed powder, and has good fluidity, and the powder can be directly compressed into tablets, which simplifies the process, saves time, and has low labor intensity; after the crude drug is pulverized, the particle size Obviously reduce, by controlling the content of disintegrating agent, the dissolution rate of the letrozole tablet made is significantly improved, and can reach more than 85% in 15min, which is a very fast dissolution tablet.

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...

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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

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