Finasteride tablet and preparation method thereof

Abstract

The invention discloses a finasteride tablet and a preparation method thereof. A prescription of the finasteride tablet comprises the following components by weight: 1kg of finasteride, 18.0 kg of lactose, 3.0 kg of low-substituted hydroxy propyl cellulose, 4.0 kg of pregelatinized starch, 2.0 kg of carboxymethyl starch sodium, 0.3 kg of magnesium stearate, 0.2 kg of hydroxypropyl methylcellulose and 1.7 kg of 95% ethanol, which are made into 200,000 tablets in total. The preparation method comprises the following steps: 1) weighing the raw materials; 2) preparing an adhesive: adding water into the 95% ethanol to prepare a 20% ethanol solution, and dissolving the hydroxypropyl methylcellulose in the 20% ethanol solution to obtain the adhesive; 3) preparing a soft material; 4) preparing wet granules; 5) performing drying; 6) performing granulation; 7) performing total mixing; 8) performing tableting; 9) performing coating; and 10) performing packing. The preparation method is simple, the hardness and the dissolution rate of the finasteride tablet can be increased by adding the low-substituted hydroxy propyl cellulose and the hydroxypropyl methylcellulose in the prescription, the subsequent coating operation is facilitated, the phenomenon of tablet breaking in the preparation process and the transportation process is effectively avoided, and the product quality is improved.

Description

technical field [0001] The invention relates to the technical field of medicine preparation, in particular to a finasteride tablet and a preparation method thereof. Background technique [0002] The main raw material of finasteride tablets is finasteride, which is a western medicine routinely used to treat benign prostatic hyperplasia. The conversion of testosterone in the prostate to dihydrotestosterone is the cause of benign prostatic hyperplasia or benign prostatic hypertrophy. Finasteride is a 4-aza steroid compound with the molecular formula C 23 h 36 N 2 o 2 , the molecular weight is 327.55, the chemical name is 17β-(N-tert-butylcarbamoyl)-4-aza-5α-androst-1-en-3-one, which is the process of testosterone metabolic conversion into dihydrotestosterone The specific inhibitor of the intracellular enzyme-type II 5a-reductase can inhibit the conversion of testosterone into dihydrotestosterone (DHT), and then effectively reduce the dihydrotestosterone in the blood and pro...

AI Technical Summary

Problems solved by technology

Although the above-mentioned patents can improve the dissolution rate of finasteride tablets, none of them involve the hardness of finasteride tablets, which directly affects the coating and other processes in the preparation process, and the hardness is relatively high. It is also very easy to appear rotten chips in the process of preparation and transportation, which reduces the quality of the product