| 摘要 |
Disclosed is a process for preparing a composition comprising (i) Nicorandil, (ii) a lubricant which is selected from a saturated higher aliphatic acid and its salts and/or a saturated higher alcohol, which is solid at ambient temperature and said lubricant being not micronized, (iii) a disintegrating agent which is sodium croscarmellose, and (iv) a diluent which is mannitol, wherein the process comprises: a first step in which, by weight, 30 parts of Nicorandil, 15 parts of sodium croscarmellose, 35 parts of mannitol and 3 parts of corn starch are mixed so as to form a first pre-mix which is calibrated, a second step in which the calibrated first pre-mix is mixed with 193 parts by weight of mannitol so as to form a second pre-mix, and a third step in which the second pre-mix is mixed with 24 parts by weight of non micronized stearic acid. Also disclosed are compositions obtained by said method, tablets obtained by direct compression, and their use as medicine.
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