| 摘要 |
The present invention provides a method of making quinolone carboxylic acids or naphthyridine carboxylic acids in free base form, the method comprising dissolving a quinolone carboxylic acid salt or naphthyridi ne carboxylic acid salt in a solvent system to form a solution; combining the solution containing the quinolone carboxylic acid salt or naphthyridine carboxylic acid salt with a calcium salt in an amount in the range of about 0.01 % to about 5.0 % by weight of the quinolone carboxyl ic acid salt or naphthyridine carboxylic acid salt and a base, the combination resulting in the formation of a precipitate; and collecting the precipitate. Also provided is a solid bulk pharmaceutical chemical composition comprising 7-(3-amino-1-pyrrolidinyl)-8-chloro-1-cyclopropyl-6- fluoro-1,4-dihydro-4-oxoquinoline-3-carboxylic acid or 7-(3-S-(2-S-aminopropionylamino)pyrrolidin-1-yl]-1-cyclopropyl-6-fluoro-1,4- dihydro-4-oxo-1,8-naphthyridine-3-carboxylic acid; and calcium in an amount in the range of 0.001 % to about 1.0 % by weight of the 7-(3-amino -1- pyrrolidinyl)-8-chloro-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxoquinoline-3- carboxylic acid or 7-[3-S-(2-S-aminopropionylamino) pyrrolidin-1-yl]-1-cyclopropyl-6- fluoro-1,4-dihydro-4-oxo- 1,8-naphthyridine-3-carboxylic acid.
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