| 摘要 |
This invention relates to a macrolide composition, more particularly an amorphous form (Form-III) of 3R, 4S, 5S, 6R, 7R, 9R, 11S, 12R, 13S, 14R-6- [(2S, 3R, 4S, 6R)-4-dimethylamino-3- hydroxy-6-methyloxan-2-yl]oxy-14- ethyl-7, 12, 13-trihydroxy-4-[(2R, 4R, 5S, 6S)-5-hydroxy-4-methoxy-4, 6- dimethyloxan-2-yl]oxy-10- (2-methoxyethoxymethoxyimino) -3, 5, 7, 9, 11, 13- hexamethyl-1-oxacyclotetradecan- 2-one or roxithromycin characterised by the absence of peaks in the infra-red spectrum of amorphous (Form-Ill) of roxithromycin at 3577.15; 3526.03; 3465.27 and 3276.24 cm-1 relative to the infra-red spectrum of the prior art roxithromycin raw material displaying peaks at 3577.15; 3526.03; 3465.27 and 3276.24 cm-1 and further characterised by an increased solubility of at least 50% over prior art anhydrous and monohydrated roxithromycin in acetate buffer (pH 4.5), phosphate buffer (pH 6.8) and water. |
