Stable crystal form medicine composition, and preparation method and application thereof

The invention relates to a N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazole-5-yl]carbonyl]-N-2-pyridyl-beta-alanine ethyl ester mesylate composition and a preparation method thereof. The composition includes a crystal form (I) of the N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazole-5-yl]carbonyl]-N-2-pyridyl-beta-alanine ethyl ester mesylate and a compound represented as the formula (b). The R1, R2 and R3 respectively are alkyl groups or aryl groups and R4 is hydrogen, alkyl group or aryl group, wherein the groups can be same or different. The n is 1, 2 or 3. The X is an acid radical ion. The composition significantly improves the stability of the crystal form (I). The preparation method is simple and is suitable for industrial application. 本发明涉及种N-[[2-[[[4-[[[(己氧基)羰基]氨基]亚氨基甲基]苯基]氨基]甲基]-1-甲基-1H-苯并咪唑-5-基]羰基]-N-2-吡啶基-β-丙氨酸乙酯甲磺酸盐组合物及其制备方法。所述组合物包含N-[[2-[[[4-[[[(己氧基)羰基]氨基]亚氨基甲基]苯基]氨基]甲基]-1-甲基-1H-苯并咪唑-5-基]羰基]-N-2-吡啶基-β