The present invention relates a pharmaceutical composition comprising bicyclo-substituted pyrazolon azo derivatives or salt and preparation method thereof. In particular, the present invention relates a pharmaceutical composition comprising (Z)-5-(2-hydroxy-3-(2-(3-methyl-5-oxo-1-(5,6,7,8-tetrahydro-naphthalen-2-yl)-1H-pyrazol-4(5H)-ylidene) hydrazino) phenyl) furan-2-carboxylic acid or medical salt thereof and at least one bulking agent optionally selects from cellulose, microcrystalline cellulose, lactose, starch. The composition has good stability, dissolution and bioavailability, and the preparation process is simple, economical and fast.本發明公開了一種含有雙環取代吡唑酮偶氮類衍生物或其鹽的藥物組成物及其製備方法。具體而言，本發明公開的藥物組成物中含有(Z)-5-(2-羥基-3-(2-(3-甲基-5-側氧基-1-(5,6,7,8-四氫萘-2-基)-1H-吡唑-4(5H)-亞基)肼基)苯基)呋喃-2-羧酸或其可藥用鹽和視需要選自纖維素、微晶纖維素、乳糖、澱粉中至少一種的填充劑，該組成物具有良好的穩定性、溶出度和生物利用度且其製備技術簡便、經濟、快捷。
