关键词: 尼可地尔, 药物稳定性, 药物载体, 色谱法, 高压液相

Abstract: ［Abstract］〓Objective〖HTSS〗〓To study the stability of refrigerated drug Nicorandil compatible with solvents of different carriers.
〖HTH〗〖WTHZ〗Methods〖HTSS〗〓The solutions of nicorandil dissolved with 0.9% sodium chloride injection or 5% glucose Injection were stored at room temperature or low temperature for 8 h. The concentration of nicorandil was determined by ultrahigh performance liquid chromatography， and the chromatographic conditions were as follows： chromatographic column was ACEC18（50 mm×2.1 mm， 2.5 μm） column and the column temperature was 40 ℃， the mobile phase was methanolwater（42〖DK〗∶58） with a flow rate of 0.4 mL/min， the detection wavelength was set at 254 nm. The changes of pH were measured with pH meter. The number of insoluble particles were surveyed by particle analyzer.
〖HTH〗〖WTHZ〗Results〖HTSS〗〓The linear ranges of nicorandil was 3.316-18.896 mg/L （r=0.999）. The concentration of  nicorandil and the value of pH were stable after dissolved in different solvents and stored at different temperatures within 8 h. Additionally，  the amount of particles（≥25 μm ） was normal， while amount of particles（≥10 μm） was relatively larger.
〖HTH〗〖WTHZ〗Conclusion〖HTSS〗〓When stored at either room temperature or low temperature，the stability of nicorandil solution after dissolved in different solvents is  desirable within 8 h， while the amount of particles（≥10 μm）  exceed the number of regulation.

Key words: nicorandil； drug stability； , drug carriers； chromatography, high pressure liquid