【摘要】 目的 研究西尼地平的光稳定性。方法 以西尼地平原料、西尼地平甲醇溶液、西尼地平片剂溶出液为对象,分别用强光(4 500lX)或自然光照射,用HPLC法测定光照射后的降解产物,以HPLC-MS研究光降解产物的结构,并研究自然光对片剂溶出度测定的影响。结果 西尼地平原料、西尼地平甲醇溶液对光敏感,在强光(4 500lx)照射下分解生成Z-异构体。自然光可影响西尼地平片剂的溶出度测定,在不避光时西尼地平片剂溶出液吸收度下降,溶出度测定结果偏低。结论 西尼地平对光敏感,西尼地平及其制剂均应该避光保存,西尼地平制剂的溶出度测定时应注意避光操作。更多还原

【Abstract】 OBJECTIVE To determine the stability of cilnidipine in light. METHODS The degradation substance of cilnidipine and cilnidipine methanol solution were determined by high performance liquid chromatography (HPLC) after exposure in strong light (4 500 Ix). The structure of the degradation substance was identified by HPLC with mass detector. Dissolution rate of cilnidipine tablets was determined in sunlight or avoiding sunlight. RESULTS Cilnidipine and cilnidipine methanol solution were sensitive to strong light (4 500 Ix), Z-isomer cilnidipine was the main degradation product. The dissolution rate of cilnidipine tablets was higher when avoiding sunlight. CONCLUSIONS Cilnidipine is sensitive to light. Clinidipine should be stored in dark, and the dissolution test should not be carried out in light.更多还原