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考察了3种包装泡罩[聚氯乙烯-铝(PVC-A1)、聚偏二氯乙烯/聚氯乙烯涂复片-铝(PVDC-Al)和双铝(Al-Al)包装泡罩]对湿敏性药物辛伐他汀片剂稳定性的影响。通过检测辛伐他汀片的药物含量与有关物质含量随时间的变化,评价包装材料的影响。采用HPLC法和LC-MS法确定了辛伐他汀的3个有关物质,分别为辛伐他汀酸、洛伐他汀以及洛伐他汀酸。其中,辛伐他汀酸为辛伐他汀的水解产物。有关物质随时间的变化主要是由辛伐他汀酸的增加引起的,表明辛伐他汀的降解主要是水解。抗湿性最强的Al-Al泡罩中辛伐他汀片剂的稳定性优于PVDC-Al和PVC-Al泡罩,证实了辛伐他汀片剂的稳定性与包装材料的抗湿性高度相关。
Three kinds of packaging blisters [PVC-A1, PVDC-Al and Al-Al blister] were investigated. Effect of simvastatin on the stability of tablets. The effects of packaging materials were evaluated by testing the drug content of simvastatin tablets and the change over time of the substance content. Three related substances of simvastatin were determined by HPLC and LC-MS, respectively simvastatin acid, lovastatin and lovastatin acid. Among them, simvastatin acid is a hydrolyzate of simvastatin. Changes in the substance over time are primarily due to an increase in simvastatin acid, suggesting that the degradation of simvastatin is mainly hydrolysis. The stability of simvastatin tablets in the most moisture-resistant Al-Al blister was better than that of PVDC-Al and PVC-Al blisters, confirming that the stability of simvastatin tablets is highly correlated with the moisture resistance of the packaging material.