| 泡罩包装对辛伐他汀片剂稳定性的影响 |
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| 引用本文： | 郭冬薇,沈园园,陈伟峦,郭圣荣. 泡罩包装对辛伐他汀片剂稳定性的影响[J]. 中国医药工业杂志, 2011, 42(7) |
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| 作者姓名： | 郭冬薇 沈园园 陈伟峦 郭圣荣 |
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| 作者单位： | 上海交通大学药学院,上海,200240 |
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| 基金项目： | 上海市教委博士学科点专项科研基金(09ZZ24) |
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| 摘 要： | 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。
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| 关 键 词： | 辛伐他汀 片剂 包装 稳定性 液相色谱-质谱 |
Effect of Packaging on Stability of Simvastatin Tablets |
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| GUO Dongwei,SHEN Yuanyuan,CHEN Weiluan,GUO Shengrong. Effect of Packaging on Stability of Simvastatin Tablets[J]. , 2011, 42(7) |
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| Authors: | GUO Dongwei SHEN Yuanyuan CHEN Weiluan GUO Shengrong |
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| Affiliation: | GUO Dongwei,SHEN Yuanyuan,CHEN Weiluan,GUO Shengrong~* (School of Pharmacy,Shanghai Jiaotong University,Shanghai 200240) |
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| Abstract: | Three types of packages[polyvinyl chloride(PVC)-aluminum(Al),polyvinyl dichloride(PVDC)-Al and Al-Al blisters]were used to investigate the effect of packaging on stability of moisture sensitive simvastatin tablets.The content changes of simvastatin and its related substances and the container moisture permeability of blisters were studied to evaluate the effects.Three related substances of simvastatin were identified to be simvastatin acid, lovastatin and lovastatin acid by HPLC and LC-MS.The increase of re... |
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| Keywords: | simvastatin tablet package stability LC-MS |
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