| 兰索拉唑肠溶片处方工艺及质量研究 |
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| 引用本文： | 刘哲鹏,邱大为,杨世霆,沈莹,王丹.兰索拉唑肠溶片处方工艺及质量研究[J].中国医药工业杂志,2010,41(2). |
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| 作者姓名： | 刘哲鹏 邱大为 杨世霆 沈莹 王丹 |
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| 作者单位： | 1. 上海理工大学医疗器械与食品学院,上海,200093;上海秀新臣邦医药科技有限公司,上海,201203
2. 上海秀新臣邦医药科技有限公司,上海,201203 |
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| 摘 要： | 考察了各种辅料与兰索拉唑之间的影响因素,筛选出合适辅料,并采用单因素法优化兰索拉唑肠溶片的处方工艺.结果表明,所研制的兰索拉唑肠溶片经高温、高湿和强光影响因素和加速试验考察,0.1 mol/L盐酸2 h药物释放量小于10%;在pH 6.8磷酸盐缓冲液中45 min药物释放度大于80%;有关物质含量小于2%.
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| 关 键 词： | 兰索拉唑 肠溶片 辅料 稳定性 |
Preparation and Quality Evaluation of Lansoprazole Enteric-coated Tablets |
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| Authors: | LIU Zhepeng QIU Dawei YANG Shiting SHEN Ying WANG Dan |
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| Abstract: | The interactions between lansoprazole and several excipients were investigated to screen suitable excipients for lansoprazole enteric-coated tablets.The preparation was optimized by single factor design.The results of the influence factors(including high temperature,high humidity and strong light)test and accelerated test showed that the 2 h accumulative amount of the enteric.coated tablets in 0.1 mol/L HCl was below 10%while the 45 min accumulative amount was above 80%in pH 6.8 phosphate buffer solution.The related substances of the enteric-coated tablets were below 2%. |
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| Keywords: | lansoprazole enteric-coated tablet excipient stability |
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