| 固体口服制剂的相转化研究进展 |
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| 引用本文： | 王弘,陈宜鸿,刘皈阳.固体口服制剂的相转化研究进展[J].中国新药杂志,2006,15(21):1824-1827. |
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| 作者姓名： | 王弘 陈宜鸿 刘皈阳 |
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| 作者单位： | 中国人民解放军总医院药品保障中心,北京,100853 |
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| 摘 要： | 固体口服制剂的相转化研究对选择工艺流程和研发新产品有重要意义。根据相转化机制，固相相变可以分为3种类型：多晶型的转化（polymorphic transition），水化与脱水（hydration／dehydration），玻璃化相与结晶（vierfication/crystallization）的相互转化。固体口服新制剂研究中应重视药物多晶型和无定形现象，预防和防治固相处方设计与工艺流程选择中发送的相转化。
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| 关 键 词： | 固体口服制剂 相转化 相转化机制 |
| 文章编号： | 1003-3734（2006）21-1824-04 |
| 收稿时间： | 2006-06-10 |
| 修稿时间： | 2006年6月10日 |
Outlines of phase transformation considerations in solid oral formulations |
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| WANG Hong,CHEN Yi-hong,LIU Gui-yang.Outlines of phase transformation considerations in solid oral formulations[J].Chinese Journal of New Drugs,2006,15(21):1824-1827. |
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| Authors: | WANG Hong CHEN Yi-hong LIU Gui-yang |
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| Institution: | Department of Pharmacy, China PLA General Hospital, Belting 100853, China |
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| Abstract: | Phase transformation considerations during process development and manufacture of solid oral dosage forms play important roles in the formulation design and process selection. According to phase transformation mechanisms, solid phase transformation were classified as 3 types: polymorphic transition , hydration/dehydration, vitrification/crystallization. This report proposes recommendations for monitoring and controlling polymorphs, amorphous and potential phase transformation during pharmaceutical processing. |
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| Keywords: | solid oral dosage form phase transformation phase transformation mechanisms |
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