| 关于缓控释制剂的处方优化指标 |
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| 引用本文： | 洪燕龙,冯怡,徐德生. 关于缓控释制剂的处方优化指标[J]. 中国中药杂志, 2006, 31(1): 5-5 |
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| 作者姓名： | 洪燕龙 冯怡 徐德生 |
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| 作者单位： | 1. 上海中医药大学,附属曙光医院,上海,200021
2. 上海中医药大学,中药学院,上海,201203 |
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| 摘 要： | 体外释放度是固体制剂质量控制的重要指标之一。它是生物等效性评价的重要指标,也是缓控释制剂处方优化、稳定性考察、生产过程的质量控制等方面的重要参数。本研究对近年来国内缓控释制剂处方优化的指标,包括相似因子和偏离度的应用进行了比较。
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| 关 键 词： | 缓控释制剂 处方优化 体外释放度 相似因子 偏离度 |
| 文章编号： | 1001-5302（2006）01-0015-03 |
| 收稿时间： | 2005-07-03 |
| 修稿时间： | 2005-07-13 |
Study on index for formulation optimization of sustained or controlled released dosage forms |
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| HONG Yan-long;FENG Yi;XU De-sheng. Study on index for formulation optimization of sustained or controlled released dosage forms[J]. China Journal of Chinese Materia Medica, 2006, 31(1): 5-5 |
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| Authors: | HONG Yan-long FENG Yi XU De-sheng |
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| Affiliation: | 1. Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200021, China ; 2. School of Pharmacy, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China |
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| Abstract: | Release in vitro is one of the indexes for quality control of solid dosage forms.It is not only the important indexes for evaluation of bioequivalence,also the important parameter of formulation optimization,study of the stability and quality control within producing of sustained or controlled release dosage forms.The review is the study on index for formulation optimization of sustained or controlled released dosege forms in China since 999,including the application of similarity factor and deviation. |
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| Keywords: | sustained or controlled release dosage forms form ulation optimization release in vitro similarity factor deviation |
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