| 引用本文: | 欧丽泉,赵国巍,张守德,曾庆云,蔡萍,徐堃杰,陈林.过程性因素对固体分散体稳定性的影响[J].中国现代应用药学,2020,37(9):1139-1144. |
| OU Liquan,ZHAO Guowei,ZHANG Shoude,ZENG Qingyun,CAI Ping,XU Kunjie,CHEN Lin.Effect of Process Factors on the Stability of Solid Dispersions[J].Chin J Mod Appl Pharm(中国现代应用药学),2020,37(9):1139-1144. |
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| 过程性因素对固体分散体稳定性的影响 |
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欧丽泉1, 赵国巍1, 张守德1, 曾庆云1, 蔡萍1, 徐堃杰2, 陈林2
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1.江西中医药大学, 现代中药制剂教育部重点实验室, 南昌 330004;2.江西中医药大学, 药学院, 南昌 330004
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| 摘要: |
| 固体分散体是改善难溶性药物溶解度、溶出行为和生物利用度的有效途径，但固体分散体稳定性差已成为制约以固体分散技术为基础的给药系统市场化的瓶颈问题。本文探讨制备方法、制剂工艺、储存条件等过程性因素对固体分散体的重结晶、药物成分含量、溶出、外观等稳定性的影响，为固体分散体研究与开发提供指导。 |
| 关键词: 固体分散体 稳定性 过程性因素 |
| DOI：10.13748/j.cnki.issn1007-7693.2020.09.021 |
| 分类号:R944.4 |
| 基金项目:国家自然科学基金项目（81560654）；江西省卫生计生委中医药科研课题项目（2015A055）；江西省教育厅科学技术研究项目（170735）；江西省中药学一流学科专项科研基金项目（JXSYLXK-ZHYAO058） |
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| Effect of Process Factors on the Stability of Solid Dispersions |
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OU Liquan1, ZHAO Guowei1, ZHANG Shoude1, ZENG Qingyun1, CAI Ping1, XU Kunjie2, CHEN Lin2
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1.Jiangxi University of Traditional Chinese Medicine, Key Laboratory of Modern Chinese Medicine Preparation, Ministry of Education, Nanchang 330004, China;2.Jiangxi University of Traditional Chinese Medicine, School of Pharmacy, Nanchang 330004, China
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| Abstract: |
| Solid dispersion(SD) is an effective way to improve the solubility, dissolution behavior and bioavailability of insoluble drugs. However, the poor stability of SD has become the bottleneck problem restricting the marketization of drug delivery system based on solid dispersion technology. The effects of process factors such as preparation method, preparation technology and storage conditions on the stability of SD recrystallization, drug composition content, dissolution and appearance are discussed, which provides guidance for SD research and development. |
| Key words: solid dispersion stability process factor |
