Determination of particle size and particle size distribution of selected component in mixed powders by its melting characteristics
文献类型：期刊论文
| 作者 | Tang Yan2; He Yuanzhi2; Wu Li7; Zhang Liu7; Guo Tao7; Wu Wenting6; Jing Guanghui5; Yin Xianzhen4; Zhu Weifeng6; Zhang Jiwen2
|
| 刊名 | Acta Pharmaceutica Sinica
 |
| 出版日期 | 2018 |
| 卷号 | 53期号:9页码:1545-1550 |
| 关键词 | melting characteristics mixed powder particle size distribution microscopic image consistent evaluation |
| ISSN号 | 0513-4870 |
| 其他题名 | 利用热熔特征检出混合粉体中目标成分粒径及其分布 |
| 文献子类 | Article |
| 英文摘要 | The particle diameters of active pharmaceutical ingredient (API) and excipients are important factors to the quality of preparations and have great significances in the reverse engineering to brand products and the consistent evaluation of generic drugs. In this study, a novel method was established for particle size determination to identify the selected component and eliminate other interferential particles by comparing the microscopic images before and after fusion caused by controllable heating. Stearic acid (SA) particles in irregular and spherical shape were selected as a typical excipient to demonstrate the methodology, which were identified from the mixed particles based upon its melting characteristics to detect their particle sizes as well as the size distributions. In the same approach, the morphology and particle size of fenofibrate particles as API in tablets were analyzed. The results illustrated that the particle diameters and particle size distributions of the selected components in the mixture of particles can be detected via the hot-melting characteristics under the prerequisite of proper pretreatment to separate selected components from other particles in microscopic field. In conclusion, this research provides a practical approach for the reverse engineering purpose to brand products and the consistent evaluation of generic drugs. |
| 资助项目 | 国家自然科学基金资助项目[00000000] ; 国家重大科技专项资助项目[00000000] |
| WOS研究方向 | Pharmacology & Pharmacy (provided by Clarivate Analytics) |
| 语种 | 中文 |
| CSCD记录号 | CSCD:6317344 |
| 源URL | [http://119.78.100.183/handle/2S10ELR8/269166]  |
| 专题 | 药物制剂研究中心 分子影像中心（筹） |
| 通讯作者 | Zhang Jiwen |
| 作者单位 | 1.Ltd.,; 2.Jiangxi University of Traditional Chinese Medicine; 3.Shanghai 4.Shanghai Institute of Materia Medica, Chinese Academy of Sciences; 5.Disha Pharmaceutical Co., Ltd., Weihai, Shandong 264200, China.; 6.Jiangxi University of Traditional Chinese Medicine, Key Laboratory of Modern Preparation of TCM, Ministry of Education, Nanchang, Jiangxi 330004, China.; 7.Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai 201203, China.; 8.; 9.Nanchang; 10.Chinese Academy of Sciences, Key Laboratory of Modern Preparation of TCM, Ministry of Education; |
| 推荐引用方式 GB/T 7714 | Tang Yan,He Yuanzhi,Wu Li,et al. Determination of particle size and particle size distribution of selected component in mixed powders by its melting characteristics[J]. Acta Pharmaceutica Sinica,2018,53(9):1545-1550. |
| APA | Tang Yan.,He Yuanzhi.,Wu Li.,Zhang Liu.,Guo Tao.,...&Zhang Jiwen.(2018).Determination of particle size and particle size distribution of selected component in mixed powders by its melting characteristics.Acta Pharmaceutica Sinica,53(9),1545-1550. |
| MLA | Tang Yan,et al."Determination of particle size and particle size distribution of selected component in mixed powders by its melting characteristics".Acta Pharmaceutica Sinica 53.9(2018):1545-1550. |
入库方式： OAI收割
来源：上海药物研究所
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