| 杨锐,王露露,赵芯,许凯,李海亮,王珏,张朝阳,孙会敏.二甲硅油分子交联的表征研究[J].中国药事,2019,33(7):774-782 |
| 二甲硅油分子交联的表征研究 |
| On Characterization of Molecular Cross-linking of Dimethicone |
| 投稿时间：2019-03-27 |
| DOI：10.16153/j.1002-7777.2019.07.009 |
| 中文关键词: 二甲硅油 超高效液相-高分辨质谱 黏度 分子交联化 |
| 英文关键词: Dimethicone UHPLC-MS viscosity molecule cross-linking |
| 基金项目:“重大新药创制”科技重大专项“新辅料关键技术研究及产业化生产”专项-“新型注射脂质辅料的产业化及应用的共性关键技术研发和国际化注册”（编号2018ZX09721002-003） |
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| 中文摘要: |
| 目的：对药用辅料二甲硅油的结构进行解析表征。方法：采用超高效液相-高分辨质谱联用方法检测，基于高分辨质谱提供的分子离子峰和碎片信息对二甲硅油的结构进行解析。利用MassHunter质谱工作站及数据分析功能对二甲硅油20、50、100、200、350、500、750、1000、12500和30000系列型号样品进行分析表征。结果：二甲硅油按照黏度不同可以分为不同的型号，随着型号的增加，黏度不断增大，通过对二甲硅油分子结构的解析发现，二甲硅油的结构中存在分子交联的现象，其分子交联的比例与其黏度成正相关。结论：二甲硅油的黏度是其重要的功能性指标，二甲硅油的黏度不仅与其聚合度有关，还与其分子交联的比例有关。 |
| 英文摘要: |
| Objective:To analytically characterize the structure of pharmaceutical excipient Dimethicone. Methods:UHPLC-HRMS detection was used to analyze the structure of Dimethicone based on molecular ion peak and fragment information provided by high resolution mass spectrometry. Samples of Dimethicone 20, 50, 100, 200, 350, 500, 750, 1000, 12500 and 30000 series numbers were analyzed and characterized by using the data analysis functions of MassHunter mass spectrometer. Results:Dimethicone could be classified into different types according to its viscosity. With the increase of the models, the viscosity increases continuously. There was phenomenon of molecular crosslinking in the structure of Dimethicone according to the analysis of the molecular structure of dimethicone. And the proportion of molecular crosslinking was positively correlated with its viscosity. Conclusion:The viscosity of Dimethicone is an important functionality-related characteristic. The viscosity of Dimethicone is related not only to its degree of polymerization, but also to the proportion of molecule crosslinking. |
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