| 如何降低乙酰谷酰胺氯化钠注射液的有关物质 |
| |
| 引用本文： | 李继强,李洁,崔健.如何降低乙酰谷酰胺氯化钠注射液的有关物质[J].齐鲁药事,2013,32(1):57-58. |
| |
| 作者姓名： | 李继强 李洁 崔健 |
| |
| 作者单位： | 山东齐都药业有限公司,山东,淄博,255400 |
| |
| 摘 要： | 目的优化乙酰谷酰胺氯化钠注射液的生产制备工艺,降低产品的有关物质,提高质量标准。方法在本品生产过程中进行影响因素试验。结果本品在配制过程中,溶解原料的加水量控制在稀配体积的1%～1.5%,加入原料及碱液并调节pH值的时间控制在10～15 min。结论利用该配制方法,检测本产品的有关物质较低,可有效提高质量标准。
|
| 关 键 词： | 乙酰谷酰胺氯化钠注射液 影响因素试验 有关物质 |
How to reduce related substances of Aceglutamide and Sodium Chloride Injection |
| |
| LI Ji-qiang
,
LI Jie
,
CUI Jian.How to reduce related substances of Aceglutamide and Sodium Chloride Injection[J].qilu pharmaceutical affairs,2013,32(1):57-58. |
| |
| Authors: | LI Ji-qiang LI Jie CUI Jian |
| |
| Institution: | (Shandong Qidu Pharmaceutical Co.,Ltd.,Zibo 255400,China) |
| |
| Abstract: | Objective To optimize the production tecnology of Aceglutamide and Sodium Chloride Injection to reduce it′s related substances,and improve the quality standard.Methods Influcencing factor test was carried out in the production.Results In the preparation process,the water volume for dissolving raw material was controlled in 1%~1.5% of dilution-preparation volume.The raw material and lixivium were added and the pH value was adjusted in 10~15 min.Conclusion The preparation method can reduce the related substances in products and improve the quality standard effectively. |
| |
| Keywords: | Aceglutamide and Sodium Chloride Injection Influence factor test Related material |
| 本文献已被 CNKI 万方数据 等数据库收录！ |
|
