|
|||||
|
|
| 注射用甲磺酸萘莫司他热原检查方法学验证 | |
| 引用本文： | 瞿飘飘,孙叶丹,朱社敏,张劲松,匡荣. 注射用甲磺酸萘莫司他热原检查方法学验证[J]. 中国药品标准, 2015, 16(3): 194-197 |
| 作者姓名： | 瞿飘飘 孙叶丹 朱社敏 张劲松 匡荣 |
| 作者单位： | 浙江工业大学,浙江省食品药品检验研究院,浙江省食品药品检验研究院,浙江省食品药品检验研究院,浙江省食品药品检验研究院 |
| 摘 要： | 目的：验证注射用甲磺酸萘莫司他热原检查方法的适用性。方法：参考《中国药典》2010年版二部附录中化学药品注射剂安全性检查法应用指导原则，对注射用甲磺酸萘莫司他进行热原检查的方法学验证。结果：注射用甲磺酸萘莫司他在剂量为8 mg?kg-1时对热原检查有一定的干扰作用，不适宜进行热原试验，4 mg?kg-1则对热原检查无干扰。结论：可以采用热原检查法检查注射用甲磺酸萘莫司他中可能存在的热原，且注射剂量为4 mg?kg-1较为合适。 |
| 关 键 词： | 热原检查法；注射用甲磺酸萘莫司他；热原 |
| 收稿时间： | 2014-12-30 |
| 修稿时间： | 2015-04-13 |
Validation on the Pyrogen Test of Nafamostat Mesilate For Injection |
|
| Qu Piaopiao,Sun Yedan,Zhu Shemin,Zhang Jinsong and Kuang Rong. Validation on the Pyrogen Test of Nafamostat Mesilate For Injection[J]. , 2015, 16(3): 194-197 | |
| Authors: | Qu Piaopiao Sun Yedan Zhu Shemin Zhang Jinsong Kuang Rong |
| Affiliation: | Zhejiang University of Technology,The food and drug inspection institute of zhejiang province,The food and drug inspection institute of zhejiang province,The food and drug inspection institute of zhejiang province and The food and drug inspection institute of zhejiang province |
| Abstract: | Objiective: To explore the applicability of pyrogen test on Nafamostat Mesilate for Injection. Mathods: Refer to the appendix of Chinese Pharmacopoeia 2010 second section :chemicals injections safety test application guidelines, methodology validation of pyrogen test of Nafamostat Mesilate for Injection was carried on. Results: At dose of 8 mg?kg-1 ,Nafamostat Mesilate for Injection was unsuitable for pyrogen test which had some interference effect,but the concentration of 4 mg?kg-1 had no interference with pyrogen test. Conclusion: Pyrogen test can be used for checking potential pyrogen in Nafamostat Mesilate for Injection at the dose of 4 mg?kg-1 . |
| Keywords: | pyrogen test Nafamostat Mesilate For Injection pyrogen |
| 点击此处可从《中国药品标准》浏览原始摘要信息 | |
| 点击此处可从《中国药品标准》下载全文 | |