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| 注射用盐酸吉西他滨细菌内毒素方法验证 | |
| 引用本文： | 王春玲 李孝壁 颜磊亭 等. 注射用盐酸吉西他滨细菌内毒素方法验证[J]. 中国医药科学, 2014, 0(1): 123-125 |
| 作者姓名： | 王春玲 李孝壁 颜磊亭 等 |
| 作者单位： | 江苏豪森医药研究院有限公司,江苏连云港222000 |
| 摘 要： | 目的对注射用盐酸吉西他滨的细菌内毒素检查方法进行探讨，建立其细菌内毒素检查方法。方法按《中国药典》2010版附录ⅪE细菌内毒素检查方法进行。结果在验证条件下，注射用盐酸吉西他滨可以采用稀释方法排除干扰。结论可以采用此法对本品的细菌内毒素进行检查。 |
| 关 键 词： | 注射用盐酸吉西他滨 细菌内毒素方法 验证 |
Validation of bacterial endotoxin test method of gemcitabine hydrochloride for injection |
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| Affiliation: | WANG Chunling LI Xiaobi YAN Leiting CHEN Juan ZHU Fengshu Jiangsu Hansoh Medicine Research Institute Co., Ltd., Lianyungang 222000, China |
| Abstract: | Objective Research and establish bacterial endotoxin test method of Gemcitabine Hydrochloride for Injection. Methods The test method was developed according to the bacterial endotoxin method of Appendix XI E in 2010 Edition of Chinese Pharmacopeia Volume II . Results In the validation conditions, the dilution method Can be used to eliminate the interference in the test of Gemcitabine Hydrochloride for Injection. Conclusion This method can be used to test the bacterial endotoxin in Gemcitabine Hydrochloride for Injection. |
| Keywords: | Gemcitabine hydrochloride for injection Bacterial endotoxin method Validation |
| 本文献已被 CNKI 维普 等数据库收录！ | |