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| 注射用甲磺酸酚妥拉明细菌内毒素检查方法的研究 | |
| 引用本文： | 沈国梁,胡丹,聂渝琼,王海玲,嵇扬,高锦,于思媛.注射用甲磺酸酚妥拉明细菌内毒素检查方法的研究[J].解放军药学学报,2010,26(2):139-141. |
| 作者姓名： | 沈国梁 胡丹 聂渝琼 王海玲 嵇扬 高锦 于思媛 |
| 作者单位： | 1. 昌平南口66325部队医院药房,北京,102202 2. 总后勤部卫生部药品仪器检验所,北京,100071 3. 北京军区总医院药剂科,北京,100700 4. 解放军总医院,北京,100853 |
| 摘 要： | 目的建立注射用甲磺酸酚妥拉明细菌内毒素的检查方法。方法采用《中国药典》2005年版附录细菌内毒素检查法。结果注射用甲磺酸酚妥拉明在0.0125mg/ml及以下浓度时,用灵敏度为0.125EU/ml的鲎试剂检测细菌内毒素,无干扰因素影响。结论注射用甲磺酸酚妥拉明可应用鲎试剂进行细菌内毒素法检查,细菌内毒素限值确定为10EU/mg。 |
| 关 键 词： | 注射用甲磺酸酚妥拉明 细菌内毒素 干扰试验 |
Application of Bacterial Endotoxin Test to Phentolamine Mesilate for Injection |
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| SHEN Guo-liang,HU Dan,NIE Yu-qiong,WANG Hai-ling,JI Yang,GAO Jin,YU Si-yuan.Application of Bacterial Endotoxin Test to Phentolamine Mesilate for Injection[J].Pharmaceutical Journal of Chinese People's Liberation Army,2010,26(2):139-141. | |
| Authors: | SHEN Guo-liang HU Dan NIE Yu-qiong WANG Hai-ling JI Yang GAO Jin YU Si-yuan |
| Institution: | (①Health Department of Unit 66325 of PLA,Beijing 102202,China;②Institute for Drug and Instrument Control,Health Dept GLD of PLA,Beijing 100071,China;③Department of Pharmacy,the General Hospital of Beijing Military Command,Beijing 100700,China;④General Hospital of PLA,Beijing 100853,China) |
| Abstract: | Objective To establish a method of application of bacterial endotoxin test to Phentolamine Mesilate for Injection. Methods The method based on the bacterial endotoxin test in Chinese Pharmacopoeia (2005 edition) was used. Results It was proved that the maximum non-interference concentration of Phentolamine Mesilate for Injection was 0.0125 mg/ml and the sensitivity of tachypleus amebocyte lysate was 0.125 EU/ml.Conclusion The results suggested that bacterial endotoxin test is suitable for the detection of e... |
| Keywords: | Phentolamine Mesilate for Injection bacterial endotoxin test interfere factors test |
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