| 呋喃西林溶液的无菌检查方法验证 |
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| 引用本文： | 陆小燕,李庆欣,赵勤,王子林. 呋喃西林溶液的无菌检查方法验证[J]. 抗感染药学, 2009, 6(1): 29-31 |
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| 作者姓名： | 陆小燕 李庆欣 赵勤 王子林 |
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| 作者单位： | 苏州市吴中人民医院,江苏,苏州,215128;南京中医药大学,江苏,南京,210009;苏州市药品检验所,江苏,苏州,215000;江苏医药科技学校,江苏,苏州,215009 |
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| 摘 要： | 目的:建立合理的无菌呋喃西林溶液无菌检查方法并进行方法验证。方法:按《中国药典》2005年版附录要求进行试验,通过薄膜过滤法消除无菌呋喃西林溶液中呋喃西林和苯甲酸钠较强的抑菌性,进行方法验证试验并建立无菌呋喃西林溶液无菌检查方法。结果:方法验证试验结果证明此方法适用于无菌呋喃西林溶液的无菌检查。结论:该方法简便易行,结果准确。
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| 关 键 词： | 呋喃西林溶液 无菌检查 方法验证 |
Validation of Aseptic Test for Furacilin Solution |
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| LU Xiao-yan,LI Qing-xin,ZHAO Qin,WANG Zi-lin. Validation of Aseptic Test for Furacilin Solution[J]. Anti-infection Pharmacy, 2009, 6(1): 29-31 |
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| Authors: | LU Xiao-yan LI Qing-xin ZHAO Qin WANG Zi-lin |
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| Affiliation: | 1Suzhou Wuzhong People＇s Hospital Suzhou Jiangsu 215000, China;2Nanjing University of Triditional Chinese Medicine, Nanjing 210009, China;3Suzhou Institute for Drug Control Suzhou Jiangsu 215000, China; 4Secondary School of Pharmaceutical Science and Technology, Suzhou jiangsu 215009, China) |
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| Abstract: | Objective： To construct the reasonable method to validate aseptic test for furacilin solution.Methods： Carrying out the aseptic test following the appendix of ＂China Pharmacopoeia （2005）＂, and clearing up the strong bacterial restrain of furacilin and sodium benzoate in furacilin solution through the method of pellicle filtration. Furthermore seting up the proper method for the aseptic test of furacilin solution, and validating this method via validation experiments. Results： The validation experiments prove that the above-mentioned method is adaptive with the aseptic test of furacilin solution. Conclusion： The method of pellicle filtration is suitable for the aseptic test of furacilin solution. |
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| Keywords: | furacilin solution aseptic test validation experiment |
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