| 丹七片的微生物限度检查方法验证试验研究 |
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| 引用本文： | 林小毅.丹七片的微生物限度检查方法验证试验研究[J].海峡药学,2012,24(8):76-78. |
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| 作者姓名： | 林小毅 |
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| 作者单位： | 福建省福州市药品检验所 福州350007 |
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| 摘 要： | 目的建立丹七片的微生物限度检查方法并对其进行验证,保证微生物限度检查方法的科学性以及检验结果的正确性和可靠性。方法采用《中国药典》2010年版一部附录微生物限度检查法项下方法进行方法验证。结果确认了丹七片的微生物限度的检查方法。结论丹七片的细菌计数采用培养基稀释法测定;霉菌、酵母菌计数、控制菌检查均采用常规法,结果可靠。
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| 关 键 词： | 丹七片 微生物限度检查法 回收率 研究 |
Research on the determination of Validation method for microbial limits test in Danqi Tablets |
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| LIN Xiao-yi.Research on the determination of Validation method for microbial limits test in Danqi Tablets[J].Strait Pharmaceutical Journal,2012,24(8):76-78. |
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| Authors: | LIN Xiao-yi |
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| Institution: | LIN Xiao-yi(Fujian Fuzhou Institute for Drug Control,Fuzhou 350007,China) |
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| Abstract: | OBJECTIVE To establisha microbial limits test of Danqi tablets and to ensure the scientificity of the test and the accuracy and reliability.METHODS The methods were validated according to Chinese Pharmacopoeia 2010 Edition 1 Appendix microbial limits test.RESULTS The microbial limit test methods were confirmed for Danqi tablets.CONCLUSION It is reliable that bacteria count can be tested by using medium dilution method for Danqi Tablets;Mildew and yeast count,Control bacteria can be tested by using the conventional method. |
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| Keywords: | Danqi tablets microbial limits test recoveries research |
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