| 复方碘化钾滴眼液无菌检查方法的验证 |
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| 引用本文： | 余晓霞,邱凯锋,廖庆权. 复方碘化钾滴眼液无菌检查方法的验证[J]. 中国实用医药, 2014, 0(29): 69-71 |
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| 作者姓名： | 余晓霞 邱凯锋 廖庆权 |
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| 作者单位： | 中山大学孙逸仙纪念医院药学部,510120 |
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| 摘 要： | 目的建立复方碘化钾滴眼液无菌检查方法。方法按《中国药典》2010年版二部无菌检查法中薄膜过滤法对复方碘化钾滴眼液的无菌检查方法进行验证。结果该制剂的无菌检查选用薄膜过滤法,以金黄色葡萄球菌为阳性对照菌,冲洗总量100 ml。结论经方法学验证,该法可行,结果可靠。
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| 关 键 词： | 复方碘化钾滴眼液 无菌检查 验证 |
Validation of sterility test of compound potassium iodide eye drops |
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| YU Xiao-xia,QIU Kai-feng,LIAO Qing-quan. Validation of sterility test of compound potassium iodide eye drops[J]. China Practical Medical, 2014, 0(29): 69-71 |
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| Authors: | YU Xiao-xia QIU Kai-feng LIAO Qing-quan |
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| Affiliation: | ( Department of Pharmacy, Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou 510120, China) |
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| Abstract: | Objective To establish the method of sterility test of compound potassium iodide eye drops.Methods According to sterility test in the appendix of Chinese Pharmacopoeia 2010 （section 2）, the membrane filteration used in the sterility test of compound potassium iodide eye drops was validated. Results The membrane filteration was used in the sterility test of compound potassium iodide eye drops, and staphylococcus aureus was used as positive control germs and the total amount of irrigation fluid was 100 ml. Conclusion Through the technological validation, the method is applicable and the result is reliable. |
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| Keywords: | Compound potassium iodide eye drops Sterility test Validation |
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