| 盐酸氮卓斯汀滴眼液无菌检查方法学验证研究 |
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| 引用本文： | 李旸华,张映娜,雷柳冰,林秋凤.盐酸氮卓斯汀滴眼液无菌检查方法学验证研究[J].中国现代药物应用,2011,5(11):12-13. |
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| 作者姓名： | 李旸华 张映娜 雷柳冰 林秋凤 |
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| 作者单位： | 东莞市食品药品检验所,523109 |
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| 摘 要： | 目的确定可行的盐酸氮卓斯汀滴眼液无菌检查方法。方法采用薄膜过滤法对样品进行无菌检查。结果样品、阴性对照及试验组菌生长良好。结论薄膜过滤加缓冲液冲洗能去除抑菌作用,并通过验证试验保证无菌检查方法的可靠性。
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| 关 键 词： | 盐酸氮卓斯汀滴眼液 无菌检查方法 方法验证 |
Studies on test for sterility of azelastine hydrochloride eye drops |
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| Institution: | LI Yang-hua,ZHANG Ying-na,LEI Lui-bing,et al.Institute for Food And Drug Control of Dongguan,GuangDong,523109,China |
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| Abstract: | Objective To establish a method for slerility test of azelastine hydrochloride eye drops.Methods Using membrane filtration method for sterility test of samples.Results The samples,negative control samples and the growth of good bacteria.Conclusion Add buffer to wash the membrane filter to remove the inhibitory effect,and through verification tests to ensure the reliability of sterility test method. |
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| Keywords: | Azelastine hydrochloride eye drops sterility test method method validation |
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