| 盐酸加替沙星滴眼液的制备及质量控制 |
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| 引用本文： | 罗凤琴,陈海燕,赵春景. 盐酸加替沙星滴眼液的制备及质量控制[J]. 中国药房, 2004, 15(5): 281-283 |
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| 作者姓名： | 罗凤琴 陈海燕 赵春景 |
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| 作者单位： | 1. 重庆医科大学附属第二医院,重庆市400010
2. 重庆市药品检验所,重庆市,400015 |
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| 摘 要： | 目的 :建立盐酸加替沙星滴眼液的制备方法及质量标准。方法 :取盐酸加替沙星 +氯化钠制成0 2 %盐酸加替沙星滴眼液 ,以磷酸盐缓冲液 -乙腈 (81∶19)为流动相 ,采用高效液相色谱法 (C18 柱 )测定盐酸加替沙星的含量。结果 :该方法能很好分离被测组分与其它杂质 ,被测组分浓度线性范围为25～400μg/ml(r=0 9996) ,平均回收率为99 89 % ,RSD=1 55 %。结论 :制备工艺简单 ,质量可控。
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| 关 键 词： | 加替沙星滴眼液 制备 质量控制 |
| 文章编号： | 1001-0408(2004)05-0281-03 |
| 修稿时间： | 2004-02-16 |
Preparation and Quality Control of Gatifloxacin Hydrochloride Eye-drops |
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| LUO Fengqin,ZHAO ChunjingThe Second Affiliated Hospital,Chongqing University of Medical Sciences,Chongqing CHEN HaiyanChongqing Institute for Drug Control,Chongqing. Preparation and Quality Control of Gatifloxacin Hydrochloride Eye-drops[J]. China Pharmacy, 2004, 15(5): 281-283 |
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| Authors: | LUO Fengqin ZHAO ChunjingThe Second Affiliated Hospital Chongqing University of Medical Sciences Chongqing CHEN HaiyanChongqing Institute for Drug Control Chongqing |
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| Affiliation: | LUO Fengqin,ZHAO ChunjingThe Second Affiliated Hospital,Chongqing University of Medical Sciences,Chongqing400010 CHEN HaiyanChongqing Institute for Drug Control,Chongqing400015 |
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| Abstract: | OBJECTIVE:To establish the preparation process and method of quality control of Gatifloxacin hydrochloride eye-drops.METHODS:Mixing Gatifloxacin hydrochloride with NaCl in water to prepare Gatifloxacin hydrochloride eye-drops.The HPLC system consisted of C 18 column and mobile phase of PBS solution-acetonitrile81∶19.RESULTS:The linear range of Gatifloxacin hydrochloride was25～400μg/ml,r=0.9996.The average recovery rate was99.89%RSD=1.55%. CONCLUSION:The preparation process of Gatifloxacin hydrochloride eye-drops is simple and the method of quality control by HPLC is reliable. |
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| Keywords: | Gatifloxacin hydrochloride eye-drops preparation quality control |
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