| 注射用加替沙星的制备及质量控制 |
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| 引用本文： | 王萍,蒋金元.注射用加替沙星的制备及质量控制[J].药学进展,2004,28(10):461-464. |
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| 作者姓名： | 王萍 蒋金元 |
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| 作者单位： | 1. 南京医科大学第二附属医院,江苏,南京,210011
2. 南京泽辰科技有限公司,江苏,南京,210009 |
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| 摘 要： | 目的：建立加替沙星注射液的制备和质量控制方法。方法：确定注射剂的配置工艺，以HPLC法测定加替沙星的含量，进行稳定性考察。结果：本品制剂质量稳定，用HPLC法测定含量，平均回收率100．3％，重复性试验RSD为1．75％。结论：制备工艺可行，质量稳定，质量控制方法可靠。
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| 关 键 词： | 加替沙星 注射用 HPLC法 质量控制方法 制剂质量 注射剂 注射液 制备 测定含量 工艺 |
| 文章编号： | 1001-5094(2004)10-0461-04 |
| 修稿时间： | 2004年5月28日 |
Preparation and Quality Control of Gatifloxcin for Injection |
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| WANG Ping ,JIANG Jin yuan.Preparation and Quality Control of Gatifloxcin for Injection[J].Progress in Pharmaceutical Sciences,2004,28(10):461-464. |
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| Authors: | WANG Ping JIANG Jin yuan |
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| Institution: | WANG Ping 1,JIANG Jin yuan 2* |
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| Abstract: | Objective: To establish a method for the preparation and quality control of gatifloxcin for injection. Methods:The preparation method for injection was employed. Gatifloxcin was determined by HPLC, and the stabitity was studied. Results: The preparation was stable. Content was determined by HPLC. The average recovery was 100 3%, and RSD was 1 75%. Conclusion: The preparation was practicable, the method for quality control was convenient, and the quality was stable. |
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| Keywords: | Gatifloxcin for injection Preparation Quality control |
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