| 复方加替沙星滴耳液的制备及质量控制 |
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| 引用本文： | 梁少琼,李国辉,廖朝峰.复方加替沙星滴耳液的制备及质量控制[J].中国药业,2008,17(10):49-50. |
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| 作者姓名： | 梁少琼 李国辉 廖朝峰 |
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| 作者单位： | 广东省深圳市宝安区人民医院,广东,深圳,518101 |
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| 摘 要： | 目的探讨复方加替沙星滴耳液的制备及建立其质量控制。方法以加替沙星和甲硝唑为主药，以甘油和乙醇为溶剂制备滴耳液，采用双波长分光光度法测定两主药含量，并进行稳定性考察。结果加替沙星和甲硝唑的平均回收率分别为．98．43％（RSD=0．68％）和98．92％（RSD=0．73％），制剂有效期达2年以上。结论本制荆制备工艺简单、稳定性好，质量控制方法简易、快速、可行。
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| 关 键 词： | 加替沙星 甲硝唑 滴耳液 制备 质量控制 |
| 文章编号： | 1006-4931(2008)10-0049-02 |
| 修稿时间： | 2008年1月12日 |
Preparation and Quality Control of Compound Gatifloxacin Ear Drops |
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| Liang Shaoqiong,Li Guohui,Liao Chaofeng.Preparation and Quality Control of Compound Gatifloxacin Ear Drops[J].China Pharmaceuticals,2008,17(10):49-50. |
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| Authors: | Liang Shaoqiong Li Guohui Liao Chaofeng |
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| Institution: | ( Bao, an People＇s Hospital of shenzhen City, Shenzhen, Guangdong, China 518101) |
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| Abstract: | Objective To investigate the preparation process and method of quality control of Compound Gatifloxacin Ear Drops（CGED）, Methods Gatifloxacin and metronidazole were taken as the chief components for the preparation of CGED with glycerine and alcohol as solvent. The contents of the 2 chief components were determined by the dual- wavelength spectrophotometric method, The stability was observed. Results The average recovery rate of gatifloxacin and metronidazole was 98.43% （ RSD = 0. 68% ） and 98.92% （ RSD = 0. 73% ）, respectively. The expiry date（shelf life）was over 2 years. Conclusion The preparation is simple in technology and good in stability. The method of quality control is simple, rapid and accurate. |
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| Keywords: | gatifloxaein metronidzaole ear drops preparation quality control |
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