| 加替沙星滴眼液的制备和质量控制 |
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| 引用本文： | 时文祥,毛志英,张发成. 加替沙星滴眼液的制备和质量控制[J]. 药学进展, 2009, 33(3): 134-137. DOI: 10.3969/j.issn.1001-5094.2009.03.007 |
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| 作者姓名： | 时文祥 毛志英 张发成 |
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| 作者单位： | 1. 南京瑞尔医药有限公司研发部,江苏,南京,210009
2. 南京荣世医药科技有限公司,江苏,南京,210028 |
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| 摘 要： | 目的：研究加替沙星滴眼液的制备和质量控制方法。方法：通过对溶剂、防腐剂、渗透压调节剂和pH值的试验性考察，优化制剂处方工艺。建立HPLC法，测定制剂含量和有关物质，并考察制剂稳定性。结果：获得最佳处方工艺，制备的加替沙星滴眼液其含量和有关物质以及稳定性均符合质量控制要求。HPLC法所测加替沙星浓度的线性范围为7．5～60．3mg·L-1（r=O．9999），平均回收率为99．7％（RSD=0．17％，n=9）。结论：该处方工艺简单、实用，质量控制方法可靠、易行。
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| 关 键 词： | 加替沙星滴眼液 制备 处方 含量 有关物质 质量控制 |
Preparation and Quality Control of Gatifloxacin Eye Drops |
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| SHI Wen-xiang,MAO Zhi-ying,ZHANG Fa-cheng. Preparation and Quality Control of Gatifloxacin Eye Drops[J]. Progress in Pharmaceutical Sciences, 2009, 33(3): 134-137. DOI: 10.3969/j.issn.1001-5094.2009.03.007 |
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| Authors: | SHI Wen-xiang MAO Zhi-ying ZHANG Fa-cheng |
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| Affiliation: | SHI Wen-xiang , MAO Zhi-ying, ZHANG Fa-cheng (1. R＆D Department, Nanjing Real Pharmaceutical Co., Ltd, Nanjing 210009, China; 2. Nanjing Runs Pharmaceutical Technology Development Co., Ltd, Nanjing 210028, China) |
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| Abstract: | Objective： To investigate the methods for preparation and quality control of Gatifloxacin Eye Drops. Methods： The formulation was optimized through the experimental study on solvent, preserva- tive, osmo-regulator and pH value for the preparation. The content of the preparation, its related substances were determined by HPLC and its stability was examined. Results： The optimal formulation was obtained. The content of the preparation and its related substances and stability met the requirements of quality control. The linear range of gatifloxacin concentration determined by HPLC was 7.5 -- 60. 3 mg.L- 1 （ r = 0. 999 9）. Its average recovery was 99.7% （ RSD = 0. 17%, n = 9）. Conclusion： The formula- tion and preparation of Gatifloxacin Eye Drops are simple and practical. The methods for its quality control are reliable and easy. |
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| Keywords: | gatifloxacin eye drops preparation formulation content related substances quality control |
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