| 夫西地酸眼用乳剂的制备及质量控制 |
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| 引用本文： | 陈茂玲,王延东,陈念芬.夫西地酸眼用乳剂的制备及质量控制[J].中国实用医药,2009,4(27):3-4. |
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| 作者姓名： | 陈茂玲 王延东 陈念芬 |
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| 作者单位： | 中山大学中山眼科中心,510075 |
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| 摘 要： | 目的制备夫西地酸眼用乳剂并建立该制剂的质量控制方法。方法采用羟丙甲纤维素为增稠剂，按处方制备夫西地酸眼用乳剂，根据中国药典2005年版眼用制剂项下规定建立夫西地酸眼用乳剂的质量控制方法，并用高效液相色谱法测定夫西地酸的含量。结果夫西地酸在20—120mg／L浓度范围内线性关系良好（r=0．9996），平均回收率为99．57％，RSD为1．53％，方法重现性的RSD为0．46％（n=6）。结论该制剂制备工艺简单，含量测定方法简便、准确，质量稳定。
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| 关 键 词： | 夫西地酸 眼用乳剂 制备 质量控制 |
Preparation and quality control of fusidic acid ophthalmic emulsion |
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| CHEN Mao-ling,WANG Yan-dong,CHEN Nian-fen.Preparation and quality control of fusidic acid ophthalmic emulsion[J].China Practical Medical,2009,4(27):3-4. |
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| Authors: | CHEN Mao-ling WANG Yan-dong CHEN Nian-fen |
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| Institution: | . (Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou , Guangdong 510060, China) |
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| Abstract: | Objective To prepare fusidic acid ophthalmic emulsion and establish its quality control methods. Methods Fusidie acid ophthalmic emulsion was prepared by means of the formula. Hypromellose was used as thickening agent. Quality control method of fusidic acid ophthalmic emulsion was established according to ChP, and its content was determined by HPLC. Results The calibration curve of fusidic acid was linear within the concentration range of 20 - 120 mg/L, r = 0. 9996. The average recovery rate of fusidic acid was99.57% （RSD=1.53%）, and the RSD of the repeatability test was 0. 46% （n=6）. Conclusion The preparation uprocess is simple. Its content determination is convenient and accurate. Its quality is stable. |
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| Keywords: | Fusidie acid Ophthalmic emulsion Preparation Quality control |
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