| 盐酸左旋多巴甲酯眼膏的制备及质量控制 |
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| 引用本文： | 黄敏,蒋伟哲,黄兴振,王健,吕立.盐酸左旋多巴甲酯眼膏的制备及质量控制[J].中国药房,2008,19(7):528-530. |
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| 作者姓名： | 黄敏 蒋伟哲 黄兴振 王健 吕立 |
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| 作者单位： | 广西医科大学药学院,南宁市,530021 |
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| 摘 要： | 目的:制备盐酸左旋多巴甲酯眼膏并建立其质量控制方法。方法:以盐酸左旋多巴甲酯为主药制备眼膏;采用高效液相色谱法测定其中主药的含量。结果:所制制剂为浅黄色软膏,鉴别、检查均符合2005年版《中国药典》中的相关规定;盐酸左旋多巴甲酯进样量的线性范围为1.016~8.128μg(r=0.9999,n=5),平均回收率为100.89%(RSD=1.60%,n=6)。结论:本制剂制备工艺简便可行,质量稳定可控。
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| 关 键 词： | 盐酸左旋多巴甲酯眼膏 高效液相色谱法 制备 质量控制 |
| 文章编号： | 1001-0408（2008）07-0528-03 |
| 收稿时间： | 2007-08-17 |
| 修稿时间： | 2007-11-20 |
Preparation and Quality Control of L-dopa Methyl Ester Hydrochloride Eye Ointment |
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| HUANG Min,JIANG Wei-zhe,HUANG Xing-zhen,WANG Jian,LU Li.Preparation and Quality Control of L-dopa Methyl Ester Hydrochloride Eye Ointment[J].China Pharmacy,2008,19(7):528-530. |
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| Authors: | HUANG Min JIANG Wei-zhe HUANG Xing-zhen WANG Jian LU Li |
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| Institution: | HUANG Min, JIANG Wei-zhe, HUANG Xing-zhen, WANG Jian, LU Li(School of Pharmacy, Guangxi Medical University, Nanning 530021, China) |
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| Abstract: | OBJECTIVE： To prepare L-dopa methyl ester hydrochloride（LDME） eye ointment and establish a method for its quality control. METHODS： The eye ointment was prepared with LDME as the principal agent, and the content of LDME was determined by HPLC. RESULTS： The preparation was yellowish ointment with its indexes （in test and identification） all in conformity with the related standards stated in China Pharmacopeia （2005 edition）. There was good linearity of LDME over the range of 1.016-8.128μg （r=0.9999, n=5）, and its average recovery was 100.89% （RSD=1.60%, n=6） . CONCLUSION： The method is simple and feasible, and the oualitv of the ointment is,stable and controllable. |
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| Keywords: | L-dopa methyl ester hydrochloride HPLC Preparation Quality control |
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