| 0.04%硫酸阿托品滴眼液的制备与质量控制 |
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| 引用本文： | 李锦燊.0.04%硫酸阿托品滴眼液的制备与质量控制[J].中国药房,2006,17(2):111-113. |
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| 作者姓名： | 李锦燊 |
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| 作者单位： | 广西医科大学附属第四医院药剂科,柳州市,545005 |
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| 摘 要： | 目的:建立0.04%硫酸阿托品滴眼液的制备工艺及其质量控制方法。方法:取硫酸阿托品与辅料制成浓度为0.04%的微量硫酸阿托品滴眼液,以乙腈-水(55∶45)为流动相,采用高效液相色谱法测定硫酸阿托品的含量。结果:所得制剂为无色澄明液体;硫酸阿托品检测浓度线性范围为10～60μg/ml(r=0.9999),平均回收率为100.2%(RSD=0.95%,n=9)。结论:该制剂制备工艺简单,含量测定方法简便、准确,质量可控。
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| 关 键 词： | 硫酸阿托品 滴眼液 制备 高效液相色谱法 |
| 文章编号： | 1001-0408(2006)02-0111-03 |
| 收稿时间： | 07 29 2005 12:00AM |
| 修稿时间： | 09 1 2005 12:00AM |
Preparation and Quality Control of Dilute Atropine Sulfate Eye-drops |
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| LI Jinshen.Preparation and Quality Control of Dilute Atropine Sulfate Eye-drops[J].China Pharmacy,2006,17(2):111-113. |
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| Authors: | LI Jinshen |
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| Institution: | Dept. of Pharmacy, The No.4 Affiliated Hospital of Guangxi Medical University, Liuzhou 545005, China |
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| Abstract: | OBJECTIVE: To establish the preparation process and method of quality control of dilute atropine sulfate eye-drops.METHODS: Mixing atropine sulfate with additives in water to prepare 0.04% atropine sulfate eye-drops.And determined the content of atropine sulfate by HPLC,the system consisted of C18 column and mobile phase of acetonitrile-water (55∶45).RESULTS: The product is colorless and clearing liquid.The linear range of atropine sulfate was 10～60μg/ml(r=0.9 999).The average recovery rate was100.2%(RSD=0.95%,n=9).CONCLUSION: The preparation process of dilute atropine sulfate eye-drops is simple and the method of quality control by HPLC is reliable. |
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| Keywords: | Atropine sulfate Eye-drops Preparation HPLC |
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