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| 乙酰半胱氨酸胶囊的制备及质量控制 | |
| 引用本文： | 代东梅,罗顺德,程天贵. 乙酰半胱氨酸胶囊的制备及质量控制[J]. 中国医院药学杂志, 2004, 24(5): 263-265 |
| 作者姓名： | 代东梅 罗顺德 程天贵 |
| 作者单位： | 1. 武汉大学药学院,湖北,武汉,430070;湖北省医药工业研究院,湖北,武汉,430061 2. 武汉大学药学院,湖北,武汉,430070 3. 湖北省医药工业研究院,湖北,武汉,430061 |
| 摘 要： | 目的:制备乙酰半胱氨酸胶囊,并进行其质量控制标准的初步研究.方法:制备乙酰半胱氨酸胶囊,测定溶出度,以氧化还原滴定法及高效液相色谱法测定含量,并建立其质量控制标准.结果:乙酰半胱氨酸溶出度限度为80%;以氧化还原滴定法进行含量测定,平均回收率为99.2%,RSD为1.4%;以高效液相色谱法进行含量测定,平均回收率为99.3%,RSD为0.6%.结论:该制剂制备工艺可行,质量可控. |
| 关 键 词： | 乙酰半胱氨酸胶囊 制备 质量控制 |
| 文章编号： | 1001-5213(2004)05-0263-03 |
| 修稿时间： | 2003-06-29 |
Preparation and quality control of acetylcysteine capsules |
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| DAI Dong-Mei,LUO Shun-De,CHENG Tian-Gui. Preparation and quality control of acetylcysteine capsules[J]. Chinese Journal of Hospital Pharmacy, 2004, 24(5): 263-265 | |
| Authors: | DAI Dong-Mei LUO Shun-De CHENG Tian-Gui |
| Abstract: | OBJECTIVE To prepare the acetylcysteine capsules and primarily discuss to its quality control. METHODS The acetylcysteine capsules were prepared, and its dissolution was determined.The content was determined by oxido-reductometric method and high performance liquid chromatography. The method for its quality control was established. RESULTS The dissolution limit of acetylcysteine dissolution was 80%. The average recovery of acetylcysteine was 99.2% with RSD of 1.4% by oxido-reductometric method. The average recovery of acetylcysteine was 99.3% with RSD of 0.6% by high performance liquid chromatography. CONCLUSION Method for the preparation and quality control of acetylcysteine capsules is reliable. |
| Keywords: | acetylcysteine capsules preparation quality control |
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