|
|||||
|
|
| 加替沙星注射液的研制和质量控制 | |
| 引用本文： | 缪玉山,倪冲,施静香,倪桃,蒋金元.加替沙星注射液的研制和质量控制[J].中国新药与临床杂志,2003,22(2):78-81. |
| 作者姓名： | 缪玉山 倪冲 施静香 倪桃 蒋金元 |
| 作者单位： | 1. 东南大学附属中大医院,药剂科,江苏,南京,210009 2. 中国药科大学制药有限公司,江苏,南京,210009 3. 南京泽辰科技有限公司,江苏,南京,210009 |
| 摘 要： | 目的 :探讨加替沙星注射液的处方、制备工艺及质量控制方法。方法 :以盐酸、氢氧化钠为 pH调节剂及氯化钠为等渗调节剂制备加替沙星注射液 ;采用高效液相色谱法测定本品的含量。结果 :制备的加替沙星注射液 (pH 5 .0 )在高温 (80°C)、光照(3 60 0lx) 1 0d及室温留样考察 2 4mo ,物理及化学性质稳定。结论 :处方及工艺经中试放大制备的注射液性质稳定 ;质量控制方法准确可靠 ;可满足临床用药要求。 |
| 关 键 词： | 注射 色谱法 高效液相 质量控制 喹诺酮类 抗感染药 抗感染药 喹诺酮 加替沙星 |
| 文章编号： | 1007-7669(2003)02-0078-04 |
Development and quality control of gatifloxacin injection |
|
| MIAO Yu shan ,NI Chong ,SHI Jing xiang ,NI Tao ,JIANG Jin yuan.Development and quality control of gatifloxacin injection[J].Chinese Journal of New Drugs and Clinical Remedies,2003,22(2):78-81. | |
| Authors: | MIAO Yu shan NI Chong SHI Jing xiang NI Tao JIANG Jin yuan |
| Institution: | MIAO Yu shan 1,NI Chong 2,SHI Jing xiang 1,NI Tao 3,JIANG Jin yuan 3 |
| Abstract: | AIM:To study the formulation, preparation, and quality control for the gatifloxacin injection. METHODS: The gatifloxacin injection was prepared using hydrochloric acid or sodium hydroxide as pH adjustment agents and sodium chloride as iso osmotic adjustment agents. The contents of gatifloxacin in the injection was determined by RP HPLC. RESULTS: The physico chemical stability was good after storing 10 d under high temperature (80 °C ), illumination (3600 lx) and 24 mo under indoor temperatuer. CONCLUSION:The selected formulation and preparation technique are good and can contribute to the development of the product. The method of quality control was accurate and reliable. |
| Keywords: | injections chromatography high gatifloxacim pressure liquied quality control quinolinones anti infective agents anti infective agents quinolone gatifloxacin [ |
| 本文献已被 CNKI 维普 万方数据 等数据库收录！ | |