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。
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.
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2003年第2期78-81,共4页
Chinese Journal of New Drugs and Clinical Remedies
关键词
加替沙星注射液
质量控制
喹诺酮类
抗感染药
处方
制备工艺
高效液色谱法
抗菌药
injections
chromatography, high gatifloxacim pressure liquied
quality control
quinolinones
anti infective agents
anti infective agents, quinolone
gatifloxacin [
