摘要
目的评价葡萄糖酸依诺沙星注射剂的质量现状和问题。方法采用法定检验方法并结合探索性研究,对葡萄糖酸依诺沙星注射剂的质量现状进行评价。结果现行标准中的有关物质项目存在明显缺陷;部分药包材对葡萄糖酸依诺沙星质量产生不良影响;由于葡萄糖酸依诺沙星在水溶液中光照降解明显,大输液的杂质含量明显高于其他剂型。结论葡萄糖酸依诺沙星注射剂现行标准存在不足,需要改进;药包材和葡萄糖酸依诺沙星注射液(大输液)的质量需加以关注。
Objective To evaluate the quality status and problems of Enoxacin Gluconate Injections. Methods The quality status of Enoxacin Gluconate Injections was evaluated using statutory testing methods combined with the exploratory research. Results The related substance item have obvious defects in the current standards. Some of the pharmaceutical packaging materials have adverse impacts on the quality of Enoxacin Gluconate Injections. Because Enoxacin Gluconate Injections can be significantly degradated in the aqueous solution by light, the impurity content in large volume parenteral formulations is significantly higher than that in other forms. Conclusion The current standards of Enoxacin Gluconate Injections have deficiencies and need improvement. The quality of pharmaceutical packaging materials and Enoxacin Gluconate Injections （large volume parenteral） need to be concerned.
出处
《中国药事》
CAS
2014年第2期198-201,共4页
Chinese Pharmaceutical Affairs
