摘要
目的 对利福霉素钠注射液的贮藏条件进行研究.方法 通过影响因素试验和加速试验对国内企业和原研企业利福霉素钠注射液进行考察,并结合国家评价性抽验中的利福霉素钠注射液,以有关物质为主要检测指标,分析贮藏条件对质量的影响.结果 温度是影响利福霉素钠注射液稳定性的主要因素,国产利福霉素钠注射液有关物质较高的原因并非处方和生产工艺不完善,而是贮藏条件不科学导致.结论 为了保证利福霉素钠注射液的质量,应将原标准中的贮藏条件“在凉暗处保存”修订为“2～8℃保存”.
Objective To study the storage condition ofrifamycin sodium injection. Methods To analyze the influence of storage condition on the quality by stress testing, accelerating testing and the related substances results of rifamycin sodium injection from evaluative testing. Results Temperature was the main influencing factor on the stability of rifamycin and its injection, the reason of high impurities of domestic rifamycin sodium injection was the unscientific storage condition,but not the prescription and the production technology. Conclusion The storage condition of rifamycin injection- ＂protected from light, store in cool place＂ should be revise to ＂protected from light,store at a temperature of 2 ℃ to 8 ℃ ＂in order to ensure the quality ofrifamycin sodium injection.
出处
《中国抗生素杂志》
CAS
CSCD
北大核心
2014年第9期675-678,共4页
Chinese Journal of Antibiotics
关键词
利福霉素钠注射液
贮藏条件
有关物质
Rifamycin sodium injection
Storage condition
Related substances
