摘要
本文采用高效液相色谱(HPLC)法测定氯地松乳膏中氯霉素含量,并通过加速试验、长期试验考察制剂稳定性,确保制剂安全、有效。结果发现,氯地松乳膏除遮光、密闭外,在冷处贮存条件下,12个月内性状、含量和微生物限度检查均符合规定,为该制剂的最佳贮存条件和有效期的制定提供了依据。
The content of chloramphenicol in chlordiazepoxide cream was determined by high performance liquid chromatography(HPLC),and the stability of this formulation was investigated by accelerated and long-term tests to ensure its safety and effectiveness.The results showed that its properties,content and microbiological limits met the requirements within 12 months stored at cold conditions except for shading and confinement,which can provide a basis for its optimal storage conditions and expiry date.
作者
赵柳娅
印杰
张建中
翁静艳
ZHAO Liuya;YIN Jie;ZHANG Jianzhong;WENG Jingyan(Department of Pharmacy,Zhongshan Hospital affiliated to Fudan University,Shanghai 200032,China)
出处
《上海医药》
CAS
2022年第19期66-69,73,共5页
Shanghai Medical & Pharmaceutical Journal
基金
上海市临床重点专科建设项目(shslczdzk06504)。
关键词
氯霉素
氯地松乳膏
高效液相色谱法
含量测定
稳定性
chloramphenicol
chlordiazepoxide cream
high performance liquid chromatography
content determination
stability
