摘要
目的观察复方氯霉素搽剂、氯黄软膏、洁肤乳膏3种氯霉素制剂在不同温度、湿度及盐雾环境下的稳定性。方法采用高效液相色谱法测定复方氯霉素搽剂(水杨酸和氯霉素)、氯黄软膏(盐酸小檗碱和氯霉素)和洁肤乳膏(醋酸地塞米松和氯霉素)中对应成分的含量变化。3种氯霉素制剂分别储存于模拟长期(28~32℃,相对湿度60%~70%)、加速(38~42℃,相对湿度70%~80%)、高温高湿(48~52℃,相对湿度85%~95%)条件下6个月,以及盐雾试验(48~52℃,相对湿度85%~95%,5%Na Cl)条件下5个月。结果3种氯霉素制剂在模拟长期试验条件下表现出良好的稳定性,在加速试验、高温高湿及盐雾试验条件下,药物主要成分含量均呈现较快的下降趋势,尤其在盐雾条件下降解速率最为显著。结论氯霉素制剂的贮存条件应严格控制温度与湿度,针对需在特殊环境下贮存的制剂,应采用具有防潮等特性的药品包装。
Objective To investigate the stability of three hospital-made chloramphenicol preparations-compound chloramphenicol liniment,chloromycetin and berberine ointment and Jiefu cream-under different temper-atures,humidities and salt spray environments.Methods The changes in the contents of salicylic acid and chloram-phenicol in compound chloramphenicol liniment,berberine hydrochloride and chloramphenicol in chloromycetin and berberine ointment,and those of dexamethasone acetate and chloramphenicol in Jiefu cream were determined using high-performance liquid chromatography.The three chloramphenicol formulations were stored under simulated long-term conditions(28-32℃,60%-70%RH),accelerated conditions(38-42℃,70%-80%RH),high-temperature and high-humidity conditions(48-52℃,85%-95%RH)for 6 months,and under salt spray condi-tions(48-52℃,85%-95%RH,5%NaCl)for 5 months.Results The three chloramphenicol formulations remained stable under simulated long-term test conditions.However,rapid decreases in contents of leading components were observed under accelerated,high-temperature and high-humidity conditions,and especially under salt spray conditions.Conclusion Chloramphenicol formulations require rigorous control over the tempera-ture and humidity.Moisture-proof packaging is critical to storage in special environments.
作者
王悦
尹畅
宋洪杰
黄婧
陆松伟
尤本明
王志君
夏琳
王卓
WANG Yue;YIN Chang;SONG Hong-jie;HUANG Jing;LU Song-wei;YOU Ben-ming;WANG Zhi-jun;XIA Lin;WANG Zhuo(The First Affiliated Hospital of Naval Medical University,Shanghai 200433,China;School of Pharmacy,Jiangxi University of Chinese Medicine,Nanchang 330004,China)
出处
《解放军药学学报》
2025年第4期380-386,共7页
Pharmaceutical Journal of Chinese People's Liberation Army
基金
军队科研自主项目,No.CHJ22J061
海军军医大学第一附属医院院内项目,No.2020YSL008。
关键词
复方氯霉素搽剂
氯黄软膏
洁肤乳膏
氯霉素
制剂稳定性
盐雾
compound chloramphenicol liniment
chloromycetin and berberine ointment
Jiefu cream
chloramphenicol
preparation stability
salt spray
