摘要
目的研究不同贮存温度对氯苯醇搽剂稳定性的影响,探索提高制剂稳定性的方法。方法选取5批次氯苯醇搽剂,平均分成2组,将对照组置于20~30℃下保存,实验组置于2~8℃冷藏,分别于0、3、6、9、12、18个月时对样品有效成分进行含量测定,评价不同贮存温度对制剂稳定性的影响。结果贮存温度对氯霉素含量影响较大,实验组样品12个月内氯霉素含量下降(4.9±1.2)%,对照组样品含量下降(22.8±0.9)%;贮存温度对盐酸苯海拉明含量几乎没有影响,18个月内2组样品的盐酸苯海拉明的含量无显著差异。结论在不改变制剂现行生产工艺情况下,2~8℃冷藏可以提高氯苯醇搽剂的稳定性,该方法简便实用。
Objective To study the effect of different storage temperatures on stability of chlorobenzene alcohol liniment and to find ways to improve the stability.Methods Five batches of chlorobenzene alcohol liniment were selected and divided into two groups.One group was stored at 20-30℃(control group)while the other group was refrigerated at 2-8℃(experimental group).The contents of active ingredients of the samples were determined at 0,3,6,9,12 and 18 months,respectively,to evaluate the effect of different storage temperatures on the stability of the preparations.Results Storage temperatures had a greater effect on the content of chloramphenicol.The content of the samples refrigerated at 2-8℃decreased by(4.9±1.2)%in 12 months while that of the samples stored at 20-30℃decreased by(22.8±0.9)%.Storage temperatures had little effect on the content of diphenylephrine hydrochloride,and there was no significant change in the content of diphenylephrine hydrochloride in the samples of the 2 groups in 18 months.Conclusion Without changing the current production process of the preparation,refrigeration at 2-8℃can improve the stability of chlorobenzene alcohol liniment,and the method is simple and practical.
作者
黄木土
李冬
刘珊
彭冉
李奕虹
曾俏龙
季波
HUANG Mu-tu;LI Dong;LIU Shan;PENG Ran;LI Yi-hong;ZENG Qiao-long;JI Bo(General Hospital of Southern Theater Command,Guangzhou 510010,China)
出处
《解放军药学学报》
CAS
2024年第6期520-522,共3页
Pharmaceutical Journal of Chinese People's Liberation Army
基金
军队医疗机构制剂标准提高科研专项课题,No.14ZJZ03-3
广州市科技计划项目,No.201509010012。
关键词
氯苯醇搽剂
氯霉素
制剂稳定性
制剂贮存温度
chlorobenzene alcohol liniment
chloramphenicol
preparation stability
preparation storage temperature
