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对拆包装药品在不同存储条件下外观及片重变化的研究
引用本文:冯凌,张梅玲,胡叶帅,宋洪杰,蔡溱.对拆包装药品在不同存储条件下外观及片重变化的研究[J].药学服务与研究,2014(5):379-381.
作者姓名:冯凌  张梅玲  胡叶帅  宋洪杰  蔡溱
作者单位:第二军医大学长海医院药学部,上海200433
摘    要:研究拆包装药品在不同存储条件下外观和片重的变化,以选择合适的备药品种,为科学备药提供参考。方法:选取住院药房孟鲁司特钠咀嚼片、复方卡比多巴-左旋多巴控释片、瑞格列奈片、溴隐亭片、缬沙坦氢氯噻嗪片、拉西地平片、替米沙坦片、丙戊酸钠缓释片、阿卡波糖片、复方α-酮酸薄膜衣片 10种以往不拆包装备药的口服药,各以带盖摆药杯(药杯组)和LOCK盒(LOCK盒组)为存储方式,观察药片从原包装剥出后0、2、4、8、24 h 5个存储时间点的外观,测定片重差异。结果:药杯组有5种药品外观发生不同程度的变化,而LOCK盒组均未出现明显变化。方差分析结果显示,每种药品在不同测定时间的片重均具有显著差异(P<0.001);药杯组阿卡波糖片24 h片重差异最大,24 h增重率达10.8%,复方卡比多巴-左旋多巴控释片差异最小,24 h增重率为0.5%。孟鲁司特钠咀嚼片、替米沙坦片、阿卡波糖片3种药品在两种存储方式下片重存在显著差异(P<0.001),其他7种药品片重无显著差异(P>0.05);除复方卡比多巴-左旋多巴控释片外,药杯组其他9种药品的24 h增重率均大于LOCK盒组。结论:实验药品中瑞格列奈片、复方卡比多巴-左旋多巴控释片、缬沙坦氢氯噻嗪片、拉西地平片、复方α-酮酸薄膜衣片5种药品以LOCK盒为存储方式,24 h内药品外观和片重是稳定的。

关 键 词:药物储藏  外观变化  片重  增重率  药品质量

Study on the changes in appearance and tablet weight of unpacked drugs under different storage conditions
FENG Ling,ZHANG MeiLing,HU YeShuai,SONG HongJie,CAI Zhen.Study on the changes in appearance and tablet weight of unpacked drugs under different storage conditions[J].Pharmaceutical Care and Research,2014(5):379-381.
Authors:FENG Ling  ZHANG MeiLing  HU YeShuai  SONG HongJie  CAI Zhen
Institution:(Department of Pharmacy, Changhai Hospital, Second Military Medical University, Shanghai 200433, China)
Abstract:Objective.. To study the changes in appearance and tablet weight of unpacked drugs under different storage con- ditions, so as to select appropriate kinds of stored drugs and provide reference for their scientific storage. Methods:Ten kinds of oral drugs, such as montelukast sodium chewable tablets, compound carbidopa and levodopa controlled-release tablets, repaglin- ide tablets, bromocriptine tablets, valsartan and hydrochlorothiazide tablets, lacidipine tablets, telmisartan tablets, sodium val- proate sustained-release tablets, acarbose tablets, compound α-ketoacid film tablets, which were rarely stored without packaging in the inpatient dispensary, were selected and each was stored under two different conditions., in the cup with a cover (the cup group) and in the LOCK box (the LOCK box group). The appearance and weight of tablets were closely observed at 0,2,4,8, 24 h after the drugs were unpacked. Results:The appearance of the 5 kinds of drugs in the cup group changed to various ex- tents, while all the drugs in the LOCK box group remained unchanged. ANOVA indicated that significant differences could be noted in the weight of each tablet at different times (P〈0. 001). The tablet weight difference of acarbose tablet was the highest at 24 h, with the weight increase rate of 10.8% at 24 h, while that of the compound carbidopa and levodopa controlled-release tablets was the lowest, with the weight increase rate of 0.5% at 24 h. Significant tablet weight differences could also be seen in montelukast sodium chewing tablets, telmisartan tablets and acarbose tablets stored under 2 different conditions (P〈0. 001), while no significant tablet weight differences could be found in the other 7 drugs (P〉0.05). With the exception of compound carbidopa and levodopa controlled-release tablets, the weight increase rate of the other 9 drugs at 24 h in the cup group was higher than that of the LOCK box group. Conclusion.. For the experimental drugs, the appearance and weight of repaglinide tablet
Keywords:drug storage appearance change tablet weight weight gaining ratio drug quality
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