摘要
目的观察摆药机工作模式下维生素C片的稳定性情况并找出新模式下可能带来安全隐患的工作环节,为完善现有工作模式和流程,建立规范的全自动单剂量口服摆药机调配模式和工作流程提供依据。方法依照2010年版《中国药典》,对维生素C片在摆药机现有工作流程中各储存、发药环节的性状、溶液颜色、含量、微生物限度进行检测并与出厂时的报告进行比对分析。结果维生素C片在摆药机工作模式下性状、溶液颜色、含量方面与出厂时无明显差异,其中两组样品在微生物限度检查的细菌菌落数方面有增加趋势。结论维生素C片在摆药机工作模式下总体质量稳定,细菌菌落数增多说明药品裸露在空气中的时间和摆药环境以及药品包材的洁净度是摆药机工作模式中控制药品质量的关键环节。
OBJECTIVE To observe the stability status of vitamin C tablets which are made by the dispensing machine in working mode and try to find out the procedures which may bring some potential hazards in the new modes. METHODS Ac- cording to the Pharmacopoeia the procedures were detected and collected data of the Vitamin C Tablets were made by dispensing machine in existing working mode. The data is collected from different aspects, including the color of drug solution, pharmic con- tent, microbial limit from the storage and dispensing process. Then we compare these data with the factory＇s report and analyse the differences. RESULTS There is no significant difference between the data we get and the factory＇s report of vitamin C tab- lets made by the dispensing machine in working mode, including the color of drug solution, pharmic content and the appearance of tablets. But there is an increasing trend of bacterial colonies in microbial limit tests for the two samples. CONCLUSION The status of vitamin C tablets made by dispensing machine in working mode is generally stable. The increasing number of bacte- rial colonies shows that the time when drugs are exposed in the air, the cleanliness of dispensing environment and pharmaceutical package material are the key for drug quality control.
出处
《中国药学杂志》
CAS
CSCD
北大核心
2015年第21期1885-1887,共3页
Chinese Pharmaceutical Journal
关键词
摆药机
药品稳定性
维生素C片
dispensing machine
drug stability
vitamin C tablets
