全自动摆药机工作模式下维生素C片的稳定性研究
发布时间：2018-07-26 14:41
【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。
[Abstract]:Objective to observe the stability of vitamin C tablets in the working mode of the dispensing machine and to find out the work links which may bring about the hidden safety problems in the new mode, in order to perfect the existing working mode and flow chart. To establish a standardized single-dose oral dispensing machine for dispensing mode and work flow to provide the basis. Methods according to the 2010 edition of Chinese Pharmacopoeia, the properties, color, content and microbial limit of vitamin C tablets in the current working process of dispensing machine were detected and compared with the reports from the factory. Results there was no significant difference in the properties, color and content of vitamin C tablets between the two groups in the working mode of the dispensing machine, and there was an increasing trend in the bacterial colony number of the two groups in microbial limit examination. Conclusion the quality of vitamin C tablets is stable under the working mode of dispensing machine. The increase of bacterial colony shows that the time of exposure to air, the environment of drug placement and the cleanliness of drug packaging are the key to control the quality of drugs in the working mode of the dispensing machine.
【作者单位】： 北京大学第一医院药剂科;双鹤药业股份有限公司;
【分类号】：R927.1
，
本文编号：2146340
[Abstract]:Objective to observe the stability of vitamin C tablets in the working mode of the dispensing machine and to find out the work links which may bring about the hidden safety problems in the new mode, in order to perfect the existing working mode and flow chart. To establish a standardized single-dose oral dispensing machine for dispensing mode and work flow to provide the basis. Methods according to the 2010 edition of Chinese Pharmacopoeia, the properties, color, content and microbial limit of vitamin C tablets in the current working process of dispensing machine were detected and compared with the reports from the factory. Results there was no significant difference in the properties, color and content of vitamin C tablets between the two groups in the working mode of the dispensing machine, and there was an increasing trend in the bacterial colony number of the two groups in microbial limit examination. Conclusion the quality of vitamin C tablets is stable under the working mode of dispensing machine. The increase of bacterial colony shows that the time of exposure to air, the environment of drug placement and the cleanliness of drug packaging are the key to control the quality of drugs in the working mode of the dispensing machine.
【作者单位】： 北京大学第一医院药剂科;双鹤药业股份有限公司;
【分类号】：R927.1
，
本文编号：2146340
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