【摘要】：目的觀察擺藥機工作模式下維生素C片的穩(wěn)定性情況并找出新模式下可能帶來安全隱患的工作環(huán)節(jié),為完善現(xiàn)有工作模式和流程,建立規(guī)范的全自動單劑量口服擺藥機調(diào)配模式和工作流程提供依據(jù)。方法依照2010年版《中國藥典》,對維生素C片在擺藥機現(xiàn)有工作流程中各儲存、發(fā)藥環(huán)節(jié)的性狀、溶液顏色、含量、微生物限度進(jìn)行檢測并與出廠時的報告進(jìn)行比對分析。結(jié)果維生素C片在擺藥機工作模式下性狀、溶液顏色、含量方面與出廠時無明顯差異,其中兩組樣品在微生物限度檢查的細(xì)菌菌落數(shù)方面有增加趨勢。結(jié)論維生素C片在擺藥機工作模式下總體質(zhì)量穩(wěn)定,細(xì)菌菌落數(shù)增多說明藥品裸露在空氣中的時間和擺藥環(huán)境以及藥品包材的潔凈度是擺藥機工作模式中控制藥品質(zhì)量的關(guān)鍵環(huán)節(jié)。
[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.
【作者單位】： 北京大學(xué)第一醫(yī)院藥劑科;雙鶴藥業(yè)股份有限公司;
【分類號】：R927.1
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本文編號：2146340