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  • 期刊

中藥製劑中微生物之調查(I)

Investigation of the Microorganism in Chinese Medicinal Preparations (CMP)

摘要


本調查為了解中藥製劑中微生物之現況,於99至100年間收集中藥濃縮製劑產品共330件,以中華藥典上所載之方法進行總生菌數(aerobic microorganisms)、大腸桿菌(Escherichia coli)及沙門氏桿菌(Salmonella)之檢驗。結果顯示總生菌數超過10^5 CFU/g者共13件,佔3.9%,所有檢體均未檢出大腸桿菌及沙門氏桿菌。本調查結果將作為行政管理之參考。

並列摘要


Three hundred and thirty samples were randomly collected for investigating the microorganisms' contamination in CMP during fiscal years of 2010 and 2011. The total viable aerobic counts and microorganisms including Escherichia coli and Salmonella were determined by methods reported in the Chinese Pharmacopoeia VI. The results indicated that 3.9% of 330 samples were out of specifications (10^5 CFU/g) by aerobic microorganisms, and neither pathogen Escherichia coli nor Salmonella was detected. This survey was a preliminary study and would provide as a reference of the administration.

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