頁籤選單縮合
題名 | 中藥製劑中微生物之調查(II)=Investigation of the Microorganism in Chinese Medicinal Preparations (II) |
---|---|
作者姓名(中文) | 林雅姿; 謝佳霖; 劉宜祝; 施養志; | 書刊名 | 食品藥物研究年報 |
卷期 | 4 2013.11[民102.11] |
頁次 | 頁244-250 |
分類號 | 412.36 |
關鍵詞 | 中藥製劑; 好氧性微生物總數; 大腸桿菌; 沙門氏桿菌; 酵母菌與黴菌總數; Chinese medicinal preparations; Total aerobic microbial counts; Escherichia coli and Salmonella; Total combined yeasts and molds counts; |
語文 | 中文(Chinese) |
中文摘要 | 本調查為了解中藥製劑中微生物之現況,於 101年度收集中藥製劑產品共 171件,以中華藥典上所載之方法進行好氧性微生物總數 (total aerobic microbial count)、大腸桿菌 (Escherichia coli)、沙門氏桿菌 (Salmonella)及酵母菌與黴菌總數 (total combined yeasts and molds count)之檢驗,並依中醫藥司公告中藥濃縮製劑中好氧性微生物總數、大腸桿菌及沙門氏桿菌之限量標準進行判定,結果顯示 87件中藥濃縮製劑均符合規範。另,因酵母菌與黴菌總數尚未納入公告限量標準中,因無相關規範,該試驗項目不允判定。此外, 84件中藥粉末單味製劑,目前亦未制定微生物限量之相關規範,本調查結果將提供行政主管機關作為行政管理之參考。 |
英文摘要 | One hundred and seventy one samples of Chinese medicinal preparations (CMP) including Chinese medicinal concentrated preparations and single herbal powder preparations were randomly collected to investigate the microorganisms contamination during the fiscal year 2012. The total aerobic microbial counts and microorganisms including Escherichia coli, Salmonella, total combined yeasts and molds count were determined by methods reported in the Chinese Pharmacopoeia VII. The permitted limit of total aerobic microbial counts, E. coli and Salmonella of Chinese medicinal concentrated preparations are promulgated by Committee on Chinese Medicine and Pharmacy (CCMP). The results indicated that all samples met the requirements. No rule of total combined yeasts and molds count, single herbal powder preparations has been set yet. This survey was a preliminary study and would provide as a reference for the administration authority. |
本系統之摘要資訊系依該期刊論文摘要之資訊為主。