中藥製劑中微生物之調查(III)

Investigation of the Microorganism in Chinese Medicinal Preparations (III)

林雅姿(Ya-Tze Lin) ； 謝佳霖(Jia-Lin Hsieh) ； 劉宜祝(Yi-Chu Liu) ； 林美智(Mei-Chih Lin) ； 施養志(Daniel Yang-Chih Shih) ； 陳惠芳(Hwei-Fang Cheng)

《食品藥物研究年報》 5期 (2014/12) Pp. 192-196

摘要

本調查為了解中藥製劑中微生物之現況，於102年度收集中藥製劑產品共152件，以中華藥典第七版上所載之方法進行好氧性微生物總數(total aerobic microbialcount)、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，並依衛生福利部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82件中藥濃縮製劑有2件不符合規範。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，70件中藥傳統製劑，於103年7月1日起需符合微生物限量標準，故本調查結果係為背景值，將提供行政主管機關作為行政管理之參考。

關鍵字

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

並列摘要

One hundred and fifty two samples of Chinese medicinal preparations(CMP) including Chinese medicinal concentrated preparations and traditional medicine preparations were randomly collected to investigate the microorganism contamination during the fiscal year 2013. 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 Department of Chinese Medicine and Pharmacy (DCMP). The results indicated that two samples were not met the requirements. Total combined yeasts and molds count will not be determined since there are no related regulations yet corresponding traditional medicine preparations will be set up after July 1^(st), 2014. This survey was a preliminary study and would provide as a reference for the administration authority.

並列關鍵字

Chinese medicinal preparations ； total aerobic microbial counts ； ＂Escherichia coli＂ and ＂Salmonella＂ ； total combined yeasts and molds counts