103-105年度中藥製劑微生物之現況調查   全文下載

Investigation of the Microorganism Status in Chinese Medicinal Preparations, 2014 - 2016

本調查為瞭解中藥製劑中微生物之現況，於103 - 105年收集中藥製劑產品共605件，依臺灣中藥典第二版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463件中藥濃縮製劑有5件不符合規範，142件中藥傳統製劑有1件不符合規範。酵母菌與黴菌總數雖尚未納入公告限量標準中，105年之248件中藥產品酵母菌與黴菌總數均於104 CFU/g以下。本調查不合格檢體均已進行相關處辦，結果並已提供行政主管機關作為行政管理之參考。

Six hundred and five samples of Chinese medicinal preparations (CMP) including Chinese medicinal concentrated preparations and traditional medicine preparations were randomly collected for the investigation of the microorganism contamination from 2014 to 2016. Microorganisms including Escherichia coli and Salmonella, total aerobic microbial counts and total combined yeasts and molds count were determined according to the methods in the Taiwan Herbal Pharmacopeia II. The limit of total aerobic microbial counts, E. coli and Salmonella in Chinese medicinal concentrated preparations are promulgated by the Department of Chinese Medicine and Pharmacy (DCMP). The results indicated that 5 samples of concentrated preparations and 1 sample of traditional medicine preparations had failed the requirements. Total combined yeasts and molds count limit was not included in the relevant regulations. However, the results indicated that all 248 Chinese medicinal preparations had total combined yeasts and molds count below 104 CFU/g in 2016. This survey was a preliminary study and would be provided as a reference for the administration authority.