查詢結果分析
來源資料
頁籤選單縮合
題 名 | 三十種傳統製劑異常物質背景值調查=The Abnormal Substances Background Value Survey of 30 Traditional Formulations |
---|---|
作 者 | 余建志; | 書刊名 | 中醫藥年報 |
卷 期 | 3 2014.12[民103.12] |
頁 次 | 頁(89)1-(89)51 |
分類號 | 413.94 |
關鍵詞 | 中藥傳統製劑; 重金屬; 微生物; Traditional herbal medicine preparations; Heavy metal; Microorganism; |
語 文 | 中文(Chinese) |
中文摘要 | 本計畫主要目的在於了解市面流通中藥之安全性以建立中藥傳統製劑之異常物質限量標準。 計畫共調查 30項市售之常用合法中藥傳統製劑方劑,每項方劑由 3~5家不同之 GMP中藥廠製造,共分析 150個品項,檢驗項目為總重金屬、砷、鎘、汞、鉛、銅及微生物總生菌數、大腸桿菌、沙門氏菌等。檢驗方法係依照目前衛生署公告建議檢驗方法,且流程符合 TAF認證,進行本案檢體分析。邀請國內相關研究專家,舉辦產、官、學座談會共兩場 (分別在期中與期末報告前舉行 ),討論中藥傳統製劑異常物質限量標準。 結果發現總重金屬均小於 30 ppm、砷介於 0.06~6.61 ppm、鉛介於 0~30.65 ppm、鎘介於 0~1.19 ppm、汞介於 ND~80.78 ppm、銅介於 0.82~97.49 ppm、微生物總生菌數 7件超過 106 cfu、大腸桿菌有 3件呈陽性反應及沙門氏菌則未檢出。 由研究統計分析結果與專家會議結論,建議中藥傳統製劑之異常物質限量標準可設定為總重金屬小於 30 ppm、砷小於 3 ppm、鎘小於 0.5 ppm、汞小於 0.5 ppm、鉛小於 10 ppm及微生物總生菌數小於 106 CFU/g、大腸桿菌與沙門氏菌不得檢出。上述結果將提供中醫藥司會進一步評估訂定限量標準。 |
英文摘要 | The main purpose of this project is to confirm the safety of Chinese herbal medicine in market, expecting to establish the standard limit of the abnormal substances of the traditional herbal medicine preparations (THMP). 30 THMP preparations that sold in the market were used in this project, sources from 3-5 different GMP plants, 150 products were analyzed in final. The analysis items include total heavy metal, arsenic, cadmium, mercury, lead, copper, total viable aerobic count, E. coli, and salmonella. The analysis methods were according to the official methods provided by government notice and pharmacopeia, and all the operating processes were executed under TAF certification. Invite relevant experts, organized by industry, government, academia symposium of two (were held before the midterm and final report) to discuss the preparation of traditional Chinese medicine abnormal substances limits. Results indicated the heavy metal contents in traditional Chinese medicine were as follows: total heavy metal contents were less than 30 ppm, arsenic levels were in the range of 0.06-6.61 ppm, lead contents were in the range of 0-30.65 ppm, cadmium contents were in the range of 0-1.19 ppm and mercury contents were in the range of ND-80.78 ppm. Seven samples were over 106 CFU/g for total aerobic plate count, all tests for Salmonella were negative and three tests for Escherichia coli were positive. According to statistic analysis and the expert meetings, we suggest the regulation limits of total heavy metals content is not more than 30 ppm, As is not more than3 ppm, Cd is not more than 0.5 ppm, Hg is not more than 0.5 ppm, Pb is not more than 10 ppm and total aerobic plate count is not more than 106 CFU/g, Escherichia coli and Salmonella shall not be detected. The results mentioned above will be applied to department of Chinese medicine and ppharmacy for evaluation of setting limiting values. |
本系統中英文摘要資訊取自各篇刊載內容。