頁籤選單縮合
題名 | 101年度市售胃腸用口服膠漿及懸液之微生物限量調查=Investigation of Microbial Limit for Oral-Gastrointestinal Gels and Suspensions |
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作者姓名(中文) | 連淑華; 郭政佑; 林育如; 許家銓; 王德原; 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162-170 |
分類號 | 412.36 |
關鍵詞 | 胃腸用口服膠漿及懸液; 好氧性微生物總數; 大腸桿菌; 綠膿桿菌; Oral-gastrointestinal gels and suspensions; Total aerobic microbial count; Escherichia coli; Pseudomonas aeruginosa; |
語文 | 中文(Chinese) |
中文摘要 | 胃腸用口服膠漿及懸液用於緩解腸胃道潰瘍擊發炎等不適症狀,為確保該類藥品使用之安全, TFDA曾於 83、88及93年度, 3次針對全國市售胃腸用口服膠漿及懸液產品進行微生物限度抽樣調查。不合格率分別為 27.5、3.0及2.4 %,為持續監測該類藥品之品質,本 (101)年度再次進行微生物限度調查。檢驗方法係依據中華藥典第七版微生物限量法檢驗,檢驗規格依行政院衛生署 71.09.29衛署藥字 398194號規定不得檢出大腸桿菌及綠膿桿菌,且好氧微生物總數不得超過 102 CFU/mL(菌落數 /毫升 )進行判定。檢體來源係委託地方衛生局於 101年1至6月間,依抽樣計畫表採分區分階段併行方式,逕至轄區醫療院所及藥廠 (包含代理商 )抽取市售品與源頭產品,共抽得檢體 85件,國產品及輸入品分別各為 73件(85.9%)及12件(14.1%);試驗結果顯示 80件檢體符合規定 (合格率 94.1%),不合格檢體 5件(不合格率 5.9%),不合格項目皆為好氧性微生物總數 (生菌數 )超過規定,其中 2件並檢出綠膿桿菌。不合格產品已移請地方衛生單位進行後續處理,本報告並提供相關單位行政管理之參考。 |
英文摘要 | Oral-gastrointestinal gels and suspensions are used in the treatment of peptic ulcer, inflammation and other stomach and gastrointestinal discomforts. The quality and bio-burden of these medicines should be well defined by the health authority to ensure their safety. According to the Chinese pharmacopoeia 7th Edition and announcement No.398194 of the Department of Health of Taiwan, the total aerobic microbial count of these gels and suspensions should be no more than 102 CFU per gram/mL and must not be contaminated with Escherichia coli and Pseudomonas aeruginosa. In oder to investigate and monitor the quality of oral-gastrointestinal gels and suspensions, three microbial limit investigations were conducted in 1994, 1999 and 2004, and the percentages of non-compliant products found were 27.5, 3.0 and 2.4% respectively. Totally, 85 samples of oral-gastrointestinal gels and suspensions were collected by local health authorities from January to June in 2012. The results showed that 5 samples were non-compliant and the non-compliant percentage of non-compliant was 5.9%. The total aerobic microbial counts of the 5 non-compliant samples exceeded the regulatory limit and 2 of them were Pseudomonas aeruginosa positive. All the non-compliant samples should be retrieved from the market and the local health authorities concened were informed to launch follow-up investigations. |
本系統之摘要資訊系依該期刊論文摘要之資訊為主。