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頁籤選單縮合
題 名 | 市售胃腸用口服膠漿及懸液之微生物限量調查=The Investigation of Oral-gastrointestinal Gels and Suspensions Microbial Limit |
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作 者 | 傅淑卿; 杜慧珍; 楊若英; 陳作琳; 林嘉伯; | 書刊名 | 藥物食品檢驗局調查研究年報 |
卷 期 | 23 民94.09 |
頁 次 | 頁28-50 |
分類號 | 412.36 |
關鍵詞 | 胃腸用口服膠漿; 懸液; 好氧性微生物總數; Oral-gastrointestinal gels; Gels; Suspensions; Microbial limit; Total 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多由醫師處方或消費者自行購買,用於緩 解腸胃道潰瘍、發炎等不適之症狀,包括中華藥典第五版等世界各國藥典雖未將其列為無菌製劑,但對其微生物存在之容許範圍則皆有明確規定,以保障服用者之權益,避免希望服藥可以恢復健康的同時,卻因吃了遭不當微生物污染之製劑而引發腸炎、腹瀉及敗血症等副作用,危害生命安全。 本類製劑原本須查驗登記並送樣進行檢驗,為簡化查驗登記流程,縮短新產品的上市時程,符合衛生署90.9.28 衛署藥字第0900058057 號公告各項規定者,改列指示藥品,仍須查驗登記,惟採書面審核,毋須送驗。為配合衛生署加強市售抽樣之政策,加以本局曾經二次對胃腸用口服膠漿及懸液之微生物限量進行調查,發現其合格率僅72.5 %及97.0 %,實有必要再評估製藥廠之改善情形。 有鑑於此,本局特委請全國各縣市及北、高二市政府,共25 個衛生局於民國九十三年四月至七月間,赴轄區內醫院、診所、藥局或西藥房抽樣胃腸用口服膠漿20 件及懸液64 件,共計84 件有效檢體進行微生物限量試驗。試驗結果顯示抽購之84 件檢體中不合格者有2 件(佔2.4%),與八十三及八十八暨八十九年度調查結果相比(不合格分別為佔27.5 %及3.0 %),可知此二類產品品質已有改善,且未因改列指示藥品而下降品質。然而本局三次調查不合格者皆屬國產製品,顯示國內製藥廠在生產原料、製程管制及環境衛生各方面,仍有改善空間。本次調查之2 件不合格產品皆為國產之“全福”康佳爾懸浮液,其不合格項目皆為好氧性微生物總數過高,超過規定之1,000倍以上,此2 件不合格檢體皆已發函原送衛生局查明處辦中。本次調查雖顯示國內市售胃腸用口服膠漿及懸液品質絕大部份都符合規定,但仍有少量不合格產品,故建議相關單位仍應就製藥廠微生物污染控管之觀念與技術持續教育與輔導,使國產藥品能符合國際品質,並維護國人用藥安全,確保消費者權益。 本調查曾於93 年12 月21 日發布新聞在案。 |
英文摘要 | Oral-gastrointestinal gels and suspensions are used for the relief of peptic ulcer, inflammation and other stomach and gastrointestinal discomfort. Although these drugs do not need sterilization, their bioburden are limited by the pharmaceutical and health authority to protect the user's safety and to avoid secondary injury. According to the No.0900058057 announcement of the Department of Health, since 2001, oral-gastrointestinal gels and suspensions are reviewed only when applying for distribution permit. In order to monitor the quality of marketed oral-gastrointestinal gels and suspensions, 20 samples of gels and 64 samples of suspensions were acquired from 25 cities and counties in Taiwan during April to July 2004. The 84 samples were processed with the microbial limit tests, including the total microbial count and the assay for Escherichia coli and Pseudomonas aeruginosa. The results showed that 2.4% of the samples failed to meet the limit of total microbial count (not more than 100 CFU/mL). The result was lower than the 27.5% in 1994 and 3.0% in 2000. The disqualified samples were from the same domestic pharmaceuticalmanufacturer. After comparing the result of this investigation with the previous two, we found that the majority of the manufacturers with products that previously failed the test improved the products quality accordingly. Generally speaking, the microbial limit quality of the marketed oral-gastrointestinal gels and suspensions in Taiwan reached a stable and adequate degree. |
本系統中英文摘要資訊取自各篇刊載內容。