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大型塑膠軟袋包裝含葡萄糖成分輸注液之品質監測

Surveillance on the Quality of Marketed Dextrose Injection in Plastic Bags in Taiwan

摘要


本調查計畫以風險評估為原則,98年度選定大型塑膠軟袋包裝含葡萄糖成分之輸注液進行品質監測。自民國98年1月至6月間委由全國各縣市衛生局,赴轄區內醫院及製藥廠抽驗市售檢體共10件,其中大型塑膠軟袋包裝含葡萄糖成分之輸注液10件(均屬國產)。參照中華藥典第六版及美國藥典第31版之檢驗規格及方法,進行一般檢查(外觀、pH值)。dextrose、(glucose)之鑑別及含量測定及微粒物質試驗。檢驗結果均符合規定。

關鍵字

大型輸注液 葡萄糖 dextrose

並列摘要


In order to survey the quality of the marketed dextrose of large volume parenteral injection in plastic bags in Taiwan area, a total of 10 samples were acquired from different counties and cities in Taiwan from January to June 2009. Samples were analyzed by the methods described in the Ch. P. VI, USP 31 with authorized specifications. The items of analysis included the appearance, pH, assay and particulate matter in injections. All samples met the compendial requirements for dextrose injection.

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