頁籤選單縮合
題 名 | 市售Lorazepam錠劑之含量均一度及品質調查=Survey on the Content Uniformity of Lorazepam Tablets |
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作 者 | 史濟振; 張沅琦; 陳玉盆; 溫國慶; | 書刊名 | 藥物食品檢驗局調查研究年報 |
卷 期 | 20 2002.09[民91.09] |
頁 次 | 頁34-41 |
分類號 | 412.36 |
關鍵詞 | 含量均一度; 含量測定; Lorazepam; Uniformity; |
語 文 | 中文(Chinese) |
中文摘要 | 有關管制藥品範圍及種類,行政院業已於八十八年十二月八日公告生效,計分為第一級至第四級,共計263 品目。Lorazepam (耐樂平)則列屬第四級管制藥品。為瞭解現階段市售Lorazepam 錠劑之含量均一度品質管制情形,本局於九十年四月至六月間函請台北市政府衛生局、及各相關縣(市)衛生局就轄區內藥局(房)、醫院診所、藥廠及代理商協助抽樣,共抽得檢體32 件分屬27 個廠牌。依據美國藥典第二十四版所載之試驗方法進行重量差異、鑑別、含量均一度及含量測定。 上述試驗項目之試驗結果顯示均合於規定。 |
英文摘要 | Lorazepam tablets are oral benzodiazpines preparations used in the treatment of patients with anxiety and epilepticus, and were approved by the FDA in September 1977. This survey was conducted to unveil the quality and content uniformity of marketed Lorazepam tablets. Thirty-two samples were taken from the drug stores, clinics, manufactures and drug agencies in Taiwan from April to June in 2001. All samples were tested according to the monograph for Lorazepam tablets described in the USP 24 and Ch.P.IV. The test categories included weight variation, identification, content uniformity and assay were performed. The results showed that all samples met the requirements of both pharmacopoeia. |
本系統中英文摘要資訊取自各篇刊載內容。