篇名 | 眼用製劑之品質監測 |
---|---|
卷期 | 26 |
並列篇名 | Surveillance on the Quality of Marketed Ophthalmic Preparations in Taiwan |
作者 | 楊明玉 、 陳玉盆 、 呂理福 、 黃明權 、 鄒玫君 |
頁次 | 12-18 |
關鍵字 | 眼用製劑 、 Ophthalmic preparations 、 Dexamethasone 、 Dexamethasone sodium phosphate 、 Betamethasone 、 Betamethasone sodium phosphate 、 Timolol maleate 、 TSCI |
出刊日期 | 200810 |
以風險評估為原則,選定眼用製劑中Dexamethasone、Dexamethasone sodium
phosphate、Betamethasone、Betamethasone sodium phosphate及Timolol maleate等成分進行品質監測,由北、高兩市及各縣市衛生局,於民國96年1月至6月間,赴轄區內醫院診
所、藥局、藥廠及代理商抽驗市售檢體,抽得眼用製劑中含Dexamethasone成分計3件、含
Dexamethasone sodium phosphate成分計10件、含Betamethasone成分計1件,含Betamethasonesodium phosphate成分計17件,含Timolol maleate成分計11件,總共42件,其中國產品35件,輸入品7件。參照USP 26版之檢驗規格及方法或自行開發並經確效之分析方法,進行一般檢查(外觀及重量差異)、鑑別及含量測定等重點項目檢驗,結果均合格。本調查計畫之結果提供藥政管理之參考。
In order to survey the quality of the marketed ophthalmic preparations in Taiwan area, a total of 42 samples,including dexamethasone, dexamethasone sodium phosphate, betamethasone, betamethasone sodium phosphate
and timolol maleate ophthalmic preparations, were acquired from different counties and cities in Taiwan during January thru June 2007. Samples were analyzed by the methods as described in the USP XXVI. The items of
analysis include the appearance, content identifcation and assay. All samples met the compendial requirements for dexamethasone, dexamethasone sodium phosphate, betamethasone, betamethasone sodium phosphate and
timolol maleate.