市售Astemizole錠劑之品質調查   全文下載

The Survey on the Quality of Astemizole Tablets in TAIWAN

為安全使用含Astemizole製劑，並防止副作用發生，行政院衛生署81.10.23.衛署藥字第8178349號公告：規定藥品Astemizole製劑中文仿單應加刊三項注意事項。本調查報告共抽樣31件檢體，且均屬一般錠劑，其標誌量均為10mg/Tab.。參照原開發廠檢驗規格、方法及相關資料進行鑑別、重量差異、崩散度及含量測定等項目檢驗，其檢驗結果均合格。檢查31件檢體所附之中文仿單，不符合衛生署公告應加刊注意事項內容共有4件（分屬國產3個廠牌），占12.9%，且約已經當地衛生主管機關依違反藥事法而加以行政處分。本調查係本局之比較檢驗，曾於八十八年六月十日發布新聞在案。

In order to prevent side effects and ensure the safety of adminstrated Astemizole tablets, the No.8178349 Announcement published by the Department of Health Executive Yuan on October 23rd 1992 regulated that three precautions shall be added to the instruction sheet of Astemizole tablets. Thirty-one samples were purchased from different counties and cities in Taiwan. All of the samples were labeled 10 mg per tablet and investigated on their mean weights, weight uniformities, identities, disintegrations, and drug contents following the methods and specifications described in the original pharmaceutical company. All of the samples passed the tests, but the instruction sheet of four samples did not meet the announcement. The results showed that 12.9% of the samples did not meet the official regulations mentioned above.