- 期刊
市售氣喘用藥吸入製劑之品質調查
Investigation on the Quality of Commercial Inhaler Preparations of Anti-Asthma Drugs in Taiwan
摘要
為瞭解國內市售氣喘用藥Fenoterol hydrobromide、Formoterol fumarate、Procaterol hydrochloride hemihydrate及Terbutaline sulfate之定量吸入劑及乾粉吸入劑的品質狀況，針對此四種氣管用藥吸入製劑進行調查。 經查含此四種氣喘用藥吸入製劑之製造廠共5家，國內1家，國外4家，本計畫委由臺北市等6個縣市衛生局於95年2至4月間，就轄區內藥廠、輸入藥品代理商、醫院及藥局進行抽樣，共抽得檢體15件。檢驗方法係依據原申請廠查驗登記時檢附之檢驗規格及方法予以檢驗並判定，項目包括：包裝標示檢查、外觀檢查、鑑別試驗、含量測定、單一劑量重量差異性(weight variation of single dose)、單一噴霧含量差異性、平均一次噴霧含量等，檢驗結果均符合原廠規格。其檢驗結果將提供藥政管理之參考。
並列摘要
The purpose of this investigation is to understand the quality of commercial inhaler preparations of anti-asthma drugs. Fifteen samples of metered dose inhalers and dry powder inhalers containing fenoterol hydrobromide, formoterol fumarate, procaterol hydrochloride hemihydrate and terbutaline sulfate were collected from local manufacturers or pharmaceutical companies of imported products from February to April. 2006. All of the samples were analyzed according to the analytical methods of the inhaler preparations specified in the Pharmacopeia or those of the manufacturers. The test items performed included identification, delivered dose uniformity, weight variation of single dose, delivered dose average. The results showed that all samples met the requirements.