民國七十五～八十八年市售藥用酵素製劑之品質調查   全文下載

An Investigation on Marketed Medicinal Enzymes from 1986 to 1999 in Taiwan Area

常見藥用酵素包括有pancreatin、diastase、lysozyme、serrapeptase、trypsin、chymotrypsin、bromelain、streptokinase等，依效能可分為消化劑與消炎輔助劑兩大類，本局曾於72及74年度調查市售lysozyme製劑之品質，之後，每年皆有送驗之各類藥用酵素製劑案件。經統計，於75年7月至88年12月間，共有126件來自各縣市衛生局（所）及法務部等22個單位送檢，期間以84年的23件為最多，送驗總檢體數以台北市衛生局（所）46 件最多。126件檢體中，國產品佔53.2%，輸入品（歐美與日本）佔28.5%，其他無法確認產地者共23件，計18.3%，效能標誌為消化與消炎輔助劑者各佔42.9及38.9%，無明確標誌者18.2%。這些檢體分別依據原廠檢驗方法與規格、藥典、其他公定書或本局相關文獻等進行檢驗，合計共進行465項次外觀、平約重量／內容量、重量差異、鑑別及效價之檢驗，平均每件3.7項次。檢驗結果因原廠規格未列效價而不判定者11件，無檢驗規格無法判定者20件，合計不判定及無法判定者31件；其餘95件中，未符合原查驗登記規格者有5件，90件尚符合相關規定。結果顯示，市售藥用酵素製劑之不合格率偏高，對於此類製劑之藥政管理應有加強的必要。

Medicinal enzymes include pancreatin、diastase、lysozyme、serrapeptase、trypsin、chymotrypsin、bromelain、streptokinase, etc. From July 1986 to December 1999, 126 preparations were sampled from the clinics or drug stores by Health Department, county (city) Bureau or transferred from the Ministry of Justice. Tests including appearance、average weight (content)、weight difference、identification and assay, were performed using the methods provided by manufactures in the pre-market approval application, or described in pharmacopoeias. Among the samples tested, there were 95 registered drugs. Five samples did not comply with their specifications; three of them were domestic, one from Japan and the other from the United States.