七十四年度臺灣地區市售Propranolol HCI口服製劑品質調查

INVESTIGATION ON THE COMMERCIAL PROPRANOLOL HYDROCHLORIDE PREPARATIONS IN TAIWAN AREA FOR THE FISCAL YEAR 1985

Propranolol hydrochloride是一種交感神經B接受器阻斷劑，常用以治療心律不整，心絞痛、高血壓等疾病。由於此種製劑能影響心血管系統，品質低劣之產品可能對使用者造成致命性傷害。有鑑於臺灣藥廠未普偏實行GMP制度，品管情況良窳不齊，而歷來有關此類製劑之廣泛品質調查報告亦付闕如，為維護國民健康，大規模的市售Propranolol hydrochloride製劑抽驗乃為刻不容緩。本局於本年度中陸續派員前往臺北市、高雄市及臺灣省各縣市抽購藥局、藥房及私立醫院、診所陳售之Propranolol hydrochloride製劑，共抽得17種品牌，66件口服製劑，其中膠囊劑2件，膜衣錠41件，未著衣錠23件。66件檢品中，國產品占26件，其中21件係由藥局、藥房購得，另40件為輸入品，有36件購自藥局、藥房，顯示國內藥局、藥房多販售此類製劑之輸入品（占63.2％）。至於一般私立醫院、診所之使用情況，則煙抽購件數過少未便予以討論。 Sixty-six samples of commercial propranolol aydrochloride preparations in Taiwan area were aken at various time of the fiscal year for analysis. For each sample, weight variation, disintegration, dentification and assay were performed according o the methods described in the Ch.P.III. All samples passed both weight variation and disintegration test. As to assay, results showed that the highest contains 109.5% while the lowest contains 90.5% of the labeled amount of Propranolol Hydrochloride. Three of the samples failed to fulfill the assay specification of Ch.P.III, which is 92.5-107.5%.