巿售Chlorpheniramine maleate錠劑之溶離度試驗及其品質調查

A STUDY ON THE DISSOLUTION QUALITY OF COMMERCIAL CHLORPHENIRAMINE MALEATE TABLETS IN TAIWAN AREA

Chlorpheniramine maleate 為供預防及治療過敏性疾患的一種抗組織胺藥品，因廣被應用且單方錠劑製備簡易，是以市售國產品牌甚多。為瞭解市售該錠劑之品質，以確保療效，於七十五年九月至七十六年二月自全省各藥局、藥房抽購檢品五十三件，並依 USPXXI 所述之方法及限量標準，進行崩散度試驗、重量差異試驗、含量測定及溶離度試驗等。在五十三件抽購檢體中，輸入品佔四件，均為同一廠牌，其各項試驗均合於 USPXXI 之規定。國產品四十九件，分屬三十一種廠牌，有二廠牌之產品不合格，其中一廠牌僅有一件檢體，係含量測定項不合格，其含量為80.5%，而溶離度試驗因合格範圍係在75%以上，故溶離試驗結果仍可達合格標準，至於重量差異與崩散度則均合格，此藥廠已被列為'已實施 GMP 之藥廠'。另一廠有二件不同批號之檢體，所檢驗各項除重量差異度外，均不合格，而此廠仍未被列入優良藥品製造小組登記在案之 GMP 藥廠。本次抽購結果不合格件數總計三件，不合格率為5.7%；若單就溶離度試驗論，不合格者計二件，不合格率為3.8%。

Fifty three samples of chlorpheniramine maleate tablets purchased from drug stores in Taiwan area were subject to testings concerning dissolution, weight variation, disintegration, and assay according to methods and criteria described in USP XXI. Only four samples were products imported from abroad but all were belong to one manufacturer and they all met the USP criteria. The other 49 samples were products manufactured by 31 local factories and three samples from two local manufacturers did not meet all criteria fully. Overall, three of the fifty three samples. 5.7%, did not meet all requirements. Two of the fifty three samples, 3.8%, did not meet the criteria for the dissolution.