台灣地區市售DICLOFENAC SODIUM錠劑之含量調查

AN INVESTIGATION FOR THE ASSAY OF DICLOFENAC SODIUM TABLETS IN TAIWAN AREA

Diclofenac Sodium在市面上有25mg、50mg、100mg等劑量之錠劑劑型，由於此成分極易吸濕，所以一般皆製成膜衣錠，少數則製成糖衣錠。Diclofenac Sodium是一種新開發之非類固醇類之鎮痛抗炎劑，投以口服，於三十分鐘內即可至血中；二小時可達血中最高濃度，並發揮鎮痛、抗炎解熱、抗僂麻質斯作用；但其伴有胃部不適、胃重感、下痢等胃腸症狀，間有浮腫現象。目前市面上有數十種品牌，競爭削價相當嚴重，為了解其品質乃進行此項市售品調查計劃，期能提供品質之現況以供參考。本計畫係於民國80年度由全省各縣市地區之藥局或藥房抽購Diclofenac Sodium錠劑，其批號均不同亦不逾有效期限，共抽購國產23件及進口7件。以下列所述之高效液相層析法鑑別並測定含量。

In order to understand the quality of Diclofenac Sodium tablets, thirty samples (23 domestic, 7 imported) were purchased from different counties and cities in Taiwan during August 1990 to June 1991. All of the samples were determined by the high performance liquid chromatographic method The results showed that all the samples met the assay requirement of the government regulation (90-110%).