市售Cimetidine錠劑品質調查

INVESTIGATION ON THE QUALITY OF COMMERCIAL CIMETIDINE TABLETS IN TAIWAN AREA FOR THE FISCAL YEAR 1985

Cimetidine係治療胃潰瘍及十二指腸潰瘍疾病最新開發之藥物，鑒於Cimetidine錠售價頗高且使用頻繁，本局乃主動抽購市售Cimetidine錠劑，就其含量、崩散度和重量差異加以分析，以了解其品質。將檢品粉末以0.1N硫酸溶出主成分並稀釋為0.01mg／ml之濃度，在紫外光波長200至300nm處測定其吸收圖譜，並與同濃度之標準品比對，其最大吸收波長應在218nm處呈現，並取其吸光度與標準品比對，以求得Cimetidine之含量。七十四年經赴台灣各地區抽購十六件、二十六種廠牌之檢體，其中輸入品十二件，國產品六十四件。試驗結果顯示崩散度與重量差異均合於規定，Cimetidine含量均在合格範圍內（90－110％），其中有五十一件含量在95－105％範圍內。 Seventy-six samples of cimetidine tablets (a H2 receptor antagonist) including sixty-four domestic products and twelve imported products from twenty-six pharmaceutical company, were taken from hospitals and drug-stores in Taiwan area. Examined by UV spectrophotometric method, all of the samples were found to be within 90% to 110% of labeled amount.