行政院衛生署藥物食品檢驗局自91 年1 月起至92 年3 月止，受理大陸產製中藥檢驗案件中，總共有22 件次計17 種品目之大陸壯陽類中藥檢出西藥成分，其中15 種檢出sildenafil，2 種檢出tadalafil，其中安徽三體醫藥保健公司產製之藥品有三種品目，其餘隸屬於12家不同之廠家。檢體篩檢方法為檢體粉末經以50 ％甲醇萃取、稀釋及過濾，取濾液直接注入液相層析串聯式質譜儀（LC/MS/MS）分別進行正離子電灑法（ESI+）之m/z 475 及m/z 390 子代離子掃描，獲得之子代離子質譜圖（Daughter ion spectrum）與本局自建液相層析質譜資料圖庫（NLFD3/LM library）比對，初步快速篩檢是否含上述兩成分，若疑似檢出者，須再經HPLC 分離及串聯式質譜儀分析。儀器之分析條件：分離管柱均為Cosmosil 5C18-AR, 4.6 150mm。移動相溶媒系，sildenafil 為甲醇：乙腈：1 ％醋酸(25:17:58)；tadalafil 為乙腈：水：1 ％醋酸（50 : 45: 5）；流速：0.5 mL/min（1：1 分流），毛細管電壓：3 kV；進樣圓錐口電壓及碰撞能量設定：sildenafil 為80 V 及25eV；而tadalafil 為60 V 及18 eV；離子源溫度：120℃；溶媒揮散溫度：300℃，配合附光二極體陣列檢出器（photodiode array）檢測之結果檢品溶液離子峰滯留時間、紫外光光譜圖及質譜圖與對照標準品比對結果均相符，確認檢品摻加sildenafil 及tadalafil 西藥成分。為探討檢體中所含相當於sildenafil citrate 及tadalafil 之量而配製系列對照標準品溶液，以pirenzepine 作為內部標準品，分別選定親代及子代離子（m/z 475.4>100.2,m/z 390.2>268.0）作多重離子裂解監控（MRM, Multiple Reaction Monitoring）定量分析並製作檢量線，其線性關係γ值分別為0.9993 及0.9985。

In this report,analysis data on cases of Chinese medicine preparation registration and samples acquired by the local health bureau officers from 2000 to 2004 were collected. The results were as following. The highest number of registration case was 828 cases in 2002, and the highest number of sampling was 744 coses in 2003.Combining the two results the highest number was 1460 cases in the fiscal year 2003. The percetange of inadequate specification in content in the two types of cases, the 10.4% in the sampling cases was much higher than the 1.3% in registration cases. In terms of failing to comply with the requirements by inspection categories,11 cases of identification and 9 for water extract content were the most serious cases in registration cases.For sampling cases, 65 for identification,35 for total ash, and 27 for acid insoluble ash were the most serious cases.