本分析報告蒐集89 年1 月至93 年12 月間中藥製劑查驗登記案件及各地方衛生機關送本局檢驗抽查案件之檢驗結果，並依據本局中藥製劑檢驗統計系統，予以統計分析。結果顯示查驗登記案件以91年度828 件最多，抽查案件則以92 年度744 件最多，這二類案件總件數以92 年度1460 件居冠。在檢驗不合格案件方面，五年來平均不合格率，抽查案件的10.4% 顯然比查驗登記的1.3% 比例高出許多。不合格項目方面，查驗登記案件以鑑別項11 件及水抽提物9 件居多，抽查檢驗方面亦以鑑別項65 件最多，另外灰分35 件及酸不溶性灰分27 件亦偏高。此外92 年度由於馬兜鈴科植物之誤用情形廣受重視，經抽驗含馬兜鈴酸藥材之製劑532 件，針對馬兜鈴酸加以檢驗，檢出者13 件佔2.4%。

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.