八十六－九十年度中藥製劑國產查驗登記及抽查檢驗案件分析

Analysis on Chinese Medicine Preparations Registration and Inspection Cases in 1997 to 2001

秦玲(Ling Chin) ； 黃成禹(Cheng-Yu Huang) ； 林哲輝(Jer-Huei Lin) ； 廖俊亨(Chen-Heng Liao)

《藥物食品檢驗局調查研究年報》 20號 (2002/09) Pp. 195-200

https://doi.org/10.6946/ASRNL.200209.0195

摘要

本分析報告蒐集86年1月至90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之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87年度698件最多，抽查案件則以90年度298件最多，這二類案件總件數以九十年度968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16.6%顯然比查驗登記的1.5%比例高出許多。不合格項目方面，查驗登記案件以稀醇抽提物14件及水抽提物12件居多，抽查檢驗方面則以灰分57件、酸不溶性灰分49件及鑑別項47件偏高。

關鍵字

中藥製劑 ； 查驗登記案件 ； 抽查案件

並列摘要

This analysis reported the inspection results on the cases of Chinese medicine preparations submitted for registration, and the Chinese medicine sampled by regional health authorities and submitted to the health bureau for inspection. Statistic analysis was also performed based on the Chinese medicine preparation inspection system set by the bureau. The statistic result indicated that the highest number of cases submitted for registration was in 1998 at 698 cases, the highest number of inspection cases was in 2001 at 298 cases. The highest combined total was in 2001 at 968 cases. On the inspection results of the average ratio in cases that failed to comply with the requirements during the 5 years, 16.6% was in inspection cases which was higher than the 1.5% in registration cases. In terms of the categories that did not comply with the requirements, the results were as following. In the registration cases, there were 14 samples with dil-ethanol extract and 12 samples with water extract that out-numbered other categories. In the inspection cases, the most frequent found were 57 samples with total ash, 49 samples with acid insoluble ash, and 47 samples for identification.

並列關鍵字

Chinese medicine preparation ； registration case ； sampling case