107－108年度市售中藥製劑異常物質之調查   全文下載

Surveillance of Abnormal Substances in Commercial Chinese Medicine in Taiwan from 2018 to 2019

本調查於107至108年間，由各地方政府衛生局至轄區內之中藥廠、中醫院所或販售藥房抽查市售中藥製劑進行檢驗。中藥製劑依製程不同，可分為濃縮製劑及傳統製劑，其亦有不同之相關限量規範。本調查針對中藥製劑之重金屬（鉛、鎘、汞及砷）、微生物限量試驗及農藥殘留等項目進行檢驗。調查結果係以衛生福利部公告之限量標準為判定依據，結果顯示444件中藥濃縮製劑有1件不符合規範，不合格率為0.2％，55件中藥傳統製劑有4件不符合規範，不合格率為7.3％，皆為好氧性微生物總數不符合規定。本調查之結果均已通知原送地方衛生機關及衛生福利部中醫藥司，以確實落實藥品品質安全及衛生之把關。

In order to understand the contents of heavy metals (including lead, cadmium, mercury, and arsenic), microorganism contamination and pesticide residues in Chinese Medicine (CM) preparations, samples including concentrated CM preparations, traditional single or multiple herbal preparations were surveyed in Taiwan CM market from 2018 to 2019. Samples were collected by local health authorities form CM factories, CM hospitals and drugstores. All samples were analyzed and the results were determined according to the standards of CM preparations announced by the Department of Chinese Medicine and Pharmacy (DCMP). The results showed 1 out of 444 (0.2%) concentrated CM preparations and 4 out of 55 (7.3%) traditional CM preparations failed in total aerobic microbial counts. This survey had been provided to the administration authorities as reference for the purpose of ensuring the quality, safety and hygiene of CM.