100－106年市售中藥製劑異常物質之調查

Surveillance of Abnormal Substances in Commercial Chinese Medicine in Taiwan between 2011 and 2017

本調查於100至106年間，由各縣市衛生局至轄區內各中藥廠、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，可區分成濃縮製劑及傳統製劑，針對不同劑型亦有不同相關規範。本調查針對中藥製劑之重金屬（比色法）、鉛、鎘、汞、砷、微生物限量試驗、農藥殘留、黃麴毒素、總灰分、酸不溶性灰分及馬兜鈴酸等項目進行檢驗。本調查係以衛生福利部公告之限量標準及原查驗登記規範為判定依據，結果顯示中藥濃縮製劑906件檢體中有9件不符合規定，分屬9家中藥廠，包括8件好氧性微生物總數及1件重金屬汞，不合格率為1.0％；中藥傳統製劑326件檢體中有15件不符合規定，分屬14家中藥廠，包括1件黃麴毒素、2件好氧性微生物總數、1件汞，11件總灰分（其中有3件之酸不溶性灰分亦不符合規定），不合格率為4.6％。本調查之結果均已逐案函復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 investigate heavy metals (including lead, cadmium, mercury, and arsenic), microbial contamination, pesticide residues, aflatoxins, total ash, acid-insoluble ash, and aristolochic acid in Chinese Medicine (CM) preparations, samples including concentrated CM preparations, traditional single or multiple herbal preparations were collected in Taiwan CM market between 2011 and 2017. The local health authorities sampled from CM factories, CM hospitals, and drugstores. All samples were analyzed and the results were determined according to the regulations of registration and residue limits of CM preparations announced by the Department of Chinese Medicine and Pharmacy (DCMP). The results showed 9 out of 906 concentrated CM preparations from 9 CM factories were not in compliance, which consisted of 8 in total aerobic microbial counts and 1 in heavy metal mercury. In traditional CM preparations from 14 CM factories, fifteen samples were not in compliance which consisted of 1 in aflatoxins, 2 in total aerobic microbial counts, 1 in heavy metal mercury, and 11 in total ash (including 3 items in acid-insoluble ash). This survey had been forwarded to the administration authorities as reference for ensuring the quality, safety, and hygiene of CM.