109年度降血壓藥、降血糖藥、抗憂鬱症藥、鎮靜安眠藥及抗思覺失調症藥物等口服製劑之品質監測   全文下載

Surveillance on the Quality of Oral Preparations of Antihypertensives, Antidiabetic Agents, Antidepressants, Sedative-hypnotics and Antipsychotics in Taiwan, 2020

109年度藥品品質監測計畫係以風險評估為原則，選定降血壓藥（含Amlodipine besylate或Bisoprolol fumarate成分）、降血糖藥（含Glimepiride成分）、抗憂鬱症藥（含Escitalopram成分）、鎮靜安眠藥（含Estazolam成分）及抗思覺失調症藥物（含Risperidone成分）等單方口服製劑市售品進行品質監測，本監測計畫於1至8月間委由全國各地方政府衛生局，前往轄區內醫院、診所、藥局、藥商及製造廠抽驗產品共95件（國產77件，輸入18件），參照中華藥典第八版及原核准檢驗規格與方法，進行主成分鑑別、含量測定及溶離試驗等項目之檢驗，總計95件檢體皆符合規定。本計畫監測結果將提供作為藥政管理參考。

The 2020 surveillance project aimed to study the quality of oral preparations of antihypertensives, antidiabetic agents, antidepressants, sedative-hypnotics and antipsychotics marketed in Taiwan. A total of 95 samples (77 domestic and 18 imported) were collected from hospitals, clinics, pharmacies, pharmaceutical firms and pharmaceutical manufacturers by local health authorities over the period of January-August 2020. All collected samples were subjected to quality control testings, including identification, assay and dissolution. The analytical methods applied consisted of the regulations of Chinese Pharmacopoeia VIII and in-house methods from the manufactures with authorized specifications. The results indicated that all of the 95 samples met the requirements.