104年度尿酸合成抑制劑(allopurinol)、皮質類固醇(prednisolone)、抗生素(cephalexin及nalidixic acid)、安眠藥(lorazepam)及抗癲癇藥(valproic acid)等口服製劑之品質監測

Quality Surveillance Study on the Oral Preparations of Uric Acid Synthesis Inhibitors (Allopurinol), Corticosteroids (Prednisolone), Antibiotics (Cephalexin and Nalidixic Acid), Hypnotics (Lorazepam) and Antiepileptic Drugs (Valproic Acid)

104年度藥品品質監測計畫係以風險評估為原則，選定尿酸合成抑制劑之allopurinol成分、皮質類固醇之prednisolone成分、抗生素之cephalexin及nalidixic acid二成分、安眠藥之lorazepam成分及抗癲癇藥之valproic acid成分等口服製劑進行藥品品質監測，並於104年1至6月間委由全國各縣市衛生局，前往轄區內醫院、診所、藥局、藥商及製藥廠抽驗市售檢體共115件（國產108件，輸入7件），參照藥典之規範及原核准之檢驗規格與方法，進行鑑別、溶離度、單位劑量均一度、含量測定、水分及有機不純物等項目之檢驗。結果計有1件國產含lorazepam成分之製劑不符合美國藥典第37版有機不純物之限量規格，其餘部分皆合格。

To present an update of drug-quality in Taiwan market, representative active ingredients in oral preparations such as allopurinol (inhibitor of uric acid synthesis), prednisolone (corticosteroid), cephalexin(antibiotic), nalidixic acid (antibiotic), lorazepam (hypnotic) and valproic acid(antiepileptic) were surveyed. This study was supported by local health authorities of Taiwan which collected drug samples (115 in total) from hospitals, clinics, pharmacy, pharmaceutical firms and pharmaceutical manufacturers between January and Jane in 2015. Samples were analyzed by the methods as described in the Chinese Pharmacopoeia VII and USP 37. Specifications of identification, dissolution, uniformity of dosage units, assay, water determination and organic impurities were investigated. The results showed only one sample which contained lorazepam as active ingredient failed to complied with the USP 37 in the specification of organic impurities; the others all met the compendial requirements.