112年度含Chlorpheniramine maleate等7項成分口服錠劑之品質（含亞硝胺類不純物）監測   全文下載

Quality Surveillance of Oral Preparations Containing Chlorpheniramine maleate, Cilostazol, Diltiazem, Diphenhydramine hydrochloride, Escitalopram oxalate, Imipramine hydrochloride, and Venlafaxine hydrochloride in 2023

112年度藥品品質監測計畫係以風險評估為原則，選定對可能生成「N-亞硝基二甲胺」（NDMA）、「N-亞硝基二乙胺」（NDEA）及「N-亞硝基-N-甲基-4-胺基丁酸」（NMBA）等亞硝胺類化合物之高風險品項，依健保使用量大、長期使用等因素及行政管理需求，選定Chlorpheniramine maleate、Cilostazol、Diltiazem、Diphenhydramine hydrochloride、Escitalopram oxalate、Imipramine hydrochloride及Venlafaxine hydrochloride成分之口服製劑進行市售品品質監測，並於1至6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計54件（國產50件，輸入4件），參照中華藥典第九版、英國藥典2022年版、日本藥典第18版、衛生福利部食品藥物管理署公布之建議檢驗方法及原核准檢驗規格與方法，進行主成分鑑別、含量測定、溶離、不純物（亞硝胺類化合物）等項目之檢驗。經檢驗54件檢體皆符合規定，且均未檢出17種亞硝胺類化合物。

This study aimed to survey the quality of marketed oral preparations containing Chlorpheniramine, Cilostazol, Diltiazem, Diphenhydramine, Escitalopram, Imipramine, and Venlafaxine that may generate nitrosamines such as N-nitrosodimethylamine (NDMA), N-nitrosodiethylamine (NDEA), and N-nitroso- N-methyl-4-aminobutyric acid (NMBA). A total of 54 samples, fifty domestic and 4 imported, were collected from hospitals, clinics, pharmacies, pharmaceutical firms and pharmaceutical manufacturers by local health authorities over the period of January to June 2023. All samples collected were subjected to quality control testings, including identification, assay, dissolution, and nitrosamine impurities. The analytical methods applied consisted of the promugated regulations of TWP. IX, BP 2022, JP XVIII, TFDA-published analytical methods and in-house methods from the manufacturers with authorized specifications. The results indicated that all of the 54 samples met the requirements and 17 nitrosamine impurities were not detected in all of the samples.