108年度胃腸用藥、肝炎用藥、泌尿生殖用藥、降血糖藥及降血脂藥等口服製劑之品質監測   全文下載

Surveillance on the Quality of Oral Preparations of Spasmolytics, Antiviral Agents, Urologicals, Antidiabetic Agents and Antihyperlipidemic Agents in Taiwan, 2019

108年度藥品品質監測計畫係以風險評估為原則，選定特定複方胃腸藥（含Dicyclomine hydrochloride成分）、肝炎用藥（含Entecavir成分）、泌尿生殖用藥（含Tamsulosin hydrochloride成分）、降血糖藥（含Gliclazide及Metformin成分）及降血脂藥（含Rosuvastatin成分）等口服製劑之市售品進行品質監測，並於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119件（國產96件，輸入23件），參照中華藥典、美國藥典及原核准檢驗規格與方法，進行主成分鑑別、含量測定、溶離、劑型單元含量均一度及有機不純物等項目之檢驗。總計119件檢體中3件不符合規定，分別為含Tamsulosin hydrochloride成分口服製劑之溶離1件不符合原廠規格；含Gliclazide成分口服製劑有2件不符合中華藥典第八版溶離檢驗規格，其中1件之含量測定亦不符合其原廠規格。本計畫監測結果將提供作為藥政管理參考。

The 2019 surveillance project aimed to study the quality of oral preparations of spasmolytics, antivirals, urologicals, antidiabetic agents and antihyperlipidemic agents marketed in Taiwan. A total of 119 samples (96 domestic and 23 imported) were collected from hospitals, clinics, pharmacies, pharmaceutical firms and pharmaceutical manufacturers by the local health authorities from January to August 2019. All samples were subjected to quality control testing, including identification, assay, dissolution, uniformity of dosage units and organic impurity tests. The analytical methods applied were from the Chinese Pharmacopoeia, United States Pharmacopoeia and in-house methods from the manufactures with authorized specifications. The results indicated that three out of the 119 samples did not meet the required specifications, including one sample of tamsulosin hydrochloride tablets failed to meet the authorized specification of dissolution test, and two samples of gliclazide tablets failed to meet the requirements of dissolution test in Ch. P VIII, while one of them also failed to meet the authorized specification of drug content. The surveillance results of this project will be provided as reference for drug administration management.