療效不等通報系統之原廠藥與學名藥品質評估

Quality Evaluation of Brand-Name and Generic Drugs Registered in the Drug Therapeutic Inequivalence Reporting System

彭姿蓉(Tzu-Rong Peng) ； 吳大圩(Ta-Wei Wu)

《北市醫學雜誌》 18卷1期 (2021/03) Pp. 44-51

https://doi.org/10.6200/TCMJ.202103_18(1).0005

摘要

目的：評估通報療效不等之原廠藥與學名藥藥品化學含量品質。方法：依據最新之美國藥典第四十／四十一版（United States Pharmacopeia, USP 40／41）所載之試驗方法進行原廠藥（對照品）與學名藥（檢測品）之檢驗，藥品將進行含量測定（assay）、含量均一度（content uniformity）及溶離試驗（dissolution）（測試三種pH值1.45、4.5、6.8）等檢驗。結果：2016年7月至2017年12月通報藥品療效不等至藥品療效不等通報系統之藥品共31件，並以其中五項藥品送至藥品檢驗。在含量、含量均一度測試中，五種檢測品與對照品之含量測定皆符合藥典的規定（90%～110%），且五種檢測品與對照品之含量均一度皆符合藥典的規定AV ≤ 15（acceptable value）。在溶離檢驗結果，此五種檢測品與對照品之皆符合藥典的規定，雖在進行溶離試驗比對評估時顯示rosuvastatin在pH 1.45（0.01N HCl）及pH 4.5（acetate buffer）及amisulpride在pH 6.8（phosphate buffer）其f_2值小於50，因溶離測試之藥品數量只有6個劑型單位，而非溶離試驗相似性要求的12個劑型單位，溶離比對試驗之結果僅能供參考且應避免過度解讀。結論：這些通報療效不等之學名藥與原廠藥品化學檢驗結果皆符合藥典之規定。因此，這些被通報療效不等學名藥之化學含量品質與原廠藥無明顯差異。

關鍵字

療效不等 ； 學名藥 ； 原廠藥

並列摘要

Objectives: To evaluate the quality of brand-name and generic drug after their drug therapeutic inequivalences were reported. Materials and Methods: Brand-name (reference product) and generic (test product) drugs were inspected through the test methods recommended by the latest edition of the United States Pharmacopoeia (USP 40/41). The drug products were assayed for their quantity, content uniformity, and dissolution (including three pH values: 1.45, 4.5, 6.8). Results: From July 2016 to December 2017, 31 therapeutic inequivalence reports were received through the report system. Five of these products were selected for inspection. In the quantitative assay, 5 test products and the reference product were conformed to the range defined in the Pharmacopoeia (90%~110%). The content uniformity AV (acceptable values) were all ≤ 15; the results of dissolution assay met the specification of Pharmacopoeia, although the f_2 values of Rosuvastatin at pH 1.45 (0.01N HCl) and pH 4.5 (acetate buffer) and Amisulpride at pH 6.8 (phosphate buffer) were less than 50. Because only 6 dosage units instead of 12 as required in the dissolution assays, these results should be used as a reference only and over-interpretation should be avoided. Conclusions: The quality of the brand-name and generic drugs for which drug therapeutic inequivalence were reported were all in line with the specifications of Pharmacopoeia. No significant differences were found in the quality of the generic drugs and their branded equivalents as shown in the chemical assays.

並列關鍵字

therapeutic inequivalence ； brand name drug ； generic drug