巿售含荷爾蒙成分眼藥水之品質調查

INVESTIGATION ON THE QUALITY OF MARKETED HORMONE CONTANING OPHTHALIC SOLUTIONS

荷爾蒙成分之眼藥水一般用於治療炎症及過敏性之眼疾，在台灣夏季結膜炎流行期更廣被使用，且此類外用劑在市面上很輕易可購得，為了解其品質現況，於七十五年十月至七十六年四月自全省各藥局、藥房購得檢體120件，其所含荷爾蒙成分分別計有十種 （Betamethasone Sodium Phosphate, Cortisone Acetate, Dexamethasone Sodium phosphate, Dexamethasone-21-Sodium Sulphobenzoate. Flucortolone Trimethyl Acetate, Hydrocortisone, Hydrocortisone Acetate, Hydrocortisone Caprylate, Prednisolone Acetate, prednisolone sodium Phosphate），利用高效液相層析法將檢品及標準品分別以 H2O 或 Etoh 稀釋成 100μg/ml 之濃度以 μ-Bodapack C18, Licrosorb S60. 之層析析管及 0.07 M Potassium phosphate monobasic:MeoH = 60:50, N-Hexane: MeoH: Tetrahydrofuran: H20 = 120:12:4 = 0.04, 70% MeoH 之三種移動相在 uv254 nm 下偵測。

In an attempt to understand the quality of commercial Hormone containing Ophthalmic solutions, the Bureau collected 120 samples in Taiwan area from Oct. 1986 to Apr. 1987, All sample were analyzed by the H. P. L. C Method described in usp x x 1, The results showed that a total of 9 samples (7. 5%) failed to meet the requirement specified in the USP XXI.