复方更昔洛韦/曲安奈德眼用凝胶的制备及其质量控制

Preparation and Quality Control of Ophthalmic Gel of Compound Ganciclovir/Triamcinolone Acetonide

目的：制备复方更昔洛韦／曲安奈德眼用凝胶，并对其进行质量控制。方法：以卡波姆为基质，制备复方更昔洛韦／曲安奈德眼用凝胶。采用高效液相色谱法测定其中更昔洛韦和曲安奈德的含量，并对其外观形状、黏度、渗透压、pH进行检测。结果：制得的眼用凝胶无色澄清透明，外观均一稳定，黏度为92mpa·S，渗透压为921．66mosmol／kg，pH为6,91；更昔洛韦和曲安奈德的检测质量浓度线性范围分别为30．3～90．9、10．5～73．5μg／ml（r=0．9998），平均回收率分别为99．20％～99．88％、100．29％～100．64％，RSD分别为0．81％～0．90％、0．24％～1．03％（n=3）。结论：该制剂制备方法简单，质量可控。

OBJECTIVE： To prepare Ophthalmic gel of compound ganciclovir/triamcinolone acetonide, and to control the quali- ty of it. METHODS： Carbomer was used as matrix to prepare Ophthalmic gel compound ganciclovir/triamcinolone acetonide. The contents of ganciclovir and triamcinolone acetonide were determined by HPLC. The appearance, viscosity, osmotic pressure and pH value of the gel were all detected. RESULTS： The ophthalmic gel was colorless, clear and transparent, uniform and stable in appearance. The viscosity was 92 mpa-s, and osmotic pressure was 921.66 mosmol/kg （pH=6.91）. The linear ranges were 30.3- 90.9 μg/ml for ganciclovir and 10.5-73.5 μg/ml for triamcinolone acetonide （r=0.999 8）; average recoveries were 99.20%-99.88% （RSD=0.81%-0.90%, n=3） for ganciclovir and 100.29%-100.64% （RSD=0.24%-1.03%, n=3） for triamcinolone acetonide. CONCLUSIONS： The method is simple and controllable in quality.