摘要
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.
出处
《中国药房》
CAS
CSCD
2014年第17期1598-1600,共3页
China Pharmacy