红倍凝胶的制备及质量控制  

Preparation and Quality Control of Hongbei Hydrogel

作　　者：苏金龙[1] 王元[1] 高晓红[1] 李军民[1] 

机构地区：[1]兰州大学第二医院,兰州市730030

出　　处：《中国药房》2010年第5期439-440,共2页China Pharmacy

摘　　要：目的:制备红倍凝胶并建立其质量控制方法。方法:以红霉素和倍他米松为主药,卡波姆-940为主要基质制备凝胶;采用紫外可见分光光度法分别在483.3、260nm波长下测定并计算主药红霉素和倍他米松的含量。结果:所制凝胶为无色细腻的半固体凝胶,红霉素、倍他米松检测浓度线性范围分别为9.69～59.43μg·mL-(1r=0.9993,n=6)、6.20～20.27μg·mL-(1r=0.9995,n=6),平均回收率分别为98.39%(RSD=1.23%)、98.24%(RSD=0.43%)。结论:该制剂制备工艺简单可行、质量控制方法有效。OBJECTIVE： To prepare Hongbei hydrogel and establish its quality control method. METHODS： Hongbei hydrogel was preparaed using erythomycin and betamethasone as principal agents and carbomer--940 as key base material. The content of erythomycin and betamethasone were determined by UV spectrophotometry at detection wavelength of 483.3 nm and 260 nm, respectively. RESULTS： The preparation assumed colorless smooth semisolid gel. The linear ranges were 9.69-59.43μg·mL^-1 for erythomycin （r=0.999 3, n=6） and 6.20-20.27 μg·mL^-1 for betamethasone （r=0.999 5, n=6）. The average recovery rate were 98.39% （RSD=1.23%） and 98.24% （RSD=0.43%）. CONCLUSION： The preparation technology was simple, feasible and practical for quality control.

关 键 词：红倍凝胶 红霉素 倍他米松 制备 质量控制 

分 类 号：R986[医药卫生—药品] R927.1[医药卫生—药学]