复方蛋黄乳膏的制备及质量控制

Preparation and Quality Control of Compound Yolk Emulsion

目的:制备复方蛋黄乳膏并建立其质量控制方法。方法:用乳化法制备复方蛋黄乳膏;分别采用显色反应及薄层色谱法对复方蛋黄乳膏中鱼肝油和制霉菌素进行定性鉴别;通过可见分光光度法测定复方蛋黄乳膏中维生素B2(VitB2)的含量;另考察3批样品的稳定性。结果:VitB2检测浓度在0.0119～0.0238mg/ml范围内与吸收度线性关系良好(r=0.9958),平均回收率为97.95%(RSD=3.45%)。制备的3批样品经4℃～8℃留样试验考察,质量稳定。结论:该制剂制备方法简便,含量测定准确,质量在保质期内稳定可控。

OBJECTIVE： To prepare compound yolk emulsion and to establish its quality control method. METHODS： Compound yolk emulsion was prepared by emulsification. Cod liver oil and Nystalin in compound yolk emulsion were identified by color reaction and TLC, respectively. The content of VitB2 was determined by visible spectrophotometric method. The stability of 3 batches of samples was investigated as well. RESULTS： The linear range of VitBg were 0.0 119-0.0 238 mg/ml （r = 0.9 958）. The average recovery of VitB2 was 97.95% （RSD = 3.45% ）. 3 batches of sample preparations were tested to be stable in quality at 4℃-8℃. CONCLUSION： This method is simple in operation, accurate in content determination, and stable and controllable in quality within expiration date.