摘要
目的:制备奥扎格雷鼻用凝胶并建立其质量控制方法。方法:以无毒、无刺激的壳聚糖为凝胶基质制成奥扎格雷凝胶剂,采用HPLC法测定其含量。结果:所制制剂为淡黄色、半透明状凝胶;奥扎格雷检测浓度的线性范围为10.46～83.68μg·ml^(-1)(r=0.999 9),平均回收率为96.88%(RSD=1.10%),3批样品经留样试验考察,质量稳定。结论:该制剂处方合理,制备工艺简便,含量测定准确。
Objective： To prepare ozagrel nasal gel and establish its quality control standard. Method： Nontoxic and non-irritant chitosan was used as the base material to prepare ozagrel gel. The content of ozagrel in the gel was determinated by HPLC. Result： The appearance of the gel showed light-yellow and translucent. The linear range of ozagrel in the gel was from 10.46 to 83.68 μg·ml- l （r = 0. 999 9 ）. The average recovery was 96. 88% （ RSD = 1.10% ）. The stability of the gel was proved to be promising through 3 batches of samples reserved for observation test. Conclusion ： The gel is reasonable in formulation, simple in preparation, accurate in content determination and stable in quality.
出处
《中国药师》
CAS
2011年第4期490-492,共3页
China Pharmacist
