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| 奥扎格雷鼻用凝胶的制备与质量控制 | |
| 引用本文： | 刘珠,郭毅,高振强,安静. 奥扎格雷鼻用凝胶的制备与质量控制[J]. 中国药师, 2011, 14(4): 490-492 |
| 作者姓名： | 刘珠 郭毅 高振强 安静 |
| 作者单位： | 1. 河北省药品检验所 石家庄050011 2. 河北医科大学第三医院 3. 河北医科大学药学院 |
| 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,制剂质量稳定 |
| 关 键 词： | 奥扎格雷 壳聚糖 凝胶剂 制备 质量控制 |
Preparation and Quality Control of Ozagrel Nasal Gel |
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| Liu Zhu , Guo Yi , Gao Zhenqiang , An Jing. Preparation and Quality Control of Ozagrel Nasal Gel[J]. China Pharmacist, 2011, 14(4): 490-492 | |
| Authors: | Liu Zhu Guo Yi Gao Zhenqiang An Jing |
| Affiliation: | Liu Zhu~1,Guo Yi~1,Gao Zhenqiang~2,An Jing~3(1.Hebei Institute for Drug Control,Shijiazhuang 050011,China,2.The Third Hospital of Hebei Medical University,3.School of Pharmacy,Hebei Medical University) |
| Abstract: | 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. |
| Keywords: | Ozagrel Chitosan Gel Preparation Quality control |
| 本文献已被 CNKI 维普 万方数据 等数据库收录！ | |