| 摘要: |
| 【目的】以氟苯尼考为主药，制备氟苯尼考长效混悬注射液，并对其进行质量控制研究。【方法】采用正交设计进行处方优化筛选，以助悬剂含量、润湿剂含量、研磨时间为可变因素，选用L9(34)正交设计表进行试验，以研磨分散法制备氟苯尼考混悬注射液，对其进行质量评价并建立测定氟苯尼考含量的方法。【结果】氟苯尼考长效混悬注射液的最佳处方为：氟苯尼考15 g，PVP 10 mL，蓖麻油15 mL，司盘 80、吐温 80、抗氧化剂和防腐剂各适量，再以CMC-Na溶液调节总量至100 mL。以紫外分光光度法测定氟苯尼考含量，标准曲线回归方程的相关系数为0.999 1，平均回收率为91.24%，专属性强，简单易操作。质量评价试验表明,该混悬注射液重分散性和通针性良好。【结论】所研制的氟苯尼考混悬注射液符合药典中有关混悬注射液的要求，制备方法简单可行。 |
| 关键词: 氟苯尼考 混悬注射液 正交设计 质量控制 |
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| 基金项目:陕西省科技攻关项目（2009K02-01） |
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| Preparation of florfenicol long-acting suspension injection and quality control |
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| Abstract: |
| 【Objective】 The study was to prepare the florfenicol long-acting suspension injection with broad spectrum antibiotic florfenicol as the main drug,and to study the quality of this suspension injection.【Method】 With orthogonal design method,the suspending agent concentration,the wetters concentration and ground time were selected as variable factors and table L9(34) were used in the experiment.Preparing the florfenicol long-acting suspension injection with grinding dispersion,its quality was evaluated and the method for content determination of florfenicol was established.【Result】The optimum prescription were：florfenicol 15 g,PVP 10 mL,span-80,tween-80,with appropriate antioxidants and aseptic.The content of florfenicol was determined by UV spectrophotometry.The coefficient of regression equation was 0.999 1,average recovery rate 91.24%.The method is specific, simple and accurate for the quality control of florfenicol long acting suspension injection.The results of quality evaluation showed that the present suspension injection was characterized by its good sedmientation and easy-redispersion.【Conclusion】 The florfenicol long-acting suspension injection was up to the mustard of pharmacopoeia,and the method was simple and feasible. |
| Key words: florfenicol suspension injection orthogonal design method quality control |
