摘要
目的:注射用奥拉西坦存在溶解不理想的问题,对此进行正交试验设计,以提高其溶解速度,优化配制方法。方法:以该药溶解时间为试验指标。影响因素主要为温度、溶媒体积和溶媒种类,每个因素选取3个水平。用直观分析法计算各水平的综合平均值,选出理论最佳试验方案。结果:通过追加试验确定最优溶解条件为:温度22℃、溶媒体积8 m L、溶媒为0.9%NS。随后开展验证性试验,表明所选溶解条件稳定可行。结论:为配制注射用奥拉西坦提供安全、方便、快捷的操作方法。
Objective： To solve the solubility problems of oxiracetam for injection, orthogonal design was carried out to improve its rate of dissolution and optimize the method of preparation. Methods： The dissolution time of oxiracetam was used as the test index. According to practice, the main factors including temperature, solvent volume and type, were chosen at three levels for each. Comprehensive average values were calculated for each level by direct analysis, and then the best test program was selected theoretically. Results： Combined with practical work, the optimal condition for the dissolution was determined as, 8 mL 0.9% NS at 22 ℃ by additional test. Confirmatory tests were conducted, proving that the selected conditions were stable and feasible. Conclusion： This study has provided a safe, easy and convenient method for the preparation of oxiracetam inPIVAS.
出处
《药学与临床研究》
2016年第5期393-394,共2页
Pharmaceutical and Clinical Research
关键词
注射用奥拉西坦
正交试验设计
优化配制
Oxiracetam for injection
Orthogonal design
Preparation optimization
