正交设计优选依沙吖啶溶液的处方及制备工艺

Optimization of preparation formulation of ethacridine solution by orthogonal design

目的比较依沙吖啶溶液在pH值、抗氧剂和惰性气体三因素共同影响下的稳定性,并结合经济效益,为医院配制依沙吖啶溶液最经济有效的方案提供途径。方法采用分光光度法测定依沙吖啶的含量,用初匀速法预测其室温储存期,按正交设计选择最优条件组合。结果在pH值4.0,0.10%对乙氧基苯胺+氮气2 min的条件下依沙吖啶稳定性最好;在pH4.5,0.00%对乙氧基苯胺+氮气2 min的条件下依沙吖啶的稳定性次之。结论综合考虑依沙吖啶溶液的刺激性、生产成本和操作难度等问题,选择pH 4,5+氮气2 min作为最优选择,后期还应补充试验,以寻找最优生产方案。

Objective To compare the stability of ethacridine solution influenced by three factors： pH value, antioxidants and inert gas, to find out the most economical and effective production of ethacridine solution for the hospital with the consideration of eco- nomic benefits. Methods The content of ethacridine solution was determined by UV spectrophotometry, and the room - temperature storage period was predicted with the initial uniform rate method, Finally, the optimal conditions for producing the ethacridine solution was selected by orthogonal design. Results Ethacridine solution was the most stable under the condition of pH4. O, 0.10% p-pheneti- dine and nitrogen of 2 minutes. Ethaeridine solution was the second most stable under the condition of pH4.5, 0.00% p-phenetidine and nitrogen of 2 minutes. Conclusion The condition of pH4.5 and nitrogen of 2 minutes was the optimal choice by considering the ir- ritation of ethacridine solution, the cost of production and operation difficulty. However, more tests should be done to find out the opti- mal plan of production.