注射用阿魏酸钠制备工艺中的影响因素  

Influential factors in preparation process of sodium ferulate for injection

作　　者：叶肖栗[1] 汤海燕[1] 任国飞 

机构地区：[1]浙江大学医学院附属儿童医院,浙江杭州310003 [2]杭州容立医药科技有限公司,浙江杭州310012

出　　处：《中国医院药学杂志》2009年第2期119-121,共3页Chinese Journal of Hospital Pharmacy

摘　　要：目的:考察注射用阿魏酸钠制备工艺中的影响因素。方法:通过正交试验筛选阿魏酸钠的处方及制备工艺,考察支持剂、冻干机真空度及升华时间对制剂的影响。紫外分光光度法测定样品中阿魏酸钠的含量,采用高效液相色谱法对样品进行有关物质检查,经加速稳定性试验初步考察样品的稳定性。结果:注射用阿魏酸钠的最佳处方及工艺:支持剂为5%的氯化钠溶液,真空度为200Pa,升华时间为25h。所制得阿魏酸钠冻干粉针经加速试验3个月后,性状、pH、含量、水分等各指标无明显变化。结论:真空度对冻干产品成形的影响较大,这为冻干制剂的制备提供了参考依据。OBJECTIVE To study the formulation and technology of sodium ferulate for injection, to investigate the effect ot support agents, vacuum of freeze dryer and sublimation time on the product preparation. METHODS Orthogonal experiment was used to optimize the formulation and technology of sodium ferulate for injection. The content of sodium ferulate in samples was determined by ultraviolet spectrophotometry. The product stability was investigated in the accelerated stability test. RESULTS The optimum formulation and technology for sodium ferulate for injection was： 5% of NaCl was the support agent, vacuum was estimated to be 200 Pa, and the time of sublimation was 25 h. In the accelerated stability test, there was no significant change on character, pH, content and water content for sodium ferulate products. CONCLUSION The vacuum of freeze dryer played an improtant role in preparation of sodium ferulate for injection.

关 键 词：注射用阿魏酸钠 正交试验 制剂工艺 真空度 

分 类 号：R944[医药卫生—药剂学]