正交试验法研究果糖二磷酸钠注射液的制备工艺  

Study on the Preparation Technology of Sodium Fructose Diphosphate Injection by Orthogonal Test

作　　者：张宽才 李晨 陈程 Zhang Kuan-cai;Li Chen;Chen Cheng(Jiangsu Jiuxu Pharmaceutical Co.,Ltd.,Jiangsu Xuzhou 221200;Zhaoke Pharmaceutical Co.,Ltd.,Guangdong Guangzhou 511462)

机构地区：[1]江苏九旭药业有限公司,江苏徐州221200 [2]兆科药业(广州)有限公司,广东广州511462

出　　处：《生物化工》2020年第2期14-16,共3页Biological Chemical Engineering

摘　　要：目的:采用正交试验研究果糖二磷酸钠注射液的制备工艺中影响含量变化的因素。方法:采用正交试验法探讨药液的中间品pH值、活性炭量以及抗氧剂量的影响因素,每个因素取3个水平,按照L9(34)表安排正交试验,选用主药含量指标作为评定制备工艺优劣标准。结果:采用中间品pH值为4.0、活性炭用量为0.40%、抗氧剂用量为0.2%的制备工艺为最佳方案。结论:在制备果糖二磷酸钠注射液的过程中,上述3种因素对成品的合格率有较大的影响。因此在生产过程中需加以严格控制,从而提高成品的含量稳定性。Objection:The preparation technology of sodium fructose diphosphate injection was studied by orthogonal assay to demonstrate the affection factors.Methods:The influencing factors such as pH in intermediate product and amount of active carbon and antioxidant were studied.3 levels of each factors was designed according to L9(34)orthogonal table.The content of main test article was selected as criterial to evaluate the technique was excellent.Results:pH in intermediate product of 4.0 and active carbon of 0.4%and antioxidants of 0.2%was the excellent technique in this system.Conclusion:3 influencing factors Mentioned above should to be controlled strictly for increase stability at preparing as the percent pass was affected mainly for sodium fructose diphosphate injection.

关 键 词：果糖二磷酸钠注射液 正交试验 制备工艺 

分 类 号：TQ460.6[化学工程—制药化工]