注射用尿素的制备工艺研究

Study of the Preparation Technology of Urea for Injection

目的:优选注射用尿素的最佳制备工艺。方法:以尿素结晶纯度为指标,以乙醇浓度、乙醇与尿素的处方配比、除母液方法、结晶干燥方法为考察因素,采用正交试验优选制备工艺,并进行验证试验。结果:优选出的制备工艺为乙醇浓度75%,乙醇与尿素的处方配比1∶1,离心机甩干除母液,结晶采用真空干燥法;所制3批尿素结晶纯度平均为99.94%。结论:优选的制备工艺可行、重现性好,尿素结晶纯度稳定且较高。

OBJECTIVE： To optimize the preparation technology of Urea for injection. METHODS： The purity of urea crystal- lization was used as index to optimize the preparation technology of urea injection by orthogonal experiment with the concentration of alcohol, the proportion between alcohol and urea, the method of removing mother solution, the method of drying as factors. RE- SULTS： The optimal preparation technology was as follows： the concentration of alcohol was 75%, the proportion between alcohol and urea was 1 ： 1, swing with centrifugal machine, drying by vacuum treatment. The purity of crystal in 3 batches of urea was 99.94%. CONCLUSION： The optimal preparation process is feasible and reproducible and urea crystal is proved to be of higher purity and safety.