维通静脉注射乳剂制备工艺研究

Technology Research on Preparation of Weitong Intravenous Emulsion

目的制备维通静脉注射乳剂(WIE),并考察其理化性质和溶血性。方法采用高压匀质法制备WIE;采用正交试验考察最佳处方和制备工艺因素对乳剂的影响,考察WIE的粒径和ζ-电位及制剂含量;采用紫外分光光度法判断有无溶血发生。结果 WIE的平均粒径为191.03 nm,平均ζ-电位为-38.83 mV,药物含量达90%以上,试管溶血试验阴性。结论维通静脉注射乳剂可提高脂溶性成分的溶解度和制剂的稳定性。

Objective To prepare Weitong Intravenous Emulsion(WIE) and investigate its physicochemical properties and hemolysis.Methods The high-pressure homogenization method was adopted to prepare WIE.The orthogonal experiment was used to investigate the influence of optimal formulation and the preparation process on the emulsion.The particle size,ζ-potential and the preparation content were investigated.The ultraviolet spectrophotometric method was adopted to judge whether hemolysis occurrence.Results The average particle size was 191.03 nm and ζ-potential was-38.83 mV.The drug content in WIE was above 90%.The test tube hemolysis test was negative.Conclusion WIE can increase the solubility of liposoluble constituents and the stability of the preparation.