氨溴索注射乳剂的处方及工艺研究

Prescription and Technology of Ambroxol Injectable Emulsion

目的确定氨溴索注射乳剂的处方及制备工艺。方法以注射用大豆油为油相,大豆磷脂和泊洛沙姆为乳化剂,加入等渗调节剂,通过改变油相比例、乳化剂种类和用量,制备温度、分散时间、压力、灭菌方式,制备氨溴索注射乳剂。结果最佳处方为0.25%氨溴索,10%油相,1.2%乳化剂,1.0%稳定剂,2.25%甘油,加水至全量。最佳工艺为水相和油相在70℃混合乳化,19 000 r/min均质5 min,60 psi压力下通过微射流仪6次制得终乳,充N2灭菌30 min。结论所制氨溴索注射乳剂物理稳定性良好。

Objective To determine the formulation and preparation technology of Ambroxol Injectable Emulsion. Methods Ambroxol In-jectable Emulsion was prepared by using soybean oil as the oil phase, soybean phospholipid and poloxamer as the complex emulsifying agent. The isoosmotic adjusting agent was also added into the formulation, the formulation and preparation technique were selected by changing the oil phase ratio, emulsifying agent, preparation temperature, dispersing time, preparation pressure and sterilization meth-ods. Results The optimal formulation was 0. 25% of ambroxol, 10% of oil phase, 1. 2% of emulsifying agent, 1. 0% of stabilizing agent and 2. 25% of glycerol, adding water to the total amount. The optimal technology was the mixture and emulsification of the water phase and the oil phase at 70℃, which was homogenized for 5 min at 19 000 r/min, the final emulsion was obtained by microfluidizer for 6 times under 60 psi pressure, sterilized with nitrogen for 30 min. Conclusion The physical stability of the prepared Ambroxol Injectable Emulsion is good, which provides a basis for the development of the product.