藿香正气口服乳剂的研制

Development of Huoxiang-Zhengqi oral emulsion

目的：制备不含乙醇且性状良好的藿香正气口服制剂，优化其制备工艺。方法分别提取藿香正气口服液处方中药材，将挥发油与卵磷脂进行高速剪切后，采用高压均质机进行乳化制备并终端灭菌，考察磷脂用量、乳化温度、剪切时间、高压均质次数、灭菌条件等因素。结果最终确定制备工艺为：提取藿香正气口服液中的挥发油，将挥发油加入50%卵磷脂，70℃水浴搅拌溶解，在10000 r/min高速剪切的作用下缓慢加入水相，加入完毕后剪切5 min制备初乳。初乳于高压均质机中高压均质8次，一级压力为800 bar，二级压力为80 bar，定容、灌装密封，116℃灭菌30 min。制备的藿香正气口服乳为棕黄色澄清溶液，性状良好。结论该方法可行，工艺简单稳定，易于推广。

Objective To determine a better technique for developing the Huoxiang-Zhengqi oral emulsion without ethanol. Methods The medicinal herb of prescription in Huoxiang-Zhengqi oral liquid was extracted, and the volatile oil was firstly sheared with lecithin by high speed shearing machine, and then was prepared by high-pressure homogenizer and finally was sterilized. The factors such as the amount of phospholipids, emulsifying temperature, shearing time, the times of high pressure homogenization and sterilization conditions were investigated. Results The optimization preparation process was that the volatile oil from Huoxiang-Zhengqi oral liquid was added into 50%lecithin and was dissolved in 70 ℃ water bath, then in 10 000 r/min high-speed shear. And in the phase of adding aqueous, it was sheared 5 min for the preparation of colostrum. In the high pressure homogenization machine, the first stage pressure was set at 800 bar and the second was at 80 bar, and based on the high pressure, colostrum was prepared by 8 times. Finally, the sterilization was 116 ℃, 30 min. The preparation was a brown clarified solution, which was qualified. Conclusion The preparation method was simple, stable, and easy to popularize.