鸦胆子油亚纳米乳注射液处方工艺研究的论文.doc

鸦胆子油亚纳米乳注射液处方工艺研究的论文.doc鸦胆子油亚纳米乳注射液处方工艺研究的论文作者:潘文, 胡海波, 崔明超, 潘金火, 欧阳强【摘要】目的确定鸦胆子油亚纳米乳注射液的处方和制备工艺。方法以精制鸦胆子油为油相, 蛋黄卵磷脂和泊洛沙姆 188 为复合乳化剂, 优选了鸦胆子油、乳化剂和稳定剂的用量, 并用正交设计优化了制备工艺。结果最优处方为 10% 油相,% 乳化剂,% 稳定剂; 最优工艺为水相和油相在 70℃混合,10 000 r/min 高速剪切 20 min, 在 900 bar 压力下高压均质 6 次。结论制得的鸦胆子油亚纳米乳注射液物理稳定性良好。【关键词】鸦胆子油;亚纳米乳;处方研究;制备工艺;稳定性 abstract : objective to optimize the prescription and technology of brucea javanica oil subnanoemulsion injection. methods using superfine brucea javanica oil as oil phase, yolk lecithin and poloxamer 188 as the plex emulsifying agents. the dosage of oil, emulsifier and stabilizer ized and the preparation ized by orthogonal experiments. results the optimum precription ulsifier and % stabilizer. the optimum technology ixed at 70℃, sheared 20 min by high speed shearing machine and then passed the ultra-high pressure nano homogenizer 6 times under the pressure of 900 bar. conclusion the physical stability of brucea javanica oil subnanoemulsion injection is good. key ulsion ; prescription ; preparation technology ; stability 鸦胆子油是苦木科植物鸦胆子的干燥成熟果实用石油醚提取所得的脂肪油, 具有抗癌作用, 主要用于肺癌、肺癌脑转移及消化道肿瘤[1] 。. 目前虽有注射用乳剂上市, 但因粒径较大, 在贮运及使用过程中易发生破乳分层现象, 且较难吸收。而亚纳米乳制剂具有粒径较小、稳定性好等优点, 可以充分发挥