辽源七厘复方中药控释微丸制备工艺研究

摘要

目的：优选辽源七厘复方中药控释微丸最佳制剂制备工艺条件。方法：采用高效液相色谱法，以1.0h时提取物中龙血素B、羟基红花黄色素A、三七皂苷R1、阿魏酸平均累积释药率为考察指标，应用均匀试验法对制剂工艺进行优化。结果：最佳制剂制备工艺条件为羟丙甲纤维素浓度2％、挤出转速20 Hz、滚圆转速50 Hz、乙基纤维素水分散体混悬液2％、丸芯增质量5％。结论：经体外释放实验证明，本研究制得的控释微丸能明显延缓药物释放，释放过程符合零级动力学。%OBJECTIVE:To optimize the preparation conditions of Liaoyuanqili controlled release pellets . METHODS: HPLC method was adopted , to set the accumulative release rates within 1.0h. of Loureirin B, Hydroxysaffior yellow A , Notoginsenoside R1 and rerulic acid as review indicators , the preparation technology was optimized by homogeneous design experiments .RESULTS:The optimized preparation conditions were identified as 2%HPMC, extrusion speed 20 Hz, spheronization speed 50 Hz, 2%surelease, controlled-release layer with 5%(weight) coating level.CONCLUSIONS: Studies on release process in vitro reveal that the release of Liaoyuanqili controlled release pellets has been retarded significantly and the release process follows the zero -order kinetics.