辽源七厘复方中药控释微丸制备工艺研究

Study on Preparation Technology of Compound Liaoyuanqili Controlled Release Pellets

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1.0 h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.