摘要
目的制备盐酸川芎嗪并优化其制备工艺方法梯度冷却法滴制,以滴丸圆整度和拖尾为指标单因素考察影响因索,通过正交试验优选制备工艺。结果确定最佳工艺为:聚乙二醇600(PEG 6000)与硬脂酸为基质,比例为PEG 6000:硬脂酸为4:1,药物与基质比例为1:3料温为70℃。冷凝柱温度梯度为:上部30～0℃。调节滴速为45滴/min,滴距5 cm时圆整度好,无拖尾现象,滴丸中药品缓慢释放。结论实验数据,图表分析,实验采用优选制备缓释滴丸的方法 ,符合实验预期结果 。
Objective To prepare the ligustrazine hydrochloride sustained-release dropping pills and optimize the preparation process. Methods The gradient cooling method was adopted. With the spherical degree and trailer of dropping pills as the evaluation indexes, the preparation process was optimized with orthogonal design. Results The optimal preparation process was as follows： the substrate contained PEG 6000 and stearic acid （4：1）; the ratio of drug to substrate was 1：3; the material temperature was 70 ℃; the temperature gradient of condenser was 30-0 ~C; the drop speed was 45 drops/min; and the drop distance was 5 cm. Conclusion The optimal preparation process can be simple and applied in the industrialization of lignstrazine hydrochloride sustained-release dropping pills.
出处
《食品与药品》
CAS
2012年第2期99-102,共4页
Food and Drug
关键词
盐酸川芎嗪
缓释滴丸
正交试验
ligustrazine hydrochloride
sustained-release dropping pills
orthogonal test
