摘要
目的研究乌参醒脑滴丸的最佳工艺条件。方法以PEG4000和PEG6000为辅料、液体石蜡和二甲基硅油为冷凝液制备乌参醒脑滴丸,采用单因素考察法确定冷凝液配比、基质质量比,并采用正交试验法考察药液温度、冷凝液温度、滴距、药物与基质质量比对制备工艺的影响。结果乌参醒脑滴丸的制备工艺条件为:V(二甲基硅油)∶V(液体石蜡)=2∶3,m(PEG4000)∶m(PEG6000)=1∶1,药液温度为72℃,冷凝液温度5℃,滴距13 cm,m(药物)∶m(基质)=1∶2。该工艺制备的滴丸外观圆整度良好,硬度较好,色泽均一。结论本法筛选的乌参醒脑滴丸制备工艺可行,符合《中国药典》中滴丸剂的质量规定。
Objective To optimize the preparation process of Wushenxingnao dropping pills. Methods Wushenxingnao dropping pills were prepared by PEG 4000 and PEG 6000 as excipieut, proportional liquid paraffin and simethicone as condensate. After single factor test was used to make sure the ratio of condensate, mass ratio of matrix, the orthogonal test was used to screen the drug-soup temperature, condensate temperature, dropping distance,mass ratio of drug and matrix on the influence of preparation technology.Results The optimized proces~ of Wushenxingnao dropping pills was as follows：V（ dimethyl silicone ） ：V（ liquid paraffin ）= 2：3, m （PEG4000） ：re（PEG6000）= l：l ,the temperature for the dropping mixture was 72℃ ,the temperature for cool aqueous was 5 ℃, dropping distance was 13 cm, m （ active ingredients ） ： m （ matrix ） = 1 ： 2, Good quality of Wusbcnxingnao dropping pill can be produced in the above process. Conclusion The optimum procedure is feasible and in accord with the quality standards of dropping pills of the Chinese Pharmacopoeia.
出处
《广东药学院学报》
CAS
2014年第2期132-135,共4页
Academic Journal of Guangdong College of Pharmacy
基金
广东省教育部产学研结合项目(2012B091100193)
广州市科技计划助资项目(11C3213078)
关键词
乌参醒脑滴丸
成型工艺
单因素法
正交试验法
：Wushenxingnao drop pills
moulding process
single factor test
orthogonal test
