摘要
目的研究影响银泽滴丸制备的各种因素,确立最佳制备工艺。方法以外观质量、溶散时限和丸重差异为评价指标,采用正交设计试验对各影响因素进行考察。结果以聚乙二醇6000-聚乙二醇4000(7∶1)为基质,药物与基质比例为1∶3,药液温度为85℃,二甲基硅油为冷凝剂,冷凝剂温度为6℃,滴速为40d.min-1,滴距为6cm。制得的滴丸外观质量好、溶散时限短、丸重差异小,与颗粒剂比较吸湿性小。结论该滴丸质量稳定,适于工业化生产。
Objective To approach the optimal preparation procedure of Yinze Dripping Pills by analyzing various influencing factors of preparation. Methods The orthogonal test was conducted to investigate various factors that influenced the preparation procedure, taking appearance quality, disintegration time and pill weight as the evaluation indexes. Results Optimal preparation conditions of the dripping pills were obtained as follows： PEG6000-PEG4000 （7 ： 1） was taken as the ground substance, the ratio of drug to the ground substance was 1 ： 3, the temperature of drug mixture liquid was set at 85 ℃, dimethylsilicone oil was used as the condensate with a temperature of 6 ~C. The dropping rate was 40 drop · min^-1 and the drop distance was 6 cm. Under the above preparation conditions, the prepared pills had high appearance quality, short disintegration time and low weight variation. The hygroscopicity of the dripping pills was lower than that of the granules. Conclusion The prepared dripping pills as described are of good and stable quality and are appropriate for mass production.
出处
《中国药事》
CAS
2012年第9期956-958,共3页
Chinese Pharmaceutical Affairs
关键词
银泽滴丸
制备工艺
正交试验
Yinze Dripping Pills
preparation procedure
orthogonal test
