蒙药5味铁屑胶囊剂型改进工艺研究

RESEARCH ON THE EXTRACTION PROCESS OF WUWEITIEXIE CAPSULE

目的:传统5味铁屑汤口感难忍、服用不便。在蒙医药理论指导下,制成5味铁屑胶囊的新剂型。方法:首先按组方药黄柏皮、诃子、川楝子、栀子的主要有效成分及理化性质指定出3种工艺路线,即工艺一、工艺二、工艺三;其次,根据5味铁屑汤的主治功能,对解热和抗炎作用进行药效学试验,筛选出最佳工艺路线;第三,利用正交设计试验,以盐酸小檗碱和游离铁离子为指标,筛选出最佳提取工艺条件;第四,模拟大生产工艺制做新剂型,并测定其休止角、崩解时限、装量差异等指标。结果:5味铁屑汤历史悠久,且蒙医治疗"血、希拉"热引起眼病的首选方之一,但传统剂型是汤剂,有较多不足之处,因此改变剂型制成胶囊剂,制定出初步的工艺指标,这不仅对其它配伍及加味方的剂型改革奠定了基础,也为广泛应用于临床开创了道路。

objective ： For the bad taste of Traditional Mongolian drug Zhagche - 5 decoction and its＇ inconven- ient taking , guided by the theory of Traditional Mongolian Medicine , the traditional Mongolian drug Zhagche - 5 decoction was developed into Wuweitiexie capsule. Methods： Firstly, According to the active constituents and characters of Terminalia chebula Retz, Gardenia jasminoides Ellis, Phellodendron chinense Sehneid and Melia toosendan sieb et. Zucc, determined the three kinds of extraction processes. Secondly, According to the main functions of Zhagehe - 5 decoction, studied its anti - inflammatory, antipyretic action, choose the best extraction process. Thirdly, using the orthogonal design to determine the best extraction technology. Fourthly, we made the general check - up of Wuweitiexie capsule in the aspect of difference of packed quantity and disintegration time limited etc. Results： Mongolian drug Zhagche -5 decoction has been one of the first choice in ophthalmopathy caused by blood and Xiri in clinic of Mongolian medicine for many years . However, it has defaults too, to over-come the defaults , Doses pattern renovation of Zhagche -5 decoction needs to be done.