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目的采用均匀设计法,筛选穿心莲内酯自乳化固体分散体的最优制备工艺。方法以穿心莲内酯体外释放度T63.2为指标,采用均匀设计法考察聚乙二醇、大豆油、吐温-80等辅料对穿心莲内酯自乳化固体分散体体外释放的影响并筛选出最优工艺;考察市售的穿心莲内酯滴丸溶出速率。结果最优工艺为吐温-80(18%),大豆油(10.8%),聚乙二醇-6000(61.2%),穿心莲内酯(10%)。结论自乳化技术与固体分散技术相结合能显著提高穿心莲内酯的体外溶出度。
OBJECTIVE To screen the optimal preparation of andrographolide self-emulsifying solid dispersion by uniform design method. Methods The in vitro release of andrographolide T63.2 as an indicator, using uniform design method of polyethylene glycol, soybean oil, Tween-80 and other excipients on the andrographolide self-emulsifying solid dispersion in vitro release and screening out the most Excellent technology; examine the market of Andrographolide dropping pills dissolution rate. Results The optimal process was Tween-80 (18%), soybean oil (10.8%), PEG-6000 (61.2%) and andrographolide (10%). Conclusion The combination of self-emulsification and solid dispersion technology can significantly improve the dissolution of andrographolide in vitro.