均匀设计法优选穿心莲内酯自乳化固体分散体

Optimization of Self-emulsifying Solid Dispersion Technology for Andrographolide by Uniform Design

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 optimize the self-emulsifying solid dispersion technology for andrographolide by uniform design. Methods With andrographolide in-vitro release rate T63.2 as the index, the effects of polyethylene glycol （PEG）, soybean oil, Tween-80 and other accessories on in-vitro release of self-emulsifying solid dispersion prescription of andrographolide were evaluated, and the optimal technology was screened. Moreover, we investigated the solubility of andrographolide dripping pills on market. Results The optimal ingredients for self-emulsifying solid dispersion prescription of andrographolide were Twain-g0（18 %）, soybean oil（ 10.8 % ）, PEG- 6000（61.2 %） , and andrographolide（ 10 %）. Conclusion The combination of self-emulsifying technology with solid dispersion technology can significantly improve the solubility of andrographolide in vitro.