穿心莲内酯固体自乳化颗粒剂的制备及质量评价  

Optimization and Quality Evaluation of Andrographolide Solid Self-emulsifying Granule

作　　者：朱双燕 尹蓉莉[2] 崔名全[2] 余泉毅 王浩[2] 孙彩霞[2] 

机构地区：[1]四川自贡食品药品检验所,四川自贡643010 [2]成都中医药大学,四川成都611137

出　　处：《成都中医药大学学报》2013年第4期25-27,42,共4页Journal of Chengdu University of Traditional Chinese Medicine

摘　　要：目的:制备穿心莲内酯自乳化颗粒剂,并对其质量进行评价。方法:以前期优选自乳化处方为基础处方,通过对不同载体形成颗粒成型率及重分散性对比,选择载体,并对载体用量,载药量进行考察,优化处方比例,以形成颗粒剂外观、溶出度、粒径、乳化时间为评价指标,对其进行质量评价。结果:穿心莲内酯自乳化颗粒径最佳处方为:穿心莲内酯0.1 g,自乳化液:泊洛沙姆-188=1∶4测得乳滴粒径为46.1 nm,自乳化时间为126 s。结论:所制备的穿心莲内酯自乳化制剂成型性好,能显著提高药物溶出度。Objective： To prepare Andrographolide solid self-emulsifying granule and evaluate its quality. Methods： Prelimina- ry preferred self-emulsifying prescription as based prescription. To select the carrier based on the different carrier rate of pellet formation and heavy dispersion contrast; Then through carrier dosage , drug loading invesligation to optimize the proportion of prescriptions; With the appearance of the granules , dissolution , particle size, emulsification time ＇after emulsified as indexes to do quality evalua- tion of preparation. Results： Optimum prescription of this preparation was： Andrographolide 0. 1 g, self-emulsion liquid： Poloxamer- 188 = 1 ： 4. particle size of this preparation was 46. 1 nm, self-emulsifying time was 126 s. Conclusion： The acquired Andrographol- ide solid self-emulsifying granule is of good formability and can significantly improve the drug dissolution.

关 键 词：穿心莲内酯 自微乳化颗粒剂 溶出度 

分 类 号：R283.6[医药卫生—中药学] R944.27[医药卫生—中医学]