新藤黄酸包合物冻干粉针制备及工艺优化  

Preparation and process optimization of gambogenic acid inclusion complex of freeze-dried powder injection

作　　者：胡海霞[1] 王效山[1] 彭代银[1] 李庆林[1] 

机构地区：[1]安徽中医学院药学院现代中药安徽省重点实验室,省部共建新安医学教育部重点实验室,安徽合肥230031

出　　处：《中草药》2012年第1期65-69,共5页Chinese Traditional and Herbal Drugs

基　　金：国家重大新药创制专项(2009ZX09103-399);安徽中医学院青年科学研究基金(2010qn005)

摘　　要：目的优化新藤黄酸羟丙基-β-环糊精(HP-β-CD)包合物冻干粉针的制备工艺。方法采用不饱和水溶液法,以L-精氨酸与新藤黄酸成盐助溶,制备新藤黄酸HP-β-CD包合物;采用冷冻干燥法制备新藤黄酸HP-β-CD包合物冻干粉针;HPLC法测定新藤黄酸的量;以包合率为指标,应用正交设计法优化制备工艺。结果优化的制备工艺为HP-β-CD与新藤黄酸质量配料比为10∶1、20℃包合5 h;制备的包合物包合率高;包合物冻干粉色泽均匀、粉末蓬松、溶解性好。结论工艺优化合理、重现性好。Objective To optimize the preparation of gambogenic acid hydroxypropyl-β-cyclodextrin（HP-β-CD） inclusion complex of freeze-dried powder injection.Methods Gambogenic acid HP-β-CD inclusion complex of freeze-dried powder injection was prepared by freeze-drying method,gambogenic acid content was determined by HPLC,and the preparation was optimized by orthogonal design taking inclusion rate as index.Results The optimized preparation process for inclusion was that the reaction mass charge ratio（HP-β-CD-gambogenic acid） was 10∶1,for 5 h at 20 ℃.The inclusion rate of prepared inclusion complex was higher;The freeze-dried powder was with color uniformity,fluffy texture,and good solubility.Conclusion The process is reasonable and with good reproducibility.

关 键 词：新藤黄酸 HP-β-CD 包合物 正交设计 工艺优化 

分 类 号：R284.2[医药卫生—中药学]