复方五指毛桃颗粒的提取工艺研究

Study on the Extraction Technology of Compound Radix Fici Hirta Granule

目的:优化复方五指毛桃颗粒的提取工艺。方法:以复方五指毛桃颗粒提取液中补骨脂素、苦杏仁苷的转移率及出膏率为指标,采用U_(12)(6×4×3)均匀设计表安排试验,考察加水倍量、提取时间、提取次数3个因素对提取工艺的影响,并通过3次放大试验对优化工艺进行验证。结果:优化工艺为加10倍量水、提取3次、每次60 min。在此条件下,提取液中补骨脂素、苦杏仁苷的转移率及出膏率分别为82.51%(RSD=1.45%,n=3)、93.69%(RSD=0.85%,n=3)、18.89%(RSD=0.74%,n=3),工艺验证结果均置于预测值的95%置信区间内。结论:优化的提取工艺稳定、可行,为该制剂的后续开发提供了科学依据。

OBJECTIVE：To optimize the extraction technology of Compound radix fici hirta granule. METHODS：Using the transfer rate of psoralen and amygdalin in extraction liquid of Compound radix fici hirta granule and extraction rate as indexes,U12（6×4×3）uniform design was used for the test,the effects of amount of adding water,extraction time,extraction times on theextraction technology were investigated,and optimized technology was verified by three pilot scale tests. RESULTS：The optimal technology was as follow as 10-fold water,extracting for 3 times,60 min each time. Under the conditions,transfer rate of psoralen and amygdalin and extraction rate were 82.51%（RSD=1.45%,n=3）,93.69%（RSD=0.85%,n=3）,18.89%（RSD=0.74%,n=3）,respectively. The validated results were in the 95% confidence interval of predictive value. CONCLUSIONS：The optimized extraction technology is stable and feasible,and provides the scientific basis for the follow-up development of the preparation.