复方金铃四逆四物失笑散颗粒挥发油提取及羟丙基—β—环糊精包合工艺研究

白春霞等

摘要：目的 优选复方金铃四逆四物失笑散颗粒中挥发油提取工艺及羟丙基-β-环糊精（HP-β-CD）包合工艺。方法 采用L9（34）正交试验，以挥发油提取量为评价指标，确定最佳提取工艺。以挥发油包合率和包合物收得率综合评分为评价指标，优选最佳包合工艺。采用薄层层析法（TLC）对包合物进行表征分析。结果 最佳提取工艺：药材粉碎度为20目，加8倍量水，蒸馏提取8 h。最优包合工艺：挥发油与HP-β-CD投料配比为1∶6，包合温度30 ℃，研磨2 h。TLC图谱显示挥发油已被包合并形成稳定包合物。结论 优选的提取和包合工艺质量稳定、可行性强。

关键词：复方金铃四逆四物失笑散颗粒；挥发油；羟丙基-β-环糊精；提取工艺；包合工艺；正交设计

DOI：10.3969/j.issn.1005-5304.2015.09.026

中图分类号：R284.2 文献标识码：A 文章编号：1005-5304（2015）09-0095-04

Study on Extraction Process of Volatile Oil and Inclusion Preparation of Hydroxypropyl- β- cyclodextrin from Compound Jinling Sini Siwu Shixiaosan Granules BAI Chun-xia1， XIE Ping2， FENG Jian2， JIANG Chuan1， NING Hai-yan1 （1.Chengdu University of TCM， Chengdu 610072， China；2.Teaching Hospital of Chengdu University of TCM， Chengdu 610072， China）

Abstract：Objective To optimize the extraction process of volatile oil and inclusion preparation of hydroxypropyl-β-cyclodextrin from compound Jinling Sini Siwu Shixiaosan Granules. Methods The orthogonal approach of L9 （34） was applied to investigate the volume of volatile oil extraction by 3 factors to obtain the optimum extraction conditions. With inclusion rate of volatile oil and yield of inclusion compound as comprehensive evaluation indexes， the optimum preparation conditions were discussed. The characterization of this prepared inclusion was analyzed by TLC. Results The optimum extraction conditions were as follows：the crude medicine with medicinal powder was shattered into 20 meshes；8 times the amount of water was added and was extracted for 8 h. The best inclusion conditions were as follows：the proportion of volatile oil to HP-β-CD was 1∶6， with inclusion temperature of 30 ℃， grinding time of 2 h. Analysis results of TLC showed that stable inclusion compound was formed from volatile oil and HP-β-CD. Conclusion The optimized extraction process and inclusion preparation are with stable quality and high feasibility.

Key words：compound Jinling Sini Siwu Shixiaosan Granules；volatile oil；HP-β-CD；extraction process；inclusion preparation；orthogonal approach

復方金铃四逆四物失笑散颗粒（以下简称“复方失笑散颗粒”）为成都中医药大学附属医院名老中医针对原发性痛经实证病机“不通则痛”，在古方基础上加减而得，处方主要由延胡索、柴胡、枳壳、当归、川芎、五灵脂等中药组成，具有理气活血、化瘀止痛之效。挥发油是方中当归、枳壳、柴胡及川芎主要活

通讯作者：冯俭，E-mail：fengjan222@tom.com

性成分，具有易挥发、氧化变质及对光、热稳定性差等特性，在制剂过程中要避免挥发损失而保证药效。

羟丙基-β-环糊精（hydroxypropyl-β- cyclodextrin，HP-β-CD）为挥发油包合辅料，其外部亲水性结构及内部亲脂性内腔能与脂溶性药物形成水溶性包合物[1]，不仅溶解性高、对热稳定，且对肾、肌肉和黏膜几乎无刺激，是一种低毒、安全、有效的水溶性包合辅料[2]。……