均匀试验设计优选产妇康颗粒挥发油的包合工艺贾永艳祝侠丽周红敏.doc

均匀实验设计优选产妇康颗粒挥发油的包合工艺 贾永艳 周红敏李翠萍(河南中医学院, 河南 郑州 450008) 【摘要】目的：优化产妇康颗粒中挥发油β环糊精包合的最佳工艺。方法：采用饱和水溶液法进行包合，以挥发油包合率为指标，以β-环糊精与挥发油的比例、包合温度、包合时间为考察因素，采用均匀试验优选包合工艺，并对包合物的物相进行验证。结果：最佳工艺为： 挥发油与β-CD的比例为1:8，包合温度40 ℃、包合时间140 min。挥发油包合率达75 %，验证结果显示，包合物已形成。结论：包合工艺合理、稳定、可行。 【关键词：】产妇康颗粒；挥发油；β-环糊精包合；均匀实验设计 Optimization of the Inclusion Technology of Volatile Oil from ChanFukang Granules by Uniform Design JIA Yong-yan ,ZHU Xia-li, ZHOU Hong-min,LI Jiu-xi,WEI chao-juan, LI Cui-ping,TIAN Xiao-zhi (Henan University of Traditional Chinese Medicine,Zhengzhou 450008,China) [Abstract] Objective:To optimize the inclusion process of the volatile oil of ChanFukang Granules. Method: The inclusion process was carried out by saturated water solution method And the inclusion process was optimized by Uniform Design with the inclusion ratio as indexes taking the ratio of volatile oil to β-CD, the temperature and the time of inclusion as factors. Detecting the physical phase of the inclusion complex .Result: The optimum inclusion process was established as follows: the ratio of oil to β-CD=1:8; the inclusion temperature was 40℃;the inclusion time was 140min ;The inclusion rate was as high as 75%. The inclusion technique was successful,which had been verified by characterizing structure. Conclusion:The developed inclusion process is stable and reliable. [Key words] ChanFukang Granules; Volatile oil;β-cyclodextrin inclusion; uniform experiment; 晚期产后出血属临床多发疾病，且起病突然、来势凶猛，严重威胁产妇的生命[1]。产妇康方剂是我院治疗晚期产后出血的临床验方，由黄芪、当归、川芎、赤芍、益母草、桃仁、莱菔子、炙甘草等多味药物组成，具有益气养血、理气化瘀、健脾和胃的作用。原方以汤剂形式用于临床多年，疗效确切，但汤剂存在服用剂量大，使用、携带不方便等缺点，故结合本方日服剂量、临床用药要求，将其制成颗粒剂，并应用超临界萃取、喷雾干燥、一步制粒等新技术确保颗粒剂的有效性、安全性、稳定性。方中 当归 、川芎均含有较多挥发油，且是主要活性成分，为减少挥发油损失，增加挥发油的溶解度，提高制剂生产和贮存过程中的稳定性， 保证药效， 本研究采用均匀实验设计，对产妇康颗粒的挥发油包合工艺进行研究，优选其最佳包合条件。并采用显微镜法，红外光谱法，薄层色谱法对包合物进行表征分析。 基金项目 产妇康颗粒的药学研究 郑州市科技攻关项目(064SGDS33221-3) 第一作者 贾永艳， 副教授，药物制剂新技术与新剂型研究， Tel: E-mail：hnzyjyy@126.com1 仪器与试剂 电子分析天平（SARTORIUS BP-210S北京赛多利斯天平有限公司）；电热套，85-2恒温磁力搅拌器（金坛市杰瑞尔电器有限公司），ERESTECH BCD-206冰箱（河南新