高良姜配方颗粒的制备工艺与质量控制  

Studies on the Preparation and Quality Control of Alpinia officiarum Formula Granules

作　　者：叶娟[1] 高文远[1] 孙立亚[1] 刘新桥[1] 张铁军[2] 陈海霞[1] 王书军[1] 

机构地区：[1]天津大学药物科学与技术学院,天津300072 [2]天津药物研究院,天津300193

出　　处：《时珍国医国药》2007年第5期1076-1078,共3页Lishizhen Medicine and Materia Medica Research

基　　金：天津市科技攻关项目(No.043180911)

摘　　要：目的确定高良姜配方颗粒的最佳制备工艺,建立高良姜配方颗粒中桉油精的含量测定方法。方法采用水蒸气蒸馏法提取高良姜药材中的挥发油,设计L9(34)正交实验确定最佳挥发油包合工艺,将水提液浓缩干燥与包合物制成配方颗粒,采用气相色谱法,FID检测器测定配方颗粒中桉油精的含量。结果将药材加水10倍量提取5 h,收集提取液和挥发油。挥发油最佳包合工艺:挥发油与β-环糊精比例为1∶9,包合温度为45℃,包合时间为1 h。含量测定中回归方程为y=26354x-0.0404,r=0.9998,平均回收率为100.72%,RSD为2.58%(n=5)。结论高良姜配方颗粒的制备工艺稳定可行,评价指标可靠、合理。Objective To optimize the preparation process of Alpinia officiarum formula granules and establish a determination method of eucalyptol in the formula granules, Methods The volatile oil was extracted with steam-distillation method and included with β-cyclodextrin to avoid its volatilization. The granule was prepared by mixing the water extracts, volatile oil and starch. The content of eucalyptol in the granule was determined with the GC method. Results The optimum extraction condition was as follows ： the crude drug was extracted with 10 times amount of water for 5 hours to collect the volatile oil. The optimal inclusion condition selected by the L9 （3^4 ）orthogonal design was as follows, the ratio of volatile oil to β-cyclodextrin was 1 ： 9（ ml/g）, the inclusion time was 1 h and the temperature of the inclusion was 45℃. The regression equation was y = 2 6 354 x-0. 040 4, r = 0. 999 8. The average recovery was 100. 72% and RSD was 2.58%. Conclusion The preparation process of Alpinia officiarum formula granules is stable and feasible. The GC method for quality control is accurate and suitable.

关 键 词：高良姜配方颗粒 桉油精 挥发油 气相色谱法 

分 类 号：R283.1[医药卫生—中药学]