砂仁挥发油滴丸质量评价  

Study On Quality Evaluation of Amomi Fructus Volatile Oil Dropping Pills

作　　者：王利国[1] 唐灿[2] 王谦[2] 赵剑[1] 黄群莲[3] 吴知桂[3] 

机构地区：[1]泸州医学院附属中医医院药剂科,四川泸州646000 [2]泸州医学院药学院中药药剂教研室,四川泸州646000 [3]泸州医学院附属医院药剂科,四川泸州646000

出　　处：《中国实验方剂学杂志》2011年第4期73-75,共3页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：四川省卫生厅科研项目(川卫办发[2006]437号);泸州医学院重点科研项目(2004-10-86)

摘　　要：目的:以砂仁挥发油滴丸主要有效成分——乙酸龙脑酯含量为主要质控指标,以滴丸重量差异限度、溶散时限及外观评价等为辅助质控指标,综合评价砂仁挥发油滴丸的质量。方法:通过测定滴丸重量差异限度,溶散时限以及对滴丸进行外观评价,气相色谱法测定砂仁挥发油滴丸中主要有效成分乙酸龙脑酯的含量,建立其较为完善的质量标准。结果:6批砂仁挥发油滴丸中乙酸龙脑酯含量,平均值为165.95 mg.g-1,RSD 2.83%;溶散时限、重量差异限度及外观评分达到《中国药典》(2010年版一部)要求。结论:上述6批滴丸的质量达到《中国药典》(2010年版一部)要求,可对砂仁挥发油滴丸的质量进行有效控制。Objective：A compregensive evaluation on quality of Amomi Fructus volatile oil dropping Pills was studied with the content of the major effective composition-bornyl acetate in volatile oil dropping pills as the ma-jor quality index and the weight difference,dissolution time as well as exterior of dropping pills as the supplementary quality indexes.Method：The quality standards were established by measuring the weight difference and dissolution time along with the exterior of droping pills and also determining the content of bornyl acetate in dropping pills by GC.Result：The average content of bornyl acetate in the six batches of dropping pills was 165.95 mg.g-1,RSD 2.83%;the weight difference and dissolution time as well as the exterior of dropping pills was up to the standards of Chinese Pharmacopoeia（2010 edition）.Conclusion：The quality of six batches of dropping pills was controllable and up the standards of Chinese Pharmacopoeia（2010 edition）.

关 键 词：砂仁挥发油滴丸 气相色谱法 乙酸龙脑酯含量 综合评价质量 

分 类 号：R284.1[医药卫生—中药学]