砂仁挥发油滴丸质量评价

Study On Quality Evaluation of Amomi Fructus Volatile Oil Dropping Pills

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）.