Optimization of the Preparation Technology of Syzygium aromaticum Oil Dropping Pills / 中国药房

ABSTRACT

OBJECTIVE： To establish the method for content determination of eugenol in Syzygium aromaticum oil dropping pills， and to optimize the preparation technology. METHODS： The content of eugenol in S. aromaticum oil dropping pills was determined by UV spectrophotometry. Based on single factor test， using the percentage of drugs in total amount， liquid temperature， falling distance of condensate， liquid drop distance as factors， taking the roundness， weight and hardness difference and comprehensive score as factors， L9（34） orthogonal design test was adopted to optimize the preparation process. RESULTS： The linear range of eugenol was 15.15-45.45 μg/mL（r＝0.999 6）； RSDs of precision， stability and reproducibility tests were all lower than 1％； the recoveries were 97.41％-100.59％（RSD＝1.35％， n＝6）. The optimal preparation technology included that the percentage of drugs in total amount was 5％； liquid temperature was 80 ℃； falling distance of condensate was 13 cm； liquid drop distance was 6 cm. The dropping pills had smooth appearance， good roundness and moderate hardness； the average content of engenol was 4.073％（RSD＝0.35％，n＝6）. CONCLUSIONS： The established method is simple， and can be used for the content determination of eugenol in S. aromaticum oil dropping pills. The optimal preparation technology is stable and feasible.