金蒿抗流感滴丸制备工艺及其含量测定

Preparation and Determination of Jinhao Drop Pills

目的研究金蒿滴丸的最佳制备工艺及含量测定方法。方法采用单因素及正交试验设计,以滴丸的圆整度、硬度、溶散时限、丸重差异为评价指标,优选滴丸成型的药液温度、滴速、滴距等工艺条件;采用高效液相色谱法测定滴丸中一枝蒿酮酸的含量。结果确定最优滴丸成型工艺为药粉与PEG4000配比1∶2,药液温度85℃,滴速40滴/min,滴距8 cm;一枝蒿酮酸质量浓度在9.72～77.76μg/mL范围内与峰面积线性关系良好,r=0.999 3,平均加样回收率为99.10%,RSD为0.56%(n=9)。结论优选的滴丸制备工艺稳定,含量测定方法准确简便。

Objective To study the preparation of Jinhao Drop Pills and establish the content determination method.Methods Single experiment and orthogonal design were used to optimize the temperature of drug,drop distance and drop rate.The hardness,weight variation,resolving time and grain roundness were used as criteria for evaluation.The orthogonal experiment was used to determine the optimum preparation according to the hardness of drop pills,appearance and weight variation.HPLC was used to determinate the concentrition of rupestric acid.Results The optimum preparation condition was PEG4000-drug 2 ∶1,the temperature of drug was 85 ℃,drop rate was 40 drops/min,the drop distance was 8 cm.The linear relationship of rupestric acid was found in the range of 9.72-77.76 μg/mL（r=0.999 3） and the average recovery was 99.10%（RSD=0.56%）.Conclusion This process is feasible.The methord is accurate and simple.