目的:制备双丹滴丸并建立丹参酮Ⅱ_A含量测定方法。方法:选择PEG4000与PEG60000作为滴丸基质,清膏与基质比是1:2,PEG4000:PEG6000是1:3,滴速是50滴/min,药液温度是70℃。采用HPLC法测定制剂中丹参酮Ⅱ_A的含量。结果:双丹滴丸丸重差异变异系数是1.67%,平均溶散时间是3.1 min,滴丸外观质量好,丸型完整,硬度较好。丹参酮Ⅱ_A在0.081 6～0.489 6μg范围内与峰面积呈良好的线性关系(r=0.999 6),平均回收率是99.66%(RSD=0.4%,n=6)。结论:双丹滴丸制备工艺合理可行,含量测定方法简便、准确、专属性强,可用于该制剂的质量控制。 Objective: To prepare Shuangdan dripping pills and to establish a method for the determination of tanshinone Ⅱ_A content. Methods: PEG4000 and PEG60000 were chosen as the dropping pills matrix. The ratio of clear paste to matrix was 1: 2, PEG4000: PEG6000 was 1: 3, the dropping speed was 50 drops / min and the temperature of the liquid was 70 ℃. HPLC method was used to determine the content of tanshinone Ⅱ_A in the preparation. Results: The difference between the pill weight and the pill weight was 1.67% and the average dissolution time was 3.1 minutes. The drop pill had good appearance, complete pill shape and good hardness. Tanshinone Ⅱ_A had a good linear relationship with the peak area in the range of 0.081 6 ~ 0.489 6 μg (r = 0.999 6). The average recovery was 99.66% (RSD = 0.4%, n = 6). Conclusion: The preparation method of Shuang Dan drop pills is reasonable and feasible. The determination of content is simple, accurate and specific. It can be used for the quality control of this preparation.