目的 建立异海松酸的HPLC测定方法 ,控制侧柏叶及其制剂侧柏号胶囊和异海松酸胶囊的质量。方法 采用高效液相色谱法。色谱条件:KromasilC18柱(200mm×4.6mm,5μm);流动相:甲醇-水-冰醋酸(60:37:3);体积流量:1mL/min;柱温:25℃;检测波长:231nm;进样量:10μL。采用外标法计算样品中异海松酸的质量分数。结果 异海松酸的线性关系范围为1.25~10.00μg,回归方程为Y=66214X+2487.9,r=1.000。平均回收率为95.8%,RSD为2.7%(n=5)。侧柏叶药材中异海松酸的测定结果 分别为3.09、3.20、3.56mg/g,侧柏Ⅴ号胶囊的测定结果 分别为10.39、9.67、10.99mg/g,异海松酸胶囊的测定结果 分别为553.89、541.50、528.83mg/g。结论 该方法 简便、准确、分离效果好、无干扰,可用于侧柏及其胶囊的质量评价。

Objective? To establish an HPLC method for the determination of isopimaric acid in the leaves of Platycladus orientalis and its preparations Cebai No.V Capsula and Isopimaric Acid Capsula to evaluate the quality of them. Methods? HPLC Method was developed. Kromasil C18(200 mm×4.6 mm, 5 μm) column was used and the mobile phase: methyl alcohol-water-acetic acid (60:37:3), float rate: 1 mL/min, temperature: 25 ℃, wavelength: 231 nm, injected volume: 10 μL. Content of isopimaric acid in samples was calculated by external standard. Results? The linearity relationship of isopimaric acid was good in the range of 1.25-10.00 μg. The equation of standard curve: Y=66 214 X+2 487.9, r=1.000. The average recovery was 95.8%, RSD=2.7% (n=5). The determination Results? of isopimaric acid in three batches of P. orientalis were 3.09, 3.20, and 3.56 mg/g; three batches of Cebai No.V Capsula were 10.39, 9.67, and 10.99 mg/g; three batches of Isopimaric Acid Capsula were 553.89, 541.50, and 528.83 mg/g. Conclusion?? The method is reliable, simple, and precise, which could be used for the quality control of P. orientalis and its capsules.

山东省中医管理局科技计划项目(ZY19981018)