高效液相法对不同厂家十八味党参丸中党参炔苷及没食子酸水平的检测研究

Study on content determination of lobetyolin and gallic acid in Eighteen Flavors Dangshen Pill from different factories

目的探讨高效液相法检测不同厂家产十八味党参丸中党参炔苷和没食子酸的水平。方法色谱柱均为VP-DOS C18柱(4.6mm×150.0mm,5μm)。党参炔苷水平测定:流动相乙腈∶0.4%冰醋酸洗脱(21∶79),流速1mL/min,检测波长267nm,柱温25℃,试样进样量10μL;没食子酸水平测定:流动相甲醇∶0.4%冰醋酸洗脱(1∶99),流速1mL/min,检测波长280nm,柱温25℃,试样进样量10μL。结果青海格拉丹东藏药厂十八味党参丸中党参炔苷和没食子酸水平分别是1.083 5、15.334 0mg/g,西藏昌都藏药厂为0.628 9、15.159 5mg/g,西藏藏医院为0.306 5、8.762 7mg/g。结论该方法重现性好、准确性好、操作简单快速;不同生产厂家产的十八味党参丸中党参炔苷水平差异显著,没食子酸水平差别较大,可为十八味党参丸质量控制提供参考。

Objective To develop a HPLC method for determining the contents of lobetyolin and gallic acid in Eighteen Fla- vors Dangshen Pill（EFDSP） produced by different factories. Methods The HPLC analysis was performed on a VP--DOS C18 col- umn （4. 6 mm×150.0mm,5μm）. The mobile phase was acetonitrile and 0.4% glacial acetic acid（21 ： 79） in the determination of lo- betyolin content. The detection wavelength was 267 nm and the flow velocity was 1 mL/min, the column temperature was25℃ and the sample size was 10μL. The mobile phase was methanol and 0.4% glacial acetic acid（ 1 ： 99） in the determination of gallic acid content. The detection wavelength was 280 nm. The column temperature was 25 ℃ and the sample size was 10μL. Results The contents of lobetyolin and gallic acid in EFDSP were 1. 0835mg g-land 15. 334 0 mg/g for Qinghai Gela Dandong Tibetan Phar- maceutical Factory,0. 628 9 mg/g and 15. 159 5 mg/g for Changdu Tibet Medicine Factory,0. 306 5 mg/g and 8. 762 7 mg/g for Ti- betan Hospital of Tibet. Conclusion This method has the advantages of good reproducibility, good accuracy, simple and fast opera- tion. The contents of lobetyolin and gallic acid in EFDSP produced by different manufacturers are significantly different. The gallic acid content has greater difference. It provides the reference for quality control of EFDSP