兽用中成药四味穿心莲散质量标准提高研究

Study on the quality standard of Siwei Chuanxinlian San

目的:开展四味穿心莲散的质量标准提高研究。方法:采用薄层色谱法对处方中大青叶进行定性鉴别。用高效液相色谱法对四味穿心莲散中穿心莲内酯和脱水穿心莲内酯进行含量测定,色谱条件:Diamonsil C18色谱柱(250 mm×4.6 mm,5μm),流动相为甲醇-水,梯度洗脱,穿心莲内酯检测波长为225 nm,脱水穿心莲内酯检测波长为254 nm,流速为1.0 mL/min。结果:该薄层鉴别方法分离度良好,专属性强。穿心莲内酯的含量测定范围为0.052 6-0.526 1μg(r=0.999 3),脱水穿心莲内酯的含量测定范围为0.051 7-0.517 3μg(r=0.999 7)。穿心莲内酯的加样回收率为99.2%,RSD为2.4%;脱水穿心莲内酯加样回收率为101.2%,RSD为1.6%。结论:该方法简便、准确、重现性好,可用于四味穿心莲散的质量控制。

Objective： To study the quality standard of Siwei Chuanxinlian San. Methods： Folium Isatidis in the prescription was identified qualitatively by TLC. The content of andrographolide and dehydroandrographolide were determined using HPLC with A Kromasil C18 （250 mmx4.6 mm, 5 p,m） column, mobile phase consisted of methanol-water and the measuring wavelength of 225 nm and 254 nm.The flow rate was 1.0 mL·min-1. Results： This method present good separation and specificity. Measuring range of andrographolide was 0.025 6-0.526 μg （r=0.999 3 ） with average recovery rate of 99.2% and RSD of 2.4%, and measuring range dehydroandrographolide was 0.051 7-0.517 3μg （r= 0.999 7） with average recovery rate of 101.2% and RSD of 1.6%. accurate, realizable and reproducible. It can be used effectively for Chuanxinlian San.