复方龙血竭胶囊质量标准研究

Study on the Quality Standard of Compound Longxuejie Capsules

目的：对复方龙血竭胶囊质量标准进行修订完善。方法：以二氯甲烷替代原标准中TLC鉴别中所使用的三氯甲烷；修订完善含量测定方法，采用Agilent SB-C18柱（4.6mm ×250mm，5μm），流动相为乙腈-0.4％磷酸溶液（37∶63），检测波长275 nm，流量1.0mL·min^-1，柱温30℃。结果：修订后的含量测定方法专属性强，龙血素A在0.0208～0.5200μg范围内呈现良好线性关系，平均回收率为100.46％，龙血素B在0.0259～0.6475μg范围内呈现良好线性关系，平均回收率为100.95％。结论：本法简便、准确，重现性良好，可以更好地控制复方龙血竭胶囊的质量。

Objective：To revise the quality standard of Compound Longxuejie Capsules.Methods：Chloroform in the original standard for TLC identifications was replaced by methylene chloride and HPLC was used to revise the assay method.Agilent SB-C18 column （4.6 mm ×250 mm,5μm） was adopted with acetonitrile-0.4%phosphoric acid solution （37∶63） as the mobile phase at a flow rate of 1.0 mL·min^-1 , the detection wavelength was 275 nm and the column temperature was 30 ℃.Results： The revised methods were specific.The curve of loureirin A was linear in the range of 0.0208-0.5200μg and the average recovery was 100.46%;The curve of loureirin B was linear in the range of 0.0259-0.6475 μg, the average recovery was 100.95%.Conclusion： The method is simple, accurate and reproducible and can be used for the quality control of Compound Longxuejie Capsules.