石榴日轮丸质量标准提升研究

Study on the Improvement of the Quality Standard of Pomegranate Rilun Pills

目的:建立藏药制剂石榴日轮丸质量标准。方法:采用薄层色谱法(TLC)对制剂中石榴子、红花进行定性鉴别;采用高效液相色谱法(HPLC)对制剂中胡椒碱进行定量分析,用CAPCELL PAK C18色谱柱(4.6 mm×250 mm,5μm),以甲醇-0.1%磷酸水溶液(70∶30)为流动相,流速为1.0 mL·min-1,柱温为30℃,检测波长为343 nm,胡椒碱在0.850~3.186μg范围内线性关系良好(r=0.9999),平均加样回收率为99.99%,RSD=0.35%(n=6).结论:此法简便、准确,具有良好的重复性和回收率、专属性强、灵敏度高,可用于石榴日轮丸的质量控制。

Objective To establish the quality standard of Tibetan medicinal preparation Pomegranate Rilun Pills.Methods Thin layer chromatography(TLC)was used for qualitative identification of pomegranate seeds and safflower;high performance liquid chromatography(HPLC)was used for quantitative analysis of piperine in CAPCELL PAK C18 column(4.6 mm×250 mm,5μm),using methanol-0.1%phosphoric acid aqueous solution(70∶30)as the mobile phase,the flow rate is 1.0 mL·min-1,the column temperature is 30℃,the detection wavelength is 343 nm,and the piperine is 0.850~3.186μg The linearity is good within the range(r=0.9999),the average sample recovery rate is 99.99%,RSD=0.35%(n=6).Conclusion This method is simple,accurate,with good repeatability and recovery rate,and specific Strong,high sensitivity,can be used for quality control of pomegranate Rilun pills.