抗癌平丸质量标准的研究

Study on quality standard of Kang Ai Ping pellets

目的:对10批抗癌平丸样品进行定性定量试验,提高抗癌平丸质量标准。方法:采用高效液相色谱法鉴别蟾酥、半枝莲和测定肿节风中的异嗪皮啶的含量。色谱柱为Prodigy ODS3100A柱(250mm×4.60mm,5μm);流动相为乙腈-0.1%磷酸(15:85);流速为1.0mL.min-1;检测波长为344nm。结果:在高效液相色谱中均能检出蟾酥、半枝莲;异嗪皮啶在9.7～97.4μg.mL-1浓度范围内呈良好的线性关系(r=0.9999);平均回收率为97.7%(n=6)。结论:该方法准确、灵敏,重复性好,能有效地控制抗癌平丸的质量。

Objective： To study the quality standard of Kang Ai Ping pellet, a Chinese Patent medicine, by testing 10 batches of drugs. Methods： Marker chemicals of Venenum bufonis, Scutellaria bartata or Actinidia chinensis that exsisted in Kang Ai Ping pellets were separately identified by HPLC methods. The quantification of isofraxidin was carried on a Prodigy ODS3 100A column（250mm×4.60mm,5μm）, with a mobile phase consisted of nitrile - 0.1% phosphoric acid at the flow rate of 1.0 mL· min^ - 1 and the detecting wavelength at 344 nm. Results： Venenum bufonis and Scutellaria bartata were successfully detected. The quatification of isofraxidin had a good linear range of 9.7 -97.41μg· mL^-1, with an average recovery of 97.7% （n = 6）. Conclusions： The proposed methods were proved to be reliable and accurate in the qualitative and quantitative study of Kang Ai Ping pellets.