一测多评法测定前列癃闭通片中8种成分

目的:采用一测多评(QAMS)的方法同时测定前列癃闭通片中8种成分(虎杖苷、柚皮苷、橙皮苷、新橙皮苷、朝藿定A、朝藿定B、朝藿定C、淫羊藿苷)的含量,为了能更全面的评价该药的质量,采用全时段多波长融合技术对270,283,306 nm波长下的色谱图进行融合。方法:对前列癃闭通片进行研究,以新橙皮苷作为内参物,分别建立虎杖苷、柚皮苷、橙皮苷、朝藿定A、朝藿定B、朝藿定C、淫羊藿苷与新橙皮苷的相对校正因子(RCF),内参物新橙皮苷的含量利用外标法(EMS)来计算,再根据RCF计算其他7种成分的含量,并将QAMS的结果与EMS的结果进行比较。结果:4批前列癃闭通片根据QAMS法计算的各有效成分的值与EMS法计算的值基本一致,从而验证了一测多评方法的可行性和准确性。结论:QAMS的方法满足前列癃闭通片中8种指标成分同步质量评价的要求。

Determination of Eight Components in Qianlielong Bitong Tablets by QAMS

Objective: To establish a quantitative analysis of multi-components with a single-marker (QAMS) method for the determination of eight components in Qianlielong Bitong tablets (polydatin, naringin, hesperidin, neohesperidin, epimedin A, epimedin B, epimedin C, icariin) and make more comprehensive assessment of the quality of the drug under 270, 283 and 306 nm wavelengths of chromatogram using full-time multi-wavelength fusion technology. Method: With Qianlielong Bitong tablets as the research object and neohesperidin as the internal reference substances, the relative correlation factors (RCF) of polydatin, naringin, hesperidin, epimedin A, epimedin B, epimedin C, icariin to neohesperidin were calculated and established.The content of neohesperidin in the samples of Qianlielong Bitong tablets was determined by using the external standard method, and the contents of the other seven ingredients were calculated by their RCFs. The QAMS results were then compared with the external standard method results. Result: The values of 8 active constituents in four batches of Qianlielong Bitong tablets calculated by QAMS method were basically the same with the values calculated by external standard method, thus verify the feasibility and accuracy of QAMS method. Conclusion: The QAMS method is feasible and credible, and could be used to determine the multiple components in Qianlielong Bitong tablets.