CAJ | 학술논문

目的：前列安胶囊质量标准仅对莪术等进行薄层色谱鉴别，暂无定量控制项目，不能全面反映制剂的质量。建立前列安胶囊的定性定量研究方法。方法对方中丹参、莪术、甘草3味药进行薄层色谱鉴别；采用高效液相色谱法对方中橙皮苷进行含量测定，并对含量测定方法学进行系统考察。结果薄层色谱鉴别专属性强；橙皮苷在11．56～310．00μg／mL范围内线性关系良好，平均回收率为99．55％，相对标准偏差为1．93％。结论建立的定性定量方法简便，重复性好，准确可靠，可用于前列安胶囊的质量控制。
목적：전렬안효낭질량표준부대아술등진행박층색보감별，잠무정량공제항목，불능전면반영제제적질량。건립전렬안효낭적정성정량연구방법。방법대방중단삼、아술、감초3미약진행박층색보감별；채용고효액상색보법대방중등피감진행함량측정，병대함량측정방법학진행계통고찰。결과박층색보감별전속성강；등피감재11．56～310．00μg／mL범위내선성관계량호，평균회수솔위99．55％，상대표준편차위1．93％。결론건립적정성정량방법간편，중복성호，준학가고，가용우전렬안효낭적질량공제。
Objective The existing Quality Standards for Qianliean Capsules lack the quantitation control item and therefore cannot completely reflect the quality of the preparation .This study aimed to establish the methods for qualitation and quantitation of Qianliean Capsules . Methods Thin-layer chromatography ( TLC) was used for the qualitative identification of Radix Salviae miltior-rhizae, Rhizoma curcumae, and Glycyrrhiza uralensis in Qianliean Capsules .The content of hesperidin was determined by high-per-formance liquid chromatography ( HPLC) , and the method of determination was systematically evaluated . Results TLC spots were clear with a strong specificity .The content of hesperidin showed a good linear relationship within the range of 11 .56-310 .00μg/mL (r=0.999 5), with a mean recovery rate of 99.55% and relative standard deviation of 1.93%. Conclusion The qualitation and quantitation methods we established were simple , accurate and reliable , with a good reproducibility , and can be used for the quality control of Qianliean Capsules .