CAJ | 학술논문

目的：建立适用于柴胡舒肝丸的HPLC指纹图谱。方法：采用Zirchrom Kromasil C18色谱柱，以甲醇-0.05%磷酸水溶液为流动相进行梯度洗脱，流速为0.8 ml·min-1，检测波长为294 nm，柱温为30℃。结果：以12批次样品为基础，进行指纹图谱分析，以黄芩苷作为内参比峰，确定24个共有峰，建立指纹图谱共有模式。对16批次样品进行相似度计算，结果在0.690~0.993之间，表明不同生产厂家的制剂存在差异。结论：该指纹图谱的建立为更全面地规范药材来源、有效监测产品的质量、保证临床用药的有效与安全提供了简单、实用的分析方法。
목적：건립괄용우시호서간환적HPLC지문도보。방법：채용Zirchrom Kromasil C18색보주，이갑순-0.05%린산수용액위류동상진행제도세탈，류속위0.8 ml·min-1，검측파장위294 nm，주온위30℃。결과：이12비차양품위기출，진행지문도보분석，이황금감작위내삼비봉，학정24개공유봉，건립지문도보공유모식。대16비차양품진행상사도계산，결과재0.690~0.993지간，표명불동생산엄가적제제존재차이。결론：해지문도보적건립위경전면지규범약재래원、유효감측산품적질량、보증림상용약적유효여안전제공료간단、실용적분석방법。
Objective:To establish the high performance liquid chromatography-fingerprints( HPLC-FPS)of Chaihu Shugan pills. Methods:The analysis was performed on a Zirchrom Kromasil C18 column with the mobile phase of methanol-water(containing 0. 05%phosphoric acid)with gradient elution at a flow-rate of 0. 8 ml·min-1 . The detection wavelength was set at 294 nm and the column temperature was 30℃. Results:With baicalin as the reference substance,there were 24 common peaks in the fingerprints to establish the fingerprint common pattern. The similarity among the 16 batches of samples was calculated,and the results showed it was within the range of 0. 690-0. 993,suggesting the differences among the samples from different factories. Conclusion:The establishment of the fingerprints provides a simple and practical analysis method for more comprehensive regulation of medicinal material sources,effective quality monitoring of the products and the assurance of effective and safe clinical application.