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机构地区:[1]扬子江药业集团上海海尼药业有限公司,上海201318
出 处:《中成药》2015年第5期1036-1040,共5页Chinese Traditional Patent Medicine
摘 要:目的根据《欧洲药典》质量标准要求,改进补骨脂中补骨脂素和异补骨脂素的HPLC测定方法。方法补骨脂以甲醇提取,YMC-Triart C18色谱柱(4 mm×250 mm,5μm),流动相为乙腈-水(35∶65),等度洗脱,体积流量为1 m L/min,检测波长为246 nm。结果补骨脂素和异补骨脂素在10~100μg/m L范围内成线性,并在Merck-Li Chrospher RP-18(4 mm×250 mm,5μm)和Waters Spherisorb ODS2 column(4 mm×250 mm,5μm)色谱柱上可重复实验结果,两成分的定量测定结果偏差分别为1.50%和1.33%。7个省和缅甸产共16批补骨脂样品中的补骨脂素和异补骨脂素含有量在1.11%(云南)和0.29%(广西)之间。结论建立的方法可符合欧盟植物药申报专属性、精密度(日间、日内)、准确度的要求。AIM To establish an HPLC method for determining the contents of psoralen and isopsoralen from Psoralea corylifolia L. in agreement with European Pharmacopoeia. METHODS The analysis of P. corylifolia L methanolic extract was carried out on YMC-Triart C18(4 mm × 250 mm,5 μm) column with acetonitrile- water(35 ∶ 65) as mobile phase in isocratic elution manner and 1 m L/min of flow speed,and detection wavelength was set at 254 nm. RESULTS The linear relationships of psoralen and isopsoralen were in the range from 10 to 100μg /m L. The same process was repeated on Merck- Li Chrospher RP-18(4 mm × 250 mm,5 μm) and Waters Spherisorb ODS2 column(4 mm × 250 mm,5 μm),their bias were restricted to the limit of 1. 50% and 1. 33%,respectively. The contents of psoralen and isopsoralen collected from seven provinces in China and Burma fell within the range of 1. 11%(Yunnan Province) and 0. 29%(Guanxi Region). CONCLUSION The established method can satisfy the requirements of European Pharmacopoeia in specificity,precision and accuracy of P. corylifolia L.
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