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作 者:梁健[1] 沈熊[1] 朱孝国 吕迁洲[1] 杨春欣[1]
机构地区:[1]复旦大学附属中山医院药剂科,上海200032 [2]江苏美通制药有限公司,泰州225300
出 处:《中国临床药学杂志》2013年第1期9-13,共5页Chinese Journal of Clinical Pharmacy
摘 要:目的建立雷公藤多苷片的HPLC指纹图谱,能够全面而有效地控制雷公藤多苷片的质量。方法采用HPLC法,色谱柱为Diamonsil C_(18)分析柱,检测波长218 nm,柱温35℃,以水-乙腈为流动相,流速1.0 mL·min^(-1),梯度冼脱,测定不同生产厂家的8个批号的雷公藤多苷片。结果共出现色谱峰近50个,其中22个为所测样品共有。以单峰面积占总峰面积的百分比≥1%为选择标准,确定了18个峰为共有色谱指纹峰,其总面积占总峰面积的90%以上。结论初步建立了雷公藤多苷片的HPLC指纹图谱,为衡量其质量优劣提供了依据。利用HPLC指纹图谱可以较好地反映雷公藤多苷片的内在质量,且该方法简便、快速、有效、灵敏,有助于雷公藤多苷片的质量控制。AIM To establish a HPLC fingerprint method of the quality control of tripterygium glycosides tablets. METHODS The HPLC method was used with Diamonsil Cls column, with detection wavelength as 218 nm and water- acetonitrile as the mobile phase. The flow rate was 1.0 mL· min-1. The column temperature was kept at 35℃. RE- SULTS The fmgerprints of tripterygium glycosides tablets and 18 peaks were identified as common peaks. There were peaks of nearly 50, among them 22 common peaks were defined in characteristic fingerprints. The individual peak area was greater than or equal to 1% for the selection criteria, a total of 18 peaks were identified for common chromatographic fingerprint peaks. Its total fingerprint peak area accounted for more than 90% of the total peak area. CONCLUSION The HPLC fingerprint of tripterygium glycosides tablets is established which provides the basis for measuring their quality. The method is simple, rapid, effective and sensitive. The present research provides new evidence for the quality control of tripterygium glycosides tablets.
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