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机构地区:[1]山东中医药大学,山东济南250355 [2]山东省医学高等专科学校,山东济南255213
出 处:《中成药》2009年第11期1697-1701,共5页Chinese Traditional Patent Medicine
基 金:山东省自然科学基金资助项目(No.Y2007C144)
摘 要:目的:应用高效液相色谱法对不同厂家56个批次样品进行丹参酮ⅡA、丹酚酸B含量检测,评价目前复方丹参片药品质量。方法:HPLC,色谱条件:检测丹参酮ⅡA,色谱柱Agela-C18(5μm,4.6 mm×250 mm),流动相:甲醇-水(73∶27),检测波长:270 nm,流速:1 mL/min。检测丹酚酸B,色谱柱Agela-C18(5μm,4.6 mm×250 mm),流动相:乙腈-甲醇-甲酸-水(10∶30∶1∶59),检测波长:286 nm,流速:1 mL/min。结果:复方丹参片样品绝大多数符合2005年版《中国药典》一部规定,但各样品间丹参酮ⅡA与丹酚酸B含量差异较大,有3个批号样品低于国家药典规定。结论:当前复方丹参片质量有待提高。ABSTRACT : AIM : To test the contents of tanshinone Ⅱ A and salvianolic acid B in 56 batches of samples byHPLC, evaluate the current quality of Compound Danshen Tables. METHODS: HPLC, chromatographic conditions: The detection column was Agela-C18 (5 μm,46 mm × 250 mm) for tanshinone ⅡA, mobile phase was metha- nol-water(73:27), UV detection wavelength was set at 270 nm. The flow rate was 1 mL/min. The detection column of Agela-C18 (5 μm,4.6 mm × 250mm) was used for salvianolic acid with mobile phase of acetonitrile- methanol-formic acid-water ( 10 : 30 : 1 : 59 ). UV wavelength was set at 286 nm. The flow rate was 1 mL/min. RESULTS : The most of samples conform to the requirement of Chinese Pharmacopoeia (2005), but the content of tanshinone Ⅱ A was widely different and three batches of salvianolic acid B were lower than the requirement of Chinese Pharmacopoeia (2005). CONCLUSION: The quality of Compound Danshen Tables will be improved.
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