摘要
目的:进一步完善九味牛黄丸的质量标准。方法:用薄层色谱(TLC)法鉴别牛黄、红花、木香,并对毒性成分马兜铃酸进行限量检查;采用反向高效液相色谱(RP-HPLC)法测定木香烃内酯和去氢木香内酯的含量。结果:TLC鉴别斑点清晰,分离好,专属性强,阴性无干扰;九味牛黄丸中马兜铃酸含量在2.5μg.6g-1以下,符合限量要求;木香烃内酯进样量和去氢木香内酯进样量分别在0.26~1.3μg(r=0.9998)和0.258~1.29μg(r=0.9998)范围内与其峰面积积分值呈良好的线性关系;平均加样回收率分别为99.8%(n=6)和98.2%(n=6),RSD分别为1.1%和1.7%。结论:所建标准可用于九味牛黄丸的质量控制。
OBJECTIVE: To establish a method for the quality control of Jiuweiniuhuang pills.METHODS: TLC was applied for the quantitative identification of Bostaurus domesticus, Carthamus tinctorius and Aucklandia lappa in this prescription as well as the testing of the limit of Aristolochic acid A. RP- HPLC method was established for determination of Costunolide and Dehydrocostuslactone.RESULTS: The TLC spots were clear, well- separated, specific and free from interference of negative sample. The content of Aristolochic acid A which stood at less than 2.5 μg ·6 g ^-1 was up to the standard.Costunolide showed a linear relationship at the concentration range of 0.26-1.3 μg with an average recovery of 99.8% (RSD = 1.1%, n = 6); and Dehydrocostuslactone showed a linear relationship at the concentration range of 0.258-1.29μg with an average recovery of 98.2% (RSD = 1.7%, n = 6) .CONCLUSION: The method is suitable for the quality control of Jiuweiniuhuang pills.
出处
《中国药房》
CAS
CSCD
北大核心
2008年第36期2836-2838,共3页
China Pharmacy