GC—MS建立醒神滴鼻液中间产物质量控制标准研究.pdfVIP

2001年9月 中成 药 Sep，2001 第23卷 第9期 Ch e Traditional Patent Medicine V01．23 No 9 [质 量] GC—MS建立醒神滴鼻液中间产物质量控制标准研究 魏 刚， 方永奇， 吴启端， 林双峰 (广州中医药大学第一附属医院广州510405) 关键词：薛神滴鼻滚；Gc．MS；麝香；石菖蒲；麝香酮；口细辛醚 摘要：目的：建立醒神滴鼻液两个“中间产物”(麝香芳香水、石菖蒲挥发油)的质量控制标准，以确保成品批敬间主要成分 含量及组成保持稳定；方法：采用 GC~MS制定了麝香芳香水中麝香酮的含量限度，同时建立了石菖蒲挥发油的特征指纹 图谱；结果：麝香芳香水中麝香酮可控{6I在0 166--0．202mg／mL之间，3批成品麝香酮含量差异RSD=4 49％，不超过 l0％；以甲基丁香酚、顺式甲基异丁香酚、反式甲基异丁香酚、榄香素、 细辛醚、 细辛醚6十主要成分的出峰先后顺序及 其相对含量为特征构成了石菖蒲挥发油的特征指纹图谱，以上特征在成品中可以重复。结论：建立“中间产物 的质量控 制标准可提高中药复方的质量水平，C,CpMS是有效手段之一。 中图分类号：R284．1 文献标识码：A 文章编号：1001 1528(2001)o9—0638 03 Study on Quality Control Standard of Intermediate Products of Xingshen Nasal Drops by GC·MS WEI Gang， FANG Yong—qi， WU Qi duan， LI Shuang—feng (The F1r~t Hospital Affiliated G… 脚 0“Unigwrsity of TCM，G g 0“5t0405-0lM) Key words：Xingshen Naml Drops；GC—MS；musk；Acorus tatarinowii Schott；muskone；13-Asarone Abstract：Objective：_r0 establish the quality control standards of two intermediate products of Xingsben Nasal Drops：musk aromatic water and volatile oil of Acorus tatarinowii Schott so that the content of main components and composition of the different batches of ultimate products remained stable．Methods：The content limit of muskone of musk aromatic water WaS ascertained by GC-MS And the characteristic finger print of volatile oi1 of Acorus tatarinowii Schott was established Results：The content of muskone of musk aromatic water should be controlled at the range of 0．166——0．202mg／mL．RSD of muskone content of 3 batches of uhimate products was 4．49％．not larger than 10％． Fhe characteristic finger point of volatile oil of Acorus tatarinowii Sehott was composed of 6 main component peaks：Methyleugenol，cis·Methyli~eugenol，trans Methylisoeugenol，El emicin，p-Asarone and a．Asarone．This characteristiz finger print could be repeated when the ultimate product was determined